Stelara. Stelara (ustekinumab) Description

Size: px
Start display at page:

Download "Stelara. Stelara (ustekinumab) Description"

Transcription

1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Stelara Page: 1 of 6 Last Review Date: December 8, 2017 Stelara Description Stelara (ustekinumab) Background Stelarais a biologic medicine that targets an underlying cause of psoriatic arthritis and plaque psoriasis, an overactive immune system. Psoriatic arthritis and plaque psoriasis is caused by inflammation due to high levels of 2 proteins (IL-12 and IL-23) found in the blood. Similarly, the cytokines IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn s Disease. Stelara targets these 2 proteins and reduces inflammation which relieves symptoms of joint pain, swelling, stiffness, plaque thickness, scaling, and redness in psoriatic arthritis and plaque psoriasis, and has been shown to significantly decrease disease activity in patients with moderately to severely active Crohn s Disease (1). Regulatory Status FDA- approved indication: Stelara is a human interleukin-12 and -23 antagonist indicated for the treatment of adult patients with: (1) 1. Moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy 2. Active psoriatic arthritis (PsA), alone or in combination with methotrexate 3. Moderately to severely active Crohn s disease (CD) who have a. Failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker or b. Failed or were intolerant to treatment with one or more TNF blockers

2 Subject: Stelara Page: 2 of 6 4. Adolescent patients (12 years or older) with moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy Stelara may increase the risk of infections and reactivation of latent infections such as bacterial, fungal, and viral infections. Stelara should not be given to patients with any clinically important active infection until the infection resolves or is adequately treated. Serious infections that require hospitalization may occur such as diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, and cholecystitis (1). Evaluate patients for tuberculosis infection prior to initiating treatment with Stelara. Do not administer Stelara to patients with active tuberculosis. Initiate treatment of latent tuberculosis prior to administering Stelara. Consider anti-tuberculosis therapy prior to initiation of Stelara in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Patients receiving Stelara should be monitored closely for signs and symptoms of active tuberculosis during and after treatment (1). Stelara is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among subjects who received Stelara. There have been post marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving Stelara who had pre-existing risk factors for developing non-melanoma skin cancer. All patients receiving Stelara should be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment should be followed closely (1). Safety and effectiveness of Stelara in pediatric patients less than 18 years of age have not been established (1). Related policies Cimzia, Cosentyx, Enbrel, Entyvio, Humira, Otezla, Remicade, Simponi, Taltz Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Stelara may be considered medically necessary for patients 12 years of age or older for the treatment of moderate to severe plaque psoriasis (Ps), or for patients 18 years of age or older

3 Subject: Stelara Page: 3 of 6 for the treatment of active psoriatic arthritis (PsA), or moderately to severely active Crohn s disease; and if the conditions below are met. Stelara may be considered investigational in patients outside of these age ranges and for all other indications. Prior-Approval Requirements Diagnoses Patient must have ONE of the following: 1. Moderate to severe plaque psoriasis (Ps) a. 12 years of age or older i. Subcutaneous administration: Patients years of age and less than 60 kg weight 0.75 mg/kg every 12 weeks ii. Subcutaneous administration: Patients years of age 60 kg to 100 kg weight and adult patients less than or equal to 100 kg weight 45 mg every 12 weeks iii. Subcutaneous administration: Patients greater than 100 kg weight c. Inadequate response, intolerance, or contraindication to either conventional systemic therapy or phototherapy 2. Active Psoriatic Arthritis (PsA) i. Subcutaneous administration: Patients less than or equal to 100 kg weight 45 mg every 12 weeks ii. Subcutaneous administration: Patients greater than 100 kg weight 3. Moderate to severely active Crohn s Disease (CD)

4 Subject: Stelara Page: 4 of 6 dose of the following: i. Subcutaneous administration: 90 mg every 8 weeks c. Inadequate response, intolerance, or contraindication to ONE of the following: i. Immunomodulators ii. Corticosteroids iii. Tumor necrosis factor (TNF) blockers AND ALL of the following: a. Result for latent TB infection is negative OR result was positive for latent TB and patient completed treatment (or is receiving treatment) for latent TB b. Absence of active infection (including tuberculosis and hepatitis B virus (HBV)) c. NOT to be used in combination with any other biologic DMARD or targeted synthetic DMARD d. NOT given concurrently with live vaccines Prior Approval Renewal Requirements Diagnoses Patient must have ONE of the following: 1. Plaque psoriasis (Ps) a. 12 years of age or older i. Subcutaneous administration: Patients years of age and less than 60 kg weight 0.75 mg/kg every 12 weeks ii. Subcutaneous administration: Patients years of age and 60 kg to 100 kg weight and adult patients less than or equal to 100 kg weight 45 mg every 12 weeks iii. Subcutaneous administration: Patients greater than 100 kg weight 2. Psoriatic Arthritis (PsA)

