Photo credit The Javorac
Information about the newly approved abortion pill
Mifegymiso was originally approved in July 2015 with an anticipated Spring 2016 roll-out date, but has since met several roadblocks including manufacturing delays. Mifegymiso (the Canadian brand name for the combination of Mifepristone and Misoprostol) will replace the current medical abortion regimen in Canada; the current regimen is a combination of Methotrexate and Misoprostol, an off-label regimen that has a higher likelihood of complications including incomplete abortion. The expected roll-out date is November 2016, with an anticipated price tag of $270 to $300 per regimen. Training of providers is set to commence by end of October 2016.
Mifegymiso is the World Health Organization’s (WHO) gold standard of medical abortion and since 2005, has been on the WHO’s list of essential drugs. It has been used for over 30 years with an outstanding safety and efficacy record and is available in over 60 countries around the world. Medical abortion uses medication rather than surgery to end a pregnancy. It can only be used early in a pregnancy. The Methotrexate and Misoprostol regimen can be used up to seven weeks from the first day of last menstrual period, while Mifegymiso can be used up to 10 weeks from the first day of last menstrual period.
The Common Drug Review process and CADTH application
In order for new medications to be added to provincial and territorial formularies (Provincial and Territorial Formularies list publically-funded drugs for individuals who qualify and/or do not have private insurance, e.g., individuals on social assistance) they must undergo a Common Drug Review that is undertaken by the independent body known as the Canadian Agency for Drugs and Technologies in Health (CADTH).
Mifegymiso’s Canadian distributor, Celopharma, submitted an application to CADTH in January 2016. This CADTH review process will cost upwards of $72,000 CAD. In May 2016, Celopharma formally withdrew its application for the process due to the high cost. However, in early October 2016, it was reported that Celopharma would resubmit the application for the Common Drug Review. CADTH is currently reviewing and completing the Common Drug Review for Mifegymiso, which will determine whether the drug is added to provincial and territorial drug formularies. The CDR process takes approximately 19-25 weeks.