chi_gov_sa · · processed · 39 chunks
# Daman Drug Formulary (DDF) Monitoring Report ## CHI'S PHARMACEUTICAL DICTIONARY: Market Monitoring and Data Harmonization **ضمان** **مجلس الضمان الصحي** **Council of Health Insurance** Confidential # Executive Summary ## Context and Challenges The Council of Health Insurance (CHI) in Saudi Arabia oversees the private health insurance sector and manages the Daman Drug Formulary (DDF). Discrepancies in pharmaceutical classification systems across SFDA list, DDF, NPHIES platforms have led to complaints, and data inconsistencies, hindering seamless integration and compliance. ## Objectives The objective of this report is to maps the drug classification systems used by SFDA, and CHI, highlighting discrepancies, while describing the methodology for harmonizing classifications using SFDA as a benchmark, and providing a reference drug list to support alignment and data analysis ## Key Outputs and Pilot Implementation The Harmonized CHI List and the BUPA List will serve as core outputs. The pilot will be implemented via NPHIES Intelligence reports, enabling direct integration into the CHI dashboard. ## Work - Approach ### Mapping Drug Classification Systems Drug classification and coding structures used by SFDA and CHI's (DDF/NPHIES) were mapped and presented ### Comparing Drug Classification Systems Drug classification and coding structures were compared to identify inconsistencies or overlaps between SFDA List, DDF, and NPHIES platforms. ### Using Data Linkage to Harmonize drug Classification Multi-steps to harmonize Drug classifications and address discrepancies across SFDA List, DDF, and NPHIES platforms were adopted. --- ### Mapping and Matching: Drugs were matched between NPHIES and SFDA using GTIN or trade names. ### Drug Type Standardization: Rule-based approach was applied to classify drugs into unified types ### Route of Administration Grouping: Synonymous & clinically equivalent administration routes were grouped. ### Strength & Strength Unit Harmonization: Drugs were grouped by scientific name, strength and unit consistency were evaluated. ### CHI Harmonized Drug List A preliminary drug list was generated benchmarking SFDA to support data analytics. ### Quality Check (QC) QC was performed to ensure accurate standardization and grouping. ضمان مجلس الضمان الصحي Council of Health Insurance Confidential # Executive Summary ## Recommendations * Implement the Use of SFDA Codes: Enforce the adoption of SFDA registration numbers and GTINs across all healthcare entities. * Training Programs: Educate stakeholders (prescribers, pharmacists, claims staff) on standardized drug terminology and substitution rules. * Joint Governance Committee: Establish a cross-agency committee to ensure alignment and consistency in drug classifications. * Automate the added fields through integration in NPHIES: Integrate the added data fields for seamless workflow alignment. * Periodic Monitoring: Regularly review and update drug classifications to address non-standard terms and ensure clarity * This List is only used for data analysis purpose and not for substitution purposes ضمان مجلس الضمان الصحي Council of Health Insurance 3 # Outline * **01** Background and Objectives * **02** Mapping Pharmaceutical Classification Systems * **03** Comparing Pharmaceutical Classification Systems * **04** Using Data Linkage to Harmonize Pharmaceutical Classification ضمان مجلس الضمان الصحي Council of Health Insurance # 01 Background and Objectives * Context and Challenges * Key Stakeholders ضمان مان الصحي Council of Health Insura 5 Confidential # CHI'S PHARMACEUTICAL DICTIONARY: Market Monitoring and Data Harmonization ## Context and Objective --- ### Context and Background The Council of Health Insurance (CHI), as the national authority overseeing the private health insurance sector in Saudi Arabia, conducts routine monitoring and compliance assessments through the NPHIES platform. Recently, CHI has observed a growing number of complaints and clarification requests, primarily from insurer, related to discrepancies between CHI's findings and data reported by market stakeholders. These issues largely stem from variations in pharmaceutical categorization, coding systems, analytical methodologies, and other inconsistencies that hinder seamless data Linkage, particularly among SFDA, NPHIES, and the DDF. --- ### Objectives This report aims to: * Map the various pharmaceutical classification systems currently used in SFDA, NPHIES and DDF, with real-world examples illustrating common discrepancies. * Describe CHI's methodology for addressing inconsistencies and harmonizing pharmaceutical classifications within the NPHIES platform for compliance and monitoring purposes, taking SFDA as a benchmark. * Provide access to a reference drug list to support alignment and compliance efforts across private sector stakeholders. --- ضمان مجلس الضمان الصحي Council of Health Insurance 6 Confidential # Main Stakeholders in the Health Insurance and Drug Regulation Ecosystem in Saudi Arabia ## Insurance/PBM/Providers Third-party administrators (TPAs), Insurers and Providers in the private sector in Saudi Arabia, serve as key users of platforms such as NPHIES and DDF. ### Saudi Food and Drug Authority (SFDA) The Saudi Food and Drug Authority (SFDA) is the national regulatory body responsible for the approval, registration, and oversight of all pharmaceutical products in Saudi Arabia. It maintains a centralized database, the Human Drug List, which includes approved drugs along with key identifiers ### Council of Health Incurance (CHI) The Council of Health Insurance (CHI) is responsible for maintaining and monitoring the Daman Drug Formulary (DDF), as part of its role in overseeing the private health insurance sector in Saudi Arabia. The National Platform for Health and Insurance Exchange Services (NPHIES) is the national unified digital health platform developed by the Saudi Health Council (SHC) in collaboration with CHI and operated by Sehati. 