Only when prescribed for children under 12 years of age for use as a phosphate binding agent and the prescription is endorsed accordingly.
Indication marked with * is an Unapproved Indication.
Clinical trials for Entocort CIR use beyond three months demonstrated no improvement in relapse rate.
Subsidised only if prescribed for helicobacter pylori eradication and prescription is endorsed accordingly.
Note: the prescription is considered endorsed if clarithromycin is prescribed in conjunction with a proton pump inhibitor and either amoxicillin or metronidazole.
For omeprazole suspension refer Standard Formulae
Only in extemporaneously compounded omeprazole suspension.
Meter funded for the purposes of blood ketone diagnostics only. Patient has had one or more episodes of ketoacidosis and is at risk of future episodes or patient is on an insulin pump. Only one meter per patient will be subsidised every 5 years.
The number of test strips available on a prescription is restricted to 50 unless:
Prescribed for a patient on insulin or a sulphonylurea and endorsed accordingly. Pharmacists may annotate the prescription as endorsed where there exists a record of prior dispensing of insulin or sulphonylurea; or
Prescribed on the same prescription as insulin or a sulphonylurea in which case the prescription is deemed to be endorsed; or
Prescribed for a pregnant woman with diabetes and endorsed accordingly; or
Prescribed for a patient on home TPN at risk of hypoglycaemia or hyperglycaemia and endorsed accordingly; or
Prescribed for a patient with a genetic or an acquired disorder of glucose homeostasis excluding type 1 or type 2 diabetes and metabolic syndrome and endorsed accordingly.
Note: Accu-Chek Performa and Freestyle Optium are not available on a PSO
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz and can be sent to:
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PHARMAC |
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PO Box 10 254 |
Facsimile: (04) 974 4788 |
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Wellington |
Email: bgstrips@pharmac.govt.nz |
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz and can be sent to:
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PHARMAC |
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PO Box 10 254 |
Facsimile: (04) 974 4788 |
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Wellington |
Email: bgstrips@pharmac.govt.nz |
A diagnostic blood glucose test meter is subsidised for a patient who:
is receiving insulin or sulphonylurea therapy; or
is pregnant with diabetes; or
is on home TPN at risk of hypoglycaemia or hyperglycaemia; or
has a genetic or an acquired disorder of glucose homeostasis excluding type 1 or type 2 diabetes and metabolic syndrome.
Only one CareSens meter per patient. No further prescriptions will be subsidised for patients who already have a CareSens meter. For the avoidance of doubt patients who have previously received a funded meter, other than CareSens, are eligible for a CareSens meter.
The prescription must be endorsed accordingly.
Pharmacists may annotate the prescription as endorsed where there exists a record of prior dispensing of insulin or sulphonylureas.
Note: Only 1 meter available per PSO
The number of test strips available on a prescription is restricted to 50 unless:
Prescribed for a patient on insulin or a sulphonylurea and endorsed accordingly. Pharmacists may annotate the prescription as endorsed where there exists a record of prior dispensing of insulin or sulphonylurea; or
Prescribed on the same prescription as insulin or a sulphonylurea in which case the prescription is deemed to be endorsed; or
Prescribed for a pregnant woman with diabetes and endorsed accordingly; or
Prescribed for a patient on home TPN at risk of hypoglycaemia or hyperglycaemia and endorsed accordingly; or
Prescribed for a patient with a genetic or an acquired disorder of glucose homeostasis excluding type 1 or type 2 diabetes and metabolic syndrome and endorsed accordingly.
Subsidy is available for disposable insulin syringes, needles, and pen needles if prescribed on the same form as the one used for the supply of insulin or when prescribed for an insulin patient and the prescription is endorsed accordingly. Pharmacists may annotate the prescription as endorsed where there exists a record of prior dispensing of insulin.
Maximum of 1 insulin pump per patient each four year period.
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
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The IPP Co-ordinator |
Phone: (04) 460 4990 |
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PHARMAC |
Facsimile: (04) 974 7806 |
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PO Box 10 254 |
Email: ipp@pharmac.govt.nz |
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Wellington |
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
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The IPP Co-ordinator |
Phone: (04) 460 4990 |
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PHARMAC |
Facsimile: (04) 974 7806 |
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PO Box 10 254 |
Email: ipp@pharmac.govt.nz |
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Wellington |
Maximum of 13 infusion sets will be funded per year.
Maximum of 13 packs of reservoir sets will be funded per year.
Maximum of 1 prescription per 180 days.
Maximum of 13 infusion sets will be funded per year.
Maximum of 13 infusion sets will be funded per year.
Maximum of 13 infusion sets will be funded per year.
Maximum of 13 infusion sets will be funded per year.
Ursodeoxycholic acid is not an appropriate therapy for patients requiring a liver transplant (bilirubin > 100 micromol/l; decompensated cirrhosis). These patients should be referred to an appropriate transplant centre. Treatment failure -- doubling of serum bilirubin levels, absence of a significant decrease in ALP or ALT and AST, development of varices, ascites or encephalopathy, marked worsening of pruritus or fatigue, histological progression by two stages, or to cirrhosis, need for transplantation.
Not funded for use in the ear.
Subject to a budgetary cap. Applications will be considered and approved subject to funding availability.
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
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The Co-ordinator, Gaucher’s Treatment Panel |
Phone: (04) 460 4990 |
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PHARMAC, PO Box 10 254 |
Facsimile: (04) 916 7571 |
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Wellington |
Email: gaucherpanel@pharmac.govt.nz |
Additional subsidy by endorsement for a patient who has oral mucositis as a result of treatment for cancer, and the prescription is endorsed accordingly.
For folinic mouthwash, pilocarpine oral liquid or saliva substitute formula refer Standard Formulae
For magnesium hydroxide mixture refer Standard Formulae
Erythropoietin alfa is indicated in the treatment of anaemia associated with chronic renal failure (CRF) where no cause for anaemia other than CRF is detected and there is adequate monitoring of iron stores and iron replacement therapy.
Indication marked with * is an Unapproved Indication
Erythropoietin alfa is indicated in the treatment of anaemia associated with chronic renal failure (CRF) where no cause for anaemia other than CRF is detected and there is adequate monitoring of iron stores and iron replacement therapy.
Indication marked with * is an Unapproved Indication
Rare Clinical Circumstances Brand of recombinant factor VIII for patients with haemophilia from 1 March 2016 until 28 February 2019. Access to funded treatment by application to the Haemophilia Treatments Panel. Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
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The Co-ordinator, Haemophilia Treatments Panel |
Phone: 0800 023 588 Option 2 |
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PHARMAC PO Box 10 254 |
Facsimile: (04) 974 4881 |
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Wellington |
Email: haemophilia@pharmac.govt.nz |
For patients with haemophilia, whose funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.
Preferred Brand of recombinant factor VIII for patients with haemophilia from 1 March 2016 until 28 February 2019. Access to funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.
For patients with haemophilia, whose funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.
Second Brand of recombinant factor VIII for patients with haemophilia from 1 March 2016 until 28 February 2019. Access to funded treatment by application to the Haemophilia Treatments Panel. Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
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The Co-ordinator, Haemophilia Treatments Panel |
Phone: 0800 023 588 Option 2 |
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PHARMAC PO Box 10 254 |
Facsimile: (04) 974 4881 |
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Wellington |
Email: haemophilia@pharmac.govt.nz |
For patients with haemophilia, whose funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.
Response to treatment is defined as a platelet count of >30,000 platelets per microlitre.
For patients with haemophilia, whose funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.
* Clopidogrel allergy is defined as a history of anaphylaxis, urticaria, generalised rash or asthma (in non-asthmatic patients) developing soon after clopidogrel is started and is considered unlikely to be caused by any other treatment.
Note: Marevan and Coumadin are not interchangeable.
Rivaroxaban is only currently indicated and subsidised for up to 5 weeks therapy for prophylaxis of venous thromboembolism following a total hip replacement and up to 2 weeks therapy for prophylaxis of venous thromboembolism following a total knee replacement.
*Febrile neutropenia risk ≥ 20% after taking into account other risk factors as defined by the European Organisation for Research and Treatment of Cancer (EORTC) guidelines.
*Febrile neutropenia risk ≥ 20% after taking into account other risk factors as defined by the European Organisation for Research and Treatment of Cancer (EORTC) guidelines.
Not funded for use as a nasal drop. Only funded for nebuliser use when in conjunction with an antibiotic intended for nebuliser use.
Only if prescribed on a prescription for renal dialysis, maternity or post-natal care in the home of the patient, or on a PSO for emergency use. (500 ml and 1,000 ml packs)
For Sodium chloride oral liquid formulation refer Standard Formulae
On a prescription or Practitioner’s Supply Order only when on the same form as an injection listed in the Pharmaceutical Schedule requiring a solvent or diluent; or
On a bulk supply order; or
When used in the extemporaneous compounding of eye drops.
Higher subsidy by endorsement is available for patients who were taking trandolapril for the treatment of congestive heart failure prior to 1 June 1998. The prescription must be endorsed accordingly. We recommend that the words used to indicate eligibility are "certified condition" or an appropriate description of the patient such as "congestive heart failure", "CHF", "congestive cardiac failure" or "CCF".
For the purposes of this endorsement, congestive heart failure includes patients post myocardial infarction with an ejection fraction of less than 40%. Patients who started on trandolapril after 1 June 1998 are not eligible for full subsidy by endorsement.
Oral liquid restricted to children under 12 years of age.
For lignocaine hydrochloride refer to NERVOUS SYSTEM, Anaesthetics, Local
Treatment should be started with small doses and titrated upwards as necessary. Hypertension should be avoided, and the usual target is a standing systolic blood pressure of 90 mm Hg.
Restricted to children under 12 years of age.
May be supplied on a PSO for reasons other than emergency.
Treatment with HMG CoA Reductase Inhibitors (statins) is recommended for patients with dyslipidaemia and an absolute 5 year cardiovascular risk of 15% or greater.
A patient who has failed to reduce their LDL cholesterol to < 2.0 mmol/litre with the use of a less potent statin should use a more potent statin prior to consideration being given to the use of non-statin therapies.
Other treatment options including fibrates, resins and nicotinic acid should be considered after failure of statin therapy.
