On Wednesday, the Institute for Clinical and Economic Review (ICER) published its
research protocol for assessing price increases of prescription drugs in California. ICER will release the state-specific report for California as a complement to its National Unsupported Price Increase (UPI) reports that identify major drugs with “substantial price increases without adequate evidence to justify the increases.” ICER will leverage the annual
California SB-17 reports
that: 1) require manufacturers to notify the state of increases to prescription drugs’ wholesale acquisition cost (WAC); and 2) determine whether there is new evidence to support year-over-year spending increases. The California UPI report will evaluate up to 10 drugs and use the same methodology of evaluation as that used in the National UPI reports. Manufacturers will have the opportunity to provide input prior to publication of the final assessment on October 13.
Additionally, on Thursday, ICER
concluded its assessment on plinabulin and trilaciclib for chemotherapy-induced neutropenia. ICER published a revised Evidence Report and canceled its public meeting due to BeyondSpring Pharmaceuticals receiving a Complete Response Letter for plinabulin on December 1.
On Tuesday,
Health Affairs released an
article describing research conducted by the Patient-Driven Values in Healthcare Evaluation
(PAVE)
Center to incorporate patient-informed value elements into health technology assessments (HTAs). The PAVE Center is testing ways to integrate patient-informed value elements, which encompass attributes of treatment effects, access, cost, and life and social impacts, into stated preferences and economic evaluations. Stated preferences can allow individuals to consider jointly different attributes of a healthcare service and make a choice depending upon their preferences. These attributes can then be quantified as additional value domains to inform economic evaluation model inputs. The PAVE Center is currently conducting 2 applied case studies in chronic obstructive pulmonary disease and major depressive disorder to determine how patient-informed value elements can be incorporated into
future economic evaluations and value assessments of treatment options.
Last Wednesday,
Value in Health published an
article
titled, “The History and Future of the ‘ISPOR Value Flower’: Addressing Limitations of Conventional Cost-Effectiveness Analysis.” In this article, the authors reviewed the history of the 2018 ISPOR Special Task Force (STF) on US Value Assessments, the “ISPOR value flower,” and described recent developments since the report. The authors conclude that it may be worth redesigning the “ISPOR value flower” to identify and include all potential novel value elements that are needed to accurately value health interventions. The “ISPOR value flower” highlights elements beyond traditional cost-effectiveness analysis (CEA) metrics (eg, quality-adjusted life-years, or QALYs), such as those related to uncertainty and risk aversion that
may be overlooked or underappreciated in conventional drug value assessments. Since the creation of the STF, the development of novel value measures has continued to evolve. For instance, researchers have reported that CEAs mainly include subgroup analyses based on age or disease characteristics, and only rarely on other sociodemographic characteristics. Other developments include emerging empirical estimates such as value of insurance, real option value, value of knowing, and value of hope to be incorporated into CEAs.
If you need assistance with all things ICER or value-related, please contact
Erika Wissinger.
