J&J's Velcade cleared by U.K. for first-line myeloma treatment in about-face

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The U.K.'s National Institute for Health and Care Excellence (NICE) has come around on Johnson & Johnson's ($JNJ) Velcade as a first-line treatment for the blood cancer multiple myeloma. It approved the drug for the new use today, four months after initially saying it was unconvinced the benefits of the drug outweighed its costs.

NICE considered J&J's input in making its decision to change course. When the agency initially shunned the drug as a first-line treatment in November, it asked for more data comparing the various combinations J&J was recommending: Velcade and dexamethasone, and Velcade plus dexamethasone and thalidomide. J&J responded. The draft guidance now recommends the drug in combination with other treatments for patients who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation (bone marrow transplant).

In a statement about the decision, NICE CEO Sir Andrew Dillon said Velcade (bortezomib) would be an important option for the 4,000 patients in the U.K. who are diagnosed with multiply myeloma every year. "Clinical specialists told the committee that induction treatment with bortezomib would enable a greater number of patients to proceed to a bone transplant and consequently prevent the disease from progressing for longer," Dillon said.

NICE CEO Sir Andrew Dillon--Courtesy of NICE

This isn't the first time J&J has tangled with NICE on Velcade. The agency initially balked at the drug back in 2007, prompting J&J to offer an unprecedented money-back guarantee. The company vowed to refund the U.K.'s National Health Service for costs associated with any patients who did not respond well to Velcade. It was just one example of a continuing string of challenges the U.K. has imposed on drugmakers, including, most recently, price caps imposed on branded products.

Velcade is one of J&J's top performers, with sales of the drug up 10.7% year-over-year in 2013 to $1.6 billion. J&J co-promotes the drug with Japan's Takeda Pharmaceutical, which has brought in $689.3 million for Velcade in the first nine months of its current fiscal year. Peter Barnes, the U.K.'s medical director of the J&J subsidiary, Janssen, told PharmaTimes he was "pleased" with NICE's latest decision in favor of Velcade. "This builds on the well-recognised utility of bortezomib in other stages of multiple myeloma," he said.

- here's the NICE statement
- read more at PharmaTimes
- here's Pharmaphorum's take

Special Report: Top 20 orphan drugs by 2018 - Velcade