PMPRB NEWSletter: March 2024, Volume 28, Issue 1
Contents
The PMPRB NEWSletter provides stakeholders with news and information about the activities of the Board and its staff. To be notified of new announcements, publications, and other initiatives, please follow us on X, formerly known as Twitter.
Board Updates
New Board Members
On August 15, 2023, the Governor in Council appointed Anie Perrault as Vice Chairperson for a five-year term. With over 30 years of experience in the public and private sectors, Ms. Perrault held several positions in the genomic research and biotechnology sector both in Quebec and nationally.
On October 12, 2023, the Governor in Council appointed Peter Moreland-Giraldeau to the Board for a five-year term. Mr. Moreland-Giraldeau is a lawyer with a Master of Laws: Common Law (L.L.M) from the University of British Columbia. In his work for the Appeals Commission for Alberta Workers' Compensation, he provides legal advice to the Commission's General Counsel, Commissioners and Executive. He is also the Chair of the Canmore Subdivision and Development Appeal Board.
On October 24, 2023, the Governor in Council appointed Dr. Emily A. Reynen to the Board for a five-year term. Dr. Reynen is an intensive care physician at the Quinte Health Care Belleville General Hospital. In addition, she is an Adjunct Assistant Professor at Queen's University and serves as a member of the Canadian Agency For Drugs And Technologies in Health's (CADTH) Canadian Drug Expert Committee.
Departing Board Member
Ingrid Sketris completed her second mandate at the PMPRB in June 2023. Ms. Sketris brought experience, expertise and perspective that will be missed. The Board thanks Ms. Sketris for her dedication to the PMPRB.
New Executive Director
After a full government wide application process that attracted many qualified applicants, Guillaume Couillard was appointed indeterminately to the Executive Director position at the PMPRB as of March 1, 2024.
Mr. Couillard has been part of the PMPRB since 2014 in various executive roles. Since April 2023, he has taken on the acting role of the Executive Director leading the organization through changes and complex policy initiatives while establishing numerous new relationships with stakeholders.
Guidelines Consultation
In November 2023, the Board released a Scoping Paper to obtain stakeholders’ views on the following themes to inform the development of final PMPRB Guidelines.
- Efficient Monitoring of Prices without Price Setting
- Transition to PMPRB11 – New versus Existing Medicines
- Price Reviews during Product Life Cycle
- Investigations and Referral to Hearing
- Relation to pan-Canadian Health Partners, Insurers (Private and Public); and Alignment with Broader Government Initiatives
- Engaging with Patients, Health Practitioners, Pharmacy, and other Stakeholders
The PMPRB invited stakeholders to participate in a Policy Roundtable on December 5 and December 6. The intent of these meetings was to foster a productive conversation, where all parties could voice their opinions regarding future Guidelines.
The PMPRB published a What We Learned report based on the feedback received during these meetings. For more information on the Policy Roundtable and the companion Scoping Paper, please visit the PMPRB website.
Events
This table contains a list of recent meetings between Board members and stakeholders for the purposes of transparency.
| Date | Stakeholder Event/Organization | PMPRB Board Member | PMPRB Staff Member | Individual/ Representative | Purpose | Duration | Mode (Virtual/ or in person) |
|---|---|---|---|---|---|---|---|
May 17-18, 2023 |
CADTH Annual Meeting, Ottawa |
Chairperson |
Acting Executive Director and multiple staff |
Diverse conference attendees and speakers |
Attending public event |
2 days |
In person |
July 21, 2023 |
IMC |
Chairperson |
Acting Executive Director and acting Board Secretariat Director |
Pamela Fralick, CEO Declan Hamill, Head of Policy |
General introduction |
1 hour |
Virtual |
August 16, 2023 |
BioteCanada |
Chairperson |
Acting Executive Director |
Andrew Casey, CEO, Pascale Lajoie, Head of Policy |
General introduction |
1 hour |
Virtual |
August 21, 2023 |
CLHIA |
Chairperson |
Acting Executive Director |
Stephen Frank, President and CEO |
General introduction |
1 hour |
Virtual |
August 24, 2024 |
Health Canada |
Chairperson |
Acting Executive Director |
The Honourable Mark Holland, Minister of Health |
General introduction |
1 hour |
Virtual |
October 13, 2023 |
CADTH |
Chairperson |
Acting Executive Director and acting Board Secretariat Director |
Suzanne McGurn, President and CEO |
General introduction |
1 hour |
Virtual |
November 7, 2023 |
Biotechnology Innovation Organization (Washington DC) |
Chairperson |
Acting Executive Director and acting Board Secretariat Director |
Rachel King CEO, John Murphy Policy Head |
General introduction |
45 minutes |
Virtual |
November 23, 2023 |
Global Affairs Public |
Chairperson |
Acting Board Secretariat Director |
Wayne Critchley, Senior Associate |
Discuss upcoming speech at CAHR |
30 minutes |
Virtual |
December 4, 2023 |
Canadian Association of Healthcare Reimbursement, Annual Meeting (Ottawa) |
Chairperson |
Acting Board Secretariat Director |
Bill Dempster, President 3Sixty Public Affairs Inc. |
1 hour |
In person |
|
February 7, 2024 |
pan-Canadian Pharmaceutical Alliance |
Chairperson |
Acting Executive Director and acting Board Secretariat Director |
Douglas Clark, Chief Executive Officer |
General introduction |
1 hour |
Virtual |
Certificates of Supplementary Protection
Rights holders are reminded of their obligation to report any applicable Certificate of Supplementary Protection (CSP) through the PMPRB online filing tool. A CSP gives the certificate holder the same legal rights given by the patent and extends patent protection for a maximum period of two years.
