FDANews
FDAnews Drug Daily Bulletin

UK Healthcare Costs Watchdog Asks Janssen for More Data on Velcade

Nov. 13, 2013

The UK’s National Institute for Health and Care Excellence (NICE) has asked Janssen for more information on its multiple myeloma treatment Velcade before an appraisal committee can make final recommendations on its use in patients untreatable with high-dose chemotherapy and haematopoietic stem cell transplant.

Draft guidance published Tuesday by the regulator requests the following information:

  • An indirect comparison between Velcade (bortezomib) and dexamethasone in comparison with a combination of cyclophosphamide, thalidomide and dexamethasone;

  • The same in comparison with an alternative comparator in situations in which the above is not appropriate; and

  • Cost-effectiveness ratios for these comparisons.

Failing that, says the committee’s report, Janssen should provide a comparison using single arms of relevant clinical trials.

NICE in 2010 rejected Velcade as a first-line treatment on grounds that the drug is not as cost-effective as Celgene’s Thalomid (thalidomide). Janssen appealed and, a year later, the institute recommended Velcade as a first-line treatment only for patients who cannot receive chemotherapy, stem cell transplant or thalidomide.

The cost of a 3.5-mg vial of Velcade is approximately $1,210, according to NICE. The approximate cost of a 21-day cycle of Velcade and dexamethasone is $19,467 and the approximate cost of a 28-day cycle of Velcade, dexamethasone and thalidomide is $39,438.

Comments are due Dec. 3 and the appraisal committee’s next meeting will take place on Feb. 4, 2014. View the draft guidance at www.fdanews.com/ext/files/11-13-13-VelcadeGuidance.pdf. — Lena Freund

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