We did not find any evidence regarding the clinical effectiveness and safety of second re-treatment with pembrolizumab for non–small cell lung cancer, classical Hodgkin lymphoma, and advanced melanoma. We did not find any evidence regarding the clinical effectiveness and safety of second re-treatment with cemiplimab for cutaneous squamous cell carcinoma. We did not find any evidence-based guidelines regarding the second re-treatment with immune checkpoint inhibitors for non–small cell lung cancer, classical Hodgkin lymphoma, advanced melanoma, and cutaneous squamous cell carcinoma.
{"title":"Re-Treatment With Immune Checkpoint Inhibitors","authors":"Cadth","doi":"10.51731/cjht.2024.937","DOIUrl":"https://doi.org/10.51731/cjht.2024.937","url":null,"abstract":"\u0000We did not find any evidence regarding the clinical effectiveness and safety of second re-treatment with pembrolizumab for non–small cell lung cancer, classical Hodgkin lymphoma, and advanced melanoma. \u0000We did not find any evidence regarding the clinical effectiveness and safety of second re-treatment with cemiplimab for cutaneous squamous cell carcinoma. \u0000We did not find any evidence-based guidelines regarding the second re-treatment with immune checkpoint inhibitors for non–small cell lung cancer, classical Hodgkin lymphoma, advanced melanoma, and cutaneous squamous cell carcinoma. \u0000","PeriodicalId":505661,"journal":{"name":"Canadian Journal of Health Technologies","volume":"3 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141810953","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? The first therapeutics based on clustered regularly interspaced short palindromic repeats (CRISPR) technologies are entering the market. These gene editing technologies have the potential to change treatment paradigms and may be used to treat conditions that cannot be treated or cured with current methods. This report aims to provide an overview of the technologies and their current and potential roles in health care. What Are the Technologies? CRISPR is a part of bacterial immune systems that can cut DNA strands and is used as a gene editing tool. A guide ribonucleic acid (RNA) sequence leads the CRISPR-associated nuclease to the target DNA sequence where the cut is made. These edits change the function of the gene, making genes nonfunctional or replacing the coding sequence for 1 gene with another. CRISPR can also be used to increase or decrease the expression of specific genes. What Is the Potential Impact? CRISPR-based technologies have a variety of potential applications in health care, including: treating genetic diseases understanding the genetic mechanisms of diseases and investigating the relevance of potential drug treatments managing infectious diseases through detection, treatment, and elimination. What Else Do We Need to Know? Ethical issues pertinent to the use of CRISPR include the ability to obtain adequately informed consent, the potential future consequences of gene editing and its potential unintended effects, and the impact gene editing could have on future generations. The long-term effects of CRISPR-based therapies are currently unknown. Further research into emerging applications is required. Long-term follow-up of the patients who have received the first CRISPR-based therapeutics will help inform understanding of the safety and effectiveness of these treatments. While the first of these therapies have been granted regulatory authorization, the next viable CRISPR-based therapies are still in the early phases of development, with the pivotal clinical trials not expected to be completed until at least 2027.
{"title":"CRISPR Technologies for In Vivo and Ex Vivo Gene Editing","authors":"Cadth Horizon, Scan","doi":"10.51731/cjht.2024.933","DOIUrl":"https://doi.org/10.51731/cjht.2024.933","url":null,"abstract":"What Is the Issue? \u0000The first therapeutics based on clustered regularly interspaced short palindromic repeats (CRISPR) technologies are entering the market. These gene editing technologies have the potential to change treatment paradigms and may be used to treat conditions that cannot be treated or cured with current methods. This report aims to provide an overview of the technologies and their current and potential roles in health care. \u0000What Are the Technologies? \u0000CRISPR is a part of bacterial immune systems that can cut DNA strands and is used as a gene editing tool. A guide ribonucleic acid (RNA) sequence leads the CRISPR-associated nuclease to the target DNA sequence where the cut is made. These edits change the function of the gene, making genes nonfunctional or replacing the coding sequence for 1 gene with another. CRISPR can also be used to increase or decrease the expression of specific genes. \u0000What Is the Potential Impact? \u0000CRISPR-based technologies have a variety of potential applications in health care, including: \u0000 \u0000treating genetic diseases \u0000understanding the genetic mechanisms of diseases and investigating the relevance of potential drug treatments \u0000managing infectious diseases through detection, treatment, and elimination. \u0000 \u0000What Else Do We Need to Know? \u0000Ethical issues pertinent to the use of CRISPR include the ability to obtain adequately informed consent, the potential future consequences of gene editing and its potential unintended effects, and the impact gene editing could have on future generations. The long-term effects of CRISPR-based therapies are currently unknown. Further research into emerging applications is required. Long-term follow-up of the patients who have received the first CRISPR-based therapeutics will help inform understanding of the safety and effectiveness of these treatments. While the first of these therapies have been granted regulatory authorization, the next viable CRISPR-based