The Medical Letter. on Drugs and Therapeutics
|
|
- Brittney Doyle
- 5 years ago
- Views:
Transcription
1 The Medical Letter publications are protected by US and international copyright laws. Forwarding, copying or any other distribution of this material is strictly prohibited. For further information call: Last updated: July 30, 2018 The Medical Letter on Drugs and Therapeutics Expanded Table: Some Biologic Agents and JAK Inhibitors for RA Some Biologic Agents and JAK Inhibitors for Rheumatoid Arthritis Tumor Necrosis Factor (TNF) Inhibitors Adalimumab Humira (Abbvie) biosimilar Cyltezo (Boehringer Ingelheim; not yet marketed) Certolizumab pegol Cimzia (UCB) Etanercept Enbrel (Amgen) Golimumab Simponi (Janssen) Simponi Aria 10 mg/0.1 ml, 10 mg/ 0.2 ml, 20 mg/0.2 ml, 20 mg/0.4 ml syringes; 40 mg/0.8 ml prefilled pens and syringes 200 mg single-dose vials; 200 mg/ml syringes 25 mg multiple-dose vials; 25 mg/0.5 ml, 50 mg/ml syringes; 50 mg/ml autoinjectors 50 mg/0.5 ml, 100 mg/ ml syringes and auto-injectors 50 mg single-dose vials 40 mg SC q2 wks Generally considered safe for use during pregnancy Initial: 400 mg SC at 0, 2, and 4 wks Maintenance: 200 mg SC every other wk or 400 mg SC q4 wks 25 mg SC 2x/wk or 50 mg SC once/wk 50 mg SC once/month Initial: 2 mg/kg IV at 0 and 4 wks Maintenance: 2 mg/kg IV q8 wks Placental transfer of anti-tnf antibodies is higher in the late second and third trimesters, especially with infliximab, adalimumab, and golimumab Injection-site reactions are common with adalimumab, certolizumab pegol, etanercept, and golimumab Infusion reactions including fever, urticaria, dyspnea, and hypotension can occur with infliximab and golimumab Cytopenias can occur with all TNF inhibitors Malignancies, especially lymphomas, have been, but a cause-andeffect relationship has not been established (continued on next page) Infliximab and golimumab are FDA-approved for treatment of RA only for use with methotrexate Combining a biologic agent with a conventional DMARD is recommended for patients with moderate to high disease activity and for those who have had an inadequate response to a conventional DMARD alone Combining different biologic agents or a biologic agent and a JAK inhibitor increases the risk of infection and is not recommended Have been shown to relieve symptoms and may be more effective than methotrexate alone in limiting joint destruction Use in combination with methotrexate has synergistic beneficial effects TNF inhibitors appear to be similar in efficacy; no headto-head trials comparing them are (continued on next page) $ N.A e130
2 Tumor Necrosis Factor (TNF) Inhibitors (continued) Infliximab Remicade (Janssen) biosimilar Inflectra (Celltrion) Renflexis (Merck) Ixifi (Pfizer; not yet marketed) 100 mg single-dose vials Initial: 3 mg/kg IV at 0, 2, and 6 wks Maintenance: 3 mg/kg IV q8 wks Some patients may require higher maintenance doses (up to 10 mg/ kg every 8 wks) or more frequent doses (up to every 4 wks) Generally considered safe for use during pregnancy Placental transfer of anti-tnf antibodies is higher in the late second and third trimesters, especially with infliximab, adalimumab, and golimumab (see previous page) Increased risk of infections, including reactivated and disseminated tuberculosis, invasive or disseminated fungal infection, and other opportunistic infections Reactivation of HBV Rarely induces or exacerbates heart failure or induces a reversible lupuslike syndrome Demyelinating conditions, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome have been (see previous page) Patients who do not respond to one TNF inhibitor may respond to another Have a faster onset of action than conventional DMARDs; some patients report substantial improvement after the first dose Tuberculin skin testing or interferon-gamma release assay is recommended before starting and periodically during treatment Serologic testing for active hepatitis B infection is recommended before starting treatment Antiviral prophylaxis against reactivation of HBV may be appropriate in some patients Patients with pre-existing demyelinating conditions should not be treated with TNF inhibitors Etanercept has a rapid onset of action and a short halflife that makes toxicity, if it occurs, relatively short-lived Golimumab has been shown to be effective in some patients who did not respond to infliximab or etanercept $ N.A. e131
3 Interleukin (IL-6) Inhibitors Sarilumab Kevzara (Sanofi/Regeneron) Tocilizumab Actemra (Genentech) 150 mg/1.14 ml, 200 mg/1.14 ml prefilled pens and syringes 80, 200, 400 mg singledose vials 162 mg/0.9 ml syringes 200 mg SC q2 wks No adequate data on use Initial: 4 mg/kg IV q4 wks Maintenance: 8 mg/kg IV q4 wks Initial: 162 mg SC every other wk (every wk for patients weighing 100 kg) Maintenance: 162 mg SC once/wk (can be administered once every other wk in patients who weigh <100 kg) Infusion reactions, hypertension, neutropenia, elevated serum transaminase levels, and dyslipidemia can occur Serious infections and hypersensitivity reactions, including anaphylaxis, can occur An increase in lower GI tract perforations, especially in patients with diverticulitis, has been with tocilizumab FDA-approved for use in patients who have had an inadequate response or intolerance to 1 DMARDs Combining a biologic agent with a conventional DMARD is recommended for patients with moderate to high disease activity and for those who have had an inadequate response to a conventional DMARD alone Combining different biologic agents or a biologic agent and a JAK inhibitor increases the risk of infection and is not recommended Sarilumab has been effective in combination with methotrexate in patients who had not responded to methotrexate or a TNF inhibitor Sarilumab monotherapy has been shown to be more effective than adalimumab in patients who had not responded to or could not tolerate methotrexate Tocilizumab monotherapy may be as effective as combination therapy with methotrexate in patients with active RA despite methotrexate therapy Clinical improvement has occurred as early as two weeks after starting tocilizumab monotherapy Tocilizumab monotherapy has been shown to be more effective than adalimumab in reducing disease activity scores No studies comparing sarilumab with tocilizumab are Monitoring of complete blood counts and liver enzymes is recommended $ e132
4 Other Biologic Agents Rituximab Rituxan (Genentech) 100, 500 mg single-use vials 1000 mg IV twice, 2 wks apart No adequate data on use Rituximab crosses the placenta and has been detected in the newborn B-cell lymphocytopenia has been in infants born to women who took the drug during pregnancy Anaphylaxis and anaphylactoid reactions can occur within 2 hours of infusion PML due to JC virus, which often causes death or severe neurological disability, has been Reactivation of HBV FDA-approved only for use with methotrexate in patients who have had an inadequate response to 1 TNF inhibitors Has been effective in patients with RA who had an inadequate response to methotrexate and/or a TNF inhibitor Patients can be retreated every 4-6 months IV methylprednisolone 100 mg or its equivalent infused 30 minutes before rituximab can reduce the incidence and severity of infusion reactions Patients at high risk for hepatitis B infection should be screened for the disease before starting treatment Antiviral prophylaxis against reactivation of HBV may be appropriate in some patients $18, Abatacept Orencia (BMS) 250 mg single-use vials 50 mg/0.4 ml, 87.5 mg/ 0.7 ml, 125 mg/ml syringes; 125 mg/ml auto-injectors <60 kg: 500 mg IV at 0, 2, and kg: 750 mg IV at 0, 2, and 4 >100 kg: 1000 mg IV at 0, 2, and mg SC once/wk 5 No adequate data on use Hypertension, headache, and dizziness can occur Anaphylactoid reactions can occur within 1 hour after the start of infusion May increase the risk of serious infections such as pneumonia, pyelonephritis, cellulitis, and diverticulitis Can be used as monotherapy or in combination with a conventional DMARD Monotherapy has been effective for treatment of RA that had not responded to methotrexate or TNF inhibitors Anakinra Kineret (Sobi) 100 mg/0.67 ml syringes 100 mg SC once/d No adequate data on use Injection-site reactions, headache, vomiting, infections, arthralgia, and nasopharyngitis have been FDA-approved for use in patients who have had an inadequate response or intolerance to 1 DMARDs Least commonly used biologic DMARD Limited evidence of efficacy compared to other biologics e133
5 Janus Kinase (JAK) Inhibitors Baricitinib Olumiant (Lilly) Tofacitinib Xeljanz (Pfizer) Xeljanz XR 2 mg tabs 2 mg PO once/d No adequate data on use 5 mg tabs 11 mg ER tabs 5 mg PO bid 11 mg PO once/d Upper respiratory tract infections and nausea are common Elevated hepatic transaminases, dyslipidemia, and cytopenias have been Thromboembolic events, malignancy, and GI perforations have been Infections, especially herpes zoster and tuberculosis, can occur Diarrhea, nasopharyngitis, upper respiratory tract infections, headache, and hypertension are common Elevated hepatic transaminases, dyslipidemia, and cytopenias have been Infections, especially herpes zoster and tuberculosis, can occur An increased incidence of solid cancers was detected in short-term ( 12 months) clinical trials Baricitinib is FDA-approved for use in patients who have had an inadequate response to 1 TNF inhibitors Tofacitinib is FDA-approved for use in patients who have had an inadequate response or intolerance to methotrexate Generally reserved for treatment of patients with moderate or high disease activity Combining a biologic agent and a JAK inhibitor increases the risk of infection and is not recommended First-line treatment with tofacitinib was superior to methotrexate in reducing the signs and symptoms of RA and in slowing progression of joint damage Efficacy of tofacitinib plus methotrexate is comparable to that of adalimumab plus methotrexate Baricitinib was more effective than placebo in patients with moderately to severely active RA that had not responded to one or more TNF inhibitors No studies comparing tofacitinib with baricitinib are Monitoring of complete blood counts is recommended ER = extended-release; N.A. = cost not yet ; PML = progressive multifocal leukoencephalopathy; HBV = hepatitis B virus 1. Dosage adjustment may be needed for hepatic or renal impairment. 2. Approximate WAC for 30 days or 4 weeks treatment with the usual dosage or lowest usual maintenance dosage (for a 70-kg patient treated with some parenteral drugs). WAC = wholesaler acquisition cost or manufacturer s published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource Monthly. July 5, Reprinted with permission by First Databank, Inc. All rights reserved Cost for 8 weeks treatment. 4. Cost of two 1000-mg doses. 5. If administered after an initial IV loading dose, the first 125-mg SC injection should be given within a day of the IV loading dose. $ e134
RHEUMATOID ARTHRITIS DRUGS
Rheumatology Biologics Criteria from the Exceptional Access Program RHEUMATOID ARTHRITIS DRUGS DRUG NAME BRS REIMBURSED DOSAGE FORM/ STRENGTH Adalimumab Humira 40 mg/0.8 syringe and 40mg/0.8 pen for Anakinra
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 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 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 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 informationStelara. 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 informationFor Rheumatoid Arthritis
For Rheumatoid Arthritis APRIL 2017 NOTICE: On April 14, 2017 the FDA issued a complete response letter for baricitinib indicating that the FDA is unable to approve the application in its current form
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 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 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 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 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 informationDERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC)
DERBYSHIRE JOINT AREA PRERIBING COMMITTEE (JAPC) Derbyshire commissioning guidance on biologic drugs f the treatment of Rheumatoid arthritis with methotrexate This algithm is a tool to aid the implementation
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 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 informationDrug Class Review Targeted Immune Modulators
Drug Class Review Targeted Immune Modulators Final Update 5 Report June 2016 The purpose of reports is to make available information regarding the comparative clinical effectiveness and harms of different
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 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 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 information(tofacitinib) are met.
