UnitedHealthcare® Value & Balance Exchange Medical Benefit Drug Policy Vibativ® (Telavancin)

Policy Number: IEXD0222.02 Effective Date: July 1, 2021  Instructions for Use

Table of Contents Page Related Policies Applicable States ...... 1 None Coverage Rationale ...... 1 Applicable Codes ...... 2 Background...... 4 Clinical Evidence ...... 5 U.S. Food and Drug Administration ...... 5 References ...... 5 Policy History/Revision Information ...... 5 Instructions for Use ...... 6

Applicable States

This Medical Benefit Drug Policy only applies to the states of Arizona, Maryland, North Carolina, Oklahoma, Tennessee, Virginia, and Washington.

Coverage Rationale

Vibativ is proven and medically necessary for the treatment of: Complicated skin and skin structure infections (cSSSI) caused by susceptible gram-positive bacteria or hospital- acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by when all of the following criteria are met: o Diagnosis of cSSSI or HABP/VABP; and o Patient is 18 years of age or older; and o One of the following: . Trial and failure with intravenous for the current active infection; or . A culture and sensitivity report indicates the cultured organism is resistant to vancomycin and o Vibativ dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling: . For cSSSI dosage of 10 mg/kg every 24 hours for 7 to 14 days . For HABP/VABP dosage of 10 mg/kg every 24 hours for 7 to 21 days . Patients with renal impairment dosing: CrCl 30—50 ml/min: 7.5 mg/kg every 24 hours. CrCl 10—29 ml/min: 10 mg/kg every 48 hours and o Authorization is for no longer than one month Bacteremia due to Staphylococcus aureus (S. aureus) when all of the following criteria are met: o Diagnosis of bacteremia due to S. aureus; and o One of the following: . Trial and failure with intravenous vancomycin for the current active infection; or

Vibativ® (Telavancin) Page 1 of 6 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 07/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

. A culture and sensitivity report indicates the cultured organism is resistant to vancomycin and o Vibativ dosing is in accordance with Infectious Diseases Society of America (IDSA) guidelines used in clinical evidence: 10 mg/kg every 24 hours; and o Authorization is for no longer than one month

Applicable Codes

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

HCPCS Code Description J3095 Injection, telavancin, 10 mg

Diagnosis Code Description A40.0 Sepsis due to streptococcus, group A A40.1 Sepsis due to streptococcus, group B A40.3 Sepsis due to Streptococcus pneumonia A40.8 Other streptococcal sepsis A40.9 Streptococcal sepsis, unspecified A41.01 Sepsis due to susceptible Staphylococcus aureus A41.02 Sepsis due to Methicillin resistant Staphylococcus aureus A41.1 Sepsis due to other specified staphylococcus A41.2 Sepsis due to unspecified staphylococcus A49.01 Methicillin susceptible Staphylococcus aureus infection, unspecified site A49.02 Methicillin resistant Staphylococcus aureus infection, unspecified site A49.1 Streptococcal infection, unspecified site B95.0 Streptococcus, group A, as the cause of diseases classified elsewhere B95.1 Streptococcus, group B, as the cause of diseases classified elsewhere B95.2 Enterococcus as the cause of diseases classified elsewhere B95.3 Streptococcus pneumoniae as the cause of diseases classified elsewhere B95.4 Other streptococcus as the cause of diseases classified elsewhere B95.5 Unspecified streptococcus as the cause of diseases classified elsewhere B95.61 Methicillin susceptible Staphylococcus aureus infection as the cause of diseases classified elsewhere B95.62 Methicillin resistant Staphylococcus aureus infection as the cause of diseases classified elsewhere B95.7 Other staphylococcus as the cause of diseases classified elsewhere B95.8 Unspecified staphylococcus as the cause of diseases classified elsewhere H00.03 Abscess of eyelid H05.01 Cellulitis of orbit H60.0 Abscess of external ear H60.1 Cellulitis of external ear J15.20 Pneumonia due to staphylococcus, unspecified J15.211 Pneumonia due to Methicillin susceptible Staphylococcus aureus

Vibativ® (Telavancin) Page 2 of 6 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 07/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

