On October 2, 2023, Knowledge Ecology International submitted written comments to the Centers for Medicare & Medicaid Services (CMS) in conjunction with the Medicare Price Negotiation public consultation process. CMS is hosting a series of patient-focused listening sessions this fall, broken out by each individual drug CMS is seeking to negotiate in the first round of the program. KEI submitted two sets of written comments focused on Ibrutinib, a cancer treatment marketed by AbbVie and J&J as Imbruvica.
One comment was written by Arianna Schouten and discusses the preclinical development of Imbruvica, and includes this comment:
The preclinical research that led to the development and FDA approval of Imbruvica/Ibrutinib benefited from studies and research by companies now owned by the drug sponsors (AbbVie and Johnson&Johnson), as well as independent research funded by the US National Institutes of Health (NIH), the German government, the European Union, the Cancer Prevention and Research Institute of Texas, the CLL Global Research Foundation, the Leukemia & Lymphoma Society, the Howard Hughes Medical Institute, and the D Warren Brown Foundation.
These comments are available as KEI Briefing Note 2023:4.
A second comment reports on the clinical studies supporting Imbruvica’s initial and subsequent FDA approvals, as well as the pediatric studies requested by FDA to extend the Imbruvica patent and regulatory exclusivities, the subsidies provided by the U.S. Orphan Drug Act and the breakdown of listed funders of studies in the NIH database ClinicalTrials.Gov. The comments are available as KEI Briefing Note 2023:3. Among the findings:
- The Orphan Drug Act tax credit provided a significant subsidy for the development of the Imbruvica. The FDA granted 14 Orphan designations for Imbruvica including eight indications that have received FDA approval. The credit was equal to 50 percent of qualifying expenditures through the end of 2017 and 25 percent thereafter.
- The 2009 Affordable Care Act (ACA) requires most health plans to pay routine care costs for patients who participate in clinical trials to prevent, detect or treat cancer and other life-threatening conditions.
- The NIH ClinicalTrials.Gov database lists companies owned by AbbVie or J&J as the sponsor and funder of 21 percent of all trials involving Imbruvica. The NIH is identified as one of the funders of Imbruvica trials 17 percent of the time. The largest funder of trials for Imbruvica is “other.”
The briefing note also discussed the pediatric studies requested by FDA to extend the Imbruvica patent and regulatory exclusivities.
On August 8, 2022, the FDA made a request to Pharmacyclics LLC (a company now owned by AbbVie), to undertake three small studies of Imbruvica on pediatric populations. The request was made under 21 U.S. Code § 355a – Pediatric studies of drugs, and grants a six month extension of the Imbruvica patent and regulatory exclusivities, imposing significant costs on the public.
The requested enrollment for the studies was . . . just 100 patients total. The cost to the public for the three studies with as few as 100 patients is expected to be massive. The 2021 Medicare and Medicaid outlays on Imbruvica were $3.2 billion and the U.S. expenditures on the drug by other payers was also substantial.