Canada Gazette | Part I: Patented Medicine Prices Review Board (PMPRB)

Review of Regulations Amending the Patented Medicines Regulations

A. Background

Believing that equitable access to a full range of mental health treatments and that recovery from mental illness is among the most pressing health concerns of the 21st century, in May 2017, mental health leaders and advocates from across the country formed the coalition of Canadians for Equitable Access to Depression Medication (CEADM). CEADM’s membership includes people with lived experience, national and regional mental health advocates, mental health centres, doctors and researchers (listed in Appendix).

Operating with a mission to fix a health care system that obstructs equitable and sustainable access for Canadians living with depression, CEADM’s aim is threefold:

  • create awareness and recognition among provincial and federal policy-makers about the complexity and heterogeneity of major depressive disorder and the effects of depression on Canadians’ overall health;
  • highlight the inequity issue for many Canadians who rely on what is a broken public drug plan approval system; and
  • make better depression care a priority among policy-makers.

National mental health organizations, such as the Mood Disorders Society of Canada (MDSC) and the Canadian Mental Health Association (CMHA) —both members of CEADM— have helped advance mental wellness for a significant segment of Canada’s population. Canadians battling major depressive disorder, a complex and devastating illness, and who do not have access to private drug plans that cover the cost of medications that can treat this disorder, must not continue to live in the shadows.

Health Canada, without adequate consultation with stakeholder groups, including patient advocacy groups, like CEADM, is proposing changes to how the Patented Medicine Prices Review Board (PMPRB) regulates prices of patented medicines in Canada, with plans to quickly implement the proposed regulatory changes by January 1, 2019. In light of these proposed changes, CEADM feels strongly that a response is required on behalf of the millions of women and men across Canada impacted by major depressive disorder, a significant number of whom do not have equitable access to innovative depression treatments.

B. Amending Canada’s Patented Medicines Regulations

Every year, one in five Canadians experience mental illness or a serious mental health problem, and thousands of women and men living with depression, and who only have access to public drug plans, are currently denied access to a full range of innovative medicines to treat their depression. Furthermore, because not all treatments are covered by provincial public drug plans, the issue of inequitable access affects the ability of the most vulnerable segments in our society — the marginalized, unemployed, single parents, veterans, seniors, people on low incomes, many Indigenous peoples — to receive a broad range of choice in depression medications. A significant number of these people are faced with the impossible decision of having to decide whether to pay for either groceries or for medication to treat their depression.

The Government of Canada’s proposal to amend Canada’s Patented Medicines Regulations claims to be protecting Canadian consumers from excessive prices. If enacted as proposed, the amended Regulations will have the opposite effect on those living with difficult-to-treat depression.

Given CEADM’s advocacy on behalf of the many Canadians who cannot access a full range of depression treatment to support their journey to recovery, this proposal provides an opportunity to underscore how Canada’s health care system fails to provide all Canadians with access to the full range of innovative depression medications. As well, diminishing the economics of how innovative medicine companies decide whether to bring new medications to Canada will further narrow the range of innovative medicines available to those living with depression and who cannot access treatment to begin their journey to recovery.

If the proposed amendments to the Regulations are adopted, the reforms will set the bar for the approval too high for most mental health treatments, leading to drastic reductions in access to new treatments.

Current research reveals that depression is a complex illness, with a staggering 227 combinations of symptoms that affect one’s emotional, cognitive and physical health. There is no ‘one-size-fits-all’ approach to treating depression. The term used among the mental health research community is ‘heterogeneity’. An increasing body of evidence is emerging to reveal that a wide choice of therapy is critical for individual patients to find a depression treatment that addresses not only mood, but also changes in sleep patterns and appetite, as well as cognition. Too often the medicines available to those who rely on a public drug plan for their depression treatment are older medications and not the incrementally improved medications that may be the beginning to an individual patient’s recovery from depression.

The good news is that over the past half-century, leading drug researchers have made significant strides in developing innovative depression treatments — with some newly developed medications able to address a broader range of these symptoms with fewer side effects, thus offering a greater probability of recovery. The bad news: these medications are only available to Canadians with private health plans.

In Canada, public- and private-sector officials, partners and patient advocates understand that newly approved drugs are submitted to a health technology assessment by Canadian Agency for Drugs and Technologies in Health (CADTH). Despite the fact that a range of innovative medications has been approved as safe and effective treatments by Health Canada, under CADTH’s complex multi-stage Common Drug Review (CDR) process, these innovative medications are not being recommended for public drug plan coverage. Of the 21 new mental health drug submissions filed with CADTH between 2004 and 2015, 76.2% were given negative recommendations for public drug plan coverage.

According to a report released in February 2017 by the Canadian Health Policy Institute (CHPI), over the 2004–2015 period:

       [A] higher percentage of non-mental health drugs compared to mental health drugs was recommended positively (with or without conditions) for public drug plan coverage by the CDR.

