National Institute for Health and Clinical Excellence (NICE) issues negative draft decision for Afinitor® (everolimus)
The National Institute for Health and Clinical Excellence (NICE) today issued an Appraisal Consultation Document (ACD) recommending that Novartis’ life extending advanced breast cancer treatment, Afinitor® (everolimus), should not be available to patients on the NHS. Everolimus is the sixth treatment that NICE has turned down for patients with advanced breast cancer since 20111-6.
Everolimus is the first new licensed therapeutic approach in fifteen years offering substantial impact on hormone responsive advanced breast cancer which affects over 30,000 women in the UK7,8.
Professor Peter Barrett-Lee, Consultant Clinical Oncologist and Medical Director, Velindre NHS Trust, Cardiff, said, “Some women with advanced breast cancer unfortunately develop resistance to commonly used hormonal or endocrine therapies. This means their cancer will progress and many will need chemotherapy at this stage with attendant side-effects. However, new and effective treatment options such as everolimus can make a real difference as they circumvent this resistance, slow down cancer cell growth and ultimately extend and enhance patients’ quality of life.”
Everolimus is approved for use in postmenopausal women with oestrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, in combination with exemestane, that has recurred or progressed following treatment with a non-steroidal aromatase inhibitor9. The most common form of advanced breast cancer is the oestrogen receptor-positive type which accounts for approximately 75% of all breast cancers10.
A comprehensive package of clinical and cost effectiveness evidence, highlighting the efficacy and safety profile of everolimus was submitted to NICE including data from a Phase III clinical trial involving more than 700 patients11. The BOLERO-2 (Breast cancer trials of OraL EverROlimus-2) study found that:
- treatment with everolimus plus exemestane more than doubled median progression-free survival (PFS) to 11.0 months compared to 4.1 months based on an independent central radiology review11
- improvements in PFS with everolimus in combination with exemestane were achieved without compromising health-related quality of life12.
Ibrahim ElHoussieny, Oncology Medical Director, Novartis UK & Ireland, commented, “We are extremely disappointed by NICE’s draft decision but we are committed to providing as much information as we can to demonstrate the value of everolimus to patients and the NHS. Our aim is to ensure that patients with this type of advanced breast cancer receive the greatest possible benefits from this breakthrough treatment.”
The public and patient organisations can comment on this decision via the NICE website. Further evidence will now be provided to the NICE appraisal committee before a final decision on using everolimus in the NHS in England and Wales is issued.
The most common grade 3-4 adverse reactions seen with everolimus treatment (incidence ³2%) were stomatitis, infections, hyperglycaemia, fatigue, weight decrease, pneumonitis and diarrhoea11.
About Everolimus (Afinitor®)
Everolimus (Afinitor®) blocks the mTOR (mammalian target of rapamycin) pathway which acts as a crucial regulator of cell growth in various cancers. By inhibiting the mTOR protein, everolimus slows cancer cell growth and boosts the efficacy of endocrine therapies13,14. Everolimus is the first licensed mTOR inhibitor in breast cancer and the first new therapeutic approach in hormone responsive advanced breast cancer in 15 years.
About advanced breast cancer
Advanced breast cancer encompasses metastatic breast cancer (stage IV) and locally advanced breast cancer (stage III A, B or C)15. Metastatic breast cancer is the most serious form of the disease and occurs when the cancer has spread to other parts of the body, such as the bones or liver 15. Locally advanced breast cancer occurs when the cancer has spread to lymph nodes and/or other tissue in the area of the breast, but not to more distant sites in the body 15.
Breast cancer is the most common form of cancer in women in the UK and accounts for around 31% of all new cancer cases7,10. Of these cases around three quarters are hormone receptor positive (HR+)10. It is estimated that advanced breast cancer affects over 30,000 women across the UK7,8.
1. National Institute for Health and Clinical Excellence. Appraisal consultation document – Everolimus in combination with exemestane for treating advanced HER2 negative hormone-receptor-positive breast cancer after endocrine therapy. Issue date: March 2013.
2. National Institute for Health and Clinical Excellence. Bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer. Available here. Accessed on 18 March 2013.
3. National Institute for Health and Clinical Excellence. Fulvestrant for the treatment of locally advanced or metastatic breast cancer. Available here . Accessed on 18 March 2013.
4. National Institute for Health and Clinical Excellence. Eribulin for the treatment of locally advanced or metastatic breast cancer. Available here. Accessed on 18 March 2013.
5. National Institute for Health and Clinical Excellence. Lapatinib or trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone-receptor-positive breast cancer that overexpresses HER2. Available here. Accessed on 18 March 2013.
6. National Institute for Health and Clinical Excellence. Bevacizumab in combination with capecitabine for the first-line treatment of metastatic breast cancer. Accessed on 18 March 2013.
7. Cancer Research UK. Breast Cancer Incidence Statistics. Prevalence. Last accessed on 18 March 2013.
8. National Institute for Health and Clinical Excellence.Advanced breast cancer costing template CG81. Accessed on 18 March 2013.
9. Afinitor Summary of Product Characteristics.
10. Murray et al. A randomised study of the effects of letrozole and anastrozole on oestrogen receptor positive breast cancers in postmenopausal women. Breast Cancer Res Treat. (2009) 114:495-501.
11. Piccart M et al. Everolimus for Postmenopausal Women with Advanced Breast Cancer: Updated Results of the BOLERO-2 Phase III Trial. Abstract #559. American Society of Clinical Oncology 2012 Annual Meeting, Chicago, IL.
12. Beck et al. BOLERO-2: Health-Related Quality-of-Life in Metastatic Breast Cancer Patients Treated with Everolimus and Exemestane. Abstract #539. American Society of Clinical Oncology 2012 Annual Meeting, Chicago, IL.
13. Advani, S. H. Targeting mTOR pathway: A New Concept in Cancer Therapy. Indian Journal Medical Pediatric Oncology. Oct-Dec 2010.
14. Baselga, J. Everolimus in Postmenopausal Hormone-Receptor-Positive Advanced Breast Cancer. New England Journal of Medicine. February 9, 2012.
15. National Cancer Institute. What You Need to Know About Advanced Breast Cancer. Accessed on 18 March 2013.