EXKIVITY

Indicated For

Non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations

About This Medication

# Takeda Oncology Here2Assist Patient Guide: How to Get EXKIVITY (mobocertinib) at Low or No Cost **Important Update: EXKIVITY (mobocertinib) is undergoing voluntary withdrawal from the market no later than March 2024, but Takeda is providing ongoing access through a Compassionate Use Program for eligible patients prescribed through that date.** This guide explains Takeda's **Takeda Oncology Here2Assist** program and related support options to help patients with EGFR Exon20 insertion-positive NSCLC access this medication.[3][4][9] ## About EXKIVITY (mobocertinib) EXKIVITY is an oral tyrosine kinase inhibitor (TKI) specifically designed for adults with **epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)** whose disease has progressed after platinum-based chemotherapy.[4][6] It was FDA-approved in September 2021 as the first targeted oral therapy for this mutation, showing clinically meaningful responses with a median duration of about 1.5 years in trials.[6] **Key warnings:** EXKIVITY carries risks like QTc prolongation (heart rhythm changes), diarrhea leading to dehydration, and cardiac toxicity. Monitor heart function and electrolytes; your doctor may adjust or stop treatment based on side effects.[6][8] In October 2023, Takeda announced plans to voluntarily withdraw EXKIVITY due to post-approval study results, but committed to access for current patients. A **Compassionate Use Program** opened in January 2024, providing **free medication** to patients prescribed through March 2024 who continue benefiting, as determined by their doctor. Shipments start after withdrawal.[4][9] ## Who Qualifies for Assistance? Takeda offers support through **Takeda Oncology Here2Assist** (primary program for EXKIVITY), **Co-Pay Program**, and **Help At Hand**. Eligibility varies:[1][2][3][10] - **Here2Assist:** For insured patients starting EXKIVITY. Helps with insurance navigation, financial options, specialty pharmacy coordination, nurse support, and text updates (opt-in required).[1][3] - **Co-Pay Program:** Commercial/private insurance holders (not government insurance like Medicare/Medicaid). Pay as little as **$0-$5 per prescription/dose** for up to 12 months, renewable. Must be 18+, U.S. resident, report changes.[3] - **Help At Hand:** Uninsured or underinsured with financial need. Provides **free medication** (eligibility varies by product; confirm for EXKIVITY).[2][10] - **Compassionate Use:** Current/new patients prescribed before March 2024 withdrawal, continuing benefit.[9] **Note:** EXKIVITY no longer available for new patients post-withdrawal except via Compassionate Use.[9] ## Income Eligibility Breakdown Specific income thresholds aren't publicly detailed and vary by program. Help At Hand is **needs-based** for uninsured/underinsured. Co-Pay requires commercial insurance without full coverage.[2][3][10] Contact programs for personalized assessment. General guidelines: | Program | Income Consideration | Insurance Type | |----------------------|---------------------------------------|-----------------------------| | Co-Pay Program | Not primary; commercial insurance focus | Private/commercial only[3] | | Help At Hand | Financial need-based (uninsured/underinsured)[10] | None or insufficient[2] | | Here2Assist | Varies; identifies options[1][3] | Any, helps navigate | | Compassionate Use | Prescription-based, clinical benefit[9] | N/A (free post-withdrawal) | Consult Takeda for exact FPL (Federal Poverty Level) limits, as they assess household income, size, and expenses. ## Insurance Requirements - **Co-Pay Program:** **Commercial/private insurance only**; invalid if government insurance (Medicare/Medicaid) or fully covered. Report changes.[3] - **Here2Assist:** Works with **any insurance** to secure coverage, bridge delays, or find alternatives.[3] - **Help At Hand:** For **no/limited insurance** with financial need.[2][10] - Medicare patients: Likely ineligible for Co-Pay; explore Help At Hand or Compassionate Use.[3] ## Step-by-Step Application Process 1. **Consult your doctor:** Confirm EXKIVITY suitability and prescription (valid through March 2024 for new starts).[9] 2. **Enroll in Here2Assist:** Visit takedaoncology.com or call 1-844-662-8532 (8am-6pm EST). Provide prescription, insurance details.[1][3][9] 3. **Get Co-Pay Card (if eligible):** Activate online or via phone; use at pharmacy for $0-$5 copay.[3] 4. **Apply for Help At Hand (if uninsured):** Online at helpathandpap.com or call; submit financial proof.[10] 5. **Compassionate Use:** Doctor submits enrollment (open Jan 2024); free supply post-withdrawal if benefiting.[9] 6. **Specialty Pharmacy:** Here2Assist coordinates shipping/filling.[3] 7. **Follow-up:** Receive texts/calls for status.[1] ## Timeline and Delivery - **Approval:** Varies; Here2Assist/Co-Pay often quick (days). Compassionate Use enrollment before March 2024 withdrawal; shipments post-withdrawal.[3][9] - **Processing:** Co-Pay instant at pharmacy; free programs 1-2 weeks. - **Delivery:** Specialty pharmacy ships to home; free via Help At Hand/Compassionate Use.[3][10] - **Refills:** Co-Pay valid 12 months; re-enroll annually. Programs track refills.[3] ## Alternatives if Denied or Ineligible - **Switch programs:** Denied Co-Pay? Try Help At Hand.[2] - **Other assistance:** RxAssist.org lists options; PAN Foundation or state programs.[5] - **Clinical trials:** Search ClinicalTrials.gov for EGFR Exon20 NSCLC. - **Generics/biosimilars:** None available (unique TKI).[6] - **Post-withdrawal:** Only Compassionate Use for ongoing patients.[4][9] ## Disclaimer This guide is for informational purposes based on available data as of early 2024. Programs change; eligibility not guaranteed. **Consult healthcare provider and Takeda directly (1-844-662-8532 or globaloncologymedinfo@takeda.com)** for latest details, especially post-withdrawal. Not medical/financial advice. EXKIVITY has serious risks; discuss with doctor.[3][4][8][9] (Word count: 942)

Program information last verified: March 30, 2026