Language selection

Government of Canada / Gouvernement du Canada

Search

PMPRB NEWSletter: April 2022, Volume 26, Issue 1

e-bulletin

Table of Contents

Notice to Readers

Reminders

  • The PMPRB no longer issues e-bulletins. To be notified of new announcements, publications, and other initiatives, please follow us on Twitter.

Departure of Dr. Mitchell Levine

In November 2021, Dr. Mitchell Levine completed his five-year term as Chairperson of the PMPRB. During Dr. Levine’s time as Chairperson, the government brought forward historic “once-in-a-generation” reforms to update and fortify the PMPRB’s regulatory framework. His intellect, vision, tenacity, background as a respected academic and many years of experience as a clinician at the front lines of Canada’s health system brought gravitas and credibility to the PMPRB’s modernization efforts. Dr. Levine’s unflappable demeanour and relaxed leadership style belied a passion for the PMPRB’s consumer protection mandate, and public policy generally, that served as an inspiration and comfort to staff at an exciting but challenging time. We would like to thank Dr. Levine for his service and wish him well in all his future endeavours. The PMPRB’s Vice-Chairperson, Mélanie Bourassa Forcier, has assumed the duties of acting Chairperson until a permanent replacement for Dr. Levine is appointed by Governor in Council.

The Chairperson and other members of the Board are part-time, Governor in Council appointees who set the overall direction of the PMPRB and preside over hearings into allegations of excessive drug pricing brought by PMPRB staff against patent-holding pharmaceutical companies.

For more information on how Board members are appointed, please visit the Governor in Council Appointments page on Canada.ca.

Update – PMPRB Response to the April 14, 2022 statement from Minister of Health on the Coming-into-Force of the 2019 Regulations Amending the Patented Medicines Regulations

In August 2019, the Government announced the adoption of Health Canada-sponsored amendments to the Patented Medicines Regulations which, upon coming into force, would change how the PMPRB regulates the ceiling price of patented medicines These amendments were originally slated to come into force in July of 2020 but were pushed back to July 2022 owing to the ongoing COVID-19 pandemic. After a recent round of consultations with stakeholders, on April 14, 2022, the Minister of Health, the Honourable Jean-Yves Duclos, issued a statement regarding Health Canada’s intentions with respect to the coming into force of these amendment.

In October 2020, after a year-long consultation, the Board issued revised guidelines which would operationalize the August 2019 regulatory package upon its coming into force. In the meantime, the PMPRB continues to administer the regulatory framework based on the existing guidelines. As neither the existing nor the October 2020 guidelines contemplate the regulatory framework which is now expected to come into force on July 1, 2022, it will be necessary for the Board to consult on a new and different set of guidelines in the coming months. In order to provide stakeholders with a reasonable period of time to provide feedback on these new guidelines, it will not be possible to finalize them by the July 1, 2022, coming into force date of the regulatory amendments. As a result, although rights holders will be required, by operation of law, to begin reporting price information based on the new group of countries as of July 1, 2022, the PMPRB will not have any guidelines to apply at that time. Accordingly, once a final set of new guidelines is issued and the price tests that apply to the new basket of countries are known, rights holders will be provided with a reasonable period of time to take the necessary steps to come into voluntary compliance with them on a go forward basis. In the interim, the Board will also hold an expedited written consultation on what price tests should apply during this temporary period when neither the old nor the new guidelines are in effect.

Details on the upcoming consultation process will be communicated upon publication of the new draft guidelines.  The Board will make every effort to develop and publish the new draft in a timely fashion but no timetable can be set for doing so until the revised regulatory package is reflected in the Canada Gazette later this Spring. Once that happens, the Board will issue draft guidance on the provisional price tests to apply during the above-mentioned interim period, followed by a targeted consultation with key stakeholders.  

Soliris - Redetermination

The Board will hold a public hearing in the matter of the price of the patented medicine Soliris and Alexion Pharmaceuticals Inc. (Alexion) beginning on June 20, 2022, in Ottawa. The purpose of the hearing is to determine whether Alexion is selling or has sold the medicine at a price that is or was excessive.

Soliris is indicated for the treatment of Paroxysmal Nocturnal Hemoglobinuria, a rare and life-threatening blood disorder characterized by excessive destruction of red blood cells, and Atypical Hemolytic Uremic Syndrome, a rare and life-threatening genetic disorder characterized by blood clots in small vessels.

