Navigation Links
AMCP Releases Consensus Recommendations to Improve Sharing of Health Care Economic Information Used in Pharmaceutical Coverage Decisions
Date:6/24/2016

ALEXANDRIA, Va., June 24, 2016 /PRNewswire-USNewswire/ -- The Academy of Managed Care Pharmacy (AMCP) today released a set of recommendations that would allow biopharmaceutical companies to more easily share health care economic information (HCEI) with entities that make formulary and coverage decisions, a move that addresses the growing need to determine the "value" of new medicines.

The recommendations address restrictions in the sharing of product information that does not appear on the drug label, a prohibition that hinders decision makers from accessing HCEI on new therapies.

"Effective communication of HCEI is more important than ever, as biopharmaceuticals entering the market today are highly complex and often very expensive," says AMCP Chief Executive Officer Susan A. Cantrell, RPh, CAE. "With the U.S. health care system increasingly focused on the concept of providing value, it is essential that pharmaceutical product value is accurately measured and disseminated. These recommendations are a major step forward in addressing a barrier that has prevented health care decision makers from obtaining such information."

Specifically, the recommendations seek to clarify Section 114 of the 1997 Food and Drug Administration Modernization Act (FDAMA). Section 114 serves as a regulatory safe harbor for the dissemination of HCEI to formulary decision makers, such as pharmacy and therapeutic (P&T) committees. The safe harbor is needed because HCEI typically is not included within the FDA-approved labeling, and the agency prohibits manufacturers from distributing such information unless it is specifically requested from a health care decision maker.

Section 114, however, has been little used because of ambiguity in its wording and lack of implementing guidance from the FDA. The FDA announced that it plans to release guidance this year. To help inform the FDA's current thinking on development of new guidance, AMCP held a diverse stakeholder partnership forum this spring that resulted in a series of consensus suggestions. Among them:

  • HCEI includes much more than costs, and should encompass such things as health care utilization (e.g., hospitalizations, emergency department visits), patient benefits, adherence, endpoint extrapolations, quality of life, and adverse events.
  • "Competent and reliable scientific evidence" — which will form the basis of HCEI — should be defined as "truthful and non-misleading tests, analyses, research, studies, models, or other evidence."
  • HCEI related to a drug in the pipeline should be communicated to appropriate stakeholders 12 to 18 months prior to approval. 
  • "Other similar entities" that could receive HCEI besides P&T and formulary committees include health plans and integrated delivery systems, and organizations that evaluate HCEI or develop value frameworks and compendia.

The recommendations are contained in the forum proceedings, published in the July issue of AMCP's Journal of Managed Care & Specialty Pharmacy (JMCP). AMCP now will lead the development of a draft guidance document to share with the FDA. This information also will be shared with Congress as it considers legislative solutions to improve sharing of HCEI.

Read the forum proceedings with the recommendations at www.jmcp.org.

Logo - http://photos.prnewswire.com/prnh/20140129/DC55513LOGO

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/amcp-releases-consensus-recommendations-to-improve-sharing-of-health-care-economic-information-used-in-pharmaceutical-coverage-decisions-300289900.html


'/>"/>
SOURCE Academy of Managed Care Pharmacy
Copyright©2016 PR Newswire.
All rights reserved


Related medicine technology :

1. TechAtlas Group Releases Innovative Chronic Kidney Disease Landscape Map
2. TRACE Releases 2012 Global Enforcement Report
3. RxAlly Releases White Paper on Necessity of Personalized Pharmacist Care
4. Pharmafocusasia.com Releases its e-Book for Year 2013
5. Endeavor Power Corporation Issues Corrections on two of its earlier Press Releases dated January 9, 2013 and March 8, 2013
6. Earnings Releases, Investment Plans, Commencement of Clinical Trials, and FDA Applications Brighten Outlook - Research Report on Bard, Centene, Exact Sciences, Ironwood, and Merrimack
7. Beckers Healthcare Releases Report on State of ASC Industry
8. Bekers Hospital Review Releases Report on State of Hospital Industry
9. Techne Corporation Releases Unaudited Fourth Quarter And Fiscal Year 2013 Results
10. Nutrastar Releases Second Quarter 2013 Results
11. Raritan Releases Dynamic Search User Interface on Amazon Web Services (AWS) Marketplace
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... Korea , Oct. 4, 2017  South Korean-based ... next-generation CPR training aide "cprCUBE" on Kickstarter. The device ... compression during cardiac arrests with better efficiency compared to ... also offers real-time feedback on efficacy of the compression ... crowdfunding campaign has a goal to raise $5,000. ...
(Date:10/2/2017)...  AllianceRx Walgreens Prime, the combined central specialty pharmacy ... benefit manager Prime Therapeutics LLC (Prime), today officially began ... unveiling of new signage at its headquarters in ... a few other company-owned facilities across the country. This ... of whom will begin to see the AllianceRx Walgreens ...
(Date:9/27/2017)... Sept. 27, 2017  Commended for their devotion to personalized ... Ranked as number one in the South Florida Business Journal,s ... Inc. 5000 yearly list, the national specialty pharmacy has found ... Bardisa will soon be honored by SFBJ as the ... Set to receive his award in October, Bardisa ...
Breaking Medicine Technology:
(Date:10/13/2017)... IL (PRWEB) , ... October 13, 2017 , ... ... which established the certification process to promote standards of excellence for the field ... Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at the ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance ... care insurance companies have a waiver for care if the client has a cognitive ... the family pays for care, is often waived, so the benefits from their insurance ...
(Date:10/13/2017)... ... , ... Talented host, actor Rob Lowe, is introducing a ... episode of "Success Files," which is an award-winning educational program broadcasted on PBS ... in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve in ...
(Date:10/12/2017)... San Francisco, CA (PRWEB) , ... October 12, ... ... and Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus ... sleep apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral ...
(Date:10/12/2017)... ... , ... Asante, a nationally recognized health system in southern ... home health joint venture through an agreement, effective October 1, 2017, to create ... health company with Asante, delivering clinically integrated care, for the past eight years. ...
Breaking Medicine News(10 mins):