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:1/18/2017)... After the recent election cycle, it is clear ... for medical and recreational purposes are shifting. The evidence shows ... of cannabis, but the focus is coming from both the ... North American legal cannabis market posted $6.7 billion in revenue ... projects sales will grow at a compound annual growth rate ...
(Date:1/17/2017)... , Jan. 17, 2017 Precision medicine ... for the treatment of disease. The approach allows ... to a therapy. The approach studies the individual ... lifestyle and environment. In January 2015, Precision Medicine ... to all diseases with more than one million ...
(Date:1/17/2017)... , Jan. 17, 2017 EU5 Glucose Monitoring ... new report, "EU5 Glucose Monitoring Market Outlook to 2022", ... market. The report provides value, in millions of US ... market segments - Blood Glucose Meters, Blood Glucose Test ... shares and distribution shares data for each of these ...
Breaking Medicine Technology:
(Date:1/18/2017)... Silver Spring, MD (PRWEB) , ... January 18, 2017 , ... ... and financial consultations to families and business owners in central Maryland and the DC ... community. , Heart disease kills 787,000 people nationally every year, making it the #1 ...
(Date:1/18/2017)... N.J. (PRWEB) , ... January 18, 2017 , ... ... delivery technologies and development solutions for drugs, biologics and consumer health products, today ... will be presenting at the upcoming WCBP Conference, to be held at the ...
(Date:1/18/2017)... Hills, CA (PRWEB) , ... January 18, 2017 ... ... of dental problems ranging from gum disease to enamel erosion, and those dental ... the Massachusetts Department of Public Health, many pregnant women are failing to get ...
(Date:1/17/2017)... ... January 17, 2017 , ... Gym Source, America’s leading retailer of ... at South Dixie Hwy in Miami, FL. , “We are elated to be opening ... innovative in-store concept is designed to give clients a seamless and motivating shopping experience.” ...
(Date:1/17/2017)... Phoenix, AZ (PRWEB) , ... January 17, 2017 ... ... new and improved supplement, Healthful-Flex. , The company, owned and operated by ... the public at a reasonable price with the highest level of customer service. ...
Breaking Medicine News(10 mins):