Pan-genotypic Hep-C drug added to Thai health system

The first pan-genotypic Hepatitis C drug, which can be prescribed without the requirement for expensive and limited testing to determine the type of Hep C someone is living with, has been approved for patients in Thailand’s universal health coverage scheme.

The National Health Security Board (NHSB), the government organization responsible for the universal health coverage scheme (UHC) in Thailand, announced that the fixed-dose combination sofosbuvir/velpatasvir was approved to be included in the health benefit package, allowing access at no cost for all patients under the UHC.   

The NHSB’s announcement was made after the Committee of the National List of Essential Medicines approved the inclusion of sofosbuvir/velpatasvir in the national drug list, replacing older versions of chronic hepatitis C treatments, on 15 January 2021.

“This is the achievement we have fought so long for. We first kicked off our access campaign in 2015, demanding the Ministry of Public Health to issue a compulsory license (CL) to address the lack of access to the lifesaving medicine due to the patent barrier. In the 5 years since the campaign kicked off, we joined hands with NGOs in several countries to file patent oppositions against Gilead’s unmerited patent applications for sofosbuvir. The turning point was the issuance of a CL on sofosbuvir by the Malaysian government in September 2017.  Gilead was afraid of a domino effect, that Thailand would enforce another CL. The company decided to extend their voluntary license allowing Thailand to import or produce all of their Hepatitis C drugs for the treatment in the country”, said Chalermsak Kittitrakul, Project Manager of AIDS Access Foundation, a Make Medicines Affordable partner.

Access campaign kick-off at the Ministry of Public Health demanding for launching CL on sofosbuvir. 26 May 2015.

Even though generic versions of sofosbuvir and sofosbuvir/ledipasvir have been available in the healthcare systems since April 2018, a limited number of patients were treated with those two drugs because it required a test to identify the type of hepatitis C virus prior to the treatment, which was very costly (about $50 USD per test). In addition, the availability of testing technology was limited, available only in well-equipped hospitals.

Chalermsak says: “We urgently needed pan-genotypic hepatitis C drugs. Up until 2020, only one generic-drug company had filed market-approval registration for pan-genotypic sofosbuvir/velpatasvir in Thailand. The generic drug firm insisted on proposing on a high price, five times higher than the prices in India. In 2020, other generic drug companies started filing registrations on the same drugs in Thailand. It makes the relevant committees more confident that it won’t have a huge budget impact, and they approved the inclusion of sofosbuvir/velpatasvir in the health benefit package.”

Nimit Tienudom, Director of AIDS Access Foundation and a member of the National Health Security Board, said: “The first shipment of generic sofosbuvir/velpatasvir has already arrived and the universal health coverage scheme is now ready to provide Hep C treatment with sofosbuvir/velpatasvir. Eligibility criteria for treatment has also been revised and simplified due to the availability of the pan-genotypic drug. Genotyping testing is not needed anymore. Diagnosis and treatment becomes simpler. We can save costs… and scale up access.”

According to a study by the Health Intervention and Technology Assessment Program, under the Ministry of Public Health, using generic sofosbuvir/velpatasvir can save 45.47 million baht (approx $1.5 million USD) compared to the formerly approved regimens.

Additionally, as the pan-genotypic version removes the need the testing, costs are further reduced by a further 11.12 million baht (over $370,000).

This data compared the diagnosis and treatment costs for 4,000 patients using sofosbuvir + pegylated interferon (for genotype 3 Hep C infection) and sofosbuvir/ledipasvir (for other genoyypes), to using the newly approved pan-genotypic sofosbuvir/velpatasvir.