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,… Continue Reading
Missing in the reporting on the Novartis price for Kymriah, its new $475,000 CAR T treatment, is that Novartis received an Orphan Drug designation in February 3, 2015, and sequently received a tax credit subsidy from the United States equal to 50 percent of the cost of qualifying clinical trials.
From the FDA database on Orphan Designations:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=463114
From the FDA page on the Orphan Drug Tax Credit. Incentives TAX CREDIT (See Footnote 1 below) FOR TESTING EXPENSES FOR DRUGS FOR RARE DISEASES OR CONDITIONS Introduction Section 45C of the Internal Revenue Code of 1954 allows a credit… Continue Reading
From the FDA page on the Orphan Drug Tax Credit.
IncentivesTAX CREDIT
(See Footnote 1 below)
FOR TESTING EXPENSES FOR
DRUGS FOR RARE DISEASES OR CONDITIONSIntroduction
Section 45C of the Internal Revenue Code of 1954 allows a credit against tax, up to 50 percent of certain clinical testing expenses related to the use of a drug for a rare disease or condition after it is designated as an orphan drug.