Disease Modifying Treatment Special Authority Criteria

Special Authority for Subsidy

Initial application – (Multiple sclerosis) from a neurologist or general physician.

Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

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 multiple sclerosis with or without underlying progression; and
3. Patients must have an EDSS score between 0 – 6.0; and
4. Patient has had at least 1 significant relapse of multiple sclerosis in the previous 12 months or 2 significant relapses in the past 24 months; and
5. All of the following:
   1. Each significant relapse must 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
   2. Each significant relapse is associated with characteristic new symptom(s)/sign(s) or substantially worsening of previously experienced symptoms(s)/sign(s); and
   3. Each significant relapse has lasted at least one week; and
   4. Each significant relapse has started at least one month after the onset of a previous relapse; and
   5. Each significant relapse can be distinguished from the effects of general fatigue; and is not associated with a fever (T> 37.5°C); and
   6. Either
      1. Each significant relapse is severe enough to change either the EDSS or at least one of the Kurtze Functional System scores by at least 1 point; or
      2. Each significant relapse is a recurrent paroxysmal symptom of multiple sclerosis (tonic seizures/spasms, trigeminal neuralgia, Lhermitte’s symptom); and
6. Evidence of new inflammatory activity on an MR scan within the past 24 months; and
7. Any of the following:
   1. A sign of that new inflammatory activity is a gadolinium enhancing lesion; or
   2. A sign of that new inflammatory activity is a lesion showing diffusion restriction; or
   3. A sign of that new inflammatory is a T2 lesion with associated local swelling; or
   4. A sign of that new inflammatory activity is a prominent T2 lesion that clearly is responsible for the clinical features of a recent relapse that occurred within the last 2 years; or
   5. A sign of that new inflammatory activity is new T2 lesions compared with a previous MR scan.

Note: Natalizumab can only be dispensed from a pharmacy registered in the Tysabri Australasian Prescribing Programme operated by the supplier. Treatment on two funded multiple sclerosis treatments simultaneously is not permitted.

Renewal– (Multiple sclerosis) only from a neurologist or general physician.  Approvals valid for 12 months where patient has had an EDSS score of 0 to 6.0 (inclusive) at any time in the last six months (i.e. the patient has walked 100 metres or more with or without aids in the last six months).