referred anagement (psm) olicy...a) approve actemra iv for 3 months if the patient meets the...

10/05/2016

© 2016 Express Scripts Holding Company. All Rights Reserved.

This document is confidential and proprietary to Express Scripts Holding Company. Unauthorized use and distribution are prohibited.

PREFERRED SPECIALTY MANAGEMENT (PSM) POLICY

POLICY: Inflammatory Conditions PSM – High Performance Formulary

(HPF) 2017

TAC APPROVAL DATE: 10/05/2016; selected revision 11/30/2016

LAY CRITERIA EFFECTIVE DATE: See Criteria Section for Criteria Effective Dates (noted

individually by product)

DRUGS AFFECTED:

Actemra® (tocilizumab intravenous [IV] infusion – Genentech/Roche)

Actemra® (tocilizumab subcutaneous [SC] injection – Genentech/Roche)

Cimzia® (certolizumab pegol SC injection [lyophilized] and SC injection [solution] UCB)

Cosentyx® (secukinumab SC injection)

Enbrel® (etanercept SC injection Immunex)

Humira® (adalimumab SC injection – AbbVie, Inc.)

Kineret® (anakinra SC injection – Swedish Orphan Biovitrim)

Orencia® (abatacept IV infusion Bristol Myers Squibb)

Orencia® (abatacept SC injection Bristol Myers Squibb)

Otezla® (apremilast tablets – Celgene Corporation)

Remicade® (infliximab recombinant IV infusion Janssen Biotech/Johnson & Johnson)

Rituxan® (rituximab IV infusion Genentech)

Simponi® (golimumab SC injection – Janssen Biotech/Johnson & Johnson)

Simponi® Aria™ (golimumab IV infusion – Janssen Biotech/Johnson & Johnson)

Stelara® (ustekinumab SC injection – Janssen Biotech/Johnson & Johnson)

Stelara® (ustekinumab IV infusion – Janssen Biotech/Johnson & Johnson)

Taltz® (ixekizumab SC injection – Eli Lilly and Company)

Xeljanz® (tofacitinib tablets – Pfizer)

Xeljanz® XR (tofacitinib extended-release tablets – Pfizer)

Several products are available for use in inflammatory conditions such as rheumatoid arthritis (RA),

ankylosing spondylitis (AS), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), plaque psoriasis,

Crohn’s disease, and ulcerative colitis (UC).1-15 This policy involves the use of the products listed above.

The FDA-approved indications for each product listed in this policy are documented in Appendix A. For

more information on criteria within a Prior Authorization (PA) program by specific condition refer to the

respective ESI Standard Inflammatory Conditions Prior Authorization Policy.

http://esidepartments/sites/Dep043/UMPolicies/PA%20Criteria%20for%20Integrated%20Policies/Forms/AllItems.aspx

Inflammatory Conditions PSM – HPF

10/05/2016



High Performance Formulary – Preferred and Non-Preferred Products (SC and Oral).

Rheumatoid Conditions Dermatology Gastrointestinal Conditions

RA AS JIA PsA Psoriasis CD UC Preferred Actemra SC

Enbrel

Humira

Enbrel Humira

Enbrel Humira

Enbrel Humira

Humira Otezla

Humira Humira

Non-Preferred (directed to ONE

Preferred agent)

Xeljanz/XR Cosentyx

-- Cosentyx Otezla

Stelara

Cosentyx Enbrel

(directed

to Humira only) Stelara

Taltz

Cimzia

Stelara SC

Simponi SC

Non-Preferred (directed to

TWO Preferred

agents)

[documentation

required]*

Cimzia Orencia SC

Simponi SC

Kineret

Cimzia Simponi SC

-- Cimzia Simponi SC

-- -- --

RA – Rheumatoid arthritis; AS – Ankylosing spondylitis; JIA – Juvenile idiopathic arthritis; PsA – Psoriatic arthritis; CD – Crohn’s

disease; UC – Ulcerative colitis; SC – Subcutaneous; * The prescriber must provide written documentation supporting the trial of

Preferred agents, noted in the criteria as [documentation required]. Documentation may include, but is not limited to, chart notes,

prescription claims records, and/or prescription receipts.

High Performance Formulary – Preferred and Non-Preferred Products (Infused).

Rheumatoid Conditions Dermatology Gastrointestinal Conditions

RA AS JIA PsA Psoriasis CD UC Preferred Enbrel

Humira

Enbrel

Humira

Enbrel

Humira

Enbrel

Humira

Humira

Humira Humira

Non-Preferred

Infused (directed to ONE

Preferred TNFi)

Actemra IV Orencia IV

Remicade

Rituxan

Simponi Aria

Remicade Actemra IV* See note, below Orencia IV

Remicade Remicade

Remicade

Stelara IV -- Note: A

Preferred is not

required prior to

Remicade for

UC.

RA – Rheumatoid arthritis; AS – Ankylosing spondylitis; JIA – Juvenile idiopathic arthritis; PsA – Psoriatic arthritis; CD – Crohn’s

disease; UC – Ulcerative colitis; TNFi – Tumor necrosis factor inhibitor; IV – Intravenous; * Directed to a Preferred tumor necrosis

factor inhibitor for polyarticular JIA only. Systemic JIA (SJIA) is not a targeted diagnosis, and patients with SJIA are not required to

try a Preferred product prior to Actemra IV.

