Pharmacy Prior Authorization Criteria

Taltz (ixekizumab)

Indications for Prior Authorization

Taltz (ixekizumab)

• For diagnosis of Plaque Psoriasis (PsO)
  Indicated for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

• For diagnosis of Psoriatic Arthritis (PsA)
  Indicated for the treatment of adult patients with active psoriatic arthritis.

• For diagnosis of Ankylosing Spondylitis (AS)
  Indicated for the treatment of adult patients with active ankylosing spondylitis.

• For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA)
  Indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Criteria

Taltz

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

• Diagnosis of moderate to severe plaque psoriasis
AND
• One of the following [2]:
• Greater than or equal to 3% body surface area involvement
• Severe scalp psoriasis
• Palmoplantar (i.e., palms, soles), facial, or genital involvement
AND
• Patient is 6 years of age or older
AND
• Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies [3]:
• corticosteroids (e.g., betamethasone, clobetasol)
• vitamin D analogs (e.g., calcitriol, calcipotriene)
• tazarotene
• calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
AND
• Prescribed by or in consultation with a dermatologist

Taltz

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

• Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following [1-3]:
• Reduction in the body surface area (BSA) involvement from baseline
• Improvement in symptoms (e.g., pruritus, inflammation) from baseline

Taltz

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Diagnosis of active psoriatic arthritis
AND
• One of the following [4]:
• Actively inflamed joints
• Dactylitis
• Enthesitis
• Axial disease
• Active skin and/or nail involvement
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Rheumatologist

Taltz

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 4]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline
• Reduction in the body surface area (BSA) involvement from baseline

Taltz

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

• Diagnosis of active ankylosing spondylitis
AND
• Prescribed by or in consultation with a rheumatologist
AND
• Minimum duration of one month trial and failure, contraindication, or intolerance to two different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen) at maximally tolerated doses [5]

Taltz

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

• Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following [1, 5]:
• Disease activity (e.g., pain, fatigue, inflammation, stiffness)
• Lab values (erythrocyte sedimentation rate, C-reactive protein level)
• Function
• Axial status (e.g., lumbar spine motion, chest expansion)
• Total active (swollen and tender) joint count

Taltz

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA)

• Diagnosis of active non-radiographic axial spondyloarthritis
AND
• Patient has objective signs of inflammation (e.g., C-reactive protein [CRP] levels above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints.) [1, 3]
AND
• Prescribed by or in consultation with a rheumatologist
AND
• Minimum duration of one month trial and failure, contraindication, or intolerance to two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses [5]

Taltz

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA)

• Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following [1, 5]:
• Disease activity (e.g., pain, fatigue, inflammation, stiffness)
• Lab values (erythrocyte sedimentation rate, C-reactive protein level)
• Function
• Axial status (e.g., lumbar spine motion, chest expansion)
• Total active (swollen and tender) joint count

P & T Revisions

2024-12-06, 2024-12-02, 2024-09-15, 2024-07-03, 2024-06-24, 2024-05-31, 2024-04-24, 2024-03-07, 2023-10-04, 2023-07-04, 2023-02-01, 2022-12-07, 2022-10-24, 2022-07-07, 2022-06-02, 2022-03-01, 2021-06-30, 2021-05-26, 2021-05-25, 2020-09-02, 2020-07-30, 2020-04-29, 2019-10-31, 2019-07-05

References

1. Taltz prescribing information. Eli Lilly and Company. Indianapolis, IN. August 2024.
2. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019;80:1029-72.
3. Elmets CA, Korman NJ, Farley Prater E, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol 2021;84:432-70.
4. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32.
5. Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/spondyloarthritis research and treatment network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613.

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Revision History

• 2024-12-06: Removed steps through other targeted immunomodulators as Taltz will be a preferred product in 2025
• 2024-12-02: Removed steps through other targeted immunomodulators as Taltz will be a preferred product in 2025
• 2024-09-15: Addition of 20 mg and 40 mg strengths for pediatric psoriasis; removed anthralin and coal tar as topical step options for PsO
• 2024-07-03: Addition of Rinvoq LQ as an additional preferred alternative for PsA; Annual review - no additional criteria changes; background updates
• 2024-06-24: No criteria changes; updated background table to specify BI manufacturer for adalimumab-adbm
• 2024-05-31: Updated background table to include CalPERS formulary; no criteria changes
• 2024-04-24: Updated verbiage in the PsO, PsA, and AS steps to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
• 2024-03-07: Updated verbiage in the PsO, PsA, and AS steps to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
• 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
• 2023-07-04: Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options for PsO, PsA, and AS; Annual review - background updates
• 2023-02-01: Addition of Amjevita as another preferred step option for PsO, PsA, and AS; addition of an age criterion to the PsO criteria to align with the labeling
• 2022-12-07: Addition of Rinvoq as another preferred step option for nr-axSpA
• 2022-10-24: Addition of Enbrel as another preferred step option for PsO, PsA, and AS; further clinical detail and criteria added
• 2022-07-07: Annual review - no criteria changes; background updates
• 2022-06-02: Added Rinvoq and Xeljanz/XR as additional preferred step options for AS
• 2022-03-01: Formulary strategy update for PsA to add Skyrizi, Rinvoq, and Xeljanz/XR as preferred step options.
• 2021-06-30: Annual review
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2020-09-02: Addition of Tremfya as a preferred step option for psoriatic arthritis; Addition of objective measures to the psoriasis reauthorization criteria; formulary strategy update to remove Simponi Aria as a preferred step option for PsA and AS
• 2020-07-30: Addition of new indication and criteria for Non-radiographic Axial Spondyloarthritis; background and reference updates
• 2020-04-29: Updated indication for psoriasis to include pediatric patients; removed drug name from reauth criteria
• 2019-10-31: Taltz is now a second-line agent for the embedded steps of all three indications, so the steps were adjusted accordingly.
• 2019-07-05: 2019 Annual Review - Removed the restriction prohibiting use in combination with a biologic disease modifying antirheumatic drug (DMARD). AJL 7/5/19

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