STANDARD COMMERCIAL AND NSA DRUG FORMULARY
PRIOR AUTHORIZATION GUIDELINES
RISANKIZUMAB-RZAA

RISANKIZUMAB RZAA Treatment of Plaque Psoriasis

GUIDELINES FOR USE

INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

1. Does the patient have a diagnosis of moderate to severe plaque psoriasis (PsO) and meet ALL of the following criteria?
   • The patient is 18 years of age or older
   • Therapy is prescribed by or in consultation with a dermatologist
   • The patient has psoriasis covering 3% or more of the body surface area (BSA) OR psoriatic lesions affecting the hands, feet, face, or genital area
   • The patient had a trial of or contraindication to one or more forms of conventional therapies such as PUVA (Phototherapy Ultraviolet Light A), UVB (Ultraviolet Light B), topical corticosteroids, calcipotriene, acitretin, methotrexate, or cyclosporine
   If yes, approve the requested strength and dosage form for a total of 6 months by GPID or GPI-14. Please enter two authorizations as follows:
   FIRST APPROVAL:
   • Skyrizi 150mg/1.66mL Kit: Approve for 1 month with a quantity limit of #1 kit (2 syringes) per 28 days.
   • Skyrizi 150mg/mL pen/syringe: Approve for 1 month with a quantity limit of

   1mL per 28 days.

   SECOND APPROVAL:
   • Skyrizi 150mg/1.66mL Kit: Approve for 5 months with a quantity limit of #1 kit (2 syringes) per 84 days (Please enter a start date of 3 WEEKS AFTER the START date of the first approval).
   • Skyrizi 150mg/mL pen/syringe: Approve for 5 months with a quantity limit of

   1mL per 84 days. (Please enter a start date of 3 WEEKS AFTER the START date

   of the first approval).
   If no, continue to #2.

2. Does the patient have a diagnosis of psoriatic arthritis (PsA) and meet ALL of the following criteria?
   • The patient is 18 years of age or older
   • Therapy is prescribed by or in consultation with a rheumatologist or dermatologist
   • The patient had a trial of or contraindication to ONE DMARD (disease- modifying antirheumatic drug), such as methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine
   If yes, approve the requested strength and dosage form for a total of 6 months by GPID or GPI-14. Please enter two authorizations as follows:
   FIRST APPROVAL:
   • Skyrizi 150mg/1.66mL Kit: Approve for 1 month with a quantity limit of #1 kit (2 syringes) per 28 days.
   • Skyrizi 150mg/mL pen/syringe: Approve for 1 month with a quantity limit of

   1mL per 28 days.

   SECOND APPROVAL:
   • Skyrizi 150mg/1.66mL Kit: Approve for 5 months with a quantity limit of #1 kit (2 syringes) per 84 days (Please enter a start date of 3 WEEKS AFTER the START date of the first approval).
   • Skyrizi 150mg/mL pen/syringe: Approve for 5 months with a quantity limit of

   1mL per 84 days. (Please enter a start date of 3 WEEKS AFTER the START date

   of the first approval).
   If no, continue to #3.

3. Does the patient have a diagnosis of moderate to severe Crohn’s disease (CD) and meet ALL of the following criteria?
   • The patient is 18 years of age or older
   • Therapy is prescribed by or in consultation with a gastroenterologist
   • The patient had a trial of or contraindication to ONE conventional agent, such as corticosteroids (e.g., budesonide, methylprednisolone), azathioprine, mercaptopurine, methotrexate, or mesalamine
   If yes, continue to #4.
   If no, do not approve.
   DENIAL TEXT: See the initial denial text at the end of the guideline.

4. Does the patient have non-self-administered (NSA) drug benefit coverage?
   If yes, continue to #5.
   If no, approve a maintenance dose of Skyrizi 360mg/2.4mL, for 6 months, by GPID or GPI- 14, with a quantity limit of #2.4 mL per 56 days.

5. Is the prescriber requesting an intravenous infusion induction dose of Skyrizi 600mg/10mL?
   If yes, approve for a total of 6 months by GPID or GPI-14. Please enter two authorizations as follows:
   FIRST APPROVAL:
   Skyrizi 600mg/10mL: Approve for 3 months with a quantity limit of #10mL per 28 days.
   SECOND APPROVAL:
   Skyrizi 360mg/2.4mL: Approve for 3 months with a quantity limit of #2.4 mL per 56 days (Please enter the start date of 11 WEEKS AFTER the START date of the first approval).

