Xenleta

Indicated For

community-acquired bacterial pneumonia (CABP)

About This Medication

# Nabriva Therapeutics Xenleta Patient Guide: How to Get Xenleta (lefamulin) at Low or No Cost Xenleta (lefamulin) is an antibiotic used to treat adults with community-acquired bacterial pneumonia (CABP), available as intravenous (IV) injection or oral tablets. While Nabriva Therapeutics, the manufacturer, does not appear to offer a traditional U.S. patient assistance program with income-based free medication, access may be available through insurance, specialty distributors, or physician-initiated named patient programs internationally; patients should consult their doctor and pharmacist for cost-saving options like copay assistance, generics (none currently), or manufacturer inquiries[1][2][6]. ## About Xenleta (lefamulin) **Xenleta** is a first-in-class pleuromutilin antibiotic approved by the FDA in 2019 for treating CABP in adults 18 years and older. It works by inhibiting bacterial protein synthesis, helping combat resistant 'superbugs' that cause serious lung infections outside the hospital. Unlike many antibiotics, Xenleta offers both **IV (150 mg over 60 minutes every 12 hours)** and **oral (600 mg tablets every 12 hours)** formulations, allowing step-down therapy from hospital to home[2][4][5][6]. Clinical trials showed Xenleta was as effective as moxifloxacin (with or without linezolid) in over 1,200 patients with CABP confirmed by chest X-ray. It's particularly useful for infections possibly caused by Streptococcus pneumoniae, methicillin-susceptible Staphylococcus aureus (MSSA), or Haemophilus influenzae. Common side effects include diarrhea, nausea, headache, and elevated liver enzymes. **Important warnings**: Not for patients with severe hepatic impairment (adjust IV dose or avoid tablets), QT prolongation risk, or certain drug interactions (e.g., avoid with strong CYP3A4 inhibitors). Always follow your doctor's dosing, typically 5-7 days total[1][4][5][6]. The wholesale cost is high—about $205 per IV day and $275 per oral day—making affordability a key concern without coverage[6]. ## Who Qualifies for Assistance? No specific U.S. prescription assistance program (PAP) from Nabriva Therapeutics is detailed in available sources, unlike many manufacturers with income-based free drug programs. Xenleta has a Medicare J-code for billing, aiding reimbursement[2]. Potential qualifiers for cost relief include: - Patients with commercial insurance facing high copays. - Medicare Part D enrollees (subject to prior authorization). - Uninsured or underinsured patients who may access via physician request through distributors or expanded access. Internationally, a **Named Patient Program (NPP)** via WEP Clinical allows physicians to request Xenleta for unmet needs in countries like Australia, EU, UK, and others where it's not commercially available. Once approved, WEP ships to the physician[1][3]. U.S. patients: Contact Nabriva directly or your prescriber for similar compassionate use. ## Income Eligibility Breakdown **No income thresholds** are specified for a Nabriva PAP, as none is publicly listed. Traditional PAPs often use Federal Poverty Level (FPL) guidelines (e.g., 400-500% FPL), but Xenleta lacks this. Here's a general comparison table for context (based on common U.S. PAPs; verify with manufacturer): | Household Size | 400% FPL (2026 est.) | 500% FPL (2026 est.) | Notes | |---------------|----------------------|----------------------|-------| | Individual | ~$60,000 | ~$75,000 | Hypothetical; no Xenleta-specific | | Couple | ~$81,000 | ~$101,000 | Contact Nabriva for updates | | Family of 3 | ~$102,000 | ~$127,000 | Medicare often excludes from PAPs | | Family of 4 | ~$123,000 | ~$154,000 | -------| *Estimates adjusted for inflation; actual FPL updated annually by HHS. Xenleta: No FPL percent listed.*[6] ## Insurance Requirements Xenleta requires **prior authorization (PA)** from most insurers, including Medicare and Medicaid plans. Criteria typically include: - Age 18+. - CABP diagnosis via chest X-ray. - Prescribed by or consulted with an infectious disease specialist. - Within FDA dosing[4]. Medicare: Product-specific J-code issued; covers under Part B (IV) or D (oral), but PA needed. Commercial insurance often requires failure of alternatives like levofloxacin. No PAP insurance exclusions noted, but confirm with plan[2][4]. ## Step-by-Step Application Process 1. **Get Prescribed**: See your doctor (ideally infectious disease specialist) for Xenleta Rx confirming CABP[4]. 2. **Check Coverage**: Ask pharmacist/insurer about PA. Provide diagnosis proof, X-ray, specialist note[4]. 3. **Contact Manufacturer**: Call Nabriva Therapeutics (no direct PAP phone listed; try investor relations or medical info: check nabriva.com or 1-877-4-XENLETA if available). Inquire about copay cards, vouchers, or compassionate access[6]. 4. **Physician NPP Request (if uninsured/international)**: Doctor contacts WEP Clinical (+44 208 004 8185, xenletanpp@wepclinical.com) for named patient supply[1][3]. 5. **Submit PA**: Insurer reviews (1-2 weeks typical). 6. **Pharmacy/Distributor**: Available via major U.S. specialty pharmacies since 2019[6]. ## Timeline and Delivery - **PA Approval**: 3-14 days; initial auth up to 1 week supply, reauth same[4]. NPP: Varies, physician-directed. - **Delivery**: Shipped to physician/pharmacy; IV for hospital, oral for home. WEP manages NPP distribution with follow-up[1][3]. Expect 1-4 weeks total from Rx to hands. ## Alternatives if Denied - **Appeal PA**: Provide more evidence (e.g., resistance testing). - **Other Antibiotics**: Moxifloxacin, levofloxacin, or linezolid combos (per trials)[5]. - **Patient Access Programs**: NeedyMeds.org, RxAssist.org for general help. - **Discount Cards**: SingleCare, GoodRx for cash pay (may reduce to $200+/day)[6]. - **Biosimilars/Generics**: None available. ## Disclaimer This guide is for informational purposes only and not medical/financial advice. Program details can change; as of 2026, no standard U.S. PAP confirmed for Xenleta. Consult your healthcare provider, pharmacist, or Nabriva for personalized help. Eligibility, costs, and availability vary. Not affiliated with Nabriva or WEP[1][2][4][6]. (Word count: 1028)

Program information last verified: March 30, 2026