PMPRB NEWSletter: June 2023, Volume 27, Issue 1
Table of 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 Twitter.
Board Updates
On January 27, 2023, the Governor in Council appointed Thomas J. Digby to a five-year term as Chairperson of the Patented Medicine Prices Review Board.
Mr. Digby is a lawyer with expertise in intellectual property and has an extensive educational background in the Biological Sciences. He has over 25 years of experience working with the pharmaceutical sector and is highly knowledgeable regarding patented medicines.
Open, transparent, and merit-based Governor in Council selection processes are currently underway to appoint a new Vice Chairperson and two Board members. The Board looks forward to announcing more information on its membership and its path forward shortly.
Executive Director Position
Douglas Clark has stepped down as Executive Director of the PMPRB as of June 1, 2023, after almost a decade at the PMPRB. Mr. Clark has agreed to remain with the PMPRB as a special advisor to the Board for a specified period as he transitions to retirement from the federal public service.
Guillaume Couillard is currently the Acting Executive Director. A staffing process to appoint Mr. Clark’s permanent successor will be launched shortly.
The PMPRB wishes to thank Mr. Clark for his years of dedicated service and leadership.
Update on Interim Investigations
The PMPRB published its Interim Guidance on August 18, 2022, following the coming-into-force of the amended Patented Medicines Regulations. This guidance document divided all patented medicines reported to the PMPRB into two categories: “New” and “Existing” patented medicines.
New patented medicines were those which had not received a Maximum Average Potential Price (MAPP) or Non-Excessive Average Price (NEAP) prior to July 1, 2022. During this interim period, these medicines would not be subject to a price review by PMPRB Staff.
Existing patented medicines were all medicines that had received a MAPP or NEAP prior to July 1, 2022. For these medicines, the Interim Guidance described investigation criteria which PMPRB Staff would apply following the receipt of the July to December 2022 semi-annual filing. An investigation would be commenced if the National Average Transaction Price (N-ATP) of a medicine exceeded its NEAP as projected in the compliance letter from PMPRB staff sent in February and March 2022 and more than $50,000 in potential cumulative excess revenues had been accrued. An investigation would also be triggered if the list price of a medicine increased by more than the allowable CPI during the January to June 2022 reporting period, or if the list price increased during the July to December 2022 reporting period.
A total of 121 investigations were commenced according to the criteria set out in the Interim Guidance document. A breakdown of the criteria which led to the investigations is as follows:
| Total | N-ATP | 22-1 List | 22-2 List | N-ATP and List |
|---|---|---|---|---|
121 |
112 |
4 |
3 |
2 |
PMPRB Staff are prioritizing the review of these interim investigations and making recommendations to the Chairperson on their closure as appropriate. Where investigations are closed by the Chairperson, Rightsholders are made aware directly by Board Staff.
Human Drug Advisory Panel Membership Update
In May 2022 we bade farewell to Dr. Fred Aoki, who has been a member of the Human Drug Advisory Panel (HDAP) since 2009. Dr. Aoki’s knowledge, wisdom and experience are matched only by his kindness, generous spirit, and commitment to excellence on behalf of Canadians. We are grateful for his dedicated service and wish him happiness in the years ahead.
With Dr. Aoki’s departure, we welcome Dr. Bishal Gyawali as a new HDAP member. Dr. Gyawali is a practicing medical doctor who also holds a Ph.D. in medical oncology and is currently Associate Professor, Department of Medical Oncology; Associate Professor, Department of Public Health Sciences; Scientist, Division of Cancer Care and Epidemiology; and Member, Health Policy Council, School of Policy Studies; all at Queen’s University in Kingston, Ontario. Dr.Gyawali began his participation in the scientific review process at the May 2023 HDAP meeting. Welcome Dr. Gyawali.
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
Webinars were held quarterly with the NPDUIS Advisory Committee members in 2022 and the Committee reconvened virtually in October for an annual meeting led by PMPRB and Canadian Institute for Health Information (CIHI) representatives. The NPDUIS Advisory Committee advises and supports the PMPRB in establishing research priorities, in the development of research methodologies, and in 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
The PMPRB has presented the findings of its analytical studies at a number of conferences over the past year, including the Canadian Agency for Drugs and Technologies in Health (CADTH) Symposium, the Canadian Association for Health Services and Policy Research (CAHSPR) Annual Conference, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) conference, the Canadian Association for Population Therapeutics (CAPT) conference, and the Canadian Centre for Applied Research in Cancer Control (ARCC) conference.
Abstracts have also been submitted for participation in the 2023 International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), and Canadian Economics Association (CEA) conferences to be held this summer.
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.
