Discounts not enough to sway U.K. gatekeeper to back Roche's Kadcyla

The drug pricing debate is heating up stateside, but across the pond, it's been hot for some time. Adding fuel to the fire--about Roche's breast cancer med Kadcyla, at least--U.K. cost-effectiveness gatekeepers at the National Institute for Health and Care Excellence (NICE) gave a final thumbs-down to the drug, two weeks after England's special oncology drugs fund agreed to cover the med at a discount.

Earlier this month, the Cancer Drugs Fund (CDF) said it would put Kadcyla back on its covered list after Roche ($RHHBY) offered a sizable discount. The drugmaker also offered NICE a "different, smaller" discount for Kadcyla, but that wasn't enough to sway the cost watchdog.

The price Roche is asking England's National Health Service to pay for Kadcyla is "too high" in the long term, NICE CEO Sir Andrew Dillon said in a statement. According to the cost gatekeeper's calculations, the drug runs at about £90,000 ($137,000) per patient at its full list price. But Roche says Kadcyla's real-world cost is actually less because the drug is given for shorter periods than NICE assumes, Reuters reports.

NICE CEO Sir Andrew Dillon

"We recognize that Kadcyla has a place in treating some patients with advanced breast cancer and we have been as flexible as we can in making our recommendation," Dillon said.

Needless to say, Roche doesn't feel the same way. The company is "extremely disappointed" by NICE's decision, Roche told FiercePharma in an emailed statement. "Kadcyla is an innovative medicine which has been shown to offer significant benefit to people with an aggressive and advanced form of breast cancer for which there is currently no cure," the company said.

Patients can still get access to Kadcyla, albeit with some added red tape, thanks to its reinstated coverage by the CDF. The fund typically pays for drugs given the boot by NICE, although it has been more restrictive lately due to budget overruns. "Roche has demonstrated that, when given the opportunity to come to the table with all parties, we can find solutions and do what's right for patients," the company said.

Roche has traveled a rocky road with Kadcyla in the U.K. Last year, NICE rejected the treatment in preliminary draft guidance, maintaining that the drug was too expensive even after Roche offered discounts. The move sparked pushback from patients and advocacy groups, who said Kadcyla offers promise for those without treatment options. The next-gen treatment combines an antibody used in Roche's cancer powerhouse Herceptin with a mechanism that delivers it directly to cancer cells, resulting in fewer side effects for patients.

The company is still counting on Kadcyla to kick things into high gear as biosimilars for its top-selling meds enter the market. The drug brought in 558 million Swiss francs ($574 million) during the first 9 months of this year, a 57% hop over the same period last year. And Kadcyla is still going strong in Europe, with recent launches in France and Spain delivering positive numbers.

- here's NICE's statement
- read the Reuters 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

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