STAINES-UPON-THAMES, United
Kingdom, June 23, 2017
/PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global
specialty pharmaceutical company, today announced new
retrospective, claims-based health economic data that show
hepatorenal syndrome (HRS), or the development of renal (kidney)
failure in patients with advanced chronic liver
disease,1,2 imposes a significant economic burden on
payers. HRS is a rare, life-threatening disease with an estimated
prevalence of greater than 22,000 diagnosed in the U.S. each
year.3 The Mallinckrodt-sponsored study was recently published
in Current Medical Research and Opinion. The intended
audience of this study is population-based decision makers with
knowledge and expertise in the area of healthcare economic analysis
and its limitations.
"HRS-related hospital admissions have risen over the past decade
and have led to increased inpatient costs, yet understanding of the
overall economic burden of this serious condition has remained
limited," said study investigator Kevin
Korenblat, M.D., Associate Professor of Medicine,
Washington University School of
Medicine. "This study aimed to provide a comprehensive and
current estimate of the costs involved with HRS in the U.S. from
the payer perspective."
The retrospective study, titled "The burden of hepatorenal
syndrome among commercially insured and Medicare patients in
the United States," evaluated
the characteristics, healthcare resource utilization (HCRU), and
payer-related costs of HRS patients covered by commercial and
Medicare insurance programs from 30 days prior to the "index date,"
defined as the date of the earliest inpatient admission with an HRS
diagnosis, through 90 days post-diagnosis (outcome period). This
includes inpatient resource utilization and costs to payers,
longitudinal measures such as rates of readmissions, costs in a
variety of non-inpatient settings such as outpatient and physician
office, rates of transplants and dialysis and, as a secondary
endpoint, mortality.
Anonymized claims from adults with HRS (18-64 years old) were
identified from two HIPAA (the Health Insurance Portability and
Accountability Act)-compliant claims databases of commercially
insured patients (OptumHealth Care Solutions Inc., 18.5 million
beneficiaries) between 1998–2014, and Medicare beneficiaries (aged
65 and older) between 2009–2013 (Standard Analytic Files, 5 percent
of 4 million beneficiaries). Eligible patients were required to
have continuous non-health maintenance organization coverage on the
index date and meet the age criteria. Demographics, including age,
gender, geographic region and clinical characteristics were
summarized for commercially insured and Medicare patients during
the 6-month baseline period and on the index date. Costs were then
extrapolated using population statistics and information on rates
of insurance coverage by payer to project the economic burden of
HRS in the U.S.
The analysis suggests HRS poses a significant economic burden to
payers estimated at $3.0–$3.8 billion
in annual total direct medical costs. Additional findings
include:
- A total of 784 commercially insured and 1061 Medicare HRS
patients met the sample selection criteria.
-
- Patients were disproportionately male (commercial: 63.0
percent; Medicare: 57.9 percent) with a mean age of 54.1 among
commercially insured and 74.1 among Medicare patients.
- Average HCRU during the 90-day outcome period was substantial
for both commercially insured and Medicare patients:
-
- Within the first 30 days, the average hospital length of stay
was 12.3 days among commercially insured and 10.8 days among
Medicare patients.
- Based on Kaplan–Meier analyses, 36 percent of commercially
insured and 26 percent of Medicare patients were readmitted within
the next 30 days.
- Many patients received dialysis (commercial: 33.0 percent;
Medicare: 22.1 percent) or liver transplant (commercial: 10.7
percent; Medicare: 1.6 percent) during follow up.
- Median survival was 95 days among commercially insured patients
and 33 days among Medicare patients.
- Per patient healthcare costs were substantial for both
commercially insured and Medicare HRS patients during the 90-day
outcome period:
-
- Average costs were $157,665 for
commercially insured and $48,322 for
Medicare patients, with 68.3 percent and 78.3 percent of the costs
incurred within the first 30 days.
- The primary cost driver was inpatient visits (commercial: 90.3
percent of costs; Medicare: 83.1 percent of costs), with
differences between the subpopulations consistent with lower
mortality, higher dialysis rates, and higher liver and kidney
transplant rates among the commercially insured.
"Liver transplant is the only definitive treatment for HRS, but
not feasible in most cases due to organ availability and
eligibility issues. Yet at present there are no approved drug
therapies for HRS type 1 in the U.S. or Canada," said Steven Romano, M.D., Chief Scientific Officer
and Executive Vice President at Mallinckrodt. "This analysis provides important
insights into the economic burden of HRS, and reinforces our
commitment to evaluating terlipressin as a potential treatment
option for patients with HRS type 1 in these countries."
