Multi-product proposal involving ten pharmaceuticals

Medicines

Consultation Closed

What we’re proposing

PHARMAC is seeking feedback on a proposal to fund five new treatments, widen access to three currently funded treatments and change the contractual terms for two currently funded treatments through a provisional agreement with Novartis New Zealand Limited (Novartis).

In summary, this proposal would result in the following changes from 1 October 2018:

  • Funding of five new treatments supplied by Novartis:
    • Secukinumab (Cosentyx) for severe chronic plaque psoriasis
    • Sacubitril with valsartan (Entresto) for chronic heart failure
    • Vildagliptin (Galvus) for type 2 diabetes mellitus
    • Vildagliptin with metformin (Galvus Met or Galvumet*) for type 2 diabetes mellitus
      (*Brand name of vildagliptin with metformin yet to be determined.)
    • Ruxolitinib (Jakavi) for myelofibrosis
  • Widening of access to three currently funded treatments supplied by Novartis:
    • Eltrombopag (Revolade) for idiopathic thrombocytopenic purpura contraindicated to splenectomy and severe aplastic anaemia
    • Omalizumab (Xolair) for chronic spontaneous urticaria and severe asthma
    • Tacrolimus (Tacrolimus Sandoz) for non-transplant indications
  • Amended contractual terms (including pricing, rebates and protection periods) for:
    • Basiliximab (Simulect) for use in solid organ transplant
    • Fingolimod (Gilenya) for relapsing remitting multiple sclerosis

Further details of this proposal, including how to provide feedback and background information, follows. Hyperlinks have been provided to make it easier for people to access the sections they are most interested in.

Consultation closes at 5.00 pm on Monday, 23 July 2018 and feedback can be emailed to Danae Staples-Moon, Therapeutic Group Manager, via consult@pharmac.govt.nz

Therapeutic area

Treatment

Brand name

Dermatology

Secukinumab

Cosentyx

Cardiology

Sacubitril with valsartan

Entresto

Diabetes

Vildagliptin

Vildagliptin with metformin

Galvus

Galvus Met/Galvumet

Haematology

Ruxolitinib

Eltrombopag

Jakavi

Revolade

Dermatology

Respiratory

Omalizumab

Xolair

Immunosuppressants

Tacrolimus

Basiliximab

Tacrolimus Sandoz

Simulect

Nervous system

Fingolimod

Gilenya

Details about our proposal

New listings

Secukinumab (Cosentyx) for severe chronic plaque psoriasis

  • Secukinumab (Cosentyx) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Proposed price and subsidy

Secukinumab

Inj 150 mg per ml, 1 ml prefilled syringe

Cosentyx

2

$1,599.00

  • A confidential rebate would apply to Cosentyx that would reduce its net price to the Funder.
  • Secukinumab would be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

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:

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:

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:

  • 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.

Secukinumab background

Secukinumab is a recombinant fully human monoclonal antibody which selectively binds interleukin-17A to inhibit its proinflammatory effects.

Secukinumab is registered for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Secukinumab is given as a 4-weekly subcutaneous injection following initial dosing. Detailed information about secukinumab dosing and administration can be found in the Medsafe datasheet(external link).

A funding application for secukinumab was reviewed by our Pharmacology and Therapeutics Advisory Committee (PTAC) in May 2017 and by the Dermatology Subcommittee of PTAC in October 2017. Both committees recommended that secukinumab be funded with a medium or high priority as a first and second-line biologic for severe chronic plaque psoriasis, subject to Special Authority criteria that include the Dermatology Quality of Life Index as an alternative assessment of treatment response.

More information, including links to the PTAC and Subcommittee minutes, can be found in the Application Tracker records for secukinumab second-line and first-line.

