Oscar Cibinqo (abrocitinib) (PG111) Form

Atopic Dermatitis (AD)

Atopic dermatitis (AD) is a chronic inflammatory skin disorder that affects approximately 10% of adults and 20% of children worldwide. It is characterized by intense itching, redness, and eczematous lesions, which can be accompanied by skin dryness, scaling, and thickening. The severity of AD can be classified as mild, moderate, or severe, depending on the extent and intensity of skin inflammation, as well as the impact on the patient's quality of life.

Moderate-to-severe AD is defined by the presence of extensive or widespread lesions, intense pruritus, and significant impairment of daily activities, sleep, and mood.

Treatment options for moderate-to-severe AD

Treatment options for moderate-to-severe AD involve a combination of topical and systemic therapies, tailored to the individual patient's needs and preferences. The goal of treatment is to control inflammation, relieve itching, restore the skin barrier, prevent flares, and improve quality of life.

• Topical treatments for moderate-to-severe AD include corticosteroids, calcineurin inhibitors, and phosphodiesterase-4 (PDE4) inhibitors. These drugs act by reducing inflammation and pruritus and promoting skin healing. However, their long-term use may be limited by adverse effects, such as skin atrophy, telangiectasias, or the potential risk of skin infections or malignancies.
• Systemic treatments for moderate-to-severe AD are reserved for patients with inadequate response or contraindications to topical therapies, or those with severe or rapidly worsening disease. The most commonly used systemic agents include oral immunosuppressants, such as cyclosporine, methotrexate, or mycophenolate mofetil, and biologic agents, such as dupilumab, which targets the interleukin-4 (IL-4)/interleukin-13 (IL-13) pathway.

Cibinqo (abrocitinib) is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of those therapies is inadvisable. Limitations of Use: Cibinqo (abrocitinib) is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

Definitions

"Atopic Dermatitis"

also known as eczema is a chronic skin condition that makes a person's skin red, itchy and scaly. Atopic dermatitis (AD) often begins during childhood and persists into adulthood. Some people experience occasional flares followed by periods of improvement or a "waxing and waning" course of the disease.

"Biologics"

are a type of medication that are designed to target specific parts of the immune system. Some biologics, such as Dupixent, Adbry, and Rinvoq, are used in the treatment of moderate to severe atopic dermatitis.

"Body Surface Area (BSA%)"

refers to the percentage of the body covered by atopic dermatitis. It is often used in determining the severity of the disease.

"Janus kinase 1 (JAK1) inhibitor"

is a type of medication that functions by inhibiting the activity of one or more enzymes in the Janus kinase family. This action helps to reduce the inflammatory response that underlies conditions like atopic dermatitis.

"Topical Corticosteroids (TCS)"

are steroid medications applied to the skin. They are used to reduce inflammation and suppress the immune response in conditions like atopic dermatitis.

Medical Necessity Criteria for Initial Authorization

The Plan considers Cibinqo (abrocitinib) medically necessary when ALL of the following criteria are met:

1. The medication is prescribed by or in consultation with a dermatologist, allergist, or immunologist; AND
2. The member is 12 years of age or older; AND
3. The member has a documented diagnosis of moderate to severe atopic dermatitis AND ONE of the following:
• Involvement of (≥) 10% or more of body surface area; or
• Involvement of sensitive body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); AND
4. The member is unable to use, or has adequately tried and failed ALL of the following topical therapies for at least 8 weeks each in the past 365 days:
• At least two (2) topical corticosteroid (TCS) from medium potency (group III to IV) classes to higher potencies (groups I to II) classes (see Table 2); and
• Tacrolimus ointment; and
• Eucrisa (crisaborole) [require members be unable to use, or has tried and failed a medium or higher potency TCS within the past 180 days]; AND
5. Cibinqo (abrocitinib) will not be used concomitantly with other JAK inhibitors, biologics (e.g., Dupixent, Adbry, or Rinvoq) in the treatment of atopic dermatitis; AND
6. Cibinqo (abrocitinib) is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature; AND

