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SMC approves Zytiga after Janssen offers discount

New guidance from Scottish HTA body recommends prostate cancer drug

Janssen Zytiga

Janssen has persuaded the Scottish Medicines Consortium (SMC) to reverse its initial negative ruling on Zytiga and recommend the prostate cancer drug.

The Scottish health technology assessment body ruled in March that Zytiga (abiraterone) should not be used within NHS Scotland, and said Janssen had not justified the drug's cost in relation to its health benefits.

That decision has now been overturned after Janssen offered a patient access scheme to improve Zytiga's cost-effectiveness by discounting its price tag.

It is the second time Janssen has been forced to reduce the cost of Zytiga in the UK, after a similar impasse with NICE was resolved earlier in May with the offer of a patient access scheme and new patient population data.

Details of the Scottish patient access scheme remain confidential, but the SMC said that without it Zytiga's annual cost to the Scottish medicines budget would have hit £4.8m within five years.

Janssen UK's director of external affairs Martin Price said: “We have gone to significant lengths to find a solution that allows eligible patients to be treated routinely on the NHS with this innovative, UK discovered medicine.

“Janssen are pleased that the SMC has accepted Zytiga (abiraterone acetate) for restricted use within NHS Scotland.”

The SMC backed the use of Zytiga, with prednisone or prednisolone, to treat metastatic castration resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

The drug's use was restricted to patients who have received only one prior chemotherapy regimen.

In trials Zytiga plus prednisone was shown to significantly improve overall survival by nearly 4 months in individual patients, compared with placebo plus prednisone in patients with mCRPC previously treated with docetaxel.

Zytiga treats mCRPC by decreasing the level of circulating testosterone, the presence of which helps cancer cells in the prostate to multiply and spread, and is given as four tablets in a single daily dose.

Scottish NHS Boards will now review the SMC advice in line with the chief medical officer's guidance strengthening the safe and effective use of new medicines across the NHS In Scotland.

The decision was welcomed by patient groups. Cancer Research UK, which noted that Janssen had “offered a better deal this time around”, said it was fantastic news for Scottish men.

The charity's policy manager Heather Walker commented: “This is a great decision that we're really pleased to see. But it has been too long in coming and raised important questions about how drugs are made available across the UK.

“As we have said before, we need the processes by which medicines are assessed to be streamlined so that patients are not left in limbo. And we need the regulators and pharmaceutical companies to work together to get the best outcome for patients."

14th August 2012

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