NICE Terminates Technology Appraisal for Afatinib in Advanced Squamous NSCLC After Platinum-based Chemotherapy

No evidence submission was received

NICE announced on 24 May 2017 that it is unable to make a recommendation about the use in the NHS of afatinib for treating locally advanced or metastatic squamous non-small-cell lung cancer (NSCLC) after platinum-based chemotherapy because no evidence submission was received from Boehringer Ingelheim. NICE will review this decision if the company decides that it wants to make a full submission.

Boehringer Ingelheim was invited to submit evidence for this single technology appraisal for afatinib in November 2016.

The company's main clinical trial (LUX-LUNG 8) to support the appraisal compared afatinib with erlotinib for treating locally advanced or metastatic squamous NSCLC progressing on or after platinum-based chemotherapy, irrespective of epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation status. At the time the trial was carried out, NICE recommended erlotinib for this patient population. NICE then updated the erlotinib guidance, recommending erlotinib after platinum-based chemotherapy only for a small group of patients with EGFR-TK mutation-positive NSCLC.

Because the NICE recommendation for erlotinib has changed, and given the resources and time involved in a NICE technology appraisal, the company felt that it would not be of value to submit evidence for this appraisal.

NICE has therefore terminated this single technology appraisal.

NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of afatinib for treating locally advanced or metastatic squamous NSCLC after platinum-based chemotherapy. If, after doing this, organisations still wish to consider afatinib for treating locally advanced or metastatic squamous NSCLC after platinum-based chemotherapy, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. This outlines the approach that should be taken when NICE guidance is unavailable.