PREZCOBIX® Insurance Coverage for Patients
Verifying Patient Insurance Coverage
Access Support to Help Navigate Payer Processes
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.
- Information on payer policies and coverage for Janssen products
Investigation of patient eligibility and coverage:
- Patient-specific benefits
- Requirements for prior authorization process
- Benefits summary for physicians, staff, and patients
- Prior authorization support and status monitoring
- Information on the appeals process for administrative denials
Janssen CarePath Provider Portal
Verifying your patients' benefits is easy with the Provider Portal. The Janssen CarePath Provider Portal gives you 24-hour online access to request and review benefits investigations, request prior authorization support and status monitoring, request exceptions and appeals research, and enroll patients in the Janssen CarePath Savings Program.
To get started
Create a Provider Portal account at JanssenCarePathPortal.com
- Complete required information, include your practice locations, add administrators and staff to your site, and set communication preferences
Complete the Business Associate Agreement (BAA) for your practice (one time only)
The completed BAA allows you to request verification of patients' insurance benefits and enroll eligible patients in the Janssen CarePath Savings Program without requiring individual patient authorization
- You can execute the BAA within the Portal and receive immediate verification and access to the Portal, or
- You can download the BAA and upload the signed document via the Portal or fax to the number provided on the form
Secure patient authorization (for each patient)
- Invite each patient to create an online account at MyJanssenCarePath.com to secure patient authorization, or
- You can download the Patient Authorization Form and upload the signed document via the Portal or fax to the number provided on the form
We cannot accept any information without an executed BAA or Patient Authorization on file.
If you have a BAA or Patient Authorization on file with us, please Sign Up for the Provider Portal at JanssenCarePathPortal.com.
Registered or returning Provider Portal users, Log In here.
Benefits Investigation Form
If you prefer, you can complete the benefits investigation form and submit it to us via fax. Download the benefits investigation form (BIF) here.
Patients can also create their own Janssen CarePath Account where they can check their insurance coverage for PREZCOBIX®, enroll in the Janssen CarePath Savings Program, and sign up for personalized treatment reminders. Encourage your patient to sign up today at MyJanssenCarePath.com.
Quick Guide to Understanding Verification of Benefits
Once your patient's benefits investigation is completed, you will receive a Verification of Benefits Form for Pharmacy Benefits. Download a guide for help understanding the Verification of Benefits.
Letter of Medical Necessity
Submit a letter of medical necessity with either the initial claim to support the medical necessity of treatment with PREZCOBIX® for your patient or submit it to support the medical necessity of treatment with PREZCOBIX® when requesting reconsideration of a denied claim.
Or download an editable Letter of Medical Necessity template for PREZCOBIX®.
Exceptions & Appeals Process
Each payer follows a different process for filing exceptions and appeals. If you are looking for general information to start the process, Janssen CarePath can help. Please call a Care Coordinator at 877-CarePath (877-227-3728). It is important to contact the payer directly or consult its website to obtain product-specific information.
Here's a helpful guide to share with your patients:
Prior Authorization Assistance
Our Prior Authorization (PA) Assistance includes*:
- Researching patient’s health plan for PA requirements
- Providing payer-specific PA form for online completion by the provider in the portal
- Monitoring status of the PA submission
*We do not fill out any information that requires the medical judgment of the prescriber, and only the prescriber can determine whether to pursue a PA.
A standardized, or "uniform," PA form may be required in certain states to submit PA requests to a health plan for review, along with the necessary clinical documentation. These standard forms can be used across payers and health benefit managers.
- Standardized PA Forms are only applicable to prescription drug benefits; they are not applicable to medical services or procedures.
- Standardized PA Forms are typically not applicable to self-funded employer-sponsored health plans, Medicare Part D plans, and Medicaid fee-for-service plans.
Please visit the Know Your State Interactive Tool to learn what is required for your state.
