Effective Date

Date of Origin 

10-01-2025            

Cibinqo®

(abrocitinib)

Tablet

Treatment of adults and pediatric patients 12 years of age and older 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 Janus kinase (JAK) inhibitors, biologic immunomodulators, or with other immunosuppressants 

1

Atopic Dermatitis (AD)

Atopic dermatitis (AD), also known as atopic eczema, is a chronic, pruritic inflammatory dermatosis affecting up to 25% of children and approximately 7% of adults.(2,3) 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, 10-30% 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 topical emollient/moisturizer use and conventional topical therapies (including corticosteroids and calcineurin inhibitors).(5,6) Moisturizers reduce signs, symptoms, and inflammation in AD, and can improve severity while also increasing time between flares. Moisturizers are considered generally safe and are strongly recommended to be used as part of a treatment regimen for AD, either as monotherapy or as concurrent use with pharmacologic treatments.(4)

Topical therapies remain the mainstay of treatment due to their proven track record and generally favorable safety profile. They can be utilized individually or in combination with other topical, physical, and/or systemic treatments; as different classes of treatment have different mechanisms of action, combining therapies allows for the targeting of AD via multiple disease pathways. The American Academy of Dermatology (AAD) strongly recommends the following topical agents:(4)

• Topical corticosteroids (TCS)
• Calcineurin inhibitors (TCIs) (e.g., tacrolimus, pimecrolimus)
• Topical phosphodiesterase (PDE)-4 inhibitors (e.g., crisaborole) [mild to moderate AD]
• Topical Janus kinase (JAK) inhibitors (e.g., ruxolitinib) [mild to moderate AD]

TCS are the most commonly utilized FDA-approved therapies in AD and are typically used as first-line treatment for mild-to-severe dermatitis in all skin regions. TCS target a variety of immune cells and suppress the release of proinflammatory cytokines. High to very high (super) potency TCS can be used to control flares and treat severe disease, while medium potency TCS are utilized for longer courses and as maintenance therapy. Lower potency TCS may be used, and it is important to consider the anatomical site (i.e., using lower potency agents on the face, neck, genitals, and body folds) and severity of the disease when choosing a steroid potency.(4) Clinical trials assessing efficacy generally had a duration of 2 to 6 weeks, and response to TCS therapy should be evaluated by week 4 in clinical practice.(3) Most studies of TCS in AD management involve twice daily application, but some studies (particularly for potent TCS) suggest once daily use may be sufficient. Traditionally, TCS were stopped once AD signs and symptoms of an AD flare were controlled. Maintenance in between AD flares with once to twice weekly use of TCS is another approach.(4)

TCIs are a safe anti-inflammatory option for mild-to-severe AD, particularly when there is concern for adverse events secondary to corticosteroid use. Both tacrolimus and pimecrolimus have been shown to be effective in treating AD, but pimecrolimus may be more appropriate for patients who have milder disease or are sensitive to local reactions.(4) Prescribing information for pimecrolimus cream and tacrolimus ointment indicate evaluation after 6 weeks if symptoms of AD do not improve for adults and pediatrics.(8,9) 

When AD is more severe or refractory to topical treatment, advanced treatment with phototherapy or systemic medications can be considered. Phototherapy is conditionally recommended by the AAD as a treatment for AD based on low certainty evidence. The AAD strongly recommends the following systemic therapies:(5)

• Monoclonal antibodies (biologics) (e.g., dupilumab, tralokinumab)
• JAK inhibitors (e.g., upadacitinib, abrocitinib, baricitinib)

In a change from the 2014 AAD AD guidelines, the use of systemic antimetabolites such as methotrexate, immunosuppressants such as systemic corticosteroids, mycophenolate mofetil, azathioprine, and cyclosporine are now conditionally recommended for AD only in a small number of select patients due to low or very low certainty of evidence and need for monitoring. The most favored first-line systemic agent is dupilumab.(5)

There is no clear consensus on how to operationalize a definition of the FDA indication for treatment of patients with "moderate to severe" AD. The severity of AD can vary substantially over time and, from a patient's perspective, can include a complex combination of intensity of itch, location, body surface area (BSA) involvement, and degree of skin impairment. Given the variability of patient phenotype and lack of familiarity among clinicians with scoring systems used in clinical trials, it is advisable to create a broad clinically relevant definition inclusive of multiple specific measures of disease intensity for example:(11)

One of the following:

• Affected BSA greater than or equal to 10%
• Investigator Global Assessment (IGA) greater than or equal to 3
• Eczema Area and Severity Index (EASI) greater than or equal to 16

OR

One of the following:

• Affected BSA greater than or equal to 10%
• Involvement of body sites that are difficult to treat with prolonged topical corticosteroid therapy (e.g., hands, feet, face, neck, scalp, genitals/groin, skin folds)
• Severe itch that has been unresponsive to topical therapies

