MedImpact Standard Commercial Drug Formulary Prior Authorization Guidelines Instructions

STANDARD COMMERCIAL DRUG FORMULARY
PRIOR AUTHORIZATION GUIDELINES

Standard Commercial Drug Formulary Prior Authorization Guidelines

ADALIMUMAB

GUIDELINES FOR USE

INITIAL CRITERIA

(NOTE: FOR RENEWAL CRITERIA SEE BELOW)

1. Does the patient have a diagnosis of moderate to severe rheumatoid arthritis (RA) and meet ALL of the following criteria?

•  The patient is 18 years of age or older
• Therapy is prescribed by or given in consultation with a rheumatologist
• The patient had a previous trial of or contraindication to at least 3 months of treatment with ONE DMARD (disease-modifying antirheumatic drug), such as methotrexate dose greater than or equal to 20mg per week or maximally tolerated dose, leflunomide, hydroxychloroquine, or sulfasalazine

If yes, approve for 6 months by GPID or GPI-14 for Humira 40mg/0.4mL OR 40mg/0.8mL with a quantity limit of #2 per 28 days.
APPROVAL TEXT: Renewal for moderate to severe rheumatoid arthritis requires that the patient has experienced or maintained a 20% or greater improvement in tender  joint count or swollen joint count while on therapy. If no, continue to #2.

CONTINUED ON NEXT PAGE

INITIAL CRITERIA (CONTINUED)

2. Does the patient have a diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis (PJIA) and meet ALL of the following criteria?

• The patient is 2 years of age or older
• Therapy is prescribed by or given in consultation with a rheumatologist
• The patient had a previous trial of or contraindication to ONE DMARD (disease-modifying antirheumatic drug), such as methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine
• Documentation of the patient’s current weight

If yes, approve for 6 months by GPID or GPI-14 with a quantity limit of #2 per 28 days based on patient weight as follows:

• If 10kg to <15kg in weight: Approve Humira 10mg/0.2mL OR 10mg/0.1mL.
• If 15kg to <30kg in weight: Approve Humira 20mg/0.4mL OR 20mg/0.2mL.
• If 30kg or heavier: Approve Humira 40mg/0.8mL OR 40mg/0.4mL.
  APPROVAL TEXT: Renewal for moderate to severe polyarticular juvenile idiopathic arthritis requires that the patient has experienced or maintained a 20% or greater  improvement in tender joint count or swollen joint count while on therapy. If no, continue to #3.

3. 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 given in consultation with a rheumatologist or dermatologist
• The patient had a previous trial of or contraindication to ONE DMARD (disease-modifying antirheumatic drugs) such as methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine

If yes, approve for 6 months by GPID or GPI-14 for Humira 40mg/0.8mL OR 40mg/0.4mL with a quantity limit of #2 per 28 days.
APPROVAL TEXT : Renewal for psoriatic arthritis requires that the patient has experienced or maintained a 20% or greater improvement in tender joint count or swollen  joint count while on therapy.

If no, continue to #4.
CONTINUED ON NEXT PAGE

INITIAL CRITERIA (CONTINUED)

4. Does the patient have a diagnosis of ankylosing spondylitis (AS) and meet ALL of the following
criteria?

• The patient is 18 years of age or older
• Therapy is prescribed by or given in consultation with a rheumatologist
• The patient had a previous trial of or contraindication to an NSAID

If yes, approve for 6 months by GPID or GPI-14 for Humira 40mg/0.8mL OR 40mg/0.4mL with a quantity limit of #2 per 28 days.
APPROVAL TEXT: Renewal for ankylosing spondylitis requires that the patient has experienced or maintained an improvement of at least 50% or 2 units (scale of 1-10) in  the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) while on therapy.

If no, continue to #5.
5. 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 given in consultation with a dermatologist
• The patient has psoriatic lesions involving greater than or equal to 10% body surface area (BSA) OR psoriatic lesions affecting the hands, feet, genital area, or face The patient had a previous 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 for a total of 6 months by GPID or GPI-14. Please enter two authorizations as follows:

• Approve for 1 fill for Humira 40mg/0.8mL Psoriasis Starter Package with a quantity of #4 pens OR for Humira Psoriasis Starter Package (contains one 80 mg/0.8 mL  pen and two 40 mg/0.4 mL pens) with a quantity limit of #3 pens.
• Approve for 5 months for Humira 40mg/0.8mL OR 40mg/0.4mL with a quantity limit of #2 per 28 days.
  APPROVAL TEXT: Renewal for moderate to severe plaque psoriasis requires that 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 while on therapy.

