Hi
I thought I would update people on the progress of the UK looking at the prescribing of Sovaldi.
The process for any major new drug is that a decision is made whether to fund it or not based on a detailed analysis of the evidence. Because of the significance of this decision (and potential lawsuits) the decisions are often couched in rather legalistic language. Several other countries follow the decisions made by the UK body.
(As the need is so urgent for some patients the healthcare system has agreed to fund treatment for the very sickest patients now whilst the long term decision is made).
The review of sofosbuvir began last year. The decision makers last week issued their draft guidance. The main thrust is that they are asking Gilead for more evidence on certain groups of patients and raised queries on some of the evidence. (The actual interim decision is that they are 'minded not to recommend its use' but I understand that is just the usual wording to keep the lawyers happy). My guess is that the final decision will reflect a stratified approach - that it will be approved for some patients but not others.
This is an excerpt from the press release:
“The available evidence shows that sofosbuvir is an effective treatment for chronic hepatitis C in certain patients. However, evidence is lacking for some subgroups of patients with chronic hepatitis C, and there are also substantial uncertainties in the evidence base presented by the manufacturer. The Committee has therefore requested further information from the manufacturer before it can decide whether sofosbuvir is a cost-effective use of NHS resources.”
The link to the press release is here and there are links from that to the full analysis of the evidence if people are interested.
www.nice.org.uk/newsroom/pressreleases/NICEOnDraftGuidanceForSofosbuvirSovaldiDrugHepatitisC.jspFinal decision is expected in October.
Ann