Proposal to widen access to etanercept and award sole supply

Medicines

Consultation Closed

We are proposing to make changes to the funding of etanercept, a biologic medicine used to reduce chronic inflammation and treat immune-mediated conditions such as arthritis and psoriasis, from 1 July 2019.

We are proposing to make changes to the funding of etanercept, a biologic medicine used to reduce chronic inflammation and treat immune-mediated conditions such as arthritis and psoriasis, from 1 July 2019.

If the proposal is approved, the following changes would occur:  

  • the current funded brand of etanercept, Enbrel (supplied by Pfizer), would remain fully funded and would be the only funded brand from 1 September 2019 until 30 June 2024;
  • funded access for severe chronic plaque psoriasis would be widened by lowering the entry severity and including an alternate measure of treatment response, from 1 July 2019;
  • a new 25 mg autoinjector would be listed in the future;
  • the net price of etanercept would reduce from 1 July 2019.

This proposal results from a competitive process for the supply of funded etanercept. It would release significant funds for PHARMAC to invest in other medicines for the benefit of New Zealanders.

Feedback to this consultation will help us decide if this proposal should be approved.

Consultation closes at 5pm on Friday, 17 May 2019 and feedback can be emailed to procurement@pharmac.govt.nz.

What would the effect be?


For patients

There would be no change for patients who currently access funded etanercept.

All current forms of etanercept would remain funded and a new 25 mg autoinjector would be funded in the future (subject to approval by Medsafe).

Patients with severe chronic plaque psoriasis would be able to access etanercept earlier in their disease course.


For prescribers

Prescribers would continue to be able to prescribe funded etanercept as they do now.

From 1 July 2019, relevant prescribers would be able to consider treatment with funded etanercept (Enbrel) in patients with severe chronic plaque psoriasis who have a PASI score of greater than 10 (previously the PASI score had to be greater than 15). Changes to the funding criteria would also allow for the DLQI to be used as an alternative assessment of treatment response. This change in access criteria for severe chronic plaque psoriasis would align with recent changes to the Special Authority criteria for adalimumab and secukinumab for this indication.

All other criteria for etanercept would remain unchanged.


For community pharmacies

There would be no impact on community pharmacies.


For hospital pharmacies

From 1 September 2019, Enbrel would be the only funded etanercept in both community and hospital settings. A discretionary variant (DV) limit of 5% would apply in DHB hospitals, meaning that only 5% of total purchases of the relevant presentation of etanercept could be a brand other than Enbrel (such as a biosimilar etanercept).


For DHBs

From 1 July 2019, the confidential net price would reduce for etanercept.

Who we think will be interested

  • People currently using etanercept and their family, whānau or caregivers
  • Consumer support groups for people living with rheumatic and skin conditions 
  • Clinicians who treat people with rheumatological and skin conditions (rheumatologists, dermatologists, general practitioners, nurse specialists, clinician groups)
  • Hospital and community pharmacists, DHBs, and wholesalers
  • Suppliers of etanercept and biologic medicines

About etanercept

Etanercept is a recombinant human tumour necrosis factor (TNF) inhibitor (a biologic medicine) that reduces chronic inflammation and immune response activation. Tumour necrosis factor (TNF) is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. TNF plays an important role in the inflammatory processes of long-term conditions such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Elevated levels of TNF are found in tissues and fluids of people with these conditions.

Etanercept has been listed on the Pharmaceutical Schedule since 2004, subject to Special Authority funding restrictions that have been widened over time.

Etanercept is delivered by weekly or twice weekly subcutaneous injections. Two other TNF-targeting agents, adalimumab and infliximab, are funded for similar indications subject to the same or similar restrictions.

Currently, etanercept (Enbrel, supplied by Pfizer) is funded for eligible patients via Special Authority criteria for the following conditions:

  • juvenile idiopathic arthritis
  • rheumatoid arthritis
  • severe chronic plaque psoriasis
  • ankylosing spondylitis
  • psoriatic arthritis
  • pyoderma gangrenosum
  • adult-onset Still’s disease

Why we’re proposing this

PHARMAC released a Request for Proposal (RFP) for the supply of etanercept in the community and DHB hospitals on 22 November 2018.

Several biosimilar etanercept products are now approved by Medsafe for use in New Zealand. A biosimilar is a highly similar, comparable version of an approved biologic medicine. The availability of biosimilars provided PHARMAC with the opportunity to promote competition and reduce the cost of etanercept. TNF inhibitors are currently among PHARMAC’s highest expenditure items.

