Tucatinib (Tukysa)

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec. This review assesses tucatinib (Tukysa), 50 mg and 150 mg tablets, orally. Tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and T-DM1 separately or in combination.

Approaches to Evaluations of Virtual Care in Primary Care

A literature search informed this Environmental Scan and identified 11 evaluations of virtual care in primary care health settings and 7 publications alluding to methods, standards, and guidelines (referred to as evaluation guidance documents in this report) being used in various countries to evaluate virtual care in primary care health settings. The majority of included literature was from Australia, the US, and the UK, with 2 evaluation guidance documents published by the Heart and Stroke Foundation of Canada. Evaluation guidance documents recommended using measurements that assess the effectiveness and quality of clinical care including safety outcomes, time and travel, financial and operational impact, participation, health care utilization, technology experience including feasibility, user satisfaction, and barriers and facilitators or measures of health equity. Evaluation guidance documents specified that the following key decisions and considerations should be integrated into the planning of a virtual care evaluation: refining the scope of virtual care services; selecting an appropriate meaningful comparator; and identifying opportune timing and duration for the evaluation to ensure the evaluation is reflective of real-world practice, allows for adequate measurement of outcomes, and is comprehensive, timely, feasible, non-complex, and non–resource-intensive. Evaluation guidance documents highlighted that evaluations should be systematic, performed regularly, and reflect the stage of virtual care implementation to encompass the specific considerations associated with each stage. Additionally, evaluations should assess individual virtual care sessions and the virtual care program as a whole. Regarding economic components of virtual care evaluations, the evaluation guidance documents noted that costs or savings are not limited to monetary or financial measures but can also be represented with time. Cost analyses such as cost-benefit and cost-utility estimates should be performed with a specific emphasis on selecting an appropriate perspective (e.g., patient or provider), as that influences the benefits, effects, and how the outcome is interpreted. Two identified evaluations assessed economic outcomes through cost analyses in the perspective of the patient and provider. Evidence suggests that, in some circumstances, virtual care may be more cost-effective and reduces the cost per episode and patient expenses (e.g., travel and parking costs) compared to in-person care. However, virtual care may increase the number of individuals treated, which would increase overall health care spending. Four identified evaluations assessed health care utilization. The evidence suggests that virtual care reduces the duration of appointments and may be more time-efficient compared to in-person care. However, it is unclear if virtual care reduces the use of medical resources and the need for follow-up appointments, hospital admissions, and emergency department visits compared to in-person care. Five identified evaluations assessed participation outcomes. Evidence was variable, with some evidence reporting that virtual care reduced attendance (e.g., reduced attendance rates) and other evidence noting improved attendance (e.g., increased completion rate and decreased cancellations and no-show rates) compared to in-person care. Three identified evaluations assessed clinical outcomes in various health contexts. Some evidence suggested that virtual care improves clinical outcomes (e.g., in primary care with integrated mental health services, symptom severity decreased) or has a similar effect on clinical outcomes compared to in-person care (e.g., use of virtual care in depression elicited similar results with in-person care). Three identified evaluations assessed the appropriateness of prescribing. Some studies suggested that virtual care improves appropriateness by increasing guideline-based or guideline-concordant antibiotic management, or elicits no difference with in-person care.

Azacitidine (Onureg)

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec. This review assesses azacitidine (Onureg), tablet 300 mg, oral. Indication: Maintenance therapy in adult patients with acute myeloid leukemia who achieved complete remission or complete remission with incomplete blood count recovery following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation.

Galcanezumab (Emgality)

CADTH recommends that Emgality should be reimbursed by public drug plans for the prevention of migraine if certain conditions are met. Emgality should only be covered to prevent migraine attacks in adult patients who have tried at least 2 other types of oral preventive medications. Emgality should only be reimbursed if the patient is being cared for by a physician who has experience managing migraine headaches. Emgality will only be reimbursed for 6 months at a time. Emgality should not be more than the least costly drug of the same class used to prevent migraine.

Macitentan and Tadalafil (Opsynvi)

CADTH recommends that Opsynvi should be reimbursed by public drug plans for the long-term treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to reduce morbidity in patients in WHO functional class (FC) II or III whose PAH is idiopathic, heritable, or associated with connective tissue disease or congenital heart disease if certain conditions are met. Opsynvi should only be covered for patients who are currently treated simultaneously with stable doses of macitentan 10 mg and tadalafil 40 mg as separate tablets. Opsynvi should only be reimbursed if prescribed by a specialist with expertise in managing and treating patients with PAH and if the price of Opsynvi is negotiated to ensure cost savings in comparison with separate macitentan and tadalafil tablets.

