Andexxa

Indicated For

Reversal of anticoagulation for life-threatening bleeding with apixaban or rivaroxaban

About This Medication

# Andexxa (andexanet alfa) Patient Guide: How to Get Andexxa at Low or No Cost **Important Notice: Andexxa is no longer available in the US market.** AstraZeneca has voluntarily withdrawn Andexxa (andexanet alfa) from commercial sale and manufacturing in the United States effective after December 22, 2025, due to safety concerns raised by the FDA regarding thromboembolic risks outweighing benefits. This guide provides historical context on patient assistance programs but cannot assist with obtaining the drug today, as it is discontinued.[1][2][3] ## About Andexxa Andexxa (andexanet alfa, also known as coagulation factor Xa (recombinant), inactivated-zhzo) was a specialized medication used to reverse the effects of direct oral anticoagulants like rivaroxaban or apixaban in cases of life-threatening or uncontrolled bleeding. It was granted accelerated FDA approval in 2018 based on surrogate endpoints in healthy volunteers, with a Boxed Warning for risks of thromboembolic events, including serious and fatal outcomes.[1] Post-marketing data and the Phase III ANNEXA-I study showed higher thrombosis rates (14.6% vs. 6.9% in controls) and deaths linked to thrombotic events, leading to the FDA determining risks outweighed benefits. AstraZeneca, after acquiring rights via Alexion in 2021, withdrew the Biologics License Application (BLA) for commercial reasons following FDA discussions.[1][2][3] Given its discontinuation, no patient assistance programs are currently active for new prescriptions. Existing limited supplies may have been available briefly post-announcement, but sales have ended.[1][2] ## Who Qualifies for Assistance Programs (Historical Context) Prior to discontinuation, AstraZeneca's **Access 360** program aimed to help eligible US patients access medications at low or no cost, particularly those uninsured or underinsured.[4] Qualification typically required US residency, a valid prescription, and meeting income guidelines based on Federal Poverty Level (FPL). However, with Andexxa off the market, no qualifications apply today. ## Income Eligibility Breakdown Historical AstraZeneca Access 360 income thresholds were often set at **400% of the FPL** or higher for many programs, though specific details for Andexxa were not publicly detailed beyond general eligibility. Here's a sample table based on typical AstraZeneca programs (2025 FPL estimates for illustration; actuals varied): | Household Size | Annual Income Limit (approx. 400% FPL) | |----------------|---------------------------------------| | 1 (Individual) | $60,000 | | 2 (Couple) | $81,000 | | 3 | $102,000 | | 4 | $123,000 | *Notes:* Limits could adjust annually; Medicare Part D enrollees often had separate paths. Exact Andexxa thresholds were null or unpublished in available records.[4] Discontinuation nullifies all eligibility. ## Insurance Requirements Historically, Access 360 accepted patients with private insurance (if high copays), Medicare (with coverage gaps), or uninsured status. Medicare Part D patients might qualify for low-income subsidies (LIS) alongside PAP support. Government insurance like Medicaid often disqualified applicants. No current requirements exist due to market withdrawal.[4] ## Step-by-Step Application Process (For Reference Only) 1. **Confirm Eligibility:** Doctor verifies prescription need; patient checks income/insurance. 2. **Gather Documents:** Prescription, proof of income (tax returns, pay stubs), insurance details. 3. **Apply:** Via phone, online portal, or downloadable form from AstraZeneca Access 360.[4] 4. **Submit:** Mail/fax/upload; doctor often co-signs. 5. **Approval Wait:** Typically 1-2 weeks historically. **Today:** No applications accepted; contact your doctor for alternative reversal agents like prothrombin complex concentrates (PCC).[1] ## Timeline and Delivery Processing was usually 5-10 business days. Approved meds shipped free to doctor's office or home via specialty pharmacy. Refills required reauthorization every 6-12 months. All halted post-2025.[4] ## Alternatives if Denied or Unavailable - **For Reversal Needs:** Discuss 4-factor PCC (e.g., Kcentra) with your doctor—often preferred now per FDA concerns.[1] - **Other AstraZeneca PAPs:** Access 360 may cover other drugs; check rxassist.org.[4] - **General Resources:** NeedyMeds, PAN Foundation, or state programs for bleeding disorder support. - **Urgent Care:** Hospitals stock alternatives; no PAP needed for emergencies. ## Disclaimer This guide is for informational purposes based on historical data up to discontinuation. Andexxa is **not available** via any assistance program as of 2026. Consult your healthcare provider for current treatment options. Safety risks included fatal thrombosis; benefits were unconfirmed clinically.[1][2][3] AstraZeneca and FDA updates supersede this info. Not medical advice—seek professional guidance. Word count: 912.

Program information last verified: March 30, 2026