Funding Recommendations

 

Belzutifan gets positive CADTH Recommendation

On August 3rd, 2023 the Canadian Agency for Drugs and Technologies in Heath (CADTH) made a positive recommendation regarding the Merck VHL drug Belzutifan. 

In part the recommendation was:

 

The CADTH pCODR Expert Review Committee (pERC) recommends that belzutifan be reimbursed for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated non-metastatic renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or non-metastatic pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery only if the conditions listed in Table 1 are met.

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The full recommendation can be found in the attached document

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Dr. Maryam Soleimani, CVHLA Scientific and Medical Advisory Council Chair, BC Cancer said the following about the CADTH recommendation:

"Belzutifan represents a true paradigm shift in the management of von-Hippel Lindau (VHL) disease. With the recent positive recommendation from CADTH, the next step is ensuring equitable access across Canada for all patients with VHL disease. This is an exciting time in VHL care and I believe it is the beginning of many more advancements to come"

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Big thank you's go to Durhane Wong-Rieger, Bob Bick, Christine Collins and Gail Ouellette who were instrumental in the submissions.

 

The following SPharm diagram shows the time needed to develop and gain approval for a drug in Canada.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

https://spharm-inc.com/the-drug-review-and-approval-process-in-canada-an-eguide/

 

 

The CADTH approval represents about half of the Regulatory Review process in the above diagram.

Here is a quick overview from the pan-Canadian Pharmaceutical Alliance (pCPA) website of the drug approval process in Canada, with links for more information.

The following pCPA diagram and information gives an overview of the drug review process in Canada

 

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Health Canada

Health Canada reviews drugs for safety, efficacy and quality before authorizing them for sale in Canada.

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 CADTH & INESSS

In Canada there are two health technology assessment organizations which review the clinical and cost-effectiveness of a drug product; the Canadian Agency for Drugs and Technologies in Health (CADTH) and in Quebec, l’Institut national d’excellence en santé et en services sociaux (INESSS). CADTH and INESSS provide a recommendation to public drug plans on whether or not a drug should be reimbursed for public funding.

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pCPA

The pCPA negotiation process begins for the majority of new drugs, once a recommendation is published by CADTH and/or INESSS. pCPA uses the recommendations from CADTH and INESSS and other factors to determine whether or not it will enter into a negotiation for a drug. Following a successful negotiation, pCPA will issue a letter of intent which sets the terms of the agreement between pCPA and the drug manufacturer.

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Public Drug Plans

Public Drug Plans make a final decision to fund a drug once a negotiation has been successfully completed and enter into a product listing agreement with the drug manufacturer.

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 pCPA Office

The pCPA office is hosted and staffed through Ontario and works closely with the jurisdictions providing support in negotiations, administration, communications, standardization, analytics, process design, and policy related to brand and generic products.

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https://www.pcpacanada.ca/about

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