H-SPAN summit examines how grants and clinical evidence shape the path to drug coverage
H-SPAN summit examines how grants and clinical evidence shape the path to drug coverage
At the H-SPAN longevity policy summit on September 9, Felipe Sierra, Catherine Kaczorowski and Michael Ringel discussed three connected stages. The US National Institutes of Health (NIH) awards grants, laboratories depend on when that funding arrives, and insurers or government programs use trial evidence to decide whether to cover a treatment.
In the panel recording, Felipe Sierra, former director of the Division of Aging Biology at the US National Institute on Aging, explained why his division was short of funding: applications were increasing while its budget stayed the same.
“I wasn't asking them to give me money. I wanted them to spend their money in another area,” Sierra said.
That area was research into aging as a shared risk factor for diseases already studied by other NIH institutes. Sierra sought to persuade their directors to fund these projects from their own budgets.
Catherine Kaczorowski, a professor at the University of Michigan, described how a grant delay affects a laboratory. Her application scored in the top 5%; she was initially told it would be funded, but the money was delayed because part of the budget had already been committed to five-year grants. Kaczorowski said universities were reducing graduate student admissions and laboratories were losing funding. In her laboratory, the delay affected which staff members she would be able to retain.
Michael Ringel, chief operating officer of the biotechnology company Life Biosciences, turned the discussion to drug development. Phase one clinical trials provide early information about safety and dosing; subsequent trials assess potential efficacy and gather further safety data. According to Ringel, each year 200 to 300 drug candidates pass phase one and then fail phase two. He therefore argued against allowing a drug onto the market after early testing.
In the spring, the New Hampshire House of Representatives approved centers where drugs can be used after phase one. This proposal gives Ringel's argument practical relevance: payers base coverage decisions on evidence that continues to accumulate after early safety testing.
Extended testing also requires funding. An analysis of trials of inexpensive gerotherapies explained why a treatment that is easy to copy may struggle to attract an investor to fund such a study: all suppliers would be able to use its results.