Prior Auth Protocol

FDA Approved Indications:

NOMID

pJIA

sJIA

PsA

Actemra

x (IV)

Cimzia

Cosentyx

Enbrel

Entyvio

Humira

Inflectra

Kineret

Orencia

x (IV)

Otezla

Remicade

Simponi

Simponi Aria

Stelara

Taltz

Tysabri

Xeljanz/

Xeljanz XR

AS=ankylosing spondylitis; CD=Crohns disease; UC=ulcerative colitis; NOMID=neonatal-onset multisystem inflammatory disease; pJIA=polyarticular juvenile idiopathic arthritis; sJIA=systemic juvenile idiopathic arthritis; PP=plaque psoriasis; PsA= psoriatic arthritis; RA=rheumatoid arthritis; HS=Hidradenitis Suppurativa, MS=multiple sclerosis, UV = uveitis

Health Net Approved Indications and Usage Guidelines:

Rheumatoid Arthritis [for Actemra, Cimzia, Enbrel, Humira, Inflectra, Kineret, Orencia, Remicade, Simponi, Simponi Aria, Xeljanz, Xeljanz XR]

Diagnosis of rheumatoid arthritis (RA)

Confirmed by a Rheumatologist

Defined at baseline prior to disease modifying anti-rheumatic drug (DMARD) treatment initiation by the (American College of Rheumatology (ACR)) criteria (refer to General Information for ACR criteria)

Failure or clinically significant adverse effects to methotrexate (MTX) in the last year for patients who are new to biologics

If patient is not a candidate for MTX (i.e., patient is a smoker [increased risk of MTX lung disease] or MTX is contraindicated), then failure or clinically significant adverse effect to sulfasalazine or 1 other DMARD

Failure or clinically significant adverse effects to a 3-month minimum trial of Humira^R AND either, Remicade^R,or Simponi^Ror Simponi Aria^R)

Psoriatic Arthritis [for Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Otezla, Remicade Simponi, Stelara]

Diagnosis of Active Psoriatic Arthritis

Confirmed by a Rheumatologist or Dermatologist

Failure or clinically significant adverse effects to MTX unless contraindicated

Failure or clinically significant adverse effects to a 3-month minimum trial of Humira^R AND either, Remicade^R, Stelara^R,Simponi^R or Otezla

Ankylosing Spondylitis [for Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Remicade, Simponi]

Diagnosis of active Ankylosing Spondylitis

Failure or clinically significant adverse effects to at least two NSAIDs for at least 1 month at maximal recommended or tolerated anti-inflammatory dose, unless contraindicated

Failure or clinically significant adverse effects to a 3-month minimum trial of Humira^R AND either, Remicade^RorSimponi^R)

Crohn`s Disease [for Cimzia, Entyvio, Humira, Inflectra, Remicade, Stelara, Tysabri]

Diagnosis of moderate to severe Crohn`s Disease

Confirmed by a gastroenterologist

Failure or clinically significant adverse effects to Humira^RAND either Remicade^R OR Stelara

Ulcerative Colitis [for Entyvio, Humira, Inflectra, Remicade, Simponi]

Diagnosis of moderate to severe ulcerative colitis

Confirmed by a gastroenterologist

For Induction:

Patient is not in remission

Failure or clinically significant adverse effects to a one-month course of aminosalicylates (e.g. sulfasalazine, mesalamine) followed by corticosteroids such as prednisone.

