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Two Canadian provinces — Prince Edward Island, and Newfoundland and Labrador — are covering the cost of the oral formulation of <a href="https://alsnewstoday.com/radicava-edaravone-for-als/">Radicava</a> (edaravone) for eligible residents with <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS).
Patients will have access through their provincial drug plans to <a href="https://alsnewstoday.com/radicava-edaravone-for-als/#Indications">Radicava Oral Suspension</a>, developed along with the infusion formulation by <a href="https://www.mt-pharma.co.jp/e/" rel="nofollow">Mitsubishi Tanabe Pharma</a>. The medication will be covered by special authorization under the PEI Pharmacare Formulary as well as the Newfoundland and Labrador Prescription Drug Program.
Residents typically have <a href="https://www.gov.nl.ca/hcs/prescription/nlpdp-plan-overview/">a medicine copay</a>, usually a small fee, to cover on their own.
&#8220;We would like to thank the Governments of Prince Edward Island and Newfoundland and Labrador for supporting eligible patients living with ALS to have publicly funded access to Radicava Oral Suspension,&#8221; Andy Zylak, president of Mitsubishi Tanabe Pharma Canada (MTP-CA), said in a <a href="https://www.newswire.ca/news-releases/mitsubishi-tanabe-pharma-canada-announces-that-company-s-oral-treatment-formulation-for-amyotrophic-lateral-sclerosis-als-has-been-added-to-the-provincial-drug-plans-in-prince-edward-island-newfoundland-and-labrador-810205320.html">company press release</a>.
[recommended-reading id=87664]
<h3>Oral formulation of Radicava seen as more convenient ALS treatment option</h3>
MTP-CA is a subsidiary of <a href="https://www.mt-pharma-america.com/" rel="nofollow">Mitsubishi Tanabe Pharma America</a>, which commercializes Radicava formulations in the U.S. There, the oral therapy is sold under the brand name Radicava ORS.
&#8220;To date, Radicava Oral Suspension is listed on the majority of provincial public drug plans. MTP-CA will continue to work with the remaining provincial, territorial and federal drug plans to help ensure that Radicava Oral Suspension is listed on all public formularies across the country,&#8221; Zylak added.
Edaravone, the active ingredient in both the oral and infusion therapies, is a free radical scavenger that helps to clear the body of the reactive molecules that can led to oxidative stress, a type of damage implicated in ALS. Their removal is expected to lessen the motor neuron damage that causes <a href="https://alsnewstoday.com/symptoms-of-als/">muscle weakness and other ALS symptoms</a>, helping to slow disease progression.
An intravenous formulation of Radicava was <a href="https://alsnewstoday.com/news/radicava-now-approved-to-treat-als-patients-in-canada/">approved in Canada in 2018</a>, becoming the first new ALS therapy available in the country in about 20 years. It is covered across Canadian provinces and territories, as well as through Veterans Affairs Canada and Indigenous Services Canada.
Health Canada <a href="https://alsnewstoday.com/news/radicava-oral-suspension-approved-canada-treat-als/">approved Radicava Oral Suspension</a> in 2022, providing ALS patients with a treatment seen as an easier, more convenient alternative to the infusion therapy. In addition to the two latest provinces, Radicava&#8217;s oral formulation is listed on public drug plans of Ontario, Quebec, Alberta, British Columbia, New Brunswick, Saskatchewan, and Nova Scotia.
&#8220;Access to new treatments plays a key role in helping people and their families live their best possible life in the face of an <a href="https://alsnewstoday.com/als-diagnosis/">ALS diagnosis</a>,&#8221; said Kathy MacNeill, past president of the ALS Society of Prince Edward Island.
According to MTP-CA, most private health insurance plans in the country also cover the oral medication.
&#8220;People living with ALS do not have the luxury of time to wait for access to new medications to slow the progression of their disease,&#8221; said Cheryl Power, executive director of the ALS Society of Newfoundland and Labrador. &#8220;For this reason, we&#8217;re pleased that people impacted by ALS in this province will now have publicly funded access to Radicava Oral Suspension.&#8221;