therapies are still in the early phases of development, with the pivotal clinical trials not expected to be completed until at least 2027.","PeriodicalId":505661,"journal":{"name":"Canadian Journal of Health Technologies","volume":"104 29","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141821884","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? Multiple sclerosis is a chronic autoimmune disorder that causes damage to central nervous system cells. Relapsing-remitting multiple sclerosis is characterized by relapses (episodes of new or worsening symptoms) followed by periods of partial or complete recovery (remission). First-line therapies for multiple sclerosis include interferons, glatiramer acetate, dimethyl fumarate, and teriflunomide. Second-line therapies include natalizumab, alemtuzumab, and fingolimod. The considerations for switching from a first-line to a second-line therapy for patients with relapsing-remitting multiple sclerosis are unclear. What Did We Do? To inform decisions around switching patients with relapsing-remitting multiple sclerosis from a first-line to a second-line therapy, we sought to identify and summarize recommendations from evidence-based guidelines. We searched key resources, including journal citation databases, and conducted a focused internet search for relevant evidence published since 2019. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included guidelines, and narratively summarized the findings. What Did We Find? We identified 2 evidence-based guidelines that included recommendations around switching from a first-line to a second-line therapy in patients with relapsing-remitting multiple sclerosis. One guideline from Spain classified therapies as moderate-efficacy (interferons, glatiramer acetate, dimethyl fumarate, and teriflunomide) and high-efficacy (fingolimod, cladribine, ocrelizumab, natalizumab, and alemtuzumab). The guideline recommends that patients switch from a moderate-efficacy disease-modifying therapy to a high-efficacy disease-modifying therapy for a variety of reasons including suboptimal response, adverse events, comorbidities, pregnancy plans, confirmed progression of disability, and tolerability issues. The guideline also included several recommendations specific to switching to natalizumab as well as washout periods when switching from a moderate-efficacy therapy. One guideline from France included recommendations regarding washout periods for switching from a first-line therapy. The guideline recommends that when switching from a first-line therapy, a second-line therapy or an induction therapy could be started without a washout period if the patient has normal biological results. The guideline also recommends validating the indication, timing, and washout period of a switch to a second-line therapy or induction therapy with a multiple sclerosis expert centre or in a multidisciplinary consensus meeting. The guideline also included specific considerations for washout periods for dimethyl fumarate and teriflunomide. What Does It Mean? The considerations for switching from a first-line to a second-line therapy in patients with relapsing-remitting multiple sclerosis — including the timing of a switch, choice of second-line therapy, and
{"title":"Review of Guidelines on Second-Line Therapy for Patients With Relapsing-Remitting Multiple Sclerosis: A 2024 Update","authors":"Cadth","doi":"10.51731/cjht.2024.931","DOIUrl":"https://doi.org/10.51731/cjht.2024.931","url":null,"abstract":"What Is the Issue? \u0000 \u0000Multiple sclerosis is a chronic autoimmune disorder that causes damage to central nervous system cells. Relapsing-remitting multiple sclerosis is characterized by relapses (episodes of new or worsening symptoms) followed by periods of partial or complete recovery (remission). \u0000First-line therapies for multiple sclerosis include interferons, glatiramer acetate, dimethyl fumarate, and teriflunomide. Second-line therapies include natalizumab, alemtuzumab, and fingolimod. \u0000The considerations for switching from a first-line to a second-line therapy for patients with relapsing-remitting multiple sclerosis are unclear. \u0000 \u0000What Did We Do? \u0000 \u0000To inform decisions around switching patients with relapsing-remitting multiple sclerosis from a first-line to a second-line therapy, we sought to identify and summarize recommendations from evidence-based guidelines. \u0000We searched key resources, including journal citation databases, and conducted a focused internet search for relevant evidence published since 2019. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included guidelines, and narratively summarized the findings. \u0000 \u0000What Did We Find? \u0000 \u0000We identified 2 evidence-based guidelines that included recommendations around switching from a first-line to a second-line therapy in patients with relapsing-remitting multiple sclerosis. \u0000One guideline from Spain classified therapies as moderate-efficacy (interferons, glatiramer acetate, dimethyl fumarate, and teriflunomide) and high-efficacy (fingolimod, cladribine, ocrelizumab, natalizumab, and alemtuzumab). The guideline recommends that patients switch from a moderate-efficacy disease-modifying therapy to a high-efficacy disease-modifying therapy for a variety of reasons including suboptimal response, adverse events, comorbidities, pregnancy plans, confirmed progression of disability, and tolerability issues. The guideline also included several recommendations specific to switching to natalizumab as well as washout periods when switching from a moderate-efficacy therapy. \u0000One guideline from France included recommendations regarding washout periods for switching from a first-line therapy. The guideline recommends that when switching from a first-line therapy, a second-line therapy or an induction therapy