By Jeremy Schafer, Precision for Value
According to a report, the Institute for Clinical and Economic Review (ICER) is considering offering a service, for a fee, to pharmaceutical manufacturers whereby ICER would provide guidance on clinical trial design.1 The change would be a departure for an organization that to date has kept manufacturers at arm’s length. ICER input in clinical trial design could improve the identification and capture of patient-reported outcomes as well as gathering of information that may be impactful for cost-effectiveness assessments. ICER would not provide such a service for free, of course. ICER’s funding to date has primarily been from independent foundations as well as grants and conference revenues. Consulting with pharmaceutical manufacturers would represent a new revenue stream but may create a perception of bias for an organization that by and large has been considered independent. The question on many stakeholders’ minds is simple: Will ICER still bite a manufacturer’s hand if that hand is feeding it? ICER will be confronted with several challenges it will need to address.
Perception Of Bias
If ICER embarks on a path of taking pharmaceutical manufacturer money in exchange for clinical trial design guidance, the primary challenge will be combating the perception of bias. What ICER is considering is not unprecedented; for instance, the cost-effectiveness entity NICE in the U.K. offers a similar service.1 However, the healthcare industry is well aware of the complications that such relationships create, which is why financial disclosures are a mainstay in the industry. Financial payments by the industry and their possible impact on prescribing have been well documented; less clear is how financial support would impact an organization such as ICER.2 U.S. health plans and pharmacy benefit managers (PBMs) in particular are wary of work done with industry funding and will undoubtedly question ICER’s ability to stay neutral. ICER will need to alleviate the concerns of these stakeholders, considering payers have been the primary proponents of ICER’s work thus far.
The Client-Vendor Conundrum
Individuals in service organizations will attest that the relationship between organizations changes dramatically when one organization is a vendor and the other a client. A vendor’s role is to provide a service to a client but also to keep that client happy in order to build business and procure additional revenue opportunities. ICER’s analyses have been met by concern, and in some cases pointed rebuttals, by manufacturers. In addition, ICER’s own press releases and headlines have been known to highlight when products are not cost-effective or when significant discounts are needed. Will ICER still make bold claims if the claim is against current or potential customers? ICER may need to consider establishing a firewall around a separate part of the organization for manufacturer-funded work and ensuring that no manufacturer funding is used in support of the cost-effective analyses. ICER predominantly relies on foundation support for analyses, so this may not be a significant change.
Critiquing One’s Own Work
If ICER moves forward with manufacturer-funded trial design support it will be an opportunity for manufacturers to better tailor clinical trials to withstand cost-effectiveness reviews. However, ICER will inevitably face the challenge of critiquing its own work. Manufacturers that utilize ICER’s services will have products that gain FDA approval and then become the subject of an ICER review. Ideally, a product will fare better in the ICER analysis if the manufacturer made use of ICER’s services. What happens when one is not cost-effective? A harsh review could, in a way, be a criticism of ICER’s own work. Too many instances of products being found not cost-effective despite ICER’s input in trial design may cast into doubt how valuable the service is to manufacturers. ICER will need to be clear to any manufacturer clients that assistance in trial design does not guarantee a glowing ICER review. Having separate divisions between the clinical trial and cost-effective groups within ICER, as noted above, would also aid in addressing this issue.
The upside of ICER providing manufacturers with insight into clinical trial design is that manufacturers may be able to better meet the needs of payer customers earlier. Payers have been frustrated with launches of expensive new products where the overall value to the healthcare marketplace is unknown. Payers react in these situations by placing restrictive criteria on the drug, which slows uptake by complicating access for patients and providers. Manufacturers similarly may be blindsided by payer management tactics upon releasing a product that has met FDA requirements for approval and received the backing of providers but now is stonewalled. ICER analyses have added further difficulties for manufacturers when new drug launches can be met by a press release announcing that the price is far too high. Many manufacturers can recount a launch where they were defending their new product’s price rather than promoting its clinical merits. If manufacturers better understand cost-effectiveness in the clinical trial phase, they may realize opportunities to capture data that cost-effectiveness stakeholders want to see, potentially easing the access environment.
The Challenge For Those Conducting Clinical Trials
For manufacturers and contract research organizations (CROs) conducting clinical trials, the challenge will be in learning about new endpoints related to cost-effectiveness, incorporating these endpoints into studies, and capturing the data for analysis later. The data that payers and cost-effectiveness stakeholders are looking for may be similar to the data currently being captured, though there are important differences. For a cholesterol drug, the FDA may be interested in impact on LDL and heart attack; the payer, meanwhile, may be interested in whether the patient is hospitalized (and for how long), visits the emergency department, uses supportive care medications due to adverse events, or needs additional therapies. Capturing costs associated with these endpoints would be an additional bonus. The result is that manufacturers and CROs will need to undergo a shift in their thinking when considering cost-effectiveness. As the shift from volume to value continues, it will be a change all healthcare stakeholders need to make.
ICER’s rising profile in the payer landscape has been aided by its funding scheme and impartiality. Advising manufacturers on clinical trial design represents a challenge and an opportunity for ICER. If ICER moves forward, it will need to take steps to ensure its cost-effectiveness assessments stay rigorous and impartial while minimizing the perception of bias. From a manufacturer’s point of view, a greater understanding of how to show cost-effectiveness is a desirable goal.
About The Author:
Jeremy Schafer, Pharm.D., MBA, is senior VP of specialty solutions at Precision for Value. In this role, he is responsible for enterprise leadership on specialty strategy across the payer team organization and integration with other enterprise groups, including health economics and outcomes research, provider marketing, access and analytics, and media outreach. He has more than 10 years of experience in specialty pharmacy programs and networks, pharmacy and therapeutics committee processes and review, fee schedule management, and pharmacy benefit migration. Before joining Precision, Schafer served as a corporate account manager for Grifols. He also spent over seven years at Prime Therapeutics, where he held a variety of leadership roles in formulary, utilization management, and specialty pharmacy.