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FOR COMMERCIALLY INSURED PATIENTS

Prescribe with Confidence. Your Patients are Covered.

Expanding Commercial Coverage

A majority of patients with commercial insurance have formulary coverage for Taltz*

Taltz will replace Cosentyx®(secukinumab) on the OptumRx National Formulary1

Taltz is now covered on the OptumRx Commercial formularies with the status of preferred IL-17A antagonist across all indications.1,†

There are four national formularies:

  • OptumRx Select
  • OptumRx Select with Focused UM
  • OptumRx Premium
  • OptumRx Premium Comprehensive

Taltz is now designated a Tier 3 drug.

Additional Formulary Plan Information

The information in this communication is subject to change without notice.

The information provided in this communication is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures. Nothing herein may be construed as an endorsement, approval, recommendation, representation or warranty of any kind by any plan or insurer referenced herein. This communication is solely the responsibility of Lilly USA, LLC.

The formulary information does not include generic medications in this therapeutic class.

This list may not be an exhaustive list of all plans in your area and the coverage of other plans in your area may vary.

Employers and employer groups may also offer additional benefit designs which may be different than described.

Lilly USA, LLC does not endorse any particular plan. Other product and company names mentioned herein are the trademarks of their respective owners.

The formulary information in this document is for select products that share an approved indication with Taltz® (ixekizumab).Inclusion of a product in this information does not establish clinical comparability of the products for any or all indications and should not be seen as making any claim regarding efficacy or safety.

UM=utilization management

*Source: Managed Markets Insights & Technology (MMIT), LLC as of August 2019, and is subject to change without notice by a health plan or state. Please contact the plan or state for the most current information. DEFINITION OF COVERAGE: on formulary, but may be subject to restrictions, step edits, tiering, prior authorizations.

†Effective January 1, 2020

INDICATIONS

Taltz is indicated for adults with active psoriatic arthritis (PsA), for adults with active ankylosing spondylitis (AS), and for adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Taltz is also indicated for patients aged 6 years or older with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

SELECT IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.


FOR ELIGIBLE COMMERCIALLY INSURED PATIENTS

Taltz Clear Access Program

National coverage may not translate into individual patient access. The Taltz Clear Access Program can ensure the treatment choice stays between you and your patient.

Access regardless of treatment history or formulary requirements for as little as‡:

  • $5 per month for patients with coverage
  • $25 per month for patients without coverage

Up to 3 years of access,§ even if insurance continues to deny coverage║

Taltz is also authorized to ship within 2 business days to ensure a quick treatment start.

*Terms and Conditions: Offer good for up to 36 months from patient qualification into the program or until 12/31/2023, whichever comes first, provided patient continues to meet program terms and conditions. Patients must first use their card by 12/31/2020. Patient must have coverage for Taltz with their commercial drug insurance to pay as little as $5 monthly for a 28-day supply of Taltz, subject to a monthly cap of wholesale acquisition cost plus usual and customary pharmacy charges and a separate $16,000 maximum annual cap. Patient must have commercial drug insurance and a prescription consistent with FDA approved product labeling to pay as little as $25 monthly for a 28-day supply of Taltz, subject to a monthly cap of wholesale acquisition cost plus usual and customary pharmacy charges. Continued participation in the $25 program requires submission of a prior authorization (PA) before the 2nd month fill and, if coverage is denied, an appeal must be submitted prior to 5th month fill. A new PA and appeal or medical exception (ME) must be submitted every 12 months to verify coverage status and potential eligibility for the $5 program. Participation in the program requires a valid patient HIPAA authorization. Patient is responsible for any applicable taxes, fees, or amounts exceeding monthly or annual caps. This offer is invalid for patients without commercial drug insurance or those whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state patient or pharmaceutical assistance program. Offer void where prohibited by law and subject to change or discontinue without notice. Card activation is required. Subject to additional terms and conditions, which can be found here.

Other product/company names are the property of their respective owner.

§Contingent upon a patient scheduling a delivery with a specialty pharmacy.

ǁConstitutes that a prior authorization has been submitted.

Shipment can be authorized within 2 business days of submitting a prescription to either a participating specialty pharmacy or Taltz Together™ and commercial insurance is verified; patient enrolls in the Taltz Savings Card program and schedules shipment.

Network of Specialty Pharmacies


FOR ELIGIBLE COMMERCIALLY INSURED PATIENTS

Access Taltz through a specialty pharmacy that is convenient for patients

Support 25-5


Choose a specialty pharmacy that fits prescription process needs

*Government beneficiaries excluded. Terms and conditions apply. See full details here.

Taltz Specialty Pharmacy Network Partners

You can start the enrollment process for your patients using one of the Taltz contracted specialty pharmacies or through Taltz Together™.

If using a specialty pharmacy, first make sure it is on the list of Taltz contracted specialty pharmacies*. Many specialty pharmacies offer enrollment forms on their website. Submit the completed specialty pharmacy enrollment form or the Taltz enrollment form to one of the contracted specialty pharmacies. If the preferred specialty pharmacy is not included in the Taltz network, submit the enrollment form to Taltz Together for assistance. If you have questions, your Taltz sales representative will be able to assist you.

