Good News for Fellow Patients in England

With Zytiga already approved for use by the National Health Service (NHS) in Wales, The U.K.’s rationing body (NICE) is expected to do an about face and recommend Zytiga (abiraterone) for patients this week.

Zytiga (abiraterone acetate) was first discovered at the U.K.'s Institute for Cancer Research in the late 1990s.

In a highly-connected world that often marches in unison, it’s surprising when we see the parade split into various routes. Such is the case with national approvals of Zytiga. In the U.S. Zytiga was approved for patients by the FDA and reimbursement agencies in April of last year. It was approved for use in the European Union in September. In February, BBC News reported that the Welsh NHS approved the drug for use in Wales. BUT, the English NHS, following recommendations from the U.K.’s National Institute for Health and Clinical Excellence (NICE), ruled that Zytiga was too expensive for use by the English NHS.

As an outsider sitting across the pond, all of this was a bit perplexing. It was, however, a good reminder that while the U.K. is a country in its own right, it is comprised of four countries–England, Wales, Scotland and Northern Ireland. That’s something many of us Yanks forget easily unless we take a closer look at their bank notes.

The original denial of Zytiga by the English NHS was seen by prostate cancer advocates as a tremendous blow to patients with advanced disease since 40,000 plus British men are diagnosed with prostate cancer each year. More than 3,300 Britons with advanced disease can benefit from Zytiga. Thankfully, an article in today’s The Telegraph reports that NICE is expected to reverse it’s original recommendation and that the English NHS will now approve Zytiga for use in patients, The about face will make it the first specific treatment for prostate cancer approved for use by that NHS in more than a decade.

The Telegraph correctly reported that studies show men taking abiraterone and a steroid survived for nearly 15 months, while those given steroid treatment and a ‘dummy’ pill lived 11 months on average. However, some receiving the treatment survived much longer than expected, including Britons who have lived for almost five years with advanced disease.

This week’s anticipated and literal turn of events would not be possible without an effective mobilization and voice of government officials and organizations such as the London-based Prostate Cancer Charity. Within days, of the original NICE recommendation, Simon Reeve, a Department of Health Official in the U.K. wrote to the rationing body asking it to “carefully consider” if Zytiga met the more lenient “end of life criteria.”

Owen Sharp, Chief Officer of the U.K's Prostate Cancer Charity

According to today’s story in The Telegraph, Owen Sharp, Chief Executive of the U.K.’s Prostate Cancer Charity, said Members of Parliament and patients had been appalled by the initial decision to ban Zytiga for NHS use when it was available in other EU countries. In an interview with The Mail, Sharp said “It was the wrong decision. This breakthrough drug will make a real difference to men with prostate cancer at the end of their life who have no alternative–it is the only hope they have.”

Thank you, Owen Sharp and everyone at the Prostate Cancer Charity for your important support. Many British men and their families will benefit from your efforts. I look forward to reading news of the final revised recommendation later this week.

Click here to view a video on the development of Zytiga.

 

UPDATE:

J&J’s Zytiga Wins U.K. Cost Agency Backing for Prostate Cancer

May 15, 2012

(Bloomberg) — Johnson & Johnson’s Zytiga is a cost-effective medicine when combined with a steroid in men whose prostate cancer has resisted treatment and spread to other organs, the U.K. drug-cost agency said.

The drug is recommended when combined with prednisone or prednisolone in men who have undergone androgen-deprivation therapy, or chemical castration, and whose disease has spread and progressed after one treatment with docetaxel, a first-choice therapy, the National Institute for Health and Clinical Excellence said in a statement. The decision reverses an earlier ruling by NICE that Zytiga’s benefits didn’t justify its cost.

The treatment “could potentially extend life by more than three months,” NICE said in the statement.

Prostate cancer is the most common cancer in men in the U.K. and strikes about 37,000 men a year, according to the London-based Prostate Cancer Charity.

Zytiga costs about 2,930 pounds ($4,700) for a 30-day supply of 120 tablets, NICE said. Manufacturer Janssen, a unit of J&J, has agreed to provide the drug to U.K. National Health Service patients at a discounted price, which wasn’t disclosed, NICE said.

“While NICE and Janssen have been considering the value of the drug over the past eight months, men were being told that they would have to get the drug through other routes because it was too expensive,” said Harpal Kumar, chief executive of Cancer Research UK, a charity that was among organizations that called on Janssen to lower Zytiga’s price and NICE to reconsider its decision.

“In part, this U-turn is down to the public’s disappointment at the initial refusal,” Kumar said in a statement.

To contact the reporter on this story: Andrea Gerlin in London at agerlin@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

 

 

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