Immune Modulating Drugs Prior Authorization Request Form

Similar documents
Drug Class Prior Authorization Criteria Therapeutic Agents in Rheumatic and Inflammatory Diseases

CIMZIA (certolizumab pegol)

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

Biologics for Autoimmune Diseases

Cimzia. Cimzia (certolizumab pegol) Description

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.

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

Stelara. Stelara (ustekinumab) Description

First Name. Specialty: Fax. First Name DOB: Duration:

Cosentyx. Cosentyx (secukinumab) Description

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

ACTEMRA (tocilizumab)

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

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description

Otezla. Otezla (apremilast) Description

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

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

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)

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES HUMIRA PEDIATRIC

Medication Policy Manual. Topic: Otezla, apremilast Date of Origin: May 9, 2014

Regulatory Status FDA-approved indication: Humira and its biosimilars are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-5)

Medication Policy Manual. Topic: Xeljanz, tofacitinib Date of Origin: January 21, 2013

Simponi / Simponi ARIA (golimumab)

Actemra. Actemra (tocilizumab) Description

Pharmacy Management Drug Policy

Therapeutic Agents in Rheumatic and Inflammatory Diseases Drug Class Prior Authorization Protocol

Circle Yes or No Y N. [If no, skip to question 7.] 2. Does the patient have a diagnosis of ulcerative colitis? Y N. [If no, skip to question 4.

Policy #: 061 Latest Review Date: October 2013

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

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

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

Cimzia. Cimzia (certolizumab pegol) Description

Cimzia. Cimzia (certolizumab pegol) Description

Medical Policy An Independent Licensee of the Blue Cross and Blue Shield Association

Drug Effectiveness Review Project Summary Report Biologics (Targeted Immune Modulators)

ADALIMUMAB Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

Subject: Remicade (Page 1 of 5)

Biologic Immunomodulators Prior Authorization with Quantity Limit Program Summary

Corporate Medical Policy

SAMPLE IgE: ESR: CRP: # Joints: %BSA: Height: Weight: BMI:

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

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

2. Is the patient responding to Remicade therapy? Y N

This Coverage Policy applies to Individual Health Insurance Marketplace benefit plans only.

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

Corporate Medical Policy

RHEUMATOID ARTHRITIS DRUGS

Infliximab/Infliximab-dyyb DRUG.00002

Remicade (infliximab) DRUG.00002

Corporate Medical Policy

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

1. Does the patient have a diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis (PJIA)?

Center for Evidence-based Policy

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

Subject: Vedolizumab (Entyvio ) Infusion

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

Policy Evaluation: Biologics for RA, Psoriasis, or Crohn s Disease

(tofacitinib) are met.

Coverage Criteria: Express Scripts, Inc. monograph dated 12/15/ months or as otherwise noted by indication

Corporate Medical Policy

1. Background: Infliximab is administered parenterally; therefore, it is not covered under retail pharmacy benefits.

3. Did the patient show evidence of remission by week 8 of Humira Y N therapy?

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

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

Infusible Biologics Medical Policy Prior Authorization Program Summary

Amjevita (adalimumab-atto)

Garrick Brown, MD. Digestive Health Specialists Tacoma Gig Harbor

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

Prior Authorization Conditions for Approval of Humira (adalimumab) Website Form Submit request via: Fax

Rituxan (rituximab) DRUG POLICY BENEFIT APPLICATION

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

2. Has the patient had a response to treatment? Y N. 3. Does the patient have a diagnosis of rheumatoid arthritis (RA)? Y N

Carefirst.+.V Family of health care plans

CLINICAL MEDICAL POLICY

Priority Health Medicare prior authorization form Fax completed form to: toll free, or

Clinical Policy: Abatacept (Orencia) Reference Number: ERX.SPA.123 Effective Date:

See Important Reminder at the end of this policy for important regulatory and legal information.

