CurrentNeighborhood Health Plan of Rhode IslandPolicy 981-D 12-2022

Vytorin (ezetimibe/simvastatin 10/80 mg) and Zocor (simvastatin 80 mg) prior authorization and step therapy

Defines CVS Caremark-administered initial step therapy and prior authorization requirements for Vytorin (ezetimibe/simvastatin 10/80 mg) and Zocor (simvastatin 80 mg) under the payer's prescription benefit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVytorin (ezetimibe/simvastatin 10/80 mg) and Zocor (simvastatin 80 mg) prior authorization and step therapy

Policy CodePolicy 981-D 12-2022

Change TypeNo material change

Effective DateDec 1, 2022

Next Review Date

Key ActionObtain prior authorization when the patient does not meet the initial step therapy requirement of a 290-day prior fill or 12 months chronic use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

290 dayminimum prior fill supply

365 daylookback period

12 mochronic use required

Coverage Criteria

Prior Authorization Coverage Criteria

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Chronic therapy OR prior fill: Patient has been taking the 10/80 mg strength of ezetimibe/simvastatin (Vytorin) OR the 80 mg strength of simvastatin (Zocor) chronically for 12 months or more OR has filled at least a 290 day supply of the same within the past 365 days under the prescription benefit administered by CVS Caremark.12 months OR >= 290 day within 365 day lookback

If initial step therapy criteria not met, claim will reject and PA is required.

Coding and Administrative Thresholds

Affected benefit codesmixed

affected codes

Policy references prior authorization/process codes administered by CVS Caremark; specific HCPCS/CPT/NDC codes not listed in document.

Prior fill supply threshold

Prior fill supply threshold>= 290 day supply of Vytorin 10/80 mg OR simvastatin 80 mg within the past 365 days

Lookback period365 day lookback for prior fills

Benefit administratorUnder prescription benefit administered by CVS Caremark

Chronic use duration

Chronic use duration>= 12 months of continuous use of Vytorin 10/80 mg OR simvastatin 80 mg

Applies toContinuation therapy / prior authorization coverage criteria

Documentation standardEvidence of chronic use for 12 months or more required for PA consideration

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Requirement

Prior authorization is required when the initial step therapy criteria are not met. If the patient does not meet the initial step therapy criteria, the claim will reject and indicate that a prior authorization (PA) is required; the PA unit will then apply the prior authorization criteria to requests submitted for evaluation.

Affected products: ezetimibe/simvastatin 10/80 mg (Vytorin) and simvastatin 80 mg (Zocor)
Time window for prior fill check: past 365 days
Prior authorization evaluation occurs when claim rejects for unmet step therapy

Denial Risk

Claim Rejection When Step Therapy Unmet

The claim will reject if the patient has not met the initial step therapy requirement; the rejection message will instruct that a prior authorization is required and route the request to the PA unit for review.

Claim reject triggers PA workflow when prior-fill criteria are unmet
Providers should submit PA documentation to avoid denial of the claim

Documentation Required

Required Prior Fill / Chronic Use Documentation

Documentation of prior pharmacy fills demonstrating chronic use is required to meet the initial step therapy criteria. Specifically, evidence must show at least a 290-day supply of Vytorin 10/80 mg OR at least a 290-day supply of simvastatin 80 mg within the past 365 days, or documentation that the patient has been taking the specified product chronically for 12 months or more.

Acceptable evidence: pharmacy fill records showing >= 290 days supplied within past 365 days
Alternate documentation: medical record notes confirming chronic use for >= 12 months

Initial Step Therapy Criteria

Initial Step Therapy

Initial step therapy requirement before coverage without prior authorization:

Prior fill requirement: Patient has filled a prescription for at least a 290 day supply of the 10/80 mg strength of ezetimibe/simvastatin (Vytorin) OR at least a 290 day supply of the 80 mg strength of simvastatin (Zocor) within the past 365 days under a prescription benefit administered by CVS Caremark.>= 290 day supply within past 365 days

If not met, the claim will reject with a message indicating a prior authorization is required.

Continuation Therapy Criteria

Continuation Therapy

Continuation/coverage for ongoing therapy:

Chronic use: Patient has been taking the 10/80 mg strength of ezetimibe/simvastatin (Vytorin) OR the 80 mg strength of simvastatin (Zocor) chronically for 12 months or more.12 months

Meets prior authorization coverage criteria.

Step Therapy Fill History

Requirement	Details
Initial step therapy — prior fill requirement
Patient has filled at least a 290-day supply of Vytorin (ezetimibe/simvastatin) 10/80 mg OR at least a 290-day supply of simvastatin 80 mg within the past 365 days under the CVS Caremark prescription benefit; if met, drug will be paid under the benefit.
If requirement not met
Claim will reject with a message indicating that a prior authorization (PA) is required; PA criteria will be applied to requests submitted to the PA unit.

Definitions

Statin / HMG-CoA reductase inhibitor

Drug classHMG-CoA reductase inhibitor (Statin)

Included productsVytorin (ezetimibe/simvastatin 10/80 mg) and Zocor (simvastatin 80 mg)

Strengths notedVytorin 10/80 mg strength only; Zocor 80 mg strength only

Vytorin Indications

Primary indicationsPrimary (heterozygous familial and non-familial) hyperlipidemia and mixed hyperlipidemia

Homozygous familial hypercholesterolemia (HoFH)Reduction of elevated total-C and LDL-C as an adjunct to other lipid-lowering treatments or when such treatments are unavailable

Overall Vytorin indicationsUsed to reduce LDL-C, total-C, Apo B, triglycerides, and non-HDL-C, and to increase HDL-C in indicated populations

Background

Vytorin (ezetimibe/simvastatin) and simvastatin are members of the HMG-CoA reductase inhibitor (statin) drug class. They are indicated as adjuncts to diet for patients with elevated LDL-C and other lipid abnormalities and should be used alongside diet and nonpharmacologic measures in patients at increased risk for atherosclerotic vascular disease.