The United Kingdom's National Institute for Health and Care Excellence (NICE) has issued two pieces of final guidance recommending Gilead's (US) Sovaldi (sofosbuvir) and Janssen's (subsidiary of Johnson & Johnson, J&J; US) Olysio (simeprevir).
IHS Life Sciences perspective | |
Significance | In two separate pieces of final guidance, the UK's National Institute for Health and Care Excellence (NICE) has recommended for reimbursement hepatitis C treatments Sovaldi (sofosbuvir; Gilead Sciences, US) and Olysio (simeprevir; Janssen, subsidiary of Johnson & Johnson, US). |
Implications | NICE has noted that it will be issuing a separate guidance for Olysio in combination with sofosbuvir. |
Outlook | Given the cost of Sovaldi, NHS England has received an extension to the timeline required to comply with NICE recommendation, with the deadline set at 31 July. |
The UK's National Institute for Health and Care Excellence (NICE) has issued two pieces of final guidance, recommending Gilead's (US), and Janssen's (subsidiary of Johnson & Johnson, J&J; US) hepatitis C treatments Sovaldi (sofosbuvir) and Olysio (simeprevir).
Sovaldi: NICE technology appraisal guidance, TA 330
Sovaldi has been recommended as a treatment option for chronic hepatitis C in adult patients as per the following:
- Sovaldi in combination with peginterferon alfa and ribavirin has been recommended for adults with genotype 1 hepatitis C virus (HCV); in treatment-experienced adults with genotype 3 HCV; and in treatment-naïve adults with genotype 3 HCV, the treatment has only been recommended for people with cirrhosis. In the case adults with genotype 4, 5 or 6 HCV, Sovaldi plus peginterferon alfa and ribavirin has been recommended only for people with cirrhosis.
- Sovaldi in combination with ribavirin has not been recommended for adults with genotype 1 HCV. The treatment has been however recommended for treatment-experienced adults with genotype 2 HCV, and also treatment-naïve adults with genotype 2 HCV but only for people who are intolerant to or ineligible for interferon. In the case of adults with genotype 3 HCV, both treatment-naïve and treatment-experienced, Sovaldi plus ribavirin has only been recommended for people with cirrhosis who are intolerant to or ineligible for interferon. The treatment has not been recommended for adults with genotype 4, 5 or 6 HCV.
The full final guidance, TA 330, including the clinical and cost-effectiveness evidence considerations, is available here.
Olysio: NICE technology appraisal guidance, TA 331
Olysio in combination with peginterferon alfa and ribavirin, has been recommended within its marketing authorisation as an option for treating genotype 1 and 4 chronic hepatitis C in adults. The full guidance, TA 331, is available here.
After having considered the cost-effectiveness evidence, NICE's Appraisal Committee concluded that incremental cost-effectiveness ratio (ICER) for Olysio plus peginterferon alfa and ribavirin versus peginterferon alfa and ribavirin alone, for treating genotype 1 HCV, fell between the range of GBP14,200 (USD22,002) and GBP9800 per quality-adjusted life year (QALY) gained. Olysio was further found to be less costly as well as providing more QALYs than both telaprevir and boceprevir, both with peginterferon alfa and ribavirin. In terms of genotype 4 HCV, the ICERs for Olysio plus peginterferon alfa and ribavirin versus peginterferon alfa and ribavirin were found to be under GBP20,000 per QALY gained.
Outlook and implications
With the publication of the final guidance for the two treatments, NICE's Director of the NICE Centre for Health Technology Evaluation, Professor Carole Longson, noted that both Olysio and Sovaldi could "shorten the length of interferon-based therapy", and under certain cases not be taken with interferon, further adding that the two drugs would be "valuable treatment options for people with chronic hepatitis C".
It is noteworthy however, that while Olysio also has marketing authorisation for use in combination with sofosbuvir (Sovaldi), NICE is going to issue a separate guidance for the treatment combination, noting that more data for the treatment combination for treating chronic hepatitis C in people who cannot tolerate or are not eligible for treatment with interferon "will be made available soon".
NICE final guidance recommending Olysio comes after the drug a number of European countries including issued their reimbursement decisions including Italy, Sweden and Germany (see Italy: 27 February 2015: Italy publishes reimbursement decision for Janssen's Olysio; Sweden: 31 October 2014: Sweden's TLV recommends restricted reimbursement for Sovaldi and Olysio; and Germany: 16 January 2015: Reimbursement contract signed for Janssen's Olysio in Germany and price almost halved, Sovaldi talks ongoing).
Separately, with regards to Sovaldi, it is also worthy to note that NHS England has been granted a two-month extension to the period in which it is required to comply with the recommendation, with the date fixed at 31 July – typically the time line for complying with NICE recommendations is three months. This decision comes after a request for the extension was made by NHS England, which as noted by PharmaTimes, was triggered by NHS wanted to ensure that it had the necessary funds for the treatment. Given the high cost of Sovaldi, the expenditure for the treatment of all eligible patients, as per PMLive, could potentially amount to GBP1 billion annually. The high cost of Sovaldi, which according to NICE, would amount to GBP34,982.94 for a 12-week course, has come into focus on previous occasions as well with more recently for instance, Gilead having agreed with Germany's National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) to an approximately 30% reimbursement price discount for Sovaldi for three years period, with further price cut in the subsequent two years (see Germany: 13 February 2015: Gilead, GKV funds agree on 30% cut to Sovaldi price for three years in Germany).