Failure or clinically significant adverse effects to Humira^RAND Remicade^Ror Simponi

For maintenance:

Failure or clinically significant adverse effects to one of the following:
- azathioprine
- 6-mercaptopurine (6-MP)
- aminosalicylates (e.g., sulfasalazine)

Plaque Psoriasis [for Cosentyx, Enbrel, Humira, Inflectra, Otezla, Remicade, Stelara, Taltz]

Diagnosis of chronic moderate to severe plaque psoriasis

Prescribed by a Dermatologist or Rheumatologist

Failure or clinically significant adverse effects to ONE of the following therapies either alone or in combination, unless contraindicated:
- Methotrexate up to a dose of 15-20 mg/week

If methotrexate is contraindicated, failure or clinically significant adverse effects to PUVA Therapy or UVB, or cyclosporine or acitretin

Failure or clinically significant adverse effects to Humira^RAND either Stelara, Remicade^R, or Otezla

Failure or clinically significant adverse effects to Humira AND either Stelara or Remicade

Polyarticular Juvenile Idiopathic Arthritis [for Actemra, Enbrel, Humira, Orencia (IV only)]

Diagnosis of Active Polyarticular Juvenile Idiopathic Arthritis

Confirmed by a Rheumatologist

Failure or clinically significant adverse effects to methotrexate for 3 months

Failure or clinically significant adverse effects to Humira^R

Neonatal-Onset Multisystem Inflammatory Disease (NOMID) [for Kineret only]

Diagnosis of Neonatal-onset multisystem inflammatory disease (NOMID) or chronic infantile neurological, cutaneous and articular syndrome (CINCA)

Hidradenitis Suppurativa (HS) [for Humira, Enbrel]:

Diagnosis of Hidradenitis Suppurativa (HS)

Prescribed by a Dermatologist or Rheumatologist or gastroenterologist

Documentation of Hurley stage II or stage III

Failure or clinically significant adverse effects to systemic antibiotic therapy unless intolerant or contraindicated

Failure or clinically significant adverse effects to Humira^R

Systemic juvenile idiopathic arthritis (SJIA) (for Actemra only):

Diagnosis of Systemic juvenile idiopathic arthritis

Prescribed by a Dermatologist or Rheumatologist or gastroenterologist

Non-infectious Uveitis (UV) [for Humira only]:

Diagnosis of non-infectious intermediate, posterior, or panuveitis

Prescribed by an ophthalmologist or rheumatologist

Failure or clinically significant adverse effects to oral corticosteroids (e.g., prednisone)

Failure or clinically significant adverse effects to non-biologic immunosuppressive therapy (e.g., azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, cyclophosphamide, chlorambucil)

Relapsing remitting multiple sclerosis (for Tysabri only)

Refer to Tysabri MS criteria.

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature
Combination use with Xeljanz or biological DMARDs such as TNF antagonists [Cimzia, Enbrel, Simponi, Remicade, Inflectra], interleukin-1 receptor (IL-1R) antagonists [Kineret], interleukin-6 receptor (IL-6R) antagonists [Actemra], anti-CD20 monoclonal antibodies [Rituxan] and selective co-stimulation modulators [Orencia] because of the possibility of increased immunosuppression, neutropenia and increased risk of infection.

General Information:

ACR Classification criteria for RA (score-based algorithm: add score of categories A-D; a score of >/= 6/10 is needed for classification of a patient as having definite RA).

1 large joint, score = 0
2-10 large joints, score = 1
1-3 small joints (with or without involvement of large joints), score = 2
4-10 small joints (with or without involvement of large joints), score = 3
>10 joints (at least 1 small joint), score = 5

Negative RF (rheumatoid factor) andnegative ACPA (anti-citrullinated protein antibody), score = 0
Low-positive RF orlow-positive ACPA, score = 2
High-positive RF orhigh-positive ACPA, score = 3

Normal CRP (C-reactive protein) andnormal ESR (erythrocyte sedimentation rate), score = 0
Abnormal CRP orabnormal ESR, score = 1

