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.
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.