Clinical chart documentation is provided for review to validate the above listed requirements. If the above prior authorization criteria are met, Cibinqo (abrocitinib) will be approved for 4 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months may be provided for members 12 years of age or older when recent chart documentation (within the past 4 months) is provided showing ALL of the following criteria are met:

1. The member is responding positively to Cibinqo (abrocitinib) treatment based upon the prescriber’s assessment as demonstrated by ONE of the following:
   • decreased disease activity (e.g., a reduction in BSA%); or
   • symptomatic improvement (e.g., redness, itching, oozing/crusting); AND
2. Cibinqo (abrocitinib) will not be used concomitantly with other JAK inhibitors, biologics (e.g., Dupixent, Adbry, or Rinvoq) in the treatment of atopic dermatitis; AND
3. Cibinqo (abrocitinib) is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature.

Experimental or Investigational / Not Medically Necessary

Cibinqo (abrocitinib) for any other indication apart from atopic dermatitis is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven. Non-covered indications include, but are not limited to, the following:

• Chronic Prurigo / Prurigo Nodularis / Pruritus / Pruritus Chronic / Skin Diseases
• Granuloma annulare lesions
• Psoriasis
• Psoriasis Vulgaris (Plaque Psoriasis)
• Sarcoidosis
• Use for dual therapy with other JAK inhibitors or biologics (e.g., Dupixent, Adbry, or Rinvoq)
• Use as a preventative agent for the development of skin conditions

Appendix

Table 1: Dosage, Retreatment, and Other Considerations

Indication: Moderate to severe atopic dermatitis
Initial dose: 100 mg PO once daily
Subsequent dose: If an adequate response is not achieved after 12 weeks, consider increasing the dose to 200 mg PO once daily
Additional Considerations: Complete any necessary immunizations, including herpes zoster vaccinations, prior to Cibingo (abrocitinib) initiation

Indication: Adults who are CYP2C19 poor metabolizers
Initial dose: 50 mg PO once daily
Subsequent dose: If an adequate response is not achieved after 12 weeks, consider increasing the dose to 100 mg PO once daily. Discontinue use of the drug if an adequate response is not achieved with the 100 mg dose

Indication: Renal Impairment: Mild (60 - 89 mL/minute eGFR)
Initial dose: 100 mg PO once daily
Subsequent dose: If an adequate response is not achieved after 12 weeks, the dose of CIBINQO can be doubled

Renal Impairment: Moderate (30 - 59 mL/minute eGFR)
Initial dose: 50 mg PO once daily
Subsequent dose: If an adequate response is not achieved after 12 weeks, the dose of CIBINQO can be doubled

Renal Impairment: Severe† (15 - 29 mL/minute eGFR)
Not recommended for use

End-Stage Renal Disease† (<15 mL/minute eGFR)
Not recommended for use

Hepatic Impairment: Severe
Not recommended for use

Taking strong inhibitors of CYP2C19
Initial dose: 50 mg PO once daily
Subsequent dose: If an adequate response is not achieved after 12 weeks, consider increasing the dose to 100 mg PO once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily

†Severe Renal Impairment and End-Stage Renal Disease include patients on renal replacement therapy.

Table 2: Topical Corticosteroid Potency

NOTE: The following chart is only for approximate comparative purposes.

Please check product-specific information to best assess product potency, which can also be affected by a multitude of factors (e.g., formulation, site of application, member and disease-specific factors)