7 # Mapping Pharmaceutical ## 02 Classification Systems * SFDA Drug Classification and Codes * DDF Drug Classification and Codes * NPHIES Drug Classification and Codes ضمان 8 مان الصحي Council of Health Insura # Mapping Pharmaceutical Classification Systems  As part of this, a review of the drug classification definitions and coding systems report used by the SFDA, CHI's Daman Drug Formulary (DDF), and the NPHIES platform. --- ## Define and Document Map and define the drug classification and structures used by the SFDA, CHI's Daman Drug Formulary (DDF), and the NPHIES platform, focusing on drug type, subtype, and coding identifiers. ## Review Regulatory and Technical References Review official databases, regulatory guidelines, and technical documents to understand the rationale behind classification logic and definitions. ## Provide Drug Examples Illustrate differences across systems using a real-world drug example, highlighting how the same product may showcase discrepancies in the different systems (SFDA, DDF, and NPHIES), reinforcing the need for harmonization. ---  9 # 1- SFDA Drug Classification and Codes Two core aspects of the SFDA drug list ## Drug classification by type and subtype ## SFDA Drug Codes ## Drug Classification SFDA classifies drug products during registration into Types and Sub-types based on their origin and nature including brand (NCE), Generic, Biological, Biosimilar ## SFDA Drug Codes SFDA uses several coding systems to categorize and identify drugs including GTIN, ATC code, Description Code, Registration number **ضمان** مجلس الضمان الصحي Council of Health Insurance Other data fields from the SFDA list are outside the scope of this report. Further details can be found in Appendix 1. 10 # 1- SFDA Drug Classification and Codes – Cont. ## Drug Classification | Drug Type/Sub-Type | Definition | |---|---| | Brand (Innovator) Product (NCE) | The first form of a drug (with a specific API and dosage form) approved by regulatory authorities, usually supported by comprehensive preclinical and clinical data. | | Generic Product | A product that contains the same API(s), in the same strength and dosage form, as the brand (innovator) product and is considered therapeutically equivalent. | | Biological Product | A product derived from living organisms, such as vaccines, monoclonal antibodies, recombinant proteins, or gene therapies. | | Biosimilar | A highly similar version of an already-approved biological product, demonstrating no clinically meaningful differences in terms of safety, purity, and potency. | The SFDA drug list also includes various other drug types that lack clear definitions, such as Allergen Products (e.g., allergen extracts), Biotechnology Products (e.g., epoetin beta), Blood Products (e.g., albumin and coagulation factors), Vaccines, IV Solutions (e.g., lidocaine and levofloxacin solutions), and Known Active Substances, which encompass a wide range of molecules such as sildenafil and cefixime.  Saudi FDA. Saudi FDA Products Classification Guidance Operations Sector. 20 Sept. 2024. 11 # 1- SFDA Drug Classification and Codes – Cont. ## SFDA Drug Codes ### SFDA Registration Number Updated code that is unique numerical SFDA generated code for each registered drug product specific to the drug trade name including its strength, route of administration and dosage form, maintained on the list to guide users when updating the mapping of the product ### Therapeutic Classification (ATC) SFDA aligns with international classification for therapeutic categories. The Anatomical Therapeutic Chemical (ATC) code is often used to classify drugs by their pharmacological class. ### Scientific Code Root The Scientific Code Root Number refers to a code that SFDA assigns to represent the active pharmaceutical ingredient(s) (API) or the scientific name of the drug --- ### Global Trade Item Number (GTIN) Global Trade Item Number (GTIN) is an identification key that uniquely identifies products worldwide. It can be encoded in various types of data carriers, including Data Matrix. ### Description Code The Description Code is typically used to capture or summarize key identifying information about a product—such as the drug's Scientific name, strength, and dosage form—in a standardized alphanumeric format. ### Pharmacological Form Code Root A code that classifies the dosage form or pharmaceutical form (e.g., tablet, capsule, injection, cream, etc.) --- **ضمان** **مجلس الضمان الصحي** Council of Health Insurance Saudi FDA. Saudi FDA Products Classification Guidance Operations Sector. 20 Sept. 2024. 12 # 1- SFDA Drug Classification and Codes – Cont. ## SFDA Registered Drug Examples | | Crestor 20 mg film coated tablets | Stelara 90mg/1ml solution for injection | |---|---|---| | SFDA Registration Number | 1506233820 | 1511222905 | | Scientific Name | Rosuvastatin | Ustekinumab | | Scientific Description Code Root | 7000001121 | 7000001301 | | Trade Name | Crestor 20 mg film coated tablets | Stelara 90mg/1ml solution for injection | | Drug Type | NCE | Biological | | Drug Subtype | - | Other | | Pharmaceutical Form | Film-coated tablet | Solution for injection in pre-filled syringe | | Pharmaceutical Form Code Root | 100000073665 | 200000016496 | | Administration Route | Oral Use | Subcutaneous use | | ATC Code | C10AA07 | L04AC05 | | Description Code | 7000001121-20-100000073665 | 7000001301-90-200000016496 | | GTIN | 5000456011013 | 05413868100990 | <p>ضمان</p> <p>مجلس الضمان الصحي</p> <p>Council of Health Insurance</p> <p>13</p> # 2- DDF Drug Classification and Codes The Council of Health Insurance (CHI) is an independent governmental entity established to oversee the implementation of the Cooperative Health Insurance System. Its mission is to support the quality and efficiency of the health insurance sector in alignment with the Kingdom's vision for an integrated and sustainable healthcare