< 6 weeks, score = 0
>/= 6 weeks, score = 1

In RA, failure of MTX or DMARD is defined as a contraindication or < 50% decrease in swollen joint count, < 50% decrease in tender joint count, and < 50% decrease in ESR, or < 50% decrease in CRP, or contraindication to at least 3 months of therapy with MTX at doses up to 25 mg per week or maximum tolerated dose.
Several ankylosing spondylitis (AS) treatment guidelines call for a trial of 2 or 3 non-steroidal anti-inflammatory drugs (NSAID) prior to use of an anti-TNF agent. A two year trial showed that continuous NSAID use reduced radiographic progression of AS versus on demand use of NSAID.
Serious infections were seen in clinical studies with concurrent use of Kineret and another TNF-blocking agent, Enbrel, with no added benefit compared to Enbrel alone. Because of the nature of the adverse reactions with this combination therapy, similar toxicities may also result from combination of anakinra and other TNF blocking agents.
For Ulcerative Colitis maintenance therapy, failure is defined as having two or more exacerbations requiring steroid therapy.
Per prescribing information, Xeljanz should not be used in combination with biologic DMARDs [such as Kineret] or potent immunosuppressants such as azathioprine and cyclosporine. As stated in the black box warning, patients treated with Xeljanz are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as MTX or corticosteroids.
Stelara is for subcutaneous administration and is intended for use under the guidance and supervision of a physician. After proper training in subcutaneous injection technique, a patient may self inject with Stelara if a physician determines that it is appropriate. Patients should be instructed to follow the directions provided in the Medication Guide.
In the PHOENIX 2 trial, dosing intensification of Stelara to every 8 weeks did not result in greater efficacy compared with continuing treatment every 12 weeks.
Other names used for NOMID are as follows: chronic infantile neurological, cutaneous and articular syndrome (CINCA), chronic neurologic, cutaneous, and articular syndrome, infantile onset multisystem inflammatory disease, IOMID syndrome, and Prieur-Griscelli syndrome.
Off-label indications:. Graft vs. Host disease is listed in Micromedex as Class IIa and Enbrel is recommended in most cases.
Hidradenitis Suppurativa (HS) is sometimes referred to as: "acne inversa, acne conglobata, apocrine acne, apocrinitis, Fox-den disease, hidradenitis axillaris, HS, pyodermia sinifica fistulans, Velpeaus disease, and Verneuils disease."
In hidradenitis suppurativa, Hurley stages are used to determine severity of disease. Hurley stage II indicates moderate disease, and is characterized by recurrent abscesses, with sinus tracts and scarring, presenting as single or multiple widely separated lesions. Hurley stage III indicates severe disease, and is characterized by diffuse or near-diffuse involvement presenting as multiple interconnected tracts and abscesses across an entire area.
Taltz is currently being studied for the treatment of rheumatoid arthritis, radiographic axial spondyloarthritis, ankylosing spondylitis, and psoriatic arthritis.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
azathioprine (Imuran^R)	Crohn's 100-250 mg PO daily Rheumatoid Arthritis 1 mg/kg PO given as a QD or BID Uveitis 1 mg/kg/day PO	Crohn's 2.5 mg/kg/day Rheumatoid Arthritis 2.5 mg/kg/day
Corticosteroids	Crohn`s Prednisone 40 mg PO QD for 2 weeks or IV 50-100 mg Q6H for 1 week budesonide (Entocort EC^R) 6-9 mg PO QD	Varies
hydroxychloroquine (Plaquenil^R)	Rheumatoid Arthritis Initial dose: 400-600 mg PO QD Maintenance dose: 200-400 mg PO QD	600 mg/day
mercaptopurine (Purinethol^R)	Crohn's, Ulcerative Colitis 75-125 mg PO QD	1.5 mg/kg/day
methotrexate (Rheumatrex^R)	Rheumatoid Arthritis 7.5 mg/week PO or 2.5 mg PO Q12hr for 3 doses/week Polyarticular Juvenile Arthritis 10mg/m² PO weekly Plaque Psoriasis 10 to 25 mg/week, IM, IV or PO Uveitis 7.5 12.5 mg/week PO	30 mg/week
Pentasa^R (mesalamine)	Crohns Disease and Ulcerative Colitis 1000 mg PO QID	4000 mg/day
sulfasalazine (Azulfidine^R)	Rheumatoid Arthritis 2 gm/day PO in divided doses Ulcerative Colitis Initial dose is 3 to 4 gm/day PO; maintenance is 2gms/day PO Administer in evenly divided doses (not exceeding 8-hour intervals)	4 gm/day
cyclosporine (Sandimmune, Neoral)	Rheumatoid Arthritis, Plaque Psoriasis 2.5 4 mg/kg/day PO divided BID Uveitis 2.5 5 mg/kg/day PO in divided doses	4 mg/kg/day (Uveitis: 10 mg/kg/day)
acitretin (Soriatane)	Plaque Psoriasis 25 or 50 mg PO daily	50 mg/day
mycophenolate mofetil (Cellcept)	Uveitis 500 mg PO BID	3 gm/day
tacrolimus (Prograf)	Uveitis 0.15-0.30 mg/kg/day PO	0.30 mg/kg/day
cyclophosphamide (Cytoxan)	Uveitis 2 mg/kg/day PO	3 mg/kg/day
chlorambucil (Leukeran)	Uveitis 0.1 mg/kg/day PO	0.2 mg/kg/day
doxycycline	Hidradenitis suppurativa 50-100 mg PO BID	Up to 3 months
minocycline	Hidradenitis suppurativa 50-100 mg PO BID	Up to 3 months
clindamycin+rifampin	Hidradenitis suppurativa clindamycin 300 mg PO BID with rifampin 300 mg PO BID	10 weeks

