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Prior Authorization Protocol

CADUETR (amlodipine/atorvastatin)

NATL

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.
    Amlodipine
    • Treatment of hypertension, to lower blood pressure
    • Coronary Artery Disease (CAD)
      • Symptomatic treatment of chronic stable angina
      • Treatment of confirmed or suspected vasospastic angina (Prinzmetal's or Variant Angina)
      • Angiographically documented CAD
        • To reduce the risk for hospitalization for angina and to reduce the risk of coronary revascularization procedure in patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%
    Atorvastatin
    • Prevention of Cardiovascular Disease:
      • Reduce the risk of myocardial infarction, reduce the risk of stroke and reduce the risk for revascularization procedures and angina in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low high-density lipoprotein cholesterol (HDL-C), or a family history of early coronary heart disease
      • Reduce the risk of myocardial infarction and reduce the risk of stroke in patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension
      • Reduce the risk of non-fatal myocardial infarction, reduce the risk of fatal and non-fatal stroke, reduce the risk for revascularization procedures, reduce the risk of hospitalization for congestive heart failure (CHF), and reduce the risk of angina in patients with clinically evident coronary heart disease
    • Hyperlipidemia
      • Heterozygous Familial and Nonfamilial Hypercholesterolemia:
        • As an adjunct to diet to reduce elevated total-cholesterol (C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglyceride (TG) levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb)
      • Elevated Serum TG (triglyceride) levels:
        • As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson type IV)
      • Primary Dysbetalipoproteinemia:
        • Treatment of patients with primary dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet
      • Homozygous Familial Hypercholesterolemia:
        • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable
      • Pediatric Patients:
        • As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
          • LDL-C remains ≥190 mg/dL or
          • LDL-C remains ≥160 mg/dL and:
            • There is a positive family history of premature cardiovascular disease or
            • Two or more other cardiovascular disease (CVD) risk factors are present in the pediatric patients
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of one of the following:
      • Hypertension
      • Chronic stable angina
      • Confirmed or suspected vasospastic angina (Prinzmetal's or Variant Angina)
      • Coronary artery disease documented by angiography and without heart failure or an ejection fraction <40%
    AND
    • Hyperlipidemia or one of the diagnoses for which atorvastatin is FDA approved
    AND
    • Medical justification by physician for not using separate agents: atorvastatin and amlodipine
    AND
    • Failure to achieve National Cholesterol Education Program (NCEP) goals or clinically significant adverse effects to one generic formulary statin (lovastatin, pravastatin, simvastatin, atorvastatin) followed by VytorinR or CrestorR.

  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

  4. General Information:
    • This section intentionally left blank.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    atorvastatin (Lipitor R)

    10-80 mg PO QD

    80 mg daily

    amlodipine (NorvascR)

    2.5-10 mg PO QD

    10 mg daily

    lovastatin (MevacorR )

    10-80 mg PO QD or BID

    80 mg daily

    pravastatin (PravacholR)

    10-40 (80) mg PO QD

    80 mg daily

    simvastatin (ZocorR)*

    5-40 mg PO QD (Coverage of the 80 mg strength requires PA)

    80 mg daily

    VytorinR* (ezetimibe/simvastatin)

    10/10 mg daily - 10/80 mg PO QD (Coverage of the 10/80 mg strength requires PA)

    10/80 mg daily

    CrestorR* (rosuvastatin)

    5 - 40 mg/day PO QD

    40 mg/daily

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Caduet

    Adult:
    2.5/10 mg up to 10/80 mg PO QD
    Pediatric Dosing (age 10 - 17 years):
    2.5/10 mg PO QD up to 5/20 mg PO QD

    Length of Benefit

  7. Product Availability:
    Tablets:
    2.5 mg amlodipine besylate/10 mg atorvastatin calcium (as base)
    2.5 mg amlodipine besylate/20 mg atorvastatin calcium (as base)
    2.5 mg amlodipine besylate/40 mg atorvastatin calcium (as base)
    5 mg amlodipine besylate/10 mg atorvastatin calcium (as base)
    5 mg amlodipine besylate/20 mg atorvastatin calcium (as base)
    5 mg amlodipine besylate/40 mg atorvastatin calcium (as base)
    5 mg amlodipine besylate/80 mg atorvastatin calcium (as base)
    10 mg amlodipine besylate/10 mg atorvastatin calcium (as base)
    10 mg amlodipine besylate/20 mg atorvastatin calcium (as base)
    10 mg amlodipine besylate/40 mg atorvastatin calcium (as base)
    10 mg amlodipine besylate/80 mg atorvastatin calcium (as base)
  8. References:
    1. Caduet [Prescribing Information] New York, NY:Pfizer;March 2015.
    2. Lipitor [Prescribing Information] New York, NY: Pfizer; March 2015.
    3. Norvasc [Prescribing Information] New York, NY: Pfizer; March 2015.
    4. MicromedexR Healthcare Series [Internet database]. Greenwood Village, CO: Thompson Healthcare. Updated periodically. Accessed June 3,2015.
    5. Caduet. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 3, 2015.
    6. Clinical Pharmacology Web Site. Available at http://clinicalpharmacology-ip.com/. Accessed June 3, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.