Proposed Pharmacoeconomics Guideline p to Saudi Food & Drug ...

2. BACKGROUND• General comments on conditionList the etiology, pathology, diagnosis, risk factors, prognosis (ifrelevant).• Technology descriptionDescribe the epidemiology (i.e., incidence or prevalence), burdenof For fthe drugs, condition state in brand Saudi diA and Arabia.generic names, dosage form, route ofDescribe administration, the economic recommended impact and dosage, burden duration of the of condition treatment, in• Regulatory statusSaudi therapeutic Arabiaclassification, mechanism of action.Describe List For the non-drug approved the current technologies, indication(s) clinical state practice in basic Saudi in features, Saudi Arabis Arabia. that underlying is Refer the toclinical topic theory of practice or the concept. study, guidelines including (if applicable relevant). population Include a description and orcomparison subgroups, List advantages and of alternatives date and of disadvantages approval.for the indication. (e.g., relating to clinical use).Give State additional adverse events, approved contraindications, indication(s) in cautions, Canada. warnings.Include Describe the setting regulatory for the status technology and approved if relevant indications (e.g., hospital-inother based) countriesGive unit cost of the intervention and comparators.