On May 18, 2021, Quebec Minister of Health and Social Services Christian Dubé ("Minister") announced a shift in the Government of Quebec's policy towards biosimilars.1 This new direction comes with several implications for the industry, including with regard to Quebec's recently announced co-pay ban.
Moving Towards Biosimilars
According to the Minister's announcement, the Government of Quebec's new policy is aimed at favouring the uptake of biosimilar drugs.
More specifically, the Minister has signalled the provincial government's intention to eventually cover only biosimilar drugs under Quebec's drug formulary, the List of Medications.2 This list identifies those drugs that are covered under Quebec's public drug insurance program. According to the Minister, biosimilars remain underused despite their inclusion on the list for several years.
The Minister has indicated that patients will be expected to switch from biological drugs to biosimilar drugs within one year, by April 12, 2022.
Comparing the Options
The Minister's announcement reminds the public of the difference between biosimilar drugs and the biologics upon which they are based.
According to Health Canada, biosimilar drugs are biologic drugs that are highly similar to a biologic drug that was already authorized for sale. While a biosimilar drug is highly similar to a biologic drug, it is not identical, since biologic drugs are large, complex, and made from living cells rather than chemicals. According to Health Canada, there is no meaningful clinical differences in safety and efficacy between a biosimilar and biologic drug that was already authorized for sale.3
Biosimilars and biologic drugs are regulated under the Food and Drugs Act and its regulations. Authorization for biosimilars is made following a comparison or reference to the original biologic drug. Typically, biosimilar drugs may enter the market following the expiry of the reference biologic drug's patents and data protection.4
Comparing the Provinces
According to the Minister, this new policy direction will lead to fewer drug costs under the public plan. Quebec's move to biosimilars aligns its policy to that of certain other provinces.
For example, British Columbia has introduced and implemented a biosimilar initiative that seeks to increase the use of biosimilars by replacing the use of biologic drugs with their biosimilar versions when possible. Alberta, Ontario, and New Brunswick have likewise announced their own biosimilar switching plans. New Brunswick's announcement is the most recent prior to Quebec's, and was announced April 21, 2021.
Certain exceptions apply under these other provincial initiatives. For example, in British Columbia, qualifying patients can submit a special authority request to consider continued coverage of the originator biologic drug. These requests are considered on a case-by-case basis. In Alberta, if a patient is unable to switch to the biosimilar version of a drug for medical reasons, then that patient's health care professional can help determine whether the patient can request exceptional coverage for the originator. A similar exception is applicable in New Brunswick.
It remains to be seen whether Quebec will introduce such exceptions.
Reducing Available Biologics
The announcement is the second recent change in Quebec's pharmaceutical system that impacts biologics for Quebec patients.
As discussed in our previous bulletin, "The Quebec Patient Financial Assistance Ban is Here", on April 15, 2021 the ban against financial assistance to patients came into effect. This ban is subject to limited exception, provided for in the regulation.
For example, the second subparagraph of section 1 of the regulation governing exceptions mentions those medications for which a generic or biosimilar version is not reimbursed under the public plan.5
In short, the effect of the co-pay ban is to reduce the use of biologics in the Quebec market where there is at least one biosimilar listed on the formulary. If Quebec transitions away from biologic drugs, and requires patients to instead use biosimilars, the use of biologics can be expected to decrease even more.
The Minister has announced that biologic drug manufacturers have been informed of the provincial government's policy shift. The Government of Quebec intends to hold discussions with the main partners and associations of Quebec's health and social services system. Information and resources should be made available to healthcare professionals and patients to support them in the transition.
Drug manufacturers, wholesalers and intermediaries who develop, distribute, and sell biologics and biosimilars will surely pay attention to any updates and further announcements on the matter from Quebec's Minister of Health and Social Services.
1 "Le ministre Christian Dubé annonce un virage vers les médicaments biosimilaires ," (available in French only) Government of Quebec, May 18th, 2021, 10:00 AM.
2 "List of Medications [PDF]," Government of Quebec, April 14, 2021.
3 "Biosimilar biologic drugs in Canada: Fact Sheet," Health Canada, August 27th, 2019.
4 "Biosimilar biologic drugs in Canada: Fact Sheet," Health Canada, supra note 3.
5 Ibid, s. 1.
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