could be started without a washout period if the patient has normal biological results. The guideline also recommends validating the indication, timing, and washout period of a switch to a second-line therapy or induction therapy with a multiple sclerosis expert centre or in a multidisciplinary consensus meeting. The guideline also included specific considerations for washout periods for dimethyl fumarate and teriflunomide. \u0000 \u0000What Does It Mean? \u0000 \u0000The considerations for switching from a first-line to a second-line therapy in patients with relapsing-remitting multiple sclerosis — including the timing of a switch, choice of second-line therapy, and ","PeriodicalId":505661,"journal":{"name":"Canadian Journal of Health Technologies","volume":" 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141824727","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}
The objective of this analysis was to examine the changes in drug expenditures with the initiation of targeted immune modulator (TIM) treatment in patients diagnosed with Crohn disease (CD) and ulcerative colitis (UC). Patient cohorts for CD and UC were identified from hospitalizations in Canada. Expenditure data for TIMs with a Health Canada–approved indication for the treatment of CD or UC were extracted from all provincial drug plans (except Quebec) and Yukon from 2016 to 2021, and a descriptive analysis was performed to assess the expenditure patterns. Annual expenditures on TIMs for patients with CD increased each year from 2016 to 2019 before decreasing in 2020 and 2021, whereas expenditures on TIMs in UC increased each year, generally by a greater percentage than was observed in CD (peak percentage growth of 92.5% for UC versus 15.9% for CD in 2018). Expenditures associated with TIM initiation among patients with CD and UC were driven by infliximab and adalimumab, with the 2 drugs accounting for nearly all expenditures in both indications in 2016 and most expenditures in 2021. In both CD and UC, vedolizumab expenditures increased over time, as did the proportions of TIM expenditures on ustekinumab in CD and tofacitinib in UC, albeit to a lesser extent than vedolizumab.
这项分析的目的是研究克罗恩病（CD）和溃疡性结肠炎（UC）患者开始接受靶向免疫调节剂（TIM）治疗后药物支出的变化。我们从加拿大的住院病例中确定了克罗恩病和溃疡性结肠炎患者队列。从所有省级药品计划（魁北克省除外）和育空地区提取了 2016 年至 2021 年经加拿大卫生部批准用于治疗 CD 或 UC 的 TIMs 支出数据，并进行了描述性分析以评估支出模式。2016 年至 2019 年，CD 患者的 TIM 年度支出逐年增加，2020 年和 2021 年则有所减少，而 UC 患者的 TIM 支出则逐年增加，增加的百分比普遍高于 CD 患者（2018 年 UC 患者的峰值百分比增长为 92.5%，而 CD 患者的峰值百分比增长为 15.9%）。CD 和 UC 患者开始使用 TIM 的相关支出主要由英夫利昔单抗和阿达木单抗驱动，这两种药物在 2016 年几乎占这两种适应症的所有支出，在 2021 年占大部分支出。在 CD 和 UC 中，韦多珠单抗的支出随着时间的推移而增加，在 CD 中用于乌司替尼（ustekinumab）和 UC 中用于托法替尼（tofacitinib）的 TIM 支出比例也在增加，尽管增加的程度低于韦多珠单抗。
{"title":"Trends in Public Drug Plan Expenditures for Patients With Crohn Disease and Ulcerative Colitis Initiating Targeted Immune Modulator Therapy","authors":"Cadth","doi":"10.51731/cjht.2024.929","DOIUrl":"https://doi.org/10.51731/cjht.2024.929","url":null,"abstract":"\u0000The objective of this analysis was to examine the changes in drug expenditures with the initiation of targeted immune modulator (TIM) treatment in patients diagnosed with Crohn disease (CD) and ulcerative colitis (UC). \u0000Patient cohorts for CD and UC were identified from hospitalizations in Canada. Expenditure data for TIMs with a Health Canada–approved indication for the treatment of CD or UC were extracted from all provincial drug plans (except Quebec) and Yukon from 2016 to 2021, and a descriptive analysis was performed to assess the expenditure patterns. \u0000Annual expenditures on TIMs for patients with CD increased each year from 2016 to 2019 before decreasing in 2020 and 2021, whereas expenditures on TIMs in UC increased each year, generally by a greater percentage than was observed in CD (peak percentage growth of 92.5% for UC versus 15.9% for CD in 2018). \u0000Expenditures associated with TIM initiation among patients with CD and UC were driven by infliximab and adalimumab, with the 2 drugs accounting for nearly all expenditures in both indications in 2016 and most expenditures in 2021. \u0000In both CD and UC, vedolizumab expenditures increased over time, as did the proportions of TIM expenditures on ustekinumab in CD and tofacitinib in UC, albeit to a lesser extent than vedolizumab. \u0000","PeriodicalId":505661,"journal":{"name":"Canadian Journal of Health Technologies","volume":"55 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141652534","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}
Biosimilars are biologic drugs that are highly similar to their reference biologics that were already authorized for sale. Interchangeability is a term used to describe when 1 drug can be exchanged for another and is expected to have the same clinical effect. Interchangeability may allow 1 medicine to be substituted for another at the time of dispensing (automatic substitution). However, the decision to allow automatic substitution is made by each jurisdiction according to its own regulations. Interchangeability of a reference biologic (the originator product) and a biosimilar is a designation in the US and Finland. The US, France, Germany, Norway, and Australia allow automatic substitution between reference biologics and biosimilars, whereas other countries do not. Interchangeability is limited to select products in the US and Australia. The countries included in this Environmental Scan (N = 13) endorse starting patients who have not yet received treatment on a biosimilar. Switching between reference biologics and biosimilars is generally allowed in all the countries included in this review; however, many jurisdictions prefer switching be clinician led with ongoing clinical monitoring of patients. Practices such as target setting, quotas, and financial incentives, as well as guidelines and recommendations for prescription of