6. Does the patient have a diagnosis of moderate to severe Crohn’s disease (CD) and meet ALL of the following criteria?

• The patient is 6 years of age or older
• Therapy is prescribed by or given in consultation with a gastroenterologist
• The patient had a previous trial of or contraindication to ONE conventional agent, such as corticosteroids (i.e., budesonide, methylprednisolone), azathioprine,  mercaptopurine, methotrexate, or mesalamine

If yes, approve for a total of 6 months by GPID or GPI-14. Please enter two authorizations as follows:

• Approve for 1 fill for Humira 40mg/0.8mL Crohn’s Disease Starter Package with a quantity limit of #6 pens, OR for Humira 40mg/0.8mL Pediatric Crohn’s Starter Package with quantity limit of either #3 syringes or #6 syringes, OR for Humira 80mg/0.8mL Pediatric Crohn’s Disease Starter Package with a quantity limit of #3 syringes, OR for Humira Pediatric Crohn’s Disease Starter Package (contains one 40mg/0.4mL syringe and one 80mg/0.8mL syringe) with a quantity limit of #2  syringes, OR for Humira 80 mg/0.8 mL Crohn’s Disease Starter Package with a quantity limit of #3 pens.
• Approve for 5 months for Humira 40mg/0.8mL, OR 40mg/0.4mL, OR 20mg/0.4mL, OR 20mg/0.2mL with a quantity limit of #2 per 28 days.

7. Does the patient have a diagnosis of moderate to severe ulcerative colitis (UC) and meet ALL of the following criteria?

• The patient is 5 years of age or older
• Therapy is prescribed by or given in consultation with a gastroenterologist
• The patient had a previous trial of or contraindication to ONE conventional agent, such as corticosteroids (i.e., budesonide, methylprednisolone), azathioprine,  mercaptopurine, methotrexate, or mesalamine

If yes, approve for a total of 6 months by GPID or GPI-14. Please enter two authorizations as follows:

• Approve for 1 fill for ONE of the following as requested:
  o Humira 40mg/0.8mL Pen Ulcerative Colitis Starter Package: #6 pens.
  o Humira 80 mg/0.8 mL Ulcerative Colitis Starter Package: #3 pens.

• Humira 80mg/0.8mL Pen Pediatric UC Starter Package: #4 pens.
  o Humira 40mg/0.8mL OR 40mg/0.4mL: #4 pens/syringes.

• Approve for 5 months for ONE of the following as requested:
  o Humira 40mg/0.8mL OR 40mg/0.4mL: #4 per 28 days.
  o Humira 80mg/0.8mL: #2 per 28 days.
  o Humira 20mg/0.4mL OR 20mg/0.2mL: #4 per 28 days.

8 Does the patient have a diagnosis of moderate to severe hidradenitis suppurativa (HS) and is 12 years of age or older?
If yes, approve for a total of 6 months by GPID or GPI-14. Please enter two authorizations as follows:
• Approve for 1 fill for Humira 40mg/0.8mL Pen Starter Package for Hidradenitis Suppurativa (HS) with a quantity limit of #6 pens OR for Humira 80 mg/0.8 mL
Hidradenitis Suppurativa Starter Package with a quantity limit of #3 pens.
• Approve for 5 months for the requested agent as follows:
o Humira 40mg/0.8mL OR 40mg/0.4mL: #4 per 28 days.
o Humira 80mg/0.8mL: #2 per 28 days.
If no, continue to #9.

9. Does the patient have a diagnosis of non-infectious intermediate, posterior and panuveitis and meet ALL of the following criteria?

• The patient is 2 years of age or older
• Therapy is prescribed by or given in consultation with an ophthalmologist
• The patient does NOT have isolated anterior uveitis
• Documentation of the patient’s current weight if between 2 to 17 years of age

If yes, approve for a total of 6 months by GPID or GPI-14 as follows:

• For age 2 to 17 years, approve with a quantity limit of #2 per 28 days based on patient weight as follows:
  o If 10kg to <15kg in weight: Approve Humira 10mg/0.2mL OR 10mg/0.1mL.
  o If 15kg to <30kg in weight: Approve Humira 20mg/0.4mL OR 20mg/0.2mL.
  o If 30kg or heavier: Approve Humira 40mg/0.8mL OR 40mg/0.4mL.

