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HealthPartners

Coverage criteria policies

Telavancin (Vibativ®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Vibativ is not covered by HealthPartners for outpatient use.

Coverage

Vibativ is not covered for outpatient use as it offers little or no clinical advantages over current therapy and has safety concerns.

Definitions

Vibativ (telavancin) 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) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S.constellatus), or Enterococcus faecalis (vancomycin-susceptible isolates only). and
  • Hospital-acquired and ventilator-associated bacterial pneumonia, caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and –resistant isolates).

Avoid use of Vibativ during pregnancy unless potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in 3 animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans.

Nephrotoxicity (either new onset or worsening) has occurred with use. Decreased efficacy is observed in moderate/severe baseline renal impairment (CrCl ≤ 50 mL/min).

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS Codes

    Codes

    Description

    J3095

    Injection, telavancin, 10 mg

NDC Codes

    Codes

    Description

    52118000201

    250 mg single use vial

    52118000101

    750 mg single use vial

    62847000101

    750mg single use vial

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

11/2016

References

  1. Vibativ Prescribing Information. Theravance, Inc. South San Francisco, CA. May 2016.
  2. Telavancin (Vibativ) FDA Review Summary.
  3. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist (Accessed 10/22/10)

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Policy activity

  • 07/01/2011 - Date of origin
  • 07/01/2011 - Effective date
Review date
  • 11/2016

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