Category: Advocacy

ALS Canada’s work is empowered by community. Discover how, in 2023, our work within the ALS community helped people affected by the disease feel empowered and informed to make decisions and engage in advocacy efforts.

Empowering advocacy with the ALS Canada Canadian ALS Learning Institute

The landscape of ALS research is ever-changing as researchers continue to make developments. However, research is just half of the journey – ensuring effective treatments are understood and accessible is critical to supporting Canadians living with ALS, and nobody understands this better than those affected by the disease right now.

ALS Canada seeks to empower Canadians affected by ALS with the right knowledge, tools, and support to navigate its current realities and advocate effectively for change. That’s why the Canadian ALS Learning Institute (CALI) was created – a small-group learning experience for people affected by the disease to better understand the Canadian ALS landscape, clinical research, therapy development, and how to advocate effectively.

Since the CALI launched in 2021, graduates of the program who become ALS Canada Community Ambassadors, have shown power in their advocacy efforts, actively putting their learnings into action. Jennifer Hutton, graduate of the 2022 CALI cohort, jumped into advocacy straight away following her husband’s ALS diagnosis in 2021. “I had the power and passion to advocate but I felt that I lacked the knowledge needed to fully put myself out there,” said Hutton, leading her to reach out to ALS Canada and discovering the CALI.

“The CALI outlined the current state of ALS from all avenues including gaps in healthcare, research, drug development and support. I’ve been able to use that knowledge when speaking with and advocating on a much broader scale than just my personal story.” Since graduating from the CALI and becoming an ALS Canada Community Ambassador, Jennifer has been able to engage various government officials in her home province, including Nova Scotia’s Premier and provincial health minister, as well as create a relationship and consistent dialogue with the Ministry of Health and Wellness support staff.

“[Participating in the CALI] you gain an entire community of people that will help support you and mentor you through your journey in not only advocacy, but ALS in general,” says Hutton. As she continues forward on her own advocacy journey, backed by the CALI community, she leaves some words of advice for anyone affected by ALS interested in beginning theirs, “Be patient. It’s not easy, but it’s worth it. Lean on the community for support and keep going.”

In early March, members of the ALS community joined ALS Canada in Ottawa for two days of advocacy training and meetings with politicians and other government officials. From people living with ALS  and their caregivers and family members to researchers, clinicians and volunteers, our delegation of 35 people made the following asks of the federal government: make substantial changes to the drug access pathway that will enable equitable, timely and affordable access to ALS therapies; and provide funding for dedicated ALS research to contribute to the development of those therapies. More specifically:

• Ensure Patented Medicines Prices Review Board (PMPRB) reforms don’t impact patient access.
• Follow through on drug access commitments, including expediting the creation of the Canadian Drug Agency so that the timeline for drug approvals and reimbursement decisions is shortened.
• Include people with lived experience in the decision-making process.
• Implement the House of Commons Standing Committee on Health (HESA) recommendations on open-label extensions.
• Fund dedicated ALS research by supporting CAPTURE ALS, a Canadian-led open science platform of comprehensive biological data from 1,000 Canadians living with ALS that will enable the study of why ALS progresses differently in people.

Our meetings were positive, with many government officials expressing a shared concern for the challenges faced by the ALS community and a willingness to take two specific actions: joining the all-party ALS Caucus and writing a letter to the Minister of Health in support of the asks. Thanks to all who took part in the day for your commitment, time and courage and to the MPs, Senators and staff who met with us.

What you can do: 

While the advocacy day meetings helped to kickstart discussions with government following the 2019 federal election, continued outreach and engagement will be essential. We have identified a number of follow-up activities that we will look to begin implementing in the coming weeks once opportunities for engagement are more available. Maintaining our momentum will be important, but must be balanced with the priority response being given to COVID-19 to ensure that our outreach is as effective as possible.

We will continue to provide updates on this blog about ways to advocate for substantial changes to Canada’s drug access pathway and dedicated ALS research funding. Also – keep an eye on our social channels for updates and information. Together we are stronger, and your actions can make a difference.

More Information

In addition to the links provided throughout the above article, these additional information resources provide more background and context about the asks:

• Webinar: How to get involved in advocacy for access to ALS therapies
• Blog post: How new drugs become approved and available to Canadians
• Letter: ALS Canada’s response to the 2020 PMPRB public consultations
• Federal Budget 2019: Moving Forward on Implementing National Pharmacare

While on Parliament Hill, we had more than 25 meetings with MPs, Senators and their staff, including:

• MP Darren Fisher, Parliamentary Secretary to Health
• MP Ron McKinnon, Chair of the House of Commons Health Committee
• MP Matt Jeneroux, Vice-Chair of the House of Commons Health Committee
• The office of MP Don Davies, NDP Health Critic
• MP Francis Drouin, Chair of the ALS Caucus

In Canada, what the provincial health care systems provide does not always match the needs of people living with ALS. This statement rings true for Ontario, where the current ALS care and support landscape in the province presents people living with ALS with significant challenges that demand immediate action. 

The Issue

The impact of an ALS diagnosis on the person living with the disease and their family, caregivers, and community is tremendous and pervasive – physically, psychologically, and financially. In Ontario, more than 1,300 people living with ALS not only face the harsh realities of this disease daily but also a health care system that fails to meet their complex and progressive needs, leaving them without adequate care and support.  

