Prices and Value Not Well Aligned for Common CV Drugs in US

Debra L Beck

August 17, 2018

The axiom "you get what you pay for" does not appear to consistently apply to cardiovascular medications in the United States.

Unlike in many countries where reimbursement for drugs is directly linked to their clinical effectiveness, a new modeling study shows a wide spectrum of cost-effectiveness for a basket of frequently prescribed cardiovascular medications.

"Our finding of a wide range of value estimates for these 30 frequently prescribed cardiology products suggests there is room for improvement in terms of achieving value-based drug pricing," first author Jonathan D. Campbell, PhD, from the University of Colorado School of Pharmacy, Aurora, told theheart.org | Medscape Cardiology in an interview.

"While I wouldn't say this was surprising, I think it serves to inform further discussion about how we might continue to nudge the system toward incentivizing payments for value to reduce wasteful spending."

Their findings are published in the August issue of Health Affairs.

Campbell and colleagues estimated the long-term effectiveness for each of 30 cardiology drugs by using evidence extrapolated from hard-endpoint randomized controlled trials. Their model estimated average lifetime quality-adjusted life-years (QALYs) and payer costs for 30 unique drug-vs-comparator pairs (active or placebo).

From this, an incremental cost-effectiveness ratio (ICER) per QALY gained was calculated for each drug.

The standard measure of effect in cost-effectiveness analysis is a QALY, which accounts for both the quantity and quality of life, while ICERs measure the difference in cost divided by the difference in health for an intervention vs its alternative. A lower ICER suggests better value for money than a higher one.

Across the 30 drugs, the ICERs ranged from cost-saving with increased QALYs to costlier with decreased QALYs, as compared to either placebo or an active comparator.

"The majority of the studies we analyzed led to an ICER near or below $100,000 per QALY gained, while five resulted in an ICER above $175,000 per QALY gained," said Campbell.

For comparison, the National Institute for Health and Care Excellence (NICE), which provides price guidance in the United Kingdom, uses a QALY threshold of around £30,000 (or $38,000) in deciding whether to pay for healthcare interventions.   

"The results of our study show the amount insurance providers pay to get one more unit of health, such as one additional year of life in perfect health, varies considerably and can exceed what is considered good value in other parts of the world," said study coauthor Melanie Whittington, PhD, research faculty at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, in a press release.

Only 6 of the 30 drugs had active comparators, and these trials resulted in higher ICERs compared with placebo comparator trials. Indeed, three of the four drugs with a cost per QALY greater than 250,000 — a finding referred to as "dominated," indicating that the drug was less effective but costlier than its alternative — came from active comparator trials. 

"If our objective is to see if we've kind of backed into a threshold for cost-effectiveness, then we really have to look at the highest cost per QALY, which exceeded $250,000, rather than the average or most common cost per QALY," said Campbell.

Cost-effectiveness Analysis Used More in US

Commenting on the study for theheart.org | Medscape Cardiology, Craig J. Beavers, PharmD, noted, "If you look at those dominated drugs, there is some indication that as we've gotten better treatments, we're getting less incremental gains with each new therapy, which might indicate that even though it's novel, the costs may outweigh the benefit."

Beavers is from the University of Kentucky College of Pharmacy, Lexington, and serves as the co-chair of the clinical pharmacist workgroup of the American College of Cardiology.

"Of course, there are some limitations to this analysis, but it pushes us to continue these kinds of discussions so we don't continue to be in a hole in terms of health care costs," he added.

In most developed countries, cost-effectiveness analysis is used to provide the public and private payers of healthcare with a structured and rational way of allocating resources. Drugs deemed to offer little value based on a predefined or implied willingness-to-pay threshold may be denied market access or allowed only limited market access.

This process, in turn, offers guidance to pharmaceutical companies hoping to set acceptable prices for their drugs. With no cost-effectiveness signal available to price setters in the United States, manufacturers are free to set prices as they wish.

"We're behind in the US in trying to assess the true value of different therapies, and the findings of this analysis speak to what people suspected, which is that there may be some therapies that have been approved but are not of much value or might even be more costly and less efficacious and maybe we shouldn't be using those agents," said Beavers.

The United States has traditionally been resistant to using cost-effectiveness analysis, preferring to avoid any hint of healthcare "rationing." However, because of escalating drug prices, the idea of value-based drug pricing is rapidly gaining adherents, with the pharmacy giant CVS being just the latest to announce plans to use cost-effectiveness analysis to curb drug costs.

Campbell and other authors report receiving consulting support from Amgen to produce the findings of this article. The second author, Vasily Belozeroff, is an employee and stockholder of Amgen. Beavers has disclosed no relevant financial relationships.

Health Aff (Millwood). 2018;37:1298-1305. Abstract

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