EXKIVITY

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:

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)