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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)
NATL
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]
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)
NATL
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 2
• 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]
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)
NATL
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 3
• Failure or clinically significant adverse effects to a 3-month minimum trial of Humira® AND
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]
• Failure or clinically significant adverse effects to a 3-month minimum trial of Humira® AND
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
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)
NATL
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 4
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]
• Failure or clinically significant adverse effects to Humira®
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
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)
NATL
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 5
OR
• If methotrexate is contraindicated, failure or clinically significant adverse effects to PUVA Therapy or UVB, or cyclosporine or acitretin
AND [for Enbrel]
• Failure or clinically significant adverse effects to Humira®
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]
• Failure or clinically significant adverse effects to Humira®
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]:
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)
NATL
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 6
• 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 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)
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)
NATL
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 7
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
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)
NATL
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 8
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.
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)
NATL
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 9
• 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
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)
NATL
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 10
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
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)
NATL
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 11
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.
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)
NATL
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 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
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
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)
NATL
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 13
Drug Dosing Regimen Authorization Limit
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
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
6 months or to member’s renewal date, whichever is longer
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)
NATL
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 14
Drug Dosing Regimen Authorization Limit
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)
COSENTYX Initial dose: 150 mg SC at weeks 0, 1, 2, 3 and 4 (or option for no
loading dose) Maintenance dose: 150 mg SC every 4 weeks (can increase to
300 mg if needed)
ENBREL 50 mg SC once weekly
HUMIRA
40 mg SC every other week
REMICADE, INFLECTRA 5 mg/kg IV initially and at weeks 2
and 6, then Q8W
6 months or to member’s renewal date, whichever is longer
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)
NATL
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 15
Drug Dosing Regimen Authorization Limit
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
6 months or to member’s renewal date, whichever is longer
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)
NATL
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 16
Drug Dosing Regimen Authorization Limit
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.
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
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)
NATL
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 17
Drug Dosing Regimen Authorization Limit
>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:
40 mg SC every other week
REMICADE, INFLECTRA 5 mg/kg IV initially and at weeks 2
and 6, then Q8W
SIMPONI
6 months or to member’s renewal date, whichever is longer
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)
NATL
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 18
Drug Dosing Regimen Authorization Limit
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
6 months or to member’s renewal date, whichever is longer
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)
NATL
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 19
Drug Dosing Regimen Authorization Limit
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
6 months or to member’s renewal date, whichever is longer
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)
NATL
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 20
Drug Dosing Regimen Authorization Limit
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
6 months or to member’s renewal date, whichever is longer
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.
6 months or to member’s renewal date, whichever is longer
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)
6 months or to member’s renewal date, whichever is longer
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)
NATL
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 21
Drug Dosing Regimen Authorization Limit
• 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
6 months or to member’s renewal date, whichever is longer
Humira Uveitis Initial dose of 80 mg SC followed by 40 mg SC every other week
starting one week after the initial dose.
6 months or to member’s renewal date, whichever is longer
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)
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)
NATL
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 22
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
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)
NATL
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 23
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.
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)
NATL
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 24
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
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)
NATL
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 25
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.
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.