If a patient's LDL cholesterol cannot be calculated because the triglyceride level is too high then a repeat test should be performed and if the LDL cholesterol again cannot be calculated then it can be considered that the LDL cholesterol is greater than 2.0 mmol/litre.
A patient who has failed to reduce their LDL cholesterol to ≤ 2.0 mmol/litre with the use of a less potent statin should use a more potent statin prior to consideration being given to the use of non-statin therapies.
Other treatment options including fibrates, resins and nicotinic acid should be considered after failure of statin therapy.
If a patient's LDL cholesterol cannot be calculated because the triglyceride level is too high then a repeat test should be performed and if the LDL cholesterol again cannot be calculated then it can be considered that the LDL cholesterol is greater than 2.0 mmol/litre.
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
The Coordinator, PAH Panel
PHARMAC, PO Box 10-254, WELLINGTON
Tel: (04) 916 7561, Fax: (04) 974 4858, Email: PAH@pharmac.govt.nz
Sildenafil is also funded for patients with Pulmonary Arterial Hypertension who are approved by the Pulmonary Arterial Hypertension Panel (an application must be made using form SA1293-PAH).
Application details may be obtained from:
The Coordinator, PAH Panel
PHARMAC, PO Box 10 254, Wellington
Phone: (04) 916 7561 Facsimile: (04) 974 4858 Email: PAH@pharmac.govt.nz
Indications marked with * are Unapproved Indications.
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
The Coordinator, PAH Panel
PHARMAC, PO Box 10-254, WELLINGTON
Tel: (04) 916 7561, Fax: (04) 974 4858, Email: PAH@pharmac.govt.nz
For systemic antibacterials, refer to INFECTIONS, Antibacterials
Applicants are recommended to either have used or be familiar with using a decision support tool accredited by their professional body.
Applicants are recommended to either have used or be familiar with using a decision support tool accredited by their professional body.
For systemic antibacterials, refer to INFECTIONS, Antibacterials
For systemic antifungals, refer to INFECTIONS, Antifungals
Only in combination with a dermatological base or proprietary Topical Corticosteriod – Plain, refer dermatological base
With or without other dermatological galenicals.
For systemic corticosteroids, refer to CORTICOSTEROIDS AND RELATED AGENTS
Up to 5% in a dermatological base (not proprietary Topical Corticosteriod – Plain) with or without other dermatological galenicals. Refer
Only if prescribed for a dialysis patient and the prescription is endorsed accordingly.
Only if prescribed for a patient identified with Methicillin-resistant Staphylococcus aureus (MRSA) prior to elective surgery in hospital and the prescription is endorsed accordingly; or
Only if prescribed for a patient with recurrent Staphylococcus aureus infection and the prescription is endorsed accordingly
Only in combination with a dermatological galenical or as a diluent for a proprietary Topical Corticosteroid – Plain.
Ivermectin is no more effective than topical therapy for treatment of standard scabies infestation.
Ivermectin is no more effective than topical therapy for treatment of standard scabies infestation.
PSO for institutional use only. Must be endorsed with the name of the institution for which the PSO is required and a valid Special Authority for patient of that institution.
Ivermectin available on BSO provided the BSO includes a valid Special Authority for a patient of the institution.
For the purposes of subsidy of ivermectin, institution means age related residential care facilities, disability care facilities or penal institutions.
Up to 10% only in combination with a dermatological base or proprietary Topical Corticosteriod – Plain, refer dermatological base
With or without other dermatological galenicals.
Only in combination with a dermatological base or proprietary Topical Corticosteroid – Plain or collodion flexible, refer dermatological base
With or without other dermatological galenicals.
Only in combination with a dermatological base or proprietary Topical Corticosteroid – Plain, refer dermatological base
With or without other dermatological galenicals.
Only if prescribed for a patient with severe photosensitivity secondary to a defined clinical condition and the prescription is endorsed accordingly.
For salicylic acid preparations refer to PSORIASIS AND ECZEMA PREPARATIONS
One of each size is permitted on a PSO.
The approval numbers of Special Authorities approved after 1 November 1999 are interchangeable between Mercilon and Marvelon.
The additional subsidy will fund Mercilon and Marvelon up to the manufacturer’s price for each of these products as identified on the Schedule at 1 November 1999.
Special Authorities approved before 1 November 1999 remain valid until the expiry date and can be renewed providing that women are still either:
on a Social Welfare benefit; or
have an income no greater than the benefit.
The approval numbers of Special Authorities approved before 1 November 1999 are interchangeable for products within the combined oral contraceptives and progestogen-only contraceptives groups, except Loette and Microgynon 20 ED
The approval numbers of Special Authorities approved after 1 November 1999 are interchangeable between Mercilon and Marvelon.
The additional subsidy will fund Mercilon and Marvelon up to the manufacturer’s price for each of these products as identified on the Schedule at 1 November 1999.
Special Authorities approved before 1 November 1999 remain valid until the expiry date and can be renewed providing that women are still either:
on a Social Welfare benefit; or
have an income no greater than the benefit.
The approval numbers of Special Authorities approved before 1 November 1999 are interchangeable for products within the combined oral contraceptives and progestogen-only contraceptives groups, except Loette and Microgynon 20 ED
Prescribers may code prescriptions “contraceptive” (code “O”) when used as indicated for contraception. The period of supply and prescription charge will be as per other contraceptives, as follows:
$5.00 prescription charge (patient co-payment) will apply.
prescription may be written for up to six months supply.
Prescriptions coded in any other way are subject to the non contraceptive prescription charges, and the non-contraceptive period of supply. ie. Prescriptions may be written for up to three months supply.
For urinary tract Infections refer to INFECTIONS, Antibacterials
Patients with enlarged prostates are the appropriate candidates for therapy with finasteride.
This does not include parathyroid adenomas unless these have become malignant.
Oral liq prescriptions:
Must be written by a Paediatrician or Paediatric Cardiologist; or
On the recommendation of a Paediatrician or Paediatric Cardiologist.
Dexamethasone phosphate injection will not be funded for oral use.
Restricted to children under 12 years of age.
Prescriptions with a valid Special Authority (CHEM) number will be reimbursed at the level of the lowest priced TDDS product within the specified dose group.
HRT should be taken at the lowest dose for the shortest period of time necessary to control symptoms. Patients should be reviewed 6 monthly in line with the updated NZGG “Evidence-based Best Practice Guideline on Hormone Replacement Therapy March 2004”.
Applications are not to be made for use in patients as contraception except where they meet the above criteria.
Applications are not to be made for use in patients as contraception except where they meet the above criteria.
Indications marked with * are Unapproved Indications (refer to Interpretations and Definitions).
Propylthiouracil is not recommended for patients under the age of 18 years unless the patient is pregnant and other treatments are contraindicated.
For the purposes of adults and adolescents, severe growth hormone deficiency is defined as a peak serum growth hormone level of ≤ 3 mcg per litre during an adequately performed insulin tolerance test (ITT) or glucagon stimulation test.
Patients with one or more additional anterior pituitary hormone deficiencies and a known structural pituitary lesion only require one test. Patients with isolated growth hormone deficiency require two growth hormone stimulation tests, of which, one should be ITT unless otherwise contraindicated. Where an additional test is required, an arginine provocation test can be used with a peak serum growth hormone level of ≤ 0.4 mcg per litre.
The dose of somatropin should be started at 0.2 mg daily and be titrated by 0.1 mg monthly until the serum IGF-I is within 1 standard deviation of the mean normal value for age and sex; and
Dose of somatropin not to exceed 0.7 mg per day for male patients, or 1 mg per day for female patients.
At the commencement of treatment for hypopituitarism, patients must be monitored for any required adjustment in replacement doses of corticosteroid and levothyroxine.
Indication marked with * is an Unapproved indication.
For topical antibacterials, refer to DERMATOLOGICALS
For anti-infective eye preparations, refer to SENSORY ORGANS
Only if prescribed for prophylaxis of endocarditis and the prescription is endorsed accordingly.
Subsidised only if prescribed for a dialysis or cystic fibrosis patient, or the treatment of gonorrhoea, or the treatment of pelvic inflammatory disease, or the treatment of suspected meningitis in patients who have a known allergy to penicillin, and the prescription or PSO is endorsed accordingly.
Note: Cefalexin grans for oral liq will not be funded in amounts more than 14 days treatment per dispensing.
Note: Cefalexin grans for oral liq will not be funded in amounts more than 14 days treatment per dispensing.
Only if prescribed for dialysis or cellulitis in accordance with a DHB approved protocol and the prescription is endorsed accordingly.
For Endorsement, patient has either:
Received a lung transplant and requires treatment or prophylaxis for bronchiolitis obliterans syndrome*; or
Cystic fibrosis and has chronic infection with Pseudomonas aeruginosa or Pseudomonas related gram negative organisms*.
Indications marked with * are Unapproved Indications
For topical antibiotics, refer to DERMATOLOGICALS
Only if prescribed for dialysis or cystic fibrosis patient and the prescription is endorsed accordingly.
Prescriptions must be written by, or on the recommendation of, an infectious disease physician or a clinical microbiologist
Only if prescribed for a dialysis or cystic fibrosis patient or complicated urinary tract infection and the prescription is endorsed accordingly.
Only if prescribed for a dialysis or cystic fibrosis patient or complicated urinary tract infection and the prescription is endorsed accordingly.
Only if prescribed for a dialysis or cystic fibrosis patient or complicated urinary tract infection and the prescription is endorsed accordingly.
Only if prescribed for dialysis or cystic fibrosis patient and the prescription is endorsed accordingly.
Only if prescribed for a cystic fibrosis patient and the prescription is endorsed accordingly.
Only if prescribed for a dialysis or cystic fibrosis patient or for prophylaxis of endocarditis or for treatment of Clostridium difficile following metronidazole failure and the prescription is endorsed accordingly.
Recommended for patients with any of the following:
microbiologically confirmed and clinically significant pseudomonas infection; or
prostatitis; or
pyelonephritis; or
gonorrhoea.
Indications marked with * are Unapproved Indications (refer to Interpretations and Definitions).
Indications marked with * are Unapproved Indications (refer to Interpretations and Definitions).
For topical antifungals refer to DERMATOLOGICALS
For topical antifungals refer to GENITO URINARY
Prescriptions must be written by, or on the recommendation of an oncologist
Patient has vaginal candida albicans and the practitioner considers that a topical imidazole (used intra-vaginally) is not recommended and the prescription is endorsed accordingly; can be waived by endorsement - Retail pharmacy - Specialist.
