Prior Authorization Guideline - OptumRx

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Prior Authorization Guideline - OptumRx

Prior Authorization Guideline

Guideline: MEDPD - Topical Immunomodulators (Saver & Comp)

Therapeutic Class: Skin and Mucous

Membrane Agents, Miscellaneous

Therapeutic Sub-Class: Miscellaneous

Client: PDP Saver & Comprehensive

Approval Date: 12/6/2005

Revision Date:


I. BENEFIT COVERAGE

Table 1. Formulary status

Non-Formulary Products

Tier 5

Elidel ® (pimecrolimus) cream 1%

Protopic ® (tacrolimus) ointment 0.03%

and 0.1%

Formulary Products

II.

INDICATIONS

A. FDA Approved Indications 1-2

Elidel ® 1% cream is FDA approved in children 2 years of age and older for short term and

intermittent long-term therapy in the treatment of mild to moderate atopic dermatitis in

non-immunocompromised patients in whom the use of alternative, conventional therapies is

deemed inadvisable because of potential risks, or in the treatment of patients who are not

adequately responsive to or intolerant of alternative, conventional therapies. 1

Protopic ® 0.03% and 0.1% Ointment are FDA approved in adults for short-term and

intermittent long-term therapy in the treatment of patients with moderate to severe atopic

dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable

because of potential risks, or in the treatment of patients who are not adequately responsive

to or are intolerant of alternative, conventional therapies. 2

Protopic ® 0.03% Ointment only is FDA approved in children ages 2 to 15 years of age

for short-term and intermittent long-term therapy in the treatment of patients with moderate

to severe atopic dermatitis in whom the use of alternative, conventional therapies are

deemed inadvisable because of potential risks or who are not adequately responsive to or

intolerant of alternative, conventional therapies. 2

III.

GUIDELINE

A. Elidel 1% or Protopic 0.03% will be approved based on one of the following criteria:

1. Patient is > 2 years of age. 1 -AND-

2. History of failure, intolerance, or contraindication to one topical corticosteroid therapy

(see Table 2) for inflammation. a

B. Protopic 0.1% will be approved based on all of the following criteria:

1. Patient is > 18 years of age. 2 -AND-

2. History of failure, intolerance, or contraindication to one topical corticosteroid therapy

(see Table 2) for inflammation. a

Table 2. Topical Corticosteroid Therapy 13-15

Potency Brand Name Generic Name


Low potency Hytone ® , Cortaid ® Hydrocortisone acetate

Aclovate ®

Alclometasone

DesOwen ® , Tridelison ® Desonide

Kenalog ®

Triamcinolone acetonide

Synalar ®

Fluocinolone acetonide

Valisone ®

Betamethasone valerate

Medium potency Cordran ® Flurandrenolide

Cutivate ®

Fluticasone

Diprosone ®

Betamethasone dipropionate

Elocon ®

Mometasone

Kenalog ®

Triamcinolone acetonide

Locoid ®

Hydrocortisone butyrate

Synalar ®

Fluocinolone acetonide

Topicort ® LP

Desoximetasone

Westcort ®

Hydrocortisone valerate

High Potency Cyclocort ® Amcinonide

Diprolene ® , Diprolene ® AF Augmented betamethasone

dipropionate

Diprosone ®

Betamethasone dipropionate

Halog ®

Halcinonide

Kenalog ®

Triamcinolone acetonide

Lidex ®

Fluocinonide

Topicort ®

Desoximetasone

Psorcon ®

Diflorasone diacetate

Temovate ®

Clobetasol propionate

Ultravate ®

Halobetasol propionate

Vanos ®

Fluocinonide

IV.

CONTRAINDICATIONS AND WARNINGS

A. Contraindications

1. Hypersensitivity reaction

B. Warnings

Elidel is contraindicated in patients with a history of hypersensitivity to pimecrolimus or

any of the components of the cream. 1

Protopic is contraindicated in patients with history of hypersensitivity to tacrolimus or

any other component of the preparation. 2

1. Carcinogenesis 1-3

The FDA issued a public health advisory to inform healthcare professionals and patients

about a potential cancer risk from use of Protopic (tacrolimus) and Elidel

(pimecrolimus). 3 This concern is based on information from animal studies, case reports

in a small number of patients, and knowledge of how drugs in this class work. It may take

human studies of ten years or longer to determine if use of Protopic or Elidel is linked to

cancer. In the meantime, this risk is uncertain, and FDA advises Protopic and Elidel

should be used only as labeled, for patients after other prescription treatments have failed

to work or cannot be tolerated.

2. Others


Before starting Elidel or Protopic therapy, clinical infections at treatment sites should be

cleared. Use of Elidel or Protopic should be carefully evaluated if varicella zoster,

herpes simplex, or eczema herpeticum virus infections are present. 1-2

Patient should minimize or avoid exposure to natural or artificial sunlight (tanning beds

or UVA/B treatment) while using Elidel or Protopic. 1-2

Both Elidel and Protopic are classified as pregnancy category C. 1-2

V. DOSING 1-2

Elidel 1%:

Protopic 0.03% and 0.1%:

Apply a thin layer to affected area twice daily.

Discontinue treatment when signs and symptoms clear.

Apply a thin layer to affected area twice daily.

Continue for 1 week after signs and symptoms clear.

The safety of Elidel and Protopic under occlusion which may promote systemic exposure

has not been evaluated and should not be used with occlusive dressings. 1-2

VI.

AVAILABILITY

Elidel cream 1% is available in 30g, 60g and 100g tubes. 1

Protopic ointment 0.03% and 0.1% are available in 30g, 60g and 100g laminate tubes. 2

VII.

BACKGROUND

A. Description 1-2

Elidel is an immunosuppressant derived from macrolactam ascomycin. Protopic is a

macrolide immunosuppressant produced by Streptomyces tsukubaensis. The exact

mechanism(s) of action of Elidel and Protopic in the treatment of atopic dermatitis are

unknown. It appears to inhibit T-lymphocytes activation, suppress cell-mediated immune

responses, inhibit skin mast cells and basophils mediator release, and down-regulate the

expression of high-affinity receptors for immunoglobulin E (IgE) on Langerhans cells.

B. Clinical Studies

1. Elidel for mild to moderate atopic dermatitis in Pediatrics 4-6

Three randomized, double-blind, vehicle-controlled, multi-center studies were conducted

to evaluate the use of Elidel in the treatment of mild to moderate AD in 1343 pediatric

patients aged 3 months to 17 years. All patients had >5% of total body surface area

(BSA) affected, and about 75% had AD affecting the face and/or neck region. Patients

were randomized to Elidel or vehicle group twice daily. At endpoint, more improvements

were seen in patients treated with Elidel than placebo based on physicians’ global

evaluation of clinical response, caregiver’s report, EASI, and pruritus assessment. One

study (n=961) also showed that significantly more patients in the Elidel group were

maintained without corticosteroid therapy compared to patients in the placebo group


(infants: 63.7% vs. 34.8%, p


statistically significant difference between Protopic 0.1% and either hydrocortisone

ointment was observed. However, significantly less improvement was observed in the

Protopic 0.03% group compared to Protopic 0.1% (p


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


or in part without Prescription Solutions’ prior written consent.

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