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

Transcription

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 x Aria Stelara x x x Tysabri x x Xeljanz/ x Xeljanz XR 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] A Myong 1

2 Diagnosis of rheumatoid arthritis (RA) 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) 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 [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 ) [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 Confirmed by a Rheumatologist or Dermatologist A Myong 2

3 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 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 Confirmed by a gastroenterologist [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 Confirmed by a gastroenterologist For Induction: Patient is not in remission A Myong 3

4 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 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 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 A Myong 4

5 Confirmed by a Rheumatologist 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) 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 [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 A Myong 5

6 III. Prescribed by a Dermatologist or Rheumatologist or gastroenterologist Failure or clinically significant adverse effects to methotrexate at least 10 mg/m 2 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 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 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 A Myong 6

7 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 = large joints, score = small joints (with or without involvement of large joints), score = 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 A Myong 7

8 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. " A Myong 8

9 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 Rheumatoid Arthritis (Imuran ) 1 mg/kg/day PO given as a single dose or in divided doses twice daily 2.5 mg/kg/day Crohn s Disease and Ulcerative Colitis mg PO daily corticosteroids Crohn s Disease Prednisone 40 mg PO daily for 2 weeks or IV mg Q6H for 1 week Varies cyclosporine (Sandimmune, Neoral ) hydroxychloroquine (Plaquenil ) mercaptopurine methotrexate (Rheumatrex ) budesonide (Entocort EC ) 6-9 mg PO daily Rheumatoid Arthritis, Plaque Psoriasis mg/kg/day PO divided BID Rheumatoid Arthritis Initial dose: mg PO QD Maintenance dose: mg PO QD Crohn s Disease, Ulcerative Colitis mg PO daily Rheumatoid Arthritis 7.5 mg/week PO or 2.5 mg PO Q12hr for 3 doses/week Polyarticular Juvenile Arthritis 4 mg/kg/day 600 mg/day 1.5 mg/kg/day 30 mg/week A Myong 9

10 Pentasa (mesalamine) Drug Dosing Regimen Dose/Limit/Maximum Dose 10mg/m 2 PO weekly Plaque Psoriasis 10 to 25 mg/week, IM, IV or PO acitretin (Soriatane) sulfasalazine (Azulfidine ) doxycycline minocycline clindamycin+rifampin *Requires prior authorization Crohn s Disease and Ulcerative Colitis 1000 mg PO QID Plaque Psoriasis 25 or 50 mg PO daily 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) Hidradenitis suppurativa mg PO BID Hidradenitis suppurativa mg PO BID Hidradenitis suppurativa clindamycin 300 mg PO BID with rifampin 300 mg PO BID 4000 mg/day 50 mg/day 4 gm/day Up to 3 months Up to 3 months 10 weeks VI. Recommended Dosing Regimen and Authorization Limit: Drug Dosing Regimen Authorization Limit See next column Rheumatoid Arthritis: 3 months initial trial ACTEMRA Intravenous 4 mg/kg by IV infusion every 4 weeks, followed by an increase to Continued treatment will be approved up to one year with documentation of response to therapy A Myong 10

11 Drug Dosing Regimen Authorization Limit 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 A Myong 11

12 Drug Dosing Regimen Authorization Limit 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 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 A Myong 12

13 Drug Dosing Regimen Authorization Limit 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: CIMZIA Initial dose: 400 mg SC initially and at Weeks 2 and 4 3 months initial trial Continued treatment will be approved up to one year with documentation of response to therapy A Myong 13

14 Drug Dosing Regimen Authorization Limit 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 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 every 4 weeks can be considered) 3 months initial trial Continued treatment will be approved up to one year with documentation of response to therapy. Otezla: Length of Benefit A Myong 14

15 Drug Dosing Regimen Authorization Limit 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 OTEZLA 30 mg PO BID after initial titration dosing 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-tosevere plaque psoriasis weighing A Myong 15

16 Drug Dosing Regimen Authorization Limit 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 3 months initial trial. Continued treatment will be approved up to one year, upon receiving written documentation of clinical remission or response. 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 A Myong 16

17 Drug Dosing Regimen Authorization Limit 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 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 Ulcerative Colitis Induction: ENTYVIO 300 mg in 250ml NS IV over 30 3 months initial trial Continued treatment will be approved up to one year with documentation of A Myong 17

