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Pharmacy Clinical Policy Bulletins

Subject: Oxazolidinone Antibiotic

Class Edit Summary*
Status Drug PR PR-QL PR-AL ST M EX‡
P Zyvox® (linezolid) X        

*P = Preferred; FE = Formulary Excluded; NP = Nonpreferred PR = Precertification; QL = Quantity Limits; AL = Age Limits; ST = Step-Therapy ‡M EX = Medical Exception - This means the physician or health care professional must obtain a medical exception from Aetna, in order for the medication to be eligible for coverage. Medical Exception criteria apply to Formulary Excluded drugs for members enrolled in or covered by closed benefits plans, and also apply to Step-Therapy drugs in cases where a member's physician believes it is medically necessary for the member to use a step-therapy drug in the first instance without a trial of the prerequisite alternative drug(s).

Important Note

This Pharmacy Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefits plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their health care providers will need to consult the member's benefits plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the following website: http://www.cms.hhs.gov/center/coverage.asp.

Policy

  1. Precertification Criteria

    Under some benefit plans, including plans that use an open or closed formulary, Zyvox is subject to precertification.* If precertification requirements apply, Aetna considers Zyvox to be medically necessary for those members who meet ANY of the following precertification criteria:

    1. A documented diagnosis of

      • vancomycin-resistant Enterococcus faecium infection; OR
      • nosocomial pneumonia (Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae(penicillin-susceptible strains only);

      OR

    2. A documented diagnosis of

      • community-acquired pneumonia (Streptococcus pneumoniae (penicillin-susceptible strains only) Staphylococcus aureus (methicillin-susceptible strains only; OR
      • complicated skin or skin structure infections, including diabetic foot infections without concomitant osteomyelitis caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae); OR
      • uncomplicated skin and skin structure infection caused by Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus pyogenes

      AND

      • Contraindication to two preferred alternatives (see table below) indicated for the member's condition OR
      • Intolerance to two preferred alternatives (see table below) indicated for the member's condition OR
      • Allergy to two preferred alternatives (see table below) indicated for the member's condition OR
      • Documented lack of bacterial sensitivity to two preferred alternatives (see table below) indicated for the member's condition OR
      • Failure of an adequate trial of three days each of two preferred alternatives (see table below) indicated for the member's condition.

      Indication Preferred Alternatives
      Community-acquired pneumonia amoxicillin
      amoxicillin/clavulanate
      ampicillin
      azithromycin
      cefaclor
      cefdinir (OMNICEF®)
      cefditoren pivoxil (SPECTRACEF®)
      cefpodoxime proxetil
      cefuroxime
      cephalexin
      cephradine
      ciprofloxacin
      clarithromycin
      doxycycline
      erythromycin
      loracarbef (LORABID®)
      moxifloxacin (AVELOX®)
      penicillin
      sulfamethoxazole/trimethoprim (cotrimoxazole)
      Skin/structure infection amoxicillin
      amoxicillin/clavulanate
      ampicillin
      azithromycin
      cefaclor
      cefaclor ER
      cefadroxil
      cefdinir (OMNICEF®)
      cefditoren pivoxil (SPECTRACEF®)
      cefpodoxime proxetil
      cefuroxime
      cephalexin
      cephradine
      ciprofloxacin
      clarithromycin
      clindamycin
      cloxacillin
      dicloxacillin
      erythromycin
      loracarbef (LORABID®)
      moxifloxacin (AVELOX®)
      penicillin VK
      MRSA clindamycin
      moxifloxacin (AVELOX®)
      trimethoprim-sulfamethosazole
      Vancomycin

Special Notes:

Methicillin-resistant Staphylococcus aureus (MRSA), an increasing cause of community-onset infections, should be considered if the patient was previously colonized with MRSA, has a history of recent hospitalization, has a delayed response to therapy, or is in a geographic area of high prevalence. Vancomycin is the drug of choice for treatment of severe infections due to MRSA. Linezolid or daptomycin (Medical Letter 2004; 46:11) are reasonable alternatives. Many community-acquired strains of MRSA can also be treated with clindamycin, trimethoprim-sulfamethoxazole or a fluoroquinolone with good gram-positive coverage (levofloxacin, gatifloxacin or moxifloxacin). (16)

*Information regarding Aetna's Preferred Drug List, Formulary Exclusions list, Precertification and Step-Therapy lists is available on our website. In addition, members should refer to their plan documents and may call the toll-free telephone number on their ID card for information regarding their benefits. Health care professionals also may obtain information by calling the Pharmacy Management Precertification Unit at 1-800-414-2386, or they can register to use our password-protected provider website. Visit www.aetna.com, select "Doctors & Hospitals" and choose "Physician Self-Service." Once registration is completed, health care professionals may use our online Precertification/medical exception email request form.

The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas (for example, step-therapy does not apply to fully insured New Jersey members).

