Belzutifan (Welireg): CADTH Reimbursement Recommendation: Indication: For the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated nonmetastatic renal cell carcinoma, central nervous system hemangioblastomas, or nonmetastatic pancreatic neuroendocrine tumours, not requiring immediate surgery. Canadian Agency for Drugs and Technologies in Health, Ottawa (ON), 2023. ![Belzutifan (Welireg): CADTH Reimbursement Recommendation: Indication: For the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated nonmetastatic renal cell carcinoma, central nervous system hemangioblastomas, or nonmetastatic pancreatic neuroendocrine tumours, not requiring immediate surgery [link]](https://bibbase.org/img/filetypes/link.svg "link")
Paper abstract bibtex CADTH recommends that Welireg should be reimbursed by public drug plans for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated nonmetastatic renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or nonmetastatic pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Welireg should only be covered to treat adult patients with VHL disease who require therapy for associated nonmetastatic RCC, CNS hemangioblastomas, or nonmetastatic pNET, not requiring immediate surgery. Patients receiving Welireg should be in relatively good health. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Welireg should only be reimbursed if it is prescribed by specialists with expertise in VHL disease-associated tumours and if the cost of Welireg is reduced. Welireg should not be used in combination with other anti-tumour drugs. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial suggested that treatment with Welireg caused tumours to shrink or disappear for adult patients with VHL-associated nonmetastatic RCC, who also could have CNS hemangioblastomas and/or nonmetastatic pNET. Welireg may meet some patient needs such as making tumours shrink or disappear, the response to treatment is durable, and it may provide an opportunity to avoid surgery. Based on CADTH’s assessment of the health economic evidence, Welireg does not represent good value to the health care system at the public list price. A price reduction is therefore required. . Based on public list prices, Welireg is estimated to cost the public drug plans approximately $52 million over the next 3 years. However, the actual budget impact is uncertain due to the lack of face validity and overly complex structure of the sponsor’s budget impact analysis., WHAT IS VHL DISEASE? VHL disease is an inherited genetic condition associated with tumours developing in multiple organs. VHL disease affects 1 in 36,000 live births and the prevalence is estimated to be 1 in 53,000 individuals. UNMET NEEDS IN VHL DISEASE: Patients with VHL disease are closely monitored to check if tumours have developed, grown, and/or spread. Patients usually need multiple surgeries and radiation over the course of their lives to treat their tumours, and these treatments are invasive and associated with complications. There is a need for treatments that can prolong patients’ lives while avoiding the need for surgery and radiation. HOW MUCH DOES WELIREG COST? Treatment with Welireg is expected to cost $17,920 per 28 days.
@book{noauthor_belzutifan_2023,
address = {Ottawa (ON)},
series = {{CADTH} {Reimbursement} {Reviews} and {Recommendations}},
title = {Belzutifan ({Welireg}): {CADTH} {Reimbursement} {Recommendation}: {Indication}: {For} the treatment of adult patients with von {Hippel}-{Lindau} disease who require therapy for associated nonmetastatic renal cell carcinoma, central nervous system hemangioblastomas, or nonmetastatic pancreatic neuroendocrine tumours, not requiring immediate surgery},
shorttitle = {Belzutifan ({Welireg})},
url = {http://www.ncbi.nlm.nih.gov/books/NBK599772/},
abstract = {CADTH recommends that Welireg should be reimbursed by public drug plans for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated nonmetastatic renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or nonmetastatic pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Welireg should only be covered to treat adult patients with VHL disease who require therapy for associated nonmetastatic RCC, CNS hemangioblastomas, or nonmetastatic pNET, not requiring immediate surgery. Patients receiving Welireg should be in relatively good health. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Welireg should only be reimbursed if it is prescribed by specialists with expertise in VHL disease-associated tumours and if the cost of Welireg is reduced. Welireg should not be used in combination with other anti-tumour drugs. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial suggested that treatment with Welireg caused tumours to shrink or disappear for adult patients with VHL-associated nonmetastatic RCC, who also could have CNS hemangioblastomas and/or nonmetastatic pNET. Welireg may meet some patient needs such as making tumours shrink or disappear, the response to treatment is durable, and it may provide an opportunity to avoid surgery. Based on CADTH’s assessment of the health economic evidence, Welireg does not represent good value to the health care system at the public list price. A price reduction is therefore required. . Based on public list prices, Welireg is estimated to cost the public drug plans approximately \$52 million over the next 3 years. However, the actual budget impact is uncertain due to the lack of face validity and overly complex structure of the sponsor’s budget impact analysis., WHAT IS VHL DISEASE? VHL disease is an inherited genetic condition associated with tumours developing in multiple organs. VHL disease affects 1 in 36,000 live births and the prevalence is estimated to be 1 in 53,000 individuals. UNMET NEEDS IN VHL DISEASE: Patients with VHL disease are closely monitored to check if tumours have developed, grown, and/or spread. Patients usually need multiple surgeries and radiation over the course of their lives to treat their tumours, and these treatments are invasive and associated with complications. There is a need for treatments that can prolong patients’ lives while avoiding the need for surgery and radiation. HOW MUCH DOES WELIREG COST? Treatment with Welireg is expected to cost \$17,920 per 28 days.},