Staffing Updates
We are pleased to announce that Kevin Pothier is the new manager of NPDUIS effective August 2, 2022. Prior to joining the PMPRB, Kevin was the Executive Director, Pharmaceutical Services for the Government of New Brunswick. Kevin is a pharmacist by training and holds a degree in mathematics. Kevin has over 20 years of practical, pharmaceutical policy, and leadership experience.
NPDUIS New and Upcoming Publications
New Releases
Reports
Drug Shortages in Canada and their Impact on Public Drug Plans, 2017/18 to 2019/20
Shortages in the supply of medications have become an issue of great importance to Canadian patients, healthcare providers, manufacturers, distributors, group purchasing organizations, pharmacists, and insurers. Published in September 2022, this study provides insight into the impact of drug shortages in Canada. Drawing on data from fiscal years 2017/18 to 2019/20, the analysis examines trends in the number, market segment, therapeutic area, and duration of drug shortages in Canada and explores their impact on public drug plan beneficiaries as well as on public plan spending.
Analyzing the 8,558 shortage reports filed by Canadian manufacturers from April 2017 to the end of March 2020, the study finds that shortages affected 29% of the medicines sold in Canada, with more than half of shortages resolved within three months. A diversity of challenges was identified. Of the drugs with a shortage reported, 70% had fewer than 1,000 monthly NPDUIS public drug plan beneficiaries before the shortage, whereas 5% had over 10,000 monthly beneficiaries.
CompassRx, 8th Edition: Annual Public Drug Plan Expenditure Report, 2020/21
The eighth edition of CompassRx was released in January 2023, exploring trends in prescription drug expenditures in NPDUIS public drug plans. This ongoing series monitors and analyzes the cost pressures driving changes in prescription drug expenditures in Canadian public drug plans.
Drug cost growth for the NPDUIS public plans in 2020/21 was driven primarily by a greater use of higher-cost drugs combined with a sizable increase in the volume of drugs used per patient. Prescription drug expenditures for the NPDUIS public drug plans grew by 4.2% in 2020/21, following a 3.7% increase in 2019/20.
Notably, the overall NPDUIS public plan beneficiary population declined by 5.8% from 2019/20 to 2020/21. Approximately 366,000 fewer Canadians filled a prescription for reimbursement to public drug plans, with the onset of the COVID-19 pandemic.
Market Intelligence Report: Antidiabetic Drugs, 2012-2021
The Market Intelligence series of reports provides short, targeted analyses of therapeutic market segments of importance to Canadians. These studies are designed to inform policy discussions, aid in evidence-based decision making, and provide Canadians with a more comprehensive view of issues pertaining to pharmaceutical drug pricing and utilization.
Published in May 2023, this report explores the market dynamics affecting spending on antidiabetic drugs with an emphasis on new-generation/non-insulin drugs that experienced substantial growth over the course of the last decade. Trends in market shares and utilization are analysed at both the national and international levels. Foreign-to-Canadian price ratios and the impact of provincial biosimilar switching policies are also studied.
Coming Soon
Reports
Meds Pipeline Monitor, 2022
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 will identify 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 will highlight potentially significant medicines currently under review by Health Canada.
Meds Entry Watch, 7th Edition
The Meds Entry Watch report series explores the market entry of new medicines in Canada and within an international context. Building on retrospective analysis of trends since 2015, this seventh edition will focus 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 will provide information on medicines that received their first Health Canada approval in 2020, as well as a retrospective review of quarterly approvals over the past five years.
Board Meetings
Summary of the Board’s March 2023 meeting
The Board held its first meeting of 2023 in Vancouver, BC on March 29, 2023. It was the first full meeting of the new Chairperson, Thomas Digby, with his fellow Board members and Board staff.
During the meeting, Board staff provided briefings and updates on the forward agenda for the regulatory framework modernization.
Wendy Hurlburt, President and CEO of LifeSciences BC, attended as a guest of the Chairperson for a discussion on the BC pharmaceutical ecosystem with the Board members and Board staff.
Board Meeting - June 2023, Halifax, Nova Scotia
The Board’s next meeting in 2023 will take place in Halifax, Nova Scotia on June 7, 2023. A summary of that Board meeting will be available in the next edition of this publication.
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. Under the Guidelines, 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 have exceeded the thresholds in the Guidelines. VCUs represent a compromise between the PMPRB and the patentee as a result of negotiation between the parties 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.
In 2022-23, $921,189.80 was repaid to Canada under VCUs entered into by six patentees based on their voluntary re-assessment of pricing on seven patented pharmaceutical products.
So far in 2023-24, the Chairperson has accepted two VCUs covering two products.
