Additional subsidy by endorsement is available for pregnant women. The prescription must be endorsed accordingly.
Clinical trials for Entocort CIR use beyond three months demonstrated no improvement in relapse rate.
Oral liquid is subsidised only for patients:
with oesophageal stricture, or
in terminal care, or
who are either too young or too old to swallow conventional tablets and the prescription is endorsed accordingly.
Note: the cost of treatment with ranitidine oral liquid is more than 10 times higher than that of ranitidine tablets. Following the derestriction of access PHARMAC will be monitoring expenditure on ranitidine oral liquid more closely and may, subject to consultation and PHARMAC Board approval, restrict access again if the expenditure was to grow substantially.
For omeprazole suspension refer
Pioglitazone is not to be used in triple oral combination (defined as a combination of metformin, sulphonylurea and pioglitazone).
Pioglitazone should not be used in patients with heart failure.
Liver function tests should be performed at baseline.
Gastrointestinal side effects are relatively common when initiating metformin therapy. Upward titration of metformin dose over several weeks and taking metformin with food will help to minimize these side effects.
Intolerance and contraindications for metformin include: serum creatinine ≥ 0.15 or creatinine clearance < 60 ml/min; significant liver impairment; severe left ventricular dysfunction; and intolerable gastrointestinal side effects that persist beyond 4 weeks duration.
Intolerance for sulphonylurea includes: nausea; diarrhoea; rash; blood disorders (thrombocytopenia, agranulocytosis, aplastic anaemia); erythema multiforme, exfoliative dermatitis, hepatitis; and syndrome of inappropriate antidiuretic hormone secretion (SIADH) with water retention and hyponatraemia.
Maximum tolerated dose of metformin defined as: A dose up to a maximum of 3 g daily.
Maximum tolerated dose of sulphonylurea defined as: A dose up to a maximum of glibenclamide 20 mg daily or glipizide 20 mg daily or gliclazide 320 mg daily.
For the purposes of these criteria “obese” is defined as body mass index (BMI) greater than 33 kg/m2.
However, as ethnic differences between patients may vary BMI scores, practitioners may use discretion as to whether the patient meets this criterion.
It is considered that when applying, that the patient may have initiated “six months diet and lifestyle changes” from the date of diagnosis of type 2 diabetes.
The number of test strips available on a prescription is restricted to 50 unless:
Prescribed with insulin or a sulphonylurea but are on a different prescription and the prescription is endorsed accordingly; 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.
A diagnostic blood glucose test meter is subsidised for patients who begin insulin or sulphonylurea therapy after 1 March 2005. Only one meter per patient. No further prescriptions will be subsidised. The prescription must be endorsed accordingly.
NovoFine pen needles 31 g × 6 mm are subsidised for children under 12 years of age.
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.
Liver biopsy is not usually required for diagnosis but is helpful to stage the disease.
Actigall is not an appropriate therapy for patients requiring a liver transplant (bilirubin > 170 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.
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:
|
The Co-ordinator, Gaucher’s Treatment Panel |
Phone: (04) 460 4990 |
|
PHARMAC, PO Box 10 254 |
Facsimile: (04) 916 7571 |
|
Wellington |
Email: erin.murphy@pharmac.govt.nz |
For folinic mouthwash, pilocarpine oral liquid or saliva substitute formula refer
For magnesium hydroxide mixture refer
Erythropoietin beta 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.
The Cockroft-Gault Formula may be used to estimate glomerular filtration rate (GFR) in persons 18 years and over:
GFR (ml/min) (male) = (140 - age) × Ideal Body Weight (kg) / 814 × serum creatinine (mmol/l)
GFR (ml/min) (female) = Estimated GFR (male) × 0.85
Specialist must be a paediatrician or paediatric cardiologist.
Aspirin intolerant patients are defined as those with aspirin induced asthma, urticaria, or anaphylaxi, or those with significant aspirin induced bleeding, excluding bruising.
Aspirin intolerant patients are defined as those with aspirin induced asthma, urticaria, or anaphylaxi, or those with significant aspirin induced bleeding, excluding bruising.
Aspirin intolerant patients are defined as those with aspirin induced asthma, urticaria, or anaphylaxi, or those with significant aspirin induced bleeding, excluding bruising.