Efficacy

The efficacy of Cibinqo was evaluated in 4 randomized, double-blind, placebo-controlled trials [Trial-AD-1 (NCT03349060), Trial-AD-2 (NCT03575871), Trial-AD-3 (NCT03720470), and Trial-AD-4 (NCT03796676)] in 1900 subjects. Trial-AD-1 and Trial-AD-2 were Cibinqo monotherapy trials and enrolled adult and pediatric subjects 12 years of age and older. Trial-AD-3 enrolled only adults and Trial-AD-4 enrolled only pediatric subjects 12 to less than 18 years of age, and subjects in both of these trials in the Cibinqo treatment arm received Cibinqo in combination with topical corticosteroid therapy. The trials enrolled subjects 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.(1)

In Trial-AD-1, Trial-AD-2, and Trial-AD-3, 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. In Trial-AD-4, 49% of subjects were female, 56% of subjects were White, 33% of subjects were Asian and 6% of subjects were Black. The median age was 15 years and the proportion of subjects with severe atopic dermatitis (IGA of 4) was 38%.(1)

The co-primary endpoints of IGA and EASI-75 responses at Week 12 were assessed in all 4 trials. IGA response was based on an IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of greater than or equal to 2 points. EASI-75 response was based on a greater than or equal to 75% improvement in EASI from baseline. In all 4 trials, significantly greater proportions of subjects treated with Cibinqo (200 mg or 100 mg) compared with placebo achieved IGA response and/or EASI-75 response at Week 12.(1)

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 (200 mg or 100 mg) compared to placebo in all 4 trials. 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.(1)

Safety

Abrocitinib carries the following boxed warnings:(1)

• 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.
• A higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients 50 years of age and older with at least one cardiovascular risk factor treated with a JAK inhibitor compared with a tumor necrosis factor (TNF) blocker for rheumatoid arthritis (RA).
• Malignancies, including non-melanoma skin cancer (NMSC), have occurred in patients treated with Cibinqo. Lymphoma and other malignancies (excluding NMSC) have occurred at a higher rate in patients receiving JAK inhibitors used to treat inflammatory conditions compared to TNF blockers. Patients who are current or past smokers are at additional increased risk.
• Major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) have occurred in patients treated with Cibinqo. In patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of MACE was observed in patients treated with a JAK inhibitor compared with a TNF blocker for RA. Patients who are current or past smokers are at additional increased risk. Discontinue Cibinqo in patients that have experienced a myocardial infarction or stroke.
• Deep venous thrombosis (DVT) and pulmonary embolism (PE) have occurred in patients treated with Cibinqo. In patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Cibinqo in patients at risk. If symptoms of thrombosis occur, discontinue Cibinqo and treat appropriately.

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)

1

Cibinqo prescribing information. Pfizer Labs. December 2023.

2

Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: Section 1. Diagnosis and assessment of atopic dermatitis. Journal of the American Academy of Dermatology. 2013;70(2):338-351. doi:10.1016/j.jaad.2013.10.010

3

Chu DK, Schneider L, Asiniwasis RN, et al. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE-and Institute of Medicine-based recommendations. Annals of Allergy Asthma & Immunology. 2023;132(3):274-312. doi:10.1016/j.anai.2023.11.009

4

Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. Journal of the American Academy of Dermatology. 2023;89(1):e1-e20. doi:10.1016/j.jaad.2022.12.029

5

Davis DM, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. Journal of the American Academy of Dermatology. 2024;90(2):e43-e56. doi:10.1016/j.jaad.2023.08.102

6

Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. Journal of the American Academy of Dermatology. 2014;71(6):1218-1233. doi:10.1016/j.jaad.2014.08.038

7

Reference no longer used.

8

Pimecrolimus cream prescribing information. Oceanside Pharmaceuticals. September 2020.

9

Tacrolimus ointment prescribing information. Glenmark Pharmaceuticals Inc., USA. August 2023.

10

Reference no longer used.

11

Atlas SJ, Brouwer E, Fox G, et al. JAK Inhibitors and Monoclonal Antibodies for the Treatment of Atopic Dermatitis: Effectiveness and Value; Final Evidence Report. Institute for Clinical and Economic Review (ICER); 2021. Updated February 27, 2023. https://icer.org/assessment/atopic-dermatitis-2021

