This Government understands the devastating effect that lung cancer has on patients like the petitioner, Mr Cole, and indeed their family. It is vitally important for him and other patients to have access to the most effect cancer treatments. This is why we established the Cancer Drugs Fund (CDF). The CDF works to ensure that patients in England have better access to effective cancer drugs not routinely funded by the NHS.

Since October 2010, the Cancer Drugs Fund has enabled over 120,000 approvals for treating people in England with life-extending cancer drugs that would not otherwise have been available to them. Since the introduction of the Fund we have spent more than £1.9 billion helping people with cancer get the treatments they need. New arrangements for the appraisal and funding of cancer drugs in England which came into effect from July 2016 are also helping to provide faster access to the most promising new cancer drugs and ensure better value for patients, taxpayers and the NHS.

NICE is the independent body that provides guidance on the prevention and treatment of ill health and the promotion of good health and social care. NICE produces a range of guidance products, including technology appraisals, clinical guidelines and quality standards. Decisions on which medicines should be routinely available on the NHS are very difficult to make and NICE only reaches its final decisions on the use of a technology after a careful and thorough consideration of the evidence and following extensive consultation with stakeholders.

NICE published technology appraisal guidance on pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer (TA447) on 28 June 2017.  NICE recommended pembrolizumab as an option for certain people with untreated PD-L1-positive metastatic non-small-cell lung cancer, within the Cancer Drugs Fund (CDF).  It was initially recommended for use within the CDF because there were clinical uncertainties that needed to be resolved using further data from an ongoing clinical trial.  When the guidance was reviewed in the light of the new data from the trial, NICE was able to confirm its effectiveness and recommend it for routine commissioning. On 28 July 2018 NICE therefore published updated recommendations which are available at Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer (TA531).

The recommendation to stop treatment at 2 years, in both the original and updated guidance, was based on the best available clinical evidence, especially one particular trial (KEYNOTE024). This trial was designed to stop treatment at 2 years, on the expectation that patients would not need to continue treatment to achieve the long-term benefit.  NICE’s independent Appraisal Committee understood that no patients in the trial on pembrolizumab completed 2 years' therapy. The committee heard from clinical experts that while the best duration of treatment with pembrolizumab is unknown, patient and clinical experts agreed that stopping treatment at 2 years independent of disease status would be acceptable to patients.

When NICE publishes guidance, a review date is suggested. NICE does not have any current plans to review its recommendations, including that the treatment should be used for no more than two years. However, NICE’s guidance may be reviewed early if there is significant new evidence that is likely to change the recommendations.

Department of Health and Social Care