Humana Says Amarin's (AMRN) Vascepa Will Require Prior Authorization for Coverage

December 28, 2012 11:02 AM EST
Amarin (Nasdaq: AMRN) is lower on the session following an update from Humana (NYSE: HUM) on its coverage determination for Vascepa

The following is a summary of the determination:

All reasonable efforts have been made to ensure consideration of medically accepted indications in this policy. Medically accepted indications are defined by CMS as those uses of a covered Part D drug that are approved under the federal Food, Drug and Cosmetic Act, or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in section 1927(g)(1)(B)(i) of the Act. These compendia guide review of off-label and off-evidence prescribing and are subject to minimum evidence standards for each compendium. Currently, this review includes the following references when applicable and may be subject to change per CMS:
  • American Hospital Formulary Service (AHFS) Compendium
  • Thomson Micromedex/DrugDex (not Drug Points) Compendium
  • National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium
  • Elsevier Gold Standardfs Clinical Pharmacology Compendium

Vascepa (icosapent ethyl) will require prior authorization. This agent may be considered medically necessary when the following criteria are met:

Severe hypertriglyceridemia
  • The member must be utilizing Vascepa (icosapent ethyl) for treatment of severe hypertriglyceridemia defined as TG > 500 mg/dL
  • The member must have documentation of previous treatment, intolerance, or contraindication to Lovaza and one of the following triglyceride-lowering drugs:
    * Fibrate
    * Nicotinic acid

Vascepa (icosapent ethyl) will be approved in plan year durations or as determined through clinical review.

The quantity limit for all strengths Vascepa (icosapent ethyl) 120 capsules per 30 days.

Humana also made the following note on coverage limitations:

"Vascepa (icosapent ethyl) therapy is not considered medically necessary for members with the following concomitant conditions:
  • Experimental/investigational use – Indications not supported by CMS recognized compendia or acceptable peer reviewed literature

Amarin is down about 0.4 percent today.

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