Decision to widen access to etanercept and award sole supply

Medicines

Decision

PHARMAC has made a decision 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.

What we are doing

PHARMAC has made a decision 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.

This decision means that:

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

This decision results from a Request for Proposal (RFP) for the supply of etanercept. It will release significant funds for PHARMAC to invest in other medicines for the benefit of New Zealanders.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 3 May 2019.

No changes were made to the original proposal.

Who we think will be most 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.

Detail about this decision

From 1 July 2019 there will 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 will be listed in the future (date to be determined), following approval by Medsafe.

From 1 September 2019, Enbrel will be the only funded etanercept in both community and hospital settings for all indications until 30 June 2024. A discretionary variant (DV) limit of 5% will apply in DHB hospitals, meaning that only 5% of total purchases of the relevant presentation of etanercept can be a brand other than Enbrel (such as a biosimilar etanercept).

A confidential rebate will apply to Enbrel that will reduce the net price to the Funder.

This proposal will free up significant funds that can be used to fund other medicines for New Zealanders.

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.

Special Authority and hospital restriction changes

The Special Authority criteria and hospital indication restrictions will be amended from 1 July 2019 to widen access for severe chronic plaque psoriasis, lowering the entry severity and including an alternate measure of treatment response. This means that patients with severe chronic plaque psoriasis can access etanercept earlier.

This change in access criteria for severe chronic plaque psoriasis will align funded access with recent changes to the Special Authority criteria for adalimumab and secukinumab for the same indication.

For full details of the changes to the Special Authority criteria please refer to the consultation letter.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal and a summary of the main themes raised in feedback and our responses to the feedback received are set out below.

Theme

PHARMAC comment

Request for the wastage rule to be applied to the dispensing of both strengths of etanercept.

The wastage rule has not been added to etanercept.

We consider that the risk of pharmacies being left with unused stock of etanercept is very low. Etanercept is available in packs of 4 prefilled syringes, autoinjectors or vials. Given that dosing is usually weekly, the pack size provides up to 4 weeks of supply only and etanercept is dispensed monthly. We note that the wastage rule has not previously applied to etanercept and we are not aware of any issues this has caused.

Request for clarification as to whether the confidential rebate applies to both community and DHB hospital expenditure.

Yes, a confidential rebate will apply to all community claims and hospital use of funded etanercept.

Request to widen access to etanercept for undifferentiated spondyloarthritis.

Widening access to etanercept for this indication did not form part of the proposal as consulted on. An application to widen funded access to undifferentiated spondyloarthritis has been assessed and ranked and remains an option for funding in the future. The commercial arrangements for Enbrel allow for new indications to be funded in the future.

For updates on the funding application for undifferentiated spondyloarthritis, please refer to the Application Tracker on PHARMAC’s website.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.