Prior Authorization Guideline - OptumRx

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Prior Authorization Guideline - OptumRx

as Protopic) and Pimecrolimus (marketed as Elidel). March 10, 2005. Available at:

http://www.fda.gov/cder/drug/advisory/elidel_protopic.htm. Accessed October 26, 2005.

4. Ho VC, Gupta A, Kaufmann R, et al. Safety and efficacy of nonsteroid pimecrolimus cream

1% in the treatment of atopic dermatitis in infants. J Pediatr 2003; 142(2):155-62.

5. Papp, K, Staab D, Harper J, et al. Effect of pimecrolimus cream 1% on the long-term course

of pediatric atopic dermatitis. Int J Dermatol 2004;43(12):978-83.Hanifin JM, Cooper KD,

Kang VW, et al. Guidelines for the care of atopic dermatitis. J Am Acad of Derma

2003;50(3):391-404.

6. Staab D, Kaufmann R. Brautigam M, et al. Treatment of infants with atopic eczema with

pimecrolimus cream 1% improves parents' quality of life: a multicenter, randomized trial.

Pediatr Allergy Immunol 2005;16(6):527-33.

7. Schachner LA, Lamerson C, Sheehan MP, et al. Tacrolimus ointment 0.03% is safe and

effective for the treatment of mild to moderate atopic dermatitis in pediatric patients: results

from a randomized, double-blinded, vehicle-controlled study. Peds 2005;116(3):334-342.

8. Luger TA, Lahfa M, Folster-Host R, et al. Long-term safety and tolerability of pimecrolimus

cream 1% and topical corticosteroid in adults with moderate to severe atopic dermatitis. J

Derm Treat. 2004;15(3):169-78.

9. Meurer M, Fartasch M, Albrecht G, et al. Long-term Efficacy and Safety of Pimecrolimus

Cream 1% in Adults with Moderate Atopic Dermatitis. Derm 2004;208(4):365-72.

10. Reitamo S, Ortonee JP, Sand C, et al. A multicenter, randomized, double-blind, controlled

study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe

atopic dermatitis. Br J Dermatol. 2005;152(6):1282-9.

11. U.S. Food and Drug Administration. FDA Public Health Advisory: Elidel cream and Protopic

ointment. 2005. Available at: http://www.fda.gov/cder/drug/advisory/elidel_protopic.htm

Accessed October 25, 2005.

12. Joint Task Force on Practice Parameters. Disease management of atopic dermatitis: an update

practice parameter. Ann Allergy Asthma Immunol 2004;93(3 Suppl 2):S1-21.

13. Lee M. The role of corticosteroids in dermatology. Aust Prescr 1998;21:9-11. Available at

http://www.australianprescriber.com/magazines/vol21no1/dermatology.htm. Accessed June

6, 2004.

14. Ellsworth A, Smith RE. Dermatotherapy and Drug Induced Skin Disorders. In: Koda-Kimble

MA, et al, eds. Applied Therapeutics: The Clinical Use of Drugs. Philadelphia, PA:

Lippincott, Willliams, & Wilkins; 2005:38-1-38-19.

15. Drug Facts and Comparisons. Available at http://www.efactsonline. Accessed June 6, 2005.

X. ENDNOTES

a. Due to concerns about potential cancer risk from the use of Elidel and Protopic, the FDA

recommended these agents be use as second line agents for short-term and intermittent

treatment of AD (eczema) in patients unresponsive to, or intolerant of other treatments.

b. Only Protopic has the label indication for severe atopic dermatitis. 2

This Prior Authorization Guideline represents the recommendation of Prescription Solutions’ Pharmacy and Therapeutics (P&T)

C i i b d h & C i ’ i f h il bl id f h d f d f i i i f hi i

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