The agency in charge of health and social services for Quebec, known as the Institut national d’excellence en santé et en services sociaux (INESSS), is recommending that Mavenclad (cladribine) be offered at discount to adults with relapsing-remitting multiple sclerosis (RRMS) enrolled in the province’s health system.
INESSS’ opinions are taken by the minister for that agency, who makes the final decision on listing prescription services and medications in Quebec’s public health plan.
Mavenclad, developed and marketed by EMD Serono (Merck KGaA outside of the U.S. and Canada), is a disease-modifying and short-course oral treatment that works to reduce the number of immune cells in circulation, limiting the inflammation that causes nervous system damage in MS.
Data from clinical trials support that Mavenclad can significantly lower relapse rates and the risk of disability progression in people with RRMS.
The therapy was first approved to treat RRMS by Health Canada in December 2017. The European Commission approved it earlier that year for highly active relapsing forms of MS, and in 2019 the U.S. Food and Drug Administration (FDA) approved it for both RRMS and active secondary progressive multiple sclerosis (SPMS).
“We are delighted with the positive recommendation from INESSS, which recognizes the therapeutic value of Mavenclad and the need for this treatment option for eligible patients who live with RRMS,” Gaby Murphy, president and managing director of EMD Serono, Canada, said in a press release.
“We welcome this as an important step to ensure broader and equitable access to Mavenclad in the province of Quebec,” Murphy added.
EMD Serono will now work with the Ministère de la Santé et des Services sociaux to add Mavenclad to the Régie de l’assurance maladie du Québec (RAMQ) List of Medications. The purpose of this list is ” to ensure that all persons in Québec have reasonable and fair access to the medication required by their state of health,” with out-of-pocket costs tailored to a family’s “economic situation,” Légis Québec reports. The therapy is covered by most private insurance plans.
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