Prior Auth Protocol

FDA Approved Indications:

Second-line therapy for the short term and non-continuous chronic treatment of MILD to MODERATE atopic dermatitis 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.

Health Net Approved Indications and Usage Guidelines:

Patient must be at least 2 years of age

AND

Failure or clinically significant adverse effects to TWO formulary medium to high potency topical corticosteroids

OR

Contraindication to the use of medium to high potency topical corticosteroids (i.e. areas involving the face, neck, and intertriginous areas)

AND

Diagnosis of mild to moderate atopic dermatitis (a form of eczema)

OR

Diagnosis of vitiligo

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
Treatment of allergic contact dermatitis

General Information:

On March 10, 2005, the FDA issued a public health advisory about a potential cancer risk from Elidel. The FDA recommends that Elidel should be used second-line, avoided in children below the age of 2, and used in minimum amounts intermittently to control symptoms. Black box warning and Medication Guide for patients have been instituted, as recommended by the FDA.
A Consensus Conference on Atopic Dermatitis sponsored by the American Academy of Dermatology recommended that topical immunomodulator agents (i.e. Elidel) should be reserved for second line therapy in patients who fail standard interventions, including low to mid potency topical corticosteroids.
The long-term safety of Elidel has not been established beyond one year of non-continuous use.
Patients with Netherton`s syndrome should not use Elidel due to potential increase in absorption.
Based on the available data, the routine use Elidel for vitiligo is supported at this time.
Based on the available data, the routine use of Elidel for the treatment of allergic contact dermatitis is not supported at this time.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
*Very High Potency* augmented betamethasone 0.05% (Diprolene^RAF) cream, ointment, gel, lotion clobetasol propionate 0.05% (Temovate^R) cream, ointment, gel, solution diflorasone diacetate 0.05% (Maxiflor^R, Psorcon E^R) cream, ointment halobetasol propionate 0.05% (Ultravate^R) cream, ointment	Apply topically to the affected area(s) BID	Should not be used for longer than 2 consecutive weeks
*High Potency* augmented betamethasone 0.05% (Diprolene^RAF) cream, ointment, gel, lotion diflorasone 0.05% cream (Florone^R, Florone E^R, Maxiflor^R, Psorcon E^R) cream fluocinonide acetonide 0.05% (Lidex^R, Lidex E^R) cream, ointment, gel, solution triamcinolone acetonide 0.5% (Aristocort^R, Kenalog^R) cream, ointment	Apply topicaly to the affected area(s) BID	Should not be used for longer than 2 consecutive weeks
*Medium Potency* desoximetasone 0.05% (Topicort^R)cream, ointment, gel fluocinolone acetonide 0.025% (Synalar^R)cream, ointment mometasone 0.1% (Elocon^R)cream, ointment, lotion triamcinolone acetonide 0.025%, 0.1% (Aristocort^R, Kenalog^R)cream, ointment	Apply topically to the affected area(s) BID	Should not be used for longer than 2 consecutive weeks
*Low Potency* aclometasone 0.05% (Aclovate^R)cream, ointment desonide 0.05% (Desowen^R)cream, ointment, lotion fluocinolone acetonide 0.01% (Synalar^R) solution hydrocortisone 2.5% (Hytone^R)cream, ointment	Apply topically to the affected area(s) BID	Should not be used for longer than 2 consecutive weeks

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Elidel	Children >/= 2 years and adults: Apply a thin layer topically to affected skin BID. Treatment should be discontinued if resolution of disease occurs.	Length of Benefit

Product Availability:

Elidel cream: 1% (30 gm, 60 gm, 100 gm tubes)

References:

1. Elidel [Prescribing information] Bridgewater, NJ: Valeant Pharmaceuticals North America; March 2014.

2. Hanifin JM, Cooper KD, Ho VC, et al. Guidelines of care for atopic dermatitis 2004. J Am Acad Dermatol. 2004 Mar;50(3):391-404.

3. Micromedex^R Healthcare Series (Internet database). Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 5, 2015.

4. Boone B, Ongenae K, van Geel N et al. Topical pimecrolimus in the treatment of vitiligo. Eur J Dermatol 2007; 17:5561.

5. Dawid M, Veensalu M, Grassberger M, , Wolff K. et al, Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: Results of a randomized, double-blind, vehicle-controlled study. Journal der Deutschen Dermatologischen Gesellschaft. 2006;4:942-946.

6. Coskun B, Saral Y, Turgut D. Topical 0.05% clobetasol propionate versus 1% pimecrolimus ointment in vitiligo. Eur J Dermatol 2005;15:8891.

7. Grimes PE, Morris R, Avaniss-Aghajani E, et al. Topical tacrolimus therapy for vitiligo: therapeutic responses and skin messenger RNA expression of proinflammatory cytokines. J Am Acad Dermatol. 2004;51:52-61.

8. Lepe V, Moncada B, Castanedo-Cazares JP, et al. A double-blind randomized trial of 0.1% tacrolimus vs. 0.05% clobetasol for the treatment of childhood vitiligo. Arch Dermatol 2003; 139:5815.

9. Eichenfield LF, Lucky AW, Boguniewicz M, et al. Safety and efficacy of pimecrolimus (ASM981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J Am Acad Dermatol. 2002;46(4):495-504.

10. Fleisher AB Jr. Tacrolimus ointment for the treatment of atopic dermatitis is not associated with an increase in cutaneous infections. J Am Acad Dermatol 2002 Oct; 47(4):562-70.

11. Boguniewicz, Mar, Leung, et al. Long term Safety of Topically Applied Tacrolimus Ointment in Adult Atopic Dermatitis Patients. The Journal of Allergy & Clinical Immunology January 2002; 109(1) S160.

12. Hanifin, JM. Tacrolimus ointment: Advancing the treatment of atopic dermatitis. Suppl to J of Am Academy of Derm January 2001; 44(1):S1-S72.

13. Siguira H, et al. Long-term efficacy of tacrolimus ointment for recalcitrant facial erythema resistant to topical corticosteroids in adult patients with atopic dermatitis. Arch Dermatol 2000;136:1062-63.

14. Fleisher AB Jr. Treatment of atopic dermatitis: Role of tacrolimus ointment as a topical noncorticosteroidal therapy. J Allergy Clin Immunol 1999;104:S126-30.

15. Boguniewicz M, et al. A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children. Pediatric Tacrolimus Study Group. J Allergy Clin Immunol 1998;102(4 Pt1):637-644.

16. Elidel. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 5, 2015.