Category: Advocacy

Press releases are used in the ALS landscape to communicate important information to journalists and the public. Press releases may be released by pharmaceutical companies, academic and research institutions, and non-profit organizations, amongst other outlets. It is important to critically analyze information from a press release to help you become a well-informed consumer of ALS information.

Today, more is known about this relentlessly progressive motor neuron disease which causes paralysis and leads to the death of approximately 1,000 people in Canada each year. And while the prognosis of ALS is variable and its progression difficult to predict, (i) we know that it can move with startling swiftness – leaving a very narrow window of time to slow it down, often further compressed by delayed diagnosis.

In this Toolkit you will find the following resources:

• Template Meeting Request: This template letter can be used to request a meeting with your federal or provincial elected officials. Tips for how to find the contact information for your elected official are included.
• ALS Fact Sheet: Which you can refer to for key facts and figures when speaking and can be shared with elected officials.
• Sample Meeting Flow: This document is a guide to help you navigate any meetings with elected officials. This is an internal document and should not be shared.
• Eversana “How to Tell Your Story”: This guide, developed by our partners at Eversana, helps you develop and tell your own story.
• The Time is Now Meeting Deck (Provincial): This presentation can be used during any meetings with Provincial elected officials to explain the issue of access to therapies. It can be sent to the elected official as background information.
• The Time is Now Meeting Deck (Federal): This presentation can be used during any meetings with Federal elected officials to explain the issue of access to therapies. It can be sent to the elected official as background information.
• Report Back Form: Use this form to share with ALS Canada how your meeting went and any other important information.

A resource that supports and empowers advocacy efforts aimed at improving the lives of people living with ALS (Amyotrophic Lateral Sclerosis).

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Earlier this year, manufacturer Amylyx announced that it plans to pursue Health Canada approval for its AMX0035 therapy. We’ve updated the blog post we first published back in 2018 about how new drugs become accessible in Canada to help orient you to the steps involved, their purpose, the milestones along the way and the timelines involved.

The bottom line is that it simply takes too long for a drug to move from regulatory approval through to public reimbursement (where a provincial drug plan decides to cover some, or all, of the cost of a drug). Ultimately, we want to see a streamlined series of processes that see Health Canada approved ALS therapies made accessible quickly and equitably regardless of where in the country someone lives. Our advocacy efforts will be ramping up to support this need. In the meantime, here is an overview of the current approach.

Health Canada must authorize the drug to be sold in Canada

How it works

• Health Canada conducts a review of the drug to assess its safety, efficacy and quality.
• The process begins when the drug manufacturer files a New Drug Submission (NDS) with Health Canada. Health Canada must accept the New Drug Submission before regulatory review begins.
• If Health Canada concludes the benefits of the drug outweigh the risks and that the risks can be mitigated, they will issue a Drug Identification Number (DIN) and a Notice of Compliance (NOC). This means the drug is approved to market in Canada and physicians can begin prescribing it. At this point, however, the drug is only accessible by paying for it out-of-pocket or through private insurance.
• If the drug does not receive a Notice of Compliance, the drug’s manufacturer has the option of providing additional information, re-submitting the application at a later date with additional supporting data, or asking Health Canada to reconsider its decision.

How long it takes

Standard review is one year; Priority Review is 180 days. ALS therapies are typically Priority Review.

Public and private drug plans must determine if they will cover the costs associated with the drug

How it works

The drug manufacturer makes a submission to the Common Drug Review, which is administered by a federal agency called the Canadian Agency for Drugs and Technologies in Health, or CADTH. (In Quebec, this process is managed by the Institut national d’excellence en santé et en services sociaux, or INESSS.)

The Common Drug Review conducts an evaluation of the clinical, economic, patient, and clinician evidence of the drug. It results in recommendations and advice that are used by federal, provincial, and territorial drug plans to make decisions about whether the drug costs will be covered whether through public programs.

Patient input  and, since 2020, clinician input, are key parts of the Common Drug Review. Patient groups are invited to share their experiences, perspectives and expectations for the drug under review and clinicians have the opportunity to comment on the benefits of the therapy from a clinical perspective. Together the patient and clinician input help to inform CADTH about the realities of an ALS diagnosis and how therapies that have even modest clinical impact can make a significant difference in quality of life.

