Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders Workshop Summary (2015) / Chapter Skim
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4 Patient Benefit and Engagement
4 Patient Benefit and Engagement
Pages 51-60
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From page 51... ...
Patients know more about their diseases than anyone else and, thus, they have much to offer any conversation about the value of any given drug, weighing risks versus benefits, and other key issues, emphasized several workshop participants. Many factors contribute to a drug's worth, and the relative importance of each one will vary greatly from drug to drug and patient to patient.
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From page 52... ...
We can change that paradigm." Lauren Chiarello, senior director of federal government relations at the National Multiple Sclerosis Society, said that acceptable risk will differ depending on the illness, an individual's disease trajectory, prognosis, personal choice, and numerous other issues. For example, the particular symptoms a person is encountering "can really dictate your risk/benefit tolerance," she said.
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From page 53... ...
Patients want to be able to drive their risk decisions, Chiarello said, and have the relevant conversations with their health care providers. The drug has returned to the market and the manufacturers have instituted a risk minimization program for PML.1 Legislation Encouraging Patient Involvement Prescription Drug User Fee Act Chiarello emphasized the importance of patient involvement for drug development, and noted that the most recent round of Prescription Drug User Fee Act2 reauthorization called for increased patient participation in the drug review process.
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From page 54... ...
The 21st Century Cures Act attempts to strengthen the ability of companies to harness surrogate markers to assess efficacy in clinical trials. Formally qualifying such endpoints might encourage their use because companies would have more confidence that FDA would accept them during the evaluation process, said several participants, including Stevin Zorn, executive vice president at Lundbeck Research USA, Inc.
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From a broader societal standpoint, the value equation is clearer. New treatments cost the health care system money, but the value in reducing disability payments, increasing gross domestic product, and generating income taxes is significant.
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. Comas-Herrrera discusseed a project thhat models the hypotheetical impact on health annd social caree costs by 2040 of a neew treatment for AD (see Box B 4-1)
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Delaying onset of the symptomatic phase delivers the largest reduction to health and social program expenses as well as unpaid-caregiver costs. Drugs that delay the onset of the symptomatic phase therefore would save large amounts of money.
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CREATIVELY ENGAGING PUBLIC−PRIVATE PARTNERSHIPS, ADVOCACY GROUPS, AND NONPROFIT HEALTH ORGANIZATIONS Public−private partnerships, advocacy groups, and nonprofit health organizations can help foster, enrich, and inform activities aimed at developing pull incentives for drug development in the neurosciences, according to many participants. Such outlets provide a mechanism for facilitating conversations among patients about appropriate trade-offs between potential risks and benefits, and for collecting and communicating relevant information to government agencies.
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From page 59... ...
Along the same lines, Boutin mentioned that members of the National Health Council, an umbrella organization for patient advocacy groups, work with NIH-funded researchers who had products that showed great promise for treating particular conditions, but insufficient patent protection to bring to market. Advocacy groups can potentially have significant impact by lobbying for what they consider appropriate measures.
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From page 60... ...
. • Work to creatively engage public−private partnerships that can advance and enhance "pull" incentives by providing patient in put, building political will, and contributing other crucial re sources (Boutin, Chiarello, Kennedy, and others)
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