Multi-product proposal involving ten pharmaceuticals

Special Authority for Subsidy – Retail Pharmacy

Initial application — (severe chronic plaque psoriasis – second-line biologic) only from a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. The patient has had an initial Special Authority approval for adalimumab or etanercept, or has trialled infliximab in a DHB hospital in accordance with the HML rules, for severe chronic plaque psoriasis; and
2. Either:
   1. The patient has experienced intolerable side effects from adalimumab, etanercept or infliximab; or
   2. The patient has received insufficient benefit from adalimumab, etanercept or infliximab; and
3. A Psoriasis Area and Severity Index (PASI) assessment or Dermatology Quality of Life Index (DLQI) assessment has been completed for at least the most recent prior treatment course, preferably while still on treatment but no longer than 1 month following cessation of each prior treatment course; and
4. The most recent PASI or DQLI assessment is no more than 1 month old at the time of application.

Initial application — (severe chronic plaque psoriasis – first-line biologic) only from a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Either:
   1. Patient has "whole body" severe chronic plaque psoriasis with a Psoriasis Area and Severity Index (PASI) score of greater than 10, where lesions have been present for at least 6 months from the time of initial diagnosis; or
   2. Patient has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
2. Patient has tried, but had an inadequate response (see Note) to, or has experienced intolerable side effects from, at least three of the following (at maximum tolerated doses unless contraindicated): phototherapy, methotrexate, ciclosporin, or acitretin; and
3. A PASI assessment or Dermatology Quality of Life Index (DLQI) assessment has been completed for at least the most recent prior treatment course, preferably while still on treatment but no longer than 1 month following cessation of each prior treatment course; and
4. The most recent PASI or DQLI assessment is no more than 1 month old at the time of application.

Note: 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.

Renewal — (severe chronic plaque psoriasis – first and second-line biologic) only from a dermatologist or medical practitioner on the recommendation of a dermatologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Either
   1. Patient’s PASI score has reduced by 75% or more (PASI 75) as compared to baseline PASI prior to commencing secukinumab; or
   2. Patient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, as compared to baseline DLQI prior to commencing secukinumab; and
2. Secukinumab to be administered at a maximum dose of 300 mg monthly.

• The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
• Cosentyx would have protection from delisting and subsidy reduction until 1 October 2020.

Special Authority for Subsidy – Retail pharmacy

Initial application from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. Patient has heart failure; and
2. Any of the following:
   1. Patient is in NYHA/WHO functional class II; or
   2. Patient is in NYHA/WHO functional class III; or
   3. Patient is in NYHA/WHO functional class IV; and
3. Patient has a documented left ventricular ejection fraction (LVEF) of less than or equal to 35%; and
4. Patient is receiving concomitant optimal standard chronic heart failure treatments.

Renewal from any relevant practitioner. Approvals valid for 12 months for applications where the treatment remains appropriate and the patient is benefiting from treatment.

Note: Due to the angiotensin II receptor blocking activity of sacubitril with valsartan it should not be co-administered with an ACE inhibitor or ARB.

• The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
• Entresto would have protection from delisting and subsidy reduction until 1 October 2021.

Special Authority for Subsidy – Retail pharmacy

Initial application only from a haematologist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient has primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis; and
2. A classification of risk of intermediate-2 or high-risk myelofibrosis according to either the International Prognostic Scoring System (IPSS), Dynamic International Prognostic Scoring System (DIPSS), or the Age-Adjusted DIPSS; and
3. A maximum dose of 20 mg b.d. per day is to be given.

Renewal 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 treatment remains appropriate and the patient is benefiting from treatment; and
2. A maximum dose of two tablets (5 mg, 15 mg or 20 mg) per day is to be given.  

• The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
• Jakavi would have protection from delisting and subsidy reduction until 1 October 2021.

All of the following:

1. Patient has a significant and well-documented contraindication to splenectomy for clinical reasons; and
2. Two immunosuppressive therapies have been trialled and failed after therapy of 3 months each (or 1 month for rituximab); and
3. Either:
   1. Patient has immune thrombocytopenic purpura* with a platelet count of less than or equal to 20,000 platelets per microliter; or
   2. Patient has immune thrombocytopenic purpura* with a platelet count of 20,000 to 30,000 platelets per microlitre and significant mucocutaneous bleeding.

Renewal – (idiopathic thrombocytopenic purpura contraindicated to splenectomy) only from a haematologist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient’s significant contraindication to splenectomy remains; and
2. The patient has obtained a response from treatment during the initial approval period; and
3. Patient has maintained a platelet count of at least 50,000 platelets per microlitre on treatment; and
4. Further treatment with eltrombopag is required to maintain response.