Radicava Oral Suspension added to drug plans of 2 Canadian provinces

New Brunswick is reimbursing, through its public health insurance program, the cost of <a href="https://www.amylyx.ca/document/albrioza-product-monograph.pdf" rel="nofollow">Albrioza</a> (sodium phenylbutyrate and ursodoxicoltaurine) for eligible residents living with <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS).
The Canadian province is the country&#8217;s fourth to provide public coverage for the oral therapy — marketed in the U.S. as <a href="https://alsnewstoday.com/amx0035/">Relyvrio</a>. Similar reimbursement decisions recently were announced in <a href="https://alsnewstoday.com/news/treat-als-ontario-quebec-add-albrioza-public-reimbursement-list/">Ontario and Quebec</a>, followed by British Columbia.
“We sincerely appreciate the New Brunswick government&#8217;s collaboration and support in providing public coverage for Albrioza, to make timely treatment possible for individuals living with ALS,” Chris Aiello, general manager and head of Canada at <a href="https://www.amylyx.com/" rel="nofollow">Amylyx Pharmaceuticals</a>, the therapy’s developer, said in a <a href="https://www.newswire.ca/news-releases/new-brunswick-to-publicly-reimburse-albrioza-tm-for-the-treatment-of-als-879073652.html">company press release</a>.
“Recognizing the speed at which this devastating disease progresses, our aim is to ensure equitable access to this treatment for all eligible Canadians, regardless of their location,” Aiello said. “We are actively working with other provincial, territorial, and federal drug plans to expedite the process and make it a reality as quickly as possible.”
[recommended-reading id=85602]
<h3>ALS oral treatment given conditional approval in Canada in 2022</h3>
Previously called AMX0035, Albrioza is an oral therapy containing a combination of two molecules that are thought to help reduce damage to nerve cells. It was granted <a href="https://alsnewstoday.com/news/amx0035-oral-als-therapy-called-albrioza-approved-canada/">conditional approval in Canada</a> for treating people with ALS in June 2022, based on clinical trial data suggesting it can <a href="https://alsnewstoday.com/news/amx0035-safe-effective-in-slowing-als-functional-decline-trial-data-shows/">slow ALS progression</a> and <a href="https://alsnewstoday.com/news/amx0035-survival-als-patients-centaur-clinical-trial-analysis-amylyx/">prolong survival</a>.
Full study results were published in <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa1916945">The New England Journal of Medicine</a> and the journal <a href="https://onlinelibrary.wiley.com/doi/10.1002/mus.27569">Muscle &amp; Nerve</a>.
The medication also is <a href="https://alsnewstoday.com/news/relyvrio-amx0035-approved-us-als-treatment/">approved for ALS patients in the U.S.</a>, while a European Union committee <a href="https://alsnewstoday.com/news/chmp-opposes-approval-amx0035s-als-treatment-europe/">recommended against conditional approval</a> last month. Amylix plans to request a formal reconsideration of its application before the European Commission makes a final decision.
Albrioza has been available in Canada commercially for nearly a year, but only recently have patients begun to gain access to reimbursement formulas through public health insurance programs, run by each province and territory individually.
Announcements of reimbursement deals, in New Brunswick and elsewhere, come on the heels of Amylyx <a href="https://alsnewstoday.com/news/amylyx-agrees-deal-albrioza-als-treatment-reimbursement-canada/">finalizing an</a><a href="https://alsnewstoday.com/news/amylyx-agrees-deal-albrioza-als-treatment-reimbursement-canada/"> agreement</a> with the pan-Canadian Pharmaceutical Alliance, a government agency that collaborates with the country&#8217;s provinces and territories in establishing public drug plan funding of approved medications.
<h3>Advocates welcome news, but argue for therapy&#8217;s inclusion in plans nationwide</h3>
Advocates welcomed the decision, though they emphasized the importance of making the therapy available at lower cost to ALS patients throughout Canada.
“We applaud the government of New Brunswick for its decision to offer public coverage” for Albrioza, as “it is of utmost importance that eligible individuals can promptly access approved treatments,” said Kimberly Carter, president and CEO of the <a href="https://www.facebook.com/ALSNBNS/">ALS Society of New Brunswick and Nova Scotia</a>.
“We express our hope that other public drug plans, especially those in Atlantic Canada, will follow suit in making this treatment accessible,” Carter added. “This will ensure that Canadians dependent on public coverage will have the opportunity to benefit from this innovative treatment.”
ALS patients “critically need timely access to treatment,” said Colleen O&#8217;Connell, MD, medical director and research chief at Horizon&#8217;s Stan Cassidy Centre for Rehabilitation in New Brunswick.
“With few existing treatment options for ALS, I and others in the community are eager to hear news of Albrioza&#8217;s listing on other public drug plans to enable wider access to this treatment and greater hope for people living with this disease,” O&#8217;Connell added.
In Canada, prescription drugs are provided at no charge to all hospitalized patients. For others, each province and territory&#8217;s <a href="https://www.canada.ca/en/health-canada/services/health-care-system/pharmaceuticals/access-insurance-coverage-prescription-medicines.html">public health insurance plan</a> can cover at least part of a prescription drug that&#8217;s included in its plan.

