Navigating the drug approval labyrinth to ensure access to new medications

With a complex approval process in Canada and new medications in rapid development, it’s important to look carefully at what a drug plan covers, according to Dr. Alexander Paterson, a medical oncologist at the Tom Baker Cancer Centre.

“There is a prevalent idea that everything in health care is covered by the state,” Paterson told participants at Benefits Canada’s Nov. 2 Calgary Drug Trends Summit. “Many patients are shocked to realize that some drugs and procedures are not funded.”

Cancer patients, for example, are increasingly facing additional needs for insurance. “For young people, generally we manage to get hold of the latest drugs,” said Paterson. “But for older patients, we do need additional insurance for some of the needed drugs.”

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Paterson noted his concern about the lack of coverage for new drugs due to delays on the public side. The drug approvals process in Canada has changed dramatically in the last five to seven years, according to Paterson. When Health Canada issues a notice of compliance, it allows a company to market its drug. In the past, it might have taken one to two months for the provinces to approve funding for a drug. Now, “one to two years after a notice of compliance is not unusual before a really important drug is funded,” said Paterson.

The approvals process, he added, has become longer and more complex because “you’ve really got to make sure the public is getting value for money.”

Among the players, he noted, are Health Canada, the provinces, the Patented Medicine Prices Review Board, the pan-Canadian Oncology Drug Review and the pan-Canadian Pharmaceutical Alliance.

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“To get through the access labyrinth in Canada, what’s required is determination, resolve and plenty of drive,” said Paterson.

“It’s a really hard problem, because you’ve got some patients who have this insurance and can access the drug and you’ve got others with no additional insurance who won’t.”

Read more articles from the Calgary Drug Trends Conference