Prior Authorization Protocol ACTEMRA (tocilizumab), CIMZIA … · 2017-02-02 · Prior...

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)

HNMC

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, 05.04.16 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, 06.22.15 A Myong10.13.15 M Hashemian, 10.20.15 MJMcClusky, 11.04.15 MJMcClusky, 12.18.15 N Nguyen, 02.04.16 TScharenberg, 07.13.16 N Nguyen, 10.17.16 S Park, 11.21.16 N Nguyen, 11.22.16 S Park, 11.30.16 N Nguyen, 12.07.16 A Myong 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 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, 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]






HNMC



• 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 only]

• Failure or clinically significant adverse effects to a 3-month minimum trial of a tumor necrosis

factor (TNF) blocking agent (e.g., Enbrel®, Humira

®, Remicade

®, Cimzia

®, Simponi

®)

AND [for intravenous Actemra, Orencia, Inflectra]

• Failure or clinically significant adverse effects to a trial of Remicade, unless contraindicated.

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

• Diagnosis of active Psoriatic Arthritis

AND

• Confirmed by a Rheumatologist or Dermatologist






HNMC



AND

• Failure or clinically significant adverse effects to MTX unless contraindicated

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

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®

or Remicade® or Stelara

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

• Diagnosis of moderate to severe ulcerative colitis

AND

• Confirmed by a gastroenterologist

AND For Induction:

• Patient is not in remission






HNMC



AND

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

� Failure or clinically significant adverse effects to Remicade®

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

OR

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

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

• Diagnosis of Active Polyarticular Juvenile Idiopathic Arthritis






HNMC



AND

• Confirmed by a Rheumatologist

AND

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

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

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

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

• Failure or clinically significant adverse effects to Humira®

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

• Diagnosis of Systemic juvenile idiopathic arthritis

AND






HNMC



• Prescribed by a Dermatologist or Rheumatologist or gastroenterologist

AND

• Failure or clinically significant adverse effects to methotrexate at least 10 mg/m2 per week for

3 months. [only one DMARD required since MTX is the only DMARD with extensive pediatric safety data]

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)

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.






HNMC



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 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.

• These agents are immunosuppressive and have the potential to increase the risk of infection and reactivate latent, chronic infections. They should not be administered to patients with a clinically important infection. Caution should be used in patients with chronic infections or history of recurrent infection. If patient develops a serious infection these agents should be discontinued.

• 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






HNMC



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.

• Failure of MTX in PJIA is defined as disease activity remaining moderate to high despite treatment with MTX.

• In PJIA, response to treatment is reflected by improvement of disease activity level and poor prognostic features including: reduction in the number of active joints, ESR or CRP, Physician global assessment, patient/parent global assessment, arthritis of the hip or cervical spine, positive RF or ACPA, radiographic damage.

• 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) 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. "






HNMC



• 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 single dose

or in divided doses twice daily Crohn’s Disease and Ulcerative Colitis

100 - 250 mg PO daily

2.5 mg/kg/day

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

or IV 50-100 mg Q6H for 1 week

budesonide (Entocort EC ) 6-9 mg PO

daily

Varies

cyclosporine

(Sandimmune,

Neoral)

Rheumatoid Arthritis, Plaque Psoriasis

2.5 - 4 mg/kg/day PO divided BID 4 mg/kg/day

hydroxychloroquine

(Plaquenil)

Rheumatoid Arthritis Initial dose: 400-600 mg PO QD

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

mercaptopurine 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

30 mg/week






HNMC



Drug Dosing Regimen Dose/Limit/Maximum Dose 10mg/m

2 PO weekly

Plaque Psoriasis 10 to 25 mg/week, IM, IV or PO

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

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 VI. Recommended Dosing Regimen and Authorization Limit:

Drug Dosing Regimen Authorization Limit

See next column

Rheumatoid Arthritis:

ACTEMRA Intravenous

4 mg/kg by IV infusion every 4 weeks, followed by an increase to

3 months initial trial

Continued treatment will be approved up to one year with documentation of

response to therapy.






HNMC




8 mg/kg based on clinical response

Subcutaneous

Under 100 kg weight: 162 mg SC every other week, followed by an increase to every week based on

clinical response 100 kg or greater weight: 162 mg

SC every week

When transitioning from Actemra IV therapy to SC administration, administer the first subcutaneous

dose instead of the next scheduled intravenous dose.

Dose reductions or interruptions

may be necessary based on laboratory results for ANC, platelet

count, and transaminases.

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

Approval of Humira dose escalation to 40 mg weekly will require

documentation of partial response to every other week dosing.

XELJANZ/XELJANZ XR: Length of

benefit






HNMC




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

Weight based IV infusion:

< 60 kg: 500 mg 60 - 100 kg: 750 mg >100 kg: 1000 mg

Following initial administration, repeat dose at weeks 2 and 4,

then every 4 weeks

Subcutaneous use for adult rheumatoid arthritis:

After a single IV infusion as a loading dose (as per body weight

categories above), 125 mg administered by a SC injection should be given within a day,

followed by 125 mg SC once a week.

Patients who are unable to receive an infusion may initiate weekly SC






HNMC




injections without an IV loading dose.

Patients transitioning from IV therapy to SC administration

should administer the first SC dose instead of the next scheduled IV

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.

Ankylosing spondylitis:


and at Weeks 2 and 4









HNMC




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


and 6, then Q6W


Psoriatic arthritis:


and at Weeks 2 and 4 Maintenance dose: 200 mg SC every other week (400 mg SC





Otezla: Length of Benefit






HNMC




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


OTEZLA 30 mg PO BID after initial titration

dosing


and 6, then Q8W


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






HNMC




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 in 250ml NS IV over 30 minutes week 0, 2, 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

17 kg to less than 40 kg Induction:80 mg (two 40mg

3 months initial trial.

Continued treatment will be approved up to one year, upon receiving written documentation of clinical remission or

response.






HNMC




injections) day 1 followed by 40 mg 2 weeks later (day15). Two weeks later (day 29) begin maintenance

dose. Maintenance:20 mg every other

week 40 kg or greater

Same as adult dosing


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

Ulcerative Colitis Induction:

ENTYVIO 300 mg in 250ml NS IV over 30








HNMC




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

4 weeks

clinical remission or response.

Plaque Psoriasis:

COSENTYX Initial dose: 300 mg SC at Weeks

0, 1, 2, 3 and 4 Maintenance dose: 300 mg SC

every 4 weeks. For some patients, a dose of 150 mg may be




Otezla: Length of Benefit






HNMC




acceptable.

ENBREL Adults:

Starting dose: 25 mg or 50 mg 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.

OTEZLA

30 mg PO BID after initial titration dosing


and 6, then Q8W

STELARA Equal or less than 100 kg: 45 mg

SC initially and 4 weeks later,






HNMC




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

by IV infusion every 2 weeks Patients at or above 30 kg: 8 mg/kg by IV infusion every 2

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



response to therapy






HNMC




≥30 kg = 40 mg SC every other week

ORENCIA

Weight based IV infusion:

< 75 kg: 10 mg/kg IV

Dose as an adult for ≥ 75 kg 75 - 100 kg: 750 mg IV >100 kg: 1000 mg IV

(maximum dose = 1,000 mg)

Following initial administration, repeat dose at weeks 2 and 4,

then every 4 weeks

Systemic Juvenile Idiopathic Arthritis:

ACTEMRA:

Patients less than 30 kg: 12 mg/kg by IV infusion every 2 weeks Patients at or above 30 kg: 8 mg/kg by IV infusion every 2

weeks




Kineret Neonatal-Onset Multisystem Inflammatory Disease (NOMID) 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.

Length of Benefit






HNMC




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

One year

Tysabri

Multiple Sclerosis 300 mg IV Q 4 Wks




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

starting one week after the initial dose.



response to therapy. VII. Product Availability:






HNMC



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

®); 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. Psoriasis/Uveitis Starter Package: 4 dose trays. Each dose tray contains a single-use 40mg/0.8ml prefilled pen. Psoriasis/Uveitis Starter Package: 4 dose trays. Each dose tray contains a single-use 40mg/0.4ml 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.






HNMC



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






HNMC



VIII. References:

1. Enbrel [Prescribing information]. Thousand Oaks, CA: Immunex Corporation; November 2016.

2. Cosentyx [Prescribing information]. East Hanover, NJ: Novartis; January 2016. 3. Humira [Prescribing information]. North Chicago, IL: AbbVie Inc; June 2016. 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. Aletaha D, Neogi T, Silman AJ et al. 2010 Rheumatoid Arthritis Classification Criteria.

Arthritis and Rheumatism September 2010;62(9):2569-2581. 10. 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. 11. 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.

12. Boulos P, Dougados M, MacLeod SM, et al. Pharmacological Treatment of Ankylosing Spondylitis. Drugs. 2005; 65: 2111-2127.

13. 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.

14. Lichtenstein G, Hanauer S, Sandborn W, et al. Management of Crohn`s Disease in Adults. Am J Gastroenterol 2009;104:465-483.

15. 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.

