Belzutifan (Welireg) Update
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.
The full recommendation can be found in the attached document
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"
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
Health Canada
Health Canada reviews drugs for safety, efficacy and quality before authorizing them for sale in Canada.
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.
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.
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.
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.
https://www.pcpacanada.ca/about
2020 - Second $120,000 CVHLA and CRS Research Grant Announced!
Fundraising led by the Rick Bracey Memorial baseball tournament in Surrey BC and the Ontario Walk and Dance fundraising and the countless individual donations from across the country have allowed the CVHLA to put up a second $60,000 which will be spread over 2020 and 2021 for Canadian Cancer Research. Our partner, the Cancer Research Society (CRS), has matched this with their own $60,000.
Click here for details on the 2018 and 2020 grants.
Click here for details on the $480,000 in Canadian VHL research that has been generated due to our fundraising.
Canadian VHL Alliance (CVHLA) Research Funding
Since 2018 we have created $480,000 in Canadian VHL research grants with our partner the Cancer Research Society!
2020 - $120,000 Research Grant Partnership
In November of 2019 the Canadian VHL Alliance (CVHLA) has entered into a second partnership with The Cancer Research Society (CRS), a Canadian based organization that will match the $60,000 CVHLA donation, to create a $120,000 grant that was awarded to Dr. Sandra Turcotte in 2020.
2018 - $120,000 Research Grant Partnership
The first partnership between the CVHLA and the CRS in 2018 created a grant that was won by Dr. Najafabadi (see above for details)
These prizes have attracted very high quality VHL related proposals that the CRS has also funded. Click here for more details.
More about the Cancer Research Society (CRS)
In 2017 the Cancer Research Society has funded the following projects that are related to the VHL gene and/or ccRCC:
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Dr. Ryan Russell, University of Ottawa: Characterization of VHL-mediated RB regulation in renal cancer
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Dr. Stefan Taubert, The University of British Columbia (UBC): Exploring Mediator-dependent stress resistance as a new target (a protein acting downstream of VHL, in the same molecular pathway)
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Dr. Yasser Riazalhosseini, McGill University: KDM5C mutations as determinants of sex-dependent therapy in renal cell carcinoma
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Dr. Damu Tang, McMaster University: Characterization of CYB5D2-mediated suppression of clear cell renal cell carcinoma (ccRCC)
Three grants on VHL were funded by the Cancer Research Society in the past years:
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Sandra Turcotte, U of Moncton (2012-2014): The late-stage of autophagy: A role for the tumor suppressor gene von Hippel-Lindau in lysosomal degradation
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Amin Pause, McGill University (2006-2008): The von Hippel-Lindau (VHL) protein suppresses angiogenesis by maintaining extracellular matrix integrity
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Stephen Lee, University of Ottawa (2004-2006): Dissecting the oncogenic pathway of VHL loss kidney cancer
Our CVHLA goal is to apply a very large percentage of our donations directly to funding Research Projects.
The video below describes a research project the US based VHL Alliance has funded. The CVHLA has supported these efforts in the past.