*To access the list of contracted specialty pharmacies in Puerto Rico, please contact your local sales representative.

Support

Taltz together logo

Taltz Together is here to provide the resources and support your patients need. For assistance, call 1-844-TALTZ-NOW (1-844-825-8966) or enroll your patients in Taltz Together by completing the Adult Dermatology Enrollment Form, Pediatric Dermatology Enrollment Form, or Rheumatology Enrollment Form.


Offerings include:

Taltz support insurance

Insurance Investigation

  • Help with preliminary insurance investigation and specialty pharmacy identification
Support injection training

Injection Training

  • Free of charge to patients and their families
  • Patients can choose either in-person or telephone training
  • Injection training videos available here
Ongoing support

Ongoing Support

  • A personal patient resource to help answer questions or concerns
  • Help is available Monday-Friday from 8 AM to 10 PM ET
Support field reimbursement

Field Reimbursement Support

The Field Reimbursement Manager is an experienced access professional who can help your patients navigate the complex access and reimbursement environment

The managers are

  • Knowledgeable: understand Taltz Together services, access challenges, and affordability options
  • Connected: integrated with the Taltz Together call center and understand the Taltz contracted specialty pharmacy network
  • Patient Focused: committed to providing information to support patient access to Taltz
Support sharps

Sharps Disposal Support

Allows patients to safely dispose of Taltz devices. Once the container is full, your patients can mail it back and contact Taltz Together to receive another one

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Assuring access so your patients* can confidently get Taltz

Download savings card(s)


*Governmental beneficiaries excluded, subject to terms and conditions.

Letters

Coverage Authorization Request Letter

Coverage Authorization Appeals Letter

Letter of Medical Necessity

References: 1. Data on File. Lilly USA, LLC. DOF-IX-US-0187.

Indications and Important Safety Information
Indications

Taltz is indicated for adults with active psoriatic arthritis (PsA), for adults with active ankylosing spondylitis (AS), and for adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Taltz is also indicated for patients aged 6 years or older with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Important Safety Information
CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS
Infections
Taltz may increase the risk of infection. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

Hypersensitivity
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

Immunizations
Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

ADVERSE REACTIONS
Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis and conjunctivitis, influenza, and urticaria in pediatric psoriasis.

Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.
IX HCP ISI 07MAY2020

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SPIRIT-H2H: Trial design9

Taltz icon

SPIRIT-H2H (N=566) was a phase 4, randomized, open-label, blinded-assessor study evaluating the efficacy and safety of Taltz vs Humira in biologic-naive patients with active psoriatic arthritis and plaque psoriasis BSA ≥3%.

Patients who met the trial design criteria for moderate to severe psoriasis (BSA ≥10%, PASI ≥12, and sPGA ≥3) in addition to psoriatic arthritis followed the psoriasis dosing regimen: Taltz patients (n=49) received an initial dose of 160 mg (two 80 mg injections), followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks thereafter. Humira patients (n=52) received an initial dose of 80 mg, then 40 mg every other week starting 1 week after the initial dose. For Taltz patients with psoriatic arthritis only (n=234), the initial dose (160 mg as 2 injections) was followed by 80 mg every 4 weeks. Humira patients (n=231) received 40 mg every other week and no initial dose.

SPIRIT-H2H: Trial design1

SPIRIT-H2H (N=566) was a phase 4, randomized, open-label, blinded-assessor study evaluating the efficacy and safety of Taltz vs Humira® (adalimumab) in biologic-naive patients with active psoriatic arthritis and plaque psoriasis BSA ≥3%. The primary efficacy endpoint was the proportion of patients simultaneously achieving ACR50 and PASI 100 at week 24. All patients were ≥18 years of age and had ≥3 swollen and ≥3 tender joints with an inadequate response to ≥1 cDMARD. Patients were randomized (1:1) to Taltz or Humira and allowed to continue a stable dose of concomitant cDMARD during the study. For Taltz patients with psoriatic arthritis only (n=234), the initial dose (160 mg as 2 injections) was followed by 80 mg every 4 weeks. Humira patients (n=231) received 40 mg every other week and no initial dose. Patients who met the trial design criteria for moderate to severe psoriasis (BSA ≥10%, PASI ≥12, and sPGA ≥3) in addition to psoriatic arthritis followed the psoriasis dosing regimen: Taltz patients (n=49) received an initial dose of 160 mg (two 80 mg injections), followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks thereafter. Humira patients (n=52) received an initial dose of 80 mg, then 40 mg every other week starting 1 week after the initial dose.

Reference:1. Data on file. Lilly USA, LLC. DOF-IX-US-0119.

BSA=body surface area; ACR50=American College of Rheumatology 50% response;
PASI=Psoriasis Area Severity Index; cDMARD=conventional disease-modifying antirheumatic drug; sPGA=static Physician's Global Assessment.

