Pharmacoeconomic review report: Tafamidis (Vyndaqel) (Pfizer Canada ULC) indication: for the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis, wild-type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalization
Mortality for patients in the "alive with transplant" health state was informed by survival data calculated from the International Society for Heart and Lung Transplantation registry
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| Format: | eBook |
| Language: | English |
| Published: |
Ottawa (ON)
CADTH
2020, April 2020
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| Edition: | Final |
| Series: | CADTH common drug review
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | Mortality for patients in the "alive with transplant" health state was informed by survival data calculated from the International Society for Heart and Lung Transplantation registry The analysis was conducted from the perspective of the Canadian publicly funded health care payer over a lifetime horizon (30 years) using one-month cycles. Future costs and benefits were discounted at a rate of 1.5% per year. A multi-state cohort Markov model was developed with three main health states: "alive without transplant," "alive with transplant," and "death." Within the "alive without transplant" health states, patients were further subdivided into the four New York Heart Association (NYHA) classes to reflect cardiac disease progression. Every six months during the first 30 months of treatment, and monthly thereafter, patients could transition to any NYHA class. Clinical efficacy was based on the ATTR-ACT trial. At any point, patients in the "alive without transplant" health states could receive a heart transplant (i.e., enter the "alive with transplant" health state). This health state consisted of two tunnel health states: a "one-month post-transplant" state, and a "greater than or equal to two months post-transplant" state. The probability of transitioning to the "alive with transplant" health states were dependent on both current NYHA class and treatment arm, informed by data from the ATTR-ACT trial. Mortality for patients in the "alive without transplant" health states were estimated separately by baseline NYHA class (i.e., NYHA class I/II and NYHA class III subgroups) and by treatment arm, based on the extrapolated all-cause overall survival observed in the ATTR-ACT trial. Gompertz curves were applied for the BSC arm in patients with baseline NYHA class I/II or NYHA class III, while gamma curves were applied for the tafamidis meglumine arm in baseline NYHA class I/II and NYHA class III patients. Tafamidis meglumine (Vyndaqel) is indicated for the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis, wild-type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalizations. Tafamidis meglumine is available as a 20 mg capsule with a recommended dose of 80 mg daily. At the sponsor's submitted price of $133.57 per capsule, the daily and annual drug cost is $534.28 and $195,012, respectively, per patient. The sponsor submitted a cost-utility analysis (CUA) comparing tafamidis meglumine with best supportive care (BSC) in the treatment of adults with both wild-type or hereditary transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM). BSC was informed by the placebo arm of the ATTR-ACT trial, which permitted patients to continue taking medications considered to be standard of care, such as diuretics. |
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| Physical Description: | 1 PDF file (33 pages) illustrations |