Canadian drug price regulator may be flexible on rare diseases

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TORONTO: Canada's patented drug price regulator, set to gain new powers next year, may be 'more forgiving' in setting price caps for drugs that ...

TORONTO: Canada's patented drug price regulator, set to gain new powers next year, may be"more forgiving" in setting price caps for drugs that treat rare diseases, the agency's executive director told Reuters, as some advocates warned the country's pricing reforms would hurt patients.

"We've signaled for some time that we're going to be a bit more forgiving in the ceilings that we apply to these drugs, because we want to be consistent with the government's broader commitment to trying to facilitate access," he said in an interview on Friday, referring back to technical documents provided to some advisory committees.

Clark's assurance was little comfort to Durhane Wong-Rieger, president of the Canadian Organization for Rare Disorders , who fears lower price caps would stop drugmakers from selling treatments for rare conditions in Canada."The overall budget impact of these drugs, even if we brought them all in, would not even reach 1 percent," she said, referring to provincial drug programs that often cover the most expensive treatments.

The government's regulatory impact assessment assumed the PMPRB would judge drugs against cost per quality-adjusted life year benchmarks of between CUS$35,000 a year and CUS$150,000 a year, with the high end for rare diseases. Final thresholds will likely be laid out in the guidelines.Under Clark, the PMPRB has formally challenged the price of two rare disease drugs: Alexion Pharmaceutical Inc's Soliris and Horizon Therapeutics' Procysbi.

 

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