On March 29 2023, the Health Minister (the "Minister") introduced Bill 15, An Act to make the health and social services system more effective (the "Bill").
The Bill, which is still at the detailed study stage, proposes a major renewal of the framework for the health and social services system. Its purpose is to put in place a more effective system, particularly by facilitating access to services, enhancing coordination of the different components of the system and bringing communities closer to decisions related to the organization and provision of services.
This bulletin focuses on one critical aspect of Bill 15: the modification of the Specific Medical Necessity Measure by adding additional conditions before making a drug eligible for a patient.
The Current Conditions of the Specific Medical Necessity Measure
In Quebec, the law stipulates that an establishment may only supply drugs that appear on the list drawn up for that purpose by the Minister. The provincial formulary is commonly referred to as the Liste des médicaments – Établissements.
However, it is currently possible for an establishment providing health or social services to supply, for reasons of specific medical necessity, drugs other than those appearing on the formulary if they have received a Notice of Compliance from Health Canada. To do so, the physician or dentist wishing to prescribe or use these drugs must first seek the opinion of his establishment's Council of Physicians, Dentists and Pharmacists (CPDP).
In addition, an establishment is authorized to supply, for exceptional treatment, (i) drugs not listed on the formulary and for which no Notice of Compliance from Health Canada has been issued, or (ii) drugs, whether or not they appear on the formulary, which are used for indications which are recognized but not approved (i.e., off-label use). Here, written authorization from the CPDP is required, except in cases of emergency.
These measures were established to allow access to and coverage by the Quebec healthcare system of drugs that are of particular and exceptional necessity for patients with conditions that are often severe and have few therapeutic alternatives. They leave some discretion to prescribers and establishments (in particular their CPDPs) to determine cases of specific medical necessity. The discretion is applied according to internal guidelines of the ministry and each establishment, but always takes into account the particularities and individual needs of the patient.
The Amendments Set Out in the Bill
Bill 15 provides more precision and limitations regarding the exceptional use of these medications.
Firstly, the proposed amendments clarify the notion of "specific medical necessity", allowing the use of a drug approved by Health Canada but not appearing on the Liste des médicaments – Établissements, where there is a demonstrated need which, given the patient's specific condition, cannot be fulfilled by any of the therapeutic options on the list.
The Bill also clarifies what is meant by "exceptional treatment". It means a drug required because of an exceptional demonstrated need which, given the seriousness of the patient's particular condition, cannot be fulfilled by any of the therapeutic indications of the drugs that have received a Notice of Compliance from Health Canada. In other words, the patient requires either, the use of an unauthorized drug or the use of an approved drug for an unauthorized (off-label) indication.
In both cases, section 336 of the Bill stipulates that any professional wishing to use these drugs must first obtain written authorization from the establishment's Committee of Pharmacology. In this way, the Bill will centralize decision-making power in the hands of an institutional committee, which is not currently the case for drugs approved by Health Canada. Presently, it is more a matter of seeking the opinion of the CPDP, with written authorization reserved for the more delicate situation of using unauthorized drugs or off-label uses.
Moreover, the government is adding an additional prerequisite for a drug to be considered eligible for a user. In particular, it's a prerequisite to authorization that the Institut national d'excellence en santé et en services sociaux (INESSS) does not refuse to recognize the therapeutic value of the drug for the requested indication. In other words, INESSS must not have issued a negative recommendation regarding the therapeutic value.
The Effects of the Amendments
The new conditions proposed in the Bill appear to be aligned with the Minister's objective of centralizing and standardizing decisions. Indeed, prescribers in establishments will lose all discretion, except in emergency cases, and will have to defer to the decisions of their establishment's committee whenever a drug is not listed on the Liste des médicaments – Établissements. The new prerequisite that INESSS must not have previously denied the recognition of a drug's therapeutic value is of even greater importance.
Some may wonder about the INESSS evaluation process. Will this process be influenced by the increased impact of a negative decision, potentially preventing not only the listing of a drug on the provincial formulary, but literally preventing its supply in establishments, even in the most exceptional cases where the severity of the patient's particular condition can not be met by any other therapy?
Furthermore, the Specific Medical Necessity Measure mirrors the Exceptional Patient Measure applicable under the Public Prescription Drug Insurance Plan. Does the Bill presage more significant changes in the conditions of access to unapproved and unrecognized drugs for exceptional purposes in Quebec?
As the Bill is still in progress, we await announcements and comments on the proposed changes. Our Life Sciences group is closely monitoring these new developments and remains available to help industry players navigate through these changes.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