Tukysa
Tukysa is indicated in combination with trastuzumab and capecitabine, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination.
On May 26, 2023, the Chairperson accepted a VCU by Seagen Canada Inc. regarding Tukysa. Seagen Canada agreed to reduce the list price of Tukysa.
Seagen also agreed that the price of Tukysa will remain within the PMPRB’s Guidelines in all future periods in which it is under the PMPRB’s jurisdiction.
Arikayce
Arikayce (amikacin liposome inhalation suspension) is not approved in Canada. In the United States, Arikayce is indicated for adults who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of six consecutive months of a multidrug background regimen therapy.
On May 25, 2023, the Chairperson accepted a VCU by Insmed Incorporated (“Insmed”) regarding Arikayce. Insmed agreed to reduce the price of Arikayce. Insmed also agreed that the price of Arikayce will remain within the PMPRB’s Guidelines in all future periods in which it is under the PMPRB’s jurisdiction.
Duobrii
Duobrii (halobetasol proprionate/tazarotene) is indicated for improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.
On November 20, 2022, the Acting Chairperson accepted a VCU by Bausch Health Canada Inc. (“Bausch”) regarding Duobrii. Bausch agreed to offset the excess revenues generated by Duobrii as of December 31, 2021 by making a payment of $97,247.04 to the Receiver General of Canada. Bausch agreed to make a further payment to the Receiver General of Canada for any remaining excess revenues as of December 31, 2022.
Bausch also agreed that the price of Duobrii will remain within the PMPRB’s Guidelines in all future periods in which it is under the PMPRB’s jurisdiction.
Patanol and Pataday
Patanol and Pataday (olopatadine hydrochloride) are indicated for the treatment of allergic conjunctivitis and the treatment of ocular itching associated with seasonal allergic conjunctivitis, respectively.
On October 13, 2022, the Acting Chairperson accepted a VCU by Novartis Pharmaceuticals Canada Inc. (“Novartis”) regarding Patanol and Pataday. Novartis agreed to offset the excess revenues generated by Patanol and Pataday as of June 19, 2022, the date the last reported patent pertaining to these medicines expired, by making a payment of $393,194.00 to the Receiver General of Canada.
Novartis also agreed that, should a new patent be issued, the prices of Patanol and Pataday will remain within the PMPRB’s Guidelines in all future periods in which they are under the PMPRB’s jurisdiction.
Xydalba
Xydalba (dalbavancin) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by gram-positive microorganisms.
On August 10, 2022, the Acting Chairperson accepted a VCU by Paladin Labs Inc. (“Paladin”) regarding Xydalba. Paladin agreed to reduce the list price of Xydalba, and to offset the excess revenues generated by Xydalba as of December 31, 2021 by making a payment of $14,830.84 to the Receiver General of Canada. Paladin agreed to make a further payment to the Receiver General of Canada for any remaining excess revenues as of December 31, 2022.
Paladin also agreed that the price of Xydalba will remain within the PMPRB’s Guidelines in all future periods in which it is under the PMPRB’s jurisdiction.
Cleviprex
Cleviprex (clevidipine) is indicated for the management of acute elevation of blood pressure in perioperative settings.
On July 14, 2022, the Acting Chairperson accepted a VCU by Chiesi USA, Inc. (“Chiesi”) regarding Cleviprex. Chiesi agreed to offset the excess revenues generated by Cleviprex as of December 31, 2021 by reducing the price of Cleviprex, and to make a payment to the Receiver General of Canada for any remaining excess revenues as of December 31, 2022.
Chiesi also agreed that the price of Cleviprex will remain within the PMPRB’s Guidelines in all future periods in which it is 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 June 28, 2022, the Acting Chairperson accepted a VCU by Astellas Pharma Canada Inc. (“Astellas”) regarding Xospata. Astellas agreed to offset the excess revenues generated by Xospata as of December 31, 2021 by making a payment of $400,000.00 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.
Ledaga
Ledaga (chlormethine hydrochloride) is indicated for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in adult patients who have received prior skin-directed therapy.
On June 2, 2022, the Acting Chairperson accepted a VCU by Recordati Rare Diseases Canada Inc. (“Recordati”) regarding Ledaga. Recordati agreed to reduce the list price of Ledaga, and to offset the excess revenues generated by Ledaga as of December 31, 2021 by making a payment of $53,403.18 to customers who purchased Ledaga between 2019 and 2021. Recordati agreed to make a further payment to the Receiver General of Canada for any remaining excess revenues as of December 31, 2022.
Recordati also agreed that the price of Ledaga will remain within the PMPRB’s Guidelines in all future periods in which it is under the PMPRB’s jurisdiction.
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