Disease Modifying Treatment Special Authority Criteria
New Special Authority criteria
From 1 March 2021, funded access to the eight funded MS treatments will be amended in Section B (the Community) of the Pharmaceutical Schedule. Equivalent changes will also be made in Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule. The new criteria will be:
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:
- Diagnosis of multiple sclerosis (MS) must be confirmed by a neurologist. Diagnosis must include MRI confirmation; and
- Patients must have Clinically Definite Relapsing multiple sclerosis with or without underlying progression; and
- Patients must have an EDSS score between 0 – 6.0; and
- 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
- All of the following:
- 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
- Each significant relapse is associated with characteristic new symptom(s)/sign(s) or substantially worsening of previously experienced symptoms(s)/sign(s); and
- Each significant relapse has lasted at least one week; and
- Each significant relapse has started at least one month after the onset of a previous relapse; and
- Each significant relapse can be distinguished from the effects of general fatigue; and is not associated with a fever (T> 37.5°C); and
- 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
- Each significant relapse is a recurrent paroxysmal symptom of multiple sclerosis (tonic seizures/spasms, trigeminal neuralgia, Lhermitte’s symptom); and
- Evidence of new inflammatory activity on an MR scan within the past 24 months; and
- Any of the following:
- A sign of that new inflammatory activity is a gadolinium enhancing lesion; or
- A sign of that new inflammatory activity is a lesion showing diffusion restriction; or
- A sign of that new inflammatory is a T2 lesion with associated local swelling; or
- 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
- 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).
For more information visit the PHARMAC website