Sacubitril with valsartan (Entresto) for chronic heart failure

  • Sacubitril with valsartan (Entresto) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Proposed price and subsidy

Sacubitril with valsartan

Tablet 24.3 mg with valsartan 25.7 mg

Entresto 24/26

56

$190.00

Sacubitril with valsartan

Tablet 48.6 mg with valsartan 51.4 mg

Entresto 49/51

56

$190.00

Sacubitril with valsartan

Tablet 97.2 mg with valsartan 102.8 mg

Entresto 97/103

56

$190.00

  • A confidential rebate would apply to Entresto that would reduce its net price to the Funder.
  • Sacubitril with valsartan would be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

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:

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.

Sacubitril with valsartan background

Sacubitril with valsartan is a combination of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker valsartan. It is registered for the treatment of adult patients with chronic heart failure (NYHA Class II-IV) with reduced ejection fraction. Information about sacubitril valsartan dosing and administration can be found in the Medsafe datasheet(external link).

A funding application for sacubitril with valsartan was reviewed by PTAC in February 2017 and February 2018 and by the Cardiovascular Subcommittee of PTAC in September 2017. Both committees recommended funding with a high priority for the treatment of patients with heart failure.

More information, including links to the PTAC and Subcommittee minutes, can be found in the Application Tracker records for sacubitril with valsartan.

Vildagliptin (Galvus) and vildagliptin with metformin (Galvus Met or Glavumet) for type 2 diabetes mellitus

  • Vildagliptin (Galvus) and vildagliptin with metformin (Galvus Met or Galvumet*) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Proposed price and subsidy

Vildagliptin

Tablet 50 mg

Galvus

60

$40.00

Vildagliptin with metformin

Tablet 50 mg with 850 mg metformin

*Galvus Met or Galvumet

60

$40.00

Vildagliptin with metformin

Tablet 50 mg with 1,000 mg metformin

*Galvus Met or Galvumet

60

$40.00

  • A confidential rebate would apply to Galvus and Galvus Met (or Galvumet) that would reduce their net prices to the Funder. (*Brand name of vildagliptin with metformin yet to be determined.)
  • Vildagliptin and vildagliptin with metformin would be listed without funding restrictions in Section B and Part II of Section H of the Pharmaceutical Schedule.
  • A vildagliptin 50 mg with metformin 500 mg tablet presentation of vildagliptin with metformin may be listed at a future date yet to be determined.

Vildagliptin background

Vildagliptin (brand name Galvus or, when in combination with metformin, Galvus Met or Galvumet) is a dipeptidyl peptidase (DPP-4) inhibitor registered for use along with diet and exercise to improve glycaemic control in people with type 2 diabetes mellitus.  It can be used either on its own (as monotherapy) or at the same time as other diabetes treatments, such as metformin, a sulfonylurea, a thiazolidinedione, or insulin.  It is best used when diet, exercise, and a single antidiabetic agent do not result in adequate glycaemic control.

Information about vildagliptin dosing and administration can be found in the Medsafe datasheet for Galvus and Galvus Met(external link).

PTAC and the Diabetes Subcommittee of PTAC have reviewed vildagliptin as a treatment for type 2 diabetes on a number of occasions, including during reviews of antidiabetic agents. Both committees recommended that a DPP-4 inhibitor be funded with a low priority.

More information, including links to the PTAC and Subcommittee minutes, can be found in the Application Tracker records for vildagliptin.

Ruxolitinib (Jakavi) for myelofibrosis

  • Ruxolitinib (Jakavi) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Proposed price and subsidy

Ruxolitinib

Tablet 5 mg

Jakavi

56

$2,500.00

Ruxolitinib

Tablet 15 mg

Jakavi

56

$5,000.00

Ruxolitinib

Tablet 20 mg

Jakavi

56

$5,000.00

  • A confidential rebate would apply to Jakavi that would reduce its net price to the Funder.
  • Ruxolitinib would be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

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.

Ruxolitinib background

Ruxolitinib is a protein kinase inhibitor of genes that help control the number of blood cells produced and is registered for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

Information about ruxolitinib dosing and administration can be found in the Medsafe datasheet(external link).

