Benefits Investigation Support
Benefits Investigation Support
Access to the Information You May Need
Click here for Prescription Enrollment Form.
Janssen CarePath provides benefits information that may help your patients get the Janssen treatments you have determined are right 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 available 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 enhanced Janssen CarePath Provider Portal gives you 24-hour online access to request and review benefits investigations, request prior authorization support and status monitoring, and request exceptions and appeals research, and enroll patients in the Janssen CarePath Savings Program. Through the benefits investigation process in the Provider Portal, you can enroll your eligible patients in additional Janssen CarePath resources, including Pretest scheduling support, Janssen CarePath Trial Offer for PONVORY™, Janssen Link for PONVORY™, and The Wellness Companion Program* by Janssen CarePath.
Download an overview of the Provider Portal here.
To get started:
- Create a Provider Portal Account at JanssenCarePathPortal.com
Secure Patient Authorization for each patient. Janssen CarePath cannot accept any patient information without an individual patient authorization on file.
- Your patient can sign the Patient Authorization section of the Prescription Enrollment Form in your office and you can upload the signed copy to your Provider Portal Account or you can fax to the number provided on the form
Direct your patient to MyJanssenCarePath.com/PatientAuth to electronically sign the patient authorization
- Patients can download the Patient Authorization and mail to the address or fax to the number provided on the form
*The Wellness Companion Program is limited to education for patients about their Janssen therapy, its administration, and/or their disease. It is intended to supplement a patient's understanding of their therapy. It does not provide medical advice, health coaching or improved wellness as a result of engaging with the program, replace a treatment plan from the patient's doctor or nurse, provide case management services, or serve as a reason to prescribe.
Prescription Enrollment Form (PEF)
If you prefer, you can complete the Prescription Enrollment Form and submit it to us via fax.* Download the Prescription Enrollment Form (PEF) here.
Patients can also create their own Janssen CarePath Account where they can learn about their insurance coverage for PONVORY™, enroll in the Janssen CarePath Savings Program, and sign up for personalized treatment reminders. Encourage your patient to sign up today at MyJanssenCarePath.com.
*Janssen CarePath cannot accept any patient information without an individual patient authorization. In addition, a benefits investigation must be submitted for each patient for whom treatment with Janssen medication is requested.
Letter of Medical Necessity
Submit a Letter of Medical Necessity to support the medical necessity of treatment with PONVORY™ either with the initial claim or when requesting reconsideration of a denied claim.
Or download an editable Letter of Medical Necessity template for PONVORY™.
Letter of Exception
Each payer follows a different process when filing exceptions. Create and submit your own exception request letter when requesting an exception for PONVORY™.
Or download an editable Letter of Exception template for PONVORY™.
Letter of Appeal
Download an editable Letter of Appeal template for PONVORY™.
Prior Authorization (PA) 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 judgement of the prescriber, and only the prescriber can determine whether to pursue a prior authorization.
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.
PONVORY™ is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
PONVORY™ is contraindicated in patients who:
- In the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure.
- Have presence of Mobitz Type II second-degree, third-degree atrioventricular (AV) block, or sick sinus syndrome, or sino-atrial block, unless patient has a functioning pacemaker.
WARNINGS AND PRECAUTIONS
Risk of Infections
PONVORY™ causes a dose-dependent reduction in peripheral lymphocyte count to 30-40% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues. PONVORY™ may increase the susceptibility to infections. Life-threatening and rare fatal infections have been reported in association with other sphingosine 1-phosphate (S1P) receptor modulators. Before initiating treatment with PONVORY™, results from a recent complete blood count including lymphocyte count should be reviewed.
Herpes Viral Infections
Cases of herpes viral infection have been reported in the development program of PONVORY™; herpes simplex encephalitis and varicella zoster meningitis have been reported with other S1P receptor modulators. Patients without a healthcare professional confirmed history of varicella (chickenpox) or without documentation of a full course of vaccination should be tested for antibodies to VZV prior to initiating PONVORY™.
