Navigation Links
New Analysis Finds $5.4 Billion In Annual Lost Savings From Strategies Geared Toward Delaying Generic Drug Entry
Date:7/23/2014

WASHINGTON, July 23, 2014 /PRNewswire-iReach/ -- Use of Risk Evaluation and Mitigation Strategies (REMS) and other restricted access programs to delay generic market entry results in $5.4 billion in lost savings annually, according to a new survey and analysis by economic consulting firm Matrix Global Advisors (MGA).

Logo - http://photos.prnewswire.com/prnh/20140723/129680

Required by the Food and Drug Administration (FDA) for certain small-molecule drugs and biologics, REMS programs are intended to improve drug safety by ensuring that the benefits for patients outweigh the risks. However, new survey results indicate that brand drug manufacturers use REMS programs and other distribution restrictions to prevent generic drug manufacturers from accessing drug samples. Because a generic drug manufacturer must test a product it is developing against a sample of the brand drug to ensure bioequivalence, this obstruction delays generic market entry and the savings generic drugs offer.

"Nearly 40 percent of new FDA drug approvals are now subject to REMS," noted Alex Brill, CEO of MGA and author of the study. "The lost savings arising from misuse of these programs has a direct effect on the cost of health care for consumers, private payors, and government."

The MGA analysis, sponsored by the Generic Pharmaceutical Association, examines forty small-molecule drugs that a survey of generic companies identified as restricted. Using U.S. sales, utilization, and price data from IMS Health, MGA estimates that the delayed market entry of generics for these products results in annual lost savings of $5.4 billion. Of this, the federal government bears a third of the burden, or $1.8 billion. Private insurance companies lose $2.4 billion, and consumers pay $960 million in extra out-of-pocket costs. State and local governments and other small payors lose savings of $240 million.

REMS misuse can be expected to extend to biosimilars once the FDA provides final guidance for biosimilars to enter the market. MGA estimates that delayed biosimilar entry from restricted access to biologics samples would result in approximately $140 million in lost savings for every $1 billion in biologics sales. In 2013, U.S. biologics sales totaled approximately $92 billion, or 28 percent of U.S. drug spending that year.

ABOUT MGA

Matrix Global Advisors (MGA) is a Washington, DC-based economic consulting firm led by Alex Brill. MGA engages in consulting and analysis on a range of health care, tax, and other policy matters. Prior to founding MGA, Brill served as policy director and chief economist to the House Ways and Means Committee and on the staff of the White House Council of Economic Advisers.

For media inquiries, please contact Jonathan Toomey at 202-558-7159.

Media Contact: Jonathan Toomey, Matrix Global Advisors, 202-558-7159, jtoomey@matrixglobaladvisors.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE Matrix Global Advisors
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
2. Global Ablation Technologies Market (2011-2016) - By Application and Devices in Radiofrequency, Cryoablation, Microwave, Ultrasound, Hydrothermal, Radiation, Electrical, Light/Laser and Hydromechanical - Global Trends & Competitive Analysis
3. Osteoporosis Drug Market- Global And China Market Analysis, Size, Trends And Forecast (2010-2015)
4. Large-Scale Meta-Analysis Shows Age Not a Social Barrier to Opioid Use and Misuse
5. Purdue Pharma L.P. To Present Analysis Of Butrans® (buprenorphine) Transdermal System CIII Clinical Data At American Pain Society Annual Meeting
6. Negative Pressure Wound Therapy (NPWT) - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2018
7. Demand for Product Pipeline Review and Analysis Rises in the Global Pharma Industry
8. Lifeline Biotechnologies, Inc. Receives Patent Award, a Device for Breast Tissue Temperature Analysis for Determining Cancer Conditions
9. Ovarian Cancer Therapeutics - Global Drug Forecasts and Treatment Analysis 2020
10. Clinical Chemistry Market Report & Forecast (2012 - 2015): Global Analysis
11. Medical Diagnostic & Therapeutic Ultrasound Devices Market (2012 - 2017) - Global Trends & Competitive Analysis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... LEXINGTON, Mass. , June 24, 2016   ... specialty pharmaceutical company developing innovative inhaled drugs, announced today ... when Russell Investments reconstituted its comprehensive set ... 2016. "This is an important milestone for ... "It will increase shareholder awareness of our progress in ...
(Date:6/23/2016)... Research and Markets has announced the ... to 2022" report to their offering. ... patients with kidney failure, it replaces the function of kidneys ... blood and thus the treatment helps to keep the patient ... Increasing number of ESRD patients & substantial ...
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it ... (procalcitonin) assay as a dedicated testing solution for people ... Roche is the first IVD company in the U.S ... assessment and management. PCT is a sepsis-specific ... blood can aid clinicians in assessing the risk of ...
Breaking Medicine Technology:
(Date:6/26/2016)... Battle Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... abuse, joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table ... held in honor of the city’s history as home to some of the world’s ...
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping ... fitness app. The fitness app plans to fix the two major problems leading the fitness ... size fits all type program , They don’t eliminate all the reasons people ...
(Date:6/25/2016)... ... 2016 , ... Austin residents seeking Mohs surgery services, can now turn to ... Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to ... fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
Breaking Medicine News(10 mins):