Skip to main content

Access and Cost Support Options for DARZALEX™

Janssen CarePath is a comprehensive support system to help patients start and stay on therapy. Janssen CarePath Case Coordinators can offer you and your patients access support and educational resources related to DARZALEX™ (daratumumab). Below are the many ways we can help you and your patients at every step.

Access Tools

Help patients start therapy by making treatment accessible with services and resources that include:

  • Benefit investigation
  • Prior authorization assistance
  • Patient cost support options
  • Dedicated Case Coordinators who work with you and your patient
  • Billing and coding information

Education Tools

Help keep your patients informed about the disease and their treatment with services and resources that include:

  • Access to nurses who can answer questions about the disease and treatment with DARZALEX™
  • Education about and referral to independent organizations that provide assistance with costs associated with travel to and from treatment
  • A tool that connects patients and caregivers to national and/or state advocacy groups that offer resources relevant to their needs
  • Personalized, live appointment reminders

Getting Started is Easy

Getting Started Images

Complete the Business Associate Agreement* (BAA) one time only

Getting Started Images

Complete the Patient Enrollment Form* (PEF) for each patient or complete online at OncologyCarePathPortal.com

Getting Started Images

Fax the completed forms to 1-844-553-2793

After receiving your completed Patient Enrollment Form, Janssen CarePath will research your patient’s health coverage and return a Verification of Benefits within 48 hours. Janssen CarePath will also attempt to call your patient to review benefits and discuss potential cost support options.

For more information, please call Janssen CarePath at 1-844-55DARZA (1-844-553-2792), Monday-Friday, 8:00 AM to 8:00 PM ET, and speak to a Janssen CarePath Case Coordinator.

Cost Support Options

Your patients may be eligible for programs that can help them afford their treatment with DARZALEX™ (daratumumab).

For more information on these programs please have your patients call Janssen CarePath at 1-844-55DARZA (1-844-553-2792), Monday-Friday, 8:00 AM to 8:00 PM ET, and speak to a Janssen CarePath Case Coordinator.

If your patient has commercial insurance

Janssen CarePath Savings Program for DARZALEX™

Eligible PatientsIf eligible, patients pay no more than $10 for each infusion. Infusions 1-8 are $5 per infusion, and infusions 9+ are $10 per infusion. Subject to a $15,000 maximum annual program benefit for each calendar year. Not valid for patients enrolled in Medicare or Medicaid. Other restrictions may apply.

Rebates are determined by medication cost only, not the cost associated with IV infusion.

For additional details including complete eligibility and restrictions, please visit www.CarePathSavingsProgram.com.

If your patient has Medicare

Janssen CarePath can refer patients to the Medicare Savings Program to discuss eligibility and program benefits. To learn more about eligibility and how the Medicare Savings Program can help patients pay for Medicare Part B products:

  • Visit www.medicare.gov/contacts
  • Click on the link for “Medicare Savings Program (MSPs)” under “Other Helpful Websites”
  • Select the appropriate state

If your patient has Medicare, Medicaid, TRICARE, or commercial insurance

If eligible, patients may able be able to receive cost assistance through independent foundations:

  • CancerCare | cancercare.org | 1-866-552-6729
  • Good Days from CDF | gooddaysfromcdf.org | 1-877-968-7233
  • Patient Advocate Foundation | copays.org | 1-800-532-5274
  • Patient Access Network Foundation | panfoundation.org | 1-866-316-7263
  • Leukemia & Lymphoma Society | lls.org | 1-877-557-2672

Other resources

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is committed to providing access to uninsured patients who lack the financial resources to pay for their medicines. If your patients need DARZALEX™ and are uninsured and unable to pay for their medicine, please contact a JJPAF program specialist at 1-800-652-6227, 9:00 AM to 6:00 PM ET, or visit the foundation website at JJPAF.org to see if they might qualify for assistance.

For a comprehensive list of cost support programs related to DARZALEX™, visit JanssenPrescriptionAssistance.com/DARZALEX.

Janssen Logo

Important Documents

Business Associate Agreement

Allows the sharing of Protected Health Information and ensures HIPAA compliance

Janssen CarePath Patient Enrollment Form for DARZALEX™

Enroll your patients in Janssen CarePath

Janssen CarePath Savings Program Enrollment Form for DARZALEX™

Help your patients apply for cost support to cover part of their treatment costs

Sample Letter of Medical Necessity

Use this template to apply for prior authorization for DARZALEX™ treatment

Sample Exception Letter

Use this template to apply for formulary exception for DARZALEX™ treatment

Contact Janssen CarePath to learn more

To find out all of the ways that CarePath by Janssen can help support you and your patients, please call 1-844-55DARZA (1-844-553-2792), Monday through Friday, 8:00 AM to 8:00 PM ET, and speak to a Janssen CarePath Case Coordinator.

Prefer we call you?

Request a call from a Janssen CarePath Case Coordinator

Please provide us with your contact information below, and one of our Janssen CarePath Case Coordinators will call you back during your preferred time window.

The information you provide will only be used by Janssen Biotech, Inc., our affiliates, and our service providers, to call you during the requested days and times, and for fulfillment of any other services you request. Our Privacy Policy governs the use of the information you provide. By providing the information and selecting the SUBMIT button, you indicate you read, understand, and agree to these terms.

*Required

Important Safety Information

IMPORTANT SAFETY INFORMATION

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.

063320-161115

 

Indication

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.

 

 
Thank you for your request!
A Janssen CarePath Case Coordinator will call you at
your requested date and time.