Deal slashes preventive TB medicine price by nearly 70%

MANILA — Global pharmaceutical company Sanofi has agreed to slash the price of its preventive tuberculosis medicine as part of a major deal that is expected to benefit an estimated 1.7 billion people.

The announcement was made on Thursday at the 50th Union World Conference on Lung Health, taking place in Hyderabad, India.

The deal involved a procurement commitment for the drug, rifapentine, from Unitaid and the Global Fund to Fight AIDS, Tuberculosis and Malaria in 2020, Robert Matiru, director of operations for Unitaid, told Devex. To secure the almost 70% price reduction for the drug, Unitaid and the Global Fund committed to procure the drug for at least 300,000 patient treatments in 2020, he said.

“It was important for us to agree on the target threshold of treatments to be supplied next year for [Sanofi] to have confidence that the product would actually be introduced and rolled out, to enable them to realize economies and to offer such a price reduction,” he explained.

The deal follows in the footsteps of the high-level meeting on TB last year in New York, where U.N. member states agreed on a political declaration that called for greater commitment to ending TB by 2030.

As part of the deal, the drug rifapentine will be available to 100 countries for $15 — a significant reduction from its current cost of approximately $45, although that doesn’t include other related costs such as transportation. The steep price tag has kept most countries from using it in their preventive TB interventions, despite its promise of a shorter treatment course.

Isoniazid has been the standard treatment medicine for TB, but it requires a daily intake of the drug for a minimum of six months for individuals with latent TB infection. A combination of rifapentine and isoniazid shortens the treatment course to 12 weeks, or three months, and the drugs need only be taken once a week.

A 12-week course of isoniazid in combination with rifapentine would cost around $16-17 all in, Matiru said.

“Isoniazid is a very cheap drug. So the isoniazid component doesn't add much to the total; the biggest component of the price is rifapentine,” he said.

The price decrease is expected to benefit people with latent TB infection, preventing them from developing the disease, which kills close to 1.5 million people each year. About 5%-10% of people with latent TB infection — between 85 million and 170 million people — are predicted to develop the disease if preventive treatment is not provided.

The 100 eligible countries account for more than 90% of the global need for preventive therapy for latent TB infection, according to Unitaid. Covering countries with the highest burden of TB, and TB and HIV co-infection, was part of the priority.

“There are those out there who argue that the eligibility should have been higher; let's say 140, 150 countries. And we don't disagree. However, this is a very important starting point, and what it recognizes is, pragmatically, not all countries are going to be in a position to start moving completely with roll out next year,” Matiru said.

“But Unitaid in subsequent agreements, particularly with generic companies, we'll be looking to expand the eligibility so that countries, once they're ready to move a bit later, certainly can access a price as good as, if not better than, $15,” he said.

The lower price of rifapentine will be accessible to international funders with TB programming, such as the Global Fund, the Global Drug Facility and the U.S. President's Emergency Plan for AIDS Relief, as well as large international NGOs such as Médecins Sans Frontières, which are likely to cover the “lion’s share of procurement” of the drug, Matiru said.

Small NGOs are “not ineligible,” but requests will be taken on a case-by-case basis, ensuring Sanofi can manage the number of buying parties, he said.

“But the key factor is that they're buying on behalf of eligible countries,” said the Unitaid official.

Unitaid and partners hope to bring two generic manufacturers into the market in the next two years, to up the supply of rifapentine as more countries are expected to roll out the regimen and to drive competition.

“Until we have healthier markets, and by that I mean at least three companies in the market, I don't think we can expect to see competition-based price reductions. So we are working to introduce an additional two companies into the market, starting with one next year — a generic company — and then the following year, another generic company,” Matiru said.

Unitaid is not currently involved in any negotiations on pricing for multidrug-resistant TB treatments, which has been a point of contention for many TB activists and MSF. At the opening of the TB conference in India this week, they called on pharmaceutical companies to make treatments for drug-resistant TB, such as bedaquiline, delamanid, and pretomanid, more affordable to make them more accessible to those who need them.

Asked why, Matiru said, “I think it’s just a question of timing.”

“Presently, the board has prioritized several areas in the TB response for first-line treatment, MDR-TB diagnosis, pediatric treatments, gene sequencing for diagnosis … But there will be probably scope for ... investments to start to bring to bear more affordability in MDR-TB,” he said.

There were 186,772 notified cases of MDR-TB or rifampicin-resistant TB in 2018 — up from 160,684 in 2017 — according to the latest global TB report by the World Health Organization. While there’s been an increase in the number of cases enrolled for treatment — to 156,071 from 139,114 in 2017 — there are still fewer people receiving treatment. In 2018, that was just 32% of the estimated case incidence of 484,000.