Clinical Criteria

Maryland Medicaid Pharmacy Program

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Clinical Criteria

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Clinical criteria have been established for some of the medications on the Preferred Drug List as well as the Non-Preferred List to insure that they are used in an efficacious, cost effective and safe manner.  Dose optimization should be adhered to when applicable.

 

 

Cymbalta®

 

  • No prior authorization required if a recipient has a diagnosis of diabetes, or a history of receiving hypoglycemic agents within the past 90 days.

  • Recipients currently receiving Cymbalta® for any diagnosis are grandfathered and may continue on Cymbalta®

  • Clinical prior authorization is required unless a recipient has a diagnosis of major depressive disorder or general anxiety disorder AND has had an 8-week trial of an SSRI (e.g. citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, Lexapro®, Paxil® CR, Pexeva®, etc.) in the past 90 days.

  • Quantities for all strengths are limited to 68 in a 34-day period.

To ensure patient safety, a 2-week trial of 60mg per day dose of Cymbalta® is required before a 120mg per day regimen will be authorized.  (According to the labeling, there is no evidence that doses greater that 60 mg/day confer any additional benefits.  Also, the increased dosage may pose an increased risk of hepatotoxicity.  The maximum FDA approved daily dose is 60mg.)

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Strattera®

Strattera® is a Tier Two product on the Preferred Drug List for recipients age 17 and under. If there is no history of use of Strattera® or a Tier One agent in the recipient’s most recent 90-day drug history, Strattera® will require a preauthorization. However, Strattera® claims may be adjudicated without a preauthorization based upon the following exceptions: 

  1. Strattera® is considered a mental health drug, and therefore, grandfathered for all recipients who are currently receiving it. 

  2. If a claim for Strattera® is submitted and the recipient (age 17 and under) has had a history of receiving a Tier One Agent within the previous 90-day period, the claim will adjudicate without a preauthorization. 

  3. If the recipient is age 18 and over, the claim will adjudicate without a preauthorization.

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Tier 2 Antipsychotics

 

Zyprexa®, Zyprexa® IM

 

Zyprexa® and ZyprexaÃ’ IM has been designated a Tier Two antipsychotic agent on the Preferred Drug List, due to the manufacturer's warnings about possible harmful metabolic side-effects.  If there is no history of use of ZyprexaÃ’ or ZyprexaÃ’ IM in the recipient's most recent 120-day history OR if there is no history of at least 42 days use of a Tier One agent in the recipient's most recent 120-day drug history (looking only at claims paid by Maryland Medical Assistance), Zyprexa®   and Zyprexa® IM will require prior authorization (PA).  At the time of PA, the call center will ascertain from the prescriber the indication for Zyprexa's® use, including off-label indications. 

Abilify®

Abilify® has been designated a Tier Two antipsychotic agent on the Preferred Drug List.   If there is no history of use of Abilify®  in the recipient’s most recent 120-day history OR if there is no history of at least 42 days use of a Tier One agent in the recipient's most recent 120-day drug history (looking only at claims paid by Maryland Medical Assistance), Abilify® will require PA.  At the time of PA, the call center will ascertain from the prescriber the indication for Abilify® use, including off-label indications.   

  • The following antipsychotic agents are Tier One drugs:

    • chlorpromazine

    • clozapine (Clozaril®)

    • fluphenazine

    • fluphenazine decanoate injection

    • haloperidol (Haldol®)

    • haloperidol decanoate injection

    • perphenazine

    • perphenazine/amitriptyline

    • risperidone

    • thioridazine (Mellaril®)

    • thiothixene (Navane®)

    • trifluoperazine (Stelazine®)

    • Fanapt®

    • Geodon®

    • Geodon IM®

    • Moban®

    • Orap®

    • Risperdal Consta®

    • Seroquel®

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Lunesta®
  • Lunesta® is a non-preferred drug. However, no prior authorization will be required if a recipient has a history of at least 14 days of a preferred sedative hypnotic drug during the preceding 30 days and there has been an interval of at least 10 days between the Date of Service of the claim for the preferred agent and the Date of Service of the new Lunesta®. Refer to Page 8 of the Preferred Drug List for "Preferred" options at: http://www.providersynergies.com/services/documents/MDM_PDL.pdf
     

  • Clinical prior authorization is required if recipient doesn't meet the clinical criteria stated above.
     

  • Recipients currently receiving Lunesta® will not be required to meet the above clinical criteria as this class of drugs is grandfathered.
     

  • Quantities for all strengths are limited to one per day for up to a 34-day supply.

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