CurrentMass General Brigham Health PlanPolicy N/A

Zyvox (linezolid) prior authorization policy

Prior authorization policy for oral linezolid (tablets and suspension) under the pharmacy benefit for Commercial/Exchange members; defines clinical indications that qualify for authorization, approval durations, monitoring and quantity limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyZyvox (linezolid) prior authorization policy

Policy CodePolicy N/A

Change TypeReviewed/revised (11/26/2018)

Effective DateNov 26, 2018

Next Review Date

Key ActionPrior authorization is required for oral linezolid under the pharmacy benefit; authorization may be granted when any of the listed clinical criteria are documented.

SourceLink

POLICY UPDATE CHANGES

Reviewed and revised in P&T Meeting on 11/26/18.

6Covered Indications (qualifying criteria)

28 daysApproval duration (some indications)

14 daysApproval duration (skin infections)

56 / 1800 mLQuantity limits (per 90 days)

Coverage Summary & Guidelines

Prior authorization policy for oral linezolid (tablets and suspension) under the pharmacy benefit for Commercial/Exchange members; covered_with_criteria. Effective 11/26/2018; last review 01/22/2020.

Coverage Guidelines (Authorization may be granted when ANY of the following are met)

Authorization may be granted for members when ANY of the following criteria are met, and documentation is provided:

Member was started on linezolid therapy in the hospital or another inpatient facility.
Member has a documented blood, sputum, tissue or urine culture positive for vancomycin-resistant Enterococcus (VRE).
Member has a documented blood, sputum, tissue or urine culture positive for methicillin-resistant Staphylococcus (MRSA) and treatment with vancomycin is not an option (e.g. lack of IV access, etc.).
Member currently has a complicated skin or skin structure infection with no concomitant osteomyelitis where a culture cannot be obtained (e.g. closed wound infections, diabetic foot infections, cellulitis infections, etc.) and patient has a history of MRSA infections.
Member has hospital-acquired or healthcare-associated pneumonia caused by S. aureus (methicillin-susceptible and -resistant isolates), or S. pneumoniae.
Member has uncomplicated skin and skin structure infections caused by S. aureus (methicillin-susceptible isolates) or S. pyogenes.

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Initial Therapy, Duration & Monitoring

Limitations (Approval durations and monitoring)

Specific approval durations and monitoring requirements apply depending on indication:

28-day approvals: Approvals for the following will be granted for 28 days: (a) Therapy started in a hospital/inpatient facility; (b) Blood, sputum, tissue or urine culture positive for VRE/MRSA; (c) Hospital-acquired or healthcare-associated pneumonia caused by S. aureus or S. pneumoniae.28 days
14-day approvals: Approvals for the following will be granted for 14 days: (a) Complicated skin or skin structure infection with no concomitant osteomyelitis and a history of MRSA infections; (b) Uncomplicated skin and skin structure infection caused by S. aureus or S. pyogenes.14 days
Monitoring requirement: For treatment duration exceeding 2 weeks, weekly monitoring of patient's complete blood count (CBC) is required.>2 weeks -> weekly CBC
Quantity limits apply: Linezolid 600mg tablets, 1 = 56 tablets per 90 days; Linezolid oral suspension, 1 = 1800 mL (12 bottles) per 90 days.56 tablets per 90 days; 1800 mL per 90 days

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Documentation Required

Monitoring requirement

If treatment exceeds 2 weeks, weekly CBC monitoring must be performed.

Prior Authorization, Documentation & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for oral linezolid under the pharmacy benefit; authorization may be granted when any of the listed clinical criteria are documented.

Documentation Required

Clinical documentation required

Documentation must support one of the qualifying criteria: inpatient initiation, positive culture for VRE or MRSA (blood, sputum, tissue, urine), inability to use vancomycin for MRSA, complicated or uncomplicated skin/soft tissue infection with stated microbiology or history, or hospital-acquired/healthcare-associated pneumonia due to S. aureus or S. pneumoniae.

Billing Rule

Approval durations

Approvals are time-limited: 28 days for inpatient-start, positive VRE/MRSA cultures, or hospital-acquired/healthcare-associated pneumonia; 14 days for specified skin/soft tissue infections.

Billing Rule

Quantity limits

Linezolid 600mg tablets: limit of 56 tablets per 90 days; Linezolid oral suspension: limit of 1800 mL (12 bottles) per 90 days.

Linezolid 600mg tablets: 56/90 days
Linezolid oral suspension: 1800 mL/90 days

References & Evidence Cited

Zyvox (linezolid) prescribing information, July 2018.

Cochrane review: Linezolid versus vancomycin for skin and soft tissue infections (2016).

Policy references prescribing information and IDSA guidelines.

Drug Background & Definitions

Linezolid is an oxazolidinone antibiotic and a reversible MAO inhibitor used to treat pneumonia, skin and soft tissue infections, and infections caused by resistant organisms such as MRSA and VRE.

VRE: Vancomycin-resistant Enterococcus.

MRSA: Methicillin-resistant Staphylococcus aureus.