Drugs, Health Technologies, Health Systems
Indication: For the treatment of cardiomyopathy in adult patients with wild-type or hereditary transthyretin-mediated amyloidosis (wtATTR or hATTR amyloidosis)
Sponsor: Alnylam Canada ULC
Recommendation: Reimburse with conditions
Summary
What Is the Reimbursement Recommendation for Amvuttra?
Canada’s Drug Agency (CDA-AMC) recommends that Amvuttra be reimbursed by public drug plans for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adult patients if certain conditions are met.
Why Did CDA-AMC Recommend Reimbursement?
The Canadian Drug Expert Committee (CDEC) determined that Amvuttra demonstrates acceptable clinical value versus placebo in adult patients with ATTR-CM. Evidence from a clinical trial showed that Amvuttra reduced the cumulative incidence rate of all-cause mortality and recurrent cardiovascular (CV) events over a follow-up period of up to 36 months compared to placebo. Indirect comparisons suggest that Amvuttra may lead to fewer deaths, fewer repeat CV events, and better functional exercise capacity than tafamidis. However, the available indirect evidence does not show that Amvuttra is more effective than tafamidis.
ATTR-CM is a rare disease that leads to heart failure and early death. Tafamidis is currently the only approved treatment in Canada, but coverage is limited and some patients do not benefit from it. Amvuttra could be useful for patients with mixed heart and nerve involvement or those who cannot tolerate or whose disease does not respond to tafamidis, offering an additional disease-modifying treatment option. CDEC concluded Amvuttra addresses a significant unmet clinical need with an acceptable level of certainty in clinical value.
Which Patients Are Eligible for Coverage?
Amvuttra should only be covered for adults with confirmed diagnoses of ATTR-CM (wild-type or hereditary). Amvuttra should only be covered for patients who have mild to moderate heart failure symptoms (i.e., New York Heart Association [NYHA] classes I to III), and a history of heart failure that required treatment or hospitalization. Amvuttra should not be covered for patients who have had a heart or liver transplant, use a mechanical heart support device, or are already receiving other disease-modifying treatment for ATTR-CM (e.g., tafamidis).
What Are the Conditions for Reimbursement?
Amvuttra should only be reimbursed if it is prescribed by a specialist experienced in diagnosing and managing ATTR-CM and if the cost of Amvuttra does not exceed that of tafamidis. Amvuttra should be discontinued in patients whose disease progresses to NYHA class IV heart failure, who undergo a heart or liver transplant, or who receive an implanted cardiac mechanical assist device.
Important budget impact considerations must be addressed for health systems to be able to adopt Amvuttra.
Disease background: ATTR-CM is a rare, progressive disease in which misfolded transthyretin protein accumulates in the heart, leading to heart failure, substantial physical impairment, and increased mortality. In Canada, the estimated prevalence of ATTR-CM was about 33 per 100,000 people in 2020.
Indication and reimbursement request: Vutrisiran (Amvuttra) has been approved by Health Canada (Notice of Compliance: December 12, 2025) for the treatment of cardiomyopathy in adult patients with wild-type or hereditary transthyretin-mediated amyloidosis. The sponsor is seeking reimbursement for this patient population.
Drug under review: Vutrisiran is a transthyretin-directed small interfering ribonucleic acid therapeutic. It is available as a single-dose prefilled syringe (25 mg per 0.5 mL) for subcutaneous injection, and the dosage recommended in the product monograph is 25 mg administered once every 3 months by subcutaneous injection.
Treatment costs: At the submitted price of $143,041.00 per prefilled syringe, the annual cost of vutrisiran is expected to be $572,164 per patient, based on the Health Canada–recommended dosage.
The patient group (Transthyretin Amyloidosis Canada) noted the following effects of the disease, unmet needs, and important outcomes:
Patients experience light-headedness, fatigue, difficulty sleeping, and challenges with eating, as well as instability when walking or climbing stairs, often leading to falls. These symptoms substantially affect daily life, relationships, financial stability, and overall well-being.
Patients want to improve their quality of life and ability to manage daily activities.
Patients value maintaining independence and being able to participate in meaningful activities such as work, travel, and social connections.
No clinician group input was submitted to CDA-AMC for this review.