Our Solution

To address this urgent issue, the ALS Society of Canada (ALS Canada), in collaboration with the five regional multi-disciplinary ALS Clinics in Ontario (Hamilton, Kingston, London, Ottawa, Toronto), developed the Ontario Provincial ALS Program.   

The Ontario Provincial ALS Program is a comprehensive solution that addresses the complex, critical needs of the ALS community. The program includes four key recommendations: 

Recommendation 1: Address the disparities in access to multi-disciplinary ALS Care 

Issue: Due to the complex nature of ALS, people living with the disease have substantial care and equipment needs that evolve and increase over time. Effective management of ALS requires access to multi-disciplinary ALS clinics where health care providers, such as speech language pathologists, dietitians, social workers, respiratory therapists, and occupational therapists, play a key role in optimizing care. However, Ontario’s five regional ALS clinics are beyond capacity, under-resourced and unable to meet the unique levels of care identified in the Canadian Best Practice Recommendations for the Management of ALS.   

Solution: The Ontario government to provide incremental investments to ALS clinics to standardize and enhance existing care models, optimizing ALS care and ensuring each person living with ALS in the province receives the highest quality care.

Recommendation 2: Improve the quality of life and help people living with ALS maintain their independence, dignity, and safety  

Issue: ALS is an incredibly isolating disease due to the lack of awareness and the increasingly difficult physical realities. To support a person living with ALS, their caregiver, and the people closest to them, they are connected to ALS Canada Community Leads located throughout Ontario. ALS Canada Community Leads provide direct, in-home support and individualized information and resource navigation to ensure people are well-supported, helping to augment the health care system.

As a person living with ALS progresses in their disease, so does their reliance on mobility and communication equipment and other assistive devices that help them maintain their independence, dignity, and safety. However, Ontario’s medical equipment programs do not meet the needs of people living with ALS as they are left with equipment for short-term use only or with devices that are outdated for their needs or not right for them, which can put both themselves and their caregivers or families at significant risk. In the end, people living with ALS and their caregivers must turn to ALS Canada, a donor–funded organization, to fill the significant gaps that exist in Ontario’s health care system.

Solution: The Ontario government to allocate funds to ALS Canada’s Community Services and Equipment Programs, ensuring people have access to the right equipment and assistive devices at the right time, improving quality of life and helping people living with ALS maintain independence, dignity, and safety for themselves and their caregivers. 

Recommendation 3: Provide coordinated oversight of ALS care  

Issue: The lack of comprehensive oversight and coordination for ALS care in Ontario hinders the province’s ability to gather critical patient information, which would inform evidence-based decisions to shape a health care system that meets the needs of the ALS community. Comprehensive data capture, knowledge dissemination, and system planning are essential for a coordinated approach to ALS care. 

Solution: Formation of a secretariat to oversee and coordinate ALS care and facilitate comprehensive data capture, efficient knowledge dissemination, and strategic system planning.

Recommendation 4: Ensure equitable ALS care in northern and rural Ontario 

Issue:  Many Ontarians living in northern and rural regions face unique challenges in health care access due to vast distances and limited health care infrastructure. This is the case for people living with ALS in northern and rural Ontario, as they must endure long journeys to attend appointments at one of the five ALS clinics located in Toronto, London, Hamilton, Kingston, and Ottawa, leading to disparities and barriers in access to care.

Solution: The development of a regional strategy to provide equitable and accessible ALS care in northern and rural Ontario ensures that people living with ALS receive timely care regardless of their geographic location. 

Our Advocacy Progress Highlights

Shortly after submitting the proposal to the Ontario Ministry of Health in June 2023, ALS Canada began advocating for the implementation of the Ontario Provincial ALS Program. 

• Government Meetings: Over the past several months, ALS Canada, along with community members, met with Ontario MPPs to discuss the implementation of the Ontario Provincial ALS Program, including the Minister of Health, Sylvia Jones, and the office of the Premier, Doug Ford. We will continue engaging with provincial elected officials, ministers, and other stakeholders to bring forward the realities of Ontarians living with ALS and the critical need for access to urgent care and support they require. 
• 2024 Ontario Pre-Budget Submission: ALS Canada submitted a written submission as part of Ontario’s 2024 Budget Consultations, urging the government to invest $6.6 million to implement the recommendations outlined in the Ontario Provincial ALS Program.  
• 2024 Ontario Pre-Budget Consultations: ALS Canada participated in six pre-budget public hearings held across Ontario by The Standing Committee on Finance and Economic Affairs (SCFEA) and local MPPs.  
• Queen’s Park Advocacy Day: On February 21, 2024, ALS Canada, joined by ALS community members, will host an advocacy day at Queen’s Park, where we will engage with MPPs, urging them to include the Ontario Provincial ALS Program as part of Budget 2024. Keep an eye on our social media channels for further updates and information on our Queen’s Park Advocacy Day. 

What you can do right now

Reach out to your elected official in Ontario, urging them to support the implementation of the Ontario Provincial ALS Program. To inform and empower your advocacy efforts, we have developed resources you can use to approach your MPP.

