Brazil wins 75% discount on new HIV drug

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The Brazilian government has announced that it has negotiated a 75% discount on the top US price of the new protease inhibitor atazanavir (Reyataz). Brazil will pay $3.25 per capsule for the drug, compared with a US price of up to $13.80 per capsule. This represents a daily price of $6.50 a day ($2372.50 a year).

Brazil represents a potentially huge market for atazanavir, since the discount negotiated makes the drug cheaper than other protease inhibitors. Atazanavir will also prove attractive because the drug can be dosed once daily in two tablets.

A drawback of atazanavir is its negative interaction with the TB drug rifampicin. Atazanavir levels are reduced by over 90% when the drug is dosed alongside rifampicin, making the protease inhibitor inappropriate for use until tuberculosis has been controlled by an initial two month phase of rifampicin-containing treatment.

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).

drug interaction

A risky combination of drugs, when drug A interferes with the functioning of drug B. Blood levels of the drug may be lowered or raised, potentially interfering with effectiveness or making side-effects worse. Also known as a drug-drug interaction.

first-line therapy

The regimen used when starting treatment for the first time.

bid

Abbreviation of a Latin term meaning twice daily.

However, atazanavir is an attractive drug for use in resource-limited settings in most other respects. It is heat stable and does not require refrigeration, unlike ritonavir-boosted protease inhibitors. It is dosed once daily, with food, and does not have negative interactions with any other anti-HIV drug apart from tenofovir. It appears safe for use during pregnancy (unlike efavirenz, one of the drugs currently favoured in first-line treatment), and is well tolerated. A 48 week international phase III study showed that less than 6% of atazanavir-treated patients discontinued treatment due to adverse events, compared with 10% of efavirenz-treated patients.

Until now, the major obstacle to atazanavir use in resource-limited settings has been its price. Although the price agreed with the Brazilian government would still set the drug out of reach for most resource-limited settings, the agreement does indicate that Bristol Myers Squibb is prepared to compete on price in middle income countries with Abbott’s lopinavir/ritonavir. In Brazil, lopinavir/ritonavir is being supplied at a price of $8.80 a day, but in other regions Abbott has been prepared to negotiate lower prices.

The speed at which atazanavir prices will fall internationally is likely to be dictated in part by the speed at which generic competition emerges. Since atazanavir is easier to synthesise than some other protease inhibitors, a generic version may appear quickly. However, the key spur to competitive pricing will be bulk ordering of the product. The Brazilian government had previously threatened several protease inhibitor manufacturers with the prospect of placing orders for generic versions of their product if they could not reach agreement. If this had occurred, it could have driven down prices charged to other customers. Bristol Myers Squibb's price agreement needs to be seen in the light of this development, together with the risk that a tough-minded Brazilian government would encourage Brazilian manufacturers to make their own versions of atazanavir eventually.

India aims for $78 a year triple therapy

Meanwhile, India’s health minister was due to meet today with representatives of five Indian manufacturers of antiretrovirals in a bid to negotiate an 80% reduction in the cost of drugs supplied to the government’s treatment programme.

The Indian government wants to reduce the price of a triple antiretroviral combination from 1500 rupees (£20/US$33) a month to 300 rupees (£4/US$6.50) a month, in effect winning the lowest price yet negotiated for a triple combination, according to The Hindu.

Industry sources are said to favour a similar mechanism to the one used by the Clinton Foundation to achieve lower drug prices. They want the Indian government to act as procurer of the raw materials needed to manufacture drugs, thus guaranteeing a market to any manufacturer that tenders to supply the government treatment programme.