The participating public drug programs raised potential implementation issues related to considerations for relevant comparators, initiation, discontinuation, prescribing of therapy, care provision issues, and system and economic issues.
With a vote of 13 in favour to 0 against, CDEC recommends that vutrisiran be reimbursed for the treatment of cardiomyopathy in adult patients with ATTR-CM only if the conditions listed in Table 1 are met.
Table 1: Reimbursement Conditions and Reasons
Reimbursement condition | Reason | Implementation guidance |
|---|---|---|
Initiation | ||
1. Treatment with vutrisiran should be reimbursed in adult patients with documented cardiac disease due to ATTR-CM (hATTR-CM or wtATTR‑CM). 1.1. Documented wtATTR‑CM consists of all the following: 1.1.1. absence of a variant TTR genotype 1.1.2. evidence of cardiac involvement by echocardiography with end diastolic interventricular septal wall thickness greater than 12 mm 1.1.3. positive findings on 99mTc PYP scintigraphy with SPECT scanning or presence of amyloid deposits in biopsy tissue (fat aspirate, salivary gland, median nerve connective tissue sheath, or cardiac) 1.1.4. TTR precursor protein identification by immunohistochemistry, scintigraphy, or mass spectrometry. 1.2. Documented hATTR‑CM consists of all the following: 1.2.1. presence of a variant TTR genotype associated with cardiomyopathy and presenting with a cardiomyopathy phenotype 1.2.2. evidence of cardiac involvement by echocardiography with end diastolic interventricular septal wall thickness greater than 12 mm 1.2.3. positive findings on 99mTc PYP scintigraphy with SPECT scanning or presence of amyloid deposits in biopsy tissue (fat aspirate, salivary gland, median nerve connective tissue sheath, or cardiac). 2. Treatment with vutrisiran should be reimbursed in adult patients who have all the following characteristics: 2.1. heart failure symptoms categorized as NYHA class I to III 2.2. a history of heart failure, defined as at least 1 prior hospitalization for heart failure or clinical evidence of heart failure that has required treatment with a diuretic 2.3. no history of heart or liver transplant 2.4. no current use of an implanted cardiac mechanical assist device 2.5. no current use of other disease-modifying treatments for transthyretin amyloidosis (e.g., tafamidis). | In the HELIOS-B trial, vutrisiran demonstrated clinically meaningful benefits in adults with ATTR-CM, resulting in a clinically meaningful reduction in the cumulative incidence rate of all-cause mortality and recurrent CV events over a follow-up period of up to 36 months compared with placebo. Compared with placebo, vutrisiran results in a clinically important reduction in all-cause mortality and likely less decline in functional status as determined by stabilization of NYHA classification. Patients’ HRQoL likely declined less with vutrisiran compared to placebo. | The clinical experts stated that although genotyping is not strictly required for the treatment of ATTR-CM, it is strongly recommended due to its importance in guiding other key clinical decisions. Vutrisiran could be initiated similarly to tafamidis as per the reimbursement criteria for each public drug plan. With respect to the criterion of end diastolic interventricular septal wall thickness (> 12 mm irrespective of sex), the clinical experts noted to CDEC that females tend to have thinner septal wall thickness than males and may take longer to reach a > 12 mm threshold. Therefore, a sex-specific septal wall thickness threshold (≥ 11 mm for females) may better align with clinical practice while ensuring appropriate patient selection. |
Discontinuation | ||
3. Treatment with vutrisiran should be discontinued for patients who: 3.1. experience disease progression to NYHA class IV 3.2. receive a heart or liver transplant 3.3. receive an implanted cardiac mechanical assist device. | There is no evidence that vutrisiran should be held to a different standard than tafamidis when considering discontinuation. | Vutrisiran could be discontinued similarly to tafamidis as per the reimbursement criteria for each public drug plan. |
Prescribing | ||
4. The patient must be under the care of a specialist with expertise in the diagnosis and management of ATTR-CM. | This is meant to ensure that vutrisiran is prescribed for appropriate patients and that adverse effects are managed in an optimized and timely manner. | — |
Pricing | ||
5. The total treatment cost of vutrisiran should be negotiated so it does not exceed the total treatment cost of tafamidis for the same indication. | Based on CDEC’s assessment of the evidence, the efficacy of vutrisiran may be comparable to that of tafamidis. Therefore, the total treatment cost of vutrisiran should be no more than that of tafamidis. | — |
Feasibility of adoption | ||
6. The economic feasibility of adoption of vutrisiran must be addressed. | At the submitted price, the incremental budget impact of vutrisiran is expected to be greater than $40 million annually in each of the 3 years. Additionally, at the submitted price, the magnitude of uncertainty in the budget impact must be addressed to ensure the feasibility of adoption, given the difference between the sponsor’s estimate and the CDA-AMC estimates. | — |
ATTR-CM = transthyretin amyloid cardiomyopathy; CDEC = Canadian Drug Expert Committee; CV = cardiovascular; hATTR-CM = hereditary transthyretin amyloid cardiomyopathy; HRQoL = health-related quality of life; NYHA = New York Heart Association; PYP = pyrophosphate; SPECT = single-photon emission CT; wtATTR-CM = wild-type transthyretin amyloid cardiomyopathy.
