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FDA Final Guidance on Patient-Reported Outcome (PRO) Measures: Use in Medical Product Development to Support Labeling Claims

Employers plan to shift more health-care costs to workers, survey reports By David S. Hilzenrath

Characteristics of Published Comparative Effectiveness Studies of Medication by Michael Hochman, MD; Danny McCormick, MD, MPH

International survey on willingness-to-pay (WTP) for one additional QALY gained: what is the threshold of cost effectiveness?

Health Care Reform — Where Do We Go from Here?

"Interpreting Hazards: The Increasing Importance of "Antidote to Anecdote" in Managed Care" by Fairman et al

"Is "Value-Based" Value Wasted? Examining Value-Based Insurance Designs Through the Lens of Cost-Effectiveness" by Melnick et al

58% of Surgeries Performed in Hospitals are Outpatient, According to AHRQ/HCUP survey.

AHRQ Introduces New Online Technical Tutorial Series With First Module on HCUP Sample Design

Doctors Face 21% Cut In Medicare Payments.

AMCP Issues Summary of White House Health Care Reform Summit

Maximus To Continue Reviewing Medicare Part D Plan Coverage Determinations

Pharmacoeconomics to Get Bigger Budgets, According to Preliminary Survey Results (Source=Marketwire)

Healthcare Rationing by Proxy: Cost-Effectiveness Analysis and the Misuse of the $50,000 Threshold in the US by Bridges et al.

The AMCP Format for Formulary Submissions, Version 3.0

Statistical Data Resources from AMCP for benchmarking in managed care

UnitedHealthcare has launched an innovative program that offers $20 discounts off certain prescription drug co-payments

Healthcare Technology News: National Health Expenditures Top 17% of GDP

UnitedHealthcare Creates Adult National Cancer Care Registry with Data and Analysis to Support Oncologists in the Fight against Cancer

Novartis’s Afinitor Cancer Drug Rejected by U.K. Cost Agency

NEJM: “Giving Teeth to Comparative-Effectiveness Research — The Oregon Experience” by Saha et al.

Oncology Innovative Pricing deal with NICE on lung cancer drug

“Medication Adherence and Enrollment in a Consumer-Driven Health Plan” by Chen,

FDA News: NICE Outlines Appeals Process for Drug Determinations

IBI: More Than Health Promotion: How Employers Manage Health and Productivity

PR Hub: NICE Recommends Approval of New Rheumatoid Arthritis (RA) Treatment Cimzia(R) (certolizumab pegol) With First of its Kind RA Patient Access Scheme

Healthcare Technology News: Privacy Survey - In Providers We Trust

NEJM article: ‘ Uncomfortable Arithmetic — Whom to Cover versus What to Cover’ by K. Baicker and A. Chandra

NEJM article: ‘ “Play-or-Pay” Insurance Reforms for Employers — Confusion and Inequity’ by B. Herring and M.V. Pauly

Centre for Reviews and Dissemination: Cost-effectiveness of interventions to promote physical activity: a modelling study

Do Health Politicians Really Listen to Health Economists? Observations from Europe by Mittendorf et al.

The Hospitalist: Evidence-Based Medicine Curveball

Health Care Reform and the Need for Comparative-Effectiveness Research

January 2010 Newsletter and Eisenberg Conference Series 2009 Are Now Available

Disease Management Care Blog: 10 Predictions for the Next Decade

Managed Care Vendor Sales Insight Article: Blue Cross Plans Join Initiative To Increase Transparency

Conference: Patient Experience and Patient Safety Culture, April 19-21

Funny Pharmacy Videos. These are Hysterical! Particularly "The PharmG's - Boom Intervention" Rap


hot jobs

Job Title Company
DIRECTOR, GHEOR, NEUROSCIENCE/IMMUNOSCIENCE/VIRGOLOGY Bristol-Myers Squibb
Director, Center for Health Outcomes Research Univ of IL College of Medicine Peoria
PRACTICE LEADER/SENIOR DIRECTOR, HEALTH ECONOMICS AND OUTCOMES RESEARCH Boston Health Economics, Inc.
Director Pharmacoeconomist SXC Health Solutions
Medical Writer PRMA Consulting Ltd


