NICE Changes Course on BI’s Vargatef

The UK’s healthcare cost authority has reversed itself and is recommending Boehringer Ingelheim’s Vargatef in combination with docetaxel for previously treated, locally advanced metastatic or locally recurrent non-small cell lung adenocarcinoma.

The committee passed on the drug in initial draft guidance last December, saying its $109,000-a-year sticker price was too high to justify 1.4 months of progression-free survival and 2.3 months of overall survival.

Since then, however, BI submitted new survival models and cost-effectiveness estimates incorporating a patient access scheme discount that puts the drug’s cost-effectiveness estimate below $76,420.

While this is above the normal $45,852 limit that NICE usually imposes, this is an extremely high-risk patient population, BI says. Most of these patients are diagnosed after their disease has metastasized and often experience recurrence after first-line therapy — at which point there are few options left.

NICE’s appraisal committee ultimately agreed that Vargatef (nintedanib) is a life-extending, end-of-life treatment, allowing it to approve a more expensive drug.

NICE expects to finalize the guidance next month. Read the final draft guidance at www.fdanews.com/06-03-15-NICElungcancer.pdf. — Lena Freund