Evidence from 1 phase III, double-blind, randomized, placebo-controlled trial (HELIOS-B, N = 654) suggests that in adults with ATTR-CM, vutrisiran results in a lower cumulative incidence rate of all-cause mortality and recurrent CV events compared with placebo over a follow-up period of up to 36 months. Additionally, vutrisiran resulted in a statistically significant reduction in all-cause mortality compared with placebo; the certainty of evidence was rated as high using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Vutrisiran was also likely to result in less of a decline in functional status, as determined by stabilization of NYHA classification of heart failure symptoms, compared to placebo.
Patients’ health-related quality of life (HRQoL) likely declined less with vutrisiran compared to placebo. However, due to the lack of longer-term data, it is uncertain if the observed beneficial effects would persist. Compared with placebo, there is moderate-certainty evidence that vutrisiran likely results in a clinically important reduction in the proportion of patients who experience at least 1 serious adverse event.
Overall, no new safety signals were identified in the HELIOS-B trial, and the observed safety profile of vutrisiran is as expected based on the product monograph and input from clinical experts. In the absence of head-to-head studies comparing vutrisiran and tafamidis (the current standard of care for ATTR-CM), a sponsor-provided indirect treatment comparison (ITC) was submitted that suggested vutrisiran improves all-cause mortality, recurrent CV events, and NYHA class stabilization compared with tafamidis. However, the results were uncertain due to methodological limitations, potential residual confounding despite statistical adjustment, and imprecise effect estimates. The ITC does not support that vutrisiran has superior efficacy compared to tafamidis. The ITC did not evaluate their comparative effects on HRQoL or harms.
Based on its assessment of the clinical evidence from the HELIOS-B trial and the ITC, CDEC concluded that vutrisiran demonstrates uncertain clinical value compared with appropriate comparators (tafamidis) in adult patients with ATTR‑CM.
Additional information on the committee’s discussion around clinical value is provided in the Summary of Deliberation section.
ATTR-CM is a rare disease that causes the TTR protein to misfold and build up in the heart. This leads to heart failure, poor physical health, and early death. Tafamidis (a once-daily oral tablet) is the only approved disease-modifying therapy for ATTR-CM in Canada. It has restricted coverage in almost all provinces and territories (except in Yukon, where it is not a benefit). There are limited therapies that improve symptoms or reverse disease progression. Some patients’ disease does not respond to tafamidis. The clinical experts consulted by CDA-AMC considered vutrisiran to be a first-line treatment option for those with a mixed phenotype of cardiomyopathy and polyneuropathy, those whose disease does not respond to tafamidis, or those who cannot tolerate tafamidis. Vutrisiran is a second disease-modifying treatment option alongside tafamidis with the potential to help manage symptoms for patients whose disease does not respond to tafamidis or for those who have limitations with oral therapy.
CDEC concluded vutrisiran addresses a significant unmet clinical need with an acceptable level of certainty in clinical value.
Further information on the committee’s discussion around unmet clinical need is provided in the Summary of Deliberation section.