5 Subject: Stelara Page: 5 of 6 i. Subcutaneous administration: Patients less than or equal to 100 kg weight 45 mg every 12 weeks ii. Subcutaneous administration: Patients greater than 100 kg weight 3. Crohn s Disease (CD) dose of the following: i. Subcutaneous administration: 90 mg every 8 weeks AND ALL of the following: a. Condition has improved or stabilized with Stelara b. Absence of active infection (including tuberculosis and hepatitis B virus (HBV)) c. NOT to be used in combination with any other biologic DMARD or targeted synthetic DMARD d. NOT given concurrently with live vaccines Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration 12 months Prior Approval Renewal Limits Duration 18 months Rationale Summary Stelara is a human interleukin-12 and -23 antagonist indicated for the treatment of patients with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy and for the treatment for active psoriatic arthritis (PsA), alone or in combination with methotrexate. Additionally, Stelara is also indicated for patients with moderately to severely active Crohn s disease (CD). Stelara may increase the risk of infections and reactivation of latent infections such as bacterial, fungal, and viral infections. Stelara should not be given to patients with any clinically important active infection until the infection resolves or is adequately

6 Subject: Stelara Page: 6 of 6 treated. Stelara should not be administered to patients with active TB. Stelara may increase the risk of malignancy (1). Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Stelara while maintaining optimal therapeutic outcomes. References 1. Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; October Policy History Date October 2013 December 2013 September 2014 September 2016 October 2016 December 2016 September 2017 October 2017 December 2017 Action Addition to PA Annual editorial review by the PMPC Annual editorial review and renewal limit to 18 months Annual editorial review and reference update Addition of not to be used in combination with any other biologic DMARD or targeted synthetic DMARD Addition of not given concurrently with live vaccines per SME Policy number change from to Addition of Crohn s Disease to diagnoses in initiation and renewal criteria Addition of criteria to Crohn s Disease diagnosis in initiation: must have inadequate treatment response to one of the following: immunomodulators, corticosteroids, or TNF blockers Annual review Annual editorial review Addition of FDA dosing requirement questions for all indications Addition of Ps dosing for 12 yrs. of age and older Annual review Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on December 8, 2017 and is effective on January 1, 2018.

Stelara. Stelara (ustekinumab) Description

Stelara. Stelara (ustekinumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.04 Subject: Stelara Page: 1 of 9 Last Review Date: September 20, 2018 Stelara Description Stelara

More information

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1)

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.18 Subject: Orencia Page: 1 of 6 Last Review Date: December 8, 2017 Orencia Description Orencia (abatacept)

More information

Cimzia. Cimzia (certolizumab pegol) Description

Cimzia. Cimzia (certolizumab pegol) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Cimzia Page: 1 of 5 Last Review Date: March 17, 2017 Cimzia Description Cimzia (certolizumab pegol)

More information

Cimzia. Cimzia (certolizumab pegol) Description

Cimzia. Cimzia (certolizumab pegol) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.11 Subject: Cimzia Page: 1 of 5 Last Review Date: December 8, 2017 Cimzia Description Cimzia (certolizumab

More information

Simponi / Simponi ARIA (golimumab)

Simponi / Simponi ARIA (golimumab) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.51 Subject: Simponi / Simponi ARIA Page: 1 of 6 Last Review Date: September 15, 2016 Simponi / Simponi

More information

Siliq. Siliq (brodalumab) Description

Siliq. Siliq (brodalumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.28 Subject: Siliq Page: 1 of 5 Last Review Date: December 8, 2017 Siliq Description Siliq (brodalumab)

More information

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1)

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.18 Subject: Orencia Page: 1 of 8 Last Review Date: March 16, 2018 Orencia Description Orencia (abatacept)

More information

Regulatory Status FDA approved indication: Kineret is an interleukin-1 receptor antagonist indicated for: (1)

