عرض الملف

chi_gov_sa · · processed · 2 chunks

政务网
مجلس الشمان المصحي
Council of Health Insurance
Drug Company External Submission Format
In order to complete the evaluation request. Dossier submission should include the below requirements and follow the below sequence.
Section 1: Executive Summary
<table><tr><td>Requirement</td><td>Submission</td><td>CCHI Comments</td></tr><tr><td colspan="3">Therapeutic and Pharmacoeconomic Value of the Intervention</td></tr><tr><td>1. Therapeutic benefits</td><td>□ Yes □ No</td><td></td></tr><tr><td>2. Pharmacoeconomic Benefits</td><td>□ Yes □ No</td><td></td></tr><tr><td>3. Summary</td><td>□ Yes □ No</td><td></td></tr></table>
Section 2: Therapeutic benefits
<table><tr><td colspan="2">Requirement</td><td>Submission</td><td>CCHI Comments</td></tr><tr><td colspan="4">Description of Intervention and Target Disease</td></tr><tr><td colspan="2">1. Description of Intervention</td><td>□ Yes □ No</td><td></td></tr><tr><td rowspan="3">2. Placement of Intervention in Therapy of Target Disease</td><td>2.1 Target Disease Description</td><td>□ Yes □ No</td><td></td></tr><tr><td>2.2 Treatment Approach</td><td>□ Yes □ No</td><td></td></tr><tr><td>2.3 Society Clinical guideline supporting their role in the indication (National and International)</td><td>□ Yes □ No</td><td></td></tr><tr><td colspan="4">Supporting Clinical Evidence: Summary of Key Clinical Studies</td></tr><tr><td colspan="2">1. All Relevant Support Data for Labelled Indications with a copy of published evidence</td><td>□ Yes □ No</td><td></td></tr><tr><td colspan="2">2. All Relevant Support Data for Off-Label Indications with a copy of published evidence</td><td>□ Yes □ No</td><td></td></tr><tr><td colspan="2">3. Clinical Evidence Spreadsheet</td><td>□ Yes □ No</td><td></td></tr><tr><td colspan="2">4. Noncompany sponsored supporting evidence</td><td>□ Yes □ No</td><td></td></tr><tr><td colspan="2">5. Secondary Source Evidence Summary</td><td>□ Yes □ No</td><td></td></tr></table>
Section 3: Pharmacoeconomic Benefits
<table><tr><td colspan="2">Requirement</td><td>Submission</td><td>CCHI Comments</td></tr><tr><td rowspan="3">1. Model Overview</td><td>1.1 Modeling for Decision Making</td><td>□ Yes □ No</td><td></td></tr><tr><td>1.2 Model Types</td><td>□ Yes □ No</td><td></td></tr><tr><td>1.3 Additional Details</td><td>□ Yes □ No</td><td></td></tr><tr><td>2. Modeling Methodology</td><td>2.1 Rationale and Framework• Guidelines</td><td>□ Yes □ No</td><td></td></tr></table>
©
11614
Saudi Arabia, Riyadh 11614
[Non-Text]
94764
P.O.Box 94764
[NO TEXT]
+966112021300
920001177
www.cchi.gov.sa
Classified as a/e/ Public

psbna
مجلس الضمان الصحي
Council of Health Insurance
<table><tr><td rowspan="3">and Rationale</td><td>Analysis FrameworkModeling MethodologyPaper Perspective and Timeframe</td><td></td><td></td></tr><tr><td>2.2 Data SourcesEffectiveness &amp; EfficacyExpert OpinionSafety DataEconomic DataUtilitiesSurrogate MarkersExpected Demographics and Projected Practice Pattern</td><td>□ Yes □ No</td><td></td></tr><tr><td>2.3 Analysis</td><td>□ Yes □ No</td><td></td></tr><tr><td rowspan="3">3. Interactive Modelling and Modeling Report</td><td>3.1 Transparency Statement</td><td>□ Yes □ No</td><td></td></tr><tr><td>3.2 Reporting Format</td><td>□ Yes □ No</td><td></td></tr><tr><td>3.3 Interactive Model</td><td>□ Yes □ No</td><td></td></tr></table>
Section 4: Other Supporting Evidence
<table><tr><td>Requirement</td><td>Submission</td><td>CCHI Comments</td></tr><tr><td>1. SFDA registration certificate</td><td>□ Yes □ No</td><td></td></tr><tr><td>2. Reimbursement status (Saudi and non-Saudi)</td><td>□ Yes □ No</td><td></td></tr><tr><td>3. Pricing</td><td>□ Yes □ No</td><td></td></tr><tr><td>4. Supporting Data (References, Appendices)</td><td>□ Yes □ No</td><td></td></tr></table>
Kindly note that the evaluation requires 3-6 month from receiving a complete dossier submission based on the priority of the request. Incomplete submission will not be accepted.
For further clarifications feel free to contact us through IDF@chi.gov.sa
©
11614 المملكه العربيه السعوديه، الرياض
Saudi Arabia, Riyadh 11614
[Non-Text]
94764
P.O.Box 94764
[NO TEXT]
+966112021300
920001177
www.cchi.gov.sa
Classified as a e/ Public