POLICY STATEMENT

For all medications, this program requires the patient to meet ESI Standard Inflammatory Conditions

Prior Authorization criteria. Additionally, this program requires trial(s) of the Preferred product(s)

according to the tables above, when clinically appropriate, prior to the approval of the Non-Preferred

products. There are also situations when trials of Non-Preferred agents will be considered; see criteria

below. Other details of the program are as follows:

Continuation of Therapy: Approval for a patient continuing therapy with a Non-Preferred SC or

oral agent must be supported with verification, noted in the criteria as either [verification in

prescription claims history required] or, if not available, [verification by prescribing physician

required].

o If the patient has at least 130 days of prescription claims history on file, claims history must

support that the patient has received the Non-Preferred product for the specified period of time

(90 or 120 days) within a 130-day look-back period; OR

o When 130 days of the patient’s prescription claim history file is unavailable for verification, the

prescriber must verify that the patient has been receiving the Non-Preferred product for a

specified period of time (90 or 120 days), AND that the patient has been receiving the Non-


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Preferred product via paid claims (e.g., patient has not been receiving samples or coupons or

other types of waivers in order to obtain access to the Non-Preferred product).

Documentation Required: When a trial of two Preferred agents is required, the prescriber must

provide written documentation supporting the trials of other agents, noted in the criteria as

[documentation required]. Documentation may include, but is not limited to, chart notes, prescription

claims records, and/or prescription receipts.

Approval Duration: All approvals for continuation of therapy for Preferred and Non-Preferred

products are provided for 1 year unless noted otherwise below. In cases where the initial approval is

authorized in months, 1 month is equal to 30 days.

Automation: None

RECOMMENDED EXCEPTION CRITERIA

Trade

Name

Exception

Actemra

IV

Lay

Criteria

Effective

Date:

01/01/2017

1. Rheumatoid Arthritis (RA), Initial Therapy.

A) Approve Actemra IV for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Actemra IV PA

Policy criteria; AND

ii. The patient meets ONE of the following (a or b)

a) The patient has tried ONE of Enbrel or Humira. Note: A trial of Cimzia,

Remicade, Simponi Aria, or Simponi SC or also counts; OR

b) According to the prescribing physician, the patient has heart failure OR a

previously treated lymphoproliferative disorder.

B) If the patient has met criterion 1Ai (the ESI Standard Inflammatory Conditions –

Actemra IV PA Policy criteria), but criterion 1Aii is not met and, offer to review for a

Preferred product (Enbrel or Humira) using the respective ESI Standard Inflammatory

Conditions – PA Policy criteria.

2. Polyarticular Juvenile Idiopathic Arthritis (PJIA), Initial Therapy.

A) Approve Actemra IV for 4 months if the patient meets the following conditions (i and ii):



ii. The patient has tried ONE of Enbrel or Humira. Note: A trial of Orencia IV or

Remicade also counts.


Actemra IV PA Policy criteria), but criterion 2Aii is not met, offer to review for a

preferred product (Enbrel or Humira) using the respective ESI Standard Inflammatory


3. RA or PJIA, Patients Currently Taking Actemra (IV or SC).

A) Approve Actemra IV for 1 year if the patient meets BOTH of the following conditions (i

and ii):


Policy criteria for Patients Currently taking Actemra (IV or SC); AND

ii. The patient meets ONE of the following conditions (a, b, or c):

a) The patient has been established on Actemra (IV or SC) for ≥ 90 days; OR

b) The patient has RA and meets ONE of the following conditions [(1) or (2)]:

(1) The patient has tried ONE of Enbrel or Humira. Note: A trial of Cimzia,


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Remicade, Simponi Aria, or Simponi SC also counts; OR

(2) According to the prescribing physician, the patient has heart failure OR a

previously treated lymphoproliferative disorder; OR

c) The patient has PJIA and has tried has tried ONE of Enbrel or Humira. Note: A

trial of Orencia IV or Remicade also counts.


Actemra IV PA Policy criteria), but criterion 3Aii is not met, offer to review for a

preferred product (Enbrel or Humira) using the respective ESI Standard Inflammatory

Conditions PA Policy criteria.

4. Other Conditions (e.g., systemic JIA [SJIA]). Approve Actemra IV (initial therapy for a

duration as directed or 1 year for patients continuing therapy) if the patient meets the ESI

Standard Inflammatory Conditions – Actemra IV PA Policy criteria.

Actemra

SC

Lay

Criteria

Effective

Date:

01/01/2017

1. All Conditions. Approve Actemra SC (initial therapy for a duration as directed or 1 year for

patients continuing therapy) if the patient meets the ESI Standard Inflammatory Conditions –

Actemra SC PA Policy criteria.

Cimzia

Lay

Criteria

Effective

Date:

01/01/2017


A) Approve Cimzia for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Cimzia PA Policy

criteria; AND

ii. The patient has tried TWO of Actemra SC, Enbrel, and Humira [documentation

required].

B) If the patient has met criterion 1Ai (the ESI Standard Inflammatory Conditions – Cimzia

PA Policy criteria), but criterion 1Aii is not met and Cimzia is not approved, offer to

review for a preferred product (Actemra SC, Enbrel, or Humira) using the respective ESI

Standard Inflammatory Conditions PA Policy criteria.

2. Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), Initial Therapy.



criteria; AND

ii. The patient has tried BOTH of Enbrel and Humira [documentation required].


PA Policy criteria), but criterion 2Aii is not met and Cimzia is not approved, offer to

review for a preferred product (Enbrel or Humira) using the respective ESI Standard

Inflammatory Conditions PA Policy criteria.

3. Crohn’s Disease in an Adult, Initial Therapy.



criteria for Crohn’s disease; AND

ii. The patient has tried Humira.


PA Policy criteria), but criterion 3Aii is not met, offer to review for the preferred product

(Humira) using the ESI Standard Inflammatory Conditions – Humira PA Policy criteria.

