PMPRB NEWSletter

December 2019, Volume 23, Issue 2

Update on Guideline Reform

On August 21, 2019, Health Canada published amendments to the Patented Medicines Regulations in the Canada Gazette, Part II. In order to operationalize the amendments, which come into force on July 1, 2020, the PMPRB must revise its pricing Guidelines. On November 21, 2019, the PMPRB published proposed new draft Guidelines for public consultation. The deadline for stakeholders and interested members of the public to provide written submissions to the PMPRB on the draft Guidelines is January 31, 2020.

As part of its consultation process, staff and Board member representatives of the PMPRB met with a number of interested stakeholders in British Columbia, Alberta, Saskatchewan and Manitoba the week of December 2. The PMPRB also hosted day-long outreach sessions with pharmaceutical industry representatives and civil society on December 9 and 10, respectively, in Ottawa, and, later that week, met bilaterally with representatives of individual pharmaceutical companies, consultancies and health system professionals.

Follow us on Twitter or visit our PMPRB consultation web page to get live updates on the consultation process.

Welcome to new Board Members

The PMPRB would like to extend a belated but warm welcome to its new Vice-Chairperson, Mélanie Bourassa Forcier. Ms. Bourassa Forcier specializes in the regulation, marketing and reimbursement of new medical technologies and is an associate professor in the Faculty of Law with the Université de Sherbrooke where she directs the Law and Health Policy and Law and Life Sciences programs.

We would also like to welcome back Carolyn Kobernick for a second term as a Board member. Before her retirement in 2013, Ms. Kobernick was Assistant Deputy Minister of Public Law for the Department of Justice, having served in that role since 2006.

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Changes in the PMPRB Management team

Matthew Kellison, Director of Regulatory Affairs and Outreach, has accepted a position with the department of Innovation, Science and Economic Development (ISED). Guillaume Couillard, formerly Director of Board Secretariat, Communications and Strategic Planning (BSCSP), will replace Matthew effective December 2, 2019. Riaz Awadia will serve as Acting Director of BSCSP until further notice.

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Federal Court dismisses Alexion’s application for judicial review

On May 23, 2019, the Federal Court dismissed an application for judicial review brought by Alexion Pharmaceuticals Inc. against the Board’s September 2017 decision regarding the price of Soliris (eculizumab). In that decision, the Board concluded that the price of Soliris in Canada was excessive and ordered Alexion to lower its price and pay back excess revenue.

In its application, Alexion submitted that the Board erred by departing from longstanding tests for assessing excessive pricing, that its decision was inconsistent with the plain language of the Patent Act and the Patented Medicines Regulations, and that it was not supported by adequate reasons.

The Federal Court disagreed with Alexion’s submissions and held that the Board’s decision was “reasonable in all respects”.

Alexion is appealing the Federal Court’s decision to the Federal Court of Appeal.

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Galderma Federal Court of Appeal Decision Issued

On June 28, 2019, the Federal Court of Appeal set aside both the judgement of the Federal Court and the decision of the Board on the Galderma (adapalene) failure to file matter and returned the matter to the Board for redetermination. The Federal Court of Appeal’s Reasons for Judgement (Canada (A.G.) v. Galderma Canada Inc., 2019 FCA 196) are available on its website.

The original Board decision, issued on December 19, 2016, ordered Galderma Canada Inc. to file certain sales and financial information with respect to its product Differin (adpalene). Galderma’s judicial review of that decision was granted by the Federal Court on November 9, 2017 (Galderma Canada Inc. v. Canada (A.G.) 2017 FC 1023). The Attorney General subsequently appealed the Federal Court’s decision, resulting in the Federal Court of Appeal’s June 28 judgement.

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Zero-Dollar Sales

Under the Patent Act and the Patented Medicines Regulations, all patentees are required to file completed Forms 1 and 2 in respect of medicines they have sold in any market in Canada. Patentees are reminded that this requirement also applies to zero-dollar sales (often referred to as “free goods”), where the sale price of the medicine, whether gross or net, is zero ($0).

