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Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Antilipidemic Agents - HMG CoA Reductase Inhibitors

Status Drug PR PR-QL PR-AL ST M EX‡
P Advicor®  (lovastatin/niacin ER)   X      
P Lescol XL®  (fluvastatin ER)   X      
P Lescol®  (fluvastatin)   X      
P lovastatin   X      
P pravastatin   X      
P simvastatin   X      
P Crestor®  (rosuvastatin)   X      
P Crestor® 5mg  (rosuvastatin)   X   X X
P Vytorin®  (ezetimibe/simvastatin)   X      
P Vytorin® 10/10mg  (ezetimibe/simvastatin)   X   X X
P Zetia®  (ezetimibe)   X      
FE Altoprev® (was Altocor)  (lovastatin ER)   X   X X
FE Caduet®  (atorvastatin/amlodipine)   X   X X
FE Lipitor®  (atorvastatin)   X   X X
FE Mevacor®  (lovastatin)   X   X X
FE Pravachol®  (pravastatin)   X   X X
FE Zocor®  (simvastatin)   X   X X


Policy:

  1. Precertification Criteria

    2. Under some plans, including plans that use an open or closed formulary, Advicor, Altoprev, Caduet, Crestor, Lescol, Lipitor, lovastatin, Mevacor, Pravachol, pravastatin, simvastatin, Vytorin, Zetia and Zocor are subject to precertification.  If precertification requirements apply Aetna considers Advicor, Altoprev, Caduet, Crestor, Lescol, Lipitor, lovastatin, Mevacor, Pravachol, pravastatin, simvastatin, Vytorin, Zetia and Zocor to be medically necessary for those members who meet the following precertification criteria:

    According to the manufacturer, the HMG CoA reductase inhibitors and Zetia can be dosed up to a maximum daily dose at the interval(s) as  indicated in the table below. A quantity of each drug will be considered medically necessary as indicated in the table below if member fulfills criteria A or B above:

    Drug Maximum Daily Dose/ Dosing Interval Dosage Strength Quantity Limits
    Advicor 2000/40 mg/ once or twice daily 500/20 mg, 750/20 mg, 1000/20 mg 1000/40mg Up to 60 tablets in 30 days
    Altoprev (was Altocor) 60 mg/ once daily 10 mg, 20 mg Up to 30 tablets in 30 days
    Altoprev (was Altocor) 60 mg/ once daily 40 mg Up to 30 tablets in 30 days
    Altoprev (was Altocor) 60 mg/ once daily 60 mg Up to 30 tablets in 30 days
    Caduet 10/80 mg/ once daily 2.5/10, 2.5/20, 2.5/40, 5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, 10/80 Up to 30 tablets in 30 days
    Crestor 40 mg/ once daily 5, 10, 20 mg Up to 30 tablets in 30 days
    Crestor 40 mg/ once daily 40 mg Up to 30 tablets in 30 days
    Lescol 80 mg/ twice daily 20 mg, 40 mg Up to 60 tablets in 30 days
    Lescol XL 80 mg/ once daily 80 mg Up to 30 tablets in 30 days
    Lipitor 80 mg/ once daily 10, 20, 40 mg Up to 30 tablets in 30 days
    Lipitor 80 mg/ once daily 80 mg Up to 30 tablets in 30 days
    lovastatin 80 mg/ twice daily 10, 20 mg Up to 60 tablets in 30 days
    lovastatin 80 mg/ twice daily 40 mg Up to 60 tablets in 30 days
    Mevacor 80 mg/ twice daily 10, 20 mg Up to 60 tablets in 30 days
    Mevacor 80 mg/ twice daily 40 mg Up to 60 tablets in 30 days
    pravastatin Pravachol 80 mg/ once daily 10, 20 mg Up to 30 tablets in 30 days
    pravastatin Pravachol 80 mg/ once daily 40 mg Up to 60 tablets in 30 days
    pravastatin Pravachol 80 mg/ once daily 80 mg Up to 30 tablets in 30 days
    Vytorin 10mg/80mg/ once daily 10-10, 10-20, 10-40, and 10-80 mg Up to 30 tablets in 30 days
    Zetia 10 mg/ once daily 10 mg Up to 30 tablets in 30 days
    simvastatin Zocor 80mg/ once daily 5, 10, 20, 40 mg Up to 30 tablets in 30 days
    simvastatin Zocor 80 mg/ once daily 80 mg Up to 30 tablets in 30 days


    For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of HMG CoA reductase inhibitors will be considered medically necessary for those members who meet ANY of the following criteria:

    • Member requires a dose including half tablets OR
    • Member's dose is being titrated by physician (3-month limit) OR
    • Member has had intolerance to drug administered as a single daily dose OR
    • Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.