Due to the uncertainty in clinical value, CDEC could not recommend whether to reimburse vutrisiran or not based on clinical value alone. Therefore, the committee also considered whether vutrisiran addresses a significant unmet clinical need. CDEC concluded that vutrisiran addresses a significant unmet clinical need with an acceptable level of certainty. Based on the preceding considerations, CDEC recommended that vutrisiran be reimbursed. As part of the deliberation on whether to recommend reimbursement, the committee also considered unmet nonclinical need and health inequity. Information on this discussion is provided in the Distinct Social and Ethical Considerations domain in the Summary of Deliberation section.
Because CDEC recommended that vutrisiran be reimbursed, the committee also deliberated on whether reimbursement conditions should be added to address important economic considerations, health system impacts, or social and ethical considerations, or to ensure clinical value is realized. The resulting reimbursement conditions, with accompanying reasons and implementation guidance, are stated in Table 1.
CDEC considered all domains of value of the deliberative framework before developing its recommendation: clinical value, unmet clinical need, distinct social and ethical considerations, economic considerations, and impacts on health systems. For further information on the domains of value, refer to Expert Committee Deliberation at Canada’s Drug Agency.
The committee considered the following key discussion points, organized by the 5 domains of value.
Appropriate comparators: Tafamidis is the only approved disease-modifying therapy for ATTR-CM and was considered the most appropriate comparator for the drug under review, as it represents the current standard of care and the most relevant treatment option for ATTR-CM.
Efficacy versus placebo: One phase III, double-blind, randomized, placebo-controlled trial (HELIOS-B) suggested that in adults with ATTR-CM, vutrisiran results in a reduction in the cumulative incidence rate of all-cause mortality and recurrent CV events over a follow-up period of up to 36 months compared with placebo (hazard ratio = 0.72; 95% confidence interval [CI], 0.56 to 0.93). Additionally, compared with placebo, vutrisiran results in a reduction in all-cause mortality with a between-group difference of ███ ████ ██ ██████ The estimated percentage of patients whose disease remained stable or whose NYHA classification improved at 30 months was 68% in the vutrisiran group and 61% in the placebo group (difference between the groups = 8.7%; 95% CI, 1.3% to 16.1%). Patients’ HRQoL likely declined less with vutrisiran compared to placebo. However, due to the lack of longer-term data, it is uncertain if the observed beneficial effects would persist. No notable safety concerns were identified with vutrisiran during the study period.
Clinical importance of treatment effects: Patient input indicated that individuals with ATTR-CM value treatments that improve quality of life and decrease hospitalizations. Patient input also emphasized the importance of maintaining autonomy and the ability to participate in meaningful activities and social engagement. The clinical experts indicated that any difference between groups could be considered clinically meaningful for the cumulative incidence rate of all-cause mortality and CV events, as well as for the cumulative incidence proportion of all-cause mortality, given that no established between-group minimal important difference (MID) exists for these outcomes. For HRQoL measured by Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) scores, the clinical experts considered the MID of 5 points identified in the literature to be reasonable and appropriate for comparing vutrisiran with placebo. Using this MID, compared with placebo, vutrisiran had clinically meaningful benefits in reducing the cumulative incidence rate of all-cause mortality and recurrent CV events and in reducing all-cause mortality. Additionally, compared with placebo, vutrisiran demonstrated benefit in stabilizing NYHA classification and maintaining HRQoL. CDEC concluded that the availability of an additional treatment option for ATTR-CM is important to patients.
Certainty of the evidence: The assessment of all-cause mortality and CV events over a follow-up period of up to 36 months, all-cause mortality alone at 42 months, and NYHA classification at 30 months was rated as high certainty (compared to placebo) using the GRADE approach. The assessment of Kansas City Cardiomyopathy Questionnaire–Overall Summary scores and serious adverse events was rated as moderate certainty due to a serious risk of imprecision.
Efficacy versus tafamidis: In the absence of head-to-head evidence comparing vutrisiran and tafamidis, the sponsor submitted an ITC using individual patient data from HELIOS-B to estimate relative efficacy. The committee noted that while appropriate statistical methods were applied (e.g., inverse probability of treatment weighting and adjustment for key prognostic factors), methodological limitations — including differences in model selection, violations of assumptions (e.g., proportional hazards), omission of time-dependent variables, residual imbalances postweighting, and imputation assumptions for NYHA classification — introduced uncertainty. Point estimates favoured vutrisiran for all-cause mortality, recurrent CV events, and NYHA class stabilization, but wide CIs crossing the null indicated critical imprecision. The ITC did not assess HRQoL or harms and, overall, the evidence does not support a claim of superiority; certainty regarding comparative efficacy remains low.
