J&J's Velcade gets stiff-armed at NICE as first-line myeloma treatment

In August, Johnson & Johnson's Velcade won European approval for first-line multiple myeloma treatment. That's an important market; it's not only larger than that for treatments used later in the disease, but it also includes fewer competitors, at a time when upstart drugs are elbowing into the third-line treatment field.

But to reap the benefits of that approval, J&J ($JNJ) has to persuade payers to, well, pay for it. And the U.K.'s tough cost-effectiveness gatekeepers say they're not yet convinced. The National Institute for Health and Care Excellence (NICE) nixed Velcade as too expensive in comparison with the current standard therapies--at least as far as the current data can show.

J&J can take heart about one thing: The agency says Velcade offers some key advantages over existing treatments, including increased response rates and improved progression-free survival. NICE just needs more information to make a comparative analysis.

According to Pharmafile, the agency is asking for more data comparing J&J's proposed drug combinations--Velcade and dexamethasone, and Velcade plus dexamethasone and thalidomide--with current drug regimens. The first combination is expected to cost £12,260, while the second would run £24,840.

NICE's appraisal committee couldn't assess whether Velcade and dexamethasone is a cost-effective option "because it did not have sufficient information to do so," Carole Longson, NICE's Health Technology Evaluation Centre director, said in a statement.

It isn't the first time Velcade has faltered on the first try at NICE. When originally reviewed by the agency, Velcade was rejected--until J&J came forward with a risk-sharing pricing strategy. J&J offered a money-back guarantee, under which J&J would refund the cost of treatment for patients who didn't respond well to treatment.

- see the NICE statement
- read the Pharmafile story

Special Reports: Top 20 Orphan Drugs by 2018 - Velcade