March 26, 2024 – Ontario’s 2024 Budget announcement, did not explicitly include a $6.6 million investment to implement the recommendations outlined in the Ontario Provincial ALS Program. We will continue our discussions with the government and relevant ministries to seek clarification.

We will continue providing relevant updates and ways to advocate on this blog post and our social media channels.

It’s been 15 years since my cousin Doug, who was like a big brother to me, was diagnosed with ALS. Our options were limited then with only one approved therapy available. We didn’t know what to do and who to turn to as we navigated the bend in the road. Today, when I reflect on developments in the ALS community, I am in awe, and most of all grateful, to the donors who continue to support our mission at ALS Canada.

As the needs of the community change, we as an organization have evolved to meet these needs. I want to share with you a few of the ways your donations help shift the reality of ALS from dying to living through research and early diagnosis, supporting families in their navigation, and advocating for meaningful policy changes.

Supporting early diagnosis

Earlier diagnosis of ALS is critical to better patient and clinical trial outcomes. A new project initiated by ALS Canada, ReferALS, seeks to reduce the time to receive an ALS diagnosis in Canada. This will be done through a set of tools and engagement strategies designed to accelerate patient referrals to neurologists specializing in ALS at Canadian ALS clinics.

Making headway in research

ALS Canada continues to be the only source of dedicated ALS research funding across Canada. This means your gift allows ALS Canada funded researchers to continue striving to better understand ALS, and identify treatments that will alter the course of the disease.

CAPTURE ALS, a national research platform made possible with the support of ALS Canada’s donors, recruited its first participant earlier this year. The project has multiple sites across Canada engaging fundamental and clinical researchers in the hunt for answers to why ALS is different in each person. This is the crucial question that will help unlock new therapeutic targets, treatment options and lead us closer to personalized medicine.

Pushing forward our advocacy efforts

ALS Canada engages with officials in the federal and Ontario governments to represent the voices and experiences of people living with ALS. With your help, ALS Canada continues to advocate for policy changes that will have a meaningful impact through equitable, timely, and affordable access to therapies, improved home and community care, and research funding.

Our Time is Now position paper was developed with stakeholders from the ALS ecosystem and we see how Health Canada, pCPA, and companies have responded. Your gifts enable ALS Canada to continue advocating to improve access to Health Canada approved therapies.

This past June, it was announced that Canada is the first country in the world to give the regulatory green light to the drug ALBRIOZA as a treatment for ALS. Health Canada’s approval is a positive step forward in the available treatment options for people living with ALS, and we are now working to make sure that every Canadian will have equitable and timely access within their province or territory.

Strengthening knowledge exchange and community support

Responding to the tremendous need for current and credible ALS knowledge, awareness, and education, ALS Canada empowers Canadians affected by the disease to navigate its current realities, be informed consumers of ALS information, and advocate effectively for change.

ALS Canada’s Canadian ALS Learning Institute (CALI) has cultivated incredibly engaged and empowered Community Ambassadors. The CALI program was launched in 2021 to inform people affected by ALS from across Canada about the Canadian ALS landscape, clinical research, and therapy development. Graduates of the CALI 2021 program continue to meet regularly, with nearly all participants still actively contributing to our advocacy and engagement efforts with government and industry. The second cohort was selected through an application process to participate in a series of learning modules this fall.

We want to see the reality of ALS change from dying to living with ALS. The current reality necessitates that families have access to a Community Lead in their region who can help them navigate the Ontario health system and access equipment at no cost to them. Over the course of a person’s disease progression, they could transition from needing the support of a walker, to needing a highly customized, powered wheelchair that can support a person living with a more advanced state of the disease. Access to the right equipment and assistive devices can help people maintain independence, dignity, and safety. The ALS Canada Equipment Program is entirely reliant on donor funding and your generosity sustains people’s quality of life.

I want to thank you for taking the time to learn about what we are doing to meet the urgent needs of the ALS community. The holidays are a time to come together, and I hope you will take the opportunity to support families grappling with ALS during this festive but often difficult time.

Together, we can make a difference to families living with this disease today, and tomorrow. I invite you to make a donation today to sustain our efforts to realize a future without ALS.

With continued gratitude,

Tammy Moore
CEO, ALS Society of Canada

History and context

Canada has a rich history in ALS clinical trials. Though an ALS research community developed here alongside the rest of the world in the late 1970s and 1980s, Dr. Andrew Eisen at Vancouver General Hospital is widely regarded as the first ALS clinical trialist in the country, leading a double blind, placebo-controlled study of lamotrigine in the early 1990s. At that time, most clinical trials were performed at a single site and were academically driven, which means the clinician conceives the idea, designs the study, and often pays for it with a limited research grant.

However, as the 1990s progressed, an informal network of Canadian ALS clinicians began collaborating and participating in trials that included testing treatments in partnership with pharmaceutical companies. In industry-supported trials, the company designs the study, often in conjunction with clinicians, and pays for the sites to perform the testing. Pharmaceutical company funding allowed for larger, multi-centre, and multi-national clinical trials that could provide more robust statistical analysis to determine if something works or not. Unfortunately, through the 2000s, our still nascent understanding of ALS limited the number of companies willing to invest in ALS clinical trials and only a handful were developing treatments at any one time.

