NICE Approves BMS’ Opdivo for Advanced Esophageal Cancer, Rejects Zeposia for Multiple Sclerosis in England and Wales

Recently, the UK National Institute for Health and Care Excellence (NICE) published a final appraisal document approving Bristol-Myers Squibb’s (BMS) anti-PD-1 therapy Opdivo (nivolumab) for the treatment of advanced, unresectable esophageal squamous cell carcinoma (OSCC) following chemotherapy failure.

With this approval, Opdivo becomes the first immuno-oncology therapy in the UK for patients with advanced OCSS who are refractory to chemotherapy and unresectable, providing an important treatment option for this patient population. Currently, chemotherapy remains the primary anticancer treatment for OSCC, with 45% of patients receiving it during curative-intent or palliative anticancer therapy.

NICE has granted approval for Opdivo, based on supportive data from the Phase III ATTRACTION-3 trial. The study evaluated the efficacy and safety of Opdivo versus chemotherapy (docetaxel or paclitaxel) in patients with unresectable advanced or recurrent OSCC who were refractory or intolerant to first-line combination therapy with fluoropyrimidine and platinum agents.

Results showed that, compared with chemotherapy, Opdivo monotherapy significantly prolonged overall survival (OS). Specifically, median OS was 10.9 months in patients receiving Opdivo versus 8.5 months in those receiving chemotherapy. Additionally, survival rates at 24 months were 20.2% and 13.4% in the Opdivo and chemotherapy groups, respectively, and at 36 months were 15.3% and 8.7%, respectively. A survival benefit with Opdivo was observed regardless of tumor PD-L1 expression levels. Exploratory analyses also demonstrated a significant improvement in quality of life for patients treated with Opdivo compared with chemotherapy.

Additionally, NICE has issued a final draft guidance for Bristol-Myers Squibb’s oral anti-inflammatory drug Zeposia (ozanimod), rejecting its use for multiple sclerosis (MS) patients in England and Wales. In February this year, the Scottish Medicines Consortium (SMC) approved funding for Zeposia for eligible MS patients or those requesting oral therapy. This decision by NICE means that the use of Zeposia will be inconsistent across the United Kingdom.

The final draft guidance issued by NICE confirms the initial draft decision published in January this year. In its decision, NICE noted that numerous oral and injectable therapies are already available on the market, including Roche's Ocrevus and Biogen's Tecfidera. Despite a discount offered by Bristol-Myers Squibb (BMS), NICE maintained its rejection, stating that Zeposia's cost-effectiveness falls outside the range typically considered an acceptable use of UK National Health Service (NHS) resources.

Zeposia is a sphingosine-1-phosphate (S1P) receptor modulator that selectively binds to S1P receptor subtypes 1 (S1P1) and 5 (S1P5) with high affinity. This drug features a "reduce damage + enhance repair" mechanism and was approved in the United States and the European Union in the first half of 2020 for the treatment of MS.

Currently, BMS positions Zeposia as a first- or second-line treatment, noting that clinical evidence shows the drug reduces relapses and brain lesions compared to Biogen’s Avonex (interferon beta-1a). However, NICE states in its guidance document that the clinical evidence provided by BMS does not clearly demonstrate Zeposia’s impact on disability progression.

The MS Trust, an MS patient organization, stated in a release that it was disappointed by NICE's decision, given that Zeposia has minimal side effects. While Biogen's Tecfidera is effective, its pronounced gastrointestinal side effects have led some patients to discontinue treatment. Additionally, Zeposia is also taken once daily, similar to Novartis's Gilenya (fingolimod), allowing patients to easily integrate it into their daily routines.

David Martin, Chief Executive of The MS Trust, stated: "As a once-daily oral medication with minimal side effects, Zeposia offers advantages over existing treatment options and will expand choices for patients with relapsing MS and their physicians." However, the trust also noted that this is NICE's final decision, with little chance of persuading it to reverse the ruling.

A Bristol-Myers Squibb (BMS) spokesperson stated that the company is disappointed that NICE did not support the use of Zeposia in England and Wales. Patients are at the core of BMS's work, and the company will continue to explore ways to support patients with neurological conditions in England and Wales. In these regions, patient needs remain unmet.

Source: NICE nod for BMS’ Opdivo in advanced oesophageal cancer