Place in therapy: CDEC discussed that vutrisiran offers a second disease-modifying treatment option alongside tafamidis and that this may represent a shift in the treatment paradigm for ATTR‑CM, as noted by the clinical experts. While both therapies target the underlying disease process, the committee discussed that combination use is unlikely due to cost and limited supporting evidence. Vutrisiran is anticipated to be considered as the preferred treatment option for patients with a mixed phenotype of cardiomyopathy and polyneuropathy, those who do not tolerate tafamidis, or those experiencing rapid disease progression. It may also serve as a second-line option for patients seeking a more convenient administration schedule or for those who have limitations with oral therapy. However, the choice between tafamidis and vutrisiran remains unclear and may depend on patient characteristics and resource considerations.
Combination use: CDEC discussed combination use of vutrisiran and tafamidis, as was the case in the HELIOS-B trial. The clinical experts indicated that they expect vutrisiran to be used as monotherapy due to its upstream mechanism of action, which likely limits any added benefit from tafamidis. CDEC noted that evidence comparing monotherapy versus combination therapy is lacking, and results of subgroup analysis for the monotherapy treatment group were unclear. CDEC also noted that if combination use were to occur, the budget impact would be substantially higher.
Clinical value: Based on all the preceding considerations, the committee determined there was uncertain clinical value versus appropriate comparators (tafamidis).
Input on unmet clinical need: Based on patient and clinician input, CDEC noted several unmet needs in the management of ATTR-CM. Patients identified substantial logistical barriers to accessing care, including the burden of frequent medical appointments, treatment infusions, and long travel distances, particularly for those in rural areas. They also expressed concerns about the high cost of therapies, which can be especially challenging for individuals who are unable to maintain employment. They reported that these factors, combined with the disease itself, limit autonomy and interfere with daily activities such as work, travel, and social engagement. Clinical experts highlighted the lack of therapies that improve symptoms or reverse disease progression, noting persistent challenges in managing fatigue, shortness of breath, and volume overload, particularly in patients whose disease does not respond to tafamidis or those who have advanced kidney disease. Experts also cited inconsistent access to care, delayed diagnoses in rural areas (especially among women), and restrictive funding criteria that may prevent early intervention. Geographic disparities in specialist availability were also a concern. These issues underscore the need for additional effective and accessible treatment options.
Severity of the disease: CDEC acknowledged that ATTR-CM is a rare, progressive, and life-threatening condition that leads to heart failure, physical impairment, reduced quality of life, and premature death. Clinical expert input indicated that, despite the availability of tafamidis, challenges remain in managing symptoms such as fatigue, shortness of breath, and volume overload, particularly for patients whose disease does not respond optimally or those who have advanced kidney disease. These factors highlight the need for additional effective and accessible treatment options.
Availability of treatment options: CDEC noted that tafamidis is currently the only approved disease-modifying therapy for ATTR-CM in Canada. Clinical experts highlighted that gene silencer therapies such as patisiran, eplontersen, and vutrisiran are available for transthyretin amyloidosis but are only approved for hereditary transthyretin amyloid polyneuropathy at present. In addition to tafamidis, symptom-targeted therapies — including diuretics, rhythm control drugs, and sodium-glucose cotransporter-2 inhibitors — are used to manage cardiac complications, but these do not address the underlying disease process. Based on clinical expert input, this reflects an important treatment gap: the need for additional effective disease-modifying options for patients with ATTR-CM.
Significant unmet clinical need: Based on these considerations, the committee determined that there is a significant unmet clinical need for vutrisiran as an additional disease-modifying treatment option for patients whose disease does not respond to tafamidis, who cannot tolerate tafamidis, or who currently have no other available treatment options.
Disparities in diagnosis and treatment availability: Patients face delayed diagnoses and limited access to specialist care, especially in rural areas and among women. Funding criteria and high treatment costs further restrict equitable access.
