On March 31, 2021 the Government of Quebec published the final Regulation restricting financial assistance to patients (this PDF is only available in French) for drugs covered by the basic plan and which appear on the Quebec formulary, the List of Medications (i.e. listed products).
Despite the passing of 2.5 years and various consultations since the draft Regulation was published, only one minor modification has been made to the regulation setting out exceptions to the financial assistance ban, as further described below.
The Regulation will be in force 15 days from now on April 15, 2021, following today’s publication of the regulatory exceptions in the Gazette officielle du Quebec.
Going forward, drug manufacturers, wholesalers and other intermediaries will have to adjust their patient support programs in order to avoid running afoul of this new prohibition.
Details about the prohibition and its exceptions follow.
1. Context: Bill 92
On December 7, 2016, the Quebec government enacted Bill 92 which, among other things, introduced a ban against financial assistance to patients through a new Section 80.2(1) of the Act respecting prescription drug insurance (the “Act”):
80.2. An accredited manufacturer or wholesaler may not, nor may an intermediary,
(1) pay or reimburse to a person covered by the basic plan all or part of the price of a medication or supply covered by the plan, except to the extent provided for by ministerial regulation, in particular for humanitarian reasons; […]
It is worth noting that the prohibition applies whether patients benefit from public or private insurance, as long as the medication or supply is covered by the basic plan in Quebec. As mentioned in the Act: “coverage under the basic plan shall be provided by the Régie de l’assurance maladie du Québec … or by the insurers transacting group insurance.”
The net effect of these provisions is that the ban applies to all patients in the province of Quebec, whether they are covered by a private plan or under the public plan.
Our understanding is that the ban may also apply to non-listed products, on a case-by-case basis, if the patient is receiving special coverage under the “mesure patient d’exception.”
2. Regulatory Exceptions
Under the Act, the prohibition applies “except to the extent provided for by ministerial regulation, in particular for humanitarian reasons.” On Wednesday, March 31st, 2021, the government of Quebec released the final regulation containing the exceptions to the co-pay ban (the “Regulation”).
We were originally expecting an exception for actual humanitarian reasons, such as the case of compassionate programs. However, rather than setting out specific and detailed exceptions, the Regulation is based on the status of the listed product or its generic/biosimilar version. In other words, assistance is allowed unless it may impact the uptake of generic or biosimilar medicines.
In particular, payments are permitted when they are made for medications:
- to which the lowest price method does not apply;
- for which a generic or biosimilar version is not listed; and,
- for which a patient has received financial assistance prior to the Regulation’s coming into force (i.e. before April 15, 2021).
There is also another small exception allowing the continuation of payments to patients for a period of 30 days following the listing of the first generic or biosimilar on the List of Medications, in order to allow a short transition of patients.
The prohibition under the Act comes into force in tandem with the Regulation. This coordination avoids any temporary blanket prohibition, without exception, against all forms of financial assistance.
The ban on financial assistance is sure to impact anyone providing financial assistance or free products to patients. Nonetheless, the full extent of the prohibition is still open to interpretation. The reach and scope of the Regulation’s exceptions will depend on how they are interpreted by the enforcers, i.e. the Minister and the RAMQ, or eventually by a court in the event of a challenge.
As it stands, the Regulation’s exceptions are open to several interpretations.
a. Substitute Drugs
Section 1(1) of the Regulation excepts from the prohibition the payment of any medications for which the lowest price method does not apply. The breadth of this exception remains to be seen. Of note, Appendix V to the List of Medications is entitled “List of drugs for which the lowest price method does not apply.” Presumably, this list contains the medications covered by the exception.
However, there is also a specific exception to the Lowest Price Method in the List of Medications for drugs where the physician indicates “Do Not Substitute” in accordance with the relevant rules. It is uncertain whether only medications expressly listed under Appendix V would be exempt from the ban, or if any drug may be exempt where a physician has written “Do Not Substitute.”
b. Exceptional Drugs
It is difficult to predict how the Regulation will be applied to exceptional drugs (“Médicamments d’exception”).
Section 1(2) of the Regulation exempts from the prohibition payments for drugs with no reimbursed generic or biosimilar versions. This exemption is open to different interpretations. On the one hand, it is clear that loyalty-type programs under which manufacturers pay the price difference between the brand and the generic are banned.
On the other hand, the Regulation makes no reference to reimbursement criteria. These criteria include indications recognized for coverage in the case of exceptional medications, called “Médicamments d’exception.” Exceptional medications permit anyone to obtain coverage for a drug provided the drug is used according to the indications recognized by the Institut national d'excellence en santé et en services sociaux.
The question arises whether the prohibition contained in the Regulation applies to a product for all its indications or only the indications for which the generic or biosimilar is listed.
The answer to this question will determine how the amended Act and Regulation integrate into and interact with the existing statutory and regulatory regime concerning exceptional medications.
c. Grandfathered Programs
Section 3 of the Regulation allows payment of reimbursements to persons who received financial assistance before the Regulation comes into force. The enrollment of new patients into existing patient support programs that provide financial assistance is therefore prohibited if there is a generic or biosimilar on the market.
This grandfather clause could be applied strictly or liberally. It is open to question whether a patient is receiving financial assistance under a support program can remain exempted if certain terms of the financial assistance change following the Regulation. Some terms might be more essential than others, such as the extent of the financial assistance.
The range of compliant adjustments available to existing patient support programs is unknown.
d. Humanitarian Programs
The application of the patient financial assistance ban is “except to the extent provided for by ministerial regulation, in particular for humanitarian reasons.”
Parliamentary debates raised the definition of “humanitarian,” and what humanitarian exceptions might entail in the context of a prohibition against copayments and reimbursements. Ultimately, however, neither the Act nor the Regulation explicitly define “humanitarian reasons” or expressly address this issue.
Based on Section 80.2(1) of the Act, one would expect compassionate use programs that provide drugs free of charge would fall under a humanitarian exception. It is curious that this notion is completely absent from the Regulation.
4. Moving Forward
It is apparent that manufacturers and others in the life sciences industry must adjust in the wake of Bill 92’s prohibition against patient financial assistance programs. The full extent of this adjustment, however, is less apparent, since it will depend heavily on the scope of the Regulation’s exceptions, which will itself depend on how the Regulation’s exceptions are interpreted.
Time will tell.