Aspirin intolerant patients are defined as those with aspirin induced asthma, urticaria, or anaphylaxi, or those with significant aspirin induced bleeding, excluding bruising.
Aspirin allergy is defined as a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates or NSAIDs.
Note: Marevan and Coumadin are not interchangeable.
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)
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.
To confirm that cholesterol levels are not still improving, two lipid tests must be carried out during treatment with simvastatin 80 mg, and have results for LDL cholesterol that have reduced by <10% in the second test. The tests must be carried out while the patient is in a fasted state (with the exception of patients with IDDM).
The following indications of intolerance to simvastatin, are known as class effects for all statins, and hence are likely to mean that the patient may also be intolerant of atorvastatin:
Statins have been shown to be generally well tolerated in clinical studies, with the rate of discontinuation due to adverse reactions being less than 5%, and similar to the discontinuation rate for patients taking a placebo.
Treatment with HMG CoA Reductase Inhibitors (statins) is recommended for patients with dyslipidaemia and an absolute 5 year cardiovascular risk of 15% or greater.
Two lipid tests are required to assess LDL cholesterol levels, the tests must be at least one week apart, and be carried out in a fasted state (other than for patients with IDDM). The results for LDL cholesterol levels in both tests must be above those specified.
Two lipid tests are required to assess LDL cholesterol levels, the tests must be at least one week apart, and be carried out in a fasted state (other than for patients with IDDM). The results for LDL cholesterol levels in both tests must be above those specified.
Oral liquid restricted to children under 12 years of age.
Perindopril and trandolapril will be funded to the level of the ex-manufacturer price listed in the Schedule for patients who were taking these ACE inhibitors 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”.
Definition of Congestive Heart Failure
At the request of some prescribers the PTAC Cardiovascular subcommittee has provided a definition of congestive heart failure for the purposes of the funding of the manufacturer’s surcharge: “Clinicians should use their clinical judgement. Existing patients would be eligible for the funding of the surcharge if the patient shows signs and symptoms of congestive heart failure, and requires or has in the past required concomitant treatment with a diuretic. The definition could also be considered to include patients post myocardial infarction with an ejection fraction of less than 40%.”
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.
Additional subsidy by endorsement is available for patients who:
were being prescribed metoprolol succinate prior to 1 October 2007; or
have experienced a myocardial infarction; or
have experienced heart failure and are either intolerant of carvedilol or it is contra-indicated.
Pharmacists may annotate prescriptions for patients who were being prescribed metoprolol succinate prior to 1 October 2007 in which case the prescription is deemed to be endorsed. The pharmacist must be able to show a clear documented dispensing history for the patient.
The prescription must be endorsed accordingly.
Specialist must be a paediatrician or paediatric cardiologist.
Specialist must be a paediatrician or paediatric cardiologist.
May be supplied on a PSO for reasons other than emergency.
Specialist must be a paediatrician or paediatric cardiologist.
Specialist must be a dermatologist.
For systemic antibacterials, refer to INFECTIONS, Antibacterials
For systemic antibacterials, refer to INFECTIONS, Antibacterials
For systemic antifungals, refer to INFECTIONS, Antifungals
Only in combination with aqueous cream, 10% urea cream, wool fat with mineral oil lotion, 1% hydrocortisone with wool fat and mineral oil lotion, and glycerol, paraffin and cetyl alcohol lotion
Up to 5% in a dermatological base (not proprietary Topical Corticosteriod – Plain) with or without other dermatological galenicals. Refer
For systemic corticosteroids, refer to CORTICOSTEROIDS AND RELATED AGENTS
Only if prescribed for a dialysis patient and the prescription is endorsed accordingly.
Only if prescribed for a dialysis patient and the prescription is endorsed accordingly.
Only if prescribed for an amputee with an artificial limb, or for a paraplegic patient and the prescription endorsed accordingly.
Only in combination with a dermatological galenical or as a diluent for a proprietary Topical Corticosteroid – Plain.
Should be strictly reserved for use as second line therapy in:
patients unable to tolerate the other medications, such as infants, young children and patients with allergies or eczema;
cases of scabies which are resistent to gamma benzene hexachloride and resistant to malathion.