comparative effectiveness

A screening change based on evidence
The U.S. Preventive Services Task Force gained considerable attention with the release of its new recommendations against the current standard practices of breast cancer screening. (Source: Amy Abernathy, NewsObserver.com, Nov. 2009)
AHRQ 2009 Annual Conference
To help advance its goal of improving health care for all Americans, the Agency for Healthcare Research and Quality (AHRQ) held its third annual conference on September 13-16, 2009, in Bethesda, MD. This conference was designed to showcase the best of the Agency's research and provide examples of how that research is being implemented at all levels in health care delivery. Entitled "Promoting Quality... Partnering for Change," the conference featured presentations in seven major themes. Click for some relevant presentations.
AMCP eDossier System
The AMCP eDossier System is a centralized, secure, web-based platform, that provides qualified health care decision makers the opportunity to easily access, review, and evaluate research to make informed, evidence-based decisions.
Assessing Comparative Effectiveness Research in the US
Assessing Comparative Effectiveness Research in the US. (Source: Applied Health Economics & Health Policy: 1 December 2009 - Volume 7 - Issue 4 - pp 219-224)
Assessing the Need to Update Comparative Effectiveness Research Reviews
This site is frequently updated, but can be used to link to the most recent reports. (Source: AHRQ, Nov. 2009)
Association between primary care physicians' evidence-based medicine knowledge and quality of care
Association between PCP's EBM knowledge and quality of care found that physicians with higher total EBM knowledge correlated modestly with better quality of care, but this explained only a small portion in the variance of clinical performance. Results indicate that there might be a need to focus on teaching all the components of EBM rather than EBM microskills. (Source: International Journal for Quality in Health Care, Nov. 4. 2009, rev. Jan. 16, 2010)
Balancing Innovation, Access, and Profits — Market Exclusivity for Biologics
Balancing Innovation, Access, and Profits — Market Exclusivity for Biologics. (Source: Alfred B. Engelberg, J.D., Aaron S. Kesselheim, M.D., J.D., M.P.H., and Jerry Avorn, M.D., NEJM, October 2009)
Comparative Effectiveness News and presentations from the Eisenberg Conference Series 2009
This new issue of Comparative Effectiveness News features a set of white papers published in the September 22, 2009, issue of Medical Decision Making that will serve as the groundwork for an AHRQ Work Group charged with creating a new methods guide to focus on comparisons of diagnostic and prognostic tests for the Effective Health Care (EHC) Program. Also in this issue, the EHC Program process for updating the Comparative Effectiveness Reviews is summarized and a new feature, “The EHC Program Spotlight,” highlights the partners involved in the EHC Program. This issue introduces the Vanderbilt EPC at Vanderbilt University Medical Center.
Comparative Effectiveness Research (CER) and Pharmaceutical Companies (PPT Presentation)
Excellent overview of the use of CER and HEOR
Comparative Effectiveness Research HHS Website
The American Recovery and Reinvestment Act of 2009 created the Federal Coordinating Council for Comparative Effectiveness Research to coordinate comparative effectiveness research across the Federal government. The Council will specifically make recommendations for the $400 million allocated to the Office of the Secretary for CER. As part of its initial work, the Council is conducting Listening Sessions to hear public comments regarding comparative effectiveness research. Individuals interested in addressing the council may nominate themselves to deliver a three minute oral presentation before the council. Individuals and organizations may also submit written comments for the council’s consideration. The public may also attend the session, listen live via audio conference or watch the session online at www.hhs.gov/recovery.
Comparative Effectiveness Research: Relevance
Primer in AJHP by Schumock and Pickard: "Comparative Effectiveness Research: Relevance and Applications to Pharmacy" is a good basic overview. (Source: Glen T. Schumock and A. Simon Pickard, American Society of Health-System Pharmacists, Inc., 2009)
Comparative-Effectiveness Research Could Find New Uses for Drugs
Comparative-Effectiveness Research Could Find New Uses for Drugs. (Source: FDA News, Washington Drug Letter, Nov. 16, 2009)
Comparative-Effectiveness Research Could Find New Uses for Drugs
Comparative-effectiveness research (CER), provided for in congressional healthcare overhaul legislation, can fill in the gaps left by standard clinical trials by pinpointing subpopulations that respond to a particular drug, an expert says. (source: FDANews, Nov. 16, 2009)
