FELTHAM, England & SURREY, England--(BUSINESS WIRE)--The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) that recommends avelumab for treating adults with metastatic Merkel Cell Carcinoma (mMCC).2 Avelumab is recommended for routine NHS use in England, Wales and Northern Ireland for treating metastatic mMCC in adults, only if they have had one or more lines of chemotherapy for metastatic disease. Avelumab is recommended for use in England within the Cancer Drugs Fund (CDF) for treating mMCC in adults only if: they have not had chemotherapy for metastatic disease and the conditions in the managed access scheme are followed.
Access to avelumab for previously untreated mMCC through the CDF applies in England. Patients across Wales will also be able to access the medicine through the New Treatment Fund, which funds all treatments with a positive recommendation from NICE (and the All Wales Medicines Strategy Group), including those in the CDF with draft recommendations. Health boards and Velindre NHS Trust have 60 days to implement a recommendation following the publication of a FAD and once a Commercial Access Agreement (CAA) has been signed. In Scotland, the outcome of an assessment by the Scottish Medicines Consortium is awaited, with a decision expected in the first half of 2018.
The NICE recommendation is not intended to affect treatment with avelumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Avelumab’s inclusion in the CDF for a time-limited period, while the first-line mMCC trial data are maturing, is NICE’s preferred option, after which the clinical and cost-effectiveness of avelumab in the first-line setting will be re-evaluated by NICE. The decision by NICE to include avelumab for first-line use in mMCC in the CDF recognises the clinical benefit and patients’ unmet need in this setting.
“Merck and Pfizer are really pleased with today’s decision by NICE, which will result in patients in England, Wales and Northern Ireland being able to access the first targeted systemic treatment option licensed in the UK for metastatic Merkel Cell Carcinoma,” commented Belinda Byrne, Medical Director at Merck. “We have worked closely with NICE and the CDF to ensure all mMCC patients can get access to avelumab as early as possible in their treatment.”
Catherine Bouvier, Chief Executive of NET Patient Foundation, UK, said: “It’s fantastic news that NICE can recommend a treatment such as avelumab for patients with metastatic Merkel Cell Carcinoma. Patients with such rare cancers often don’t have access to funded treatments. This is a great outcome for patients and their families.”
Patients with mMCC have a very poor prognosis, with fewer than half of patients surviving more than one year and fewer than 20% surviving beyond five years.3 There are thought to be approximately 70 new cases of mMCC in England every year, although the accuracy of this figure is difficult to determine due to the rarity of Merkel Cell Carcinoma.4 Data show that the incidence of MCC is rising,5,6 possibly due to an ageing population or increased UV exposure.6 MCC exhibits aggressive clinical features, including frequent lymph node involvement and early metastases.7,8,9
While earlier-stage MCC can be generally managed with surgery and radiotherapy, treatment options for mMCC are severely limited.10,11 Until the UK launch of avelumab in November 2017, the only licensed treatment option for mMCC was cytotoxic chemotherapy, which has limited efficacy and is not generally well-tolerated. The preferred standard of care for mMCC, according to the NCCN guidelines, is clinical trials, but other immuno-oncology drugs are also stated as options.11
The recommendation in the FAD forms the basis of NICE’s final guidance (Technology Appraisal Guidance, TAG), anticipated over the coming weeks.
Avelumab received marketing authorisation on 20th September 2017 in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland, and was subsequently launched in the UK in November 2017.