Verification of drug resistance is dependent on the persistence of the condition after treatment. In order to establish whether there is drug resistance, the following criteria should be fulfilled:
a definite diagnosis of scabies should be made;
it should be ascertained that the medication was administered properly;
the possibility of reinfestation should have been excluded.
Specialist must be a dermatologist.
Up to 10 %
Only in combination with a dermatological base or proprietary Topical Corticosteriod – Plain, refer
With or without other dermatological galenicals.
Only in combination with a dermatological base or proprietary Topical Corticosteroid – Plain or collodion flexible, refer
With or without other dermatological galenicals.
Maximum 20 g or 20 ml per prescription when prescribed with white soft paraffin or collodion flexible.
Only in combination with a dermatological base or proprietary Topical Corticosteroid – Plain, refer
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
Subsidised only if prescribed for post-herpetic neuralgia or diabetic peripheral neuropathy and the prescription is endorsed accordingly.
For aspirin & chloroform application refer
When ordered with a spermicide.
Distributed by Pharmaco NZ Ltd, PO Box 4079, Auckland Ph 09 377 3336
One of each size is permitted on a PSO.
The approval numbers of Special Authorities approved after 1 November 1999 are interchangeable between Mercilon, Marvelon, Minulet and Femodene.
The additional subsidy will fund Mercilon, Marvelon, Minulet and Femodene 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, Marvelon, Minulet and Femodene.
The additional subsidy will fund Mercilon, Marvelon, Minulet and Femodene 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:
$3.00 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.
Distributed by MDS Diagnostics, PO Box 24-162, Royal Oak, Auckland. Ph 09 570 5761
For urinary tract Infections refer to INFECTIONS, Antibacterials
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.
Oral liq prescriptions:
Must be written by a Paediatrician or Paediatric Cardiologist; or
On the recommendation of a Paediatrician or Paediatric Cardiologist.
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.
Subject to budgetary cap. Applications will be considered and approved subject to funding availability.
Applications to be made on the approved forms which are available from:
Theresa Delany, Administrative Co-ordinator, Liggins Institute, Faculty of Medicine and Health Science,
University of Auckland, Private Bag 92019, AUCKLAND
Tel: (09) 373 7599 ext 86229, Fax: (09) 373 8763, Email: t.delany@auckland.ac.nz
Not to be prescribed with an anti-androgen except for a period of three weeks, if necessary, when GnRH analogue therapy is intiated
The maximum treatment period for a GnRH analogue is:
If a patient had an approval for any GnRH analogue prior to 1 July 2006 the applicant is required to submit a fresh initial application, not a renewal application.
If a patient had an approval for any GnRH analogue prior to 1 July 2006 the applicant is required to submit a fresh initial application, not a renewal application.
If a patient had an approval for any GnRH analogue prior to 1 July 2006 the applicant is required to submit a fresh initial application, not a renewal application.
Not to be prescribed with an anti-androgen except for a period of three weeks, if necessary, when GnRH analogue therapy is intiated.
The maximum treatment period for a GnRH analogue is:
If a patient had an approval for any GnRH analogue prior to 1 July 2006 the applicant is required to submit a fresh initial application, not a renewal application.
If a patient had an approval for any GnRH analogue prior to 1 July 2006 the applicant is required to submit a fresh initial application, not a renewal application.
If a patient had an approval for any GnRH analogue prior to 1 July 2006 the applicant is required to submit a fresh initial application, not a renewal application.
Not to be prescribed with an anti-androgen except for a period of three weeks, if necessary, when GnRH analogue therapy is intiated.
The maximum treatment period for a GnRH analogue is:
If a patient had an approval for any GnRH analogue prior to 1 July 2006 the applicant is required to submit a fresh initial application, not a renewal application.
If a patient had an approval for any GnRH analogue prior to 1 July 2006 the applicant is required to submit a fresh initial application, not a renewal application.
If a patient had an approval for any GnRH analogue prior to 1 July 2006 the applicant is required to submit a fresh initial application, not a renewal application.
Only a prescription for a female patient.
Only if prescribed for prophylaxis of endocarditis and the prescription is endorsed accordingly.
Only if prescribed for dialysis or cystic fibrosis patient and the prescription is endorsed accordingly.
