‘Antibiotic apocalypse’ looming without dramatic new policies, report finds

‘Antibiotic apocalypse’ looming without dramatic new policies, report finds

By Sarah Owermohle  |POLITICO

01/21/2020 08:01 AM EST

Drug companies have made “modest” progress in the fight against superbugs but not at the scale needed to arrest antibiotic resistance increases worldwide, the leader of a European health care nonprofit told POLITICO.

Relatively low profits for antibiotics mean the world is “precariously reliant” on just a handful of pharmaceutical companies to keep the supply going or launch new superbug killers, according to a report released by the Netherlands-based Access to Medicines Foundationthis morning. 

World economic powers need to know that “this is going to be an antibiotic apocalypse if people don’t take this seriously,” Executive Director Jayasree Iyer said. The report, which the foundation releases every two years, will be presented at the World Economic Forum in Davos on Thursday.

Compounding the revenue challenge is the fact that antibiotics must be used sparingly to remain effective. That makes it difficult for drugmakers to rely on typical sales strategies that depend on volume for profits.

Pharmaceutical companies have made some progress in the two years since the foundation released its last study on antimicrobial resistance. They’re trying to discourage the overselling of antibiotics to providers, keep antibacterial residue out of industrial wastewater and share what they know about drug resistance. But development of treatments is not keeping pace with the rising rate of resistance, the report found.

Even as the foundation compiled its report, the antibiotic industry continued to whittle down: Two of the 30 companies analyzed in the report, Achaogen and Melinta Therapeutics, have recently filed for bankruptcy — Melinta just weeks ago.

The U.S. government has recognized a need for a national strategy on antibiotics, Iyer said, pointing to the 2014 stewardship plan from CMS finalized last year, as well as funding and public-private partnerships to develop new options through HHS’ Biomedical Advanced Research and Development Authority. CMS also said last year that it would make it easier for essential new antibiotics to be covered and pay more for them in the future to further promote new treatments. 

In Congress, Sen. Johnny Isakson (R-Ga.) and two Democrats last year introduced the DISARM Act, S. 1712 (116), a bill that would let Medicare reimburse hospitals at higher rates for critical new antibiotics — ideally creating incentives for newer, more effective antibiotics. Neither that bill nor its House companion, H.R. 4100 (116), have been marked up by committees.

“But in a way that’s not enough,” Iyer said. “In order to solve the economic situation, you need to create a system that is not necessarily based on the volume of products, because in the end you want to conserve antibiotics.”

Some countries are experimenting: The U.K. is developing a pilot program based on a ‘subscription’ payment model that pays drugmakers upfront and doesn’t link cost to the volume of drugs sold. Sweden has a similar pilot approach that guarantees a minimum annual payment to antibiotic makers regardless of how much is used.

In the U.S., some states have struck similar subscription payment deals with drugmakers — a so-called Netflix model — or agreements that link payments for certain medicines to patients' outcomes. But most of these are for pricey drugs like hepatitis C treatments; only one, Oklahoma’s value-based agreement with Melinta, deals with an antibiotic.

To solve the global need and encourage drugmakers to develop new treatments, models like these need to be implemented on a much larger scale, Iyer said.

“The thing that CMS and the U.S. have is that they are a very large market,” she said. Any payment-based incentive system or pooling of American customers to create a steady demand “can have a big effect on keeping the pharmaceutical industry incentivized to produce these products.”

For new antibiotics, FDA and its EU counterpart, the European Medicines Agency, have been in discussion about lowering the costs of filing applications to speed new products to market, Iyer said. But to ensure access — especially in lower-income countries — some advocates have pushed regulators to attach conditions to those approvals that would commit drugmakers to keeping prices affordable.

That would be unprecedented in the U.S. market, where FDA and the government at large historically do not get involved in the price of a drug. But incentives to produce new antibiotics, such as higher prices, should not inhibit global access, Iyer said. 

“In the end, society should be able to benefit both in terms of price and supply," she said. "That is the big fear with any regulatory incentive. There is a big danger if it is not set up right.”