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Topical Doxepin Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1020

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

01-01-2025            

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Prudoxin®

(doxepin)

5% cream*

Short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus

*generic available

2

Zonalon®

(doxepin)

5% cream*

Short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus

*generic available 

3

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Atopic Dermatitis

Atopic dermatitis is a chronic, pruritic, inflammatory skin disease. Clinical features include skin dryness, erythema, oozing and crusting, and lichenification. Pruritus is responsible for much of the disease burden for patients. The goals of treatment are to reduce symptoms of pruritus and dermatitis, prevent exacerbations, and minimize therapeutic risks.(4) Initial nonpharmacological therapy for atopic dermatitis, as recommended by American Academy of Dermatology (AAD) guidelines, is use of moisturizing agents. Moisturizers are the cornerstone of atopic dermatitis therapy as an important component of maintenance treatment and for the prevention of flares. Recommended topical therapy for atopic dermatitis, indicated when nonpharmacologic interventions have failed, includes topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI).(6,7) Proactive, once to twice weekly application of mid-potency TCS for up to 40 weeks has not demonstrated adverse events in clinical trials. AAD notes that mid- to higher-potency topical corticosteroids are appropriate for short courses to gain rapid control of symptoms, but long-term management should use the least-potent corticosteroid that is effective. TCIs (e.g., pimecrolimus, tacrolimus) are recommended by the AAD as second-line therapy, and are particularly useful in selected clinical situations such as recalcitrance to steroids; for sensitive areas (face, anogenital, skin folds); for steroid-induced atrophy; and when there is long-term uninterrupted topical steroid use.(6) Prescribing information for Elidel (pimecrolimus) cream and Protopic (tacrolimus) ointment indicate evaluation after 6 weeks if signs and symptoms of atopic dermatitis persist.(9,10) While topical doxepin does provide short-term decrease in pruritus, it is not recommended for atopic dermatitis by the AAD guidelines due to the risk of absorption, contact dermatitis, and noting that studies have shown no significant reduction in disease severity or control.(6)

Lichen Simplex Chronicus

Lichen simplex chronicus (LSC) is a common form of chronic neurodermatitis that presents as localized dry, patchy areas of skin that are scaly and thick. The plaques form as a result of constant and repeated scratching and/or rubbing of specific areas. The root of the disorder may be both a primary symptom reflective of a psychological component, or secondary to other cutaneous issues such as eczema or psoriasis. The treatment of LSC centers on breaking the itch-scratch cycle. Reducing inflammation is another cornerstone to treatment. As LSC is usually localized, topical agents are often used with high-potency topical corticosteroids considered first-line for treatment.(1,8)

Safety

Prudoxin and Zonalon are contraindicated in the following:(2,3)

  • Patients with untreated narrow angle glaucoma or a tendency to urinary retention
  • Individuals who have shown previous sensitivity to any of its components

REFERENCES                                                                                                                                                                           

Number

Reference

1

Ju T, Does AV, Mohsin N, Yosipovitch G. Lichen simplex chronicus itch: an Update. Acta Dermato-venereologica. 2022;102:adv00796. doi:10.2340/actadv.v102.4367

2

Prudoxin prescribing information. Mylan Pharmaceuticals, Inc. June 2017.

3

Zonalon prescribing information. Mylan Pharmaceuticals, Inc. June 2017.

4

Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis. Journal of the American Academy of Dermatology. 2014;70(2):338-351. doi:10.1016/j.jaad.2013.10.010

5

Reference no longer used 

6

Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis. Journal of the American Academy of Dermatology. 2014;71(1):116-132. doi:10.1016/j.jaad.2014.03.023

7

Eichenfield LF, Ahluwalia J, Waldman A, Borok J, Udkoff J, Boguniewicz M. Current guidelines for the evaluation and management of atopic dermatitis: A comparison of the Joint Task Force Practice Parameter and American Academy of Dermatology guidelines. The Journal of Allergy and Clinical Immunology/Journal of Allergy and Clinical Immunology/The Journal of Allergy and Clinical Immunology. 2017;139(4):S49-S57. doi:10.1016/j.jaci.2017.01.009

8

Charifa A, Badri T, Harris BW. Lichen simplex chronicus. StatPearls - NCBI Bookshelf. Published August 7, 2023. https://www.ncbi.nlm.nih.gov/books/NBK499991/

9

Elidel prescribing information. Bausch Health Companies Inc. September 2020.   

10

Protopic prescribing information. Leo Pharma Inc. June 2022.   

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Prudoxin ; Zonalon

doxepin hcl cream

5 %

M ; N ; O ; Y

O ; Y

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Prudoxin ; Zonalon

Doxepin HCl Cream 5%

5 %

45

Grams

30

DAYS

Quantity Limit is cumulative across agents

ADDITIONAL QUANTITY LIMIT INFORMATION

Wildcard

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Additional QL Information

Targeted NDCs When Exclusions Exist

Effective Date

Term Date

90220015103710

Prudoxin ; Zonalon

Doxepin HCl Cream 5%

5 %

Quantity Limit is cumulative across agents

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Prudoxin ; Zonalon

doxepin hcl cream

5 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Prudoxin ; Zonalon

Doxepin HCl Cream 5%

5 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

PA

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. The patient has a diagnosis of moderate pruritus associated with atopic dermatitis AND ONE of the following:
      1. The patient has tried and had an inadequate response to BOTH a topical corticosteroid used for a minimum of 4 weeks AND a topical calcineurin inhibitor used for a minimum of 6 weeks OR
      2. The patient has an intolerance or hypersensitivity to a topical corticosteroid AND a topical calcineurin inhibitor OR
      3. The patient has an FDA labeled contraindication to ALL topical corticosteroids AND topical calcineurin inhibitors OR
    2. The patient has a diagnosis of moderate pruritus associated with lichen simplex chronicus AND ONE of the following:
      1. The patient has tried and had an inadequate response to ONE topical corticosteroid OR
      2. The patient has an intolerance or hypersensitivity to ONE topical corticosteroid OR
      3. The patient has an FDA labeled contraindication to ALL topical corticosteroids OR
    3. The patient has another FDA labeled indication for the requested agent OR
    4. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
  2. If the patient has an FDA labeled indication, then ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
    2. There is support for using the requested agent for the patient’s age for the requested indication AND
  3. If the request is for one of the following brand agents with an available generic (listed below), then ONE of the following:

Brand

Generic 

Prudoxin cream
Zonalon cream


doxepin hydrochloride cream 5%
    1. The patient has an intolerance or hypersensitivity to the generic that is not expected to occur with the brand agent OR
    2. The patient has an FDA labeled contraindication to the generic that is not expected to occur with the brand agent OR
    3. There is support for the use of the requested brand agent over the generic AND
  2. The patient will NOT be using the requested agent in combination with another topical doxepin agent for the requested indication AND
  3. The patient has NOT already received 8 days of therapy with a topical doxepin agent for the current course of therapy AND
  4. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence 

Length of Approval: pruritus associated with atopic dermatitis or lichen simplex chronicus - 1 month; or all other requests - 12 months 

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

QL with PA

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
    1. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR
    3. BOTH of the following:
      1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication

Length of Approval:  up to 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

 

Commercial _ CSReg _ Topical_Doxepin_PAQL _ProgSum_ 01-01-2025