How IRA influence innovation round medicine for orphan illness? – Healthcare Economist

Whereas the Inflation Discount Act (IRA) goals to decrease the costs of prescription drugs, on the identical time it exempts medicine treating uncommon illnesses (i.e., orphan medicine) from drug value negotiation. Nonetheless, this exemption is simply legitimate if the orphan medicine has a single permitted indication. Thus, a key query is how steadily orphan medicine are later developed for different indications. In that case, IRA might might de-incentivize R&D investments in new indications for orphan medicine.

A brand new paper by Chambers et al. (2023) in JAMA Community Open FDA approval database between 2003 and 2022 to see how frequent new indications are for orphan medicine. They discover that:

FDA permitted 282 novel orphan medicine from 2003 to 2022…General, the FDA permitted 152 separate follow-on indications; 92 (61%) of those follow-on indications have been additionally for orphan drug circumstances. The imply (SD) time from novel orphan drug approval to follow-on indication was 53 (43) months…FDA included 58 (38%) follow-on indications in a single expedited evaluation program, 46 (30%) in 2 applications, and 17 (11%) in 3 applications; none have been included in all 4 applications.

You’ll be able to learn the total article here.