Proposal to fund treatment earlier for relapsing remitting multiple sclerosis

Medicines Consultation Closed

We’re proposing to make funded treatments for relapsing remitting multiple sclerosis available sooner.

What we’re proposing

We are proposing to widen access to eight treatments currently funded for relapsing remitting multiple sclerosis, from 1 July 2022. This would mean some people could access treatment earlier, after only one clinical attack of multiple sclerosis. 

We anticipate that around 110 people would benefit from earlier treatment with multiple sclerosis treatments in the next five years as a result of this proposal. 

Consultation closes at 5 pm on Thursday, 2 June 2022 and feedback can be emailed to consult@pharmac.govt.nz

What would the effect be?

For patients

Currently people have to wait until they have had two clinical attacks of multiple sclerosis before they can access funded treatment. This proposal would mean that people who have had one clinical attack of multiple sclerosis (also known as clinically isolated syndrome, CIS), and meet the proposed criteria, would be able to start funded treatment sooner in the course of the disease than is currently possible. 

People currently using funded multiple sclerosis treatments would continue to access their funded treatment as they do now. 

Who we think will be interested

  • People with multiple sclerosis and their whānau
  • Healthcare professionals involved in the management of multiple sclerosis
  • Community and hospital pharmacies and DHBs
  • Suppliers and wholesalers 

About multiple sclerosis

Multiple sclerosis is an autoimmune condition where the immune system attacks the central nervous system. It may cause numerous sensory and physical symptoms, and often progresses to physical and cognitive disability. 

Clinicians use the Revised McDonald Criteria(external link) to help diagnose multiple sclerosis.[1] The McDonald criteria were most recently revised in 2017, following an update from the McDonald criteria of 2010. One of the main differences between the 2017 and 2010 criteria is that with the 2017 criteria people may be formally diagnosed with multiple sclerosis after one clinical attack of multiple sclerosis (also known as clinically isolated syndrome, CIS). 

Pharmac is proposing to update the Special Authority to include the 2017 McDonald criteria, so that people could access treatment sooner than they can now (currently a person has to experience another attack (ie. a relapse) before they can receive funded treatment). 

About multiple sclerosis treatments

Pharmac currently funds eight treatments for relapsing remitting multiple sclerosis. These treatments are:

  • dimethyl fumarate (Tecfidera)
  • fingolimod (Gilenya)
  • glatiramer acetate (Copaxone)
  • interferon beta-1-alpha (Avonex)
  • interferon beta-1-beta (Betaferon)
  • natalizumab (Tysabri)
  • ocrelizumab (Ocrevus)
  • teriflunomide (Aubagio) 

These multiple sclerosis treatments are taken in different ways, some are capsules taken every day and others are given as infusions. The treatments work by delaying disability progression and reducing the frequency of relapses. 

Our clinical advisors have told us that widening access to these treatments, to include the 2017 McDonald criteria, would mean that some people could access treatment earlier. This is likely to result in benefits such as delaying the transition from clinically isolated syndrome to clinically definite multiple sclerosis, decreasing the frequency of relapses, delaying the transition to secondary progressive multiple sclerosis, and reducing brain atrophy. 

You can read more about what PTAC has told us about widening access to multiple sclerosis treatments on the Pharmac Application Tracker.(external link) 

Why we’re proposing this

In 2020 we received a funding application to widen access to multiple sclerosis treatments for relapsing remitting disease for people who meet the 2017 McDonald criteria. PTAC reviewed this application and recommended that access to multiple sclerosis treatments be widened with a medium priority. 

You can read more the history of this funding application and the clinical advice received on the Application tracker(external link).

Details about our proposal

The Special Authority, which applies to all funded multiple sclerosis treatments would be updated to the following from 1 July 2022 (changes in bold and strikethrough): 

Initial application — (Multiple sclerosis) Applications only 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) meets the McDonald 2017 diagnostic criteria for MS and has been 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
    Patient must have has an EDSS score 0 - 6.0; and
  3. Patient has had at least one significant attack relapse of MS in the previous 12 months or two significant attacks relapses in the past 24 months; and
  4. All of the following:
    1. Each significant attack relapse must be confirmed by the applying neurologist or general physician (the patient may not necessarily have been seen by them during the attack relapse, but the neurologist/physician must be satisfied that the clinical features were characteristic); and
    2. Each significant attack relapse is associated with characteristic symptom(s)/sign(s) or substantially worsening of previously experienced symptoms(s)/sign(s); and
    3. Each significant attack relapse 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 relapse 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 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 attack relapse is a recurrent paroxysmal symptom of multiple sclerosis (tonic seizures/spasms, trigeminal neuralgia, Lhermitte’s symptom); and
  5. Evidence of new inflammatory activity on an MRI scan within the past 24 months; and
  6. 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 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 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.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 2 June 2022.

All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.

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Footnote:

[1] The Revised McDonald Criteria, published by the International Panel on the Diagnosis of Multiple Sclerosis, include specific guidelines for using magnetic resonance imaging (MRI) and cerebrospinal fluid analysis to speed the diagnostic process. The MRI can be used to look for a second area of damage in a person who has experienced only one attack (also called a relapse or an exacerbation) of multiple sclerosis-like symptoms — referred to as clinically-isolated syndrome(external link) (CIS). The MRI can also be used to confirm that damage has occurred at two different points in time. In some circumstances, the presence of oligoclonal bands in a person's cerebrospinal fluid analysis(external link) can be used instead of dissemination in time to confirm the MS diagnosis