A funding application for ruxolitinib was reviewed by PTAC in November 2016 and by the Haematology Subcommittee of PTAC in October 2017. Recommendations for the high-risk and intermediate-2 group were for funding with a medium and high priority by PTAC and the Subcommittee, respectively.

More information, including links to the PTAC and Subcommittee minutes, can be found in the Application Tracker records for ruxolitinib.

Existing listings – access widening and amendment of contractual terms

Eltrombopag (Revolade) for idiopathic thrombocytopenic purpura contraindicated to splenectomy and severe aplastic anaemia

  • The price and subsidy for eltrombopag (Revolade) would be reduced in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 as follows (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Current price and subsidy

Proposed price and subsidy

Eltrombopag

Tab 25 mg

Revolade

28

$1,771.00

$1,550.00

Eltrombopag

Tab 50 mg

Revolade

28

$3,542.00

$3,100.00

  • An amended confidential rebate would apply to Revolade that would reduce its net price to the Funder.
  • Access to eltrombopag (Revolade) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 to include idiopathic thrombocytopenic purpura contraindicated to splenectomy and severe aplastic anaemia as follows (new criteria only are shown below):

Initial application - (idiopathic thrombocytopenic purpura contraindicated to splenectomy) only from a haematologist. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

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:

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.

Eltrombopag background

Eltrombopag is used to treat idiopathic thrombocytopenic purpura with the aim of increasing the number of platelets in the blood in order to reduce the risk of bleeding. It is currently funded for patients with ITP as preparation for splenectomy and post splenectomy. Evidence now also supports the use of eltrombopag in the rare blood disorder aplastic anemia to increase blood cell counts.

Information about eltrombopag dosing and administration can be found in the Medsafe datasheet(external link).

PHARMAC has received a number of applications for the proposed patient groups under its Named Patient Pharmaceutical Assessment (NPPA) pathway and has sought expert clinical advice on those groups.  

Omalizumab (Xolair) for chronic spontaneous urticaria and severe asthma

  • The price and subsidy for the vial presentation of omalizumab (Xolair) would be reduced, and a new prefilled syringe presentation of omalizumab (Xolair) would be listed, in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 as follows (ex-manufacturer, excluding GST):
Chemical Presentation Brand Pack size Current price and subsidy Proposed price and subsidy
Omalizumab Inj 150 mg vial Xolair 1 $500.00 $450.00
Omalizumab Inj 150 mg prefilled syringe Xolair 1 N/A $450.00
  • A confidential rebate would apply to Xolair (both vial and prefilled syringe) that would reduce its net price to the Funder.
  • Access to omalizumab (Xolair) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 as follows:
    • New indication of chronic spontaneous urticaria would apply subject to the criteria outlined below (new criteria only are shown below):

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:

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:

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.

Omalizumab background

Omalizumab is a humanised monoclonal antibody indicated for the treatment of:

  • chronic idiopathic urticaria for patients who remain symptomatic despite H1 antihistamine treatment; and
  • the reduction of asthma exacerbations and control of asthma symptoms when given as add on therapy for patients with severe persistent allergic asthma.

It is currently funded for patients with severe, life-threatening asthma.

Omalizumab is given as a subcutaneous injection. Information regarding omalizumab, dosing and administration can be found in the Medsafe datasheet(external link).

In November 2015, PTAC recommended that access to omalizumab should be widened for the treatment of chronic idiopathic urticaria with a low priority. The Respiratory Subcommittee of PTAC in August 2017 and PTAC in November 2017 recommended that access be widened to omalizumab for severe asthma.

More information, including a link to the PTAC and Subcommittee minutes, can be found in the Application Tracker records for omalizumab for urticaria and asthma.

Tacrolimus (Tacrolimus Sandoz) for non-transplant indications

  • The price and subsidy for tacrolimus (Tacrolimus Sandoz) would be reduced in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 as follows (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Current price and subsidy

Proposed price and subsidy

Tacrolimus

Cap 0.5 mg

Tacrolimus Sandoz

100

$85.60

$55.64

Tacrolimus

Cap 1 mg

Tacrolimus Sandoz

100

$171.20

$111.28

Tacrolimus

Cap 5 mg

Tacrolimus Sandoz

50

$428.00

$278.20

  • An amended confidential rebate would apply to Tacrolimus Sandoz that would reduce its net price to the Funder.
  • There would be a further price decrease for tacrolimus (Tacrolimus Sandoz) in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 September 2019 which would be notified prior to this date.
  • Access to tacrolimus would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 to include non-transplant indications as follows (new criteria below):

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.

The access criteria that currently apply to patients with nephrotic syndrome would be replaced with the above criteria. Patients who currently have an active Special Authority approval for steroid resistance nephrotic syndrome would be eligible for funding under the proposed criteria.

The criteria that currently apply to transplant recipients would remain unchanged meaning that tacrolimus would remain a first line option for these patients. 

Tacrolimus background

Tacrolimus is an immunosuppressive agent mainly used to reduce the risk of organ rejection following organ transplant. It is currently funded subject to Special Authority and HML restrictions(external link) for organ transplant recipients and patients with steroid resistant nephrotic syndrome (unapproved indication). Information about tacrolimus dosing and administration can be found in the Medsafe datasheet(external link).

Tacrolimus is known to have a favourable adverse effect profile compared to another funded calcineurin inhibitor, ciclosporin. The proposal would provide another oral immunosuppressant option and may also delay progression to other immunosuppressants such as biologic agents.

In 2015, PTAC and the Transplant Immunosuppressant Subcommittee of PTAC recommended widening access to tacrolimus for patients with non-transplant indications. More information, including a link to the PTAC and Subcommittee minutes, can be found in the Application Tracker records for tacrolimus for non-transplant indications.

Basiliximab (Simulect) for use in solid organ transplant

  • The price for basiliximab (Simulect) would be reduced in Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 as follows (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Current price

Proposed price

Basiliximab

Inj 20 mg vial

Simulect

1

$3,200.00

$2,560.00

  • A confidential rebate would apply to Simulect that would further reduce its net price to the Funder.
  • No changes to the current funding criteria for basiliximab are proposed.

Basiliximab background

Basiliximab is a monoclonal antibody immunosuppressant used for prophylaxis of acute organ rejection following transplantation in adult and paediatric patients. It is indicated for use in renal transplant, however is also used for other organ transplants (unapproved indications).

Basiliximab is listed on the HML(external link) for use in solid organ transplant. Patients receive two doses intravenously in the first few days following transplant, determined by local DHB clinical protocols for each organ. Information about basiliximab dosing and administration can be found in the Medsafe datasheet(external link).

Fingolimod (Gilenya) for relapsing remitting multiple sclerosis

  • The price and subsidy for fingolimod (Gilenya) would be reduced in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 October 2018 as follows (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Current price and subsidy

Proposed price and subsidy

Fingolimod

Cap 0.5 mg

Gilenya

28

$2,650.00

$2,200.00

  • An amended confidential rebate would apply to Gilenya that would reduce its net price to the Funder.
  • Gilenya would have protection from delisting and subsidy reduction until 1 April 2020.
  • No changes to the current funding criteria for fingolimod are proposed.

Fingolimod background

Fingolimod is a sphingosine-1-phosphate receptor modulator indicated for the treatment of relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of relapses and to delay the progression of disease. Fingolimod is an oral capsule taken once daily.

Fingolimod was first listed in the Pharmaceutical Schedule from 1 November 2104, subject to funding criteria. No changes to the current funding criteria are proposed in this consultation.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5.00 pm on Monday, 23 July 2018.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.