Prior Authorization Protocol ACTEMRA …...Prior Authorization Protocol ACTEMRA ®...

Prior Authorization Protocol

ACTEMRA® (tocilizumab),CIMZIA® (certolizumab pegol), COSENTYX®

(secukinumab), ENBREL (etanercept), ENTYVIO® (vedolizumab), HUMIRA

(adalimumab), INFLECTRA (infliximab-dyyb),KINERET (anakinra), ORENCIA® (abatacept), OTEZLA® (apremilast), REMICADE® (infliximab), SIMPONI®, SIMPONI® ARIA™ (golimumab), STELARA™ (ustekinumab), TALTZ® (ixekizumab), TYSABRI®

(natalizumab), XELJANZ®, XELJANZ® XR (tofacitinib)

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Interim Guidelines; Final Review and Approval by the P&T Committee Pending

Draft Prepared: 05.01.03 Approved by Health Net HNCAHNCAHNCA& Therapeutics Committee: 05.28.03, 04.13.04, 04.12.05. 11.17.06, 5.16.07, 08.15.07, 05.21.08, 11.18.09, 11.17.10, 11.9.11, 08.15.12, 11.14.12, 11.20.13, 11.19.14, 11.18.15, 5.4.16, 08.24.16 Updated: 04.13.04, 04.15.05 SA, 05.24.05 SA, 02.08.06 MJM, 03.28.06 CM, 04.11.06 CM, 08.11.06 RG, 11.29.06 RG, 02.07.07 SB, 06.01.07 RG, 01.02.08 S Butler, 07.11.08 S Butler, 04.15.09 mjmcclusky, 07.27.09 Tjaghasspanian, 07.01.10 T Jaghasspanian. 01.07.11 S Tabarangao, 07.07.11 MJMcClusky, 01.05.12 MJMcClusky, R. Gedey 2.20.12, 07.05.12 D. Duane, 10.15.12 R. Olegario, 2.14.13 S Redline, 7.16.13 T Jaghasspanian, 2.6.14 A Myong, 6.12.14 A Myong, 9.9.14 A Myong, S Ara, 01.20.15 R Olegario, 06.08/15 S Mirando, 10.13.15 M Hashemian, 12.18.15 MJMcClusky, 01.13.16 N Nguyen, 02.01.16 TScharenberg, 3.15.16 A Myong, 06.15.16 N Nguyen , 07.11.16 N Nguyen, 09.01.16 T Pang, 09.19.16 N Nguyen, 09.26.19 N Nguyen, 10.10.16 N Nguyen, 10.31.16 S Park, 11.21.16 N Nguyen, 11.22.16 S Park, 11.30.16 N Nguyen, 12.05.16 S Park, 12.07.16 A Myong, 12.15.16 M Del Nero 1

Coverage of drugs is first determined by the member`s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document I. FDA Approved Indications:

AS CD UC NOMID pJIA sJIA PP PsA RA HS MS UV Actemra x (IV) x (IV) x Cimzia x x x x Cosentyx x x x Enbrel x x x x x Entyvio x x Humira x x x x x x x x x Inflectra x x x x x x Kineret x x Orencia x (IV) x Otezla x x Remicade x x x x x x Simponi x x x x Simponi Aria

x

Stelara x x x Taltz x Tysabri x x Xeljanz/ Xeljanz XR

x

AS=ankylosing spondylitis; CD=Crohn’s 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 II. Health Net Approved Indications and Usage Guidelines:

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






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• Diagnosis of rheumatoid arthritis (RA)

AND

• Confirmed by a Rheumatologist

OR

• 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)

AND

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

OR

• 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

AND [for Kineret, Cimzia, Orencia, Actemra, Enbrel, Xeljanz, Xeljanz XR, Inflectra]

• Failure or clinically significant adverse effects to a 3-month minimum trial of Humira® AND

either Remicade® or Simponi

® or Simponi Aria

®)

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

• Diagnosis of Active Psoriatic Arthritis

AND

• Confirmed by a Rheumatologist or Dermatologist

AND

• Failure or clinically significant adverse effects to MTX unless contraindicated

AND [for Cimzia, Cosentyx, Enbrel, Inflectra]






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either Remicade®, Stelara

®, Simponi

® or Otezla)

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

• Diagnosis of active Ankylosing Spondylitis

AND

• 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

AND [for Cimzia, Enbrel, Cosentyx, Inflectra]


either Remicade® or Simponi

®)

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

• Diagnosis of moderate to severe Crohn`s Disease

AND

• Confirmed by a gastroenterologist

AND [for Cimzia, Entyvio, Tysabri, Inflectra]

• Failure or clinically significant adverse effects to Humira®

AND either Remicade® OR Stelara

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

• Diagnosis of moderate to severe ulcerative colitis






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AND

• Confirmed by a gastroenterologist

AND For Induction:

• Patient is not in remission

AND

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

AND [for Entyvio, Inflectra]


AND Remicade®

or 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

AND

• Prescribed by a Dermatologist or Rheumatologist

AND

• 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






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OR

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

AND [for Enbrel]


AND either Stelara, Remicade®, or

Otezla

OR [for Cosentyx, Taltz, Inflectra]

• 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

AND

• Confirmed by a Rheumatologist

AND

• Failure or clinically significant adverse effects to methotrexate for 3 months

AND [for Orencia, Enbrel]


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]:






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• Diagnosis of Hidradenitis Suppurativa (HS)

AND

• Prescribed by a Dermatologist or Rheumatologist or gastroenterologist

AND

• Documentation of Hurley stage II or stage III

AND

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

AND [for Enbrel]


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

• Diagnosis of Systemic juvenile idiopathic arthritis

AND

• Prescribed by a Dermatologist or Rheumatologist or gastroenterologist

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

• Diagnosis of non-infectious intermediate, posterior, or panuveitis

AND

• Prescribed by an ophthalmologist or rheumatologist

AND

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

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






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Relapsing remitting multiple sclerosis (for Tysabri only):

• Refer to Tysabri MS criteria.