Access and administration: Vutrisiran is administered via subcutaneous injection every 3 months, whereas tafamidis is a capsule taken orally once daily. Patients must visit their health care provider to receive vutrisiran injections, which may be inconvenient for some patients; however, the patient group did not consider 1 visit every 3 months a substantial burden if patients have a good response to vutrisiran. Some patients may prefer the less frequent treatment (every 3 months) with vutrisiran compared to daily oral treatment.
Health impacts of vutrisiran versus relevant comparators: Due to methodological limitations, potential residual confounding despite statistical adjustment, and imprecise effect estimates, the sponsor-submitted ITC does not support that vutrisiran has superior efficacy to tafamidis. Furthermore, no conclusion can be drawn regarding the safety of vutrisiran relative to tafamidis, as safety outcomes were not assessed in the sponsor-submitted ITC.
Cost of vutrisiran versus tafamidis: If there are no differences in health outcomes between vutrisiran and tafamidis, then the impact of vutrisiran on costs will be most dependent on the drug acquisition costs. The cost of vutrisiran versus tafamidis will also be affected by administration costs if they are paid for by the health system.
Key findings of the economic evaluation: The cost-effectiveness of vutrisiran compared to tafamidis is uncertain. Based on the CDA-AMC clinical review of the sponsor-submitted ITC comparing vutrisiran monotherapy and tafamidis monotherapy, there is no robust evidence to suggest that vutrisiran provides greater health benefit than tafamidis. If there are no differences in health outcomes between vutrisiran and tafamidis, then the total cost of vutrisiran to the health system should not exceed that of tafamidis for the treatment of ATTR-CM.
Certainty of the evidence: The ITC used to compare vutrisiran with tafamidis did not demonstrate significant differences in efficacy outcomes between the treatments. Additionally, the lack of long-term data and treatment effect postdiscontinuation introduced additional uncertainty in the economic evidence.
Other considerations: The HELIOS-B trial permitted the inclusion of patients receiving both vutrisiran and tafamidis; however, the economic evidence did not evaluate the cost-effectiveness or budget impact of combined therapy. Additionally, CDEC noted that data exclusivity for Vyndamax (tafamidis) will expire in 2028 and that reimbursement of potential future generic versions would affect the price of tafamidis. The potential impact of such a price change was not assessed in the economic review.
Anticipated budget impact: CDA-AMC estimated that by year 3 of reimbursement, 2,319 patients would be eligible for treatment with vutrisiran; of these, 931 would be expected to receive vutrisiran. The estimated incremental budget impact of reimbursing vutrisiran is predicted to be approximately $779 million over the first 3 years, with an expected expenditure of $1.2 billion on vutrisiran. The economic feasibility of adoption of vutrisiran must be addressed. First, the incremental budget impact of vutrisiran is expected to be greater than $40 million annually in each of the 3 years. Second, the magnitude of uncertainty in the budget impact must be addressed to ensure the feasibility of adoption, given the difference between the sponsor’s estimate and the CDA-AMC estimates.
To make its recommendation, the committee considered the following information (links to the full documents for the review can be found on the project web page):
the CDA-AMC review of the clinical and pharmacoeconomic evidence submitted by the sponsor, as well as relevant ethical issues related to vutrisiran (refer to the Main Report and Supplemental Material documents)
the sponsor’s comments on the draft report and the CDA-AMC responses
patients' perspectives gathered by 1 patient group, Transthyretin Amyloidosis Canada (refer to the Patient and Clinician Group Input document)
no clinician group input was submitted to CDA-AMC for this review
input from public drug programs that participate in the reimbursement review process (refer to the Supplemental Material document)
input from 3 clinical experts with expertise in the management of transthyretin amyloidosis consulted by CDA-AMC.
Dr. Peter Jamieson (Chair), Dr. Kerry Mansell (Vice-Chair), Sally Bean, Daryl Bell, Dan Dunsky, Dr. Ran Goldman, Dr. Trudy Huyghebaert, Dr. Dennis Ko, Dr. Christine Leong, Dr. Alicia McCallum, Dr. Srinivas Murthy, Dr. Nicholas Myers, Dr. Krishnan Ramanathan, Dr. Marco Solmi, Carla Velastegui, Dr. Edward Xie, and Dr. Peter Zed.
Meeting date: November 26, 2025
Regrets: Three expert committee members did not attend.
Conflicts of interest: None
ISSN: 2563-6596
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