Authors' recommendations: There are no exact figures on the total number of people who have been infected with the hepatitis C virus in Belgium. The combinations of new-generation drugs, known as direct-acting antivirals (DAAs) show very high sustained virological response (SVR) rate. They are well tolerated and also allow for a reduction in the duration of the therapy (often to 12 weeks), which is a considerable improvement on the earlier therapies. Currently, only patients suffering from advanced fibrosis (score F3 or F4) and transplant patients (pre and post-transplantation) qualify for reimbursement of these new direct-acting antiviral therapies. This represents, in our country, a few hundred patients each year. Given the efficacy of these therapies, the question arises whether this target group should not be broadened. Traditionally, the fibrosis score was determined by means of a liver biopsy. Other non-invasive tests are now available (notably elastography and blood tests) but there are no robust data on the performance of a combination of these tests. This study looks into the cost and benefits of various possible strategies: no treatment, treating from F3 (the current situation), treating from F2 (on the basis of an elastography and blood tests of fibrosis), treating all patients whose blood tests only is positive and, lastly, treating everyone who carries the virus. Given that the damage caused by the virus is by and large irreversible, the quality of life of patients will especially improve if they are treated at an early stage. The economic evaluation shows that the more patients can be treated at an early stage (i.e. more we are inclusive), the more QALYs we gain at an additional cost of less than € 50,000/QALY. However, the option to treat every infected patient as early as possible before their condition has a chance to deteriorate is likely to take a heavy impact on the budget. For that reason, we suggest a progressive expansion of the DAA therapy reimbursement conditions. The scale of the budget impact of this gradual reimbursement is nevertheless difficult to predict because of the various uncertainties that prevail, such as the number and profile of patients who are currently infected and not yet treated. A quarterly monitoring of the number of patients treated and, where appropriate, an urgent renegotiation of the prices and reimbursement criteria are required if we want to prevent a budget explosion. Furthermore, any expansion of the eligible population must go hand in hand with an additional reduction in the cost of these therapies to ensure that the entire healthcare system is not put in jeopardy. To obtain a more significant price reduction, which would allow reimbursements to be broadened faster, other options could be explored, such as joint procurement agreements with other countries to purchase these medicines.

Project Status: Completed

Year Published: 2016

URL for published report: https://doi.org/10.57598/R276C

URL for additional information: https://kce.fgov.be/sites/default/files/page_documents/KCE_276Cs_Reimbursement_Hepatitis%20C_Summary.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Belgium

DOI: 10.57598/R276C

Organisation Name: Belgian Health Care Knowledge Centre

Contact Address: Administrative Centre Botanique, Doorbuilding (10th floor), Boulevard du Jardin Botanique 55, B-1000 Brussels, Belgium tel: +32 2 287 33 88 fax: +32 2 287 33 85

Contact Name: info@kce.fgov.be

Contact Email: info@kce.fgov.be

Copyright: Belgian Health Care Knowledge Centre (KCE)