Helping Patients Afford SIMPONI®
Helping Patients Afford SIMPONI®
Janssen CarePath can help you find out what affordability assistance may be available for your patients taking SIMPONI®. You may download the Affordability Options for SIMPONI® resource for your patients to help them learn about cost support options.
Support for Patients Using Commercial or Private Insurance to Pay for Medication
Janssen CarePath Savings Program for SIMPONI®
Eligible patients using commercial or private insurance can save on out-of-pocket medication costs for SIMPONI®. Depending on their health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Your eligible patients will pay $5 per injection with a $20,000 maximum program benefit per calendar year. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. Program does not cover the cost to give patients their treatment. See full eligibility requirements.
Get your eligible patients started today:
In the Janssen CarePath Provider Portal, you can enroll your eligible patients in the Janssen CarePath Savings Program, review your patients' available benefits, review their Savings Program transactions with the patient's permission, and receive timely alerts and program updates. You can also request and review benefits investigations, and request prior authorization or appeals support.
Already registered? Log In
If you only want to check your patients' eligibility and enroll them in the Janssen CarePath Savings Program for SIMPONI®, click here for the Express Enrollment Site. There is a "Print a Card" feature to provide the patient with a Savings Program card. Your patients will not have a Janssen CarePath account and will not be able to view and manage their Savings Program benefits.
Patients can also create their own Janssen CarePath account where they can enroll in the Janssen CarePath Savings Program, learn about their insurance coverage for SIMPONI®, and sign up for personalized treatment reminders. Encourage your patient to sign up today at MyJanssenCarePath.com.
If your patients' pharmacy is unable to process their Savings Program card, or if you choose to obtain SIMPONI® for your patients, they can complete, sign and return the rebate form, with the required proof of purchase, to receive a rebate check from the Janssen CarePath Savings Program. Click here to get the rebate form.
Support for Patients Using Government-Funded Healthcare Programs or Patients without Insurance Coverage
Janssen CarePath can provide information about other resources that may be able to help your patients with their out-of-pocket medication costs:
- State Pharmaceutical Assistance Programs (SPAPs)
- State Health Insurance Programs (SHIPs)
- Medicare Savings Program
- Medicare Part D Extra Help—Low-Income Subsidy
- Independent Foundations*
Call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728) or click here for more information on affordability programs that may be available.
*Independent co-pay assistance foundations have their own rules for eligibility. We have no control over these independent foundations and can only refer your patients to a foundation that supports their disease state. We do not endorse any particular foundation.
Johnson & Johnson Patient Assistance Foundation, Inc.
The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson. Patients may be eligible if they don't have insurance, if their medicine is not covered by insurance, or if they have Medicare coverage and can't pay for their medicine.
Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 800-652-6227 (Monday through Friday, 9:00 AM to 6:00 PM ET).
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
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.
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.
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.
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.
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.
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.
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.
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.