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
See next column	Rheumatoid Arthritis: ACTEMRA Patients less than 100 kg: 162 mg SC QOW Patients 100 kg or more: 162 mg SC Q Week Or 4 mg/kg IV every 4 weeks followed by an increase to 8 mg/kg IV every 4 weeks based on clinical response CIMZIA Initial dose: 400 mg SC initially and at Weeks 2 and 4 Maintenance dose: 200 mg SC every other week (400 mg SC every 4 weeks can be considered) ENBREL 50 mg SC once weekly HUMIRA 40 mg SC every other week If not on concomitant methotrexate, may benefit from increasing the dosing frequency to 40 mg SC every week. KINERET 100 mg/day by SC injection. ORENCIA Patients less than 60 kg: 500 mg Patients 75 kg to 100 kg: 750 mg Patients more than 100 kg: 1,000 mg IV initially then at weeks 2 and 4 then, Q 4 Weeks Or 125 mg SC Q Week. May be used following an initial IV loading dose REMICADE, INFLECTRA 3 mg/kg IV initially and at weeks 2 and 6, then Q8W SIMPONI 50 mg SC once a month SIMPONI ARIA 2 mg/kg IV infusion over 30 minutes at weeks 0 and 4, then every 8 weeks Xeljanz 5 mg PO BID Xeljanz XR 11 mg PO QD Do not crush, split, or chew Xeljanz XR.	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy. Approval of Humira dose escalation to 40 mg weekly will require documentation of partial response to every other week dosing.
See next column	Ankylosing spondylitis: CIMZIA Initial dose: 400 mg SC initially and at Weeks 2 and 4 Maintenance dose: 200 mg SC every other week (400 mg SC every 4 weeks can be considered) COSENTYX Initial dose: 150 mg SC at weeks 0, 1, 2, 3 and 4 (or option for no loading dose) Maintenance dose: 150 mg SC every 4 weeks ENBREL 50 mg SC once weekly HUMIRA 40 mg SC every other week REMICADE, INFLECTRA 5 mg/kg IV initially and at weeks 2 and 6, then Q8W SIMPONI 50 mg SC once a month	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.
See next column	Psoriatic arthritis: CIMZIA Initial dose: 400 mg SC initially and at Weeks 2 and 4 Maintenance dose: 200 mg SC every other week (400 mg SC every 4 weeks can be considered) COSENTYX Initial dose: 150 mg SC at weeks 0, 1, 2, 3 and 4 (or option for no loading dose) Maintenance dose: 150 mg SC every 4 weeks (can increase to 300 mg if needed) ENBREL 50 mg SC once weekly HUMIRA 40 mg SC every other week REMICADE, INFLECTRA 5 mg/kg IV initially and at weeks 2 and 6, then Q8W SIMPONI 50 mg SC once a month STELARA 45 mg SC initially and 4 weeks later, followed by 45 mg every 12 weeks With co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg: 90 mg SC initially and 4 weeks later, followed by 90 mg SC every 12 weeks	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.
See next column	Crohn`s Disease: CIMZIA Initial dose: 400 mg SC initially and at weeks 2 and 4 Maintenance dose: In patients who obtain a clinical response, 400 mg SC every 4 weeks ENTYVIO 300 mg IV initially and at weeks 2 and 6, then Q8W HUMIRA Induction: 160 mg SC (four 40mg injections) day 1 followed by 80 mg SC 2 weeks later (day15). 160mg can be given as 4 injections in one day or divided over 2 days. Two weeks later (day 29) begin maintenance dose of 40mg SC every other week Maintenance: 40 mg SC every other week Pediatric Crohns Disease 17 kg (37 lbs) to < 40 kg (88 lbs): Initial dose (Day 1): 80 mg (two 40 mg injections in one day) Second dose two weeks later (Day 15): 40 mg Two weeks later (Day 29): Begin a maintenance dose of 20 mg every other week. ≥ 40 kg (88 lbs): Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day) Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week. REMICADE, INFLECTRA 5 mg/kg IV initially and at weeks 2 and 6, then Q8W STELARA A single intravenous infusion using weight-based dosing: Up to 55kg: 260 mg 55 85kg: 390 mg >85kg: 520 mg A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter. TYSABRI 300 mg IV Q4W	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.