Subsidised only if prescribed for a dialysis or cystic fibrosis patient, or the treatment of confirmed ciprofloxacin-resistant gonorrhoea, or the treatment of suspected meningitis in patients who have a known allergy to penicillin, and the prescription or PSO is endorsed accordingly.
Only if prescribed for a dialysis or cystic fibrosis patient and the prescription is endorsed accordingly.
Only if prescribed for dialysis or cystic fibrosis patient and the prescription is endorsed accordingly.
Subsidised only if prescribed for patients with uncomplicated urethritis or cervicitis proven or presumed to be due to chlamydia trachomatis and their sexual contacts and prescription or PSO is endorsed accordingly.
Maximum of two prescriptions (two courses) per patient.
Only if prescribed for dialysis or cystic fibrosis patient and the prescription is endorsed accordingly.
Only if prescribed for a dialysis or cystic fibrosis patient and the prescription is endorsed accordingly.
Only if prescribed for a dialysis or cystic fibrosis patient or for prophylaxis of endocarditis and the prescription is endorsed accordingly.
Only if prescribed for a dialysis or cystic fibrosis patient or for prophylaxis of endocarditis 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 dialysis or cystic fibrosis patient or in the treatment of pseudomembranous colitis or for prophylaxis of endocarditis and the prescription is endorsed accordingly.
For topical antibiotics, refer to DERMATOLOGICALS
For topical antibacterials, refer to DERMATOLOGICALS
For anti-infective eye preparations, refer to SENSORY ORGANS
For topical antifungals refer to DERMATOLOGICALS
For topical antifungals refer to GENITO URINARY
Note: There is no co-payment charge for all pharmaceuticals listed in the Antituberculotics and Antileprotics group regardless of immigration status.
Lamivudine should be added to adefovir dipivoxil if a patient develops documented resistance to adefovir dipivoxil, defined as:
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.
For eye preparations refer to Eye Preparations, Anti-Infective Preparations
Combivir counts as two anti-retroviral medications for the purposes of the anti-retroviral Special Authority.
Note: Kivexa counts as two anti-retroviral medications for the purposes of the anti-retroviral Special Authority.
Subsidies for a combination of up to three anti-retroviral medications, including a maximum of two protease inhibitors. Combinations including ritonavir plus indinavir or saquinavir or atazanavir will be counted as one protease inhibitor for the purpose of accessing funding to anti-retrovirals.
Subsidies for a combination of up to three anti-retroviral medications, including a maximum of two protease inhibitors. Combinations including ritonavir plus indinavir or saquinavir or atazanavir will be counted as one protease inhibitor for the purpose of accessing funding to anti-retrovirals.
Subsidies for a combination of up to three anti-retroviral medications, including a maximum of two protease inhibitors. Combinations including ritonavir plus indinavir or saquinavir or atazanavir will be counted as one protease inhibitor for the purpose of accessing funding to anti-retrovirals.
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.
is available between 1 March and 30 June each year for patients who meet the following criteria, as set by the Ministry of Health:
all people 65 years of age and over;
people under 65 years of age with:
the following cardiovascular disease:
ischaemic heart disease,
congestive heart disease,
rheumatic heart disease,
congenital heart disease, or
cerebo-vascular disease;
the following chronic respiratory disease:
asthma, if on a regular preventative therapy, or
other chronic respiratory disease with impaired lung function;
diabetes;
chronic renal disease;
any cancer, excluding basal and squamous skin cancers if not invasive;
the following other conditions:
autoimmune disease,
immune suppression,
HIV,
transplant recipients,
neuromuscular and CNS diseases,
haemoglobinopathies, or
children on long term aspirin.
The following conditions are excluded from funding:
asthma not requiring regular preventative therapy,
hypertension and/or dyslipidaemia without evidence of end-organ disease,
pregnancy in the absence of another risk factor.
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.
Influenza Vaccine does not fall within the definition Community Pharmaceutical as it is not funded directly from the Pharmaceutical Budget. Pharmacists are unable to claim for the dispensing of influenza vaccine from the Funder.
Patient should have full blood count and liver function tests regularly monitored.
