Navigation Links
EU Study Finds UK Health Product Benefit Metric Flawed
Date:2/1/2013

Washington, D.C. (PRWEB) January 31, 2013

RegLink News, in its monitoring of developments at regulatory and health technology assessment (HTA) agencies around the world, is accustomed to reporting on decisions as to coverage or not of new drugs and medical devices. This week’s HTA news has significance well beyond a particular product: A study funded by the European Commission has just concluded that the formula used by the UK’s healthcare cost containment watchdog, the National Institute for Health and Clinical Excellence (NICE), doesn’t work – and in so doing has sparked off a debate on the subject of determining patient access to new therapies.

The study, conducted by the European Consortium on Healthcare Outcomes and Cost-Benefit research (ECHOUTCOME), examined the scientific validity NICE’s formula – Quality Adjusted Life Years (QALY) – and found that it doesn’t reflect real world needs and preferences of patients.

QALY weighs the number of life years and the improvement to quality of life, and is the basis for reimbursement decisions delivered by many health technology assessment (HTA) agencies around the world, including – in addition to NICE – those in Canada and Australia. The metric has, however, been rejected by some HTA bodies, including notably Germany’s IQWiG.

The ECHOUTCOME group’s report on NICE’s methodology comes right out and says that the use of QALY “produce[s] hugely inconsistent, wrong results, on which important [reimbursement] decisions are based.” The report concludes that all four of the assumptions which allegedly support the use of QALY are invalid: (1) that time and quality of life can be measured in consistent intervals; (2) that life years and quality of life are linked; (3) that people are neutral about risk; and (4) that willingness to sacrifice life years is constant over time. The head of the ECHOUTCOME study group is quoted by the UK’s Independent as saying that "agencies such as NICE should abandon QALY in favor of other approaches,” and that “European health technology assessment agencies currently looking to adopt the NICE model must seriously reconsider.”

Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry, said the study “shows why NICE so often delivers conclusions that are out-of-step with other bodies and can undermine clinical work in the UK and most importantly deny UK patients in need, access to new and proven treatments.”

RegLink partner Ansis Helmanis points out that “the European debate is timely and should be taken up on this side of the Atlantic as well,” and that “reimbursement gatekeepers here, both public and private, are gearing up for health care reform and are refining the criteria they use – or will be using – to make the same kind of decisions that are being made by European gatekeepers such as NICE. Something flawed yet determinative as to whether patients will or will not get access to a new and possibly life extending therapy should not be used.”

The ECHOUTCOME consortium’s eight entities recommend replacing QALY with a more flexible case by case approach, such as a cost-benefit analysis of how effective a drug is in achieving disease remission or preventing relapse.

About RegLink:
RegLink Associates, LLC is an online publisher of two e-weekly Global Updates that provide a round-up of the previous week’s regulatory, clinical, reimbursement, commercial and health technology assessment developments worldwide. Its Global Drugs and Biologics Update and Global Medical Device Update aggregate the “What’s New” from major markets around the world by country, region and topic with links to source documents and brief translation of title and content. RegLink offers a free 30-day trial of its Updates.

Read the full story at http://www.prweb.com/releases/2013/1/prweb10382028.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Positive Clinical Study Results for BSPs HyperQ Technology
2. 15-Minute Data From Phase 3 Study of Avanafil Featured as a Late Breaking Abstract at SMSNA Annual Meeting
3. DermTechs Non-invasive Melanoma Detection Assay Poised to Enter Clinical Validation Study
4. Marshall study shows nanoparticles used as additives in diesel fuels can travel from lungs to liver
5. Clionsky Neuro Systems (CNS-Neuro) Announces Publication of Study Finding Elderly Patients Unable to Recognize Their Memory Loss
6. Convergence Pharmaceuticals Initiates Phase I Multiple Ascending Dose Study for CNV2197944
7. AtheroNova Inc. Preclinical Study Demonstrates 95% Reduction in Arterial Plaque Formation
8. Singapore scientists lead human embryonic stem cell study
9. GeneTex Antibody Company to Launch New Line of Primary Antibodies for the Study of Spindle Assembly
10. Nutra Pharma Announces Publication of a New Mechanism Study of Alpha-Cobratoxin in the Treatment of Pain
11. Metabolex Announces Positive Results From its Clinical Study of Arhalofenate in Combination With Febuxostat
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... ... October 11, 2017 , ... Proscia ... be hosting a Webinar titled, “Pathology is going digital. Is your lab ready?” ... pathology adoption best practices and how Proscia improves lab economics and realizes an ...
(Date:10/11/2017)... the Netherlands and LAGUNA HILLS, Calif. ... The Institute of Cancer Research, London ... use MMprofiler™ with SKY92, SkylineDx,s prognostic tool to risk-stratify patients ... trial known as MUK nine . The University of ... trial, which is partly funded by Myeloma UK, and ICR ...
(Date:10/11/2017)... ... 2017 , ... A new study published in Fertility and ... in vitro fertilization (IVF) transfer cycles. The multi-center matched cohort study ... comparing the results from the fresh and frozen transfer cohorts, the authors of ...
(Date:10/10/2017)... ... ... San Diego-based team building and cooking events company, Lajollacooks4u, has unveiled a ... new look is part of a transformation to increase awareness, appeal to new markets ... It will also expand its service offering from its signature gourmet cooking classes and ...
Breaking Biology Technology:
(Date:4/4/2017)... 2017   EyeLock LLC , a leader of ... States Patent and Trademark Office (USPTO) has issued U.S. ... of an iris image with a face image acquired ... company,s 45 th issued patent. ... given the multi-modal biometric capabilities that have recently come ...
(Date:3/30/2017)... , March 30, 2017 Trends, opportunities ... (physiological and behavioral), by technology (fingerprint, AFIS, iris recognition, ... recognition, and others), by end use industry (government and ... immigration, financial and banking, and others), and by region ... , Asia Pacific , and ...
(Date:3/24/2017)... Controller General of Immigration from Maldives Mr. Mohamed Anwar and ... international IAIR Award for the most innovative high security ePassport and eGates  ... ... Maldives Immigration Controller General, Mr. Mohamed Anwar ... right) have received the IAIR award for the "Most innovative high security ...
Breaking Biology News(10 mins):