Policy Applies to

• Healthcare Reform plans with an Essential formulary

 

Drugs Addressed in this Policy

• fluvastatin
• rosuvastatin
• Livalo (pitavastatin)

 

FDA-Approved Indications

·         fluvastatin

o    Coronary arteriosclerosis and prophylaxis

o    Primary hypercholesterolemia, Heterozygous familial and non-familial

o    Mixed hyperlipidemia

o    Familial hypercholesterolemia, heterozygous in adolescents

·         Rosuvastatin

o    Disorder of cardiovascular system, primary; prophylaxis

o    Familial hypercholesterolemia-homozygous

o    Familial type 3 hyperlipoproteinemia

o    Generalized atherosclerosis

o    Hyperlipidemia, primary

o    Hypertriglyceridemia

o    Mixed hyperlipidemia

·         Livalo (pitavastatin)

o    hyperlipidemia

 

 

Background

·         Fluvastatin, rosuvastatin and pitavastatin are inhibitors of hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase. HMG-CoA reductase is the rate-limiting hepatic enzyme responsible for converting HMG-CoA to mevalonate, a precursor of sterols including cholesterol. Inhibition of HMG-CoA reductase reduces cholesterol levels in hepatic cells. This, in turn, results in upregulation of LDL-receptors and increased hepatic uptake of LDL-cholesterol from the circulation.

·         This policy defines the criteria under which coverage of a non-preferred statin product will be considered.

 

Preferred generic statins:

o    atorvastatin

o    lovastatin

o    pravastatin

o    simvastatin

 

Low-Intensity Statin Therapy	Moderate-Intensity Statin Therapy	High-Intensity Statin Therapy
Daily dose lowers LDL-C by < 30% on average	Daily dose lowers LDL-C by 30% to 50%, on average	Daily dose lowers LDL-C by ≥ 50%, on average
·      Simvastatin 10 mg ·      Pravastatin 10-20 mg ·      Lovastatin 20 mg ·      Fluvastatin 20-40 mg ·      Pitavastatin (Livalo) 1 mg	·      Atorvastatin 10-20 mg ·      Rosuvastatin (Crestor) 5-10 mg ·      Simvastatin 20-40 mg ·      Pravastatin 40-80 mg ·      Lovastatin 40 mg ·      Fluvastatin XL (Lescol XL) 80 mg ·      Fluvastatin 40 mg twice daily ·      Pitavastatin (Livalo) 2-4 mg	·      Atorvastatin 40-80 mg ·      Rosuvastatin (Crestor) 20-40 mg

 

 

Approval Criteria: 

 

I.      Fluvastatin, rosuvastatin 5-10 mg or pitavastatin (Livalo)

When a benefit, coverage may be approved when all of the following criteria are met (1 & 2):

1.     The medication is being prescribed for an FDA-approved indication AND

2.     The member has tried and failed at least 3 preferred generic statin alternatives (i.e.; atorvastatin, lovastatin, pravastatin, simvastatin).

 

II.    Rosuvastatin 20-40 mg

When a benefit, coverage for rosuvastatin 20-40 mg may be approved when all of the following criteria are met (1 & 2):

1.     The medication is being prescribed for an FDA-approved indication AND

2.     The member has tried and failed the preferred high-intensity generic statin alternative atorvastatin.

 

·         Coverage of fluvastatin, rosuvastatin or pitavastatin for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

·         For HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.

 

Automatic Approval Criteria:

Members who meet the criteria as outlined below will receive automatic authorization at the pharmacy point of service without documentation of additional information. Claims will automatically adjudicate on-line, with no prior authorization required.

 

I.      Fluvastatin, rosuvastatin 5-10 mg or pitavastatin (Livalo)

1.     The member at least one paid claim for 3 different preferred generic statins within the past 720 days.

 

II.    Rosuvastatin 20-40 mg

1.     The member has at least one paid claim for atorvastatin within the past 720 days.

 

 

Authorization Duration

 

• HCR Plans: If approved, up to a lifetime authorization may be granted

 

 

References

1.     DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2015. Accessed July 14, 2016.

2.     Crestor [prescribing information]. Wilmington, DE: AstraZeneca Pharmacetuticals; 2016.

3.     Lescol [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals; 2012.

4.     Livalo [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals and Lilly USA; 2012.

5.  Stone, N. J., Robinson, J., Lichtenstein, A. H., et al. 2013 ACC/AHA Guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. Circulation 2013. Retrieved from: http://circ.ahajournals.org.