Vibativ (Telavancin) (for Kentucky Only) - UHCprovider.com
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UnitedHealthcare® Community Plan
Medical Benefit Drug Policy
Vibativ ® (Telavancin) (for Kentucky Only)
Policy Number: CSKYD0224.01
Effective Date: January 1, 2021 Instructions for Use
Table of Contents Page Related Policies
Application ..................................................................................... 1 None
Coverage Rationale ....................................................................... 1
Applicable Codes .......................................................................... 2
Background ................................................................................... 4
Clinical Evidence ........................................................................... 5
U.S. Food and Drug Administration ............................................. 5
Centers for Medicare and Medicaid Services ............................. 5
References ..................................................................................... 5
Policy History/Revision Information ............................................. 5
Instructions for Use ....................................................................... 6
Application
This Medical Benefit Drug Policy only applies to the state of Kentucky.
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 Staphylococcus aureus when all of the following
criteria are met:
Diagnosis of cSSSI or HABP/VABP; and
Patient is 18 years of age or older; and
One of the following:
o Patient has reported trial and failure with intravenous vancomycin for the current active infection; or
o A culture and sensitivity report indicates the cultured organism is resistant to vancomycin
and
Vibativ dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling:
o For cSSSI dosage of 10 mg/kg every 24 hours for 7 to 14 days
o For HABP/VABP dosage of 10 mg/kg every 24 hours for 7 to 21 days
o 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
Authorization is for no longer than 1 month
Bacteremia due to Staphylococcus aureus (S. aureus) when all of the following criteria are met:
Diagnosis of bacteremia due to S. aureus; and
One of the following:
Vibativ® (Telavancin) (for Kentucky Only) Page 1 of 6
UnitedHealthcare Community Plan Medical Benefit Drug Policy Effective 01/01/2021
Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.o Patient has reported trial and failure with intravenous vancomycin for the current active infection; or
o A culture and sensitivity report indicates the cultured organism is resistant to vancomycin
and
Vibativ dosing is in accordance with guidelines used in clinical evidence: 10 mg/kg every 24 hours; and
Authorization is for no longer than 1 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 Methicillin 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
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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
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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 (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 daptomycin. Data from a small randomized, double-blind, phase 2 trial demonstrated utility for the treatment of
uncomplicated S. aureus bacteremia.3
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 lipoglycopeptide 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.
Centers for Medicare and Medicaid Services (CMS)
Medicare does not have a National Coverage Determination (NCD) for VIBATIV® (telavancin). Local Coverage Determinations
(LCDs)/Local Coverage Articles (LCAs) do not exist.
In general, Medicare covers outpatient (Part B) drugs that are furnished "incident to" a physician's service provided that the
drugs are not usually self-administered by the patients who take them. Refer to the Medicare Benefit Policy Manual, Chapter 15,
§50 - Drugs and Biologicals. (Accessed July 9, 2020)
References
1. Vibativ® [prescribing information]. Nashville, TN: Cumberland Pharmaceuticals Inc.; July 2020.
2. Jääskeläinen, I.h., et al. “Treatment of Complicated Skin and Skin Structure Infections in Areas with Low Incidence of
Antibiotic 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
01/01/2021 • New Medical Benefit Drug Policy
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Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.Instructions for Use
This Medical Benefit Drug Policy provides assistance in interpreting UnitedHealthcare standard benefit plans. When deciding
coverage, the federal, state, or contractual requirements for benefit plan coverage must be referenced as the terms of the
federal, state, or contractual requirements for benefit plan coverage may differ from the standard benefit plan. In the event of a
conflict, the federal, state, or contractual requirements for benefit plan coverage govern. Before using this policy, please check
the federal, state, or contractual requirements for benefit plan coverage. 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 uses InterQual® or MCG™ (Milliman) for the primary medical/surgical criteria, and the American Society of
Addiction Medicine (ASAM) for substance use, in administering health benefits. If InterQual® or MCG™ do not have applicable
criteria, UnitedHealthcare may also use UnitedHealthcare Medical Benefit Drug Policies. The 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.
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