biosimilars, can be effective ways to encourage biosimilar use. Mandatory switching is also implemented in 11 Canadian jurisdictions. Extrapolation is the regulatory and scientific process of granting a clinical indication to a medicine without clinical efficacy and safety data to support that indication. Extrapolation of indications for reference biologics to biosimilars is reasonable, provided several factors are comparable: mechanism of action across indications, pharmacokinetics and biodistribution, safety, immunogenicity, and other factors that affect the safety and efficacy for each indication and patient population. Pricing and procurement practices vary internationally. Some countries implement policies controlling the list price of a biosimilar (and its reference drug less commonly) at the time of biosimilar launch. Pricing policies include a free-pricing policy (i.e., manufacturers are free to set the price of biosimilars) and mandatory price reductions. Tendering is the most common practice in procurement to achieve lower prices and to increase biosimilar uptakes in 8 countries reviewed in this Environmental Scan. Biosimilar-related policies and markets are rapidly evolving, so recent changes might have not been fully captured in this Environmental Scan. Therefore, caution is required in interpreting the findings.
{"title":"National and International Policies on the Use of Biosimilars: An Environmental Scan","authors":"Jaemin Kim, Jessica Arias, S. Gavura","doi":"10.51731/cjht.2024.927","DOIUrl":"https://doi.org/10.51731/cjht.2024.927","url":null,"abstract":"\u0000Biosimilars are biologic drugs that are highly similar to their reference biologics that were already authorized for sale. \u0000Interchangeability is a term used to describe when 1 drug can be exchanged for another and is expected to have the same clinical effect. Interchangeability may allow 1 medicine to be substituted for another at the time of dispensing (automatic substitution). However, the decision to allow automatic substitution is made by each jurisdiction according to its own regulations. \u0000Interchangeability of a reference biologic (the originator product) and a biosimilar is a designation in the US and Finland. The US, France, Germany, Norway, and Australia allow automatic substitution between reference biologics and biosimilars, whereas other countries do not. Interchangeability is limited to select products in the US and Australia. \u0000The countries included in this Environmental Scan (N = 13) endorse starting patients who have not yet received treatment on a biosimilar. Switching between reference biologics and biosimilars is generally allowed in all the countries included in this review; however, many jurisdictions prefer switching be clinician led with ongoing clinical monitoring of patients. \u0000Practices such as target setting, quotas, and financial incentives, as well as guidelines and recommendations for prescription of biosimilars, can be effective ways to encourage biosimilar use. Mandatory switching is also implemented in 11 Canadian jurisdictions. \u0000Extrapolation is the regulatory and scientific process of granting a clinical indication to a medicine without clinical efficacy and safety data to support that indication. Extrapolation of indications for reference biologics to biosimilars is reasonable, provided several factors are comparable: mechanism of action across indications, pharmacokinetics and biodistribution, safety, immunogenicity, and other factors that affect the safety and efficacy for each indication and patient population. \u0000Pricing and procurement practices vary internationally. Some countries implement policies controlling the list price of a biosimilar (and its reference drug less commonly) at the time of biosimilar launch. Pricing policies include a free-pricing policy (i.e., manufacturers are free to set the price of biosimilars) and mandatory price reductions. Tendering is the most common practice in procurement to achieve lower prices and to increase biosimilar uptakes in 8 countries reviewed in this Environmental Scan. \u0000Biosimilar-related policies and markets are rapidly evolving, so recent changes might have not been fully captured in this Environmental Scan. Therefore, caution is required in interpreting the findings. \u0000","PeriodicalId":505661,"journal":{"name":"Canadian Journal of Health Technologies","volume":" 17","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141678333","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? Immune checkpoint inhibitor (ICI) therapy has become a treatment option for various types of advanced cancer, resulting in significant improvement in disease outcomes. However, ICIs can overstimulate the immune system leading to various side effects known as immune-related adverse events (irAEs) that can occur in any organ system. Administration of corticosteroids is the initial mainstay treatment of irAEs. However, there is little evidence of how to treat steroid-resistant irAEs. Treatment of steroid-resistant irAEs includes holding ICI and starting immunosuppressive therapy. Decision-makers are interested in understanding the use of infliximab, a selective immunosuppressive drug, for the treatment of steroid-resistant irAEs affecting various organs. What Did We Do? We identified and summarized the literature regarding the efficacy and safety of infliximab for the treatment of steroid-resistant irAEs. Due to the limitation of evidence, we included studies of any design, including case reports and case series. A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2019 and April 8, 2024. One reviewer screened citations for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. What Did We Find? The evidence presented in this report was based on 2 systematic reviews of case reports and case series, 1 retrospective