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An application is being made to the Scottish Medicines Consortium (SMC) which is part of NHS Scotland for assessment of Nivolumab.
SMC helps the NHS plan the speedy introduction of beneficial treatments across Scotland.

There is a paucity of effective and tolerable treatment options available for the treatment of patients with Head & Neck cancer (SCCHN) who have progressed on or after platinum-based therapy. The chemotherapy agents presently used for them can be associated with high levels of toxicity which can negatively affect patients’ quality of life. and as many as half of all patients at this stage are not fit enough to tolerate chemotherapy and/or are unwilling to undergo further treatment. There is therefore a considerable unmet clinical need in Scotland and elsewhere for effective and well-tolerated treatments for this patient group

Nivolumab is an antibody (a special type of protein), designed and developed to harness the body’s own immune system to directly fight cancer cells. More specifically it is known as an ‘immune checkpoint inhibitor’. The efficacy of nivolumab for patients with this condition has been demonstrated in the international, phase 3 randomised controlled trial, CheckMate 141. The results of this trial demonstrated that survival is significantly improved in patients treated with nivolumab compared to ‘investigator’s choice’ of current therapies:
  • Median survival time (i.e. the time point when half the patients in each group have died) was increased from 5.1 months in the ‘investigator’s choice’ group to 7.5 months in the nivolumab group; this 2.4-month increase represents a 47% increase in median survival with nivolumab compared to ‘investigator’s choice’
  • The proportion of patients who were alive at 12 months was more than twice as high in the nivolumab group (36.0%) compared to the ‘investigator’s choice’ group (16.6%)

Nivolumab has been studied in over 2,227 patients with different types of cancer as part of clinical trials. Nivolumab is generally well-tolerated but like any medication is also associated with side effects. The most frequent side effects experienced by patients receiving nivolumab include fatigue, rash, pruritus (itching), diarrhoea, and nausea.

Changes in quality of life, as reported by patients themselves, were measured as part of the CheckMate 141 trial using validated and routinely-used questionnaires. Patients in the ‘investigator’s choice’ group reported having a meaningful decline in their ability to function (physical and social) and had worsening symptoms (such as pain, fatigue, hair loss and appetite loss) during the CheckMate 141 trial. In contrast, quality of life tended to remain stable for patients treated with nivolumab, with deteriorations in quality of life occurring, on average, much later than in the ‘investigator’s choice’ group.

Nivolumab has been demonstrated to be effective in improving both the length of life and the quality of life of patients. Given that patients with this condition are already at an ‘end-of-life’ stage, the ability to maintain levels of quality of life during their final months represents a valuable benefit for both patients and their families/carers.

The Mouth Cancer Foundation is seeking your views to allow it to make a patient-centred recommendation to SMC for the use of Nivolumab.

Please leave any comments about making Nivolumab available on the NHS below by replying to the poll. Thank you
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