Medical Policy

BIOLOGICS FOR GASTROINTESTINAL DISEASE

X.44

Preauthorization Required

X.44 BIOLOGICS FOR GASTROINTESTINAL DISEASE

Description

Cimzia^® (certolizumab) is FDA approved for the following:

· for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

· for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

· for the treatment of adult patients with active psoriatic arthritis (PsA).

· for the treatment of adults with active ankylosing spondylitis (AS).

· for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

· for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

^{Entyvio IV and SQ®} (vedolizumab) is FDA approved for the following:

· for the treatment of moderately to severely active ulcerative colitis in adults.

· for the treatment of moderately to severely active Crohn's Disease in adults.

Humira^® (adalimumab) is FDA approved for the following:

· for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

· for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate.

· for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs.

· for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

· for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

· for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

· for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician

· for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

· for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

^Omvoh® (mirikizumab) is FDA approved for the following:

· for the treatment of moderately to severely active ulcerative colitis in adults.

Rinvoq^® (upadacitinib) is FDA approved for the following:

· for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.

· for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.

Simponi^® (golimumab) is FDA approved for the following:

· in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

· alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis.

· for the treatment of adult patients with active ankylosing spondylitis.

· in adult and pediatric patients weighing at least 15kg with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine

Skyrizi^® (risankizumab) is FDA approved for the following:

· for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

· for the treatment of active psoriatic arthritis in adults.

· for the treatment of moderately to severely active Crohn's disease in adults.

· for the treatment of moderately to severely active ulcerative colitis in adults.

Stelara^® (ustekinumab) is FDA approved for the following:

· for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy

· for the treatment of patients 6 years or older with active psoriatic arthritis.

· for the treatment of adult patients with moderately to severely active Crohn's disease.

· for the treatment of adult patients with moderately to severely active ulcerative colitis.

^Tremfya® (guselkumab) is FDA approved for the following:

· for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

· for the treatment of adult and pediatric patients 6 years of age and older who also weigh at least 40kg with active psoriatic arthritis.

· for the treatment of adult patients with moderately to severely active ulcerative colitis

· for the treatment of adult patients with moderately to severely active Crohn's Disease

Xeljanz solution^® (tofacitinib) is FDA approved for the following:

· for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.

Xeljanz tablet^® (tofacitinib) is FDA approved for the following:

· for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers.

Xeljanz XR tablet^® (tofacitinib) is FDA approved for the following:

· for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers.

· for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers.

**There are no other preferred products under the medical benefit, therefore, healthcare administered products (i.e. lyophilized powder certolizumab, etc.) are not subject to trial and failure of a medical or self-inject product.**