New Brunswick adds Albrioza for ALS to its public health plan

The <a href="https://als.ca/">ALS Society of Canada</a> (ALS Canada) and <a href="https://braincanada.ca/">Brain Canada</a> are collaboratively investing CA$1.4 million (about $1.1M US) in nine grants for studies ranging from the development of new treatments for <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS) to finding ways to predict disease progression.
The ALS Canada <a href="https://als.ca/research/apply-for-funding/">Discovery grant program</a> supports projects that seek to identify causes of the neurodegenerative disorder, treatments for ALS or related diseases, and ways for patients to live optimally.
This funding round also received financial support from the <a href="https://sla-quebec.ca/en/jean-pierre-canuel-order-break-ice-need-find-cure/">Dr. Jean-Pierre Canuel Fund</a> at the nonprofit patient support organization <a href="https://twitter.com/sla_als_quebec?s=11&amp;t=kNsxGZs4Wc2EGxGFgQSySQ">SLA Quebec</a>.
[recommended-reading id=82805]
<h3>Grant projects chosen after competitive peer-review process</h3>
“The Discovery Grant program continues to support critical Canadian research that contributes to the global effort on understanding and treating ALS,&#8221; David Taylor, PhD, vice president of research and strategic partnerships at ALS Canada, said in a <a href="https://www.globenewswire.com/news-release/2023/03/22/2632250/0/en/ALS-Canada-and-Brain-Canada-invest-more-than-1-4-million-in-ALS-research-grants.html">press release</a> from the organization.
&#8220;Over the past 15 years, many discoveries made with these funds have provided a foundation for studies that are impacting humans today, whether through clinical trials or critical initiatives like CAPTURE ALS,” Taylor said.
Of note, CAPTURE ALS is a Canadian-based platform that enables ALS researchers to share common resources, including vast amounts of data from ALS patients.
Grant projects were chosen following a competitive peer-review process in which global ALS experts considered each applicant’s merit, the project’s quality, and the potential to advance the field of ALS research.
As part of the partnership’s commitment to back more ambitious research, the Discovery grant program includes two CA$300,000 funding opportunities, an increase from the CA$125,000 at which additional projects had been funded.
[quote=&#8221;center&#8221;]The Discovery Grant program continues to support critical Canadian research that contributes to the global effort on understanding and treating ALS.[/quote]
<h3>List of grant recipients</h3>
This year, one of the CA$300,00 Discovery grants went to Alex Parker, PhD, of the Universite de Montreal, and Gary Armstrong, PhD, of McGill University, to study whether axon protection could be a promising ALS treatment strategy. Funding for this particular project came from two CA$150,000 contributions from Brain Canada and SLA Quebec.
The other grant went to Richard Robitaille, PhD, Danielle Arbour, PhD, and Roberta Piovesana, PhD, of the University of Montreal, and Robert Bowser, PhD, of the Barrow Neurological Institute, who will use their CA$300,000 award to study whether neuromuscular junction proteins could aid in the development of ALS biomarkers.
Recipients of the CA$125,000 Discovery grants:
<ul>
<li>Carlos Rodrigo Camara-Lemarroy, MD, and Minh Dang Nguyen, PhD, both of the University of Calgary, and Deepak Kaushik, PhD, of the Memorial University of Newfoundland, will study whether a certain routine and inexpensive procedure could have a neuroprotective effect in ALS.</li>
<li>Renee Douville, PhD, of the University of Winnipeg, Jody Haigh, PhD, of the University of Manitoba, and Domenico Di Curzio, PhD, of St. Boniface Hospital Albrechtsen Research Centre will investigate the potential role of retroviruses using a new mouse model of ALS.</li>
<li>Thomas Durcan, PhD, and Yasser Iturria-Medina, PhD, both of McGill University, will study whether a new three-dimensional cell culture model can help predict ALS progression.</li>
<li>Gary Shaw, PhD, and Martin Duennwald, PhD, of Western University, and Elizabeth Meiering, PhD, of the University of Waterloo, will determine if improving the mechanisms of toxic protein disposal in motor neurons can become a treatment strategy.</li>
<li>Maria Stepanova, PhD, in collaboration with Holger Wille, PhD, of the University of Alberta, will use their grant to examine the potential for computational methods to aid in the design of antibodies for ALS diagnosis and treatment.</li>
<li>Christine Vande Velde, PhD, of the Universite de Montreal, and Marlene Oeffinger, PhD, of the Institut de recherches cliniques de Montreal will investigate if restoring G3BP1 levels could be a promising ALS treatment strategy.</li>
<li>Maria Vera Ugalde, PhD, and Heather Durham, PhD, of McGill University, will study whether a novel way of viewing certain protective proteins could better explain their role in ALS.</li>
</ul>
“These nine leading-edge projects led by teams across Canada are contributing to global scientific discovery,” said Viviane Poupon, PhD, Brain Canada president and CEO. “Our unique partnership with ALS Canada has the potential to lead to better diagnosis and treatment for people living with ALS, and it’s something that we are very proud of.”