David Eddy Delivers Controversial Lecture on the Future of EBM
Kent Bottles discusses David Eddy's history and recent speach in this posting. (Source: ICSI Health Care Blog, Nov. 30, 2009)
Developing Nations Special Issue
This includes HTA, CEA, and discussion of barriers for Asia as a whole, Thailand, Taiwan, Uganda, Latin America and Caribbean, and low- and middle-income countries. (Source: Pharmaeconomics, Nov. 1. 2009)
Evidence in Medicine: Correlation and Causation
First in a series of articles to discuss how to use evidence to arrive at reliable scientific conclusions? (Source Steven Novella, Science-Based Medicine, Nov. 18, 2009)
Evidence-Based Medicine Workbook
Based on workshops. Great resource
Evidence-based protocols
This unpublished opinion from the Second Circuit is instructive in showing that evidence-based protocols, e.g., clinical studies, may exceed what is required to show medical necessity, even under an abuse of discretion standard of review. (Source: Roy Harmon III, Health Plan Law, Nov. 18, 2009)
Evidenced-based Medicine Workbook
Evidence-based Medicine Workbook, Finding and applying the best research evidence to improve patient care. (Source: Glasziou, Del Mar, Salsbury, BMJ Books, September 2009)
Federal Coordinating Council for Comparative Effectiveness Research (Report to the President and the Congress)
June 30, 2009 77 page report with definition, criteria, infrastructure, strategic framework, priorities, etc.
Future of Evidence-based Medicine, by David Eddy
Blog posting about November 2010 lecture questioning the value of EBM, by one of the formidable experts in the field. (Source: ICSI Health Care Blog)
Giving Teeth to Comparative-Effectiveness Research — The Oregon Experience
Experts believe that comparative-effectiveness research (CER) can substantially reduce future health care spending and improve the quality of care. (Source: NEJM, Feb.3,2010)
Growing Application of Pharmacoeconomics and
Growing Application of Pharmacoeconomics and Outcomes Research in Health-Care Decision-Making in the Asia-Pacific Region. (Source: Bong-min Yang, PhD, and Kenneth Lee, PhD, Values in Health, Vol. 12, 2009)
Has the influence of managed care waned? Evidence from the market for physician services
Based on data from the Community Tracking Study, the authors found that MCOs were becoming less restrictive over time in terms of limiting provider services, and were more like non-managed care organizations. (Source: International Journal of Health Care Finance and Economics, March 2010)
Healthcare Debate - The Economist
This house believes that the widespread use of comparative effectiveness reviews and cost/benefit analyses will stifle medical innovation and lead to an unacceptable rationing of health care. (Source: The Economist, October 2009)
Healthcare Rationing by Proxy: Cost-Effectiveness Analysis and the Misuse of the $50 000 Threshold in the US
Authors advocate $US 50,000 per QALY benchmark for determining value for money should be updated, and must vary across payers, populations and even procedures. (Source: PharmacoEconomics: 1 March 2010 - Volume 28 - Issue 3 - pp 175-184)
I n n ova t i ve Pricing Ag reements to Enhance Access Pro s p e c t s
REPRODUCED FROM IMS PHARMA PRICING & REIMBURSEMENT, AUGUST 2009. There is clearly an increasing need for more innovative pricing and reimbursement agreements to help to balance the often conflicting objectives of pharmaceutical and medical technology manufacturers, payers, health technology assessors (HTA), physicians and patients. The industry faces a sustained increase in the cost of healthcare and an ever-increasing range of expensive drugs and technologies available as potential therapies. Clearly, difficult choices need to be made by payers and HTAs about which products receive funding from increasingly restricted healthcare budgets, especially with often insufficient clinical and real-life evidence available. In terms of innovative agreements, more manufacturers, in more countries, are proposing risk-sharing and value-based schemes more often.
Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform
This article presents the idea the further investment in and analysis of comparative effectiveness is required for health care reform. (Source: Harry P. Selker, M.D., M.S.P.H., and Alastair J.J. Wood, M.D., NEJM, Nov. 18, 2009)
Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform
Comprehensive health care should reduce the use of ineffective and suboptimal medical interventions and investigations in order to improve medical care and reduce wasted expense. To do that effectively, we need data on the comparative effectiveness of therapies and medical tests, which unfortunately we currently lack. (Source: NEJM, Nov. 18, 2009)
