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 SIMPONI® 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 SIMPONI® 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 Prescription Information and Enrollment 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 Prescription Information and Enrollment 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 SIMPONI® for an FDA-approved indication

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

OR

Download Benefits Investigation & Prescription Form: Gastroenterology, Rheumatology

Complete the form and fax to Janssen CarePath at 855-224-5072

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 SIMPONI® 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 annually 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 just been prescribed SIMPONI® 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 SIMPONI® Prescription Enrollment Form (PEF) through my usual Specialty Pharmacy Provider (SPP)?

No. The SIMPONI® PEF needs 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 SIMPONI® for my commercial patients enrolled in the Janssen Link program?

If insurance coverage is delayed >5 business days or denied, Janssen CarePath will provide SIMPONI® 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 Español

Benefits Investigation & Prescription Form – en Español para Puerto Rico (Reumatólogo)

Prescribing Information & Medication Guide (en Español)

INDICATIONS

SIMPONI® is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with:

  • Moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX)
  • Active psoriatic arthritis (PsA) alone, or in combination with MTX
  • Active ankylosing spondylitis (AS)
  • Moderately to severely active ulcerative colitis (UC) who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6‑mercaptopurine for:
    • Inducing and maintaining clinical response
    • Improving endoscopic appearance of the mucosa during induction
    • Inducing clinical remission
    • Achieving and sustaining clinical remission in induction responders
Important Safety Information For SIMPONI®

SERIOUS INFECTIONS

Patients treated with SIMPONI® (golimumab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI® if a patient develops a serious infection.

Reported infections with TNF blockers, of which SIMPONI® is a member, include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before SIMPONI® use and during therapy. Treatment for latent infection should be initiated prior to SIMPONI® use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with SIMPONI® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Do not start SIMPONI® in patients with clinically important active infections, including localized infections. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with SIMPONI®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.

Risk of infection may be higher in patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. Other serious infections observed in patients treated with SIMPONI® included sepsis, pneumonia, cellulitis, abscess and hepatitis B infection.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers of which SIMPONI® is a member. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children or adolescents. Malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

In the controlled portions of clinical trials of all TNF-blocking agents including SIMPONI®, more cases of lymphoma have been observed among patients receiving TNF-blocking treatment compared with control patients. In the Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), and Ankylosing Spondylitis (AS) clinical trials, the incidence of lymphoma per 100 patient-years of follow-up was 0.21 (95% CI: 0.03, 0.77) in the combined SIMPONI® group compared with an incidence of 0 (95% CI: 0, 0.96) in the placebo group. In clinical trials, the incidence of malignancies other than lymphoma was not increased with exposure to SIMPONI® and was similar to what would be expected in the general population. In controlled and uncontrolled portions of the Phase 2/3 studies in ulcerative colitis (UC) with a mean follow-up of approximately 1 year, there were no cases of lymphoma with SIMPONI®. Short follow-up periods, such as those of 1 year or less in the studies above, may not adequately reflect the true incidence of malignancies. Cases of acute and chronic leukemia have been reported with TNF-blocker use, including SIMPONI®. The risks and benefits of TNF-blocker therapy should be considered prior to initiating therapy in patients with a known malignancy or who develop a malignancy.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers. These cases have had a very aggressive disease course and have been fatal. Nearly all reported cases have occurred in patients with Crohn’s disease or UC, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. A risk for the development for HSTCL in patients treated with TNF blockers cannot be excluded.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including SIMPONI®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

HEPATITIS B REACTIVATION

The use of TNF-blocking agents including SIMPONI® has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants.

All patients should be tested for HBV infection before initiating TNF-blocker therapy. For patients who test positive for hepatitis B surface antigen, consult a physician with expertise in the treatment of hepatitis B before initiating TNF-blocker therapy. Exercise caution when prescribing SIMPONI® for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy with SIMPONI®. Discontinue SIMPONI® in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of SIMPONI®, and monitor patients closely.

HEART FAILURE

Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers, including SIMPONI®. Some cases had a fatal outcome. Exercise caution and monitor patients with heart failure. Discontinue SIMPONI® if new or worsening symptoms of heart failure appear.

DEMYELINATING DISORDERS

TNF-blocking agents, of which SIMPONI® is a member, have been associated with rare cases of new-onset or exacerbation of demyelinating disorders, including multiple sclerosis (MS) and Guillain-Barré syndrome. Cases of central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy have rarely been reported with SIMPONI®. Exercise caution in considering the use of SIMPONI® in patients with these disorders. Consider discontinuation if these disorders develop.

AUTOIMMUNITY

Treatment with TNF blockers, including SIMPONI®, may result in the formation of antinuclear antibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms suggestive of a lupus-like syndrome develop.

HEMATOLOGIC CYTOPENIAS

There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia in patients receiving SIMPONI®. Exercise caution when using SIMPONI® in patients who have or had significant cytopenias.

USE WITH OTHER DRUGS

The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections; therefore the use of SIMPONI® in combination with these products is not recommended. Care should be taken when switching from one biologic to another since overlapping biological activity may further increase the risk of infection. A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. The concomitant use of SIMPONI® with biologics approved to treat RA, PsA, or AS is not recommended because of the possibility of an increased risk of infection.

VACCINATIONS/THERAPEUTIC INFECTIOUS AGENTS

People receiving SIMPONI® can receive vaccinations, except for live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections. Administration of live vaccines to infants exposed to SIMPONI® in utero is not recommended for 6 months following the mother’s last SIMPONI® injection during pregnancy due to an increased risk of infection. It is recommended that therapeutic infectious agents not be given concurrently with SIMPONI® due to the possibility of clinical infections, including disseminated infections.

HYPERSENSITIVITY REACTIONS

Serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported with SIMPONI®, some occurring after the first dose. If an anaphylactic or other serious allergic reaction occurs, discontinue SIMPONI® immediately and institute appropriate therapy.

ADVERSE REACTIONS

The most serious adverse reactions were serious infections and malignancies.

Upper respiratory tract infection and nasopharyngitis were the most common adverse reactions reported in the combined Phase 3 trials through Week 16, occurring in 7% and 6% of patients treated with SIMPONI® as compared with 6% and 5% of patients in the control group, respectively. The rate of injection-site reactions was 6% with patients treated with SIMPONI® compared with 2% of patients in the control group.

In the Phase 2/3 trials in UC evaluating SIMPONI®-treated patients, no new adverse drug reactions were identified, and the frequency of adverse drug reactions was similar to the safety profile observed in patients with RA, PsA, and AS.

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

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