The network of ALS clinics to support clinical trials across Canada was formalized in 2008 as the Canadian ALS Research Network (CALS) through a collaboration with ALS Canada and under the initial leadership of Dr. Lorne Zinman at Sunnybrook Hospital in Toronto. The establishment of CALS was bolstered by a collaborative clinical trial of lithium chloride with the Northeast ALS Consortium (NEALS) in the United States, a study that ultimately failed, but visibly solidified the network for wider engagement in clinical trials run by pharmaceutical companies. By 2012, Cytokinetics had selected 12 sites across Canada to participate in the BENEFIT-ALS clinical trial of tirasemtiv, and CALS clinics have since participated in more than 20 different industry-sponsored studies over the past decade.

Where we are today

ALS Canada plays an important supportive role in bringing new experimental and proven treatments to Canada. By establishing early relationships with industry who are invested in clinical development of new treatments, ALS Canada helps to facilitate connections with Canadian ALS clinical trial sites and strives to continually keep Canada on every company’s radar. Whether we are advocating for a promising experimental treatment to be tested in Canada during the next trial phase or creating relationships to keep Health Canada top of mind should a company demonstrate efficacy in a trial elsewhere, the work is always ongoing to advocate for Canadians to have faster access to effective treatments.

As of 2022, Canada joins countries like the United Kingdom and Italy as top tier clinical trial sites behind the United States for testing the most promising experimental therapeutics from Phase 1 to Phase 3. This comes not only from having world-class clinics and ALS specialists, but also a long-term collaborative investment in infrastructure that supports trial access and capabilities. Canada has a large ALS research community with strong and varied expertise that can support enhancements like biomarker studies, CAPTURE ALS— a cross-Canada platform for biomarker discovery and better understanding of the differences between people living with the disease that is designed to support collaboration with pharma —and the Canadian Neuromuscular Disease Registry, which has become a very exciting resource for post-marketing real world evidence analyses.

Despite all of this, there are still things we can do to improve Canada’s standing as a primary destination for the most promising clinical trials. Pharmaceutical and biotechnology companies who wish to test their treatment in ALS have many important considerations when deciding which countries and clinics they want to work with to run their clinical trials. One of the key considerations is the capacity to recruit participants, as the faster this happens, the better; for them and everyone. When meeting with industry, ALS Canada highlights the value of our world-class clinicians and clinics, the CALS Network and our organization’s role as a central facilitator, but we are only able to look to past recruitment numbers and reputation to extrapolate the demand on the part of Canadians to contribute to research. Moving forward, having a tangible indication of this enthusiasm to relay will only strengthen the desire for companies to do their research here and to consider Canada a primary market for their treatment once proven.

It’s also not lost on ALS Canada that there are disparities in clinical trial access depending on where someone lives. The Clinical Research Fellowship is offered annually to support a young neurologist to focus their efforts on ALS care and research, building capacity in ways that can also support underserved areas to access clinical trials. Dr. Kerri Schellenberg, the current Chair-Elect of the CALS Network and the first recipient of this fellowship in 2007, has brought clinical trials and multidisciplinary care to Saskatchewan for the first time. With additional support the collaboration of ALS Canada and CALS could also pursue creative ways of advocating for trials nationwide such as virtual trials or supporting clinics differently to enhance trial capabilities.

Take Action

This ALS Awareness Month, ALS Canada is asking you to raise your hand in support of more opportunities to participate in ALS research and a desire to see Canada as a “must have” destination for industry in their future trials.

Share this blog post and our social media posts this June to raise awareness within your community about clinical trials and the work ALS Canada does as it relates to ALS clinical trials.

Our understanding of ALS is evolving at a rapid pace, and the resulting experimental treatments now being developed, based on stronger ALS science, are expected to have a greater potential for efficacy. By helping us create Canada as a clinical trials destination, our clinicians will have more opportunities to host the most promising studies. Further investment in clinical development in Canada will also support longstanding efforts to start, maintain and bring back clinical trials to underserviced regions of the country such as British Columbia, Manitoba, Nova Scotia, and more. Building capacity nationwide will enhance opportunities for all Canadians and has always been an important goal for both the CALS Network and ALS Canada.

Help us strive towards a goal of equitable, affordable, and timely access to the most promising experimental and proven ALS treatments available.

Now more than ever it is important to know the issues that matter to you before you cast your ballot on Thursday, June 2nd , 2022.  

ALS Canada reached out to each major political party to get more details about how they, if elected, would support access to therapies for the Canadian ALS community. We asked them how they would accelerate access to approved therapies and whether they would involve the ALS community in a meaningful way at critical decision-making tables. 

As Ontarians go to the poll on June 2nd, we hope this blog post provides you with more information on how different provincial parties’ policies will affect people and families living with ALS. 

Below are the questions the parties received from ALS Canada. ALS Canada gave each party until May 18th to share their responses with the ALS community. 

This blog post will be updated as we receive responses.  

QUESTIONS:

QUESTION ONE:

The existing pathway for drug access is too long for a person living with ALS and other terminal illnesses.