Xeljanz (tofacitinib) Policy Number: 5.01. 560 Origination: 3/2014 Last Review: 3/2014 Next Review: 3/2015 Policy BCBSKC will provide coverage for Xeljanz (tofacitinib) when it is determined to be medically
More informationMEDICATION GUIDE XELJANZ (ZEL JANS ) (tofacitinib)
MEDICATION GUIDE XELJANZ (ZEL JANS ) (tofacitinib) Read this Medication Guide before you start taking XELJANZ and each time you get a refill. There may be new information. This Medication Guide does not
More informationCorporate Medical Policy
Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: abatacept_orencia 4/2008 2/2018 2/2019 2/2018 Description of Procedure or Service Abatacept (Orencia ), a
More informationOlumiant (baricitinib) NEW PRODUCT SLIDESHOW
Olumiant (baricitinib) NEW PRODUCT SLIDESHOW Introduction Brand name: Olumiant Generic name: Baricitinib Pharmacological class: Janus kinase (JAK) inhibitor Strength and Formulation: 2mg; tabs Manufacturer:
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 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 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 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 informationCimzia (certolizumab pegol) Data Showed Broad and Rapid Relief From Burden of Symptoms In Rheumatoid Arthritis Patients
Cimzia (certolizumab pegol) Data Showed Broad and Rapid Relief From Burden of Symptoms In Rheumatoid Arthritis Patients Rapid, sustained and clinically meaningful improvement in wideranging patient-reported
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 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 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 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 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 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 informationBIOLOGICS & What You Need to Know
BIOLOGICS & What You Need to Know Biologic are given to improve how your immune system works & helps to control your disease. They are highly specific genetic copies of human proteins, given as s or infusions
More informationCorporate Medical Policy
Corporate Medical Policy Rituximab for the Treatment of Rheumatoid Arthritis File Name: Origination: Last CAP Review: Next CAP Review: Last Review: rituximab_for_the_treatment_of_rheumatoid_arthritis 4/2008
More informationThe Medical Letter. on Drugs and Therapeutics. Sulfasalazine can cause reversible. therapy may be more effective Lialda (Shire)
The Medical Letter publications are protected by US and international copyright laws. Forwarding, copying or any other distribution of this material is strictly prohibited. For further information call:
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 informationDrug Class Prior Authorization Criteria Therapeutic Agents in Rheumatic and Inflammatory Diseases
Drug Class Prior Authorization Criteria Therapeutic Agents in Rheumatic and Inflammatory Diseases Line of Business: Medicaid P & T Approval Date: August 16, 2017 Effective Date: August 16, 2017 This policy
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 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 informationTechnology appraisal guidance Published: 26 January 2016 nice.org.uk/guidance/ta375
Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed Technology
More informationPRIOR AUTHORIZATION REQUEST GUIDE
PRIOR AUTHORIZATION REQUEST GUIDE Drafting a Prior Authorization Request The following information is presented for informational purposes only and is not intended to provide reimbursement or legal advice.
More informationDRAFT. Remission rates, calculated using observed case (OC) analyses were as follows: Year 1 Year 2 Year 3 Year 4 All patients 62.
DRAFT New Efficacy Data Shows Cimzia (certolizumab pegol) Provides Long-Term Remission of Moderate to Severe Crohn s Disease Regardless of Prior Anti-TNF Exposure, According to Data Presented at DDW Oral
More informationGet an Insurance Benefits Review for ORENCIA (abatacept)
Get an Insurance Benefits Review for ORENCIA (abatacept) If you and your doctor decide that ORENCIA is right for you, you can call 1-800-ORENCIA (1-800-673-6242) to do an Insurance Benefits Review. Our
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 informationCimzia shows duration of response up to week 26 in moderate to severe Crohn s patients who failed the intravenous infusion treatment infliximab.
