UK Advisory Group Reverses Decision on Abiraterone; Drug Expected to Be Funded

The prostate cancer drug abiraterone acetate (Zytiga, Janssen) is expected be provided for patients through England’s publicly funded healthcare system after an independent advisory organization reversed its initial recommendation not to fund the drug on the grounds that its cost outweighed its benefits.

In February, the National Institute for Health and Clinical Excellence (NICE), which provides guidance and sets standards on healthcare issues in the UK, issued a draft recommendation against including abiraterone in the list of drugs covered by the country’s National Health Service (NHS). Indicated for patients with metastatic castrate-resistant prostate cancer who have failed at least one round of docetaxel, the drug costs approximately £3,000 per monthly supply of 120 tablets.

NICE uses an incremental cost-effectiveness ratio to determine whether the benefits gained from taking a particular drug outweigh the costs. The group has established a threshold for determining coverage of £30,000 per quality-adjusted life year (QALY), with any amount above that figure requiring very strong evidence to be considered for coverage. In February, after various estimates were considered, NICE determined that the cost of abiraterone would be approximately £63,200 for every QALY gained through the use of the drug.

However, NICE recently met with abiraterone’s manufacturer, Janssen, and the company provided more information on which patients, and how many, could benefit from the drug. Additionally, Janssen offered to provide the drug at a discounted price to the NHS, although that price has not been officially disclosed. After taking the discount into consideration, the adjusted cost of abiraterone would be less than £50,000 per QALY gained, which those at NICE believed to be more in line with the benefits of the drug.

“We are very pleased that Janssen's submission to our consultation means that we are able to produce draft guidance recommending abiraterone,” said Sir Andrew Dillon, chief executive, NICE, in a statement released Wednesday. “It is an effective treatment, potentially extending life by more than three months, and it also allows patients to be treated at home as it can be taken orally.”

Abiraterone was approved by the FDA in the United States last year. In a study that was published in The New England Journal of Medicine last May, researchers found that patients with metastatic castration-resistant prostate cancer (CRPC) who received the drug had a median overall survival (OS) of 14.8 months, compared with 10.8 months in patients who received a placebo (hazard ratio [HR] = 0.646; 95% CI, 0.543-0.768; P <.0001).1

Ongoing research continues to support the use of abiraterone in prostate cancer. On Wednesday, the American Society of Clinical Oncology (ASCO) presented results from a phase II trial that tested the efficacy of abiraterone when it was used in a neoadjuvant setting along with hormonal therapy before a prostatectomy was performed.2 The study found that the combination therapy eradicated or nearly eradicated tumors in 34% of patients with localized high-risk prostate cancer.

If all of the regulatory hurdles are passed, abiraterone will be covered in England and Wales in June. However, the drug will not be available in Scotland, since it was turned down in March by the Scottish Medicines Consortium on the same grounds as NICE’s initial decision. Janssen is meeting with the group to have similar discussions.

References

1. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011; 364(21): 1995-2005.
2. Taplin ME, Montgomery RB, Logothetis CJ, et al. Effect of neoadjuvant abiraterone acetate (AA) plus leuprolide acetate (LHRHa) on PSA, pathological complete response (pCR), and near pCR in localized high-risk prostate cancer (LHRPC): Results of a randomized phase II study. J Clin Oncol. 2011;(suppl; abstr 4521).