NEW YORK — A new pricing agreement for HIV drugs could represent an “unprecedented” step toward making superior medications available faster and at a large scale in low- and middle-income countries.
A generic, single-pill HIV treatment, which has been a preferred option in high-income countries but is rarely used in Africa due to cost, could soon be widely available for roughly $75 per person, per year — about a tenth of the current price. The pricing agreement is the result of a coordinated effort by pharmaceutical manufacturers, United Nations agencies, NGOs, and national governments.
Kenya already debuted the new generic drug — a Dolutegravir, or DTG-based tablet — earlier this year. South Africa’s Minister of Health Dr. Aaron Motsoaledi said Thursday that his country — where nearly 4 million people are currently on HIV treatment — will feature the new drug option in its 2018 drug tender with the aim of making it available in April 2018.
The announcement was made in a press briefing during the U.N. General Assembly in New York. Under the agreement, the generic drug can be sublicensed in 92 countries, and the price ceiling can be applied in middle-income countries — a provision that will help increase access for countries that graduate beyond low-income status.
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DTG has been on the market in the United States, where it is considered a preferred first-line treatment by the U.S. Department of Health and Human Services, since 2013. About a quarter of a million people use DTG in the U.S. and Europe. It offers faster viral load suppression, fewer side effects, and better defense against drug resistance, but until now has been prohibitively expensive for lower income markets.
“We’re getting better at taking innovation from the West and making it available [elsewhere],” Anil Soni, head of global infectious diseases at the generics manufacturer Mylan, told Devex.
The first generation of antiretroviral HIV treatments took 12 years to move from affordable use in developed countries to use in low-income countries. The second generation took six years. This third generation of ARVs, Soni explained, took three years to find its way from wealthy pharmaceutical markets to countries struggling to increase the number of HIV-positive people on treatment.
“It should be zero, frankly,” said Soni, who previously was chief executive officer at the Clinton Health Access Initiative, one of the organizations involved in forging the agreement.
After DTG’s original manufacturer, ViiV Healthcare, issued licensing agreements, the Bill and Melinda Gates Foundation and Clinton Health Access Initiative worked with generics manufacturers Mylan and Aurobindo to enter the market and set a price ceiling for their version of the drug, which the World Health Organization ushered in through regulatory approval.
In the past, the process of licensing drugs to generics, securing regulatory approval, and then finding ways to distribute them to patients in developing countries has been “sequential and reactive,” Soni said.
“In this case, all of those things were different,” he said.
The partners who collaborated on expanding access to generic DTG, recognizing that a shift to generics would eventually be possible, began coordinating earlier in the process.
South Africa has both a heavy HIV burden and daunting goals to reduce it. The UNAIDS “90-90-90” targets call for 90 percent of people to know their HIV status, 90 percent of HIV-positive people to be on treatment, and 90 percent of people receiving treatment to have viral suppression. Reaching those targets will require South Africa to roughly double the number of HIV-positive people on treatment. Doing so will require additional funding, decreased costs, or some combination of the two.
By some estimates, South Africa could save up to $900 million over six years by using generic DTG. The drug, despite being considered superior to alternative treatments, will actually be cheaper than the first-line ARVs South Africa’s health ministry currently purchases.
“This shows the power of global partnership,” Motsoaledi said.
“As we move towards the implementation of universal health coverage and full implementation of the SDGs, we must be able to work together,” he said. “The spiraling cost of health care provision in every country in the world needs to be addressed, and we can only address this in ways that increase equity in access to services, based in need and not on ability to pay.”
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