FDA Approved Dosage/QL Reference

Brand (generic)	Indication	DOSE
		IV	SQ	ORAL
Cimzia	Crohns Disease		400mg at wk 0,2,4, then 400mg every 4 weeks	n/a
	Rhematoid Arthritis		400mg at wk 0,2,4, then 200mg every other week (400mg every 4 weeks may be considered)	n/a
	Psoriatic Arthritis		400mg at wk 0,2,4, then 200mg every other week (400mg every 4 weeks may be considered)	n/a
	Ankylosing Spondylitis		400mg at wk 0,2,4, then 200mg every 2 weeks or 400mg every 4 weeks	n/a
	Non-radiographic Axial Spondyloarthritis		400mg at wk 0,2,4, then 200mg every other week or 400mg every 4 weeks	n/a
	Plaque Psoriasis		400mg every other week.	n/a
Humira	Rheumatoid Arthritis	n/a	40mg every other week *Some patients not taking concomitant MTX may derive additional benefit from 40mg weekly or 80mg every other week	n/a
	Juvenile Idiopathic Arthritis (age 2 years and up)	n/a	-Patients 10kg to less than 15kg: 10mg every other week -Patients 15kg to less than 30kg: 20mg evey other week -Patients 30kg or greater: 40mg every other week	n/a
	Psoriatic Arthritis	n/a	40mg every other week	n/a
	Ankylosing Spondylitis	n/a	40mg every other week	n/a
	Crohn’s Disease	n/a	Adults: 160mg on day 1, then 80mg on day 15, then 40mg every other week starting day 29 Pediatric (6yrs old and older): -Patients 17kg to less than 40kg weight: 80mg on day 1, 40mg on day 15, then 20mg every other week starting day 29 -Patients 40kg and greater: 160mg on day 1, 80mg on day 15, then 40mg every other week starting day 29	n/a
	Ulcerative Colitis	n/a	Adults: 160mg on day 1, then 80mg on day 15, then 40mg every other week starting day 29 Pediatrics (5yrs old and older): -Patients 20kg to less than 40kg: 80mg on day 1, 40mg on day 8 and day 15, then 40mg every other week OR 20mg weekly starting day 29 -Patients 40kg and greater: 160mg on day 1, 80mg on day 8 and 15, then 80mg every other week or 40mg weekly starting day 29 *Discontinue Humira in adult patients without evidence of clinical remission by eight weeks of therapy.	n/a
	Plaque Psoriasis	n/a	80mg on day 1, then 40mg every other week starting day 8	n/a
	Hidradenitis Suppurativa	n/a	Adults: 160mg on day 1, then 80mg on day 15, then 40mg weekly or 80mg every other week starting day 29 Pediatrics (12yrs of age and older): -Patients 30kg to less than 60kg: 80mg on day 1, then 40mg every other week starting day 8 -Patients 60kg and greater: 160mg on day 1, then 80mg on day 15, then 40mg every week or 80mg every other week starting day 29.	n/a
	Uveitis	n/a	Adult: 80mg on day 1, then 40mg every other week starting day 8 Pediatrics (2yrs old and older): -Patients 10kg to less than 15kg: 10mg every other week -Patients 15kg to less than 30kg: 20mg evey other week -Patients 30kg or greater: 40mg every other week	n/a
Omvoh	Ulcerative Colitis	300mg IV induction at week 0, 4, and 8	200mg SQ at week 12, then every 4 weeks	n/a
Rinvoq	Rheumatoid arthritis	n/a	n/a	15mg once daily
	Psoriatic arthritis	n/a	n/a	15mg once daily
	Atopic Dermatitis	n/a	n/a	Adults 15mg once daily Pediatrics (12yrs and up, weighing at least 40kg) 15mg once daily
	Ulcerative Colitis	n/a	n/a	45mg once daily for 8 weeks, then 15mg once daily (30mg daily may be considered for patients with severe or refractory disease)
	Crohns Disease	n/a	n/a	45mg once daily for 12 weeks, then 15mg once daily (30mg daily may be considered for patients with severe or refractory disease)
	Ankylosing Spondylitis	n/a	n/a	15mg once daily
	Non-radiographic Axial Spondyloarthritis	n/a	n/a	15mg once daily
Simponi	Rheumatoid arthritis	n/a	50mg once every month	n/a
	Psoriatic arthritis	n/a	50mg once every month	n/a
	Ankylosing Spondylitis	n/a	50mg once every month	n/a
	Ulcerative colitis	n/a	200mg at week 0, 100mg at week 2, then 100mg every 4 weeks	n/a
Skyrizi	Plaque Psoriasis	n/a	150mg at wk 0&4, then every 12 weeks	n/a