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 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.






HNMC



17. 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.

18. 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

19. 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.

20. Enbrel, Cimzia, Humira, Kineret, Simponi, Stelara. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 8, 2015.

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 February 16, 2016.

23. Orencia [Prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; June 2016. 24. Aletaha D, Neogi T, Silman AJ et al. 2010 Rheumatoid Arhritis Classification Criteria.

Arthritis and Rheumatism September 2010;62(9):2569-2581. 25. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987

revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988;31(3):315-24.

26. Genovese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med. 2005 15;353:1114-23.

27. Kremer JM, Dougados M, Emery P, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52(8):2263-71.

28. Maini R, St Clair EW, Breedveld F, Furst D, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet. 1999 ;354:1932-9.






HNMC



29. Orencia. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 2017.

30. Hyrick KL et al. Effects of switching between anti-TNF therapies on HAQ response in patients who do not respond to their first anti-TNF drug. Rheumatology 2008; 47:1000–1005

31. Rendas-Baum R et al. Evaluating the efficacy of sequential biologic therapies for rheumatoid arthritis patients with an inadequate response to tumor necrosis factor-a inhibitors. Arthritis Research & Therapy 2011 13:R25.

32. Furst DE, Gaylis N, Bray V, et al. Open-label, pilot protocol of patients with rheumatoid arthritis who switch to infliximab after an incomplete response to etanercept: the opposite study. Ann Rheum Dis. 2007 Jul;66(7):893-9. Epub 2007 Apr 5.

33. J. A. Karlsson, L. E. Kristensen, M. C. Kapetanovic, A., et al. Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register. Rheumatology 2008;47:507–513.

34. Orencia. In: DRUGDEX® System (electronic version). Truven Health Analytics, Greenwood

Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/. Accessed July 2016.

35. Actemra [Prescribing information]. South San Francisco, CA: Genentech, Inc; November 2014.

36. Singh JA, et al. 2012 Update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care & Research. May 2012;64(5):625-39.

37. DRUGDEX. Micromedex online database. Truven Health Analytics. Accessed July 2017. 38. Entyvio [Prescribing Information] Deerfield, IL: Takeda Pharmaceuticals America, Inc.; May

2014. 39. Micromedex® Healthcare Series [Internet database]. Greenwood Village, CO: Thomson

Healthcare. Updated periodically. Accessed January 28, 2016. 40. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance

therapy for ulcerative colitis. N Engl J Med 2013;369:699-710. 41. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance

therapy for crohn`s disease. N Engl J Med 2013;369:711-721. 42. Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed January 28,

2016. 43. Pharmacist`s Letter [Internet database]. Stockton, CA: Therapeutic Research Center.

Updated periodically. Accessed June 21, 2015.






HNMC



44. WebMD. Inflammatory Bowel Disease Health Center. Available at: www.webmd.com/ibd-crohns-disease/default.htm . Accessed January 28, 2016.

45. Mayo Clinic. Inflammatory Bowel Disease. Available at: www.mayoclinic.org/diseases-conditions/inflammatory-bowel-disease/basics/definition/CON-20034908 . Accessed January 28, 2016.

46. Lichtenstein GR, Abreumt, Cohen R, Tremaine W. American gastroenterological association institute medical position statement on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology 2006; 130:936-939.

47. Thomas A, Lodnia N. Advanced therapy for inflammatory bowel disease: A guide for the primary care physician. J Am Board Fam Med May-June Vol. 27 No. 3 411-420

48. Xeljanz/Xeljanz XR [Prescribing Information] New York, NY: Pfizer Labs. February 2016. 49. Aletaha D, Neogi T, Silman AJ et al. 2010 Rheumatoid Arthritis Classification Criteria.

Arthritis and Rheumatism. September 2010:62(9):2569-2581. 50. Singh J, Furst D, Bharat A, et al. 2012 update of the 2008 American College of

Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care & Research. May 2012;64(5):625-639.

51. Van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;367:508-519.

52. Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;367:495-507.

53. Taltz [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company; March 2016. 54. Inflectra [Prescribing information]. Lake Forest, IL: Hospira; April 2016. 55. 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.






HNMC



The materials provided to you are guidelines used by this health plan to authorize, modify, or determine coverage for persons with similar illnesses or conditions. Specific care and treatment

may vary depending on individual needs and the benefits covered under your contract.

Prior Authorization Protocol ACTEMRA (tocilizumab), CIMZIA … · 2017-02-02 · Prior...

Documents

Transcript of Prior Authorization Protocol ACTEMRA (tocilizumab), CIMZIA … · 2017-02-02 · Prior...