New bipartisan legislation can encourage needed antibiotic development
The next health crisis might be one where our existing drugs no longer work. The world’s antibiotic arsenal is dwindling.
When antibiotics fail, people die. We have watched it happen to our friends.
Together, we already live in a post-antibiotic era. We were born with a rare inherited condition called cystic fibrosis (CF). The dysfunctional protein at the heart of CF leads our bodies to produce an unusually thick and sticky mucus inside our lungs, which creates the perfect environment for infectious pathogens to permanently infect them. We use antibiotics regularly to survive, but with each dose we take, the bacteria living in our lungs slowly evolve to a point where the drugs no longer work as intended. This phenomenon is called antibiotic resistance.
Between us, we have used 15 different types of antibiotics, but as our infections have become resistant this arsenal has become ineffective. We now rely on antibiotics of “last resort” to survive.
While our experience dancing with deadly lung infections may seem rare, the CDC estimates that 2 million Americans develop antibiotic-resistant infections every year, and 35,000 die from these infections. Antibiotic resistance appears in infections many of us have experienced: strep throat, pneumonia, meningitis. In the U.S. alone, over 200 million antibiotics are prescribed per year, representing millions of opportunities for resistance to develop. By 2050, it is forecasted as many as 10 million people across the globe could die per year from these infections, outpacing cancer as a killer.
We need new antibiotics, but drug discovery is stagnant.
We rely on the same antibiotic classes today as in the 1960s because the economic disincentives standing in front of antibiotic development are becoming increasingly difficult to overcome. In fact, although the antibiotic market is large at over $40 billion globally, newer, branded drugs only account for about 10 percent of it.
Since resistance to antibiotics develops over time, the standard operating practice says newly approved antibiotics must sit on the shelf unless they are absolutely required so their efficacy can be preserved. Further, when patients are treated with antibiotics, the courses only last a short period of time, limiting sales. Hospitals also face an incentive to use older generic drugs instead of newer ones: Medicare, the largest antibiotic purchaser in the U.S., pays similarly for antibiotics prescribed in hospitals whether they are generic drugs or novel branded ones. When a hospital chooses to prescribe an antibiotic, the institution might lose money on a branded prescription, and thus is incentivized to choose a cheaper drug. That not only contributes to drug resistance when an older drug may no longer work, but also hurts the antibiotic pipeline because drugmakers in the U.S. rely on branded drugs to drive more revenue to recoup their research and development investments. Those R&D costs can quickly add up to $1.5 billion.
These problems largely don’t exist for other drugs, but they do for antibiotics, and when combined they stand as a brick wall in front of drug makers.
Big pharmaceutical companies have largely abandoned antibiotic development and left discovery to small biotechnology companies. The above reimbursement risk can quickly lead those companies to insolvency.
A bipartisan group of legislators is trying to encourage antibiotic development with new legislation called the PASTEUR act, which is like a Netflix subscription but for antibiotics, with value-based on clinical need and novelty.
Currently, sales volume drives drug revenue. Instead, with PASTEUR the government would pay a flat annual subscription fee to drug makers to access their novel antibiotics for federally subsidized health plans, preventing the company from going insolvent and allowing for a meaningful profit to incentivize more drug makers to enter the space.
The law allows a new antibiotic to stay on the shelf unless absolutely needed while alleviating the reimbursement risk for the drugmaker.
PASTEUR is a meaningful step towards preventing a post-antibiotic era.
The last 18 months have shown us the cost of failing to have the right tools to combat communicable disease, with hundreds of thousands of Americans dead and trillions in economic output lost.
Our country is already feeling the brunt of antibiotic resistance with a cost of $20 billion in excess healthcare costs annually.
In comparison, PASTEUR makes economic sense because the payouts for each new drug will total $750 million to $3 billion.
Playing catch up with an infectious disease is costly. Politicians across the aisle possess a rare opportunity to prevent a coming health challenge with the PASTEUR Act.
Gunnar Esiason, MBA lives with cystic fibrosis, is a patient advocate with the Boomer Esiason Foundation. Emma D’Agostino, PhD lives with cystic fibrosis, is a medical writer, and is a patient advocate with the Cystic Fibrosis Foundation.