Regulatory Status FDA approved indication: Kineret is an interleukin-1 receptor antagonist indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.50 Subject: Kineret Page: 1 of 5 Last Review Date: March 17, 2017 Kineret Description Kineret (anakinra)

More information

Cosentyx. Cosentyx (secukinumab) Description

Cosentyx. Cosentyx (secukinumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.11 Subject: Cosentyx Page: 1 of 7 Last Review Date: September 20, 2018 Cosentyx Description Cosentyx

More information

Remicade. Remicade (infliximab), Inflectra (infliximab-dyyb) Description

Remicade. Remicade (infliximab), Inflectra (infliximab-dyyb) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.02 Subsection: Gastrointestinal nts Original Policy Date: May 20, 2011 Subject: Remicade Page: 1 of

More information

Cimzia. Cimzia (certolizumab pegol) Description

Cimzia. Cimzia (certolizumab pegol) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.11 Section: Prescription Drugs Effective Date: April 1, 2018 Subject: Cimzia Page: 1 of 5 Last Review

More information

Remicade. Remicade (infliximab), Inflectra (infliximab-dyyb) Description

Remicade. Remicade (infliximab), Inflectra (infliximab-dyyb) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Remicade Page: 1 of 9 Last Review Date: June 22, 2017 Remicade Description Remicade (infliximab),

More information

Regulatory Status FDA- approved indication: Simponi and Simponi ARIA are tumor necrosis factor (TNF) blockers indicated for the treatment of:

Regulatory Status FDA- approved indication: Simponi and Simponi ARIA are tumor necrosis factor (TNF) blockers indicated for the treatment of: Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.51 Subject: Simponi / Simponi ARIA Page: 1 of 8 Last Review Date: March 17, 2017 Simponi / Simponi

More information

Regulatory Status FDA- approved indication: Simponi and Simponi ARIA are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3)

Regulatory Status FDA- approved indication: Simponi and Simponi ARIA are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.51 Subject: Simponi / Simponi ARIA Page: 1 of 9 Last Review Date: March 16, 2018 Simponi / Simponi

More information

Otezla. Otezla (apremilast) Description

Otezla. Otezla (apremilast) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Otezla Page: 1 of 5 Last Review Date: March 16, 2018 Otezla Description Otezla (apremilast) Background

More information

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.24 Subject: Xeljanz Page: 1 of 5 Last Review Date: March 17, 2017 Xeljanz Description Xeljanz, Xeljanz

More information

Regulatory Status FDA-approved indication: Orencia is a selective T cell co-stimulation modulator indicated for: (1)

Regulatory Status FDA-approved indication: Orencia is a selective T cell co-stimulation modulator indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Orencia Page: 1 of 9 Last Review Date: September 20, 2018 Orencia Description Orencia (abatacept)

More information

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.24 Subject: Xeljanz Page: 1 of 6 Last Review Date: March 16, 2018 Xeljanz Description Xeljanz, Xeljanz

More information

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.24 Subject: Xeljanz Page: 1 of 5 Last Review Date: March 18, 2016 Xeljanz Description Xeljanz, Xeljanz

More information

STELARA (ustekinumab)

STELARA (ustekinumab) STELARA (ustekinumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs

More information

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare Pharmacy Clinical Pharmacy Programs UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2018 P 1097-7 Program Prior Authorization/Notification Medication *Stelara (ustekinumab) *This program applies to the subcutaneous formulation

More information

Regulatory Status FDA-approved indications: Entyvio is an α4β7integrin receptor antagonist indicated for: (1)

Regulatory Status FDA-approved indications: Entyvio is an α4β7integrin receptor antagonist indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.12 Subject: Entyvio Page: 1 of 7 Last Review Date: September 20, 2018 Entyvio Description Entyvio

More information

Regulatory Status FDA-approved indication: Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of:

Regulatory Status FDA-approved indication: Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Section: Prescription Drugs Effective Date: Oct 1, 2016 Subject: Enbrel Page: 1 of 7 Last Review Date:

More information

Regulatory Status FDA-approved indication: Humira and Amjevita are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3)

Regulatory Status FDA-approved indication: Humira and Amjevita are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.29 Subject: Humira Page: 1 of 10 Last Review Date: June 22, 2017 Humira Description Humira (adalimumab),

