Canada’s Drug Agency (CDA-AMC) has recommended that Canadian public drug plans cover the cost of the gynecological cancer therapy Elahere (mirvetuximab soravtansine) under certain conditions.
The treatment, marketed by Abbvie, was approved by Health Canada in September for adults with folate receptor-alpha (FR-alpha)-positive, platinum-based, chemotherapy-resistant, ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior lines of treatment. Ovarian cancer has the lowest survival rate of gynecological cancers in Canada, according to a company press release.
“CDA-AMC’s positive reimbursement recommendation for ELAHERE represents the first new treatment option in Canada for hard-to-treat platinum resistant ovarian cancers in over 10 years,” said Tania Vrionis, CEO of Ovarian Cancer Canada. “This recommendation not only addresses a significant challenge in the treatment of ovarian cancer, it offers real hope to the women diagnosed with this disease.”
According to the recommendation from CDA-AMC, previously known as the Canadian Agency for Drugs and Technologies in Health, Elahere should be reimbursed only when prescribed by a gynecologic cancer specialist and administered in an oncology facility with FR-alpha testing and eye care services.
The reimbursement also depends on a reduction in the price of Elahere, which is currently expected to cost about CA$29,307 ($22,790) per patient per 28-day cycle.
Pricing negotiations next
Abbvie will now negotiate with the Pan-Canadian Pharmaceutical Alliance (pCPA) to agree on national pricing and access terms. If successful, each province/territory can then make its own funding decision and list the drug for public coverage.
“Patients can only benefit from medicines if they can access [them],” said Rami Fayed, vice president and general manager of Abbvie Canada. “We look forward to working with the pCPA to ensure the next steps progress without delay so that women can access Elahere as soon as possible.”
Abbvie submitted Elahere for reimbursement review 180 days before its approval, aligning with CDA-AMC’s new Target Zero initiative. This program aims to accelerate access to new treatments by eliminating delays between Health Canada approval and CDA-AMC’s reimbursement recommendation.
“Target Zero represents a great example of collaboration across the approval of medicines in Canada’s reimbursement landscape, helping to shorten the time it takes for patients to access new, proven therapies,” Fayed said. “We applaud CDA-AMC for their patient-focused approach – this is great news for Canadians.”
Gynecological cancers like epithelial ovarian — the most common type of ovarian cancer — fallopian tube, and primary peritoneal cancers all arise from the same type of tissue, sharing several molecular features, and are treated the same way.
Patients often receive these diagnoses when the cancer is already at an advanced stage. Treatment typically involves surgery followed by platinum-based chemotherapy. However, many of these cancers later become resistant to these treatments.
Elahere contains a toxic molecule, DM4, linked to an antibody that binds to the FR-alpha receptor protein found at the surface of ovarian cancer cells. When the antibody binds to the cells, it allows DM4 to enter, promoting the cells’ death. The therapy is approved in the U.S. and the European Union for the same indication.
“This treatment represents a positive step forward in bringing better outcomes to people living with hard-to-treat ovarian cancers,” said Shannon Salvador, MD, an associate professor at McGill University in Montreal and president of the Society of Gynecologic Oncology of Canada. “But innovation only matters if it’s accessible to patients.”
CDA-AMC’s rationale for the recommendation was based on results from the Phase 3 MIRASOL clinical trial (NCT04209855), which enrolled 453 adults with platinum-resistant, FR-alpha-positive ovarian cancer. Participants were randomly assigned to receive either Elahere or standard chemotherapy, infused into the bloodstream once every three weeks.
Data showed that Elahere significantly outperformed chemotherapy, further reducing the risk of disease progression or death by 35% and the risk of death by 33%. The proportion of participants who responded to treatment, or showed at least tumor shrinkage, was also significantly higher with Elahere (42% vs. 16%). One in 20 patients (5%) achieved a complete response, indicating that no detectable cancer was present.
“Time is of the essence for our patient community, and we are encouraged to see CDA-AMC’s commitment to accelerating how quickly they can access innovative treatments,” Vrionis said.
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