Effective Date

Date of Origin 

1/1/2023

Cibinqo™

(abrocitinib)

Tablet

Treatment of adults with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Limitation of use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants

1

Atopic Dermatitis

Atopic dermatitis (AD), also known as atopic eczema, is a chronic, pruritic inflammatory dermatosis affecting up to 25% of children and 1-5% of adults. AD follows a relapsing course and is associated with elevated serum immunoglobulin (IgE) levels and a personal or family history of type I allergies, allergic rhinitis, and/or asthma. Onset is most common between 3 and 6 months of age, with approximately 60% of patients developing the eruption in the first year of life and 90% by age 5. While the majority of affected individuals have resolution of disease by adulthood, 10 to 30% do not, and a smaller percentage first develop symptoms as adults. AD has a complex pathogenesis involving genetic, immunologic, and environmental factors, which lead to a dysfunctional skin barrier and dysregulation of the immune system. Clinical findings include erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and lichenification. These clinical findings vary by patient age and chronicity of lesions. Pruritus is a hallmark of the condition that is responsible for much of the disease burden borne by patients and their families. Typical patterns include facial, neck and extensor involvement in infants and children; flexure involvement in any age group, with sparing of groin and axillary regions.(2)

Goals of treatment are to reduce symptoms (pruritus and dermatitis), prevent exacerbations, and minimize therapeutics risks.(6) Despite its relapsing and remitting nature, the majority of patients with AD can achieve clinical improvement and disease control with nonpharmacological interventions (e.g., emollient use), conventional topical therapies (including corticosteroids and calcineurin inhibitors) and environmental and occupational modifications, when necessary.(4,5,6) The American Academy of Dermatology (AAD) guidelines suggest application of moisturizers should be an integral part of the treatment of patients with AD as there is strong evidence that their use reduces disease severity and need for pharmacologic intervention. They are an important component of maintenance treatment and prevention of flares.(4) The AAD recommends topical corticosteroids (TCS) for patients who fail to respond to good skin care practices and regular use of emollients alone. Proactive, intermittent use of topical corticosteroids as maintenance therapy (1-2 times weekly) on areas that commonly flare is recommended to help prevent relapses and is more effective than use of emollients alone. Monitoring by physical exam for cutaneous side effects during long-term, potent steroid use is suggested. Proactive, once to twice weekly application of mid-potency TCS for up to 40 weeks has not demonstrated adverse events (e.g., purpura, telangiectasia, striae, focal hypertrichosis, acneiform/rosacea-like eruptions, skin atrophy) in clinical trials.(4) It is recommended that patients with acute flares use super high or high potency topical corticosteroids for one to two weeks, and then replace these with lower potency preparations until the lesions resolve.(7) AAD notes that mid- to higher potency topical corticosteroids are appropriate for short courses to gain rapid control of symptoms, but long-term management should use the least-potent corticosteroid that is effective.(4) In general, if AD is not responding after 2 weeks of treatment, evaluation to determine other treatment plans is indicated.(3,7)

Topical calcineurin inhibitors (TCIs) (e.g., pimecrolimus, tacrolimus) are recommended by the AAD as second-line therapy and are effective for acute and chronic treatment. They are particularly useful in selected clinical situations such as recalcitrance to steroids; for sensitive areas (face, anogenital, skin folds); for steroid-induced atrophy; and when there is long-term uninterrupted topical steroid use. TCIs are recommended for use on actively affected areas as a steroid-sparing agent. Proactive, intermittent use of TCIs as maintenance therapy (2-3 times per week) on areas that commonly flare is recommended to help prevent relapses while reducing need for topical corticosteroids and is more effective than use of emollients alone.(4) Prescribing information for Elidel^® (pimecrolimus) cream and Protopic^® (tacrolimus) ointment indicate evaluation after 6 weeks if symptoms of AD do not improve for adults and pediatrics.(8,9)

Phototherapy is recommended as a treatment for both acute and chronic AD in children and adults, after failure of the mentioned above. Systemic immunomodulator agents are indicated and recommended for the subset of adult and pediatric patients in whom optimized topical regimens using emollients, topical anti-inflammatory therapies, adjunctive methods, and/or phototherapy do not adequately control the signs and symptoms of disease. Photo therapy and systemic immunomodulating agents may also be used in patients whose medical, physical, and/or psychological states are greatly affected by their skin disease. Oral cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil are the most commonly used systemic immunomodulators and most efficacious for treating AD. The AAD recommends that systemic corticosteroids should be avoided if possible and should exclusively be reserved for acute, severe exacerbations and as a short-term bridge to other systemic, steroid sparing therapies.(5,10)

Efficacy(1)

The efficacy of Cibinqo as monotherapy and in combination with background topical corticosteroids was evaluated in 3 randomized, double-blind, placebo-controlled trials [Trial-AD-1 (NCT03349060), Trial-AD-2 (NCT03575871), and Trial-AD-3 (NCT03720470)] in 1615 subjects 12 years of age and older (Cibinqo is not approved for use in pediatric patients) with moderate-to-severe atopic dermatitis as defined by Investigator’s Global Assessment (IGA) score greater than or equal to 3, Eczema Area and Severity Index (EASI) score greater than or equal to 16, body surface area (BSA) involvement greater than or equal to 10%, and Peak Pruritus Numerical Rating Scale (PP-NRS) greater than or equal to 4 at the baseline visit prior to randomization.

