Janssen's Zytiga access scheme and patient data win over NICE

The UK's National Institute for Health and Clinical Excellence (NICE) has reversed its decision on Zytiga after manufacturer Janssen revised its patient access scheme.

The pharma company also submitted further information on which patients would benefit most and clarified how many patients could receive the drug, enabling it to be considered under NICE's end of life criteria

NICE's new draft guidance recommends the use of Zytiga (abiraterone) to treat castration-resistant metastatic prostate cancer, in combination with prednisone or prednisolone after a treatment cycle that included docetaxel.

A spokesman told PMLiVE: “Janssen has gone to significant lengths to find a solution that allows eligible patients to be treated with this innovative, UK-discovered medicine, routinely on the NHS and we are delighted with NICE's positive recommendation.”

The decision comes after NICE's ruling in February that, although it was happy with the drug's safety and efficacy, its price tag was too high to justify Zytiga's routine use by the NHS in Engalnd and Wales.

The list price of Zytiga is £2,930 for a 30-day supply of 120 tablets and it is taken as a single dose of 1g per day, taken as four 250mg tablets.

Under Janssen's revised patient access scheme it will offer the drug to the NHS at a discounted price, details of which are confidential. 

Sir Andrew Dillon, chief executive of NICE, said: “We are very pleased that Janssen's submission to our consultation means that we are able to produce draft guidance recommending abiraterone – it is an effective treatment, potentially extending life by more than three months, and it also allows patients to be treated at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.“

The Committee concluded that the ICER (cost per quality-adjusted life year) for the one prior chemotherapy subgroup would be more than the manufacturer's estimate of £46,800 per QALY gained, but less than £50,000 after taking into account the discount agreed between the manufacturer and the Department of Health.

The decision follows negative final guidance from NICE for another prostate cancer drug, Sanofi's Jevtana (cabazitaxel). Issuing its recommendation on that drug last week NICE was not swayed by clinical evidence suggesting the treatment could achieve a mean overall survival of greater than three months and decided its high cost was still an issue.

The draft guidance on Janssen's Zytiga is out for consultation and until NICE issues final guidance, expected in June, NHS bodies should make decisions locally on whether to fund Zytiga or not.

Meanwhile, Janssen has also resubmitted Zytiga to the Scottish Medicines Consortium, which gave the drug a negative recommendation in March and is due to make a decision on the resubmission in the summer.

The company told PMLiVE it was disappointed with that decision and now, after resubmitting it to the SMC on April 2 - in time for the May 29 New Drugs Committee (NDC) meeting, expects an announcement on Zytiga's use in Scotland on August 13. 

“We continued to explore options to demonstrate the value of Zytiga and are committed to striving for a positive outcome for patients in Scotland,” the spokesman said.

“Historically, few treatment options have been available to patients with metastatic castration resistant prostate cancer, and it therefore remains an area of significant unmet medical need.