The day the Globe and Mail reported that the abortion pill Mifegymiso (RU-486) would not be covered by provincial drug plans because it had not passed a bureaucratic approval process, Celopharma Ltd., the Canadian distributor for the drug, said it might seek approval if the costs could be reduced or deferred.
Provincial drug plans outside Quebec will not cover pharmaceuticals that have not been approved by the Common Drug Review under the auspices of the Canadian Agency for Drugs and Technologies in Canada (CADTH). Abortion groups such as the National Abortion Federation say women who do not have private insurance will not pay for the out-of-pocket $300 cost for a medical abortion when surgical abortions are free in the socialized health system. “It’s going to be a huge, significant barrier,” NAF’s Canadian director Dawn Fowler told the Globe and Mail.
Initially, Celopharma Ltd. says the $72,000 fee to apply for approval is too steep and asked the Common Drug Review to drop or defer the fee. CADTH said giving Celopharma a break on the application fee would violate agency policy and set a bad precedent because all pharmaceutical companies will then seek a discount or deferment. Celopharma initially sought approval by the Review, but withdrew their application in July.
Celopharma president Paula Tanenbaum said her company has at “significant” financial risk because the abortion pill is controversial. Appearing to drop the request that the fee be set aside, she indicated that payment over several years rather than upfront would do the trick to bring Celopharma back to the table.
Health Canada — which is not affiliated with the Common Drug Review — has placed limitations on Mifegymisio, including requiring that doctors do an ultrasound to ensure the preborn child is younger than 49 days and that the pregnancy was not ectopic, that prescribing doctors take an online course about the drug, and that it be distributed directly by physicians rather than pharmacies. These guidelines were implemented at the request of the drug’s European manufacturer, Linepharma International Ltd. Women are also supposed to return to the doctor afterward to ensure the abortion is complete.
The National Abortion Federation has requested that these restrictions be scrapped, saying it reduces access to chemical abortions. British Columbia Health Minister Terry Lake said the approval fee and the prescribing guidelines should be reversed: “taken together, these regulations are onerous, create administrative and practical barriers for women to access medical abortion, and do not contribute to patient safety.” Federal Health Minister Jane Philpott said she will look at the rules, although she has not commented on the CADTH’s Common Drug Review application fee; the review process is independent of Health Canada and the Ministry of Health.
The drug was approved for use beginning January 2016 by Health Canada in July 2015, but is not expected to be available until November.