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Pembrolizumab for adjuvant treatment of renal cell carcinoma

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1 Recommendations

1.1 The committee was minded not to recommend pembrolizumab for the adjuvant treatment of renal cell carcinoma at increased risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions in adults.

1.2 The committee noted that pembrolizumab may be suitable for use in the Cancer Drugs Fund. Therefore the company is invited to submit a proposal for including pembrolizumab in the Cancer Drugs Fund for the adjuvant treatment of renal cell carcinoma at increased risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions.

1.3 The committee recommends that NICE requests further clarification and analyses from the company to be made available for the second appraisal committee meeting, which should include:

  • cost-effectiveness scenario analyses, in which the estimate of treatment effect is disease-free survival assessed by blinded independent central review and this is used in the company's base case

  • scenario analyses of alternative survival extrapolations using other approaches as described in section 3.12.

Why the committee made these recommendations

Renal cell carcinoma that is at increased risk of recurrence and has been treated surgically with either a partial or radical nephrectomy is followed up with routine surveillance (regular monitoring). Pembrolizumab plus routine surveillance is a possible option as an adjuvant treatment (that is, after surgery).

Evidence from a clinical trial suggests that, after surgery, pembrolizumab plus routine surveillance increases the time people have before their cancer comes back and how long they live compared with placebo plus routine surveillance. But the clinical trial is ongoing, so how long the treatment effects last and the risk of relapse are uncertain.

The uncertainty in the clinical evidence means that the cost-effectiveness estimates are uncertain. Also, some of the most likely cost-effectiveness estimates are higher than what NICE usually considers an acceptable use of NHS resources. Therefore, pembrolizumab is not recommended for routine use. However, pembrolizumab meets the criteria for inclusion in the Cancer Drugs Fund. So, the company is invited to present a Cancer Drugs Fund submission for consideration at the second appraisal committee meeting.