cohort study, and 40 additional publications consisting of 29 case reports and 11 case series. We identified 4 main irAEs, which were colitis, hepatitis, pneumonitis, and myocarditis. Very low-quality evidence, which was mainly derived from case reports and case series, suggests that infliximab may be effective for the treatment of steroid-resistant immune-induced colitis, while there are concerns regarding its use for the treatment of hepatitis due to potential hepatotoxicity and infectious complications. There is mixed evidence regarding the use of infliximab for the treatment of immune-induced pneumonitis and myocarditis. Recent consensus guidelines recommend the use of infliximab as first-line treatment for steroid-resistant immune-induced colitis, while its use for hepatitis is not recommended due to potential hepatotoxicity and infectious complications. The use of infliximab for the treatment of pneumonitis is an option, while its use for myocarditis remains to be determined. The usual dose of infliximab was 5 mg/kg, administered by IV. A higher dose of 10 mg/kg was seen in some cases. The number of infusions, the period between infusions and the length of treatment varied depending on the responsiveness of infliximab and the type and severity of irAEs. Treatment with infliximab as compared with vedolizumab resulted in comparable immune-induced colitis response rates, higher recurrent rate of colitis, and more hospitalizations despite a sho
{"title":"Infliximab for Immune Checkpoint Inhibitor Therapy-Related Toxicities","authors":"Cadth","doi":"10.51731/cjht.2024.915","DOIUrl":"https://doi.org/10.51731/cjht.2024.915","url":null,"abstract":"What Is the Issue? \u0000 \u0000Immune checkpoint inhibitor (ICI) therapy has become a treatment option for various types of advanced cancer, resulting in significant improvement in disease outcomes. \u0000However, ICIs can overstimulate the immune system leading to various side effects known as immune-related adverse events (irAEs) that can occur in any organ system. \u0000Administration of corticosteroids is the initial mainstay treatment of irAEs. However, there is little evidence of how to treat steroid-resistant irAEs. Treatment of steroid-resistant irAEs includes holding ICI and starting immunosuppressive therapy. \u0000Decision-makers are interested in understanding the use of infliximab, a selective immunosuppressive drug, for the treatment of steroid-resistant irAEs affecting various organs. \u0000 \u0000What Did We Do? \u0000 \u0000We identified and summarized the literature regarding the efficacy and safety of infliximab for the treatment of steroid-resistant irAEs. Due to the limitation of evidence, we included studies of any design, including case reports and case series. \u0000A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2019 and April 8, 2024. One reviewer screened citations for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. \u0000 \u0000What Did We Find? \u0000 \u0000The evidence presented in this report was based on 2 systematic reviews of case reports and case series, 1 retrospective cohort study, and 40 additional publications consisting of 29 case reports and 11 case series. \u0000We identified 4 main irAEs, which were colitis, hepatitis, pneumonitis, and myocarditis. \u0000Very low-quality evidence, which was mainly derived from case reports and case series, suggests that infliximab may be effective for the treatment of steroid-resistant immune-induced colitis, while there are concerns regarding its use for the treatment of hepatitis due to potential hepatotoxicity and infectious complications. There is mixed evidence regarding the use of infliximab for the treatment of immune-induced pneumonitis and myocarditis. \u0000Recent consensus guidelines recommend the use of infliximab as first-line treatment for steroid-resistant immune-induced colitis, while its use for hepatitis is not recommended due to potential hepatotoxicity and infectious complications. The use of infliximab for the treatment of pneumonitis is an option, while its use for myocarditis remains to be determined. \u0000The usual dose of infliximab was 5 mg/kg, administered by IV. A higher dose of 10 mg/kg was seen in some cases. The number of infusions, the period between infusions and the length of treatment varied depending on the responsiveness of infliximab and the type and severity of irAEs. \u0000Treatment with infliximab as compared with vedolizumab resulted in comparable immune-induced colitis response rates, higher recurrent rate of colitis, and more hospitalizations despite a sho","PeriodicalId":505661,"journal":{"name":"Canadian Journal of Health Technologies","volume":"98 32","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141359251","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? Lab test overuse can contribute to further unnecessary follow-up and testing, negative patient experiences, potentially inappropriate treatments, and the inefficient use of health care resources. One review of lab testing in Canada found that around 22% of blood tests were likely unnecessary. One strategy to address lab test overuse is to establish minimal retesting intervals that can be implemented in medical laboratories to help identify and manage potentially inappropriate lab test requests. Minimum retesting intervals suggest the minimum time before a test should be repeated based on the biochemical properties of the test and the clinical situation in which it is used. They are intended to inform clinical decisions about repeat testing. The importance of lab resource stewardship is being addressed by Choosing Wisely Canada through Using Labs Wisely, a consortium of more than 150 hospitals committed to driving the appropriate use of lab testing in Canada. The hospitals participating in Using Labs Wisely identified a need for