PA applies to new starts only

Kisqali, Kisqali Femara, and Verzenio 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 agent

OR

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

AND

    2. ONE of the following:

        A. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days

OR

        B. The prescriber states the patient is currently being treated with the requested agent

OR

        C. ALL of the following:

                i. Genetic testing has been completed, if required, for therapy with the requested agent and results indicate the requested agent is appropriate

AND

                ii. The patient does NOT have any FDA labeled contraindication(s) to the requested agent

AND

                iii. ONE of the following:

                    a. The patient has tried appropriate FDA-labeled or compendiasupported therapy that are indicated in NCCN guidelines as first-line therapy

OR

                    b. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to the first-line therapy

AND

                iv. The patient does NOT have any FDA labeled limitation(s) of use that is not otherwise supported in NCCN guidelines

AND

                v. ONE of the following:

                    a. The patient’s medication history indicates use of Ibrance for the requested indication (if applicable)

OR

                    b. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to Ibrance

OR

                    c. CMS approved compendia do not support the use of Ibrance for the requested indication

OR

                    d. The prescriber has provided information in support of use of Kisqali, Kisqali/Femara, or Verzenio over Ibrance for the requested indication

AND

    3. ONE of the following:

        A. The requested quantity (dose) is NOT greater than the program quantity limit

OR

        B. ALL of the following:

            i. The requested quantity (dose) is greater than the program quantity limit

AND

            ii. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose

AND

            iii. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

        C. ALL of the following:

            i. The requested quantity (dose) is greater than the program quantity limit

AND

            ii. The requested quantity (dose) is greater than the maximum FDA labeled dose

AND

            iii. The prescriber has submitted documentation in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

FDA Approved Genetic Tests

FDA Companion Diagnostics