Friday, August 15, 2014

UK Recommends Covering Sovaldi Hepatitis C Pill

UK Recommends Covering Sovaldi Hepatitis C Pill
By Ed Silverman

The U.K. agency that evaluates the cost effectiveness of prescription drugs has recommended the government pay for the controversial Sovaldi hepatitis C treatment, although not for all patients.
After reviewing the data, though, NICE agrees that Sovaldi is an effective improvement over existing treatments. The Gilead drug, by the way, can cure nine of 10 patients. The decision was likely helped by the lower price tag in the U.K. Gilead is selling its drug for about $56,000, according to a NICE spokesman. “It’s a lot cheaper here,” he tells us.
The agency is recommending Sovaldi, plus interferon and ribavirin, for adults with genotype 1, which is the most common form of hepatitis C, and accounts for 46% of all cases in the U.K., a NICE spokesman says. The recommendation also extends to patients with genotype 3, which accounts for 43% of hepatitis C sufferers (read the complete NICE document here).
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UK cost body backs pricey Gilead hepatitis pill for some patients

LONDON Fri Aug 15, 2014 5:06am IST(Reuters) - Gilead Sciences' expensive new hepatitis C pill has been endorsed for use in certain patients by Britain's healthcare cost-effectiveness watchdog, after the U.S. firm provided more information.

The National Institute for Health and Care Excellence (NICE) had told Gilead in June to come back with more data to support the use of Sovaldi, a drug whose sky-high U.S. price of $1,000 per pill has sparked fierce debate over costly modern medicines.

Carole Longson, director of the NICE Centre for Health Technology Evaluation, said on Friday it was now provisionally recommending Sovaldi, also known as sofosbuvir, as a cost-effective treatment for some people with chronic hepatitis C.

Gilead welcomed the decision to endorse Sovaldi as part of a combination treatment regimen, which it said would potentially make the drug available for the majority of hepatitis C patients.

The new drug is recommended for people chronically infected with certain strains, or genotypes, of the disease, which can cause liver cirrhosis and, in a small percentage of people, liver cancer. The conditions attached to its use vary according to a patient's disease state and any past treatments.

Gilead argues its drug's high price is justified by the near guarantee of a cure, far fewer side effects and the treatment's ability to help patients avoid far more expensive hospital treatment, including potential liver transplants.

But the sheer cost of the drug - which has already sold $5.8 billion in its first six months, making it the most successful new drug launch ever - has fueled controversy. Two members of the U.S. Senate Finance Committee wrote to Gilead last month asking the company to justify the price.

In Britain, where NICE's control over which drugs are used on the state health service exerts downward pressure on prices, Sovaldi is priced at 35,000 pounds ($58,400) for a 12-week course of treatment - 30 percent less than in the United States.

NICE was set up by the government in 1999 to decide in a rational way which drugs and treatments should be available on the National Health Service in England and Wales, making it an early pioneer of so-called healthcare technology assessment.

Since then it has had numerous run-ins with the pharmaceuticals industry, especially over cancer drugs.

The latest cancer drug row involves a decision, also announced on Friday, not to recommend the use of Johnson & Johnson's prostate cancer medicine Zytiga before chemotherapy, even though it is already recommended for use afterwards.

J&J said it was very disappointed by the ruling, which comes hard on the heels of a rebuff for Roche's new breast cancer drug Kadcyla last week.
(Editing by Raissa Kasolowsky)

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.


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