Table 2: Topical Corticosteroid Potency

• Group I - Ultra High Potency
  • Betamethasone dipropionate (augmented), Gel, Lotion, Ointment
  • Clobetasol propionate, Cream, Emollient Cream, Foam, Gel, Lotion, Ointment, Spray, and Solution
  • Desoximetasone, Spray
  • Diflorasone diacetate, Ointment
• Group II
  • Fluocinonide, 0.1% Cream
  • Flurandrenolide, 0.05% Tape
  • Halobetasol propionate, 0.05% and 0.01% Cream, Foam, Lotion, and Ointment
• Group III - Upper Medium
  • Amcinonide, Cream and Lotion
  • Betamethasone dipropionate, Cream
  • Betamethasone valerate, Foam
  • Betamethasone valerate, Ointment
  • Fluticasone propionate, 0.005% Ointment
  • Mometasone furoate, 0.1% Ointment
  • Triamcinolone acetonide, Cream
  • Triamcinolone acetonide, Ointment
• Group IV - Medium
  • Betamethasone dipropionate, 0.05% Spray
  • Clocortolone pivalate, 0.1% Cream
  • Desoximetasone, 0.05% Cream and Ointment
• Group V - Lower Medium
  • Fluocinolone acetonide, 0.025% Ointment, 0.025% Cream, 0.01% Shampoo
  • Flurandrenolide, 0.05% Lotion
  • Hydrocortisone valerate, 0.2% Ointment
  • Mometasone furoate, Cream, Lotion, and Solution
  • Triamcinolone acetonide, Cream and Spray
• Group VI - Low Potency
  • Alclometasone dipropionate, 0.05% Cream and Ointment
  • Fluocinolone acetonide, 0.01% Cream, Oil, and Solution
  • Triamcinolone acetonide, 0.025% Cream and Lotion
• Group VII - Lowest Potency
  • Hydrocortisone acetate, 0.5% and 1% Cream and Ointment
  • Hydrocortisone base, 0.5% to 2.5% Cream, Lotion, Ointment, Solution, and Spray

References

1. Bieber, T., Simpson, E. L., Silverberg, J. I., et al; JADE COMPARE Investigators. "Abrocitinib versus placebo or dupilumab for atopic dermatitis." New England Journal of Medicine, vol. 384, no. 12, 2021, pp. 1101-1112. doi:10.1056/NEJMoa2019380.
2. Boguniewicz, M., Fonacier, L., Guttman-Yassky, E., Ong, P. Y., Silverberg, J., Farrar, J. R. "Atopic dermatitis yardstick: Practical recommendations for an evolving therapeutic landscape." Annals of Allergy, Asthma & Immunology, vol. 120, no. 1, 2018, pp. 10-22.e2.

1. doi: 10.1016/j.anai.2017.10.039. PMID: 29273118.
2. Cibinqo (abrocitinib) [prescribing information]. New York, NY: Pfizer Labs; February 2023.
3. Eichenfield, L. F., Flohr, C., Sidbury, R., et al. "Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: the JADE TEEN randomized clinical trial." JAMA Dermatology, vol. 157, no. 10, 2021, pp. 1165-1173. doi:10.1001/jamadermatol.2021.2830.
4. Eichenfield, L. F., Tom, W. L., Berger, T. G., et al. "Guidelines of care for the management of atopic dermatitis: Section 2. Management and treatment of atopic dermatitis with topical therapies." Journal of the American Academy of Dermatology, vol. 71, 2014, pp. 116-132. (Including potencies of topical corticosteroids).
5. Mayo Clinic.org - Atopic Dermatitis. Available at: https://www.mayoclinic.org/diseases-conditions/atopic-dermatitis-eczema. Last Update June 2020. Accessed Feb 28, 2022.
6. Schwartz, D. M., Kanno, Y., Villarino, A., Ward, M., Gadina, M., O'Shea, J. J. "JAK inhibition as a therapeutic strategy for immune and inflammatory diseases." Nature Reviews Drug Discovery, vol. 17, no. 1, 2017, p. 78. doi:10.1038/nrd.2017.267.
7. Seger, E. W., et al. "Relative efficacy of systemic treatments for atopic dermatitis." Journal of the American Academy of Dermatology, vol. 80, 2019, pp. 411. doi:10.1016/j.jaad.2018.09.053.
8. Silverberg, J. I., Simpson, E. L., Thyssen, J. P., et al. "Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial." JAMA Dermatology, vol. 156, no. 8, 2020, pp. 863-873. doi:10.1001/jamadermatol.2020.1406.

Clinical Guideline Revision / History Information

Original Date: 03/17/2022

Reviewed/Revised: 06/29/2023