A patient declaration form http://www.pharmac.govt.nz/special_authority_forms/SA0667-declaration.pdf must be signed by the legal guardian of the patient and the prescriber in the presence of a witness (over 18 years of age)
A patient declaration form http://www.pharmac.govt.nz/special_authority_forms/SA0812-declaration.pdf must be signed by the legal guardian of the patient and the prescriber in the presence of a witness (over 18 years of age).
Applicants are requested to register the treatment with the New Zealand Rheumatology Association by completing the forms and questionnaire http://www.pharmac.govt.nz/special_authority_forms/SA0812-survey.pdf.
Only if prescribed on prescription for a dialysis patient or child with rheumatic fever or on a PSO for emergency use.
Only if prescribed on prescription for a dialysis patient or child with rheumatic fever or on a PSO for emergency use.
Only if prescribed on prescription for a dialysis patient or child with rheumatic fever or on a PSO for emergency use.
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
Prescribers should note that oxycodone is significantly more expensive than long-acting morphine sulphate and clinical advice suggests that it is reasonable to consider this as a second-line agent to be used after morphine.
For Anti-inflammatory NSAIDS refer to MUSCULO-SKELETAL
Note:
There is a significant cost differential between moclobemide and fluoxetine (moclobemide being about three times more expensive). For depressive syndromes it is therefore more cost-effective to start treatment with fluoxetine first before considering prescribing moclobemide.
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.
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.
If the patient had an approval for gabapentin, lamotrigine, topiramate or vigabatrin for epilepsy prior to 1 August 2007 the applicant is required to submit a fresh initial application in the first instance, not a renewal application.
“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.
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.
If the patient had an approval for gabapentin, lamotrigine, topiramate or vigabatrin for epilepsy prior to 1 August 2007 the applicant is required to submit a fresh initial application in the first instance, not a renewal application.
If the patient had an approval for gabapentin for neuropathic pain prior to 1 August 2007 the applicant is required to submit a fresh initial application in the first instance, not a renewal application.
“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.
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.
If the patient had an approval for gabapentin, lamotrigine, topiramate or vigabatrin for epilepsy prior to 1 August 2007 the applicant is required to submit a fresh initial application in the first instance, not a renewal application.
For phenobarbitone oral liquid refer
For Beta Adrenoceptor Blockers refer to CARDIOVASCULAR SYSTEM
For Anti-inflammatory NSAIDS refer to MUSCULO-SKELETAL
Not more than one prescription per month.
Not more than one prescription per month; can be waived by Special Authority see SA0887 below.
For Antispasmodics refer to ALIMENTARY TRACT
Specialist must be a neurologist, geriatrician or general physician.
Initial prescriptions to be written by psychiatrists or psychiatric registrars and subsequent prescriptions can be written by General Practitioners.
Ziprasidone is subsidised for patients suffering from schizophrenia or related psychoses after a trial of an effective dose of risperidone or quetiapine that has been discontinued because of unacceptable side effects or inadequate response, and the prescription is endorsed accordingly.
Risperidone microspheres 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 microspheres.
Subject to budgetary cap. Applications will be considered and approved subject to funding availability.
Initial prescriptions to be written by psychiatrists and subsequent prescriptions can be written by psychiatric registrars or General Practitioners.
Risperdal Quicklets cost significantly more than Risperdal Tablets and should only be used where necessary.
Initial prescriptions to be written by psychiatrists and subsequent prescriptions can be written by psychiatric registrars or General Practitioners.
Diagnosis: Schizophrenia and related psychoses when positive symptoms (delusions, hallucinations and thought disorder) are prominent and/or disabling or when both positive symptoms and negative symptoms (flattened affect, emotional and social withdrawal and poverty of speech) are present.
Treatment: Before initiating atypical antipsychotic therapy, physicians should consider whether the patient is likely to respond to and/or tolerate conventional antipsychotic therapy and, where appropriate, trial one or more conventional agent prior to use of an atypical agent.
If the patient had an approval for dexamphetamine for ADHD prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.
If the patient had an approval for dexamphetamine for ADHD in patients under 5 prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.
If the patient had an approval for dexamphetamine for narcolepsy prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.
If the patient had an approval for methylphenidate for ADHD prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.
If the patient had an approval for methylphenidate for ADHD in patients under 5 prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.
