Roche’s Kadcyla ‘unaffordable’ for NHS

Roche's new breast cancer treatment Kadcyla has been rejected by NICE in draft guidance, with the cost effectiveness watchdog criticising the high price set by the company.

NICE says Kadcyla costs more than £90,000 per patient, and that it is not effective enough to justify the price the NHS is being asked to pay.

Kadcyla (trastuzumab emtansine) is Roche's 'next generation' version of its hugely successful breast cancer drug Herceptin for people with HER2 positive breast cancer. Kadcyla is being evaluated as a treatment option for HER2 positive patients whose breast cancer has spread to other parts of the body, cannot be surgically removed and has stopped responding to initial treatment.

NICE's draft guidance, now published for consultation, says that despite some evidence of clinical efficacy, Kadcyla doesn't work well enough to justify its high cost and therefore should not be routinely used on the NHS.

Cancer drugs fund

The impact of NICE's ruling – if it were to remain a 'no' – would be softened by the fact that Kadcyla is already being funded through England's Cancer Drugs Fund (CDF).

Kadcyla was launched in the UK in February, and in its corporate financial results for the first quarter of 2014, Roche proclaimed that Kadcyla had enjoyed strong uptake in Germany and the UK in its first few months on the market.

This rapid uptake in the UK is thanks to funding through the CDF, but the Fund is unlikely to sustain a continued growth in its use.

Only NICE can approve the drug for broader use across England, and the cost-effectiveness watchdog has chastised the firm for its pricing policy.

Sir Andrew Dillon, NICE Chief Executive, said: "We had hoped that Roche would have recognised the challenge the NHS faces in managing the adoption of expensive new treatments by reducing the cost of Kadcyla to the NHS.

"This drug is already being funded through the special Cancer Drugs Fund. Our job is to recommend whether it should transfer into the NHS budget. We are very aware of the importance that people place on life-extending cancer drugs and a decision not to recommend a cancer treatment for routine NHS funding is never taken lightly. We apply as much flexibility as we can in approving new treatments, but the reality is that given its price and what it offers to patients, it will displace more health benefit which the NHS could achieve in other ways, than it will offer to patients with breast cancer."

The independent Appraisal Committee, which develops recommendations on behalf of NICE, considered evidence from the manufacturer, doctors and patient experts. It heard that Kadcyla is most likely to be given as a 'second-line' treatment and could potentially help to extend life by nearly six months compared with the treatment combination of lapatinib plus capecitabine (GSK's Tyverb and Roche's Xeloda). However, a course of treatment with Kadcyla is expected to cost £90,831 per patient – tens of thousands of pounds more than other currently available second-line treatments. Considering the high cost of the drug, the committee concluded that it could not recommend trastuzumab emtansine as a cost-effective use of NHS money.

Sir Andrew continued: "We hope the manufacturer will act in the best interests of patients and use this consultation period to look again at their evidence and consider if there is more they can do."

Consultees, including the manufacturer, healthcare professionals and members of the public are able to comment on the draft recommendations via the NICE website until Monday 19 May 2014.

Roche response

Jayson Dallas, general manager of Roche UK responded: "Roche is extremely disappointed that NICE has failed to safeguard the interests of patients with this advanced stage of aggressive disease."

He added that he hoped NICE would arrive at a "sustainable solution that builds upon the success" of the Cancer Drugs Fund, so that "patients continue to have rapid access to much needed cancer medicines".

NICE's remarks make it clear that it wants Roche to offer a 'patient access scheme' (PAS), which amounts to a price discount. However previous stand-offs between Roche and NICE – most notably over bowel cancer treatment Avastin – have not been resolved through this route.

Links

Roche's 'smart bomb' Kadcyla launched in UK