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Interleukin-13 (IL-13) Antagonist Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1170

 

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

1/1/2024

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Adbry®

(tralokinumab-ldrm)

Subcutaneous injection

Treatment of moderate-to-severe atopic dermatitis (AD) in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

1

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

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.(4-6) 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 and regular use of emollients alone. Proactive, intermittent use (1-2 times weekly) of topical corticosteroids as maintenance therapy 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. Phototherapy 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)

 

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(1)

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.

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.

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.

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.

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.

 

ECZTRA 1

ECZTRA 2

ECZTRA 3

 

ADBRY 300 mg every other week

Placebo

ADBRY 300 mg every other week

Placebo

ADBRY 300 mg every other week + TCS

Placebo + TCS

Number of subjects randomized and dosed (FAS)a

601

197

577

193

243

123

IGA 0 or 1b,c

Difference from Placebo (95% CI)

16%

 

9% (4%,13%)

7%

21%

 

12% (7%,17%)

9%

38%

 

9% (1%,21%)

27%

EASI-75c

Difference from Placebo (95% CI)

25%

 

9%

(6%,18%)

13%

33%

 

9% (17%,28%)

10%

56%

 

9% (9%,30%)

37%

Number of subjects with baseline Worst Daily Pruritus NRS (weekly average) score greater than or equal to 4

594

194

563

192

240

123

Worst Daily Pruritus NRS (greater than or equal to 4 point reduction)c

Difference from Placebo (95% CI)

20%

 

10% (4%,15%)

10%

25%

 

16% (11%,21%)

9%

46%

 

11% (1%,22%)

35%

  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.

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.

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.

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.

Safety(1)

Tralokinumab is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in Adbry.

REFERENCES                                                                                                                                                                           

Number

Reference

1

Adbry prescribing information. LEO Pharma Inc. November 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 February 2023. Literature review current through February 2023.

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. September 2020.

9

Protopic prescribing information. Astellas Pharma US Inc. February 2019.

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.

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

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Adbry

tralokinumab-ldrm subcutaneous soln prefilled syr

150 MG/ML

M ; N ; O ; Y

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Adbry

Tralokinumab-ldrm Subcutaneous Soln Prefilled Syr

150 MG/ML

4

Syringes

28

DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Adbry

tralokinumab-ldrm subcutaneous soln prefilled syr

150 MG/ML

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

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Adbry

Tralokinumab-ldrm Subcutaneous Soln Prefilled Syr

150 MG/ML

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

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

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:

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

      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 
    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 of greater than or equal to 3 AND
      2. ONE of the following:
        1. The patient has tried and had an inadequate response to an oral systemic immunosuppressant (e.g., methotrexate, azathioprine, mycophenolate mofetil, cyclosporine) used for a minimum of 3 months for the treatment of AD OR
        2. The patient has an intolerance or hypersensitivity to an oral systemic immunosuppressant OR
        3. BOTH of the following:
          1. ONE of the following:
            1. The patient has tried and had an inadequate response to at least a mid-potency topical steroid used for a minimum of 4 weeks OR
            2. The patient has an intolerance or hypersensitivity to at least a mid-potency topical steroid 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 for a minimum of 6 weeks OR 
            2. The patient has an intolerance or hypersensitivity to a topical calcineurin inhibitor OR
        4. The patient has an FDA labeled contraindication to ALL oral systemic immunosuppressants, mid-, high-, and super-potency topical steroids, AND topical calcineurin inhibitors AND
      3. 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
      4. The patient will be using standard maintenance therapy (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 OR
    3. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
  1. If the patient has an FDA approved 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. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
  2. 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. The prescriber has provided information in support of therapy using 300 mg every 2 weeks OR
      2. The patient weighs greater than or equal to 100 kg 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. 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
  5. 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 NoteApprove Adbry subcutaneous loading dose for 1 month, then maintenance dose can be approved for the remainder of 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 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. 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. The prescriber has provided information in support of 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. 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 CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

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) exceeds 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

Note: Approve Adbry subcutaneous loading dose for 1 month, then maintenance dose can be approved for the remainder of 6 months

CONTRAINDICATION AGENTS

Contraindicated as Concomitant Therapy

Agents NOT to be used Concomitantly

Abrilada (adalimumab-afzb)

Actemra (tocilizumab)

Adbry (tralokinumab-ldrm)

Amjevita (adalimumab-atto)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Cyltezo (adalimumab-adbm)

Dupixent (dupilumab)

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)

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)

Sotyktu (deucravacitinib) 

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Yusimry (adalimumab-aqvh)

Zeposia (ozanimod)

 

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

 

Commercial _ PS _ Interleukin-13 (IL-13) Antagonist _PAQL _ProgSum_ 1/1/2024