In a reversal of course, the company that is bringing the abortion pill to Canada has decided to go ahead with a crucial cost-effectiveness review that could clear the way for provincial drug plans to cover the $300 medication, Health Canada says.
The federal drug regulator told The Globe and Mail on Monday that Celopharma Inc., the Canadian distributor of Mifegymiso, is planning to resubmit its application to a committee of experts that advises every province except Quebec on which new drugs they should reimburse for patients who qualify.
"The drug's Canadian sponsor has recently confirmed to Health Canada that it intends to proceed with a submission to the Common Drug Review," Anna Maddison, a spokeswoman for Health Canada, said by e-mail. "This will allow Mifegymiso to be assessed and added to public drug plan formularies."
The Globe reported last week that Celopharma had formally withdrawn its application to the Common Drug Review (CDR) in July because it could not afford the $72,000 cost of the review.
Without the endorsement of the CDR, the provincial drug plans in English-speaking Canada said they would not consider covering the two-drug combination, meaning that women who want to end their pregnancies with Mifegymiso rather than have a surgical abortion would have to pay out of pocket or rely on private insurance – potentially a significant barrier to access.
Quebec, which has a separate, free process to assess the cost-effectiveness of new drugs, is reviewing Mifegymiso.
Dawn Fowler, the Canadian director of the National Abortion Federation (NAF), called the company's new plans "great news."
If the provinces do opt to add Mifegymiso to their formularies – the lists of drugs they cover for all patients in hospitals and for certain patients outside hospitals – access to medical abortion could increase significantly, she said.
"It would mean that women wouldn't have to travel a significant distance all the time to obtain the medication. And it would mean that it could be on formularies for people on low income, social assistance and [for] aboriginal women."
In an e-mail last week, Celopharma said it had tried and failed to persuade the Canadian Agency for Drugs and Technologies in Health (CADTH), the independent, not-for-profit agency that oversees the CDR, to cut it a break on the fees.
A spokeswoman for the CADTH said on Monday that the agency had not yet received a new submission from Celopharma and therefore could not comment.
The CADTH aims to complete its reviews within six months, meaning that it is unlikely the provinces would make funding decisions on Mifegymiso before next year.
Celopharma did not respond to e-mails seeking comment on Monday.
Mifegymiso is made up of two medications, sold together in a combination pack. The first, mifepristone, blocks the hormone progesterone, causing the lining of the uterus to break down. The second drug, misoprostol, is taken 24 to 48 hours later, and induces contractions similar to a natural miscarriage.
Mifespristone, which is widely considered the gold standard in abortion drugs, is already approved in more than 60 countries, including the United States, where it has been available since 2000.
Canada finally approved the drug in July of 2015, three and a half years after Linepharma International, a small European drug company, first applied to Health Canada.
Manufacturing challenges have since delayed its sale; Celopharma hopes that Mifegymiso will finally be available in Canada some time next month.
However, doctors who want to distribute Mifegymiso still have to complete an online training course, which is not yet ready, something that could further postpone sale of the pills.