OBJECTIVES:

Lung cancer is the third-most commonly diagnosed cancer and accounts for 13% of all new cases in the UK. Approximately 80% of lung cancer is of the non-small-cell type (NSCLC) and 35% of NSCLC have squamous histology. Till date, 13 immunotherapies have been approved by EMA for NSCLC. Recently, immunotherapies have demonstrated durable response in patients with metastatic NSCLC. The objective of the current review is to understand the strategies and challenges with value proposition of immunotherapies (immune check-point inhibitors) in NSCLC.

METHODS:

HTA website (NICE) and regulatory agency (EMA) for the UK were searched for immunotherapies in NSCLC.

RESULTS:

Immunotherapies with check-point inhibitors have demonstrated durable clinical response and manageable toxicity in patients with advanced NSCLC. Therefore, regulatory agencies have developed programs for expedited clinical development and approval of these immunotherapies. Of 13 approved immunotherapies in NSCLC by EMA, currently approved immune-check point inhibitors include nivolumab and pembrolizumab. Clinical trials are being conducted on atezolizumab, durvalumab, avelumab, ipilimumab, and tremelimumab as monotherapy as well as in combination with chemotherapy, radiation, and targeted therapies.

According to NICE TA, pembrolizumab is the only recommended immunotherapy in NSCLC; however, with patient access scheme (PAS). Pembrolizumab has been recommended for treating PD-L1-positive NSCLC in adults who have had prior chemotherapy. The TA review of atezolizumab and nivolumab are still in progress by NICE. Additionally, in 2016-17, four immunotherapies for NSCLC were either terminated or not recommended by NICE owing to their higher cost.

CONCLUSIONS:

Despite better clinical outcomes, immunotherapies are associated with higher cost. The pricing strategy should thus be carefully planned based on evidence that is able to communicate value. Possible approaches include evidence planning for specific efficacy in sub-groups with intensive unmet need or specific safety value planning. Further, PAS schemes could also be designed to support reimbursement.