Developing Multimodal Therapies for Brain Disorders Proceedings of a Workshop (2017) / Chapter Skim
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4 Regulatory and Reimbursement Considerations
4 Regulatory and Reimbursement Considerations
Pages 29-36
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From page 29... ...
. • If a multimodal therapy combines a drug or biologic plus an un regulated intervention such as a psychosocial intervention, the usu al standards of evidence apply to the drug or biologic component, that is, substantial evidence of effectiveness and evidence that the drug is safe (Bryan)
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From page 30... ...
For example, with regard to novel outcome measures, the overarching principle is that the outcome should demonstrate a clinically meaningful impact on the disease, said Dunn. If sponsors are able to define what that effect is and demonstrate that they are able to measure it, the agency may accept the outcome measure, but may ask that it be included in the trial design along with other established measures to provide some grounding with experience.
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From page 31... ...
Typically, one investigational application is needed for a combination product, and according to Love, combination products are assigned to the center based on the primary mode of action by which the product achieves its intended purpose. For example, a product consisting of a drug and delivery device, in which the primary mode of action resides with the drug, would be assigned to CDER as the lead center, said Love.
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From page 32... ...
When OCP determines that the primary mode of action of a multimodal product derives from a device, it is assigned to CDRH, although as Peña noted, the centers engage in substantial cross-talk when a submission contains multiple components that cross the lines of responsibility of the respective centers. For combinations that include a drug or
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From page 33... ...
The major dilemma for payers is that health costs are intolerably high, said Robinson-Beale, and multimodal therapies may contribute to escalating costs. She added that many other factors contribute to the rising cost of health care, including practice variation, uninformed preferences, and supply and demand of new technologies.
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From page 34... ...
Although this may be more resource efficient, whether payers will approve reimbursement will depend largely on having reliable, measurable endpoints with good enough follow-up to ensure that the investment is paying off, said Steven Pizer, associate professor of health economics at Northeastern University and chief economist, health care financing and economics at the U.S. Department of Veterans Affairs (VA)
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From page 35... ...
This is changing in the United States as federal and state governments are paying a larger share of the total health care budget, said Pizer. Public payers manage costs differently than private payers do, said Pizer, who is also the chief economist for PEPReC (Partnered EvidenceBased Policy Resource Center)
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From page 36... ...
Moreover, the label and practice guidelines are complimentary pieces of information, although the label is constrained by a high level of evidence that is required, while the practice guidelines can reflect nuance, filling in the gaps between knowledge and professional views of how to put the information together, said Califf. Jeffrey Nye, vice president of neuroscience innovation and scientific partnership strategy at Janssen Research and Development, noted that a license from the FDA does not assure widespread use in practices, and that other barriers, such as restrictive reimbursement, may limit utilization.
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