Pancreatology 21 (2021) 1009e1010
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Pancreatology
journal homepage: www.elsevier.com/locate/pan
Projected 30- day out-of-pocket costs and total spending on pancreatic
enzyme replacement therapy under Medicare Part D*
Keywords:
Pancreatic enzymes
Cost
Medicare
Pancreatic ductal adenocarcinoma (PDAC)
Exocrine pancreatic insufficiency
Introduction
Pancreatic enzyme replacement therapy (PERT) can reduce
symptoms of indigestion and improve nutrition in patients with
exocrine pancreatic insufficiency [1]. Several brand-name prepara-
tions of PERT are available in the United States [1,2]. Because PERT is
under-prescribed [3], and anecdotally related to costs and pre-
scriber sensitivity to costs, we aimed to assess PERT costs.
Methods
We used Medicare Part D formulary and pricing files for the first
quarter of 2020 to describe total (patient and payer) and out-of-
pocket costs for each PERT formulation among Part D stand-alone
and Medicare Advantage prescription drug plans. We calculated
costs across nationwide plans under three scenarios: (1) standard
benefit design ($435 deductible and 25% coinsurance after the
deductible is met); (2) 25% coinsurance (for fills after the deductible
and in the coverage gap until the patient spends $6,350 out-of-
pocket); and (3) 5% coinsurance (once catastrophic coverage is
reached).
PERT doses are identified by the lipase content per capsule (in
United States Pharmacopeia, USP, units). We calculated the number
of units for each PERT formulation/dose form that would provide
optimally dosed PERT for the average adult (250,000 USP units of
lipase per day), based on guidelines and consensus (1000 USP units
per kilogram per meal) [2].
We first calculated costs for a single unit of PERT. Next, we calcu-
lated the number of units needed daily for each formulation/dose
form to provide optimally dosed PERT, and multiplied by 30 to
generate 30-day requirements and costs. We used SAS studio for
*
Prior presentation: This work was presented in abstract form at the 2021
ASCO Gastrointestinal Cancers Symposium held in San Francisco (virtual) in January
2021.
https://doi.org/10.1016/j.pan.2021.05.002
1424-3903/© 2021 IAP and EPC. Published by Elsevier B.V. All rights reserved.
this analysis.
Results
Across all Part D plans available in 2020, 4 PERT formulations in
17 different doses were covered. The range of lipase content in a
single unit ranged from 3,000 to 40,000 USP units, and the per-
unit list price ranged from $1.44 to $13.89. The point-of-sale price
for a 30-day supply of optimally dosed PERT ranged from $2,109
to $4,840. For patients, the expected out-of-pocket costs for a 30-
day supply of optimally dosed PERT averaged $999 across formula-
tions (range, $853 to $1536) for those paying a deductible and coin-
surance, $673 (range, $527 to $1210) for fills made after meeting
the deductible until reaching catastrophic coverage, and $135
(range, $105 to $242) after reaching catastrophic coverage
(Supplementary Table 1 and Fig. 1).
Discussion
In this analysis of 2020 Medicare Part D plans, the estimated 30-
day out-of-pocket cost for PERT was highd more than $100 in the
catastrophic phase and approximately $1000 in the initial phase.
Common indications for PERT in a Medicare population are pancre-
atic cancer and chronic pancreatitis, disease states already associ-
ated with heavy symptom burden and distress. In this setting, the
financial burden from supportive care interventions, such as
PERT, can be underappreciated.
The high costs of PERT may be related to the lack of generic for-
mulations and limited competition. In the late 2000s, in response to
new Food and Drug Administration (FDA) requirements that PERT
formulations undergo new drug applications with prospective tri-
als, the number of formulations decreased from 25 to 6, with an in-
verse relationship between the number of products and costs [4].
We also noted costs were relatively higher for lower potency prep-
arations, and clinicians should try to avoid their use when possible.
The underprescription extends beyond Medicare; in one anal-
ysis, <10% of more than 60,000 patients with pancreatic disease
in a commercially insured dataset received appropriate PERT [3].
Clinicians and patients often rely on patient assistance programs,
which decrease immediate costs to patients, but can drive up prices
long-term [5]. Patients also end up using cheaper, over-the-counter
preparations, which are unregulated, and not recommended by the
FDA [5]. Tellingly, patient-focused pancreatic disease websites spe-
cifically feature content on managing PERT costs [5,6]. In 2017, 8% of
all beneficiaries and 21% of patients receiving an anti-cancer medi-
cation through Part D reached catastrophic coverage, often within
the first 2 months of the year [7].
A. Gupta, N. Premnath, R. Sedhom et al. Pancreatology 21 (2021) 1009e1010

In conclusion, out-of-pocket costs for PERT may serve as a bar- cancer cachexia. Supp Care Cancer 2021. https://doi.org/10.1007/s00520-021-
06240-7.
rier to drug access. Symptom control is an underappreciated source
[9] Premnath N, Sumarsono A, Sedhom R, et al. Use of peripheral mu-opioid recep-
of financial toxicity [8,9]. tor antagonists for treating opioid-induced constipation among US Medicare
beneficiaries from 2014 to 2018. J Palliat Med 2021. https://doi.org/10.1089/
Disclosures/funding information jpm.2021.0021.

None. Arjun Gupta*

The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
Acknowledgements University, Baltimore, MD, USA
Naveen Premnath
We thank Leonce Nshuti, MS for their help in creating the data-
Department of Internal Medicine, University of Texas Southwestern
set. Arjun Gupta and Ramy Sedhom is supported by a Conquer Can-
Medical Center, Dallas, TX, USA
cer Foundation American Society of Clinical Oncology Young
Investigator Award. There are no conflicts of interest for any author. Ramy Sedhom
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
Appendix A. Supplementary data University, Baltimore, MD, USA
Muhammad S. Beg
Supplementary data to this article can be found online at
Department of Internal Medicine, University of Texas Southwestern
https://doi.org/10.1016/j.pan.2021.05.002.
Medical Center, Dallas, TX, USA
Rohan Khera
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