Floatation Therapy for Physical Conditions

The clinical effectiveness of floatation therapy for the treatment of physical conditions remains uncertain. One randomized controlled trial was identified that evaluated floatation-restricted environmental stimulation therapy (REST) compared with placebo and waitlist control groups for the treatment of patients with chronic pain. The trial reported no significant differences between the 3 treatment groups on any of the outcomes measured including those related to pain, medication use, quality of life, sleep impairment, anxiety, or depression. One guideline was identified that states that there is insufficient evidence to recommend for or against the use of sensory deprivation tanks in patients with symptoms attributed to mild traumatic brain injury. The cost-effectiveness of floatation therapy for the treatment of physical condition is unknown as no relevant economic evaluations were identified.

Lenalidomide, Bortezomib, and Dexamethasone as Induction Therapy Before Autologous Stem Cell Transplant for Multiple Myeloma

One relevant systematic review and network meta-analysis (which included 1 relevant randomized controlled trial), 4 non-randomized studies, and 6 evidence-based guideline reports, representing 5 evidence-based guidelines were identified in this report. The clinical effectiveness regarding response, relapse, progression-free survival, and overall survival broadly favoured bortezomib-lenalidomide-dexamethasone (RVd) over bortezomib-cyclophosphamide-dexamethasone (CyBorD), although the magnitude and direction of association was not always consistent, and few estimates were statistically significant. Limited evidence on the safety of RVd relative to CyBorD was found. No evidence on the cost-effectiveness of RVd as induction therapy before autologous stem cell transplant for multiple myeloma was found. Among the 5 included guidelines, 3 specifically recommend RVd as a first option for induction therapy among transplant-eligible newly diagnosed multiple myeloma patients, and 2 recommend more broadly defined 3-drug induction regimens that include RVd.

Luspatercept (Reblozyl)

CADTH recommends that Reblozyl should be reimbursed by public drug plans for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, if certain conditions are met. Reblozyl should only be covered to treat patients who have failed or are not suitable for erythropoietin-based therapy. Reblozyl should only be reimbursed if prescribed by a specialist in MDS and if the cost of Reblozyl is reduced. Reimbursement should only be renewed if Reblozyl shows benefit to the patient such that the patient no longer requires RBC transfusions.

Self-Sampling Devices for HPV Testing

This Horizon Scan summarized the available information regarding the use of self-sampling devices for HPV testing as part of cervical cancer screening programs. HPV testing for primary cervical cancer screening is not currently a part of any Canadian screening programs. However, several provinces are in the process of implementation and some pilot testing. Self-sampling is generally as accurate as clinician-collected sampling for HPV testing. Self-sampling devices for HPV testing could likely be used to increase participation in cervical cancer screening programs. Self-sampling for primary HPV screening was highly acceptable to study participants. Culturally appropriate care, appropriate educational materials, and providing people with choice in the screening process may contribute to increased uptake of cervical cancer screening. Health care providers identified self-sampling as an area where they might benefit from increased knowledge and training.

Cost-Effectiveness and Guidelines for Opioid Substitution Treatment

There was evidence indicating that in the treatment of opioid use disorder, injectable hydromorphone, or injectable methadone provided more benefit at less cost compared with injectable diacetylmorphine over a 6-month time horizon. Evidence suggests that in the treatment of opioid use disorder, both injectable hydromorphone and injectable diacetylmorphine are likely to provide more benefit at less cost than methadone maintenance treatment. Treatment with injectable hydromorphone was more cost-effective than injectable diacetylmorphine in opioid use disorder patients who do not respond to or relapse from drug treatments. The evidence is limited because observed data were collected during a short-term follow-up, and long-term cost-effectiveness outcomes were based on extrapolations beyond data from the actual studies. One guideline provided a weak recommendation, supported by low-quality evidence, for using slow-release oral morphine in older adults with adequate renal function in whom buprenorphine and methadone maintenance have been ineffective to treat opioid use disorder or could not be tolerated. Another guideline recommends using injectable hydromorphone or injectable diacetylmorphine for individuals with severe opioid use disorders who relapsed previous treatments failed. No relevant cost-effectiveness evidence or guidelines with recommendations regarding the use of oral hydromorphone, fentanyl patches, or fentanyl buccal tablets for opioid use disorder treatment were identified; therefore, no summary can be provided.