Patentees already report zero-dollar sales in the Form 2 that they file with the Board. However, when a medicine’s first sale is itself a zero-dollar sale, the Regulations require that patentees file completed Forms 1 and 2 within seven (7) and thirty (30) days of this first sale, respectively. This includes medicines that are first made available through Health Canada’s Special Access Programme (SAP), even if those medicines are exclusively provided to patients free of charge.

Notwithstanding the filing requirements above, Board Staff will conduct the introductory price review of a medicine once it is sold for a price above the zero-dollar level and will consider that price the introductory benchmark price. The Regulatory Affairs and Outreach branch remains available to offer individualized information sessions on the PMPRB price regulation framework to patentees. To request an information session, please contact Richard Lemay, Manager, Outreach and Investigations.

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NPDUIS update

NPDUIS Advisory Committee Meeting

A teleconference was held with the NPDUIS Advisory Committee on June 19, 2019 to discuss current and upcoming projects and priorities. The 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, the Canadian Institute for Health Information (CIHI), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the pan-Canadian Pharmaceutical Alliance (pCPA) Office.

Conference participation

Poster presentations from this spring’s conference season are now available on Analytical Studies page of the PMPRB website.

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New and upcoming publications

New Release

Meds Pipeline Monitor, 2018 (May 30, 2019)

This annual publication is a horizon scanning report featuring 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. Continuing the analysis published in the New Drug Pipeline Monitor, this report brings a renewed methodology and focuses on new medicines that may address previously unmet therapeutic needs, offer a therapeutic benefit over existing treatments, and/or treat serious conditions. The final selection highlights 30 medicines from a wide range of therapeutic areas, including nine gene therapies.

Meds Pipeline Monitor is a companion publication to Meds Entry Watch. Together these two PMPRB publications provide readers with information on the new and emerging drug landscape by monitoring the market continuum of late-stage pipeline medicines and recent launches.

Generics360, 2017 (August 14, 2019)

This report series examines the latest trends in Canadian generic drug sales, utilization, and pricing within an international context. The coming issue tracks 2018 data to capture the impact of the latest generic pricing policy that reduced the prices of nearly 70 generic drugs to as little as 10% of their brand reference price. The report highlights the extent to which generic prices have declined in Canada and provides an assessment of Canada’s relative position internationally following the implementation of the latest pricing policy.

CompassRx 2017/18 (September 5, 2019)

This flagship NPDUIS publication explores the recent trends in public drug plan costs and utilization in Canada, as well as the shifting cost pressures that contribute to the growth in prescription drug expenditures. This edition provides insight into the factors driving the growth in drug and dispensing costs in 2017/18, including the initial impact of the OHIP+ program.

Coming Soon

Several studies are slated for publication in the coming months:

Meds Entry Watch, 2018

The PMPRB’s Meds Entry Watch series explore the market entry of new medicines in Canada and other countries. Building on the retrospective analysis of trends since 2009, this report 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 2017 and 2018, and will analyze their uptake, pricing, sales, and availability as of the last quarter of 2018 (Q4-2018). This edition will include a new Canadian section with information on medicines that received their first Health Canada approval in 2017, as well as those that were approved for new indications.

Market Intelligence Report: Combination Asthma Inhalers, 2018

The Market Intelligence Report series provides detailed information on specific therapeutic market segments of importance to Canadians. Asthma is a debilitating chronic lung disease affecting over three million Canadians. As a therapeutic class, anti-asthmatic medicines represent relatively high domestic sales and some of the largest gaps between Canadian and international prices. This analysis examines Canadian and international market and price trends for the four inhaled corticosteroid / long-acting beta-agonist (ICS/LABA) combination asthma inhalers available in Canada: fluticasone/salmeterol (Advair); budesonide/formoterol (Symbicort); mometasone/formoterol (Zenhale); and fluticasone/vilanterol (Breo Ellipta).

