Economic outcomes among Medicare patients receiving bioengineered cellular technologies for treatment of diabetic foot ulcers

Abstract

Objective:

To assess the real-world medical services utilization and associated costs of Medicare patients with diabetic foot ulcers (DFUs) treated with Apligraf (bioengineered living cellular construct (BLCC)) or Dermagraft (human fibroblast-derived dermal substitute (HFDS)) compared with those receiving conventional care (CC).

Methods:

DFU patients were selected from Medicare de-identified administrative claims using ICD-9-CM codes. The analysis followed an ‘intent-to-treat’ design, with cohorts assigned based on use of (1) BLCC, (2) HFDS, or (3) CC (i.e., ≥1 claim for a DFU-related treatment procedure or podiatrist visit and no evidence of skin substitute use) for treatment of DFU in 2006–2012. Propensity score models were used to separately match BLCC and HFDS patients to CC patients with similar baseline demographics, wound severity, and physician experience measures. Medical resource use, lower-limb amputation rates, and total healthcare costs (2012 USD; from payer perspective) during the 18 months following treatment initiation were compared among the resulting matched samples.

Results:

Data for 502 matched BLCC-CC patient pairs and 222 matched HFDS-CC patient pairs were analyzed. Increased costs associated with outpatient service utilization relative to matched CC patients were offset by lower amputation rates (−27.6% BLCC, −22.2% HFDS), fewer days hospitalized (−33.3% BLCC, −42.4% HFDS), and fewer emergency department visits (−32.3% BLCC, −25.7% HFDS) among BLCC/HFDS patients. Consequently, BLCC and HFDS patients had per-patient average healthcare costs during the 18-month follow-up period that were lower than their respective matched CC counterparts (−$5253 BLCC, −$6991 HFDS).

Limitations:

Findings relied on accuracy of diagnosis and procedure codes contained in the claims data, and did not account for outcomes and costs beyond 18 months after treatment initiation.

Conclusion:

These findings suggest that use of BLCC and HFDS for treatment of DFU may lower overall medical costs through reduced utilization of costly healthcare services.

Keywords::

• Cost-effectiveness
• Diabetic foot ulcers
• Bioengineered cellular technologies
• Advanced wound care

Transparency

Declaration of funding

This study was funded by Organogenesis, Inc., Canton, MA.

Declaration of financial relationship

MS and NBP are employees of Organogenesis, Inc., which provided research funding to Analysis Group (employer of JBR, UD, LR, AKGC, and HGB) for this project. DJM is a Professor at the Perelman School of Medicine, University of Pennsylvania, and has consulted to Organogenesis. The authors report no other conflict of interest.