PCSK9 inhibitors not cost-effective at current prices
medwireNews: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are not currently cost effective for the prevention of cardiovascular events in patients with familial hypercholesterolemia (FH) or atherosclerotic cardiovascular disease (ASCVD), US research shows.
Indeed, achieving the commonly accepted cost-effectiveness threshold of less than US$ 100,000 (€ 88,719) per quality-adjusted life–year (QALY) would require price reductions of nearly 70%, report Kirsten Bibbins-Domingo (University of California, San Francisco) and colleagues in JAMA.
Their findings were derived from the Cardiovascular Disease Policy Model, which gave a simulation of coronary heart disease and stroke incidence, prevalence, mortality and costs in the entire population of US adults aged 35 years or older in 2015, and incorporated a mean 2015 annual PCSK9 inhibitor cost of $ 14,350 (€ 12,731).
The model showed that adding PCSK9 inhibitors to statin treatment of heterozygous FH could prevent 316,300 lifetime major adverse cardiovascular events (MACE: cardiovascular death, nonfatal myocardial infarction or stroke) resulting in 628,500 additional QALYs at a cost of $ 503,000 (€ 446,258) per QALY gained compared with adding ezetimibe to statins.
For the treatment of ASCVD, adding PCSK9 inhibitors to statins could prevent 4.3 million more MACE than the addition of ezetimibe, producing 7.9 million additional QALYs at a cost of $ 414,000 (€ 376,298) per QALY.
The researchers estimated that, at 2015 prices, PCSK9 inhibitor use in all eligible patients would reduce cardiovascular care costs by $ 29 billion (€ 25.7 billion) over 5 years, but increase drug costs by $ 592 billion (€ 525.2 billion), resulting in a net increase in healthcare spending of $ 568 billion (€ 503.9 billion).
Furthermore, annual PCSK9 inhibitor costs would need to fall by nearly $ 10,000 (€ 8872) to $ 4536 (€ 7871) per patient to be cost-effective at less than $ 100,000 (€ 88,719) per QALY.
By contrast, initiating statins in patients with heterozygous FH and ASCVD who are not current users and can tolerate the treatment would result in an estimated 214,500 fewer MACE over 5 years, with a net healthcare cost saving of $ 12 billion (€10.7 billion) compared with current usage.
Bibbins-Domingo et al say “the high cost of PCSK9 inhibitors is uniquely challenging.”
They explain: “This is because PCSK9 inhibitors are meant to be lifelong therapy not only for the relatively small number of patients with FH but also for a large and growing population with ASCVD. As a result, the potential increase in health care expenditures at current or even moderately discounted prices could be staggering, despite cost savings from averted ASCVD events.”
They add that restricting the population treated with PCSK9 inhibitors could reduce spending, but not to cost-effective levels.
Therefore, “reducing the price of PCSK9 inhibitors remains the primary approach to improving the value of these therapies”, Bibbins-Domingo and team conclude.
By Laura Cowen
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