Chartbooks

A new reporting format for the PMPRB, chartbooks are short, graphic-based analyses that spotlight key pharmaceutical trends. In the coming months, the PMPRB will release chartbooks covering the markets for biosimilars, expensive drugs for rare diseases, and oncology medicines.

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2020 Human Drug Advisory Panel Meetings

The Human Drug Advisory Panel (HDAP) provides credible, independent, and expert scientific advice to Board Staff in conducting scientific reviews of information submitted by patentees. The HDAP meets four times a year; meeting dates and deadlines for submission for 2020 are indicated below:

Patentees are also encouraged to file their electronic submissions through a commonly used and acceptable file sharing service. Notification of an online file submissions should be sent by email to PMPRB.Regulatory-Reglementation.CEPMB@pmprb-cepmb.gc.ca, including any password if required. More information on HDAP filing requirements is available on the PMPRB’s website.

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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 negotiations 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.

Benlysta

Benlysta is indicated in addition to standard therapy for reducing disease activity in adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE).

On March 19, 2019, the Chairperson of the Board accepted a VCU by GlaxoSmithKline Inc. (GSK) regarding Benlysta. GlaxoSmithKline agreed to reduce the price of Benlysta and to offset excess revenues accrued as of December 31, 2017.

GSK will also ensure that the price of Benlysta remains within the thresholds set out in the Guidelines in all future periods during which it is under the PMPRB’s jurisdiction.

Trelstar

Trelstar is indicated for the palliative treatment of hormone dependent advanced carcinoma of the prostate gland.

On March 19, 2019, the Chairperson of the Board accepted a VCU by Paladin Labs Inc. (Paladin) regarding Trelstar. Paladin agreed to offset excess revenues accrued up to December 31, 2017 by making a payment of $157,159.70 to the Receiver General of Canada.

Symtuza

Symtuza is an antiretroviral agent indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 infection in adults and adolescents aged 12 years and older with no known mutations associated with resistance to the individual components of Symtuza.

On April 25, 2019, the Chairperson of the Board accepted a VCU by Janssen Inc. (Janssen) regarding Symtuza. Janssen agreed to reduce the list price of Symtuza and to offset excess revenues accrued up to December 31, 2018 by making a payment of $4,590.73 to the Receiver General of Canada.

Janssen will also ensure that the price of Symtuza remains within the thresholds set out in the Guidelines in all future periods during which it is under the PMPRB’s jurisdiction.

Praluent

Praluent is human monoclonal antibody indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD) who require additional lowering of low density lipoprotein cholesterol (LDL-C).

On April 25, 2019, the Chairperson of the Board accepted a VCU by Sanofi-Aventis Canada Inc. (Sanofi-Aventis) regarding Praluent. Sanofi-Aventis agreed to reduce the list price of Praluent and to offset excess revenues accrued up to December 31, 2018 by making a payment of $426,955.62 to the Receiver General of Canada.

Sanofi-Aventis will also ensure that the price of Praluent remains within the thresholds set out in the Guidelines in all future periods during which it is under the PMPRB’s jurisdiction.

Dupixent

Dupixent is an interleukin inhibitor indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

On April 25, 2019, the Chairperson of the Board accepted a VCU by Sanofi-Aventis regarding Dupixent. Sanofi-Aventis agreed to reduce the list price of Dupixent and to offset excess revenues accrued up to December 31, 2018 by making a payment of $1,654,520.73 to the Receiver General of Canada.

Sanofi-Aventis will also ensure that the price of Dupixent remains within the thresholds set out in the Guidelines in all future periods during which it is under the PMPRB’s jurisdiction.

Ciprodex / Vigamox

Ciprodex is indicated for the treatment of infections caused by most strains of gram-positive and gram-negative microorganisms in the specific conditions including in part acute otitis media with otorrhea and acute otitis externa.

