An assessment of the current reimbursement of biologics used to treat adults with moderate-to-severe plaque psoriasis (PsO) is needed given the significant expenditures on biologics and the changing dynamics because of loss of exclusivity and new-generation biologic entrants. This Environmental Scan assessed the regulatory, exclusivity, Canada's Drug Agency review, and reimbursement status of biologics for PsO relevant to public drug plans.
Each federal, provincial, and territorial (FPT) public drug plan provides access to prescription medications for specific populations. FPTs rely on guidance from health technology assessment agencies such as Canada's Drug Agency; however, reimbursement decisions for individual medications follow different local processes. This Environmental Scan sought to compare these reimbursement decision-making processes (e.g., drug review processes, decision-making principles and/or frameworks, decision-making committee structures).
Single-entry models (SEMs) are an approach to waitlist management that have been used extensively in the Canadian and international context. There is a small body of evidence that shows SEMs contribute to reduced wait times and waitlist lengths. This briefing note examines four SEMs that have been implemented in the Canadian context and describes key success factors and challenges in SEM implementation.
1. What are the experiences and perspectives of adults and children with severe respiratory failure and their families on being offered, receiving, and recovering from ECMO? 2. What are the experiences and perspectives of health care providers on offering, providing, and supporting patients’ recovery after ECMO for severe respiratory failure?
This review used a framework analysis to synthesize 9 included studies on the perspectives and experiences of patients, family members, and providers on extracorporeal membrane oxygenation (ECMO). Patients’ perspectives on their experiences are limited due to their sedated status when treated with ECMO. Supporting a relative treated with ECMO is stressful for family members. They feel anxious and worried about their relative because of the patient’s critical condition, and they struggle to juggle multiple roles at work and home while supporting their relative receiving ECMO. Family members often have to travel to see their critically ill relative. Financial and logistical support for temporary relocation near the ECMO centre may ease the burden of travel. Family members benefit from clear and frequent communication from health care providers as a source of support and reassurance while their loved ones are being treated with ECMO. There may be a role for informal or formal peer support for family members of patients receiving ECMO. Clinicians’ decisions to offer, continue, and withdraw ECMO are based on their assessments of prognostic factors from patients’ medical histories and clinical conditions. Additional clinical research and/or refinements of prognostic guidance for ECMO may further support evidence-informed decision-making around ECMO. Patients, family members, and clinical team members may differ in their assessment of the limits of ECMO treatment and the decision to transition from active treatment to the withdrawal of life support. These findings point to the role of ethical considerations and processes when engaging in transitioning to end-of-life support in the provision of ECMO. After discharge, patients who had received ECMO and their family members continued to have feelings of anxiety, intrusive thoughts, and a need to process the event. ECMO programs that can offer continued or ongoing support or referral for patients and their family members’ mental health may help address these needs.
Smoke-free campus policies at inpatient health facilities are most effective when situated within comprehensive smoking cessation programs that include cessation support for staff and patients and effective communications and signage for staff, patients, and visitors.
Canadian jurisdictions such as Ontario, New Brunswick, Prince Edward Island, Alberta, British Columbia, Northwest Territories, and Nunavut have smoke-free legislation that applies to the grounds of health facilities. This approach permits public health inspectors and peace officers to enforce the smoke-free grounds rules with the option of issuing fines to individuals or hospital corporations for non-compliance. There is very little existing evidence on the effectiveness of issuing fines as a means of enforcing smoke-free policies.
There can be unique considerations associated with implementing smoke-free policies in inpatient psychiatric facilities or units, given the relationship between mental health and substance use issues and tobacco use. Evidence shows that smoke-free policies are feasible and result in positive health outcomes in psychiatric facilities or units.
Staff may require additional education and training in smoking cessation and tools to support productive conversations with patients, visitors, or colleagues who are not in compliance with smoke-free policies. Examples of tools and communications materials used in other jurisdictions are provided in Appendix 1.
Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelets and an increase in bleeding risk.
This Health Technology Assessment is a narrative review of 15 publications (including 10 randomized controlled trials) found through a systematic literature search. The review addressed the following policy questions: what treatment(s) should be used in adult patients with ITP who have failed first-line treatments, and what is the place in therapy of splenectomy in adult patients with ITP?
Convalescent plasma (CP) therapy is an intervention in which plasma collected from convalescent or recovered patients is used to treat certain infectious diseases. The purpose of this report is to summarize the evidence regarding the clinical effectiveness of CP therapy for the treatment of coronavirus disease (COVID-19).
In Canada, as of July 2021, CP therapy for COVID-19 is available only as an investigational drug treatment.