guidance on minimum retesting intervals for commonly used lab tests. What Did We Do? Choosing Wisely Canada and CADTH partnered to convene an independent time-limited advisory panel to develop consensus-based recommendations for minimum retesting intervals for 7 commonly used lab tests (antinuclear antibody [ANA], B-type natriuretic peptide [BNP] and N-terminal pro b-type natriuretic peptide [NT-proBNP], Hemoglobin A1C, lipase, lipid panel, serum protein electrophoresis [SPEP], and thyroid stimulating hormone [TSH]) in prespecified patient populations. The advisory panel included core and specialist members who were recruited from across Canada. The 7 core advisory panel members brought together expertise in laboratory medicine, family practice, and patient lived experience. Seven additional specialist members brought expertise in endocrinology, cardiology, pediatric cardiology, rheumatology, hematology oncology, gastroenterology, and general internal medicine. The Advisory Panel on Minimum Retesting Intervals considered patient group input, evidence from focused literature reviews, equity considerations, and clinical expertise. Through facilitated discussion, they reached consensus on the recommendations for minimum retesting intervals. Following external feedback, the recommendations for BNP and NT-proBNP and lipid panels were removed, and this document includes recommendations for minimum retesting intervals for 5 lab tests. These are not recommendations for repeat testing. They are recommendations that if testing is undertaken, it should not be repeated sooner than the indicated intervals. They are not intended to replace clinical judgment as there may be exceptions in which the recommendations do not apply. What Is the Potential Impact? The recommendations on minimum retesting intervals can support the hospitals participating in Choosing Wisely Canada’s Using Labs Wisely program
{"title":"Advisory Panel Guidance on Minimum Retesting Intervals for Lab Tests","authors":"Cadth","doi":"10.51731/cjht.2024.916","DOIUrl":"https://doi.org/10.51731/cjht.2024.916","url":null,"abstract":"What Is the Issue? \u0000 \u0000Lab test overuse can contribute to further unnecessary follow-up and testing, negative patient experiences, potentially inappropriate treatments, and the inefficient use of health care resources. One review of lab testing in Canada found that around 22% of blood tests were likely unnecessary. \u0000One strategy to address lab test overuse is to establish minimal retesting intervals that can be implemented in medical laboratories to help identify and manage potentially inappropriate lab test requests. \u0000Minimum retesting intervals suggest the minimum time before a test should be repeated based on the biochemical properties of the test and the clinical situation in which it is used. They are intended to inform clinical decisions about repeat testing. \u0000The importance of lab resource stewardship is being addressed by Choosing Wisely Canada through Using Labs Wisely, a consortium of more than 150 hospitals committed to driving the appropriate use of lab testing in Canada. The hospitals participating in Using Labs Wisely identified a need for guidance on minimum retesting intervals for commonly used lab tests. \u0000 \u0000What Did We Do? \u0000 \u0000Choosing Wisely Canada and CADTH partnered to convene an independent time-limited advisory panel to develop consensus-based recommendations for minimum retesting intervals for 7 commonly used lab tests (antinuclear antibody [ANA], B-type natriuretic peptide [BNP] and N-terminal pro b-type natriuretic peptide [NT-proBNP], Hemoglobin A1C, lipase, lipid panel, serum protein electrophoresis [SPEP], and thyroid stimulating hormone [TSH]) in prespecified patient populations. \u0000The advisory panel included core and specialist members who were recruited from across Canada. The 7 core advisory panel members brought together expertise in laboratory medicine, family practice, and patient lived experience. Seven additional specialist members brought expertise in endocrinology, cardiology, pediatric cardiology, rheumatology, hematology oncology, gastroenterology, and general internal medicine. \u0000The Advisory Panel on Minimum Retesting Intervals considered patient group input, evidence from focused literature reviews, equity considerations, and clinical expertise. Through facilitated discussion, they reached consensus on the recommendations for minimum retesting intervals. Following external feedback, the recommendations for BNP and NT-proBNP and lipid panels were removed, and this document includes recommendations for minimum retesting intervals for 5 lab tests. \u0000These are not recommendations for repeat testing. They are recommendations that if testing is undertaken, it should not be repeated sooner than the indicated intervals. They are not intended to replace clinical judgment as there may be exceptions in which the recommendations do not apply. \u0000 \u0000What Is the Potential Impact? \u0000 \u0000The recommendations on minimum retesting intervals can support the hospitals participating in Choosing Wisely Canada’s Using Labs Wisely program","PeriodicalId":505661,"journal":{"name":"Canadian Journal of Health Technologies","volume":"76 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141357966","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 Awiqli be reimbursed by public drug plans for the once-weekly treatment of adults with type 2 diabetes mellitus (T2DM) to improve glycemic control if certain conditions are met. Awiqli should only be covered to treat adults with T2DM whose glycated hemoglobin (hemoglobin A1C) is between 7.0% and 11.0% (inclusive). To ensure cost-effectiveness, the total drug cost of Awiqli should not exceed the total drug cost of the least costly long-acting basal insulin analogue.
