Reimbursement urged in Canada for drug for chronic hypoparathyroidism
Canadian agency recommends public drug plan coverage for new med
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Canada’s Drug Agency (CDA-AMC) is urging that Yorvipath (palopegteriparatide) — an injection therapy approved in the country earlier this year — be reimbursed for eligible adults with hard-to-treat chronic hypoparathyroidism.
The agency, responsible for aligning drug policy across Canada, has recommended that patients prescribed Yorvipath be eligible for reimbursement, a key step toward public drug plan coverage in the North American nation. Still, individual federal, provincial, and territorial drug plans make the final listing decisions.
“This recommendation is an important milestone for adults whose chronic hypoparathyroidism remains inadequately controlled despite conventional therapy,” Jad Isber, vice president and general manager at Pendopharm, the company authorized to market the therapy in Canada, said in a press release issued in collaboration with Ascendis Pharma, the drug’s developer.
“We welcome CDA-AMC’s recognition of the needs of eligible adults with chronic hypoparathyroidism and will continue to work through the Canadian reimbursement process,” Isber said.
In hypoparathyroidism, the parathyroid glands don’t produce enough parathyroid hormone (PTH), which helps regulate calcium and vitamin D levels in the body. Clinicians often manage the condition with oral calcium and active vitamin D supplements, though this approach does not fully control symptoms — which can range from muscle spasms and bone problems to kidney issues, seizures, and heart problems — in all patients.
“People living with chronic hypoparathyroidism can face significant daily challenges even while taking intensive calcium and active vitamin D therapy,” said Aliya Khan, MD, clinical professor of medicine and director of the calcium disorders clinic at McMaster University in Hamilton, Canada.
Yorvipath approved for use in Canada earlier this year
Yorvipath, administered as a daily under-the-skin (subcutaneous) injection, is an approved hormone replacement therapy for helping manage blood calcium levels. It aims to ease symptoms in adults with hypoparathyroidism.
Khan explained the role of this new treatment option within existing recommendations: “Guidelines suggest conventional therapy as first-line; PTH therapy may be considered when conventional therapy is unsatisfactory. For appropriate adults, a PTH replacement therapy may offer a different treatment approach by addressing the underlying hormone deficiency.”
According to Khan, “this recommendation is an important development for appropriate patients whose disease remains inadequately controlled with conventional therapy.”
This recommendation is meaningful for our community because it recognizes the challenges experienced by some people living with chronic hypoparathyroidism and the need for access discussions for eligible patients.
Health Canada, the country’s regulatory agency, approved Yorvipath in January. Before making its recommendation, CDA-AMC reviewed data from the Phase 3 PaTHway clinical trial (NCT04701203) that supported the therapy’s approval.
That trial enrolled 82 adults with hypoparathyroidism, who received Yorvipath or a placebo for about six months. After that, all participants could enter a three-year extension phase and continue or start the medication.
Results reported in June showed that at least three years of Yorvipath treatment normalized and stabilized patients’ calcium and phosphate levels. It also benefited the kidneys, small intestine, central nervous system (brain and spinal cord), and bones, and improved quality of life. In most cases, patients stopped taking vitamin D and calcium supplements.
Those long-term observations were generally consistent with five-year data from the now-completed Phase 2 PaTH Forward trial (NCT04009291).
The CDA-AMC’s recommendation was welcomed by the broader hypoparathyroidism community and advocacy groups.
“This recommendation is meaningful for our community because it recognizes the challenges experienced by some people living with chronic hypoparathyroidism and the need for access discussions for eligible patients,” said Patty Keating, executive director of the HypoPARAthyroidism Association (USA).
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