Innovative Pricing Agreements to Enhance Access Prospects
This PDF summarizes a 2009 Brussels Conference on these types of pricing schemes (eg, Price/Volume, Expenditure Caps, Price Cuts, Conditional Discounts), with emphasis on Europe. Contains nice table with examples of schemes by drug/country. (Source: IMS Pharma Pricing and Reimbursement, August 2009)
Innovative Pricing Agreements, Risk Sharing, Market Access Agreements
This PDF summarizes a 2009 Brussels Conference on these types of pricing schemes (eg, Price/Volume, Expenditure Caps, Price Cuts, Conditional Discounts), with emphasis on Europe. Contains nice table with examples of schemes by drug/country. (Source: IMS Pharma Pricing & Reimbursement, August 2009)
International survey on willingness-to-pay (WTP) for one additional QALY gained: what is the threshold of cost effectiveness? by Shiroiwa et al.
International survey on willingness-to-pay (WTP) for one additional QALY gained: what is the threshold of cost effectiveness? by Shiroiwa et al.
ISPOR: PHARMACOECONOMICS: Identifying the Issues
This paper summarizes the results of an interdisciplinary conference to identify the issues in conducting pharmacoeconomic studies, interpreting the results of these studies, and using pharmacoeconomic information in health care decisions. (Source: Advisory Board & Marilyn Dix Smith PhD, ISPOR, 1998)
It's Time to Embrace Evidence-Based Medicine
This short article helps to define and explore EBM. (Source: Andrew Mcafee, HBR, Nov. 2009)
January 2010 Newsletter and Eisenberg Conference Series 2009 Are Now Available
This new issue of Comparative Effectiveness News features a set of white papers published in the September 22, 2009, issue of Medical Decision Making that will serve as the groundwork for an AHRQ Work Group charged with creating a new methods guide to focus on comparisons of diagnostic and prognostic tests for the Effective Health Care (EHC) Program. Also in this issue, the EHC Program process for updating the Comparative Effectiveness Reviews is summarized and a new feature, “The EHC Program Spotlight,” highlights the partners involved in the EHC Program. This issue introduces the Vanderbilt EPC at Vanderbilt University Medical Center. (Source: AHRQ, Newsletter, Jan. 2010)
Keeping the Patient in the Equation — Humanism and Health Care Reform
This article addresses the influence of growing interest in humanism and comparative effectiveness on health care reform. (Source: Pamela Hartzband, M.D., and Jerome Groopman, M.D, NEJM, Aug. 5, 2009)
Lost in Transmission — FDA Drug Information That Never Reaches Clinicians
Article is critical about the dissemination of information for comparative effectiveness. (Source: Lisa M. Schwartz, M.D., and Steven Woloshin, M.D., NEJM, Oct 2009)
Map of Medicine Uses Evidence-Based Medicine to Help Physicians
Map of Medicine Uses Evidence-Based Medicine to Help Physicians with care pathways, with major focus on the role of pathology and laboratory results in diagnosis. (Source: Dark Daily, Nov. 16, 2009)
MedPAC Focus Group Findings on Comparative Effectiveness: Physician Perspective, by MedPAC
Comparative effectiveness research has become a pivotal term in Washington these days, particularly after the federal government passed the American Recovery and Reinvestment Act of 2009, which authorized $1.1 billion for comparative effectiveness research. Now an analysis of findings (17-page PDF; About PDFs) from six focus groups commissioned by the Medicare Payment Advisory Commission, or MedPAC, finds that although physicians think comparative effectiveness research studies are a good idea, their support for such studies depends on a number of factors.
Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews
The Methods Guide for Comparative Effectiveness Reviews intends to improve the transparency, consistency, and scientific rigor of this work, which consists of systematic reviews of existing research on effectiveness, comparative effectiveness, and comparative harm of different health care interventions. (Source: Agency for Healthcare Research and Quality. Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews)
MS drugs scheme fails to deliver results
A pioneering scheme designed by government to impose a money-back guarantee on pharmaceutical companies if their drugs did not adequately treat patients has failed to provide any clear conclusions more than seven years after it was launched. (Source: The Health Economics Blog / The Financial Times, Dec. 4, 2009)
New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling
New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling. (Source: Stafford, Wagner, and Lavori, NEJM, Aug. 12, 2009)
NICE Outlines Appeals Process for Drug Determinations
