(Uxbridge, Middlesex, 10 October 2016) – Bristol-Myers Squibb today announced that the Scottish Medicines Consortium (SMC) has recommended the breakthrough and potentially life-extending cancer immunotherapy Opdivo®ï± (nivolumab) to treat Scottish NHS patients with the most common form of advanced lung cancer.1 Today’s recommendation means that Scottish patients will become the first in the UK to be treated with nivolumab on the NHS for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), where disease has progressed after prior chemotherapy.1* The decision broadens funding for the medicine following the SMC approval of nivolumab for a smaller group of NSCLC patients - those with squamous NSCLC - earlier this year.2 In contrast, nivolumab remains unavailable on the NHS to lung cancer patients in England, Wales and Northern Ireland.3,4,5 Lung cancer is a significant health burden in Scotland: in 2014 around 5,300 people were diagnosed and approximately 4,100 people died from the disease – more than breast, colorectal and prostate cancers combined.6
Nivolumab is the first in an innovative class of medicines (PD-1 immune checkpoint inhibitors) for the treatment of lung cancer patients. It has a mode of action that works by harnessing the ability of the immune system to fight this type of advanced lung cancer,7 as well as advanced forms of kidney cancer and melanoma (a type of skin cancer).7
“We are very happy for advanced lung cancer patients in Scotland who will now have the option of treatment with nivolumab on the NHS.” said Benjamin Hickey, General Manager, Bristol-Myers Squibb UK & Ireland. “The SMC has recognised that lung cancer patients are in urgent need of a new treatment option that has the potential to help them live longer and give them more time with their families. However, because the NICE process has been ongoing for many months, NHS patients in England, Northern Ireland and Wales face the desperately unfair situation of not having the same access to nivolumab treatment as those across the border in Scotland. We are exploring all possible options in order to resolve this disparity as soon as possible.”
The SMC submission was based on a pivotal Phase III study of advanced non-squamous NSCLC patients in which 16% more of those who received nivolumab were still alive at 18 months, compared to those who received treatment with standard of care chemotherapy, docetaxel (39% [95% CI, 34 to 45] vs. 23% [95% CI, 19 to 28] respectively).8 Patients treated with nivolumab also reported significantly fewer treatment-related adverse events (grade 3 or 4) compared tothe docetaxel group (10% vs. 54% respectively).8
The majority of lung cancer patients are diagnosed at an advanced stage and the prognosis for survival in these patients is poor. In Scotland, only 10% of patients diagnosed with lung cancer will survive five years or more.6
* Treatment with nivolumab should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by patient and is subject to a two-year clinical stopping rule.
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1 Scottish Medicines Consortium. nivolumab - Detailed Advice Document. 09 September 2016
2 Scottish Medicines Consortium. nivolumab (Opdivo). Available at: https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1144_16_nivolumab_Opdivo_for_metastatic_squamous_NSCLC/nivolumab_Opdivo_for_metastatic_squamous_NSCLC. Last accessed October 2016
3 National Institute of Health and Care Excellence (NICE). Appraisal Consultation Document (ACD). Nivolumab for previously treated locally advanced or metastatic squamous non-small cell lung cancer. Available at: https://www.nice.org.uk/guidance/GID-TAG506/documents/appraisal-consultation-document. Last accessed October 2016
4 All Wales Medicine Strategy Group. nivolumab (Opdivo®). Available at: http://www.awmsg.org/awmsgonline/app/appraisalinfo/1989. Last accessed October 2016
5 National Centre of Pharmacoeconomics NCPE Ireland. Nivolumab (Opdivo®) for non-squamous NSCLC. Available at: http://www.ncpe.ie/drugs/nivolumab-opdivio-for-non-squamous-nsclc/. Last accessed October 2016
6 Information Services Division (ISD) Scotland. Cancer in Scotland. Available at: http://www.isdscotland.org/Health-Topics/Cancer/Publications/2016-05-17/Cancer_in_Scotland_summary_m.pdf. Last accessed October 2016
7 Opdivo. Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/30476 Last accessed October 2016
8 Hossein Borghaei, D.O., et al. Nivolumab versus Docetaxel in Advanced Non squamous Non–Small-Cell Lung Cancer. N Engl J Med 2015; 373:1627-1639
9 Hossein Borghaei, D.O., et al. Nivolumab vs Docetaxel in Patients With Advanced NSCLC: CheckMate 017/057 2-Year Update and Exploratory Cytokine Profile Analyses. Presented at the American Society of Clinical Oncology 2016 Annual Meeting; June 3–7, 2016; Chicago, IL, USA
Last updated on: 10/10/2016
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