PREZCOBIX® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
- Do not coadminister PREZCOBIX® and the following drugs due to the potential for serious and/or life-threatening events or loss of therapeutic effect: alfuzosin, carbamazepine, colchicine (in patients with renal and/or hepatic impairment), dihydroergotamine, dronedarone, elbasvir/grazoprevir, ergotamine, ivabradine, lomitapide, lovastatin, lurasidone, methylergonovine, oral midazolam, naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John’s wort (Hypericum perforatum), sildenafil for pulmonary arterial hypertension, simvastatin, and triazolam.
Warnings and Precautions
Hepatotoxicity: Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse reactions. Drug-induced hepatitis and cases of liver injury, including some fatalities, have been reported.
Appropriate laboratory testing should be conducted prior to initiating and during therapy with PREZCOBIX®. Evidence of new or worsening liver dysfunction in patients on PREZCOBIX® should prompt consideration of interruption or discontinuation of treatment.
Severe Skin Reactions: Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported in patients receiving darunavir coadministered with ritonavir. Mild-to-moderate rash was also reported and often occurred and resolved with continued dosing. Discontinue PREZCOBIX® immediately if signs or symptoms of severe skin reaction develop.
Sulfa Allergy: Monitor patients with a known sulfonamide allergy after initiating PREZCOBIX®.
Effects on Serum Creatinine: Cobicistat decreases estimated creatinine clearance (CrCl) due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. Prior to starting PREZCOBIX®, assess estimated CrCl. Patients who experience a confirmed increase in serum creatinine of greater than 0.4 mg/dL from baseline should be closely monitored for renal safety. Consider alternative medications that do not require dosage adjustments in patients with renal impairment.
Renal Impairment When Used With Tenofovir Disoproxil Fumarate: Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported with the use of tenofovir DF and cobicistat. Coadministration with tenofovir DF is not recommended in patients who have an estimated CrCl <70 mL/min. In all patients, monitor estimated CrCl, urine glucose, and urine protein prior to initiating and during therapy. Measure serum phosphorus in patients at risk of renal impairment. Coadministration of PREZCOBIX® and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended.
Risk of Serious Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Initiation of PREZCOBIX®, which inhibits CYP3A, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PREZCOBIX® may increase plasma concentrations of medications metabolized by CYP3A and reduce plasma concentrations of active metabolite(s) formed by CYP3A. Initiation of medications that inhibit or induce CYP3A may respectively increase or decrease concentrations of PREZCOBIX®. These interactions may lead to clinically significant adverse reactions, potentially leading to severe, life threatening, or fatal events from higher exposures of concomitant medications; clinically significant adverse reactions from higher exposures of PREZCOBIX®; loss of therapeutic effect of concomitant medications from lower exposures of active metabolite(s); or loss of therapeutic effect of PREZCOBIX® and possible development of resistance from lower exposures of PREZCOBIX®.
Antiretrovirals Not Recommended: Do not use PREZCOBIX® in combination with other antiretroviral drugs that require pharmacokinetic boosting or which contain the individual components of PREZCOBIX® (darunavir and cobicistat) or with ritonavir.
Diabetes Mellitus/Hyperglycemia and Hemophilia: New onset or exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported in patients receiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. Increased bleeding in hemophiliacs has been reported in patients receiving protease inhibitors.
Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy.
Immune Reconstitution Syndrome including the occurrence of autoimmune disorders with variable time to onset has been reported.
- The most common clinical adverse reactions (incidence ≥5%) of at least moderate intensity (≥Grade 2) were diarrhea, nausea, rash, headache, abdominal pain, and vomiting during the darunavir clinical development program, where darunavir was coadministered with ritonavir.
This is not a complete list of all adverse drug reactions reported with the use of PREZCOBIX®. Please refer to the full Prescribing Information for a complete list of adverse drug reactions.
- Consult the full Prescribing Information for PREZCOBIX® for information on potentially significant drug interactions, including clinical comments.
Use in Specific Populations
- PREZCOBIX® is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.
PREZCOBIX® should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with PREZCOBIX®.
Lactation: The Centers for Disease Control and Prevention recommends that HIV-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.
The safety and effectiveness of PREZCOBIX® have not been established and is not recommended in pediatric patients weighing less than 40 kg.
- Consult the full Prescribing Information for PREZCOBIX® for additional information on the Uses in Specific Populations.
Please see full Prescribing Information for more details.