	Psoriatic arthritis	n/a	150mg at wk 0&4, then every 12 weeks	n/a
	Crohn’s Disease	600mg IV induction only at wk 0, 4, 8	180mg or 360mg at week 12, then every 8 weeks	n/a
	Ulcerative Colitis	1200mg IV induction only at wk 0, 4, 8	180mg or 360mg at week 12, then every 8 weeks	n/a
Stelara	Psoriasis	n/a	Adult -Patients weighing 100kg or less: 45mg at wk 0&4, then every 12 weeks -Patients weighing more than 100kg: 90mg at wk 0&4, then every 12 weeks Pediatric (6-17 yrs old) -Patients less than 60kg weight: 0.75mg/kg wk 0&4, then every 12 weeks -Patients 60kg-100kg: 45mg at wk 0&4, then every 12 weeks -Patients more than 100kg: 90mg at wk 0&4, then every 12 weeks	n/a
	Psoriatic arthritis	n/a	Adult 45mg at wk0&4, then every 12 weeks For patients with co-existent plaque psoriasis and weigh more than 100kg, dose of 90mg at wk 0&4, then every 12 weeks may be used Pediatric (6-17 yrs of age) -Patients less than 60kg weight: 0.75mg/kg wk 0&4, then every 12 weeks -Patients 60kg or more: 45mg at wk 0&4, then every 12 weeks -Patients more than 100kg with co-existent plaque psoriasis: 90mg at wk 0&4, then every 12 weeks	n/a
	Crohn’s Disease	IV induction dose -Patients less than 55kg: 260mg once -Patients more than 55kg-85kg: 390mg once -Patients more than 85kg: 520mg once	90mg every 8 weeks starting 8 weeks after IV loading dose	n/a
	Ulcerative Colitis	IV induction dose -Patients less than 55kg: 260mg once -Patients more than 55kg-85kg: 390mg once -Patients more than 85kg: 520mg once	90mg every 8 weeks starting 8 weeks after IV loading dose	n/a
Tremfya	Plaque psoriasis	n/a	100mg at wk 0 and 4, then 100mg every 8 weeks
	Psoriatic arthritis	n/a	100mg at wk 0 and 4, then 100mg every 8 weeks
	Crohns	200mg IV at week 0,4,8 for induction only	400mg SQ at wk 0,4,8, then 100mg at wk 16, then every 8 weeks OR 200mg at wk 12, then every 4 weeks
	Ulcerative colitis	200mg IV at week 0,4,8 for induction only	400mg SQ at week 0,4,8 for induction only then 100mg at wk 16, then every 8 weeks OR 200mg at wk 12, then every 4 weeks
Xeljanz	Rheumatoid arthritis	n/a	n/a	Xeljanz: 5mg twice daily Xeljanz XR: 11mg once daily
	Psoriatic arthritis	n/a	n/a	Xeljanz: 5mg twice daily Xeljanz XR: 11mg once daily
	Ankylosing spondylitis	n/a	n/a	Xeljanz: 5mg twice daily Xeljanz XR: 11mg once daily
	Ulcerative colitis	n/a	n/a	Xeljanz: 10mg twice daily for 8 weeks, then 5mg twice daily (10mg twice daily may be continued up to 16 weeks) Xeljanz XR: 22mg once daily for 8 weeks, then 11mg once daily (22mg once daily may be continued up to 16 weeks)
	Polyarticular Course Juvenile Idiopathic Arthritis	n/a	n/a	Xeljanz tablet or oral solution: -10kg to less than 20kg: 3.2mg twice daily -20kg to less than 40kg 4mg twice daily -Weight greater than 40kg: 5mg twice daily
Entyvio IV	Crohn's Disease and Ulcerative Colitis	300mg IV at week 0 and 2, then every 8 weeks thereafter starting at week 6	n/a	n/a
Entyvio SQ	Crohn's Disease and Ulcerative Colitis	n/a	Must receive 300mg IV at wk 0 and 2 At week 6 may start 108mg SQ every 2 weeks	n/a
Remicade (Avsola and Inflectra biosimilars)	Crohn’s Disease	5mg/kg at wk 0,2,6 then every 8 weeks; dose may be escalated up to 10mg/kg every 8 weeks		n/a
	Pediatric Crohn’s Disease	Pediatric 6yrs of age and up 5mg/kg at wk 0,2,6 then every 8 weeks	n/a	n/a
	Ulcerative Colitis	5mg/kg at wk 0,2,6 then every 8 weeks	n/a	n/a
	Pediatric Ulcerative Colitis	Pediatric 6yrs of age and up 5mg/kg at wk 0,2,6 then every 8 weeks	n/a	n/a
	Rheumatoid Arthritis	3mg/kg at wk 0,2,6, then every 8 weeks; dose may be escalated up to 10mg/kg every 8 weeks	n/a	n/a
	Ankylosing Spondylitis	5mg/kg at wk 0,2,6 then every 6 weeks	n/a	n/a
	Psoriatic arthritis	5mg/kg at wk 0,2,6 then every 8 weeks	n/a	n/a
	Plaque psoriasis	5mg/kg at wk 0,2,6 then every 8 weeks	n/a	n/a

