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

According to the manufacturer, the HMG CoA reductase inhibitors 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:

For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna 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 has failed combination therapy and requires higher dose of HMG CoA Reductase Inhibitor (for highest dosage strength of each drug only) OR
• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
  

Under some plans, including plans that use an open or closed formulary, Altoprev, Caduet, Lescol, Lescol XL, Mevacor, Pravachol, Simcor and Zocor are subject to step-therapy.  Aetna considers these drugs to be medically necessary for those members who meet the step-therapy criteria as specified below:

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

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

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

For Pravachol
A documented trial of one month of the preferred generic equivalent pravastatin (any strength).

For Simcor
A documented trial of one month EACH of one of the following preferred niacin drugs: Niaspan or Niacor AND a preferred statin: lovastatin, pravastatin, simvastatin, Crestor, Lipitor or Vytorin.

For Zocor
A documented trial of one month of the preferred generic equivalent simvastatin (any strength)

If it is medically necessary for a member to be initially treated 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.)

Advicor, Altoprev, Caduet, Lescol, Lescol XL, Mevacor, Pravachol, Simcor and Zocor are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.*  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 Advicor, Altoprev, Caduet, Lescol, Lescol XL, Mevacor, Pravachol, Simcor and Zocor to be medically necessary for those members who meet ANY of the following criteria:

For Lescol and Lescol XL

A. Member has a documented

• Contraindication to Crestor, Lipitor, lovastatin, pravastatin, simvastatin or Vytorin OR
• Intolerance to Crestor, Lipitor , lovastatin, pravastatin, simvastatin or Vytorin OR
• Allergy to Crestor, Lipitor, lovastatin, pravastatin, simvastatin or Vytorin OR
• Failure of an adequate trial of one month of Crestor, Lipitor (at a dose of 40mg/day or higher), lovastatin (at a dose of 20mg or higher), pravastatin,  simvastatin (at a dose of 40mg/day or higher) or Vytorin
   

OR

B. Member is receiving another medication with a potentially clinically significant drug interaction with Crestor, Lipitor, lovastatin, pravastatin, simvastatin or Vytorin

• 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); 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 generic alternative lovastatin OR
• Intolerance to the preferred generic alternative lovastatin OR
• Allergy to the preferred generic alternative lovastatin OR
• Failure of an adequate trial of one month of the preferred generic alternative lovastatin (any strength)

For Advicor

A.   Member has a documented

• Contraindication to Crestor, fenofibrate, gemfibrozil, Lipitor, lovastatin, pravastatin, simvastatin, Tricor or Vytorin OR
• Intolerance to Crestor, fenofibrate, gemfibrozil, Lipitor, lovastatin, pravastatin, simvastatin, Tricor or Vytorin OR
• Allergy to Crestor, fenofibrate, gemfibrozil, Lipitor, lovastatin, pravastatin, simvastatin, Tricor or Vytorin OR
• Failure of an adequate trial of one month of Crestor, fenofibrate, gemfibrozil, Lipitor, lovastatin, pravastatin, simvastatin, Tricor or Vytorin OR
• Member is already receiving lovastatin and niacin ER for antilipidemic therapy (Advicor only )

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 (any strength)

For Simcor

A.    Member has a documented

• Contraindication to one of the preferred niacin drugs: Niaspan or Niacor AND a preferred statin: lovastatin, pravastatin, simvastatin, Crestor, Lipitor or Vytorin OR
• Intolerance to one of the preferred niacin drugs: Niaspan or Niacor AND a preferred statin: lovastatin, pravastatin, simvastatin, Crestor, Lipitor or Vytorin OR
• Allergy to one of the preferred niacin drugs: Niaspan or Niacor AND a preferred statin: lovastatin, pravastatin, simvastatin, Crestor, Lipitor or Vytorin OR
• Failure of an adequate trial of one month EACH of one of the following preferred niacin drugs: Niaspan or Niacor AND a preferred statin: lovastatin, pravastatin, simvastatin, Crestor, Lipitor or Vytorin

For Zocor

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 (any strength)

For Caduet

A.     Member is already receiving amlodipine AND atorvastatin/Lipitor for antihypertensive and
         antilipidemic therapy.
 
OR

              
B.     Member is documented to be currently on Caduet.

OR

C.    Member is receiving amlodipine and has a documented:

• Contraindication to one of the preferred alternatives, Crestor,  simvastatin or Vytorin  OR
• Intolerance to one of the preferred alternatives, Crestor, simvastatin or Vytorin  OR
• Allergy to one of the preferred alternatives, Crestor, simvastatin or Vytorin  OR
• Failure of an adequate trial of one month of one of the preferred alternatives, Crestor, simvastatin (at a dose of 40mg/day or higher) or Vytorin