The following medications are included in this program: Asceniv, Bivigam, Cutaquig, Cuvitru, Flebogamma, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Hizentra, HyQvia, Octagam, Panzyga, Privigen, and Xembify

Initial Evaluation

The requested medication will be approved when ALL of the following are met:

    1. ONE of the following:

        A. The patient has an FDA labeled indication for the requested medication

OR

        B. The patient has an indication that is supported in CMS approved compendia for the requested medication

AND

    2. The patient does NOT have any FDA labeled contraindications to the requested medication

AND

    3. The requested dose is within the FDA labeled or CMS approved compendia dosing for the requested indication

Length of Approval: up to 12 months

Renewal Evaluation

The requested medication will be approved when ALL of the following are met:

    1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria

AND

    2. ONE of the following:

        A. The patient has an FDA labeled indication for the requested medication

OR

        B. The patient has an indication that is supported in CMS approved compendia for the requested medication

AND

    3. The patient has had clinical benefit with the requested medication

AND

    4. The patient does NOT have any FDA labeled contraindications to the requested medication

AND

    5. The requested dose is within the FDA labeled or CMS approved compendia dosing for the requested indication

Length of Approval: 12 months

Notes:

• These criteria apply to immune globulin medications that are not administered in the home.
• Length of approval may be shorter due to provider network participation status.
• Coverage of one Medicare Part B medication could equate to multiple medication authorizations when they share the same Medicare Part B criteria.
• LCD/NCD criteria review completed, if applicable, in addition to the Plan’s Medicare Part B criteria.