Funded for tinea vesicolor where topical treatment has not been successful and diagnosis has been confirmed by mycology, or for tinea unguium where terbinafine has not been successful in eradication or the patient is intolerant to terbinafine and diagnosis has been confirmed by mycology and the prescription is endorsed accordingly.
Can be waived by endorsement - Retail pharmacy - Specialist
Specialist must be an infectious disease physician, clinical microbiologist, clinical immunologist or dermatologist.
* Graft versus host disease (GVHD) on significant immunosuppression is defined as acute GVHD, grade II to IV, or extensive chronic GVHD, or if they were being treated with intensive immunosuppressive therapy consisting of either high-dose corticosteroids (≥1 mg per kilogram of body weight per day for patients with acute GVHD or ≥0.8 mg per kilogram every other day for patients with chronic GVHD), antithymocyte globulin, or a combination of two or more immunosuppressive agents or types of treatment.
Note: There is no co-payment charge for all pharmaceuticals listed in the Antituberculotics and Antileprotics group regardless of immigration status.
Prescriptions must be written by, or on the recommendation of, an infectious disease physician, clinical microbiologist or dermatologist.
Prescriptions must be written by, or on the recommendation of, an infectious disease physician, clinical microbiologist or dermatologist
Prescriptions must be written by, or on the recommendation of, an internal medicine physician, paediatrician, clinical microbiologist, dermatologist or public health physician
Prescriptions must be written by, or on the recommendation of, an infectious disease physician, clinical microbiologist or respiratory physician
For confirmed recurrent Staphylococcus aureus infection in combination with other effective anti-staphylococcal antimicrobial based on susceptibilities and the prescription is endorsed accordingly; can be waived by endorsement - Retail pharmacy - Specialist. Specialist must be an internal medicine physician, clinical microbiologist, dermatologist, paediatrician, or public health physician.
Prescriptions must be written by, or on the recommendation of, an infectious disease physician, respiratory physician or gastroenterologist
Prescriptions must be written by, or on the recommendation of, an infectious disease physician, clinical microbiologist or respiratory physician
Prescriptions must be written by, or on the recommendation of, an infectious disease physician, clinical microbiologist or respiratory physician.
Specialist must be an infectious disease specialist, clinical microbiologist or respiratory specialist.
Specialist must be an infectious disease specialist, clinical microbiologist or respiratory specialist.
For eye preparations refer to Eye Preparations, Anti-Infective Preparations
Lamivudine should be added to adefovir dipivoxil if a patient develops documented resistance to adefovir dipivoxil, defined as:
raised serum ALT (> 1 × ULN); and
HBV DNA greater than 100,000 copies per mL, or viral load ≥ 10 fold over nadir; and
Detection of N236T or A181T/V mutation.
Adefovir dipivoxil should be stopped 6 months following HBeAg seroconversion for patients who were HBeAg+ prior to commencing adefovir dipivoxil.
The recommended dose of adefovir dipivoxil is no more than 10mg daily.
In patients with renal insufficiency adefovir dipivoxil dose should be reduced in accordance with the datasheet guidelines.
Adefovir dipivoxil should be avoided in pregnant women and children.
Entecavir should be continued for 6 months following documentation of complete HBeAg seroconversion (defined as loss of HBeAg plus appearance of anti-HBe plus loss of serum HBV DNA) for patients who were HBeAg positive prior to commencing this agent. This period of consolidation therapy should be extended to 12 months in patients with advanced fibrosis (Metavir Stage F3 or F4).
Entecavir should be taken on an empty stomach to improve absorption.
for the purpose of this Special Authority "immunocompromised" includes transplant recipients, patients with immunosuppressive diseases (e.g. HIV) or those receiving immunosuppressive treatment for other conditions.
Tenofovir disoproxil fumarate should be stopped 6 months following HBeAg seroconversion for patients who were HBeAg positive prior to commencing this agent and 6 months following HBsAg seroconversion for patients who were HBeAg negative prior to commencing this agent.
The recommended dose of Tenofovir disoproxil fumarate for the treatment of all three indications is 300 mg once daily.
In patients with renal insufficiency (calculated creatinine clearance less than 50ml/min), Tenofovir disoproxil fumarate dose should be reduced in accordance with the approved Medsafe datasheet guidelines.
Tenofovir disoproxil fumarate is not approved for use in children.
Endorsement for treatment of HIV: Prescription is deemed to be endorsed if tenofovir disoproxil fumarate is co-prescribed with another anti-retroviral subsidised under Special Authority SA1364 and the prescription is annotated accordingly by the Pharmacist or endorsed by the prescriber.
Note:
Tenofovir disoproxil fumarate prescribed under endorsement for the treatment of HIV is included in the count of up to 4 subsidised antiretrovirals for the purposes of Special Authority SA1364
Due to risk of severe sepsis boceprevir should not be initiated if either Platelet count < 100 x109 /l or Albumin <35 g/l
The wastage rule applies to boceprevir to allow dispensing to occur more frequently than monthly
Tenofovir disoproxil fumarate prescribed under endorsement for HIV is included in the count of up to 4 subsidised antiretrovirals.
Subsidies for a combination of up to four antiretroviral medications. The combination of a protease inhibitor and low-dose ritonavir given as a booster (either as part of a combination product or separately) will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals.
Tenofovir disoproxil fumarate prescribed under endorsement for HIV is included in the count of up to 4 subsidised antiretrovirals.
Subsidies for a combination of up to four antiretroviral medications. The combination of a protease inhibitor and low-dose ritonavir given as a booster (either as part of a combination product or separately) will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals.
Some antiretrovirals are unapproved or contraindicated for this indication. Practitioners prescribing these medications should exercise their own skill, judgement, expertise and discretion, and make their own prescribing decisions with respect to the use of a Pharmaceutical for an indication for which it is not approved or contraindicated.
Tenofovir disoproxil fumarate prescribed under endorsement for HIV is included in the count of up to 4 subsidised antiretrovirals.
Subsidies for a combination of up to four antiretroviral medications. The combination of a protease inhibitor and low-dose ritonavir given as a booster (either as part of a combination product or separately) will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals.
Tenofovir disoproxil fumarate prescribed under endorsement for HIV is included in the count of up to 4 subsidised antiretrovirals.
Subsidies for a combination of up to four antiretroviral medications. The combination of a protease inhibitor and low-dose ritonavir given as a booster (either as part of a combination product or separately) will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals.
Note: zidovudine [AZT] with lamivudine (combination tablets) counts as two anti-retroviral medications for the purposes of the anti-retroviral Special Authority.
Note: abacavir with lamivudine (combination tablets) counts as two anti-retroviral medications for the purposes of the anti-retroviral Special Authority.
Note: Efavirenz with emtricitabine and tenofovir disoproxil fumarate counts as three anti-retroviral medications for the purposes of the anti-retroviral Special Authority
Note: Emtricitabine with tenofovir disoproxil fumarate counts as two anti-retroviral medications for the purposes of the anti-retroviral Special Authority
Physicians considering treatment of patients with hepatitis C should discuss cases with a gastroenterologist or an infectious disease physician. All subjects undergoing treatment require careful monitoring for side effects.
Patients should be otherwise fit.
Hepatocellular carcinoma should be excluded by ultrasound examination and alpha-fetoprotein level.
Diagnosis
Anti-HCV positive on at least two occasions with a positive PCR for HCV-RNA and preferably confirmed by a supplementary RIBA test; or
PCR-RNA positive for HCV on at least 2 occasions if antibody negative; or
Anti-HCV positive on at least two occasions with a positive supplementary RIBA test with a negative PCR for HCV RNA but with a liver biopsy consistent with 2(b) following.
Autoimmune liver disease. (Interferon may exacerbate autoimmune liver disease as well as other autoimmune diseases such as thyroid disease).
Pregnancy.
Neutropenia (<2.0 × 109) and/or thrombocytopenia.
Continuing alcohol abuse and/or continuing intravenous drug users.
The current recommended dosage is 3 million units of interferon alfa-2a or interferon alfa-2b administered subcutaneously 3 times a week for 52 weeks (twelve months)
The patient’s response to interferon treatment should be reviewed at either three or four months. Interferon treatment should be discontinued in patients who do not show a substantial reduction (50%) in their mean pre-treatment ALT level at this stage.
Prescriptions must be written by, or on the recommendation of, an internal medicine physician or ophthalmologist
Prescriptions must be written by, or on the recommendation of, an internal medicine physician or ophthalmologist
Consider stopping treatment if there is absence of a virological response (defined as at least a 2-log reduction in viral load) following 12 weeks of treatment since this is predictive of treatment failure.
Consider reducing treatment to 24 weeks if serum HCV RNA level at Week 4 is undetectable by sensitive PCR assay (less than 50IU/ml) AND Baseline serum HCV RNA is less than 400,000IU/ml
Approved dose is 180 mcg once weekly.
The recommended dose of Pegylated Interferon alfa-2a is 180 mcg once weekly.
In patients with renal insufficiency (calculated creatinine clearance less than 50ml/min), Pegylated Interferon-alfa 2a dose should be reduced to 135 mcg once weekly.
In patients with neutropaenia and thrombocytopaenia, dose should be reduced in accordance with the datasheet guidelines.
Pegylated Interferon-alfa 2a is not approved for use in children.
Only if prescribed for a patient with an uncomplicated urinary tract infection that is unresponsive to a first line agent or with proven resistance to first line agents and the prescription is endorsed accordingly.
BMD (including BMD used to derive T-Score) must be measured using dual-energy x-ray absorptiometry (DXA). Quantitative ultrasound and quantitative computed tomography (QCT) are not acceptable.
Evidence suggests patients aged 75 years and over who have a history of significant osteoporotic fracture demonstrated radiologically are very likely to have a T-Score ≤ -2.5 and, therefore, do not require BMD measurement for treatment with bisphosphonates.
Osteoporotic fractures are the incident events for severe (established) osteoporosis, and can be defined using the WHO definitions of osteoporosis and fragility fracture. The WHO defines severe (established) osteoporosis as a T-score below -2.5 with one or more associated fragility fractures. Fragility fractures are fractures that occur as a result of mechanical forces that would not ordinarily cause fracture (minimal trauma). The WHO has quantified this as forces equivalent to a fall from a standing height or less.
