Decisions relating to multiple sclerosis treatments

Medicines

Decision

PHARMAC announces funding of new multiple sclerosis treatments and changes to the funding criteria for multiple sclerosis medicines.

PHARMAC is pleased to announce that, from 1 November 2014, it will:

  • list fingolimod (Gilenya);
  • list natalizumab (Tysabri); and
  • change the restrictions for funded access for interferon beta-1-alpha (Avonex), interferon beta-1-beta (Betaferon) and glatiramer acetate (Copaxone)

in both the community and hospital sections of the Pharmaceutical Schedule.

This decision was the subject of a consultation letter dated 7 August 2014.

The fingolimod listing is the result of a multiproduct agreement with Novartis. For information about the decision regarding the multi-product agreement (including details on the other products involved), see our website.

In summary, the effect of the decision relating to multiple sclerosis (MS) treatments is that from 1 November 2014:

  • The new MS treatments (natalizumab and fingolimod) will be subsidised from first confirmed diagnosis of definitive relapsing remitting MS, for patients with an EDSS score of 0–4.0, who meet the funding criteria. The new funding criteria for all MS treatments have reduced relapse rate requirements. (The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in MS and is used to measure and assess disability and disease progression in MS.)
  • The currently available treatments – beta interferons and glatiramer acetate – will have changes to funding criteria. These treatments continue to be funded and will also be available for people earlier in their disease, for whom both fingolimod and natalizumab are not tolerated or clinically not appropriate.
  • The criterion requiring funded treatment to stop if the patient’s relapse rate is stable has been removed. Under the new stopping criteria, funded treatment would stop if patients have an increasing relapse rate. In addition, funding would cease if there is progression of disability by any of the following EDSS points (the first point is the EDSS at treatment entry, the second when treatment stops):
    • 0–3.0,  1.0–3.0,  1.5–3.5,  2.0–4.0,  2.5–4.5,  3.0–4.5,  3.5–4.5,  4.0–4.5
  • People currently receiving funded treatments can choose to stay on their existing treatment, or change to one of the new treatments (provided they meet the new EDSS entry criteria; 0–4).
  • People currently receiving funded treatments who do not meet the new EDSS entry criteria, and are therefore not eligible to switch, can continue funded treatment with interferon beta-1-alpha, interferon beta-1-beta or glatiramer acetate until they meet the stopping criteria that existed prior to 1 November 2014.

Following consideration of feedback to consultation some changes have been made to the Special Authority criteria to ensure clarity and/or better reflect the intent of the criteria. In addition to wording changes, there have been some substantive changes to the criteria, as detailed below. Note, a summary of the feedback received is provided in this notification from page 14 onwards.

  • The type of applicant for the MS treatments has been amended to include general physicians.
  • For the interferons and glatiramer acetate the word ‘contraindicated’ has been changed to ‘clinically inappropriate’. PHARMAC acknowledges that patients’ clinical situations are not static and therefore considers it appropriate for patients to be able to access treatment with the interferons or glatiramer acetate first-line, should treatment with both natalizumab and fingolimod be clinically not appropriate.
  • The funding criteria for the beta interferons or glatiramer acetate have been expanded to include a transition period for a small group of patients who are not currently accessing funded treatments, but who would actually be eligible under the pre-1 November 2014 funding criteria, as follows:
  • People with an EDSS of 4.5-5.5 and otherwise eligible for current funded MS treatments (e.g. 2 or more significant relapses in the previous year) but who had not previously accessed funded treatments, will have until 31 October 2015 to apply for treatment with one of the interferons or glatiramer acetate. Should they access funding they can continue funded treatment until they meet the stopping criteria, in the same way as patients with this EDSS score who are already receiving funding.

For purposes of comparison, the funding criteria that were consulted on can be found on our website. If you prefer to view all of the specific changes made since consultation as edits with deletions and new text, please email or write to us, we will be happy to provide it in this format.

Details of the decision and a summary of the feedback received can be found on the following pages.

Details of the decision

Questions and answers

More information

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.