C3073-0409 CIMZIA (certolizumab pegol) PROVIDES LONG-TERM REMISSION AND RESPONSE RATES IN INFLIXIMAB-REFRACTORY CROHN S PATIENTS Cimzia shows duration of response up to week 26 in moderate to severe Crohn
More informationMEDICATION GUIDE. (tocilizumab)
MEDICATION GUIDE ACTEMRA (AC-TEM-RA) (tocilizumab) Read this Medication Guide before you start ACTEMRA and before each infusion. There may be new information. This Medication Guide does not take the place
More informationCorporate Medical Policy
Corporate Medical Policy Infliximab, Infliximab-dyyb, Infliximab-abda File Name: Origination: Last CAP Review: Next CAP Review: Last Review: infliximab 5/2002 2/2018 2/2019 7/2018 Description of Procedure
More informationMedication Policy Manual. Topic: Xeljanz, tofacitinib Date of Origin: January 21, 2013
Medication Policy Manual Policy No: dru289 Topic: Xeljanz, tofacitinib Date of Origin: January 21, 2013 Committee Approval Date: January 19, 2015 Next Review Date: January 2016 Effective Date: April 1,
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION TOFACITINIB (Xeljanz Pfizer Canada Inc.) Indication: Rheumatoid Arthritis Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that tofacitinib be listed, in combination
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 informationCanadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC
Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC Update on the Treatment of Rheumatoid Arthritis Sabrina Fallavollita MDCM McGill University Canadian Society of Internal Medicine
More informationSteps TO HELP YOU TALK WITH YOUR DOCTOR ABOUT YOUR TREATMENT OPTIONS
Moderate to Severe Rheumatoid Arthritis (RA) 3 Steps TO HELP YOU TALK WITH YOUR DOCTOR ABOUT YOUR TREATMENT OPTIONS INDICATION/USAGE Adult Rheumatoid Arthritis (RA): ORENCIA (abatacept) is a prescription
More informationCorporate Medical Policy
Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: infliximab_remicade 5/2002 2/2017 2/2018 2/2017 Description of Procedure or Service Infliximab (REMICADE
More informationActemra (tocilizumab) CG-DRUG-81
Market DC Actemra (tocilizumab) CG-DRUG-81 Override(s) Prior Authorization Approval Duration 1 year Medications Line of Business Quantity Limit Actemra (tocilizumab) vials VA MCD and All L-AGP May be subject
More informationPATIENT ASSISTANCE PROGRAM APPLICATION Patient Application for XELJANZ XR (tofacitinib) extended release tablets/xeljanz (tofacitinib) tablets
PATIENT ASSISTANCE PROGRAM APPLICATION Patient Application for XELJANZ XR (tofacitinib) extended release tablets/xeljanz (tofacitinib) tablets Phone 1-844-XELJANZ (1-844-935-5269) Fax 1-866-297-3471 2730
More informationSpring How will that pipeline drug impact my benefit plan?
Spring 2012 How will that pipeline drug impact my benefit plan? How will that pipeline drug impact my benefit plan? It can be difficult to predict the impact pipeline drugs will have once they reach the
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 informationCenter for Evidence-based Policy
P&T Committee Brief Targeted Immune Modulators: Comparative Drug Class Review Alison Little, MD Center for Evidence-based Policy Oregon Health & Science University 3455 SW US Veterans Hospital Road, SN-4N
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 informationKEEP UP THE FIGHT WITH. Little Victories
FOR MODERATE TO SEVERE RHEUMATOID ARTHRITIS (RA) KEEP UP THE FIGHT WITH Little Victories Small improvements in your daily activities may be a sign that ORENCIA (abatacept) is working for you. Use this
More information2019 COLLECTION TYPE: MIPS CLINICAL QUALITY MEASURES (CQMS) MEASURE TYPE: Process
Quality ID #337: Psoriasis: Tuberculosis (TB) Prevention for Patients with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier National Quality Strategy Domain:
More informationNew Cimzia data, with sites in the US, demonstrate safety and efficacy, increased participation in social activities for adult RA patients
Long-term Cimzia (certolizumab pegol) data demonstrated rapid sustained improvements in clinical outcomes and quality of life in moderate to severe rheumatoid arthritis (RA) patients New Cimzia data, with
More informationCommon Drug Review Pharmacoeconomic Review Report
Common Drug Review Pharmacoeconomic Review Report August 2015 Drug tocilizumab (Actemra) (162 mg/0.9 ml solution for subcutaneous injection) Indication Adult patients with moderately to severely active
More informationo Your healthcare provider should test you for TB before starting CIMZIA.
