Negative NICE Decision For Avastin® (Bevacizumab) Highlights Challenges Facing UK Access To Medicines
Roche is disappointed that the National Institute for Health and Clinical Excellence (NICE) has published a negative final recommendation (FAD) for the use of Avastin (bevacizumab) in combination with paclitaxel and carboplatin for women with newly-diagnosed advanced ovarian cancer*.(1)
This negative decision means that women will continue to rely on their clinicians’ successful application to the Cancer Drug Fund (CDF) to access this treatment for advanced ovarian cancer in England.** However, there is considerable uncertainty about how medicines currently funded through the CDF will continue to be available to patients after the Fund’s end date due in March 2014.
There needs to be a clear transition plan for these medicines to provide much-needed reassurance for patients eligible for treatments currently funded by the CDF. It is still uncertain how the new method of medicines assessment (value-based pricing) being introduced in January 2014 will be applied to existing medicines.
Dr Marcia Hall, from Mount Vernon Cancer Centre commented “Avastin is a useful treatment option and has become a standard of care in advanced ovarian cancer. Whilst it is unfortunate that NICE were not able to recommend Avastin for front-line ovarian cancer, patients should be encouraged that the Cancer Drug fund does allow access to Avastin if their clinician feels this is appropriate. This medicine can improve the outcome for women with advanced ovarian cancer and can delay the time to disease progression by up to six months, which comes at a critical time in the lives of patients and their families”.
Women in the UK suffer a disproportionate burden of ovarian cancer, with the UK experiencing one of the highest incidences in Europe, as well as one of the highest mortality rates from the disease.(2) Ovarian cancer is the fourth highest cause of female cancer mortality (after lung, breast and colorectal cancer), and results in over 4,000 deaths among UK women each year.(2)
Avastin is the first drug that has been shown to improve outcomes for women with advanced ovarian cancer for the past 15 years,(3,4) and can halt the progression of the disease for an average of six months compared to chemotherapy alone.(3,4) It is available in England through the CDF for women with newly-diagnosed advanced ovarian cancer, should their clinician feel it is a suitable treatment for them.(5) In recurrent platinum-sensitive ovarian cancer, Avastin is expected to be reviewed shortly by the Chemotherapy Cancer Review Group (CRG) for inclusion on the centralised CDF list.
Avastin has a well-established tolerability profile in the treatment of ovarian cancer; the most frequently observed adverse drug reactions in clinical trials for ovarian cancer were hypertension, neutropenia, pain and proteinuria.(6) The most common side effects are generally manageable, for example, hypertension can usually be managed with conventional antihypertensive treatment.
Roche remains committed to improving outcomes for cancer sufferers and will continue to work with NICE and the Department of Health to find alternative mechanisms to fund treatments for patients with metastatic cancer.
About Avastin (bevacizumab)
Avastin is approved in the EU for the treatment of the advanced stages of five common cancer types: colorectal cancer, breast cancer, lung cancer, kidney cancer and ovarian cancer.(6) More than 1.3 million patients have been treated with Avastin so far.(7) Please refer to the Avastin Summary of Product Characteristics for full details, available at: http://www.emc.medicines.org.uk.
The European Medicines Agency (EMA) approved Avastin, in combination with standard chemotherapy (carboplatin and paclitaxel) for the treatment of women with advanced ovarian cancer in December 2011 and approved Avastin, in combination with carboplatin and gemcitabine for the treatment of women with advanced recurrent ovarian cancer in October 2012.(6)
The Avastin SPC can be found at: https://emc.medicines.org.uk
1 National Institute for Health and Clinical Excellence (NICE). Final Appraisal Determination. Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer [ID435]. Available at: http://guidance.nice.org.uk/TA/Wave25/16
2 Ovarian Cancer Awareness Month Facts and Figures. Available at: http://www.ocam.org.uk/page.aspx?sitesectionid=26&sitesectiontitle=Facts+and+figures(Last accessed March 2013)
3 Perren TJ, Swart AM, Pfisterer, et al. A phase 3 trial of bevacizumab in ovarian cancer. New England Journal of Medicine 2011; 365: 2484-96.
4 Burger RA, Brady MF, Bookman MA, et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. New England Journal of Medicine 2011; 365:2473-83.
5 Cancer Research UK. Bevacizumab (Avastin) as a first treatment for advanced ovarian cancer. Available here (PDF). (Last accessed March 2013)
6 Electronic Medicines Compendium. Avastin Summary of Product Characteristics. Available at: http://www.medicines.org.uk/ (Last accessed March 2013)
7 Data on file RXUKDONF00210.
* International Federation of Gynaecology and Obstetrics [FIGO] stages IIIB, IIIC and IV epithelial ovarian, fallopian tube or primary peritoneal cancer.
** There is no CDF access for patients in Wales, Scotland and Northern Ireland.