Overall, 53% of subjects were male, 69% of subjects were white, 64% of subjects had a baseline IGA score of 3 (moderate AD), and 36% of subjects had a baseline IGA score of 4 (severe AD). The baseline mean EASI score was 30. The baseline mean age was 36 years old with 8% of subjects 12 to less than 18 years old and 92% of subjects 18 years of age or older. Subjects in these trials were those who had inadequate response to previous topical therapy or were subjects for whom topical treatments were medically inadvisable, or who had received systemic therapies including dupilumab. In each of the trials, over 40% of subjects had prior exposure to systemic therapy. In Trial-AD-1 and Trial-AD-2, 6% of the subjects had received dupilumab, whereas prior use of dupilumab was not allowed in Trial-AD-3.

The proportion of subjects achieving PP-NRS4 at week 2 (defined as an improvement of greater than or equal to 4 points from baseline in PP-NRS) was higher in subjects treated with Cibinqo monotherapy 200 mg once daily (28% in Trial-AD-1 and 24% in Trial-AD-2) and 100 mg once daily (11% in both trials) compared to placebo (2% in

both trials). A higher proportion of subjects in the Cibinqo monotherapy 100 mg or 200 mg once daily arm compared to placebo achieved improvement in itching at week 12.

The proportions of subjects achieving PP-NRS4 at week 2 was higher in subjects treated with Cibinqo 200 mg once daily (30%) and 100 mg once daily (14%) in combination with background medicated topical therapies compared to placebo (8%). Examination of age, gender, race, weight, and previous systemic AD therapy treatment did not identify differences in response to Cibinqo 100 mg or 200 mg once daily among these subgroups in Trial-AD-1, Trial- AD-2, and Trial-AD-3.

Safety(1)

Abrocitinib carries the following boxed warnings:

• Increased risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with Cibinqo if serious or opportunistic infection occurs. Test for latent TB before and during therapy, and if positive, start treatment for TB prior to use. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
• Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus Kinase (JAK) inhibitor vs tumor necrosis factor (TNF) blockers in RA patients
• Malignancies have occurred in patients treated with Cibinqo. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs TNF blockers in RA patients
• MACE (defined as cardiovascular death, myocardial infarction, and stroke) has occurred with Cibinqo. Higher rate of MACE with another JAK inhibitor vs TNF blockers in RA patients
• Thrombosis has occurred in patients treated with Cibinqo. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs TNF blockers.

Abrocitinib is contraindicated in patients taking antiplatelet therapies, except for low dose aspirin (less than or equal to 81 mg daily), during the first 3 months of treatment.

1

Cibinqo prescribing information. Pfizer Labs. January 2022.

2

Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, et al. Guidelines of Care for the Management of Atopic Dermatitis: Section 1. Diagnosis and Assessment of Atopic Dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51.

3

Weston, William L., MD., et al. Treatment of Atopic Dermatitis (eczema). UpToDate. Last updated December 2021. Literature review current through December 2021.

4

Eichenfield L, Tom W, Berger T, et al. Guidelines of care for the management of atopic dermatitis. Section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol 2014;71(1):116-32.

5

Sidbury, Robert, MD., et al. Guidelines of Care for the Management of Atopic Dermatitis. Section 3. Management and Treatment with Phototherapy and Systemic Agents. J Am Acad Dermatol 2014; 71 (2): 327-349.

6

Sidbury R, Tom WL, Bergman JN, Cooper KD, Silverman RA, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33.

7

Schneider L, Tilles S, Lio P, et al. Atopic dermatitis: a practice parameter update 2012. J Allergy Clin Immunol 2013; 131:295.

8

Elidel prescribing information. Valeant Pharmaceuticals. December 2017.

9

Protopic prescribing information. Astellas Pharma US Inc. May 2012.

10

European Task Force on Atopic Dermatitis (ETFAD) / European Academy of Dermatology and Venereology (EADV) Eczema Task Force Position Paper on Diagnosis and Treatment of Atopic Dermatitis in Adults and Children. J Eur Acad Dermatol Venereol. 2020;34(12):2717-2744.

