At Quintiles we continuously monitor the assessments published by global Health Technology Assessment (HTA) organizations to identify the trends in payer decision-making that are shaping our industry. One of the recent trends we are watching is the growing influence of ICER, the new USA-based HTA body, and how its findings compare to international agencies.

All eyes on ICER

The Institute for Clinical and Economic Review (ICER) is a relatively new player to the world of HTAs, but given the absence of a comprehensive and transparent HTA program in the USA, it has emerged as an influential source of information for drug decision-making. Its prominence increased considerably in late 2015 when it launched a new emerging therapy assessment program that is aimed at evaluating new pharmaceuticals gaining imminent Food and Drug Administration (FDA) approval. The assessment program will produce public reports on new drugs that have the potential to significantly change patient care and health system budgets. The reports will be produced near the time of FDA approval, with 15 to 20 reports planned by the end of 2017.

Its first report set the tone for ICER’s perspective on value based pricing in the US. The report argued that drug prices for newly approved PCSK9 inhibitors for lowering bad cholesterol were too high, and that the ex-factory price should be reduced by as much as 85% to justify the broad label population. It sent a clear message that the organization is keenly focused on affordability.

In contrast with many countries that have established requirements for appraising medicines for market access and formulary coverage, the USA has a fragmented approach to HTA with different organisations applying varying requirements and methodologies for evaluation. Historically, health economic and outcomes research (HEOR) evidence has not been considered an essential component in many payer or state-sponsored HTA guidelines, and decision-makers placed varying levels of importance on these outcomes. But with rising drug prices and healthcare expenditures, a focus on value-based decision making has gained increased attention from multiple stakeholders. ICER claims that its assessment framework can fill the need for a more transparent method to judge the value of new treatments using a combination of trusted methodologies and an innovative approach to affordability.

How it compares

Our analysis of ICER’s value framework and results shows that its output from traditional analysis of clinical and economic evidence does not appear to vary from international HTA agencies using similar methodologies. However, while other HTA bodies make decisions directly based on cost-effectiveness analyses (CEA) output and ability to achieve commonly cited willingness-to-pay thresholds, ICER’s final recommendation is underpinned by the unique approach of assessing a drug’s affordability and its value-based price benchmark.

Now the question is, what impact will it have? At a time when drug pricing faces increased scrutiny in the USA, ICER’s value-based price benchmark echoes the public’s demands for affordable treatments. While it is still too early to say how much influence the organization will ultimately wield, manufactures should consider what will happen if their prices exceed ICER's threshold of value and societal affordability. Some industry payers are already using ICER analyses to negotiate pricing tiers and determine which plans will cover these drugs, and others may soon follow suit.

To stay abreast of these trends, manufactures should communicate early-on with third party drug investigators, not limited to ICER, to improve the understanding on both the payer and manufacturer side about the drug’s value. They should also take every opportunity to engage with ICER through public comment on scoping documents and on initial draft reviews and voting questions. ICER’s influence in the drug pricing debate will likely continue to grow and stakeholders should give attention to its role as a voice in the drug evaluation conversation.


> Read more about the growing influence of ICER and how its findings compare to international agencies in the July issue of HTA Uncovered.

Topics in this blog post: Biopharma, EU, Evidence, Market Access, HTA, Payers, Value