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NICE has issued final guidance on the use of axitinib for treating kidney cancer and sipuleucel-T for prostate cancer.

In guidance issued to the NHS today, NICE has recommended that the drug axitinib, also known as Inlyta and marketed by Pfizer, should be available as a second-line treatment for kidney cancer. In separate new guidance, NICE has not recommended sipuleucel-T, also known as Provenge and marketed by Dendreon, for the treatment of prostate cancer, because the available evidence showed that the price the NHS is being asked to pay for the drug is too high for the benefit it may provide to patients.

Commenting on the axitinib guidance, Professor Carole Longson, Health Technology Evaluation Centre Director said: “NICE has previously recommended two drugs for advanced renal cell carcinoma, sunitinib and pazopanib both as first-line treatments and we are pleased to confirm that axitinib will be made available through the NHS for patients after these first-line treatments have failed. Based on the evidence available and the discount on the cost of the drug offered by Pfizer, the committee concluded that axitinib would offer good value for NHS money.”

Commenting on the sipuleucel-T guidance Professor Longson said:“Unfortunately Dendreon has been unable to show that sipuleucel-T works better than other treatments currently available. It was also not proven to delay the progression of the disease, unlike current treatments. Based on the evidence presented, NICE is unable to recommend the NHS provides funding for this drug, as it costs too much for the extra benefit it may provide.”

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the axitinib guidance

1. The guidance will be available at /guidance/TA333 from 25 February 2015. 
2. Axitinib is recommended as an option for treating adults with advanced renal cell carcinoma after failure of treatment with a first-line tyrosine kinase inhibitor or a cytokine, only if the company provides axitinib with the discount agreed in the patient access scheme. At the time of publication (February 2015), axitinib has a UK marketing authorisation only for use after failure with first-line sunitinib or a cytokine. If it is considered for use after any other first-line treatments, the prescriber should obtain and document informed consent and follow the relevant guidance published by the General Medical Council. Because the remit referred to NICE by the Department of Health for this technology appraisal only includes adults who have been previously treated with sunitinib, the use of axitinib after treatment with other tyrosine kinase inhibitors is not subject to statutory funding.
3. For end-of-life considerations, the Committee concluded that that axitinib was shown to be a life-extending, end-of-life treatment for the prior-sunitinib group although uncertainty remained around the prior-cytokine group, uncertainty remained around the naive comparison, and the end-of-life criteria could only be considered met if best supportive care were the only comparator. The Committee concluded that axitinib could be considered a cost-effective use of NHS resources in the prior-sunitinib population under the supplementary criteria for appraising life-extending, ‘end-of-life’ treatments. The Committee concluded that, because axitinib almost met the end-of-life criteria and was comparable to the other alternatives (sunitinib and pazopanib), a cost per QALY above but close to the upper limit of the normal range was acceptable  and could be considered a cost-effective use of NHS resources for the prior-cytokine group.
4. The Committee concluded that the most plausible cost per QALY (Quality Adjusted Life Year) for axitinib after sunitinib would be around halfway between £33,500 and £52,900.
5. Axitinib is available in 1-mg and 5-mg film-coated tablets at net prices of £703.40 and £3,517 per 56-tablet pack. It is administered orally at a recommended starting dose of 5 mg twice daily. This dose may be increased to 7 mg and then up to 10 mg, or decreased to 3 mg and then down to 2 mg, depending on individual safety and tolerability. The manufacturer has agreed a patient access scheme with the Department of Health. The size of the discount is commercial in confidence.

About the sipuleucel-T guidance

1. The guidance will be available at /guidance/TA332 from 25 February 2015. 
2. Sipuleucel-T is not recommended within its marketing authorisation for treating adults who have asymptomatic or minimally symptomatic metastatic non-visceral hormone-relapsed prostate cancer for which chemotherapy is not yet clinically indicated.
3. The Committee concluded that sipuleucel-T compared with placebo extended life for people with asymptomatic or minimally symptomatic metastatic non-visceral hormone-relapsed prostate cancer for which chemotherapy is not yet clinically indicated. It also concluded that the trials did not show that sipuleucel-T delayed disease progression compared with placebo.
4. The Committee noted that the cost per QALY (Quality Adjusted Life Year) for sipuleucel-T was well above the range usually considered a cost effective use of NHS resources, and that sipuleucel-T did not meet the criteria for end-of-life consideration.
5. For the subgroup of patients who had not received prior chemotherapy the cost per QALY was at least £512,000 (company’s analyses) or at least £244,000 (Evidence Review Group’s analyses) for sipuleucel-T compared with abiraterone. When abiraterone was not included in the Evidence Review Group’s analysis, the cost per QALY for sipuleucel-T compared with best supportive care was £112,000.
6. For the subgroup with a baseline prostate-specific antigen concentration of 22.1 nanogram/ml or below, the company’s original analyses resulted in a cost per QALY of £48,700 for sipuleucel-T compared with best supportive care. The company’s revised analyses resulted in a higher cost per QALY. The Evidence Review Group’s exploratory analysis resulted in a cost per QALY of £61,400 for sipuleucel-T compared with best supportive care.
7. According to Dendreon, the cost of sipuleucel-T is £16,141.33 per dose, including the costs of leukapheresis, patient tests associated with leukapheresis, manufacture and transportation, and excluding VAT. The summary of product characteristics states that the recommended course of treatment is 3 doses at approximately 2 week intervals. The cost for a course of treatment is £47,132.68, based on a mean of 2.92 doses per patient.
8. The Committee considered that the mean life expectancy for people with metastatic hormone-relapsed prostate cancer for which chemotherapy is not yet indicated was unlikely to be less than 24 months, so sipuleucel-T at this stage in the treatment pathway did not meet the first end-of-life criterion for short life expectancy. 
9. The company estimated that sipuleucel-T was licensed for a population of about 4600 patients in England.
10. The Scottish Medicines Consortium (SMC) is not currently considering the use of sipuleucel-T for this indication.

About NICE

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