Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Three-Quarters of U.S. Health Plans Reimburse for Off-Label Uses of Prescription Drugs, According to Tufts Center for the Study of Drug Development

By Pharmaceutical Processing | March 10, 2009

Reflecting recent rapid growth of off-label prescribing of prescription drugs, 75 percent of all health plans in the United States now reimburse patients for such treatments, according to a study recently completed by the Tufts Center for the Study of Drug Development. Of health plans that reimburse for off-label uses, over half impose conditions, including step therapy, indication restrictions, prior authorization, and quantity limits, and nearly 90% rely on pharmaceutical compendia to inform their off-label use reimbursement decisions, the study found. The findings were based on a Tufts CSDD survey of 179 third-party payers in the U.S. that administer Medicare and Medicaid pharmacy benefits. “Since patients do not pay directly for most off-label uses, third-party payers have become crucial for market access,” said Joshua Cohen, a senior research fellow at Tufts CSDD and lead investigator on the study. “While reimbursement decisions with respect to on-label indications are relatively well understood in terms of evidence requirements, off-label use reimbursement until now has been less transparent.” The practice of off-label use involves prescribing medicines for a purpose outside the scope of a drug’s intended purpose, as indicated on its label. Once a drug is approved in the U.S., the Food and Drug Administration does not regulate its use, and doctors may prescribe the drug for an off-label use. Cohen noted that with off-label prescribing likely to increase, “health plans will need to balance the value of rapid patient access to the best pharmaceutical care possible, sometimes through the off-label use of a drug, with the need for comprehensive data on the benefits and risks of such care.” The Tufts CSDD study, reported in the March/April Tufts CSDD Impact Report, released today, found that: Sixty percent of the health plans surveyed require that off-label uses must be referenced in one or more pharmaceutical compendia to be reimbursed. More than three-quarters of health plans ascribed a “very important” role to peer-reviewed literature as a factor in determining off-label use reimbursement decisions. Almost four-fifths of plans ascribed a role to cost-effectiveness in off-label use reimbursement decisions; almost one-fifth said cost-effectiveness data play a “very important” role.

Related Articles Read More >

Great Point Partners logo.
Great Point Partners acquires majority stake in Eutecma to fuel sustainable cold chain growth
Driving success in fast-paced high-tech pharma construction projects
This is a photo of the Fujifilm Diosynth Biotechnologies plant under construction in Holly Springs, North Carolina.
Fujifilm, Regeneron ink $3B U.S. manufacturing agreement
This is the logo of Johnson & Johnson.
J&J breaks ground on $2B manufacturing facility in North Carolina
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE