CADTH recommends that relugolix (Orgovyx) should be reimbursed by public drug plans for the treatment of advanced prostate cancer if certain conditions are met. Orgovyx should only be covered to treat adult patients who have advanced prostate cancer and are not candidates for chemotherapy or surgical therapy soon after initiating treatment. Orgovyx should only be reimbursed if it is prescribed by a clinician with expertise in managing prostate cancer. The cost of Orgovyx should not exceed the drug program cost of treatment with the least costly alternative treatment. Orgovyx should be stopped if the patient experiences severe side effects.
{"title":"Relugolix (Orgovyx)","authors":"Cadth","doi":"10.51731/cjht.2024.946","DOIUrl":"https://doi.org/10.51731/cjht.2024.946","url":null,"abstract":"\u0000CADTH recommends that relugolix (Orgovyx) should be reimbursed by public drug plans for the treatment of advanced prostate cancer if certain conditions are met. \u0000Orgovyx should only be covered to treat adult patients who have advanced prostate cancer and are not candidates for chemotherapy or surgical therapy soon after initiating treatment. \u0000Orgovyx should only be reimbursed if it is prescribed by a clinician with expertise in managing prostate cancer. The cost of Orgovyx should not exceed the drug program cost of treatment with the least costly alternative treatment. Orgovyx should be stopped if the patient experiences severe side effects. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"11 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141927499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
What Is the Issue? Chronic pain is pain that lasts beyond 3 months. Chronic non-cancer pain conditions include osteoarthritis, low back pain, musculoskeletal pain, fibromyalgia, and neuropathic pain. Approximately 1 in 5 people in Canada live with chronic pain. Nabilone (a cannabinoid) is indicated for the management of severe nausea and vomiting associated with cancer chemotherapy. Nabilone is also used in the management of chronic non-cancer pain. It is important to understand the potential benefits and harms of nabilone in people living with chronic non-cancer pain to support decision-making. What Did We Do? We sought to identify, summarize, and critically appraise literature comparing the clinical effectiveness of nabilone and placebo or alternative pharmacological options. We also searched for evidence-based guidelines that provide recommendations about the use of nabilone for the treatment of chronic non-cancer pain. We searched key resources, including journal citation databases, and conducted a focused internet search for relevant evidence published since 2015. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. What Did We Find? We found 1 overview of reviews and 2 systematic reviews that assessed the clinical efficacy and safety of nabilone for the treatment of chronic non-cancer pain. The evidence on the clinical efficacy of nabilone was mixed with some studies reporting an improvement in pain in those treated with nabilone versus placebo or active comparators and other studies reporting no difference between groups. Adverse events were more common in people living with chronic non-cancer pain who received nabilone than those who received placebo, ibuprofen, or amitriptyline. Adverse events were more common in those who received dihydrocodeine or gabapentin than nabilone. It is uncertain if nabilone is an effective treatment for people living with chronic non-cancer pain due to the varied results and methodological limitations of the included studies. We found 1 guideline that included a recommendation specific to nabilone and 2 guidelines that included recommendations on the use of cannabinoids in general. One guideline recommends against the use of nabilone for chronic pain, 1 guideline recommends offering a trial of non-inhaled cannabinoids (such as nabilone) for people living with chronic pain, and 1 guideline suggests cannabinoids be avoided in people with osteoarthritis and low back pain and discussed with people with neuropathic pain. What Does This Mean? Due to the uncertainty of the clinical evidence, decision-makers may wish to consider other factors such as costs, equity, and patient values and preferences when making decisions on the use of nabilone for people living with chronic non-cancer pain. Future high-quality, longer-term (e.g., RCT with follow-up studies) studies are needed to understand the efficacy and
{"title":"Nabilone for Chronic Non-Cancer Pain","authors":"Cadth","doi":"10.51731/cjht.2024.900","DOIUrl":"https://doi.org/10.51731/cjht.2024.900","url":null,"abstract":"What Is the Issue?\u0000\u0000Chronic pain is pain that lasts beyond 3 months. Chronic non-cancer pain conditions include osteoarthritis, low back pain, musculoskeletal pain, fibromyalgia, and neuropathic pain. Approximately 1 in 5 people in Canada live with chronic pain.\u0000Nabilone (a cannabinoid) is indicated for the management of severe nausea and vomiting associated with cancer chemotherapy. Nabilone is also used in the management of chronic non-cancer pain. It is important to understand the potential benefits and harms of nabilone in people living with chronic non-cancer pain to support decision-making.\u0000\u0000What Did We Do?\u0000\u0000We sought to identify, summarize, and critically appraise literature comparing the clinical effectiveness of nabilone and placebo or alternative pharmacological options. We also searched for evidence-based guidelines that provide recommendations about the use of nabilone for the treatment of chronic non-cancer pain.\u0000We searched key resources, including journal citation databases, and conducted a focused internet search for relevant evidence published since 2015. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings.\u0000\u0000What Did We Find?\u0000\u0000We found 1 overview of reviews and 2 systematic reviews that assessed the clinical efficacy and safety of nabilone for the treatment of chronic non-cancer pain.\u0000The evidence on the clinical efficacy of nabilone was mixed with some studies reporting an improvement in pain in those treated with nabilone versus placebo or active comparators and other studies reporting no difference between groups. Adverse events were more common in people living with chronic non-cancer pain who received nabilone than those who received placebo, ibuprofen, or amitriptyline. Adverse events were more common in those who received dihydrocodeine or gabapentin than nabilone.\u0000It is uncertain if nabilone is an effective treatment for people living with chronic non-cancer pain due to the varied results and methodological limitations of the included studies.\u0000We found 1 guideline that included a recommendation specific to nabilone and 2 guidelines that included recommendations on the use of cannabinoids in general. One guideline recommends against the use of nabilone for chronic pain, 1 guideline recommends offering a trial of non-inhaled cannabinoids (such as nabilone) for people living with chronic pain, and 1 guideline suggests cannabinoids be avoided in people with osteoarthritis and low back pain and discussed with people with neuropathic pain.\u0000\u0000What Does This Mean?\u0000\u0000Due to the uncertainty of the clinical evidence, decision-makers may wish to consider other factors such as costs, equity, and patient values and preferences when making decisions on the use of nabilone for people living with chronic non-cancer pain.\u0000Future high-quality, longer-term (e.g., RCT with follow-up studies) studies are needed to understand the efficacy and","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"20 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141105103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
What Is the Issue Congenital cytomegalovirus (cCMV) infection is a leading cause of childhood hearing loss. It is estimated that 85% to 90% of newborns infected with cCMV will not show any symptoms at birth. Of those newborns with cCMV infection who are asymptomatic at birth, 10% to 15% will go on to develop long-term symptoms, including vision loss, hearing loss, and developmental delays. What Did We Do? This brief provides a summary about newborn screening for cCMV in Canada, including whether screening is available for cCMV in each province and territory, and if so, whether screening is universal or targeted using publicly available information. What Did We Find? Currently in Canada, 4 provinces (Alberta, Saskatchewan, Manitoba, Ontario) have or are implementing universal newborn screening for cCMV. Three provinces (British Columbia, New Brunswick, Nova Scotia) have province-wide targeted screening programs that offer cCMV testing to newborns who fail newborn hearing tests or who have suspected cCMV as identified by a clinician. Current clinical guidance and practice remain mixed on whether targeted or universal newborn screening is recommended, with each having a different distribution of benefits and harms. cCMV infections can be detected using blood, urine, or saliva tests. Most universal newborn screening programs use dried blood spot tests, which are likely to produce false-negative results; saliva tests have a lower number of false-negative results but can result in a higher number of false-positives. Some programs recommend additional testing using a different method (either saliva or urine) after an initial positive test as a validation. What Does This Mean? As both universal and targeted newborn screening programs have been adopted by several jurisdictions in Canada, there is wide recognition that cCMV infection is a serious health issue and that early detection is important. Moreover, there is an opportunity to generate data and evidence about test performance and program impact over time that could support future decision-making. As evidence and new test and treatment options become available, such data will help to inform the type of newborn screening approach used for cCMV.
