Information about the newly approved abortion pill

MIFEGYMISO

There are two types of abortion in Canada: surgical abortion and medical abortion. Both are safe procedures with exceptionally low rates of complications and are not known to affect future pregnancies. 

Medical abortion uses medication (a combination of pills) rather than surgery to end a pregnancy. While some clinics and hospitals have been offering medical abortion, it has not been a widely available option in Canada.  

Action Canada for Sexual Health and Rights welcomes an important development, which may make medical abortion more accessible across Canada.

In July of 2015, after one of its lengthiest drug approval processes on record, Health Canada approved the abortion pill Mifegymiso, the Canadian brand name for the combination of Mifepristone and Misoprostol. This combination of medications is set to replace the regimen that has been used in Canada up until now to provide a medical abortion. Before the approval of Mifepristone, health care providers were using a combination of Methotrexate prescribed off-label and Misoprostol. While the overall success rates, side effects and low rates of complications are similar for both regimens, abortions induced with Mifepristone complete faster than those induced with methotrexate and medical abortions can be offered until 10 weeks of gestation versus an average of seven weeks with Methotrexate. The acceptability of Mifepristone is also higher among patients. 

The combination of Mifepristone and Misoprostol is the World Health Organization’s (WHO) recommended method for medical abortion, making it the gold standard when it comes to this reproductive health service. It has been on the WHO list of essential drugs since 2005. Mifepristone has been used for close to 30 years with an outstanding safety and efficacy record and is available in over 60 countries around the world. Making it available to people in Canada is an important step in ensuring access to the best possible care when it comes to sexual and reproductive health services.

It was anticipated that Mifegymiso would be available to the public in the Spring of 2016 but its distribution faced several roadblocks, including manufacturing delays. The wait period can also be attributed in part to the need to accommodate some of the restrictions Health Canada included in its approval of the drug, one of them being a mandatory training for providers and pharmacists (which had to be developed).

The training of providers and pharmacists which is no longer mandatory for pharmacists since Health Canada lifted this requirement in may of 2017, is offered through the Society of Obstetricians and Gynaecologists of Canada. 

Action Canada continues to encourage health care practitioners to take the SOGC training and for both prescribers and pharmacists to list themselves on directories connecting providers, dispensers and the public. 

Mifegymiso finally hit the shelves in January 2017 and while that was a positive step forward, many more unnecessary barriers still make it difficult for the public to access the medical abortion drug. For one, the price tag for Mifegymiso hovers between $300 and $450. For many individuals who must pay out of pocket, this continues to put it out of reach.

Action Canada has therefore been calling on all provincial and territorial governments, as well as the Federal government, to promptly ensure that the cost of medication abortion is covered under public health care. 

As of April 2017, New Brunswick, Alberta and Ontario have announced universal coverage of Mifegymiso for all persons covered under provincial health care. It was also announced that federal patients covered by the Non-Insured Health Benefits would also be able to access Mifegymiso free of charge.


THE COMMON DRUG REVIEW PROCESS AND CADTH APPLICATION

For provinces and territories, as well as the federal government, to provide universal coverage for new medications, or to add them to their formularies (Provincial and Territorial Formularies list publicly-funded drugs for individuals who are on some form of social assistance), the drugs 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 initial application to the Common Drug Review in January 2016. This process entails the review and assessment of any drug new to Canada, comparing them to existing drugs used for the same medical purposes, and assessing the cost-effectiveness of the medication based on the price set by the drug manufacturer. From this, the body responsible for completing the Common Drug Review – the Canadian Drug Expert Committee (CDEC) – makes a non-binding recommendation on whether coverage for a medication should be offered through public drug plans.

In May 2016, Celopharma formally withdrew its initial application to the Common Drug Review because it could not afford the $72,000 cost of the review. This move generated a new delay in addressing the issue of the prohibitive cost of the medication. However, in early October 2016, it was reported that Celopharma resubmitted its application. 

A few weeks before the Common Drug Review’s recommendation was made public, New Brunswick announced its intention to ensure universal coverage for Mifegymiso. On April 4th 2017, Health Minister Victor Boudreau announced that his government intends to make the abortion drug available at no charge to all people with a valid health card. That said, this plan will not take effect until the alliance that negotiates drug prices on behalf of the provinces and territories reaches a deal with the manufacturer.

On April 20th 2017, the CADTH Canadian Drug Expert Committee made its final recommendation on the newly approved abortion pill. The expert committee recommended provincial and territorial cost reimbursement of Mifegymiso.

After the recommendation was made public, Alberta joined New Brunswick in becoming the second Canadian province to commit to universal cost coverage of Mifegymiso through provincial health care and Ontario followed suit shortly after. Then an announcement was made that the First Nations and Inuit people covered by the Non-Insured Health Benefits would also get coverage.

While we welcome the news from these three provinces, there is still no widespread cost coverage for Mifegymiso. People in British Columbia, Saskatchewan, Manitoba, Quebec, the Northwest Territories, Nunavut, the Yukon, Nova Scotia, Prince Edward Island and Newfoundland and Labrador are still expected to pay out of pocket. The same is true for most Federal patients, including some categories of refugee claimants eligible for the Interim Federal Health program, people who are incarcerated with a sentence of more than two years, serving members of the Canadian Forces and eligible veterans. Some private insurers may offer coverage for the medication through their policy, but for the remaining individuals with no private insurance or who are not on some form of social assistance, they are required to pay for the medication themselves.