A n award-winning study found that the Institute for Clinical and Economic Review (ICER) rejects nearly all (97%) evidence submitted by manufacturers when preparing its annual Unsupported Price Increase (UPI) reports.

The UPI reports identify major drugs with substantial price increases without what the organization considers to be adequate evidence to justify the increases, the investigators reported at the AMCP Nexus 2023 meeting, in Orlando, Fla. (poster U12).

Of 40 payors surveyed by Cencora, almost 70% “indicated that these UPI reports have been at least somewhat influential in reinforcing or changing an actual decision,” said study co-author Jane Ha, PharmD, MS, a manager on the Value and Access Strategy team at Cencora (formerly AmerisourceBergen/Xcenda), such as “using results for pricing negotiations, implementing prior authorization criteria, moving drugs to a higher or lower tier, or even excluding drugs from coverage altogether.”

However, she said, ICER’s methodology has received “significant critique and concern from stakeholders regarding restrictive criteria and lack of transparency.” To evaluate how ICER appraises evidence submitted by manufacturers and identifies trends that influence ICER’s decisions, Dr. Ha and colleague Kimberly Westrich, MA, reviewed evidence submitted by manufacturers for the four national UPI reports published from 2019 to 2022. They developed a codebook to compile and categorize types of evidence and ICER’s reasons for rejecting or accepting that evidence.

ICER UPI reports from 2019 to 2022 included 44 drugs, 34 of which had evidence submitted by manufacturers. Manufacturers submitted 1,145 pieces of evidence across the four reports, which averaged out to 34 pieces of evidence per drug. The number of pieces of evidence submitted per report decreased over time, from 468 in 2019 to 140 in 2022. Evidence submitted per drug also declined over time, from 67 pieces in 2019 to 17 in 2022.

ICER rejected 1,107 pieces of evidence (97%) of the total submitted by manufacturers over the four years studied, researchers found. Some 708 pieces of evidence (64% of rejected evidence) did not meet ICER’s UPI review criteria. Reasons included a study design did not meet the criteria for assessing efficacy; the study was published outside of the time frame of the organization’s review; outcomes were not relevant to the scope; or a particular indication accounts for less than 10% of use.

There was a slight decrease in rejected evidence over time, Dr. Ha noted, from 99% rejected in 2019 to 94% in 2022. Thirty-eight pieces of evidence (3%) were accepted as high-quality findings demonstrating important new information, from 18 distinct randomized clinical trials. Accepted evidence typically was from phase 3 studies that demonstrated new information on improved outcomes or supported FDA label expansion.

ICER revised its methods since its first UPI report, including developing more descriptive categories when citing reasons for accepting evidence. Such changes are encouraging based on the stakes involved, Dr. Ha noted. For example, the National Academy for State Health Policy created model legislation for states to impose penalties on products with unsupported price increases identified in the reports.

The sources reported no relevant financial disclosures.