Andexxa (andexanet alfa) is the name of a life-saving drug that reverses the effects of uncontrolled bleeding caused by the popular blood thinner drugs, Xarelto and Eliquis. Despite the fact that this blood thinner reversal agent is the only known “antidote” to bleeding caused by Xarelto and Eliquis, and despite the fact that it has been shown to be safe and effective, many hospitals are refusing to carry Andexxa because “the price is too high.” The result is that people are still dying of uncontrolled bleeding — unnecessarily. In 2016, there were approximately 117,000 hospital admissions related to Factor Xa-inhibitor-related bleeding and approximately 2,000 bleeding-related deaths every month in the United States. It’s uncertain how many deaths Andexxa could have prevented, but many patients are now wondering why their hospitals don’t carry the life-saving drug and what can be done to make them accountable for this negligence.
Andexxa: A Factor Xa Inhibitor
As an antidote, Andexxa (andexanet alfa) works as a factor xa inhibitor for:
- Xarelto (rivaroxaban)
- Eliquis (apixaban)
Andexxa has not been approved for Savaysa (edoxaban) or Bevyxxa (betrixaban) – for which there are no specific FDA-approved antidotes.
Alternative blood thinner reversal agents are available on the market:
- Praxbind (idarucizumab) – for treating Pradaxa (dabigatran) patients
- Vitamin K or Fresh Frozen Plasma – for treating Coumadin (warfarin) patients
Xarelto and Eliquis were introduced as next-generation blood thinners to prevent stroke and treat atrial fibrillation complications. Patients liked that the dosage of these newer drugs did not depend on routine blood work, diet, exercise, or alcohol consumption. Unlike Warfarin, there was no known antidote for Xarelto or Eliquis, should an adverse bleeding event occur.
Andexxa: An Anticoagulant Reversal Agent
Andexxa is a drug developed by Portola Pharmaceuticals for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Andexxa works by targeting and binding to Factor Xa molecules, enzymes that aid in blood clotting. Medical care providers administer the drug as a lyophilized powder dissolved in solution for intravenous injection. The drug is released as a bolus at a rate of 30 mg/minute, with continuous infusion sustained for up to 120 minutes.
Research shows there is a 92 percent reduction in anti-factor Xa activity with a dose of Andexxa, and 82 percent of patients given the drug returned to “excellent” or “good” hemostasis.
How Much Does Andexxa Cost?
Treatment with the high-dose costs $49,500 for the drug alone. The low-dose costs half as much. While the Andexxa cost may seem high, it pales in comparison to the cost of caring for severe life-threatening bleeds in the hospital, which exceeds $100,000. Reimbursement coverage reduces the cost burden further. The MS-DRG payment covers up to 50% of the cost, while the New Technology Add-on Payment (NTAP) allows up to $14,062.
When Did the FDA Approve Andexxa?
Andexxa received authorization to continue down the FDA’s Accelerated Approval pathway on May 3, 2018. Initially, 40 stroke centers and acute treatment facilities were included in the early pilot program to assess the drug’s real-world results. The U.S. Food and Drug Administration granted full Andexxa approval on December 31, 2018.
Along with this announcement, Portola President and CEO Scott Garland issued a statement saying: “We are pleased to now be able to stock hospitals nationwide and serve all patients in the U.S. who could benefit from the potential life-saving impact of Andexxa.” The second gen production launch was aimed at producing enough drugs to stock 1,000 hospitals nationwide.
How Can I Check Andexxa Availability at My Hospital?
Andexxa availability was extremely limited until the full commercial launch in January 2019. However, hospitals in some areas have been slow to adopt the new reversal agent. Patients can enter their zip codes into the Andexxa website to locate the product at local health care providers.
Needed Andexxa, But Couldn’t Get It? Contact Showard Law Firm
If you needed Andexxa, but your hospital did not carry this life-saving antidote, you may be eligible to file a lawsuit for damages. If your loved one sustained uncontrolled bleeding or you were unable to undergo necessary surgery due to Xarelto and Eliquis, and your hospital or healthcare provider failed to treat them with Andexxa, you may be entitled to recover compensation for any injuries or losses directly resulting from the bleeding, including medical bills and lost wages, as well as pain and suffering. Further, family members may be eligible to file a wrongful death lawsuit against the hospital or medical care provider for failing to exercise proper duty of care in the treatment of their loved ones. Compensation may be available to cover the tangible funeral and burial costs, medical expenses, and lost wages, as well as the loss of financial support, guidance, and companionship. Contact Showard Law Firm for a case review with experienced personal injury lawyers. We offer free consultations to all clients. Our promise to you is this: No recovery, no legal fee!
- Bio Process International, Lonza begins second gen production of Portola’s Andexxa, https://bioprocessintl.com/bioprocess-insider/facilities-capacity/lonza-begins-second-gen-production-of-portolas-andexxa/
- Portola Pharmaceuticals, Portola Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Corporate Update, https://portola.gcs-web.com/news-releases/news-release-details/portola-pharmaceuticals-reports-first-quarter-2019-financial
- Drug Topics, Why a New Anticoagulant Reversal Agent Is Significant, https://www.drugtopics.com/anticoagulants/why-new-anticoagulant-reversal-agent-significant