The CHPI report further states:

[The] CDR took less time to provide recommendations for non-mental health drugs compared to mental health drugs. Schizophrenia and bipolar disorder are the only two mental health indications that received any positive (with or without conditions) recommendations from the CDR over this period. In contrast, 100% of the drugs for attention deficit hyperactivity disorder (5), dementia/Alzheimer’s disease (2), major depressive disorder (4) received negative CDR recommendations for listing.

Public drug plans eventually covered many of the drugs rejected by the CDR, but only after lengthy waits. It was estimated that in 2015, spending by the public drug plans of 9 provinces (excl. Quebec) and the federal NIHB on the direct costs of new mental health drugs represented less than 1% (0.9%) of the more than $54.6 billion in annual societal costs associated with the economic burden of mental illness in Canada.

Of particular concern is the fact that all the drugs used to treat depression were rejected.

Currently, CADTH applies the same criteria to every new therapy when considering effectiveness — a single and inflexible evaluation is applied to all therapies, regardless of the conditions they treat. Bringing CADTH’s tools for clinical and cost-effectiveness into a process designed to evaluate prices will set the bar too high for most mental health drugs.

Economic Burden

According to the WHO, over 7 million Canadians have a mental illness, 4,000 people die by suicide every year, including about 1,000 children, and the annual economic and social burden of mental illness is estimated at $51 billion.

As a reference to what’s being achieved globally, of Canada’s $187.51/person total investment in health care (2011 dollars), a mere $5.22/person represents the mental health care portion. Compare this to three other OECD countries: $62.22/person in the United Kingdom; $98.13/person in Australia; and $198.93/person in New Zealand.

The proposed regulatory changes to PMPRB would result in societal costs rising exponentially higher. For employees, there will be increased incidents of absenteeism and presenteeism, loss of productivity and employment; for employers, the result will be increased health insurance premiums, and greater investments in recruiting and training of new or temporary employees.

Furthermore, these proposed amendments will result in a decrease in healthy outcomes for those living with depression — and cause a further burden on a segment of Canada’s population who already feel marginalized.

The WHO advocates that there’s no health without mental health. CEADM believes that the treatments available to Canadians living with difficult-to-treat depression must better reflect this priority, placing equal focus and resources on mental health and physical health. A wide choice of therapy is critical when it comes to finding the best option for treating individual patients with mental illness.

No Canadian should be made to feel less worthy of a full range of treatment options because of an illness of their brain. Enacting the changes proposed regarding how medicines are priced in

Canada would result in a further impairment of mental illness treatment care that appears to be lopsided now based on employer health coverage as a determinant of wellness.

The results of CADTH’s health technology assessments offer the clearest evidence of why a better-coordinated approach is warranted. CEADM believes the proposed changes to PMPRB’s Patented Medicines Regulation will only to intensify such discrimination.

C. Final Thoughts

Before PMPRB moved forward with proposing amendments to Canada’s Patented Medicines Regulation, widespread consultation with relevant stakeholder should have been conducted. In particular, the voice of lived experience should inform public policy development at every stage, not least one as key to how medicines and drug treatments are priced and accessed by Canadians.

Improving the mental wellness of the more than 7 million Canadians who have mental illness must be one of Canada’s top priorities. The Government of Canada needs to move to improve a system that for far too long has provided only one segment of the Canadian population with timely access to the latest and best drugs to treat such a complex illness as depression.

Women and men in recovery from depression are our family members, colleagues and neighbours, and we must provide them with the recovery support they need when they are seriously ill.

Appendix

Members of the Coalition for Canadians for Equitable Access to Depression Medication to date:

  • Dave Gallson, National Leadership Co-Chair, Mood Disorders Society of Canada
  • Patrick Smith, National Leadership Co-Chair, Canadian Mental Health Association
  • Phil Upshall, Regional Chair, Mood Disorders Society of Canada
  • Centre for Addictions and Mental Health (CAMH)
  • The Royal Ottawa Mental Health – Care and Research (The Royal)
  • Waypoint Centre for Mental Health Care (Waypoint)
  • University of Ottawa Brain and Mind Research Institute (uOBMRI)
  • Ann Marie MacDonald, Regional Ontario Co-Chair; Mood Disorders Association of Ontario
  • Michael Landsberg, Regional Ontario Co-Chair; #SickNotWeak
  • Laureen MacNeil, Regional Alberta Co-Chair; Canadian Mental Health Association, Calgary
  • Ron Campbell, Regional Alberta Co-Chair; person with lived experience
  • Dave Grauwiler, Canadian Mental Health Association, Alberta
  • Camille Quenneville, Canadian Mental Health Association, Ontario
  • Sid Kennedy, University Health Network
  • Pratap Chokka, Chokka Centre for Integrative Health
  • Aly Abdulla, Medical Director, The Kingsway Health Centre Ottawa
  • Bill Gaudette, formerly CMHA, Past Member, Provincial Mental Health Board (Alberta)
  • Brianne Moore, person with lived experience, Ontario
  • Jean-François Claude, person with lived experience, Ontario, The Men’s D.E.N., The Men’s Depression Education Network