In line with the Australian guidelines for funding alendronate, a vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
Etidronate for osteoporosis should be prescribed for 14 days (400 mg in the morning) and repeated every three months. It should not be taken at the same time of the day as any calcium supplementation (minimum dose – 500 mg per day of elemental calcium). Etidronate should be taken at least 2 hours before or after any food or fluid, except water.
BMD (including BMD used to derive T-Score) must be measured using dual-energy x-ray absorptiometry (DXA). Quantitative ultrasound and quantitative computed tomography (QCT) are not acceptable.
Evidence suggests that patients aged 75 years and over who have a history of significant osteoporotic fracture demonstrated radiologically are very likely to have a T-Score ≤ -2.5 and, therefore, do not require BMD measurement for treatment with bisphosphonates.
Osteoporotic fractures are the incident events for severe (established) osteoporosis and can be defined using the WHO definitions of osteoporosis and fragility fracture. The WHO defines severe (established) osteoporosis as a T-score below -2.5 with one or more associated fragility fractures. Fragility fractures are fractures that occur as a result of mechanical forces that would not ordinarily cause fracture (minimal trauma). The WHO has quantified this as forces equivalent to a fall from a standing height or less.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
BMD (including BMD used to derive T-Score) must be measured using dual-energy x-ray absorptiometry (DXA). Quantitative ultrasound and quantitative computed tomography (QCT) are not acceptable.
Evidence suggests that patients aged 75 years and over who have a history of significant osteoporotic fracture demonstrated radiologically are very likely to have a T-Score ≤ -2.5 and, therefore, do not require BMD measurement for raloxifene funding.
Osteoporotic fractures are the incident events for severe (established) osteoporosis, and can be defined using the WHO definitions of osteoporosis and fragility fracture. The WHO defines severe (established) osteoporosis as a T-score below -2.5 with one or more associated fragility fractures. Fragility fractures are fractures that occur as a result of mechanical forces that would not ordinarily cause fracture (minimal trauma). The WHO has quantified this as forces equivalent to a fall from a standing height or less.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
The bone mineral density (BMD) measurement used to derive the T-score must be made using dual-energy x-ray absorptiometry (DXA). Quantitative ultrasound and quantitative computed tomography (QCT) are not acceptable
Antiresorptive agents and their adequate doses for the purposes of this Special Authority are defined as: alendronate sodium tab 70 mg or tab 70 mg with cholecalciferol 5,600 iu once weekly; raloxifene hydrochloride tab 60 mg once daily; zoledronic acid 5 mg per year. If an intolerance of a severity necessitating permanent treatment withdrawal develops during the use of one antiresorptive agent, an alternate antiresorptive agent must be trialled so that the patient achieves the minimum requirement of 12 months’ continuous therapy.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
A maximum of 18 months of treatment (18 cartridges) will be subsidised.
Benzbromarone has been associated with potentially fatal hepatotoxicity.
In chronic renal insufficiency, particularly when the glomerular filtration rate is 30 ml/minute or less, probenecid may not be effective. Optimal treatment with allopurinol in patients with renal impairment is defined as treatment to the creatinine clearance-adjusted dose of allopurinol then, if serum urate remains greater than 0.36 mmol/l, a gradual increase of the dose of allopurinol to 600 mg or the maximum tolerated dose.
The New Zealand Rheumatology Association has developed information for prescribers which can be accessed from its website at
www.rheumatology.org.nz/downloads/Benzbromarone-prescriber-information-NZRA-V2.pdf
In chronic renal insufficiency, particularly when the glomerular filtration rate is 30 ml/minute or less, probenecid may not be effective. The efficacy and safety of febuxostat have not been fully evaluated in patients with severe renal impairment (creatinine clearance less than 30 ml/minute). No dosage adjustment of febuxostat is necessary in patients with mild or moderate renal impairment. Optimal treatment with allopurinol in patients with renal impairment is defined as treatment to the creatinine clearance-adjusted dose of allopurinol then, if serum urate remains greater than 0.36 mmol/l, a gradual increase of the dose of allopurinol to 600 mg or the maximum tolerated dose.
Subsidised only for use in a programmable pump in patients where oral antispastic agents have been ineffective or have caused intolerable side effects and the prescription is endorsed accordingly.
Subsidised only for use in a programmable pump in patients where oral antispastic agents have been ineffective or have caused intolerable side effects and the prescription is endorsed accordingly.
Subsidised only if prescribed for urethral or cervical administration and the prescription is endorsed accordingly.
Subsidised only if prescribed for urethral or cervical administration and the prescription is endorsed accordingly.
For Anti-inflammatory NSAIDS refer to MUSCULOSKELETAL
For aspirin & chloroform application refer Standard Formulae
Subsidised only if prescribed for post-herpetic neuralgia or diabetic peripheral neuropathy and the prescription is endorsed accordingly.
Extemporaneously compounded methadone will only be reimbursed at the rate of the cheapest form available (methadone powder, not methadone tablets).
For methadone hydrochloride oral liquid refer Standard Formulae
Subsidised by endorsement
When prescribed for a patient who cannot swallow whole tablets or capsules and the prescription is endorsed accordingly; or
When prescribed in a daily dose that is not a multiple of 20 mg in which case the prescription is deemed to be endorsed. Note: Tablets should be combined with capsules to facilitate incremental 10 mg doses.
PSO must be endorsed “not for anaesthetic procedures”.
``Optimal treatment with other antiepilepsy agents'' is defined as treatment with other antiepilepsy agents which are indicated and clinically appropriate for the patient, given in adequate doses for the patient's age, weight, and other features affecting the pharmacokinetics of the drug with good evidence of compliance.
Vigabatrin is associated with a risk of irreversible visual field defects, which may be asymptomatic in the early stages.
As a guideline, clinical trials have referred to a notional 50% reduction in seizure frequency as an indicator of success with anticonvulsant therapy and have assessed quality of life from the patient's perspective.
Vigabatrin is associated with a risk of irreversible visual field defects, which may be asymptomatic in the early stages.
"Optimal treatment with other antiepilepsy agents" is defined as treatment with other antiepilepsy agents which are indicated and clinically appropriate for the patient, given in adequate doses for the patient's age, weight, and other features affecting the pharmacokinetics of the drug with good evidence of compliance.
As a guideline, clinical trials have referred to a notional 50% reduction in seizure frequency as an indicator of success with anticonvulsant therapy and have assessed quality of life from the patient's perspective.
Indications marked with * are Unapproved Indications (see Interpretations and Definitions). Dosage adjustment of gabapentin is recommended for patients with renal impairment.
For phenobarbitone oral liquid refer Standard Formulae
"Optimal treatment" is defined as treatment which is indicated and clinically appropriate for the patient, given in adequate doses for the patient's age, weight and other features affecting the pharmacokinetics of the drug with good evidence of compliance. Women of childbearing age are not required to have a trial of sodium valproate.
As a guideline, clinical trials have referred to a notional 50% reduction in seizure frequency as an indicator of success with anticonvulsant therapy and have assessed quality of life from the patient's perspective.
For Anti-inflammatory NSAIDS refer to MUSCULOSKELETAL
For Beta Adrenoceptor Blockers refer to CARDIOVASCULAR SYSTEM
For Antispasmodics refer to ALIMENTARY TRACT
Risperdal Quicklets cost significantly more than risperidone tablets and should only be used where necessary.
Indications marked with * are Unapproved Indications
Risperidone depot injection should ideally be used as monotherapy (i.e. without concurrent use of any other antipsychotic medication). In some cases, it may be clinically appropriate to attempt to treat a patient with typical antipsychotic agents in depot injectable form before trialing risperidone depot injection.
The patient should be monitored for post-injection syndrome for at least two hours after each injection.
Subsidised for patients who were taking pipothiazine palmitate prior to 1 August 2014 and the prescription or PSO is endorsed accordingly. Pharmacists may annotate the prescription as endorsed where there exists a record of prior dispensing of pipothiazine palmitate.
Paliperidone depot injection should ideally be used as monotherapy (i.e. without concurrent use of any other antipsychotic medication). In some cases, it may be clinically appropriate to attempt to treat a patient with typical antipsychotic agents in depot injectable form before trialling paliperidone depot injection.
Special Authority approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC). Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria (below).
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
|
The coordinator |
Phone: 04 460 4990 |
|
Multiple Sclerosis Treatment Assessment Committee |
Facsimile: 04 916 7571 |
|
PHARMAC PO Box 10 254 |
|
|
Wellington |
Completed application forms must be sent to the coordinator for MSTAC and will be considered by MSTAC at the next practicable opportunity.
Notification of MSTAC's decision will be sent to the patient, the applying clinician and the patient's GP (if specified).
Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis must include MRI confirmation; and
patients must have Clinically Definite Relapsing Remitting MS with or without underlying progression; and
patients must have:
EDSS score 0 - 4.0 and:
Experienced at least 1 significant relapse of MS in the previous 12 months or 2 significant relapses in the past 24 months; and
Evidence of new inflammatory activity on an MR scan within the past 24 months, any of the following:
a gadolinium enhancing lesion; or
a Diffusion Weighted Imaging positive lesion; or
a T2 lesion with associated local swelling; or
a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse; or
new T2 lesions compared with a previous MR scan; and
A significant relapse must:
be confirmed by the applying neurologist or general physician (the patient may not necessarily have been seen by them during the relapse but the neurologist/physician must be satisfied that the clinical features were characteristic and met the specified criteria);
be associated with characteristic new symptom(s)/sign(s) or substantial worsening of previously experienced symptom(s)/sign(s);
last at least one week;
start at least one month after the onset of a previous relapse;
be severe enough to change either the EDSS or at least one of the Kurtzke Functional System scores by at least 1 point;
be distinguishable from the effects of general fatigue; and
not be associated with a fever (T>37.5°C); and
applications must be made by the patient's neurologist or general physician; and
patients must have no previous history of lack of response to fingolimod; and
patients must have not previously had intolerance to fingolimod; and
patient must not be co-prescribed beta interferon or glatiramer acetate.