ALS Canada is planning a CADTH patient input submission for AMX0035 and will be inviting the Canadian ALS community to contribute to it. If you would like to participate, sign up for our e-newsletter to be notified.

At the conclusion of the Common Drug Review, one of the following recommendations is made:

• That the drug be reimbursed;
• That the drug be reimbursed with clinical criteria and/or conditions; or
• That the drug not be reimbursed.

The final recommendation is shared with participating drug plans and the manufacturer and is posted on cadth.ca.

Following the completion of the Common Drug Review, the federal, provincial and territorial drug plans can choose to work together through the pan-Canadian Pharmaceutical Alliance (pCPA) to determine what public reimbursement could look like within each jurisdiction based on negotiation with the manufacturer.

Each jurisdiction then typically does its own independent review to determine if and how the drug will be covered by its particular public drug plan. Once the review is complete, the jurisdiction’s health authority (e.g. Ministry of Health) will make the final decision about public drug plan coverage. Federal, provincial and territorial drug plans choosing to cover the therapy in whole or in part will have a Product Listing Agreement with the manufacturer.

Increasingly, private health plans are referencing the CADTH recommendation when making decisions about whether they will cover the drug.

How long it takes

• In 2018 Health Canada, CADTH and INESSS announced an aligned review process where the Common Drug Review will accept submissions six months before they expect to receive a Notice of Compliance from Health Canada.
• The Common Drug Review has a target timeline of approximately six months. However, there are multiple variables that can affect the process and extend it upwards of one year or more.
• Timelines associated with the pan-Canadian Pharmaceutical Alliance and subsequently the Product Listing Agreements with individual federal, provincial and territorial drug plans can easily take up to two years complete, depending on the jurisdiction. Throughout the process there are often ways for patients, caregivers, patient groups and health care professionals to push for an expedited process.

The price of the drug is set

How it works

• While Health Canada approval and reimbursement reviews are in process, and throughout the duration of the drug’s patent, the drug is subject to price controls, which fall under the authority of the Patented Medicine Prices Review Board (PMPRB). The PMPRB is a federal agency that sets the maximum price at which companies sell their drug products in the Canadian marketplace (e.g. to hospitals, pharmacies, public drug plans, private drug plans, out of pocket payers).
• Drug manufacturers must submit specific pricing information to the PMPRB when the drug is first introduced and then on a semi-annual basis. PMPRB publishes information on its price reviews on its website.
• The federal government recently updated the guidelines that set out how patented therapies are priced in Canada. They are set to come into effect on July 1, 2021. ALS Canada is one of many organizations that have voiced concerns about the potential impact of these reforms. We believe that the model used to determine pricing must balance affordability with access.

How I access a therapy if a price has not yet been set?

A final price does not have to be determined by PMPRB before the drug can be purchased by a patient. In general, as long as Health Canada has approved the therapy and supply is available, clinicians are able to prescribe it based on the product monograph. However, depending on the status and outcome of the pCPA negotiations and reimbursement decisions by public and private drug plans, a patient may have to pay out of pocket to ultimately get access.

Case study: Radicava

Here are the timelines associated with the approval and reimbursement of Radicava, the most recent ALS therapy to become available in Canada. ALS Canada made a patient input submission and initiated an advocacy campaign that saw more than 3,600 Canadians email their provincial Health Ministers (or equivalent) to advocate for the province to make a quick decision in favour of covering the drug. As of May 2021, the province of PEI has still not made a reimbursement decision, so if you are a PEI resident please consider contacting your Health Minister.

Updated August 5, 2020 

BACKGROUND:

• In December 2017, the federal government proposed amendments to the Patented Medicines Regulations. These guidelines govern how the Patented Medicine Prices Review Board (PMPRB) sets the price at which companies sell their drug to distributors across the country.
• The PMPRB Amended Regulations were published in August 2018 in the Canada Gazette Part 1.
• In February 2018, ALS Canada submitted a response to the public consultation on the proposed amendments.
• On November 21, 2019, the PMPRB published a draft set of new guidelines for consultation with stakeholders and the public. The guidelines were set to come into force on June 1, 2020.
• In February 2020, ALS Canada submitted a response to the public consultation on the November 2019 draft guidelines.
• In April 2020, ALS Canada sent Minister Patty Hajdu a letter requesting the federal government pause the implementation of the guidelines due to COVID-19 as to allow sufficient time to consult with stakeholders.
• On June 1, 2020, the implementation of the guidelines deferred to January 1, 2021.
• On June 19, 2020, the PMPRB published another set of guidelines and launched a 30-day consultation period with stakeholders and the public.
• On July 8, the PMPRB extends the consultation period to August 4, 2020.