More information

Actemra. Actemra (tocilizumab) Description

Actemra. Actemra (tocilizumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.12 Subject: Actemra Page: 1 of 13 Last Review Date: September 20, 2018 Actemra Description Actemra

More information

INFLIXIMAB Remicade (infliximab), Inflectra (infliximab-dyyb), Ixifi* (infliximabqbtx), Renflexis (infliximab-abda)

INFLIXIMAB Remicade (infliximab), Inflectra (infliximab-dyyb), Ixifi* (infliximabqbtx), Renflexis (infliximab-abda) Pre - PA Allowance None Prior-Approval Requirements Diagnoses Patient must have ONE of the following: 6 years of age or older 1. Moderate to severe Crohn s disease (CD) a. Patient has fistulizing disease

More information

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare Pharmacy Clinical Pharmacy Programs UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2018 P 1017-7 Program Prior Authorization/Notification Medication Cimzia (certolizumab) P&T Approval Date 1/2007, 6/2008, 4/2009, 6/2009,

More information

COSENTYX (secukinumab)

COSENTYX (secukinumab) COSENTYX (secukinumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs

More information

Regulatory Status FDA-approved indication: Tysabri is an integrin receptor antagonist indicated for treatment of:

Regulatory Status FDA-approved indication: Tysabri is an integrin receptor antagonist indicated for treatment of: Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.08.27 1 of 6 Last Review Date: December 5, 2014 Tysabri Description Tysabri (natalizumab) Background

More information

ustekinumab (Stelara )

ustekinumab (Stelara ) Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided

More information

Cyltezo (adalimumab-adbm) CG-DRUG-64, CG-DRUG-65

Cyltezo (adalimumab-adbm) CG-DRUG-64, CG-DRUG-65 Market DC Cyltezo (adalimumab-adbm) CG-DRUG-64, CG-DRUG-65 Override(s) Prior Authorization Quantity Limit Medications Cyltezo (adalimumab-adbm) 40 mg/0.8 ml prefilled syringe #* ^ Approval Duration 1 year

More information

Regulatory Status FDA-approved indication: Tysabri is an integrin receptor antagonist indicated for treatment of (1):

Regulatory Status FDA-approved indication: Tysabri is an integrin receptor antagonist indicated for treatment of (1): Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.60.13 Subject: Tysabri Page: 1 of 6 Last Review Date: June 22, 2017 Tysabri Description Tysabri (natalizumab)

More information

USTEKINUMAB Generic Brand HICL GCN Exception/Other USTEKINUMAB STELARA GUIDELINES FOR USE

USTEKINUMAB Generic Brand HICL GCN Exception/Other USTEKINUMAB STELARA GUIDELINES FOR USE Generic Brand HICL GCN Exception/Other USTEKINUMAB STELARA 36187 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of psoriatic arthritis (PsA)

More information

CIMZIA (certolizumab pegol)

CIMZIA (certolizumab pegol) Pre - PA Allowance None Prior-Approval Requirements Age Diagnoses 18 years of age or older Patient must have ONE of the following: 1. Moderate to severe Crohn s Disease (CD) a. Inadequate response, intolerance

More information

CIMZIA (certolizumab pegol)

CIMZIA (certolizumab pegol) CIMZIA (certolizumab pegol) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices

More information

Xgeva. Xgeva (denosumab) Description

Xgeva. Xgeva (denosumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.30.18 Subject: Xgeva Page: 1 of 5 Last Review Date: March 16, 2018 Xgeva Description Xgeva (denosumab)

More information

Medical Coverage Guidelines are subject to change as new information becomes available.

Medical Coverage Guidelines are subject to change as new information becomes available. ENBREL (etanercept) Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline

More information

Regulatory Status FDA-approved indication: Enbrel and Erelzi are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3)

Regulatory Status FDA-approved indication: Enbrel and Erelzi are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.27 Subject: Enbrel Page: 1 of 8 Last Review Date: March 16, 2018 Enbrel Description Enbrel (etanercept),

More information

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

Medical Policy An independent licensee of the Blue Cross Blue Shield Association Otezla (apremilast) Page 1 of 7 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Otezla (apremilast) Prime Therapeutics will review Prior Authorization requests Prior

More information

Regulatory Status FDA-approved indication: Humira is a tumor necrosis factor (TNF) blocker indicated for the treatment of: (2)

