Proposal to award sole supply of infliximab in DHB hospitals
We are proposing to award sole supply of infliximab, a biologic medicine used to treat a range of inflammatory and autoimmune conditions, from 1 September 2020.
A decision has been made
If the proposal is approved, this would mean:
- the Remicade brand of infliximab 100 mg injection, supplied by Janssen-Cilag Pty Ltd (Janssen), would have Hospital Supply Status from 1 September 2020 until 30 June 2024
- a maximum of 5% of total purchases of infliximab 100 mg injection could be a brand other than Remicade
- there would be no changes to the current funding criteria for infliximab 100 mg injection
- the net price of infliximab 100 mg injection would reduce from 1 July 2020.
As Remicade is currently the only funded brand of infliximab, this proposal would not result in any changes for patients currently using infliximab.
This proposal results from a competitive process for the supply of funded infliximab. 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 Wednesday 10 June 2020 and feedback can be emailed to email@example.com.
What would the effect be?
For people using infliximab
There would be no change for people who currently use funded infliximab.
Prescribers would continue to be able to prescribe infliximab as they do now and there would be no change to the funded brand or the funding criteria for infliximab.
For community pharmacies
There would be no impact on community pharmacies, because infliximab is only funded for use in the hospital setting.
For hospital pharmacies
The Remicade brand of infliximab 100 mg injection would have Hospital Supply Status until 30 June 2024.
From 1 September 2020, a discretionary variance (DV) limit of 5% would apply in DHB hospitals, meaning that a maximum of 5% of total purchases of infliximab 100 mg injection could be a brand other than Remicade.
From 1 July 2020, the confidential net price of Remicade would reduce. The list price in the Pharmaceutical Schedule would remain the same at $806.00 per 100 mg injection. The price of infliximab injection 1 mg for ECP would remain the same in the Pharmaceutical Schedule at $8.29 per 1 mg.
Who we think will be 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, nurse specialists, general practitioners)
- Hospital and community pharmacists, DHBs and wholesalers
- Suppliers of infliximab
About infliximab and its uses
Infliximab is a chimeric monoclonal antibody that binds to human tumour necrosis factor alpha (TNF-α). TNF-α is a signalling protein that increases the activities of cells involved in inflammation. Infliximab binds to TNF-α, interfering with TNF-α activity and reducing inflammation.
Infliximab (brand name Remicade, supplied by Janssen) has been listed on the Pharmaceutical Schedule as the only funded brand of infliximab since 1 July 2013 for patients who meet certain clinical criteria. [download no longer available].
Infliximab is administered by intravenous infusion, usually in a DHB hospital outpatient clinic setting. Infliximab is funded at various doses depending on the indication (disease setting), typically 3-5 mg/kg every 6-8 weeks.
Infliximab is currently funded for a range of inflammatory and autoimmune conditions, which include both approved and unapproved indications as follows:
- rheumatoid arthritis
- ankylosing spondylitis
- Crohn’s disease
- psoriatic arthritis
- plaque psoriasis
- ulcerative colitis
- severe Behcet’s disease
- severe and chronic ocular inflammation
- steroid refractory acute graft vs host disease of the gut
- pulmonary sarcoidosis
Why we’re proposing this
As a result of the RFP, PHARMAC has entered into a provisional agreement with Janssen for the sole supply of infliximab (Remicade).
This proposal would release significant funds for PHARMAC to invest in other medicines for the benefit of New Zealanders.
Feedback from this consultation will help us decide if the agreement with Janssen should be confirmed.
Multiple biosimilars of infliximab are approved by Medsafe for use in New Zealand and are available overseas. A biosimilar is a highly similar, comparable version of an approved biological medicine. The availability of biosimilars provided PHARMAC with the opportunity to promote competition to secure supply and reduce the cost of infliximab. Medicines that inhibit TNF-α, like infliximab, are currently among the highest expenditure items funded from the Combined Pharmaceutical Budget.
Background to RFP
The first competitive process for infliximab was a Request for Tender (RFT) issued in September 2014. Prior to release of that RFT, PHARMAC sought clinical advice regarding biosimilar infliximab, the proposed competitive process and the implementation support for any brand change in the infliximab market. The relevant records are available below:
- PTAC meeting May 2014 [PDF, 286 KB]
- Gastrointestinal Subcommittee of PTAC meeting May 2014 [PDF, 124 KB]
- Ophthalmology Subcommittee of PTAC meeting October 2014 [PDF, 135 KB]
- Rheumatology Subcommittee of PTAC July 2014 [PDF, 75 KB]
The sole supply arrangement that resulted from this RFT expired in February 2020, opening the way for a further open competitive process to occur, and an RFP was released in August 2019.
Following receipt of proposals in response to the RFP, PHARMAC undertook extensive evaluation of the proposals. This included seeking additional clinical advice from members of PTAC and the above three Subcommittees in March 2020 as part of the evaluation process. Following the RFP evaluation process, Janssen’s proposal for sole supply of the Remicade brand of infliximab was selected as the preferred proposal.
Details about our proposal
From 1 September 2020, there would be no change to the current listing of Remicade in Section B and Part II of Section H of the Pharmaceutical Schedule; the current Special Authority criteria and hospital restrictions for Remicade would continue to apply. The price of infliximab injection 1 mg for ECP would remain at the current price listed on the Pharmaceutical Schedule at $8.29 per 1 mg.
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 would 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.
While the Pharmaceutical Schedule list price would remain the same, at $806.00 per 100 mg injection, a new confidential rebate would apply to Remicade from 1 July 2020, which would reduce the net price to the funder.
To provide feedback
Send us an email: firstname.lastname@example.org by 5pm Wednesday 10 June 2020.
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.