Asset Publisher

ph-1028

print Print

Atopic Dermatitis (Elidel [pimecrolimus], Eucrisa, Protopic [tacrolimus]) Step Therapy Program Summary

Policy Number: PH-1028

This program applies to Commercial, SourceRx, Blue Partner, and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

1/1/2023

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Elidel®

(pimecrolimus)*

Cream 1%

Second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

generic available

2

Eucrisa™

(crisaborole)

Ointment 2%

Topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.

3

Protopic®

(tacrolimus)

Ointment 0.03%, 0.1%*

Second-line therapy for short-term and non-continuous chronic moderate to severe AD in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for AD, or when those treatments are not advisable.

(0.03% and 0.1% for adults; 0.03% only for children ages 2-15).

generic available

1

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

CLINICAL RATIONALE

Atopic Dermatitis

Atopic dermatitis (AD) is a chronic, pruritic inflammatory skin disease that occurs most frequently in children, but also affects many adults.  If follows a relapsing course.  Topical agents are the mainstay of AD therapy, with topical corticosteroids being the primary pharmacological treatment.  Continuous application of topical corticosteroids for long periods of time should be avoided to limit the occurrence of negative changes.  Cutaneous side effects include purpura, telangiectasia, striae, focal hypertrichosis, and acneiform or rosacea-like eruptions.  Of greatest concern is skin atrophy, especially through use of higher-potency agents, use on thinner skin, and older patient age.(4)      

 

Topical calcineurin inhibitors (TCI) such as topical pimecrolimus and topical tacrolimus, are approved as second-line agents for the short-term and noncontinuous chronic treatment of AD in non-immunocompromised individuals who have failed to respond adequately to other topical prescription treatments for AD, or when those treatments are not advisable.  TCIs do not carry the risk of skin atrophy with little effect on collagen synthesis and skin thickness.  Use of TCIs have been studied in long-term studies to 12 months and have shown to reduce the need for topical corticosteroid use.  TCIs may be preferable over corticosteroids in certain situations:

  • Recalcitrance to steroids
  • Use in sensitive areas (e.g., face, anogenital, skin folds)
  • Steroid-induced atrophy
  • Long-term uninterrupted topical steroid use(4)

 

A meta-analysis (2016; 12 RCTs) compared calcineurin inhibitors (n equal to 3492) vs. corticosteroids (n equal to 3462) in treatment of atopic dermatitis. Calcineurin inhibitors and corticosteroids had similar rates of improvement of dermatitis (81% vs. 71%; p equal to 0.01) and treatment success (72% vs. 68%; p equal to 0.04). Calcineurin inhibitors were associated with higher costs and had more adverse events (74% vs. 64%; p equal to 0.02) including a higher rate of skin burning (30% vs. 9%; p less than 0.00001) and pruritus (12% vs. 8%; p less than 0.00001). There were no differences in atrophy, skin infections, or adverse events that were serious or required discontinuation of therapy.(5)

 

Crisaborole 2% ointment is a topical nonsteroidal treatment for mild to moderate AD.  It is well tolerated by most patients.  It has shown superiority to emollient treatment alone.  There is no data on long-term effectiveness because studies lasted for only 28 days.  Crisaborole has not been compared directly with other treatments for atopic dermatitis.(6)    

Psoriasis

The American Academy of Dermatology Guidelines (2009-2011) state that although corticosteroids remain the mainstay of topical therapy for psoriasis, the most potent and efficacious of these agents are approved for only short-term treatment (2-4 weeks). Consideration should be given to use of medications that have been developed to either replace potent topical corticosteroids in longer term treatment, or to be used in combination to provide greater efficacy with lesser exposure to steroid containing agents. Pursuit of these goals with agents including vitamin D analogues, topical retinoids, and TCIs has shown benefit.(7) Although tacrolimus and pimecrolimus have not been found beneficial for plaque psoriasis, these agents have shown some benefit for intertriginous and facial psoriasis.(8)

 

A review (2013) on treatment of psoriasis suggests tacrolimus and pimecrolimus generally improve symptoms with less skin atrophy than topical corticosteroids, and are considered first-line treatments for facial and flexural psoriasis. Tacrolimus is superior to pimecrolimus in reducing psoriasis symptoms.(7)

 

For additional clinical information see the Prime Therapeutics Formulary Chapter 14.5Y: Topical Immunomodulators.

