Effective Date

Date of Origin   

04-01-2025           

Adbry®

(tralokinumab-ldrm)

Subcutaneous injection

Treatment of moderate-to-severe atopic dermatitis (AD) in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids. 

1

Ebglyss™

(lebrikizumab-lbkz)

Subcutaneous injection

Treatment of moderate-to-severe atopic dermatitis (AD) in patients aged 12 years and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Ebglyss can be used with or without topical corticosteroids.

3

Atopic Dermatitis (AD)

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 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 PDE-4 inhibitors (e.g., crisaborole) [mild to moderate AD]
• Topical JAK inhibitors (e.g., ruxolitinib) [mild to moderate AD]

TCS are the most commonly utilized FDA-approved therapies in AD and are commonly 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. 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 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

Adbry

The efficacy of Adbry was assessed in three randomized, double-blind, placebo-controlled trials [ECZTRA 1 (NCT03131648), ECZTRA 2 (NCT03160885), and ECZTRA 3 (NCT03363854)]. Efficacy was assessed in a total of 1934 subjects 18 years of age and older with moderate-to-severe atopic dermatitis (AD) not adequately controlled by topical medication(s). Disease severity was defined by an Investigator’s Global Assessment (IGA) score greater than or equal to 3 in the overall assessment of AD lesions on a severity scale of 0 to 4, an Eczema Area and Severity Index (EASI) score greater than or equal to 16 on a scale of 0 to 72, and a minimum body surface area (BSA) involvement of greater than or equal to 10%. At baseline, 58% of subjects were male, 69% of subjects were white, 50% of subjects had a baseline IGA score of 3 (moderate AD), and 50% of subjects had a baseline IGA score of 4 (severe AD). The baseline mean EASI score was 32 and the baseline weekly averaged Worst Daily Pruritus Numeric Rating Scale (NRS) was 8 on a scale of 0-10.(1)

In all three trials, subjects received subcutaneous injections of Adbry 600 mg or placebo on Day 0, followed by 300 mg every other week or placebo for 16 weeks. Responders were defined as achieving an IGA 0 or 1 (“clear” or “almost clear”) or EASI-75 (improvement of at least 75% in EASI score from baseline) at week 16.(1)

To evaluate maintenance of response in the monotherapy trials (ECZTRA 1 and ECZTRA 2), subjects responding to initial treatment with Adbry 300 mg every other week were re-randomized to Adbry 300 mg every other week, Adbry 300 mg every 4 weeks or placebo every other week for another 36 weeks following first dose administration. Subjects randomized to placebo in the initial treatment period who achieved a clinical response at week 16 continued to receive placebo every other week for another 36 weeks. Non-responders at week 16, and subjects who lost clinical response during the maintenance period were placed on open-label treatment with Adbry 300 mg every other week and optional use of TCS.(1)

The ECZTRA 3 trial studied the use of Adbry in combination with either a topical corticosteroid or topical calcineurin inhibitor. Subjects received either Adbry 300 mg every other week with TCS or placebo with TCS and as needed topical calcineurin inhibitors (TCI) until week 16. Subjects in the Adbry 300 mg with TCS group who achieved clinical response at week 16 were re-randomized to Adbry 300 mg every other week with TCS or Adbry every 4 weeks with TCS for another 16 weeks following first dose administration. Subjects in the placebo with TCS group who achieved clinical response at week 16 continued on placebo with TCS for another 16 weeks. Subjects who did not achieve clinical response at week 16 received Adbry 300 mg every other week for another 16 weeks. A mid-potency TCS (i.e., mometasone furoate 0.1% cream) was dispensed at each dosing visit. Subjects were instructed to apply a thin film of the dispensed TCS as needed once daily to active lesions from week 0 to week 32 and were to discontinue treatment with TCS when control was achieved. An additional, lower potency TCS or TCI could be used at the investigator’s discretion on areas of the body where use of the supplied TCS was not advisable, such as areas of thin skin.(1)