If the patient had an approval for methylphenidate for narcolepsy prior to 1 April 2008 the applicant is required to submit a fresh initial application in the first instance, not a renewal application. Please phone HealthPAC on 0800 243 666 for clarification if needed.
Indications marked with * are Unapproved Indications, oxaliplatin is indicated for adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumour.
Indications marked with * are Unapproved Indications, # capecitabine is approved for stage III (Duke's stage C) colon cancer.
Indications marked with a * are Unapproved Indications.
indications marked with * are Unapproved Indications.
It is recommended that treatment with anagrelide be initiated only on the recommendation of a haematologist.
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.
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.
Application forms are available from, and prescriptions should be sent to:
|
The Glivec 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 600 mg/day for accelerated or blast phase, and 400 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.
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.
Funded for patients:
with a diagnosis (confirmed by an oncologist) of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST); and
who have immunohistochemical documentation of c-kit (CD117) expression by the tumour.
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).
The use of octretide in patients with fistulae, oesophageal varices, miscellaneous diarrhoea and hypotension will not be funded as a Special Authority item
For GnRH ANALOGUES – refer to HORMONE PREPARATIONS, Trophic Hormones
Mycophenolate powder for oral liquid is subsidised only for patients unable to swallow tablets and capsules, and when the prescription is endorsed accordingly.
Only one multidose cartridge starter pack to be prescribed and dispensed per patient.
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 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.
For no more than 8 treatment cycles.
For no more than 4 treatment cycles.
For no more than 8 treatment cycles.
For no more than 4 treatment cycles for low grade NHL.
Indications marked with * are Unapproved Indications.
indications marked with * are Unapproved Indications.
It is recommended that for early breast cancer trastuzumab be administered concurrently with docetaxel prior to anthracyclines as per the FinHer regimen (Joensuu H, Kellokumpu-Lehtinen P, Bono P, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006;354(8):809-20).
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.
Establishing Active Chronic Liver Disease
Confirmed HCV infection and serum ALT/AST levels measured on at least three occasions over six months averaging > 1.5 × upper limit of normal. (ALT is the preferable enzyme); or
Liver biopsy showing significant inflammatory activity (active hepatitis) with or without cirrhosis. This is not a necessary requirement for those patients with coagulopathy. (Some patients have active disease on histology with normal transaminase enzymes).
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 alpha-2a or interferon aplha-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.
Budget managed by appointed clinicians on the Multiple Sclerosis Treatment Assessments 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).
Applications to be made on the approved forms which are available from the co-ordinator for MSTAC:
|
The Co-ordinator |
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 co-ordinator 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 co-ordinator.
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.
Appeals against MSTAC's decision and/or the processing of any application may be lodged with the MSTAC co-ordinator. Concerns that cannot be or have not been adequately addressed by MSTAC will be forwarded to a separate Appeal Committee if necessary.
Switching between treatments is permitted within the 12 month approval period without reapproval by MSTAC. The MSTAC co-ordinator should be notified of the change and a new prescription provided.
Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis should as a rule include MRI confirmation. For patients diagnosed before MRI was widely utilised in New Zealand, confirmation of diagnosis via clinical assessment and laboratory/ancillary data must be provided; and
patients must have active relapsing MS (confirmed by MR scan where necessary) with or without underlying progression; and
patients must have either:
EDSS score 2.5 - 5.5 with 2+ relapses:
experienced at least 2 significant relapses of MS in the previous 12 months, and
an EDSS score of between 2.5 and 5.5 inclusive; or
EDSS score 2.0 with 3+ relapses:
experienced at least 3 significant relapses of MS in the previous 12 months, and
an EDSS score of 2.0; and
Each relapse must:
be confirmed by a neurologist or general physician (the patient may not necessarily have been seen 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;
follow a period of stability of at least one month;
be severe enough to change either the EDSS or at least one of the Kurtzke functional systems 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 at least four weeks after the date of the onset of the last known relapse; and
patients must have no previous history of lack of response to beta-interferon or glatiramer acetate (see criteria for stopping).
applications must be submitted to the Multiple Sclerosis Treatment Assessment Committee (MSTAC) by the patient’s neurologist or a general physician; and
patients must agree (via informed consent) to co-operate if as a result of their meeting the stopping criteria, funding is withdrawn. Patients must agree to the collection of clinical data relating to their MS and use of those data by PHARMAC; and
patients must agree to allow clinical data to be collected and reviewed by MSTAC annually for each year in which they receive funding for beta-interferon or glatiramer acetate.