See next column	Ulcerative Colitis Induction: ENTYVIO 300 mg IV initially and at weeks 2 and 6, then Q8W HUMIRA Initial dose (Day 1): 160 mg SC (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) Second dose two weeks later (Day 15): 80 mg SC Two weeks later (Day 29): Begin a maintenance dose of 40 mg SC every other week. Maintenance: 40 mg SC every other week REMICADE, INFLECTRA 5 mg/kg IV initially and at weeks 2 and 6, then Q8W SIMPONI 200 mg SC at week 0, 100 mg SC at week 2, then 100 mg SC every 4 weeks	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.
See next column	Plaque Psoriasis: COSENTYX 300 mg SC at weeks 0, 1, 2, 3 and 4 followed by 300 mg SC every 4 weeks. For some patients, a dose of 150 mg may be acceptable. ENBREL Adults: Starting dose: 25 mg or 50 mg or SC twice weekly for 3 months Maintenance dose: 25 mg or 50 mg SC per week Pediatric: Less than 63 kg: 0.8 mg/kg SC per week given as single injection. Maximum dose of 50 mg per week 63 kg or more: 50 mg SC per week HUMIRA Initial dose of 80 mg SC followed by 40 mg SC every other week starting one week after the initial dose. REMICADE, INFLECTRA 5 mg/kg IV initially and at weeks 2 and 6, then Q8W STELARA Equal or less than 100 kg: 45 mg SC initially and 4 weeks later, followed by 45 mg every 12 weeks Greater than 100 kg: 90 mg SC initially and 4 weeks later, followed by 90 mg every 12 weeks TALTZ: 160 mg (two 80 mg injections) SC at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg SC every 4 weeks	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.
See next column	Polyarticular Juvenile Idiopathic Arthritis: ACTEMRA Patients less than 30 kg: 10 mg/kg IV Q 4 Weeks Patients 30 kg or more: 8 mg/kg IV Q 4 Weeks ENBREL Less than 63 kg: 0.8 mg/kg SC per week given as single injection. Maximum dose of 50 mg per week 63 kg or more: 50 mg SC per week HUMIRA 10 kg to <15 kg = 10 mg SC every other week 15 kg to <30 kg = 20 mg SC every other week ≥30 kg = 40 mg SC every other week. ORENCIA Patients less than 75 kg: 10 mg/kg Patients 75 kg to 100 kg: 750 mg Patients more than 100 kg: 1,000 mg IV initially then at weeks 2 and 4 then, Q 4 Weeks	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.
Systemic juvenile idiopathic arthritis (SJIA)	ACTEMRA Patients less than 30 kg: 12 mg/kg IV Q 2 Weeks Patients 30 kg or more: 8 mg/kg IV Q 2 Weeks	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.
Neonatal-Onset Multisystem Inflammatory Disease (NOMID)	KINERET 1-2 mg/kg/day by SC injection. Maximum of 8 mg/kg daily. Once daily administration is generally recommended, but the dose may be split into twice daily administrations.	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.
Hidradenitis Suppurativa (HS):	HUMIRA Initial dose (Day 1): 160 mg SC (given as four 40 mg injections on Day 1 or as two 40 mg injections per day on Days 1 and 2) Second dose two weeks later (Day 15): 80 mg SC (two 40 mg injections in one day) Third (Day 29) and subsequent doses: 40 mg SC every week. ENBREL 25-50 mg SC twice weekly	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.
Tysabri	Multiple Sclerosis 300 mg IV Q 4 Wks	HNCA: 6 months or to member's renewal period, whichever is later NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.
Otezla	Plaque Psoriasis, Psoriatic Arthritis 30 mg PO BID after initial titration dosing	Length of benefit
Humira	Uveitis Initial dose of 80 mg SC followed by 40 mg SC every other week starting one week after the initial dose.	HNCA: 6 months or to members renewal date, whichever is longer NATL: 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy.

