The Department of Health and Social Care has asked the National Institute for Health and Care Excellence (NICE) to produce guidance on using Nivolumab for adjuvant treatment of completely resected melanoma with lymph node
involvement or metastatic disease in the NHS in England.
The appraisal committee considered the evidence submitted by the company and the views of non-company consultees and commentators, clinical experts and patient experts. The recommendations were that Nivolumab is not recommended, within its marketing authorisation as monotherapy for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease.
Bristol-Meyers Squibb (BMS) is obviously disappointed with this decision as it was based on the report from the Evidence Review Group (ERG) which it believes does not reflect current UK clinical practice. If this draft guidance does not recommend Nivolumab within its marketing authorisation, and this becomes the final guidance without any changes, it will mean that patients in England and Wales with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection will not be able to access Nivolumab as adjuvant therapy.
BMS will obviously be responding robustly to the ACD to try to change the guidance. Whilst there remains a huge unmet need across the adjuvant melanoma population, they will remain committed to get this decision overturned by the 2nd ACM, scheduled for the 16th October.
Unmet patient need
The committee has acknowledged that people with fully resected melanoma are still at high risk of disease recurrence and that the potential curative aim of Nivolumab represented a substantial benefit to patients.
The committee raised questions about patients who may not relapse and as such the impact of adjuvant treatment with Nivolumab affecting the subsequent treatments for patients developing disseminated disease.
Because the clinical trial of Nivolumab versus Ipilimumab is still ongoing, data for overall survival are not yet available. This means the data are focused on recurrence-free survival. Recurrence-free survival is important because increasing the length of time before tumours come back could lead to patients living longer and a better quality of life as relapse is associated with advanced disease.
The committee recognised Nivolumab was more effective than Ipilimumab in the clinical trial. However, the comparison with ‘watch and wait’ was conducted through an indirect treatment comparison. The committee noted some differences between the trials the comparison was based on and, so in their view, the results were uncertain.
Here at the Melanoma Fund, we believe that patients deserve to have an option to this stressful ‘watch and wait’ scenario that they will undoubtedly be left with if BMS fails to reverse this decision. To provide this alternative course of treatment will create hope at a vital time for these stage 3 and 4 patients, and the Melanoma Fund will be making a submission, responding to with its own comments.
The closing date for all comments is 5.00pm on Friday 28 September. If you able and willing to support this appraisal, simply register or sign in to your NICE account and leave your comments. Full details of the consultation are online here: https://www.nice.org.uk/guidance/indevelopment/gid-ta10286/consultation/html-content-2.