Safety

Elidel is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.  Elidel also carries the following black box warning:(2)

  • Long-term safety of topical calcineurin inhibitors has not been established
  • Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Elidel Cream, 1%. Therefore:
    • Continuous long-term use of topical calcineurin inhibitors, including Elidel Cream, 1%, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis
    • Elidel Cream, 1% is not indicated for use in children less than 2 years of age

 

Eucrisa is contraindicated in individuals with known hypersensitivity to crisaborole or any component of the formulation.(3)

 

Protopic is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment. Protopic also carries the following black box warning:(1)

  • Long-term safety of topical calcineurin inhibitors has not been established
  • Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Protopic Ointment. Therefore:
    • Continuous long-term use of topical calcineurin inhibitors, including Protopic Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
    • Protopic Ointment is not indicated for use in children less than 2 years of age. Only 0.03% Protopic Ointment is indicated for use in children 2-15 years of age.

REFERENCES                                                                                                                                                                            

Number

Reference

1

Protopic prescribing information. LEO Pharma Inc. April 2019.

2

Elidel prescribing information. Bausch Health US, LLC. September 2020.

3

Eucrisa prescribing information. Pfizer, Inc. March 2020.

4

Eichenfield LF, Tom WL, Berger TG, et. al. Guidelines of care for the management of atopic dermatitis.  J Am Acad Dermatol.  July 2014;71(1) 116-132.  https://www.jaad.org/article/S0190-9622(14)01257-2/fulltext  

5

Broeders JA, Ali UA, Fischer, G. Systematic review and meta-analysis of randomized clinical trials (RCTs) comparing topical calcineurin inhibitors with topical corticosteroids for atopic dermatitis: A 15-year experience.  Journal of the American Academy of Dermatology. 2016;75(2):410-419.e3.

6

Castelli G and Schaffer M.  Crisaborole (Eucrisa) for Mild to Moderate Atopic Dermatitis.  Am Fam Physician.  2018 Sep 15;98(6):379-380.  https://www.aafp.org/afp/2018/0915/p379.html  

7

Weigle N, Mc Bane S. Psoriasis. Am Fam Physician. 2013;87(9):626-633. https://www.aafp.org/afp/2013/0501/p626.html  

 

POLICY AGENT SUMMARY STEP THERAPY

Agent Names

Strength

Targeted MSC

Available MSC

Preferred Status

Effective Date

ELIDEL*pimecrolimus cream  ; PIMECROLIMUS*pimecrolimus cream

1 %

M ; N ; O ; Y

O ; Y

EUCRISA*crisaborole oint

2 %

M ; N ; O ; Y

N

NUJO*tacrolimus (topical) soln  ; NUJU*tacrolimus cream  ; PROTOPIC*tacrolimus oint  ; TACROLIMUS*tacrolimus cream  ; TACROLIMUS*tacrolimus oint

0.03 % ; 0.1 %

M ; N ; O ; Y

N ; O ; Y

CLIENT SUMMARY – STEP THERAPY

Agent Names

Strength

Client Formulary

ELIDEL*pimecrolimus cream  ; PIMECROLIMUS*pimecrolimus cream

1 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

EUCRISA*crisaborole oint

2 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

NUJO*tacrolimus (topical) soln  ; NUJU*tacrolimus cream  ; PROTOPIC*tacrolimus oint  ; TACROLIMUS*tacrolimus cream  ; TACROLIMUS*tacrolimus oint

0.03 % ; 0.1 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

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

  1. The requested agent is for use on the face (including eyelids), neck, or skin folds (e.g. groin, armpit/under arm) OR
  2. The patient’s medication history includes use of a topical corticosteroid or topical corticosteroid combination preparation within the past 90 days OR
  3. The patient has an intolerance, or hypersensitivity to a topical corticosteroid or topical corticosteroid combination preparation OR
  4. The patient has an FDA labeled contraindication to ALL topical corticosteroids and topical corticosteroid combination preparations

Length of approval: 12 months

This program applies to Commercial, SourceRx, Blue Partner, and Health Insurance Marketplace formularies.

 

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 _ Atopic Dermatitis (Elidel [pimecrolimus], Eucrisa, Protopic [tacrolimus]) Step Therapy _ProgSum_ 1/1/2023  _