Confirmed progression of disability that is sustained for six months. Progression of disability is defined as progress by any of the following EDDSS points:
from starting at EDSS 0 increasing to (i.e. stopping on reaching) EDSS 3.0; or
1.0 to 3.0; or
1.5 to 3.5; or
2.0 to 4.0; or
2.5 to 4.5; or
3.0 to 4.5; or
3.5 to 4.5; or
4.0 to 4.5.
increasing relapse rate over 12 months of treatment (compared with the relapse rate on starting treatment)(see note); or
intolerance to fingolimod; or
non-compliance with treatment, including refusal to undergo annual assessment.
Note: Switching between natalizumab, fingolimod, dimethyl fumarate and teriflunomide is permitted provided the EDSS stopping criteria are not met. Switching to interferon or glatiramer acetate is only permitted provided the EDSS stopping criteria are not met and both fingolimod and natalizumab are either not tolerated or treatment with both agents would be clinically inappropriate. Continued relapses on treatment would be expected to lead to a switch of treatment provided the stopping criteria are not met. If a relapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to stopping criteria, a period of 6 months is allowed from the start of the relapse for recovery to occur.
Special Authority approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC). Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria (below).
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
|
The coordinator |
Phone: 04 460 4990 |
|
Multiple Sclerosis Treatment Assessment Committee |
Facsimile: 04 916 7571 |
|
PHARMAC PO Box 10 254 |
|
|
Wellington |
Completed application forms must be sent to the coordinator for MSTAC and will be considered by MSTAC at the next practicable opportunity.
Notification of MSTAC's decision will be sent to the patient, the applying clinician and the patient's GP (if specified).
Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis must include MRI confirmation; and
patients must have Clinically Definite Relapsing Remitting MS with or without underlying progression; and
patients must have:
EDSS score 0 - 4.0 and:
Experienced at least 1 significant relapse of MS in the previous 12 months or 2 significant relapses in the past 24 months; and
Evidence of new inflammatory activity on an MR scan within the past 24 months, any of the following:
a gadolinium enhancing lesion; or
a Diffusion Weighted Imaging positive lesion; or
a T2 lesion with associated local swelling; or
a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse; or
new T2 lesions compared with a previous MR scan; and
A significant relapse must:
be confirmed by the applying neurologist or general physician (the patient may not necessarily have been seen by them during the relapse but the neurologist/physician must be satisfied that the clinical features were characteristic and met the specified criteria);
be associated with characteristic new symptom(s)/sign(s) or substantial worsening of previously experienced symptom(s)/sign(s);
last at least one week;
start at least one month after the onset of a previous relapse;
be severe enough to change either the EDSS or at least one of the Kurtzke Functional System scores by at least 1 point;
be distinguishable from the effects of general fatigue; and
not be associated with a fever (T>37.5°C); and
applications must be made by the patient's neurologist or general physician; and
treatment must be initiated and supervised by a neurologist who is registered in the Tysabri Australasian Prescribing Programme operated by the supplier; and
patients must have no previous history of lack of response to natalizumab; and
patients must have not previously had intolerance to natalizumab; and
Patient is JC virus negative, or
Patient is JC virus positive and has given written informed consent acknowledging an understanding of the risk of progressive multifocal leucoencephalopathy (PML) associated with natalizumab
patient must not be co-prescribed beta interferon or glatiramer acetate.
Confirmed progression of disability that is sustained for six months. Progression of disability is defined as progress by any of the following EDDSS points:
from starting at EDSS 0 increasing to (i.e. stopping on reaching) EDSS 3.0; or
1.0 to 3.0; or
1.5 to 3.5; or
2.0 to 4.0; or
2.5 to 4.5; or
3.0 to 4.5; or
3.5 to 4.5; or
4.0 to 4.5.
increasing relapse rate over 12 months of treatment (compared with the relapse rate on starting treatment)(see note); or
intolerance to natalizumab; or
non-compliance with treatment, including refusal to undergo annual assessment.
Note: Natalizumab can only be dispensed from a pharmacy registered in the Tysabri Australasian Prescribing Programme operated by the supplier.
Switching between natalizumab, fingolimod, dimethyl fumarate and teriflunomide is permitted provided the EDSS stopping criteria are not met. Switching to interferon or glatiramer acetate is only permitted provided the EDSS stopping criteria are not met and both fingolimod and natalizumab are either not tolerated or treatment with both agents would be clinically inappropriate. Continued relapses on treatment would be expected to lead to a switch of treatment provided the stopping criteria are not met. If a relapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to stopping criteria, a period of 6 months is allowed from the start of the relapse for recovery to occur.
Special Authority approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC). Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria (below).
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
|
The coordinator |
Phone: 04 460 4990 |
|
Multiple Sclerosis Treatment Assessment Committee |
Facsimile: 04 916 7571 |
|
PHARMAC PO Box 10 254 |
|
|
Wellington |
Completed application forms must be sent to the coordinator for MSTAC and will be considered by MSTAC at the next practicable opportunity.
Notification of MSTAC's decision will be sent to the patient, the applying clinician and the patient's GP (if specified).
Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis must include MRI confirmation; and
patients must have Clinically Definite Relapsing Remitting MS with or without underlying progression; and
patients must have:
EDSS score 0 - 4.0 and:
Experienced at least 1 significant relapse of MS in the previous 12 months or 2 significant relapses in the past 24 months; and
Evidence of new inflammatory activity on an MR scan within the past 24 months, any of the following:
a gadolinium enhancing lesion; or
a Diffusion Weighted Imaging positive lesion; or
a T2 lesion with associated local swelling; or
a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse; or
new T2 lesions compared with a previous MR scan; and
A significant relapse must:
be confirmed by the applying neurologist or general physician (the patient may not necessarily have been seen by them during the relapse but the neurologist/physician must be satisfied that the clinical features were characteristic and met the specified criteria);
be associated with characteristic new symptom(s)/sign(s) or substantial worsening of previously experienced symptom(s)/sign(s);
last at least one week;
start at least one month after the onset of a previous relapse;
be severe enough to change either the EDSS or at least one of the Kurtzke Functional System scores by at least 1 point;
be distinguishable from the effects of general fatigue; and
not be associated with a fever (T>37.5°C); and
applications must be made by the patient's neurologist or general physician; and
patients must have no previous history of lack of response to dimethyl fumarate; and
patients must have not previously had intolerance to dimethyl fumarate; and
patient must not be co-prescribed beta interferon or glatiramer acetate.
Confirmed progression of disability that is sustained for six months. Progression of disability is defined as progress by any of the following EDDSS points:
from starting at EDSS 0 increasing to (i.e. stopping on reaching) EDSS 3.0; or
1.0 to 3.0; or
1.5 to 3.5; or
2.0 to 4.0; or
2.5 to 4.5; or
3.0 to 4.5; or
3.5 to 4.5; or
4.0 to 4.5.
increasing relapse rate over 12 months of treatment (compared with the relapse rate on starting treatment)(see note); or
intolerance to dimethyl fumarate; or
non-compliance with treatment, including refusal to undergo annual assessment.
Note: Switching between natalizumab, fingolimod, dimethyl fumarate and teriflunomide is permitted provided the EDSS stopping criteria are not met. Switching to interferon or glatiramer acetate is only permitted provided the EDSS stopping criteria are not met and both fingolimod and natalizumab are either not tolerated or treatment with both agents would be clinically inappropriate. Continued relapses on treatment would be expected to lead to a switch of treatment provided the stopping criteria are not met. If a relapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to stopping criteria, a period of 6 months is allowed from the start of the relapse for recovery to occur.
Special Authority approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC). Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria (below).
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
|
The coordinator |
Phone: 04 460 4990 |
|
Multiple Sclerosis Treatment Assessment Committee |
Facsimile: 04 916 7571 |
|
PHARMAC PO Box 10 254 |
|
|
Wellington |
Completed application forms must be sent to the coordinator for MSTAC and will be considered by MSTAC at the next practicable opportunity.
Notification of MSTAC's decision will be sent to the patient, the applying clinician and the patient's GP (if specified).
Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis must include MRI confirmation; and
patients must have Clinically Definite Relapsing Remitting MS with or without underlying progression; and
patients must have:
EDSS score 0 - 4.0 and:
Experienced at least 1 significant relapse of MS in the previous 12 months or 2 significant relapses in the past 24 months; and
Evidence of new inflammatory activity on an MR scan within the past 24 months, any of the following:
a gadolinium enhancing lesion; or
a Diffusion Weighted Imaging positive lesion; or
a T2 lesion with associated local swelling; or
a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse; or
new T2 lesions compared with a previous MR scan; and
A significant relapse must:
be confirmed by the applying neurologist or general physician (the patient may not necessarily have been seen by them during the relapse but the neurologist/physician must be satisfied that the clinical features were characteristic and met the specified criteria);
be associated with characteristic new symptom(s)/sign(s) or substantial worsening of previously experienced symptom(s)/sign(s);
last at least one week;
start at least one month after the onset of a previous relapse;
be severe enough to change either the EDSS or at least one of the Kurtzke Functional System scores by at least 1 point;
be distinguishable from the effects of general fatigue; and
not be associated with a fever (T>37.5°C); and
applications must be made by the patient's neurologist or general physician; and
patients must have no previous history of lack of response to teriflunomide; and
patients must have not previously had intolerance to teriflunomide; and
patient must not be co-prescribed beta interferon or glatiramer acetate.
Confirmed progression of disability that is sustained for six months. Progression of disability is defined as progress by any of the following EDDSS points:
from starting at EDSS 0 increasing to (i.e. stopping on reaching) EDSS 3.0; or
1.0 to 3.0; or
1.5 to 3.5; or
2.0 to 4.0; or
2.5 to 4.5; or
3.0 to 4.5; or
3.5 to 4.5; or
4.0 to 4.5.
increasing relapse rate over 12 months of treatment (compared with the relapse rate on starting treatment)(see note); or
intolerance to teriflunomide; or
non-compliance with treatment, including refusal to undergo annual assessment.
Note: Switching between natalizumab, fingolimod, dimethyl fumarate and teriflunomide is permitted provided the EDSS stopping criteria are not met. Switching to interferon or glatiramer acetate is only permitted provided the EDSS stopping criteria are not met and both fingolimod and natalizumab are either not tolerated or treatment with both agents would be clinically inappropriate. Continued relapses on treatment would be expected to lead to a switch of treatment provided the stopping criteria are not met. If a relapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to stopping criteria, a period of 6 months is allowed from the start of the relapse for recovery to occur.