CIBINQO*abrocitinib tab

100 MG ; 200 MG ; 50 MG

M ; N ; O ; Y

N

10-01-2022

902720050003

CIBINQO*abrocitinib tab

100 MG ; 200 MG ; 50 MG

30.0

TABS

30

Days

10-01-2022

CIBINQO*abrocitinib tab

100 MG ; 200 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CIBINQO*abrocitinib tab

100 MG ; 200 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following:
   1. The requested agent is eligible for continuation of therapy AND ONE of the following:

1. 1. 1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
      2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
   2. The patient has a diagnosis of moderate-to-severe atopic dermatitis (AD) AND ALL of the following: 
      1. ONE of the following:
         1. The patient has at least 10% body surface area involvement OR
         2. The patient has involvement of the palms and/or soles of the feet AND
      2. ONE of the following:
         1. The patient has tried and had an inadequate response to at least a mid- potency topical steroid used in the treatment of AD for a minimum of 4 weeks AND a topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) used in the treatment of AD for a minimum of 6 weeks OR
         2. The patient has an intolerance or hypersensitivity to at least a mid- potency topical steroid AND a topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) used in the treatment of AD OR
         3. The patient has an FDA labeled contraindication to ALL mid-, high-, and super-potency topical steroids AND topical calcineurin inhibitors used in the treatment of AD AND
      3. ONE of the following:
         1. The patient has tried and had an inadequate response to a systemic immunosuppressant, including a biologic, used in the treatment of AD for a minimum of 3 months OR
         2. The patient has an intolerance or hypersensitivity to therapy with systemic immunosuppressants, including a biologic, used in the treatment of AD OR
         3. The patient has an FDA labeled contraindication to ALL systemic immunosuppressants, including biologics, used in the treatment of AD AND
      4. ONE of the following:
         1. The patient has tried and had an inadequate response to Dupixent used for a minimum of 4 months for the treatment of AD OR
         2. The patient has an intolerance or hypersensitivity to Dupixent OR
         3. The patient has an FDA labeled contraindication to Dupixent AND
      5. ONE of the following:
         1. The patient has tried and had an inadequate response to Rinvoq used for a minimum of 4 months for the treatment of AD OR
         2. The patient has an intolerance or hypersensitivity to Rinvoq OR
         3. The patient has an FDA labeled contraindication to Rinvoq AND
      6. ONE of the following: 
         1. The patient has tried and had an inadequate response to Adbry used for a minimum of 4 months for the treatment of AD OR
         2. The patient has an intolerance or hypersensitivity to Adbry OR
         3. The patient has an FDA labeled contraindication to Adbry AND
      7. The prescriber has assessed the patient’s baseline (prior to therapy with the requested agent) pruritus and other symptom severity (e.g., erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and/or lichenification) AND
      8. The patient will be using standard maintenance therapy (e.g., topical emollients, good skin care practices) in combination with the requested agent OR
   3. The patient has another FDA approved indication for the requested agent and route of administration OR
   4. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
2. ONE of the following:
   1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
   2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
3. The patient has been tested for latent tuberculosis (TB) AND if positive the patient has begun therapy for latent TB  AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, allergist, immunologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis  AND
5. The patient will NOT be using the requested agent in combination with Dupixent or Adbry for the requested indication AND
6. ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 
   1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
   2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
      2. The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required) AND
7. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

Length of Approval: 6 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process  AND
2. ONE of the following:
   1. The patient has a diagnosis of moderate-to-severe atopic dermatitis AND BOTH of the following:
      1. The patient has had a reduction or stabilization from baseline (prior to therapy with the requested agent) of ONE of the following:
         1. Affected body surface area OR
         2. Flares  OR
         3. Pruritus, erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and/or lichenification AND
      2. The patient will continue standard maintenance therapies (e.g., topical emollients, good skin care practices) in combination with the requested agent OR
   2. The patient has another FDA approved indication for the requested agent and route of administration AND has had clinical benefit with the requested agent OR
   3. The patient has another indication that is supported in compendia for the requested agent and route of administration AND has had clinical benefit with the requested agent AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, allergist, immunologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis  AND
4. The patient will NOT be using the requested agent in combination with Dupixent or Adbry for the requested indication AND
5. ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 
   1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
   2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
      2. The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required) AND
6. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

Length of Approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

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

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. ALL of the following:
   1. The requested quantity (dose) is greater than the program quantity limit AND
   2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
   3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

Length of Approval: Initial Approval - 6 months, Renewal Approval - 12 months

Agents NOT to be used Concomitantly

Adbry (tralokinumab-ldrm)

Actemra (tocilizumab)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Dupixent (dupilumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Humira (adalimumab)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Nucala (mepolizumab)

Olumiant (baricitinib)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Siliq (brodalumab)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Zeposia (ozanimod)