Terlipressin is being investigated in a Phase 3 clinical trial
for the treatment of HRS type 1, an acute form of the condition.
The safety and effectiveness of terlipressin has not been
established with the U.S. Food and Drug Administration or Health
Canada. Terlipressin is approved for use in countries outside the
U.S., including several in Europe.4,5,6,7
Limitations of the Study
- Limitations of the study include its reliance on the accuracy
of diagnosis codes to identify patients with HRS, to evaluate their
comorbidity profiles at baseline, and their HCRU during the outcome
period.
- Diagnosis codes do not differentiate between HRS type 1 and HRS
type 2, and accuracy of all codes may vary.
- The HCRU and cost findings may not be generalizable to other
patients, such as those enrolled in Medicaid.
- The economic burden of HRS is likely underestimated as this
study did not assess the longer- term economic burden of HRS, and
cost estimates were not inflation adjusted over the study periods
(1998-2014 for commercial and 2009-2013 for Medicare cohort).
The Current Medical Research and Opinion study may be
accessed here: http://dx.doi.org/10.1080/03007995.2017.1331211
About Hepatorenal Syndrome
HRS is characterized by
rapid, progressive functional renal failure and has a very poor
prognosis, with >80 percent mortality within three months. HRS
is a rare syndrome of marked renal dysfunction in patients with
cirrhosis, decompensated liver disease and portal hypertension. At
present, there are no approved drug therapies for HRS type 1 in the
U.S. or Canada. The only curative
treatment for HRS type 1 and the underlying end-stage cirrhosis is
liver transplantation. However, more patients will not survive long
enough to receive a liver transplant.
About Terlipressin
Terlipressin is a synthetic
vasopressin analogue being investigated for the treatment of HRS
type 1 in the U.S. and Canada.
Safety and efficacy has not been established with nor has approval
been granted by regulatory authorities in either country.
ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops,
manufactures, markets and distributes specialty pharmaceutical
products and therapies. Areas of focus include autoimmune and rare
diseases in specialty areas like neurology, rheumatology,
nephrology, pulmonology and ophthalmology; immunotherapy and
neonatal respiratory critical care therapies; and analgesics and
hemostasis products. The company's core strengths include the
acquisition and management of highly regulated raw materials and
specialized chemistry, formulation and manufacturing capabilities.
The company's Specialty Brands segment includes branded medicines
and its Specialty Generics segment includes specialty generic
drugs, active pharmaceutical ingredients and external
manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a
channel of distribution of important company information, such as
press releases, investor presentations and other financial
information. It also uses its website to expedite public access to
time-critical information regarding the company in advance of or in
lieu of distributing a press release or a filing with the U.S.
Securities and Exchange Commission (SEC) disclosing the same
information. Therefore, investors should look to the Investor
Relations page of the website for important and time-critical
information. Visitors to the website can also register to receive
automatic e-mail and other notifications alerting them when new
information is made available on the Investor Relations page of the
website.
CONTACTS
Investor
Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
1 Arroyo V, Gines P, Gerbes AL, et al. Definition and
diagnostic criteria of refractory ascites and hepatorenal syndrome
in cirrhosis. International Ascites Club. Hepatology
1996;23:164-76.
2 Betrosian AP, Agarwal B, Douzinas EE. Acute renal
dysfunction in liver diseases. World J Gastroenterol
2007;13:5552-9.
3 Do A, Ezaz G. Increasing incidence and cost, but
decreasing mortality in patients with hepatorenal syndrome: a study
of the National Inpatient Sample 2005-2011. Hepatology 2015;62(21
Supplement):abstract no. 283.
4 Nadim, M., et al. Management of the critically
ill patient with cirrhosis: A multidisciplinary perspective.
Journal of Hepatology. 2016, vol. 64, 717–735.
5 Angeli, P., et al. Diagnosis and management of
acute kidney injury in patients with cirrhosis: Revised consensus
recommendations of the International Club of Ascites. Journal of
Hepatology. 2015, vol. 62, 968–974.
6 4 Nadim, M., et al. Hepatorenal syndrome: the 8th
international consensus conference of the Acute Dialysis Quality
Initiative (ADQI) Group. Critical Care 2012 16:R23.
7 5 European Association for the Study of the Liver
clinical practice guidelines on the management of ascites,
spontaneous bacterial peritonitis, and hepatorenal syndrome in
cirrhosis. Journal of Hepatology. 2010, vol. 53, 397–417.
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SOURCE Mallinckrodt Pharmaceuticals