PREZCOBIX® Insurance Coverage for Patients
Verifying Patient Insurance Coverage
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.
- 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 new Janssen CarePath Provider Portal gives you 24-hour online access to request and review benefits investigations, provide prior authorization support and status monitoring, request exceptions and appeals research, and enroll patients in the Janssen CarePath Savings Program.
To get started
Complete a Business Associate Agreement (BAA) for your practice one time only. The completed BAA allows you to request verification of patient benefits without requiring individual patient authorization.
- Complete an individual Patient Authorization for each patient including the patient signature. Individual patient authorization is not required if BAA is on file.
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 benefit investigation form and submit it to us via fax. Download the benefit investigation form (BIF) here.
Patients can also create their own Janssen CarePath Account where they can learn about 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.
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 click here for a sample format letter 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 Web site to obtain product-specific information.
Here's a helpful guide to share with your patients:
Prior Authorization Information
Some health plans in select states must use their state's Uniform Prior Authorization Request Form.
Click here to see if your state is included:
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 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, cisapride, colchicine (in patients with renal and/or hepatic impairment), dihydroergotamine, dronedarone, elbasvir/grazoprevir, ergotamine, lomitapide, lovastatin, lurasidone, methylergonovine, oral midazolam, 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: PREZCOBIX® is a CYP3A inhibitor. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PREZCOBIX® or the concomitant medications. This may lead to clinically significant adverse reactions (potentially leading to severe, life threatening, or fatal events) from higher exposures of the concomitant medications or adverse reactions from higher exposures of PREZCOBIX®. Decreased concentrations of PREZCOBIX® may result in loss of therapeutic effect and possible development of resistance.
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.
- Consult the full Prescribing Information for PREZCOBIX® for additional information on the Uses in Specific Populations.
Please see full Prescribing Information for more details.