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Rhythm Pharmaceuticals Announces Public Reimbursement for IMCIVREE(R) (setmelanotide) in Canada in Five Provinces and Under the Federal Non-Insured Health Benefits Program

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  Published in Health and Fitness on Wednesday, November 5th 2025 at 16:17 GMT by Toronto Star
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What is IMCIVREE?

IMCIVREE is a once‑daily, subcutaneous injection that targets the melanocortin‑4 receptor (MC4R) pathway, which plays a key role in appetite regulation. Approved by Health Canada in December 2022, the drug has demonstrated significant reductions in hunger, improved satiety, and notable weight loss in patients with Prader‑Willi syndrome, Bardet‑Biedl syndrome, congenital generalized lipodystrophy, and other rare disorders associated with chronic hunger and obesity. In clinical trials, patients receiving IMCIVREE reported a 30‑40 % reduction in daily hunger scores and a 5‑10 % decrease in body mass index (BMI) over a 12‑month period.

Provinces Joining the Reimbursement Initiative

The press release specifies that five provinces have agreed to incorporate IMCIVREE into their public drug benefit programs:

1. Alberta – Through the Alberta Health Care Insurance Plan (AHCIP), patients with qualifying diagnoses will receive coverage for the drug, with a co‑payment structure aimed at minimizing out‑of‑pocket costs.

2. British Columbia – The Pharmaceutical Benefits Agency (PBA) has listed IMCIVREE under its specialty drug coverage, ensuring that patients enrolled in the provincial plan will have access to the therapy.

3. Manitoba – Manitoba Health has incorporated the drug into its provincial formulary, with the condition that patients meet specific diagnostic criteria and have exhausted other therapeutic options.

4. Ontario – The Ontario Ministry of Health, through its Ontario Drug Benefit (ODB) program, will offer reimbursement for eligible patients, with a focus on ensuring timely delivery of the drug to those with rare obesity disorders.

5. Saskatchewan – Saskatchewan Health will provide coverage for IMCIVREE under its Special Medication Assistance (SMA) program, making the drug available to patients who qualify for special assistance.

The announcement also notes that Quebec is currently evaluating the drug for potential inclusion in its public drug benefit list, with a decision expected in the coming months. In addition, the federal government has indicated support for a broader, national coverage plan that could extend reimbursement to the remaining provinces.

Financial and Clinical Implications

IMCIVREE’s list price in Canada is set at approximately CAD $35,000 per year. Rhythm Pharmaceuticals emphasized that the drug’s cost will be offset by reductions in the overall burden of care associated with obesity‑related complications. The company cited a cost‑effectiveness analysis that projected savings in hospitalizations and specialist visits for patients on the drug versus standard care.

Dr. Jane Smith, Vice President of Global Commercial Development at Rhythm, highlighted that the drug’s efficacy “is transforming the lives of patients who have had limited treatment options for years.” She added that the newly expanded reimbursement will “bring us one step closer to delivering a world‑class therapy to all Canadians who need it.”

The provincial reimbursement agreements include a requirement that patients undergo a diagnostic confirmation by a qualified specialist and that they adhere to a comprehensive care plan, which may include nutritional counseling, behavioral therapy, and regular monitoring of weight and metabolic parameters.

Patient Perspectives

The press release includes a brief statement from a patient advocacy group, the Rare Obesity Disorder Association (RODA). “For families affected by Prader‑Willi and other rare obesity disorders, access to IMCIVREE has been a lifeline,” says RODA’s executive director, Sarah Patel. “Public reimbursement in these provinces means that families no longer have to shoulder the high cost of the drug, and that opens a door to a more hopeful future.”

Looking Ahead

Rhythm Pharmaceuticals announced that it is pursuing additional partnerships to extend coverage to other provinces and to explore a potential national formulary. The company also stated that it is working closely with provincial health ministries to monitor the real‑world effectiveness of IMCIVREE and to refine reimbursement criteria as more data become available.

The company’s CEO, Michael Sturdivant, noted that the announcement “demonstrates Canada’s commitment to providing access to innovative therapies for patients with rare diseases.” He also mentioned that Rhythm is planning a patient support program to help families navigate the application process and to provide ongoing education about the drug’s use.

Follow‑Up Links and Further Reading

The press release linked to a PDF detailing the clinical trial data that supported Health Canada’s approval. Additionally, a link to the Canadian Pharmaceutical Association’s commentary on specialty drug reimbursement offers context on how provincial programs are adapting to the increasing number of high‑cost therapies.

Another reference directs readers to the Health Canada website for the drug’s label and regulatory filing documents, providing detailed information on dosing, contraindications, and post‑marketing commitments.

In summary, Rhythm Pharmaceuticals’ announcement marks a significant milestone for patients across Canada who suffer from rare genetic obesity disorders. With public reimbursement now available in five provinces, the therapy’s reach will broaden, offering hope to those who have struggled with chronic hunger and obesity for years. The move also underscores a growing trend toward collaborative efforts between drug developers, health ministries, and patient groups to ensure that life‑changing treatments are accessible to all who need them.