Regulatory Status FDA-approved indication: Humira is a tumor necrosis factor (TNF) blocker indicated for the treatment of: (2) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.29 Subject: Humira Page: 1 of 9 Last Review Date: September 15, 2016 Humira Description Humira (adalimumab)

More information

ENTYVIO (vedolizumab)

ENTYVIO (vedolizumab) ENTYVIO (vedolizumab) Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline

More information

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES Generic Brand HICL GCN Exception/Other CERTOLIZUMAB PEGOL CIMZIA 35554 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Is the request for a patient with a diagnosis of moderate

More information

2. Does the patient have a diagnosis of Crohn s disease? Y N

2. Does the patient have a diagnosis of Crohn s disease? Y N Pharmacy Prior Authorization MERC CARE PLA (MEDICAID) Stelara (Medicaid) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign and date. Fax

More information

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 3041-8 Program Step Therapy Medications UnitedHealthcare Pharmacy Clinical Pharmacy Programs *Orencia (abatacept) *This step criteria refers to the subcutaneous formulation of abatacept

More information

What prescribers need to know

What prescribers need to know HUMIRA Citrate-free presentations in an Electronic Medical Record (EMR) What prescribers need to know 2 / This is your guide to identifying HUMIRA Citrate-free presentations in your Electronic Medical

More information

Drug Name (specify drug) Quantity Frequency Strength

Drug Name (specify drug) Quantity Frequency Strength Prior Authorization Form GEHA FEDERAL - STANDARD OPTION Autoimmune Conditions (FA-PA) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign

More information

1 P a g e. Systemic Juvenile Idiopathic Arthritis (SJIA) (1.3) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.

1 P a g e. Systemic Juvenile Idiopathic Arthritis (SJIA) (1.3) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. LENGTH OF AUTHORIZATION: Initial: 3 months for Crohn s or Ulcerative Colitis; 1 year for all other indications. Renewal: 1 year dependent upon medical records supporting response to therapy and review

More information

Clinical Policy: Ustekinumab (Stelara) Reference Number: CP.PHAR.264

Clinical Policy: Ustekinumab (Stelara) Reference Number: CP.PHAR.264 Clinical Policy: (Stelara) Reference Number: CP.PHAR.264 Effective Date: 08/16 Last Review Date: 05/16 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory

More information

Biologic Immunomodulators Prior Authorization with Quantity Limit Program Summary

Biologic Immunomodulators Prior Authorization with Quantity Limit Program Summary Biologic Immunomodulators Prior Authorization with Quantity Limit Program Summary Biologic Immunomodulators Prior Authorization with Quantity Limit (with a preferred option) OBJECTIVE The intent of the

More information

Clinical Policy: Ustekinumab (Stelara) Reference Number: ERX.SPMN.167

Clinical Policy: Ustekinumab (Stelara) Reference Number: ERX.SPMN.167 Clinical Policy: (Stelara) Reference Number: ERX.SPMN.167 Effective Date: 10/16 Last Review Date: 12/16 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory

More information

CYTOKINE AND CAM ANTAGONIST UTILIZATION IN MISSISSIPPI MEDICAID

CYTOKINE AND CAM ANTAGONIST UTILIZATION IN MISSISSIPPI MEDICAID CYTOKINE AND CAM ANTAGONIST UTILIZATION IN MISSISSIPPI MEDICAID BACKGROUND Cytokine and cell-adhesion molecule (CAM) antagonists have a major role in the treatment of chronic inflammatory diseases such

More information

Regulatory Status FDA-approved indication: Enbrel and Erelzi are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3)

Regulatory Status FDA-approved indication: Enbrel and Erelzi are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.27 Subject: Enbrel Page: 1 of 10 Last Review Date: June 22, 2018 Enbrel Description Enbrel (etanercept),

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: golimumab_simponi 8/2013 2/2018 2/2019 3/2018 Description of Procedure or Service Golimumab (Simponi and

More information

Siklos. Siklos (hydroxyurea) Description

Siklos. Siklos (hydroxyurea) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.27 Subject: Siklos Page: 1 of 5 Last Review Date: November 30, 2018 Siklos Description Siklos (hydroxyurea)

More information

Nucala. Nucala (mepolizumab) Description

Nucala. Nucala (mepolizumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.45.07 Subject: Nucala Page: 1 of 5 Last Review Date: December 2, 2016 Nucala Description Nucala (mepolizumab)