• For age 18 years and above, please enter two authorizations as follows:
  o Approve for 1 fill for Humira 40mg/0.8mL Uveitis Starter Package with a quantity limit of #4 pens OR for Humira Uveitis Starter Package (contains one 80 mg/0.8 mL pen and two 40 mg/0.4 mL pens) with a quantity limit of #3 pens.
  O Approve for 5 months for Humira 40mg/0.8mL OR 40mg/0.4mL with a quantity limit of #2 per 28 days.
  APPROVAL TEXT: Renewal for Uveitis requires that the patient has not experienced treatment failure, defined as development of new inflammatory chorioretinal or retinal vascular lesions, a 2-step increase from baseline in anterior chamber cell grade or vitreous haze grade, or a worsening of best- corrected visual acuity (BCVA) by at least 15 letters relative to  best state achieved.

If no, do not approve.
DENIAL TEXT : See the initial denial text at the end of the guideline.

*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  definition(s) in it.**

Our guideline named ADALIMUMAB (Humira) requires the following rule(s) be met for approval:
A. You have ONE of the following diagnoses:

1. Moderate to severe rheumatoid arthritis (RA: inflammation and stiffness in joints)
2. Psoriatic arthritis (PsA: joint pain and swelling with red scaly skin patches)
3. Moderate to severe polyarticular juvenile idiopathic arthritis (PJIA: swelling and stiffness in joints in children)
4. Ankylosing spondylitis (AS: inflammation and stiffness affecting spine and large joints)
5. Moderate to severe plaque psoriasis (PsO: dry, itchy skin patches with scales)
6. Moderate to severe Crohn’s disease (CD: type of inflammatory disease that affects lining of digestive tract)
7. Moderate to severe ulcerative colitis (UC: type of inflammatory disease that affects lining of digestive tract)
8. Moderate to severe hidradenitis suppurativa (skin condition with lumps)
9. Non-infectious intermediate posterior and panuveitis (serious inflammation of eye)

B. If you have moderate to severe rheumatoid arthritis (RA), approval also requires:

1.  You are 18 years of age or older
2. The medication is prescribed by or given in consultation with a rheumatologist (a doctor who specializes in conditions that affects the muscles and skeletal system, especially the joints)
3. You have previously tried at least 3 months of treatment with ONE DMARD (diseasemodifying antirheumatic drug), unless there is a medical reason why you cannot (contraindication), such as methotrexate dose greater than or equal to 20mg per week or maximally tolerated dose, leflunomide, hydroxychloroquine, or sulfasalazine

C. If you have moderate to severe polyarticular juvenile idiopathic arthritis (PJIA), approval also requires:

1. You are 2 years of age or older
2. The medication is prescribed by or given in consultation with a rheumatologist (a doctor who specializes in conditions that affects the muscles and skeletal system, especially the joints)
3. You have previously tried ONE DMARD (disease-modifying antirheumatic drug), unless there is a medical reason why you cannot (contraindication), such as  ethotrexate, leflunomide, hydroxychloroquine, or sulfasalazine
4. There is documentation of your most current weight (Initial denial text continued on next page)

D. If you have psoriatic arthritis (PsA), approval also requires:

1. You are 18 years of age or older
2. The medication is prescribed by or given in consultation with a rheumatologist (a doctor who specializes in conditions that affects the muscles and skeletal system,  especially the joints) or dermatologist (skin doctor)
3. You previously tried ONE DMARD (disease-modifying antirheumatic drug), unless there is a medical reason why you cannot (contraindication), such as methotrexate,  leflunomide, hydroxychloroquine, or sulfasalazine

E. If you have ankylosing spondylitis (AS), approval also requires:

1. You are 18 years of age or older
2. The medication is prescribed by or given in consultation with a rheumatologist (a doctor who specializes in conditions that affects the muscles and skeletal system, especially the joints)
3. You have previously tried an NSAID (non-steroidal anti-inflammatory drug), unless there is a medical reason why you cannot (contraindication)

F. If you have moderate to severe plaque psoriasis (PsO), approval also requires:

1. You are 18 years of age or older
2. The medication is prescribed by or given in consultation with a dermatologist (skin doctor)
3. You have psoriatic lesions (rashes) involving greater than or equal to 10% body surface area (BSA) OR psoriatic lesions (rashes) affecting the face, hands, feet, or genital  area
4. You have previously tried ONE or more forms of standard therapies, unless there is a medical reason why you cannot (contraindication), such as PUVA (Phototherapy Ultraviolet Light A), UVB (Ultraviolet Light B), topical corticosteroids, calcipotriene, acitretin, methotrexate, or cyclosporine