4. RA, AS, PsA, or CD, Patients Currently Taking Cimzia.

A) Approve Cimzia for 1 year if the patient meets BOTH of the following conditions (i and


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ii):


criteria for Patients Currently taking Cimzia; AND

ii. The patient meets ONE of the following conditions (a, b, c, or d):

a) The patient has been established on Cimzia for at least 90 days and prescription

claims history indicates at least a 90-day supply of Cimzia was dispensed within

the past 130 days [verification in prescription claims history required] or, if not

available, [verification by prescribing physician required]. Note: In cases when

130 days of the patient’s prescription claim history file is unavailable to be

verified, an exception to this requirement is allowed if the prescriber has verified

that the patient has been receiving Cimzia for at least 90 days AND the patient

has been receiving Cimzia via paid claims (e.g., patient has not been receiving

samples or coupons or other types of waivers in order to obtain access to

Cimzia); OR

b) The patient has RA and has tried TWO of Actemra SC, Enbrel, and Humira

[documentation required]; OR

c) The patient has AS or PsA and has tried BOTH of Enbrel and Humira


d) The patient has CD and has tried Humira.


PA Policy criteria), but criterion 4Aii is not met, offer to review for a preferred product

using the respective ESI Standard Inflammatory Conditions – PA Policy criteria:

i. Patients with RA: Actemra SC, Enbrel, or Humira.

ii. Patients with AS or PsA: Enbrel or Humira

iii. Patients with CD: Humira.

5. Other Conditions. Approve Cimzia (initial therapy for a duration as directed or 1 year for


Cimzia PA Policy criteria.

Cosentyx

Lay

Criteria

Effective

Date:

01/01/2017


A) Approve Cosentyx for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Cosentyx PA


ii. The patient meets ONE of the following (a or b):

a) The patient has tried ONE of Enbrel and Humira. Note: A trial of Cimzia,

Remicade, or Simponi SC also counts; OR

b) According to the prescribing physician, the patient has experienced a previous

intolerance to a TNFi or has one of the following relative contraindications to

use of a TNFi: demyelinating disease, history of malignancy, or heart failure.


Cosentyx PA Policy criteria), but criterion 1Aii is not met, offer to review for a preferred

product (Enbrel or Humira) using the respective ESI Standard Inflammatory Conditions

PA Policy criteria.

2. Plaque Psoriasis, Initial Therapy.

A) Approve Cosentyx for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Cosentyx PA Policy

criteria; AND


a) The patient has tried ONE of Humira and Otezla; OR



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intolerance to a TNFi or has one of the following relative contraindications to use

of a TNFi: demyelinating disease, history of malignancy, or heart failure.



product (Humira or Otezla) using the respective ESI Standard Inflammatory Conditions

PA Policy criteria)

3. Plaque Psoriasis, AS, or PsA, Patients Currently Taking Cosentyx.

A) Approve Cosentyx for 1 year if the patient meets BOTH of the following conditions (i

and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Cosentyx PA Policy

criteria for Patients Currently taking Cosentyx; AND


a) The patient has been established on Cosentyx for at least 90 days and

prescription claims history indicates at least a 90-day supply of Cosentyx was

dispensed within the past 130 days [verification in prescription claims history

required] or, if not available, [verification by prescribing physician required].

Note: In cases when 130 days of the patient’s prescription claim history file is

unavailable to be verified, an exception to this requirement is allowed if the

prescriber has verified that the patient has been receiving Cosentyx for at least 90

days AND the patient has been receiving Cosentyx via paid claims (e.g., patient

has not been receiving samples or coupons or other types of waivers in order to

obtain access to Cosentyx); OR

b) The patient has AS or PsA and has tried ONE of Enbrel and Humira. Note: A

trial of Cimzia, Remicade, or Simponi SC also counts; OR

c) The patient has plaque psoriasis and meets ONE of the following has tried ONE

of Humira and Otezla; OR

d) According to the prescribing physician, the patient has experienced a previous





product using the respective ESI Standard Inflammatory Conditions – PA Policy criteria:

i. Patients with AS or PsA: Enbrel or Humira.

ii. Patients with plaque psoriasis: Humira or Otezla.

4. Other Conditions. Approve Cosentyx (initial therapy for a duration as directed or 1 year for


Cosentyx PA Policy criteria.

Enbrel

Lay

Criteria

Effective

Date:

01/01/2017

1. Plaque Psoriasis in an Adult ≥ 18 years of age, Initial Therapy. (For patients < 18 years

of age, see criterion #3.)

A) Approve Enbrel for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Enbrel PA Policy

criteria; AND


B) If the patient has met criterion 1Ai (the ESI Standard Inflammatory Conditions – Enbrel

PA Policy criteria), but criterion 1Aii is not met, offer to review for Humira using the ESI

Standard Inflammatory Conditions – Humira PA Policy criteria.

2. Plaque Psoriasis in an Adult ≥ 18 years of age, Patients Currently Taking Enbrel. (For

patients < 18 years of age, see criterion #3.)

A) Approve Enbrel for 1 year if the patient meets BOTH of the following conditions (i and


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ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Enbrel PA Policy

criteria for Patients Currently taking Enbrel; AND

ii. The patient meets ONE of the following conditions (a or b):

a) The patient has been established on Enbrel for at least 90 days and prescription

claims history indicates at least a 90-day supply of Enbrel was dispensed within





that the patient has been receiving Enbrel for at least 90 days AND the patient

has been receiving Enbrel via paid claims (e.g., patient has not been receiving

samples or coupons or other types of waivers in order to obtain access to Enbrel);

OR

b) The patient has tried Humira.

B) If the patient has met criterion 2Ai (the ESI Standard Inflammatory Conditions – Enbrel

PA Policy criteria), but criterion 2Aii is not met, offer to review for Humira using the

ESI Standard Inflammatory Conditions – Humira PA Policy criteria.

3. Other Conditions (including Plaque Psoriasis in a Patient < 18 years of age). Approve

Enbrel (initial therapy for a duration as directed or 1 year for patients continuing therapy) if

the patient meets the ESI Standard Inflammatory Conditions – Enbrel PA Policy criteria.

