When the gold standard in medical abortion drugs finally becomes available in Canada later this year, the $300 cost of the pills will not be covered by most provincial drug plans, The Globe and Mail has learned.
The company that makes Mifegymiso has bowed out of an essential step on the path to public reimbursements for new drugs over the $72,000 price tag for a standard review of the medication's cost effectiveness.
Provincial governments everywhere but Quebec say the company's decision is preventing them from adding the two-drug abortion regimen to their list of publicly funded drugs, meaning women will have to reach into their own wallets or rely on private insurance to pay for Mifegymiso.
"It's going to be a huge, significant barrier," warned Dawn Fowler, the Canadian director of the National Abortion Federation (NAF), which represents abortion providers in North America.
The funding impasse is just the latest obstacle for Canadian women who want to end their pregnancies with the pill originally known as RU-486, a drug that has been approved in more than 60 countries, including the United States, where it has been available since 2000.
Manufacturing problems have already delayed the sale of Mifegymiso in Canada for more than a year, while restrictive rules requiring doctors, not pharmacists, to distribute the pills directly to patients have abortion advocates warning that few physicians outside existing abortion clinics will go to the trouble of offering Mifegymiso in their offices.
The pills' price tag could be one more impediment to improving abortion access in rural and small-town Canada. Surgical abortions remain for the most part free across the country, but they are nearly impossible to obtain outside big cities.
At least one Health Minister, in British Columbia, has already asked federal Health Minister Jane Philpott to intervene on the price issue and to overhaul Health Canada's rules for Mifegymiso before it becomes available as early as November.
"Taken together, these regulations are onerous, create administrative and practical barriers for women to access medical abortion and do not contribute to patient safety," B.C. Health Minister Terry Lake wrote in a July letter to Dr. Philpott.
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.
Bringing the drug to Canada has been a long and sometimes arduous process. Linepharma International Ltd., a small European drug company, first applied to Health Canada to sell mifepristone here in December of 2011.
Health Canada finally approved the drug in July of 2015, with a list of conditions proposed by the company, including a requirement that doctors distribute the pills directly to patients and perform an ultrasound beforehand to make sure the pregnancy is neither ectopic (outside the uterus) nor further along than 49 days.
The rules also require women to make a return visit to their doctor to ensure the abortion is complete. In the rare instances where pregnancy has continued after the pills are ingested, there is a risk of birth defects in the baby. There have also been rare cases of sepsis, or blood poisoning, following use of mifepristone, but the risk is similar to that of surgical abortions, spontaneous miscarriages and births.
On the whole, mifepristone is considered extremely safe. A review of 45,000 medical abortions published in 2013 in the journal Contraception found serious complications in 0.4 per cent of cases.
Celopharma Ltd., the Canadian distributor for Mifegymiso, had hoped to make the drug available earlier this year, but "a change in manufacturer," of one of the drugs forced the company to submit fresh paperwork to Health Canada, a spokeswoman for the company said by e-mail.
Celopharma declined an interview request and did not reply to followup questions sent by e-mail.
Ms. Fowler of NAF, which has been providing technical support and advice to the company, said a factory in Asia that was set to supply the second drug, misoprostol, failed an inspection, prompting the company to switch to a supplier in Britain.
Ms. Fowler predicted that women would not be able to access Mifegymiso until early next year.
Even if the drug is technically available in November, it cannot be distributed until the doctors who want to provide it have taken an online course that is still being finalized, she said.
Separately, Celopharma in February submitted an application to the Common Drug Review, a committee of experts that advises the English-speaking provinces and territories on whether they should add new drugs to their formularies, the lists of drugs that are publicly funded for patients who qualify. (Quebec, which has a separate, free process, is currently reviewing Mifegymiso.)
But the company struggled to pay for the review – which costs about $72,000 start to finish – and decided tentatively to pull out in May. Celopharma withdrew formally in July.
A May 20 letter written on behalf of all the public drug plans in English Canada acknowledged that Celopharma had tried and failed to persuade the Canadian Agency for Drugs and Technologies in Health (CADTH), the independent body that oversees the Common Drug Review, to either drop or defer the fee.
CADTH refused, saying that would go against its guidelines.
The letter warned that the provinces "will not consider this product [Mifegymiso] for listing," without a recommendation from the Common Drug Review.
"It's extremely rare that we would ever encounter this kind of situation, even for drugs that I would say have a much smaller patient population," said Brent Fraser, vice-president of pharmaceutical reviews at CADTH. "I can't think of any others myself."
Paula Tenenbaum, a spokeswoman for Celopharma, declined in an e-mail to elaborate on why the company withdrew its submission.
"Celopharma is working very hard to make Mifegymiso an option to all women in urban and rural areas of Canada," she wrote. "We are committed to providing Health Care Providers with Mifegymiso thereby allowing women of Canada improved access to abortion care."
Ellen Wiebe, the medical director of the Willow Women's Clinic in Vancouver, said paying $300 for Mifegymiso would be a challenge, especially for women who are young or poor or both.
"Women having abortions, a large number of them are new to the work force and are not covered by extended benefits through their work," Dr. Wiebe said. "It's a real problem."
Health Canada has no role in deciding which drugs provinces cover. But the federal department said it is open to changing some of the rules around the drug, so long as the risks to women can be minimized.
"In almost every other country, because of the potential risks associated with [mifepristone], there is some sort of constraints and restraints on how to access that," said Supriya Sharma, chief medical officer for Health Canada. "We're always open to making changes. [But] if I can underscore one thing, it has to be supported by appropriate science and evidence."