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

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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.
3. LITERATURE REVIEW• Discuss existing economic studies that addressthe same technology, and similar studyquestion(s).• Comment on the relevance and generalizability ofthe results of the reviewed studies to the targetaudience.
Page 1 and 2: Proposed Pharmacoeconomics Guidelin
Page 3 and 4: Situations where economic evaluatio
Page 5 and 6: International Experiencee • Sever
Page 7 and 8: International ExperienceReimburseme
Page 9 and 10: Why do guidelines differ?• Some i
Page 11 and 12: Primary AudienceSaudi decision and
Page 13 and 14: Standard Reporting Format• A stru
Page 16 and 17: Executive Summary• The Executive
Page 20 and 21: 4. METHODS4.1 Perspective- State an
Page 22 and 23: 4. METHODS cont.4.6 Outcome measure
Page 24 and 25: 4. METHODS cont.4.8 Modelling- Econ
Page 26 and 27: 4. METHODS cont.4.10 Time horizon-
Page 28 and 29: 5. RESULTS cont5.2 Results of varia
Page 30 and 31: 7. CONCLUSIONS• Address the resea

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