All three trials assessed the primary endpoints of the proportion of subjects with an IGA 0 or 1 at week 16 and the proportion of subjects with EASI-75 at week 16. Secondary endpoints included the reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 points on the 11-point itch NRS from baseline to week 16.(1)

1. Full Analysis Set (FAS) includes all subjects randomized and dosed
2. Responders was defined as a subject with an IGA 0 or 1 (“clear” or “almost clear”)
3. Subjects who received rescue treatment or with missing data were considered as non-responders

Note: Difference and 95% CI are based on the CMH test stratified by region and baseline IGA score

Examination of age, gender, race, body weight, and previous treatment, including immunosuppressants, did not identify differences in response to Adbry 300 mg every other week among these subgroups.(1)

In ECZTRA 1, 179 Adbry 300 mg every other week responders (IGA 0/1 or EASI-75) were re-randomized (and dosed) at week 16 to Adbry 300 mg every other week (68 subjects), Adbry 300 mg every 4 weeks (76 subjects) or placebo (35 subjects). Among these subjects, 39 subjects in Adbry 300 mg every other week arm, 36 subjects in Adbry 300 mg every 4 weeks arm and 19 subjects in placebo arm were IGA 0/1 responders at week 16. Maintenance of IGA 0/1 response at week 52 was as follows: 20 subjects (51%) in the every other week arm, 14 subjects (39%) in the every 4 weeks arm and 9 subjects (47%) in the placebo arm. Among the re-randomized subjects, 47 subjects in Adbry 300 mg every other week arm, 57 subjects in Adbry 300 mg every 4 weeks arm and 30 subjects in placebo arm were EASI-75 responders at week 16. Maintenance of EASI-75 response at week 52 was as follows: 28 subjects (60%) in the every other week arm, 28 subjects (49%) in the every 4 weeks arm and 10 subjects (33%) in the placebo arm.(1)

In ECZTRA 2, 218 Adbry 300 mg every other week responders (IGA 0/1 or EASI-75) were re-randomized (and dosed) at week 16 to Adbry 300 mg every other week (90 subjects), Adbry 300 mg every 4 weeks (84 subjects) or placebo (44 subjects). Among these subjects, 53 subjects in Adbry 300 mg every other week arm, 44 subjects in Adbry 300 mg every 4 weeks arm and 26 subjects in placebo arm were IGA 0/1 responders at week 16. Maintenance of IGA 0/1 response at week 52 was as follows: 32 subjects (60%) in the every other week arm, 22 subjects (50%) in the every 4 weeks arm and 6 subjects (23%) in the placebo arm. Among the re-randomized subjects, 76 subjects in Adbry 300 mg every other week arm, 69 subjects in Adbry 300 mg every 4 weeks arm and 40 subjects in placebo arm were EASI-75 responders at week 16. Maintenance of EASI-75 response at week 52 was as follows: 43 subjects (57%) in the every other week arm, 38 subjects (55%) in the every 4 weeks arm and 8 subjects (20%) in the placebo arm.(1)

In ECZTRA 3, 131 Adbry 300 mg every other week + TCS responders (IGA 0/1 or EASI-75) were re-randomized (and dosed) at week 16 to Adbry 300 mg every other week + TCS (65 subjects) or Adbry 300 mg every 4 weeks + TCS (66 subjects). Among these subjects, 45 subjects in Adbry 300 mg every other week + TCS arm and 46 subjects in Adbry 300 mg every 4 weeks + TCS arm were IGA 0/1 responders at week 16. Maintenance of IGA 0/1 response at week 32 was as follows: 40 subjects (89%) in the every other week arm and 35 subjects (76%) every 4 weeks arm. Among the re-randomized subjects, 65 subjects in Adbry 300 mg every other week arm and 62 subjects in Adbry 300 mg every 4 weeks arm were EASI-75 responders at week 16. Maintenance of EASI-75 response at week 32 was as follows: 60 subjects (92%) in the every other week arm and 56 subjects (90%) in the every 4 weeks arm.(1)

