We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Novartis Can Provide CAR-T Therapy for Free, OIG Says

Novartis Can Provide CAR-T Therapy for Free, OIG Says

March 30, 2021

HHS’ Office of Inspector General (OIG) said Novartis is free to pay for low-income patients to receive its pricey CAR-T therapy Kymriah (tisagenlecleucel), and those payments will not be considered illegal.

OIG told Novartis that while payments for the $475,000 one-time gene therapy could in theory compel doctors or treatment centers to use the treatment or influence patients to choose it, patients are able to get the drug at many different healthcare centers so they would be unlikely to accept the payment simply to get the drug at one specific place or from one specific doctor.

Novartis provides Kymriah for free to eligible patients who do not have insurance coverage or have been denied coverage.

Approved by the FDA in 2017, Kymriah, which makes use of the body’s own T-cells to fight cancer, is used to treat B-cell acute lymphoblastic leukemia.

View today's stories

Drugs Regulatory Affairs

    Upcoming Events

    • 28Sep

      The Cost of Counterfeiting: Why You Need a Plan to Secure Your Medical Device Supply Chain

    • 28Sep

      Calculating Sample Size to Satisfy FDA Expectations

    • 11Oct

      GMP Quality Management vSummit 2023: Where Quality Meets Risk

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    • 08Nov

      18th Annual FDA Inspections vSummit

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • Culture of Quality and Compliance Go Hand in Hand, Says Expert

    • First-in-Human Studies of Artificial Wombs Subject of FDA’s Adcomm This Week

    • BCBS of Louisiana Sues Celgene, BMS for Patent Fraud of Blockbuster Drug Pomalyst

    • AI/ML Data Collection Needs to Avoid Bias, FDA Dep. Director Says

    The Revised ICH E8: A Guide to New Clinical Trial Requirements

    Learn More
    • Drug Products
      • Quality
      • Regulatory Affairs
      • GMPs
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Device Products
      • Quality
      • Regulatory Affairs
      • QSR
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Clinical Products
      • Trial Design
      • Data Integrity
      • GCP
      • Inspections and Audits
      • Transparency
    • Privacy Policy
    • Do Not Sell or Share My Data
    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing