The negotiated price agreements have reduced costs and will improve access to quality treatment for people living with HIV.
New York: A groundbreaking pricing agreement has been announced that will accelerate the availability of the first affordable, generic, single-pill HIV treatment regimen containing dolutegravir (DTG) for public sector purchasers in low- and middle-income countries (LMICs) at US$75 per person, per year. The agreement is expected to accelerate the rollout of the treatment as part of global efforts to reach the 36.7 million people living with HIV with high-quality antiretroviral therapy. UNAIDS estimates that in 2016, just over half (19.5 million) of all people living with HIV had access to lifesaving medicines.
DTG, the best-in-class integrase inhibitor, is widely used in high-income countries and is recommended by the World Health Organization (WHO) as an alternative first-line HIV regimen, as well as a preferred treatment by the U.S. Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, among many others. In addition to improving the quality of and adherence to treatment, widespread use of DTG is expected to reduce the cost of first-line HIV treatment regimens while simultaneously decreasing the need for more expensive second- and third-line regimens. In July 2017, the WHO issued guidance for countries on how to safely and rapidly track DTG use.
This agreement, announced by the governments of South Africa and Kenya, together with the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative (CHAI), the Bill & Melinda Gates Foundation (BMGF), Unitaid, the UK Department for International Development (DFID), the US President's Emergency Plan for AIDS Relief (PEPFAR), the United States Agency for International Development (USAID), and the Global Fund to Fight AIDS, Tuberculosis and Malaria, with Mylan Laboratories Limited and Aurobindo Pharma, takes an important step towards ensuring the availability of high-quality HIV treatments worldwide.
This agreement will improve the quality of life for millions of people living with HIV,” said UNAIDS Executive Director Michel Sidibé. “To achieve the 90-90-90 treatment targets, newer, affordable and effective treatment options must be made available—from Baltimore to Bamako—without any delay.”
WHO Director-General, Dr. Tedros Adhanom stated, «WHO welcomes this agreement which will make it possible to reach millions of people with better, more affordable and durable HIV drugs. This will save lives for the most vulnerable, bringing the world closer to the elimination of HIV. We congratulate South Africa, Kenya, CHAI and others on this landmark agreement. “WHO will support countries in the safe introduction and a swift transition to this game-changing new treatment.”
This one pill, once-a-day generic fixed-dose combination of tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD) was developed by Mylan and Aurobindo under licensing agreements from ViiV Healthcare, the original developer of DTG. Mylan and Aurobindo both recently received tentative approval from the US Food and Drug Administration (FDA) for their products under the United States PEPFAR program. Clinical studies demonstrated that treatment regimens that use DTG result in more rapid suppression of viral load, fewer side effects, and greater potency against drug resistance than current regimens used in LMICs.
“I am excited about this groundbreaking agreement that will allow the South African government to accelerate the introduction of the dolutegravir-based fixed-dose combination, which will greatly benefit our patients due to its superior therapeutic qualities,” said South African Minister of Health Dr. Aaron Motsoaledi. “The substantial price reductions could generate savings of up to US$900 million over the next six years for us, meaning we can initiate additional patients on treatment with the same amount of resources. Scaling up treatment with good viral suppression will allow us to achieve control of the HIV epidemic more quickly. We aim to launch the new tender in April 2018.” “In the antiretroviral therapy guidelines released in July 2016, the Ministry of Health made provisions for the use of newer antiretroviral drugs such as dolutegravir,” said Dr. Cleopa Mailu, Cabinet Health Secretary in Kenya. “Research has shown that dolutegravir offers better tolerability, fewer adverse drug reactions, fewer drug interactions, and a higher genetic barrier to resistance. With this in mind, in July of this year, Kenya approved its inclusion in the National ART Program.” “The Global Fund is excited to be part of this great initiative that will help us save more lives,” said Marijke Wijnroks, Interim Executive Director of the Global Fund. “As we strive to end HIV as an epidemic, we are committed to supporting people affected by disease to access better products.”
The BMGF, with support from CHAI, recently finalized price cap agreements with Mylan and Aurobindo to accelerate the availability of the new fixed-dose combination to the public sector in more than 90 LMICs at reduced prices. By some estimates, the agreements, which establish a price ceiling for TLDs, are expected to save public sector purchasers more than US$1 billion over the next six years. “As a physician with profound personal experience of the anguish and despair caused by HIV and AIDS, I am excited about the prospect of providing better treatment to more people than ever before,” said BMGF CEO Sue Desmond-Hellmann. “This unprecedented new partnership, the largest of its kind ever seen in global health, will transform millions of lives by making a highly effective medicine more affordable for countries with the highest number of people living with HIV. The Bill & Melinda Gates Foundation is uniquely positioned to assist in this effort, and I am delighted that our investment will give millions more people the opportunity to lead healthy and productive lives.” Ministries of health and program managers should anticipate the possibility of ordering TLD in 2018 at a projected average price of US$75 per patient, per year. Further pricing details are available upon request from Mylan or Aurobindo. The maximum price agreements apply to purchases for public sector use in the 92 countries covered by ViiV Healthcare’s dolutegravir licensing agreement, which represents more than 90 percent of people with low- and middle-income individuals currently living with HIV.
To build momentum for TLD and familiarize healthcare workers with the drug in resource-limited settings, Unitaid partnered with CHAI starting in late 2016 to make single-tablet generic DTG tablets available in three early adopter countries: Kenya, Nigeria, and Uganda. In partnership with the WHO, USAID, and Ministries of Health, this innovative initiative provides countries with the opportunity to enhance treatment options for their patients while simultaneously generating critical evidence on DTG use in specific populations, including pregnant women and tuberculosis (TB) co-infected patients. “Unitaid’s investments have laid the groundwork for the innovative introduction of TLD at an affordable price,” said Lelio Marmora, Executive Director of Unitaid. “Through our catalytic work, we are breaking down barriers, enabling countries like Kenya to access the latest HIV treatments on the market.” “This groundbreaking agreement will help improve the lives of millions of patients by reducing costs and increasing the availability of a one-pill, fixed-dose combination that includes dolutegravir,” said Ira Magaziner, CEO of CHAI. “This drug combination is better tolerated and more effective, and will lead to improved health outcomes by ensuring fewer HIV patients develop drug resistance and more remain on treatment.”