TALTZ (ixekizumab)

TALTZ (ixekizumab)

Self-Administration – subcutaneous (SC) injection by prefilled autoinjector and prefilled syringe

Office-Administration - subcutaneous (SC) injection by prefilled syringe (doses of 20 mg or 40 mg must be prepared and administered by a qualified healthcare professional).

Indications for Prior Authorization:

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. 

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

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

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.

Coverage Criteria:

For diagnosis of plaque psoriasis (PsO):

• Documented diagnosis of moderate to severe PsO; AND
• Prescribed by or in consultation with a dermatologist; AND
• One of the following:
  • Greater than or equal to 3% body surface area involvement 
  • Severe scalp psoriasis 
  • Palmoplantar (i.e., palms, soles), facial, or genital involvement; AND
• Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies: 
  • corticosteroids (e.g., betamethasone, clobetasol) 
  • vitamin D analogs (e.g., calcitriol, calcipotriene) 
  • tazarotene 
  • calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) 
  • anthralin 
  • coal tar; AND
• One of the following:
  • Trial and failure, contraindication, or intolerance to ONE of the following: 
    • Cimzia (certolizumab pegol) 
    • Enbrel (etanercept) 
    • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
    • Skyrizi (risankizumab) 
    • Stelara (ustekinumab) 
    • Tremfya (guselkumab)
  • For continuation of prior Taltz therapy, defined as no more than a 45-day gap in therapy

For diagnosis of psoriatic arthritis (PsA):

• Documented diagnosis of active PsA; AND
• Prescribed by or in consultation with a rheumatologist or dermatologist; AND
• One of the following:
  • actively inflamed joints 
  • dactylitis 
  • enthesitis 
  • axial disease 
  • active skin and/or nail involvement; AND
• One of the following:
  • Trial and failure, contraindication, or intolerance to ONE of the following: 
    • Cimzia (certolizumab pegol)
    • Enbrel (etanercept)
    • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
    • Simponi (golimumab)
    • Stelara (ustekinumab)
    • Tremfya (guselkumab)
    • Skyrizi (risankizumab-rzaa)
    • Rinvoq (upadacitinib)
    • Xeljanz/XR (tofacitinib/ER)
  • For continuation of prior Taltz therapy, defined as no more than a 45-day gap in therapy

For diagnosis of ankylosing spondylitis (AS):

• Documented diagnosis of active AS; 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, indomethacin, meloxicam, diclofenac) at maximally tolerated doses; AND
• One of the following:
  • Trial and failure, contraindication, or intolerance to ONE of the following, or attestation demonstrating a trial may be inappropriate*: 
    • Cimzia (certolizumab pegol)
    • Enbrel (etanercept)
    • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
    • Simponi (golimumab)
    • Rinvoq (upadacitinib)
    • Xeljanz/XR (tofacitinib/ER)
  • For continuation of prior Taltz therapy, defined as no more than a 45-day gap in therapy.

* Includes attestation that a total of two TNF inhibitors have already been tried in the past, and the patient should not be made to try a third TNF inhibitor.

For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA):

• Documented diagnosis of active nr-axSpA; AND
• Prescribed by or in consultation with a rheumatologist; AND
• Patient has objective signs of inflammation (e.g. C-reactive protein [CRP] levels above the upper limit of normal, or sacroiliitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints); AND
• Minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses; AND
• One of the following:
  • Trial and failure, contraindication, or intolerance to ONE of the following:
    • Cimzia (certolizumab pegol)
    • Rinvoq (upadacitinib) †
  • For continuation of prior Taltz therapy, defined as no more than a 45-day gap in therapy.

† Requires inadequate response or intolerance to one or more TNF-inhibitors.

Reauthorization Criteria:

For diagnosis of PsO:

• Documentation of positive clinical response to therapy as evidenced by one of the following:
  • Reduction the body surface area (BSA) involvement from baseline 
  • Improvement in symptoms (e.g., pruritus, inflammation) from baseline 

For diagnosis of PsA:

• Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
  • 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 

For diagnosis of AS:

• Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least one of the following: 
  • 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 

For diagnosis of nr-axSpA:

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

Dosing:

PsO (adults and pediatrics 6 years of age or older):

• Adults:
  • 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.
• Pediatric, 6 to 17 years old:
  • less than 25 kg: 40 mg by subcutaneous injection at Week 0, followed by 20 mg every 4 weeks.
  • 25 kg to 50 kg: 80 mg by subcutaneous injection at Week 0, followed by 40 mg every 4 weeks.
  • greater than 50 kg: 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.

PsA (adults):

• 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.
• PsA with coexistent moderate-to-severe PsO: 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

AS (adults):

• 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.

nr-axSpA (adults):

• 80 mg by subcutaneous injection every 4 weeks.

Coverage Duration:

PsO, PsA, AS, nr-axSpA:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. 
• Taltz may increase the risk of infection. 
• Patients treated with Taltz may be at increased risk of inflammatory bowel disease. During Taltz treatment, monitor for onset or exacerbation of inflammatory bowel disease.
• Avoid the use of live vaccines in patients treated with Taltz.
• Taltz doses of 20 mg or 40 mg must be prepared and administered by a qualified healthcare professional. Use only the commercial Taltz 80 mg/1 mL prefilled syringe when preparing the prescribed 20 mg and 40 mg pediatric dose.

Review History:

• 10/20/2020 - Original review.
• 02/16/2021 - Annual review.  Criteria and format updated; P&T Ad Hoc review of PA guidelines: removed reference to chart note requirement; removed TB testing requirements; added medical necessity guidance for reauthorization requests; updated approval duration to 1 year.
• 04/20/2021 - Removed prerequisite for one TNF-blocker for UC and CD.
• 01/01/2023 - Update prerequisite drugs for PsO, PsA, AS, nr-axSpA; add symptom requirements for PsO, PsA; add reauthorization criteria for all indications. (P&T 11/15/2022)
• 09/01/2023 - Addition of Amjevita, Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options for PsO, PsA, and AS. (P&T date on 08/15/2023)
• 11/14/2023 – Update Hyrimoz preferred agent to Sandoz manufacturer only.

References:

1. Taltz prescribing information. Eli Lilly and Company. Indianapolis, IN. May 2022. 
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.