  2. Step Therapy Criteria

    3. Under some plans, including plans that use an open or closed formulary, Altoprev, Caduet, Crestor 5mg, Lipitor, Mevacor, Pravachol, Vytorin 10/10 mg and Zocor are subject to step-therapy.  Aetna considers Altoprev, Caduet, Crestor 5mg, Lipitor, Mevacor, Pravachol, Vytorin 10/10 mg and Zocor to be medically necessary for those members who meet step-therapy criteria as specified below:

    For Lipitor (40mg or higher)
    A documented trial of one month EACH of the preferred Vytorin at a dose >10/10 mg/day AND Crestor at a dose of 10 mg/day or higher.

    For Crestor 5mg
    A documented trial of one month of the preferred generic alternative, simvastatin at a dose of 40 mg/day or higher

    For Altoprev, Mevacor
    A documented trial of one month of the preferred generic alternative lovastatin (any strength)

    For Lipitor (10mg, 20mg)
    A. A documented trial of one month of Lescol/Lescol XL (at a dose of 40mg/day or higher) OR lovastatin (at a dose of 20mg/day or higher) OR Advicor (any dose), OR pravastatin (at a dose of 40 mg/day or higher), OR simvastatin (at a dose of 40mg/day or higher)
    AND
    B. Vytorin AND/OR Crestor - alternatives on the Preferred Drug List.

    Note: Failure of ONE agent from A AND ONE agent from B
              OR
              Failure of TWO agents from B meets criteria.

    For Caduet
    A documented trial of one month of concurrent use of  both Norvasc/amlodipine AND one of the following: Lipitor (any dose) OR Vytorin (any dose) OR Crestor (at a dose of 10 mg/day or higher) OR Zocor/ simvastatin (at a dose of 40mg/day or higher); Vytorin, Crestor and simvastatin are alternatives on the Preferred Drug List.

    For Pravachol

    A documented trial of one month of the preferred generic equivalent pravastatin on the Preferred Drug List.

    For Vytorin 10/10 mg
    A documented trial of one month of the preferred generic alternative, simvastatin at a dose of 40 mg day or higher.

    For Zocor
    A documented trial of one month of the preferred generic equivalent simvastatin on the Preferred Drug List


    If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below.)

  3. Medical Exception Criteria

    4.  

    Altoprev, Caduet, Lipitor, Mevacor, Pravachol, and Zocor are currently listed on the Aetna Formulary Exclusions List.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Altoprev, Caduet, Lipitor, Mevacor, Pravachol and to be medically necessary for those members who meet the criteria as specified below:

     

    Crestor 5mg and Vytorin 10/10mg are currently listed on the Aetna Step Therapy List.* If it is medically necessary for a member to be treated initially with Crestor 5mg or Vytorin 10/10mg, Aetna considers Crestor 5mg or Vytorin 10/10mg  to be medically necessary for those members who meet the criteria specified below:

     

    For Lipitor (40mg or higher) – A OR B OR C

     

                                                                     A.            Member has a documented:

    §         Contraindication to the preferred alternatives Crestor AND Vytorin or one of it’s components OR

    §         Intolerance to the preferred alternatives Crestor AND Vytorin or one of it’s components OR

    §         Allergy to the preferred alternatives, Crestor AND Vytorin or one of it’s components OR

    §         Failure of an adequate trial of one month EACH of the preferred alternatives, Crestor AND Vytorin  

                                                                     B.            Member is receiving another medication with a potentially clinically significant drug interaction with Crestor: cyclosporine (Neoral, Sandimmune), warfarin (Coumadin), and gemfibrozil (Lopid)

                                                               

    OR

                                                                     C.            Member receiving another medication with a potentially clinically significant drug interaction with Vytorin or Zocor or simvastatin

     

    Potentially interacting drugs include, but are not limited to: gemfibrozil (Lopid), fenofibrate (Tricor), niacin (dose > 1 gram/day); verapamil; amiodarone (Cordarone); cyclosporine (Neoral, Sandimmune); itraconazole (Sporanox); ketoconazole (Nizoral); danazol; erythromycin; clarithromycin (Biaxin); telithromycin (Ketek); nefazodone (Serzone); warfarin (Coumadin); ranolazine (Ranexa); HIV reverse transcriptor inhibitors: such as Zerit (stavudine or d4T) and HIV protease inhibitors: such as amprenavir (Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Fortovase, Invirase); tipranavir (Aptivus).

     

    For Altoprev and Mevacor –

     

    A.         Member has a documented:

    §         Contraindication to the preferred alternative lovastatin OR

    §         Intolerance to the preferred alternative lovastatin OR

    §         Allergy to the preferred alternative lovastatin OR

    §         Failure of an adequate trial of one month of the preferred alternative, lovastatin (any strength)

     

    For Lipitor (10mg, 20mg) – A OR B


    A.    Member has a documented:

    §        Contraindication to TWO* preferred alternatives;  [lovastatin or simvastatin or pravastatin or Advicor or Lescol/Lescol XL or Zetia] AND/OR  Vytorin AND/OR Crestor OR

    §         Intolerance to TWO*  preferred alternatives: [lovastatin or simvastatin or pravastatin or Advicor or Lescol/Lescol XL or Zetia] AND/OR  Vytorin AND/OR Crestor OR