Confirmed progression of disability that is sustained for three months after a minimum of one year of treatment. Progression of disability is defined as either an increase of 1 EDSS point from the starting EDSS or an increase in EDSS score to 6.0 or more; or
stable or increasing relapse rate over 12 months of treatment (compared with the relapse rate on starting treatment); or
pregnancy and/or lactation; or
within the 12 month approval year, 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 or refusal to allow the results of the assessment to be submitted to MSTAC; or
patients may, subject to conclusions drawn from published evidence available at the time, be excluded if they develop a high titre of neutralising anti-bodies to beta-interferon or glatiramer acetate.
Subsidy applies for either primary or rescue therapy.
All patients require frequent monitoring for creatinine levels and blood pressure:
fortnightly, in the first three months of therapy and then monthly, if results are stable;
if dose is increased or there is a rise in serum creatinine or blood pressure, then more frequent monitoring is required.
Cyclosporin A is contraindicated in patients with the following conditions:
current or past malignancy;
uncontrolled hypertension;
renal dysfunction (abnormal serum creatinine for age and sex);
immunodeficiency and neutropenia;
abnormally low white blood cell count or platelet count; or
liver function tests more than twice the upper limit of normal.
age above 65 years;
controlled hypertension;
use of anti-epileptic medications;
use of ketoconazole, fluconazole, trimethoprim, erythromycin, verapamil, and diltiazem;
concurrent or previous use of alkylating agents such as cyclophosphamide;
use of any experimental drug within the past three months;
premalignant conditions such as leukoplakia, monoclonal paraproteinaemia, myelodysplastic syndrome and dysplastic naevi;
active infection may necessitate temporary discontinuation;
pregnancy and lactation.
Therapy should be discontinued if there has been no improvement after 6 months with the patient on the maximum tolerated dose.
For further information please consult the data sheet.
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
The addition of inhaled long-acting beta-adrenoceptor agonists (LABAs) to inhaled corticosteroids is recommended:
For younger children (aged under 12 years) where asthma is poorly controlled despite using inhaled corticosteroids for at least three months at total daily doses of 200 µg beclomethasone or budesonide (or 100 µg fluticasone).
For adults and older children (aged 12 years and over) where asthma is poorly controlled despite using inhaled corticosteroids for at least three months at total daily doses of 400 µg beclomethasone or budesonide (or 200 µg fluticasone).
Note:
Further information on the place of inhaled corticosteroids and inhaled LABAs in the management of asthma can be found in the New Zealand guidelines for asthma in adults (www.nzgg.org.nz) and in the New Zealand guidelines for asthma in children aged 1-15 (www.paediatrics.org.nz).
Application details may be obtained from:
|
The Co-ordinator, Cystic Fibrosis Advisory Panel |
Phone: (04) 460 4990 |
|
PHARMAC, PO Box 10 254 |
Facsimile: (04) 916 7571 |
|
Wellington |
Email: erin.murphy@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.
Spacer devices and masks also available to paediatricians employed by a DHB on a wholesale supply order signed by the paediatrician. Limited to one pack of 20 per order. Orders via a hospital pharmacy.
Only available for children aged six years and under.
For Space Chamber and Foremount Child’s Silicone Mask wholesale supply order must indicate clearly if either the spacer device, the mask, or both are required.
Distributed by Airflow Products. Forward orders to:
|
Airflow Products |
Telephone: 04 499 1240 or 0800 AIR FLOW |
|
|
PO Box 1485, Wellington |
Facsimile: 04 499 1245 or 0800 323 270 |
For Vosol ear drops with hydrocortisone powder refer
For treatment of bacterial keratitis or severe bacterial conjunctivitis resistant to chloramphenicol.
Trusopt, Cosopt and Azopt are subsidised for use as either monotherapy or as an adjunctive agent for the treatment of glaucoma.
Trusopt, Cosopt and Azopt should not be prescribed for a person in whom less expensive first line agents for the treatment of glaucoma are not contraindicated unless:
that person has previously trialled all other such subsidised agents (except brimonidine tartrate); and
those trials have indicated that that person does not respond adequately to treatment with those other agents.