More information

ACTEMRA (tocilizumab)

ACTEMRA (tocilizumab) Pre - PA Allowance None Prior-Approval Requirements Diagnoses Patient must have ONE of the following: 1. Active Polyarticular Juvenile Idiopathic Arthritis (PJIA) b. Patient has an intolerance or has experienced

More information

Xgeva. Xgeva (denosumab) Description. Section: Prescription Drugs Effective Date: January 1, 2016

Xgeva. Xgeva (denosumab) Description. Section: Prescription Drugs Effective Date: January 1, 2016 Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.07.18 Subject: Xgeva Page: 1 of 5 Last Review Date: December 3, 2015 Xgeva Description Xgeva (denosumab)

More information

Inflectra (infliximab-dyyb), Remicade (infliximab), Renflexis (infliximab-abda) DRUG CG-DRUG-64

Inflectra (infliximab-dyyb), Remicade (infliximab), Renflexis (infliximab-abda) DRUG CG-DRUG-64 Inflectra (infliximab-dyyb), Remicade (infliximab), Renflexis (infliximab-abda) DRUG.00002 CG-DRUG-64 Override(s) Prior Authorization *Washington Medicaid See State Specific Mandates Medications Inflectra

More information

Infliximab/Infliximab-dyyb DRUG.00002

Infliximab/Infliximab-dyyb DRUG.00002 Infliximab/Infliximab-dyyb DRUG.00002 Override(s) Prior Authorization Step Therapy Medications Remicade (infliximab) Inflectra (inflectra-dyyb) Approval Duration 1 year Comment Intravenous administration

More information

Remicade (infliximab) DRUG.00002

Remicade (infliximab) DRUG.00002 Applicability/Effective Date *- Florida Healthy Kids Remicade (infliximab) DRUG.00002 Override(s) Prior Authorization Step Therapy Medications Remicade (infliximab) Approval Duration 1 year Comment Intravenous

More information

Pharmacy Management Drug Policy

Pharmacy Management Drug Policy SUBJECT: Cimzia (Certolizumab pegol) - for Ankylosing Spondylitis, Crohn s Disease, Psoriatic Arthritis and Rheumatoid Arthritis POLICY NUMBER: PHARMACY-07 EFFECTIVE DATE: 5/2009 LAST REVIEW DATE: 6/13/2018

More information

Biologics for Autoimmune Diseases

Biologics for Autoimmune Diseases Biologics for Autoimmune Diseases Goal(s): Restrict use of biologics to OHP funded conditions and according to OHP guidelines for use. Promote use that is consistent with national clinical practice guidelines

More information

ENTYVIO (vedolizumab)

ENTYVIO (vedolizumab) ENTYVIO (vedolizumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs

More information

Regulatory Status FDA-approved indication: Otrexup and Rasuvo are folate analog metabolic inhibitors indicated for: (1-2)

Regulatory Status FDA-approved indication: Otrexup and Rasuvo are folate analog metabolic inhibitors indicated for: (1-2) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.37 Subject: Methotrexate Injections Page: 1 of 5 Last Review Date: March 16, 2018 Methotrexate Injections

More information

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare Pharmacy Clinical Pharmacy Programs UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 1041-8 Program Prior Authorization/Notification Medication Humira (adalimumab) P&T Approval Date 1/2007, 6/2008, 4/2009, 6/2009,

More information

Announcing HUMIRA. Psoriasis Starter Package

Announcing HUMIRA. Psoriasis Starter Package Announcing HUMIRA (adalimumab) Psoriasis Starter Package HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy

More information

Clinical Policy: Ustekinumab (Stelara) Reference Number: ERX.SPA.01 Effective Date:

Clinical Policy: Ustekinumab (Stelara) Reference Number: ERX.SPA.01 Effective Date: Clinical Policy: (Stelara) Reference Number: ERX.SPA.01 Effective Date: 04.01.17 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal

More information

INFLIXIMAB Remicade (infliximab), Inflectra (infliximab-dyyb), Renflexis (infliximab-abda)

INFLIXIMAB Remicade (infliximab), Inflectra (infliximab-dyyb), Renflexis (infliximab-abda) RATIONALE FOR INCLUSION IN PA PROGRAM Background Remicade, Renflexis and Inflectra are tumor necrosis factor (TNFα) blockers. Tumor necrosis factor is an endogenous protein that regulates a number of physiologic

