NICE asks for more information on skin cancer drug

NICE, the healthcare guidance body, has issued draft guidance requesting Roche, the manufacturer of vemurafenib (Zelboraf) provides further information on the use of their drug for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma.

NICE published draft guidance not recommending vemurafenib for consultation in June. Publication of this new draft follows the submission of additional analysis on the cost effectiveness of the drug by the manufacturer. The new draft guidance has been issued today (10 August) for consultation. Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Commenting on the new draft recommendations, Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost the NHS is being asked to pay. Vemurafenib is an expensive drug and its long term benefits are difficult to quantify.

"During consultation on the first draft recommendations, the manufacturer of vemurafenib submitted additional analyses on the effectiveness of the drug in relation to its cost. When it was asked to consider this new information, our independent advisory committee concluded that they required further clarification to be able to make the decision to recommend or not recommend it for routine use in the NHS. It has therefore asked the manufacturer provide further analyses and clarification.

"We hope that Roche will be able to provide this additional information so that the Committee can consider it at its next meeting on the topic."

Ends

About the guidance

1. The draft guidance will be available at http://guidance.nice.org.uk/TA/Wave27/5 from 10 August 2012. Embargoed copies of the draft guidance are available from the NICE press office on request.

2. Evidence from the BRIM3 study indicates that treatment offers an extension to life of at least an additional 3 months, compared with current NHS treatment.

3. Patients with advanced or metastatic malignant melanoma are usually treated with carboplatin-based chemotherapy or dacarbazine, or given best supportive care.

4. The Committee agreed that the most plausible ICER for vemurafenib was highly uncertain (given the assumptions made on estimating overall survival and the long-term benefit of vemurafenib) and could be significantly higher than ?50,000 per QALY gained.

5. Vemurafenib costs ?1750 for one pack of 56 x 240-mg tablets (1 week's supply). Treatment for an average duration of 7 months (30 weeks) would cost ?52,500

The manufacturer of vemurafenib has agreed a patient access scheme with the Department of Health, in which a discount on the list price of vemurafenib is offered. The size of the discount is commercial-in-confidence.

6. The Committee heard from the manufacturer and clinical specialists that the total number of people who would be eligible for treatment with vemurafenib was less than 1,000 each year in England and Wales

7. The Scottish Medicines Consortium will publish guidance on this topic in September 2012.

8. The Appraisal Committee felt that the evidence from the BRIM3 study was uncertain as many of the patients receiving dacarbazine transferred to vemurafenib and patients whose disease progressed after treatment with dacarbazine were able to receive a range of other therapies including ipilimumab and investigational treatments.

9. The Committee recommends that NICE requests further clarification from the manufacturer on the following:

• A full explanation of the assumptions made and parameter values used for the rank preserving structural failure time (RPSFT) method to adjust survival estimates to account for patients who switched from dacarbazine to vemurafenib on disease progression. A discussion of the plausibility of using alternative approaches that adjust for switching in the BRIM3 study population, or the use of data from other trials to represent the clinical effectiveness of dacarbazine should also be provided.
• An additional scenario analysis for vemurafenib compared with dacarbazine, estimated by separately fitting exponential hazards to each arm of the BRIM3 study (using February 2012 data cut-off) from 14 months.
• For the above scenario analysis:

  - Information that would allow sufficient critique of the model and its parameters should be provided, including details of how censoring was incorporated into the progression-free survival, post-progression survival and overall survival analyses

  - Probabilistic sensitivity analyses should be provided

  - Incremental costs and QALYs gained should be reported

  - A revised fully executable economic model should be provided that is amenable to verification of the above revisions

About NICE

10. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

11. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

12. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

13. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 10 August 2012

Source: http://www.nice.org.uk/newsroom/pressreleases/VemurafenibForMelanomaACD2.jsp

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