{"title":"Newborn Screening for Congenital Cytomegalovirus in Canada","authors":"Cadth","doi":"10.51731/cjht.2024.899","DOIUrl":"https://doi.org/10.51731/cjht.2024.899","url":null,"abstract":"What Is the Issue \u0000 \u0000Congenital cytomegalovirus (cCMV) infection is a leading cause of childhood hearing loss. It is estimated that 85% to 90% of newborns infected with cCMV will not show any symptoms at birth. Of those newborns with cCMV infection who are asymptomatic at birth, 10% to 15% will go on to develop long-term symptoms, including vision loss, hearing loss, and developmental delays. \u0000 \u0000What Did We Do? \u0000 \u0000This brief provides a summary about newborn screening for cCMV in Canada, including whether screening is available for cCMV in each province and territory, and if so, whether screening is universal or targeted using publicly available information. \u0000 \u0000What Did We Find? \u0000 \u0000Currently in Canada, 4 provinces (Alberta, Saskatchewan, Manitoba, Ontario) have or are implementing universal newborn screening for cCMV. Three provinces (British Columbia, New Brunswick, Nova Scotia) have province-wide targeted screening programs that offer cCMV testing to newborns who fail newborn hearing tests or who have suspected cCMV as identified by a clinician. Current clinical guidance and practice remain mixed on whether targeted or universal newborn screening is recommended, with each having a different distribution of benefits and harms. \u0000cCMV infections can be detected using blood, urine, or saliva tests. Most universal newborn screening programs use dried blood spot tests, which are likely to produce false-negative results; saliva tests have a lower number of false-negative results but can result in a higher number of false-positives. Some programs recommend additional testing using a different method (either saliva or urine) after an initial positive test as a validation. \u0000 \u0000What Does This Mean? \u0000 \u0000As both universal and targeted newborn screening programs have been adopted by several jurisdictions in Canada, there is wide recognition that cCMV infection is a serious health issue and that early detection is important. Moreover, there is an opportunity to generate data and evidence about test performance and program impact over time that could support future decision-making. As evidence and new test and treatment options become available, such data will help to inform the type of newborn screening approach used for cCMV. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"31 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141113012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"2023 Abstracts of the Canadian Association for Population Therapeutics","authors":"Capt","doi":"10.51731/cjht.2024.897","DOIUrl":"https://doi.org/10.51731/cjht.2024.897","url":null,"abstract":"","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"75 14","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141116582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Model validation is critical to ensure that the results from an economic model address the needs of the decision-maker, measure what it intends to measure, and are valid. There is a need for a comprehensive and accessible tool to support both the conceptual and technical validation of models. Tools to assist in this important aspect are currently lacking. Through a targeted literature search, and in consultation with other health economists, CADTH developed a tool that will assist researchers and decision-makers to ensure economic models are fit for purpose and function properly. This model validation tool was considered robust and practical to implement through internal testing and in consultation with health economists external to CADTH. This tool summarizes the approach taken by CADTH in model validation. Although this is not a requirement for submissions to CADTH, the tool will help ensure a more consistent and reproducible approach to model validation for economic evaluations of all health technologies.
{"title":"The Development of a Model Validation Tool to Assist in the Conduct of Economic Evaluations","authors":"Doug Coyle, Alex Haines, Karen Lee","doi":"10.51731/cjht.2024.862","DOIUrl":"https://doi.org/10.51731/cjht.2024.862","url":null,"abstract":"\u0000Model validation is critical to ensure that the results from an economic model address the needs of the decision-maker, measure what it intends to measure, and are valid. There is a need for a comprehensive and accessible tool to support both the conceptual and technical validation of models. Tools to assist in this important aspect are currently lacking. \u0000Through a targeted literature search, and in consultation with other health economists, CADTH developed a tool that will assist researchers and decision-makers to ensure economic models are fit for purpose and function properly. \u0000This model validation tool was considered robust and practical to implement through internal testing and in consultation with health economists external to CADTH. \u0000This tool summarizes the approach taken by CADTH in model validation. Although this is not a requirement for submissions to CADTH, the tool will help ensure a more consistent and reproducible approach to model validation for economic evaluations of all health technologies. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"4 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140372597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
CADTH recommends that public drug plans should not reimburse Lumakras for the treatment of adult patients with Kirsten rat sarcoma viral oncogene homologue (KRAS) G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non–small cell lung cancer (NSCLC) who have received at least 1 prior systemic therapy. The clinical evidence reviewed by CADTH was insufficient to conclude that treatment with Lumakras results in a clinically meaningful delay in disease progression compared with docetaxel. It was impossible to assess whether treatment with Lumakras would prolong survival relative to docetaxel. Patients identified the need for more effective treatments that delay disease progression, prolong survival, control disease symptoms, improve quality of life, reduce side effects, and offer an oral route of administration. While Lumakras offers an oral route of administration, it is not clear whether Lumakras meets the other needs identified by patients.
