The United Kingdom's National Institute for Health and Care Excellence (NICE) is recommending Sovaldi as a cost-effective option to treat some people who have chronic hepatitis C.
The United Kingdom’s National Institute for Health and Care Excellence (NICE) is recommending Sovaldi as a cost-effective option to treat some people who have chronic hepatitis C.
Officials from the health agency that is assigned to assess the value of drugs sold in England made the recommendation after reviewing additional information about the cost effectiveness of the drug, known generically as sofosbuvir, from the manufacturer Gilead Sciences, a California based company, according an agency statement.
“We are pleased to be able to provisionally recommend sofosbuvir as a clinically and cost effective treatment for some people with chronic hepatitis C,” Carole Longson, NICE Director of the Centre for Health Technology Evaluation, said in release about the decision.
In the US, Sovaldi is priced at about $1000 a pill for a once-daily, 12-week treatment course but in the UK the cost is expected to be just under $700 a day.
“Our previous draft guidance concluded that the available evidence showed sofosbuvir to be an effective treatment for chronic hepatitis C in certain patients,” Longson said in the statement. “However, there were some uncertainties in the evidence base for some subgroups of patients with chronic hepatitis C. The Committee has considered the additional evidence it requested from the manufacturer and we are pleased to be able to provisionally recommend sofosbuvir as a clinically and cost effective treatment for some people with chronic hepatitis C.”
Sovaldi is authorized for marketing in the UK for use in combination with other medications for treating chronic hepatitis C with a 12- or 24-week treatment duration, depending on a patient’s hepatitis C virus genotype and history of interferon treatment. Out of the six major genotypes of hepatitis C, genotype 1 is the most common and along with genotype 3 accounts for the majority of chronic hepatitis C cases in England (46% and 43% respectively).
In late 2013, the FDA approved Sovaldi, which is considered a breakthrough drug for hepatitis C treatment because of a high cure rate and because it is taken only once a day in combination with an antiviral treatment regimen. However, debate continues over the cost of the drug in the US, where a standard 12-week course totals about $84,000, not including the cost of interferon and ribavirin.
Hepatitis C is a bloodborne virus that can severely damage the liver if left untreated. It can lead to cirrhosis, cancer, and the need for a liver transplant in a small percentage of patients.
UK officials estimate that 160,000 people in England are chronically infected with hepatitis C, one of the most prevalent of global diseases. However many people who are infected may not know they have the virus because they have little or no symptoms for a long period of time.
The NICE recommendation is provisional as part of a draft guidance that has not yet been finalized with the National Health Service.