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Landmark UNAIDS pricing deal to accelerate HIV treatment

Dr Aaron Motsoaledi, Minister of Health, says a landmark pricing deal announced by the Joint United Nations Programme on HIV/AIDS (UNAIDS), will accelerate the availability of the first affordable, generic, single-pill HIV treatment.

Health-e News reports that the agreement, which Motsoaledi helped unveil in New York last week, could save South Africa an estimated R11bn over six years. It could also revolutionise the treatment and management of HIV in low to middle income countries, boosting global efforts to get high-quality ARVs to all 36.7m people living with HIV.

UNAIDS estimates that just over half of this number has access to the lifesaving medicines. The new fixed dose combination will be available to low and middle-income countries (LMICs) at a reduced price of $75 (just under R1,000) per person, per year.

Motsoaledi said the pricing agreement is a breakthrough for the 3.9m South Africans that rely on ARVs, particularly those in the public health sector.

The report says South Africa’s HIV programme has grown from 923,000 patients on treatment in 2009 to 3.9m patients on treatment as of the end of August this year. In September 2016, Motsoaledi announced the roll-out of the test and treat initiative with the aim to have 6m HIV positive patients on treatment by 2022.

Apart from the financial savings, which will decrease pressure on the fiscus, its introduction will also have significant benefits for patients. Dolutegravir is a highly effective antiretroviral, which is well tolerated by patients and has fewer side effects. Patients are therefore more likely to be adherent and more likely to be virally suppressed – which means that they are not likely to transmit the virus to others.

The South African government together with the government of Kenya, in partnership with the Clinton Health Access Initiative (CHAI), UNAIDS, the Bill & Melinda Gates Foundation (BMGF), UNITAID, the UK’s department for international development (DFID), the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the US Agency for International Development (USAID), and the Global Fund to Fight AIDS, Tuberculosis and Malaria were all involved in this ground breaking pricing agreement.

“We estimate over the next six years, South Africa will potentially save about R11bn; it is very critical,” Motsoaledi said, adding that he was excited about the agreement which would be of great benefit to patients due to its “superior therapeutic qualities”. “Ramping up treatment with good viral suppression will enable us to reach HIV epidemic control more quickly. We are aiming at launching the new tender in April 2018,” Motsoaledi said.

South Africa’s commitment to make TLD available to patients was key to securing this ground-breaking pricing agreement, the report says.

 

 

Global health experts hope the deal will help address two looming problems in the HIV epidemic – the rising threat of resistance developing to standard Aids drugs, and the need for more investment in manufacturing capacity, reports Moneyweb. Bill Gates’ charitable foundation will guarantee minimum sales volumes of the new combination pills using dolutegravir, a so-called integrase inhibitor that avoids the drug resistance that often develops with older treatments. In return the drugmakers, India-based Mylan Laboratories and Aurobindo Pharma, will agree the maximum price of about $75 per patient for a year’s supply – less than the list price for one day’s supply of a dolutegravir combination in the US

The report says under the deal, Mylan and Aurobindo will ramp up availability of a new fixed-dose combination of tenofovir disoproxil fumarate, lamivudine and dolutegravir (TLD). Health ministries and other public sector purchasers will be able to buy TLD from next year at the capped price.

The report says as well as improving treatment, the drug combination should also reduce the need for more expensive second- and third-line drugs.

The TLD combination pill developed by Mylan and Aurobindo has already received tentative approval from the US Food and Drug Administration under the PEPFAR programme.

 

 

DTG, a best-in-class integrase inhibitor, is widely used in high-income countries and is recommended by the World Health Organisation (WHO) as an alternative first-line HIV regimen, as well as a preferred treatment by the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, among many others. In addition to improving treatment quality and retention, widespread use of DTG is expected to lower the cost of first-line HIV treatment regimens while also reducing the need for more expensive second- and third-line regimens. In July 2017, WHO issued guidance to countries on how to safely and rapidly transition to DTG-based antiretroviral treatment.

“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 said: "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."

“In the antiretroviral therapy guidelines launched in July 2016, the Ministry of Health made provisions for use of newer antiretroviral medicines such as dolutegravir,” said Dr Cleopa Mailu, Cabinet Secretary of Health in Kenya. “Research has shown that dolutegravir offers better tolerability, fewer adverse drug reactions, fewer drug interactions, and higher genetic barrier to resistance. It is with this in mind that, in July this year, Kenya approved its inclusion in the National ART Programme.”

“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 diseases to access better products.”

“As a doctor with deep, personal experience of the heartache and despair caused by HIV and Aids, I’m excited by the prospect of bringing better treatment to more people than ever before,” stated 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 drug more affordable to countries with the largest numbers of people living with HIV. The Bill & Melinda Gates Foundation is uniquely placed to help in this endeavour – and I’m delighted that our investment will give millions more people a shot at leading a healthy, productive life.”

To build momentum for TLD and familiarise healthcare workers with the drug in resource-limited settings, UNITAID partnered with CHAI beginning in late 2016 to make generic DTG single tablets available in three early adopter countries: Kenya, Nigeria, and Uganda. Partnering with WHO, USAID, and the Ministries of Health, this innovative initiative is giving countries an opportunity to improve treatment offerings for their patients while also generating critical evidence on the use of DTG in certain populations, including pregnant women and tuberculosis (TB) co-infected patients.

“UNITAID’s investments have laid the foundation for the ground-breaking introduction of TLD at an affordable price,” said Lelio Marmora, UNITAID’s executive director. “Through our catalytic work we are overcoming barriers, thereby enabling countries like Kenya to access the latest HIV treatments on the market.”

“This ground-breaking agreement will help improve the lives of millions of patients by reducing costs and increasing availability of a one pill, once daily fixed-dose-combination including dolutegravir,” stated Ira Magaziner, CEO of CHAI. “This drug combination is better tolerated and more effective and will lead to improved health outcomes by ensuring that fewer HIV patients develop drug resistance and that more remain on treatment.”

 

 

"It's not often in medicine we get something safer and more effective that is also cheaper. This is a big step forward‚” said deputy director of the Wits Reproductive Health and HIV Institute Professor Francois Venter in a report in The Times. In medicine‚ usually better drugs are more expensive‚ he explained.

Health Department spokesperson Joe Maila said: “Dolutegravir is …. well tolerated by patients and has fewer side effects. Patients are therefore more likely to be adherent and more likely to be virally suppressed – which means that they are not likely to transmit the virus to others."

The report says South Africa has the largest HIV treatment programme in the world with the lowest-priced ARVs. There was no way to manufacturer the current treatment any cheaper‚ which is sold at less than R90-a-month per patient.

The new drug Dolutegravir is cheaper because less ingredient is needed in the pill. "It is cheaper to make‚" said Venter.

 

 

Only two pharmaceutical companies have applied to register three-in-one pills containing the state-of-the-art ingredient dolutegravir, according to the Medicines Control Council. Business Day reports that this means there will be limited competition for the next Aids drug tender, as there will not be time for rival manufacturers to get their products approved when the pill is introduced in April.

The report sayas GlaxoSmithKline has already launched dolutegravir-containing products in South Africa, but their high cost means they are available only in the private sector. Tivicay contains dolutegravir alone and costs more than R850 a month, while Trelavue contains dolutegravir, lamivudine and abacavir and costs more than R1,000 a month.

Treatment Action Campaign spokesperson Lotti Rutter said more generic manufacturers needed to enter the market to ensure the new regimen reached the lowest possible price. "It is impressive that the entire three-drug regimen will be available for a maximum of $75 per year.

"Currently, a month’s supply of the originator version of dolutegravir alone costs almost that much in SA," Rutter said.

[link url="https://www.health-e.org.za/2017/09/22/landmark-arv-pricing-deal-save-sa-r11-bn-six-years/"]Health-e News report[/link]
[link url="https://www.moneyweb.co.za/news-fast-news/africa-to-get-state-of-art-hiv-drugs-for-75-a-year/"]Moneyweb report[/link]
[link url="http://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2017/september/20170921_TLD"]UNAIDS material[/link]
[link url="https://www.timeslive.co.za/news/south-africa/2017-09-25-new-hiv-drug-safer-more-effective-and-cheaper/"]The Times report[/link]
[link url="https://www.businesslive.co.za/bd/national/health/2017-09-26-only-two-drugs-firms-in-breakthrough-aids-medication-tender/"]Business Day report[/link]

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