Sovaldi® (sofosbuvir) should be made available, as part of a combination treatment regimen, to treat the majority of adult patients with chronic hepatitis C (HCV) in England and Wales.(1)
The recommendation comes from the National Institute for Health and Care Excellence (NICE), which has been welcomed by Gilead Sciences.
The rigorous health technology appraisal process has recommended that sofosbuvir, a new once-daily oral therapy, represents good value for money for the NHS in an area of high unmet medical need. Sofosbuvir will be reviewed at a committee meeting in September with final guidance expected later in the year.
Sofosbuvir in clinical trials
Sofosbuvir has been shown in clinical trials to offer cure rates of ≥90% in treatment-naïve adults patients, with a short 12-week course of combination antiviral therapy (peg-IFN+RBV/RBV for G2).(2) The societal, clinical and economic burden of untreated hepatitis C is substantial, with HCV-related healthcare costs directly related to disease severity.(3,4) Sofosbuvir is generally well tolerated with a good safety profile and allows many more patients the opportunity of cure.(2)
Treatment with sofosbuvir has been provisionally recommended by NICE (1) for the following populations:
“We are pleased that, following a very complex assessment, NICE have recognised the clinical and economic benefit of treatment with sofosbuvir and have determined it is a valuable use of NHS resources for the majority of hepatitis C patients. Given the high unmet need in this area, we will be working with NICE and other stakeholders to ensure hepatitis C patients are able to benefit from the treatment as quickly as possible,” said Stelios Karagiannoglou, General Manager, UK, Gilead Sciences Ltd.
Sofosbuvir in terms of draft recommendations
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for those with specific sub-types of hepatitis C, who are not recommended for treatment with sofosbuvir under this draft guidance.
The draft recommendation also aligns with Government objectives in this therapy area. As highlighted in the recently published Hepatitis C in the UK 2014 report, Public Health England has identified that there is a substantive need to treat those living with hepatitis C and highlights that both increased uptake and new treatments are needed to prevent hepatitis C-related end-stage liver disease in England.(5)
Left untreated, the consequences of hepatitis C are serious and can cause irreversible scarring to the liver (cirrhosis), liver disease, transplantation and liver cancer, leading to a significant burden on the individual, their family and the NHS.(6)
While hepatitis C can be cured, up until now many patients have been ineligible, intolerant or unwilling to endure the side effects of standard treatments.(7) Existing standard of care can involve up to 48 weeks of treatment and has been associated with side effects such as flu-like symptoms.(8) Once a patient is cured of hepatitis C, their risk of developing associated liver disease is substantially reduced. Cure also eliminates the risk of hepatitis C transmission.(1)
NICE’s draft recommendation confirming the cost-effectiveness of sofosbuvir is broadly in line with other health technology appraisal body findings. Patients in Scotland have already been granted access to sofosbuvir following a recommendation by the Scottish Medicines Consortium in June that enables a broad range of hepatitis C patients to receive treatment with sofosbuvir.(9)
Gilead Sciences will be working closely with NICE to help ensure a positive final recommendation can be reached without further delay so that sofosbuvir can become available for the majority of hepatitis C patients across England and Wales.
- National Institute for Health and Care Excellence (NICE). Appraisal Consultation Document. Sofosbuvir for treating Hepatitis C. 15 August 2014.
- Sovaldi SmPC. January 2014.
- El Khoury A et al. Economic burden of hepatitis C-associated diseases: Europe, Asia Pacific, and the Americas. J Med Econ 2012;5(5):887–96.
- Blachier M et al. Available at www.easl.eu/assets/application/files/54ae845caec619f_file.pdf (accessed January 2014).
- Public Health England (PHE). Hepatitis C in the UK 2014 report. July 2014. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/337115/HCV_in_the_UK_2014_24_July.pdf (accessed August 2014).
- Van der Meer AJ et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012;308(24):2584–93.
- North CS et al. Hepatitis C treatment and SVR: the gap between clinical trials and real-world treatment aspirations. Gen Hosp Psych 2012;35:122–8.
- NHS Choices. Hepatitis C – Treatment. Available at: http://www.nhs.uk/Conditions/Hepatitis-C/Pages/Treatment.aspx (accessed August 2014).
- Scottish Medicines Consortium. Advice for sofosbuvir. 9 June 2014.