Humira

Lay

Criteria

Effective

Date:

01/01/2017

1. All Conditions. Approve Humira (initial therapy for a duration as directed or 1 year for


Humira PA Policy criteria.

Kineret

Lay

Criteria

Effective

Date:

01/01/2017


A) Approve Kineret for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Kineret PA Policy

criteria; AND

ii. The patient has tried TWO of Actemra SC, Enbrel, and Humira [documentation

required]. Note: A trial of Actemra IV, Cimzia, Orencia (IV or SC), Remicade, or

Simponi (SC or Aria) also counts [documentation required].

B) If the patient has met criterion 1Ai (the ESI Standard Inflammatory Conditions – Kineret


(Actemra SC, Enbrel, or Humira) using the respective ESI Standard Inflammatory


2. RA, Patients Currently Taking Kineret.

A) Approve Kineret for 1 year if the patient meets BOTH of the following conditions (i and

ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Kineret PA Policy

criteria for Patients Currently taking Kineret; AND


a) The patient has been established on Kineret at least 90 days and prescription

claims history indicates at least a 90-day supply of Kineret was dispensed within




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that the patient has been receiving Kineret for at least 90 days AND the patient

has been receiving Kineret via paid claims (e.g., patient has not been receiving

samples or coupons or other types of waivers in order to obtain access to

Kineret); OR

b) The patient has tried TWO of Actemra SC, Enbrel, or Humira [documentation

required]. Note: A trial of Actemra IV, Cimzia, Orencia (IV or SC), Remicade,

or Simponi (SC or Aria) also counts [documentation required].


Kineret PA Policy criteria), but criterion 2Aii is not met, offer to review for a preferred

product (Actemra SC, Enbrel, or Humira) using the respective ESI Standard

Inflammatory Conditions – PA Policy criteria.

3. Other Conditions (e.g., Cryopyrin-Associated Periodic Syndromes [CAPS], SJIA).

Approve Kineret (initial therapy for a duration as directed or 1 year for patients continuing

therapy) if the patient meets the ESI Standard Inflammatory Conditions – Kineret PA Policy

criteria.

Orencia

IV

Lay

Criteria

Effective

Date:

01/01/2017


A) Approve Orencia IV for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Orencia IV PA Policy

criteria; AND




b) According to the prescribing physician, the patient has heart failure, a previously

treated lymphoproliferative disorder, OR a previous serious infection.

B) If the patient has met criterion 1Ai (the ESI Standard Inflammatory Conditions – Orencia

IV PA Policy criteria), but criterion 1Aii is not met, offer to review for a preferred

product (Enbrel or Humira) using the respective ESI Standard Inflammatory Conditions –

PA Policy criteria.

2. Juvenile Idiopathic Arthritis (JIA)/Juvenile Rheumatoid Arthritis (JRA), Initial

Therapy.

A) Approve Orencia IV for 3 months if the patient meets the ESI Standard Inflammatory

Conditions – Orencia IV PA Policy criteria for JIA, Initial Therapy.

B) If the patient has NOT met criterion 2Ai (the ESI Standard Inflammatory Conditions –

Orencia IV PA Policy criteria): offer to review for a preferred product (Enbrel or

Humira) using the respective ESI Standard Inflammatory Conditions – PA Policy criteria.

3. RA or JIA/JRA, Patients Currently Taking Orencia (IV or SC).

A) Approve Orencia IV for 1 year if the patient meets BOTH of the following conditions (i

and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Orencia IV Policy

criteria for Patients Currently taking Orencia (IV or SC); AND


a) The patient has been established on Orencia (IV or SC) for ≥ 90 days; OR

b) The patient has RA and meets ONE of the following conditions [(1) or (2)]:

(1) The patient has tried ONE of Enbrel or Humira. Note: A trial of Cimzia,


(2) According to the prescribing physician, the patient heart failure, a

previously treated lymphoproliferative disorder, OR a previous serious


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infection; OR

c) The patient has JIA/JRA and has tried ONE of Enbrel or Humira. Note: A trial

of Actemra IV or Remicade also counts.


IV PA Policy criteria), but criterion 3Aii is not met, offer to review for a preferred

product (Enbrel or Humira) using the respective ESI Inflammatory Conditions – Standard

PA Policy criteria.

4. Other Conditions. Approve Orencia IV (initial therapy for a duration as directed or 1 year

for patients continuing therapy) if the patient meets the ESI Standard Inflammatory

Conditions – Orencia IV PA Policy criteria.

Orencia

SC

Lay

Criteria

Effective

Date:

01/01/2017


A) Approve Orencia SC for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Orencia SC PA



a) The patient has tried TWO of Actemra SC, Enbrel, or Humira [documentation

required]. Note: A trial of Actemra IV, Cimzia, Remicade, or Simponi (Aria or

SC) also counts [documentation required].

b) According to the prescribing physician, the patient heart failure, a previously



SC PA Policy criteria), but criterion 1Aii is not met, offer to review for a preferred



2. RA, Patients Currently Taking Orencia (SC or IV).

A) Approve Orencia SC for 1 year if the patient meets BOTH of the following conditions (i

and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Orencia SC Policy

criteria for Patients Currently taking Orencia (SC or IV); AND


a) The patient has been established on Orencia SC for at least 90 days and

prescription claims history indicates at least a 90-day supply of Orencia SC was





prescriber has verified that the patient has been receiving Orencia SC for at least

90 days AND the patient has been receiving Orencia SC via paid claims (e.g.,

patient has not been receiving samples or coupons or other types of waivers in

order to obtain access to Orencia SC); OR

b) According to the prescribing physician, the patient has been established on

Orencia IV for at least 90 days; OR

c) The patient has tried TWO of Actemra SC, Enbrel, and Humira [documentation

required]. Note: A trial of Actemra IV, Cimzia, Remicade, Simponi Aria, and

Simponi SC also counts [documentation required]; OR

d) According to the prescribing physician, the patient heart failure, a previously



Orencia SC PA Policy criteria), but criterion 2Aii is not met, offer to review for a


10/05/2016



preferred product (Actemra SC, Enbrel or Humira) using the respective ESI Standard


3. Other Conditions. Approve Orencia SC (initial therapy for a duration as directed or 1 year


Conditions – Orencia SC PA Policy criteria.