• What is your party’s position on improving how Ontarians access new drugs?
  

QUESTION TWO:

In consultation with the broader Canadian ALS community, ALS Canada released a Position Paper – The Time is Now that offers two solutions to getting Health Canada-approved therapies to Canadians living with ALS in a timeframe that more accurately reflects the urgent needs of this community. Will you and your party support the following two priorities, and if so, please explain how: 

• Your party will work with the ALS community to build a plan that would see Ontario implementing these two solutions and championing the need for quicker reimbursement within all provinces? 
• Your party will work with your counterparts in the federal government to make sure the total time associated with approving and reimbursing ALS therapies takes no longer than 18 months? 

PARTY RESPONSES:

Progressive Conservative Party of Ontario

From day one, our government, under the leadership of Premier Ford, has been committed to ending
hallway healthcare and making real investments to fix our province’s broken healthcare system. We
increased healthcare spending from $59.3 billion in 2019-2020 to $64.1 billion in 2021-22 and through
Ontario’s Action Plan: Protecting People’s Health and Our Economy, we invested an additional $1.8
billion for the hospital sector. This includes $778 to hospitals which will provide each hospital with
increases to their operating budgets and $300 million to support hospitals in reducing surgical and
diagnostic imaging backlogs from delayed or cancelled surgeries and help reduce wait time.
Since the Fall of 2020, our government has invested more than half a billion dollars to enable the
delivery of more surgeries, MRI and CT scans and procedures for Ontarians. Our recent budget, Ontario’s
Plan to Build, further outlines our plan, if re-elected, to increase capacity and build a strong, resilient
healthcare system across the province. This includes an investment of more than $40 billion over the
next 10 years in hospital infrastructure, including about $27 billion in capital grants. This investment will
help address demands for health care services and support essential improvements and expansions to
emergency rooms, surgical facilities, and patient spaces across the province.

Our Progressive Conservative government has invested more in healthcare than any government in
Ontario’s history and our plan to build a more modern and connected healthcare system includes
improving access to a faster and better coordinated health care system. That is why we have focused
existing drug benefits programs on Ontarians who don’t have coverage and ensured that Ontarians
under 25, who don’t have access to private health insurance plans, are eligible for OHIP+. In government,
we also followed through on our promise to provide high-quality routine dental care to low income
seniors and took action to make rare disease drugs cheaper for the Ontarians that need them.
We are committed to providing access to the best, specialized, most effective care and treatment for
those who need it, when they need it. If re-elected, the Ontario Progressive Conservative’s will continue
to work with key stakeholders, experts and federal, provincial and territorial partners to identify
additional initiatives to achieve long‐term sustainability of public drug programs.

Our party is proud of our record over the last four years getting things done and we will continue to say
YES to getting shovels in the ground and make long term investments in our healthcare system to ensure
Ontario families have a health care system they can rely on.

Read a PDF version of the Progressive Conservative Party’s response.

Read the Progressive Conservative Party’s full platform.

Ontario New Democratic Party

No response received yet.

Read the Ontario New Democratic Party’s full platform.

Ontario Liberal Party

No response received yet.

Read the Ontario Liberal Party’s full platform.

Green Party of Ontario

Question 1:
Ontario Greens understand the quickly shifting nature of ALS and the need to access treatments in a
timely manner. We believe that it’s important that everybody has access to the treatment they need and
deserve. Ontario Greens will partner with the federal government to implement a universal pharmacare
program. As an interim measure, we will publicly fund rare disease medications. In addition, we will
simplify the system for accessing life-altering treatments that are available to make them less arduous
and more timely.

Question 2:
If elected, Ontario Greens would work with the ALS community to build a plan that ensures all ALS
treatments, upon approval by Health Canada, be publicly funded on an interim basis.

Ontario Greens understand that one of the devastating impacts of ALS is the rapidity of its progression,
and that our system is currently overly cumbersome and slow to meet the needs faced by the ALS
community. If elected, we will work with the federal government to make sure all ALS treatments are
approved, reviewed for public reimbursement and publicly funded through a single expedited time
frame. We will also work to simplify the process for receiving treatments that are essential for those
faced with this illness. Our plan will also Improve integration and connectivity across healthcare service
providers through the use of digital data sharing and patient health coordinators to be more supportive
of patients with complex care needs, such as those with ALS. We will also increase base funding for
home care by 10% and increase PSW salaries to a minimum of $25 an hour to improve quality access at
home.

Read a PDF version of the Green Party’s response.

Read the Green Party’s full platform.

Over the past several years, ALS Canada, together with the ALS community and a coalition of patient groups across Canada, has raised the alarm about the consequences of the proposed changes to Patented Medicine Prices Review Board (PMPRB) regulations for Canadians.

Our concern was that the new proposed changes – which included additional price regulatory factors and increasing the number of countries from which PMPRB compares drug prices – would create further barriers to accessing innovative therapies for people living with ALS.

And so, together with community advocates, we joined the voices of people across Canada and asked the government to balance efforts intended to lower prices in a way that encourages innovation and provides flexibility for the needs of Canadians living with rare diseases.

