Olpasiran

Indicated For

Atherosclerotic cardiovascular disease with elevated lipoprotein(a)

About This Medication

# Olpasiran Expanded Access Program Patient Guide: How to Get Olpasiran at Low or No Cost Olpasiran is an investigational small interfering RNA (siRNA) therapy developed by Amgen to significantly reduce elevated **lipoprotein(a)** or **Lp(a)** levels in adults with **atherosclerotic cardiovascular disease (ASCVD)**, helping lower the risk of heart attacks, strokes, and other cardiovascular events.[1][2][7][8] This patient-friendly guide explains the **Olpasiran Expanded Access Program**, Amgen's pathway for eligible patients to access this promising treatment outside of clinical trials when no other options exist and benefits outweigh risks.[3][4] ## About Olpasiran and Why It Matters **Olpasiran** targets Lp(a), a genetically determined type of cholesterol that's hard to treat with standard medications like statins. High Lp(a) levels increase inflammation, plaque buildup in arteries (atherosclerosis), and cardiovascular risks, even if other cholesterol levels are controlled.[1][7][8] Phase 2 trials, like OCEAN(a)-DOSE, showed olpasiran reduced Lp(a) by over **95%** at certain doses, with effects lasting up to a year after stopping treatment.[1][7] No new safety issues emerged in extended studies.[1] Currently in **Phase 3 trials** (expected to wrap up around 2028), olpasiran isn't FDA-approved yet, so it's only available through Amgen's Expanded Access Program for those who can't join trials.[2][3][5] This program provides free access to the drug if you meet strict criteria, as it's investigational and not commercially available.[4] ## Who Qualifies for the Program? This isn't a traditional patient assistance program based on income—it's an **expanded access** initiative for serious conditions where standard treatments fall short.[3][4] Ideal candidates are **adults** with: - **Elevated Lp(a) levels** (typically >150 nmol/L, though exact cutoffs aren't specified).[3][7] - Diagnosed **ASCVD** (e.g., history of heart attack, stroke, or artery blockages).[2][3][7] - **Serious or life-threatening disease** with no comparable alternatives.[4] - Inability to join an active clinical trial.[4] - Situations where potential benefits justify risks, without delaying olpasiran's development or straining supply.[4] Amgen reviews each case individually. Exclusions might include severe kidney/liver issues, recent major bleeding, or prior Lp(a)-targeted RNA therapies.[6] Discuss with your doctor if you have conditions like advanced heart failure or planned surgeries.[6] **Income Eligibility Breakdown** No specific income thresholds apply, as this is expanded access, not financial aid.[4] Here's a summary: | Household Size | Income Threshold | FPL % | Notes | |----------------|------------------|-------|-------| | Individual | Not applicable | N/A | Based on medical need, not finances. | | Couple | Not applicable | N/A | Physician-requested for eligible patients. | | Family of 3 | Not applicable | N/A | No financial docs typically required. | | Family of 4 | Not applicable | N/A | Criteria focus on disease severity and trial ineligibility. | *Eligibility criteria not specified in available sources beyond medical need.*[3][4] ## Insurance Requirements **Insurance isn't a barrier**—expanded access is for patients lacking other options, regardless of coverage.[4] Medicare, Medicaid, or private insurance holders may qualify if olpasiran isn't an alternative via those plans (it's investigational, so usually not covered).[4] Your doctor submits the request; Amgen provides the drug **free of charge** if approved, with physicians handling safety reporting.[4] No reauthorization details are specified, but continued access may be possible post-trial for participants.[4] ## Step-by-Step Application Process 1. **Talk to Your Physician**: You can't apply directly—your treating doctor must request on your behalf. Share this guide and ClinicalTrials.gov ID **NCT07079267**.[3][4] 2. **Contact Amgen**: Doctor calls Amgen Medical Information at **+1 800-772-6436 (800-77-AMGEN)** or emails **medinfo@amgen.com**.[4] Provide patient details, Lp(a) levels, ASCVD history, and why no alternatives/trials work. 3. **Amgen Review**: Expect acknowledgment within **3 business days**. Experts assess against criteria (serious condition, no alternatives, supply availability, etc.).[4] 4. **Approval and Shipment**: If approved, Amgen ships olpasiran to your doctor or site. You'll get it via subcutaneous injection (like other siRNA therapies), dosing based on trials (e.g., every 12 weeks).[1][4] 5. **Follow-Up**: Your doctor monitors safety and reports to Amgen/FDA as required.[4] **Required Documents**: Not explicitly listed, but likely include medical records, lab results (Lp(a), liver/kidney function), and physician justification.[3][4][6] ## Timeline and Delivery - **Acknowledgment**: 3 business days.[4] - **Full Review/Decision**: Varies; no standard processing time given. Phase 3 trials are ongoing, so supply-dependent.[2][4] - **Delivery**: Direct to healthcare provider; self-administration unlikely—injections probably clinic-based.[1] Track via your doctor. Program status is **AVAILABLE**.[3] ## Alternatives if Denied or Ineligible - **Join a Clinical Trial**: Check OCEAN(a) trials (NCT05581303) if you qualify—many sites worldwide.[2][5] - **Standard ASCVD Care**: Maximize statins, ezetimibe, PCSK9 inhibitors, or lifestyle changes to manage risks.[7] - **Lp(a) Apheresis**: For severe cases (not excluded here).[6] - **Other Investigational Options**: Ask about similar siRNA therapies. No biosimilars exist yet.[ ] ## Important Disclaimer This guide is for informational purposes only and based on publicly available data as of early 2026. It's **not medical advice**—consult your healthcare provider. Expanded access isn't guaranteed; Amgen can deny based on criteria, supply, or regulations.[4] Olpasiran is **investigational**; risks (e.g., injection reactions, unknown long-term effects) may apply despite Phase 2 safety data.[1] Program details can change—verify with Amgen. Not a substitute for professional care.

Program information last verified: March 30, 2026