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Influencing the Development of NICE Technology Appraisals and Guidelines: Lessons for the Pharmaceutical Industry


Description: Introduction:

The U.K. National Institute for Health and Clinical Excellence (NICE) is increasingly influencing the fate of drugs, other health care technologies, and general clinical practice in many countries. Pharmaceutical and device manufacturers will greatly benefit from engaging in NICE processes. The author’s experience as a systematic reviewer and project manager for NICE clinical guidelines supplements this report.

Get the Answers You Need to Shape Your Strategy:

- Manufacturers can participate in the development of NICE guidance on specific health care technologies through NICE’s health care technology appraisals (HTAs). At what points in NICE HTA development can manufacturers participate? Why is such participation becoming increasingly important? How can manufacturers influence NICE HTA guidance to achieve the most favorable outcome for their products?

- NICE guidelines offer guidance for the clinical diagnosis, management, and referral of diseases and other health-related conditions. How can manufacturers benefit from providing input on the development of these guidelines? How closely are physicians currently following these guidelines?

- NICE guidance has become internationally recognized as being developed to the highest standards in health services research. How are NICE’s recommendations affecting use of health care technologies in other countries? Will NICE be a model for similar organizations in other European countries? In what areas of product evaluation is NICE most likely to lead the way?

- Health economics and cost-effectiveness modeling are playing an increasingly important role in NICE decision making. How is cost-effectiveness-based evaluation of drugs and other health care technologies evolving to become increasingly important in regulators’ decisions? How can manufacturers be involved in or influence NICE’s evaluation processes in this area?

Scope:

Role of NICE: How NICE provides guidance to National Health Service (NHS) health care providers in England and Wales for the use of drugs and other health care technologies.

Impact of NICE guidance: NICE’s impact on the success or failure of drugs and other health care technologies in the United Kingdom and other countries as well as on influencing general clinical practice.

NICE HTA development process: Manufacturer involvement in developing the scope, submitting evidence and models, commenting on the assessment report, and participating in the appeals process.

NICE clinical guidelines development process: Manufacturer involvement in developing the scope, submitting invited evidence, and commenting on draft guidelines.

Cost-effectiveness modeling: NICE and the cost per quality-adjusted life year (QALY), determining a threshold cost per QALY, threshold cost per QALY and the NICE appraisal decision, and NICE use of health economic data and model design.


Contents: Executive Summary
Strategic Considerations
Stakeholder Implications
Role of NICE
Impact of NICE Guidance
NICE Development Processes
HTA Development Process
Development of the Scope
Submission of Evidence and Models
Commenting on the Assessment Report
Appeals Process
Clinical Guideline Development Process
Development of the Scope
Invited Submission of Evidence
Commenting on Draft Guidelines
Cost-Effectiveness Modeling
Cost per Quality-Adjusted Life Year
Determining a Threshold Cost per QALY
Threshold Cost per QALY and the NICE Appraisal Decision
Health Economic Data and Model Design
Outlook
About the Author.
Appendix A. Bibliography

Tables
1. Key NICE Documentation on Technology Appraisals and Clinical Guidelines
2. Physician Survey Results on Compliance with NICE Guidance for Select
Drugs/Drug Classes

Figures
1. Prescription Volume of Beta Blockers and ACE Inhibitors in 2005 and in 2006,
Following Publication of NICE Hypertension Guideline in June 2006
2. Manufacturer Involvement in the HTA Development Process
3. Manufacturer Involvement in NICE Clinical Guideline Development Process
4. Infl uence of RCT Evidence on NICE’s Cautionary and Noncautionary Recommendations
for Interventional Procedures




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