{"title":"Sotorasib (Lumakras)","authors":"Cadth","doi":"10.51731/cjht.2024.857","DOIUrl":"https://doi.org/10.51731/cjht.2024.857","url":null,"abstract":"\u0000CADTH recommends that public drug plans should not reimburse Lumakras for the treatment of adult patients with Kirsten rat sarcoma viral oncogene homologue (KRAS) G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non–small cell lung cancer (NSCLC) who have received at least 1 prior systemic therapy. \u0000The clinical evidence reviewed by CADTH was insufficient to conclude that treatment with Lumakras results in a clinically meaningful delay in disease progression compared with docetaxel. It was impossible to assess whether treatment with Lumakras would prolong survival relative to docetaxel. \u0000Patients identified the need for more effective treatments that delay disease progression, prolong survival, control disease symptoms, improve quality of life, reduce side effects, and offer an oral route of administration. While Lumakras offers an oral route of administration, it is not clear whether Lumakras meets the other needs identified by patients. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"53 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140228814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Health Canada has approved 4 sodium-glucose cotransporter-2 (SGLT2) inhibitors (ertugliflozin, dapagliflozin, canagliflozin, and empagliflozin) and 5 glucagon-like peptide-1 (GLP-1) receptor agonists (semaglutide, liraglutide, dulaglutide, lixisenatide, and exenatide), with 5 fixed-dose combination products (SGLT2 inhibitors: dapagliflozin-metformin, canagliflozin-metformin, and empagliflozin-metformin; GLP-1 receptor agonists: liraglutide–insulin degludec and lixisenatide–insulin glargine). Data protection has ended for all SGLT2 inhibitors in Canada as well as their fixed-dose combinations. Eleven dapagliflozin generics are currently available, and there are several canagliflozin and empagliflozin generics under review at Health Canada. Patent protection has not expired for GLP-1 receptor agonists. There is heterogeneity in public drug program reimbursement criteria for each SGLT2 inhibitor and GLP-1 receptor agonist ranging from restricted to unrestricted benefit. This Environmental Scan highlights that as SGLT2 inhibitors and GLP-1 receptor agonists have matured, additional indications (heart failure, chronic kidney disease, weight management) have been added to their initial Health Canada–approved indication (type 2 diabetes mellitus). SGLT2 inhibitors are beginning to lose their exclusivity status and are experiencing generic competition.
{"title":"Formulary Management of Sodium-Glucose Cotransporter-2 Inhibitors and Glucagon-Like Peptide-1 Receptor Agonists","authors":"Daniel Trinh, Matthew McDonald","doi":"10.51731/cjht.2024.861","DOIUrl":"https://doi.org/10.51731/cjht.2024.861","url":null,"abstract":"\u0000Health Canada has approved 4 sodium-glucose cotransporter-2 (SGLT2) inhibitors (ertugliflozin, dapagliflozin, canagliflozin, and empagliflozin) and 5 glucagon-like peptide-1 (GLP-1) receptor agonists (semaglutide, liraglutide, dulaglutide, lixisenatide, and exenatide), with 5 fixed-dose combination products (SGLT2 inhibitors: dapagliflozin-metformin, canagliflozin-metformin, and empagliflozin-metformin; GLP-1 receptor agonists: liraglutide–insulin degludec and lixisenatide–insulin glargine). \u0000Data protection has ended for all SGLT2 inhibitors in Canada as well as their fixed-dose combinations. Eleven dapagliflozin generics are currently available, and there are several canagliflozin and empagliflozin generics under review at Health Canada. Patent protection has not expired for GLP-1 receptor agonists. \u0000There is heterogeneity in public drug program reimbursement criteria for each SGLT2 inhibitor and GLP-1 receptor agonist ranging from restricted to unrestricted benefit. \u0000This Environmental Scan highlights that as SGLT2 inhibitors and GLP-1 receptor agonists have matured, additional indications (heart failure, chronic kidney disease, weight management) have been added to their initial Health Canada–approved indication (type 2 diabetes mellitus). SGLT2 inhibitors are beginning to lose their exclusivity status and are experiencing generic competition. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"41 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140229016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
CADTH recommends that Lonsurf be reimbursed by public drug plans in combination with bevacizumab for the treatment of metastatic colorectal cancer (mCRC) in adults who have been previously treated with or are not candidates for available therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies; anti–vascular endothelial growth factor (anti-VEGF) biological agents; and, if positive for RAS wild-type disease, anti-epidermal growth factor receptor (anti-EGFR) agents, if certain conditions are met. Lonsurf should be covered for use in adults with histologically confirmed adenocarcinoma that cannot be surgically removed or has spread to other parts of the body and if the patient’s disease progressed or the patient was intolerant to a maximum of 2 prior chemotherapy regimens. Eligible patients should have good overall health (performance status) and no unstable neurologic issues related to the central nervous system (CNS) or need increasing doses of steroids to control CNS disease. Lonsurf should be reimbursed in combination with bevacizumab. It should be prescribed by doctors who specialize in diagnosing and treating patients with mCRC. Lonsurf plus bevacizumab should be stopped if the disease worsens or the patient has severe side effects. The cost of Lonsurf should be reduced.
