CurrentOklahoma Health Care AuthorityPolicy N/A

Elidel and Protopic Coverage Criteria

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Coverage and prior authorization requirements for Elidel (pimecrolimus) and Protopic (tacrolimus) for short-term and intermittent treatment of mild to moderate atopic dermatitis.

Policy Summary

PayerOklahoma Health Care Authority

PolicyElidel and Protopic Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material change

Effective DateN/A

Next Review DateN/A

Key ActionAfter the initial 90 days, submit documentation of a six-week tier-1 topical corticosteroid trial completed within the past 90 days.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3,365FY 2010 claims

$515,079FY 2010 paid

2,253Members receiving therapy

654Prior authorization petitions

No changesRecommendation

Policy Summary

PayerOklahoma Health Care Authority

PolicyElidel and Protopic Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material change

Effective DateN/A

Next Review DateN/A

Key ActionAfter the initial 90 days, submit documentation of a six-week tier-1 topical corticosteroid trial completed within the past 90 days.

SourceLink

On This Page

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CurrentOklahoma Health Care AuthorityPolicy N/A

Elidel and Protopic Coverage Criteria

Customize your policy alerts

Sign up for all Oklahoma Health Care Authority policy alerts

Know when Oklahoma Health Care Authority releases new policies or updates existing guidance.

Monitor payer policy activity

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Coverage and prior authorization requirements for Elidel (pimecrolimus) and Protopic (tacrolimus) for short-term and intermittent treatment of mild to moderate atopic dermatitis.

Policy Summary

PayerOklahoma Health Care Authority

PolicyElidel and Protopic Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material change

Effective DateN/A

Next Review DateN/A

Key ActionAfter the initial 90 days, submit documentation of a six-week tier-1 topical corticosteroid trial completed within the past 90 days.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3,365FY 2010 claims

$515,079FY 2010 paid

2,253Members receiving therapy

654Prior authorization petitions

No changesRecommendation

Policy Summary

PayerOklahoma Health Care Authority

PolicyElidel and Protopic Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material change

Effective DateN/A

Next Review DateN/A

Key ActionAfter the initial 90 days, submit documentation of a six-week tier-1 topical corticosteroid trial completed within the past 90 days.

SourceLink

On This Page

Covered indication and safety

Covered when the member meets all of the following requirements:

Clinical indication: Short-term and intermittent treatment for mild to moderate atopic dermatitis (eczema).
Safety: Member is not immunocompromised.

Subsequent authorization criteria

After the first 90 days of a 12-month period, all applicable authorization requirements must be met:

Subsequent authorization

Step therapy: Documentation of one trial of a tier-1 topical corticosteroid for six weeks within the past 90 days.6 weeks within the past 90 days
Utilization limit: Authorization is issued no more than once during each 90-day period.Once per 90-day period

Age and clinical exception criteria

The requested product and strength must meet the applicable age requirement, unless a qualifying clinical exception is documented:

Product and age eligibility

Elidel 1%: Member is at least 2 years of age.≥2 years
Protopic 0.03%: Member is at least 2 years of age.≥2 years
Protopic 0.1%: Member is at least 15 years of age.≥15 years
Approved for adult use only.

Immunocompromised patients are excluded from authorization. Requests must otherwise meet the applicable coverage requirements for short-term and intermittent treatment of mild to moderate atopic dermatitis.

Coverage Parameters

Initial coverage period

Coverage duration90 days

Reference period12-month period

Prior authorizationCovered without prior authorization during the initial period

Tier-1 corticosteroid trial

Required therapyOne trial of a tier-1 topical corticosteroid

Trial duration6 weeks

Completion windowWithin the past 90 days

Face, neck, and groin quantity limit

Treatment sitesFace, neck, and groin

Quantity limit30 grams

Authorization frequencyOnce each 90-day period

Other areas quantity limit

Treatment sitesAll other areas

Quantity limit100 grams

Authorization frequencyOnce each 90-day period

Authorization and Documentation Requirements

Prior Authorization

Initial 90 Days Covered Without Prior Authorization

The first 90 days of a 12-month period are covered without prior authorization. After the initial 90-day period, continued coverage requires the documentation described below.

Prior Authorization

One Authorization per 90-Day Period

Therapy may be approved no more than once during each 90-day period to support the FDA-recommended short-term and intermittent utilization.

Documentation Required

Age Restriction Exceptions

Age-restriction exceptions may be considered when the applicable clinical exception is documented. For members meeting the product age restriction, exceptions include a documented adverse effect, drug interaction, or contraindication to tier-1 products; atopic dermatitis on the face or groin where the physician does not want to use topical corticosteroids; or prescription by a dermatologist. For members not meeting the product age restriction, an exception requires prescription by a dermatologist; refer members who need help accessing a dermatologist to case management.

