Stelara®

Janssen CarePath Provider Portal

SIGN UP LOG IN

  • Benefits investigations & prior authorizations
  • Enroll eligible patients in Savings Program
  • View Savings Program transactions

Janssen Link

Janssen Link logo

Supports eligible, commercially insured patients until they receive coverage for their prescribed treatment

Janssen Link enables eligible patients to receive subcutaneous STELARA® at no cost until they receive coverage or until the end of the current program year if the following program requirements are met.

Janssen Link Program Requirements

Janssen CarePath Patients
  • Patient has been prescribed subcutaneous STELARA® for an on-label, FDA-approved indication
  • Patient has commercial insurance that has delayed (>5 business days) or denied their treatment
  • Patient does not use any state or federal government-funded healthcare program to cover a portion of medication costs, such as Medicare, Medicaid, TRICARE, Department of Defense, or Veterans Administration
  • Patient cannot submit the value of the free product as a claim for payment to any third-party payer
  • Patient is not eligible if the prior authorization is denied due to missing information on coverage determination form, use for a non-FDA-approved indication, or invalid clinical rationale
  • Patient must contact Janssen CarePath if the patient switches from commercial health insurance coverage to a government-funded healthcare program at any point during the program year
Janssen CarePath HCP
  • Prescriber must complete and submit an electronic enrollment in the Provider Portal or fax the Benefits Investigation and Prescription Form to Janssen CarePath to enroll patient in Janssen Link
    • Janssen CarePath cannot accept any information without an executed Business Associate Agreement or Patient Authorization on file. The patient authorization can be found on the Benefits Investigation and Prescription Form. Or patient can create an account on MyJanssenCarePath.com and electronically sign a patient authorization there.
  • Prescriber agrees to not purchase the Janssen medication on behalf of Janssen Link patient participants, and not bill commercial payers for any part of the prescribed subcutaneous treatment
  • Prescriber completes and submits a form of coverage determination (ie, prior authorization or prior authorization with exception) to the commercial insurance
  • If coverage is denied, prescriber challenges the coverage denial with an exception, Letter of Medical Necessity, or appeal

How Janssen Link Works

  • Program covers the cost of therapy only - not associated administration cost
  • No portion of the value of the free product will count towards the patient's applicable out-of-pocket cost-sharing obligations
  • Program year runs March 1 - February 28
  • Janssen CarePath reserves the right to cancel or modify Janssen Link at any time

Getting started with Janssen Link

Prescribe subcutaneous STELARA® for an FDA-approved indication

Complete a benefits investigation request in the Provider Portal at JanssenCarePathPortal.com

OR

Download Benefits Investigation and Prescription Form

Complete the form and fax to Janssen CarePath at 866-769-3903

Participating prescribers authorize Janssen CarePath to:

  • Conduct a benefits investigation and confirm prior authorization requirements
  • Provide prior authorization form assistance and status monitoring, including the exceptions and appeals processes
  • Coordinate shipment of subcutaneous STELARA® from the program Specialty Pharmacy to eligible patients at no charge until they have coverage or until the end of the current program year
  • Support the transition of patients to commercial product if a favorable coverage determination is made within 90 days of the PA submission
  • Conduct verification of insurance coverage in January of each year for patients enrolled in the program and any time for patients who have coverage change throughout the program year to confirm eligibility criteria are met for continued participation

FAQs

Which of my patients are eligible for the Janssen Link program?

Eligible patients are those who have been prescribed subcutaneous STELARA® for an FDA-approved indication and who are commercially insured and whose insurance has delayed (>5 business days) or denied their treatment. Patients using any state or federal government-funded healthcare programs, such as Medicare, Medicaid, TRICARE, Department of Defense, and Veterans Administration, are excluded from participating.

Can I submit the subcutaneous STELARA® Benefits Investigation and Prescription Forms (PEFs) through my usual Specialty Pharmacy Provider (SPP)?

No. Subcutaneous STELARA® PEFs need to be submitted through Janssen CarePath for your patient to be eligible for Janssen Link.

Can my office participate in Janssen Link without an executed Business Associate Agreement (BAA)?

Yes. If you do not have an executed BAA on file, each of your patients will simply have to sign the Patient Authorization on the PEF to opt in to Janssen CarePath support services. Or you can invite each patient to create an account on MyJanssenCarePath.com and electronically sign a patient authorization there.

If you would prefer to complete a BAA, fill out the form available here.

How long will Janssen CarePath provide subcutaneous STELARA® for my commercial patients enrolled in the Janssen Link program?

If insurance coverage is delayed >5 business days or denied, Janssen CarePath will provide subcutaneous STELARA® at no cost through the program year. For example, if your patient enrolls in the program in May or June, he or she will be enrolled until the end of February if his or her commercial insurance continues to be delayed (>5 business days) or denied.

Applicants in November or December who are approved will be covered through the following year if insurance coverage continues to be delayed (>5 business days) or denied.

If, at the end of one year, insurance coverage has not been secured, patients can repeat the program process and re-enroll for another program year if they remain eligible and you and the patient choose to continue treatment.

Program Materials en Espanol

Rheum Prescription Enrollment Form – en Espanol para Puerto Rico

Derm Prescription Enrollment Form – en Espanol para Puerto Rico

Full Prescribing Information and Medication Guide – en Espanol

Indications

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 12 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.

Important Safety Information For STELARA®

STELARA® (ustekinumab) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients.

Infections

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, e.g., 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.

Malignancies

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

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®.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

One case of reversible posterior leukoencephalopathy syndrome (RPLS) was observed in clinical studies of psoriasis and psoriatic arthritis. No cases of RPLS were observed in clinical studies of Crohn’s disease or ulcerative colitis. If RPLS is suspected, administer appropriate treatment and discontinue STELARA®. RPLS is a neurological disorder, which is not caused by an infection or demyelination. RPLS can present with headache, seizures, confusion, and visual disturbances. RPLS has been associated with fatal outcomes.

Immunizations

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.

Concomitant Therapies

The safety of STELARA® in combination with other 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®.

Noninfectious Pneumonia

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.

Allergen Immunotherapy

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 adolescents with plaque psoriasis through Week 60 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%).

Please see full Prescribing Information and Medication Guide for STELARA®. Provide the Medication Guide to your patients and encourage discussion.

cp-124933v1