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:6/23/2016)... ... June 23, 2016 , ... Supplyframe, ... of the Supplyframe Design Lab . Located in Pasadena, Calif., the Design ... of how hardware projects are designed, built and brought to market. , The ...
(Date:6/23/2016)... LOUISVILLE, Ky. , June 23, 2016 /PRNewswire/ ... from two Phase 1 clinical trials of its ... double-blind, placebo-controlled, single and multiple ascending dose studies ... and pharmacodynamics (PD) of subcutaneous injection in healthy ... APL-2 subcutaneously (SC) either as a single dose ...
(Date:6/23/2016)... , June 23, 2016 On Wednesday, ... at 4,833.32, down 0.22%; the Dow Jones Industrial Average edged ... closed at 2,085.45, down 0.17%. Stock-Callers.com has initiated coverage on ... ), Nektar Therapeutics (NASDAQ: NKTR ), Aralez Pharmaceuticals ... (NASDAQ: BIND ). Learn more about these stocks ...
(Date:6/23/2016)... ... June 23, 2016 , ... Velocity Products, a ... designed, tuned and optimized exclusively for Okuma CNC machining centers at The International ... a collaboration among several companies with expertise in toolholding, cutting tools, machining dynamics ...
Breaking Biology Technology:
(Date:4/28/2016)... First quarter 2016:   , Revenues amounted ... quarter of 2015 The gross margin was 49% (27) ... the operating margin was 40% (-13) Earnings per share ... operations was SEK 249.9 M (21.2) , Outlook   ... M. The operating margin for 2016 is estimated to ...
(Date:4/15/2016)... , April 15, 2016 ... the,  "Global Gait Biometrics Market 2016-2020,"  report to ... http://photos.prnewswire.com/prnh/20160330/349511LOGO ) , ,The global gait biometrics ... of 13.98% during the period 2016-2020. ... angles, which can be used to compute factors ...
(Date:3/29/2016)... 29, 2016 LegacyXChange, Inc. (OTC: ... and SelectaDNA/CSI Protect are pleased to announce our successful ... a variety of writing instruments, ensuring athletes signatures against ... collectibles from athletes on LegacyXChange will be assured of ... DNA. Bill Bollander , CEO states, ...
Breaking Biology News(10 mins):