Diagnosis Code Description J15.212 Pneumonia due to Methicillin resistant Staphylococcus aureus J15.29 Pneumonia due to other staphylococcus J34.0 Abscess, furuncle and carbuncle of nose J95.851 Ventilator associated pneumonia K12.2 Cellulitis and abscess of mouth K61.0 Anal abscess K61.1 Rectal abscess K61.2 Anorectal abscess K61.3 Ischiorectal abscess K61.4 Intrasphincteric abscess L02.01 Cutaneous abscess of face L02.02 Furuncle of face L02.03 Carbuncle of face L02.11 Cutaneous abscess of neck L02.12 Furuncle of neck L02.13 Carbuncle of neck L02.21 Cutaneous abscess of trunk L02.22 Furuncle of trunk L02.23 Carbuncle of trunk L02.31 Cutaneous abscess of buttock L02.32 Furuncle of buttock L02.33 Carbuncle of buttock L02.41 Cutaneous abscess of limb L02.42 Furuncle of limb L02.43 Carbuncle of limb L02.51 Cutaneous abscess of hand L02.52 Furuncle of hand L02.53 Carbuncle of hand L02.61 Cutaneous abscess of foot L02.62 Furuncle of foot L02.63 Carbuncle of foot L02.81 Cutaneous abscess of other sites L02.82 Furuncle of other sites L02.83 Carbuncle of other sites L02.91 Cutaneous abscess, unspecified L02.92 Furuncle, unspecified L02.93 Carbuncle, unspecified L03.01 Cellulitis of finger L03.03 Cellulitis of toe L03.11 Cellulitis of other parts of limb L03.211 Cellulitis of face L03.213 Periorbital cellulitis

Vibativ® (Telavancin) Page 3 of 6 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 07/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

Diagnosis Code Description L03.221 Cellulitis of neck L03.311 Cellulitis of abdominal wall L03.312 Cellulitis of back [any part except buttock] L03.313 Cellulitis of chest wall L03.314 Cellulitis of groin L03.315 Cellulitis of perineum L03.316 Cellulitis of umbilicus L03.317 Cellulitis of buttock L03.319 Cellulitis of trunk, unspecified L03.811 Cellulitis of head [any part, except face] L03.818 Cellulitis of other sites L03.90 Cellulitis, unspecified L08.0 Pyoderma L08.89 Other specified local infections of the skin and subcutaneous tissue L08.9 Local infection of the skin and subcutaneous tissue, unspecified N48.22 Cellulitis of corpus cavernosum and penis

Background

Skin and skin-structure infections (SSSI) are among the most frequent human bacterial infections and a rapidly increasing reason for hospitalization. Although, there is no clear clinical definition, SSSI is generally considered as complicated (cSSSI) if it involves deep subcutaneous tissues or needs surgery in addition to antimicrobial therapy. Gram-positive cocci, in particular streptococci but in some cases also Staphylococcus aureus, are the most common causative agents of SSSI, but in complicated cases Gram-negative rods and anaerobic bacteria may play a role. However, in most cases the pathogens cannot be identified because of the lack of purulent discharge necessary for microbiological tests and because blood cultures are rarely (<5%) positive. Treatment with antimicrobials before hospitalization can also reduce the growth of pathogens in bacterial culture. Streptococci are still mostly sensitive to but the possibility of other causative agents with increasing antimicrobial resistance and in particular methicillin-resistant Staphylococcus aureus (MRSA) may have to be taken into account in empiric treatment.2