{"title":"Trifluridine-Tipiracil (Lonsurf)","authors":"Cadth","doi":"10.51731/cjht.2024.858","DOIUrl":"https://doi.org/10.51731/cjht.2024.858","url":null,"abstract":"\u0000CADTH recommends that Lonsurf be reimbursed by public drug plans in combination with bevacizumab for the treatment of metastatic colorectal cancer (mCRC) in adults who have been previously treated with or are not candidates for available therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies; anti–vascular endothelial growth factor (anti-VEGF) biological agents; and, if positive for RAS wild-type disease, anti-epidermal growth factor receptor (anti-EGFR) agents, if certain conditions are met. \u0000Lonsurf should be covered for use in adults with histologically confirmed adenocarcinoma that cannot be surgically removed or has spread to other parts of the body and if the patient’s disease progressed or the patient was intolerant to a maximum of 2 prior chemotherapy regimens. Eligible patients should have good overall health (performance status) and no unstable neurologic issues related to the central nervous system (CNS) or need increasing doses of steroids to control CNS disease. \u0000Lonsurf should be reimbursed in combination with bevacizumab. It should be prescribed by doctors who specialize in diagnosing and treating patients with mCRC. Lonsurf plus bevacizumab should be stopped if the disease worsens or the patient has severe side effects. The cost of Lonsurf should be reduced. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"13 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140229776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
What Is the Indication Under Review? The indication under review is for the treatment of adults with newly diagnosed glioblastoma multiforme (ndGBM) following maximal debulking surgery and completion of radiotherapy together with and after standard of care maintenance chemotherapy. Glioblastoma is the development of cancer among glial cells in the central nervous system and is the most common form of brain cancer in Canada. What Is Optune? Optune is a medical device that produces alternating electrical fields called tumour-treating fields to target the growth of cancerous cells in addition to chemotherapy. Current treatment for glioblastoma consists of a combination of surgery, radiotherapy, and chemotherapy. How Did CADTH Evaluate This Device? To examine the value of Optune for the treatment of ndGBM, CADTH: reviewed and critically appraised the clinical and economic evidence submitted by the sponsor reviewed the literature to identify and describe ethical considerations relevant to the use of Optune, as well as to assess the validity of the sponsor’s modelling approaches, assumptions, and estimates regarding Optune sought input from patient and clinician groups and consulted an expert panel. What Did CADTH Find? Clinical Evidence This review included the EF-14 trial, a pivotal, multicentre, open-label randomized controlled trial that assessed the efficacy and safety of Optune plus temozolomide in adults with ndGBM following maximal debulking surgery and completion of radiotherapy, together with and after standard of care maintenance chemotherapy. Based on the single trial, there is evidence of low to moderate certainty that Optune plus temozolomide likely increases progression-free survival at 6 months of treatment and overall survival at 24 months of treatment compared to temozolomide alone. The treatment effect of Optune plus temozolomide on progression-free survival and overall survival may be dose-dependent, with at least 18 hours of daily use required for the most benefit. Overall, the evidence was of very low to moderate certainty due to concerns regarding selection bias and low generalizability of the results to real-world settings. Economic Evidence The submitted fee for Optune is $27,000 per month, which is added to the cost of temozolomide based on its public list price. The incremental cost-effectiveness ratio for Optune plus temozolomide versus temozolomide alone was $899,470 per quality-adjusted life-year (QALY) gained (incremental costs = $336,902; incremental QALYs = 0.37). Optune plus temozolomide was not considered cost-effective relative to temozolomide alone at conventional willingness-to pay thresholds (i.e., $50,000 per QALY gained and $100,000 per QALY gained). Consequently, a price reduction of between 91% and 97% would be required for Optune plus temozolomide to be considered cost-effective at a willingness-to-pay threshold between $50,000 and $100,000 per QALY gained. The budget