Otezla

Lay

Criteria

Effective

Date:

01/01/2017

1. Psoriatic Arthritis (PsA), Initial Therapy.

A) Approve Otezla for 4 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Otezla PA Policy

criteria, Initial Therapy; AND


a) The patient has tried ONE Enbrel or Humira. Note: A trial of Cimzia,

Remicade, or Simponi SC also counts; OR

b) The patient has experienced a previous intolerance to a TNFi or has one of the

following conditions or relative contraindications to use of a TNFi: a history of

hepatitis B, hepatitis C, demyelinating disease, or malignancy; heart failure; the

patient is on chronic systemic corticosteroid therapy (e.g., prednisone,

dexamethasone); the patient has a chronic infection or is at high risk of infection

(e.g., human immunodeficiency virus [HIV], malignancy, neutropenia, diabetes),

as determined by the prescribing physician; or the patient has a history of

recurrent infections, as determined by the prescribing physician.

2. PsA, for Patients Currently Receiving Otezla.

A) Approve for 1 year if the patient meets BOTH of the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Otezla PA Policy

criteria; AND


a) The patient has been established on Otezla for at least 120 days and prescription

claims history indicates at least a 120-day supply of Orencia SC was dispensed

within the past 130 days [verification in prescription claims history required] or,

if not available, [verification by prescribing physician required]. Note: In cases

when 130 days of the patient’s prescription claim history file is unavailable to be


that the patient has been receiving Otezla for at least 120 days AND the patient

has been receiving Otezla via paid claims (e.g., patient has not been receiving

samples or coupons or other types of waivers in order to obtain access to Otezla);

OR

b) The patient has PsA and has tried ONE of Enbrel or Humira. Note: A trial of

Cimzia, Remicade, and Simponi SC also counts; OR

c) The patient has experienced a previous intolerance to a TNFi or has one of the

following conditions or relative contraindications to use of a TNFi: a history of

hepatitis B, hepatitis C, demyelinating disease, or malignancy; congestive heart

failure (CHF); the patient is on chronic systemic corticosteroid therapy (e.g.,

prednisone, dexamethasone); the patient has a chronic infection or is at high risk

of infection (e.g., human immunodeficiency virus [HIV], malignancy,

neutropenia, diabetes), as determined by the prescribing physician; or the patient

has a history of recurrent infections, as determined by the prescribing physician.

B) If the patient meets criterion 2Ai (the ESI Standard Inflammatory Conditions – Otezla PA

Policy criteria), but criterion 2Aii is not met, offer to review for a preferred product

(Enbrel or Humira) using the respective ESI Standard Inflammatory Conditions PA

Policy criteria.


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3. Other Conditions (e.g., plaque psoriasis). Approve Otezla (initial therapy for a duration as

directed or 1 year for patients continuing therapy) if the patient meets the ESI Standard

Inflammatory Conditions – Otezla PA Policy criteria.

Remicade

Lay

Criteria

Effective

Date:

01/01/2017

1. Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), or Psoriatic Arthritis (PsA),

Initial Therapy Initial Therapy.

A) Approve Remicade for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Remicade PA Policy

criteria; AND

ii. The patient has tried ONE of Enbrel or Humira. Note: A trial of Cimzia or Simponi

SC also counts.


Remicade PA Policy criteria), but criterion 1Aii is not met, offer to review for a preferred


PA Policy criteria.

2. Plaque Psoriasis or Crohn’s Disease (CD) in an Adult, Initial Therapy (Note: for

fisulizing CD and pediatric patients with CD, see criterion #4).

A) Approve Remicade for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Remicade PA


ii. The patient has tried Humira. Note: For CD, a trial of Cimzia also counts.


Remicade PA Policy criteria), but criterion 2Aii is not, offer to review for Humira using

the ESI Standard Inflammatory Conditions – Humira PA Policy criteria.

3. RA, AS, PsA, Plaque Psoriasis, or Crohn’s Disease, Patients Currently Taking

Remicade.

A) Approve Remicade for 1 year if the patient meets BOTH of the following conditions (i

and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Remicade PA Policy

criteria for Patients Currently taking Remicade; AND


a) The patient has been established on Remicade for ≥ 90 days; OR

b) The patient has RA, AS, or PsA and has tried ONE of Enbrel or Humira. Note:

A trial of Cimzia or Simponi SC also counts; OR

c) The patient has plaque psoriasis or CD and has tried Humira. Note: For CD, a

trial of Cimzia also counts (for fisulizing CD and pediatric patients, see criterion

#4).


Remicade PA Policy criteria), but criterion 3Aii is not met, offer to review for a preferred


i. Patients with RA, AS, or PsA: Enbrel or Humira.

ii. Patients with psoriasis or CD: Humira.

4. Other Conditions (e.g., fistulizing Crohn’s disease, Crohn’s disease in a pediatric

patient, JIA, ulcerative colitis). Approve Remicade (initial therapy for a duration as

directed or 1 year for patients continuing therapy) if the patient meets the ESI Standard

Inflammatory Conditions – Remicade PA Policy criteria.

Rituxan

Lay

Criteria


A) Approve Rituxan for 1 month if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Rituxan PA Policy

criteria for RA; AND


10/05/2016



Effective

Date:

01/01/2017




b) According to the prescribing physician, the patient has heart failure OR a

previously treated lymphoproliferative disorder.

