The Department of Health has asked the National Institute for Health and Clinical Excellence(NICE) to produce guidance for the NHS in England and Wales on the treatment of metastatic colorectal cancer with bevacizumab (Avastin) in combination with oxaliplatin and either 5-fluorouracil plus folinic acid (Folfox) or capecitabine (Xelox).
Having considered the evidence submitted by the manufacturer (Roche) and the views of non-manufacturer consultees and commentators, clinical specialists and patient experts; NICE’s Appraisal Committee has now published its appraisal consultation document (ACD). The ACD sets out the draft recommendations of the Committee. Once NICE has reviewed comments upon the ACD from the consultees, commentators and the public, it will then produce a final appraisal determination which, subject to any appeal by the consultees, will form the basis of the final technology appraisal guidance.
As it stands, the ACD does not recommend the use of Avastin with Folfox/Xelox for the treatment of metastatic colorectal cancer. The committee concluded that Avastin, in combination with oxaliplatin-containing regimens, produced a modest benefit in terms of clinical effectiveness over regimens without Avastin, that Avastin was clinically effective as a second-line treatment and that the benefits of Avastin were achieved at the expense of "small but definite" increases in adverse effects.
In assessing cost-effectiveness, the committee took account of the patient access scheme proposed by Roche, despite concerns voiced by the Department of Health about the scheme’s complexity and the administrative burden it would impose. It concluded that both with and without the access scheme, the cost-effectiveness ratios estimated by the manufacturer were likely to be underestimates.
As a final consideration, the committee did not consider that Avastin represented a sufficiently innovative technology in the treatment of metastatic colorectal cancer because it did not result in a substantial improvement in progression-free or overall survival. The committee therefore concluded that Avastin in combination with oxaliplatin-containing regimens could not be recommended as a cost-effective use of NHS resources for either first or second line treatment of metastatic colorectal cancer.
The Chairman of NICE, Professor Sir Michael Rawlins, has cast doubt on the growing use of complex pricing schemes that offer money-back guarantees or discounts to keep down the costs of expensive new drugs, saying that it would often be better for the NHS if pharmaceutical companies offered more significant initial mark-downs on their drugs. Despite this, since its inception, NICE has authorised about a dozen patient access schemes for treatments for multiple myeloma, cancer, macular degeneration, psoriasis and rheumatoid arthritis.