G. If you have moderate to severe Crohn’s disease (CD), approval also requires:

1. You are 6 years of age or older
2.  The medication is prescribed by or given in consultation with a gastroenterologist (a doctor who specializes in conditions of the stomach, intestine and related organs)
3. You have previously tried ONE standard therapy, unless there is a medical reason why you cannot (contraindication), such as corticosteroids (such as budesonide, methylprednisolone), azathioprine, mercaptopurine, methotrexate, or mesalamine

H. If you have moderate to severe ulcerative colitis (UC), approval also requires:

1. You are 5 years of age or older
2. The medication is prescribed by or given in consultation with a gastroenterologist (a doctor who specializes in conditions of the stomach, intestine and related organs)
3. You have previously tried ONE standard therapy, unless there is a medical reason why you cannot (contraindication), such as corticosteroids (such as budesonide, methylprednisolone), azathioprine, mercaptopurine, methotrexate, or mesalamine

I. If you have moderate to severe hidradenitis suppurativa (HS), approval also requires:

1. You are 12 years of age or older (Initial denial text continued on next page)

J. If you have non-infectious intermediate, posterior and panuveitis, approval also requires:

1. You are 2 years of age or older

2. The medication is prescribed by or given in consultation with an ophthalmologist (eye
   doctor)

3. You do not have isolated anterior uveitis (a different type of eye inflammation)

4. If you are 2 to 17 years of age, we require documentation of your current weight

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 rheumatoid arthritis (RA)?
   If yes, continue to #2.
   If no, continue to #4.

2. Is the request for Humira 40mg dosed every other week and has the following criterion been met?
   • The patient has experienced or maintained a 20% or greater improvement in tender joint count or swollen joint count while on therapy
   If yes, approve for 12 months by GPID or GPI-14 for Humira 40mg/0.8mL OR 40mg/0.4mL with a quantity limit of #2 per 28 days.

3. Is the request for Humira 40mg dosed every week OR Humira 80mg dosed every other week and have ALL of the following criteria been met?
   • The patient has experienced or maintained a 20% or greater improvement in tender joint count or swollen joint count while on therapy
   • The patient had a trial of at least a 3-month regimen of Humira 40mg dosed every other week
   If yes, approve for 12 months by GPID or GPI-14 for the requested agent with the following quantity limits:
   • Humira 40mg/0.8mL OR 40mg/0.4mL: #4 per 28 days.
   • Humira 80mg/0.8mL: #2 per 28 days.
   If no, do not approve.
   DENIAL TEXT : See the renewal denial text at the end of the guideline.
   PAC NOTE : Please enter a proactive prior authorization for 12 months by GPID or GPI-14 for Humira 40mg/0.8mL syringe/pen OR 40mg/0.4mL syringe/pen with  a quantity limit of #2 syringes/pens per month.

4. Does the patient have a diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis (PJIA) AND meet the following criterion?
   • The patient has experienced or maintained a 20% or greater improvement in tender joint count or swollen joint count while on therapy
   If yes, approve for 12 months by GPID or GPI-14 for Humira 10mg/0.1mL, OR 10mg/0.2mL, OR 20mg/0.2mL, OR 20mg/0.4mL, OR 40mg/0.4mL, OR  40mg/0.8mL with a quantity limit of #2 per 28 days.
   If no, continue to #5.

5. 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 tender joint count or swollen joint count while on therapy
   If yes, approve for 12 months by GPID or GPI-14 for Humira 40mg/0.8mL OR 40mg/0.4mL with a quantity limit of #2 per 28 days.

6. Does the patient have a diagnosis of ankylosing spondylitis (AS) AND meet the following criterion?
   • The patient has experienced or maintained an improvement of at least 50% or 2 units (scale of 1-10) in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) while on therapy
   If yes, approve for 12 months by GPID or GPI-14 for Humira 40mg/0.8mL OR 40mg/0.4mL with a quantity limit of #2 per 28 days.
   If no, continue to #7.

7. 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 while on therapy
   If yes, approve for 12 months by GPID or GPI-14 for Humira 40mg/0.8mL OR 40mg/0.4mL with a quantity limit of #2 per 28 days.
   If no, continue to #8.

8. 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 Humira 40mg/0.8mL, OR 40mg/0.4 mL, OR 20mg/0.4mL, OR 20mg/0.2mL with a quantity limit of #2 per 28 days.
   If no, continue to #9.