Bimatoprost, lantanoprost and travoprost are subsidised for use in the treatment of glaucoma as either monotherapy or as an adjunctive agent for patients in whom prostaglandin analogue monotherapy has been ineffective in controlling intraocular pressure.
Bimatoprost, lantanoprost and travoprost should not be prescribed for a person in whom less expensive first line agents for the treatment of glaucoma are not contraindicated unless:
That person has previously trialled all other such subsidised agents (beta-blockers, pilocarpine, carbonic anhydrase inhibitors); and
Those trials have indicated that that person does not respond adequately to treatment with those other agents.
Minims for a general practice are considered to be “tools of trade” and are not approved as special authority items.
Brimonidine tartrate is subsidised for use as either monotherapy or as an adjunctive agent for the treatment of glaucoma.
Brimonidine tartrate should not be prescribed for a person in whom less expensive first line agents for the treatment of glaucoma are not contraindicated unless:
that person has previously trialled all other such subsidised agents (except dorzolamide hydrochloride); and
those trials have indicated that that person does not respond adequately to or does not tolerate treatment with those other agents.
Combigan is subsidised for use as either monotherapy or as an adjunctive agent for the treatment of glaucoma.
Combigan should only be prescribed when:
less expensive first line agents for the treatment of glaucoma are contraindicated; or
the response to such subsidised agents is inadequate; or
the patient cannot tolerate such subsidised agents.
For acetylcysteine eye drops refer
See also to MUSCULO-SKELETAL, Anticholinesterases
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 suspension.
Only in aspirin and chloroform application.
Only in extemporaneously compounded oral liquid preparations.
These products are to be used only as supplements to a person’s dietary needs. Subsidy for up to 500 ml a day. Amounts prescribed in excess of this amount must be paid for by the patient.
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.
Where possible, the requirements for oral supplementation should be established in conjunction with assessment by a dietician.
This group of products can be used either as a supplement or as a complete diet.
If a product is being used as a supplement, the limit is 500 ml per day.
Cystic fibrosis patients are exempt the 500 ml per day volume restriction when using Ensure Plus, Fortisip or Resource Plus as a supplement.
This product can be used either as a supplement or as a complete diet.
If it is being used as a supplement, the limit is 500 ml per day.
It can cost up to $70,000 a year to keep an adult on protein supplements. Because protein substitutes are so expensive and because they are only effective in controlling PKU if a restricted diet is followed, adults with PKU will be required to demonstrate they are following the prescribed diet by regular blood testing. The requirement for testing applies to those aged over 16 years. Failure to follow an appropriate diet results in high blood phenylalanine levels.
The subsidy for these products reflects the philosophy that the patient incurs no additional financial burden for purchasing specialised more expensive products.
It can cost up to $70,000 a year to keep an adult on protein supplements. Because protein substitutes are so expensive and because they are only effective in controlling PKU if a restricted diet is followed, adults with PKU will be required to demonstrate they are following the prescribed diet by regular blood testing. The requirement for testing applies to those aged over 16 years. Failure to follow an appropriate diet results in high blood phenylalanine levels.
The subsidy for these products reflects the philosophy that the patient incurs no additional financial burden for purchasing specialised more expensive products.
Neocate should be used only as a last resort when the infant is unable to absorb any of the below formulae. The objective with each of the formulae prescribed is to get the infant off them as soon as possible. This may take six months, it may take three years. Because of this, variation on age limit is not regarded as appropriate.These formulae will be available only from a hospital pharmacy.
Vivonex Pediatric may be a suitable and less expensive alternative for many children that would otherwise be eligible for a subsidy for Neocate and should, therefore, be tried first in these cases.
The subsidy for these products reflects the philosophy that the patient incurs no additional financial burden for purchasing specialised more expensive products.
Secondary lactose intolerance in children is usually short lasting, and can be controlled by dietary measures and by giving sufficient calories to regenerate digestive enzymes.
The subsidy for these products reflects the philosophy that the patient incurs no additional financial burden for purchasing specialised more expensive products.
The subsidy for these products reflects the philosophy that the patient incurs no additional financial burden for purchasing specialised more expensive products.