Radicava Oral Suspension Favored for Reimbursement in Canada
CADTH opinion opens way to ALS treatment being included on public plans
An oral suspension form of Radicava (edaravone), an approved treatment of amyotrophic lateral sclerosis (ALS), was favored for patient reimbursement in Canada by a branch of the Canadian Agency for Drugs and Technologies in Health (CADTH).
The opinion issued by the CADTH Canadian Drug Expert Committee recommended that Radicava Oral Suspension be reimbursed through the public drug plans of the country’s provinces and territories.
Certain conditions must be met, including a prescription for this formulation and the cost of oral Radicava not exceeding that of Radicava in its initial intravenous formulation.
“The positive recommendation from CADTH is an important first step in ensuring access to Radicava Oral Suspension for all eligible Canadians living with ALS,” Atsushi Fujimoto, president of Mitsubishi Tanabe Pharma Canada, said in a company press release.
Oral Radicava can be taken at the home by mouth or feeding tube
CADTH’s recommendation is nonbinding, with the public drug plans of each province and territory deciding whether to list the oral medication based on the agency’s recommendation and factors such as its own priorities and resources.
Mitsubishi Tanabe Pharma Canada, a subsidiary of Mitsubishi Tanabe Pharma America that markets Radicava in Canada, Â stated it will continue to work with insurance companies and public agencies to make Radicava Oral Suspension available to patients via public formularies and private insurance. Public formularies are lists of prescription treatments covered as benefits for those eligible.
“While we are delighted by this milestone, we know there is more work to do, and we look forward to continued discussions with stakeholders to secure coverage for Radicava Oral Suspension on public formularies,” Fujimoto said.
Oxidative stress is seen as a central mechanism in the neuronal damage taking place in ALS. Radicava is a free-radical scavenger, meaning it helps to remove the reactive molecules that can contribute to oxidative stress to lessen nerve damage and slow ALS progression.
The intravenous (IV) formulation was approved in Canada in 2018, and patients using it are reimbursed through public formularies across Canada, as well as via the Veterans Affairs Canada and Indigenous Services Canada.
Radicava Oral Suspension, approved by Health Canada in November, was developed to be as effective as Radicava IV but more convenient. Â It n can be self-administered at home, either by mouth or via a feeding tube, while Radicava IV is infusion treatment administered at a center, with each infusion lasting about one hour.
Available as Radicava ORSÂ in the U.S., the medication comes in a portable bottle and includes a 5 mL oral syringe for accurate dosing. It should be taken at a dose of 105 mg (the equivalent to 5 mL of the solution) in the morning after overnight fasting. Patients are recommended to take only water for one hour after administration.
The oral formulation is given in the same dosing regimen as Radicava IV: in a first cycle, patients receive daily dosing for 14 days, followed by a two-week treatment-free period. In subsequent cycles, the medication is given for 10 of the first 14 days, followed by two weeks with no treatment.
U.S. and Canadian approvals of Radicava Oral Suspension were supported by clinical trials showing that the oral formulation delivers similar amounts of edaravone, its active ingredient, to the body.
They also were based on interim results of the open-label Phase 3 trial (NCT04165824) in 185 ALS patients, which showed that six months of treatment with Radicava Oral Suspension was generally well tolerated and slowed functional decline.
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