{"title":"Optune (NovoTTF-200A)","authors":"Cadth","doi":"10.51731/cjht.2024.859","DOIUrl":"https://doi.org/10.51731/cjht.2024.859","url":null,"abstract":"What Is the Indication Under Review? \u0000 \u0000The indication under review is for the treatment of adults with newly diagnosed glioblastoma multiforme (ndGBM) following maximal debulking surgery and completion of radiotherapy together with and after standard of care maintenance chemotherapy. Glioblastoma is the development of cancer among glial cells in the central nervous system and is the most common form of brain cancer in Canada. \u0000 \u0000What Is Optune? \u0000 \u0000Optune is a medical device that produces alternating electrical fields called tumour-treating fields to target the growth of cancerous cells in addition to chemotherapy. Current treatment for glioblastoma consists of a combination of surgery, radiotherapy, and chemotherapy. \u0000 \u0000How Did CADTH Evaluate This Device? \u0000 \u0000To examine the value of Optune for the treatment of ndGBM, CADTH: \u0000 \u0000reviewed and critically appraised the clinical and economic evidence submitted by the sponsor \u0000reviewed the literature to identify and describe ethical considerations relevant to the use of Optune, as well as to assess the validity of the sponsor’s modelling approaches, assumptions, and estimates regarding Optune \u0000sought input from patient and clinician groups and consulted an expert panel. \u0000 \u0000 \u0000 \u0000What Did CADTH Find? \u0000Clinical Evidence \u0000 \u0000This review included the EF-14 trial, a pivotal, multicentre, open-label randomized controlled trial that assessed the efficacy and safety of Optune plus temozolomide in adults with ndGBM following maximal debulking surgery and completion of radiotherapy, together with and after standard of care maintenance chemotherapy. \u0000Based on the single trial, there is evidence of low to moderate certainty that Optune plus temozolomide likely increases progression-free survival at 6 months of treatment and overall survival at 24 months of treatment compared to temozolomide alone. The treatment effect of Optune plus temozolomide on progression-free survival and overall survival may be dose-dependent, with at least 18 hours of daily use required for the most benefit. \u0000Overall, the evidence was of very low to moderate certainty due to concerns regarding selection bias and low generalizability of the results to real-world settings. \u0000 \u0000Economic Evidence \u0000 \u0000The submitted fee for Optune is $27,000 per month, which is added to the cost of temozolomide based on its public list price. \u0000The incremental cost-effectiveness ratio for Optune plus temozolomide versus temozolomide alone was $899,470 per quality-adjusted life-year (QALY) gained (incremental costs = $336,902; incremental QALYs = 0.37). \u0000Optune plus temozolomide was not considered cost-effective relative to temozolomide alone at conventional willingness-to pay thresholds (i.e., $50,000 per QALY gained and $100,000 per QALY gained). Consequently, a price reduction of between 91% and 97% would be required for Optune plus temozolomide to be considered cost-effective at a willingness-to-pay threshold between $50,000 and $100,000 per QALY gained. \u0000The budget","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"67 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140229745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
CADTH recommends that Trecondyv in combination with fludarabine should be reimbursed by public drug plans as part of conditioning treatment before allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) at increased risk for standard conditioning therapies if certain conditions are met. Trecondyv in combination with fludarabine should only be covered to treat adult patients with AML or MDS who are eligible for alloHSCT, are at least 50 years old at transplant, and/or have a Hematopoietic Cell Transplantation-Comorbidity Index score greater than 2. Patients should have good performance status. Trecondyv should only be reimbursed in combination with fludarabine if prescribed by clinicians with appropriate training and experience in transplant centres with alloHSCT programs and if the cost of Trecondyv is not more than the least costly alternative conditioning treatment.
{"title":"Treosulfan (Trecondyv)","authors":"Cadth","doi":"10.51731/cjht.2024.855","DOIUrl":"https://doi.org/10.51731/cjht.2024.855","url":null,"abstract":"\u0000CADTH recommends that Trecondyv in combination with fludarabine should be reimbursed by public drug plans as part of conditioning treatment before allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) at increased risk for standard conditioning therapies if certain conditions are met. \u0000Trecondyv in combination with fludarabine should only be covered to treat adult patients with AML or MDS who are eligible for alloHSCT, are at least 50 years old at transplant, and/or have a Hematopoietic Cell Transplantation-Comorbidity Index score greater than 2. Patients should have good performance status. \u0000Trecondyv should only be reimbursed in combination with fludarabine if prescribed by clinicians with appropriate training and experience in transplant centres with alloHSCT programs and if the cost of Trecondyv is not more than the least costly alternative conditioning treatment. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"11 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140231951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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