system. --- ## DDF Formulary * **Indication Sheet** * **Mapped IDF to SFDA Sheet** --- ## Key goals of the DDF include * Standardizing medication coverage and prescribing practices across private insurers * Enhancing equitable access to essential therapies * Promoting cost-effective treatment, with a particular emphasis on the use of generic medications to support financial sustainability --- **ضمان** **مجلس الضمان الصحي** **Council of Health Insurance** 14 # 2- DDF Drug Classification and Codes ## What Information Does the Indication Sheet Provide? The Indication sheet includes the list of approved indications mapped with the corresponding scientific molecules and relative prescribing information. | Field | Definition # 2- DDF Drug Classification and Codes ## What Information Does the Mapped DDF To SFDA Sheet Provide? The "Mapped DDF to SFDA" includes the list of scientific molecules included in the "Indication Sheet" regularly mapped with SFDA medication list. This mapping, based on the SFDA description prices code, is used to identify corresponding trade names and associated. | Scientific Name | Scientific Description Code Root | ATC Code | Pharmaceutical Form and Code | Description Code | Administration Rout | Strength and Strength unit | Trade Name | |---|---|---|---|---|---|---|---| | Registration Number (new and old) | GTIN | Last Update Date | Register Year | Product Type | Drug Type and Sub-Type | ATC Code 2 | Size and Size Unit | | Package Types and Size | Legal Status | Product Control | Distribute area | Public Price | Shelf Life | Storage conditions | Marketing Company and Country | | Manufacture Name, DMS ID and country | Secondary Package Manufacture | Agent (main, 2nd and 3rd) | Marketing Status | Authorization Status | | | | These fields are like those of the SFDA, please refer to Appendix 1  مجلس الضمان الصحي Council of Health Insurance 16 # 2- DDF Drug Classification and Codes Examples from the "Indication Sheet" | | Crestor 20 mg film coated tablets | Stelara 90mg/1ml solution for injection | |---|---|---| | **Indication** | Dyslipidemia | Psoriasis | | **ICD 10 AM Code** | E78 | L40 | | **Drug pharmacological Class** | Lipid modifying agents, plain | Immunosuppressants | | **Drug pharmacological Subclass** | HMG-Coa reductase inhibitors | Interleukin inhibitors | | **Description Code** | 7000001121-20-100000073665 | 7000001301-90-200000016496 | | **Scientific Name** | Rosuvastatin | Ustekinumab | | **Scientific Description Code Root** | 7000001121 | 7000001301 | | **ATC Code** | C10AA07 | L04AC05 | | **Pharmaceutical Form** | Film-coated tablet | Solution for injection in pre-filled syringe | | **Pharmaceutical Form Code Root** | 100000073665 | 200000016496 | | **Administration Route** | Oral use | Subcutaneous use | | **Strength** | 20 | 90 | | **Strength Unit** | Mg | Mg/ml | | **Substitutable** | - | - | | **Prescribing Edit** | CU | PA, MD, QL | | **MDD Adults** | NA | 300 mg subcutaneous at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks | | **MDD Pediatric** | NA | NA | | **Notes** | | | | **Appendix** | Appendix 54 | Appendix | | **Patient Type** | | - | | **SFDA Registration Status** | Yes | Yes |  17 # 3- NPHIES Drug Classification and Codes ## Overview of NPHIES The National Platform for Health and Insurance Exchange Services (nphies) is a joint initiative led by the Council of Health Insurance (CHI) in collaboration with the National Health Information Center and the Ministry of Health in Saudi Arabia. Launched as part of the Kingdom's Vision 2030 goals to enhance the healthcare sector, nphies aims to establish a unified digital infrastructure for exchanging patient health information across stakeholders, including healthcare providers, insurance companies, third-party administrators, and system suppliers. ## NPHIES Features nphies provides a unified digital platform designed to streamline healthcare operations and improve data integrity across Saudi Arabia's health ecosystem. Its core features include a unified health record, standardized medical codes, and reliable, interoperable data exchange. The platform supports digitization of services, governance and regulatory oversight, and facilitated access to care. By minimizing administrative burdens and reducing operational costs, nphies enables greater efficiency for providers, payers, and third-party administrators. Ultimately, it aims to enhance beneficiary health outcomes and align healthcare delivery. ## NPHIES Metadata The extracted core metadata fields outlined in slides 17 and 18 from the NPHIES platform are essential for drug-level claims analysis. They support standardized data structuring, enable precise mapping to regulatory sources, and facilitate analyses of utilization trends, substitution behavior, and reimbursement compliance. The full NPHIES metadata contains many additional fields, only those directly applicable to drug-related claims have been included in this report **ضمان** **مجلس الضمان الصحي** Council of Health Insurance "Nphies Activation.” Chi.gov.sa, 11 Mar. 2021, www.chi.gov.sa/en/MediaCenter/News/Pages/News-11-3-2021.aspx. NPHIES التبادل الصحي والتاميني الرقمي | نفيس. “منصه نفيس”. Nphies.sa, 2025, nphies.sa/about. 