See the PMPRB's recent news release on the matter for more information.

Launch of the Online Filing Tool

The PMPRB launched the new online filing tool on January 1, 2022.  Please note that the following information must be submitted via the online filing tool:

Should you have any questions related to the online filing tool please contact compliance@pmprb-cepmb.gc.ca.

Upcoming Human Drug Advisory Panel Meetings

The Human Drug Advisory Panel (HDAP) provides credible, independent, and expert scientific advice to PMPRB staff in conducting scientific reviews of information submitted by patentees. The HDAP meets four times a year; the next scheduled meetings of the Human Drug Advisory Panel are as follows:

Please see the PMPRB website for corresponding filing dates and further details.  

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 2021 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), 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) Biosimilars Forum, 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 2022 ISPOR and CAHSPR Conferences to be held this spring.

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.

NPDUIS New and Upcoming Publications

New Releases

Reports

Alignment Among Public Formularies in Canada

This three-part series compares the coverage for medicines across provincial and federal public drug plans. The information contained in these reports will inform the dialogue on improving the affordability and accessibility of necessary prescription medicines, including exploring the need for a national formulary.

The third and latest report, published February 2022, examines medicines reviewed through the Common Drug Review (CDR) process. These medicines were selected as they represent a majority of the medicines launched in Canada over the past two decades and accounted for more than 43% of total pharmaceutical spending in 2019. The report finds that formulary listings for CDR-reviewed medicines are relativity consistent across most of Canada’s public drug plans and vary only slightly across the market segments analyzed. Most notably, with the exception of a few smaller public drug programs, listing rates for expensive drugs for rare diseases were higher than those for other CDR medicines.

CompassRx, 7th Edition: Annual Public Drug Plan Expenditure Report, 2019/20

In November 2021, the PMPRB released the seventh edition of its flagship CompassRx report, which monitors and analyzes the cost pressures driving changes in prescription drug expenditures in Canadian public drug plans. This edition provides insight into the factors driving growth in drug and dispensing costs in 2019/20, as well as a retrospective review of recent trends in public drug plan costs and utilization.

Prescription drug expenditures for the NPDUIS public drug plans increased by 3.7% in 2019/20 to reach $12.5 billion, driven primarily by a marked rise in the use of higher-cost drugs and pulled downward by new restrictions to coverage in Ontario’s OHIP+ program.

Chartbooks

Expensive Drugs for Rare Diseases: Canadian Trends and International Comparison, 2011-2020

This NPDUIS series of short, graphics-based analyses expanded in January 2022 with the release of a chartbook on the Canadian market for expensive drugs for rare diseases (EDRDs). The study explores the 104 EDRDs currently sold in Canada, looking at the market impact and price levels of these medicines, as well as the approvals and assessments conducted by Canadian health agencies. In addition, the chartbook includes an analysis focused on newer EDRD approvals, providing a comparison of Canadian and international markets.

EDRD sales in Canada reached $3.1 billion in 2020, more than 11 times their sales in 2011. Given this pace of growth, there is a need for a better understanding of the impact of this important class of medicines on Canadian patients and payers alike.

Coming Soon

Reports

Meds Entry Watch, 6th Edition

This 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 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 2019 and 2020, and analyzes their uptake, pricing, sales, and availability as of the last quarter of 2020. In addition to the international analysis, a Canadian-focused section provides information on medicines that received their first Health Canada approval in 2019, as well as a retrospective review of quarterly approvals over the past five years.

Meds Pipeline Monitor, 2021

Meds Pipeline Monitor (MPM) is a horizon scanning report 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 2021 edition identifies a broad range of late-stage medicines in the pipeline in 2021 and reviews those featured in the 2020 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.

This edition of the report also includes a new section on COVID-19 that provides an overview of medicines undergoing Phase I, II, and III clinical trials or in pre-registration for the treatment and prevention of the novel coronavirus disease.

Drug Shortages in Canada

Drug shortages are an issue of great importance to Canadian patients, healthcare providers, pharmacists, and insurers. This report aims to provide broad insight into the problem of drug shortages in Canada and its consequences, with a focus on publicly insured Canadians and public insurance plans. The analysis focuses on the three-year period spanning from 2017/18 to 2019/20, which precedes most of the supply complications during the COVID-19 pandemic.

Market Intelligence Report: New Oral Anti-Diabetic Drugs

This series of reports provides short, targeted analyses of therapeutic market segments of importance to Canadians. It highlights the uptake in utilization, market shares, pricing and treatment costs of the related drug class, and identifies opportunities for potential cost savings. 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.