III. Coverage 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.

IV. 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). A. Joint involvement (swollen or tender)

• 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 B. Serology (at least 1 test result is needed for classification)

• Negative RF (rheumatoid factor) and negative ACPA (anti-citrullinated protein antibody), score = 0

• Low-positive RF or low-positive ACPA, score = 2

• High-positive RF or high-positive ACPA, score = 3 C. Acute-phase reactants (at least 1 test result is needed for classification)

• Normal CRP (C-reactive protein) and normal ESR (erythrocyte sedimentation rate), score = 0

• Abnormal CRP or abnormal ESR, score = 1






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D. Duration of symptoms

• < 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.






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• Hidradenitis Suppurativa (HS) is sometimes referred to as: "acne inversa, acne conglobata, apocrine acne, apocrinitis, Fox-den disease, hidradenitis axillaris, HS, pyodermia sinifica fistulans, Velpeau’s disease, and Verneuil’s 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.

V. Therapeutic Alternatives:

Drug Dosing Regimen Dose/Limit/Maximum Dose azathioprine (Imuran

®)

Rheumatoid Arthritis 1 mg/kg/day PO given as a QD or BID

Crohn’s Disease and Ulcerative Colitis

100 - 250 mg PO daily Uveitis

1 mg/kg/day PO

2.5 mg/kg/day

corticosteroids Crohn’s Disease Prednisone 40 mg PO QD for 2 weeks

or IV 50-100 mg Q6H for 1 week

budesonide (Entocort EC ) 6-9 mg PO

QD

Varies

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)

hydroxychloroquine

(Plaquenil)

Rheumatoid Arthritis Initial dose: 400-600 mg PO QD

Maintenance dose: 200-400 mg PO QD 600 mg/day






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Drug Dosing Regimen Dose/Limit/Maximum Dose mercaptopurine (Purinethol

R)

Crohn’s Disease, Ulcerative Colitis

75 – 125 mg PO daily 1.5 mg/kg/day

methotrexate (Rheumatrex

®)

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®

(mesalamine) Crohn’s Disease and Ulcerative

Colitis 1000 mg PO QID

4000 mg/day

acitretin (Soriatane) Plaque Psoriasis 25 or 50 mg PO daily

50 mg/day

sulfasalazine

(Azulfidine)

Rheumatoid Arthritis 2 gm/day PO in divided doses

Ulcerative Colitis

Initial dose is 3 to 4 gm/day PO; maintenance is 2 gms/day PO.

Administer in evenly divided doses (not exceeding 8-hour intervals)

4 gm/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 Up to 3 months






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Drug Dosing Regimen Dose/Limit/Maximum Dose 50-100 mg PO BID

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 VI. 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

6 months or to member’s renewal date, whichever is longer

Approval of Humira dose escalation to 40 mg weekly will require

documentation of partial response to every other week dosing.






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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






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every 8 weeks

Xeljanz 5 mg PO BID

Xeljanz XR

11 mg PO QD Do not crush, split, or chew

Xeljanz XR.

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


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


HUMIRA

40 mg SC every other week

REMICADE, INFLECTRA 5 mg/kg IV initially and at weeks 2







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and 6, then Q6W

SIMPONI 50 mg SC once a month

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


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)


HUMIRA



and 6, then Q8W







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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

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







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weeks later (day 29) begin maintenance dose of 40mg SC

every other week Maintenance: 40 mg SC every

other week

Pediatric Crohn’s 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.


and 6, then Q8W

STELARA A single intravenous infusion using

weight-based dosing: Up to 55kg: 260 mg 55 – 85kg: 390 mg






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>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

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:



and 6, then Q8W

SIMPONI







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200 mg SC at week 0, 100 mg SC at week 2, then 100 mg SC every

4 weeks

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







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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

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







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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

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


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.


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)







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• Third (Day 29) and subsequent doses: 40 mg SC every week.

ENBREL

25-50 mg SC twice weekly

Tysabri

Multiple Sclerosis 300 mg IV Q 4 Wks

6 months or to member's renewal

period, whichever is later

Otezla Plaque Psoriasis, Psoriatic Arthritis

30 mg PO BID after initial titration dosing


Humira Uveitis Initial dose of 80 mg SC followed by 40 mg SC every other week

starting one week after the initial dose.


VII. 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)






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Syringe: 150 mg/ml; carton of 1 or 2 syringes Pen: 150 mg/ml (Sensoready

®); carton of 1 or 2 pens

ENTYVIO single use vial, 300 mg/20 mL ENBREL Multi-use vials: 25 mg Single-use pre-filled syringes: 25 and 50 mg Pre-filled SureClick Autoinjector: 50 mg 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 Crohn’s 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






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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

VIII. 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.






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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






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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® 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.

28. Margesson LJ, Danby FW. Hidradenitis suppurativa (acne inversa): Treatment. In: UpToDate, Waltham, MA: Walters Kluwer Health; 2016. Available at: www.UpToDate.com. Accessed November 2016.

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