Opdivo for head and neck cancer too expensive for NHS use, says NICE
In yet another negative decision of a new cancer drug, the medicines cost-effectiveness watchdog for England and Wales has issued new draft guidance that has also come in for criticism from the Institute for Cancer Research, though the latter sees a role for Pharma to reduce the cost of drug development.
The National Institute for Health and Care Excellence (NICE) said today that it does not recommend US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) for the treatment of head and neck cancer. The anticipated marketing authorization for nivolumab is for treating squamous cell carcinoma of the head and neck which has progressed during or after platinum-based chemotherapy.
The NICE appraisal committee found that the evidence showed a significant improvement in overall survival rates in the short term after nivolumab. However, its value for money was considerably above that which is usually a cost-effective use of National Health Service resources.
“The committee heard that treatment options for patients in this area are limited, and it’s important to patients that treatment extends their life and improves the quality of life,” noted Professor Carole Longson, director of the Health Technology Evaluation Centre at the NICE, adding: “But the additional costs of nivolumab were considered to be very high in relation to its benefit to be recommended for routine NHS use at present.”
Consultees, including the company, healthcare professionals and members of the public are now able to comment on the draft recommendations via the NICE website until Thursday 4 May. All comments received during this consultation will be fully considered by the committee and a second draft of the guidance will be published.
If there are no objections at that stage, NICE will publish final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.
Although the NICE draft guidance does not recommend nivolumab for treating head and neck cancer, it does state that people already receiving the drug may continue until they or their doctor thinks it’s appropriate to stop.
“Disappointing and frustrating,” says ICR expert
“It is disappointing and frustrating that today’s decision means doctors will not be able to offer this game-changing immunotherapy to patients with advanced head and neck cancer. Once it has relapsed or spread, the disease is extremely difficult to treat and options, including surgery and radiotherapy, are very limited,” said Kevin Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research (ICR), London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, who led the UK arm of the phase III clinical trial of nivolumab for advanced head and neck cancer.
He continued: “Nivolumab is an expensive drug but it is also the only treatment shown in a Phase III trial to improve survival for this group of patients – and it did so without worsening patients’ quality of life, and with fewer side-effects than other options. It’s crucial that talks on the drug’s availability continue and ultimately that this decision is reversed, since otherwise patients face missing out on a genuinely effective treatment simply because of cost.”
ICR chief executive Prof Paul Workman added: “This decision denies patients a genuine breakthrough treatment that makes a real difference for people with relapsed of metastatic head and neck cancer. It is another example, and a particularly stark one, of an innovative cancer therapy not being made available on the NHS because of cost. I’d urge NICE and the manufacturer to work together to reach an agreement on price so that this decision can be overturned as soon as possible.
“We need to recognize that the price of cancer drugs is much too high, and that’s particularly the case with the exciting new wave of immunotherapies. We need pharmaceutical companies to bring down the cost of drug development through smaller, more targeted trials, and to do much more to pass on the savings to patients. NICE for its part must take much greater account of innovation in its appraisal processes, to give exciting treatments like nivolumab a better chance of reaching patients.”
ICER and QALY of Opdivo
The appraisal committee concluded that the incremental cost effectiveness ratios (ICERs) for nivolumab would be above the range of £66,000 to £75,000 ($81,774-$92,925; ERG) per quality-adjusted life-year (QALY) gained compared to other treatments – considerably above that usually considered to be a cost-effective use of NHS resources (£20,000 to £30,000 per QALY gained).
The committee concluded that nivolumab met all the criteria to be considered a life-extending end-of-life treatment. The committee considered that the most plausible ICER was likely to be above £50,000 per QALY gained, and concluded that the amount of additional weight that would need to be assigned to the QALY benefits in this patient group would be too great for nivolumab to be considered a cost-effective use of NHS resources. The company has agreed a patient access scheme with the Department of Health.
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