Drugmakers appealing a final appraisal determination will be allowed to use three basic arguments, including unfair action by the institute. (Source: FDAnews Drug Daily Bulletin, Feb. 3, 2010)
NICE Stats Spur Controversy and Back Patting
With several drugs exceeding predicted use and several used less than predicted, the annual report which shows how NICE approval has affected medicine uptake in the UK has received mixed reviews. (Source: Sarah Houlton, PharmExecBlog.com, September 23, 2009)
Premera to Contribute Market Data, Experience to Seattle-Based Federal Stimulus Funded Research
Four important projects are being backed by approximately $16 million in federal stimulus funding for comparative-effectiveness research in cancer. Premera Blue Cross is taking an important role in one of the four studies, which will evaluate the effectiveness of cancer diagnostics. (Source: Premera Blue Cross, BusinessWire, October 2009)
Rethinking Randomized Clinical Trials for Comparative Effectiveness Research: The Need for Transformational Change
Rethinking Randomized Clinical Trials for Comparative Effectiveness Research: The Need for Transformational Change. (Source: Various authors, Annals of Internal Medicine, Aug. 4, 2009)
Role of Evidence-Based Medicine in Informing Clinical Decision-Making Addressed by American College of Physicians in House Testimony
This article provides a summary of testimony that Donna Sweet, MD, MACP provided on Dec 2, 2009 to the Subcommittee on Health of the House Energy and Commerce Committee. She addresses the recent breast cancer screening guidlines. (Source: ACP - American College of Physicians, Dec. 2009)
Take the lead on late-phase studies, urges Quintiles executive
Pharma Co's must "get a grip" on late-phase research, or other groups (e.g., payers, FDA) will do it for you, and decisions will be based on price! The article cites the recent head-to-head clinical trial of the blood thinners Plavix (clopidogrel, Bristol-Myers Squibb/Sanofi Aventis) and Effient (prasugrel, Eli Lilly/Daiichi Sankyo) conducted by Medco. (Source: PharmaTimes, Dec. 9, 2009)
The AMCP Format for Formulary Submissions
A Format for Submission of Clinical and Economic Evidence of Pharmaceuticals in Support of Formulary Consideration.FMCP Format Executive Committee. (Source: Journal of Managed Care Pharmacy, Jan. 2010)
The AMCP Format for Formulary Submissions, Version 3.0
A Format for Submission of Clinical and Economic Evidence of Pharmaceuticals in Support of Formulary Consideration FMCP Format Executive Committee
The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health
The European Medicines Agency has launched a three-month public consultation on its draft of The Road Map to 2015: The Agency's Contribution to Science, Medicines, Health with comments due by April 30, 2010. (Source: European Medicines Agency, Jan. 2010)
The Pharmacoeconomics Outlook: Turning value-for-money requirements into a competitive advantage (PPT Presentation)
Basic overview, regulatory issues, case studies on valuation, including NICE. (Source: Business Insights, 2003)
VALUE 1000 – A PRACTICAL PROPOSAL FOR MEASURING QUALITY IN HEALTHCARE
VALUE 1000 – A PRACTICAL PROPOSAL FOR MEASURING QUALITY IN HEALTHCARE: This paper explores some practical ways of measuring quality and value in healthcare. (Source: Kishore Somanathan, Meta Analytics LLC, 2009)
Value-Based Purchasing and Comparative Effectiveness Research:
Value-Based Purchasing and Comparative Effectiveness Research: Why the Pharmaceutical, Biotechnology, and Medical-Surgical Device Industries Should Embrace the Coming Market Evolution. (Source: MarCom Group International, Inc.)
Value-Based Purchasing and Comparative Effectiveness Research:
Effectiveness Research: Why the Pharmaceutical, Biotechnology, and Medical-Surgical Device Industries Should Embrace the Coming Market Evolution. (Source: Josh Feldstein & Elizabeth Brooks, MarCom Group International, Inc.)
When Doctors Create Their Own Evidence-Based Medicine
The argument against evidence-based care says that no two patients are alike, so doctors must be flexible in their use of evidence and can't be bound by rigid protocols based on large studies. But Intermountain Healthcare, a network of hospitals and clinics in Utah and Idaho, has been pushing for more evidence-based care at its facilities for a while now, with some pretty interesting results. (Source: WSJ -- Health Blog, Nov. 5, 2009)
Why should economic evaluations of medical innovations have a societal perspective?
Why should economic evaluations of medical innovations have a societal perspective? (Source: Prof Magnus Johannesson, Prof Bengt Jönsson, Linus Jönsson, Gisela Kobelt, Niklas Zethraeus, Office of Health Economics, Oct 2009)




 

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