Genentech/roche: Uk's Nice Remains Negative Over Avastin For Colorectal Cancer

Genentech/Roche: UK's NICE remains negative over Avastin for colorectal cancer

NICE, the UK's cost effectiveness watchdog, has again rejected the use of Avastin in combination with chemotherapy for first-line colorectal cancer patients, arguing that the drug isn't a cost effective use of NHS resources. Limited access to Avastin in the NHS will allow Erbitux to further penetrate the first-line colorectal cancer market in the UK, for which it was approved earlier this year.( http://www.bharatbook.com/detail.asp?id=68636&rt=Genentech-Inc-PharmaVitae-Profile.html )

An appraisal committee at the National Institute for Health and Clinical Excellence (NICE) provided a negative decision on Avastin after estimating that the drug's costs per quality-adjusted life year (QALY) gained overshot its GBP30,000 threshold in the first-line metastatic colorectal cancer (CRC) setting. Preliminary recommendations published this week estimated that Avastin plus XELOX (capecitabine, oxaliplatin) as a first-line CRC treatment produced an incremental cost effectiveness ratio (ICER) of GBP36,400 per QALY compared to XELOX alone. Similarly, Avastin and FOLFOX (leucovorin, 5-fluorouracil, oxaliplatin) resulted in an ICER of GBP31,500 compared with FOLFOX alone. The committee concluded that these estimates were at the lowest end of the range and plausible adjustments in the QALY calculations, for example, in the risk share agreement, or assumptions on quality of life scores for metastatic patients, could potentially increase these estimates substantially.

Roche supported its submission with data from pooled analyses of an initial two-arm and a subsequent four-arm study as part of the NO16966 trial. Avastin was compared in combination with either XELOX or FOLFOX over placebo in combination with XELOX or FOLFOX. However, the appraisal committee deemed these pooled results 'inappropriate' because there was an imbalance of prognostic factors between the arms of the trial. It concluded that Avastin in combination with oxaliplatin-containing regimens only gave a modest benefit in terms of effectiveness for first-line metastatic CRC compared with regimens without Avastin.

Avastin (bevacizumab; Genentech/Roche/Chugai) is a humanized monoclonal antibody directed towards vascular endothelial growth factor (VEGF). VEGF plays an important role in angiogenesis, a key driver of tumor growth. The drug was approved in the US in 2004 and the EU in 2005 for first-line metastatic CRC in combination with 5-fluorouracil-based chemotherapy. Since then, Avastin has gained approval for non-small cell lung cancer, breast cancer, renal cell carcinoma and glioma. However, despite receiving marketing authorization in the UK, Avastin has yet to be recommended for use in the UK's National Health Service (NHS).

NICE's negative decision will still serve to bolster Erbitux's (cetuximab; Merck KGaA/Eli Lilly/ImClone) position in the UK CRC market. Erbitux was recommended by NICE in August 2009 for the treatment of first-line wild type KRAS metastatic CRC patients on the NHS. NICE specified that only patients with unresectable metastatic disease limited to the liver should be eligible for Erbitux treatment, which should not exceed six weeks. The decision was based on data showing that Erbitux shrinks liver metastases, making them resectable in advanced CRC patients with unmutated KRAS. To date, Avastin treatment has not been shown to significantly improve liver resection rates.

The ability to select patients according to KRAS mutation status influenced the positive NICE recommendation for Erbitux. Merck KGaA will offer a GBP300 companion diagnostic test with Erbitux that will generate significant savings as it will screen out nearly 40% of CRC patients with the mutated form of KRAS, known to be unresponsive to the agent. So while the specific criteria required may limit the overall commercial potential of Erbitux, NICE's negative decision on Avastin will give Merck's drug the opportunity to become the standard targeted therapy of choice in these specific metastatic colorectal cancer patients, and boost its sales accordingly. Moreover, other healthcare systems in the seven major markets are likely to follow the example of NICE by demanding better cost-effectiveness from this expensive class of drugs.

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