Cases of fatal cryptococcal meningitis (CM) and disseminated cryptococcal infections have been reported with other S1P receptor modulators. Physicians should be vigilant for clinical symptoms or signs of CM. Patients with symptoms or signs consistent with a cryptococcal infection should undergo prompt diagnostic evaluation and treatment. PONVORY™ treatment should be suspended until a cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.
Progressive Multifocal Leukoencephalopathy (PML)
PML has been reported in patients treated with a S1P receptor modulator and other multiple sclerosis (MS) therapies and has been associated with some risk factors (e.g., immunocompromised patients, polytherapy with immunosuppressants). Physicians should be vigilant for clinical symptoms or magnetic resonance imaging (MRI) findings that may be suggestive of PML. MRI findings may be apparent before clinical signs or symptoms. If PML is suspected, treatment with PONVORY™ should be suspended until PML has been excluded.
If PML is confirmed, treatment with PONVORY™ should be discontinued.
Prior and Concomitant Treatment with Anti-neoplastic, Immune-Modulating, or Immunosuppressive Therapies
Anti-neoplastic, immune-modulating, or immunosuppressive therapies (including corticosteroids) should be co-administered with caution because of the risk of additive immune system effects.
Patients without a confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating PONVORY™ treatment. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with PONVORY™, following which initiation of treatment should be postponed for 4 weeks to allow the full effect of vaccination to occur.
No clinical data are available on the efficacy and safety of vaccinations in patients taking PONVORY™. Vaccinations may be less effective if administered during PONVORY™ treatment. If live attenuated vaccines are required, administer at least 1 month prior to initiation of PONVORY™. Avoid the use of live attenuated vaccines during and for 1 to 2 weeks after treatment of PONVORY™.
Bradyarrhythmia and Atrioventricular Conduction Delays
Since initiation of PONVORY™ treatment results in a transient decrease in heart rate and atrioventricular (AV) conduction delays, an up-titration scheme must be used to reach the maintenance dosage of PONVORY™ (20 mg).
Reduction in Heart Rate
Initiation of PONVORY™ may result in a transient decrease in heart rate. After the first titration dose of PONVORY™, the decrease in heart rate typically begins within an hour and reaches its nadir within 2-4 hours. The heart rate typically recovers to baseline levels 4-5 hours after administration.
Atrioventricular Conduction Delays
Initiation of PONVORY™ treatment has been associated with transient atrioventricular conduction delays that follow a similar temporal pattern as the observed decrease in heart rate during dose titration. If treatment with PONVORY™ is considered, advice from a cardiologist should be sought for individuals:
- With significant QT prolongation (QTc greater than 500 msec).
- With atrial flutter/fibrillation or arrhythmia treated with Class Ia or Class III anti-arrhythmic drugs.
- With unstable ischemic heart disease, cardiac decompensated failure occurring more than 6 months prior to treatment initiation, history of cardiac arrest, cerebrovascular disease (TIA, stroke occurring more than 6 months prior to treatment initiation), or uncontrolled hypertension.
- With a history of Mobitz Type II second degree AV block or higher-grade AV block, sick-sinus syndrome, or sino-atrial heart block.
Obtain an ECG in all patients to determine whether preexisting conduction abnormalities are present. For patients taking other drugs that decrease heart rate, treatment with PONVORY™ should generally not be initiated without consultation from a cardiologist because of the potential effect on heart rate. In all patients, a dose titration is recommended for initiation of PONVORY™ treatment to help reduce cardiac effects.
Dose-dependent reductions in forced expiratory volume over 1 second (FEV1) and reductions in diffusion lung capacity for carbon monoxide (DLCO) were observed in PONVORY™-treated patients mostly occurring in the first month after treatment initiation. Spirometric evaluation of respiratory function should be performed during therapy with PONVORY™ if clinically indicated.
Elevations of transaminases may occur in PONVORY™-treated patients. Obtain transaminase and bilirubin levels, if not recently available (i.e., within last 6 months) before initiation of PONVORY™ therapy.
Patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, rash with eosinophilia, or jaundice and/or dark urine during treatment, should have hepatic enzymes checked. PONVORY™ should be discontinued if significant liver injury is confirmed.