18 # 3- NPHIES Drug Classification and Codes ## Drug Examples | Variables | Crestor 20 mg film coated tablets | Stelara 90mg/1ml solution for injection | |---|---|---| | Item Code | 5000456011013 | 05413868100990 | | Item Description | Crestor 20 mg film coated tablets | Stelara 90mg/1ml solution for injection | | Type | Medication | Medication | --- **ضمان** مجلس الضمان الصحي Council of Health Insurance 19 # Comparing Pharmaceutical ## 03 Classification Systems * SFDA VS CHI Formulary “Daman Drug Formulary" * Consistency of Drug Classification with SFDA Specifications ضمان الضمان الصحي Council of Health Insurance 20 # Comparing Pharmaceutical Classification Systems This section presents a comparative mapping of drug classifications across SFDA, DDF, and NPHIES. The exercise aims to uncover areas of consistency and discrepancy, highlighting overlapping definitions and terminologies. **ضمان** مجلس الضمان الصحي Council of Health Insurance 21 # SFDA VS CHI Formulary "Daman Drug Formulary" ## SFDA vs Indication Sheet The CHI Indication Sheet shares core data fields with the SFDA database, allowing for alignment and traceability between formulary entries and registered products. It also includes additional fields specific to insurance coverage and utilization management, which are beyond the scope of the SFDA dataset. --- ### Left Column (Thumbs Up) * **Scientific Name and Scientific Description Code Root** * **ATC code** * **Pharmaceutical Form and Pharmaceutical Form Code Root** * **Description Code** * **Pharmaceutical Form and Pharmaceutical Form Code Root** * **Description Code** ### Right Column (Thumbs Down) * **Indication and ICD 10-Am Code** * **Drug Pharmacological Class and sub-class** * **Prescribing Edits** * **Quantity Limit (adults and pediatrics)** * **Notes and Patient Type** * **SFDA Registration Status** ---  مجلس الضمان الصحي Council of Health Insurance 22 # SFDA VS CHI Formulary "Daman Drug Formulary" ## SFDA vs Mapped DDF to SFDA Sheet The "Mapped DDF to SFDA" sheet links CHI's formulary with SFDA's drug database. It lists scientific molecules mapped to SFDA trade names and public prices, using the same layout and fields as the SFDA list. This ensures easy cross-referencing and keeps CHI's formulary aligned with SFDA updates.  **SFDA List** **Mapped DDF to SFDA** --- **ضمان** مجلس الضمان الصحي Council of Health Insurance 23 # SFDA VS CHI Formulary "Daman Drug Formulary" ## SFDA vs NPHIES Two key fields serve as common linkage points between the systems: * GTIN, referred to as "product_or_service_code" in NPHIES * Trade Name, displayed as "product_or_service_description" or "Display" in NPHIES SFDA and NPHIES operate in distinct yet interconnected domains The shared identifiers between SFDA and NPHIES enable seamless integration, while ensuring alignment with SFDA's standardized drug codes and classifications for consistent drug identification and regulatory compliance.  Council of Health Insurance 24 # Consistency of Drug Classification with SFDA Specifications Crestor 20 Mg Film Coated Tablets | | Register Number | Register Year | Old register Number | Product type | Drug Type | Sub-Type | Scientific Name | Scientific Description Code Root | Trade Name | Strength / unit | |---|---|---|---|---|---|---|---|---|---|---|---| | SFDA | 1506233820 | 2004 | 54-7-04 | Human | NCE | (Blank) | Rosuvastatin | 7000001121 | Crestor 20 mg film coated tablets | 20 mg | | DDF Indication Sheet | | | | | | | | | | | | DDF Mapped Sheet | | | | | | | | | | | | NPHIES | | | | | | | | | | | | | Pharma Form | Pharma form Code Root | Administratio n Route | AtcCode1 | AtcCode2 | Size | Size Unit | Package Types | Package Size | Legal Status | |---|---|---|---|---|---|---|---|---|---|---| | SFDA | Film-coated tablet | 100000073665 | Oral use | C10AA07 | (Blank) | (Blank) | (Blank) | Blister | 28 | Prescription | | DDF Indication Sheet | | | | | | | | | | | | DDF Mapped Sheet | | | | | | | | | | | | 'NPHIES | | | | | | | | | | | مجلس الضمان الصحي Council of Health Insurance Consistent Not Consistent 25 # Consistency of Drug Classification with SFDA Specifications ## Crestor 20 Mg Film Coated Tablets | | Product Control | Distribute area | Public price | shelfLife | Storage conditions | Marketing Company | Marketing Country | Manufacture Name | Manufacture Country | 2nd Manufacture Name | |---|---|---|---|---|---|---|---|---|---|---| | SFDA | Uncontrolled | Pharmacy | 130.65 | 36 | store below 30°c | AstraZeneca | United Kingdom | LPR pharmaceuticals | United States | (Blank) | | DDF Indication Sheet | • | • | • | • | • | • | • | • | • | • | | DDF Mapped Sheet | • | • | • | • | • | • | • | • | • | • | | NPHIES | • | • | • | • | • | • | • | • | • | • | | | 2nd Manufacture Country | Secondary package manufacture | Main Agent | Second Agent | Third Agent | Marketing Status | Authorization Status | Description Code | GTIN | Last Update | |---|---|---|---|---|---|---|---|---|---|---| | SFDA | (Blank) | Tabuk pharma | Al Naghi Company | (Blank) | (Blank) | Marketed | Valid | 7000001121-20-100000073665 | 5000456011013 | 10/1/2023 | | DDF Indication Sheet | • | • | • | • | • | • | • | • | • | • | | DDF Mapped Sheet | • | • | • | • | • | • | • | • | • | • | | NPHIES | • | • | • | • | • | • | • | • | • | • | مجلس الضمان الصحي Council of Health Insurance Consistent Not Consistent 26 # Consistency of Drug Classification with SFDA Specifications Stelara 90mg/ml solution for injection | | Register Number | Register Year | Old register Number | Product type | Drug Type | Sub-Type | Scientific Name | Scientific Description Code Root | Trade Name | Strength / unit | |---|---|---|---|---|---|---|---|---|---|---| | SFDA | 1511222905 | 2013 | 20-626-21 | Human | Biological | Other | Ustekinumab | 7000001301 | Stelara 90mg/1ml | 90 mg/ml | | DDF Indication Sheet | | | | | | | | | | | | DDF Mapped Sheet | | | | | | | | | | | | NPHIES | | | | | | | | | | | | | Pharma Form | Pharma form Code Root | Administration Route | AtcCode1 | AtcCode2 | Size | Size Unit | Package Types | Package Size | Legal Status | |---|---|---|---|---|---|---|---|---|---|---| | SFDA | Solution for injection in pre-filled syringe | 200000016496 | Subcutaneous use | L04AC05 | (Blank) | 1 | ml | Pre-filled syringe | 1 | Prescription | | DDF Indication Sheet | | | | | | | | | | | | DDF Mapped Sheet | | | | | | | | | | | | NPHIES | | | | | | | | | | | مجلس الضمان الصحي Council of Health Insurance Consistent Not Consistent 27 # Consistency of Drug Classification with SFDA Specifications Stelara 90mg/ml solution for injection | Product Control | Distribute area | Public price | shelfLife | Storage conditions | Marketing Company | Marketing Country | Manufacture Name | Manufacture Country | 2nd Manufacture Name | | :-------------- | :-------------- | :----------- | :-------- | :----------------- | :---------------- | :---------------- | :--------------- | :------------------ | :------------------- | | SFDA | Uncontrolled | Hospital | 11103.25 | 36 | store in a refrigerator | Janssen-Cilag International NV | Belgium | Baxter pharmaceutic als | United States | (Blank) | | DDF Indication Sheet | | | | | | | | | | | DDF Mapped Sheet | | | | | | | | | | | NPHIES | | | | | | | | | | | | 2nd Manufacture Country | Secondary package manufacture | Main Agent | Second Agent | Third Agent | Marketing Status | Authorization Status | Description Code | GTIN | Last Update | | :-------------- | :---------------------- | :---------------------------- | :----------- | :----------- | :---------- | :--------------- | :------------------- | :--------------- | :--------------- | :---------- | | SFDA | (Blank) | (Blank) | Cigalah Group | (Blank) | (Blank) | Marketed | Valid | 7000001301-90-200000016496 | 5413868100990 | 30/28/2023 | | DDF Indication Sheet | | | | | | | | | | | | DDF Mapped Sheet | | | | | | | | | | | | NPHIES | | | | | | | | | | | Council of Health Insurance Consistent Not Consistent 28 # Using Data Linkage to Harmonize ## 04 Pharmaceutical Classification * NPHIES to SFDA Matching * Drug Type Standardization * Route of Administration Grouping * Strength and Strength Units Harmonization * CHI Harmonized Drug List * Proposed Preliminary List * Final Quality Check and Cleaning ضمان Council of Health 29 # Using Data Linkage to Harmonize Pharmaceutical Classification  ## Objectives For analysis of generic and biosimilar penetration, cost savings, and other data, a **matching process** between NPHIES and SFDA datasets, combined with **standardization steps**, followed by a cleaning process was performed to accurately classify drugs, enabling reliable analysis and promoting alignment across the system. As part of CHI's ongoing monitoring efforts within the NPHIES platform, analyzing pharmaceutical data requires robust data linkage to harmonize drug classification. This alignment will enhance CHI's capacity to effectively assess generic and biosimilar uptake, enabling more accurate monitoring and identification of cost-saving opportunities. ---  **Council of Health Insurance** 30 # Steps Towards a Harmonized Drug List ## Step 1: ### NPHIES and SFDA Matching NPHIES data is matched with SFDA to retrieve drug attributes including type, route of administration, package size, and strength. ## Step 2: ### Drug Type Standardization A rule-based approach was applied to standardize drug type classification by referencing SFDA's classification. This involved mapping diverse entries based on shared attributes like scientific name. ## Step 3: ### Route of Administration Grouping Routes of administration were harmonized using SFDA's official list by grouping synonymous or equivalent terms under a unified standard. ## Step 4: ### Strenght and Strength Unit Harmonization Strength values were standardized to a common unit within each scientific name to maintain consistency across different products. **ضمان** مجلس الضمان الصحي Council of Health Insurance 31 # Step 1: Matching NPHIEs to SFDA ## 01 Exact Matching * Identify exact matches between NPHIES and SFDA drugs by product codes (GTIN and Product_or_Service_Code) or drug names (Trade Name and Display). * Matched drugs automatically receive SFDA attributes. ## 02 Approximate Matching For unmatched drugs, compare drug names based on: * Drug base Name (first word): Similarity at ≥95% accuracy. * Drug Numbers: Numeric parts of the drug name must match exactly. * If the drug base name matches, SFDA attributes that describe the general identity of the drug are added (Scientific Name, Drug Type, ...). * If numeric parts also match exactly, additional SFDA attributes that are sensitive to precise dosage and packaging details are added (Description Code, Strength, ...). ## 03 Remaining Unmatched Drugs Drugs without a successful match after the above steps remain unmatched and don't receive additional attributes from SFDA. ### Disclaimer: Unmatched Drugs **Delisted:** Include the unmatched drugs, despite matching with GTIN and Descriptions. **Unlisted:** Include unlisted drugs from SFDA, having GTIN codes like 9999999999999,999999990,9999999999996, etc. A qualitative assessment to explore the breakdown of the Unmatched Drugs will be detailed in another report. --- مجلس الضمان الصحي Council of Health Insurance 32 # Step 2: Drug Type Standardization ## Rules Based Approach to Drug Type Classification 1. **Reading the primary drug type (e.g., NCE, Biologic, Generic).** 2. **Interpreting the subtype field, if available (e.g., Biosimilar, blood product).** 3. **Applying rules to assign a clear, unified category for consistent classification.** | SFDA DRUG TYPE | SFDA DRUG SUB-TYPE | STANDARDIZED AS | | :------------------------------------------------- | :------------------------------------------------------------------------------ | :-------------- | | Radiopharmaceuticals or Blank or NCE (New Chemical Entities) | - | Brand (NCE) | | Biological | Biological, Allergen Products, Biotech Products, Blood Products, Vaccines, Other, or Blank | Originator | | Biological | Biosimilar | Biosimilar | | Generics | Blood products | Originator | | Generics | NCE | Brand (NCE) | | Generics | IV Solution, Known Active Substance, Other, or Blanks | Generic | Please refer to Appendix 8 for the rationale behind SFDA Drug Type standardization was suggested. --- **ضمان** **مجلس الضمان الصحي** **Council of Health Insurance** 33 # Step 2: Drug Type Standardization ## Manual Corrections Following the Rules-Based Approach to Drug Type Classification, certain inconsistencies were identified that required manual correction to ensure accurate and unified classification. --- ## Errors Necessitating Manual Correction