Decision to award sole supply of infliximab in DHB hospitals

Source: Pharmac

What we’re doing

This decision means that:

• The Remicade brand of infliximab 100 mg injection, supplied by Janssen-Cilag Pty Ltd (Janssen), will have Hospital Supply Status with a 5% DV limit from 1 September 2020 until 30 June 2024.

• There will be no change in brand of infliximab for patients.

• A maximum of 5% of total DHB hospital purchases of infliximab 100 mg injection could be a brand other than Remicade.

• There will be no changes to the current funding criteria for infliximab 100 mg injection.

• The net price of infliximab 100 mg injection will reduce from 1 July 2020 via a confidential rebate.

This decision results from a Request for Proposal (RFP) for the supply of funded infliximab. 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 21 May 2020.

No changes were made to the original proposal following consultation feedback.

Who we think will be most interested

• People currently using infliximab and their family, whānau or caregivers
• Consumer support groups for people living with conditions that are treated with infliximab
• Clinicians who treat people with inflammatory and/or autoimmune conditions commonly treated with infliximab (dermatologists, gastroenterologists, ophthalmologists, neurologists, respiratory physicians, rheumatologists)
• Hospital and community pharmacists, DHBs and wholesalers
• Suppliers of infliximab

Detail about this decision

The following changes will occur in Section B and Part II of Section H of the Pharmaceutical Schedule.

Section H (Hospital Medicines List) and Section B changes

From 1 September 2020, there will be no change to the current listing of Remicade in Section B and Part II of Section H of the Pharmaceutical Schedule:

Infliximab 100 mg injection is listed in Section B of the Pharmaceutical Schedule under Special Authority criteria for hospital claiming purposes only; it is not available for dispensing from community pharmacy.

From 1 September 2020, the Remicade brand of infliximab 100 mg injection will be awarded Hospital Supply Status in the Pharmaceutical Schedule (the only available brand of infliximab in DHB hospitals, subject to a 5% DV limit) until 30 June 2024.

Summary of funding of infliximab

Chemical	Formulation	Brand	Pack size	Price and subsidy
Infliximab	Inj 100 mg	Remicade	1	$806.00
Infliximab	Inj 1 mg for ECP	Baxter	1 mg	$8.29

While the Pharmaceutical Schedule list price will remain the same, at $806.00 per 100 mg injection, a new confidential rebate will apply to Remicade from 1 July 2020 that will reduce the net price to the funder. The price and subsidy of infliximab injection 1 mg for ECP will remain unchanged at $8.29 per 1 mg.

This proposal will free up significant funds that can be used to fund other medicines for better health outcomes 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 help us to improve health outcomes by releasing additional funds for investing in other medicines for the benefit of New Zealanders.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in the feedback and our responses to these are summarised in the table below. Some feedback was of a commercial nature in relation to the RFP and this has been responded to separately.

Theme	PHARMAC Comment
Support for the proposal
Support for the proposal as it provides continuity of treatment for patients currently on infliximab.	We are pleased to be able to ensure ongoing access to infliximab while freeing up funds to fund other medicines for the benefit of New Zealanders.
Concerns about the impact of the proposal on biosimilar competition
Responders queried the impact of proceeding with the incumbent supplier on future competitive processes regarding biosimilars.	We remain supportive of biosimilar medicines. We continue to be driven by our overall objective to ensure the best health outcomes for New Zealanders from pharmaceuticals within the funding provided. In pursuit of this objective, we will continue to consider implementing brand changes, including to biosimilar medicines.
Request to amend infliximab criteria and fund other agents for patients with inflammatory bowel disease (IBD)
Responders made a number of requests for wider access to infliximab and adalimumab as well as funding of new treatments for IBD, including ustekinumab, vedolizumab, golimumab and tofacitinib.	A number of funding applications for wider access and new treatments for IBD are currently under consideration by PHARMAC. Full details of the advice received and the status of applications relating to IBD are available via the Application Tracker: We have not received a funding application for tofacitinib for gastrointestinal conditions. We would welcome an application, with supporting evidence for funding of tofacitinib for the treatment of Crohn’s disease and/or Ulcerative Colitis.  This decision will not prevent PHARMAC from considering widened access to infliximab, or funding of new agents for IBD, in the future and these remain options under consideration for funding.
Request to amend infliximab criteria for patients with psoriasis
Request for infliximab Special Authority criteria for patients with severe chronic plaque psoriasis to be amended to align with the currently listed criteria for other biologics.	We acknowledge there is a difference in access between these agents and following consultation feedback we are in the process of progressing changes to align the criteria across the funded biologics. Any changes would be notified via the Pharmaceutical Schedule Update.

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 660 050.

MIL OSI