    §         Allergy to TWO* preferred alternatives [lovastatin or simvastatin or pravastatin or Advicor or Lescol/Lescol XL or Zetia] AND/OR  Vytorin AND/OR Crestor OR

    §         A documented failure of one month trial of TWO* (preferred alternatives ;[Lescol/Lescol XL (at a dose of 40 mg/day or higher) OR lovastatin (at a dose of 20 mg/day or higher) OR Advicor (any dose), OR pravastatin (at a dose of 40 mg/day or higher), OR simvastatin (at a dose of 40 mg/day or higher) or Zetia]
    AND/OR Vytorin AND/OR Crestor

     

    * = one of these agents [lovastatin or simvastatin or pravastatin or Advicor or  Lescol/Lescol XL or Zetia]  AND one of these agents:

        Vytorin or Crestor

    OR

    Both of these agents:  Vytorin AND Crestor          

     

                   OR

    A.     Member is receiving another medication with a potentially clinically significant drug interaction with simvastatin - Lipitor (10mg, 20mg) ONLY

    Potentially interacting drugs include, but are not limited to: gemfibrozil (Lopid), fenofibrate (Tricor), niacin (dose > 1 gram/day); verapamil; amiodarone (Cordarone); cyclosporine (Neoral, Sandimmune); itraconazole (Sporanox); ketoconazole (Nizoral); danazol; erythromycin; clarithromycin (Biaxin); telithromycin (Ketek); nefazodone (Serzone); warfarin (Coumadin); ranolazine (Ranexa); HIV reverse transcriptor inhibitors: such as Zerit (stavudine or d4T) and HIV protease inhibitors: such as amprenavir (Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Fortovase, Invirase); tipranavir (Aptivus).

     

    For Caduet – A, B, or C

     

    A.     Member is documented to be receiving both amlodipine (Norvasc) AND atorvastatin (Lipitor).

    OR

    B.     Member is documented to be currently on Caduet.

     

         OR

     

    C.     Member is receiving amlodipine (Norvasc) and has a documented:

    §         Contraindication to one of the alternatives, Vytorin, Crestor, or Zocor/simvastatin OR

    §         Intolerance to one of the alternatives, Vytorin, Crestor, or Zocor/simvastatin OR

    §         Allergy to one of the alternatives, Vytorin, Crestor or Zocor/simvastatin OR

    §         Failure of an adequate trial of one month of one of the  alternatives, Crestor (at a dose of 10 mg/day or higher), Vytorin or Zocor/simvastatin (at a daily dose of 40 mg or higher); Vytorin, Crestor and simvastatin are alternatives on the Preferred Drug List

     

    For Pravachol

    A.          Member has a documented:

    §         Contraindication to the preferred generic equivalent, pravastatin OR

    §         Intolerance to the preferred generic equivalent, pravastatin OR

    §         Allergy to the preferred generic equivalent, pravastatin OR

    §         Failure of an adequate trial of one month of the preferred generic equivalent, pravastatin

     

    For Zocor –A only

    A.     Member has a documented:

    §         Contraindication to the preferred generic equivalent, simvastatin OR

    §         Intolerance to the preferred generic equivalent, simvastatin OR

    §         Allergy to the preferred generic equivalent, simvastatin OR

    §         Failure of an adequate trial of one month of the preferred generic equivalent, simvastatin

    For Crestor 5mg and Vytorin 10/10 mg – only (A or B)

    A.         Member has a documented:

    §         Contraindication to the preferred generic alternative - simvastatin OR

    §         Intolerance to the preferred generic alternative – simvastatin
     OR

    §         Allergy to a preferred generic alternative, – simvastatin
    OR

    §         Failure of an adequate trial of one month ofthe preferred generic alternative, simvastatin at a dose of 40 mg/day or higher
    OR

    §         Member is of  Asian descent – Applies only to Crestor

    OR

    B.      Member is receiving another medication with a potentially clinically  significant drug interaction with simvastatin –

     

    Potentially interacting drugs include, but are not limited to: gemfibrozil (Lopid), fenofibrate (Tricor), niacin (dose > 1 gram/day); verapamil; amiodarone (Cordarone); cyclosporine (Neoral, Sandimmune); itraconazole (Sporanox); ketoconazole (Nizoral); danazol; erythromycin; clarithromycin (Biaxin); telithromycin (Ketek); nefazodone (Serzone); warfarin (Coumadin); ranolazine (Ranexa); HIV reverse transcriptor inhibitors: such as Zerit (stavudine or d4T) and HIV protease inhibitors: such as amprenavir (Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Fortovase, Invirase); tipranavir (Aptivus).


Place of Service:

Outpatient

The above policy is based on the following references:
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  2. AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
  3. DRUGDEX® System: Klasco RK (Ed):DRUGDEX® System. Online edition. Thomson Micromedex, Greenwood Village, CO.
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