Breast cancer care campaigners have slammed draft guidelines from the National Institute for Health and Care Excellence turning down NHS funding for Roche's Kadcyla (trastuzumab emtansine) because it costs "tens of thousands of pounds more than other treatments".
The Institute has concluded that despite some evidence of efficacy, extending life in patients with metastatic HER2-positive breast cancer by up to six months, the magnitude of the drug's effect is not enough to justify its high cost and so it does not represent value for money.
Kadcyla is currently available to patients in England via the Cancer Drugs Fund, but this is only currently scheduled to run until 2016 and, at around £90,000 per patient, is it unlikely to ever be 'routinely' available on the NHS unless its price drops significantly.
"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," Sir Dillon said, and called on the Swiss drug giant to "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".
“The drug appraisal process in England, and the cost of drugs, must change if prospects for patients are going to improve," said Breakthrough Breast Cancer’s Senior Policy Manager, Caitlin Palframan, noting that this is "the third highly-effective breast cancer drug to be rejected by NICE on the basis of cost".
"We are now looking to the Department of Health and the pharmaceutical industry to find a way to work together to bring the cost of expensive drugs down and put a sustainable system in place by which new treatments can be made available on the NHS on a routine basis," she added.
Giotrif for NSCLC gets in
Elsewhere, there was good news for lung cancer patients with an EGFR-TK mutation after the cost regulator approved the use of a third targeted therapy for the disease - Boehringer Ingelheim's Giotrif (afatinib) on the NHS in England and Wales.
NICE has now published final guidance recommending the drug to treat patients with non-small-cell lung cancer (NSCLC) which is locally advanced or has spread to other parts of the body and whose tumours test positive for the mutation.
In line with its licensed indication, the Committee agreed that the drug should only be used in patients who have not been previously treated with an EGFR tyrosine kinase inhibitor.
The anticipated NHS list price is £2,023.28 per pack of 28 tablets, which translates to a cost of around £22,000 per patient per year (based on a progression-free survival of 11 months), but BI has agreed a patient access scheme with the Department of Health under which a confidential discount is applied at the point of purchase or invoice.
Alimta turned down in maintenance setting
In disappointing news for patients, the cost watchdog has now issued final guidance rejecting Lilly's Alimta (pemetrexed) for the maintenance treatment of non-squamous NSCLC following induction therapy with the drug and cisplatin, on grounds that, with an potential incremental cost of nearly £75,000 per QALY, it is simply too expensive.
NICE already recommends the drug in the maintenance setting following a different first treatment, but while pemetrexed is effective when given after induction treatment with pemetrexed/cisplatin, "it did not offer sufficient benefit to justify the costs that Eli Lilly is asking the NHS to pay," said chief executive Sir Andrew Dillon, stressing that the Institute can only recommend treatments "which are both clinically and cost effective.”