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

Pharmacy Prior Authorization

CIMZIA (certolizumab pegol)

Pharmacy Management Drug Policy

Drug Class Review Targeted Immune Modulators

Pharmacy Prior Authorization

Clinical Policy: Natalizumab (Tysabri) Reference Number: ERX.SPA.162 Effective Date:

Prior Authorization Policy

Drugs and Applicable Coding: J-code: Enbrel-J1438; Humira-J0135; Remicade-J1745; Inflectra-Q5102; Cimzia-J0718; Simponi-J1602 Renflexis - pending

DRAFT. Therapeutic Class Code: D6A, S2J, S2M, S2Q, Z2U, Z2Z, S2Z, L1A, S2V, Z2V, D6K Therapeutic Class Description: Injectable Immunomodulators

MEDICAL COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 04/09/18 SECTION: DRUGS LAST REVIEW DATE: LAST CRITERIA REVISION DATE: 09/05/18 ARCHIVE DATE:

ETANERCEPT Generic Brand HICL GCN Exception/Other ETANERCEPT ENBREL GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

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

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

o Your healthcare provider should test you for TB before starting CIMZIA.

Pharmacy Medical Necessity Guidelines: Cimzia (certolizumab pegol)

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

Fml Limits. Azathioprine (Imuran) 50mg, 75mg, 100mg - $26.85 Cyclosporine, 25mg, 100mg. $ Leflunomide (Arava) 10mg Tablet - $144.

Transcription:

Patient: HPHC member ID #: Requesting provider: Phone: Servicing provider: Diagnosis: Contact for questions (name and phone #): Projected start and end date for requested Requesting provider NPI: Fax: Servicing provider NPI: ICD 10 code: Actemra (tocilizumab) Diagnosis (Check all that apply): Clinical and Dosing Information (Check all that apply): For the subcutaneous formulation of this drug FAX: 800-232-0816 For Buy and Bill Physician Administered Drugs Only Rheumatoid Arthritis (RA) Systemic juvenile idiopathic arthritis (SJIA) Polyarticular Juvenile Idiopathic Arthritis (PJIA) Immune Modulating Drugs Prior Authorization Request Form Concurrent treatment with traditional DMARD agent (e.g., azathioprine, cyclosporine, d-penicillamine, gold sodium, thiomalate, methotrexate, auranofin, aurothioglucose, hydroxychloroquine, leflunomide, and sulfasalazine) Treatment failure with traditional DMARD agent Contraindication to traditional DMARD agent Treatment failure with Enbrel (etanercept) or Humira (adalimumab) Contraindication to Enbrel or Humira Cimzia (certolizumab pegol) Diagnosis (Check all that apply): Clinical and Dosing Information (Check all that apply): reauthorization For the subcutaneous formulation of this drug Ankylosing Spondylitis Crohn s Disease Psoriatic Arthritis Rheumatoid Arthritis Treatment failure with, or contraindication to: Corticosteroids (e.g. prednisone, prednisolone, methylprednisolone, budesonide) 5-Aminosalicylates (e.g. sulfasalazine, mesalamine, olsalazine, balsalazide) Immunosupressants/immunomodulators (e.g. 6-mercaptopurine, azathioprine, methotrexate) Previous treatment failure with Humira Previous treatment failure with Enbrel Treatment failure with prescription NSAID Harvard Pilgrim Health Care Provider Manual D.69 April 2016

Entyvio (vedolizumab) Chrohn s Disease Ulcerative Colitis Treatment failure with, or contraindication to two or more: Corticosteroids (e.g., prednisone, prednisolone, methylprednisolone) 5-Aminosalicylates (e.g., balsalazide disodium, sulfasalazine, Azulfidine, Apriso, Delzicol,Pentasa, Rowasa, Dipentum, Colazal) 6-mercaptopurine (6-MP, Purinethol) and or azathioprine, (Imuran) Methotrexate And Treatment failure or contraindication to tumor necrosis factor (tnf) blocker (e.g., Remicade, Humira) Ilaris (canakinumab) Diagnosis (Check all that apply): Clinical and Dosing Information (Check all that apply): If obtaining through Accredo Specialty Pharmacy, Cryopyrin-associated periodic syndromes (CAPS) including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome Systemic Juvenile Idiopathic Arthritis (SJIA) Treatment failure with, or contraindication to: One or more Corticosteriods or NSAIDs Required Dose and Dosing Interval: Harvard Pilgrim Health Care Provider Manual D.70 April 2016