More information

Ustekinumab (Stelara )

Ustekinumab (Stelara ) Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided

More information

Benlysta. Benlysta (belimumab) Description

Benlysta. Benlysta (belimumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.99.01 Subject: Benlysta Page: 1 of 5 Last Review Date: June 22, 2018 Benlysta Description Benlysta (belimumab)

More information

Yescarta. Yescarta (axicabtagene ciloleucel) Description

Yescarta. Yescarta (axicabtagene ciloleucel) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.105 Subject: Yescarta Page: 1 of 5 Last Review Date: September 20, 2018 Yescarta Description Yescarta

More information

Limitations of Use: Imlygic has not been shown to improve overall survival or have an effect on visceral metastases (1).

Limitations of Use: Imlygic has not been shown to improve overall survival or have an effect on visceral metastases (1). Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.66 Subject: Imlygic Page: 1 of 5 Last Review Date: June 22, 2017 Imlygic Description Imlygic (talimogene

More information

Pharmacy Management Drug Policy

Pharmacy Management Drug Policy SUBJECT: Inflammatory Conditions Clinical Review Prior Authorization (CRPA) Rx and Medical Drugs POLICY NUMBER: PHARMACY-73 EFFECTIVE DATE: 01/01/2018 LAST REVIEW DATE: 06/11/2018 If the member s subscriber

More information

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES Generic Brand HICL GCN Exception/Other GOLIMUMAB SIMPONI 22533, 22536, 34697, 35001 ROUTE = SUBCUTANE. GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Is the request for a

More information

IL-5 Antagonists (IgG1 kappa) Fasenra (benralizumab) Nucala (mepolizumab) Description

IL-5 Antagonists (IgG1 kappa) Fasenra (benralizumab) Nucala (mepolizumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.45.07 Subject: IL-5 Antagonists (IgG1 kappa) Page: 1 of 6 Last Review Date: June 22, 2018 IL-5 Antagonists

More information

HELPING YOU AND YOUR PATIENTS TALK OPENLY ABOUT MODERATELY TO SEVERELY ACTIVE RA

HELPING YOU AND YOUR PATIENTS TALK OPENLY ABOUT MODERATELY TO SEVERELY ACTIVE RA SIMPONI ARIA (golimumab) is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with MTX, active psoriatic arthritis, and active ankylosing

More information

Lokelma (sodium zirconium cyclosilicate), Veltassa (patiromer)

Lokelma (sodium zirconium cyclosilicate), Veltassa (patiromer) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.30.42 Subject: Potassium Binders Page: 1 of 5 Last Review Date: November 30, 2018 Potassium Binders Description

More information

Psoriatic Arthritis- Secondary Care

Psoriatic Arthritis- Secondary Care Psoriatic Arthritis- Secondary Care Our Psoriatic Arthritis: First Line Treatments information sheet gives information on the treatments that can be prescribed by a GP, or that might be prescribed if the

More information

ACTEMRA (tocilizumab)

ACTEMRA (tocilizumab) RATIONALE FOR INCLUSION IN PA PROGRAM Background Actemra is an agent in the class of drugs known as biologic disease modifiers. It is used to treat adult onset rheumatoid (RA) arthritis, polyarticular

More information

C. Assess clinical response after the first three months of treatment.

C. Assess clinical response after the first three months of treatment. Government Health Plan (GHP) of Puerto Rico Authorization Criteria Tumor Necrosis Factor Alpha (TNFα) Adalimumab (Humira ) Managed by MCO Section I. Prior Authorization Criteria A. Physician must submit

More information

Benlysta. Benlysta (belimumab) Description

Benlysta. Benlysta (belimumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Benlysta Page: 1 of 5 Last Review Date: December 3, 2015 Benlysta Description Benlysta (belimumab)

More information

certolizumab pegol (Cimzia )

certolizumab pegol (Cimzia ) Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided

More information

Humira (adalimumab) DRUG.00002

Humira (adalimumab) DRUG.00002 Humira (adalimumab) DRUG.00002 Override(s) Prior Authorization Quantity Limit Approval Duration 1 year Medications Humira 10 mg/0.2 ml syringe Humira pediatric Crohn s Disease starter pack 40 mg/0.8 ml

More information

Promacta. Promacta (eltrombopag) Description

Promacta. Promacta (eltrombopag) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.15 Subject: Promacta Page: 1 of 6 Last Review Date: September 15, 2017 Promacta Description Promacta

More information

Remicade (infliximab), Inflectra (infliximab-dyyb), Renflexis (infliximababda)

Remicade (infliximab), Inflectra (infliximab-dyyb), Renflexis (infliximababda) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.02 Subject: Infliximab Page: 1 of 13 Last Review Date: December 8, 2017 Infliximab Description Remicade

More information

Pediatric Use: Safety and effectiveness of Ustekinumab (STELARA ) in pediatric patients have not been evaluated.

