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    Xenical

    Drug - Xenical (orlistat)

    January 2007

    Therapeutic area - Weight loss

    Criteria

    Patients who have hyperlipidemia

    • The use of Xenical may be authorized for the treatment of hyperlipidemias if the recipient has failed on at least ONE drug from EACH of the following categories:
    Category Examples of drugs in the category
    Statins Crestor, Lescol, Lipitor, Mevacor, Pravachol, Zocor
    Bile acid sequestrants cholestyramine (Questran,) colesevelam HCL (WelChol,) colestipol (Colestid)
    Fibric acid derivatives clofibrate (Atromid-S), fenofibrate (Tricor), gemfibrozil (Lopid)
    Niacin Niacor, Niaspan, SloNiacin, others
    Lipotropics exetimibe (Zetia)
    • The provider requesting the PA must provide written documentation confirming the hyperlipidemia diagnosis along with documentation of the past trials of the above-mentioned lipid-lowering agents, including reasons for treatment failures.
    • Initial authorization should be for no more than three months. For positive results, there should be at least a 10% decrease in total cholesterol and LDL cholesterol. If there is a positive response after 3 months, an additional 12 fills can be authorized.
    • Document each drug that the recipient tried and the reason for the failure.
    • If the recipient has a primary insurance that will pay for Xenical, Medical Assistance WILL NOT authorize payment of the copayment unless the recipient meets the criteria.

    Patients who have Type 2 diabetes

    • the patient is at least 12 years old AND
    • is obese (BMI ≥27), with type 2 diabetes AND
    • is receiving dietary advice AND
    • If the patient has had previous positive response* to Xenical, authorization MAY BE granted for up to 12 months OR
    • If the patient has no history of Xenical use, then initial authorization MAY BE granted for up to 3 months. Subsequent authorization will be granted only if the patient has had a positive response, including both weight loss and improvement of diabetic markers.
    • Authorization WILL NOT be granted if a patient has already tried and failed Xenical. A failed trial of Xenical is defined as a reduction in weight of <5% of baseline and no change an increase in HbA1c as compared to pre-therapy levels.

    *A positive response to Xenical is defined as a ≥5% reduction in weight as compared to pre-therapy weight and a reduction in HbA1c ≥0.5% as compared to pre-therapy levels.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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