For continuation only
Note: Epoetin beta is considered a Discretionary Variance Pharmaceutical for epoetin alfa.
Indications marked with * are unapproved indications
Response to treatment is defined as a platelet count of > 30,000 platelets per microlitre
Preferred Brand of recombinant factor VIII from 1 March 2016 until 28 February 2019. When used in the treatment of haemophilia, funded treatment is managed by the Haemophilia Treaters Group in conjunction with the National Haemophilia Management Group.
Rare Clinical Circumstances Brand of recombinant factor VIII from 1 March 2016 until 28 February 2019. When used in the treatment of haemophilia, 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:
The Co-ordinator, Haemophilia Treatments Panel |
Phone: 0800 023 588 Option 2 |
PHARMAC PO Box 10 254 |
Facsimile: (04) 974 4881 |
Wellington |
Email: haemophilia@pharmac.govt.nz |
Second Brand of recombinant factor VIII from 1 March 2016 until 28 February 2019. When used in the treatment of haemophilia, 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:
The Co-ordinator, Haemophilia Treatments Panel |
Phone: 0800 023 588 Option 2 |
PHARMAC PO Box 10 254 |
Facsimile: (04) 974 4881 |
Wellington |
Email: haemophilia@pharmac.govt.nz |
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
*Febrile neutropenia risk greater than or equal to 20% after taking into account other risk factors as defined by the European Organisation for Research and Treatment of Cancer (EORTC) guidelines
For continuation only
For continuation only
Due to the angiotensin II receptor blocking activity of sacubitril with valsartan it should not be co-administered with an ACE inhibitor or another ARB.
For continuation only
For continuation only
For continuation only
For continuation only
Note: DV limit applies to the pack sizes of 30 g or less.
Note: DV limit applies to the pack sizes of greater that 30 g.
Note: DV limit applies to the pack sizes of greater than 100 g.
Note: DV limit applies to the pack sizes of 100 g or less.
Note: DV limit applies to pack sizes of less than 200 g.
Note: DV limit applies to pack sizes of greater than 200 g.
Note: DV limit applies to the pack sizes of greater than 100 g.
Note: DV limit applies to the pack sizes of 100 g or greater.
Note: DV limit applies to pack sizes of 30 g or less, and to both white soft paraffin and yellow soft paraffin.
For continuation only
Note: DV limit applies to the pack sizes of greater than 100 g.
Note: DV limit applies to the pack sizes of less than or equal to 100 g.
endometriosis is an unregistered indication.
Indications marked with * are unapproved indications.
This does not include parathyroid adenomas unless these have become malignant.
For the purposes of adults and adolescents, severe growth hormone deficiency is defined as a peak serum growth hormone level of less than or equal to 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 less than or equal to 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 it is within 1 standard deviation of the mean normal value for age and sex; and
The 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.
Propylthiouracil is not recommended for patients under the age of 18 years unless the patient is pregnant and other treatments are contraindicated.
Cranial diabetes insipidus and the nasal forms of desmopressin are contraindicated.
For continuation only
Indications marked with * are unapproved indications
Indications marked with * are unapproved indications. A maximum of 24 months of azithromycin treatment for non-cystic fibrosis will be subsidised in the community.
Indications marked with * are unapproved indications. A maximum of 24 months of azithromycin treatment for non-cystic fibrosis will be subsidised in the community.
For continuation only
For continuation only
Only for use in patients with approval by the Hepatitis C Treatment Panel (HepCTP). Applications will be considered by HepCTP at its regular meetings and approved subject to eligibility according to the Access Criteria (set out in Section B of the Pharmaceutical Schedule).
Note: Only for use in patients who have received supply of treatment via PHARMAC's approved direct distribution supply. Application details for accessing treatment may be obtained from PHARMAC's website http://www.pharmac.govt.nz/hepatitis-c-treatments/.
Note: Only for use in patients who have received supply of treatment via PHARMAC's approved direct distribution supply. Application details for accessing treatment may be obtained from PHARMAC's website http://www.pharmac.govt.nz/hepatitis-c-treatments/.
Note: The restriction on the use of oseltamivir to hospitalised patients means that supply into the community for a new course is not permitted. Supply of a part original pack on discharge where initiated as a hospital inpatient is permitted.
Note: The restriction on the use of zanamivir to hospitalised patients means that supply into the community for a new course is not permitted. Supply of a part original pack on discharge where initiated as a hospital inpatient is permitted.
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.
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 less than or equal to -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 less than or equal to -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 greater than or equal to -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 less than or equal to -2.5 and, therefore, do not require BMD measurement for treatment with denosumab.
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.
Antiresorptive agents and their adequate doses for the purposes of this Special Authority are defined as: risedronate sodium tab 35 mg once weekly; alendronate sodium tab 70 mg or tab 70 mg with cholecalciferol 5,600 iu once weekly; raloxifene hydrochloride tab 60 mg once daily. 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.
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 less than or equal to -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 restriction are defined as: alendronate sodium tab 70 mg or tab 70 mg with colecalciferol 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.
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/home/resources-2/
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.
