EMD Serono, Canada Sign Agreement for Public Health Plan Funding of Mavenclad for RRMS

People with relapsing-remitting multiple sclerosis (RRMS) across Canada are a major step closer to having access to EMD Serono’s Mavenclad (cladribine).

EMD Serono, known as Merck KGaA outside of North America, has finish negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) that oversees new drugs coming in, and signed a letter of intent to an agreement that will allow Mavenclad to be available at low or no cost through the country’s publicly supported health programs.

Details on the financial arrangements were not disclosed.

This signing brings the two parties closer to bringing Mavenclad, a short-course and oral disease-modifying treatment, to eligible people across Canada, which has the world’s highest MS rate. Currently, the treatment is reimbursed to patients using private health insurance plans.

Company officials can now begin to work with agencies in each of the country’s 10 provinces and three northern territories for public funding of Mavenclad.

“We’re excited to complete the pCPA negotiations and reach an agreement on the terms of public reimbursement for Mavenclad,” Gaby Murphy, president & managing director at EMD Serono, Canada, said in a press release.

“We look forward to working with participating jurisdictions to achieve the timely listing of Mavenclad by their respective public drug plans, and ensure broader access to this treatment option for Canadians living with MS,” Murphy added.

Mavenclad was approved by Health Canada to reduce the frequency of MS flares and delay disease progression in adults with RRMS in November 2017. It is recommended for patients who had not an adequate response to, or cannot tolerate, one or more other approved MS therapies.

Mavenclad works by selectively and periodically targeting lymphocytes in the immune system (particularly B-lymphocytes and T-lymphocytes) that are thought to trigger RRMS. A Phase 3 clinical trial reported that 75.6% of patients who finished two courses of treatment — a maximum 20 days of Mavenclad tablets at 3.5 mg/kg taken over two years — remained relapse-free for four years, without continuous suppression of their immune systems.

“Canada has one of the highest rates of MS [multiple sclerosis] in the world,” said Ji-Won Oh, MD, a neurologist at the St. Michael’s Hospital MS Clinic in Toronto. “We are fortunate to have new and innovative MS drugs approved by Health Canada for optimal MS management.

“Patients need access to new treatment options,” he added, “and it is encouraging that Mavenclad is now a step closer to being available to Canadian RRMS patients who receive their benefits from public drug plans.”

Mavenclad is approved in 70 countries to date for different MS indications, Serono reports, including the United States, the European Union, Australia and Switzerland.

Researchers confirmed Mavenclad’s safety and efficacy in several clinical trials, including the Phase 3 CLARITY trial (NCT00213135), Phase 3 CLARITY EXTENSION (NCT00641537), Phase 3 ORACLE-MS (NCT00725985), Phase 2 ONWARD (NCT00436826), and the long-term Phase 2 PREMIERE study (NCT01013350).

These  trials involved more than 2,700 RRMS patients, some of whom were observed for more than 10 years.