In August 2018, the Pharmacology and Therapeutics Advisory Committee (PTAC) reviewed a funding application for a biosimilar etanercept and recommended that PHARMAC run a competitive process for the supply of etanercept for currently funded indications. Overall, PTAC considered that biosimilar etanercept would provide the same or similar quality, safety and efficacy to etanercept (Enbrel) and that patients could be changed to biosimilar etanercept with implementation support [PDF, 665 KB]

As a result of the RFP, PHARMAC has entered into a provisional agreement with Pfizer New Zealand Limited for the sole supply of etanercept (Enbrel) prefilled syringes, autoinjectors and vials.

This proposal would release significant funds for PHARMAC to invest in other medicines for the benefit of New Zealanders. Feedback to this consultation will help us decide if this agreement should be confirmed.

PHARMAC remains supportive of, and will continue to consider, funding other biosimilar medicines in the future. We remain committed to implementing changes to introduce biosimilar medicines where they would release additional funds for PHARMAC to invest in other medicines for the benefit of New Zealanders.

Details about our proposal

From 1 July 2019 there would be no change to the current listing of Enbrel in Section B and Part II of Section H of the Pharmaceutical Schedule.

A new 25 mg autoinjector would be listed in the future (date to be determined), following approval by Medsafe.

A confidential rebate would apply to all presentations of Enbrel, which would reduce the net price to the funder.

From 1 July 2019 the Special Authority criteria for etanercept for severe chronic plaque psoriasis would be amended in Section B (community) of the Pharmaceutical Schedule for as follows (changes in bold and strikethrough – relevant criterion only shown):

Special Authority for Subsidy

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

Either:

  1. Both:

1.1.   The patient has had an initial Special Authority approval for adalimumab for severe chronic plaque psoriasis; and

1.2.   Either:

1.2.1.  The patient has experienced intolerable side effects from adalimumab; or

1.2.2.  The patient has received insufficient benefit from adalimumab to meet the renewal criteria for adalimumab for severe chronic plaque psoriasis; or

  1. All of the following:

2.1.   Either:

2.1.1.  Patient has "whole body" severe chronic plaque psoriasis with a Psoriasis Area and Severity Index (PASI) score of greater than 15 greater than 10, where lesions have been present for at least 6 months from the time of initial diagnosis; or

2.1.2.  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

2.2.   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

2.3.   A PASI assessment or Dermatology Quality of Life Index (DLQI) assessment has been completed for at least the most recent prior treatment course (but preferably all prior treatment courses), preferably while still on treatment but no longer than 1 month following cessation of each prior treatment course; and

2.4.   The most recent PASI or DLQI assessment is no more than 1 month old at the time of application.


Note: "Inadequate response" is defined as: for whole body severe chronic plaque psoriasis, a PASI score of greater than 15 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 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.

Renewal — (severe chronic plaque psoriasis) only from a dermatologist or Practitioner on the recommendation of a dermatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Either:

1.1.   Applicant is a dermatologist; or

1.2.   Applicant is a Practitioner and confirms that a dermatologist has provided a letter, email or fax recommending that the patient continues with etanercept treatment; and

  1. Either:

2.1.   Both:

2.1.1.Patient had "whole body" severe chronic plaque psoriasis at the start of treatment; and

2.1.2.Either

2.1.2.1.            Following each prior etanercept treatment course the patient has a PASI score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-treatment baseline value; or

2.1.2.2.            Following each prior etanercept treatment course the patient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, when compared with the pre-treatment baseline value; or

2.2.   Both:

2.2.1.Patient had severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot at the start of treatment; and

2.2.2.Either:

2.2.2.1.            Following each prior etanercept treatment course the patient has a reduction in the PASI symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the treatment course baseline values; or

2.2.2.2.            Following each prior etanercept treatment course the patient has a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-treatment baseline value; and

  1. Etanercept to be administered at doses no greater than 50 mg every 7 days.

Note: A treatment course is defined as a minimum of 12 weeks of etanercept treatment

The same changes to the restrictions for etanercept (Enbrel) would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

From 1 September 2019, Enbrel would be awarded Sole Subsidised Supply status in the community and Hospital Supply Status (the only available brand of etanercept in DHB hospitals, subject to a 5% DV limit) for all funded indications until 30 June 2024.

To provide feedback

Send us an email: procurement@pharmac.govt.nz by 5pm on 17 May 2019.

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.