NICE is planning to bar patients with a particular form of lung cancer from access to Bristol-Myers Squibb’s ground-breaking immunotherapy Opdivo on the NHS in England and Wales.

Opdivo (nivolumab) is the first in a new class of medicines, called PD-1 immune checkpoint inhibitors, to be licensed for use in squamous pre-treated lung cancer patients, and is currently available in the UK to some patients through the Early Access to Medicines Scheme.

The drug’s innovative mode of action works by harnessing the ability of the immune system to find and fight cancer, and clinical trials have shown its ability to improve survival, with 42% of patients taking Opdivo still alive at one year compared with 24% of those treated with docetaxel.

But the cost-regulator has issued preliminary guidelines rejecting the drug’s use in adults with locally advanced or metastatic squamous non-small cell lung (NSCLC) whose disease has progressed after prior chemotherapy.

If guidance becomes final, it will mean that treatment options for these patients will remain limited to chemotherapies, such as docetaxel, which was first approved for use 17 years ago, BMS said, also noting that lung cancer survival rates in the UK lag almost a decade behind some of its European peers. 

The decision, says Johanna Mercier, general manager of BMS UK & Ireland, “is deeply disappointing for lung cancer patients and for us as we have worked extensively with the UK Health Authorities to enable prompt patient access”.

But Paul Workman, chief executive of The Institute of Cancer Research, London, said: “recently we have seen drug companies setting very high prices for promising immunotherapies, including nivolumab. There is no question that this pioneering and innovative treatment improves and extends the life of patients with non-small cell lung cancer – a disease that has very limited treatment options – but at this price it is very clearly too expensive for the NHS to afford”.  

Final ’no’ for Kadcyla

Elsewhere, patients with breast cancer will be disappointed with news that the Institute is sticking by its rejection of Roche’s Kadcyla (trastuzumab-emtansine), because its price is “too high for routine NHS funding”.

“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,” said a spokesperson, explaining the decision.

Kadcyla is licensed to treat HER2-positive breast cancer which has spread to other parts of the body, cannot be surgically removed and has stopped responding to initial treatment, and offers the first and only targeted chemotherapy for these patients. However, the cost regulator has balked at the drug’s high cost - around £90,000 per patient at its full list price.

Patients in England will still be able to access Kadcyla in England through the country’s Cancer Drugs Fund, but those in Wales - who had been getting access after support from the All Wales Medicines Strategy Group pending NICE’s ruling - and those in Scotland are unable to access NHS-funded treatment with the drug.

“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,” said Sally Greenbrook, Policy Manager at Breast Cancer Now.

“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,” she warned.