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Medication Policy Manual
Policy No: dru336
Topic: High-Cost Lipid-Modifying Medications:
- atorvastatin (Lipitor®)
- fluvastatin (generic, Lescol®)
- fluvastatin ER (Lescol XL®);
- lovastatin ER (Altoprev®);
- omega-3 acids (Epanova®, Lovaza®,
Omtryg®, Vascepa®, generics)
- pitavastatin (Livalo®);
- simvastatin/ezetimibe (Vytorin®)
- simvastatin/niacin (Simcor®)
Date of Origin: March 14, 2014
Committee Approval Date: September 9, 2016
Next Review Date: July 2017
Effective Date: October 1, 2016
IMPORTANT REMINDER
This Medication Policy has been developed through consideration of medical necessity, generally
accepted standards of medical practice, and review of medical literature and government approval
status.
Benefit determinations should be based in all cases on the applicable contract language. To the
extent there are any conflicts between these guidelines and the contract language, the contract
language will control.
The purpose of medication policy is to provide a guide to coverage. Medical Policy is not intended
to dictate to providers how to practice medicine. Providers are expected to exercise their medical
judgment in providing the most appropriate care.
Description
Fluvastatin ER (Lescol XL), fluvastatin (Lescol), lovastatin ER (Altoprev), pitavastatin (Livalo),
and simvastatin/ezetimibe (Vytorin) are oral medications used to treat high LDL cholesterol.
This policy does not apply to rosuvastatin (Crestor®), or ezetimibe (Zetia®). This policy also
addresses certain high cost lipid modifying agents in which comparable, yet lower cost, generic
and/or over-the-counter (OTC) products are available.
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Policy/Criteria
I.
Most contracts require prior authorization approval certain high cost lipid modifying
agents prior to coverage. High cost lipid modifying agents may be considered medically
necessary when criterion A or B below is met.
A.
Fluvastatin (Lescol, Fluvastatin ER (Lescol XL), lovastatin ER (Altoprev),
pitavastatin (Livalo), and simvastatin/ezetimibe (Vytorin) may be considered
medically necessary when at least two generic statin products have been
ineffective after at least two months of treatment, have been not tolerated, or are
not indicated.
OR
B.
Lipid modifying agents included in Table 1 may be considered medically
necessary when there is an intolerance or contraindication to an inactive
ingredient in all specified alternative(s) listed in Table 1.
Table 1. High cost lipid modifying agents with alternatives
II.
High Cost Drug
Alternative(s)
Epanova
omega-3 acids (OTC)
Lipitor
atorvastatin
Lovaza
omega-3 acids (OTC)
Omtryg
omega-3 acids (OTC)
omega-3 acids (generic)
omega-3 acids (OTC)
Simcor
niacin (OTC or Rx) + simvastatin
Vascepa
omega-3 acids (OTC)
Administration, Quantity Limitations, and Authorization Period
A.
OmedaRx considers the medications in this policy to be self-administered.
B.
Authorization may be reviewed at least annually to confirm that current medical
necessity criteria are met and that the medication is effective.
Position Statement
-
Statins have been proven to reduce cardiovascular events and mortality.
-
Other medication classes, including omega-3 acids, may improve cholesterol levels, but
there is insufficient evidence that they improve clinically meaningful outcomes.
-
There is no evidence that branded medications, statin or non-statin, are safer or more
effective than generic treatment options at optimized doses. Generics are available for
statins, fibrates, and omega-3-acids.
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-
There are many generic statin options available, including those with high-intensity
LDL-lowering ability (see Appendix 1) and provide the best value. Fluvastatin ER
(Lescol XL), lovastatin ER (Altoprev), pitavastatin (Livalo), and simvastatin/ezetimibe
(Vytorin) have not been proven to be safer or more effective than other equipotent-dosed
statins, but are more costly.
AB-rated generic products are lower cost and considered to be pharmaceutical equivalents of the
branded products, with the same clinical effect and safety profile when administered to patients
under the conditions specified in the package labelling. Patients who are adherent, yet do not
respond to equivalent doses of the generic/OTC product(s) are not likely to respond to the
branded product. Clinical Efficacy
-
Several outcomes trials have demonstrated that statins reduce the risks of
cardiovascular and cerebrovascular events. [1-4]
-
Reduction in cardiovascular and cerebrovascular risk is not unique to any specific statin
and has been demonstrated with many of the available statins in a variety of patient
populations, such as in patients with coronary heart disease, high cholesterol levels,
normal cholesterol levels, hypertension, diabetes and previous stroke. [1-4]
-
Several primary or secondary prevention trials with simvastatin, pravastatin,
lovastatin, and atorvastatin consistently demonstrate that reductions in cardiovascular
events correlate with LDL-C reduction. [1-4]
-
When given at equipotent doses, statins provide similar reductions in LDL-C. [3]
-
The 2013 American College of Cardiology and American Heart Association (ACC/AHA)
treatment guidelines recommend choosing a specific statin based on the magnitude of
LDL-lowering desired (e.g. low-, moderate-, or high-intensity). [5]
Safety [7]
-
All marketed statin-containing medications have safety records that are consistent for
the statin class.