{"title":"Insulin Icodec (Awiqli)","authors":"Cadth","doi":"10.51731/cjht.2024.912","DOIUrl":"https://doi.org/10.51731/cjht.2024.912","url":null,"abstract":"\u0000CADTH recommends that Awiqli be reimbursed by public drug plans for the once-weekly treatment of adults with type 2 diabetes mellitus (T2DM) to improve glycemic control if certain conditions are met. \u0000Awiqli should only be covered to treat adults with T2DM whose glycated hemoglobin (hemoglobin A1C) is between 7.0% and 11.0% (inclusive). \u0000To ensure cost-effectiveness, the total drug cost of Awiqli should not exceed the total drug cost of the least costly long-acting basal insulin analogue. \u0000","PeriodicalId":505661,"journal":{"name":"Canadian Journal of Health Technologies","volume":"6 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141384794","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) is estimated to affect between 0.2% and 2.4% of newborns worldwide, and may cause long-term effects, including hearing loss and neurodevelopmental disability. Newborn screening for cCMV can identify affected neonates and provide an opportunity for early treatment, which may reduce any long-term effects from infection. We wanted to know if universal newborn screening is a clinically effective and cost-effective intervention for identifying and managing cCMV. What Did We Do? We identified and summarized published literature comparing the clinical effectiveness and cost-effectiveness of universal newborn screening with either targeted newborn screening or no screening for congenital cytomegalovirus in neonates. We also identified and summarized published, evidence-based guidelines that make recommendations concerning the use of newborn screening for congenital cytomegalovirus to help inform decisions considering the use of this intervention. An information specialist searched for peer-reviewed and grey literature sources published between January 1, 2014, and March 19, 2024. The search was limited to English-language documents. One reviewer screened articles for eligibility based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. What Did We Find? Evidence from 1 prospective cohort study in the US found that, compared to universal newborn screening for cCMV, targeted newborn screening failed to identify a significant proportion of neonates who developed hearing loss associated with infection. Three cost-effectiveness evaluations concluded that universal newborn screening for cCMV was cost-effective when compared to targeted newborn screening or no screening. None of these analyses were specific to the Canadian context. While 1 of 3 evidence-based guidelines identified by this review makes a recommendation favouring universal newborn screening for cCMV, 2 evidence-based guidelines recommend against the implementation of universal newborn screening for cCMV (including 1 from the Canadian context), generally citing a lack of sufficient clinical evidence. What Does This Mean? The included cost-effectiveness studies and evidence-based guidelines in this report emphasize that limited clinical evidence is currently available to inform decision-making concerning newborn screening for cCMV. Jurisdictions where universal newborn screening for cCMV has been implemented provide an opportunity for clinical research to support and inform future decision-making. The current limitation of available clinical data describing newborn screening for cCMV will require decision-makers to draw from a broader set of inputs and sources than those available from empirical studies.
{"title":"Newborn Screening for Congenital Cytomegalovirus","authors":"Cadth","doi":"10.51731/cjht.2024.895","DOIUrl":"https://doi.org/10.51731/cjht.2024.895","url":null,"abstract":"What Is the Issue? \u0000 \u0000Congenital cytomegalovirus (cCMV) is estimated to affect between 0.2% and 2.4% of newborns worldwide, and may cause long-term effects, including hearing loss and neurodevelopmental disability. \u0000Newborn screening for cCMV can identify affected neonates and provide an opportunity for early treatment, which may reduce any long-term effects from infection. \u0000We wanted to know if universal newborn screening is a clinically effective and cost-effective intervention for identifying and managing cCMV. \u0000 \u0000What Did We Do? \u0000 \u0000We identified and summarized published literature comparing the clinical effectiveness and cost-effectiveness of universal newborn screening with either targeted newborn screening or no screening for congenital cytomegalovirus in neonates. We also identified and summarized published, evidence-based guidelines that make recommendations concerning the use of newborn screening for congenital cytomegalovirus to help inform decisions considering the use of this intervention. \u0000An information specialist searched for peer-reviewed and grey literature sources published between January 1, 2014, and March 19, 2024. The search was limited to English-language documents. One reviewer screened articles for eligibility based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. \u0000 \u0000What Did We Find? \u0000 \u0000Evidence from 1 prospective cohort study in the US found that, compared to universal newborn screening for cCMV, targeted newborn screening failed to identify a significant proportion of neonates who developed hearing loss associated with infection. \u0000Three cost-effectiveness evaluations concluded that universal newborn screening for cCMV was cost-effective when compared to targeted newborn screening or no screening. None of these analyses were specific to the Canadian context. \u0000While 1 of 3 evidence-based guidelines identified by this review makes a recommendation favouring universal newborn screening for cCMV, 