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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 

7/1/2023

FDA APPROVED 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 avoidance of soaps with alkaline pH and use of moisturizing agents. 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 symptoms of atopic dermatitis do not improve.(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 and contact dermatitis.(6)

Lichen Simplex Chronicus

Lichen simplex chronicus is a form of chronic neurodermatitis that presents as dry, patchy areas of skin that are scaly and thick.(5,8) 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. (8) Patients typically complain of intense pruritus in the affected areas. (8) The treatment of lichen simplex chronicus centers on the discontinuation of the itch/scratch cycle. Topical corticosteroids and topical emollients are commonly used therapies.(5,8) Efficacy of topical calcineurin inhibitors for unresponsive patients has been cited by some studies. Doxepin is also an option for local treatment of pruritis.(8)

Safety

Prudoxin and Zonalon are contraindicated in the following:(1-3)

  • 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

Doxepin prescribing information. Mylan Pharmaceuticals, Inc. May 2017. Reference no longer used.

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: Part 1: Diagnosis and Assessment of Atopic Dermatitis. J Am Acad Dermatol 2014 Feb;70(2):338-351.

5

Lichen Simplex (syn. Circumscribed Neurodermatitis). Primary Care Dermatology Society. Created October 2013. Last updated March 2019. Available at: http://www.pcds.org.uk/clinical-guidance/lichen-simplex-chronicus. Accessed July 2020.

6

Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of Care for the Management of Atopic Dermatitis: Part 2: Management and Treatment of Atopic Dermatitis with Topical Therapies. J Am Acad Dermatol 2014 Jul;71(1):116-132.

7

Eichenfield LF, Ahluwalia J, Waldman A, et al. 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. J Allergy Clin Immunol 2017 April;139(4):S49-S57.

8

Charifa A, Badri T. Lichen Simplex Chronicus. [Updated May 2020]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; Jan 2020. Available at: https://www.ncbi.nlm.nih.gov/books/NBK499991/. Accessed July 2020.

9

Elidel prescribing information. Valeant Pharmaceuticals. December 2017.

10

Protopic prescribing information. Astellas Pharma US Inc. May 2012.

 

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Preferred Status

Effective Date

Prudoxin ; Zonalon

doxepin hcl cream

5 %

M ; N ; O ; Y

M ; 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

Effective Date

Prudoxin ; Zonalon

Doxepin HCl Cream 5%

5 %

45

GRAMS

30

Days

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

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

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

  1. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
    2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
  2. 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 BOTH a topical corticosteroid AND a topical calcineurin inhibitor 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
    3. The patient has another FDA approved indication for the requested agent AND
  3. The patient will NOT be using the requested agent in combination with another topical doxepin agent for the requested indication AND
  4. The patient has NOT already received 8 days of therapy with a topical doxepin agent for the current course of therapy AND
  5. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval:  1 month

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

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. BOTH of the following:
    1. The requested quantity (dose) is greater than the program quantity limit AND
    2. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval:  1 month

 

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 _ PS _ Topical Doxepin Prior Authorization with Quantity Limit _ProgSum_ 7/1/2023