Special Authority approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC). Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria (below).
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
|
The coordinator |
Phone: 04 460 4990 |
|
Multiple Sclerosis Treatment Assessment Committee |
Facsimile: 04 916 7571 |
|
PHARMAC PO Box 10 254 |
|
|
Wellington |
Completed application forms must be sent to the coordinator for MSTAC and will be considered by MSTAC at the next practicable opportunity.
Notification of MSTAC's decision will be sent to the patient, the applying clinician and the patient's GP (if specified).
These agents will NOT be subsidised if dispensed from a community or hospital pharmacy. Regular supplies will be distributed to all approved patients or their clinicians by courier.
Prescribers must send quarterly prescriptions for approved patients to the MSTAC coordinator.
Only prescriptions for 6 million iu of interferon beta-1-alpha per week, or 8 million iu of interferon beta-1-beta every other day, or 20 mg glatiramer acetate daily will be subsidised.
Switching between treatments is permitted within the 12 month approval period without reapproval by MSTAC. The MSTAC coordinator should be notified of the change and a new prescription provided.
Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis must include MRI confirmation; and
patients must have Clinically Definite Relapsing Remitting MS with or without underlying progression; and
patients must have:
EDSS score 0 - 4.0 and:
Experienced at least 1 significant relapse of MS in the previous 12 months or 2 significant relapses in the past 24 months; and
Evidence of new inflammatory activity on an MR scan within the past 24 months, any of the following:
a gadolinium enhancing lesion; or
a Diffusion Weighted Imaging positive lesion; or
a T2 lesion with associated local swelling; or
a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse; or
new T2 lesions compared with a previous MR scan; and
A significant relapse must:
be confirmed by the applying neurologist or general physician (the patient may not necessarily have been seen by them during the relapse but the neurologist/physician must be satisfied that the clinical features were characteristic and met the specified criteria);
be associated with characteristic new symptom(s)/sign(s) or substantial worsening of previously experienced symptom(s)/sign(s);
last at least one week;
start at least one month after the onset of a previous relapse;
be severe enough to change either the EDSS or at least one of the Kurtzke Functional System scores by at least 1 point;
be distinguishable from the effects of general fatigue; and
not be associated with a fever (T>37.5°C); and
applications must be made by the patient's neurologist; and
patients must have no previous history of lack of response to beta-interferon or glatiramer acetate; and
patients must have either:
intolerance to both natalizumab and fingolimod; or
treatment with both natalizumab and fingolimod is considered clinically inappropriate; and
patient will not be co-prescribed natalizumab or fingolimod.
Confirmed progression of disability that is sustained for six months during a minimum of one year of treatment. Progression of disability is defined as progress by any of the following EDDSS Points:
from starting at EDSS 0 increasing to (i.e. stopping on reaching) EDSS 3.0; or
1.0 to 3.0; or
1.5 to 3.5; or
2.0 to 4.0; or
2.5 to 4.5; or
3.0 to 4.5; or
3.5 to 4.5; or
4.0 to 4.5.
increasing relapse rate over 12 months of treatment (compared with the relapse rate on starting treatment)(see note); or
intolerance to interferon beta-1-alpha, and/or interferon beta-1-beta and/or glatiramer acetate; or
non-compliance with treatment, including refusal to undergo annual assessment.
Note: Treatment with interferon beta -1-beta, interferon beta-1-alpha and glatiramer acetate, is permitted only if treatment with both natalizumab and fingolimod is not tolerated or treatment with both would be clinically inappropriate. Beta-interferon or glatiramer acetate will not be funded as second line treatments if EDSS progression has occurred on treatment with natalizumab or fingolimod. Patients who have an increasing relapse rate over 12 months of treatment (compared with the relapse rate on starting treatment) and who do not meet the EDSS Stopping Criteria at annual review may switch from either of the beta-interferon's [interferon beta-1-beta or interferon beta-1-alpha] to glatiramer acetate or vice versa. Patients may switch from either of the beta-interferon's [interferon beta-1-beta or interferon beta-1-alpha] to glatiramer acetate or vice versa for increased relapses only once, after which they will be required to stop funded treatment if they meet any of the Stopping Criteria at annual review (including the criterion relating to increasing relapse rate over 12 months of treatment). If a relapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to stopping criteria, a period of 6 months is allowed from the start of the relapse for recovery to occur. In this setting anti-JCV antibody positive status may be accepted as a clinically inappropriate reason for treatment with natalizumab.
A "subsidised formulation of a stimulant" refers to currently subsidised methylphenidate hydrochloride tablet formulations (immediate-release, sustained-release and extended-release) or dexamphetamine sulphate tablets.
Modafinil will not be subsidised for hypersomnia associated with any condition other than narcolepsy.
Nicotine will not be funded under the Dispensing Frequency Rule in amounts less than 4 weeks of treatment.
Varenicline will not be funded under the Dispensing Frequency Rule in amounts less than 2 weeks of treatment.
A maximum of 12 weeks' varenicline will be subsidised on each Special Authority approval, including the starter pack
a maximum of 12 weeks' varenicline will be subsidised on each Special Authority approval.
This includes the 2-week 'starter' pack.
Prescription must be written by a registered prescriber in the thalidomide risk management programme operated by the supplier.
Maximum dose of 400 mg daily as monotherapy or in a combination therapy regimen.
Indication marked with * is an Unapproved Indication.
Indication marked with a * is an Unapproved Indication. Temozolomide is not subsidised for the treatment of relapsed glioblastoma multiforme. Reapplications will not be approved.
Studies of temozolomide show that its benefit is predominantly in those patients with a good performance status (WHO grade 0 or 1 or Karnofsky score >80), and in patients who have had at least a partial resection of the tumour.
Indications marked with * are Unapproved Indications.
Indications marked with * are Unapproved Indications.
Responding relapsed/refractory multiple myeloma patients should receive no more than 2 additional cycles of treatment beyond the cycle at which a confirmed complete response was first achieved. A line of therapy is considered to comprise either:
a known therapeutic chemotherapy regimen and supportive treatments; or
a transplant induction chemotherapy regimen, stem cell transplantation and supportive treatments.
Refer to datasheet for recommended dosage and number of doses of bortezomib per treatment cycle.
Indication marked with * is an Unapproved Indication (refer to Interpretations and Definitions). A line of treatment is considered to comprise either: a) a known therapeutic chemotherapy regimen and supportive treatments or b) a transplant induction chemotherapy regimen, stem cell transplantation and supportive treatments. Prescriptions must be written by a registered prescriber in the lenalidomide risk management programme operated by the supplier.
Note: Imatinib-AFT is not a registered for the treatment of Gastro Intestinal Stromal Tumours (GIST). The Glivec brand of imatinib mesilate (supplied by Novartis) remains fully subsidised under Special Authority for patients with unresectable and/or metastatic malignant GIST, see SA1460 in Section B of the Pharmaceutical Schedule.
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz, and prescriptions should be sent to:
|
The CML/GIST Co-ordinator |
Phone: (04) 460 4990 |
|
PHARMAC |
Facsimile: (04) 916 7571 |
|
PO Box 10 254 |
|
|
Wellington |
Funded for patients:
With a diagnosis (confirmed by an oncologist) of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST).
Maximum dose of 400 mg/day.
Applications to be made and subsequent prescriptions can be written by an oncologist.
Initial and subsequent applications are valid for one year. The re-application criterion is an adequate clinical response to the treatment with imatinib (prescriber determined).
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz, and prescriptions should be sent to:
|
The CML/GIST Co-ordinator |
Phone: (04) 460 4990 |
|
PHARMAC |
Facsimile: (04) 916 7571 |
|
PO Box 10 254 |
|
|
Wellington |
Funded for patients with diagnosis (confirmed by a haematologist) of a chronic myeloid leukaemia (CML) in blast crisis, accelerated phase, or in chronic phase.
Maximum dose of 140 mg/day for accelerated or blast phase, and 100 mg/day for chronic phase CML.
Subsidised for use as monotherapy only.
Initial approvals valid seven months.
Subsequent approval(s) are granted on application and are valid for six months. The first reapplication (after seven months) should provide details of the haematological response. The third reapplication should provide details of the cytogenetic response after 14-18 months from initiating therapy. All other reapplications should provide details of haematological response, and cytogenetic response if such data is available. Applications to be made and subsequent prescriptions can be written by a haematologist or an oncologist.
Note: Dasatinib is indicated for the treatment of adults with chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.
Prescribers should consider discontinuation of treatment if, after 6 months from initiating therapy, a patient did not obtain a haematological response as defined as any one of the following three levels of response:
complete haematologic response (as characterised by an absolute neutrophil count (ANC) > 1.5 × 109/L, platelets > 100 × 109/L, absence of peripheral blood (PB) blasts, bone marrow (BM) blasts < 5% (or FISH Ph+ 0-35% metaphases), and absence of extramedullary disease); or
no evidence of leukaemia (as characterised by an absolute neutrophil count (ANC) > 1.0 × 109/L, platelets > 20 × 109/L, absence of peripheral blood (PB) blasts, bone marrow (BM) blasts < 5% (or FISH Ph+ 0-35% metaphases), and absence of extramedullary disease); or
return to chronic phase (as characterised by BM and PB blasts < 15%, BM and PB blasts and promyelocytes < 30%, PB basophils < 20% and absence of extramedullary disease other than spleen and liver).
Prescribers should consider discontinuation of treatment if, after 18 months from initiating therapy, a patient did not obtain a major cytogenetic response defined as 0-35% Ph+ metaphases.
Sunitinib treatment should be stopped if disease progresses.
Poor prognosis patients are defined as having at least 3 of criteria 5.1-5.6. Intermediate prognosis patients are defined as having 1 or 2 of criteria 5.1-5.6
It is recommended that response to treatment be assessed using Choi's modified CT response evaluation criteria (J Clin Oncol, 2007, 25:1753-1759). Progressive disease is defined as either: an increase in tumour size of ≥ 10% and not meeting criteria of partial response (PR) by tumour density (HU) on CT; or: new lesions, or new intratumoral nodules, or increase in the size of the existing intratumoral nodules.
Pazopanib treatment should be stopped if disease progresses.
Poor prognosis patients are defined as having at least 3 of criteria 5.1-5.6. Intermediate prognosis patients are defined as having 1 or 2 of criteria 5.1-5.6.
