Report: Lifesaving New AIDS Drugs Remain Costly; Older Versions Get Cheaper

DURBAN, South Africa – The international medical humanitarian organisation Médecins Sans Frontières (MSF) has found that prices of older HIV drugs continue to decline, but newer drugs largely remain expensive.

The results were released on 21 July in Untangling the Web, the 18th edition of MSF’s report on HIV drug pricing and access, at the International AIDS Conference in Durban.

The report provides key data on HIV treatment access, the latest HIV treatment guidelines from World Health Organization, an overview on pricing for first-line, second-line, and salvage regimens, and a summary of the opportunities for – and threats to – expanding access to affordable antiretroviral therapy (ART).

The lowest price for a quality-assured, WHO-recommended first-line one-pill-a-day combination (tenofovir/emtricitabine/efavirenz) is US$100 per person per year says the report – a decrease of 26 percent since MSF last recorded the lowest price for first-line treatment at $136 in 2014.

For the second-line regimen, the lowest available price is now $286 per person per year (zidovudine/lamivudine + atazanavir/ritonavir) – an 11 percent decrease from $322 two years ago.

MSF attributes the fall in price to competition among generics manufacturers in key producing countries, mainly India. The price of newer drugs, however, needed for people who have run out of other HIV treatment options remain high, largely because of patent monopolies held by drug corporations.

The current lowest price for salvage treatment today, (raltegravir + darunavir/ritonavir + etravirine) is $1,859 per person annually, which is more than 18 times the price of first-line therapy, and more than six times the price of today’s most affordable second-line combination. This combination’s price has come down only by seven percent, from $2,006 per year in 2014, said the report.

According to AIDS InfoNet, a project of the International Association of Providers of AIDS Care, antiretroviral therapy (ART) sometimes needs to be changed if the treatment is not working and this usually happens when the HIV viral load rises instead of staying very low. When the viral load in ART users increases, it means that HIV has developed resistance, treatment has failed.

Treatment failure requires healthcare providers to use salvage therapy, and change the ARVs to a new combination that can reduce the HIV viral load despite the resistance. Salvage therapy is often required when a patient is losing weight, CD4 count is dropping, serious side effects are noted and there is an increase in symptoms.

Due to pharmaceutical patents that block countries from using generics, MSF said, many countries, especially ‘middle-income’ countries, pay much higher prices for these medicines.

“We have to be able to afford the newer HIV drug combinations that people will need over time, or else they will have no other options,” Dr. Vivian Cox, medical referent for MSF’s Eshowe project in South Africa, said in a statement.

“We need to be shouting about this now to make sure we don’t end up with another treatment crisis like the one we faced over a decade ago, when life-saving medicines were simply priced out of reach for millions of people who needed them,” said Cox.

In 2000, MSF began providing antiretroviral therapy to a small number of people living with HIV/AIDS in projects in Thailand, South Africa and Cameroon, when treatment for one person for a year cost more than US$10,000. Then multilateral programmes funding the fight against HIV, TB, and malaria did not exist nor many donors. But as the availability of low-cost, quality antiretroviral drugs, increased, MSF now provides antiretroviral treatment to 247,000 people in 18 countries.

UNAIDS says 70 percent of all HIV-positive people will be living in middle-income countries by 2020 and several ARVs are still on patent in middle-income countries. In some lower- and upper-middle-income countries, patents on key ARVs prevent production or buying of generics is outlawed. The drugs are not included in voluntary licensing agreements, or have not used TRIPS flexibilities such as compulsory licences.

“Ensuring sustainable access to affordable generic ARVs will save millions of lives,” said MSF.

Scaling up the UNAIDS three-pillar effort – 90 percent of HIV-positive people know their status, 90 percent can access antiretroviral treatment, and 90 percent of those on treatment by the year 2020 – is projected to save over 1.1 million lives. 873,000 new HIV infections would be prevented in the next five years while keeping up the pace for 10 years will save more than 2.4 million lives.

Monitoring systems to identify more people who are failing on their first- or second-line treatment has shown that the number of people who require salvage therapy is relatively small in developing countries. Within MSF’s HIV programmes, the number of people having moved to second-line therapy has almost doubled since 2013.

Industry Support for Access to Medicines

At the backdrop of these contested interests, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said, they share a common goal with all partners in healthcare to ensure that patients across the world have rapid access to the latest life changing or lifesaving medicines.

“Our industry is working with governments and healthcare systems to find solutions to make medicines accessible and healthcare more sustainable, whilst securing future medical innovation,” said Mario Ottiglio, director, public affairs and global health policy at IFPMA.

“This is critical as factors determining access to antiretroviral therapy include political commitment, investment in healthcare infrastructures and resources,” he told Intellectual Property Watch.

Ottiglio said, looking at HIV/AIDS, a recent report, ‘The Evolution of Access to Essential Medicines for the Treatment of HIV/AIDS,’ from Charles River Associates, demonstrated that industry has contributed to the affordability of antiretroviral therapy in several ways, particularly through partnering, voluntary licensing and differential pricing (IPW, Public Health, 18 July 2016). He said continued collaboration will be critical to meet the targets ahead.

“Efforts should be done to reach new patients in need, enhance data collection, and promote policies which favour continued investments in health systems and further R&D,” Ottiglio said.

Pressure on India

India, the world’s main producer of affordable HIV medicines, is often called the ‘pharmacy of the developing world.’ More than 97 percent of the HIV medicines MSF uses in its treatment programmes are generic medicines from India. India’s patent law sets a high bar for what deserves a patent. This allows robust competition among generic producers, which has driven down first-line HIV treatment prices by 99 percent – from $10,000 per person per year in 2000, to $100 today.

But India is facing immense pressure to roll back its pro-health patent policies, especially from the United States, backed by its pharmaceutical corporation lobby.

Other countries, such as those in the EU, along with Japan and South Korea, are preparing or actively pursuing trade agreements with India that would restrict the country’s production of affordable medicines in the future. Should India be forced to change its policies for these trade agreements, it could pose a serious threat to affordable medicines production in India, according to MSF.

“India is under massive pressure to turn off its tap of affordable medicines, which are a lifeline to millions of people not only in India, but across the developing world,” said Leena Menghaney, South Asia head of MSF’s Access Campaign. “If India doesn’t stand strong against the pharmaceutical corporations and governments that are pushing for change in the country’s patent law and policies, people around the world will face a crisis in access to medicines in the future.”

 

Image Credits: Munyaradzi Makoni