Expensive treatments for hepatitis C will now be available to more patients in the UK, according to final draft guidance from the National Institute for Health and Care Excellence (NICE) published on 16 January 2015.
NICE has extended its original draft recommendations for simeprevir and sofosbuvir to cover more people with hepatitis C. However, patients will have to wait until August 2015 for sofosbuvir, and simeprevir will be available only under a groundbreaking ‘pay if you clear’ deal agreed with the manufacturer.
There are six major genotype forms of hepatitis C (1-6), and genotypes 1 and 3 account for the majority of chronic hepatitis C cases in England (46% and 43%, respectively).
NICE has issued final draft guidance
recommending simeprevir (Olysio, Janssen), in combination with peginterferon alfa and ribavirin, as an option for treating two forms of hepatitis – genotype 1 and genotype 4 (4% of diagnoses). The previous draft guidance did not recommend simeprevir for treating genotype 4.
It has also extended its earlier positive draft recommendations that recommended sofosbuvir (Sovaldi, Gilead Sciences) in combination with peginterferon alfa and ribavirin for certain patients with genotype 1, 2 and 3 to now also include some patients with genotypes 4, 5 and 6
Charles Gore, chief executive of the Hepatitis C Trust, says the decisions represent “a notable step forward in our campaign to eliminate hepatitis C” because it means that patients will now have access to generally well tolerated treatments that offer a better chance of clearing hepatitis C.
Final guidance for simeprevir and sofosbuvir for treating chronic hepatitis C is due to be published in February 2015. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
But eligible patients will have to wait until August 2015 to be certain of accessing sofosbuvir because NICE has extended the length of time that NHS England has to comply with its recommendations to 31 July 2015, at NHS England’s request.
“The good news is that this recommendation will allow broad use of sofosbuvir among people with hepatitis C; however many patients will have to wait another six months before this guideline is implemented,” says Stephen Ryder, consultant hepatologist at Nottingham University Hospitals NHS Trust. “For some patients, who already have established liver disease, this delay may cause further negative impact on their health and it is therefore very important to ensure that the plan to obtain earlier access for people with cirrhosis from April happens.”
Meanwhile, patients will be tested before being prescribed simeprevir to see if they are likely to respond to the drug under a ‘pay if you clear’ reimbursement scheme, agreed with NHS England. Janssen will pay for the £120 test and refund the cost of the 12-week course of simeprevir for patients who do not successfully clear the virus. A patient is considered to have cleared the virus if they have an undetectable viral load six months after treatment.
At the moment, NICE recommends peginterferon alfa and ribavirin combination therapy as the standard treatment for the majority of people with chronic hepatitis C. Monotherapy with peginterferon alfa is recommended for patients who are unable to take ribavirin.
Current interferon-based treatments for chronic hepatitis C are associated with a number of unpleasant side effects, such as chronic fatigue, neuropsychological effects and flu-like symptoms. “As a result many people with the disease either don’t complete the full course, or are reluctant to seek treatment in the first place,” says Carole Longson, director of the NICE Centre for Health Technology Evaluation.
New treatments can shorten the duration of interferon-based therapy and, in some cases, do not need to be taken with interferon at all, she explains.
A 12-week course of simeprevir plus peginterferon alfa and ribavirin (both for 24 weeks) costs around £27,000, while a course of simeprevir (12 weeks) plus peginterferon alfa and ribavirin (both for 48 weeks) costs about £32,000. Treatment-naÃ¯ve and prior-relapser patients also take pegylated interferon and ribavirin for 24 weeks, and prior non-responders take them for 48 weeks.
A 12-week course of sofosbuvir costs around £35,000 and a 24-week course is about £70,000, not including the cost for ribavirin and peginterferon alfa.
Gilead is already under pressure in the United States to reduce the cost of sofosbuvir. The cost of sofosbuvir in the UK is two thirds of that in the United States where a 12-week course costs around US$84,000 (£55,000). The drug was the first of the new wave of hepatitis C drugs to become available in the United States, but since the US Food and Drug Administration approved AbbVie Inc’s combination of ombitasvir, paritaprevir and dasabuvir (Viekira Pak) in December 2014, the country’s largest pharmacy benefits manager Express Scripts Co has dropped reimbursement for sofosbuvir.
Express Scripts said it had received a substantial (but undisclosed) discount from AbbVie, which is a departure from pharmaceutical industry practice in the United States of pricing new drugs close to existing competitor drugs for as long as possible.
NICE has postponed a decision on the use of simeprevir in combination with sofosbuvir, with or without ribavirin, to treat chronic hepatitis C in people who cannot tolerate or are not eligible for treatment with interferon and will await more data. Its recommendation on this will be made in separate guidance. A course of simeprevir plus sofosbuvir (both for 12 weeks) would cost around £57,000.