NICE Turns Down Avastin(R) (bevacizumab) For Kidney Cancer Depriving Patients Of Vital Treatment Option, UK

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology
Article Date: 27 Aug 2009 - 0:00 PDT

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Roche announces that it is considering all options after the National Institute for Health and Clinical Excellence (NICE) turned down Avastin (bevacizumab) for kidney cancer (metastatic renal cell carcinoma)1. The appraisal committee accepted Avastin in combination with interferon has a similar clinical and cost-effectiveness profile to the already approved Sutent®(sunitinib), but turned it down simply because it has a licence in other indications - despite the fact that these indications are not currently routinely reimbursed on the NHS.

The implication of this guidance is that patients who are unsuitable for sunitinib may be condemned to faster disease progression of their terminal cancer because they will now be denied access to another treatment option. This choice is essential because bevacizumab has a different adverse event profile to sunitinib which may make it more suitable for some patients.

John Melville, General Manager of Roche UK, said: "This decision is entirely illogical and neither addresses the needs of patients with renal cancer, nor advances the innovation agenda. Avastin demonstrates the same value to the NHS as sunitinib and this guidance goes against the spirit of end of life criteria which were devised for this very setting".

In making its decision NICE ruled that the recent end of life criteria2 (see 'notes to editors' below for details) relating to small patient populations and does not apply if the treatment option already has a licence in other indications. The decision by NICE not to recommend the use of Avastin (bevacizumab) for advanced kidney cancer1 is fundamentally flawed and serves only to reduce treatment access and options for those UK patients who are sadly dying from this disease whilst being available to other patients in comparable countries.

About Kidney Cancer

On an annual basis, approximately 7,000 people in the UK will receive a diagnosis of kidney cancer and more than 3,500 people in the UK will lose their lives to the disease3.

Renal cell carcinoma (RCC) is the most common type of kidney cancer4. Prognosis for RCC depends in the degree of cancer spread. Unfortunately, because kidney cancer is often asymptomatic, the majority of patients are diagnosed at later disease stages where the cancer has spread to the lymph nodes or other organs5. Treatment options for patients with kidney cancer are limited. Surgical removal of part or the entire kidney forms the mainstay of treatment but is only really successful in early stage disease. In later stage disease, treatment is more often employed with a view of controlling the cancer and improving associated symptoms.

Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and/or metastatic renal cell cancer5.

Adding bevacizumab to interferon offers patients with advanced renal cell cancer the chance to live almost twice as long without their disease advancing (progression free survival) compared with interferon alone (10.2 months vs. 5.4 months) 6.

Side effects specific to Avastin include proteinuria and hypertension7, which are largely manageable and asymptomatic. Side effects specific to interferon include flu-like symptoms, fatigue, anorexia and neuropsychiatric symptoms8.

About Avastin (bevacizumab)

Avastin(bevacizumab) is a biologic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF) protein that plays an important role in the development and maintenance of blood vessels, a process known as angiogenesis. VEGF is a potent activator of angiogenesis throughout the lifecycle of a tumour and is thought to be critical to a tumor's ability to grow and spread in the body (metastasise). Bevacizumab is approved in EU for the treatment of the advanced stages of four common cancer types: colorectal cancer, breast cancer, lung cancer and kidney cancer. More than 500,000 patients have been treated with bevacizumab so far.

Bevacizumab's Summary of Product Characteristics are available at: http://www.emc.medicines.org.uk.

References

1. NICE Final Guidance for bevacizumab (first line), sorafenib (first and second line), sunitinib (second line) and temsirolimus (first line) for the treatment of advanced and/or metastatic renal cell carcinoma. August 2009.

2. NICE Appraising life extending, end of life treatments. January 2009.

3. Cancer Research UK. http://info.cancerresearchuk.org/cancerstats/types/kidney/ accessed on 24/4/9

4. Medline Plus Medical Encyclopedia. http://www.nlm.nih.gov/medlineplus/ency/article/000516.htm accessed on 24/4/9

5. ibid

5. Avastin SmPC

6. Escudier et al (2007) 'Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial' in The Lancet: 370:2103-11

7. Avastin SmPC

8. Roferon A SmPC

Source
Roche

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