Decision in relation to infliximab, tocilizumab and rituximab

Medicines

Decision

We’re pleased to announce a decision on how three hospital medicines (infliximab, tocilizumab and rituximab) are managed within the Pharmaceutical Schedule.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 6 September 2018. Some changes were made to the proposal as a result of feedback that we received:

  • Minor changes to the renewal criteria for infliximab for inflammatory bowel disease have been made to allow existing patients to continue on their current treatment plans.
  • The initial application criteria for infliximab for ocular inflammation have been amended to better align with current treatment practices in paediatrics.
  • The criteria for pulmonary sarcoidosis and neurosarcoidosis have been updated to include diagnosis by a multidisciplinary team.

Who we think will be most interested

Anyone with an interest in the supply, provision or use of infliximab, rituximab or tocilizumab within DHB hospitals. As this proposal is an administrative change, we expect that patients should not notice any differences in the way they access these treatments.

Detail about this decision

We will make the following changes to the Pharmaceutical Schedule on 1 February 2019:

  • Infliximab and tocilizumab will be listed in Section B of the Pharmaceutical Schedule under Special Authority criteria and a ‘PCT only’ restriction, meaning that only DHB hospitals will be able to submit subsidy claims.
  • The Special Authority criteria for rituximab will be amended to include non-cancer uses such as rheumatoid arthritis and nephrotic syndrome.
  • The General Rules of the Schedule will be modified to expand the scope of the PCT claiming mechanism, which is currently limited to cancer treatments.

These changes will allow DHB hospitals to apply for Special Authority approvals for their existing patients from 1 February 2019, so these are in place by 1 April 2019. From 1 April 2019, DHB hospitals will submit subsidy claims for their use of infliximab, rituximab and tocilizumab. We will be in touch with DHBs in the near future with more information about this decision.

This change supports the Government’s decision to expand the scope of the Combined Pharmaceutical Budget (CPB) to include the cost of all hospital medicines. The CPB now encompasses medicines and medical devices funded in the community, all hospital medicines and all funded vaccines.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. All consultation responses received were considered in their entirety. As a result of the feedback received, we have made some changes to the original proposal.

We received a range of feedback on the proposed Special Authority criteria – both suggested amendments to the access criteria within the proposed indications, and some suggesting more broader funding changes. A summary of this feedback is below.

Issue Comment

Requests for the maximum dosing of infliximab in inflammatory bowel disease to allow higher doses as part of the use of therapeutic dose monitoring.

Some respondents noted that this has started to be used within DHB hospitals already.

PHARMAC has received, and has started to consider, a funding application for the use of higher infliximab doses for inflammatory bowel disease.

Patients already being treated with higher doses will be able to continue on their current treatment plans as we recognise abrupt mandatory reductions may cause management issues in these patients. In other cases, and all new patients, clinicians will be expected to follow the existing dosing limitations that exist to ensure this expensive treatment is targeted appropriately in an equitable manner.

Requests for the infliximab criteria relating to uveitis to be modified to better accommodate use of this agent in paediatrics.

We have amended the uveitis criteria to reflect the feedback that we received.

A suggestion for the initiation criteria for infliximab for both pulmonary sarcoidosis and neurosarcoidosis to include diagnosis by a multidisciplinary team.

We have amended the criteria accordingly.

Requests for the criteria for infliximab be modified to bring it more in line with other funded biologic treatments, specifically:

  • Allowing infliximab to be used as a first-line biologic agent in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis
  • Reducing the PASI score threshold to 10 to be to be in line with the restriction for secukinumab.

We would welcome a funding application supported by evidence for such wider use of infliximab.

We note that in considering its use as a first-line agent, the additional costs of administration of infliximab compared to other self-administered biologics would be considered as part of that process.

Requests for the infliximab criteria to include for other forms of sarcoidosis.

We have not received, but would welcome, a funding application for the use of infliximab for these indications.

Requests for the criteria for rituximab to be expanded to include:

  • myasthenia gravis
  • neuromyelitis optica spectrum disorder
  • Anti-MAG neuropathy
  • antibody mediated rejection in solid organ transplant

We have previously considered a funding application for use of rituximab in severe refractory myasthenia gravis. PTAC recommended expanding access for this indication with a low priority.

Rituximab is currently listed in Section H for antibody-mediated rejection in renal transplants.

We would welcome funding applications for the other indications.

Requests for tocilizumab to be funded for uveitis.

We have not received, but would welcome, a funding application for the use of tocilizumab in this indication.

Requests for vedolizumab to be funded for inflammatory bowel disease.

We have received a funding application for the listing of vedolizumab, although we note that this medicine has not yet been submitted to Medsafe for registration in New Zealand.

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.