If no, approve a maintenance dose of Skyrizi 360mg/2.4mL, for 6 months, by GPID or GPI14, with a quantity limit of #2.4 mL per 56 days.
INITIAL DENIAL TEXT: *Some terms are already pre-defined in parenthesis. Please use these definitions if the particular text you need to use does not already have a definition(s) in it.
Our guideline named RISANKIZUMAB-RZAA (Skyrizi) requires the following rules be met for approval:

A. You have ONE of the following diagnoses:

1. Moderate to severe plaque psoriasis (PsO: a type of skin condition)
2. Psoriatic arthritis (PsA: a type of skin and joint condition)
3. Moderate to severe Crohn’s disease (CD: a type of bowel disorder)

B. If you have moderate to severe plaque psoriasis, approval also requires:

1. You are 18 years of age or older
2. Therapy is prescribed by or in consultation with a dermatologist (a type of skin doctor)
3. You have psoriasis covering 3% or more of the body surface area (BSA) OR psoriatic lesions (rashes) affecting the hands, feet, genital area, or face
4. You have tried or have a contraindication (harmful for) to one or more forms of standard therapies, such as PUVA (Phototherapy Ultraviolet Light A), UVB (Ultraviolet Light B), topical corticosteroids, calcipotriene, acitretin, methotrexate, or cyclosporine

C. If you have psoriatic arthritis, approval also requires:

1. You are 18 years of age or older
2. Therapy is prescribed by or in consultation with a rheumatologist (a type of immune system doctor) or dermatologist (a type of skin doctor)
3. You have tried or have a contraindication (harmful for) to ONE DMARD (disease-modifying antirheumatic drug), such as methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine

D. If you have moderate to severe Crohn’s disease, approval also requires:

1. You are 18 years of age or older
2. Therapy is prescribed by or in consultation with a gastroenterologist (a doctor who treats digestive conditions)
3. You had a trial of or contraindication (harmful for) to ONE standard therapy, such as corticosteroids (such as budesonide, methylprednisolone), azathioprine, mercaptopurine, methotrexate, or mesalamine

Your doctor told us [INSERT PT SPECIFIC INFO PROVIDED]. We do not have information showing you [INSERT UNMET CRITERIA]. This is why your request is denied. Please work with your doctor to use a different medication or get us more information if it will allow us to approve this request.

RENEWAL CRITERIA

1. Does the patient have a diagnosis of moderate to severe plaque psoriasis (PsO) AND meet the following criterion?
   • The patient has achieved or maintained clear or minimal disease or a decrease in PASI (Psoriasis Area and Severity Index) of at least 50% or more
   If yes, approve the requested strength and dosage form for 12 months by GPID or GPI-14 with the following quantity limits:
   • Skyrizi 150mg/1.66mL Kit: #1 kit (2 syringes) per 84 days.
   • Skyrizi 150mg/mL pen/syringe: #1mL per 84 days.
   If no, continue to #2.

2. Does the patient have a diagnosis of psoriatic arthritis (PsA) AND meet the following criterion?
   • The patient has experienced or maintained a 20% or greater improvement in the tender joint count or swollen joint count while on therapy
   If yes, approve the requested strength and dosage form for 12 months by GPID or GPI-14 with the following quantity limits:
   •  Skyrizi 150mg/1.66mL Kit: #1 kit (2 syringes) per 84 days.
   •  Skyrizi 150mg/mL pen/syringe: #1mL per 84 days.
   If no, continue to #3.

3. Does the patient have a diagnosis of moderate to severe Crohn’s disease (CD)?
   If yes, approve for 12 months by GPID or GPI-14 for Skyrizi 360mg/2.4mL with a quantity limit of #2.4 mL per 56 days.

If no, do not approve.
RENEWAL DENIAL TEXT: *Some terms are already pre-defined in parenthesis. Please use these definitions if the particular text you need to use does not already have a definition(s) in it.
Our guideline named RISANKIZUMAB-RZAA (Skyrizi) requires the following rule(s) to be met for renewal:
A. You have ONE of the following diagnoses:

1. Moderate to severe plaque psoriasis (PsO: a type of skin condition)
2. Psoriatic arthritis (PsA: a type of skin and joint condition)
3. Moderate to severe Crohn’s disease (CD: a type of bowel disorder)

B. If you have moderate to severe plaque psoriasis, renewal also requires:
1. You have achieved or maintained clear or minimal disease or a decrease in PASI (Psoriasis Area and Severity Index) of at least 50% or more
C. If you have psoriatic arthritis, renewal also requires:
1. You experienced or maintained a 20% or greater improvement in the tender joint count or swollen joint count while on therapy
Your doctor told us [INSERT PT SPECIFIC INFO PROVIDED]. We do not have information showing you [INSERT UNMET CRITERIA]. This is why your request is denied. Please work with your doctor to use a different medication or get us more information if it will allow us to approve this request.
RATIONALE
For further information, please refer to the Prescribing Information and/or Drug Monograph for Skyrizi.
REFERENCES
Skyrizi [Prescribing Information]. North Chicago, IL: AbbVie, Inc.; June 2022.

Part D Effective: N/A
Commercial Effective: 09/12/22
Created: 05/19
Client Approval: 09/22
P&T Approval: 01/22
Copyright © 2022 MedImpact Healthcare Systems, Inc. All rights reserved. This document is proprietary to MedImpact.
MedImpact maintains the sole and exclusive ownership, right, title, and interest in and to this document.

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