Patients currently receiving pembrolizumab will not be affected as a result of the NICE consultation document
Hoddesdon, [04 October 2016] – MSD is today responding to a draft recommendation made today by the National Institute for Health Care and Excellence (NICE). NICE has not recommended immunotherapy Keytruda (pembrolizumab) as a monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express programmed death ligand-1 (PD-L1) and who have had at least one prior chemotherapy regimen, patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) tumour mutations should also have received approved therapy for these mutations prior to receiving pembrolizumab.[i] Without a positive recommendation, these patients will not have access to pembrolizumab on the NHS.for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express programmed death ligand-1 (PD-L1) and who have received at least one prior chemotherapy regimen. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) tumour mutations should also have received approved therapy for these mutations prior to receiving pembrolizumab
MSD is disappointed with the draft decision not to recommend this treatment at this stage in the process.
Louise Houson, UK Managing Drector, MSD said; “This initial consultation document from NICE is very disappointing and we are working with both NICE and NHS England to ensure we can find a solution to get back on track and make sure this much needed treatment option is made available to people with previously treated advanced NSCLC as quickly as possible. This is particularly important as these patients have a very poor prognosis, with limited time.”
MSD has collaborated with the NHS and Government to ensure access to important medicines for patients, as demonstrated by success with innovative programmes such as the Early Access to Medicines Scheme (EAMS). Through EAMS, MSD has made pembrolizumab available at no cost to over 140 previously treated advanced NSCLC patients to date. Eligibility for this scheme ended in August, once pembrolizumab received an EU license for this patient population, and a negative recommendation from NICE in their final guidance would prevent further patient access.
The final guidance from NICE is expected later this year. This initial recommendation will not affect patients currently receiving treatment, they will continue to receive pembrolizumab via whichever funding arrangements were in place for them, until they and their clinician considers it appropriate to stop treatment. New patients do not have access at this time and future access will depend on the final guidance from NICE.Editor's Details
Last updated on: 04/10/2016
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