2 evidence-based guidelines recommend against the implementation of universal newborn screening for cCMV (including 1 from the Canadian context), generally citing a lack of sufficient clinical evidence. \u0000 \u0000What Does This Mean? \u0000 \u0000The included cost-effectiveness studies and evidence-based guidelines in this report emphasize that limited clinical evidence is currently available to inform decision-making concerning newborn screening for cCMV. \u0000Jurisdictions where universal newborn screening for cCMV has been implemented provide an opportunity for clinical research to support and inform future decision-making. \u0000The current limitation of available clinical data describing newborn screening for cCMV will require decision-makers to draw from a broader set of inputs and sources than those available from empirical studies. \u0000","PeriodicalId":505661,"journal":{"name":"Canadian Journal of Health Technologies","volume":"32 13","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140971585","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? Health care providers rely on laboratory tests to differentiate between respiratory illnesses that manifest in similar symptoms, such as COVID-19 and influenza. However, samples may travel to centralized laboratories to process, delaying test results and treatment. Point-of-care tests (POCTs) allow for diagnosis at the site of care but at the expense of diagnostic performance. Several commercial POCTs, specifically for COVID-19, have become increasingly available in Canada since the start of the pandemic. Decision-makers will need to consider which commercial POCT can meet their jurisdiction’s testing needs. POCTs in Canada and their Potential Impact Some POCTs, called “Multiplex tests,” can detect and differentiate between certain illnesses using a single sample. Some studies suggest that using POCTs for respiratory illness in hospitals and emergency departments can expedite diagnosis, improve patient flow, reduce admissions, and shorten the length of stay. Commercial POCTs vary in diagnostic performance, complexity, and costs. There are at least 37 authorized POCTs for COVID-19, influenza, or both in Canada. All devices accept a nasal, nasopharyngeal sample, or both sample types for testing. Some tests require a reader or analyzer to use test kits for diagnosis. POCTs can provide results in 1 hour or less. However, laboratory testing (i.e., nucleic acid amplification tests) remains the standard of care to diagnose COVID-19 and influenza, given their better diagnostic performance compared to POCTs. What Else Do We Need to Know? Confirmatory laboratory tests can reaffirm the diagnosis from POCTs. However, budget impact analyses and clinical studies on authorized tests in Canada do not consider how confirmatory lab tests impact findings on POCT use. Future studies should investigate the cost-effectiveness of POCTs with confirmatory testing, as well as the impact of incorrect diagnosis from POCT on patient outcomes. Rural and remote communities may benefit from POCTs for respiratory illness, given their distance to centralized laboratories.
{"title":"Point-of-Care Tests for COVID-19 and Influenza in Canada","authors":"Cadth","doi":"10.51731/cjht.2024.894","DOIUrl":"https://doi.org/10.51731/cjht.2024.894","url":null,"abstract":"What Is the Issue? \u0000 \u0000Health care providers rely on laboratory tests to differentiate between respiratory illnesses that manifest in similar symptoms, such as COVID-19 and influenza. However, samples may travel to centralized laboratories to process, delaying test results and treatment. \u0000Point-of-care tests (POCTs) allow for diagnosis at the site of care but at the expense of diagnostic performance. Several commercial POCTs, specifically for COVID-19, have become increasingly available in Canada since the start of the pandemic. Decision-makers will need to consider which commercial POCT can meet their jurisdiction’s testing needs. \u0000 \u0000POCTs in Canada and their Potential Impact \u0000 \u0000Some POCTs, called “Multiplex tests,” can detect and differentiate between certain illnesses using a single sample. Some studies suggest that using POCTs for respiratory illness in hospitals and emergency departments can expedite diagnosis, improve patient flow, reduce admissions, and shorten the length of stay. \u0000Commercial POCTs vary in diagnostic performance, complexity, and costs. There are at least 37 authorized POCTs for COVID-19, influenza, or both in Canada. All devices accept a nasal, nasopharyngeal sample, or both sample types for testing. Some tests require a reader or analyzer to use test kits for diagnosis. \u0000POCTs can provide results in 1 hour or less. However, laboratory testing (i.e., nucleic acid amplification tests) remains the standard of care to diagnose COVID-19 and influenza, given their better diagnostic performance compared to POCTs. \u0000 \u0000What Else Do We Need to Know? \u0000 \u0000Confirmatory laboratory tests can reaffirm the diagnosis from POCTs. However, budget impact analyses and clinical studies on authorized tests in Canada do not consider how confirmatory lab tests impact findings on POCT use. Future studies should investigate the cost-effectiveness of POCTs with confirmatory testing, as well as the impact of incorrect diagnosis from POCT on patient outcomes. \u0000Rural and remote communities may benefit from POCTs for respiratory illness, given their distance to centralized laboratories. \u0000","PeriodicalId":505661,"journal":{"name":"Canadian Journal of Health Technologies","volume":"66 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140972665","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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