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. 2008 Jan;4(1):2–7. doi: 10.1200/JOP.0812001

Table 2.

Outline of Decision Process Phases and Their Attributes

Attributes Clinical Evaluation Phase Clinical/Administrative Evaluation Phase Policy Decision Phase
Objective To evaluate the clinical appropriateness, and relative clinical value of a new drug technology for its introduction into the formulary for cancer treatment To evaluate financial and systems-related factors in relation to the relative clinical value of new drug technologies for introduction into the formulary for cancer treatment; to compare the relative merits of competing drugs for funding. To ensure fair process in evaluation of new drug technologies; to evaluate policy-related factors; and to integrate clinical, administrative, and policy determinants in making decisions about public financing of new drug technologies
Expertise required Clinical knowledge Methodological skills Workplace familiarity, practical Pharmacy policy Clinical knowledge Financial Systems flow Governance Population perspective Relative value and affordability Health systems factors Political factors
Participants Clinical care teams (tumor groups)Pharmacist Methodologists (may be clinicians)Patient representative (preferred) Pharmacy and therapeutics committee (clinicians, clinical administrators, pharmacist)Patient representative (preferred) Organizational Executives Trustees as appropriate, clinical, and methodological resource person Patient representative (optional)May include physicians
Responsibilities Provide critical evaluation of strength of evidence, relative clinical benefit in relation to current standards, likely impacts on patients, availability of reasonable alternatives to patients, and feasibility of delivery of a new drug technology Provide comparative estimates of projected usage and cost implications of competing new drugs if approved, benchmark comparators, determine relative value for degree of benefit against benchmarks Ensure appropriate decision process. Weigh relative value to patients, opportunity costs to the population/ society, and mechanisms for funding
Outcome A critical evaluation of the drug technology's clinical performance and relative clinical value, prioritize indications for use A priority-based recommendation regarding inclusion of drugs in the formulary, and appropriate conditions for funding A decision regarding funding conditions and mechanisms of funding, or recommendations to government