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PBS listing for MAVENCLAD® (cladribine tablets) for RRMS not recommended by PBAC

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20 April 2018

The Pharmaceutical Benefits Advisory Committee (PBAC) announced at 4pm today (20/4/18), they have not recommended the listing of MAVENCLAD® (cladribine tablets) for relapsing remitting MS (RRMS) on the Pharmaceutical Benefits Scheme (PBS).

The PBAC said that it, “did not recommend the listing of cladribine for the treatment of relapsing remitting multiple sclerosis (RRMS), on the basis of uncertainty in the non-inferior efficacy claim of cladribine versus fingolimod over two and four years.”

Source: http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2018-03/subsequent-decisions-not-to-recommend-03-2018.pdf (refer pages 4-5)
Source document located here: http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes

Previously, MAVENCLAD® was registered for use in Australia by the Therapeutic Goods Administration (TGA), for the treatment of patients with RRMS, to reduce inflammation in the nervous system caused by MS. It is administered in two treatment courses, over two years; each treatment course consists of two treatment weeks.

As you may recall, submissions to PBAC to recommend MAVENCLAD® for RRMS for listing on the PBS were originally made in November 2017, but were unsuccessful. A new call for submissions opened in early 2018 for PBAC recommendation for this medicine, which were again unsuccessful.

As the national advocacy organisation for people living with MS, MS Australia continues to work with our partner organisations to ensure the MS community and their healthcare teams, have access to the broadest range of affordable treatments as possible.

MAVENCLAD® for RRMS is available for patients to purchase privately; the price at pharmacy level may vary. Please consult your neurologist if you are interested in this medication to see if MAVENCLAD® is the right treatment for you and to discuss treatment pathways.

We will keep you posted on any developments.