Table 13: Lipid Lowering Agents

A  B   C   D   E   F   G   H I   J K   L   M   N   O   P   Q   R   S   T   U   V   W   X   Y   Z

Drug Category: Cardiovascular

Medication Class/Individual Agent: Lipid-Lowering Agent

I. Prior Authorization Requirements

# This is a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.

* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization

^$   This value represents the average monthly cost of the most commonly prescribed quantities as of 7/2009. Where applicable, cost represents that of an “A”-rated generic equivalent (#).

¹  All statins are subject to a quantity limit of 30 units/month.

II. Therapeutic Uses

• Fibric Acids
• Ezetimide (Zetia)
• Statins
• Miscellaneous Products - Lovaza

III. Evaluation Criteria for Approval

• Fibric Acids
• Ezetimide (Zetia)
• Statins
• Miscellaneous Products - Lovaza

 II. Therapeutic Uses

Fibric Acids

FDA-approved, for example:

• hypertriglyceridemia
• hypercholesterolemia
• mixed dyslipidemias

Note: The above list may not include all FDA-approved indications.

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Ezetimide (Zetia)

FDA- approved, for example:

• primary hyperlipidemia (as monotherapy or in combination with a statin)
• mixed hyperlipidemia (in combination with fenofibrate)
• homozygous sitosterolemia
• homozygous familial hypercholesterolemia

Note: The above list may not include all FDA-approved indications.

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Statins

FDA-approved, for example:

• hypertriglyceridemia
• mixed hyperlipidemia
• primary hyperlipidemia
• primary and secondary progression of coronary heart disease

Note: The above list may not include all FDA-approved indications.

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Miscellaneous Products - Lovaza

FDA-approved, for example:

• hypertriglyceridemia

Note: The above list may not include all FDA-approved indications.

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III. Evaluation Criteria for Approval

Fibric Acids

• All prior-authorization requests must include clinical diagnosis, drug name, dose and frequency.
• Documentation of the following is required:
  • failure of an adequate trial of a therapeutically equivalent formulation; and
  • compelling rationale (medical necessity) why brand-name fenofibrate would offer a therapeutic advantage over the therapeutically equivalent fenofibrate formulations.

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Ezetimide (Zetia)

Documentation of all of the following is required:

• clinical diagnosis, drug name, dose, and frequency;
• a daily dose of not more than 10 mg/day; and
• an inadequate response to (> 40 mg/day simvastatin or an equipotent dose of another statin) for a therapeutically appropriate time period or an adverse reaction or contraindication to a statin.

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Statins

• All prior-authorization requests must include clinical diagnosis, drug name, dose, and frequency.
• Additional criteria may apply depending upon requested medication (see four subcategories below). 
        (1) All agents if  > 30 units/month
  • Documentation of rationale why dose consolidation is not possible is required.
    (2) Altoprev, Crestor, Lescol, Lescol XL, Lipitor, and Vytorin
  • Documentation of one of the following is required:
    • an inadequate response to (> 40 mg/day simvastatin) for a therapeutically appropriate time period; or
    • adverse reaction (not class specific), or contraindication to simvastatin (see special considerations below). 
    (3) Special considerations for organ transplant/HIV
  • Requests for nonreference statins will be considered for members receiving medications that may result in drug interactions.
    (4) Combination products (Advicor, Caduet, Simcor)
  • Documentation of one of the following is required:
    • treatment with stable doses of the separate agents for a minimum of three months; or
    • stabilized for at least three months on the combination product.

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Miscellaneous Products - Lovaza

• All prior-authorization requests must include clinical diagnosis, drug name, dose, and frequency.
• Documentation of an adverse reaction or inadequate response to niacin and a fibric acid derivative (i.e., fenofibrate or gemfibrozil) is required.

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Original Effective Date: 10/2002                                                     Last Revised Date: 02/2010

Last updated 02/04/2010