Ebglyss

Three multicenter, randomized, double-blind, placebo-controlled trials, ADvocate 1, ADvocate 2 and ADhere (NCT04146363, NCT04178967, NCT04250337) enrolled a total of 1062 subjects 12 years of age and older with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s) and who were candidates for systemic therapy. A total of 148 subjects (14%) were 12 to less than 18 years who weighed at least 40 kg and 914 (86%) were adult subjects. Disease severity was defined by an Investigator's Global Assessment (IGA) score greater than or equal to 3 in the overall assessment of AD lesions on a severity scale of 0 to 4, an Eczema Area and Severity Index (EASI) score greater than or equal to 16 on a scale of 0 to 72, and a minimum body surface area involvement of greater than or equal to 10%.(3)

At baseline, 63% of subjects had a baseline IGA score of 3 (moderate AD) and 37% of subjects had a baseline IGA of 4 (severe AD). The baseline mean EASI was 29, and the baseline Pruritus Numeric Rating Scale (NRS) was 7 on a scale of 0-10. Of all subjects, 99% had received prior treatment for AD.(3)

In all three trials, subjects in the Ebglyss group received subcutaneous injections of Ebglyss 500 mg at Week 0 and at Week 2, followed by 250 mg every other week (Q2W) through Week 16. To evaluate the maintenance and durability of response in the monotherapy trials (ADvocate 1 and ADvocate 2), subjects originally randomized to Ebglyss who achieved an IGA score of 0 or 1, or at least a 75% reduction in EASI from baseline [EASI-75] at Week 16 and did not require rescue therapy were re-randomized to an additional 36 weeks of either a maintenance dose of Ebglyss 250 mg Q2W (every 2 weeks), Ebglyss 250 mg Q4W (every 4 weeks), or placebo. Subjects who did not achieve IGA 0 or 1 or EASI-75 at Week 16 or subjects who required rescue therapy during the first 16 weeks were treated with open-label Ebglyss 250 mg Q2W. In the concomitant therapy trial (ADhere), subjects received Ebglyss + TCS or placebo + TCS. Topical calcineurin inhibitors (TCI) were permitted for sensitive areas only, such as the face, neck, intertriginous and genital areas.(3)

All three trials assessed the primary endpoint, the proportion of subjects who achieved an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-point improvement from baseline at Week 16. Other evaluated outcomes at Week 16 included the proportion of subjects with EASI-75 and EASI-90, and improvement in itch severity as defined by a reduction of at least 4 points on an 11-point Pruritus NRS. ADvocate 1 and ADvocate 2 also evaluated the maintenance and durability of response through Week 52. The results of the Ebglyss monotherapy trials (ADvocate 1 and ADvocate 2) are presented below:(3)

The results in the concomitant therapy trial (ADhere) at Week 16, where subjects received Ebglyss + TCS or placebo + TCS were consistent with the results in the monotherapy trials (ADvocate 1 and ADvocate 2).(3)

Ebglyss-treated subjects achieving IGA 0 or 1 or EASI-75, and who did not receive rescue therapy at Week 16 were re-randomized to 36 weeks of maintenance treatment with Ebglyss 250 mg Q2W, Ebglyss 250 mg Q4W, or placebo in ADvocate 1 and ADvocate 2. The results are presented below:(3)

Combining the results of ADvocate 1 and ADvocate 2, the proportion of patients who maintained an IGA of 0 or 1 with a greater than or equal to 2-point improvement at week 52 was 71.2%, 76.9% and 47.9% in those assigned to the lebrikizumab Q2W, lebrikizumab Q4W and lebrikizumab withdrawal treatment arms, respectively. At week 52, patients assigned to the lebrikizumab Q2W, lebrikizumab Q4W and lebrikizumab withdrawal treatment arms exhibited durable EASI 75 response rates of 78.4%, 81.7% and 66.4%, respectively.(7)

Safety

Adbry (tralokinumab-ldrm) is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in the product.(1)

Ebglyss (lebrikizumab-lbkz) is contraindicated in patients with prior serious hypersensitivity to lebrikizumab-lbkz or any excipients of the product.(3)

1

Adbry prescribing information. LEO Pharma Inc. June 2024.

