The company that is bringing the gold standard in abortion drugs to Canada says it is "open" to re-entering a review process that could lead to provincial drug plans reimbursing women for the $300 cost of the medication.
But Celopharma Inc. signalled it would need some sort of fee reduction or forgiveness from the independent body that assesses the cost effectiveness of new drugs because of the "significant" financial risk the fledgling company has already shouldered in its quest to make Mifegymiso available in this country.
"As a woman committed to women's health, who has been at this approval process for several years, I hope and expect that over the next year, most all provincial drug plans will cover Mifegymiso," Paula Tenenbaum, the president of Celopharma, said by e-mail Tuesday.
"Mifegymiso has been the gold standard for most of the developed world for over 25 years. Yet no established Canadian pharmaceutical company has been prepared to take on the significant financial risk and the several years' commitment in the approval process," she wrote, adding the Canadian market is too small, the revenue opportunity too limited and the abortion pill too politically controversial for other drug companies to tackle.
As The Globe and Mail reported Monday, Celopharma officially withdrew in July from the Common Drug Review, a committee of experts that advises every province except Quebec about which new medications they should reimburse for patients who qualify. The company said it couldn't afford the $72,000 fee.
The English-speaking provinces say they will not cover the drug without a thumbs-up from the Common Drug Review, meaning that women who want to end their pregnancies with Mifegymiso rather than have a surgical abortion will have to pay out of pocket or rely on private insurance – potentially a significant barrier to access.
In her e-mail response Tuesday, Ms. Tenenbaum elaborated on why Celopharma, which is the Canadian distributor for Mifegymiso, is struggling to pay for the review.
She said that when the company began the Health Canada application process in late 2011, the Common Drug Review – which is a separate process, not run by Health Canada – was offered at no cost to pharmaceutical companies. "As a result, we did not budget for the $72,000," she said. The company asked for a fee reduction or a two-year payment plan, but that proposal was rebuffed.
The Canadian Agency for Drugs and Technologies in Health (CADTH), which oversees the Common Drug Review, confirmed the fees only came into effect in September of 2014. (Ms. Tenenbaum said the full process would actually cost between $100,000 and $150,000; CADTH disagreed and reiterated the $72,000 figure.)
Brent Fraser, the vice-president of pharmaceutical reviews for CADTH, said on Tuesday that giving Celopharma a break on the fees could set a bad precedent.
"It's difficult for us to do a one-off decision on this without consulting more broadly with our stakeholders," he said. "There's the risk that other manufacturers will see this as an opportunity to potentially not pay fees in future."
The National Abortion Federation (NAF), which represents abortion providers in North America and has been advising Celopharma, is urging the company to find the money and get on with the Common Drug Review process.
"Most women are not going to pay out of pocket [for a pill] when they can have a safe and effective surgical abortion [at no cost to them]," Vicki Saporta, the president of NAF, told The Globe and Mail Tuesday. "It diminishes the promise of opening access to women in more rural areas where surgical abortions are not readily available."