During the past week, the UK's National Institute for Health and Clinical Excellence (NICE) has issued mixed recommendations on the use of drugs for the treatment of renal cell carcinoma (RCC) and metastatic colorectal cancer (MCRC).
NICE has not recommended Genentech's (Roche) Avastin (bevacizumab), Bayer HealthCare/Onyx Pharmaceuticals' Nexavar (sorafenib) and Wyeth Pharmaceuticals' Torisel (temsirolimus) as first-line treatment options for advanced and/or metastatic RCC. In addition, Nexavar and Pfizer's Sutent (sunitinib) are not recommended for second-line treatment, although both are licensed in the EU for this therapy. According to NICE, the evidence to support the use of the first- and second-line treatments is not strong enough to justify using NHS funds, which could be used for other cancer treatment programmes or in other treatment areas.
In response to this NICE decision, Roche is considering all options. The Appraisal Committee accepted that Avastin in combination with interferon has a similar clinical and cost-effectiveness profile to the already-approved Sutent, but turned it down because it has a licence in other indications, despite the fact that these indications are not currently routinely reimbursed on the NHS.
John Melville, General Manager of Roche UK, commented: "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."
On a positive note, NICE has recommended the use of Merck Serono's (Merck KGaA) Erbitux (cetuximab) in combination with FOLFOX for the first-line treatment of MCRC, but only when all of the following criteria are met: (a) the primary colorectal tumour has been resected or is potentially operable; (b) the metastatic disease is confined to the liver and is unresectable; (c) the patient is fit enough to undergo surgery to resect the primary colorectal tumour and to undergo liver surgery if the metastases become resectable after treatment with Erbitux; and (d) the manufacturer rebates 16 per cent of the amount of Erbitux used on a per patient basis.
Further, NICE recommended that patients who meet the above criteria should receive treatment with Erbitux for no more than 16 weeks. After this period, treatment with Erbitux should stop and the patient should be assessed for resection of liver metastases. It was also recommended that people with MCRC with metastatic disease confined to the liver who receive Erbitux should have their treatment managed only by multidisciplinary teams that involve highly-specialised liver surgical services. The Appraisal Committee concluded that under the specific circumstances outlined in the guidance, the cost of Erbitux in relation to how well it works is an effective use of NHS resources.
Although the NICE guidance on the use of Erbitux means many MCRC patients will have a new treatment opinion, the decision not to recommend Avastin, Nexavar or Torisel as a first-line therapy for RCC will reduce treatment options for UK patients who are fighting this disease, yet is available for the same indication in comparable countries.
Alice Rossiter - Cancer Drug News Editor
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