It is looking unlikely that lung cancer patients will get full access to Bristol-Myers Squibb's immunotherapy Opdivo on the NHS after cost-regulators rejected the drug in the second-line setting.
The National Institute for Health and Care Excellence has now issued draft guidelines turning down funding for Opdivo (nivoumab) to treat adults with the most common form of lung cancer - locally advanced or metastatic non-small cell lung cancer (NSCLC) - after prior chemotherapy.
The Institute did say that it would consider funding the drug via the Cancer Drugs Fund to enable the collection of more data on its use, but with a restriction - testing for biomarker PD-L1 - that is contrary to its license and could deny treatment for up to two thirds of patients, according to BMS.
Explaining its position, NICE said its appraisal committee calculated that the most plausible incremental cost effectiveness ratios for Opdivo for squamous or non-squamous NSCLC are £73,500 per QALY and £150,000 per QLAY, respectively, and thus well outside of the bounds of what is normally considered value for money for the NHS.
However, the committee did conclude that the drug appeared to benefit some more patients than others. According to NICE, clinical trials show that people taking Opdivo who had more PD-L1 on their cancer cells lived up to seven months longer than those with less, and that is why it has asked the company to make its case for including the drug on the CDF so more information can be gathered on its cost-effectiveness in patients with tumour PD-L1 levels of 10 percent or more.
But Dr Alastair Greystoke, clinical senior lecturer at Newcastle Hospitals, argues that "pivotal clinical trials of nivolumab have shown that it offers superior overall survival for these patients compared with chemotherapy regardless of PD-L1 status," and noted that NICE's decision "will be a bitter blow to patients and their families".
"We strongly disagree with the notion that nivolumab treatment should be restricted to around one third of patients because this is inconsistent with the clinical evidence," added Benjamin Hickey, general manager of BMS UK & Ireland.
"Over the last year BMS has been in discussion with NICE and NHS England and we continue to be open to finding a solution for all advanced lung cancer patients who could potentially benefit from nivolumab."
Again highlighting the postcode lottery of access to medicines on the NHS in the UK, NICE's sister body the Scottish Medicines Consortium has approved funding for Opdivo in Scotland to treat both squamous and non-squamous NSCLC patients within the drug's licensed indications.