CurrentOklahoma Health Care AuthorityPolicy N/A

Immunomodulators: Elidel / Protopic Coverage Criteria

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This policy governs Oklahoma SoonerCare coverage and prior authorization for Elidel (pimecrolimus) and Protopic (tacrolimus) topical immunomodulators, including age requirements, corticosteroid trial requirements, quantity limits, utilization frequency, approved indications, and immunocompromised-member restrictions.

Policy Summary

PayerOklahoma Health Care Authority

PolicyImmunomodulators: Elidel / Protopic Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionAfter the initial 90-day coverage period, submit documentation of a six-week topical corticosteroid trial completed within the previous 90 days unless a stated clinical exception applies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Products in therapeutic category

3,135FY 2008 members with paid claims

5,239FY 2008 claims

$711,639FY 2008 paid amount

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CurrentOklahoma Health Care AuthorityPolicy N/A

Immunomodulators: Elidel / 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.

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Policy Summary

PayerOklahoma Health Care Authority

PolicyImmunomodulators: Elidel / Protopic Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionAfter the initial 90-day coverage period, submit documentation of a six-week topical corticosteroid trial completed within the previous 90 days unless a stated clinical exception applies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Products in therapeutic category

3,135FY 2008 members with paid claims

5,239FY 2008 claims

$711,639FY 2008 paid amount

398FY 2008 petitions denied

Coverage Criteria

Initial Therapy

Initial therapy is covered when ALL of the following are met:

ALL of the following

The member meets the applicable product-specific age requirement.
The requested therapy is for short-term and intermittent use consistent with FDA guidance.
Quantity is limited to 30 grams for use on the face, neck, and groin, or 100 grams for all other areas.

Subsequent Authorization

After the initial 90-day period, subsequent authorization is covered when ALL of the following are met:

ALL of the following

Documentation shows a trial of a topical corticosteroid for six weeks within the past 90 days, unless a clinical exception applies.
The authorization is limited to one approval in each 90-day period to support short-term and intermittent utilization.
Quantity is limited to 30 grams for use on the face, neck, and groin, or 100 grams for all other areas.
ONE of the following clinical exceptions
- A documented adverse effect, drug interaction, or contraindication to topical corticosteroid products is present.
- The member has atopic dermatitis on the face, neck, or groin and the physician does not want to use topical corticosteroids.
- The prescription is written by an allergist or dermatologist, regardless of age.

Covered Indications and Age Criteria

Coverage is limited to an FDA-approved indication and the applicable product and formulation age requirement. At least ONE of the following must apply:

ONE of the following covered product/indication combinations

ALL of the following
- Elidel (pimecrolimus) 1% cream is prescribed for short-term and intermittent treatment of mild to moderate atopic dermatitis (eczema).
- Member is >= 2 years of age.>= 2 years
ALL of the following
- Protopic (tacrolimus) 0.03% cream is prescribed for short-term and intermittent treatment of moderate to severe atopic dermatitis (eczema).

Authorizations are restricted to members who are not immunocompromised.

Utilization and Authorization Parameters

Topical corticosteroid trial

Trial durationSix weeks

Lookback periodWithin the past 90 days

Applies afterThe initial 90-day coverage period

Initial coverage period

Coverage periodFirst 90 days of a 12-month period

Prior authorizationCovered without prior authorization

RequirementMember must meet the applicable age requirement

Provider Requirements and Decision Points

Prior Authorization

Initial Coverage and Subsequent Authorization

For an eligible member who meets the applicable age requirement, the first 90 days of therapy within a 12-month period are covered without prior authorization. After that initial period, authorization is required and must meet the applicable documentation and clinical criteria.

Authorization is limited to members who are not immunocompromised.
Quantities are limited to 30 grams for use on the face, neck, and groin, and 100 grams for all other areas.

Billing Rule

90-Day Authorization Frequency

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

Background

Elidel (pimecrolimus) and Protopic (tacrolimus) are topical immunosuppressants classified as topical calcineurin inhibitors. They are used for short-term and intermittent treatment of atopic dermatitis (eczema).

Definitions

Topical calcineurin inhibitors

ClassificationTopical immunosuppressants

Drug classTopical calcineurin inhibitors

Products in policyElidel and Protopic

Atopic dermatitis

ConditionChronic inflammatory skin condition

Also calledEczema

Elidel labelingMild to moderate atopic dermatitis

Initial Therapy Criteria

Initial coverage is available without prior authorization when all applicable requirements are met.