JUNE 2020 PMPRB GUIDELINES

ALS Canada has connected with a variety of stakeholders, including CORD, Health Charities Coalition of Canada, other health charities and industry, to understand the complex changes made in the June 2020 draft of the PMPRB guidelines (June 2020 guidelines) and how they could impact people living with ALS.

We understand that the revised PMPRB guidelines have been developed with the goal of making medicines more affordable to Canadians, and we appreciate the opportunity to provide feedback as well as the additional effort that has gone into updating them. However, our review of the revised guidelines in order to provide meaningful feedback on them has been a challenging undertaking.

The revised June 2020 Draft Guidelines, which could have significant implications for how medicines are priced in the future, is in itself a barrier to meaningful dialogue and feedback because the language used is not accessible to the Canadians it aims to protect.

We are concerned the lack of clarity around the real-world application of these proposed reforms and how this uncertainty could impact the number of clinical trials available in Canada, create longer timelines for the review of therapies, and ultimately result in fewer therapies coming to Canada limiting access for patient populations with an unmet need. Without case study validation of the guidelines, we cannot assess how Canadians will ultimately be affected.

At the same time, we are aware of numerous developments that have created a murky environment in which to implement the revised PMPRB guidelines.

Ultimately, we believe the guidelines implemented by PMPRB must result in fair prices for patented medicines. While we do not have the expertise or mandate to determine whether a drug’s price is too high or too low, the model used to determine pricing must balance affordability with access.

IMPACT ON PEOPLE LIVING WITH ALS

Affordable access to therapies is important for people living with ALS, but as a community that continues to face a devastating terminal disease, this cannot be achieved at the expense of timely access.

There is currently a significant pipeline of promising Phase 2 and Phase 3 clinical trials underway and Canadians living with ALS today – and those diagnosed with ALS in the future – need the ability to access these therapies in Canada. For this to happen, pharmaceutical companies must see Canada as a viable market to run clinical trials and pursue regulatory approval. Efforts intended to lower prices must be made in a balanced way that continues to encourage innovation and does not result in the delay of launches and introduction of new medicines in the Canadian market.

Any changes to Canada’s drug access pathway – including the PMPRB – must be flexible and responsive to the needs of people living with ALS and encourage more proven therapies to be developed, sold, and reimbursed in Canada. It is essential that tomorrow’s proven ALS therapies be accessible to Canadians in a timely, equitable and affordable way.

RECOMMENDATIONS:

Efforts to improve affordable access to therapies must be done in a way that ensures Canadians’ swift access to innovative treatments and clinical trials of new medicines and is representative of the needs, experiences and perspectives of all Canadians.

• Recommendation #1: That the Federal Government require PMPRB to engage an independent third party to conduct a formal assessment of the real-time and potential impacts of the reforms on access to therapies and research investment in Canada (including clinical trials), with specific consideration to therapies for rare diseases, before the PMPRB guidelines are implemented.
• Recommendation #2: That the PMPRB undertake a phased approach to enacting its proposed reforms in order to assess the impact of each change on research investment and access to therapies for both rare and non-rare disease therapies. Only then should additional reforms be considered.
• Recommendation #3: That the PMPRB implements a distinct pathway for medicines for rare diseases.
• Recommendation #4: That the Federal Government require that PMPRB decision-making and processes include patient representatives.

Read ALS Canada’s response to the June 2020 PMPRB public consultation here.

With the 2019 federal election campaign underway, are you curious about what the parties are saying about the issues that could affect Canada’s ALS community?

ALS Canada asked each of the major parties what they would do, if elected, to help people and families affected by ALS.

Specifically, we asked them about how they would improve equitable, timely and affordable access to proven ALS therapies and patient engagement, provide dedicated ALS research funding, and implement a palliative care strategy.

