BALVERSA® (erdafitinib) HCP

Support for BALVERSA^®

Specialty Distributor and Specialty Pharmacy Flashcard
See specialty distributor and specialty pharmacy information for access to BALVERSA^®, in addition to services provided by CVS Specialty^®.

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Access Support

To help you get your patients started on BALVERSA^®, the following resources may be helpful to your patients and your practice:

Supporting Appropriate Payer Coverage Decisions
This brochure has been developed to help healthcare providers understand how to work with payers for coverage of medically necessary drug therapies.
Extra Help with Prescription Drug Costs: Medicare Low-Income Subsidy (LIS) Overview
Learn about extra help available to low-income residents of the United States who are enrolled in Medicare Prescription Drug Plans.
Know Your State Interactive Tool
This interactive tool provides information on affordability options for patients at the state level.
Sample Exception Letter
Each payer follows a different process when filing exceptions and appeals. Submit an exception letter when requesting an exception for BALVERSA^®.
Sample Letter of Medical Necessity
Submit a letter to support the medical necessity of treatment with BALVERSA^® either with the initial claim or when requesting reconsideration of a denied claim.
Prior Authorization Considerations Checklist
Learn more about general Prior Authorization processes including items and information that may be requested from your patient’s insurer.
Appeal Considerations Checklist
If your patient’s insurer denies coverage for your patient, learn more about general insurance appeals processes.
Exception Considerations Checklist
General information on exception processes for your patient’s coverage of medically necessary drug therapies.

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Affordability Support

Affordability Options for Prescription Drugs – This summary presents resources that may assist patients with their prescription drug costs based on their primary insurance status.

Support for patients using commercial or private insurance to pay for medication

Janssen CarePath Savings Program for BALVERSA^® can help eligible patients receive instant savings on their out-of-pocket medication costs for BALVERSA^®. Depending on their health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Your eligible patients will pay $5 per fill with a $25,000 maximum program benefit per 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. See full eligibility requirements at Balversa.JanssenCarePathSavings.com.

Providers can check patients’ eligibility and enroll them in the Janssen CarePath Savings Program for BALVERSA^® at JanssenCarePathPortal.com/express. There is a "Print a Card" feature to provide the patient with a card.

Your patients and their caregivers can enroll the patient in the Janssen CarePath Savings Program for BALVERSA^® at MyJanssenCarePath.com/express.

Support for patients using government-funded healthcare programs or patients without insurance coverage

Patients without commercial or private health insurance may find help from the programs and resources found on JanssenCarePath.com.

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Treatment Support

Advocacy Connector

AdvocacyConnector.com is a Janssen-sponsored resource that connects patients and caregivers to national and state-specific advocacy groups that offer resources.

Cancer.com Web Site

Cancer.com is an online resource designed to connect patients to educational, emotional, and community support they may need through their cancer journey. Tailored content provided by leading advocacy organizations, together with a suite of tools that may help users navigate life with cancer, including My Care Activator, The Advocacy Connector, and The Survivorship Guide.

US Bioservices is an AmerisourceBergen specialty pharmacy.

Other Resources

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization that is committed to helping eligible patients without insurance coverage receive prescription products donated by Johnson & Johnson operating companies. To see if they might qualify for assistance, please have your patient contact a JJPAF program specialist at 1-800-652-6227 (Monday−Friday, 9 AM to 6 PM ET) or visit the foundation website at www.JJPAF.org.

Warnings and Precautions

Ocular Disorders — BALVERSA^® can cause ocular disorders, including central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED) resulting in visual field defect.

CSR/RPED was reported in 25% of patients treated with BALVERSA^®, with a median time to first onset of 50 days. Grade 3 CSR/RPED, involving central field of vision, was reported in 3% of patients. CSR/RPED resolved in 13% of patients and was ongoing in 13% of patients at the study cutoff. CSR/RPED led to dose interruptions and reductions in 9% and 14% of patients, respectively, and 3% of patients discontinued BALVERSA^®. Dry eye symptoms occurred in 28% of patients during treatment with BALVERSA^® and were Grade 3 in 6% of patients. All patients should receive dry eye prophylaxis with ocular demulcents as needed.

Perform monthly ophthalmological examinations during the first 4 months of treatment and every 3 months afterwards, and urgently at any time for visual symptoms. Ophthalmological examination should include assessment of visual acuity, slit lamp examination, fundoscopy, and optical coherence tomography. Withhold BALVERSA^® when CSR occurs and permanently discontinue if it does not resolve within 4 weeks or if Grade 4 in severity. For ocular adverse reactions, follow the dose modification guidelines [see Dosage and Administration (2.3)].

Hyperphosphatemia and Soft Tissue Mineralization — BALVERSA^® can cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis and vascular calcification. Increases in phosphate levels are a pharmacodynamic effect of BALVERSA^® [see Pharmacodynamics (12.2)]. Hyperphosphatemia was reported as adverse reaction in 76% of patients treated with BALVERSA^®. The median onset time for any grade event of hyperphosphatemia was 20 days (range: 8–116) after initiating BALVERSA^®. Thirty-two percent of patients received phosphate binders during treatment with BALVERSA^®. Cutaneous calcinosis, non-uremic calciphylaxis and vascular calcification have been observed in 0.3% of patients treated with BALVERSA^®.