For continuation only
Note - The DV limit of 1% applies to the celecoxib chemical rather than each individual line item.
For continuation only
For continuation only
For continuation only
"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.
Note: Pregabalin not to be given in combination with gabapentin
Note: Gabapentin not to be given in combination with pregabalin
"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 continuation only
For continuation only
For continuation only
For continuation only
Note: Only for use in compounding an oral liquid formulation, for in-hospital use only.
A "subsidised formulation of a stimulant" refers to currently listed methylphenidate hydrochloride tablet formulations (immediate-release, sustained-release and extended-release) or dexamphetamine sulphate tablets.
'Chronic lymphocytic leukaemia (CLL)' includes small lymphocytic lymphoma (SLL). Chemotherapy treatment is considered to comprise a known standard therapeutic chemotherapy regimen and supportive treatments.
'indolent, low-grade lymphomas' includes follicular, mantle cell, marginal zone and lymphoplasmacytic/ Waldenström's macroglobulinaemia.
Note: DV limit applies to all 50 mg presentations of doxorubicin hydrochloride.
Indication marked with * is an unapproved indication. 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.
Indication marked with a * is an unapproved indication. Temozolomide is not funded for the treatment of relapsed high grade glioma.
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
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.
*treatment failure as defined by Leukaemia Net Guidelines.
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
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.
RCC - 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.
GIST - 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% or more 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.
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.
restriction applies only to the long-acting formulations of octreotide
Indications marked with * are unapproved indications
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 starting treatment.
Average normal chest expansion corrected for age and gender:
Age | Male | Female |
---|---|---|
18-24 | 7.0 cm | 5.5 cm |
25-34 | 7.5 cm | 5.5 cm |
35-44 | 6.5 cm | 4.5 cm |
45-54 | 6.0 cm | 5.0 cm |
55-64 | 5.5 cm | 4.0 cm |
65-74 | 4.0 cm | 4.0 cm |
75+ | 3.0 cm | 2.5 cm |
"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.
Indications marked with * are unapproved indications.
A trial withdrawal should be considered after every 24 months of stability, unless the patient is deemed to have extremely high risk of irreversible vision loss if infliximab is withdrawn.
A trial withdrawal should be considered after every 24 months of stability, unless the patient is deemed to have extremely high risk of irreversible vision loss if infliximab is withdrawn.
"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.
Behcet’s disease diagnosed according to the International Study Group for Behcet’s Disease. Lancet 1990;335(8697):1078-80. Quality of life measured using an appropriate quality of life scale such as that published in Gilworth et al J Rheumatol. 2004;31:931-7.
Treatments appropriate for the particular symptoms are those that are considered standard conventional treatments for these symptoms, for example intravenous/oral steroids and other immunosuppressants for ocular symptoms; azathioprine, steroids, thalidomide, interferon alpha and ciclosporin for mucocutaneous symptoms; and colchicine, steroids and methotrexate for rheumatological symptoms.
*Inadequate response defined as less than 50% reduction in baseline UAS7 and DLQI score, or an increase in Urticaria Control Test (UCT) score of less than 4 from baseline. Patient is to be reassessed for response after 4 doses of omalizumab. Complete response is defined as UAS7 less than or equal to 6 and DLQI less than or equal to 5; or UCT of 16. Relapse of chronic urticaria on stopping prednisone/ciclosporin does not justify the funding of omalizumab.
Chronic lymphocytic leukaemia includes small lymphocytic lymphoma. Comorbidity refers only to illness/impairment other than CLL induced illness/impairment in the patient. ’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 obinutuzumab is expected to improve symptoms and improve ECOG score to <2.
* greater than or equal to 1.5 x 109/L and platelets greater than or equal to 75 x 109/L
Criteria 2.3 and 2.4 will be removed from 1 January 2019.
Criterion 2 will be removed from 1 January 2019.
A treatment course is defined as a minimum of 12 weeks of treatment. "Inadequate response" is defined as: for whole body severe chronic plaque psoriasis, a PASI score of greater than 10, 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 sub scores 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.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
'Indolent, low-grade lymphomas' includes follicular, mantle, marginal zone and lymphoplasmacytic/Waldenstrom macroglobulinaemia. *Unapproved indication. 'Hairy cell leukaemia' also includes hairy cell leukaemia variant.
'Indolent, low-grade lymphomas' includes follicular, mantle, marginal zone and lymphoplasmacytic/Waldenstrom macroglobulinaemia. *Unapproved indication. 'Hairy cell leukaemia' also includes hairy cell leukaemia variant.
'Aggressive CD20 positive NHL' includes large B-cell lymphoma and Burkitt's lymphoma/leukaemia.
'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.
'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.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with * are unapproved indications.
Indications marked with a * are unapproved indications.
Indications marked with a * are unapproved indications.
Indications marked with a * are unapproved indications.
Indications marked with a * are unapproved indications.
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 starting treatment.
Average normal chest expansion corrected for age and gender:
Age | Male | Female |
---|---|---|
18-24 | 7.0 cm | 5.5 cm |
25-34 | 7.5 cm | 5.5 cm |
35-44 | 6.5 cm | 4.5 cm |
45-54 | 6.0 cm | 5.0 cm |
55-64 | 5.5 cm | 4.0 cm |
65-74 | 4.0 cm | 4.0 cm |
75+ | 3.0 cm | 2.5 cm |
"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.
Indications marked with * are unapproved indications.
Disease responses to be assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (Eisenhauer EA, et al. Eur J Cancer 2009;45:228-47). Assessments of overall tumour burden and measurable disease to be undertaken on a minimum of one lesion and maximum of 5 target lesions (maximum two lesions per organ). Target lesions should be selected on the basis of their size (lesions with the longest diameter), be representative of all involved organs, and suitable for reproducible repeated measurements. Target lesion measurements should be assessed using CT or MRI imaging with the same method of assessment and the same technique used to characterise each identified and reported lesion at baseline and every 12 weeks.
Response definitions as follows:
Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Disease responses to be assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (Eisenhauer EA, et al. Eur J Cancer 2009;45:228-47). Assessments of overall tumour burden and measurable disease to be undertaken on a minimum of one lesion and maximum of 5 target lesions (maximum two lesions per organ). Target lesions should be selected on the basis of their size (lesions with the longest diameter), be representative of all involved organs, and suitable for reproducible repeated measurements. Target lesion measurements should be assessed using CT or MRI imaging with the same method of assessment and the same technique used to characterise each identified and reported lesion at baseline and every 12 weeks.
Response definitions as follows:
Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive 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.
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
Note: inhaled glycopyrronium treatment must not be used if the patient is also receiving treatment with subsidised tiotropium or umeclidinium.
Note: Umeclidinium must not be used if the patient is also receiving treatment with subsidised inhaled glycopyrronium or tiotropium bromide.
Note: tiotropium treatment must not be used if the patient is also receiving treatment with subsidised inhaled glycopyrronium or umeclidinium.
Note: Combination long acting muscarinic antagonist and long acting beta-2 agonist must not be used if the patient is also receiving treatment with a combination inhaled corticosteroid and long acting beta-2 agonist.
disease progression is defined as a decline in percent predicted FVC of 10% or more within any 12 month period.
disease progression is defined as a decline in percent predicted FVC of 10% or more within any 12 month period.
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.
While pre-thickened drinks and supplements have not been included in Section H, DHB hospitals may continue to use such products for patients with dysphagia, provided that:
use was established prior to 1 July 2013; and
the product has not been specifically considered and excluded by PHARMAC; and
use of the product conforms to any applicable indication restrictions for similar products that are listed in Section H (for example, use of thickened high protein products should be in line with the restriction for high protein oral feed in Section H).
PHARMAC intends to make a further decision in relation to pre-thickened drinks and supplements in the future, and will notify of any change to this situation.
Patients are required to meet any Special Authority criteria associated with all of the products used in the modular formula.
A reasonable trial is defined as a 2-4 week trial, or signs of an immediate IgE mediated allergic reaction.
‘Volume intolerant’ patients are those who are unable to tolerate an adequate volume of infant formula to achieve expected growth rate. These patients should have first trialled appropriate clinical alternative treatments, such as concentrating, fortifying and adjusting the frequency of feeding.
A reasonable trial is defined as a 2-4 week trial.
Note: Community subsidy of Sustagen Hospital Formula is subject to both Special Authority criteria and a manufacturer’s surcharge. Higher subsidy by endorsement is available for patients meeting the following endorsement criteria; fat malabsorption, fat intolerance or chyle leak.
Please refer to the Immunisation Handbook for appropriate schedule for catch up programmes
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.
A list of countries with high rates of TB are available at http://www.health.govt.nz/tuberculosis (Search for Downloads) or www.bcgatlas.org/index.php
Please refer to the Immunisation Handbook for the appropriate schedule for catch up programmes.
Tdap is not registered for patients aged less than 10 years. Please refer to the Immunisation Handbook for the appropriate schedule for catch up programmes.
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.
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.
Please refer to the Immunisation Handbook for the appropriate schedule for catch up programmes
Please refer to the Immunisation Handbook for the appropriate schedule for catch up programmes
hypertension and/or dyslipidaemia without evidence of end-organ disease is excluded from funding.
asthma not requiring regular preventative therapy is excluded from funding.
hypertension and/or dyslipidaemia without evidence of end-organ disease is excluded from funding.
asthma not requiring regular preventative therapy is excluded from funding.
hypertension and/or dyslipidaemia without evidence of end-organ disease is excluded from funding.
asthma not requiring regular preventative therapy is excluded from funding.
Please refer to the Immunisation Handbook for appropriate schedule for catch up programmes.
Please refer to the Immunisation Handbook for the appropriate schedule for catch up programmes.
* immunosuppression due to steroid or other immunosuppressive therapy must be for a treatment period of greater than 28 days
In addition to the products expressly listed here in Part III: Optional Pharmaceuticals, a range of hospital medical devices are listed in an addendum to Part III which is available at www.pharmac.govt.nz. The Optional Pharmaceuticals listed in the addendum are deemed to be listed in Part III, and the Rules of the Pharmaceutical Schedule applying to products listed in Part III apply to them.