As you go to the polls on October 21, we hope this blog post helps inform you about the issues affecting people and families living with ALS. Read each of the party’s responses below to learn more.

ALS Canada would like to thank the parties for their participation and responses.

*NOTE: All responses are directly from the parties. ALS Canada did not edit or change the responses in any way.

Question #1

The existing pathway for drug access is too long for a person living with a terminal illness. As recently experienced with one new ALS therapy, it has been a year since Health Canada priority-review approval and there is still no timeline in sight for public reimbursement and pricing decisions. With more than 60 prospective ALS therapies in development right now, what will your party do to improve equitable, timely and affordable access to proven ALS therapies and how will you ensure that the perspectives of people with lived experience are meaningfully considered throughout the process?

Conservative Party of Canada

No response was received.

Green Party of Canada

The Green Party will expand the single-payer Medicare model to include Pharmacare for all Canadians. We will also create a bulk drug purchasing agency, and reduce drug patent protection periods.

Liberal Party of Canada

Liberals believe that all Canadians – but especially those living with ALS – deserve consistent, timely access to the treatments they rely on. That’s why our government has taken several steps over the past four years to streamline this process. We are reviewing drugs and medical devices more quickly and finding ways to support innovative treatments coming to Canada.

Health Canada has accelerated the review of many new medicines, and we continue to expedite reviews so that Canadians get quicker access. We’ve also taken steps to reduce the time between our approval and the recommendation for reimbursement, which means that new drugs will be covered by drug plans sooner. Finally, we are modernizing the Special Access Programme to better meet the needs of patients and physicians. Most recently, Health Canada approved Edaravone (Radicava) in Canada for the treatment of patients with ALS in October 2018.

As well, we are in the process of establishing the new Canada Drug Agency which will help to further streamline the process through which new treatments are approved in Canada. A re-elected Liberal government will also move forward, working with provinces, territories and stakeholders, with the creation of a national formulary and the implementation of a $500 million per year rare disease strategy so that Canadians can have better access to high-cost treatments.

New Democratic Party of Canada

Decades of Conservative and Liberal cuts and inaction have left too many Canadians digging deep into their pockets to pay for prescription medication. Many people cannot take the medication they are prescribed because it’s too expensive or because the medication is not readily available.

Instead of making things better, Andrew Scheer and the Conservatives have closed the door on implementing universal pharmacare and negotiating fair prices and timely
access to new therapies with drug companies.

The Trudeau Liberals claim that pharmacare is on its way but they have made no realistic investments that would help implement pharmacare soon rather than decades
from now.

This hurts Canadians, especially those who need expensive, life-saving medication. It’s time for Canadians to have a federal government that’s in it for them.

Jagmeet Singh and the NDP have a bold vision to provide Canadians with head-to-toe health coverage. Affordable health care is our top priority – this is why we’re making a historic investment in universal pharmacare.

Our pharmacare plan ensures that all Canadians will have access to prescribed medication, at no cost.

An NDP government will invest $10 billion in our pharmacare plan. Investing in people and expanding access to medication will improve Canada’s position as a priority country for new drug launches and health research.

We will work with drug companies, experts, provinces and territories, and patients with lived experiences to develop a national formulary and ensure that patients and their
families have timely access to new drug therapies covered by our plan.

Question #2

There has been more progress in ALS research in the past five years than in the previous 100 – momentum that needs to be built upon in order to develop effective treatments. Right now, the ALS Canada Research Program is the only program in Canada that provides dedicated funding for ALS research, and it is funded entirely by donors. We believe government has a role to play in providing dedicated ALS research funding. What will your party do to invest in dedicated funding for ALS research?

Conservative Party of Canada

No response was received.

Green Party of Canada

The federal government can and should lead the way in demonstrating a better model of health care. It is important that health care challenges are addressed at a federal level and that vulnerable populations receive equal access to care.

Scientific research is the foundation of innovation. The Green Party will invest in scientific research and implement the full funding recommendations from Canada’s Fundamental Science Review. We are happy to work with members of the ALS Society of Canada to determine research priorities at the federal level.

Liberal Party of Canada

Liberals know that health research is one of the most important investments we can make as a nation – transforming lives at home and abroad. Unlike the last government – who cut funding and muzzled scientists – we strongly support our health researchers, investing over $1.1 billion annually in the Canadian Institutes of Health Research, with an additional $350 million in 2018. This includes significant investments in ALS research, with close to $20 million in ALS research over the past five years.