Many medications on the Preferred Drug List are subject to manufacturer rebate arrangements between Aetna and the manufacturer of those medications. If the member's prescription benefits plan has a deductible or copay levels based on a percentage of Aetna's contracted rate with the participating pharmacy, the contracted rate does not include or reflect any manufacturer rebate arrangements between Aetna and the medication manufacturer. In prescription plans with a deductible or copayment or coinsurance tiers, use of drugs from the Preferred Drug List generally will result in lower costs to members. However, where the prescription plan utilizes a deductible or copayments or coinsurance calculated on a percentage basis, there could be some circumstances in which a preferred drug would cost the member more than a nonpreferred drug because (1) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the nonpreferred drug, and (2) rebates received by Aetna from drug manufacturers are not reflected in the cost of a prescription drug obtained by a member. The Preferred Drug List is subject to change.

In evaluating clinically and therapeutically similar drugs for selection for the Preferred Drug List, Aetna reviews the costs of drugs and takes into account rebates negotiated between Aetna and drug manufacturers. Consequently, a drug may be included on the Preferred Drug list that is more expensive than a nonpreferred alternative before any rebates Aetna may receive from a drug manufacturer are taken into account. In addition, certain drugs may be chosen for "preferred" status because of their clinical or therapeutic advantages or level of acceptance among physicians even though they cost more than nonpreferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (1) the terms of Aetna's arrangements with participating pharmacies; (2) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (3) the percentage, if any, of rebates to which the plan sponsor is entitled under its agreement with Aetna. As a result, a self-funded plan sponsor's actual claim expense per prescription for a particular preferred drug may in some circumstances be higher than for a nonpreferred alternative.

For members in Texas, additions to the 2006 Preferred Drug List will be effective no later than January 1, 2006. In accordance with state law, fully insured members in Texas who are receiving coverage for medications that are removed from the Preferred Drug List during the plan year will continue to have those medications covered at the same benefit level until their plan's renewal date.

This definition of precertification is not the same as the definition used by Texas law. Our use of the term "precertification" relates to the prior authorization of your services by Aetna, based on our decision of whether the service is medically necessary. Precertification is not a guarantee of payment or "verification" as defined by Texas law.

California HMO members enrolled in a closed formulary benefits plan who are receiving coverage for medications that are moved to the Formulary Exclusions List, and California HMO members who are receiving coverage for medications added to the Precertification or Step-Therapy lists, will continue to have those medications covered, for as long as the treating physician continues prescribing them. This coverage, in accordance with state law, is only provided when the drug is appropriately prescribed and is considered safe and effective for treating the member's medical condition.

Nothing in this section shall preclude the prescribing health care professional from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to prohibit generic drug substitutions.

Place of Service:

    Outpatient

The above policy is based on the following references:

  1. Product Information Insert. Linezolid tablets/suspension, Pharmacia, Kalamazoo, Michigan December revised September 2003.
  2. Thomson Micromedex USPDI; Oxazolidinones: (online version) Montvale, NJ. 2004.
  3. McEvoy GK, editor. American Hospital Formulary Service First Professional Edition (thru stat-ref-online). Bethesda, Maryland 2004.
  4. Thomson Physicians Desk Reference; Oxazolidinones: (electronic online) Montvale, NJ. 2004
  5. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
  6. Medispan Drug Information. 2004.
  7. Sandford, Jay P., Gilbert, David N., Moellering, R.C. Sande, M.A.: Sandford Guide to Antimicrobial Therapy, 31st edition, Copyright 2003, Antimicrobial Therapy Inc. Hyde Park, Vt.
  8. Centers for Disease Control and Prevention. “2002 Guidelines for Treatment of Sexually Transmitted Diseases”. MMWR 2002; 51(RR06); 1-170
  9. Stevens DL, Herr D, Lampiris H, et.al. Linezolid versus Vancomycin for the Treatment of Methicillin-Resistant Staphylococcus Aureus Infections. Clinical Infectious Disease January 2002; 34(11): 1481-1490.
  10. Linden, PK. Treatment Options for Vancomycin-Resistant Enterococcal Infections. Drugs 2002; 62(3): 425-441.
  11. Bruss JB, Seas C, Duvall SE, et al: Comparison of linezolid to oxacillin followed by oral dicloxacillin in the treatment of complicated skin infections: Results from a multinational phase III trial. Proceedings of the 9th International Congress on Infectious Disease, April 13, 2000
  12. Duvall SE, Bruss JB, McConnell-Martin MA et al: Comparison of oral linezolid to oral clarithromycin in the treatment of uncomoplicated skin infections: results from a multinational phase III trial. International Soceity of Infectious Diseases, Boston, MA 2000
  13. Grudinina SA - Comparison of linezolid and vancomycin in nosocomial pneumonia: results of the multicenter double-blind study Antibiot Khimioter - 01-JAN-2002; 47(1): 12-7
  14. FDA briefing package-AIDAC meeting: Guidance for Diabetic Foot Infections http://www.fda.gov/ohrms/dockets/ac/03/briefing/
    3997B1_01_FDA%20Diabetic%20Foot.htm
  15. Diabetic foot infection clinical trial design for antimicrobials http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/
    Committees/Anti-Infective+Drugs/102803_Diabetesfoot/102803_DiabeticfootA.htm
  16. Treatment Guidelines from Medical Letter Vol 2(Issue 19) March 2004.

Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

March 1, 2006