Benefits Investigation Support

Benefits Investigation Support

Access to the Information You May Need

Janssen CarePath provides benefits information that may help your patients get the Janssen treatment you may be considering for them. Contact us directly and get started today.

  • Investigation of patient eligibility and coverage:
    • Patient-specific benefits
    • Requirements for prior authorization process
    • Prior authorization support and status monitoring
  • Benefits summary for physicians and staff
  • Information on payer policies and coverage for Janssen products
  • Information on the appeals process for administrative denials
  • Billing and coding information

Benefits Investigation Form (BIF)

If you’d like us to research coverage for your patient, simply submit a Benefits Investigation Form (BIF).

Business Associate Agreement (BAA)

Use this Business Associate Agreement to help be compliant with the Health Insurance Portability and Accountability Act of 1996 ("HIPAA").

Sample Letter of Medical Necessity

Sample letter that you can submit with either the initial claim to support the medical necessity of treatment with SYLVANT® for your patient or submit it to support the medical necessity of treatment with SYLVANT® when requesting reconsideration of a denied claim. Click here for the sample letter.

Indication

SYLVANT® (siltuximab) is indicated for the treatment of patients with Multicentric Castleman's Disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Limitation of Use. SYLVANT® was not studied in patients with MCD who are HIV-positive or HHV-8 positive because SYLVANT® did not bind to virally produced IL-6 in a nonclinical study.

Important Safety Information For SYLVANT®

CONTRAINDICATIONS – Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT®.

Concurrent Active Severe Infections – Do not administer to patients with severe infections until the infection resolves. SYLVANT® may mask signs and symptoms of acute inflammation including suppression of fever and of acute phase reactants such as C-reactive protein (CRP). Monitor patients closely for infections. Institute prompt anti-infective therapy and do not administer further SYLVANT® until the infection resolves.

Vaccinations – Do not administer live vaccines to patients receiving SYLVANT® because interleukin-6 (IL-6) inhibition may interfere with the normal immune response to new antigens.

Infusion Related Reactions and Hypersensitivity – Stop the infusion if the patient develops signs of anaphylaxis. Discontinue further therapy.

Stop the infusion if the patient develops mild to moderate infusion reactions. If the reaction resolves, the infusion may be restarted at a lower infusion rate. Consider medicating with antihistamines, acetaminophen, and corticosteroids. Discontinue SYLVANT® if the patient does not tolerate the infusion following these interventions.

Administer SYLVANT® in a setting that provides resuscitation equipment, medication, and personnel trained to provide resuscitation.

Gastrointestinal (GI) Perforation – Use with caution in patients who may be at increased risk for GI perforation. Promptly evaluate patients presenting with symptoms that may be associated with or suggestive of GI perforation.

Adverse Reactions – The most common adverse reactions (>10% compared to placebo) in the MCD clinical trial were pruritus, increased weight, rash, hyperuricemia, and upper respiratory tract infection.

Drug Interactions Cytochrome P450 (CYP450) Substrates – Upon initiation or discontinuation of SYLVANT®, in patients being treated with CYP450 substrates with narrow therapeutic index, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) as needed and adjust dose. Exercise caution when SYLVANT® is co-administered with CYP3A4 substrate drugs where a decrease in effectiveness would be undesirable (e.g., oral contraceptives, lovastatin, atorvastatin).

Please click here to read full Prescribing Information for SYLVANT®.

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