Kadcyla

NICE says no to NHS funding for Kadcyla

pharmafile | December 16, 2015 | News story | Research and Development, Sales and Marketing Breast Cancer Now, Kadcyla, NHS, NICE, Roche, advanced breast cancer, breast cancer 

NICE has turned down Roche’s application for NHS funding for Kadcyla as a treatment for a type of advanced breast cancer.

In its final guidance the UK healthcare watchdog has decided the routine use of Kadcyla (trastuzumab-emtansine) is too expensive for the NHS.

In November NICE published draft guidance in which it rejected the drug. At the time chief executive Andrew Dillon said that despite Roche dropping its price from £90,000 to £70,000, “the price that the manufacturer is asking the NHS to pay in the long-term is too high.”

A spokesperson for NICE says: “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 to the patient access scheme available for the NICE appraisal, which means it is still above the top of our specially extended range of cost effectiveness for cancer drugs.”

Some funding provision remains for Kadcyla through the Cancer Drugs Fund, after NHS England reinstated the drug to the list after successful price negotiations with Roche. But funding for this and other drugs in the Fund remains uncertain pending the outcome of a consultation on its future, as it is due to be replaced in April 2016. However, NICE insists this guidance does not mean that people currently taking Kadcyla will stop receiving it, as the watchdog says patients “have the option to continue treatment until they and their doctors consider it appropriate to stop.”

Kadcyla is licensed to treat HER2-positive breast cancer that has spread to other parts of the body, which cannot be surgically removed and has stopped responding to initial treatment. Roche estimates that about 800 women are suitable to receive treatment each year. NICE first rejected Kadcyla in draft guidance in April 2014, which did not recommend the treatment due to is high price. Following a public consultation on this guidance, Roche did submit a patient access scheme to make access to Kadcyla more cost-effective. But NICE says “Roche proposed a simple discount on the price of the drug, but this had a minimal effect on its cost-effectiveness.”

In a atstement, NICE says it is willing to continue to work with NICE to ensure that Kadcyla is made available to women throughout the UK – though it is not clear how this will be achieved. Deborah Lancaster, who is director of Roche UK, says: “Through the hard work by all stakeholders this year, we have been able to maintain access to life-extending medicine Kadcyla on the NHS, through the CDF, for people with cancer living in England.

“We have written to NICE to say that we are prepared to offer the same discount that was required to retain Kadcyla on the CDF. 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, and becomes available to women living in Wales, Scotland and Northern Ireland who do not benefit from the CDF.

“Roche has demonstrated that, when given the opportunity to come to the table with all parties, we can come to an agreement and do the right thing for patients, wherever they may live; this principle that should be at the heart of the access system moving forward.”

The decision was met with disappointment from patient groups. Sally Greenbrook, policy manager at the charity Breast Cancer Now, says: “Women in England who could benefit from Kadcyla are covered – for now – by the Cancer Drugs Fund, but with just months until the new Fund is introduced, we’re yet to be convinced that the proposals will improve the outlook for breast cancer patients.

“We’ll do all we can to ensure that reform of the Fund leads to positive change but given that the plans include using similar thresholds to those used by NICE, and no mention of pricing negotiations, we’re concerned that the new Fund will fail to improve on the existing one and may make matters worse.

“Questions around how access to cancer medicines can be improved outside of England, and beyond the Fund, also remain unanswered by the Government and people living with incurable cancer need answers.”

Lilian Anekwe

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