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Canada Health approves Novartis' CAR-T therapy Kymriah

Published on 18/01/19 at 10:05am

Health Canada has approved Novartis’ CAR-T therapy Kymriah for use in paediatric and young adult patients aged between three and twenty-five years old with B-cell acute lymphoblastic leukaemia (ALL) and for adults with relapsed or refractory (r/r) large B-cell lymphoma.

However the one time treatment, which harnesses the patient’s immune system in the fight against cancer, is expected to cost the Canadian healthcare system more than $400 million over three years.

While providing Kymriah for young patients with ALL is expected to cost just $25.6 million in the first three years; the panel believe it may cost as much as $387.4 million to cover adults with lymphoma due to the higher prevalence of the disease.

Kymriah’s list price in the United States is US$475,000 for patients with ALL and US$373,000 for patients with lymphoma.

The Canadian panel recommended that Kymriah be made available as long as the Swiss-firm agreed to reduce the price. Novartis is currently in talks with Cancer Care Ontario who are leading negotiations. The therapy will not be made available , apart from through clinical trials, until a deal is reached.

"The price for Kymriah is currently being finalized,” a Novartis spokeswoman said by e-mail. “We are exploring innovative ways we can support health system stakeholders including innovative pricing models, early access mechanisms, risk-sharing with payers and patient and caregiver support."

If negotiations are successful, Kymriah will be made available to young patients with ALL who are refractory, have relapsed after allogenic stem cell transplant (SCT) or are otherwise ineligible for SCT, or have experienced second or later relapse; and also to adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma(i).

“This first approval of a CAR-T cell therapy in Canada heralds the start of what promises to be a new age in the way cancer is treated. Novartis is working collaboratively with a number of treatment centres to build a delivery system that did not previously exist,” said Daniel Hébert, Medical Director, Novartis Pharmaceuticals Canada Inc. “Kymriah is a concrete demonstration of our commitment to reimagine medicine and to develop new practice-changing technologies.”

Louis Goss

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