In May 2023, during our Global Hepatitis Resource Mobilisation Conference, we negotiated with the Clinton Health Access Initiative (CHAI), a memorandum of understanding with leading generic manufacturers Viatris and Hetero to secure historic ceiling prices for life-saving hepatitis B and C treatments.
These new drug prices significantly reduce the cost of treatment to low- and middle-income countries – an estimated savings of US$2 billion – and scale up hepatitis programmes to meet growing demand, all towards eliminating hepatitis.
Viatris and Hetero now offer WHO-prequalified sofosbuvir and daclatasvir, a 12-week, once-daily oral treatment for hepatitis C, at a ceiling price of US$60 per person for a course of treatment.
Both manufacturers also offer WHO-prequalified and/or US FDA-approved tenofovir disoproxil fumarate (TDF) 300 mg single tablets, used for hepatitis B treatment (once-daily lifelong oral treatment) at a ceiling price of US$2.4 per 30 tablets, a month’s course of treatment.
These ceiling prices are the lowest for WHO-prequalified hepatitis B and C drugs globally. They represent over a 90% reduction from the lowest cost of hepatitis C treatment by originators in 2016 and align the price of TDF for hepatitis B with that of TDF used in HIV treatment.
Thanks to these agreements, the cost of treatment in low- and middle-income countries is significantly reduced, contributing to access to treatment for many more healthcare clients in countries with the highest epidemiological burden. Furthermore, they have the potential to scale up hepatitis programmes and reduce the funding needed to achieve hepatitis elimination.
This is a golden opportunity for governments to increase financing for viral hepatitis elimination, showing solid political will and interest to attract donors.
FAQ: What you need to know about the pricing deal for generic viral hepatitis medicines
What is the agreement?
Viatris and Hetero will supply WHO-prequalified generic versions of Sofosbuvir and Daclatasvir at or
below the ceiling price to the public sector, for a minimum order quantity (MOQ) per order of 2,500
packs of each product for Viatris and 3,500 packs of each product for Hetero. One pack is 28 tablets – 4
weeks treatment course.
Viatris and Hetero will offer WHO-prequalified and/or US FDA-approved Tenofovir disoproxil fumarate
(TDF) 300 mg single tablets, used for Hepatitis B treatment (once-daily lifelong oral treatment) at a
ceiling price of US$2.4 per 30 tablets – a month’s course of treatment.
Are there any minimum order quantity requirements associated with the agreements?
Yes. Pricing will be available for WHO-prequalified generic versions of Sofosbuvir and Daclatasvir for a minimum order quantity (MOQ) per order of 2,500 packs (1 pack is 28 tablets – 4 weeks treatment course) of each product for Viatris and 3,500 packs (1 pack is 28 tablets – 4 weeks treatment course) of each product for Hetero. There is no MOQ for the supply of TDF.
Which countries are eligible to access the terms of the agreements?
Low-middle-income countries which satisfy the below conditions:
- Permitted under Amended and Restated License Agreement between Gilead Sciences Ireland UC, and generic manufacturers governing the license of Sofusbuvir (“SOF Agreement”) for the permitted countries. For this list of countries – see here: Sofosbuvir: country list in appendix 1 (page 31) of Gilead licensing agreement –
https://www.gilead.com/-/media/files/pdfs/other/form-ar-hcv-license-agmt-gild-11202017.pdf - Permitted under the sublicense and technology transfer agreement between Bristol-Myers Squibb (BMS), Medicine Patent Pool and generic manufacturers governing the license of daclatasvir (“DAC Agreement”) for the permitted countries – see here: Daclatasvir: country list in daclatasvir License Agreement (Schedule D) through MPP – https://medicinespatentpool.org/licence-post/daclatasvir-dac#country-list0
Note, in 2020, BMS announced that the marketing authorizations for Daklinza® (daclatasvir) will be withdrawn or will be allowed to lapse in countries where the product is no longer routinely prescribed or where there are other therapeutic options available. This means that patients diagnosed with hepatitis C in additional countries will soon have access to generic versions of daclatasvir1. - Eligible products are registered in the country by manufacturers. This would vary country by country.
Which purchasers are eligible to access the terms of the agreements?
Any organisation or entity that is purchasing these medicines on behalf of public sector patients in the territory as per the agreement with Gilead and MPP. Public sector is defined to include all governments (including any agency or political subdivision thereof), nongovernmental organizations, and entities that purchase products on behalf of the public sector (e.g., The Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, UNICEF, PAHO, etc.).
Are there any additional costs associated?
The ceiling price mentioned above is Ex-works International Commercial Terms (INCO terms); additional costs would include shipping, storage, import taxes/duties, insurance, and any other cost to ship the product from origin to final destination.
How much of a price reduction does this pricing deal represent?
These ceiling prices are the lowest prices for WHO-prequalified hepatitis B and C drugs globally. They represent over a 90 percent reduction from the lowest cost of hepatitis C treatment by originators in 2016 and align the price of TDF for hepatitis B with that of TDF used in HIV treatment.
Previously, no ceiling prices were set for Sofosbuvir, Daclatasvir and Tenofovir for hepatitis treatment.
Prices at which these drugs were procured varied and depended on agreement between specific buyer and these manufacturers. This has led to significant variability in prices accessed across LMICs. Refer to CHAI’s Market intel reports for more detail on pricing across countries.
Hepatitis C: https://www.clintonhealthaccess.org/news/hepatitis-c-report-2021/
https://www.clintonhealthaccess.org/report/chai-releases-the-2022-hepatitis-c-market-memo/
Hepatitis B: https://www.clintonhealthaccess.org/report/2022-hepatitis-b-market-report/
Watch the drug pricing agreements announced at our Global Hepatitis Resource Mobilisation Conference in May 2023:
Watch the drug pricing agreements announced at our Global Hepatitis Resource Mobilisation Conference in May 2023:
Photo caption: from left: Rahul Lande, Hetero, Dr David Ripin, CHAI, Finn Jarle Rode, The Hepatitis Fund, and Kedar Madhekar, Viatris. Photo ©: Steve Forrest/Workers’ Photos/The Hepatitis Fund.