On April 14, 2022, Hon. Jean-Yves Duclos, the Minister of Health, announced that the government will not proceed with the amendments related to the new price regulatory factors – meaning the reforms will only move forward with changes to the comparator countries.

This announcement is a significant milestone for the ALS community in reforming the drug access processes and shows that by working together to approach government through a combination of channels at an organizational level and at an individual level, we can make our voices heard.

ALS Canada thanks the members of the ALS community for their inspiring and invaluable advocacy efforts.

“The need for timely access to therapies for people living with ALS is critical, which is why we want to see Canada as a first-place country for ALS therapies. We are encouraged by the government’s decision to not proceed with the regulations as proposed. This is just one step of many in making sure the entire drug access processes are streamlined and meet the needs of Canadians.” Tammy Moore, ALS Canada CEO

Why were the PMPRB reforms an issue?

• The PMPRB is a federal regulatory and reporting agency that sets the price at which companies sell their patented medicines to distributors across the country.
• While the proposed changes to the PMPRB guidelines were intended to result in lower drug prices, they had several potential implications for people living with ALS, specifically regarding access to innovative therapies.
• The proposed changes created potential barriers for Canada to be seen as a viable market to run clinical trials and bring therapies to market.
• This could have meant that ALS therapies being tested in clinical trials today might not be available to Canadians down the road as urgently as they are needed, even after they are deemed by Health Canada to be safe and effective.
• With several ALS therapies currently in clinical trials worldwide, we believe it is essential for Canada’s drug access pathway to encourage more proven therapies to be developed, sold, and reimbursed in Canada while ensuring these therapies are accessible to all Canadians in a timely and affordable way.

Raising our voices together:

• ALS Canada began advocating around this issue as a member of the Health Charities Coalition of Canada (HCCC) in December 2017, when the federal government proposed the amendments.
• Over the course of five years, we have reached out to the government directly by leveraging opportunities to respond directly to the PMPRB:
  • February 2018
  • February 2020
  • June 2020
  • August 2020
  • July 2021
  • December 2022
• We have reached out to Hon. Patty Hajdu, the previous Federal Health Minister, to express our concern over the implications of the proposed changes for the ALS community.
• Our delegation of 35 community advocates and ALS Canada staff extensively discussed the negative impact of the changes on people living with ALS during our March 2020 Hill Day.
• In 2020, ALS Canada joined a coalition with other health charities that launched a campaign to inform the public and elevate the issue of PMPRB regulations with government. The coalition continues today and advocates for reforms to the drug access process.

How you helped create change:

• The government’s decision not to proceed with the amendments that would create barriers for companies to bring innovative medicines to Canada indicates that our voices were heard, and the government responded.
• This change was made possible thanks to the members of the ALS community and other patient groups as they raised their voices against PMPRB reforms and advocated for Canadians’ access to innovative therapies.

What happens now?

• The changes to the regulation will be reflected in the Canada Gazette in late Spring 2022 and come into force on July 1, 2022
• This is an astounding win for people living with ALS, their loved ones, and all Canadians living with rare diseases.
• ALS Canada will continue to advocate for Canadians living with ALS to access proven ALS therapies in a timely, equitable, and affordable way.
• Update – December 2022: In October 2022, the Patented Medicine Prices Review Board (PMPRB) released its new draft Guidelines and launched a consultation period with stakeholders. Read ALS Canada’s feedback on the consultation and letter to Health Minister Duclos as a Protect Our Access coalition member.

Update: July 7, 2022:

Following Health Canada’s approval of ALBRIOZA (AMX0035) under a Notice of Compliance with Conditions (NOC/c), CADTH posted reimbursement recommendations for ALBRIOZA (AMX0035) in late June. ALS Canada provided feedback on the recommendations, bringing forward the perspectives of the ALS community to help ensure alignment with the realities of the diagnosis and treatment of ALS. You can read our submission here.

Update: December 22, 2021:

Wow! More than 600 of you responded to this call for input, making for a CADTH patient input submission that reflects diversity of perspectives and experiences from across the country (and beyond!). You can read our submission here, and an abridged version of it will be posted on CADTH’s website.

November 10, 2021

Are you, or someone you love, living with ALS? Or are you a caregiver or family member who has lost someone to ALS? Then we want to hear from you!

The Canadian Agency for Drugs and Technologies in Health (CADTH) has recently posted a call for patient input on AMX0035 (sodium phenylbutyrate and tauroursodeoxycholic acid). ALS Canada will be preparing a submission reflecting the perspectives of the ALS community and we are inviting you to contribute.

Patient input is key to helping ensure the realities of ALS are understood by the decision-makers at CADTH, which is the agency that ultimately recommends whether public drug plans should cover a drug if it is approved by Health Canada.

To ensure that your experiences and views are taken into account during this vital review process, we are asking you to complete a short, 20 – 25-minute survey. The results from the survey will be used to inform our patient input submission to CADTH.

Participation is voluntary and anonymous. You do not need to live in Canada, or have specific experience with AMX0035, to complete this survey.

The survey closes on November 24, 2021 (the survey is now closed).

Thank you in advance for contributing. You can learn more about how CADTH fits into the drug access processes in Canada by visiting our blog post on this topic. If you have any questions, please contact ALS Canada at advocacy@als.ca.