Elidel 1%: member must be at least 2 years of age.
Protopic 0.03%: member must be at least 2 years of age.
Protopic 0.1%: member must be at least 15 years of age; approved for adult use only.

Step Therapy

Tier-1 Topical Corticosteroid Trial Required

Before coverage after the initial 90 days, document one six-week trial of a tier-1 topical corticosteroid completed within the preceding 90 days.

Documentation Required

Document Prior Corticosteroid Therapy

Submit documentation of the qualifying six-week tier-1 topical corticosteroid trial when requesting authorization after the initial 90-day coverage period.

Documentation Required

Document Clinical Exception

If requesting an exception based on clinical circumstances, provide documentation of the qualifying adverse effect, drug interaction, or contraindication to tier-1 products.

For members meeting the product age restriction, also document any applicable face-or-groin corticosteroid concern or dermatologist prescription supporting the exception.
For members not meeting the product age restriction, document the dermatologist prescription.

Denial Risk

Missing Required Corticosteroid Trial

Coverage may be denied after the initial 90 days when documentation of the required six-week tier-1 topical corticosteroid trial within the preceding 90 days is not submitted.

Denial Risk

Contraindication or Age Restriction

Coverage may be denied for immunocompromised members or when the member does not meet the applicable product age restriction and no qualifying age exception is documented.

Elidel 1% and Protopic 0.03%: minimum age 2 years.
Protopic 0.1%: minimum age 15 years and approved for adult use only.

Billing Rule

Frequency and Quantity Limits

Authorization frequency and site-specific quantity limits apply. Limit quantities to 30 grams for use on the face, neck, and groin, and 100 grams for all other areas; products are available in 30-, 60-, and 100-gram tubes.

No more than one authorization during each 90-day period.
Face, neck, and groin: 30 grams.
All other areas: 100 grams.

Therapy Background

Elidel (pimecrolimus) and Protopic (tacrolimus) are topical calcineurin inhibitors used for the short-term and intermittent treatment of mild to moderate atopic dermatitis (eczema). Coverage is subject to product-specific age restrictions, immunocompromised-status requirements, treatment-site quantity limits, and additional authorization requirements after the initial coverage period.

Key Definitions

Covered indication

ConditionMild to moderate atopic dermatitis (eczema)

Treatment useShort-term and intermittent

Covered productsElidel and Protopic

Initial coverage period

Initial periodFirst 90 days

Reference period12-month period

Prior authorizationNot required during the initial coverage period

Initial Therapy

Initial therapy eligibility

The first 90 days of a 12-month period are covered without prior authorization when the following requirements are met:

Initial product eligibility

Indication: Member has mild to moderate atopic dermatitis (eczema).
Safety: Member is not immunocompromised.
Age: Member meets the age restriction for the requested product and strength.Elidel 1% ≥2 years; Protopic 0.03% ≥2 years; Protopic 0.1% ≥15 years

Continuation Therapy

Intermittent continuation therapy

Ongoing therapy is limited to short-term and intermittent utilization and must meet all of the following:

Continuation requirements

Authorization frequency: Continuation authorization is requested no more than once per 90-day period.Once per 90-day period
Quantity limits: Requested quantities are within the applicable site-based limit.30 grams for the face, neck, and groin; 100 grams for all other areas
Age and safety: The member continues to meet the applicable product-specific age requirement and is not immunocompromised.

Required Prior Therapy

Step	Required therapy	Timing
1	Document one trial of a tier-1 topical corticosteroid	Six weeks, completed within the past 90 days after the initial 90-day coverage period

Product Quantity Limits

Elidel and Protopic quantity limit

ProductsElidel and Protopic

Treatment sitesFace, neck, and groin

Quantity limit30 grams per 90-day authorization period

Elidel and Protopic quantity limit

ProductsElidel and Protopic

Treatment sitesAll areas other than the face, neck, and groin

Quantity limit100 grams per 90-day authorization period

Site-Specific Limits

Billing Rule

Face, neck, and groin quantity limit

Limit quantity to 30 grams when Elidel or Protopic is used on the face, neck, or groin.

Billing Rule

Quantity limit for other treatment areas

Limit quantity to 100 grams when Elidel or Protopic is used on areas other than the face, neck, or groin.

Clinical exception: A documented adverse effect, drug interaction, or contraindication to a tier-1 product; atopic dermatitis on the face or groin where the physician does not want to use topical corticosteroids; or prescription by a dermatologist is present.

For members who do not meet the age restriction, the stated exception is prescription by a dermatologist.