During October and November 2019, we saw the FDA approve thirteen new investigational drugs. Five of these drugs have annual costs in excess of $100,000. Each of these potential budget busters was approved months ahead of their PDUFA Dates, targeting such indications as the most common cystic fibrosis mutation, mantle cell lymphoma for patients who have received at least one prior therapy, sickle cell disease, partial-onset seizures in adults, and complicated urinary tract infections.
Here’s a link to a relevant article about the five budget busters from the November 27th ENDPOINTS News about approval process, Congress’ viewpoint and what FDA is analyzing https://endpts.com/fda-approves-5-new-costly-drugs-well-ahead-of-pdufa-dates/
Thirteen October and November Approvals
ICER’s Review of Migraine Medications
ICER released a draft review of lasmiditan, ubrogepant and rimegepant in November 2019. ICER found the drugs to be comparable to each other in efficacy, but not as efficacious as triptans. Lasmiditan, ubrogepant and rimegepant would provide a benefit for patients with cardiovascular disease that have a contraindication to triptans, were not helped by triptans or do not tolerate them. Since triptans are available as generics, ICER concludes that triptans would provide a greater benefit at a lower cost than lasmiditan, ubrogepant or rimegepant. To reach a threshold of $150,000 per quality-adjusted life year ICER estimated an annual cost of $1,850 for lasmiditan, $1,780 for rimegepant and $1,740 for ubrogepant.
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