Each drug is grouped at the molecule level, based on its scientific name (active substance). If any product associated with a molecule shows inconsistent or conflicting drug type classification (e.g., mixture of brand, generic, originator, or biosimilar labels within the same molecule group), the entire group is flagged for review. --- ## Manual Label Adjustments within Flagged Groups Once a group is flagged, the following manual corrections were applied to standardize classification: * Products labeled as "Generic" within a flagged molecule group are reclassified as "Biosimilar" if the molecule is a biologic, reflecting the correct regulatory category. * Products labeled as "Brand (NCE)" within a flagged molecule group are reclassified as "Originator" if they represent the original branded product for that molecule. * All other product labels (e.g., already correctly classified as Originator, Biosimilar, Brand (NCE), or Generic) remain unchanged. --- ## Examples | Trade Name | Standardized Drug Type | Manually Amended Drug Type | | :------------------------ | :--------------------- | :------------------------- | | HERCEPTIN 150MG VIAL | Generic | Originator | | SANDOSTATIN LAR 20MG VIAL | Originator | Brand (NCE) | | SANDOSTATIN LAR 30MG VIAL | Originator | Brand (NCE) | | SANDOSTATIN 0.1MG-ML AMP | Originator | Brand (NCE) | --- مجلس الضمان الصحي Council of Health Insurance Please refer to Appendix 2 for the comprehensive list of manual corrections applied during the Drug Type Standardization process. 34 # Step 3: Route of Administration Grouping ## Why Grouping Was Needed Similar or synonymous routes (e.g., IV, Injection, Parenteral) are often labeled differently. This variability hinders accurate classification, comparability, and data analysis. For meaningful and standardized data analysis, route of administration grouping was performed (e.g., IV, SC, and IM grouped as Parenteral). | Trade Name | Scientific Name | Administration Route | strength | | :------------------------- | :--------------------- | :-------------------------- | :------- | | MIACIN 500MG-2ML AMP | Amikacin | Parenteral use | 500 mg | | AMCOCID 500MG-2 ML AMP | Amikacin | Parenteral use | 500 mg | | AMKANT | Amikacin | Intramuscular and intravenous use | 500 mg | | Trade Name | Scientific Name | Administration Route | strength | | :----------------------------- | :--------------------- | :-------------------------- | :------- | | UNASYN 1000:500MG VIAL | Ampicillin, Sulbactam | Intramuscular and intravenous use | 1500 mg | | AMPIPLUS 1.5GM POWDER FOR INGECTION | Ampicillin, Sulbactam | Parenteral use | 1500 mg | <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> < <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> # Step 3: Route of Administration Grouping Cont'd ## Grouped Categories ### Parenteral use * Intravenous * Intravenous use * Parenteral use * Intramuscular use * Subcutaneous use * Intramuscular, subcutaneous * Intravenous, Intravesical * Intramuscular and intravenous use * Intrathecal, Intravenous, Intramuscular * Intravenous, Subcutaneous * Intravenous, Intramuscular, Subcutaneous * Intravenous bolus use ### Oral use * Oral use * Oromucosal use * Sublingual use ### Topical use * Topical * Cutaneous use * Epilesional use ### Nasal use * Nasal use * nasal use ### Ocular use * Ophthalmic use * Ocular use ## Manual Corrections ### LUCENTIS 10 Mg-mL Intravitreal Injection Intravenous use $\rightarrow$ Intravitreal use ### DEVARIN 10 Mg Orodispersible Tablet Ocular use $\rightarrow$ Oral Use The finalized standardized routes were then integrated into the dataset for consistent reporting and analysis. **ضمان** مجلس الضمان الصحي Council of Health Insurance 36 # Step 4: Strength and Strength Units Harmonization ## Grouping by Scientific Name * Products were first grouped based on their scientific (generic) name. * This grouping allowed for evaluating consistency in strength and strength unit across all product variations under the same molecule. ## Retaining Original Strengths When Units Were Uniform * If all products within a scientific name group used the same strength unit (e.g., mg or IU), the original strength values were retained. * No conversion was needed, as the data was already consistent and directly comparable. ## Converting to a Dominant Strength Unit When Units Varied When products under the same scientific name had varying strength units, all values were converted to the most common (dominant). For example: * Products listed in mcg were converted to mg. * Products in mg/mL were converted to mg by multiplying by the package size | Scientific Name | Administration Route | Strength | Strength Unit | Size | Size Unit | New Strength | New Strength Unit | |---|---|---|---|---|---|---|---| | Risperidone | oral use | 1 | mg | | | 1 | mg | | Risperidone | oral use | 2 | mg | | | 2 | mg | | Risperidone | oral use | 3 | mg | | | 3 | mg | | Risperidone | oral use | 4 | mg | | | 4 | mg | | Risperidone | oral use | 1 | mg/ml | 100 | ml | 100 | mg |  37 # Step 5: CHI Harmonized Drug List Proposed Preliminary List ## Matching Methodology The methodology relies on a combination of product-specific attributes retrieved through matching NPHIES and SFDA datasets. (refer to appendix 5 for example) * To support analyses related to generic utilization and cost savings, a standardized classification approach was developed to determine whether a drug has an available alternative. * A drug is classified as with alternative if another product with the same scientific name and matching attributes (such as route of administration and strength) is available but categorized under a different drug type* (such as a Brand with a Generic alternative, or an Originator with a Biosimilar alternative). | Key Matching Attributes | Scientific name | Drug Type | Administration Route | Strength | | :---------------------- | :-------------- | :-------- | :------------------- | :------- | | | As recorded in SFDA | As Standardized | As Grouped | As Harmonized | مجلس الضمان الصحي Council of Health Insurance This List is only used for data analysis purpose and not for substitution purposes. 