National Partnership for Women & Families

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Company seeks approval so that Canadian provinces can reimburse cost of medication abortion drug

Canada's public health ministry on Monday announced that the drug distributor working to bring medication abortion to Canada is requesting a cost-effectiveness review that could enable almost all the country's provinces to cover the cost of the medication abortion drugs, The Globe and Mail reports (Grant, The Globe and Mail, 10/3).

Background

In July 2015, Health Canada approved mifepristone, one of the drugs involved in a medication abortion, for use in the country. The approval aligned Canada with roughly 60 other countries where mifepristone has been legal for some time.

In Canada, mifepristone is also referred to by the brand name Mifegymiso. The drug is approved for use through 49 days of pregnancy.

While the drug was scheduled to be available via physician prescription as of July 1, the drug will not be available in Canada until November. Paula Gelbfarb -- president of Celopharma, the company that distributes Mifegymiso -- said the drug is not yet available because of an ingredient change currently pending government approval.

Celopharma is seeking to expand the gestational age limit for the medication abortion drug, citing the U.S. Food and Drug Administration's decision to approve mifepristone for abortions up to 70 days of gestation. According to Gelbfarb, the company is also seeking to ease certain distribution restrictions on the drug as well.

Cost concerns

Currently, the drug costs $300 and is not covered by health care programs at the provincial or territorial level (Women's Health Policy Report, 7/28). Celopharma said it previously submitted and withdrew its application to the Canadian Agency for Drugs and Technologies in Health's (CADTH) Common Drug Review (CDR) panel, an expert panel tasked with making recommendations to all the country's provinces other than Quebec about what drugs to reimburse for qualifying patients.

At the time, Celopharma said it could not afford the $72,000 cost for review. The company said it had tried and failed to have the CADTH ease the cost of review.

Without the panel's recommendation, provincial drug plans said they would not reimburse for the drug. As a result, women seeking abortion care would have to pay out of pocket for the drug, use private insurance to cover the cost of care or have a surgical abortion.

Latest developments

According to Health Canada, Celopharma intends to resubmit its application to CDR. Meanwhile, Quebec, which has a free drug reimbursement review process, is independently assessing Mifegymiso, The Globe and Mail reports.

Anna Maddison, spokesperson for Health Canada, said, "The drug's Canadian sponsor has recently confirmed to Health Canada that it intends to proceed with a submission to the Common Drug Review," which "will allow Mifegymiso to be assessed and added to public drug plan formularies." According to The Globe and Mail, provinces' formularies refer to the list of drugs they cover for all patients in hospitals and for qualifying patients outside of the hospital.

CADTH typically has a six-month turnaround process on drug reviews, which means that provincial drug plans likely will not finalize any decision on Mifegymiso until next year.

Dawn Fowler, the Canadian director of the National Abortion Federation, said Celopharma's announcement was "great news."

Fowler explained that medication abortion access could increase substantially if Canadian provinces add the drug to their formularies. "It would mean that women wouldn't have to travel a significant distance all the time to obtain the medication," she said, adding, "And it would mean that it could be on formularies for people on low income, social assistance and (for) aboriginal women" (The Globe and Mail, 10/3).