Tegsedi

Indicated For

Hereditary transthyretin-mediated amyloidosis (hATTR) polyneuropathy

About This Medication

# Tegsedi (Inotersen) Patient Assistance Guide: How to Get Tegsedi at Low or No Cost **Important Notice: Tegsedi (inotersen) was discontinued in the US as of September 27, 2024.[2] This guide provides information on legacy access, remaining supplies, or transition support. Consult your doctor for alternatives like Amvuttra (vutrisiran) or Onpattro (patisiran).[2]** ## About Tegsedi (Inotersen) Tegsedi is a transthyretin-directed antisense oligonucleotide (ASO) used to treat **polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis)** in adults.[6][7][8] It works by inhibiting hepatic synthesis of transthyretin to reduce amyloid deposits causing nerve damage.[6] Administered as a **weekly subcutaneous injection of 284 mg** (self-administered at home after training).[5][6] **Key Risks:** Tegsedi carries **boxed warnings** for thrombocytopenia (low platelets risking serious bleeding) and glomerulonephritis (kidney inflammation).[5][7] It is only available through the mandatory **Tegsedi REMS program** requiring prescriber/patient/pharmacy enrollment, baseline labs, and ongoing monitoring (platelets, kidney function every 2 weeks).[1][2][5] ## Who Qualifies for Assistance? Patient assistance programs (PAPs) from manufacturers like **Akcea Therapeutics (now part of Ionis Pharmaceuticals)** help uninsured, low-income, or underinsured patients access Tegsedi at low or no cost.[2][3] Eligibility typically targets those with **hATTR amyloidosis diagnosis confirmed by TTR gene mutation** and polyneuropathy symptoms.[2][6] **General Qualifications:** - FDA-approved use: Polyneuropathy in hATTR amyloidosis adults.[8] - Prescribed by specialist (neurologist or amyloidosis expert).[2] - Enrolled in Tegsedi REMS.[1][2] - No adequate alternatives (e.g., failure of first-line treatments).[1] Since Tegsedi is discontinued, assistance may focus on **remaining inventory, copay support, or transition aid** via nonprofits like HealthWell Foundation or Patient Access Network.[2][3] ## Income Eligibility Breakdown Specific income thresholds for Akcea/Ionis PAP are not publicly detailed in available sources (programName: null).[Provided Data] Programs often use **Federal Poverty Level (FPL)** guidelines. Below is a typical breakdown for similar specialty drug PAPs (400% FPL common cap; verify current via manufacturer).[3] | Household Size | 100% FPL | 200% FPL | 300% FPL | 400% FPL (Typical PAP Cap) | |---|---|---|---|---| | 1 | $15,060 | $30,120 | $45,180 | $60,240 | | 2 | $20,440 | $40,880 | $61,320 | $81,760 | | 3 | $25,820 | $51,640 | $77,460 | $103,280 | | 4 | $31,200 | $62,400 | $93,600 | $124,800 | | +1 Person | +$5,380 | +$10,760 | +$16,140 | +$21,520 | *Notes: 2026 FPL estimates; excludes insurance. Medicare patients often ineligible for PAPs but qualify for copay cards.[3]* ## Insurance Requirements Tegsedi requires **prior authorization (PA)** from most insurers, REMS enrollment, and specialty pharmacy use.[1][5] - **Commercial Insurance:** PA needed; step therapy (fail first-line like Vyndaqel/Wainua); lab monitoring.[1][6] - **Medicare:** Covered as specialty drug; high copays possible. PAPs for low-income/uninsured; copay assistance via foundations.[3] - **Medicaid:** PA with diagnosis proof, REMS; quantity limits (4 syringes/28 days).[6] - **Specialty Pharmacy:** Mandatory (e.g., CenterWell, in-network); handles PA, delivery, training.[1][2] **Site of Care:** Some plans require medical necessity justification for home vs. infusion center.[5] ## Step-by-Step Application Process 1. **Confirm Diagnosis & Prescriber:** Get hATTR confirmation (TTR mutation), polyneuropathy assessment from specialist.[2][8] 2. **Enroll in REMS:** Prescriber trains at www.tegsedirems.com; patient enrolls, agrees to monitoring.[2] 3. **Baseline Labs:** Platelets, renal function (eGFR, UPCR) within 30 days.[2] 4. **Contact Manufacturer:** Call Akcea/Ionis support (details via 1-888-466-2219 or similar advocate lines).[1] Request PAP application.[2] 5. **Gather Documents:** Proof of income (taxes, paystubs), insurance denial (if insured), ID, prescription, REMS confirmation.[1] 6. **Submit Application:** Online, mail, or phone (applicationMethod: null; check tegsedirems.com).[Provided Data] 7. **Specialty Pharmacy Coordination:** They verify benefits, assist PA.[1] ## Timeline and Delivery - **PA Approval:** 30-45 days standard, 3-7 days expedited.[1] - **PAP Processing:** 2-4 weeks typical for similar programs (processingTime: null).[Provided Data] - **Delivery:** Home via specialty pharmacy with injection training/supplies; 24/7 support.[1] - **Initial Approval:** 6-9 months; reauth 12 months with response proof (e.g., stable neuropathy).[5][6] **Ongoing:** Labs every 2 weeks; safety attestation every 90 days.[2][7] ## Alternatives if Denied or Discontinued **Denial Appeals:** Provide medical necessity docs (hATTR progression, peer-reviewed efficacy evidence). California: DMHC IMR.[1][2] Common fixes: Complete labs, REMS proof.[1] **Post-Discontinuation Alternatives:**[2] - **Amvuttra (vutrisiran):** SubQ every 3 months; similar hATTR polyneuropathy. - **Onpattro (patisiran):** IV infusion. - **Wainua (eplontersen):** Newer ASO option.[6] - **Copay/Grants:** HealthWell, PAN Foundation.[2][3] - **State Aid:** Medi-Cal, other pharmaceutical programs.[2] ## Disclaimer This guide is for informational purposes only and not medical/financial advice. Tegsedi discontinuation impacts availability—verify with Ionis/Akcea (manufacturer).[2] Eligibility/rules change; contact programs directly. Consult healthcare provider for personalized plan. Data as of legacy sources; no guarantees.[1][2][3] (Word count: 942)

Program information last verified: March 30, 2026