Benefits Investigation Support
Benefits Investigation Support
Access Support to Help Navigate Payer Processes
Janssen CarePath provides benefits information that may help your patients get the Janssen medication you have determined is right for them. Contact us directly and get started today.
Investigation of patient eligibility and coverage:
- Patient-specific benefits, including investigation for both IV induction and SC maintenance doses for Crohn’s disease and ulcerative colitis patients
- Requirements for prior authorization process
- Prior authorization support and status monitoring
- Convenient electronic portal for online benefits investigations and prior authorization submissions
- Benefits summary available 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
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 use the Provider Portal 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 Forms
Select the appropriate benefits investigation form, complete, and submit to us via fax.*
For gastroenterology: STELARA® Gastro Benefits Investigation and Prescription Form (BIF/PEF)
For dermatology: STELARA® Derm Benefits Investigation and Prescription Form (PEF)
For rheumatology: STELARA® Rheum Benefits Investigation and Prescription Form (PEF)
*Janssen CarePath cannot accept any patient information without an executed BAA or individual patient authorization.
Quick Guides to Understanding Verification of Benefits Forms
Once your patient's benefits investigation is completed, you will receive either a Pharmacy Benefits or a Medical Benefits Verification of Benefits Form, depending on your patient's insurance coverage. Download a quick guide to Verification of Benefits Forms that may help with quickly understanding these forms.
Letter of Medical Necessity
Submit a letter to support the medical necessity of treatment with STELARA® either with the initial claim or when requesting reconsideration of a denied claim.
Or download an editable Letter of Medical Necessity template for STELARA®.
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
- Notifying your office 30 days before PA expiration
† 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.
Patient insurance benefits investigation and other Janssen CarePath program offerings are provided by third-party service providers for Janssen CarePath, under contract with Johnson & Johnson Health Care Systems Inc. on behalf of Janssen Pharmaceuticals, Inc., Janssen Biotech, Inc., and Janssen Products, LP (Janssen). Janssen CarePath is not available to patients participating in the Patient Assistance Program offered by Johnson & Johnson Patient Assistance Foundation. The availability of information and assistance may vary based on the Janssen medication, geography and other program differences. Janssen CarePath assists healthcare providers (HCPs) in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer, and patient information provided by the HCP under appropriate authorization following the provider's exclusive determination of medical necessity. This information and assistance are made available as a convenience to patients, and there is no requirement that patients or HCPs use any Janssen product in exchange for this information or assistance. Janssen assumes no responsibility for and does not guarantee the quality, scope, or availability of the information and assistance provided. The third-party service providers, not Janssen, are responsible for the information and assistance provided under this program. Each HCP and patient is responsible for verifying or confirming any information provided. All claims and other submissions to payers should be in compliance with all applicable requirements.
STELARA® (ustekinumab) is indicated for the treatment of adult patients with active psoriatic arthritis. STELARA® can be used alone or in combination with methotrexate (MTX).
STELARA® (ustekinumab) is indicated for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.
STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
STELARA® (ustekinumab) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients.
STELARA® may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections requiring hospitalization or otherwise clinically significant infections were reported. In patients with psoriasis, these included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. In patients with psoriatic arthritis, this included cholecystitis. In patients with Crohn’s disease, these included anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and Listeria meningitis. In patients with ulcerative colitis, these included gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.
Treatment with STELARA® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA® in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA® and consider discontinuing STELARA® for serious or clinically significant infections until the infection resolves or is adequately treated.
Theoretical Risk for Vulnerability to Particular Infections
Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA® may be susceptible to these types of infections. Appropriate diagnostic testing should be considered (eg, tissue culture, stool culture) as dictated by clinical circumstances.
Pre-Treatment Evaluation of Tuberculosis (TB)
Evaluate patients for TB prior to initiating treatment with STELARA®. Do not administer STELARA® to patients with active tuberculosis infection. Initiate treatment of latent TB before administering STELARA®. Closely monitor patients receiving STELARA® for signs and symptoms of active TB during and after treatment.
STELARA® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among patients who received STELARA® in clinical studies. The safety of STELARA® has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA® who had risk factors for developing non-melanoma skin cancer (NMSC). All patients receiving STELARA®, especially those >60 years or those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.
Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA®. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA®.
Posterior Reversible Encephalopathy Syndrome (PRES)
Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.
Monitor all patients treated with STELARA® for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STELARA®.
Prior to initiating therapy with STELARA®, patients should receive all age-appropriate immunizations recommended by current guidelines. Patients being treated with STELARA® should not receive live vaccines. BCG vaccines should not be given during treatment or within one year of initiating or discontinuing STELARA®. Exercise caution when administering live vaccines to household contacts of STELARA® patients, as shedding and subsequent transmission to STELARA® patients may occur. Non-live vaccinations received during a course of STELARA® may not elicit an immune response sufficient to prevent disease.
The safety of STELARA® in combination with other biologic immunosuppressive agents or phototherapy was not evaluated in clinical studies of psoriasis. Ultraviolet-induced skin cancers developed earlier and more frequently in mice. In psoriasis studies, the relevance of findings in mouse models for malignancy risk in humans is unknown. In psoriatic arthritis studies, concomitant methotrexate use did not appear to influence the safety or efficacy of STELARA®. In Crohn’s disease and ulcerative colitis induction studies, concomitant use of 6-mercaptopurine, azathioprine, methotrexate, and corticosteroids did not appear to influence the overall safety or efficacy of STELARA®.
Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA®. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and, in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue STELARA® and institute appropriate treatment.
STELARA® may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.
Most Common Adverse Reactions
The most common adverse reactions (≥3% and higher than that with placebo) in adults from psoriasis clinical studies for STELARA® 45 mg, STELARA® 90 mg, or placebo were: nasopharyngitis (8%, 7%, 8%), upper respiratory tract infection (5%, 4%, 5%), headache (5%, 5%, 3%), and fatigue (3%, 3%, 2%), respectively. The safety profile in pediatric patients with plaque psoriasis was similar to that of adults with plaque psoriasis. In psoriatic arthritis (PsA) studies, a higher incidence of arthralgia and nausea was observed in patients treated with STELARA® when compared with placebo (3% vs 1% for both). In Crohn’s disease induction studies, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 8 for STELARA® 6 mg/kg intravenous single infusion or placebo included: vomiting (4% vs 3%). In the Crohn’s disease maintenance study, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 44 for STELARA® 90 mg subcutaneous injection or placebo were: nasopharyngitis (11% vs 8%), injection site erythema (5% vs 0%), vulvovaginal candidiasis/mycotic infection (5% vs 1%), bronchitis (5% vs 3%), pruritus (4% vs 2%), urinary tract infection (4% vs 2%) and sinusitis (3% vs 2%). In the ulcerative colitis induction study, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 8 for STELARA® 6 mg/kg intravenous single infusion or placebo included: nasopharyngitis (7% vs 4%). In the ulcerative colitis maintenance study, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 44 for STELARA® 90 mg subcutaneous injection or placebo included: nasopharyngitis (24% vs 20%), headache (10% vs 4%), abdominal pain (7% vs 3%), influenza (6% vs 5%), fever (5% vs 4%), diarrhea (4% vs 1%), sinusitis (4% vs 1%), fatigue (4% vs 2%), and nausea (3% vs 2%).