Nine randomized controlled trials and 28 non-randomized studies were included in this report. The included studies had several methodological limitations, unclear reporting, high heterogeneity, and limited generalizability to Canadian settings; overall, the evidence was of low-to-moderate quality.
There were mixed findings regarding a survival benefit associated with CP therapy compared to standard care or placebo (15 studies found no significant effects and 13 studies found favourable effects on mortality with CP). Given the limitations of the evidence as aforementioned, the potential survival benefit is unclear.
Whether CP was more effective than standard care or placebo for other outcomes (e.g., clinical improvement, disease progression, viral clearance, requirement for supplemental oxygen or other respiratory support such as mechanical ventilation, or duration of hospital stay) was unclear. In some studies, there were no significant differences between CP and standard care alone; in others, CP appeared to be comparatively favourable and, in a few instances, CP was comparatively unfavourable (e.g., 1 study for the outcome duration of hospitalization). However, because of the limited quality of the evidence, the comparative clinical effectiveness remains inconclusive.
CP therapy may be less effective than remdesivir or other active therapies in terms of mortality, requirement for O2 supplementation, and duration of hospitalization, as observed in 2 non-randomized studies of limited quality. Evidence from a non-randomized study of limited quality showed that that CP therapy and tocilizumab were equally effective in improving the clinical status of patients.
The incidence of adverse events was similar between patients treated with CP therapy or standard care alone in the few studies in which adverse events were assessed in patients who received either treatment. Adverse events were reported in 30 studies and were relatively infrequent. The most common adverse events in patients who received CP were fever and allergic reactions. Most of the included studies did not report whether there were adverse events in the control groups (e.g., patients who received standard care, remdesivir, or other medications).
This report includes a list of ongoing clinical trials that could provide additional evidence regarding the clinical effectiveness of CP therapy for COVID-19.
This report was conducted as a living review from May 2020 until July 2021. This is the final version of this report. A list of ongoing clinical trials is provided in Appendix 6. Key information regarding each version of this report can be found in Appendix 7.
Evidence on the clinical utility and cost-effectiveness of point-of-care devices could not be identified.
Two evidence-based guidelines recommend a 2-bag regimen of N-acetylcysteine, consisting of both a loading dose and maintenance dose, administered by IV for patients with acute acetaminophen overdose.
Four systematic reviews (SRs) and 6 retrospective cohort studies provided evidence for the clinical effectiveness of transcatheter mitral valve repair (TMVR) versus open heart conventional surgical mitral valve repair or replacement (SMVR) in patients with primary or secondary mitral regurgitation (MR). No relevant evidence regarding the cost-effectiveness of TMVR versus SMVR in patients with primary or secondary MR was identified; therefore, no summary can be provided.
There was evidence indicating a statistically significant difference in favour of TMVR over SMVR regarding the odds of post-procedure bleeding, need for permanent pacemaker implantation, 30-day readmission, and a shorter duration of hospitalization.
There was evidence suggesting a statistically significant difference in favour of SMVR over TMVR regarding the odds of recurrent MR, the need for reoperation, and mortality rate (i.e., during hospitalization, at 1 year, and > 3 years). Also, compared with TMVR, the likelihood of residual MR grade > 2 or freedom from MR grade ≥ 2 or ≥ 3 at 4 years was statistically significantly lower or higher, respectively, with SMVR.
Evidence regarding the comparative clinical effectiveness of TMVR versus SMVR concerning stroke, acute kidney injury (AKI), cardiogenic shock, and death during hospitalization was conflicting and inconclusive.
There was no evidence of a significant difference between the 2 interventions regarding overall mortality or mortality at 5 years, overall survival, freedom from cardiac death at 4 years, cardiac arrest, acute myocardial infarction (MI), and respiratory or vascular complications.
A major limitation of the evidence was that it derives from studies of low or unknown quality and risk of bias, Furthermore, all the findings are confounded by differences in patient selection, which reflect the approved indications for the interventions but prevent a direct comparison between the TMVR and SMVR groups.
The cost-effectiveness of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement was examined in patients with severe symptomatic aortic stenosis at high, intermediate, and low surgical risk, and the findings were mixed. When compared to surgical aortic valve replacement, some studies suggest that TAVI is cost-effective (less costly and/or more effective) and some studies suggest that TAVI is not cost-effective.
Factors such as the type of TAVI system used, the cost of treatment-associated expenses (such as post-operative follow-up costs and hospitalization costs), and the characteristics of patients selected for treatment likely impact the cost-effectiveness of TAVI for patients with severe symptomatic aortic stenosis.