Amendments made to the Patented Medicines section of the Patent Act, published in the Canada Gazette, which came into force on June 30, 2021, extended the PMPRB’s jurisdiction to medicines that are protected by a CSP.
Medicines without a Maximum Average Potential Price under Interim Guidance
As per the amended Interim Guidance announced on September 27, 2023, PMPRB Staff will assign the status of “Reviewed” to medicines without a Maximum Average Potential Price (MAPP) or Non-Excessive Average Price (NEAP) as of June 30, 2022 whose list price was below the Median International Price (MIP); and will assign the status of “Under Review” for those medicines if their list price was above the MIP.
As of the January to June 2023 filing period, 155 DINs related to medicines with no MAPP were filed with the PMPRB. Of those, 59 DINs had reported sufficient information in order for the analysis to be conducted. The pricing data for 93.2% of these 59 DINs has been analyzed, and 60.4% of the completed DINs received the status of “Reviewed”. PMPRB Staff is currently analyzing the July to December 2023 filings.
Voluntary Compliance Undertakings
A Voluntary Compliance Undertaking (VCU) is a written undertaking by a patentee to adjust its price and/or offset potential excess revenues. Patentees are given an opportunity to submit a VCU when the price set by the patentee for a patented drug product sold in Canada appears to be excessive. VCUs are submitted by rights holders in view of the specific facts and underlying context of a particular case, and are purely administrative in that they are used to close investigations only. As such, VCUs are not intended to have precedential value.
Since the last edition of the NEWSletter in June 2023, the Chairperson has accepted the closure of three investigations based on the receipt of VCUs covering four medicines (eight DINs).
Suboxone Film / Sublocade
Suboxone Film (buprenorphine/naloxone) is indicated for substitution treatment in adults with opioid drug dependence. Sublocade (buprenorphine) is indicated for the management of moderate to severe opioid use disorder in adult patients who have been inducted and clinically stabilized on a transmucosal buprenorphine-containing product.
On June 22, 2023, the Chairperson accepted a VCU by Indivior UK LTD (“Indivior”) regarding both Suboxone Film and Sublocade.
Indivior agreed to offset the excess revenues generated by Suboxone Film and Sublocade as of December 31, 2021, by reducing the 2022 prices of Suboxone Film and Sublocade, and to make a payment to the Receiver General of Canada for any remaining excess revenues, as calculated based on the semi-annual price and sales data filed by Indivior.
Indivior also agreed that the prices of Suboxone Film and Sublocade will remain within the PMPRB’s Guidelines in all future periods in which they are under the PMPRB’s jurisdiction.
Xospata
Xospata (gilteritinib) is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation.
On July 4, 2023, the Chairperson accepted the closure of an investigation following a VCU by Astellas Canada Pharma, Inc (“Astellas”) regarding Xospata.
Astellas acknowledged that the 2023 and 2024 Non-Excessive Average Price (“NEAP”) of Xospata 40 mg/tablet is $276.6847 per tablet. It agreed to offset the cumulative potential excess revenues by making a payment of $635,774.92 to the Receiver General of Canada. Astellas also agreed that the price of Xospata will remain within the PMPRB’s Guidelines in all future periods in which it is under the PMPRB’s jurisdiction.
Clindoxyl Gel
Clindoxyl Gel (clindamycin/benzoyl peroxide) is indicated for the topical treatment of moderate acne vulgaris characterized by the presence of comedones, papules and pustules.
On September 20, 2023, the Chairperson accepted a VCU by GlaxoSmithKline Inc. (“GSK”) regarding Clindoxyl Gel.
GSK undertook to reduce the price of Clindoxyl Gel. GSK also agreed to offset the excess revenues generated by Clindoxyl Gel by making a payment of $571,128.77 to the Receiver General of Canada and make a further payment to the Receiver General of Canada for any remaining excess revenues as of
June 30, 2024.
GSK also agreed that the price of Clindoxyl Gel will remain within the PMPRB’s Guidelines in all future periods in which it is under the PMPRB’s jurisdiction.
NPDUIS Activities
The PMPRB continues to engage with and support Canadians through the NPDUIS initiative. In addition to publishing a number of analytical studies, as detailed below, the PMPRB has hosted information sessions to share the results of its recent reporting.
