Rayaldee

Indicated For

secondary hyperparathyroidism, chronic kidney disease

About This Medication

# Rayaldee Patient Assistance Program Patient Guide: How to Get Rayaldee (calcifediol) at Low or No Cost Rayaldee (calcifediol) is an extended-release oral capsule FDA-approved to treat **secondary hyperparathyroidism (SHPT)** in adults with **stage 3 or 4 chronic kidney disease (CKD)** and **vitamin D insufficiency**. This condition occurs when your parathyroid glands produce too much hormone due to low vitamin D levels and poor kidney function, which can weaken bones, raise calcium levels, and increase risks like fractures or heart issues. Unlike standard vitamin D supplements, **Rayaldee** activates in the body to help regulate parathyroid hormone (PTH), serum calcium, and phosphorus more effectively.[1][2][8] Manufactured by **OPKO Pharmaceuticals**, Rayaldee comes in 30 mcg capsules, typically taken once daily at bedtime with food, without chewing or crushing. Your doctor will monitor blood levels of PTH, calcium, phosphorus, and vitamin D to adjust dosing. Common side effects include hypercalcemia (high blood calcium), increased creatinine, and muscle spasms—report symptoms like nausea, fatigue, or confusion promptly. It's not for end-stage kidney disease patients on dialysis.[1][9] The **Rayaldee Patient Assistance Program (PAP)**, run by **OPKO Connect**, provides **free medication** to eligible patients who are **uninsured or functionally uninsured** (meaning insurance doesn't cover Rayaldee or copays are unaffordable). This program helps ensure access to vital therapy without financial burden.[1][2][4] ## Who Qualifies for the Program? Eligibility focuses on **lack of insurance coverage for Rayaldee** and financial need, with **criteria that apply** (specific income thresholds like Federal Poverty Level percentages are not publicly detailed). You must: - Have a valid prescription for **on-label use** (SHPT in stage 3-4 CKD with vitamin D insufficiency).[4] - Be **uninsured or functionally uninsured** for Rayaldee.[1][2] - Provide proof of financial hardship via supporting documents.[3][4] **Annual re-enrollment** is required to confirm ongoing eligibility.[2][4][9] ### Income Eligibility Breakdown Detailed income limits (e.g., 400% FPL) are not specified online; eligibility is determined case-by-case based on financial documentation. OPKO Connect reviews household income, assets, and expenses.[4] Here's a general overview: | Household Size | Estimated Threshold Example* | Notes | |---------------|-----------------------------|-------| | Individual | Case-by-case review | Financial docs required; no fixed FPL listed[4] | | Couple | Case-by-case review | Includes all household income[3] | | Family of 3 | Case-by-case review | Proof of hardship key[4] | | Family of 4+ | Case-by-case review | Annual reassessment needed[2] | *Examples based on typical PAP structures; call (844) 414-6756 for your situation. Program excludes those with government insurance covering Rayaldee.[1][10] ## Insurance Requirements You must be **uninsured or functionally uninsured** for Rayaldee—meaning no pharmacy benefit covers it, or copays are unaffordable despite commercial/Medicare plans.[1][2][4] OPKO Connect first verifies your insurance: they check coverage, help with prior authorizations (PAs), and appeals if denied.[2][4] - **Commercially insured?** Use separate $0 copay programs like eVoucherRx or OPKO's copay assistance first (not PAP).[2][7][9] - **Medicare Part D?** Check Extra Help/Low-Income Subsidy (LIS)—eligible patients pay $0-$10.35/month. PAP may not apply if Medicare covers it.[9][10] - **Medicaid/government insurance?** Typically ineligible for PAP.[4][10] OPKO Connect explores **all options** before PAP, including state programs or alternatives.[4][10] ## Step-by-Step Application Process 1. **Get Prescribed**: Ask your doctor (often a nephrologist) for Rayaldee and discuss OPKO Connect.[1][2] 2. **Complete Rayaldee Service Request Form (SRF)**: Download from rayaldee.com, fill with your doctor. Includes authorization for OPKO to contact you and verify insurance.[3][6] 3. **Submit SRF**: Email to opkoconnect@rxallcare.com or fax 1-844-660-7083. Or call (844) 414-OPKO (6756) Mon-Fri 8am-8pm ET.[2][3][9] 4. **OPKO Contact**: A Support Specialist calls to guide enrollment, request **financial documentation** (e.g., tax returns, pay stubs, bank statements).[3][4] 5. **Eligibility Review**: OPKO assesses insurance and finances. They'll notify you and your doctor of approval.[4] 6. **Receive Medication**: If approved, shipped **directly to your home** free of charge.[1][2] **Multiple methods** available: phone, email, fax, or specialty pharmacy prescription.[2] ## Timeline and Delivery Processing time varies (not specified exactly), but OPKO aims to minimize delays. Expect a call soon after SRF receipt for next steps. Once approved, medication ships to your address promptly. **Reauthorization** needed annually—OPKO contacts you for renewal.[2][4] Track status by calling (844) 414-6756.[9] ## Alternatives if Denied - **Appeal**: OPKO helps with insurance appeals using letters of medical necessity.[4] - **Copay Programs**: For commercial insurance, eVoucherRx or $0 copay card.[2][7][9] - **Medicare Extra Help**: Apply if low-income; covers copays.[10] - **State Programs**: Check state pharmaceutical assistance via Dept. of Aging.[10] - **Other PAPs/GoodRx**: Discount cards or nonprofit aid, but verify Rayaldee coverage.[5][10] - **No biosimilars** available; discuss generics or other SHPT treatments (e.g., vitamin D analogs) with your doctor.[1] ## Important Disclaimer This guide is for informational purposes only and based on publicly available data as of 2026. Eligibility, processes, and availability can change—**always contact OPKO Connect at (844) 414-6756 or visit rayaldee.com for latest details**. Not medical advice; consult your healthcare provider. OPKO may discontinue the program anytime. Financial privacy protected per HIPAA.[1][2][3][4]

Program information last verified: March 30, 2026