9. Does the patient have a diagnosis of moderate to severe ulcerative colitis (UC)?
   If yes, approve for 12 months by GPID or GPI-14 for the requested agent as follows:
   • Humira 40mg/0.8mL OR Humira 40mg/0.4mL: #4 per 28 days.
   • Humira 80mg/0.8mL: #2 per 28 days.
   • Humira 20mg/0.4mL OR Humira 20mg/0.2mL: #4 per 28 days.
   If no, continue to #10.

10. Does the patient have a diagnosis of moderate to severe hidradenitis suppurativa (HS)?
    If yes, approve for 12 months by GPID or GPI-14 for the requested agent as follows:
    • Humira 40mg/0.8mL OR 40mg/0.4mL: #4 per 28 days.
    • Humira 80mg/0.8 mL: #2 per 28 days.
    If no, continue to #11.

11. Does the patient have a diagnosis of non-infectious intermediate, posterior and panuveitis AND meet the following criteria?
    • The patient has not experienced treatment failure, defined as ONE of the following criteria:
    o Development of new inflammatory chorioretinal or retinal vascular lesions
    o A 2-step increase from baseline in anterior chamber cell grade or vitreous haze grade
    o A worsening of best-corrected visual acuity (BCVA) by at least 15 letters relative to best state achieved
    If yes, approve for 12 months by GPID or GPI-14 for Humira 10mg/0.1mL, OR 10mg/0.2mL, OR 20mg/0.2mL, OR 20mg/0.4mL, OR 40mg/0.8mL, OR  40mg/0.4mL with a quantity limit of #2 per 28 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 definition(s) in it.

Our guideline named ADALIMUMAB (Humira) requires the following rule(s) be met for renewal:

A. You have ONE of the following diagnoses:

1. Moderate to severe rheumatoid arthritis (RA: inflammation and stiffness in joints)
2. Psoriatic arthritis (PsA: joint pain and swelling with red scaly skin patches)
3. Moderate to severe polyarticular juvenile idiopathic arthritis (PJIA: swelling and stiffness in joints in children)
4. Ankylosing spondylitis (AS: inflammation and stiffness affecting spine and large joints)
5. Moderate to severe plaque psoriasis (PsO: dry, itchy skin patches with scales)
6. Moderate to severe Crohn’s disease (CD: type of inflammatory disease that affects lining of digestive tract)
7. Moderate to severe ulcerative colitis (UC: type of inflammatory disease that affects lining of digestive tract)
8. Moderate to severe hidradenitis suppurativa (skin condition with lumps)
9. Non-infectious intermediate posterior and panuveitis (serious inflammation of eye)

B. If you have moderate to severe rheumatoid arthritis (RA), renewal also requires:

1. You have experienced or maintained a 20% or greater improvement in tender joint count or swollen joint count while on therapy
2. If you are requesting Humira 40mg weekly dosing OR Humira 80mg every other week dosing, we require you have tried at least a 3-month of Humira 40mg every other week

C. If you have moderate to severe polyarticular juvenile idiopathic arthritis (PJIA), renewal also requires:

1. You have experienced or maintained a 20% or greater improvement in tender joint count or swollen joint count while on therapy (Renewal denial text continued on next page)

D. If you have psoriatic arthritis (PsA), renewal also requires:
1. You have experienced or maintained a 20% or greater improvement in tender joint count
or swollen joint count while on therapy
E. If you have ankylosing spondylitis (AS), renewal also requires:
1. You have experienced or maintained an improvement of at least 50% or 2 units (scale of 1-10) in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) while on therapy
F. If you have moderate to severe plaque psoriasis (PsO), 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 while on therapy
G. If you have non-infectious intermediate, posterior and panuveitis, renewal also requires:
1. You have not experienced treatment failure, defined as ONE of the following:
a. You have development of new inflammatory chorioretinal or retinal vascular lesions (eye tumors)
b. A 2-step increase from baseline in anterior chamber cell grade or vitreous haze grade (types of classifications on how bad eye inflammation is)
c. A worsening of best-corrected visual acuity (BCVA) by at least 15 letters relative to best visual acuity achieved

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 Humira.

REFERENCES
• Humira [Prescribing Information]. North Chicago, IL: AbbVie Inc.; February 2021.

Part D Effective: N/A
Commercial Effective: 04/10/21
Created: 05/03
Client Approval: 03/21 =
P&T Approval: 04/21 Copyright © 2021 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.
Revised: 3/ 19/2021

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