SPIRIT-P1 and -P2 Trial Design1-4

SPIRIT-P1 (N=417) and -P2 (N=363) were phase 3, randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of Taltz compared with placebo in patients with active psoriatic arthritis. Patients in SPIRIT-P1 were biologic-naive. Patients in SPIRIT-P2 were tumor necrosis factor inhibitor (TNFi)-experienced, having had an inadequate response and/or intolerance to 1 or 2 prior TNFis. In both trials, the primary efficacy endpoint was the proportion of patients achieving ACR20 response at week 24. All patients were ≥18 years of age and had ≥3 swollen and ≥3 tender joints. Patients were randomized to placebo or Taltz 80 mg every 2 or 4 weeks following a 160 mg starting dose. In SPIRIT-P1, an active reference arm of Humira® (adalimumab) 40 mg every 2 weeks was included. Patients in all study arms were allowed to continue taking stable background medications during the trial. Inadequate responders (as defined by blinded criteria of <20% improvement in tender and in swollen joint counts) at week 16 received rescue therapy and were analyzed as nonresponders after week 16 until the primary endpoint. After receiving rescue therapy, inadequate responders in the placebo and Humira arms were re-randomized to Taltz 80 mg every 2 or 4 weeks. Nonresponder imputation (NRI) methods were used for categorical efficacy analyses during the double-blind treatment period.

Reference: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase 3 trial SPIRIT-P1. Ann Rheum Dis. 2017;76(suppl):1-30. 3. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. 4. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix.

ACR20=American College of Rheumatology 20% response.

SPIRIT-P1 and -P2: Trial design12-15

Registration Trials

SPIRIT-P1 (N=417) and SPIRIT-P2 (N=363) were phase 3, randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of Taltz compared with placebo in patients with active psoriatic arthritis. Patients in SPIRIT-P1 were biologic-naive. Patients in SPIRIT-P2 were tumor necrosis factor inhibitor (TNFi)-experienced, having had an inadequate response and/or intolerance to 1 or 2 prior TNFis. In both trials, the primary efficacy endpoint was the proportion of patients achieving ACR20 response at week 24. All patients were ≥18 years of age and had ≥3 swollen and ≥3 tender joints. Patients were randomized to placebo or Taltz 80 mg every 2 or 4 weeks following a 160 mg starting dose. In SPIRIT-P1, an active reference arm of adalimumab 40 mg every 2 weeks was included. Patients in all study arms were allowed to continue taking stable background medications during the trial. Inadequate responders (as defined by blinded criteria of <20% improvement in tender and in swollen joint counts) at week 16 received rescue therapy and were analyzed as nonresponders after week 16 until the primary endpoint. After receiving rescue therapy, inadequate responders in the placebo and adalimumab arms were re-randomized to Taltz 80 mg every 2 or 4 weeks. Nonresponder imputation (NRI) methods were used for categorical efficacy analyses during the double-blind treatment period.

IXORA-PEDS TRIAL DESIGN

IXORA-PEDS (N=171) is an ongoing, multicenter, randomized, double-blind, placebo-controlled phase 3 study designed to evaluate the efficacy and safety of Taltz in pediatric patients aged 6 to <18 years with moderate to severe plaque psoriasis. All patients have a diagnosis of moderate to severe plaque psoriasis for at least 6 months, with a body surface area (BSA) of ≥10%, a static Physician’s Global Assessment (sPGA) score ≥3, and a Psoriasis Area Severity Index (PASI) score ≥12, and are candidates for systemic therapy or phototherapy. Patients were randomized to receive Taltz every 4 weeks (n=115), with dosing based on body weight, or placebo (n=56). Of patients receiving Taltz, those weighing <25 kg were randomized to Taltz 20 mg every 4 weeks following a 40 mg starting dose, those weighing 25 to 50 kg were randomized to Taltz 40 mg every 4 weeks following an 80 mg starting dose, and those weighing >50 kg were randomized to Taltz 80 mg following a starting dose of 160 mg. Co-primary efficacy endpoints were the percentage of patients achieving PASI 75 and sPGA 0,1 at week 12. Secondary endpoints were the percentage of patients achieving the following measures: PASI 75 at week 4, sPGA 0,1 at week 4, PASI 90 at week 12, PASI 100 at week 12, sPGA 0 at week 12, and Itch Numeric Rating Scale (I-NRS) ≥4-point improvement at week 12. Nonresponder imputation methods (NRI) were used for categorical efficacy analyses.

Following the double-blind treatment period, patients are allowed to transition to an open-label maintenance period (weeks 12-60) and extension period (weeks 60-108) where all patients, regardless of initial treatment, will receive Taltz every 4 weeks through week 108. Patients who were taking placebo were initiated to Taltz with the appropriate weight-based starting dose, followed by the appropriate weight-based Q4W dose.

References: 1.Data on file. Lilly USA, LLC. DOF-IX-US-0211.