OFIRMEV® (Acetaminophen) Injection Health Economic Data Presented at Women’s Health 2016: The 24th Annual Congress
-- Retrospective data show that, when compared to IV opioids alone, treating acute OB/GYN surgical pain with OFIRMEV and IV opioids decreases hospital length of stay, costs and overall inpatient opioid use --
CHESTERFIELD, United Kingdom – April 18, 2016 - Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced the results from a retrospective analysis of health economic data on the use of OFIRMEV (acetaminophen) injection together with intravenous (IV) opioids for the treatment of acute obstetrics and gynecology (OB/GYN) surgical pain. This retrospective analysis is the first solely focused on this patient population for OFIRMEV. The results were presented as a poster at the 24th Annual Congress of the Academy of Women's Health: Women's Health 2016 on Saturday, April 16, in Washington, DC.
The study, "Comparative Analysis of Inpatient Costs for Obstetrics and Gynecology Surgery Patients Treated with IV Acetaminophen and IV Opioids Versus IV Opioids Alone for Postoperative Pain," undertaken in collaboration with the University of Washington in Seattle, evaluated data from the Premier Inpatient Hospitalization Database of more than 225,000 anonymous female adult inpatient surgical admissions across U.S. hospitals from January 2009 to June 2015. The retrospective analysis assessed length of stay and related hospitalization costs among surgical OB/GYN patients who received perioperative pain management with a combination of OFIRMEV and IV opioids compared with those who received IV opioid monotherapy alone, starting on the day of surgery and continuing up to the second post-operative day. Subjects underwent Caesarean sections and total hysterectomies, averaged 36 years of age and were predominately Caucasian (60 percent).
Key findings associated with use of OFIRMEV together with IV opioids across these OB/GYN surgical patients were:
- A length of stay of 3.1 days versus 3.3 days for patients who received IV opioid monotherapy, lower by 0.20 days (p<0.0001)
- Hospitalization costs of $9,043 versus $9,546 for IV opioid monotherapy, lower by $503 (p<0.0001); differences in hospitalization costs remained statistically significant after controlling for confounders with OFIRMEV associated with $484 less in hospitalization costs (p=0.0006); and
- Decreased inpatient opioid utilization of 27.5 mg versus 29.6 mg for IV opioid monotherapy, lower by 2.2 mg (p<0.0001).
LIMITATIONS OF STUDY
- The differences observed between OFIRMEV and IV opioid monotherapy patients could be explained by unmeasured confounders. Investigators attempted to account for this through the use of instrumental variable regression, adjusting models for potentially confounding variables, but unmeasured factors might still play a role in the associations reported.
- The medication use data in the Premier database reflects the amount and dose charged rather than what was administered. However, systematic differences in billing of IV opioids between patients who did or did not receive OFIRMEV is not suspected.
- The population of patients seen in Premier hospitals is not randomly sampled. Therefore these results may not be generalizable outside of Premier hospitals. However, the database represents 20 percent of all hospitalizations in the U.S.
The average number of days a patient stays at the facility
ABOUT THE DATA
Comparative Analysis of Inpatient Costs for Obstetrics and Gynecology Surgery Patients Treated with IV Acetaminophen and IV Opioids Versus IV Opioids Alone for Postoperative Pain. Ryan N. Hansen, PharmD, Ph.D. School of Pharmacy, University of Washington, Seattle, WA.
Abstract available online (No. 37): http://online.liebertpub.com/doi/full/10.1089/jwh.2016.29006.abstracts
IMPLICATIONS OF THE DATA
This analysis may offer important insight on possible ways to help provide savings to the hospital system, reduce OB/GYN inpatient opioid use and improve OB/GYN patient outcomes. The use of opioids alone has been a mainstay for acute pain management. There is an overreliance on opioids as monotherapy to treat acute pain in U.S. hospitals today and 7 out of 10 hospital patients treated with IV analgesia receive IV opioids alone.
ABOUT OFIRMEV (Acetaminophen) Injection
OFIRMEV (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever. OFIRMEV (acetaminophen) injection is the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. The U.S. Food and Drug Administration approved OFIRMEV in November 2010. OFIRMEV is available to hospitals and outpatient and ambulatory surgical centers across the U.S.
IMPORTANT RISK INFORMATION
- Acetaminophen is contraindicated in patients with: --known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation.
--severe hepatic impairment or severe active liver disease.
- Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
- Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.
For additional Important Risk Information, including complete boxed warning, see Full Prescribing Information.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. 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; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit http://www.mallinckrodt.com.
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2 Premier Healthcare Alliance [paid-access hospital research database: data from January 2011-March 2015].
Charlotte, NC: Premier, Inc. Updated June 2015