Previous reports in this series have explored the market impact of biologic response modifier agents for the treatment of chronic inflammatory diseases, anti-VEGFs used to treat age-related macular degeneration and other retinal conditions, and combination inhalers for asthma. The coming report will focus on oral anti-diabetic agents (DPP-4s and SGLT-2s) used in the treatment of type 2 diabetes, which accounts for 90% of cases globally.

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 exceed 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.  As such, VCUs are not intended to have precedential value.

2020

Taltz

Taltz is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and for the treatment of adult patients with active psoriasis who have responded inadequately to, or who are intolerant to one more disease-modifying antirheumatic drugs.

On February 18, 2020, the Chairperson of the Board accepted a VCU by Lilly regarding Taltz.

Lilly agreed to offset the excess revenues generated by Taltz as of December 31, 2018 by making a payment of $75,844.49 to the Receiver General of Canada. Taltz also agreed to pay any remaining excess revenues, should there have been any following a review of 2019 price and sales data.

Onpattro

Onpattro is indicated for the treatment of polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).

On October 28, 2020, the Chairperson of the Board accepted a VCU by Alnylam regarding Onpattro. Alnylam agreed to reduce the list price for the years 2020 and 2021.

Alnylam also agreed to ensure that the price of will remain within the thresholds set out in the Guidelines in all future periods during which it is under PMPRB’s jurisdiction.

Tegsedi

Tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

On September 23, 2020, the Chairperson of the Board accepted a VCU by Akcea regarding Tegsedi.  Akcea agreed to reduce the list price of Tegsedi.

Akcea also agreed to ensure that the price of Tegsedi remains within the PMPRB’s Guidelines in all future periods in which Tegsedi remains under the PMPRB’s jurisdiction.

Aimovig

Aimovig is indicated for the prevention of migraine in adults who have at least four migraine days per month.

On November 5, 2020, the Chairperson of the Board accepted a VCU by Novartis regarding Aimovig.

Novartis also agreed to ensure that the price of Aimovig will remain within the thresholds set out in the Guidelines in all future periods during which it is under PMPRB’s jurisdiction.

2021

Nerlynx

Nerlynx is indicated for treatment of early-stage hormone receptor positive, amplified breast cancer

On March 26, 2021, the Chairperson accepted a VCU by Knight regarding Nerlynx.  Knight agreed to reduce the list price for Nerlynx.

Knight also agreed to ensure that the price of Nerlynx will remain within the thresholds set out in the Guidelines in all future periods during which it is under PMPRB’s jurisdiction.

Dayvigo

Dayvigo is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

On November 7, 2021, the Chairperson accepted a VCU by Eisai regarding Dayvigo. Eisai agreed to reduce the list price for Dayvigo and to offset excess revenues accrued up to December 31, 2021.

Eisai also agreed that the price of Dayvigo will remain within the thresholds set out in the Guidelines in all future periods during which it is under PMPRB’s jurisdiction.

2022

Crysvita

Crysvita is indicated for the treatment of X-linked hypophosphataemia (XLH) in adult and pediatric patients 6 months of age and older

On March 23 2022, the Acting Chairperson accepted a VCU by Ultragenyx regarding Crysvita.  Ultragenyx agreed to reduce the list price of Crysvita. 

Ultragenyx also agreed that the prices of Crysvita will remain within the PMPRB’s Guidelines in all future periods in which it is under the PMPRB’s jurisdiction.

Ajovy

Ajovy is indicated for the prevention of migraine in adults who have at least four migraine days per month.

On March 25, 2022, the Acting Chairperson accepted a VCU by Teva regarding Ajovy.  Teva agreed to reduce the list price of Ajovy and offset any excess revenues accrued as of December 31, 2022.

Teva also agreed that the price of Ajovy will remain within the PMPRB’s Guidelines in all future periods in which it is under the PMPRB’s jurisdiction.

Staying Informed

The PMPRB hosts webinars to explain the key findings in its NPDUIS reports. If you are interested in receiving notifications related to the release of upcoming NPDUIS reports and invitations to the corresponding webinars, please send a request to: pmprb.npduis-sniump.cepmb@pmprb-cepmb.gc.ca.

For more information on future research topics and publications, see the NPDUIS Research Agenda and follow the PMPRB on Twitter.

Page details

Date modified: