Appendix I: Identifying and defining economic inputs and outcomes
Appendix I to the Guidelines for the Pharmaceutical Industry on Preparation of Submissions to the Pharmaceutical Benefits Advisory Committee including major submissions involving economic analyses.
Parts I, II, III, IV and Appendices
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>> Part I - Roles and Responsibilites of the PBAC
>> Part II - Basic information on preparing a submission for the PBAC
>> Part III - Guidelines for preparing the main body of a major submission
>> Part IV - About these guidelines
Definition of direct medical resources
Identify and list the resource items for which there will be a change in use associated with substituting the proposed drug for the main comparator (see also the Manual of Resource Items and their Associated Costs). Sometimes only changes in drug use will need to be identified. The following should be considered where appropriate:
a. drugs (direct costs of treatment and of drugs used to treat side effects);
b. medical services including procedures;
c. hospital services;
d. diagnostic and investigational services;
e. community-based services; and
f. any other direct medical costs.
Definition of direct non-medical resources
Occasionally because of the condition under treatment or the age of the patients, consideration of direct non-medical costs such as social services (home help, day care, meals on wheels, nursing and physiotherapy services etc) may be relevant. Some of these are included in the Manual of Resource Items and their Associated Costs.
Definition of natural units of direct resources
Define the natural units (such as number of GP consultations or admissions per DRG) used to measure the change in the amount of resources provided (see also the Manual of Resource Items and their Associated Costs). See Appendix L for advice on tabulating the identified resources and their natural units of measurement alongside their associated unit costs.
Definition of indirect economic outcomes
These include potential working time gained or lost measured in time units (days, weeks, years etc). They may also include potential impaired working time gained or lost by sick patients continuing to work measured in similar time units together with a measure of the extent of impairment.
Particular care is needed when considering indirect economic outcomes when using surrogate outcome indicators (their combination may be inappropriate) or utilities (to avoid double-counting the estimates of benefit, see also Appendix O).
Definition of economic outcomes to be excluded
Limit costs to those associated with the disease under treatment. In these evaluations do not attempt to include outcomes of other diseases which, in the fullness of time, are likely to afflict patients who live longer as a result of effective treatment which they receive now.