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Volume 4 Clinical Pediatric Dermatology
ISSN: 2472-0143
Page 19
Notes:
October 15-16, 2018 Rome, Italy
&
JOINT EVENT
14th International Conference on Clinical Dermatology
5th International Conference on
Advances in Skin, Wound Care and Tissue Science
Wound Congress 2018 &
Clinical Dermatology Congress 2018
October 15-16, 2018
Marissa J. Carter
Strategic Solutions, Inc, USA
Marissa J. Carter, Clin Pediatr Dermatol 2018, Volume 4
DOI: 10.21767/2472-0143-C2-004
How are we going to pay for advanced therapeutics in wound care?
The clinical phenotype of atopic dermatitis (AD) results from complex interactions between genetic and environmental
Although wound care is not a recognized specialty, the cost of treating wounds, especially chronic wounds, is phenomenal.
Most wound care products categorized by the FDA as devices have been approved as adjunctive treatments based on the
concept that these products may accelerate wound healing directly or indirectly. Many new products such as CTPs (cellular
and/or tissue-based products) are expensive, and may need to have several applications. At the same time, in the USA the
Centers for Medicare and Medicaid are exerting pressure in regard to reimbursement amounts for these products. Current
reimbursement amounts for the application of some products may not be sufficient to keep a dedicated wound care clinic
profitable when half of all patients are on Medicare or Medicaid and a further 10-15% have no medical insurance. Indeed,
some patients may not receive any such products due to poor or no medical insurance. The majority of device clinical trials
are post-market because of 510(k) approval and are frequently limited to non-severe wounds in indication (although many
patients may have serious comorbidities). Thus, and most important, the performance of many products used to treat more
severe wounds is unknown due to a scarcity of randomized controlled trials. Payers are also fixated on “episodes of care,” which
is hard to define when half of all patients have multiple wounds that overlap over long periods of time (many years). Part of this
chaos has resulted from lack of will at the national level to officially use health economic studies to weed out cost-inefficient
products, and lack of understanding of health economics by payers. The situation will only get better when trials involving
more severe wounds are commonplace, we have more FDA–approved endpoints appropriate for some products, and we are
willing to formally include health economic analyses in our decision-making.
Biography
Marissa Carter is the President of Strategic Solutions, Inc., and has an extremely broad science background, which includes work in several medical fields, as well as
physical and engineering disciplines. Her expertise includes health economics modeling, evidence-based medicine, biostatistics, and clinical trial design and analysis.
Although she works mostly in wound care research, she has also worked in epidemiology, ophthalmology, orthopedics, neurology, and psychology. She holds an MA in
biochemistry from Oxford University and a PhD in chemistry from Brandeis University. She is the author or coauthor of over 100 peer-reviewed articles and book chapters
in medicine and her studies have won several awards.