-
Rhabdomyolysis is a rare side-effect of all statins (0.1%).
-
∗
Myopathy (muscle weakness) and rhabdomyolysis are commonly linked to
additional factors that may increase statin serum levels, such as impaired
hepatic and renal function, hypothyroidism, or concomitant use of certain
medications, such as fibrates or azole antifungals.
∗
Based on clinical trial safety data and world-wide post-marketing adverse
reports, the incidence of myopathy and rhabdomyolysis among available statins
is similar.
Hepatotoxicity occurs rarely (less than 1%) with statins.
∗
Statins are contraindicated in patients with active liver disease or unexplained
persistent elevations of serum transaminases.
∗
At equipotent doses, there are no differences in rates of clinically relevant
elevations in LFTs among statins.
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∗
Prescribing information indicates initial and routine liver function tests (LFTs)
(as clinically indicated) are necessary with all statins.
-
Increases in HbA1c and fasting serum glucose levels have been reported with all statins.
-
The FDA issued a statement in June 2011 to recommend limiting the use of simvastatin
80 mg to those patients who have been taking this dose for 12 months without evidence
of muscle injury. Labeling was also updated to reflect new contraindications and dose
limitations for use with certain medications (see Appendix 3).[8]
-
Risks for certain drug-drug interactions are inherent with all statins (see Appendix 3).
Half Tablet Program
-
Atorvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin are eligible
medications under the OmedaRx Half-Tablet Program.
∗
As part of this program, when a higher strength tablet of these statins can be
split and used for the prescribed dose, the member pays only one copayment for a
two month supply of medication.
∗
More information about the OmedaRx Half-Tablet Program can be found at
http://www.omedarx.com/node/43.
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Appendix 1: Statin Comparison Chart [5, 7]
% LDL- C
Lowering
Preferred/
Formulary
fluvastatin
20 mg, 40 mg
√
lovastatin
10 mg, 20 mg
lovastatin ER (Altoprev®)
20 mg
pitavastatin (Livalo®)
1 mg
√
pravastatin
10 mg, 20 mg
√
simvastatin
5 mg, 10 mg
√
atorvastatin
10 mg, 20 mg
fluvastatin ER (Lescol XL®)
80 mg
lovastatin
40 mg
lovastatin ER (Altoprev®)
40 mg, 60 mg
pitavastatin (Livalo®)
2 mg, 4 mg
√
pravastatin
40 mg, 80 mg
√
rosuvastatin
5 mg, 10 mg
simvastatin
20 mg, 40 mg
√
simvastatin/ ezetimibe (Vytorin®)
10 mg/ 10 mg
√
atorvastatin
40 mg, 80 mg
rosuvastatin
20 mg, 40 mg
simvastatin/ ezetimibe (Vytorin®)
10 mg/20 mg, 10 mg/40 mg
√
Highintensity:
≥ 50%
Strength
√
Lowintensity:
< 30%
Moderate
-intensity:
31% - 49%
Statin Name
√
Cross References
Juxtapid™, lomitapide, dru302
Kynamro™, mipomersen, dru301
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Codes
Number
Description
N/A
References
1.
2.
3.
4.
5.
6.
7.
8.
Taylor, F, Huffman, MD, Macedo, AF, et al. Statins for the primary prevention of
cardiovascular disease. The Cochrane database of systematic reviews. 2013;1:CD004816.
PMID: 23440795
Fodor, G. Primary prevention of CVD: treating dyslipidaemia. Clinical evidence. 2010;2010.
PMID: 21418693.
Smith MEB, Lee NJ, Haney E, Carson S. Drug Class Review: HMG-CoA Reductase
Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin: Final Report
Update 5 [Internet]. Portland (OR): Oregon Health & Science University; 2009 Nov.
Available from http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=statins09.
Manktelow BN, Potter JF. Interventions in the management of serum lipids for preventing
stroke recurrence. Cochrane Database Syst Rev. 2009 Jul 8 ;(3):CD002091. Review.
Stone, NJ, Robinson, J, Lichtenstein, AH, 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. PMID: 24222016
Sharma M, Ansari MT, Soares-Weiser K, Abou-setta AM, Ooi TC, Sears M, Yazdi F,
Tsertsvadze A, Moher D. Comparative Effectiveness of Lipid-Modifying Agents [Internet].
Rockville (MD): Agency for Healthcare Research and Quality (US); 2009 Sep. Available from
http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=cer16.
DRUGDEX® System. [Internet database]. Greenwood Village, Colo: Thomson Reuters
(Healthcare) Inc. Updated periodically.
FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations
for Zocor (simvastatin) to reduce the risk of muscle injury. [cited February 5, 2014]. Available
from: http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm.
Revision History
Revision Date
Revision Summary
09/09/2016
Added drugs that were previously included in dru420 [Epanova, Lipitor,
Lovaza, Omtryg, omega-2 acids (generic), Simcor, Vascepa].
Added Crestor, effective January 2017
06/10/2016
12/11/2015
No criteria changes
• Retitled policy “High-Cost Lipid-Modifying Medications”
• Removed Omega-3 fatty acids from policy
• Added fluvastatin (Lescol) and fluvastatin generics to policy
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