ORSERDU

Indicated For

ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

About This Medication

# Stemline ARC Patient Assistance Program Patient Guide: How to Get ORSERDU (elacestrant) at Low or No Cost ORSERDU (elacestrant) is a prescription medication for postmenopausal women and adult men with **ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer** after progression on at least one line of endocrine therapy. The **Stemline ARC Patient Assistance Program** offers eligible uninsured or functionally uninsured patients access to ORSERDU at no cost, providing crucial support during treatment.[1][2] ## About ORSERDU (elacestrant) ORSERDU is an oral targeted therapy that works by blocking estrogen receptors in cancer cells, specifically for those with **ESR1 mutations**. ESR1 mutations are genetic changes that can make breast cancer resistant to standard endocrine therapies. It's taken as a 345 mg tablet once daily, with or without food, and is indicated for **estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer** that has progressed following prior endocrine therapy.[1][2] **Important safety notes**: ORSERDU can cause side effects like nausea, fatigue, increased cholesterol, and decreased hemoglobin. Females of reproductive potential and males with female partners should use effective birth control during treatment and for 1 week after the last dose. Always discuss with your healthcare provider.[1] Stemline ARC provides comprehensive support beyond medication, including **Patient Advocates** who offer a single point of contact for questions on financial assistance, insurance coverage, reimbursement, and resources on ER+/HER2- metastatic breast cancer.[1][4] ## Who Qualifies for the Program? The Stemline ARC Patient Assistance Program is designed for **uninsured or functionally uninsured patients** who meet eligibility criteria. 'Functionally uninsured' typically means those with insurance that doesn't cover ORSERDU adequately, such as high copays or denials, but program specifics are determined after enrollment and benefits verification.[2][3] **Key eligibility factors**: - U.S. resident. - Diagnosis of ER+/HER2-, ESR1-mutated advanced/metastatic breast cancer. - Prior endocrine therapy. - Uninsured or functionally uninsured status. - Willingness to provide required documentation and reapply annually.[7] Note: Separate programs exist for commercially insured patients (Co-pay Card, up to $25,000/year, not for Medicare/Medicaid) and third-party foundations.[2][3] ## Income Eligibility Specific income thresholds (e.g., Federal Poverty Level percentages) are not publicly detailed; eligibility focuses on **uninsured status** rather than strict income limits. After enrollment, a Stemline ARC Patient Advocate assesses financial need based on provided proof of income.[7] | Household Size | Income Threshold | Notes | |---------------|------------------|-------| | Individual | Not specified | For eligible uninsured or functionally uninsured patients[2] | | Couple | Not specified | Proof of income required; annual reapplication needed[7] | | Family of 3 | Not specified | Advocate verifies based on submission | | Family of 4+ | Not specified | Focus on insurance status over income | Contact the program for personalized assessment, as criteria may include overall financial hardship.[1] ## Insurance Requirements The Patient Assistance Program is strictly for **uninsured or functionally uninsured patients**. It is **not available** for those enrolled in **Medicare, Medicaid, or other federal/state healthcare programs**. Commercially insured patients may qualify for the Co-pay Card instead. A benefits investigation occurs post-enrollment to confirm options.[2][3][5] ## Step-by-Step Application Process Applying is straightforward with **multiple methods** (phone, fax, mail). Here's how: 1. **Discuss with your doctor**: Confirm ORSERDU is appropriate and obtain a prescription. Ask them to download the enrollment form from stemlineARC.com.[5][7] 2. **Complete the enrollment form**: Your doctor fills out patient details, diagnosis (ICD-10 code), prior therapy confirmation, insurance info, and consent. Include patient/caregiver signature. Check 'Patient Assistance Program' in Section 6 and provide financial info.[7] 3. **Gather required documents**: - **Enrollment form** (signed). - **Proof of income** (e.g., tax returns, pay stubs). - **Proof of residency** (e.g., utility bill). - **Proof of insurance status** (e.g., denial letter or insurance card showing no coverage).[7] 4. **Submit the application**: - **Phone**: Call 1-833-478-3654 (9 AM-6 PM ET, Mon-Fri) for assistance.[9] - **Fax**: 1-833-329-7836.[5] - **Mail**: Stemline ARC, PO Box 5490, Louisville, KY 40255.[5] 5. **Benefits verification**: A **Stemline ARC Patient Advocate** contacts you and your doctor to review coverage and eligibility. They guide you to the right program.[4][5] For urgent starts, ask about the **Rapid Start Program** (15-day free supply while awaiting PA; government insurance waits 5 days post-PA).[9] ## Timeline and Delivery Processing time varies but expect contact from a Patient Advocate soon after submission. Medication, if approved, is **shipped via specialty pharmacies** directly to you or your provider. Reauthorization is required (annual reapplication); notify if circumstances change.[7] **Rough timeline**: - Submission: Immediate. - Advocate contact: Within days. - Approval/shipment: Varies; Rapid Start in ~15 days if eligible.[5][9] ## Alternatives if Denied - **Co-pay Card Program**: For commercial insurance (as low as $0; max $25,000/year).[3] - **Rapid Start**: Short-term bridge.[9] - **Third-party foundations**: Advocate can connect you.[3] - **Other PAPs**: Check rxassist.org or PAN Foundation. - Discuss alternatives with your doctor, like other ESR1-targeted therapies. ## Disclaimer This guide is for informational purposes based on available program details as of latest updates. Eligibility, terms, and availability can change; Stemline Therapeutics reserves the right to amend/revoke. Always verify with Stemline ARC (1-833-478-3654) or your healthcare provider. Not a substitute for medical advice. ORSERDU has risks; read full Prescribing Information.[1][2][7]

Program information last verified: March 30, 2026