HAP is usually caused by bacteria, is currently the second most common nosocomial infection in the United States, and is associated with high mortality and morbidity. Although HAP is not a reportable illness, available data suggest that it occurs at a rate of between five and 10 cases per 1,000 hospital admissions, with the incidence increasing by as much as 6- to 20-fold in mechanically ventilated patients. It is often difficult to define the exact incidence of VAP, because there may be an overlap with other lower respiratory tract infections, such as infectious tracheobronchitis in mechanically ventilated patients. The exact incidence varies widely depending on the case definition of pneumonia and the population being evaluated. For example, the incidence of VAP may be up to two times higher in patients diagnosed by qualitative or semiquantitative sputum cultures compared with quantitative cultures of lower respiratory tract secretions. HAP accounts for up to 25% of all ICU infections and for more than 50% of the prescribed. VAP occurs in 9–27% of all intubated patients. In ICU patients, nearly 90% of episodes of HAP occur during mechanical ventilation. In mechanically ventilated patients, the incidence increases with duration of ventilation. HAP, VAP, and HCAP may be caused by a wide spectrum of bacterial pathogens, may be polymicrobial, and are rarely due to viral or fungal pathogens in immunocompetent hosts. Common pathogens include aerobic gram-negative bacilli, such as P. aeruginosa, Escherichia coli, Klebsiella pneumoniae, and Acinetobacter species. Infections due to gram-positive cocci, such as Staphylococcus aureus, particularly methicillin-resistant S. aureus (MRSA), have been rapidly emerging in the United States. Pneumonia due to S. aureus is more common in patients with diabetes mellitus, head trauma, and those hospitalized in ICUs.4

Vibativ® (Telavancin) Page 4 of 6 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 07/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

Clinical Evidence

Based on the Infectious Diseases Society of America (IDSA) guidelines for the Treatment of Methicillin-Resistant Staphylococcus aureus (MRSA) Infections in Adults and Children, telavancin, as monotherapy or in combination with other agents, may be considered as an alternative agent for persistent bacteremia due to MRSA that has reduced susceptibility to vancomycin and . Data from a small randomized, double-blind, phase 2 trial demonstrated utility for the treatment of uncomplicated S. aureus bacteremia3

U.S. Food and Drug Administration (FDA)

This section is to be used for informational purposes only. FDA approval alone is not a basis for coverage.

Vibativ is a antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria: Complicated skin and skin structure infections (cSSSI) Hospital-Acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus.

Vibativ should be reserved for use when alternative treatments are not suitable. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vibativ and other antibacterial drugs Vibativ should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

References

1. Vibativ [prescribing information]. Nashville, TN: Cumberland Pharmaceuticals Inc.; January 2021. 2. Jääskeläinen, I.h., et al. “Treatment of Complicated Skin and Skin Structure Infections in Areas with Low Incidence of Resistance—a Retrospective Population Based Study from Finland and Sweden.” Clinical Microbiology and Infection, vol. 22, no. 4, 19 Jan. 2016, doi:10.1016/j.cmi.2016.01.002. 3. Stryjewski ME, Lentnek A, O’Riordan W, et al. A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study. BMC Infect Dis. 2014;14:289. 4. “Guidelines for the Management of Adults with Hospital-Acquired, Ventilator-Associated, and Healthcare-Associated Pneumonia.” American Journal of Respiratory and Critical Care Medicine, vol. 171, no. 4, 2005, pp. 388–416., doi:10.1164/rccm.200405-644st.

Policy History/Revision Information

Date Summary of Changes 07/01/2021 Template Update Removed CMS section Coverage Rationale Revised coverage criteria: o Replaced criterion requiring “patient has reported trial and failure with intravenous vancomycin for the current active infection” with “trial and failure with intravenous vancomycin for the current active infection” o Updated criterion for the treatment of bacteremia due to Staphylococcus aureus (S. aureus) to clarify Vibativ dosing is in accordance with Infectious Diseases Society of America (IDSA) guidelines used in clinical evidence: 10 mg/kg every 24 hours Supporting Information Updated References section to reflect the most current information Archived previous policy version IEXD0222.01

Vibativ® (Telavancin) Page 5 of 6 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 07/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

Instructions for Use

This Medical Benefit Drug Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the member specific benefit plan document must be referenced as the terms of the member specific benefit plan may differ from the standard benefit plan. In the event of a conflict, the member specific benefit plan document governs. Before using this policy, please check the member specific benefit plan document and any applicable federal or state mandates. UnitedHealthcare reserves the right to modify its Policies and Guidelines as necessary. This Medical Benefit Drug Policy is provided for informational purposes. It does not constitute medical advice.

UnitedHealthcare may also use tools developed by third parties, such as the InterQual® criteria, to assist us in administering health benefits. UnitedHealthcare Medical Benefit Drug Policies are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.

Vibativ® (Telavancin) Page 6 of 6 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 07/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.