Initial therapy

ONE of the following product-specific age requirements
- The request is for Elidel 1% cream and the member is at least 2 years of age.
- The request is for Protopic 0.03% cream and the member is at least 2 years of age.
- The request is for Protopic 0.1% cream and the member is at least 15 years of age.
The request falls within the first 90 days of a 12-month period.First 90 days of a 12-month period

Continuation Therapy Criteria

Subsequent or Continuation Therapy

Continuation or subsequent authorization is available when all applicable requirements are met.

Continuation requirements

ONE of the following product-specific age requirements
- The request is for Elidel 1% cream and the member is at least 2 years of age.
- The request is for Protopic 0.03% cream and the member is at least 2 years of age.
- The request is for Protopic 0.1% cream and the member is at least 15 years of age.
Topical corticosteroid requirement or clinical exception

Step Therapy

Step	Requirement	Clinical exceptions
1	After the initial 90-day coverage period, try a topical corticosteroid for six weeks within the past 90 days before subsequent authorization of Elidel or Protopic.	The trial requirement may be excepted for a documented adverse effect, drug interaction, or contraindication; facial, neck, or groin atopic dermatitis where the physician does not want to use a topical corticosteroid; or a prescription written by an allergist or dermatologist.

Quantity Limits

Quantity limit for face, neck, and groin

ProductsElidel and Protopic topical immunomodulators

Covered areasFace, neck, and groin

Quantity limit30 grams per 90-day period

Quantity limit for all other areas

ProductsElidel and Protopic topical immunomodulators

Covered areasAll other areas

Quantity limit100 grams per 90-day period

Policy Summary

PayerOklahoma Health Care Authority

PolicyImmunomodulators: Elidel / Protopic Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionAfter the initial 90-day coverage period, submit documentation of a six-week topical corticosteroid trial completed within the previous 90 days unless a stated clinical exception applies.

SourceLink

On This Page

Member is >= 2 years of age.>= 2 years

ALL of the following

Protopic (tacrolimus) 0.1% cream is prescribed for short-term and intermittent treatment of moderate to severe atopic dermatitis (eczema).
Member is >= 15 years of age.>= 15 years

Authorization frequency

Authorization frequencyOnce each 90-day period

Utilization purposeSupports short-term and intermittent utilization

ProductsElidel and Protopic topical immunomodulators

Step Therapy

Topical Corticosteroid Step Requirement

After the initial 90-day coverage period, document a trial of a topical corticosteroid lasting six weeks and occurring within the preceding 90 days before requesting authorization.

Documentation Required

Trial Documentation After Initial Coverage

Documentation of the topical corticosteroid trial is required after the first 90 days of each 12-month period when continued therapy is requested.

Documentation Required

Clinical Exception Documentation

A corticosteroid trial may be excepted when the member meets the applicable age requirement and documentation supports a clinical exception.

Document an adverse effect, drug interaction, or contraindication to topical corticosteroid products.
Document atopic dermatitis of the face, neck, or groin when the physician does not want to use a topical corticosteroid.
A prescription by an allergist or dermatologist qualifies for the exception, regardless of age.

Denial Risk

Failure to Meet Product Authorization Criteria

Deny authorization when the member does not meet the product's age requirement, the required topical corticosteroid trial or approved exception is not documented, or another authorization criterion is not met.

Elidel (pimecrolimus) 1% cream: member must be at least 2 years of age.
Protopic (tacrolimus) 0.03% cream: member must be at least 2 years of age.
Protopic (tacrolimus) 0.1% cream: member must be at least 15 years of age.
Restrict authorization to members who are not immunocompromised.

Denial Risk

Non-Approved Indication or Age

Deny coverage when the product, strength, age, or diagnosis is not FDA-approved for the requested use. Covered indications are short-term and intermittent treatment of atopic dermatitis (eczema).

Elidel (pimecrolimus): mild to moderate atopic dermatitis.
Protopic (tacrolimus): moderate to severe atopic dermatitis.
Apply the applicable product-strength age restriction before authorization.

Moderate to severe atopic dermatitis

Coverage is available without prior authorization during this initial period when the applicable age requirement is met.

Documentation shows one trial of a topical corticosteroid lasting six weeks within the previous 90 days.Six weeks within the past 90 days

ONE of the following documented clinical exceptions applies

The member has a documented adverse effect, drug interaction, or contraindication to topical corticosteroid products.
The member has atopic dermatitis on the face, neck, or groin, and the physician does not want to use topical corticosteroids.
The prescription is written by an allergist or dermatologist.
This exception applies regardless of age.

Therapy is requested no more than once during each 90-day period.Once each 90-day period

Requested quantities remain within policy limits: no more than 30 grams for use on the face, neck, and groin, or 100 grams for all other areas, per 90-day period.

The member is not immunocompromised.