NICE rejects Roche's hot new breast cancer drug Kadcyla, then invites negotiations


Let the games begin. More precisely, let the price negotiations begin, the top executive for the U.K. price watchdog suggested today after the agency nixed Roche's ($RHHBY) pioneering breast cancer drug Kadcyla as too expensive.  

This could get interesting. That is because the antibody-drug conjugate for treating HER2-positive metastatic breast cancer carries a price that the National Institute for Health and Care Excellence (NICE) doesn't want to pay but is a drug that patients and doctors very much want to use.

"A breast cancer treatment that can cost more than £90,000 [$151,000] per patient is not effective enough to justify the price the NHS is being asked to pay," NICE said in a statement.

"We had hoped that Roche would have recognized the challenge the NHS faces in managing the adoption of expensive new treatments by reducing the cost of Kadcyla to the NHS," Sir Andrew Dillon, NICE chief executive, reiterated.

Roche countered, dinging the price protector by pointing out that Kadclya was the eighth consecutive treatment for advanced breast cancer to be rejected by NICE since 2011. "Roche is extremely disappointed that NICE has failed to safeguard the interests of patients with this advanced stage of aggressive disease," said Jayson Dallas, general manager of Roche Products. Roche has told Pharmafile that as a treatment until the disease progresses, trials indicated an average use of 9.6 months at a cost of around £44,310 ($74,405). 

Kadcyla, the first armed-antibody treatment for breast cancer, was only introduced into the U.K. in February, but according to a recent report, in the first 9 months since its approval in the U.S, it is being prescribed by more than 80% of oncologists. As Pharmafile points out, the antibody, trastuzumab, binds to the HER2-positive cancer cells and is believed to block signals that spur the cancer cells' growth. After the cancer cells absorb the drug, it releases the DM1 to destroy them.

Dr. Caitlin Palframan, senior policy manager for Breakthrough Breast Cancer

And patients in the U.K. want access to it, giving Roche more leverage on price. "Kadcyla is a very impressive drug that has been shown to extend life by up to 6 months in HER2-positive secondary breast cancer patients, and with more manageable side effects than alternative drugs," Dr. Caitlin Palframan, senior policy manager for Breakthrough Breast Cancer, said in a statement today. She said that the U.K.'s approval process is not keeping up with the pace of drug development and suggested that the group would be putting pressure on the government to do something about it.

The treatment is being paid for already through the government's special Cancer Drugs Fund. It would get wider use and generate more revenues for Roche, however, if it were approved by NICE for use throughout the National Health System. NICE invited comments by May 19 and then will publish a second draft. Many companies do return with discounts, but because those negotiations and the final price are not publicized, it is never clear who caved the most on their position.

- here's what NICE said
- read the Pharmafile story
more from Breakthrough Breast Cancer