Multi-product proposal involving nine pharmaceuticals

Special Authority for Subsidy

Initial application – (chronic lymphocytic leukaemia) only from a haematologist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient has progressive Binet stage A, B or C CD20+ chronic lymphocytic leukaemia requiring treatment; and
2. The patient is obinutuzumab treatment naive; and
3. The patient is not eligible for full dose FCR due to comorbidities with a score > 6 on the Cumulative Illness Rating Scale (CIRS) or reduced renal function (creatinine clearance <70mL/min); and
4. Patient has absolute neutrophil count ≥1.5 x 10⁹/L and platelets ≥75 x 10⁹/L and no evidence of additional bone marrow dysfunction; and
5. Patient has good performance status; and
6. Obinutuzumab to be administered at a maximum cumulative dose of 8000 mg and in combination with chlorambucil for a maximum of 6 cycles.

Notes: Chronic lymphocytic leukaemia includes small lymphocytic lymphoma. Comorbidity refers only to illness/impairment other than CLL induced illness/impairment in the patient.

• The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
• Gazyva would have protection from delisting and subsidy reduction until 31 December 2019.

PCT only – Specialist – Special Authority

Special Authority for Subsidy

Initial application – (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
2. Either:
   1. Patient is chemotherapy treatment naïve; or
   2. Patient has not received prior treatment for their metastatic disease and has had a treatment free interval of at least 12 months between prior (neo)adjuvant chemotherapy treatment and diagnosis of metastatic breast cancer; and
3. The patient has good performance status (ECOG grade 0-1);
4. Pertuzumab to be administered in combination with trastuzumab;
5. Pertuzumab maximum first dose of 840 mg, followed by maximum of 420 mg every 3 weeks; and
6. Pertuzumab to be discontinued at disease progression.

Renewal application - (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

Both:

1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including ISH or other current technology); and
2. The cancer has not progressed at any time point during the previous 12 months whilst on pertuzumab and trastuzumab.

• The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
• Note that pertuzumab would not be funded for patients with metastatic breast cancer who have already started trastuzumab treatment prior to 1 January 2017.
• Perjeta would have protection from delisting and subsidy reduction until 31 December 2019.

Retail Pharmacy - Specialist

Special Authority for Subsidy

Initial application – (idiopathic pulmonary fibrosis) only from a respiratory specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. Patient has been diagnosed with idiopathic pulmonary fibrosis as confirmed by histology, CT or biopsy; and
2. Forced vital capacity is between 50% and 80% predicted; and
3. Pirfenidone is to be discontinued at disease progression (See Notes).

Renewal application – (idiopathic pulmonary fibrosis) only from a respiratory specialist. Approvals valid for 12 months for applications meeting the following criteria:

Both:

1. Treatment remains clinically appropriate and patient is benefitting from and tolerating treatment.
2. Pirfenidone is to be discontinued at disease progression (See Notes).

Notes: disease progression is defined as a decline in percent predicted FVC of 10% or more within any 12 month period.

• The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
• Esbriet would have protection from delisting and subsidy reduction until 30 June 2018.

Initial approval criteria for children under the age of 5

Approvals valid for twelve months for applications meeting the following criteria:

All of the following:

1. Patients must be assessed at regional cystic fibrosis clinics or centres which are under the control of specialist respiratory physicians/paediatricians with experience and expertise in the management of cystic fibrosis and the prescribing of dornase alfa under the Pharmaceutical Schedule is limited to such physicians; and 

2. Any of the following:
   1. Requiring more than two hospital respiratory admissions in a 12 month period; or
   2. Requiring a hospital admission to have a PICC line inserted to manage exacerbations; or
   3. A chest x-ray showing clear mucus plugging, focal consolidation or a Brasfield score <22/25 done at a time of stability despite currently approved treatment, including repeated physiotherapy assessment and education, and having had at least one admission to hospital; or
   4. A bronchoscopy done as far as possible at a time of stability which shows significant mucus plugging despite currently approved treatment, including repeated physiotherapy assessment and education, and having had at least one admission to hospital; or
   5. Diagnosis of allergic bronchopulmonary aspergillosis (ABPA); or
   6. Undertaking eradication treatment is proposed; and
3. Patient has previously undergone a trial with, or are currently being treated with, hypertonic saline; and
4. All patients having treatment with dornase alfa should be included in the national cystic fibrosis database. Prescribing physicians/paediatricians are required to supply updated patient information on a six monthly basis.

Renewal for children under the age of 5

Approvals valid for twelve months for applications meeting the following criteria:

All of the following:

1. Patient is compliant with therapy; and

2. In the opinion of the patients treating clinician they believe dornase alfa to be of worthwhile benefit to the patient; and
3. Any of the following:
   1. Reduction in hospital admissions in the previous 12 months; or
   2. Reduction in the number of treatment courses of oral antibiotics in the 
previous 12 months; or
   3. Significant improvement in radiological or bronchoscopy findings; or
   4. An eradication of a pathological organism.

• We anticipate a subsequent change to the existing renewal criteria may be required to provide an opportunity for those children under the age of 5 who have demonstrated benefit from dornase alfa (as per the new renewal criteria above) to be eligible for long term therapy.
• There would be no change to the wording of the restrictions applying to dornase alfa in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
• An amended confidential rebate would apply to Pulmozyme that would reduce its net price to the Funder.
• Pulmozyme would have protection from delisting and subsidy reduction until 31 December 2019.

PCT Only – Specialist – Special Authority for Subsidy

Initial application - (Hairy cell leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:

Both:

1. Patient has CD20+ hairy cell leukaemia* requiring treatment; and
2. Any of the following:
   1. Patient has residual disease following purine analogue treatment; or
   2. Patient has relapsed or refractory disease following purine analogue treatment; or
   3. Patient is ineligible for purine analogue therapy.

Renewal - (Hairy cell leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

1. The patient has had a rituximab treatment-free interval of 12 months or more; and
2. The patient has hairy cell leukaemia*with relapsed disease following prior chemotherapy; and
3. To be used for no more than 6 treatment cycles.

Note: *Unapproved indication. “Hairy cell leukaemia’ also includes hairy cell leukaemia variant.

Initial application — (Chronic lymphocytic leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient has progressive Binet stage A, B or C chronic lymphocytic leukaemia (CLL) requiring treatment; and
2. The patient is rituximab treatment naïve; and
3. Either:
   1. The patient is chemotherapy treatment naïve; or
   2. Both:
      1. The patient’s disease has relapsed following no more than three prior lines of chemotherapy treatment; and
      2. The patient has had a treatment-free interval of 12 months or more if previously treated with fludarabine and cyclophosphamide chemotherapy; and
4. The patient has good performance status; and
5. The patient has good renal function (creatinine clearance ≥ 30 ml/min); and
6. The patient does not have chromosome 17p deletion CLL; and
7. Rituximab to be administered in combination with fludarabine and cyclophosphamide for a maximum of 6 treatment cycles; and
8. It is planned that the patient receives full dose fludarabine and cyclophosphamide (orally or dose equivalent intravenous administration).

Note: '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.

Renewal application – (Chronic lymphocytic leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patients disease has relapsed following no more than one prior line of treatment with rituximab for CLL; and
2. The patient has had a rituximab treatment–free interval of 36 months or more; and
3. The patient does not have chromosome 17p deletion CLL; and
4. It is planned that the patient receives full dose fludarabine and cyclophosphamide (orally or dose equivalent intravenous administration); and
5. Rituximab to be administered in combination with fludarabine and cyclophosphamide for a maximum of 6 treatment cycles.

Note: '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.

• Amendments to the indication of ANCA-associated vasculitis would apply to the listing of rituximab Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML) as follows (deletions in strikethrough, additions in bold – amended criteria only shown):

Restricted

Initiation - ANCA associated vasculitis

Re-assessment required after 4 weeks

All of the following:

1. Patient has been diagnosed with ANCA associated vasculitis*; and
2. Either:
   1. Patient does not have MPO-ANCA positive vasculitis*; or
   2. Mycophenolate mofetil has not been effective in those patients who have MPO-ANCA positive vasculitis*; and
3. The total rituximab dose would not exceed the equivalent of 375 mg/m² of body-surface area per week for a total of 4 weeks; and
4. Any of the following:
   1. Induction therapy with daily oral or pulse intravenous cyclophosphamide has failed to achieve complete absence significant improvement of disease after at least 3 months; or
   2. Patient has previously had a cumulative dose of cyclophosphamide >15 g or a further repeat 3 month induction course of cyclophosphamide would result in a cumulative dose >15 g; or
   3. Cyclophosphamide and methotrexate are contraindicated; or
   4. Patient is a female of child-bearing potential; or
   5. Patient has a previous history of haemorrhagic cystitis, urological malignancy or haematological malignancy.

Note: Indications marked with * are Unapproved Indications.

Continuation - ANCA associated vasculitis

Re-assessment required after 4 weeks

All of the following:

1. Patient has been diagnosed with ANCA associated vasculitis*; and
2. Patient has previously responded to treatment with rituximab but is now experiencing an acute flare of vasculitis; and
3. The total rituximab dose would not exceed the equivalent of 375 mg/m² of body-surface area per week for a total of 4 weeks.

Note: Indications marked with * are Unapproved Indications.

• No other changes to the current funding criteria for rituximab are proposed.
• An amended confidential rebate would apply to Mabthera that would reduce its net price to the Funder.
• Mabthera would have protection from delisting and subsidy reduction until 30 June 2019.

Restricted

Initiation – polyarticular juvenile idiopathic arthritis

Rheumatologist

Re-assessment required after 4 months.

Either:

1. Both:
   1. The patient has had an initial Special Authority approval for both etanercept and adalimumab for juvenile idiopathic arthritis (JIA); and
   2. The patient has experienced intolerable side effects, or has received insufficient benefit from, both etanercept and adalimumab; or
2. All of the following:
   1. Treatment with a tumour necrosis factor alpha inhibitor is contraindicated; and
   2. Patient has had severe active polyarticular course JIA for 6 months duration or longer; and
   3. Patient has tried and not responded to at least three months of oral or parenteral methotrexate (at a dose of 10-20 mg/m² weekly or at the maximum tolerated dose) in combination with either oral corticosteroids (prednisone 0.25 mg/kg or at the maximum tolerated dose) or a full trial of serial intra-articular corticosteroid injections; and
   4. To be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
   5. Both:
      1. Either:
         1. Patient has persistent symptoms of poorly-controlled and active disease in at least 20 swollen, tender joints; or
         2. Patient has persistent symptoms of poorly-controlled and active disease in at least four joints from the following: wrist, elbow, knee, ankle, shoulder, cervical spine, hip; and
      2. Physician's global assessment indicating severe disease.

Renewal – polyarticular juvenile idiopathic arthritis

Rheumatologist

Re-assessment required after 6 months

Both:

1. Treatment is to be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
2. Either:
   1. Following 3 to 4 months' initial treatment, the patient has at least a 50% decrease in active joint count and an improvement in physician's global assessment from baseline; or
   2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count and continued improvement in physician's global assessment from baseline.

Initiation – idiopathic multicentric Castleman’s disease

Haematologist or rheumatologist

Re-assessment required after 6 months

All of the following:

1. Patient has severe HHV-8 negative idiopathic multicentric Castleman’s disease; and
2. Treatment with an adequate trial of corticosteroids has proven ineffective; and
3. Tocilizumab to be administered at doses no greater than 8 mg/kg IV every 4 weeks.

Continuation – idiopathic multicentric Castleman’s disease

Haematologist or rheumatologist

Re-assessment required after 12 months

The treatment remains appropriate and the patient has a sustained improvement in inflammatory markers and functional status.

