CurrentOklahoma Health Care AuthorityPolicy N/A

Lamisil Granules Prior Authorization

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This policy governs Oklahoma Medicaid prior authorization for Lamisil granules, primarily for members with tinea capitis. It establishes clinical criteria for approval and summarizes fiscal year 2011 utilization, petition activity, and safety-labeling updates.

Policy Summary

PayerOklahoma Health Care Authority

PolicyLamisil Granules Prior Authorization

Policy CodePolicy N/A

Change TypeAnnual review—no material changes

Effective DateN/A

Next Review DateN/A

Key ActionDocument that the member has tinea capitis, failed at least 3 weeks of griseofulvin therapy or has qualifying intolerance, and cannot swallow tablets.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Prior authorization criteria

41FY2011 petitions

16FY2011 claims

11*FY2011 members

$4,610.04

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CurrentOklahoma Health Care AuthorityPolicy N/A

Lamisil Granules Prior Authorization

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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

PolicyLamisil Granules Prior Authorization

Policy CodePolicy N/A

Change TypeAnnual review—no material changes

Effective DateN/A

Next Review DateN/A

Key ActionDocument that the member has tinea capitis, failed at least 3 weeks of griseofulvin therapy or has qualifying intolerance, and cannot swallow tablets.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Prior authorization criteria

41FY2011 petitions

16FY2011 claims

11*FY2011 members

$4,610.04

Lamisil Granules Coverage Criteria

Initial Lamisil Granules Authorization

Coverage requires ALL of the following criteria:

ALL of the following

FDA-approved indication of tinea capitis
Intolerance or hypersensitivity to griseofulvin or penicillin
No improvement after at least 3 weeks of therapy with griseofulvin≥ 3 weeks
Member is unable to swallow tablets

Authorization Requirements and Denial Risks

Prior Authorization

Meet All Lamisil Granules Criteria

Authorization requires documentation that all Lamisil granules criteria are met for the member.

FDA-approved indication of tinea capitis
No improvement after at least 3 weeks of therapy with griseofulvin
Intolerance or hypersensitivity to griseofulvin or penicillin
Member is unable to swallow tablets

Step Therapy

Prior Griseofulvin Therapy or Intolerance

Document either lack of response to griseofulvin after the required trial or a qualifying intolerance or hypersensitivity. The member must have had no improvement after at least 3 weeks of griseofulvin therapy, or have intolerance or hypersensitivity to griseofulvin or penicillin.

At least 3 weeks of griseofulvin therapy without improvement
Qualifying intolerance or hypersensitivity to griseofulvin or penicillin

Clinical and Utilization Background

Lamisil granules are reviewed for the FDA-approved indication of tinea capitis. During fiscal year 2011, utilization totaled 16 claims for 11 members*, with total costs of $4,610.04. The review also records 41 petitions submitted during the fiscal year. In November 2011, FDA-approved safety-labeling updates addressed drug interactions that may convert extensive CYP2D6 metabolizers to poor metabolizer status, added photosensitivity adverse reactions, and advised patients to minimize exposure to natural and artificial sunlight while using Lamisil. Based on the review, the College of Pharmacy recommended no changes to the current prior authorization criteria.

Initial Therapy

Initial Therapy Criteria

For initial Lamisil granules therapy, all of the following criteria must be met:

All criteria required

FDA-approved indication of tinea capitis
Griseofulvin treatment failure: No improvement after therapy with griseofulvinat least 3 weeks
Drug intolerance or hypersensitivity: Intolerance or hypersensitivity to griseofulvin or penicillin
Unable to swallow tablets:

Required Griseofulvin Trial

Step	Requirement	Duration or exception
1	Try griseofulvin before Lamisil granules	At least 3 weeks of therapy without improvement, unless the member has intolerance or hypersensitivity to griseofulvin or penicillin

Denial Risk

Failure to Meet Authorization Criteria

Authorization may be denied when the requested use does not meet the approved indication, the required prior griseofulvin therapy or qualifying intolerance or hypersensitivity is not documented, or any other required criterion is missing.

No FDA-approved indication of tinea capitis
No documented lack of improvement after at least 3 weeks of griseofulvin therapy and no qualifying intolerance or hypersensitivity to griseofulvin or penicillin
Member can swallow tablets or another required criterion is not met