language = {eng},
urldate = {2025-05-04},
publisher = {Canadian Agency for Drugs and Technologies in Health},
year = {2023},
pmid = {38295215},
}
Downloads: 0
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WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Welireg should only be covered to treat adult patients with VHL disease who require therapy for associated nonmetastatic RCC, CNS hemangioblastomas, or nonmetastatic pNET, not requiring immediate surgery. Patients receiving Welireg should be in relatively good health. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Welireg should only be reimbursed if it is prescribed by specialists with expertise in VHL disease-associated tumours and if the cost of Welireg is reduced. Welireg should not be used in combination with other anti-tumour drugs. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial suggested that treatment with Welireg caused tumours to shrink or disappear for adult patients with VHL-associated nonmetastatic RCC, who also could have CNS hemangioblastomas and/or nonmetastatic pNET. Welireg may meet some patient needs such as making tumours shrink or disappear, the response to treatment is durable, and it may provide an opportunity to avoid surgery. Based on CADTH’s assessment of the health economic evidence, Welireg does not represent good value to the health care system at the public list price. A price reduction is therefore required. . Based on public list prices, Welireg is estimated to cost the public drug plans approximately $52 million over the next 3 years. However, the actual budget impact is uncertain due to the lack of face validity and overly complex structure of the sponsor’s budget impact analysis., WHAT IS VHL DISEASE? VHL disease is an inherited genetic condition associated with tumours developing in multiple organs. VHL disease affects 1 in 36,000 live births and the prevalence is estimated to be 1 in 53,000 individuals. UNMET NEEDS IN VHL DISEASE: Patients with VHL disease are closely monitored to check if tumours have developed, grown, and/or spread. Patients usually need multiple surgeries and radiation over the course of their lives to treat their tumours, and these treatments are invasive and associated with complications. There is a need for treatments that can prolong patients’ lives while avoiding the need for surgery and radiation. HOW MUCH DOES WELIREG COST? 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WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Welireg should only be covered to treat adult patients with VHL disease who require therapy for associated nonmetastatic RCC, CNS hemangioblastomas, or nonmetastatic pNET, not requiring immediate surgery. Patients receiving Welireg should be in relatively good health. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Welireg should only be reimbursed if it is prescribed by specialists with expertise in VHL disease-associated tumours and if the cost of Welireg is reduced. Welireg should not be used in combination with other anti-tumour drugs. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial suggested that treatment with Welireg caused tumours to shrink or disappear for adult patients with VHL-associated nonmetastatic RCC, who also could have CNS hemangioblastomas and/or nonmetastatic pNET. Welireg may meet some patient needs such as making tumours shrink or disappear, the response to treatment is durable, and it may provide an opportunity to avoid surgery. Based on CADTH’s assessment of the health economic evidence, Welireg does not represent good value to the health care system at the public list price. A price reduction is therefore required. . Based on public list prices, Welireg is estimated to cost the public drug plans approximately \\$52 million over the next 3 years. However, the actual budget impact is uncertain due to the lack of face validity and overly complex structure of the sponsor’s budget impact analysis., WHAT IS VHL DISEASE? VHL disease is an inherited genetic condition associated with tumours developing in multiple organs. VHL disease affects 1 in 36,000 live births and the prevalence is estimated to be 1 in 53,000 individuals. UNMET NEEDS IN VHL DISEASE: Patients with VHL disease are closely monitored to check if tumours have developed, grown, and/or spread. Patients usually need multiple surgeries and radiation over the course of their lives to treat their tumours, and these treatments are invasive and associated with complications. There is a need for treatments that can prolong patients’ lives while avoiding the need for surgery and radiation. HOW MUCH DOES WELIREG COST? 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