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. J Am Acad Dermatol. 2014 Feb;70(2):338-51.

3

Ebglyss prescribing information. Eli Lilly and Company. September 2024.

4

Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20.

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, 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

Blauvelt A, Thyssen JP, Guttman-Yassky E, et al. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo-controlled phase III trials. British Journal of Dermatology. 2023;188(6):740-748. doi:10.1093/bjd/ljad022

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

Institute For Clinical and Economic Review (ICER). JAK Inhibitors and Monoclonal Antibodies for the Treatment of Atopic Dermatitis: Effectiveness and Value. Final Evidence Report. August 2021. Updated February 2023.

Ebglyss

lebrikizumab-lbkz solution prefilled syringe

250 MG/2ML

M ; N ; O ; Y

N

Ebglyss

lebrikizumab-lbkz subcutaneous soln auto-inject

250 MG/2ML

M ; N ; O ; Y

N

Adbry

tralokinumab-ldrm subcutaneous soln auto-injector  ; tralokinumab-ldrm subcutaneous soln prefilled syr

150 MG/ML ; 300 MG/2ML

M ; N ; O ; Y

N

Adbry

tralokinumab-ldrm subcutaneous soln auto-injector

300 MG/2ML

2

Pens

28

DAYS

Adbry

Tralokinumab-ldrm Subcutaneous Soln Prefilled Syr

150 MG/ML

4

Syringes

28

DAYS

Ebglyss

lebrikizumab-lbkz solution prefilled syringe

250 MG/2ML

1

Syringe

28

DAYS

Ebglyss

lebrikizumab-lbkz subcutaneous soln auto-inject

250 MG/2ML

1

Pen

28

DAYS

Adbry

tralokinumab-ldrm subcutaneous soln auto-injector  ; tralokinumab-ldrm subcutaneous soln prefilled syr