*treatment failure as defined by Leukaemia Net Guidelines.
For GnRH ANALOGUES – refer to HORMONE PREPARATIONS, Trophic Hormones
Indications marked with * are Unapproved Indications.
In patients with Acromegaly octreotide treatment should be discontinued if IGF1 levels have not decreased after 3 months treatment. In patients treated with radiotherapy octreotide treatment should be withdrawn every 2 years, for 1 month, for assessment of remission. Octreotide treatment should be stopped where there is biochemical evidence of remission (normal IGF1 levels) following octreotide treatment withdrawal for at least 4 weeks
The use of octreotide in patients with fistulae, oesophageal varices, miscellaneous diarrhoea and hypotension will not be funded as a Special Authority item
Mycophenolate powder for oral liquid is subsidised only for patients unable to swallow tablets and capsules, and when the prescription is endorsed accordingly.
"Inadequate response" is defined as: for whole body severe chronic plaque psoriasis, a PASI score of greater than 15, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment; for severe chronic plaque psoriasis of the face, hand or foot, at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe, and the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment.
The BASDAI must have been determined at the completion of the 3 month exercise trial, but prior to ceasing NSAID treatment. The BASDAI measure must be no more than 1 month old at the time of initial application.
Average normal chest expansion corrected for age and gender:
18-24 years - Male: 7.0 cm; Female: 5.5 cm
25-34 years - Male: 7.5 cm; Female: 5.5 cm
35-44 years - Male: 6.5 cm; Female: 4.5 cm
45-54 years - Male: 6.0 cm; Female: 5.0 cm
55-64 years - Male: 5.5 cm; Female: 4.0 cm
65-74 years - Male: 4.0 cm; Female: 4.0 cm
75+ years - Male: 3.0 cm; Female: 2.5 cm
Indications marked with * are Unapproved Indications (refer to Interpretations and Definitions).
A treatment course is defined as a minimum of 12 weeks of etanercept treatment
Subsidised only for bladder cancer.
Indications marked with * are Unapproved Indications.
'Indolent, low-grade lymphomas' includes follicular, mantle, marginal zone and lymphoplasmacytic/Waldenstrom macroglobulinaemia.
'Aggressive CD20 positive NHL' includes large B-cell lymphoma and Burkitt's lymphoma/leukaemia
'Chronic lymphocytic leukaemia (CLL)' includes small lymphocytic lymphoma. A line of chemotherapy treatment is considered to comprise a known standard therapeutic chemotherapy regimen and supportive treatments. 'Good performance status' means ECOG score of 0-1, however, in patients temporarily debilitated by their CLL disease symptoms a higher ECOG (2 or 3) is acceptable where treatment with rituximab is expected to improve symptoms and improve ECOG score to <2.
Indications marked with * are Unapproved Indications.
'Indolent, low-grade lymphomas' includes follicular, mantle, marginal zone and lymphoplasmacytic/Waldenstrom macroglobulinaemia.
'Aggressive CD20 positive NHL' includes large B-cell lymphoma and Burkitt's lymphoma/leukaemia
* For patients with relapsed HER-2 positive disease who have previously received adjuvant trastuzumab for early breast cancer.
"Inadequate response" is defined as: for whole body severe chronic plaque psoriasis, a PASI score of greater than 15, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment; for severe chronic plaque psoriasis of the face, hand or foot, at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe, and the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment.
The BASDAI must have been determined at the completion of the 3 month exercise trial, but prior to ceasing NSAID treatment. The BASDAI measure must be no more than 1 month old at the time of initial application.
Average normal chest expansion corrected for age and gender:
18-24 years - Male: 7.0 cm; Female: 5.5 cm
25-34 years - Male: 7.5 cm; Female: 5.5 cm
35-44 years - Male: 6.5 cm; Female: 4.5 cm
45-54 years - Male: 6.0 cm; Female: 5.0 cm
55-64 years - Male: 5.5 cm; Female: 4.0 cm
65-74 years - Male: 4.0 cm; Female: 4.0 cm
75+ years - Male: 3.0 cm; Female: 2.5 cm
A maximum of 4 months’ adalimumab will be subsidised on an initial Special Authority approval for fistulising Crohn’s disease.
Note: Indications marked with * are Unapproved Indications (refer to (Interpretations and Definitions).
A treatment course is defined as a minimum of 12 weeks adalimumab treatment
Note: Siltuximab is to be administered at doses no greater than 11 mg/kg every 3 weeks.
Indications marked with * are Unapproved Indications
Subsidy applies for either primary or rescue therapy.
Rescue therapy defined as unresponsive to calcineurin inhibitor treatment as defined by refractory rejection; or intolerant to calcineurin inhibitor treatment due to any of the following:
GFR<30 ml/min; or
Rapidly progressive transplant vasculopathy; or
Rapidly progressive obstructive bronchiolitis; or
HUS or TTP; or
Leukoencepthalopathy; or
Significant malignant disease
MRI should be performed at minimum once every 12 months, more frequent scanning should be performed with new onset of symptoms such as headaches, visual complaints, nausea or vomiting, or increase in seizure activity.
Tiotropium treatment will not be subsidised if patient is also receiving treatment with subsidised inhaled glycopyrronium or umeclidinium.
Inhaled glycopyrronium treatment will not be subsidised if patient is also receiving treatment with subsidised tiotropium or umeclidinium.
Glycopyrronium powder for inhalation 50 mcg per dose is subsidised only for patients who have been diagnosed as having COPD using spirometry, and the prescription is endorsed accordingly.
Umeclidinium will not be subsidised if patient is also receiving treatment with subsidised inhaled glycopyrronium or tiotropium bromide.
Umeclidinium powder for inhalation 62.5 mcg per dose is subsidised only for patients who have been diagnosed as having COPD using spirometry, and the prescription is endorsed accordingly.
Combination long acting muscarinic antagonist and long acting beta-2 agonist will not be subsidised if patient is also receiving treatment with a combination inhaled corticosteroid and long acting beta-2 agonist.
Prescribing Guideline: Clinical evidence indicates that the effectiveness of montelukast is strongest when montelukast is used in short treatment courses.
Application details may be obtained from PHARMAC's website http://www.pharmac.govt.nz or:
|
The Co-ordinator, Cystic Fibrosis Advisory Panel |
Phone: (04) 460 4990 |
|
PHARMAC, PO Box 10 254 |
Facsimile: (04) 916 7571 |
|
Wellington |
Email: CFPanel@pharmac.govt.nz |
Prescriptions for patients approved for treatment must be written by respiratory physicians or paediatricians who have experience and expertise in treating cystic fibrosis.
Not funded for use as a nasal drop.
Only for children aged six years and under
For Vosol ear drops with hydrocortisone powder refer Standard Formulae
Eye preparations are only funded for use in the eye, unless explicitly stated otherwise.
Funded for use in the ear*.
Indications marked with * are Unapproved Indications.
For treatment of bacterial keratitis or severe bacterial conjunctivitis resistant to chloramphenicol.
Subsidised for oral use pursuant to the Standard Formulae.
Minims for a general practice are considered to be “tools of trade” and are not approved as special authority items.
For acetylcysteine eye drops refer Standard Formulae
Hylo-Fresh has a 6 month expiry after opening. The Pharmacy Procedures Manual restriction allowing one bottle per month is not relevant and therefore only the prescribed dosage to the nearest OP may be claimed.
May only be claimed once per patient.
Only in extemporaneously compounded oral mixtures.
Only in extemporaneously compounded methyl hydroxybenzoate 10% solution.
Only in extemporaneously compounded codeine linctus diabetic or codeine linctus paediatric.
Only in extemporaneously compounded oral liquid preparations.
Extemporaneously compounded methadone will only be reimbursed at the rate of the cheapest form available (methadone powder, not methadone tablets).
Only in children up to 12 years
Only in extemporaneously compounded omeprazole and lansoprazole suspension.
Only in aspirin and chloroform application.
Only in extemporaneously compounded oral liquid preparations.
Only in combination with Ora-Plus.
Only in combination with Ora-Plus.
Patients are required to meet any Special Authority criteria associated with all of the products used in the modular formula.
Patients are required to meet any Special Authority criteria associated with all of the products used in the modular formula.
Patients are required to meet any Special Authority criteria associated with all of the products used in the modular formula.
Patients are required to meet any Special Authority criteria associated with all of the products used in the modular formula.
Each of these products is highly specialised and would be prescribed only by an expert for a specific disorder. The alternative is hospitalisation.
Elemental 028 Extra is more expensive than other products listed in this section and should only be used where the alternatives have been tried first and/or are unsuitable.
Additional subsidy by endorsement is available for patients being bolus fed through a feeding tube, who have severe epidermolysis bullosa, or as exclusive enteral nutrition in children under the age of 18 years for the treatment of Crohn's disease. The prescription must be endorsed accordingly.
Note: Higher subsidy for Sustagen Hospital Formula will only be reimbursed for patients with both a valid Special Authority number and an appropriately endorsed prescription.
Additional subsidy by endorsement is available for patients with fat malabsorption, fat intolerance or chyle leak. The prescription must be endorsed accordingly.
Additional subsidy by endorsement is available for patients with fat malabsorption, fat intolerance or chyle leak. The prescription must be endorsed accordingly.
Additional subsidy by endorsement is available for patients being bolus fed through a feeding tube, or who have severe epidermolysis bullosa. The prescription must be endorsed accordingly.
Additional subsidy by endorsement is available for patients being bolus fed through a feeding tube, or who have severe epidermolysis bullosa. The prescription must be endorsed accordingly.
The funding of gluten free foods is no longer being actively managed by PHARMAC from 1 April 2011. This means that we are no longer considering the listing of new products, or making subsidy, or other changes to the existing listings. As a result we anticipate that the range of funded items will reduce over time. Management of Coeliac disease with a gluten free diet is necessary for good outcomes. A range of gluten free options are available through retail outlets.
A reasonable trial is defined as a 2-4 week trial.
