A study published in The Lancet discusses access to reimbursement for direct-acting antivirals (DAAs) is globally uneven, with low and middle-income countries (LMICs) facing notably lower rates of reimbursement compared to high-income nations. DAAs for hepatitis C virus (HCV) infection offer high response rates (>95%) and have simplified HCV treatment management, allowing non-specialist healthcare providers to treat patients without advanced liver disease. To align with the World Health Organization’s (WHO) objectives for the elimination of HCV, it is essential to support countries, especially LMICs, in enhancing access to DAA reimbursement and eliminating barriers to reimbursement, with a particular focus on removing restrictions related to the type of prescriber to guarantee universal access.

As of mid-2023, 145 countries, accounting for 91%, had approved at least one of the DAA treatments, including sofosbuvir–velpatasvir, sofosbuvir–velpatasvir–voxilaprevir, glecaprevir–pibrentasvir, sofosbuvir–daclatasvir, or sofosbuvir alone. Out of these, 109 countries (68%) provided reimbursement for at least one type of DAA therapy. Within the cohort of 102 LMICs, 89 countries (87%) had approved at least one form of Hepatitis c DAA treatment, with 53 (52%) offering reimbursement for at least one DAA therapy. Of the countries offering DAA reimbursement (totaling 109), 66 (61%) imposed specialist prescription requirements, eight (7%) included retreatment restrictions, seven (6%) enforced restrictions based on illicit drug use, five (5%) on alcohol use, and three (3%) on the presence of liver disease.

“Our findings suggest suboptimal levels of DAA reimbursement among countries where these treatments are registered, with considerable variation in regional access,” according to investigators. “Compared with all other countries, fewer reimbursed DAAs were provided in central Asia, the Caribbean, Pacific Island Countries and Territories, and sub-Saharan Africa. Although the development and approval timelines varied for DAAs, our findings illustrate disparities in reimbursement, with LMICs particularly disadvantaged.”¹

The methods for assessing restrictions on DAA reimbursements mirrored those used in earlier studies in Canada, Europe, and the USA. This investigation focused on the availability of subsidized DAAs (originators or generics) through government reimbursement, subsidy, or fee-free policies for people living with Hepatitis c. Data on DAA access for individuals aged 18 years and older was collected.

“Our data indicate that prescriber restrictions were the most common DAA restriction. 66 (61%) countries implemented specialist-only prescribing, consistent with findings from a European study,” investigators wrote. “This restriction reduces the proportion of available prescribers and requires patients to receive treatment from a specialist center. This restriction is a major barrier for marginalized population groups, who are more likely to experience stigma in health-care settings and avoid attending hospital-based centers, and for people residing in remote areas, who live further away from specialists.”¹

This study faced limitations, including a lack of written documentation outside of Canada and Europe, particularly in LMICs, where many do not have online drug formularies or updated clinical guidelines. The research highlighted a focus on individuals aged 18 and over, noting a gap in data for younger populations. Despite efforts to update data through a global network of collaborators, changes in DAA registration and reimbursement could have occurred within the study period. The study also acknowledges that information on all DAAs was not covered, possibly underestimating access. Issues such as drug criminalization laws and other socio-political factors impacting DAA access were beyond the scope of this paper. The research underscores the need for further investigation into both public and private healthcare’s role in HCV treatment and elimination efforts, acknowledging the contribution of in-country experts to provide a comprehensive overview despite data gaps.

Among the examined limitations, enabling non-specialist prescribing stands out as a crucial area for enhancement. To achieve WHO objectives, initiatives should focus on helping countries enhance DAA reimbursement access and guarantee universal availability by eliminating barriers to reimbursement for Hepatitis c.

Reference

1. Marshall A, Willing A, Kairouz A, Cunningham E, Wheeler A, et. al. Direct-acting antiviral therapies for hepatitis c infection: global registration, reimbursement, and restrictions. The Lancet. Published February 14, 2024. Accessed February 15, 2024. DOI: https://doi.org/10.1016/S2468-1253(23)00335-7