Dates

Original Effective
04-23-2012
Last Review
11-05-2025
Next Review
11-10-2026

Policy

CRITERIA FOR USE

Initial Evaluation

I. ONE of the following:

A. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR

B. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy changed AND

II. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist) or has consulted with a specialist in the area of the patient’s diagnosis AND

III. The patient will NOT be using the requested agent in combination with another biologic immunomodulator AND

IV. The patient does not have any FDA labeled contraindications to the requested agent AND

V. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB AND

VI. The patient has ONE of the following diagnoses:

A. The patient has diagnosis of moderately to severely active Crohn’s disease (CD) OR

B. The patient has diagnosis of moderately to severely active ulcerative colitis (UC) AND

VII. ONE of the following:

A. The requested dosage is within FDA approved dosage guidelines OR

B. The requested dosage is outside FDA approved dosing guidelines and BOTH of the following:

i. The prescriber has provided supporting documentation that the patient has had continued or increased disease activity (e.g. active inflammation shown on colonoscopy or endoscopy findings; elevated laboratory markers (e.g. CRP, ESR); increased disease symptoms) on current dose/frequency of the requested medication AND

ii. The request for dose/frequency increase is NOT based solely on serum drug levels AND

VIII. ONE of the following:

A. The request is for a self-administered product being obtained under the pharmacy benefit. Patients must try and fail preferred agents prior to approval of a non-preferred agent as indicated in self-administered preferred agent table OR both of the following:

i. Self-administered preferred agents are not clinically appropriate AND

ii. The prescriber has provided a complete list of previously tried agents OR

B. The request is for an infliximab product being obtained under the medical or pharmacy benefit. Patients must have trial and failure or contraindication to at least ONE preferred biosimilar product in preferred product table OR

C. The request is for a healthcare administered product being obtained under the medical benefit (e.g., lyophilized powder certolizxumab, vedolizumab, risankizumab).

**All other used not addressed in this policy for adalimumab, etanercept, anakinra, abatacept, certolizumab, golimumab, tocilizumab, tofacitinib, canakinumab, secukinumab, infliximab, upadacitinib, ixekizumab, sarilumab are considered investigational**

Renewal Evaluation

I. Renewal of Target Agent(s) may be considered medically necessary when

A. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND

B. The patient has had clinical benefit with requested agent (e.g. symptom improvement, improved physical function, inhibition of structural damage progression) AND

C. The patient has no FDA approved contraindication to use of requested medication AND

D. The requested medication is not being used in combination with another biologic immunomodulator agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) AND

E. The requested dose is within FDA approved dosage limits or has off-label dosing previously approved AND

F. The prescriber is a specialist in the area of the patient’s diagnosis or the prescriber has consulted with a specialist in the area of the patient’s diagnosis.

Length of Approval: 12 months

Guidelines

Self Administered Preferred Agent Step Table

Disease State

Step 1a (preferred)

Step 1b (Directed to ONE preferred TNF inhibitor-Step 1a)

Step 2 (non-preferred, directed to ONE step 1 agents)

Step 3a (non-preferred, directed to TWO agents step 1 agents)

Step 3b (non-preferred, directed to TWO agents from step 1 and/or step 2)

Step 3c (non-preferred, directed to THREE step 1 agents)

Crohn’s Disease (CD)

SQ: Skyrizi, Entyvio SQ, Tremfya, **See adalimumab or ustekinumab table for preferred products.**

N/A

SQ: Omvoh

Oral: Rinvoq

SQ: Zymfentra, Cimzia (formulary adalimumab biosimilar or Humira is a required Step 1 agent

N/A

SQ:Wezlana, **See adalimumab or ustekinumab table for preferred products.**

Ulcerative Colitis (UC)

SQ: Skyrizi, Tremfya, Entyvio SQ **See adalimumab or ustekinumab table for preferred products.**

Oral: Xeljanz, Xeljanz XR

SQ: Omvoh, Simponi (formulary adalimumab biosimilar or Humira is a required Step 1 agent)

Oral: Rinvoq

SQ: Zymfentra

Oral: Zeposia

N/A

SQ:Wezlana, **See adalimumab or ustekinumab table for preferred products.**

Oral: Velsipity

*Note: A trial of either or both Xeljanz products (Xeljanz and Xeljanz XR) collectively counts as ONE product.

**For infliximab under the medical benefit, BCBSNE requires the use of a preferred infliximab product as listed below. There are no benefits available for non-preferred infliximab biosimilar products.**

Preferred Agent(s)

Non-preferred Agent(s)

Avsola (infliximab-axxq)

Inflectra (infliximab-dyyb)

Renflexis (infliximab-abda)

Remicade (infliximab)

Infliximab

**Humira (adalimumab) biosimilars**

Formulary	Preferred adalimumab products (Step 1a)	Non-preferred adalimumab products (Step 3c)
PDL10	Brand Humira, adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Julio, Idacio, Hyrimoz,Amjevita, Yuflyma, Yusimry
NetResults Select (PDL20)	Brand Humira, adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry
PDL25	adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Brand Humira, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry
NetResults Balaned (PDL30)	Brand Humira, adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry
NetResults Performance (PDL40)	Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry
PDL50	adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Brand Humira, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry
PDL66	Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry
TraditionalRXList (Ind ACA 6-tier) (PDL68)	Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry
Value RXList (Ind ACA 4-tier (PDL69)	Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz
BluePride RXChoices (90)	Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry
BluePride RXChoices (91)	Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi	Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry

Formulary	Preferred ustekinumab product (step 1a)	Non-preferred ustekinumab product (step 3c)
PDL10	Steqeyma, Yesintek, Selarsdi, Brand Stelara
PDL20	Steqeyma, Yesintek, Selarsdi, Brand Stelara
PDL30	Steqeyma, Yesintek, Selarsdi, Brand Stelara
PDL40	Steqeyma, Yesintek, Selarsdi	Brand Stelara
PDL68	Steqeyma, Yesintek, Selarsdi	Brand Stelara
PDL69	Steqeyma, Yesintek, Selarsdi	Brand Stelara
PDL90	Steqeyma, Yesintek, Selarsdi	Brand Stelara
PDL91	Steqeyma, Yesintek, Selarsdi	Brand Stelara
PDL25	Steqeyma, Yesintek, Selarsdi	Brand Stelara

Quick Code Search

Use this feature to find out if a procedure and diagnosis code pair will be approved, denied or held for review. Simply put in the procedure code, then the diagnosis code, then click "Add Code Pair". If the codes are listed in this policy, we will help you by showing a dropdown to help you.

Procedure

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Diagnosis

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Codes

Full Description

Injection, vedolizumab, 1 mg

Full Description

Injection, secukinumab, intravenous, 1 mg

Full Description

Injection, mirikizumab-mrkz, 1 mg

Full Description

Ustekinumab, for intravenous injection, 1 mg

Full Description

Injection, adalimumab, 20 mg

Full Description

Injection, adalimumab, 1 mg

Full Description

Injection, certolizumab pegol, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)

Full Description

Injection, certolizumab pegol, 1 mg

Full Description

Injection, golimumab, 1 mg, for intravenous use

Full Description

Injection, guselkumab, 1 mg

Full Description

Injection infliximab, 10 mg

Full Description

Injection, infliximab-dyyb (zymfentra), 10 mg

Full Description

Injection, risankizumab-rzaa, intravenous, 1 mg

Full Description

Injection, ustekinumab, 1 mg

Full Description

Ustekinumab, for intravenous injection, 1 mg

Full Description

Injection, vedolizumab, 1 mg

Full Description

Injection, Infliximab, Biosimilar, 10 mg

Full Description

Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg

Full Description

Injection, infliximab-abda, biosimilar, (renflexis), 10 mg

Full Description

Injection, infliximab-axxq, biosimilar, (avsola), 10 mg

Full Description

Injection, adalimumab-aacf (idacio), biosimilar, 20 mg

Full Description

Injection, ustekinumab-auub (wezlana), biosimilar, subcutaneous, 1 mg

Full Description

Injection, ustekinumab-auub (wezlana), biosimilar, intravenous, 1 mg

Full Description

Injection, adalimumab-fkjp, biosimilar, 1 mg

Full Description

Injection, adalimumab-aaty, biosimilar, 1 mg

Full Description

Injection, adalimumab-ryvk biosimilar, 1 mg

Full Description

Injection, adalimumab-adbm, biosimilar, 1 mg

Full Description

Injection, adalimumab-aacf (idacio), biosimilar, 1 mg

Full Description

Injection, adalimumab-afzb (abrilada), biosimilar, 1 mg

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Injection, trastuzumab-strf (hercessi), biosimilar, 10 mg

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Ustekinumab, for Intravenous Injection, 1 mg

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Injection, ustekinumab-ttwe (pyzchiva), subcutaneous, 1 mg

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Injection, ustekinumab-ttwe (pyzchiva), intravenous, 1 mg

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Injection, ustekinumab-aekn (selarsdi), 1 mg

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Injection, ustekinumab-aauz (otulfi), biosimilar, 1 mg

References

2011 Chaparro M, Panes, J, García V, et al. Long-term durability of infliximab treatment in Crohn’s disease and efficacy of dose “escalation” in patients losing response. J Clin Gastroenterol 2011;45:113-8.
2010 Remicade® (infliximab) [package insert]. Malvern, PA: Centocor, Inc., April 2010.
2012 Humira® (adalimumab) [package insert]. North Chicago, IL: Abbott Laboratories, September 2012.
2012 Hyams J, Griffiths A, Markowitz J, et al. Safety and Efficacy of Adalimumab for Moderate to Severe Crohn’s Disease in Children. Gastroenterology 2012;143:365-374.
2013 Feagan, B. et al. Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis. The New England Journal of Medicine. August 22, 2013; 369:8.
2013 Sandborn, W. et al. Vedolizumab as Induction and Maintenance Therapy for Crohn’s Disease. The New England Journal of Medicine. August 22, 2013; 369:8.

