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NICE backs Gilead’s Sovaldi in hepatitis C

But health watchdog denies earlier use of Janssen’s Zytiga

NHS patients in England received mixed news today as the region's health watchdog backed a new drug for use in hepatitis C but denied expanded use of another medicine in prostate cancer.

The National Institute for Health and Care Excellence (NICE), which provides guidance on the cost-effectiveness of medicines, issued draft guidance that recommends the use of Gilead Science's fast-growing Sovaldi (sofosbuvir) in people with chronic hepatitis C.

However, other draft guidance published today by NICE did not recommend changing the indication for Janssen's Zytiga (abiraterone) so that it can be used before chemotherapy in people with prostate cancer whose disease has spread.

The guidance for Sovaldi overturns a previous negative NICE decision for the revolutionary hepatitis C treatment, with the expert committee raising concerns about the cost of the drug, which has a UK list price of £35,983 (€45,041) or £69,966 (€87,575) depending on the length of treatment.

This reflected unease in the other countries such as in the US where politicians have questioned the $84,000 price for a 12-week course.

It appears Gilead has now provided extra data to appease NICE, with the agency stating that it has received “additional information about the drug's cost effectiveness from the manufacturer”.

Sovaldi is seen as a major advancement in hepatitis C treatment as it can shorten or remove the need for interferon-based therapy, a form of treatment associated with serious side effects.

This has led to huge uptake of the drug, despite its high price, with Gilead report revenues of nearly $6bn for Sovaldi in the first six months of 2014.

The NICE recommendation does not cover all hepatitis C patients, however, and Sovaldi is recommended in combination with peginterferon alfa and ribavirin in certain patients with genotype 1 and genotype 3 hepatitis C and in combination with ribavirin alone in certain patients with genotype 2 and genotype 3 hepatitis C.

Gilead commented: “While the draft recommendation will potentially grant access to sofosbuvir for the majority of hepatitis C patients, an unmet need still exists for those with specific sub-types of hepatitis C, who are not recommended for treatment with sofosbuvir under this draft guidance.”

No early use for Zytiga
Janssen had harsher words to say about NICE's final draft guidance that denied earlier use of oncology drug Zytiga in men with prostate cancer.

The drug was recommended in 2012 to treat castration-resistant metastatic prostate cancer, in combination with prednisone or prednisolone after a treatment cycle that included docetaxel.

However, Janssen is looking to move the drug further up the treatment pathway so it can be used prior to chemotherapy.

NICE recommends against this use in its latest guidance, with chief executive Sir Andrew Dillon claiming that the economic model provided by Janssen demonstrated that the drug “does not offer enough benefit to justify its price”.

Responding to this guidance Janssen's medical director for the UK Dr Peter Barnes said the decision “will leave thousands of men in England in the advanced stages of prostate cancer with no option but to accept chemotherapy - which they may not necessarily need or want yet”.

“These men will eventually be able to receive abiraterone on the NHS after chemotherapy anyway, but will be denied the option of taking it earlier on in their illness,” he added.

“Abiraterone is the second most requested medicine through the Cancer Drugs Fund and so the support for this treatment from doctors and patients is clear.”

In both cases final guidance is still to be issued by NICE.

Article by
Thomas Meek

15th August 2014

From: Sales, Healthcare



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