Canadian Journal of Health Technologies

Trastuzumab Deruxtecan (Enhertu)

CDA-AMC — 2026-04-21

Canada’s Drug Agency (CDA-AMC) recommends that Enhertu be reimbursed by public drug plans for second-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2–based regimen, if certain conditions are met.
CDA-AMC previously reviewed Enhertu for the second-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2–based regimen and issued a recommendation of time-limited reimbursement. This is a reassessment based on additional evidence to address the uncertainties in the original data. This recommendation supersedes the previous recommendation for this drug and indication dated April 23, 2025.
The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) recommended that Enhertu continue to be reimbursed by the participating drug programs in accordance with the initiation, discontinuation, and prescribing criteria that were previously recommended. The sponsor has satisfied the reassessment requirements, and the time-limited condition has been removed from the recommendation.
Evidence from a clinical trial showed that Enhertu likely results in added clinical benefit in overall survival (OS) and may delay disease progression, compared with ramucirumab plus paclitaxel, in patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2–based regimen. Evidence from an indirect treatment comparison suggested that Enhertu may offer survival and disease control benefits compared to leucovorin (folinic acid), fluorouracil, and irinotecan (FOLFIRI), paclitaxel, irinotecan, and docetaxel. However, the clinical value was uncertain due to the methodological limitations of the indirect comparisons.
Enhertu meets some patient needs, given that it is an alternative treatment option that may offer benefits in disease control and life prolongation.
Enhertu should only be covered to treat adult patients with unresectable locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have previously received anti-HER2–based treatment for locally advanced or metastatic disease, are in relatively good health, and do not have symptomatic spinal cord compression, clinically active central nervous system metastases, or current interstitial lung disease (ILD) or pneumonitis.
Enhertu should only be reimbursed if it is prescribed by clinicians with experience and expertise in treating gastric or GEJ adenocarcinoma and if the cost of Enhertu is reduced.

Olaparib

CDA-AMC — 2026-04-21

The Formulary Management Expert Committee (FMEC) recommends that olaparib be reimbursed for the maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutated pancreatic adenocarcinoma whose disease has not progressed on prior systemic therapy, provided certain conditions are met.
Olaparib may be reimbursed for the maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutated pancreatic adenocarcinoma whose disease has not progressed on prior systemic therapy, provided the following conditions are met: no progression after at least 16 weeks of first-line systemic chemotherapy and good performance status. Olaparib should be discontinued if there is disease progression or unacceptable toxicities. Olaparib should be priced no higher than the least costly therapy available for this population.
FMEC reviewed 1 trial of olaparib versus placebo and a cost comparison of olaparib versus other treatments used in Canada. Overall, the evidence demonstrates that, compared to placebo, olaparib maintenance therapy provides a clinically meaningful improvement in progression-free survival (PFS), does not contribute to a decline in health-related quality of life (HRQoL), and has a tolerable safety profile.
FMEC concluded that there is a significant unmet need in BRCA-mutated pancreatic adenocarcinoma, given the rarity of BRCA mutations and poor prognosis of this condition. FMEC also concluded that it is uncertain whether olaparib demonstrates acceptable clinical value versus appropriate comparators; however, olaparib would potentially address significant nonclinical needs (e.g., treatment burden, travel requirements, out-of-pocket costs, access inequities). FMEC noted that economic considerations are important to address when implementing olaparib.

Blinatumomab

CDA-AMC — 2026-04-13

The Formulary Management Expert Committee (FMEC) recommends that blinatumomab in combination with a tyrosine kinase inhibitor (TKI) not be reimbursed for the first-line treatment of adult and pediatric patients with Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL).
FMEC reviewed 3 single-arm, open-label phase II trials (GIMEMA LAL2116 D-ALBA, SWOG-1318, and MDACC) in adult patients with Ph-positive ALL, as well as a cost comparison of blinatumomab versus other treatments used in Canada. There was no direct or indirect clinical evidence available that compared blinatumomab with a relevant comparator (e.g., standard of care chemotherapy) as first-line treatment for adult patients with Ph-positive ALL and no evidence that met the inclusion criteria for the pediatric population.
Patients and clinicians identified a need for first-line treatments that prolong disease remission and survival, reduce toxicities, and maintain health-related quality of life (HRQoL). FMEC agreed that the use of blinatumomab in combination with a TKI may potentially avoid the use of high-dose chemotherapy with or without an allogeneic stem cell transplant (allo-SCT), which are highly toxic. However, based on the available evidence, FMEC concluded that there was significant uncertainty in the clinical value demonstrated by blinatumomab in combination with a TKI due to the limitations of the available evidence (e.g., lack of formal hypothesis testing, small sample size, missing information, and indirectness of the population). The committee recognized that patients want longer survival, less toxicity, and improved HRQoL. However, without direct evidence, FMEC concluded it is uncertain whether blinatumomab in combination with a TKI addresses these significant unmet clinical and nonclinical needs.