Revisions

04-22-2026 Updated preferred status of Rinvoq per Prime Therapeutics Trade agreement.
01-06-2026 Updated preferred products for changes to brand Humira and brand Stelara.
01-05-2026 Updated Simponi dosage for pediatric weight requirement included in FDA approved labeling.
12-02-2025 Addition of Tremfya SQ induction dosing.
10-22-2025 Updated Omvoh for Crohns to step 2 status based on trade contracts.
05-16-2025 Added J1628 to codes section
04-30-2025 Updated Tremfya to preferred product for treatment of Crohns and UC per trade contracts.
03-28-2025 Addition of Tremfya for treatment of Crohn's disease.
03-26-2025 Addition of Entyvio SQ dosage to table.
03-24-2025 Added new HCPC code for 04/01/2025 Q9999
02-18-2025 Updated Entyvio SQ to Step 1 per trade contracts and addition of Steqeyma, Wezlana, Yesintek to Step 3c agents per trade contracts.
02-12-2025 Updated Zymfentra to step 3a for Crohns and Omvoh to step 2 for Crohns per trade contracts
01-02-2025 Added new codes for 01/01/2025: J0139, Q5140-Q5146, Q9996-Q9998
01-01-2025 Updated Omvoh from step 3b to 2, per trade contracts. Updated Zymfentra and Zeposia to Step 3a per trade contracts. Updated adalimumab preferred products per formulary.
11-07-2024 Addition of Tremfya for treatment of UC
10-01-2024 Addition of Omvoh
09-25-2024 Updated adalimumab biosimilar preferred product
09-24-2024 Updated Skyrizi preferred status for indication of UC.
08-21-2024 Reformated and updated entire policy
07-01-2024 Addition of Entyvio SQ as Step 3b agent.
06-26-2024 Added new 07/01/2024 HCPCS codes; J1748 Q5137 Q5138
05-02-2024 Updated criteria for use of non-preferred infliximab product to require only failure of 1 preferred biosimilar product.
04-03-2024 Adding new 04/01/2024 codes: C9166 C9168
11-21-2023 Policy reviewed at Medical Policy Committee meeting on 11/8/2023 – no changes to policy
08-22-2023 Addition of Rinvoq for treatment of Crohns Disease
07-06-2023 Updated preferred criteria for addition of Cyltezo, Hadlima, Hulio, Idacio, Yuflyma, Yusimry
07-01-2023 Update to preferred products for Remicade and addition of Amjevita as preferred biosimilar.
06-28-2023 Added new code for 07/01/2023: Q5131
12-29-2022 Added new code effective 01/01/2023 J2327
09-14-2022 Updated Cimzia to Step 3 non-preferred per Prime contracting requirement
09-01-2022 Updated preferred status of Rinvoq and Xeljanz/Xeljanz XR as Prime contract requirement.
08-24-2022 Updated self-administered preferred products to include Skyrizi for diagnosis of Crohn's disease.
06-13-2022 Addition of Rinvoq to step criteria for treatment of UC.
03-09-2022 Added table of preferred/non-preferred infliximab products.
03-03-2022 Addition of Zeposia for treatment of UC.
12-16-2021 Addition of infliximab biosimilar products and preferred status.
05-19-2021 Updated Humira indication UC in pediatric patients age 5 and up.
05-15-2021 Updated criteria for use for request for dosage outside current guidelines.
03-17-2021 Revised preferred product step table.
03-09-2021 Removed the step through criteria for Crohns and UC, now allowing for moderate to severe disease
07-01-2020 Added new 07/01/2020 HCPC code: Q5121
06-29-2020 Updated policy
07-01-2019 Added Remicade as preferred infliximab product
11-07-2018 Added Xeljanz to policy
12-21-2017 Added new code J3358 for 01/01/2018
11-02-2017 Added Q9989
08-08-2017 Added C9487 and Q5102 to policy
03-31-2017 policy updated for the use of ustekinumab.
11-09-2016 Stelara added to policy
05-20-2016 Added new code for 07/01/2016 Q5102
07-01-2015 Removed golimumab criteria from ulcerative colitis policy section.
01-20-2014 Added code association: J0135 J0717 J0718 J1745 J1602