PASTEUR Act Proposes Subscription Payment Model to Encourage Novel Antibiotic Development

Date: June 18, 2021 | Country: UNITED STATES | Region: NORTH AMERICA | Type: Editor’s ChoicePolicy | Keywords: #antimicrobialresistance #cdc #criticalneedantimicrobial #hhs #incentive 
#pasteuract #subscriptionpaymentmodel #supplycontract

PRICENTRIC BRIEF:

  • United States Senators Michael Bennet (D-CO) and Todd Young (R-IN) and Representatives Mike Doyle (D-PA) and Drew Ferguson (R-GA) have reintroduced the Pioneering Antimicrobial Subscriptions to End Up Surging Resistance (PASTEUR) Act to incentivize development of novel antibiotics and introduce a subscription-style model of payment for them
  • Whereas current government contracts with manufacturers base payment on value, the PASTEUR Act would establish a subscription-style payment model that offers antibiotic developers an upfront payment for access to their antibiotics, with contracts ranging from $750 million to $3 billion and lasting either 10 years or through patent exclusivity
  • With a total of $11 billion in funding marked for the next 10 years, the Department of Health and Human Services (HHS) Secretary would appoint a new “Committee on Critical Need Antimicrobials” and “Critical Need Advisory Group” to identify infections to target antimicrobial development, select an office to manage subscription contracts, and develop regulations and guidance determining the monetary valuations and terms of these contracts–antimicrobial developers can apply for “Critical Need Antimicrobial” Designation, and HHS will evaluate and determine the drug’s subscription contract eligibility and value

THE DETAILS

WASHINGTON, D.C., United States – United States Senators Michael Bennet (D-CO) and Todd Young (R-IN) and Representatives Mike Doyle (D-PA) and Drew Ferguson (R-GA) have reintroduced the Pioneering Antimicrobial Subscriptions to End Up Surging Resistance (PASTEUR) Act to incentivize development of novel antibiotics and introduce a subscription-style model of payment for them.

Under the U.S. National Action Plan for Combatting Antibiotic-Resistant Bacteria of March 2015, federal agencies were directed to accelerate the government’s response to antibiotic resistance by increasing and incentivizing the development of innovative antimicrobial drugs, but “market failures” led to many innovative companies filing for bankruptcy and stopping production.

Whereas current government contracts with manufacturers base payment on value, the PASTEUR Act would establish a subscription-style payment model that offers antibiotic developers an upfront payment for access to their antibiotics, with contracts ranging from $750 million to $3 billion and lasting either 10 years or through patent exclusivity.

With a total of $11 billion in funding marked for the next 10 years, the Department of Health and Human Services (HHS) Secretary would appoint a new “Committee on Critical Need Antimicrobials” and “Critical Need Advisory Group” to identify infections to target antimicrobial development, select an office to manage subscription contracts, and develop regulations and guidance determining the monetary valuations and terms of these contracts.

Antimicrobial developers can apply for “Critical Need Antimicrobial” Designation, and HHS will evaluate and determine the drug’s subscription contract eligibility and value. The contract value will be determined by evidence-based preferred drug characteristics to incentivize development and be delinked, with payments adjusted down by any amount federal health programs pay for the drug.

Developers can apply to HHS for a subscription at or within five years following Food and Drug Administration (FDA) approval, however, during the transition period, HHS may use funding to enter smaller contracts, as long as these include terms of participation, appropriate use strategies, FDA-require post-marketing studies, and a reliable supply chain. In general, once contracts are due to expire, HHS and the manufacturer can negotiate smaller, secondary contracts to extend the subscription or adjust the value.

Patients covered by federal insurance will receive these drugs at no cost. HHS and the Centers for Disease Control and Prevent (CDC) will use health surveillance systems to collect relevant data on antibiotic use, with CDC conducting an annual report for Congress. Further, within six years, the Government Accountability Office will conduct a study on the efficacy of this program.

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