Durata falls on news of CMS NTAP denial
Durata Therapeutics Inc. (NASDAQ:DRTX) fell $1.93 (12%) to $13.65 on Thursday after an analyst published a note highlighting CMS's denial of a new technology add on payment (NTAP) for Dalvance dalbavancin, which the company launched in the U.S. in July for acute bacterial skin and skin structure infections (ABSSSIs). The stock move also comes the day after FDA approved competitor Orbactiv oritavancin from The Medicines Co. (NASDAQ:MDCO) to treat ABSSSIs. Medicines Co. said pricing for the single dose IV antibiotic will be based on value. Dalvance has a wholesale acquisition cost (WAC) of $4,470 for a recommended two-dose IV regimen.
The NTAP denial came in a CMS final rule released earlier this week. Through the NTAP program, CMS offers hospitals supplemental reimbursement for using products that, in addition to being new, meet two criteria: the drug must increase the overall cost of treatment, and demonstrate a "substantial clinical benefit" over standard of care (SOC). In the rule, CMS said it does not believe Dalvance "meets the substantial clinical improvement criterion" to qualify for NTAP. The agency noted that the trials that served as the basis for approval were non-inferiority trials. ...