TEMBEXA

Indicated For

smallpox

About This Medication

# TEMBEXA Patient Assistance Guide: How to Get TEMBEXA at Low or No Cost TEMBEXA (brincidofovir) is a specialized antiviral medication, and while Emergent BioSolutions manufactures it, specific details on a dedicated patient assistance program are not publicly detailed in available resources. This guide explains eligibility for general support options, the drug's uses, and steps to access help, including Medicare resources and physician-led requests. ## About TEMBEXA (brincidofovir) **TEMBEXA** is an FDA-approved oral antiviral for treating human smallpox disease caused by the variola virus in adults, children, and neonates. It works as a nucleotide analog that inhibits viral DNA polymerase, blocking virus replication. Approved in June 2021, it's a prodrug converted to cidofovir inside cells.[2][3][5][6] Though smallpox is eradicated, TEMBEXA may be used off-label for other orthopoxviruses like mpox via FDA emergency expanded access requests by physicians.[5] **Dosing** is weight-based: for patients 10-48 kg, 4 mg/kg oral suspension weekly for two doses; under 10 kg, 6 mg/kg. Tablets are also available. Avoid crushing tablets; handle suspension carefully to prevent skin contact.[2] **Key warnings** include a boxed warning for mortality risk with prolonged use, liver enzyme elevations, diarrhea, embryo-fetal toxicity, and male infertility. Monitor liver labs and pregnancy test females before starting.[2][3][4] Common side effects: diarrhea, nausea, vomiting, abdominal pain.[6] It's not for routine use outside smallpox and requires specialist oversight.[3] ## Who Qualifies for Assistance? No specific Emergent BioSolutions patient assistance program (PAP) with income thresholds is listed in current resources. **Qualification** typically targets uninsured, underinsured, or low-income patients needing antivirals. Contact Emergent at their general line (check emergentbiosolutions.com) or physician for compassionate use, especially in outbreaks.[8] **Medicare patients**: Use Part D coverage. From 2025, out-of-pocket cap is $2,000/year; Prescription Payment Plan spreads costs monthly (voluntary, no extra savings).[1] **Extra Help** (Low-Income Subsidy) offers no premiums/deductibles and low copays if income/assets qualify (limits vary yearly; apply via SSA.gov).[1] State programs like Pennsylvania's PACE/PACENET or others via Medicare's tool may help seniors.[1] General PAPs (e.g., NiceRx, Prescription Hope) cover antivirals if income <~400% FPL, but verify TEMBEXA inclusion.[10] ## Income Eligibility Breakdown Without a TEMBEXA-specific PAP, use these **general benchmarks** for similar programs (2026 FPL estimates; confirm current via ASPE.hhs.gov): | Household Size | 400% FPL (Common PAP Threshold) | Extra Help (Approx. 150% FPL + Assets) | |----------------|---------------------------------|---------------------------------------| | Individual | ~$60,000 | ~$22,500 income; $17,550 assets | | Couple | ~$81,000 | ~$30,000 income; $35,000 assets | | Family of 3 | ~$102,000 | Varies; add ~$6,000/person | | Family of 4 | ~$123,000 | Varies; add ~$6,000/person | Notes: Assets exclude home/car. Medicare Extra Help auto-applies in some states.[1][10] No insurance often required for free drug PAPs. ## Insurance Requirements **Commercial insurance**: Prior authorization likely needed, confirming smallpox/mpox diagnosis, lab monitoring, and pregnancy test.[4] Coverage varies; appeal denials. **Medicare Part D**: Covered; use GoodRx for copay cards if applicable. Extra Help ideal for low-income.[1] **Uninsured**: Physician FDA request for emergency access (e.g., mpox).[5] No insurance? Explore general PAPs like Patient Advocate Foundation (copays.org).[10] ## Step-by-Step Application Process 1. **Consult Specialist**: Discuss with infectious disease doctor; confirm diagnosis (smallpox/mpox).[4][5] 2. **Check Medicare/State Aid**: Apply for Extra Help (ssa.gov/extrahelp) or state programs.[1] 3. **Contact Manufacturer**: Call Emergent BioSolutions (301-795-1800 or website) for PAP/compassionate use inquiry. No dedicated URL/phone listed; use prescriber.[8][9] 4. **Physician FDA Request**: For off-label (mpox), submit emergency IND.[5] 5. **Gather Docs**: Proof of income (taxes, paystubs), ID, prescription, insurance denial (if insured).[10] 6. **Submit**: Via prescriber or online portals for general PAPs. 7. **Follow Up**: Track status weekly. ## Timeline and Delivery Processing: 2-4 weeks for PAPs; urgent FDA requests faster in outbreaks. Delivery via mail/specialty pharmacy; two-dose course shipped directly.[2] Medicare Payment Plan: Immediate at pharmacy.[1] ## Alternatives if Denied - **Extra Help/State Programs**.[1] - **Copay Assistance**: GoodRx, copays.org.[1][10] - **Generic/Other Antivirals**: None for smallpox; tecovirimat (Tpoxx) alternative for mpox. - **Appeal/Generic PAPs**: NiceRx ($49/mo if eligible).[10] - **Clinical Trials**: Search clinicaltrials.gov for orthopoxviruses. ## Disclaimer This guide is for informational purposes (March 2026 data). Not medical/financial advice. Consult healthcare provider/pharmacist. Program details change; verify with Emergent/Medicare. FDA limits TEMBEXA to smallpox.[3] (Word count: 942)

Program information last verified: March 30, 2026