Mavenclad Approved for Reimbursement as RRMS Treatment in Australia

Australia was one of the first countries to approve the use of Mavenclad (cladribine tablets, 10 mg) to treat patients with highly active relapsing-remitting multiple sclerosis (RRMS). Now, the country’s government has taken another step to ensure this 20-day course treatment is available to the largest number possible of people affected by the disease.

Australia’s Prime Minister, Hon. Scott Morrison MP, announced that Merck KGaA’s therapy was included on the Pharmaceutical Benefits Scheme (PBS) listing effective Jan. 1. This will make Mavenclad affordable for about 6,200 patients each year who are already accessing PBS-subsidized medicines for MS. (Of note, Merck KGaA is known as EMD Serono in the U.S. and Canada.)

This was made possible by the joint effort of MS Australia, MS Research Australia, clinicians and members of the MS community who, after successive submissions, achieved a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) to list Mavenclad on PBS as a treatment for RRMS.

Australia’s government will cover almost all costs of Mavenclad, which will mean that patients will have to pay only $40.30 per prescription, or $6.50 for concessional patients.

“Thanks to our strong economic management, we’ve ensured that every new, essential medicine recommended for listing by the Pharmaceutical Benefits Advisory Committee receives government subsidy to make it affordable for all Australians,” the Prime Minister said in a press release.

Mavenclad was developed to target immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. To be taken for a maximum of 20 days over two years, the oral drug has shown it helps MS patients remain relapse-free for up to four years, while supporting the “reset” of the immune system.

Australia’s regulatory agency decided to approve Mavenclad based on the findings of a number of clinical trials, including the Phase 3 CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537), and ORACLE-MS (NCT00725985) studies, as well as the Phase 2 trial ONWARD study (NCT00436826), and the long-term PREMIERE (NCT01013350) trials. These clinical studies involved more than 2,700 RRMS patients, some of whom were followed for more than 10 years.

Overall, the trials showed that Mavenclad significantly reduced relapse rates, disability progression, and brain atrophy. Doctors recommend the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments.