IAS 2017: Aim for $90-$90-$90 Target on HIV, Hepatitis, and TB Drug Prices, Study Says

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HIV, hepatitis B and C, and tuberculosis (TB) can each be treated for less than $90 a year where generic drugs can be made available, Dzintars Gotham of Imperial College London reported at the 9th International AIDS Society Conference on HIV Science (IAS 2017) last month in Paris.

[Produced in collaboration with aidsmap.com]

The findings come from an analysis of the prices paid for the raw materials that are used to make drugs for the treatment of each disease, and the costs of manufacturing each product.

Although the cost of antiretroviral treatment has fallen dramatically since generic manufacturers first began to produce versions of antiretroviral drugs in India in 2001, generic products have not been available in all countries due to patent restrictions. Over the next few years it will begin to be possible to provide recommended first-line treatment for HIV using generic drugs as patents expire on some of the key drugs used in HIV treatment.

The cost of treating other diseases remains extremely high in most countries, and is affected not only by patent restrictions, but also by the ability of governments to negotiate competitive prices. Gotham said that the cost of treating hepatitis C with a 12-week course of sofosbuvir (brand Sovaldi) and daclatasvir (brand name Daklinza) ranges from $108 in India and $174 in Egypt, to $11,598 in Australia, $29,361 in Brazil, and $47,972 in Argentina.

To achieve global targets for HIV treatment and viral suppression, hepatitis C elimination, and reducing the burden of TB and drug-resistant TB, large increases in the number of people treated for each disease will be necessary. Cutting the prices paid for medicines will be essential if countries are to afford large treatment programs for HIV or viral hepatitis.

In particular, countries that are seeking to move to treat-all targets will have to keep up with the increase in newly infected people, Andrew Hill of Liverpool University told a symposium on how to reduce drug costs.

The number of people who will need HIV treatment is likely to grow at a rate of 800,000 a year, from 30 million in 2017 to 36.4 million in 2025, he pointed out, while the current rate of hepatitis C virus infection means that the global burden of disease will remain the same at current treatment levels up to 2030, the target date for elimination of hepatitis C.

To find out what scope might exist for further price reductions, Gotham and researchers from Howard University in Washington D.C., St Stephen’s AIDS Trust in London, the University of Liverpool, and the University of Cambridge looked at costs of shipments of active pharmaceutical ingredients (APIs), the raw material of drug manufacture, in and out of India.

Until November 2016 information on the value of shipments of APIs was freely available from the India customs service. The research group used these costs, added manufacturing costs calculated from a range of published and unpublished sources, and added a 10% profit margin. Their prices did not include the costs of bioequivalence studies for regulatory approval or transport.

They compared their calculated costs to the lowest prices currently available from generic manufacturers according to the Médecins Sans Frontières 2016 guide to antiretroviral drug costs.

They found that there is room for further reductions in the costs of several widely used antiretroviral drugs in lower- and lower-middle income countries, and also showed how far higher-income countries can expect to reduce treatment costs as antiretroviral and hepatitis C drugs begin to go off patent over the next few years.

Drug

U.S. price

(annual or per course)

Global lowest price

Estimated price

U.S. patent expiry date

Abacavir

$1938

$72

$149

2018

Atazanavir

$16,093

$170

$126

2017-2019

Darunavir

$15,980

$438

$364

2016-2019

Tenofovir disoproxil fumarate (TDF)/emtricitabine/efavirenz

$28,204

$100

$78

2017-2029

TDF/lamivudine(3TC)/efavirenz

No equivalent

$107

$82

Generic

TDF/emtricitabine

$17,258

$67

$54

2017-2032

Lopinavir/ritonavir

$10,818

$231

$262

2016-2028

Entecavir

$5195

$409

$82

Generic

Sofosbuvir

$81,925

$45

$42

2028-2030

Sofosbuvir/ledipasvir

$91,207

$307

$79

2028-2031

Sofosbuvir/daclatasvir

$142,710

$108

$47

2028-2031

TB first-line therapy

$945

$27

$38

Generic

High-quality regimens for the treatment of each disease can now be produced for less than $90 per course of treatment or per year, and there is no need for governments or donors to pay more, provided that intellectual property restrictions can be overcome. Countries and donors should aim for a new $90-$90-$90 target on HIV, viral hepatitis, and TB drug prices if the current global targets for disease elimination are to be achieved, Gotham concluded.

The lack of accurate information on current prices -- and potential future prices -- is deterring governments and donors from scaling up treatment for hepatitis C, speakers at the symposium on drug pricing agreed.

"Donors need to understand just how cheaply these drugs can be made. It’s misleading for Gilead to say that they can offer sofosbuvir for $900 when we’ve shown that it can be made for $90," said Hill.

"One of the most important things we have to do is re-frame [the debate about hepatitis C drug prices]. The focus on $1000 a pill has done us a disservice with donors. We need to be talking about a $150 course of treatment," said Margaret Hellard of the Burnet Institute in Melbourne.

Governments also need to adopt a tougher stance in price negotiations and start thinking in terms of their strategic aims for public health, several panelists argued.

"One of the jobs of government should be negotiating hard for the best price and not just accepting the price offered," said Hellard. "We need our governments to make strong and brave decisions on behalf of their people."

8/17/17

Source

D Gotham et al. Generic treatments for HIV, HBV, HCV, TB could be mass produced for < $90 per patient. 9th International AIDS Society Conference on HIV Science.Paris, July 23-26, 2017. Abstract TUAD0104.