Countries and donors should aim for new $90-$90-$90 target on HIV, hepatitis, TB drug prices, study shows

Dzintars Gotham presenting at IAS 2017. Image credit: Enzo Poultreniez / http://aides.org

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) in Paris on Tuesday.

“One of the jobs of government should be negotiating hard for the best price and not just accepting the price offered.” Dr Margaret Hellard

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 manufacture 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 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. Dr Gotham said that the cost of treating hepatitis C with a 12-week course of sofosbuvir and daclatasvir ranges from $108 in India and $174 in Egypt, to $11,598 in Australia, $29,361 in Brazil and $47,972 in Argentina.

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

middle income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. There are around 50 lower-middle income countries (mostly in Africa and Asia) and around 60 upper-middle income countries (in Africa, Eastern Europe, Asia, Latin America and the Caribbean).

equivalence trial

A clinical trial which aims to demonstrate that a new treatment is no better or worse than an existing treatment. While the two drugs may have similar results in terms of virological response, the new drug may have fewer side-effects, be cheaper or have other advantages. 

first-line therapy

The regimen used when starting treatment for the first time.

virological suppression

Halting of the function or replication of a virus. In HIV, optimal viral suppression is measured as the reduction of viral load (HIV RNA) to undetectable levels and is the goal of antiretroviral therapy.

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 programmes for HIV or viral hepatitis.

In particular, countries that are seeking to move to treat-all targets will have to have keep up with the growth in newly-infected people, Dr 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 infections 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, Dzintars Gotham and researchers from Howard University, Washington DC, St Stephen’s AIDS Trust, London, the University of Liverpool and the University of Cambridge looked at costs of shipments of active pharmaceutical ingredients (API), 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 and 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 scope 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 drugs begin to go off patent over the next few years.

Drug

US price (p.a)

Global lowest price

Estimated price

US 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 (FTC)/

efavirenz (EFV)

$28,204

$100

$78

2017-2029

TDF/lamivudine (3TC)/EFV

No equivalent

$107

$82

Generic

TDF/FTC

$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

$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, he 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 Andrew 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 Dr Margaret Hellard of the Burnet Institute, 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 panellists argued.

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

References

Gotham D 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, abstract TUAD0104, July 2017.

View the abstract on the conference website.

Download the presentation slides from the conference website.

Watch the webcast of this session on YouTube.