Cibinqo

abrocitinib tab

100 MG ; 200 MG ; 50 MG

M ; N ; O ; Y

N

Cibinqo

abrocitinib tab

100 MG ; 200 MG ; 50 MG

30

Tablets

30

DAYS

Cibinqo

abrocitinib tab

100 MG ; 200 MG ; 50 MG

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

Cibinqo

abrocitinib tab

100 MG ; 200 MG ; 50 MG

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

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. 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. BOTH of the following:
      1. ONE of the following:
         1. The patient has a diagnosis of moderate-to-severe atopic dermatitis (AD) AND BOTH 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 body sites that are difficult to treat with prolonged topical corticosteroid therapy (e.g., hands, feet, face, neck, scalp, genitals/groin, skin folds) OR
               3. The patient has an Eczema Area and Severity Index (EASI) score greater than or equal to 16 OR
               4. The patient has an Investigator Global Assessment (IGA) score greater than or equal to 3 AND
            2. ONE of the following:
               1. BOTH of the following:
                  1. The patient has ONE of the following:
                     1. Has tried and had an inadequate response to ONE at least medium-potency topical corticosteroid used in the treatment of AD after at least a 4-week duration of therapy OR
                     2. Has an intolerance or hypersensitivity to ONE at least medium-potency topical corticosteroid used in the treatment of AD OR
                     3. Has an FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in the treatment of AD AND
                  2. The patient has ONE of the following:
                     1. Has tried and had an inadequate response to ONE topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) used in the treatment of AD after at least a 6-week duration of therapy OR
                     2. Has an intolerance or hypersensitivity to ONE topical calcineurin inhibitor used in the treatment of AD OR
                     3. Has an FDA labeled contraindication to ALL topical calcineurin inhibitors used in the treatment of AD OR
               2. The patient's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of AD OR
         2. The patient has another FDA labeled indication for the requested agent and route of administration AND
      2. If the patient has an FDA labeled indication, then ONE of the following:
         1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
         2. There is support for using the requested agent for the patient’s age for the requested indication OR
   3. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
2. If the patient has a diagnosis of moderate-to-severe atopic dermatitis (AD), then BOTH of the following:
   1. The patient is currently treated with topical emollients and practicing good skin care AND
   2. The patient will continue the use of topical emollients and good skin care practices in combination with the requested agent 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. 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. There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or 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: 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 [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
2. The patient has had clinical benefit with the requested agent AND
3. If the patient has a diagnosis of moderate-to-severe atopic dermatitis, the patient will continue standard maintenance therapies (e.g., topical emollients, good skin care practices) in combination with the requested agent 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. 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. There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required) AND
6. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

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

QL with PA

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. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
   1. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
   2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support for why 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: up to 12 months

Agents NOT to be used Concomitantly

Abrilada (adalimumab-afzb)
Actemra (tocilizumab)
Adalimumab
Adbry (tralokinumab-ldrm)
Amjevita (adalimumab-atto)
Arcalyst (rilonacept)
Avsola (infliximab-axxq)
Avtozma (tocilizumab-anoh)
Benlysta (belimumab)
Bimzelx (bimekizumab-bkzx)
Cibinqo (abrocitinib)
Cimzia (certolizumab)
Cinqair (reslizumab)
Cosentyx (secukinumab)
Cyltezo (adalimumab-adbm)
Dupixent (dupilumab)
Ebglyss (lebrikizumab-lbkz)
Enbrel (etanercept)
Entyvio (vedolizumab)
Fasenra (benralizumab)
Hadlima (adalimumab-bwwd)
Hulio (adalimumab-fkjp)
Humira (adalimumab)
Hyrimoz (adalimumab-adaz)
Idacio (adalimumab-aacf)
Ilaris (canakinumab)
Ilumya (tildrakizumab-asmn)
Imuldosa (ustekinumab-srlf)
Inflectra (infliximab-dyyb)
Infliximab
Kevzara (sarilumab)
Kineret (anakinra)
Leqselvi (deuruxolitinib)
Litfulo (ritlecitinib)
Nemluvio (nemolizumab-ilto)
Nucala (mepolizumab)
Olumiant (baricitinib)
Omlyclo (omalizumab-igec)
Omvoh (mirikizumab-mrkz)
Opzelura (ruxolitinib)
Orencia (abatacept)
Otezla (apremilast)
Otulfi (ustekinumab-aauz)
Pyzchiva (ustekinumab-ttwe)
Remicade (infliximab)
Renflexis (infliximab-abda)
Riabni (rituximab-arrx)
Rinvoq (upadacitinib)
Rituxan (rituximab)
Rituxan Hycela (rituximab/hyaluronidase human)
Ruxience (rituximab-pvvr)
Saphnelo (anifrolumab-fnia)
Selarsdi (ustekinumab-aekn)
Siliq (brodalumab)
Simlandi (adalimumab-ryvk)
Simponi (golimumab)
Simponi ARIA (golimumab)
Skyrizi (risankizumab-rzaa)
Sotyktu (deucravacitinib) 
Spevigo (spesolimab-sbzo) subcutaneous injection
Stelara (ustekinumab)
Steqeyma (ustekinumab-stba)
Taltz (ixekizumab)
Tezspire (tezepelumab-ekko)
Tofidence (tocilizumab-bavi)
Tremfya (guselkumab)
Truxima (rituximab-abbs)
Tyenne (tocilizumab-aazg)
Tysabri (natalizumab)
Ustekinumab
Velsipity (etrasimod)
Wezlana (ustekinumab-auub)
Xeljanz (tofacitinib)
Xeljanz XR (tofacitinib extended release)
Xolair (omalizumab)
Yesintek (ustekinumab-kfce)
Yuflyma (adalimumab-aaty)
Yusimry (adalimumab-aqvh)
Zeposia (ozanimod)
Zymfentra (infliximab-dyyb)