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

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 UnionAustralia 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.

Iqra holds a MSc in Cellular and Molecular Medicine from the University of Ottawa in Ottawa, Canada. She also holds a BSc in Life Sciences from Queen’s University in Kingston, Canada. Currently, she is completing a PhD in Laboratory Medicine and Pathobiology from the University of Toronto in Toronto, Canada. Her research has ranged from across various disease areas including Alzheimer’s disease, myelodysplastic syndrome, bleeding disorders and rare pediatric brain tumors.
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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Iqra holds a MSc in Cellular and Molecular Medicine from the University of Ottawa in Ottawa, Canada. She also holds a BSc in Life Sciences from Queen’s University in Kingston, Canada. Currently, she is completing a PhD in Laboratory Medicine and Pathobiology from the University of Toronto in Toronto, Canada. Her research has ranged from across various disease areas including Alzheimer’s disease, myelodysplastic syndrome, bleeding disorders and rare pediatric brain tumors.
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