Kadcyla’s Rejection Confirms that NICE Must Change the Way it Considers Cancer Treatment

Further to NICE's rejection of Roche's Kadcyla, Jamie Mallinson, GlobalData’s Analyst covering Oncology and Hematology, says:“The National Institute for Health and Care Excellence’s (NICE) recent rejection of Kadcyla, Roche’s latest HER2 positive cancer drug, in the UK comes as no big surprise, as it is the seventh breast cancer drug to be rejected since 2011. NICE gave Roche the chance to negotiate a discounted price for Kadcyla in April this year, but this offer was not deemed cost effective for use within the National Health Service (NHS).

“Kadcyla is currently one of the most effective drugs used to treat metastatic HER2 positive breast cancer. It extends life by 5.8 months and has the potential to be used by more than 1500 women in the UK alone. Although NICE’s rejection means that Kadcyla will not be reimbursed within the NHS, the drug is still available to women in the UK via the Cancer Drugs Fund (CDF).

“The CDF challenges the NICE approval process for cancer drugs. Products that are not reimbursed by the NHS are still available to NHS patients, and UK physicians interviewed by GlobalData have not had problems in acquiring the drugs needed for their patients.

“The CDF was introduced in 2010 to give NHS patients free access to cancer drugs that are often available in other developed countries, but which have not been approved by NICE. The scheme was intended to end in January 2014, with the introduction of a new value-based pricing system, which would consider a drug’s wider social and economic impact.

“However, the fact that CDF funding has been extended to 2016 signals that value-based pricing will not be vastly different to the current system. While the budget for the CDF has remained stable at £200 million ($335 million) every year, the amount available for each patient has continually decreased in real terms, due to increased cancer incidence in an aging population, and the rising cost of innovative new drugs.

“The CDF is currently a convenient buffer between NICE and Big Pharma, but when this buffer disappears, patients will lose out unless government and industry can become more flexible in the assessment and pricing of new drugs.”