Effective Date

Date of Origin   

01-01-2026           

Prudoxin®

(doxepin hydrochloride)

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 hydrochloride)

Cream*

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

*generic available

3

Atopic Dermatitis

Atopic dermatitis (AD), also known as atopic eczema, is a chronic, pruritic inflammatory dermatosis affecting up to 25% of children and approximately 7% of adults.(4,7) AD follows a relapsing course and is associated with elevated serum immunoglobulin (IgE) levels and a personal or family history of type I allergies, allergic rhinitis, and/or asthma. Onset is most common between 3 and 6 months of age, with approximately 60% of patients developing the eruption in the first year of life and 90% by age 5. While the majority of affected individuals have resolution of disease by adulthood, 10-30% do not, and a smaller percentage first develop symptoms as adults. AD has a complex pathogenesis involving genetic, immunologic, and environmental factors, which lead to a dysfunctional skin barrier and dysregulation of the immune system. Clinical findings include erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and lichenification. These clinical findings vary by patient age and chronicity of lesions. Pruritus is a hallmark of the condition that is responsible for much of the disease burden borne by patients and their families. Typical patterns include facial, neck and extensor involvement in infants and children; flexure involvement in any age group, with sparing of groin and axillary regions.(4)

Goals of treatment are to reduce symptoms (pruritus and dermatitis), prevent exacerbations, and minimize therapeutics risks. Despite its relapsing and remitting nature, the majority of patients with AD can achieve clinical improvement and disease control with topical emollient/moisturizer use and conventional topical therapies (including corticosteroids and calcineurin inhibitors).(6) Moisturizers reduce signs, symptoms, and inflammation in AD, and can improve severity while also increasing time between flares. Moisturizers are considered generally safe and are strongly recommended to be used as part of a treatment regimen for AD, either as monotherapy or as concurrent use with pharmacologic treatments.(5)

Topical therapies remain the mainstay of treatment due to their proven track record and generally favorable safety profile. They can be utilized individually or in combination with other topical, physical, and/or systemic treatments; as different classes of treatment have different mechanisms of action, combining therapies allows for the targeting of AD via multiple disease pathways. The American Academy of Dermatology (AAD) strongly recommends the following topical agents:(5)

• Topical corticosteroids (TCS)
• Calcineurin inhibitors (TCIs) (e.g., tacrolimus, pimecrolimus)
• Topical phosphodiesterase (PDE)-4 inhibitors (e.g., crisaborole) [mild to moderate AD]
• Topical Janus kinase (JAK) inhibitors (e.g., ruxolitinib) [mild to moderate AD]

TCS are the most commonly utilized FDA labeled therapies in AD and are typically used as first-line treatment for mild-to-severe dermatitis in all skin regions. TCS target a variety of immune cells and suppress the release of proinflammatory cytokines. High to very high (super) potency TCS can be used to control flares and treat severe disease, while medium potency TCS are utilized for longer courses and as maintenance therapy. Lower potency TCS may be used, and it is important to consider the anatomical site (i.e., using lower potency agents on the face, neck, genitals, and body folds) and severity of the disease when choosing a steroid potency.(5) Clinical trials assessing efficacy generally had a duration of 2 to 6 weeks, and response to TCS therapy should be evaluated by week 4 in clinical practice.(7) Most studies of TCS in AD management involve twice daily application, but some studies (particularly for potent TCS) suggest once daily use may be sufficient. Traditionally, TCS were stopped once AD signs and symptoms of an AD flare were controlled. Maintenance in between AD flares with once to twice weekly use of TCS is another approach.(5)

TCIs are a safe anti-inflammatory option for mild-to-severe AD, particularly when there is concern for adverse events secondary to corticosteroid use. Both tacrolimus and pimecrolimus have been shown to be effective in treating AD, but pimecrolimus may be more appropriate for patients who have milder disease or are sensitive to local reactions.(5) Prescribing information for pimecrolimus cream and tacrolimus ointment indicate evaluation after 6 weeks if symptoms of AD do not improve for adults and pediatrics.(9,10)

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

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: Section 1. Diagnosis and assessment of atopic dermatitis. Journal of the American Academy of Dermatology. 2014;70(2):338-351. doi:10.1016/j.jaad.2013.10.010

5

Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. Journal of the American Academy of Dermatology. 2023;89(1). doi:10.1016/j.jaad.2022.12.029

6

Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. Journal of the American Academy of Dermatology. 2014;71(6):1218-1233. doi:10.1016/j.jaad.2014.08.038

7

Chu DK, Schneider L, Asiniwasis RN, et al. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE-and Institute of Medicine-based recommendations. Annals of Allergy Asthma & Immunology. 2023;132(3):274-312. doi:10.1016/j.anai.2023.11.009

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.   

Prudoxin ; Zonalon

doxepin hcl cream

5 %

M ; N ; O ; Y

O ; Y

Prudoxin ; Zonalon

Doxepin HCl Cream 5%

5 %

45

Grams

30

DAYS

Quantity Limit is cumulative across agents

90220015103710

Prudoxin ; Zonalon

Doxepin HCl Cream 5%

5 %

Quantity Limit is cumulative across agents

Prudoxin ; Zonalon

doxepin hcl cream

5 %

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

Prudoxin ; Zonalon

Doxepin HCl Cream 5%

5 %

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

PA

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

1. ONE of the following:
   1. BOTH of the following:
      1. The patient has ONE of the following: 
         1. A diagnosis of moderate pruritus associated with atopic dermatitis (AD) AND ALL of the following:
            1. The patient has ONE of the following: 
               1. Tried and had an inadequate response to ONE topical corticosteroid used in the treatment of AD after at least a 4-week duration of therapy OR
               2. An intolerance or hypersensitivity to ONE topical corticosteroid used in the treatment of AD OR
               3. An FDA labeled contraindication to ALL topical corticosteroids used in the treatment of AD AND
            2. The patient has ONE of the following: 
               1. Tried and had an inadequate response to ONE topical calcineurin inhibitor used in the treatment of AD after at least a 6-week duration of therapy OR
               2. An intolerance or hypersensitivity to ONE topical calcineurin inhibitor used in the treatment of AD OR
               3. An FDA labeled contraindication to ALL topical calcineurin inhibitors used in the treatment of AD AND
            3. BOTH of the following:
               1. The patient is currently treated with topical emollients and practicing good skin care AND
               2. The patient will continue the use of topical emollients and good skin care practices in combination with the requested agent OR
         2. A diagnosis of moderate pruritus associated with lichen simplex chronicus AND ONE of the following:
            1. Tried and had an inadequate response to ONE topical corticosteroid OR
            2. An intolerance or hypersensitivity to ONE topical corticosteroid OR
            3. An FDA labeled contraindication to ALL topical corticosteroids AND
      2. The patient has NOT already received 8 days of therapy with a topical doxepin agent for the current course of therapy OR
   2. The patient has another FDA labeled indication for the requested agent and route of administration OR
   3. The patient has an 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 equivalent, then the patient has ONE of the following:

3. 1. An intolerance or hypersensitivity to the generic equivalent that is NOT expected to occur with the requested brand agent OR
   2. An FDA labeled contraindication to the generic equivalent that is NOT expected to occur with the requested brand agent OR
   3. Support for the use of the requested brand agent over the generic equivalent AND
4. The patient will NOT be using the requested agent in combination with another topical doxepin agent AND
5. 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.

Universal QL

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