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. 1. Diagnosis of multiple sclerosis (MS) meets the McDonald 2017 diagnostic criteria for MS and has been confirmed by a neurologist; and
   2. Patient has an EDSS score 0 – 6.0; and
   3. Patient has had at least one significant attack of MS in the previous 12 months or two significant attacks in the past 24 months; and
   4. All of the following:
      1. Each significant attack must be confirmed by the applying neurologist or general physician (the patient may not necessarily have been seen by them during the attack, but the neurologist/physician must be satisfied that the clinical features were characteristic); and
      2. Each significant attack is associated with characteristic symptom(s)/sign(s) or substantially worsening of previously experienced symptoms(s)/sign(s); and
      3. Each significant attack has lasted at least one week and has started at least one month after the onset of a previous attack (where relevant); and
      4. Each significant attack can be distinguished from the effects of general fatigue; and is not associated with a fever (T> 37.5°C); and
      5. Either:
         1. Each significant attack 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 attack 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 MRI scan within the past 24 months; and
      7. Any of the following:
         1. A sign of that new inflammatory activity on MRI scanning (in criterion 5 immediately above) 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 attack that occurred within the last 2 years; or
         5. A sign of that new inflammatory activity is new T2 lesions compared with a previous MRI

   Note: Natalizumab can only be dispensed from a pharmacy registered in the Tysabri Australasian Prescribing Programme operated by the supplier. Treatment on two or more 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) with or without the use of unilateral or bilateral aids 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).

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