Orencia (abatcept) Diagnosis (Check all that apply): Clinical and Dosing Information (Check all that apply): For the subcutaneous formulation of this drug Rheumatoid Arthritis Active polyarticular juvenile idiopathic arthritis Treatment failure with traditional DMARD agent (azathioprine, cyclosporine, d-penicillamine, gold sodium, thiomalate, methotrexate, auranofin, aurothioglucose, hydroxychloroquine, leflunomide, sulfasalazine) Contraindication to traditional DMARD agent Treatment failure with biological DMARD agent (e.g., Cimzia [certolizumab], Kineret [anakinra], Orencia [abatacept], Remicade [infliximab], Simponi [golimumab]). Contraindication to biological DMARD agent Previous treatment failure with Enbrel or Humira. Harvard Pilgrim Health Care Provider Manual D.71 April 2016

Remicade (imfliximab ) Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): Moderately to severely active rheumatoid arthritis Active psoriatic arthritis Moderately to severely active Crohn s Disease Fistulizing Crohn s Disease Moderately to severely active ulcerative colitis Active ankylosing spondylitis Severe (extensive, disabling) plaque psoriasis Treatment failure with oral or injectable DMARD agent (e.g., azathioprine, cyclosporine, d-penicillamine, gold sodium thiomalate, methotrexate, auranofin, aurothioglucose, hydroxychloroquine, leflunomide, sulfasalazine) Contraindication to one oral or injectable DMARD agent Treatment failure with: Corticosteroids (e.g., prednisone, prednisolone, methylprednisolone) 5-Aminosalicylates (e.g. sulfasalazine, mesalamine, olsalazine, balsalazide) Immunosupressants/immunomodulators (e.g., 6-mercaptopurine, azathioprine, methotrexate) Prescription NSAID Systemic therapy for psoriasis (e.g., acitretin, azathioprine, cyclosporine, hydroxyurea, methotrexate, Mycophenolate mofetil, oral methoxsalen plus UVA light [PUVA], propylthiouracil, sulfasalazine, tacrolimus, 6-thioguanine) Previous treatment failure with Humira Previous treatment failure with Enbrel Harvard Pilgrim Health Care Provider Manual D.72 April 2016

Rituxan (rituximab) Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): Acute Lymphoblastic Leukemia (ALL) Central Nervous System Cancers (CNS) Chronic Lymphocytic Leukemia (CLL) Neuromyelitis Optica Non-Hodgkin s Lymphoma (NHL)* Post-transplant B-lymphoproliferative disorder Bullous Pemphigoid (refractory) Chronic Graft Versus Host Disease (GVHD Dermatomyositis Granulomatosis with Polyangiitis (GPA/Wegener s Granulomatosis) Bullous Pemphigoid (refractory) Idiopathic thrombocytopenic purpura (ITP) Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids Authorized when documentation confirms diagnosis. Documentation of prior treatment failure is not required. Must have all: Treatment failure with or contraindication to, corticosteroids (e.g., prednisone) Treatment failure with, or contraindication to, a calcineurin inhibitor (e.g., cyclosporine, tacrolimus) Treatment failure with, or contraindication to, glucocorticoid therapy. Treatment failure with, or contraindication to, methotrexate and/or cyclophosphamide in combination with glucocorticoids, or Documented concerns about fertility, high risk of malignancy, relapsing disease or cyclophosphamide resistance. Treatment failure or contraindication to: Systemic, or high-dose topical steroids, or Immunosuppressive glucocorticoid-sparing agent (e.g., mycophenolate mofetil, azathioprine, or methotrexate) Treatment failure or contraindication to steroid therapy: Corticosteroids High-dose topical steroids Systemic steroids Treatment failure with or contraindication to methotrexate and/or cyclophosphamide in combination with glucocorticoids. Documented concerns about fertility, high risk of malignancy, relapsing disease or cyclophosphamide resistance. Harvard Pilgrim Health Care Provider Manual D.73 April 2016