B) If the patient has met criterion 1Ai (the ESI Standard Inflammatory Conditions – Rituxan


(Enbrel or Humira) using the respective ESI Standard Inflammatory Conditions – PA

Policy criteria.

2. Adult Patient who has Received a Course of Rituxan for RA. Approve Rituxan for 1

month if the patient meets the ESI Standard Inflammatory Conditions – Rituxan PA Policy

criteria. Note: Patients with RA who have not received a course of Rituxan and patients with

conditions other than RA should follow criterion 1 and criterion 3, respectively.

3. Other Conditions (e.g., granulomatosis with polyangiitis [GPA], microscopic

polyangiitis [MPA], Chronic Lymphocytic Leukemia [CLL], Non-Hodgkin’s

Lymphoma [NHL]). Approve Rituxan for 1 year if the patient meets the ESI Standard

Inflammatory Conditions – Rituxan PA Policy criteria.

Simponi

SC

Lay

Criteria

Effective

Date:

01/01/2017


A) Approve Simponi SC for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Simponi SC PA


ii. The patient has tried TWO of Actemra SC, Enbrel, or Humira [documentation

required].

B) If the patient has met criterion 1Ai (the ESI Standard Inflammatory Conditions – Simponi



Inflammatory Conditions – PA Policy criteria.





ii. The patient has tried BOTH of Enbrel and Humira [documentation required].




PA Policy criteria.

3. Ulcerative Colitis (UC), Initial Therapy.






SC PA Policy criteria), but criterion 3Aii is not met, offer to review for Humira using the

ESI Standard Inflammatory Conditions – Humira PA Policy criteria.

4. RA, AS, PsA, or UC, Patients Currently Taking Simponi (SC or Aria).

A) Approve Simponi SC for 1 year if the patient meets BOTH of the following conditions (i

and ii):


Policy criteria for Patients Currently taking Simponi (SC or Aria); AND


10/05/2016



ii. The patient meets ONE of the following conditions (a, b, c, d, or e):

a) The patient has been established on Simponi SC for at least 90 days and

prescription claims history indicates at least a 90-day supply of Simponi SC was





prescriber has verified that the patient has been receiving Simponi SC for at least

90 days AND the patient has been receiving Simponi SC via paid claims (e.g.,


order to obtain access to Simponi SC); OR

b) According to the prescribing physician, the patient has been established on

Simponi Aria for at least 90 days; OR

c) The patient has RA and has tried TWO of Actemra SC, Enbrel, and Humira


d) The patient has AS or PsA and has tried BOTH of Enbrel AND Humira


e) The patient has UC and has tried Humira.




i. Patients with RA: Actemra SC, Enbrel, or Humira.

ii. Patients with AS or PsA: Enbrel or Humira.

iii. Patients with UC: Humira.

5. Other Conditions. Approve Simponi SC (initial therapy for a duration as directed or 1 year


Conditions – Simponi (SC) PA Policy criteria.

Simponi

Aria

Lay

Criteria

Effective

Date:

01/01/2017


A) Approve Simponi Aria for 3 months if the patient meets the following conditions (i and

ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Simponi Aria PA


ii. The patient has tried ONE Enbrel or Humira. Note: A trial of Cimzia or Simponi SC

also counts.


Aria PA Policy criteria), but criterion 1Aii is not met, offer to review for a preferred


PA Policy criteria.

2. RA, Patients Currently taking Simponi (Aria or SC).

A) Approve Simponi Aria for 1 year if the patient meets BOTH of the following conditions

(i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Simponi Aria PA

Policy criteria for Patients Currently taking Simponi (Aria or SC); AND


a) The patient has been established on Simponi (Aria or SC) for ≥ 90 days; OR

b) The patient has tried ONE of Enbrel or Humira. Note: A trial of Cimzia or

Simponi SC also counts.


Aria PA Policy criteria), but criterion 2Aii is not met, offer to review for a preferred


10/05/2016




PA Policy criteria.

3. Other Conditions. Approve Simponi Aria (initial therapy for a duration as directed or 1

year for patients continuing therapy) if the patient meets the ESI Standard Inflammatory

Conditions – Simponi Aria PA Policy criteria.

Stelara

IV

Lay

Criteria

Effective

Date:

01/01/2017

1. Crohn’s Disease in an Adult, Induction Therapy.

A) Approve Stelara IV for one dose if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Stelara IV PA Policy

criteria; AND

ii. The patient has tried Humira. Note: Trial of Cimzia, Remicade, or Entyvio also

counts.

B) If the patient has met criterion 1Ai (the ESI Standard Inflammatory Conditions – Stelara

IV PA Policy criteria), but criterion 1Aii is not met, offer to review for Humira using the

ESI Standard Inflammatory Conditions – PA Policy criteria.

2. All Other Conditions. Stelara IV is only indicated in Crohn’s disease and is not covered for

any other diagnosis.

Stelara

SC

Lay

Criteria

Effective

Date:

01/01/2017

1. Psoriatic Arthritis (PsA), Initial Therapy.

A) Approve Stelara SC for 3 months if the patient meets the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Stelara SC PA Policy

criteria; AND



Remicade, or Simponi SC also counts.



of a TNFi: demyelinating disease or heart failure.




PA Policy criteria.


A) Approve Stelara SC for 3 months if the patient meets the following conditions (i and ii):


criteria; AND


a) The patient has tried ONE of Humira or Otezla; OR






product (Humira or Otezla) using the respective ESI Standard Inflammatory Conditions –

PA Policy criteria

3. Crohn’s Disease in an Adult, Initial Therapy.

A) Approve Stelara SC for 3 months if the patient meets BOTH of the following conditions

(i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Stelara SC PA

Policy Criteria; AND



10/05/2016



a) The patient has tried Humira. Note: Trial of Cimzia, Entyvio, or Remicade

also count; OR

b) The patient has received a single induction dose with Stelara IV.



product (Humira) using the ESI Standard Inflammatory Conditions – PA Policy criteria.