NPDUIS Advisory Committee Meeting
Teleconferences were held regularly with the NPDUIS Advisory Committee members in 2023 and the Committee reconvened virtually in October for an annual meeting led by the PMPRB and the Canadian Institute for Health Information (CIHI) representatives. The NPDUIS Advisory Committee advises and supports the PMPRB in establishing NPDUIS research priorities, in the development of related research methodologies, and the interpretation of analytical results. It is composed of public drug plan representatives, including Quebec and participants from Health Canada, CIHI, the Canadian Agency for Drugs and Technologies in Health (CADTH), the Canadian Drug Agency Transition Office (CDATO), and the pan-Canadian Pharmaceutical Alliance (pCPA) Office.
Conference Participation
In summer and fall 2023, the PMPRB presented the findings of analytical studies at the International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) in Halifax
(August 23-27, 2023) and the Canadian Association for Population Therapeutics (CAPT) conference in Toronto (October 23-24, 2023).
PMPRB presentations from conferences and other forums are available for download on the Presentations page of the website. Poster presentations developed as part of the NPDUIS initiative are also available on the PMPRB website under Analytical Studies.
Academic Article
Research by PMPRB staff was published in the June 12, 2023 issue of the Canadian Medical Association Journal (CMAJ). The article titled “Is Canada missing out? An assessment of drugs approved internationally between 2016 and 2020 and not submitted for Health Canada review” is available to read through the CMAJ website.
NPDUIS New and Upcoming Publications
New Releases
Reports
The Meds Pipeline Monitor (MPM) is a horizon-scanning report series that features a selection of new medicines in the late stages of clinical evaluation that may have a significant impact on future clinical practice and drug spending in Canada. The 2022 edition identifies a broad range of late-stage medicines in the pipeline in 2022 and reviews those featured in the 2021 MPM to report on changes to their status in the pipeline. A section focused on Canada highlights potentially significant medicines currently under review by Health Canada.
The Meds Entry Watch report series explores the market entry of new medicines in Canada and within an international context. Building on a retrospective analysis of trends since 2016, this seventh edition focuses on medicines that received first-time market approval through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2020 and 2021 and analyzes their uptake, pricing, sales, and availability as of the last quarter of 2021. In addition to the international analysis, a Canadian-focused section provides information on medicines that received their first Health Canada approval in 2020, as well as a retrospective review of annual marketing rates over the past five years.
CompassRx, 9th edition: Annual Public Drug Plan Expenditure Report, 2021/22
The PMPRB’s flagship CompassRxreport monitors and analyzes the cost pressures driving changes in prescription drug expenditures in Canadian public drug plans. The ninth edition of the report provides insight into the factors driving growth in drug and dispensing costs in 2021/22, as well as a retrospective review of recent trends in public drug plan costs and utilization.
Coming Soon
Reports
Meds Entry Watch, 8th Edition
The Meds Entry Watch report series explores the market entry of new medicines in Canada and within an international context. Building on a retrospective analysis of trends since 2017, this eighth edition focuses on medicines that received first-time market approval through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2021 and 2022 and analyzes their uptake, pricing, sales, and availability as of the last quarter of 2022. In addition to the international analysis, a Canadian-focused section provides information on medicines that received their first Health Canada approval in 2021, as well as a retrospective review of annual marketing rates over the past five years.
Board Meetings
Board Meeting - June 2023, Halifax, Nova Scotia
The Board met in Halifax, Nova Scotia on June 7, 2023. This meeting was the last meeting of Ms. Ingrid Sketris.
During the meeting, Board staff provided briefings and updates on the strategic plan related to its ongoing and future operations.
Dr. Sharon Batt, PhD, Researcher in Health & Pharmaceutical Policy, Author and Adjunct Professor, Department of Bioethics and Department of Political Science at the Dalhousie University addressed the Board to discuss her experience as a patient group advocate.
Board Meeting – September 2023, Videoconference
The Board met virtually on September 12, 2023. This meeting was the first with Ms. Anie Perrault as Vice-Chair.
During the meeting, Board staff provided briefings and updates on various topics including on results of the Notice and Comment initiative related to Amended Interim Guidance for New Medicines. The Board made a decision which was communicated on September 27, 2023.
Board Meeting – October 2023, Ottawa, Ontario
The Board met in person in Ottawa on October 20, 2023.
The Board discussed the way forward for its consultation launched on October 25, 2023. The Board selected various themes of interest for its consultations from the diverse issues and trends that impact health care, pharmaceuticals and the vast inter-connected ecosystem from lab bench to patients in Canada and around the world. The meeting also resulted in the publication of a scoping paper on November 10, 2023.
Board Meeting – January 2024, Videoconference
The Board met virtually on January 16, 2024. The meeting was the first meeting of Dr. Emily Reynen and Mr. Peter Moreland-Giraldeau as new Board members.
A recap of the initial phase of the Guidelines consultation and the related Board decisions were presented for the benefit of the new Board members. The Board discussed the stakeholders’ views presented to them at the December Policy Roundtable as well as in the written submissions to the scoping paper.
The meeting resulted in the decision to publish the What we learned report which was commissioned by the PMPRB to summarize the opinions shared by stakeholders during the Policy Roundtable.
Board meeting – February 2024, Montreal, Quebec
The Board met in person in Montreal on February 29, 2024.
The Board discussed how best to engage with Canadians to ensure that the various groups of stakeholders impacted by the upcoming Guidelines have an opportunity to be heard.
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