The 2021 federal election is wrapping up in less than a week! With Election Day scheduled for Monday, September 20, 2021, now more than ever, it’s important to know the issues that matter to you before you cast your vote.

ALS Canada reached out to each major political party to get more details about how they, if elected, would support the Canadian ALS community. We asked them about how they would accelerate access to newly approved ALS therapies, invest in much-needed ALS research and brand Canada as a viable environment for innovative treatments, and engage in meaningful patient involvement at critical decision-making tables.

As you go to the polls on September 20, we hope this blog post provides you with more information on how different parties’ policies will affect people and families living with ALS. Read each of the party’s responses and platforms below to learn more.

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

Note: Additional responses sent to ALS Canada before Election Day will be posted as they are received. ALS Canada gave each party approx. three weeks – until September 10, 2021 – to respond to our request. Responses received after this date were not included in this blog’s original publication.

QUESTIONS:

QUESTION ONE:

The existing pathway for drug access is too long for a person living with ALS and other terminal illnesses. In consultation with the broader Canadian ALS community, ALS Canada released a Position Paper in June that offers two solutions to getting Health Canada-approved therapies to Canadians living with ALS in a timeframe that more accurately reflects the urgent needs of this community.

Will you and your party support the following two priorities, and if so, please explain how:

1. Working with the Provinces and Territories to implement an interim funding mechanism to immediately publicly reimburse Health Canada-approved ALS treatments.
2. Condensing the entire drug access pathway – including parts under federal jurisdiction – so that the total approval and reimbursement processes associated with ALS therapies take no longer than 18 months.

QUESTION TWO:

Foundational investments in ALS research are critical to developing more effective ALS treatments and making Canada a leader in the health research and life sciences sectors. Our 2022 Pre-Budget Submission asked the government to invest $35 million over five years to expand CAPTURE ALS from a pilot initiative to a world-leading, self-sustainable Open Science platform. CAPTURE ALS is a comprehensive research platform that will enable Canadian researchers to study why people experience ALS symptoms and progression differently. We believe the federal government has a role in supporting this essential initiative. At the same time, Canada’s pharmaceutical regulations are vital to transforming Canada into a viable market that will facilitate quick access to the newest and most innovative treatments. The government must create an environment where Canada is seen as a viable market to run clinical trials, pursue regulatory approval, and launch new and innovative ALS treatments early.

What will your party do to invest in dedicated ALS research funding and strengthen Canada’s position as a viable market for new therapies and R&D that will facilitate Canadians’ early access to new therapies, especially given the limited options available to Canadians living with ALS?

QUESTION THREE:

People, patients, and their families are the central focus of health care – they are the ultimate benefactors and are directly affected when health system changes take place. This is especially the case when it comes to changes that will affect Canadians living with ALS and other terminal rare diseases. Given the vital importance of patient input in respect to the ongoing creation of a national strategy for rare diseases and the Canadian Drug Agency, people living with ALS and other rare diseases must have their perspectives listened to and acted upon.

When considering new policy changes regarding Canadians living with rare diseases, how will your party commit to meaningful patient engagement with the ALS community at decision-making tables?

Party Responses:

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

Bloc Québécois

No response received yet.

Read the Bloc Québécois’s full platform (French only).

Conservative Party of Canada

Six years before becoming the Leader of Canada’s Conservatives, Erin O’Toole participated in the Ice Bucket Challenge and added his voice to those raising awareness about ALS. He joined the Internet phenomenon in memory of Gerry Johnston, a business leader and former police officer from Durham, Ontario.

Many Canadians, including Mr. O’Toole, know someone who has been affected by this devastating terminal disease. That is why Canada’s Conservatives stand with the ALS Society in your efforts to raise awareness and promote advocacy so that scientists can continue to research and help those who are suffering.

We know that it is only through awareness, advocacy, and understanding that the ALS community can promote research and help Canadians with the services they need. Continued research into slowing and stopping ALS is critical. We will also ensure that Health Canada includes the voices of patients and their families in its efforts to bring an end to the devastating effects of ALS.

Within Canada’s Recovery Plan, we have a detailed plan to secure the future of Canada’s universal healthcare system. We have attached the chapter of our plan addressing this important priority.

A Detailed Plan to Secure Healthcare
The COVID-19 pandemic has exposed the cracks in our healthcare system and reminded us all of the need to strengthen it. Canada’s Conservatives believe that the federal government should pay its fair share. Under the last Conservative government, federal transfers to the provinces grew at six per cent per year. Unfortunately, in 2017, the Trudeau government cut this in half, putting lives at risk.

Canada’s Conservatives will take immediate action to restore health funding and to tackle the urgent crises of mental health and addiction.

Secure, Predictable Funding
Canada’s Conservatives will meet with the Premiers within the first 100 days of forming government to propose a new health agreement with the provinces and territories that boosts the annual growth rate of the Canada Health Transfer to at least six per cent. This will inject nearly $60 billion into our healthcare system over the next 10 years.

Treating Mental Health as Health – the Canada Mental Health Action Plan
Mental health and addiction were serious problems long before COVID hit. After a year of lockdowns made them worse, these are crises that our government needs to address. Canadians are suffering and dying. It’s time for real action – and a new approach.

