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# Quality Management System **HEALTHCARE PROVIDER ADDITION REQUEST FORM** Code: IDF-FR-F-17-01 Effective Date: **1 January 2024** # Request Form ## 1. Complete the Following Information | Field | Input # Quality Management System ## HEALTHCARE PROVIDER ADDITION REQUEST FORM **Code:** IDF-FR-F-17-01 **Effective Date:** DD Month 2023 [within 2 weeks from last approval date] 3. Are there any other drugs available in the unified drug formulary which are used for the same indication(s) as the requested drug? * Yes * No 4. If the answer of Question 3 is Yes, please complete the following table: | Indication | ICD-10-Am | Scientific Name | Drug Code | Therapeutic Class | |---|---|---|---|---| | a. | | | | | | b. | | | | | | c. | | | | | | d. | | | | | a. Provide a copy of the supportive literature in the form of published studies in peer-reviewed journals and clinical practice guidelines if available. (Abstract presentations, and promotional literature by pharmaceutical companies are not acceptable). Levels of evidence for effectiveness of a healthcare intervention are defined as follows: * I-from meta-analysis or systematic review of randomized controlled trials (RCT's)/ large multi-center RCT's; * II-from one or more RCT; * III-from controlled trials without randomization; cohort, case control, analytic studies, multiple time series, before and after studies (preferably from than one center or research group); * IV-from other observational studies; * V-from opinions of scientific societies based on clinical experience, descriptive studies, or reports issued by expert committees within the field. المملكه العربيه السعوديه, الرياض 11614 Saudi Arabia, Riyadh 11614 Council of Health Insurance - Confidential ص.ب 94764 P.O.Box 94764 +966112021300 Classified as عام / Public 1 920001177 www.cchi.gov.sa # Quality Management System Code: IDF-FR-F-17-01 ## HEALTHCARE PROVIDER ADDITION REQUEST FORM Effective Date: DD Month 2023 [within 2 weeks from last approval date] 5. Summarize the comparative efficacy of this drug with alternative formulary agents. Please use evidence-based clinical studies and pharmacoeconomic comparisons 6. Summarize the comparative safety of this drug with alternative formulary agents. | Drug Name | Serious Reactions | % | Common Reactions | % | Occasional/Rare Reactions | % | |---|---|---|---|---|---|---| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 7. List the main drug-drug interaction of this drug. المملكه العربيه السعوديه, الرياض 11614 Saudi Arabia, Riyadh 11614 Council of Health Insurance - Confidential 94764 صب P.O.Box 94764 +966112021300 Classified as عام / Public 2 920001177 www.cchi.gov.sa # Quality Management System **HEALTHCARE PROVIDER ADDITION REQUEST FORM** Code: IDF-FR-F-17-01 Effective Date: DD Month 2023 [within 2 weeks from last approval date] 8. List the contraindications/precautions for this drug. 9. List any other potential advantages of this over current unified drug formulary products. 10. Common drug dosages: a) Adult: b) Children: 11. Should the prescribing of this drug be limited to a subgroup of patients with this condition? ☐ No ☐ Yes If yes, please provide guidelines indicating patient selection criteria, dosage, monitoring parameters, duration of therapy, and criteria for discontinuation of the drug. 12. What is the estimated usage per patient? [may indicate by treatment course, monthly or annually]. 13. Should the prescribing of this drug be restricted to certain members/subspecialty of the medical staff? ☐ No ☐ Yes ☐ If yes, who? 14. Have you received research support or other incentives from the manufacturer of this drug? ☐ No ☐ Yes المملكه العربيه السعوديه, الرياض 11614 Saudi Arabia, Riyadh 11614 Council of Health Insurance - Confidential 94764 صب P.O.Box 94764 +966112021300 Classified as عام / Public 3 920001177 www.cchi.gov.sa # Quality Management System ## HEALTHCARE PROVIDER ADDITION REQUEST FORM **Code:** IDF-FR-F-17-01 **Effective Date:** DD Month 2023 [within 2 weeks from last approval date] 15. Are you involved in a research study or an evaluation of drug samples of this drug? * No ☐ * Yes ☐ If the answer to questions 14 and/or 15 is yes, please explain 16. Do you suggest the deletion of any formulary drug if this drug addition request is approved? If so, specify name of the drug and the reason for the proposed deletion. 17. If no drug will be replaced, state the reason(s) for maintaining the current formulary product. 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