A reasonable trial is defined as a 2-4 week trial, or signs of an immediate IgE mediated allergic reaction.
is available each year for patients who meet the following criteria, as set by PHARMAC:
all people 65 years of age and over; or
people under 65 years of age who:
have any of the following cardiovascular diseases:
ischaemic heart disease, or
congestive heart failure, or
rheumatic heart disease, or
congenital heart disease, or
cerebo-vascular disease; or
have either of the following chronic respiratory diseases:
asthma, if on a regular preventative therapy, or
other chronic respiratory disease with impaired lung function; or
have diabetes; or
have chronic renal disease; or
have any cancer, excluding basal and squamous skin cancers if not invasive; or
have any of the following other conditions:
autoimmune disease, or
immune suppression or immune deficiency, or
HIV, or
transplant recipients, or
neuromuscular and CNS diseases/disorders, or
haemoglobinopathies, or
are children on long term aspirin, or
have a cochlear implant, or
errors of metabolism at risk of major metabolic decompensation, or
pre and post splenectomy, or
down syndrome, or
are pregnant; or
children aged four years and under who have been hospitalised for respiratory illness or have a history of significant respiratory illness;
Unless meeting the criteria set out above, the following conditions are excluded from funding:
asthma not requiring regular preventative therapy,
hypertension and/or dyslipidaemia without evidence of end-organ disease.
Doctors are the only Contractors entitled to claim payment from the Funder for the supply of influenza vaccine to patients eligible under the above criteria for subsidised immunisation and they may only do so in respect of the influenza vaccine listed in the Pharmaceutical Schedule.
Individual DHBs may fund patients over and above the above criteria. The claiming process for these additional patients should be determined between the DHB and Contractor, or
Stock of the seasonal influenza vaccine is typically available from February until late July with suppliers being required to ensure supply until at least 30 June. Exact start and end dates for each season will be notified each year.
Any of the following:
For vaccination of patients aged 45 and 65 years old; or
For vaccination of previously unimmunised or partially immunised patients; or
For revaccination following immunosuppression; or
For boosting of patients with tetanus-prone wounds; or
For use in testing for primary immunodeficiency diseases, on the recommendation of an internal medicine physician or paediatrician.
Note: Please refer to the Immunisation Handbook for appropriate schedule for catch up programmes.
Maximum of three doses for patient meeting any of the following criteria:
Females aged under 20 years old; or
Patients aged under 26 years old with confirmed HIV infection; or
For use in transplant (including stem cell) patients; or
An additional dose for patients under 26 years of age post chemotherapy.
Funded for patients meeting any of the following criteria:
for household or sexual contacts of known acute hepatitis B patients or hepatitis B carriers; or
for children born to mothers who are hepatitis B surface antigen (HBsAg) positive; or
for children up to and under the age of 18 years inclusive who are considered not to have achieved a positive serology and require additional vaccination; or
for HIV positive patients; or
for hepatitis C positive patients; or
for patients following non-consensual sexual intercourse; or
for patients following immunosuppression; or
for transplant patients; or
following needle stick injury.
Funded for any of the following criteria:
for dialysis patients; or
for liver or kidney transplant patient.
Funded for patients meeting any of the following criteria:
for household or sexual contacts of known acute hepatitis B patients or hepatitis B carriers; or
for children born to mothers who are hepatitis B surface antigen (HBsAg) positive; or
for children up to and under the age of 18 years inclusive who are considered not to have achieved a positive serology and require additional vaccination; or
for HIV positive patients; or
for hepatitis C positive patients; or
for patients following non-consensual sexual intercourse; or
for patients following immunosuppression; or
for transplant patients; or
following needle stick injury.
Funded for any of the following:
A single dose for children up to the age of 7 who have completed primary immunisation; or
A course of four vaccines is funded for catch up programmes for children (to the age of 10 years) to complete full primary immunisation; or
An additional four doses (as appropriate) are funded for (re-)immunisation for patients post HSCT, or chemotherapy; pre- or post splenectomy; pre- or post solid organ transplant, renal dialysis and other severely immunosuppressive regimens; or
Five doses will be funded for children requiring solid organ transplantation.
Note: Please refer to the Immunisation Handbook for appropriate schedule for catch up programmes.
One dose for patients meeting any of the following:
For primary vaccination in children; or
An additional dose (as appropriate) is funded for (re-)immunisation for patients post haematopoietic stem cell transplantation, or chemotherapy; functional asplenic; pre or post splenectomy; pre- or post solid organ transplant, pre- or post cochlear implants, renal dialysis and other severely immunosuppressive regimens; or
For use in testing for primary immunodeficiency diseases, on the recommendation of an internal medicine physician or paediatrician.
A maximum of two doses for any patient meeting the following criteria:
For primary vaccination in children; or
For revaccination following immunosuppression; or
For any individual susceptible to measles, mumps or rubella; or
A maximum of three doses for children who have had their first dose prior to 12 months.
Note: Please refer to the Immunisation Handbook for appropriate schedule for catch up programmes.
Any of the following:
A primary course of four doses for previously unvaccinated individuals up to the age of 59 months inclusive; or
Up to three doses as appropriate to complete the primary course of immunisation for individuals under the age of 59 months who have received one to three doses of PCV10; or
One dose is funded for high risk children (over the age of 17 months and up to the age of 18) who have previously received four doses of PCV10; or
Up to an additional four doses (as appropriate) are funded for (re-)immunisation of patients with HIV, for patients post haematopoietic stem cell transplantation, or chemotherapy; pre- or post splenectomy; functional asplenia, pre- or post- solid organ transplant, renal dialysis, complement deficiency (acquired or inherited), cochlear implants, or primary immunodeficiency; or
For use in testing for primary immunodeficiency diseases, on the recommendation of an internal medicine physician or paediatrician.
Note: please refer to the Immunisation Handbook for the appropriate schedule for catch up programmes
Either:
Up to three doses (as appropriate) for patients with HIV, for patients post haematopoietic stem cell transplant, or chemotherapy; pre- or post-splenectomy or with functional asplenia, pre- or post-solid organ transplant, renal dialysis, complement deficiency (acquired or inherited), cochlear implants, or primary immunodeficiency; or
Up to two doses are funded for high risk children to the age of 18.
Funded for any of the following criteria:
A single vaccine for pregnant woman between gestational weeks 28 and 38; or
A course of up to four vaccines is funded for children from age 7 up to the age of 18 years inclusive to complete full primary immunisation; or
An additional four doses (as appropriate) are funded for (re-)immunisation for patients post haematopoietic stem cell transplantation or chemotherapy; pre or post splenectomy; pre- or post solid organ transplant, renal dialysis and other severely immunosuppressive regimens.
Notes: Tdap is not registered for patients aged less than 10 years. Please refer to the Immunisation Handbook for appropriate schedule for catch up programmes.
For infants at increased risk of tuberculosis. Increased risk is defined as:
living in a house or family with a person with current or past history of TB; or
having one or more household members or carers who within the last 5 years lived in a country with a rate of TB > or equal to 40 per 100,000 for 6 months or longer; or
during their first 5 years will be living 3 months or longer in a country with a rate of TB > or equal to 40 per 100,000
Note a list of countries with high rates of TB are available at www.health.govt.nz/tuberculosis (search for downloads) or www.bcgatlas.org/index.php.
Funded for patients meeting any of the following criteria:
Up to four doses for children up to and under the age of 10 for primary immunisation; or
An additional four doses (as appropriate) are funded for (re-)immunisation for children up to and under the age of 10 who are patients post haematopoietic stem cell transplantation, or chemotherapy; pre or post splenectomy; pre- or post solid organ transplant, renal dialysis and other severely immunosuppressive regimens; or
Up to five doses for children up to and under the age of 10 receiving solid organ transplantation.
Note: A course of up-to four vaccines is funded for catch up programmes for children (up to and under the age of 10 years) to complete full primary immunisation. Please refer to the Immunisation Handbook for the appropriate schedule for catch up programmes.
Up to three doses for patients meeting either of the following:
For partially vaccinated or previously unvaccinated individuals; or
For revaccination following immunosuppression.
Note: Please refer to the Immunisation Handbook for appropriate schedule for catch-up programmes.
Funded for patients meeting any of the following criteria:
Two vaccinations for use in transplant patients; or
Two vaccinations for use in children with chronic liver disease; or
One dose of vaccine for close contacts of known hepatitis A cases.
Any of the following:
Up to three doses and a booster every five years for patients pre- and post splenectomy and for patients with functional or anatomic asplenia, HIV, complement deficiency (acquired or inherited), or pre or post solid organ transplant; or
One dose for close contacts of meningococcal cases; or
A maximum of two doses for bone marrow transplant patients; or
A maximum of two doses for patients following immunosuppression*.
Note: children under seven years of age require two doses 8 weeks apart, a booster dose three years after the primary series and then five yearly.
*Immunosuppression due to steroid or other immunosuppressive therapy must be for a period of greater than 28 days.
Maximum of two doses for any of the following:
For non-immune patients:
with chronic liver disease who may in future be candidates for transplantation; or
with deteriorating renal function before transplantation; or
prior to solid organ transplant; or
prior to any elective immunosuppression*.
For patients at least 2 years after bone marrow transplantation, on advice of their specialist.
For patients at least 6 months after completion of chemotherapy, on advice of their specialist.
For HIV positive non immune to varicella with mild or moderate immunosuppression on advice of HIV specialist.
For patients with inborn errors of metabolism at risk of major metabolic decompensation, with no clinical history of varicella.
For household contacts of paediatric patients who are immunocompromised, or undergoing a procedure leading to immune compromise where the household contact has no clinical history of varicella.
For household contacts of adult patients who have no clinical history of varicella and who are severely immunocompromised, or undergoing a procedure leading to immune compromise where the household contact has no clinical history of varicella.
* immunosuppression due to steroid or other immunosuppressive therapy must be for a treatment period of greater than 28 days
Maximum of three doses for patients meeting the following:
first dose to be administered in infants aged under 15 weeks of age; and
no vaccination being administered to children aged 8 months or over.
Any of the following:
Up to three doses and a booster every five years for patients pre- and post splenectomy and for patients with functional or anatomic asplenia, HIV, complement deficiency (acquired or inherited), or pre or post solid organ transplant; or
One dose for close contacts of meningococcal cases; or
A maximum of two doses for bone marrow transplant patients; or
A maximum of two doses for patients following immunosuppression*.
Note: children under seven years of age require two doses 8 weeks apart, a booster dose three years after the primary series and then five yearly.
*Immunosuppression due to steroid or other immunosuppressive therapy must be for a period of greater than 28 days.