NICE Recommends BMS’s Opdivo for Routine NHS Use in Recurrent or Metastatic Head and Neck Cancer

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The UK's National Institute for Health and Care Excellence (NICE) recently issued final draft guidance recommending Bristol-Myers Squibb's cancer immunotherapy Opdivo (nivolumab) for routine use in the National Health Service (NHS) for the treatment of patients with metastatic and recurrent head and neck cancer.

In January this year, NICE issued draft guidance rejecting Opdivo for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) following platinum-based chemotherapy. At the time, NICE stated that evidence from Opdivo clinical trials, along with data collected through the NICE Cancer Drugs Fund (CDF), indicated that patients with SCCHN treated with Opdivo had longer survival compared to those in the control group who received one of three therapies.

However, NICE added that there is uncertainty surrounding these results. This is because one of the comparator therapies—docetaxel—is used as the standard of care for these patients within the NHS. NICE stated that this raises doubts regarding the long-term overall survival benefit of Opdivo. Furthermore, the cost-effectiveness estimate for Opdivo exceeds the "acceptable" threshold that NICE considers appropriate for the use of NHS resources.

However, new evidence collected from the CDF indicates that patients treated with Opdivo may experience a 9-month extension in overall survival compared to those receiving other therapies. NICE added that, despite this, it remains unclear how Opdivo compares with the "most relevant comparator drug," docetaxel.

Ultimately, NICE concluded that Opdivo meets the criteria to be considered as a life-extending treatment at the end of life. In terms of cost-effectiveness assessment, Opdivo is now considered to fall within an acceptable range for the use of NHS resources.

Head and neck cancer refers to a group of cancers that originate in the head and neck region, typically arising from the squamous cells lining the moist mucosal surfaces of this area, such as the mouth, nose, and throat. Head and neck cancer is the sixth most common cancer worldwide, with an estimated 930,000 new cases and 467,000 deaths annually. Squamous cell carcinoma of the head and neck (SCCHN) accounts for more than 90% of all head and neck cancers. Risk factors for SCCHN include behavioral factors (such as smoking or alcohol consumption) and viral factors associated with human papillomavirus (HPV) infection.

Opdivo is an anti-PD-1 monoclonal antibody that was approved in the European Union in May 2017, becoming the first drug to treat SCCHN in this market in over a decade, and the first immuno-oncology drug approved in this market for the treatment of platinum-refractory SCCHN.

This approval is based on data from the pivotal phase 3 CheckMate-141 study. The study was conducted in 361 adult patients with recurrent or metastatic platinum-refractory SCCHN, comparing Opdivo with investigator's choice of therapy (one of three: methotrexate, docetaxel, or cetuximab). Data demonstrated that, compared with investigator's choice, Opdivo significantly prolonged overall survival (median OS: 7.5 months vs. 5.1 months, p=0.0101), reducing the risk of death by 30%.

Source: NICE backs Opdivo for head and neck cancer - PharmaTimes

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