Consider pharmaceutical firms claiming access to a national market for an innovative drug.

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Please carefully and precisely answer the following questions, using this template:

1. Consider pharmaceutical firms claiming access to a national market for an innovative drug. Access and pricing are regulated by the national Health Technology Assessment (HTA) agency.

2. Consider an initial situation where access and pricing negotiations between the firm and the HTA agency only go through a Cost-Effectiveness Analysis (CEA) submitted by the firm and assessed by the agency. What kind of information is provided by that CEA?

3. After that initial period, the HTA agency decides to bring Budget Impact Analysis (BIA) into the evaluation process. What kind of information is contained in the BIA provided by the firm? Is BIA a complement or a substitute for CEA? How does BIA affect the uncertainty surrounding the evaluation procedure? How and to what extent does its introduction change the negotiation process?

4. On one side, many countries regulate market access to innovative drugs only through medical and clinical assessment. On the other side, an increasing number of countries require CEA and BIA beside medical and clinical assessment. What are the advantages and drawbacks of those extra requirements, both for firms and agencies?

*the main gaol is to show my knowledge of and opinion on Budget
Impact Analysis and Cost-effectiveness Analysis
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