CurrentAvMedPolicy N/A

Ezetimibe-Simvastatin (Vytorin)

Prior authorization / step-edit form and clinical criteria for coverage of the combination product ezetimibe-simvastatin (Vytorin) for AvMed members; documents required, required trials of statin therapy, and laboratory documentation required to support approval.

Policy Summary

PayerAvMed

PolicyEzetimibe-Simvastatin (Vytorin)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and print name on the request and fax the completed form with all documentation (lab results, diagnostics, chart notes) to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

>=2Required prior statin therapies failed

>=12 wksMinimum maximally tolerated statin duration

1Required lipid panel submission

Coverage Summary

This is a prior authorization / step-edit form and the clinical criteria for coverage of the combination product ezetimibe-simvastatin (Vytorin) for AvMed members. The form requires documentation to support approval, including verification of required statin trials and laboratory data.

Approval Criteria (Initial Therapy)

Approval Criteria (All must be met)

All criteria must be met for approval. To support each line checked, documentation including lab results, diagnostics, and/or chart notes must be provided.

ALL of the following

Statin therapies listed (examples provided on form)
- atorvastatin 40-80 mg
- atorvastatin 10-20 mg
- simvastatin 10 mg
- rosuvastatin 20-40 mg
- rosuvastatin 5-10 mg
- pravastatin 10-20 mg
- simvastatin 20-40 mg
- lovastatin 20 mg
- pravastatin 40-80 mg
- fluvastatin 20-40 mg
- fluvastatin 40 mg BID
Provider has submitted the results of member's lipid panel showing further reduction in LDL cholesterol is required despite compliant use of maximally tolerated statin monotherapy.
Form requests Current LDL-C and LDL-C Goal values.
Member has tried and had an inadequate response with a statin therapy and ezetimibe used at the same time.
Document inadequate response to concurrent statin + ezetimibe trial.
Provider has submitted chart notes to document the clinical rationale for why requested combination agent is medically necessary and not only for convenience.

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Provider Actions / Prior Authorization Requirements

Prior Authorization

Submit prior authorization form with prescriber signature

Prescribing physician must sign and print name on the request; fax completed form to 1-305-671-0200. All documentation (lab results, diagnostics, chart notes) must be provided or request may be denied.

Fax completed prior authorization form with prescriber signature to 1-305-671-0200
Include all supporting documentation: lab results, diagnostics, and chart notes

Documentation Required

Document prior statin trials and LDL results

Provide verification of trials (chart notes or pharmacy paid claims) showing two failed high-intensity statins or maximally tolerated statin for >=12 weeks and include the member's lipid panel with current LDL-C and LDL-C goal.

Verification of two failed high-intensity statins OR maximally tolerated statin >= 12 consecutive weeks
Lipid panel results showing Current LDL-C and LDL-C Goal

Documentation Required

Document prior combination trial

If applicable, provide documentation showing an inadequate response when a statin therapy and ezetimibe were used concurrently prior to approval.

Chart notes or other documentation of concurrent statin + ezetimibe trial and inadequate response

Documentation Required

Do not rely on drug samples

Use of samples to initiate therapy does not meet step edit/preauthorization criteria and should not be relied upon to satisfy prior authorization or step requirements.

Background

This pharmacy prior authorization/step-edit form for ezetimibe-simvastatin (Vytorin) collects member and prescriber information, drug details (form/strength, dosing schedule, recommended dosage: 1 tablet once daily in the evening), and the clinical criteria that must be met for coverage determination.

Key Thresholds / Stats

Required prior statin therapies failed>=2

Minimum maximally tolerated statin duration>=12 weeks

Required lipid panel submission1

Statin trial duration>= 12 consecutive weeks at maximally tolerated dose

Clinical Evidence

The brief contains no formal evidence items. Required documentation listed on the form includes submission of the member's lipid panel (current LDL-C and LDL-C goal) and chart notes or pharmacy paid claims to verify inadequate LDL-C response and prior statin trials (two failed high-intensity statins or statin at maximally tolerated dose for at least 12 consecutive weeks). Do not rely on drug samples to meet step-edit/preauthorization criteria.

Policy Summary

PayerAvMed

PolicyEzetimibe-Simvastatin (Vytorin)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and print name on the request and fax the completed form with all documentation (lab results, diagnostics, chart notes) to 1-305-671-0200.

SourceLink

On This Page

OpenPayer

Ezetimibe-Simvastatin (Vytorin)

Coverage Summary

Approval Criteria (Initial Therapy)

Provider Actions / Prior Authorization Requirements

Applicable Codes

Background

Clinical Evidence

Revision History