This supports research from institutions across Canada through investigator-initiated research programs and is focused on understanding the underlying mechanisms of ALS and trying to find treatments. For example, we’re supporting the work of Dr. Janice Robertson from the University of Toronto, who is investigating the potential cause of ALS. CIHR has a long history of partnering with the ALS Society of Canada to advance ALS research and supporting the Canada Brain Research Fund. Finally, we were thrilled to appoint world leading ALS researcher Dr. Michael Strong as the new President of the Canadian Institutes of Health Research in 2018. Dr. Strong actually developed the international criteria for diagnosing ALS, the aptly named “Strong Criteria.”

A re-elected Liberal government will continue to make major investments in health research – including ALS research – to ensure our researchers keep making life changing breakthroughs that make a meaningful difference in the lives of Canadians with ALS.

New Democratic Party of Canada

In 2017, the NDP supported ALS Society of Canada’s pre-budget request for $25 million over five years in research to help build upon the momentum of the ice-bucket challenge at the time. The Trudeau Liberals rejected the request – the Liberals have made its priorities quite clear.

An NDP government will ensure that Canada is a leader in innovative health research. We will work with universities and health professionals to make sure that public
research on critical health issues continues to flourish. This is especially needed for rare diseases like ALS.

Question #3

Whereas challenges and gaps in Canada’s palliative care system are increasing, how will your party implement the Framework on Palliative Care in Canada and improve the access and quality of palliative care for Canadians, including for people living with ALS.

Conservative Party of Canada

No response was received.

Green Party of Canada

The Green Party is committed to implementing the Framework on Palliative Care in Canada . We support innovative home-sharing plans and other measures to allow people to stay in their own homes as long as possible. We will work to create more long-term care beds in neighbourhood facilities. We will also consult with caregivers and employers to create a work environment where caregivers are not penalised for taking care of a loved one, exploring options to increase flexibility, EI and tax credits, and work sharing.

Liberal Party of Canada

Liberals believe that Canadians approaching the end of their lives should live out their days in comfort and dignity, in the setting of their choice. We know that palliative care is both one of the most essential and most difficult parts of our health care system – it’s literally a matter of life and death.

We were proud to unveil Canada’s first-ever Palliative Care Framework, but we know that it alone is not enough – so we’re putting our money where our mouth is. This starts with the largest investment in Canadian history in home and community care – which includes palliative care – an unprecedented six billion dollars. We’re also supporting targeted initiatives that – bit-by-bit – help more Canadians get access to palliative care. These range from $1.9 million for the Canadian Hospice Palliative Care Association to improve advance care planning to two million for the Canadian Virtual Hospice to expand virtual services and resources to $600,000 for the Canadian Home Care Association to improve delivery of care at home.

We also know that in order to make palliative care more accessible it needs to be well integrated all throughout the health care system. That is why we have provided more than $6 million to Pallium Canada in order to expand palliative care training across the country so that health professionals are fully able to support Canadians and their families in their end of life needs.

These investments will help bring the comfort of palliative care to more Canadians. But we’re just getting started. A re-elected Liberal government will continue to expand access to to palliative care nationwide, supported by an additional six billion dollar towards our health care system.

New Democratic Party of Canada

New Democrats have made health care our priority, which is why we are advocating for head-to-toe health coverage, including palliative care.

We successfully put forward the motion in 2013 that helped establish the Framework on Palliative Care in Canada.

Now, our historical investment in pharmacare means that people can afford expensive medication they need if they choose to receive palliative care outside hospital settings.
This is important because drug therapy helps control symptoms at the end of life.

We will improve access and quality of palliative care as part of our National Seniors Strategy so that we have a stronger, cohesive approach to planning care for our aging
population.

We will ensure that caregivers are supported as part of this strategy. In order to help make life a little more affordable for caregivers, who are overwhelmingly women, we’ll
make the Canada Caregiver Tax Credit refundable. This will provide thousands of dollars to the most low-income caregivers, many of whom have given up work
completely to care for a loved one.

New Democrats believe Canadians and their families have the right to make the choice for the kind of care they would like to receive that is dignified and compassionate.