Notes to Editors
About metastatic Merkel Cell Carcinoma (mMCC)
Metastatic MCC is a rare and aggressive disease in which cancer cells form in the top layer of the skin, close to nerve endings.12,13 Merkel Cell Carcinoma, which is also known as neuroendocrine carcinoma of the skin or trabecular cancer, often starts in those areas of skin that are most often exposed to the sun, including the head and neck, and arms.12,14 Risk factors for MCC include sun exposure and infection with Merkel cell polyomavirus. Caucasian males older than 50 are at increased risk.12, 14 MCC is often misdiagnosed as other skin cancers and grows at an exponential rate on chronically sun-damaged skin.11 Previous treatment options for MCC included surgery, radiation and chemotherapy.11,13 Treatment for metastatic or Stage IV MCC is generally palliative.13
About BAVENCIO® (avelumab)
BAVENCIO® (avelumab) is a human antibody specific for a protein called PD-L1, or programmed death ligand-1. Avelumab is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, avelumab is thought to prevent tumour cells from using PD-L1 for protection against white blood cells, such as T cells, exposing them to anti-tumor responses. Avelumab has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialise avelumab. For more information, please see the avelumab Summary of Product Characteristics.1
About the Merck-Pfizer Alliance
Immuno-oncology is a top priority for Merck and Pfizer Inc. The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialise avelumab and advance Pfizer’s PD-1 antibody programme. The alliance is focused on developing high-priority international clinical programmes to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of €15.0 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the “Merck” name and brand except in the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with healthcare providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more information, please visit us at: www.pfizer.co.uk.
1 BAVENCIO® (avelumab) EU SmPC. Available from: http://www.ema.europa.eu/ema/. Accessed February 2018
2 National Institute for Health and Care Excellence. Avelumab for treating metastatic Merkel cell carcinoma. Final Appraisal Determination. Issued March 2018.
3 Lemos B, Storer B, Iyer J, et al. Pathologic Nodal Evaluation Improves Prognostic Accuracy in Merkel Cell Carcinoma: Analysis of 5,823 Cases as the Basis of the First Consensus Staging System for this Cancer. Journal of the American Academy of Dermatology. 2010;63(5):751–761.
4 Merck submission to NICE STA: Avelumab for Merkel cell carcinoma [ID1102]: Company Evidence Submission; August 2017. Available at: https://www.nice.org.uk
5 Goon PK, et al. Merkel Cell Carcinoma: rising incidence in the East of England. J Eur Acad Dermatol Venereol 2016; epub Aug 12
6 Fitzgerald TL, et al. Dramatic increase in the incidence and mortality from Merkel cell carcinoma in the United States Am Surg 2015;81:802–806.On327-333.
7 Saini AT, Miles BA. Merkel cell carcinoma of the head and neck: pathogenesis, current and emerging treatment options. Onco Targets Ther 2015;8:2157–2167.
8 Chen MM, Roman SA, Sosa JA, Judson BL. The role of adjuvant therapy in the management of head and neck Merkel cell carcinoma: an analysis of 4815 patients. JAMA Otolaryngol Head Neck Surg 2015;141:137–141.
9 Smith VA, Camp ER, Lentsch EJ. (2012) Merkel cell carcinoma: identification of prognostic factors unique to tumors located in the head and neck based on analysis of SEER data. Laryngoscope 2012;122:1283–1290
10 Duprat J, Landman G, Salvajoli J and Brechtbühl E. A Review of the Epidemiology and Treatment of Merkel Cell Carcinoma. Clinics. 2011;66(10):1817–1823.
11 NCCN Merkel Cell Carcinoma Guidelines version I. 2016. Available from: www.nccn.org/professionals/physician_gls/PDF/mcc.pdf. Last accessed September 2017
12 Schadendorf D et al. Merkel cell carcinoma: epidemiology, prognosis, therapy and unmet medical needs. European Journal of Cancer 2017;71;53–69
13 American Cancer Society. What is Merkel cell carcinoma? http://www.cancer.org/cancer/skincancer-merkelcell/detailedguide/skin-cancer-merkel-cell-carcinoma-what-is-merkel-cell-carcinoma. Last accessed June 2017.
14 Nghiem P. Systematic literature review of efficacy, safety and tolerability outcomes of chemotherapy regimens in patients with metastatic Merkel cell carcinoma. Future Oncology 2017;13(14):1263–1279.