Most public health plans in Canada now cover Ruzurgi for LEMS

Over 90% of patients in country now insured for approved therapy

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by Mary Chapman |

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Months after a Federal Court of Appeal of Canada decision restored the availability of the Lambert-Eaton myasthenic syndrome (LEMS) treatment Ruzurgi (amifampridine) in that country, the therapy is now covered by most provincial and federal public health programs and by many private insurance plans through special authorization.

Overall, coverage by public and private payers means that more than 90% of all LEMS patients in Canada will be insured for Ruzurgi, according to Médunik Canada, the company that markets the treatment in the North American country. The therapy, developed by Jacobus Pharmaceuticals, is indicated for the symptomatic treatment of LEMS in patients ages 6 and older.

Médunik, a member of the Duchesnay Pharmaceutical Group, has detailed information about provincial and federal health program coverage for Ruzurgi in Canada on its website. Those updated data have provided welcome news for patient support organizations.

“We are glad that amifampridine treatment options are available and that some benefit from extended coverage by several public and private plans,” Jonathan Pratt, PhD, executive director of the Regroupement Québécois des Maladies Orphelines, said in a press release from Médunik Canada.

“This is great news for people affected by Lambert-Eaton Myasthenic Syndrome (LEMS) who suffer daily from the debilitating symptoms of this disease,” Pratt said.

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Ruzurgi for Children and Adults With LEMS Returning to Canada

Médunik says demand for Ruzurgi is growing in Canada

Since the appeals court decision, Médunik said it has resumed activities with healthcare professionals and LEMS patient groups — and is responding to what it calls a growing demand for Ruzurgi.

The January ruling returned for a second time the notice of compliance given to Ruzurgi by Health Canada in August 2020. The therapy’s approval had been challenged in Canada by Catalyst Pharmaceuticals, which developed Firdapse, a LEMS treatment whose active ingredient also is amifampridine.

Catalyst had contended that, because data backing Ruzurgi’s approval had been derived from studies of Firdapse, Jacobus’ application was invalid. Firdapse also had been approved in Canada in August 2020 under terms providing years of market exclusivity.

In the U.S., Catalyst successfully challenged Ruzurgi’s approval on similar grounds, resulting in a U.S. Food and Drug Administration move to vacate its 2019 decision allowing the Jacobus therapy.

Following the Canadian appeals court decision, Médunik said it would work to re-establish the Canadian availability of Ruzurgi. The therapy’s approval in Canada was first suspended in May 2021 in a trial division court ruling. Later that year, approval was reinstated before again being withdrawn in March 2022. The January federal court ruling set aside that March decision.