Canada’s Conservatives will introduce the Canada Mental Health Action Plan that will:

• Propose to the provinces that they partner with us by dedicating a significant portion of the stable, predictable health funding to mental health to ensure that an additional million Canadians can receive mental health treatment every year;
• Encourage employers to add mental health coverage to their employee benefit plans by offering a tax credit for 25% of the cost of additional mental health coverage for the first three years;
• Create a pilot program to provide $150 million over three years in grants to non-profits and charities delivering mental health and wellness programming; and
• Create a nationwide three-digit suicide prevention hotline.

Supporting Canadians Suffering from Addiction
Canada’s Conservatives will treat the opioid epidemic as the health issue that it is. We believe that law enforcement should focus on dealers and traffickers. The last thing that those suffering from addiction should have to worry about is being arrested. Any interaction the government has with them should focus on keeping them safe and helping them recover.

To help more Canadians recover from addiction, Canada’s Conservatives will revise the federal government’s substance abuse policy framework to make recovery its overarching goal. We will reorient the Canadian Drugs and Substances Strategy towards ensuring that everyone suffering from addiction has the opportunity to recover and to lead a drug-free life and that all policies that fall under the Strategy have the reduction of harm and promotion of recovery as their objectives. To realize this goal, we will:

• Invest $325 million over the next three years to create 1,000 residential drug treatment beds and build 50 recovery community centres across the country.
  • This will give spaces to those who suffer from addiction, their families, and those who have recovered where they can get the help they need and support each other.
• Support innovative approaches to address the crises of mental health challenges and addiction, such as land-based treatment programs developed and managed by Indigenous communities as part of a plan to enhance the delivery of culturally appropriate addictions treatment and prevention services in First Nations communities with high needs.
• Partner with the provinces to ensure that Naloxone kits are available for free across Canada.

Supporting Canadians Who Are Suffering
Canada’s Conservatives believe that the Government of Canada should have appealed the Quebec Superior Court decision on Medical Assistance in Dying. Instead, the Trudeau government passed a vague law with no safeguards that devalues human life.

When it comes to Medical Assistance in Dying (MAID), Conservatives will:

• Reinstate the ten-day waiting period to make sure somebody does not make this decision at their lowest point.
• Restore the requirement for two fully independent witnesses to ensure that a vulnerable person is not being forced or coerced.
• Require that any discussion of MAID only occur if raised by the patient and prevent healthcare workers from suggesting it to someone who is not seeking it. Canadians living with disabilities report regularly being in situations where MAID is suggested to or pushed on them and report how this undermines their sense of security in healthcare environments.
• Repealing the Bill C-7 provision allowing MAID for those with mental health challenges.
• Require any patient receiving MAID to be informed/reminded immediately before receiving it and given the opportunity to withdraw consent.
• Protect the right of patients to choose to receive care in a MAID-free environment.
• Require healthcare practitioners approving MAID requests (MAID accessors) to examine and consult directly with the patient before approving the request (with allowances made for virtually-enabled examination where required).
• Require MAID assessors to complete MAID assessor training to ensure full awareness of and compliance with laws and best practices around MAID.

A Conservative government will also invest in palliative care. To help Canada become a place where all Canadians who suffer are offered relief, we will double the direct federal investments in palliative care. The Canadian Hospice and Palliative Care Association has estimated that under 30 percent of Canadians who need it have access to palliative care services.

Read a PDF version of the Conservative Party’s response.

Read the Conservative Party of Canada’s full platform.

Green Party of Canada

No response received yet.

Read the Green Party of Canada’s full platform.

Liberal Party of Canada

No response received yet.

Read the Liberal Party of Canada’s full platform.

New Democratic Party of Canada

New Democrats believe that Canada must seize this moment to work towards a cure for ALS, and we must ensure that all Canadians impacted by this devastating disease have access to high-quality treatment and compassionate care.

That’s why a New Democratic government will work in partnership with the provinces and territories to establish universal public pharmacare as rapidly as possible – with a target launch date of 2022. We will create an arms-length agency that will be responsible for establishing and overseeing the list of medications and devices covered by pharmacare. The agency will be governed collaboratively by the federal, provincial, and territorial governments and include strong patient representation.

We are very mindful of the need to ensure that Canadians with rare diseases and disorders are well-served and that promising drug therapies are appropriately accessible. We believe that special care must be taken to ensure that formulary listing decisions are responsive to these requirements and future pharmaceutical innovation. Our goal is to construct a broad, comprehensive formulary that all provinces and territories will agree to cover with no direct cost to patients in exchange for dedicated federal transfer payments.

Furthermore, New Democrats believe the federal government has a responsibility to fund research that will accelerate progress towards the development of effective treatments for ALS. The low prevalence of ALS makes competition for CIHR grants more difficult, and funding research less attractive to industry partners. Additionally, without a survivor population, grassroots funding is limited – all resulting in a need for targeted public support. We agree that CAPTURE ALS represents an important investment in ALS research that has the potential to make meaningful and impactful discoveries about the disease.

Read a PDF version of the NDP’s response.

Read the New Democratic Party of Canada’s full platform.

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.

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.

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.

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.