Monitor for hyperphosphatemia throughout treatment. In all patients, restrict phosphate intake to 600‑800 mg daily. If serum phosphate is above 7.0 mg/dL, consider adding an oral phosphate binder until serum phosphate level returns to <5.5 mg/dL. Withhold, dose reduce, or permanently discontinue BALVERSA^® based on duration and severity of hyperphosphatemia [see Dosage and Administration (2.3), Table 2: Dose Modifications for Adverse Reactions].

Embryo-Fetal Toxicity — Based on the mechanism of action and findings in animal reproduction studies, BALVERSA^® can cause fetal harm when administered to a pregnant woman. In a rat embryo-fetal toxicity study, erdafitinib was embryotoxic and teratogenic at exposures less than the human exposures at all doses studied. Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment with BALVERSA^® and for one month after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with BALVERSA^® and for one month after the last dose [see Use in Specific Populations (8.1, 8.3) and Clinical Pharmacology (12.1)].

Most common adverse reactions including laboratory abnormalities ≥20%:

Phosphate increased (76%), stomatitis (56%), fatigue (54%), creatinine increased (52%), diarrhea (47%), dry mouth (45%), nail disorder (45%), alanine aminotransferase increased (41%), alkaline phosphatase increased (41%), sodium decreased (40%), decreased appetite (38%), albumin decreased (37%), dysgeusia (37%), hemoglobin decreased (35%), dry skin (34%), aspartate aminotransferase increased (30%), magnesium decreased (30%), dry eye (28%), alopecia (26%), palmar-plantar erythrodysesthesia syndrome (26%), constipation (28%), phosphate decreased (24%), abdominal pain (23%), calcium increased (22%), nausea (21%), and musculoskeletal pain (20%). The most common Grade 3 or greater adverse reactions (>1%) were stomatitis (9%), nail dystrophy*, palmar-plantar erythrodysesthesia syndrome (6%), paronychia (3%), nail disorder (10%), keratitis^†, and hyperphosphatemia (1%).

*Included within nail disorder. ^†Included within dry eye.

An adverse reaction with a fatal outcome in 1% of patients was acute myocardial infarction.
Serious adverse reactions occurred in 41% of patients, including eye disorders (10%).
Permanent discontinuation due to an adverse reaction occurred in 13% of patients. The most frequent reasons for permanent discontinuation included eye disorders (6%).
Dosage interruptions occurred in 68% of patients. The most frequent adverse reactions requiring dosage interruption included hyperphosphatemia (24%), stomatitis (17%), eye disorders (17%), and palmar-plantar erythrodysesthesia syndrome (8%).
Dose reductions occurred in 53% of patients. The most frequent adverse reactions for dose reductions included eye disorders (23%), stomatitis (15%), hyperphosphatemia (7%), palmar-plantar erythrodysesthesia syndrome (7%), paronychia (7%), and nail dystrophy (6%).

Drug Interactions

Moderate CYP2C9 or strong CYP3A4 inhibitors: Consider alternative agents or monitor closely for adverse reactions. (7.1)
Strong CYP2C9 or CYP3A4 inducers: Avoid concomitant use with BALVERSA^®. (7.1)
Moderate CYP2C9 or CYP3A4 inducers: Increase BALVERSA^® dose up to 9 mg. (7.1)
Serum phosphate level-altering agents: Avoid concomitant use with agents that can alter serum phosphate levels before the initial dose modification period. (2.3, 7.1)
CYP3A4 substrates: Avoid concomitant use with sensitive CYP3A4 substrates with narrow therapeutic indices. (7.2)
OCT2 substrates: Consider alternative agents or consider reducing the dose of OCT2 substrates based on tolerability. (7.2)
P-gp substrates: Separate BALVERSA^® administration by at least 6 hours before or after administration of P-gp substrates with narrow therapeutic indices. (7.2)

Use in Specific Populations

Lactation — Because of the potential for serious adverse reactions from erdafitinib in a breastfed child, advise lactating women not to breastfeed during treatment with BALVERSA^® and for one month following the last dose.

Please click here to see full BALVERSA^® Prescribing Information.

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Support for BALVERSA^®

Access Support

Affordability Support

Support for patients using commercial or private insurance to pay for medication

Support for patients using government-funded healthcare programs or patients without insurance coverage

Treatment Support

Advocacy Connector

Cancer.com Web Site

Other Resources

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Support for BALVERSA®

Access Support

Affordability Support

Support for patients using commercial or private insurance to pay for medication

Support for patients using government-funded healthcare programs or patients without insurance coverage

Treatment Support

Advocacy Connector

Cancer.com Web Site

Other Resources

DOSING

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For Healthcare Professionals

Support for BALVERSA^®

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