Use of Outpatient Therapy for Certain Skin Infections

Infectious diseases are a significant public health problem, garnering increased attention from media, government, and industry in the last several months and causing a significant economic burden on the U.S. healthcare system.¹

As the prevalence of serious infections continues to increase, hospitals and other healthcare institutions face pressures to reduce hospitalizations for certain infections while maintaining the highest quality of care for patients.¹

So, what role can industry play in helping reduce the cost of care while maintaining quality of care for patients?

Allergan continues to be committed to developing IV antibiotics that may help patients with serious infections. Over the last few years, Allergan has developed a single dose intravenous (IV) antibiotic to treat acute bacterial skin and skin structure infections (ABSSSI) that can be administered in the outpatient setting as an alternative to admitting a patient into the hospital to receive a course of IV antibiotics.

Impact of ABSSSI on Healthcare Costs

Acute bacterial skin and skin structure infections (ABSSSI) are complicated bacterial infections of the skin and associated tissues – such as cellulitis, wound infections, and major skin abscesses – primarily caused by Gram-positive pathogens, including Staphylococcus aureus and Streptococcus pyogenes.

While ABSSSI are common, they often result in prolonged hospital stays and patient exposure to the healthcare environment. Such hospitalizations have become increasingly prevalent over the last two decades due to an increase in ABSSSI cases caused by more resistant pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).¹ According to one retrospective database analysis, there was a 17.3 percent increase observed in ABSSSI-associated hospitalizations from 2005 to 2011, and more than 750,000 hospital admissions were attributed to ABSSSI in 2011 alone.² According to the same study, hospitalizations for these types of infections can last an average of nearly 5 days, at a cost of approximately $10,000 to the system.²

While several expert panels have suggested hospital admissions for ABSSSI can be limited to patients with unstable comorbidities or more severe infections,³ many patients continue to be treated in the inpatient setting, with physicians citing the need for intravenous (IV) antibiotic treatment as a key factor in their decision to hospitalize. In fact, more than 40 percent of physicians in a recent study noted IV treatment as the only reason they hospitalized patients for skin and soft-tissue infections.⁴

Potential Benefits of Outpatient Therapy for Patients with ABSSSI

Studies have shown that some patients with ABSSSI without major complications can be successfully managed in the outpatient setting.³ But to help reduce inpatient admissions for ABSSSI and facilitate a transition to outpatient care, physicians need IV antibiotic treatments with dosing options that allow them to manage ABSSSI outside of the hospital. Ultimately, those options may help reduce the overall cost of treatment and allow more patients to potentially avoid a hospital admission.¹

In early 2016, the U.S. Food and Drug Administration (FDA) approved an updated dosing regimen for DALVANCE^® (dalbavancin), making it the first and only 30-minute, one dose IV antibiotic that delivers a complete course of therapy for ABSSSI.⁵ DALVANCE is indicated for the treatment of adult patients with ABSSSI caused by designated susceptible Gram-positive bacteria, including MRSA. See full indication below. DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin. See additional Important Safety Information below.

With this update, DALVANCE provides physicians with an alternative option to treat appropriate ABSSSI patients with a long-acting agent in the outpatient setting, without having to admit them to the hospital for IV infusion.

Allergan's Commitment to Providing Anti-Infective Options

At Allergan, we recognize the importance of providing anti-infectives that give physicians options in their approach to treating patients with ABSSSI in and out of hospital settings. Our commitment to anti-infectives goes beyond our ongoing research and development of therapies, and is fully realized by how we can also help facilitate access to treatments that help streamline care pathways for patients and healthcare institutions.

For more information on DALVANCE, please see the full indication and usage, additional Important Safety Information and a link to the full Prescribing Information below, or visit www.DALVANCE.com.

INDICATION AND USAGE

DALVANCE^® (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin-susceptible strains).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT SAFETY INFORMATION

Contraindications

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DALVANCE should be discontinued.

Infusion-related Reactions

Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.

Hepatic Effects

ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

Development of Drug-resistant Bacteria

Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

ADVERSE REACTIONS

The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%).

USE IN SPECIFIC POPULATIONS

• There have been no adequate and well-controlled studies with DALVANCE in pregnant or nursing women. DALVANCE should only be used if the potential benefit justifies the potential risk in these populations.
• In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen of DALVANCE is 1125 mg, administered as a single dose, or 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis.
• Caution should be exercised when prescribing DALVANCE to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients.

Please click here for the full Prescribing Information for DALVANCE.

Footnotes

1. Pollack CV Jr, Amin A, Ford WT Jr, et al. Acute bacterial skin and skin structure infections (ABSSSI): practice guideline for management and care transitions in the emergency department and hospital. J Emerg Med. 2015;48(4):508-519.
2. Khachatryan A, Patel D, Stephens J, et al. Rising United States hospital admissions for Gram+ acute bacterial skin and skin structure infections (ABSSSIs). Presented at Society of Hospital Medicine Annual Meeting. 2014. [poster].
3. Lodise TP, Fan W, Sulham KA. Economic Impact of Oritavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in the Emergency Department or Observation Setting: Cost Savings Associated with Avoidable Hospitalizations. Clinical Therapeutics. 2016;38(1):136-148.
4. Talan DA, Salhi BA, Moran GJ, et al. Factors associated with the decision to hospitalize emergency department patients with a skin and soft tissue infection. West J Emerg Med. 2015;16(1):89-97.
5. DALVANCE (dalbavancin) [prescribing information]. Parsippany, NJ: Durata Therapeutics U.S. Limited, 2016.

Allergan^® and its design are trademarks of Allergan, Inc.

DALVANCE^® is a registered trademark of Durata Therapeutics Holding C.V., an Allergan affiliate.

Mark Devlin is senior vice president of Managed Markets for Allergan, a leading global pharmaceutical company, where he is responsible for market access strategies for the U.S. Pharmaceutical and U.S. Medical Dermatology portfolios. Devlin also serves on the Allergan Global Leadership Team, North American Commercial Leadership Team and Corporate Governance and Pricing committee.