Vigamox is indicated for the treatment of patients one year of age and older with bacterial conjunctivitis caused by susceptible aerobic gram-positive and gram-negative bacterial strains.

On June 26, 2019, the Chairperson of the Board accepted a VCU by Novartis Pharmaceuticals Canada Inc. (Novartis) regarding Ciprodex and Vigamox. Novartis agreed to reduce the prices of Ciprodex and Vigamox and to offset excess revenues accrued up to December 31, 2018 by making a payment of $141,159.41 to the Receiver General of Canada.

Novartis will also ensure that the prices of Ciprodex and Vigamox remain within the thresholds set out in the Guidelines in all future periods during which they are under the PMPRB’s jurisdiction.

Pataday

Pataday® (olopatadine hydrochloride) is indicated for the treatment of ocular itching associated with seasonal allergic conjunctivitis.

On June 26, 2019, the Chairperson of the Board accepted a VCU by Novartis regarding Pataday. Novartis agreed to reduce the price of Pataday and to offset excess revenues accrued up to December 31, 2018 by making a payment of $72,691.53 to the Receiver General of Canada.

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

Xalkori

Xalkori is indicated as monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastic non-small cell lung cancer (NSCLC).

On July 5, 2019, the Chairperson of the Board accepted a VCU by Pfizer Canada ULC (Pfizer) regarding Xalkori. Pfizer agreed to reduce the price of Xalkori and to offset excess revenues accrued up to December 31, 2018 by making a payment of $54,955.56 to the Receiver General of Canada.

Pfizer will also ensure that the price of Xalkori remains within the thresholds set out in the Guidelines in all future periods during which it is under the PMPRB’s jurisdiction.

Zoloft

Zoloft is indicated for the symptomatic relief of depressive illness, for the symptomatic relief of panic disorder with or without agoraphobia, and for the symptomatic relief of obsessive-compulsive disorder (OCD).

On July 5, 2019, the Chairperson of the Board accepted a VCU by Upjohn Canada ULC (Upjohn) regarding Zoloft. Upjohn agreed to reduce the price of Zoloft and to offset excess revenues accrued up to December 31, 2018 by making a payment of $754,647.71 to the Receiver General of Canada.

Upjohn will also ensure that the price of Zoloft remains within the thresholds set out in the Guidelines in all future periods during which it is under the PMPRB’s jurisdiction.

Nocdurna

Nocdurna is an antidiuretic indicated for treatment of nocturia in adults with four or less nocturnal voids.

On July 17, 2019, the Chairperson of the Board accepted a VCU by Ferring Inc. (Ferring) regarding Nocdurna. Ferring agreed not to increase the list price of Nocdurna while it is under the PMPRB’s jurisdiction and to offset excess revenues accrued up to December 31, 2017 by making a payment of $94,977.75 to the Receiver General of Canada.

Ferring will also ensure that the price of Nocdurna remains within the thresholds set out in the Guidelines in all future periods during which it is under the PMPRB’s jurisdiction.

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P&EA Staffing Updates

Elena Lungu has accepted a new position with the Policy and Economic Analysis Branch as manager of policy development. Elena takes on this key role at a critical time of reform and transformation. In her former role as the NPDUIS manager, Elena was instrumental in elevating the relevance and awareness of the PMPRB’s reporting mandate and advancing evidence based policy development in Canada. Prior to joining the PMPRB, Elena held various management and senior economist positions in the private sector related to market access and public and private reimbursement. Elena holds a Masters of Arts in Economics from Carleton University and has 16 years of pharmaceutical market experience.

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Summary of the Board’s May 28 meeting

The Board held its second meeting of 2019 on May 28, 2019 in Halifax, Nova Scotia.

During this meeting, the Chairperson provided an update on Board operations . Board Members were also debriefed on the latest developments with respect to regulatory framework modernization, the work of the Steering Committee and Technical Working Group on framework modernization, the 2018 Annual Report and on NPDUIS activities.

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