Initiation —Rheumatoid Arthritis

Rheumatologist

Re-assessment required after 6 months

Either

1. All of the following:
   1. The patient has had an initial Special Authority approval for adalimumab and/or etanercept for rheumatoid arthritis; and
   2. Either:
      1. The patient has experienced intolerable side effects from adalimumab and/or etanercept; or
      2. The patient has received insufficient benefit from at least a three-month trial of adalimumab and/or etanercept such that they do not meet the renewal criteria for rheumatoid arthritis; and
   3. Either:
      1. The patient is seronegative for both anti-cyclic citrullinated peptide (CCP) antibodies and rheumatoid factor; or
      2. Both:
         1. The patient has been started on rituximab for rheumatoid arthritis in a DHB hospital in accordance with the Section H rules; and
         2. Either:
            1. The patient has experienced intolerable side effects from rituximab; or
            2. At four months following the initial course of rituximab the patient has received insufficient benefit such that they do not meet the renewal criteria for rheumatoid arthritis; or
2. All of the following:
   1. Patient has had severe and active erosive rheumatoid arthritis for six months duration or longer; and
   2. Tocilizumab is to be used as monotherapy; and
   3. Either:
      1. Treatment with methotrexate is contraindicated; or
      2. Patient has tried and did not tolerate oral and/or parenteral methotrexate; and
   4. Either:
      1. Patient has tried and not responded to at least three months therapy at the maximum tolerated dose of cyclosporine alone or in combination with another agent; or
      2. Patient has tried and not responded to at least three months therapy at the maximum tolerated dose of leflunomide alone or in combination with another agent; and
   5. Either:
      1. Patient has persistent symptoms of poorly controlled and active disease in at least 20 active, swollen, tender joints; or
      2. Patient has persistent symptoms of poorly controlled and active disease in at least four active joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip; and
   6. Either:
      1. Patient has a C-reactive protein level greater than 15 mg/L measured no more than one month prior to the date of this application; or
      2. C-reactive protein levels not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so for more than three months.

Continuation – Rheumatoid arthritis

Rheumatologist

Re-assessment required after 6 months

Either:

1. Following 6 months’ initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician.

• No other changes to the current funding criteria for tocilizumab are proposed.
• An amended confidential rebate would apply to Actemra that would reduce its net price to the Funder.
• Actemra would have protection from delisting and subsidy reduction until 31 December 2019.

TRASTUZUMAB – PCT only - Specialist

Special Authority for Subsidy

Initial application - (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

Either: Any of the following:

1. All of the following:
   1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
   2. The patient has not previously received lapatinib treatment for HER-2 positive metastatic breast cancer; and
   3. Trastuzumab not to be given in combination with lapatinib; and
   4. Trastuzumab to be discontinued at disease progression; or
2. All of the following:
   1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
   2. The patient started lapatinib treatment for metastatic breast cancer but discontinued lapatinib within 3 months of starting treatment due to intolerance; and
   3. The cancer did not progress whilst on lapatinib; and
   4. Trastuzumab not to be given in combination with lapatinib; and
   5. Trastuzumab to be discontinued at disease progression; or
3. All of the following:
   1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
   2. Either:
      1. Patient is chemotherapy treatment naïve; or
      2. Patient has not received prior treatment for their metastatic disease and has had a treatment free interval of at least 12 months between prior (neo)adjuvant chemotherapy treatment and diagnosis of metastatic breast cancer; and
   3. The patient has good performance status (ECOG grade 0-1); and
   4. Trastuzumab to be administered in combination with pertuzumab; and
   5. Trastuzumab to be discontinued at disease progression.

Renewal- (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
2. The cancer has not progressed at any time point during the previous 12 months whilst on trastuzumab; and
3. Trastuzumab not to be given in combination with lapatinib; and
4. Trastuzumab to be discontinued at disease progression.

• No other changes to the current funding criteria for trastuzumab are proposed.
• An amended confidential rebate would apply to Herceptin that would reduce its net price to the Funder.
• Herceptin would have protection from delisting and subsidy reduction until 31 December 2018.

Special Authority for Subsidy

Initial application only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Patient has locally advanced or metastatic, unresectable, non-squamous Non Small Cell Lung Cancer (NSCLC); and
2. There is documentation confirming that the disease expresses activating mutations of EGFR tyrosine kinase; and
3. Any of the following:
   1. Patient is treatment naive; or
   2. Both:
      1. Patient has documented disease progression following treatment with first line platinum based chemotherapy; and
      2. Patient has not received prior treatment with gefitinib; or
   3. Both:
      1. The patient has discontinued gefitinib within 12 weeks of starting treatment due to intolerance; and
      2. The cancer did not progress while on gefitinib; and or
   4. Both:
      1. Patient has had treatment with gefitinib prior to 1 April 2017; and
      2. Patient’s disease has not progressed; and
4. Erlotinib is to be given for a maximum of 3 months.

Renewal only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months where radiological assessment (preferably including CT scan) indicates NSCLC has not progressed.