38 # First Layer of Quality Check To pilot the harmonization approach, a representative sample of products across various therapeutic areas and molecule types was selected. This is a manual check related to the findings, for cleaning purposes. ## Methodology * Include chemical entities * Include biologics * Filter by TA (1st letter of ATC Code) ## Scientific Names 61 ## Biologic Products 21 ## Chemical Products 40 ## Results of Quality Check: 72% Success | | 44 | 6 | 9 | 1 | 1 | | :---------------------------------- | :---------------- | :------------------------------ | :------------------------------ | :------------------------------------------ | :-------------------------------------- | | | Correct Scientific Names | Strength Modification Required | Modification in Drug Type Required | Modification Required in Both Strength and Drug Type | Modification in Salt Formulation of Scientific Name | ## Rounding Errors in Strength Standardization Budesonide 0.125 mg/mL and 0.25 mg/mL were both rounded to 0 mg. They were wrongly reported as alternatives. ## Scientific Name Order Mismatch Scientific names reported in reverse order were not captured as alternatives to each other: * Metformin HCL, Pioglitazone vs Pioglitazone, Metformin HCL ## Missing Salt Forms Salt forms missing in records led to mapping errors (e.g., Atovaquone/ Proguanil vs Atovaquone/ Proguanil Hydrochloride). ## Blank Strength Records Blank strength records, such as Haluran Inhalation Solution (Sevoflurane), required manual correction (e.g., assign 250 mL strength to match similar products). **ضمان** **مجلس الضمان الصحي** **Council of Health Insurance** 39 # Second Layer of Quality Check: Coding and Systematic Validation To further strengthen drug type standardization, a second quality check was performed, involving coding techniques to capture and map trade names systematically. This step aimed to identify and standardize trade names that were still reported with inconsistent drug type classifications. ## Coding and Mapping of Trade Names A search strategy was applied to automatically capture trade names with unique first word and their reported drug types. This enabled efficient detection of inconsistencies for targeted manual review. For example, for Valium, all instances of "VALIUM" and similar trade name variants were retrieved along with their assigned drug type. ## Manual Review Criteria The manual verification process after coding relied on: * Grouping by scientific name, trade name, year of registration in SFDA, and product strength. * Identifying the first registered product for a molecule (typically classified as Brand (NCE) or Originator, with unique strength), while noting that If a new product introduced a new dosing strength, it was also classified as Brand or Originator. * Where multiple products were labeled as Brand, year of SFDA registration and globally acknowledged trade names were used to confirm correct Brand/Originator status. ## Resolution of Discrepancies All inconsistencies were reviewed and corrected to align with regulatory definitions and market realities. --- | | | | | :---------------------------- | :---------------------------------- | :----------------------------------------------------------- | | **116** | **UNIQUE FIRST-WORD TRADE NAMES IDENTIFIED** | **31** | | **UNIQUE FIRST-WORD TRADE NAMES FLAGGED FOR REVIEW** | **53** | | | | **TOTAL NUMBER OF SFDA PRODUCTS WITH MANUAL CORRECTIONS** | ---  مجلس الضمان الصحي Council of Health Insurance Please refer to Appendix 6 for the comprehensive list of manual corrections applied during the Final Layer of Quality Check. 40 # Results of Both Quality Checks ## Results of Piloting: 77.14% Success | | | | | | |---|---|---|---|---| | 189 | 6 | 48 | 1 | 1 | | Correct Scientific Names | Strength Modification Required | Modification in Drug Type Required | Modification Required in Both Strength and Drug Type | Modification in Salt Formulation of Scientific Name | ## Scientific Names  245 ## Biologic Products  27 ## Chemical Products  218 **ضمان** **مجلس الضمان الصحي** **Council of Health Insurance** 41 # 05 Key Outputs & Pilot Implementation ضمان Council of Health Insurance 42 # Key Output and Pilot Implementation **ضمان** **مجلس الضمان الصحي** **Council of Health Insurance** ## Key Output  Please refer to the CHI Harmonized Drug List (December). Periodically Updated & Published Every 3 Months.  **CHI** **Harmonized** **Drug List** To provide a standardized and classified dataset by adding four fields, standardized drug type, strength, route of administration, and therapeutic alternatives status, to the existing SFDA list The pilot will be implemented via NPHIES Intelligence reports, enabling direct integration into the CHI dashboard for automated extraction and streamlined analysis.  This List is only used for data analysis purpose and not for substitution purposes. 