Stelara. Stelara (ustekinumab) Description
|
|
- Pierce McDonald
- 5 years ago
- Views:
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
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 informationRegulatory 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 informationCimzia. 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 informationCimzia. 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 informationSimponi / 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 informationSiliq. 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 informationRegulatory 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 informationRegulatory 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 informationCosentyx. 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 informationRemicade. 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 informationCimzia. 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 informationRemicade. 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 informationRegulatory 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 informationRegulatory 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 informationOtezla. 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 informationXeljanz. 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 informationRegulatory 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 informationXeljanz. 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 informationXeljanz. 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 informationSTELARA (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 informationUnitedHealthcare 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 informationRegulatory 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 informationRegulatory 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 informationRegulatory 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 informationActemra. 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 informationINFLIXIMAB 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 informationUnitedHealthcare 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 informationCOSENTYX (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 informationRegulatory 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 informationustekinumab (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 informationCyltezo (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 informationRegulatory 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 informationUSTEKINUMAB 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 informationCIMZIA (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 informationCIMZIA (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 informationXgeva. 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 informationMedical 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 informationRegulatory 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 informationMedical 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 informationRegulatory 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 informationENTYVIO (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 informationHARVARD 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 information2. 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 informationUnitedHealthcare 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 informationWhat 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 informationDrug 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 information1 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 informationClinical 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 informationBiologic 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 informationClinical 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 informationCYTOKINE 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 informationRegulatory 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 informationCorporate 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 informationSiklos. 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 informationNucala. 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 informationACTEMRA (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 informationXgeva. 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 informationInflectra (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 informationInfliximab/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 informationRemicade (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 informationPharmacy 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 informationBiologics 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 informationENTYVIO (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 informationRegulatory 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 informationUnitedHealthcare 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 informationAnnouncing 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 informationClinical 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 informationINFLIXIMAB 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 informationUstekinumab (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 informationBenlysta. 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 informationYescarta. 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 informationLimitations 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 informationPharmacy 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 informationHARVARD 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 informationIL-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 informationHELPING 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 informationLokelma (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 informationPsoriatic 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 informationACTEMRA (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 informationC. 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 informationBenlysta. 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 informationcertolizumab 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 informationHumira (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 informationPromacta. 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 informationRemicade (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 informationPediatric 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 informationKymriah. 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 informationDrug 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 informationAmjevita (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 informationHUMIRA (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 informationXeljanz (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 informationCorporate 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 informationCarelirst.+.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 informationPsoriatic 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 informationIMPORTANT 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 informationPromacta. 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 informationAmjevita (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