4. Plaque Psoriasis or PsA or Crohn’s Disease in an Adult, Patients Currently Taking

Stelara SC.

A) Approve Stelara SC for 1 year if the patient meets BOTH of the following conditions (i

and ii):


criteria for Patients Currently taking Stelara SC; AND

ii. The patient meets ONE of the following conditions (a, b, c, d, or e):

a) The patient has been established on Stelara SC for at least 90 days and

prescription claims history indicates at least a 90-day supply of Stelara SC was





prescriber has verified that the patient has been receiving Stelara SC for at least

90 days AND the patient has been receiving Stelara SC via paid claims (e.g.,


order to obtain access to Stelara SC); OR

b) The patient has plaque psoriasis and has tried ONE of Humira or Otezla; OR

c) The patient has PsA and has tried ONE of Enbrel or Humira. Note: A trial of

Cimzia, Remicade, or Simponi SC also counts; OR

d) The patient has CD and has tried Humira. (Note: Trial of Cimzia, Entyvio, or

Remicade also counts) OR has received a single induction dose with Stelara IV;

OR

e) According to the prescribing physician, the patient has experienced a previous




Simponi SC PA Policy criteria), but criterion 4Aii is not met, offer to review for a

preferred product using the respective ESI Standard Inflammatory Conditions – PA

Policy criteria:

i. PsA: Enbrel or Humira.

ii. Plaque psoriasis: Humira or Otezla.

iii. CD: Humira.

5. Other Conditions. Approve Stelara SC (initial therapy for a duration as directed or 1 year


Conditions – Stelara PA Policy criteria.

Taltz

Lay

Criteria

Effective

Date:

01/01/2017


C) Approve Taltz for 3 months if the patient meets the following conditions (i and ii):

iii. The patient meets the ESI Standard Inflammatory Conditions – Taltz PA Policy

criteria; AND

iv. The patient meets ONE of the following conditions (a or b):

a) The patient has tried ONE of Humira or Otezla; OR



10/05/2016





D) If the patient has met criterion 1Ai (the ESI Standard Inflammatory Conditions – Taltz


(Humira or Otezla) using the respective ESI Standard Inflammatory Conditions – PA

Policy criteria.

2. Plaque Psoriasis, Patients Currently Taking Taltz.

A) Approve Taltz for 1 year if the patient meets BOTH of the following conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Taltz PA Policy

criteria for Patients Currently taking Taltz; AND


a) The patient has been established on Taltz for at least 90 days and prescription

claims history indicates at least a 90-day supply of Taltz was dispensed within


available, [verification by prescribing physician required]. Note: In cases

when 130 days of the patient’s prescription claim history file is unavailable to

be verified, an exception to this requirement is allowed if the prescriber has

verified that the patient has been receiving Taltz for at least 90 days AND the

patient has been receiving Taltz via paid claims (e.g., patient has not been

receiving samples or coupons or other types of waivers in order to obtain

access to Taltz); OR

b) The patient has tried ONE of Humira or Otezla; OR

c) According to the prescribing physician, the patient has previously experienced

an intolerance to a TNFi or has one of the following relative contraindications

to use of a TNFi: demyelinating disease, history of malignancy, or heart

failure.

B) If the patient has met criterion 2Ai (the ESI Standard Inflammatory Conditions – Taltz


(Humira or Otezla) using the respective ESI Standard Inflammatory Conditions – PA

Policy criteria.

3. Other Conditions. Approve Taltz (initial therapy for a duration as directed or 1 year for


Taltz PA Policy criteria.

Xeljanz/

Xeljanz

XR

Lay

Criteria

Effective

Date:

01/01/2017


A) Approve Xeljanz/Xeljanz XR for 3 months if the patient meets the following conditions

(i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Xeljanz/Xeljanz XR

PA Policy criteria; AND

ii. The patient has tried ONE of Actemra SC, Enbrel, or Humira.


Xeljanz/Xeljanz XR PA Policy criteria), but criterion 1Aii is not met, offer to review for a

Preferred product (Actemra SC, Enbrel or Humira) using the respective ESI Standard


2. RA, Patients Currently Taking Xeljanz.

A) Approve Xeljanz/Xeljanz XR for 1 year if the patient meets BOTH of the following

conditions (i and ii):

i. The patient meets the ESI Standard Inflammatory Conditions – Xeljanz/Xeljanz XR

PA Policy criteria for Patients Currently taking Xeljanz/Xeljanz XR; AND



10/05/2016



a) The patient has been established on Xeljanz/Xeljanz XR for at least 90 days and

prescription claims history indicates at least a 90-day supply of Xeljanz/Xeljanz

XR was dispensed within the past 130 days [verification in prescription claims

history required] or, if not available, [verification by prescribing physician

required]. Note: In cases when 130 days of the patient’s prescription claim

history file is unavailable to be verified, an exception to this requirement is

allowed if the prescriber has verified that the patient has been receiving

Xeljanz/Xeljanz XR for at least 90 days AND the patient has been receiving

Xeljanz/Xeljanz XR via paid claims (e.g., patient has not been receiving samples

or coupons or other types of waivers in order to obtain access to Xeljanz/Xeljanz

XR); OR

b) The patient has tried ONE of Actemra SC, Enbrel, or Humira.


Xeljanz/Xeljanz XR PA Policy criteria but criterion 2Aii is not met, offer to review for a

Preferred product (Actemra SC, Enbrel, or Humira) using the respective ESI Standard


3. Other Conditions. Approve Xeljanz/Xeljanz XR (initial therapy for a duration as directed

or 1 year for patients continuing therapy) if the patient meets the ESI Standard Inflammatory

Conditions – Xeljanz/Xeljanz XR PA Policy criteria.

