Mavenclad has been approved for reimbursement on PBS

17 August, 2018
  • Pharmaceutical Benefits Advisory Committee (PBAC) has recommended Mavenclad (cladribine) for reimbursement under the Pharmaceutical Benefit Scheme at their August meeting.
  • Mavenclad is an oral medication that is approved by the Therapeutic Goods Administration (TGA) for use in relapsing-remitting MS.
  • Previously approved in Australia under the trade name Movectro, it was withdrawn from the market and then reintroduced after further clinical data showed positive outcomes for relapse rates, brain shrinkage and disability.

The Pharmaceutical Benefits Advisory Committee (PBAC) has announced today that it will recommend Mavenclad (cladribine) to be reimbursed for relapsing-remitting MS under the Pharmaceutical Benefits Scheme. This is the third time that this medication has been put before the PBAC.

Mavenclad is an oral medication that selectively targets the immune cells that play a role in MS. It was previously approved for the Australian market under the trade name Movectro, but later withdrawn after failing to be approved for use in other countries. The treatment has been shown to have a positive effect on relapse rates, rates of brain shrinkage and reduced the number of new lesions in clinical trials in people with relapsing-remitting MS. New research studies have also shown that overall quality of life was improved on Mavenclad. Taken together, the overall data now available for Mavenclad, including more comprehensive follow-up of patients has resulted in this medication being reintroduced to the market (see our research article for further details). The new data was also used in the PBAC submission by the Australian sponsor Merck.

Mavenclad is given as one or two tablets for 5 consecutive days in the first week and this is repeated 4 weeks later. This dosing is then repeated one year later. The treatment regime for Mavenclad provides a potentially convenient option for people with MS for whom other medication and dosing schedules are not suitable. In Australia, Mavenclad is approved as a 4 year treatment with 2 years of active treatment followed by 2 years of observation. The observation period will allow the medical team to track how long the effects of the therapy last and whether any further treatment is necessary.

The PBAC is required to consider a number of factors when making recommendations, including the effectiveness and cost of a treatment relative to other available medicines and the cost to the government of a new listing. This decision is the first step in a process which will now see the decision go before the Federal Government for final approval. If approved, it will then allow people with MS across Australia access to this new treatment option.

MS Research Australia supports affordable access to all proven treatment options to increase the opportunity for people with MS and their doctors to find effective therapies suited to their individual circumstances and welcomes the addition of Mavenclad as a treatment option for people with MS.

MS affects everyone differently and not everyone with MS responds to medications in the same way. It is important to discuss all medication options with your medical team to determine which medication is suited to your personal circumstances.

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