Rituxan (rituximab) continued Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): Multiple Sclerosis (MS) Primary Progressive Relapse remitting Secondary Progressive Member is < 50 years of age, or Documentation shows enhancement on MRI Positive serology to JC virus, or History of previous immunosuppressant therapy, or History of treatment failure with, or contraindication to, Tysabri (natalizumab History of previous immunosuppressant therapy, or History of treatment failure with, or contraindication to, at least one second-line or oral MS drug (e.g. Aubagio [teriflunomide], Tecfidera [dimethylfumarate], or Gilenya [fingolimod]) Polymyositis Treatment failure with, or contraindication to, glucocorticoid therapy. Refractory Pemphigus Vulgaris Confirmed diagnosis in members 18 or older and all of the following: Failed first-line therapy Treatment failure with or contraindication to, corticosteroids Rheumatoid Arthritis (RA) Must have all: Treatment failure with, or contraindication to, one traditional DMARD agent Treatment failure with or contraindication to Enbrel (etanercept) OR Humira (adalimumab), and at least one other biological DMARD3 Inadequate response to one or more tumor necrosis factor Solid Organ Transplant Recipients Documented need to reduce anti-hla antibodies in member at high risk of antibody-mediated rejection (e.g., highly sensitized patients, patients receiving an ABO incompatible organ). Harvard Pilgrim Health Care Provider Manual D.74 April 2016

Simponi -Aria (Golimumab) Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): For the subcutaneous formulation of this drug Moderately to severely active rheumatoid arthritis Treatment failure with or contraindication to oral or injectable traditional DMARD agent (e.g., azathioprine, cyclosporine, d-penicillamine, gold sodium, thiomalate, methotrexate, auranofin, aurothioglucose, hydroxychloroquine, leflunomide, and sulfasalazine) Treatment failure with or contraindication to Enbrel or Humira Stelara (ustekinumab) Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): If obtaining through Accredo Specialty Pharmacy, Moderate to severe plaque psoriasis Active psoriatic arthritis Other: Treatment failure or contraindication to one course of systemic therapy for psoriasis (e.g., methotrexate, azathioprine, acitretin, tacrolimus, cyclosporine, mycophenolate mofetil, 6-thioguanine, sulfasalazine, hydroxyurea, propylthiouracil, oral methoxsalen plus UVA light (PUVA). Previous treatment failure with Enbrel or Humira Treatment failure with oral or injectable DMARD agent (e.g., Hydroxychloroquine (Plaquenil), Leflunomide (Arava), Cyclosporine (Neoral), Sulfasalzine (Azulfidine), Methotrexate (Rheumatrex, Trexall), Azathioprine (Imuran), Cyclophosphamide (Cytoxan), Biologics (Actemra, Cimzia, Kineret, Orencia, Remicade, Rituxan, Simponi) Contraindication to oral or injectable DMARD agent Required Dose and Dosing Interval: Harvard Pilgrim Health Care Provider Manual D.75 April 2016

Tysabri (natalizumab) Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): Multiple sclerosis Moderately to severely active Crohn s Disease Relapsing Multiple Sclerosis Documentation of anti-jcv antibody testing (include date) Treatment failure with, or contraindication to at least 2 within the past 6 months Avonex, Betaseron, Copaxone, Rebif, Plegridy, Aubagio, Gilenya, Tecfidera Crohn s Disease Treatment failure with two (or more) of the following: Documentation of anti-jcv antibody testing (include date) Corticosteroids (e.g., Prednisone, prednisolone, methylprednisolone) 5-Aminosalicylates (e.g., Sulfasalazine, Azulfidine, Delzicol, Pentasa, Rowasa, Dipentum, Colazal ) 6-Mercaptopurine (6-mp, Purinethol ) and/or azathioprine (Imuran ) Methotrexate (MTX), and treatment failure with, or contraindication to tumor necrosis factor (TNF) blocking agent (e.g., Cimzia, Humira or Remicade ) symptom improvement(s) and documentation of anti-jcv antibody testing (include date) Harvard Pilgrim Health Care Provider Manual D.76 April 2016