No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A). PONVORY™ is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh class B and C, respectively).
Increased Blood Pressure
PONVORY™-treated patients had an average increase of 2.9 mmHg in systolic blood pressure and 2.8 mmHg in diastolic blood pressure. Blood pressure should be monitored during treatment with PONVORY™ and managed appropriately.
Cases of basal cell carcinoma and other skin malignancies have been reported in patients treated with S1P receptor modulators, including PONVORY™. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Providers and patients are advised to monitor for suspicious skin lesions. If a suspicious skin lesion is observed, it should be promptly evaluated. As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor. Concomitant phototherapy with UV-B radiation or PUVA-photochemotherapy is not recommended in patients taking PONVORY™.
Based on animal studies, PONVORY™ may cause fetal harm. Because it takes approximately 1 week to eliminate PONVORY™ from the body, women of childbearing potential should use effective contraception to avoid pregnancy during and for 1 week after stopping PONVORY™ treatment.
S1P receptor modulators, including PONVORY™, have been associated with an increased risk of macular edema. An ophthalmic evaluation of the fundus, including the macula, is recommended in all patients before starting treatment and again at any time if a patient reports any change in vision while on PONVORY™ therapy. Continuation of therapy in patients with macular edema has not been evaluated.
Macular Edema in Patients with a History of Uveitis or Diabetes Mellitus
Patients with a history of uveitis and patients with diabetes mellitus are at increased risk of macular edema during therapy with S1P receptor modulators, including PONVORY™. Therefore, these patients should have regular follow-up examinations of the fundus, including the macula, during treatment with PONVORY™.
Posterior Reversible Encephalopathy Syndrome
Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving a sphingosine 1-phosphate (S1P) receptor modulator. Such events have not been reported for PONVORY™-treated patients in the development program. However, should a PONVORY™-treated patient develop any unexpected neurological or psychiatric symptoms/signs (e.g., cognitive deficits, behavioral changes, cortical visual disturbances, or any other neurological cortical symptoms/signs), any symptom/sign suggestive of an increase of intracranial pressure, or accelerated neurological deterioration, the physician should promptly schedule a complete physical and neurological examination and should consider an MRI. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, PONVORY™ should be discontinued.
Unintended Additive Immunosuppressive Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Therapies
When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered in order to avoid unintended additive effects on the immune system while at the same time minimizing risk of disease reactivation, when initiating PONVORY™. Initiating treatment with PONVORY™ after treatment with alemtuzumab is not recommended.
Severe Increase in Disability After Stopping PONVORY™
Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping PONVORY™ treatment. Patients should be observed for a severe increase in disability upon PONVORY™ discontinuation and appropriate treatment should be instituted, as required.
Immune System Effects After Stopping PONVORY™
After stopping PONVORY™ therapy, ponesimod remains in the blood for up to 1 week.
Starting other therapies during this interval will result in concomitant exposure to ponesimod. Lymphocyte counts returned to the normal range in 90% of patients within 1 week of stopping therapy, however, residual pharmacodynamics effects, such as lowering effects on peripheral lymphocyte count, may persist for 1 to 2 weeks after the last dose. Use of immunosuppressants within this period may lead to an additive effect on the immune system, and therefore caution should be applied 1 to 2 weeks after the last dose of PONVORY™.
In patients with overdosage of PONVORY™, especially upon initiation/re-initiation of treatment, it is important to observe for signs and symptoms of bradycardia as well as AV conduction blocks, which may include overnight monitoring. Regular measurements of pulse rate and blood pressure are required, and ECGs should be performed.
There is no specific antidote to ponesimod. Neither dialysis nor plasma exchange would result in meaningful removal of ponesimod from the body. The decrease in heart rate induced by PONVORY™ can be reversed by atropine.
In the event of overdose, PONVORY™ should be discontinued, and general supportive treatment given until clinical toxicity has been diminished or resolved. It is advisable to contact a poison control center to obtain the latest recommendations for the management of an overdose.
Most common adverse reactions (incidence at least 10%) are upper respiratory tract infection, hepatic transaminase elevation, and hypertension.