Product Availability:

ACTEMRA
single use vial, 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL; 162 mg/0.9mL prefilled syringe

CIMZIA
Vial: 200 mg lyophilized powder
Single-use prefilled syringe: 200 mg/mL

COSENTYX
Vial: 150 mg lyophilized powder (for healthcare professional use only)
Syringe: 150 mg/ml; carton of 1 or 2 syringes
Pen: 150 mg/ml (Sensoready^R); carton of 1 or 2 pens

ENBREL
Multi-use vials: 25 mg
Single-use pre-filled syringes: 25 and 50 mg
Pre-filled SureClick Autoinjector: 50 mg

ENTYVIO
single use vial, 300 mg/20 mL

HUMIRA
Pre-filled Pen Carton: 2 dose trays. Each dose tray contains a single-use 40mg/0.8ml pen.
Crohn`s Disease/Ulcerative Colitis Starter Package: 6 dose trays. Each dose tray contains a single-use 40mg/0.8ml prefilled pen.
Pre-filled Syringe Carton: 40mg: 2 dose trays. Each dose tray contains a single-use 40mg/0.8ml prefilled syringe.
Pre-filled Syringe Carton: 20 mg: 2 dose trays. Each dose tray contains a single-use 20mg/0.4ml prefilled syringe.
Pre-filled Syringe Carton: 10 mg: 2 dose trays. Each dose tray contains a single-use 10 mg/0.2 ml prefilled syringe.
Pediatric Crohns Disease Starter Package: 3 dose trays or 6 dose trays. Each dose tray contains a single-use 40 mg/0.8 ml prefilled syringe.
Psoriasis/Uveitis Starter Package: 4 dose trays. Each dose tray consists of a single-use 40 mg/0.8 mL prefilled syringe.
Psoriasis/Uveitis Starter Package: 4 dose trays. Each dose tray consists of a single-use 40 mg/0.4 mL prefilled syringe.