Coverage With Evidence Development: An Environmental Scan of Funding Programs Leveraging Real-World Evidence to Support Funding Decisions

Caroline Muñoz — 2026-04-02

Coverage with evidence development (CED) programs provide early access to promising therapies while additional evidence is generated to support a final funding decision. This Environmental Scan sought to identify CED programs globally, specifically where real-world evidence (RWE) is generated to support decision-making. This Environmental Scan reports how 13 jurisdictions (2 Canadian, 11 international) have used CED to support interim patient access to new drugs while gathering data to resolve uncertainties.
There is variation in how CED is applied between jurisdictions and limited transparency into CED agreement details, financial agreements applied with CED, and the impact of RWE on final funding decisions.
Real-world data collected from prospective observational studies, disease or drug registries, and administrative health databases are used to generate RWE during interim funding. Jurisdictions apply performance-based or outcomes-based agreements and/or financial agreements as part of CED agreements to support risk-sharing between payers and drug manufacturers.
CED agreements come with limitations, including the following: outcomes of analysis may not support final funding decision-making, entry and exit criteria may not be established, project timelines may not be clear, agreements may lack transparency, and data collection and evidence generation to address uncertainties may not be feasible in practice.
CED provides an opportunity for RWE to address evidence gaps while facilitating patient access to new cancer drugs. Lessons learned from other jurisdictions may support careful design of a Canadian CED model.
CED programs should include defined roles and responsibilities for system partners, drug and indication eligibility criteria, exit plans, deliverables to support final funding decisions, reporting intervals, and timelines. RWE generation plans should include defined research questions, objectives, data collection plans, and end points. Details of CED programs should be made publicly available to ensure transparency and accountability, and to reduce duplication of efforts across jurisdictions.

Durvalumab (Imfinzi)

CDA-AMC — 2026-04-21

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 nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses Durvalumab (Imfinzi), 50 mg/mL, concentrate for IV infusion.
Indication: For the treatment of patients with resectable muscle invasive bladder cancer (MIBC)a in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by adjuvant Imfinzi monotherapy treatment after radical cystectomy.

Olezarsen (Tryngolza)

CDA-AMC — 2026-04-20

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 nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses Olezarsen (Tryngolza), 80 mg per 0.8 mL solution in a single-dose autoinjector for subcutaneous use.
Indication: As an adjunct to diet in adult patients for the treatment of FCS.

Lemborexant (Dayvigo)

CDA-AMC — 2026-04-16

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 nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses lemborexant (Dayvigo), 5 mg film-coated tablet and 10 mg film-coated tablet, oral.
Indication: The treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Toripalimab (Loqtorzi)

CDA-AMC — 2026-04-16

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 nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses toripalimab (Loqtorzi), 240 mg/6 mL (40 mg/mL) solution for IV infusion.
Indication: as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

Acalabrutinib (Calquence)

CDA-AMC — 2026-04-15

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 nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses acalabrutinib (Calquence), 100 mg tablets, oral.
Indication: in combination with venetoclax for the treatment of patients with previously untreated CLL.

Atezolizumab (Tecentriq)

CDA-AMC — 2026-04-07

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 nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses Tecentriq (atezolizumab)
- 1200 mg/20 mL and 840 mg/14 mL single use vials, Concentrate for solution for infusion
- 1875 mg/15 mL single use vial sterile solution for subcutaneous injection.
Indication: As monotherapy for the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of TCs or PD-L1 stained tumour-infiltrating immune cells [ICs] covering ≥ 10% of the tumour area), as determined by a validated test and who do not have EGFR or ALK genomic tumour aberrations.

Fecal Microbiota (Rebyota)

CDA-AMC — 2026-04-02

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 nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses fecal microbiota (Rebyota), 150 mL, rectal suspension.
Indication: For the prevention of recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI.
Fecal microbiota (Rebyota) is not indicated for the treatment of CDI.

Asciminib (Scemblix)

CDA-AMC — 2026-04-01

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 nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses asciminib (Scemblix), 20 mg and 40 mg, film-coated tablets, oral.
Indication: For the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who are newly diagnosed or who have previously received 1 or more tyrosine kinase inhibitors.

Osimertinib (Tagrisso)

CDA-AMC — 2026-04-01

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 nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses osimertinib (Tagrisso), 40 mg and 80 mg daily, oral tablets.
Indication: For the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum-based chemoradiation therapy.
Osimertinib has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. The condition for authorization includes submission of the final Clinical Study Report of the LAURA trial.

Inavolisib (Itovebi)

CDA-AMC — 2026-04-01

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 nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses inavolisib (Itovebi), 3 mg and 9 mg, film-coated oral tablet.
Indication: Inavolisib in combination with palbociclib and fulvestrant is indicated for the treatment of adult patients with endocrine-resistant, PIK3CA‑mutated, hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine treatment.