Commercial Payer Information

Commercial Payer Information

Payers create their own policies with regard to product coverage. Since information varies by payer, it is important to contact the payer directly or consult its Web site to obtain product-specific coverage.

Commercial and Medicare Part D payers each have their own forms and requirements for requesting prior authorization of a prescription drug. In the Commercial table below are links to payer Web sites where you may obtain more information on the approval process, policies and direct links to drug prior authorization forms. For Medicare Part D, click on the link for Contact Janssen CarePath Support. It is important to contact the payer directly or consult its Web site to obtain product-specific information.

Uniform Prescription Drug Prior Authorization Request Form & Notification Requirements for Health Plans

California, Colorado and Oregon require that certain health plans must use the uniform Prior Authorization (PA) Request Form. In addition, there are new rules regarding the PA process. The rules are effective based on the type of health plan for each state. Click on the PDF below for more information:

Disclaimer: Clicking on any of the links below will take you to a Web site to which this privacy policy does not apply. We encourage you to read the privacy policy of every Web site you visit.

Payer Prior Authorization Information
Aetna Pharmacy Clinical Policy Bulletins and Prior Authorization
Health Care Professional (Pharmacy) Forms
Arkansas Blue Cross and Blue Shield Prior Authorization Request Form
Provider Forms
Blue Cross of Idaho Provider Prior Authorization Requirements: Pharmacy Requests
Blue Cross and Blue Shield of Alabama Specialty Pharmacy Form
Prescription Drug Guides
Blue Cross Blue Shield of Arizona Prior Authorization Guidelines (Standard Pharmacy Plans)
Prior Authorization Guidelines (Employer Sponsored Plans)
Blue Cross and Blue Shield of Florida/Florida Blue Medication Guides
Quantity Limit Request Form
Specialty Pharmacy Request Form
Blue Cross and Blue Shield of Illinois Prior Authorization and Step Therapy Programs
Blue Cross and Blue Shield of Kansas Prescription Drugs
Precertification / Pre-authorization
Blue Cross and Blue Shield of Minnesota Prescription Drugs
Minnesota Uniform Form for PA Requests and Formulary Exceptions
Blue Cross and Blue Shield of Montana Provider Forms and Documents
Prior Authorization and Step Therapy Programs
Blue Cross and Blue Shield of Nebraska Policies & Forms: Pre-Authorization Forms
Blue Cross and Blue Shield of New Mexico Prior Authorization and Step Therapy Programs
Blue Cross and Blue Shield of North Carolina Prior Review and Limitations
Blue Cross and Blue Shield of Oklahoma Prior Authorization and Step Therapy Programs
BlueCross BlueShield of South Carolina Drug Management and Prior Authorization
BlueCross BlueShield of Texas Prior Authorization and Step Therapy Programs
Blue Cross Blue Shield of Wyoming Pharmacy Guide & Forms
CareFirst BlueCross BlueShield Prior Authorization/Step Therapy
Pharmacy Forms
Cigna Pharmacy Resources and Forms
CVS Caremark Prior Authorization Information
Electronic Prior Authorization
Electronic Prior Authorization FAQs
Clinical Prior Authorization Criteria Request Form
Geisinger Health/Geisinger Health Plan Prior Authorization Form
Gundersen Health Plan Pharmacy Forms for Healthcare Providers: Prior Authorization
Highmark (formerly Blue Cross of Northeastern Pennsylvania) Provider Rx Prior Authorization Form
Drug Utilization Management Criteria
Humana Pharmacy Prior Authorizations
Independence Blue Cross Prior Authorization: Pharmacy Benefit
Midwest Health Plan, Inc. Pharmacy Approval Criteria
Pharmacy Documents
Medical Mutual of Ohio Provider Home
Prior Approval List
Prior Approval Form
Neighborhood Health Plan Standardized Prior Authorization Request Form
Regence BlueCross BlueShield Prior Authorization Form
Wellmark Blue and Cross Blue Shield Provider Drug Information
Provider Prior Authorization

Medicare Part D

Contact Janssen CarePath Support

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The information provided presents no statement, promise, or guarantee by Janssen Biotech, Inc., concerning levels of reimbursement, payment, or charge. Please consult your payer organizations with regard to local or actual coverage and reimbursement policies and determination processes.

Indication

DARZALEX® is indicated:

  • in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy
  • as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
Important Safety Information For DARZALEX®

CONTRAINDICATIONS - None

WARNINGS AND PRECAUTIONS

Infusion Reactions – DARZALEX® can cause severe infusion reactions. Approximately half of all patients experienced a reaction, most during the first infusion. Infusion reactions can also occur with subsequent infusions. Nearly all reactions occurred during infusion or within 4 hours of completing an infusion. Prior to the introduction of post-infusion medication in clinical trials, infusion reactions occurred up to 48 hours after infusion. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, laryngeal edema and pulmonary edema. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting and nausea. Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypotension.

Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt infusion for reactions of any severity and institute medical management as needed. Permanently discontinue therapy for life-threatening (Grade 4) reactions. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.

To reduce the risk of delayed infusion reactions, administer oral corticosteroids to all patients following DARZALEX® infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.

Interference with Serological Testing - Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX®. Type and screen patients prior to starting DARZALEX®.

Neutropenia – DARZALEX® may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. DARZALEX® dose delay may be required to allow recovery of neutrophils. No dose reduction of DARZALEX® is recommended. Consider supportive care with growth factors.

Thrombocytopenia – DARZALEX® may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. DARZALEX® dose delay may be required to allow recovery of platelets. No dose reduction of DARZALEX® is recommended. Consider supportive care with transfusions.

Interference with Determination of Complete Response – Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

Adverse Reactions – In patients who received DARZALEX® in combination with lenalidomide and dexamethasone, the most frequently reported adverse reactions (incidence ≥20%) were: neutropenia (92%), thrombocytopenia (73%), upper respiratory tract infection (65%), infusion reactions (48%), diarrhea (43%), fatigue (35%), cough (30%), muscle spasms (26%), nausea (24%), dyspnea (21%) and pyrexia (20%). The overall incidence of serious adverse reactions was 49%. Serious adverse reactions were pneumonia (12%), upper respiratory tract infection (7%), influenza (3%) and pyrexia (3%).

In patients who received DARZALEX® in combination with bortezomib and dexamethasone, the most frequently reported adverse reactions (incidence ≥20%) were: thrombocytopenia (90%), neutropenia (58%), peripheral sensory neuropathy (47%), infusion reactions (45%), upper respiratory tract infection (44%), diarrhea (32%), cough (27%), peripheral edema (22%), and dyspnea (21%). The overall incidence of serious adverse reactions was 42%. Serious adverse reactions were upper respiratory tract infection (5%), diarrhea (2%) and atrial fibrillation (2%).

In patients who received DARZALEX® as monotherapy, the most frequently reported adverse reactions (incidence ≥20%) were: neutropenia (60%), thrombocytopenia (48%), infusion reactions (48%), fatigue (39%), nausea (27%), back pain (23%), pyrexia (21%), cough (21%), and upper respiratory tract infection (20%). Serious adverse reactions were reported in 51 (33%) patients. The most frequent serious adverse reactions were pneumonia (6%), general physical health deterioration (3%), and pyrexia (3%).

DRUG INTERACTIONS
Effect of Other Drugs on Daratumumab: The coadministration of lenalidomide or bortezomib with DARZALEX® did not affect the pharmacokinetics of daratumumab.

Effect of Daratumumab on Other Drugs: The coadministration of DARZALEX® with bortezomib did not affect the pharmacokinetics of bortezomib.

Please see full Prescribing Information.

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