Specialty medications top the list of some of the costliest US drug price hikes not supported by new clinical evidence in 2017 and 2018, according to a report released by the Institute for Clinical and Economic Review (ICER).

The report is the first of its kind by the Boston-based research group, which has become known for their analysis of pharmaceutical pricing. For its selection process, the researchers sought to identify the top drugs whose estimated net price growth over a 2-year period would have caused the greatest increase in US drug spending. In an appendix published with the report, however, several manufacturers challenged ICER's methodology and findings. For example, the assessment only includes indications representing greater than 10% of use, not accounting for smaller indications such as rare diseases that may reflect improvements in net health benefit, some of the pharmaceutical manufacturers noted. 

After identifying the 100 drugs with largest US sales revenue in 2018, the ICER then narrowed the list to 77 treatments that experienced wholesale acquisition cost increases at rates of more than twice the medical Consumer Price Index across 2017 and 2018. The final list consists of the top 7 treatments that had estimated net price increases responsible for the largest growth in US spending over those 2 years.

A total of 9 drugs were assessed, but 2 were removed from the list due to new important positive clinical evidence that was identified. Those 2 drugs were lenalidomide (Revlimid, Celgene) and elvitegravir/cobicstat/emtricitabine/tenofovir alafenamide (Genovya, Gilead).

According to the final review, the top 7 drugs with what they termed the largest "unsupported" price hikes are:
  1. Adalimumab (Humira, AbbVie)
  2. Rituximab (Rituxan, Genentech)
  3. Pregabalin (Lyrica, Pfizer)
  4. Tenofovir disoproxil fumarate (Truvada, Gilead)
  5. Pegfilgrastim (Neulasta, Amgen)
  6. Tadalafil (Cialis, Eli Lilly)
  7. Dimethyl fumarate (Tecfidera, Biogen)
Adalimumab, initially approved by the FDA in 2002, has indications for 10 different chronic diseases, but is mostly used in the treatment of rheumatoid arthritis, psoriatic arthritis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.

The total impact on drug spending for all 7 drugs listed was $5.1 billion over the 2-year period.

Price hikes are a norm in the United States for many pharmaceutical manufacturers on an annual basis. However, the latest report provides insight into whether these cost increases could potentially be supported by new clinical evidence.

“If new evidence emerges that shows a treatment may be more beneficial than what was previously understood, perhaps that new evidence could warrant some level of price increase,” David Rind, MD, chief medical officer of ICER, said in a statement. “For the 7 of the 9 drugs we reviewed, however, we found that the price increases lacked justification in new evidence.”

References

Institute for Clinical and Economic Review. Unsupported Price Increase Report. October 8, 2019. https://icer-review.org/wp-content/uploads/2019/01/ICER_UPI_Final_Report_and_Assessment_100819_Final.pdf. Accessed October 9, 2019.

ICER Identifies Costliest US Drug-Price Hikes That Are Not Supported by New Clinical Evidence [news release]. Institute for Clinical and Economic Review’s website. https://icer-review.org/announcements/icer-identifies-costliest-us-drug-price-hikes-that-are-not-supported-by-new-clinical-evidence/. Accessed October 9, 2019.