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

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

IMPACT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSSI) ON HEALTHCARE COSTS

Acute bacterial skin and skin structure infections 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.

ABSSSIs are common, and often result in prolonged hospital stays and increased 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 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 Options that help reduce inpatient admissions may help lower the overall cost of treatment and potentially allow more patients to avoid a hospital admission.1

ALLERGAN’S COMMITMENT TO PROVIDING ANTI-INFECTIVE OPTIONS

Industry has a key role to play in helping reduce the cost of care while ensuring high-quality care for patients.

Allergan is committed to developing IV antibiotics to treat serious infections. The development of a single dose intravenous (IV) antibiotic to treat acute bacterial skin and skin structure infections (ABSSSI) is one proof point.  In early 2016, Dalvance was approved by the FDA 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.

DALVANCE® is the first and only 30-minute, one dose IV antibiotic delivering a complete course of therapy for ABSSSI.  DALVANCE provides physicians with an option to treat appropriate ABSSSI patients in the outpatient setting, without having to admit them to the hospital for IV infusion.

Allergan recognizes 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 help facilitate access to treatments that 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.

ABOUT THE AUTHOR
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.

References:
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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.

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

DALVANCE® is a registered trademark of Allergan Pharmaceuticals International Limited.

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