‘Breakthrough’ prostate cancer drug rejected by NICE

In a decision that will leave thousands hugely disappointed, the National Institute for Health and Clinical Excellence (NICE) hasn’t recommended the use of the medicine abiraterone (trade name Zytiga) for the treatment of advanced prostate cancer, leaving many men denied of the life-extending drug. However, there is still hope, as several private medical insurance (PMI) companies, including Bupa, will cover the cost of the treatment for those who hold policies with them.

Prostate cancer is the most common cancer in men in the UK (not counting non-melanoma skin cancer), with around 37,000 diagnosed each year, highlighting the need for effective drugs to be available. Abiraterone, manufactured by the pharmaceutical company, Janssen (part of the Johnson & Johnson group), was licensed by the European Medicines Agency (EMA) in September 2011 for men who have advanced prostate cancer. However, NICE believes that the drug is too expensive and doesn’t provide enough benefit to patients to justify its high price – the medicine costs around £3,000 per month for each patient.

NHS patients who have already been treated with, or who are currently taking, abiraterone have received it through the Cancer Drugs Fund, a Government-initiated fund set up to enable patients to access cancer drugs not yet available through the NHS. The Fund was founded in 2010 and provides £200 million a year for cancer drugs that doctors believe will help their patients. However, the Cancer Drugs Fund will cease to exist past the end of 2013 when the money dries up, meaning that thousands of men with advanced prostate cancer won’t be able to receive the treatment.

NICE came to its decision despite acknowledging that abiraterone can extend the lives of those in the final stages of prostate cancer. Results from a clinical trial of abiraterone showed that certain men with advanced prostate cancer who had previously received chemotherapy lived, on average, four months longer when treated with abiraterone (plus another medicine called prednisone), compared to those who were treated with a dummy treatment (placebo) plus prednisone (14.8 months versus 10.9 months). Researchers also found that the level of prostate-specific antigen (PSA) in the men who received abiraterone was more likely to fall and on average took longer for their prostate cancer to start growing again.

Although abiraterone hasn’t been recommended for use within the NHS, there is a silver lining, as several PMI companies are happy to fund the drug for their members, regardless of the guidance set by NICE.

Dr Virginia Warren, Assistant Medical Director, Bupa, commented: “We’ve been routinely funding abiraterone for our policy holders for almost a year now. Even though NICE is not recommending its use, we believe that abiraterone is an effective treatment that can extend the lives of those with advanced prostate cancer.

“Regardless of its price, we will fund cancer drugs if there is good evidence to suggest that they are effective and will truly benefit our members. Unfortunately, it’s increasing becoming the case that NICE can’t recommend effective drugs because of the high costs. Abiraterone is one of the biggest breakthroughs the cancer community has seen for the treatment of prostate cancer for a long time, and it has come as a blow to thousands that this drug won’t be readily available on the NHS. However, all is not lost and Bupa will happily fund effective drugs, as long as there is firm evidence to show their benefits."

Abiraterone is indicated for men who have castration-resistant prostate cancer that has spread to other parts of their body and have already received hormone treatment and chemotherapy. Castration-resistant means that the prostate cancer is resistant to medicines and/or surgical treatments that lower testosterone.

The drug works by reducing the amount of androgen (a male sex hormone) that's produced in the body. Androgens are primarily made by the testes and adrenal glands, but in men with castration-resistant prostate cancer, the tumour itself also makes the hormone. Abiraterone blocks the androgen-making process at these three sources – the testes, the adrenal glands and the tumour itself. It’s administered as a single dose of 1g per day, taken as four 250 milligram (mg) tablets.

Produced by Alice Rossiter, Bupa Health Information Team, February 2012.