U.K. cost watchdog gives one-two punch to Roche's Kadcyla and BMS' Opdivo

The U.K. cost gatekeeper National Institute for Health and Care Excellence (NICE) gave a one-two punch to Roche ($RHHBY) and Bristol-Myers Squibb's ($BMY) costly cancer drugs, rejecting Roche's breast cancer therapy Kadcyla and giving its thumbs-down to BMS' lung cancer med Opdivo.

NICE nixed Kadcyla in final guidance even after Roche offered discounts. And the cost watchdog in draft guidance rejected BMS' Opdivo for a new use in squamous non-small cell lung cancer, citing the drug's high cost.

The cost-effectiveness gatekeeper has been singing a similar tune lately amid skyrocketing prices for new cancer drugs and the ongoing debates about those costs on both sides of the Atlantic. England's Cancer Drugs Fund (CDF), which covers meds that NICE rejects, recently pared away its line-up of covered drugs, too. Those decisions have riled the industry and patient groups, who claim that restrictive funding limits patients' access to potentially life-extending therapies.

But the drug-funding crisis is a two-way street, and some experts have urged companies to bring down sky-high cancer prices. Drugmakers should work with NICE to reduce "very high prices for promising immunotherapies," Paul Workman, chief executive of The Institute of Cancer Research, said in the wake of the BMS rejection (as quoted by Pharmafile). With next-gen combo regimens on their way--pairing drugs such as Opdivo with other immunotherapies--the industry needs to keep in mind the total costs, he said: "New drug combinations will be a cornerstone of the improvements we make in cancer survival rates over the next ten years, and while innovative drugs should command relatively higher prices, the overall cost of treatment must be affordable."

NICE in a statement said Kadcyla was just too expensive to cover at £90,000 ($136,000) per patient, capping off almost two years of negotiations with the company. Back in November, Roche offered an undisclosed discount to the cost-effectiveness gatekeeper after the CDF said it would put Kadcyla back on its covered list.

"Although Roche recently agreed a price discount with NHS England to allow Kadcyla to be retained on the Cancer Drugs Fund, they made no changes in the patient access scheme available for the NICE appraisal, which means it is still above the top of our specialty extended range of cost-effectiveness for cancer drugs," a NICE spokesperson said in a statement.

But Roche says it's willing to match the discount it offered the CDF, Bloomberg reports. "We are willing to be collaborative and continue discussions with NICE to ensure that Kadcyla remains available to patients in England with advanced breast cancer for the long term."

In the meantime, patients taking the med can continue treatment "until they and their doctors consider it appropriate to stop," NICE said in a statement. They can also get the drug through the CDF, albeit with a few strings attached.

Meanwhile, BMS got an early no-go from the cost gatekeeper for Opdivo in lung cancer. In draft guidance, NICE said that the drug is too expensive to justify, despite substantial clinical benefits compared with the only other alternative for relapsed patients, Sanofi's ($SNY) Taxotere (docetaxel). According to NICE's calculations, Opdivo costs £86,599 ($130,090) per patient.

"Although nivolumab was innovative and met the criteria to be considered a life-extending, end-of-life treatment, the Committee did not recommend nivolumab as a cost-effective use of NHS resources," NICE's appraisal committee said in an assessment document.

BMS is not pleased with this conclusion, calling NICE's decision on Opdivo "deeply disappointing," Reuters reports.

- here's NICE's statement on Kadcyla
- here's the cost watchdog's guidance on Opdivo (PDF)
- read the Bloomberg story
- get the Reuters article
- and here's the Pharmafile story

Special Reports: The top 10 most expensive drugs of 2013 | The top 15 pharma companies by 2014 revenue - Roche | Top 15 Drug Launch Superstars - Kadcyla - Roche/Genentech | Top 10 best-selling cancer drugs of 2013 | The new drug approvals of 2014 - Opdivo

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