Medication Guide CIMZIA (CIM-zee-uh) (certolizumab pegol) lyophilized powder or solution for subcutaneous use Read the Medication Guide that comes with CIMZIA before you start using it, and before each
More informationKevzara (sarilumab) NEW PRODUCT SLIDESHOW
Kevzara (sarilumab) NEW PRODUCT SLIDESHOW Introduction Brand name: Kevzara Generic name: Sarilumab Pharmacological class: Interleukin-6 antagonist Strength and Formulation: 150mg/1.14mL, 200mg/1.14mL;
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 informationPfizer Announces Modification To Ongoing Tofacitinib FDA Post- Marketing Requirement Study In Patients With Rheumatoid Arthritis
February 19, 2019 Media Contact: Neha Wadhwa M: +1 212-733-2835 E: Neha.Wadhwa@pfizer.com Investor Contact: Charles Triano O: +1 212-733-3901 E: Charles.E.Triano@pfizer.com Pfizer Announces Modification
More informationDrugs and Applicable Coding: J-code: Enbrel-J1438; Humira-J0135; Remicade-J1745; Inflectra-Q5102; Cimzia-J0718; Simponi-J1602 Renflexis - pending
Policy Subject: Anti-TNF Agents Policy Number: SHS PBD16 Category: Rheumatology & Autoimmune Policy Type: Medical Pharmacy Department: Pharmacy Product (check all that apply): Group HMO/POS Individual
More informationAntirheumatic drugs. Rheumatic Arthritis (RA)
Antirheumatic drugs Rheumatic Arthritis (RA) Disease Modifying Antirheumatic drugs (DMARDs) DMARDs are used in the treatment of rheumatic arthritis RA and have been shown to slow the course of the disease,
More informationRheumatoid Arthritis Update
Rheumatoid Arthritis Update Beth Valashinas, DO, FACOI, FACR Disclosures Speaker for AbbVie Pharmaceuticals Learning Objectives Upon completion of this session, participants should be able to discuss:
More informationREFERENCE CODE GDHC504DFR PUBLICAT ION DATE DECEMBER 2014 SARILUMAB (RHEUMATOID ARTHRITIS) FORECAST AND MARKET ANALYSIS TO 2023
REFERENCE CODE GDHC504DFR PUBLICAT ION DATE DECEMBER 2014 SARILUMAB (RHEUMATOID ARTHRITIS) Executive Summary The table below presents the key metrics for Sarilumab in the 10MM Rheumatoid Arthritis (RA)
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 informationDrug Class Review Targeted Immune Modulators
Drug Class Review Targeted Immune Modulators Final Update 3 Report March 2012 The Agency for Healthcare Research and Quality has not yet seen or approved this report The purpose of the is to summarize
More informationBACK FIGHT. It s time to. Take action today. Ask your rheumatologist about ORENCIA.
For moderate to severe Rheumatoid Arthritis (RA) It s time to FIGHT BACK Model, not actual patient. Take action today. Ask your rheumatologist about ORENCIA. What is ORENCIA? ORENCIA (abatacept) is a prescription
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 informationUCB s Cimzia (certolizumab pegol) approved by the U.S. FDA for adult patients suffering from moderate to severe rheumatoid arthritis
UCB s Cimzia (certolizumab pegol) approved by the U.S. FDA for adult patients suffering from moderate to severe rheumatoid arthritis Available this week, Cimzia (certolizumab pegol), the only pegylated
More informationREFERENCE CODE GDHC497DFR PUBLICAT ION DATE DECEMBER 2014 ORENCIA (ABATACEPT) (RHEUMATOID ARTHRITIS) - FORECAST AND MARKET ANALYSIS TO 2023
REFERENCE CODE GDHC497DFR PUBLICAT ION DATE DECEMBER 2014 ORENCIA (ABATACEPT) (RHEUMATOID ARTHRITIS) - Executive Summary The table below provides the key metrics for Orencia (abatacept) in the 10MM (US,
More informationThe ORENCIA (abatacept) JIA Observational Registry
Moderate to Severe Juvenile Idiopathic Arthritis (JIA) Injection for Intravenous Use Injection for Subcutaneous Use The ORENCIA (abatacept) JIA Observational Registry Injection for Intravenous Use Injection
More informationMedication Policy Manual. Topic: Otezla, apremilast Date of Origin: May 9, 2014
Medication Policy Manual Policy No: dru342 Topic: Otezla, apremilast Date of Origin: May 9, 2014 Committee Approval Date: January 19, 2015 Next Review Date: January 2016 Effective Date: April 1, 2015 IMPORTANT
More informationMEDICATION GUIDE HUMIRA
MEDICATION GUIDE HUMIRA (Hu-MARE-ah) (adalimumab) injection Read the Medication Guide that comes with HUMIRA before you start taking it and each time you get a refill. There may be new information. This
More informationClinical Policy: Abatacept (Orencia) Reference Number: ERX.SPA.123 Effective Date:
Clinical Policy: (Orencia) Reference Number: ERX.SPA.123 Effective Date: 10.01.16 Last Review Date: 05.18 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
More informationFml Limits. Azathioprine (Imuran) 50mg, 75mg, 100mg - $26.85 Cyclosporine, 25mg, 100mg. $ Leflunomide (Arava) 10mg Tablet - $144.
MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Rheumatoid Arthritis (RA) P&T DATE: 2/15/2017 CLASS: Rheumatology/Anti-inflammatory Disorders REVIEW HISTORY 2/16, 5/15,
More informationMEDICAL COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 04/09/18 SECTION: DRUGS LAST REVIEW DATE: LAST CRITERIA REVISION DATE: 09/05/18 ARCHIVE DATE:
ILARIS (canakinumab) 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 informationACTEMRA IV Dosing & Administration Pocket Guide
IMPORTANT SAFETY INFORMATION BOXED WARNING Serious Infections Serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic
More informationStelara. 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 6 Last Review Date: December 8, 2017 Stelara Description Stelara (ustekinumab)
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 informationWARNING: RISK OF SERIOUS INFECTIONS
RA PROGRESSION INTERRUPTED 1 DOSAGE AND ADMINISTRATION GUIDE No structural damage progression was observed at week 52 in 55.6% and in 47.8% of patients receiving KEVZARA 200 mg + MTX or 150 mg + MTX, compared
More informationOlumiant (baricitinib) tablets
READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION OLUMIANTTM (Ō-loo'-mē-ant) baricitinib tablets Read this carefully before you start taking OLUMIANT and each time you
More informationMonitoring Patients on Biologic Therapies Murlidhar Rajagopalan, MBBS, MD
Monitoring Patients on Biologic Therapies Murlidhar Rajagopalan, MBBS, MD Biologics available for psoriasis 1) tumor necrosis factor alpha (TNF-α) inhibitors, 2) interleukin (IL)-12/23 inhibitors, and
More informationTechnology appraisal guidance Published: 11 October 2017 nice.org.uk/guidance/ta480
Tofacitinib for moderate to severeere rheumatoid arthritis Technology appraisal guidance Published: 11 October 2017 nice.org.uk/guidance/ta480 NICE 2018. All rights reserved. Subject to Notice of rights
More informationMMS Pharmacology Lecture 2. Antirheumatic drugs. Dr Sura Al Zoubi
MMS Pharmacology Lecture 2 Antirheumatic drugs Dr Sura Al Zoubi Revision Rheumatoid Arthritis Definition (RA): is the most common systemic inflammatory disease characterized by symmetrical inflammation
More informationLecture: Rheumatology Update on DMARDs in Common Rheumatologic Diseases for the Family Physician. Sco Jay Harris, DO, FACFR
Lecture: Rheumatology Update on DMARDs in Common Rheumatologic Diseases for the Family Physician Sco Jay Harris, DO, FACFR UPDATE ON DMARDS, BIOLOGICALS, CYTOKINE INHIBITORS/B CELL DEPLETIONS/CO-STIMULATION
More informationHumira. (adalimumab) Drug Update Slideshow NEW INDICATION
Humira (adalimumab) NEW INDICATION Drug Update Slideshow Introduction Brand name: Humira Generic name: Adalimumab Pharmacological class: Tumor necrosis factor (TNF) blocker Strength and Formulation: 10mg/0.2mL,
More informationACTEMRA (tocilizumab) injection, for intravenous use injection, for subcutaneous use Initial U.S. Approval: 2010
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ACTEMRA safely and effectively. See full prescribing information for ACTEMRA. ACTEMRA (tocilizumab)
More informationREFERENCE CODE GDHC501DFR PUBLICAT ION DATE DECEMBER 2014 XELJANZ (TOFACITINIB) (RHEUMATOID ARTHRITIS) - FORECAST AND MARKET ANALYSIS TO 2023
REFERENCE CODE GDHC501DFR PUBLICAT ION DATE DECEMBER 2014 XELJANZ (TOFACITINIB) (RHEUMATOID ARTHRITIS) - Executive Summary The table below provides the key metrics for Xeljanz (tofacitinib) in the 10MM
More information