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Pricing & Reimbursement |
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Health Economics in the Drug Life Cycle
Achieving success in drug discovery, development, reimbursement and marketing
Publication Date January 2003
Publisher URCH Publishing
Product Type Report
Pages not applicable
ISBN Number not applicable
Product Code URC046
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Summary
The increasingly cost-conscious nature of formulary decisions and the willingness of reimbursers to reject a drug for listing on budget impact grounds means that drug companies must address the issue of affordability at a very early stage in the drug development process.
If correctly applied, health economics techniques will deliver a product unit price which creates a win-win situation between the manufacturer and the purchaser or prescriber of the drug, thus ensuring early product reimbursement, rapid product uptake and maximum market share.
Health Economics in the Drug Life Cycle - achieving success in drug discovery, development, reimbursement and marketing identifies the clusters of health economic activities which should accompany drug development from discovery through to marketing approval and then market reimbursement, market entry and the support of the product through the product life cycle. This unique report shows how health economics can create substantial added-value, as well as providing the basis for early decisions to continue or abandon product development.
The Business Opportunity Assessment (BOA)
A Business Opportunity Assessment is a spreadsheet model that attempts to project, over the life cycle of the product, annual cost and revenue streams as the basis for an evaluation of the rate of return from investing
in that product. A well prepared BOA should be transparent and involves;
Identifying and projecting the product life cycle annual treatment prevalence for a disease state;
Identifying and projecting the current direct costs of treating patients in that disease state (medical and pharmacy costs);
Identifying and projecting patient switching scenarios over the product life cycle;
Identifying and projecting development costs, reimbursement and sales and advertising costs; and
Identifying and projecting sales revenues at contract prices.
This report clearly describes the methodology used to generate a sound BOA which will underpin decision making in drug development.
A 60-step practical activity programme
Applying theory in practice is difficult. So how do health economists actually go about successfully preparing the health economics case? Using his extensive experience, Dr Langley has prepared a programme that all biopharmaceutical company health economists should follow to build a successful business case for a product’s development and market entry.
These step-by-step activities should accompany a drug’s development from discovery through to marketing approval and then to the critical market reimbursement and market entry stages of the life cycle. The 60 essential activities detailed in Health Economics in the Drug Life Cycle are divided into 13 clusters:
Pre-Clinical Phase Ii: Health Economics Activities
1. Stage A: Foundation Health Economics Assessment
2. Stage B: First Revised Health Economics Assessment
Clinical Phase IiI Health Economics Activities
3. Stage C: Outcomes Assessment for Health Economics Case
4. Stage D: Second Revised Health Economics Assessment
Clinical Phase Iii (Phase IIIa): Health Economics Activities
5. Stage E: Health Economics Input to Protocol Development for Phase III
6. Stage F: Health Economics Training for Medical/Health Economics Liaison Staff
7. Stage G: Third Revised Health Economics Assessment
8. Stage H: Phase IIIa Trial Based Health Economics Studies
Clinical Phase IIIb and Market Pre-Entry: Health Economics Activities
9. Stage I: Phase IIIB Trial Based Effectiveness and Associated Health Economics Studies
10. Stage J: Finalise Health Economics Case for Product Reimbursement
11. Stage K: Develop Training Materials and Implement Sales Training for Health Economics Case
Clinical Phase IV and Post-Market Entry: Health Economics Activities
12. Stage L: Submission and Monitoring of Reimbursement Applications
13. Stage M: Monitoring of Product Status and Implementation of Value-Added Health Economics to Maintain Product Status
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Content
Content
Marketing Brochure
Executive Summary
1. The Pricing and Reimbursement Decision
2. Cost-Outcomes Claims and Budget Impact Assessment
3. Clinical Pre-Phase II Health Economics Activities
4. Clinical Phase II: Health Economics Activities
5. Clinical Phase IIIa: Health Economics Activities
6. Clinical Phase IIIb and Market Pre-Entry
7. Formulary Approval, Clinical Phase IV and Postmarket Entry
8. Summary and Conclusions
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