ALS Canada, Brain Canada to fund more than $1M in research grants

An oral suspension form of <a href="https://alsnewstoday.com/radicava-edaravone-for-als/">Radicava</a> (edaravone), an approved treatment of <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS), was favored for patient reimbursement in Canada by a branch of the Canadian Agency for Drugs and Technologies in Health (CADTH).
The opinion issued by the CADTH Canadian Drug Expert Committee recommended that Radicava Oral Suspension be reimbursed through the public drug plans of the country&#8217;s provinces and territories.
Certain conditions must be met, including a prescription for this formulation and the cost of oral Radicava not exceeding that of Radicava in its initial intravenous formulation.
&#8220;The positive recommendation from CADTH is an important first step in ensuring access to Radicava Oral Suspension for all eligible Canadians living with ALS,&#8221; Atsushi Fujimoto, president of <a href="https://www.mt-pharma-ca.com/" rel="nofollow">Mitsubishi Tanabe Pharma Canada</a>, said in a <a href="https://www.newswire.ca/news-releases/radicava-r-edaravone-oral-suspension-receives-positive-recommendation-from-cadth-for-the-treatment-of-patients-with-als-882129765.html">company press release</a>.
[recommended-reading id=79659]
<h3>Oral Radicava can be taken at the home by mouth or feeding tube</h3>
CADTH&#8217;s recommendation is nonbinding, with the public drug plans of each province and territory deciding whether to list the oral medication based on the agency&#8217;s recommendation and factors such as its own priorities and resources.
Mitsubishi Tanabe Pharma Canada, a subsidiary of <a href="https://www.mt-pharma-america.com/" rel="nofollow">Mitsubishi Tanabe Pharma America</a> that markets Radicava in Canada,  stated it will continue to work with insurance companies and public agencies to make Radicava Oral Suspension available to patients via public formularies and private insurance. Public formularies are lists of prescription treatments covered as benefits for those eligible.
&#8220;While we are delighted by this milestone, we know there is more work to do, and we look forward to continued discussions with stakeholders to secure coverage for Radicava Oral Suspension on public formularies,&#8221; Fujimoto said.
Oxidative stress is seen as a central mechanism in the neuronal damage taking place in ALS. Radicava is a free-radical scavenger, meaning it helps to remove the reactive molecules that can contribute to oxidative stress to lessen nerve damage and slow ALS progression.
The intravenous (IV) formulation was <a href="https://alsnewstoday.com/news/radicava-now-approved-to-treat-als-patients-in-canada/">approved in Canada</a> in 2018, and patients using it are <a href="https://als.ca/blogs/access-to-therapies-radicava-edaravone-update/">reimbursed through public formularies</a> across Canada, as well as via the Veterans Affairs Canada and Indigenous Services Canada.
Radicava Oral Suspension, <a href="https://alsnewstoday.com/news/radicava-oral-suspension-approved-canada-treat-als/#:~:text=Radicava%20Oral%20Suspension%2C%20an%20oral%20formulation%20of%20edaravone%2C,in%20Canada%20for%20treating%20amyotrophic%20lateral%20sclerosis%20%28ALS%29.">approved by Health Canada</a> in November, was developed to be as effective as Radicava IV but more convenient.  It n can be self-administered at home, either by mouth or via a feeding tube, while Radicava IV is infusion treatment administered at a center, with each infusion lasting about one hour.
Available as <a href="https://www.radicava.com/patient/taking-radicava-ors/">Radicava ORS</a> in the U.S., the medication comes in a portable bottle and includes a 5 mL oral syringe for accurate dosing. It should be taken at a dose of 105 mg (the equivalent to 5 mL of the solution) in the morning after overnight fasting. Patients are recommended to take only water for one hour after administration.
The oral formulation is given in the same dosing regimen as Radicava IV: in a first cycle, patients receive daily dosing for 14 days, followed by a two-week treatment-free period. In subsequent cycles, the medication is given for 10 of the first 14 days, followed by two weeks with no treatment.
U.S. and Canadian approvals of Radicava Oral Suspension were supported by clinical trials showing that the oral formulation delivers similar amounts of edaravone, its active ingredient, to the body.
They also were based on interim results of the open-label <a href="https://clinicaltrials.gov/ct2/show/NCT04165824">Phase 3 trial (NCT04165824)</a> in 185 ALS patients, which showed that six months of treatment with Radicava Oral Suspension was <a href="https://alsnewstoday.com/news/oral-edaravone-appears-safe-patients-interim-trial-data/">generally well tolerated and slowed functional decline</a>.

Tag: Canada

Radicava Oral Suspension added to drug plans of 2 Canadian provinces

New Brunswick adds Albrioza for ALS to its public health plan

ALS Canada, Brain Canada to fund more than $1M in research grants

Radicava Oral Suspension Favored for Reimbursement in Canada