The US Health and Human Services agency isn’t ready to go all in on “pull” incentives to encourage the development of new antibiotics, the agency indicated in response to a new Government Accountability Office report.
“It is still unclear whether post-market financial incentives should necessarily be part of HHS’s forthcoming strategic framework to further incentivize the development of new treatments to combat antibiotic resistance,” Sarah Arbes, acting assistant secretary for legislation, wrote in response to a sweeping two-year audit of HHS’s work to address the antibiotic resistance crisis.
“Pull” incentives include new reimbursement schemes or other forms of post-market financial support that could make antibiotic development attractive to drug companies, as opposed to “push” incentives, which are designed to help spur research, development, and regulatory approval by making those steps less expensive for firms.
The response doesn’t rule out the agency eventually backing reimbursement boosts for antibiotics. Arbes says that HHS is still conducting analyses to understand whether these pull incentives should be included in an upcoming strategic framework being worked on by HHS along with a working group of non-governmental, industry and international groups, that will include specific proposals to address a variety of scientific and market challenges facing antibiotic developers.
HHS agrees that additional incentives are needed to address the limited antibiotic pipeline, she said.
But the GAO appears to believe HHS should be moving faster, noting that the Presidential Advisory Council On Combating Antibiotic-Resistant Bacteria and the Transatlantic Taskforce on Antimicrobial Resistance has called for additional post-market pull incentives to increase the antibiotic pipeline since at least 2017 (Also see “Antibiotic Incentives: Prize Fund Is Focus Of Presidential Report On Incentives” – Pink Sheet, 17 Oct, 2017.).
GAO’s audit found “limited” impacts of existing pull incentives in the US, including the qualified infectious disease product designation created by the 2012 FDA Safety and Innovation Act. QIDP-products may receive five years of additional marketing exclusivity. But drug companies told the GAO this extension is unlikely to extend past a drug’s typical patient life, thus not providing enough of a perk to stimulate development of new antibiotics.
The Center for Medicare and Medicaid Services’ decision to bump reimbursement by increasing the new technology add-on payments for certain antibiotics given to hospitalized patients starting in fiscal year 2020 was also seen as inadequate because such payments are limited only to a portion of US patients. Hospitals often still face other costs for providing the drugs that aren’t covered by the Medicare patients, GAO wrote.
Drug industry representatives told GAO that “add-on payments do not directly incentivize hospital pharmacies to purchase the drug,” as the extra money doesn’t necessarily go back to the pharmacy department’s budget.
As for other pull incentives, most told the GAO that while further reimbursement reform might be useful, payment changes on their own are unlikely to … Next Page »