Disease Modifying Treatment Special Authority Criteria

Special Authority for Subsidy

Special Authority approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC). Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria (below).
Application details may be obtained from PHARMAC’s website www.pharmac.govt.nz or contact:

The Coordinator
Multiple Sclerosis Treatment Assessment Committee
PHARMAC
PO Box 10 254
Wellington

Phone: 04 460 4990
Fax: 04 916 7571
Email: mstaccoordinator@pharmac.govt.nz

Completed application forms must be sent to the coordinator for MSTAC and will be considered by MSTAC at the next practicable opportunity. Notification of MSTAC’s decision will be sent to the patient, the applying clinician and the patient’s GP (if specified).

Entry Criteria

1. Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis must include MRI confirmation; and
2. patients must have Clinically Definite Relapsing Remitting MS with or without underlying progression; and
3. patients must have:
   1. EDSS score 0-4.0 and:
      • Experienced at least 1 significant relapse of MS in the previous 12 months or 2 significant relapses in the past 24 months; and
      • Evidence of new inflammatory activity on an MRI scan within the past 24 months, any of the following:
        1. a gadolinium enhancing lesion; or
        2. a Diffusion Weighted Imaging positive lesion; or
        3. a T2 lesion with associated local swelling; or
        4. a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse; or
        5. new T2 lesions compared with a previous MR scan; and
4. A significant relapse must:
   1. be confirmed by the applying neurologist or general physician (the patient may not necessarily have been seen by them during the relapse but the neurologist/physician must be satisfied that the clinical features were characteristic and met the specified criteria);
   2. be associated with characteristic new symptom(s)/sign(s) or substantial worsening of previously experienced symptom(s)/sign(s);
   3. last at least one week;
   4. start at least one month after the onset of a previous relapse;
   5. be severe enough to change either the EDSS or at least one of the Kurtzke Functional System scores by at least 1 point;
   6. be distinguishable from the effects of general fatigue; and
   7. not be associated with a fever (T>37.5°C);  and
5. applications must be made by the patient’s neurologist or general physician; and
6. patients must have no previous history of lack of response to the prescribed treatment;  and
7. patients must have not previously had intolerance to the prescribed treatment; and
8. patient must not be co-prescribed any other MS treatment.

Stopping Criteria

Any of the following:

1. Confirmed progression of disability that is sustained for six months.  Progression of disability is defined as progress by any of the following  EDSS points:
   1. From starting at EDSS 0 increasing to (i.e. stopping on reaching)  EDSS 3.0; or
   2. 1.0 to 3.0; or
   3. 1.5 to 3.5; or
   4. 2.0 to 4.0; or
   5. 2.5 to 4.5; or
   6. 3.0 to 4.5; or
   7. 3.5 to 4.5; or
   8. 4.0 to 4.5.
2. increasing relapse rate over 12 months of treatment (compared with the relapse rate on starting treatment) (see note);or
3. intolerance to the prescribed treatment; or
4. non-compliance with treatment, including refusal to undergo annual assessment.

Switching between natalizumab, fingolimod, dimethyl fumarate and teriflunomide is permitted provided the EDSS stopping criteria are not met.

Switching to interferon or glatiramer acetate from one of the first-line treatments is only permitted provided the EDSS stopping criteria are not met and both fingolimod and natalizumab are either not tolerated or treatment with both agents would be clinically inappropriate.
Continued relapses on treatment would be expected to lead to a switch of treatment provided the stopping criteria are not met.

If are lapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to stopping criteria, a period of 6 months is allowed from the start of the relapse for recovery to occur.

Glatiramer acetate (Copaxone) and Interferons

Treatment with glatiramer acetate is permitted only if treatment with the four first-line treatments are not tolerated or treatment with either would be clinically inappropriate. Glatiramer acetate will not be funded as second line treatment if EDSS progression has occurred on treatment with a first-line treatment.

Patients who have an increasing relapse rate over 12 months of treatment(compared with the relapse rate on starting treatment) and who do not meet the EDSS Stopping Criteria at annual review may switch from either of the beta-interferon’s [interferonbeta-1-beta or interferonbeta-1-alpha] to glatiramer acetate or vice versa.

Patients may switch from either of the beta-interferon’s [interferonbeta-1-beta or interferonbeta-1-alpha] to glatiramer acetate or vice versa for increased relapses only once, after which they will be required to stop funded treatment if they meet any of the Stopping Criteria at annual review(including the criterion relating to increasing relapse rate over 12 months of treatment).

If a relapse has resulted in an increased EDSS score that potentially may lead to discontinuation of treatment according to stopping criteria, a period of 6 months is allowed from the start of the relapse for recovery to occur. In this setting anti-JCV antibody positive status maybe accepted as a clinically inappropriate reason for treatment with natalizumab.