None of the new class of drugs on the market for movement disorder tardive dyskinesia are cost-effective at their current prices, independent price advisory group the Institute for Clinical and Economic Review said in a final report.
ICER concluded that Teva Pharmaceutical Industries Ltd.'s Austedo and Neurocrine Biosciences Inc.'s Ingrezza — both approved earlier this year — would need significant cost cuts to fall into a cost-effective range for patients with TD, a movement disorder often arising after long-term use of antipsychotic medicines.
Ingrezza's wholesale acquisition cost of $75,789 would have to drop between 85% and 90%, while Austedo's $90,071 price tag would need to be slashed about 90% to 93%.
The findings echoed an earlier draft document that concluded that the two drugs are too costly and have uncertain long-term safety profiles for patients with TD.
ICER also assessed H. Lundbeck A/S' Xenazine, which is approved for treating Huntington's disease but has been used for TD.
"While the evidence [for Austedo and Ingrezza] is promising, uncertainty remains around the true spectrum of clinical benefit and long-term safety with these treatments, and current prices are far out of alignment with the benefits measured in clinical trials," Dan Ollendorf, ICER chief scientific officer, said in a statement.
The "promising but inconclusive" rating given to the two drugs was based largely on a lack of long-term data and some uncertainty around key outcome measures in the studies the drugs do have, ICER said. There was not enough evidence to assess Lundbeck's Xenazine.
ICER said it did consider additional benefits that may not be incorporated in clinical trials, such as the cost that TD symptoms can have to patients' work and social lives, and the caregiver burden.
The report will be the subject of a Dec. 5 public meeting of an independent evidence committee of ICER known as the New England Comparative Effectiveness Public Advisory Council.