150 MG/ML ; 300 MG/2ML

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

Ebglyss

lebrikizumab-lbkz solution prefilled syringe

250 MG/2ML

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

Ebglyss

lebrikizumab-lbkz subcutaneous soln auto-inject

250 MG/2ML

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

Adbry

tralokinumab-ldrm subcutaneous soln auto-injector

300 MG/2ML

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

Adbry

Tralokinumab-ldrm Subcutaneous Soln Prefilled Syr

150 MG/ML

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

Ebglyss

lebrikizumab-lbkz solution prefilled syringe

250 MG/2ML

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

Ebglyss

lebrikizumab-lbkz subcutaneous soln auto-inject

250 MG/2ML

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

PA

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. 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
3. BOTH of the following:
   1. ONE of the following:
      1. 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 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. ONE of the following:
                  1. The patient has tried and had an inadequate response to at least a medium-potency topical corticosteroid used in the treatment of AD after at least a 4-week duration of therapy OR
                  2. The patient has an intolerance or hypersensitivity to at least a medium-potency topical corticosteroid used in the treatment of AD OR
                  3. The patient has an FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in the treatment of AD AND
               2. ONE of the following:
                  1. The patient has tried and had an inadequate response to a 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. The patient has an intolerance or hypersensitivity to a topical calcineurin inhibitor used in the treatment of AD OR
                  3. The patient 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 AND
         3. If the requested agent is Ebglyss, then ONE of the following (medical records required):
            1. The patient has tried and had an inadequate response to THREE of the following preferred biologic immunomodulator agents (i.e., Adbry, Cibinqo, Dupixent, Rinvoq) after at least a 3-month trial per agent OR
            2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to THREE of the following preferred biologic immunomodulator agents (i.e., Adbry, Cibinqo, Dupixent, Rinvoq) OR
            3. The patient has an FDA labeled contraindication to ALL of the following preferred biologic immunomodulator agents (i.e., Adbry, Cibinqo, Dupixent, Rinvoq) OR
            4. BOTH of the following:
               1. ALL of the preferred biologic immunomodulator agents are not clinically appropriate for the patient AND
               2. The prescriber has provided a complete list of previously tried agents for the requested indication AND
         4. The prescriber has documented 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) 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
4. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
5. 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
6. If the requested agent is Adbry for a diagnosis of atopic dermatitis, then ONE of the following:
   1. The patient is initiating therapy with the requested agent OR
   2. The patient has been treated with the requested agent for less than 16 consecutive weeks OR
   3. The patient has been treated with the requested agent for at least 16 consecutive weeks AND ONE of the following:
      1. The patient weighs less than 100 kg and ONE of the following:
         1. The patient has achieved clear or almost clear skin AND the patient’s dose will be reduced to 300 mg every 4 weeks OR
         2. The patient has NOT achieved clear or almost clear skin OR
         3. There is support for therapy using 300 mg every 2 weeks OR
      2. The patient weighs greater than or equal to 100 kg AND
7. If the requested agent is Ebglyss for a diagnosis of atopic dermatitis, the patient weighs 40 kg or greater AND
8. 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
9. 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
10. 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. 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 OR
         4. A decrease in the Eczema Area and Severity Index (EASI) score OR
         5. A decrease in the Investigator Global Assessment (IGA) score 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 a diagnosis other than moderate-to-severe atopic dermatitis AND has had clinical benefit with the requested agent AND
3. If the requested agent is Adbry for a diagnosis of atopic dermatitis, then ONE of the following:
   1. The patient is initiating therapy with the requested agent OR
   2. The patient has been treated with the requested agent for less than 16 consecutive weeks OR
   3. The patient has been treated with the requested agent for at least 16 consecutive weeks AND ONE of the following:
      1. The patient weighs less than 100 kg and ONE of the following:
         1. The patient has achieved clear or almost clear skin AND the patient’s dose will be reduced to 300 mg every 4 weeks OR
         2. The patient has NOT achieved clear or almost clear skin OR
         3. There is support for therapy using 300 mg every 2 weeks OR
      2. The patient weighs greater than or equal to 100 kg 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: 12 months

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

QL

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. The requested agent is Ebglyss for a diagnosis of atopic dermatitis AND ONE of the following:
      1. BOTH of the following:
         1. The request is for an initial loading dose AND the patient has received less than 16 consecutive weeks of treatment AND
         2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for atopic dermatitis OR
      2. BOTH of the following:
         1. There is support for therapy for the dose exceeding the quantity limit (e.g., the patient has not achieved adequate clinical response on 250 mg every 2 weeks during the initial 16 week induction dosing) (medical records required) AND
         2. The requested quantity (dose) does NOT exceed 250 mg every 2 weeks OR
   2. ​​​​​​​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
   3. 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

Note:
If approving initial loading dose for Adbry for atopic dermatitis, approve quantity for loading dose plus maintenance for 1 month per FDA labeling followed by maintenance dose for the remainder of the length of approval. Maintenance dosing begins 2 weeks after patient receives the loading dose.
If approving initial loading dose for Ebglyss for atopic dermatitis, approve quantity for loading dose for 16 weeks per FDA labeling, followed by maintenance dose for the remainder of the length of approval. Subsequent requests for continuation of dosing at 250 mg every 2 weeks may be approved for up to 3 months at a time.

Agents NOT to be used Concomitantly

Abrilada (adalimumab-afzb)
Actemra (tocilizumab)
Adalimumab
Adbry (tralokinumab-ldrm)
Amjevita (adalimumab-atto)
Arcalyst (rilonacept)
Avsola (infliximab-axxq)
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)
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)
Taltz (ixekizumab)
Tezspire (tezepelumab-ekko)
Tofidence (tocilizumab-bavi)
Tremfya (guselkumab)
Truxima (rituximab-abbs)
Tyenne (tocilizumab-aazg)
Tysabri (natalizumab)
Velsipity (etrasimod)
Wezlana (ustekinumab-auub)
Xeljanz (tofacitinib)
Xeljanz XR (tofacitinib extended release)
Xolair (omalizumab)
Yuflyma (adalimumab-aaty)
Yusimry (adalimumab-aqvh)
Zeposia (ozanimod)
Zymfentra (infliximab-dyyb)