REFERENCES 1. Actemra [prescribing information]. South San Francisco, CA: Genentech; September 2016.

2. Cimzia for injection [prescribing information]. Smyrna, GA: UCB, Inc.; February 2016.

3. Cosentyx injection [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.; January 2015.

4. Enbrel [prescribing information]. Seattle, WA: Immunex Corporation; March 2015.

5. Humira injection [prescribing information]. North Chicago, IL: AbbVie, Inc.; September 2015.

6. Kineret injection [prescribing information]. Thousand Oaks, CA: Swedish Orphan Biovitrium; October 2013.

7. Orencia for injection [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; June 2015.

8. Otezla® tablets [prescribing information]. Summit, NJ: Celgene Corporation; September 2014.

9. Remicade injection [prescribing information]. Malvern, PA: Janssen Biotech; October 2015.

10. Rituxan injection [prescribing information]. South San Francisco, CA: Genentech, Inc; August 2014.

11. Simponi injection [prescribing information]. Horsham, PA: Janssen Biotech Inc; January 2016.

12. Simponi™ Aria® injection for intravenous use [prescribing information]. Horsham, PA: Janssen Biotech, Inc; January 2016.

13. Stelara injection [prescribing information]. Horsham, PA: Janssen Biotech; September 2016.

14. Taltz® injection [prescribing information]. Indianapolis, IN: Eli Lilly and Company; March 2016.

15. Xeljanz®/Xeljanz XR tablets/extended release tablets [prescribing information]. New York, NY: Pfizer Inc; February 2016.

HISTORY Type of

Revision

Summary of Changes* TAC

Approval

Date

Lay Criteria Effective Date

New policy -- 10/05/2016 01/01/2017

Selected

revision

For Enbrel’s new indication in pediatric plaque psoriasis, update

criteria so that patients < 18 years of age with plaque psoriasis

are not directed to Humira. Add criteria for Stelara IV to

approve if for one dose if the ESI Standard Stelara IV PA

criteria are met for Crohn’s Disease, Initial Therapy and if he

patient has tried Humira (Cimzia, Remicade, or Entyvio also

count). Add Stelara SC as Non-Preferred for Crohn’s disease;

approve if the patient has met PA criteria for Stelara SC and has

tried Humira or is beginning Stelara SC 8 weeks after an

induction dose of Stelara IV or has already been established on

11/30/2016 01/01/2017


10/05/2016



Stelara SC.

TAC – Therapeutic Assessment Committee; * For a further summary of criteria changes, refer to respective TAC minutes available

at: http://esidepartments/sites/Dep043/Committees/TAC/Forms/AllItems.aspx.

Table 1. FDA-Approved Indications for the Tumor Necrosis Factor Inhibitors (TNFis).*2,4-5,9,11-12

Rheumatoid Conditions Dermatology

Conditions

Gastrointestinal

Conditions

Ophthalmic

Condition

RA JIA AS PsA Plaque

Psoriasis

HS CD UC Uveitis

Cimzia √ -- √ √ -- -- √ -- -- Enbrel √ √ √ √ √ -- -- -- -- Humira √ √ √ √ √ √ √ √ √ Remicade √ -- √ √ √ -- √ √ -- Simponi

SC √ -- √ √ -- -- -- √ --

Simponi

Aria √ -- -- -- -- -- -- -- --

* Refer to the selected ESI Inflammatory Conditions Standard Prior Authorization Policies for the specific patient population

approved for each indication; RA – Rheumatoid arthritis; JIA – Juvenile idiopathic arthritis; AS – Ankylosing spondylitis; PsA –

Psoriatic arthritis; HS – Hidradenitis suppurativa; CD – Crohn’s disease; UC – Ulcerative colitis.

Table 2. FDA-Approved Inflammatory Conditions for Other Biologics and Targeted Synthetic DMARDs.

*1,3,6-8,10,13-15

Rheumatoid Conditions Derma-

tology

GI Other

RA AS JIA SJIA PsA Plaque

Psoriasis

CD GPA/

MPA

CAPS

Actemra IV √ -- √ √ -- -- -- -- --

Actemra SC √ -- -- -- -- -- -- -- --

Cosentyx -- √ -- -- √ √ -- -- -- Kineret √ -- -- -- -- -- -- -- √

Orencia IV √ -- √ -- -- -- -- -- --

Orencia SC √ -- -- -- -- -- -- -- --

Otezla -- -- -- -- √ √ -- -- --

Rituxan^ √ -- -- -- -- -- -- √ -- Stelara SC -- -- -- -- √ √ √^ -- --

Stelara IV -- -- -- -- -- -- √# -- --

Taltz -- -- -- -- -- √ -- -- --

Xeljanz/XR √ -- -- -- -- -- -- -- --

DMARDs – Disease-modifying antirheumatic drugs; * Refer to the selected ESI Standard Prior Authorization Policies for the

specific patient population approved for each indication; GI – Gastrointestinal; RA – Rheumatoid arthritis; AS – Ankylosing

spondylitis; JIA – Juvenile idiopathic arthritis; SJIA – Systemic JIA; PsA – Psoriatic arthritis; CD – Crohn’s disease; GPA –

Granulomatosis with polyangiitis; MPA – Microscopic polyangiitis; CAPS – Cryopyrin-Associated Periodic Syndromes; ^

Rituxan is also indicated in other non-rheumatology conditions. Refer to Rituxan for RA Prior Authorization Policy for these

indications; ^ Maintenance dosing only; # Induction dosing only.

http://esidepartments/sites/Dep043/Committees/TAC/Forms/AllItems.aspx

referred anagement (psm) olicy...a) approve actemra iv for 3 months if the patient meets the...

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