18 Drug Dosing Regimen Authorization Limit 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: 40 mg SC every other week clinical remission or response. 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 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 3 months initial trial Continued treatment will be approved up to one year with documentation of response to therapy. Otezla: Length of Benefit A Myong 18

19 Drug Dosing Regimen Authorization Limit 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 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, A Myong 19

20 Drug Dosing Regimen Authorization Limit 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 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy 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 A Myong 20

21 Drug Dosing Regimen Authorization Limit 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 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 Kineret 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 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. 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy. Length of Benefit A Myong 21

22 Drug Dosing Regimen Authorization Limit Hidradenitis Suppurativa (HS): One year Tysabri 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 mg SC twice weekly Multiple Sclerosis 300 mg IV Q 4 Wks 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy. Humira Uveitis Initial dose of 80 mg SC followed by 40 mg SC every other week starting one week after the initial dose. 3 months initial trial. Continued treatment will be approved up to one year with documentation of response to therapy. VII. Product Availability: A Myong 22

23 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 A Myong 23

24 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 A Myong 24

25 VIII. References: 1. Enbrel [Prescribing information]. Thousand Oaks, CA: Immunex Corporation; November Cosentyx [Prescribing information]. East Hanover, NJ: Novartis; January Humira [Prescribing information]. North Chicago, IL: AbbVie Inc; June Stelara [Prescribing information] Horsham, PA: Janssen Biotech Inc; March Cimzia [Prescribing Information] Smyrna, GA: UCB, Inc; April Simponi [Prescribing information]. Horsham, PA: Janssen Biotech Inc; January Simponi Aria [Prescribing information]. Horsham, PA: Janssen Biotech Inc; April Kineret [package insert]. Stockholm, Sweden: Swedish Orphan Biovitrum AB (publ). May Aletaha D, Neogi T, Silman AJ et al Rheumatoid Arthritis Classification Criteria. Arthritis and Rheumatism September 2010;62(9): 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: 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: Boulos P, Dougados M, MacLeod SM, et al. Pharmacological Treatment of Ankylosing Spondylitis. Drugs. 2005; 65: 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: Lichtenstein G, Hanauer S, Sandborn W, et al. Management of Crohn`s Disease in Adults. Am J Gastroenterol 2009;104: 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: 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): A Myong 25

26 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: 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 /j.jaad Braun J, van den Berg R, Baraliako X, et al Update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011; 70: Enbrel, Cimzia, Humira, Kineret, Simponi, Stelara. American Hospital Formulary Service Drug Information. Available at: Accessed June 8, DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 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 Accessed February 16, Orencia [Prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; June Aletaha D, Neogi T, Silman AJ et al Rheumatoid Arhritis Classification Criteria. Arthritis and Rheumatism September 2010;62(9): 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): Genovese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med ;353: 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): 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 ;354: A Myong 26

27 29. Orencia. American Hospital Formulary Service Drug Information. Available at: Accessed July 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: 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 :R 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 Jul;66(7): Epub 2007 Apr 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: Orencia. In: DRUGDEX System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: Accessed July Actemra [Prescribing information]. South San Francisco, CA: Genentech, Inc; November Singh JA, et al 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): DRUGDEX. Micromedex online database. Truven Health Analytics. Accessed July Entyvio [Prescribing Information] Deerfield, IL: Takeda Pharmaceuticals America, Inc.; May Micromedex Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed January 28, Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2013;369: Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for crohn`s disease. N Engl J Med 2013;369: Clinical Pharmacology Web site. Available at: Accessed January 28, Pharmacist`s Letter [Internet database]. Stockton, CA: Therapeutic Research Center. Updated periodically. Accessed June 21, A Myong 27

28 44. WebMD. Inflammatory Bowel Disease Health Center. Available at: Accessed January 28, Mayo Clinic. Inflammatory Bowel Disease. Available at: Accessed January 28, 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: 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 Xeljanz/Xeljanz XR [Prescribing Information] New York, NY: Pfizer Labs. February Aletaha D, Neogi T, Silman AJ et al Rheumatoid Arthritis Classification Criteria. Arthritis and Rheumatism. September 2010:62(9): Singh J, Furst D, Bharat A, et al 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): Van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;367: Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;367: Taltz [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company; March Inflectra [Prescribing information]. Lake Forest, IL: Hospira; April Margesson LJ, Danby FW. Hidradenitis suppurativa (acne inversa): Treatment. In: UpToDate, Waltham, MA: Walters Kluwer Health; Available at: Accessed November A Myong 28

29 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 A Myong 29