3rd-party assessors having impact on drug price discussions, value, report says
Researchers argue that third-party drug assessors have emerged due to a general lack of information
Third-party nonprofits promising scientific and transparent drug value assessments are gaining ground in healthcare, even as many drug manufacturers are challenging their methodologies, according to new research by the Health Research Institute.
Drug value assessors hope their independent analysis can illustrate the connection between prices and value. As new FDA drug approvals trend upward, the study authors predict that this third-party assessment could become an increasingly important factor for pricing strategy and drug selection.
Citing the opinion of Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, the research argues that third-party drug assessors have emerged due to a general lack of information -- not to mention contradicting assumptions and incomplete outcomes data. But the various groups differ in their methodology, which complicates consensus on the factors that determines a drug's value.
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Trade groups have started providing point-by-point recommendations on the assessors' methodologies. For example, in examining the methods of the Institute for Clinical and Economic Review, the National Pharmaceutical Council highlighted some areas of concern, such as ICER's use of "adoption rates that might not accurately reflect the uptake of a drug" at the time of launch.
The NPC also recommends a longer window of time -- greater than five years -- to fully account for a drug's impact on patient outcomes. Regardless, the NPC expressed solidarity with ICER in efforts to make the healthcare system more effective and efficient, and lauded ICER's consideration of drug benefits beyond basic cost effectiveness -- such as the level of unmet need in a disease area, and the collective impact of disease burden across population groups.
In November 2015, Pharmaceutical Research and Manufacturers of America suggested many different patient perspectives should be included in assessor's methodologies; a lack of them, it said, could be a barrier to individualized treatment decision-making, as well as patient access to appropriate therapies. In praise, the trade group singled out third-party assessor American Society of Clinical Oncology for reconsidering its use of an average "net health benefit" to calculate drug value across broad populations. ASCO's revised framework will be published later this year.
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Third-party efforts to augment clinical practice guidelines with financial information are beginning to gain traction. The study said Harvard Pilgrim Health Care, for one, is considering a financial incentive for oncologists who use ASCO, or another mutually agreed-upon framework, to help reduce treatment variation, thereby reducing cost. The program may launch a pilot phase after results are gleaned from a recent internal analysis.
ICER, meanwhile, has had a significant influence due to the scope of its assessments and the publicity they've garnered, the research said -- even impacting payer contracting decisions. ICER's attention is based partly on its "value-based benchmark price" recommendation for new drugs at the time of launch. PhRMA, in its October statement, wrote that ICER's benchmark price doesn't consider market dynamics, which can lead to substantial price rebates for new drugs.
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Additionally, ICER's insurer budget thresholds are based on increases relative to current spending levels -- and a focus on upfront costs for newer drugs -- without what PhRMA considers "due consideration of current medical and surgical costs" that could be reduced, or outright eliminated, by giving patients access to new therapies. The study said ICER is working on a formal procedure for examining drugs a second time.
The pharmaceutical and life sciences industry recognize a "mutual interest in promoting informed, evidence-based decision making when it comes to product selection," the study said. But industry support for third party assessors may largely depend on the level of input and collaboration between both parties -- as well as a consensus about what constitutes value for payers, policymakers, physicians and patients.
Twitter: @JELagasse