Initial application – (severe aplastic anaemia) only from a haematologist. Approvals valid for 3 months for applications meeting the following criteria:

Both:

1. Two immunosuppressive therapies have been trialled and failed after therapy of at least 3 months duration; and
2. Either:
   1. Patient has severe aplastic anaemia with a platelet count of less than or equal to 20,000 platelets per microliter; or
   2. Patient has severe aplastic anaemia with a platelet count of 20,000 to 30,000 platelets per microlitre and significant mucocutaneous bleeding.

Renewal – (severe aplastic anaemia) only from a haematologist. Approvals valid for 12 months for applications meeting the following criteria:

Both:

1. The patient has obtained a response from treatment of at least 20,000 platelets per microlitre above baseline during the initial approval period; and
2. Platelet transfusion independence for a minimum of 8 weeks during the initial approval period.

Initial application – (severe chronic spontaneous urticaria) only from a clinical immunologist or dermatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Patient must be 12 years or older; and
2. Patient is symptomatic with Urticaria Activity Score 7 (UAS7) of 20 or above; and
3. Patients has a Dermatology life quality index (DLQI) of 10 or greater; and
4. Any of the following:
   1. Patient has been taking high dose antihistamines (e.g. 4 times standard dose) and ciclosporin (>3 mg/kg day) for at least 3 months; or
   2. Patient has been taking high dose antihistamines (e.g. 4 times standard dose) and corticosteroids (>20 mg prednisone per day); or
   3. Patient has developed significant adverse effects whilst on corticosteroids or ciclosporin; and
5. Treatment to be stopped if inadequate response* following 4 doses.

Renewal – (severe chronic spontaneous urticaria) only from a clinical immunologist or dermatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Patient has previously responded to 6 doses of omalizumab; and
2. Patient’s current Urticaria Activity Score is greater than 6; and
3. Patient’s current DLQI score is greater than 5.

Note: *Patient is to be reassessed for response (50% reduction in baseline UAS7 and DLQI score) after 4 doses of omalizumab. Relapse of chronic urticaria on stopping prednisone/ciclosporin does not justify the funding of omalizumab.

• Amendments to the indication of severe, life-threatening asthma would apply as follows (note that final proposed criteria are shown for asthma, rather than marked up changes from the current criteria):

Initial application – (severe asthma)only from a respiratory specialist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Patient must be aged 6 years or older; and
2. Patient has a diagnosis of severe, life threatening asthma; and
3. Past or current evidence of atopy, documented by skin prick testing or RAST; and
4. Total serum human immunoglobulin E (IgE) between 76 IU/mL and 1300 IU/ml at baseline; and
5. Proven adherence with optimal inhaled therapy including high dose inhaled corticosteroid (budesonide 1,600 mcg per day or fluticasone propionate 1,000 mcg per day or equivalent), plus long-acting beta-2 agonist therapy (at least salmeterol 50 mcg bd or eformoterol 12 mcg bd) for at least 12 months, unless contraindicated or not tolerated; and
6. Either:
   1. Patient has received courses of systemic corticosteroids equivalent to at least 28 days treatment in the past 12 months, unless contraindicated or not tolerated; or
   2. Patient has had at least 4 exacerbations needing systemic corticosteroids in the previous 12 months, where an exacerbation is defined as either documented use of oral corticosteroids for at least 3 days or parenteral steroids; and
7. Patient has an Asthma Control Test (ACT) score of 10 or less; and
8. Baseline measurements of the patient’s asthma control using the ACT and oral corticosteroid dose must be made at the time of application, and again at around 26 weeks after the first dose to assess response to treatment.

Renewal – (severe asthma) only from a respiratory physician. Approvals valid for 2 years for applications meeting the following criteria:

Both

1. An increase in the Asthma Control Test (ACT) score of at least 5 from baseline; and
2. A reduction in the maintenance oral corticosteroid dose or number of exacerbations of at least 50% from baseline

• Xolair would have protection from delisting and subsidy reduction until 1 October 2020.

Initial application – (non-transplant indications) only from a relevant specialist. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Both:

1. Patient requires long-term systemic immunosuppression; and
2. Ciclosporin has been trialled and discontinued treatment because of unacceptable side effects or inadequate clinical response.

• Tacrolimus Sandoz would have protection from delisting and subsidy reduction until 1 October 2020.