Pediatric Use: Safety and effectiveness of Ustekinumab (STELARA ) in pediatric patients have not been evaluated. Original Issue Date (Created): January 1, 2010 Most Recent Review Date (Revised): January 28, 2014 Effective Date: April 1, 2014 I. POLICY Preauthorization Requirements for Ustekinumab (STELARA ) Note:

More information

Kymriah. Kymriah (tisagenlecleucel) Description

Kymriah. Kymriah (tisagenlecleucel) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.101 Subject: Kymriah Page: 1 of 5 Last Review Date: September 20, 2018 Kymriah Description Kymriah

More information

Drug Therapy Guidelines

Drug Therapy Guidelines Simponi, Simponi Aria Applicable Medical Benefit x Effective: 2/13/18 Pharmacy- Formulary 1 x Next Review: 12/18 Pharmacy- Formulary 2 x Date of Origin: 7/2010 Pharmacy- Formulary 3/Exclusive x Review

More information

Amjevita (adalimumab-atto) CG-DRUG-64, CG-DRUG-65

Amjevita (adalimumab-atto) CG-DRUG-64, CG-DRUG-65 Market DC Amjevita (adalimumab-atto) CG-DRUG-64, CG-DRUG-65 Override(s) Prior Authorization Quantity Limit Medications Amjevita 20 mg/0.4 ml prefilled syringe Amjevita (adalimumab-atto) 40 mg/0.8 ml 2

More information

HUMIRA (adalimumab) injection, for subcutaneous use Initial U.S. Approval: 2002

HUMIRA (adalimumab) injection, for subcutaneous use Initial U.S. Approval: 2002 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HUMIRA safely and effectively. See full prescribing information for HUMIRA. HUMIRA (adalimumab) injection,

More information

Xeljanz (tofacitinib), Xeljanz XR (tofacitinib extended-release)

Xeljanz (tofacitinib), Xeljanz XR (tofacitinib extended-release) Market DC Xeljanz (tofacitinib), Xeljanz XR (tofacitinib extended-release) Override(s) Prior Authorization Quantity Limit Medications Xeljanz (tofacitinib) Approval Duration 1 year Quantity Limit May be

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: ustekinumab_stelara 02/2010 10/2018 10/2019 10/2018 Description of Procedure or Service Plaque psoriasis

More information

Carelirst.+.V Family of health care plans

Carelirst.+.V Family of health care plans Carelirst.+.V Family of health care plans CVS Caremark POLICY Document for ACTEMRA The overall objective of this policy is to support the appropriate and cost effective use of the medication, specific

More information

Psoriatic Arthritis- Second Line Treatments

Psoriatic Arthritis- Second Line Treatments Psoriatic Arthritis- Second Line Treatments Second line treatments for Psoriatic Arthritis (PsA) are usually prescribed by a Rheumatologist, Dermatologist, or in a combined clinic where both the Dermatologist

More information

IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS ON SAFETY AND RISK MINIMISATION FOR INFLIXIMAB

IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS ON SAFETY AND RISK MINIMISATION FOR INFLIXIMAB This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare Professionals are asked to report any suspected adverse reactions.

More information

Promacta. Promacta (eltrombopag) Description

Promacta. Promacta (eltrombopag) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.15 Subject: Promacta Page: 1 of 6 Last Review Date: September 20, 2018 Promacta Description Promacta

More information

Amjevita (adalimumab-atto)

Amjevita (adalimumab-atto) *- Florida Healthy Kids Amjevita (adalimumab-atto) Override(s) Prior Authorization Quantity Limit Medications Amjevita 20 mg/0.4 ml prefilled syringe Amjevita (adalimumab-atto) 40 mg/0.8 ml 2 #* ^ prefilled

More information