INFLECTRA
Single use vial: 100 mg/10 mL

KINERET
Prefilled glass syringe: 100 mg/0.67 ml (single-use)

ORENCIA
single use vial, 250 mg/15 mL; 125 mg/1 mL prefilled syringe

OTEZLA
30 mg tablet; 14 day and 28 day starter kits containing 10 mg, 20 mg and 30 mg tablets

REMICADE
single use vial, 100 mg/10 mL

SIMPONI
Single dose prefilled SmartJect autoinjector: 50 mg/0.5 mL and 100mg/1mL
Single dose prefilled syringe: 50 mg/0.5 mL and 100mg/1mL

SIMPONI ARIA
Vial: 50 mg/4 mL (12.5 mg/ml)

STELARA
Single-use prefilled syringe: 45 mg/0.5 mL or 90mg/1mL
Single-use glass vial: 45 mg/0.5 mL or 90 mg/1 mL

TALTZ
Autoinjector 80 mg/mL solution in a single-dose prefilled autoinjector
Prefilled Syringe 80 mg/mL solution in a single-dose prefilled syringe

TYSABRI
single use vial, 300 mg/15 mL

XELJANZ Tablet: 5 mg
XELJANZ XR Tablet: 11 mg

References:

1. Cosentyx [Prescribing information]. East Hanover, NJ: Novartis; January 2016.
2. Enbrel [Prescribing information]. Thousand Oaks, CA: Immunex Corporation; November 2016.
3. Humira [Prescribing information]. North Chicago, IL: AbbVie Inc; September 2015.
4. Stelara [Prescribing information] Horsham, PA: Janssen Biotech Inc; March 2014.
5. Cimzia [Prescribing Information] Smyrna, GA: UCB, Inc; April 2016.
6. Simponi [Prescribing information]. Horsham, PA: Janssen Biotech Inc; January 2016.
7. Simponi Aria [Prescribing information]. Horsham, PA: Janssen Biotech Inc; April 2016.
8. Kineret [package insert]. Stockholm, Sweden: Swedish Orphan Biovitrum AB (publ). May 2016.
9. Remicade [Prescribing information]. Horsham, PA: Janssen Biotech, Inc.; October 2015.
10. Aletaha D, Neogi T, Silman AJ et al. 2010 Rheumatoid Arthritis Classification Criteria. Arthritis and Rheumatism September 2010;62(9):2569-2581.
11. Zochling J, van der Heijde D, Burgos-Vargas, R, et al. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2006;65:442-452.
12. Braun J, Davis J, Dougados M, et al. First update of the international ASAS consensus statement for the use of anti-TNF agents in patients with ankylosing spondylitis. Ann Rheum Dis. 2006;65:316-320.
13. Boulos P, Dougados M, MacLeod SM, et al. Pharmacological Treatment of Ankylosing Spondylitis. Drugs. 2005; 65: 2111-2127.
14. Colombel JF, Sandborn WJ, Rutgeerts P, et.al. Adalimumab for Maintenance of Clinical Response and Remission in Patients With Crohn`s Disease: The CHARM Trial. Gastroenterology 2007;132:52-65.
15. Lichtenstein G, Hanauer S, Sandborn W, et al. Management of Crohn`s Disease in Adults. Am J Gastroenterol 2009;104:465-483.
16. Menter A, Gottlieb A, Feldman SR, et al. American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58:826-850.
17. Menter A, Gottlieb A, Feldman, SR, et al. American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol May 2008; 58(5): 826-50.
18. Menter A, Korman, NJ, Elmets CA, et al. American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60:643-659.
19. Menter A, Korman NF, Elmets cA, et al. American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 10.1016/j.jaad.2009.03.027
20. Braun J, van den Berg R, Baraliako X, et al. 2010 Update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011; 70:896-904.
21. DRUGDEX^R System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 2016.
22. Ward M, Deodhar A, Akl E, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Available at http://www.rheumatology.org. Accessed July 2016.
23. Xeljanz/Xeljanz XR [Prescribing Information] New York, NY: Pfizer Labs. February 2016.
24. Taltz [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company; March 2016.
25. Inflectra [Prescribing information]. Lake Forest, IL: Hospira; April 2016.
26. Jabs DA, Rosenbaum JT, Foster CS, et al. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000;130(4):492-513.
27. Levy-clarke G, Jabs DA, Read RW, Rosenbaum JT, Vitale A, Van gelder RN. Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders. Ophthalmology. 2014;121(3):785-96.e3.
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Interim Guidelines; Final Review and Approval by the P&T Committee Pending