43 # Appendix **ضمان** مجلس الضمان الصحي Council of Health Insurance 44 # Abbreviations * **AMCP** Academy of Managed Care Pharmacy * **API** Active Pharmaceutical Ingredient * **ATC** Anatomical Therapeutic Chemical * **CHI** Council of Health Insurance * **DDF** Daman Drug Formulary * **GTIN** Global Trade Item Number * **NCE** New Chemical Entity * **NPHIES** National Platform for Health and Insurance Exchange Services * **NHIC** National Health Information Center * **SFDA** Saudi Food and Drug Authority * **SHC** Saudi Health Council * **TPAs** Third-party Administrators * **WHO** World Health Organization  مجلس الضمان الصحي Council of Health Insurance 45 # Terminologies * **DDF Indication Sheet:** this sheet includes the list of approved indications mapped with the corresponding scientific molecules and relative scientific description code root number. The main end users are healthcare providers who can use it to identify the approved indications with their respective ICD 10 codes, in addition to the corresponding approved scientific molecule, dosage form, strength, and prescribing edits. * **DDF Mapped IDF to SFDA Sheet:** this sheet includes the list of scientific molecules regularly mapped with SFDA medication list to identify trade names and related prices. The main end users are insurance companies, hospitals, pharmacies and others.SFDA: The Saudi Food and Drug Authority (SFDA) is the national regulatory body responsible for the approval, registration, and oversight of all pharmaceutical products in Saudi Arabia. * **CHI:** The Council of Health Insurance (CHI) is responsible for the National Unified Drug Formulary (DDF), also known as the Insurance or Daman Drug Formulary, as part of its regulatory role in the private health insurance sector in Saudi Arabia. * **NPHIES:** National Platform for Health and Insurance Exchange Services (NPHIES) is the national unified digital health platform developed by the Saudi Health Council (SHC) in collaboration with CHI and operated by Sehati. * **Drug Type:** Refers to the classification of a drug based on its type: originator, generic, brand, or biosimilar. * **Brand:** A brand drug is a medication approved through a full application that includes all required data on safety, effectiveness, and manufacturing. It is typically protected by patents and is the reference standard for generic versions. It is sold under a proprietary (trademarked) name chosen by the manufacturer. * **Generic:** A generic drug is a medication that is the same as its brand-name counterpart in active ingredient, dosage form, strength, route of administration, safety, effectiveness, and intended use. It demonstrates bioequivalence and meets the same quality standards but may differ in inactive ingredients or appearance. Generics are approved through an abbreviated pathway, allowing faster and more affordable access to treatments. * **Biologics:** Biologics are medical products such as vaccines, blood components, gene therapies, and therapeutic proteins. They are derived from natural sources (human, animal, or microorganism) and are often produced using biotechnology. * **Reference Product (herein referred to as Originator):** A reference product is an FDA-approved biological product that was approved through a stand-alone application containing full data on its safety and effectiveness for each of the indications being sought. It serves as the standard against which a proposed biosimilar is evaluated. * **Biosimilar:** A biosimilar is a biologic that is highly similar to its reference product (originator), with no clinically meaningful differences in safety, purity, or potency. It is approved through an abbreviated pathway focused on demonstrating similarity rather than independently proving safety and effectiveness.  مجلس الضمان الصحي Council of Health Insurance CHI Drug Formulary Master Excel Sheet User Guide. 2023. FDA. "Generic Drugs: Questions & Answers." FDA, 16 Mar. 2021, www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers. Wagener, Dan. "What's the Difference between a Brand-Name Drug and a Generic Name Drug?" GoodRx, GoodRx, 16 Aug. 2019, www.goodrx.com/drugs/medication-basics/brand-vs-generic-drugs. Center for Biologics Evaluation and Research. "What Are "Biologics" Questions and Answers." FDA, 6 Feb. 2018, www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers. FDA. "Review and Approval." FDA, 13 Dec. 2022, www.fda.gov/drugs/biosimilars/review-and-approval. 46 # Appendix 1 – SFDA Fields and Definitions | Field Name | Definition # Appendix 1 – SFDA Fields and Definitions Cont' | Field Name | Definition | |---|---| | Distribute Area | describes the area authorized by the SFDA to stock and utilize the medication either as hospital item or pharmacy "retail" | | Public Price | the maximum price set by the SFDA that a pharmacy can sell the product to consumers. | | Shelf Life | The true but unknown limit on the period of storage time during which the pharmaceutical or drug product is considered fit for use and effective. | | Storage Conditions | Describes a climatic condition or a general storage condition under which a substance or product is stored | | Marketing Company | the company name of the company authorized by the SFDA to market and disrepute the product in KSA. | | Marketing Country | دوله الشركه المسوقه | | Manufacture Name | المصنع المعتمد | | Manufacture Country | Refers to Saudi Arabia (local) or any other manufacturing country (imported). | | Second Manufacturer Name | | | Second Manufacturer Country | | | Secondary Package Manufacture | مصنع التغليف الثانوي | | Main Agent | الوكيل الاول | | Second Agent | الوكيل الثاني | | Third Agent | الوكيل الثالث | | Marketing Status | describe the SFDA assigned marketing status for the product as marketed, or non-marketed | | Authorization Status | describe the SFDA assigned authorization of the product in local market as Valid, Invalid, suspended, withdrawn by MAH, withdrawn by regulatory authority | | Description Code | Unique numerical SFDA generated code for each registered scientific name that is composed of 3 main blocks representing (Active ingredient code- strength -dosage form) name including its strength, route of administration and dosage form, maintained on the list to guide users when updating the mapping of the product. | | GTIN | Global Trade Item Number (GTIN) is an identification key that uniquely identifies products worldwide. It can be encoded in various types of data carriers, including Data Matrix. |  مجلس الضمان الصحي Council of Health Insurance 48 # Appendix 2 – List of Manual Corrections on Drug Type Standardization | Trade Name | Standardized Drug Type | Manually Amended Drug Type | Trade Name | Standardized Drug Type | Manually Amended Drug Type | | :---------------------------------------------------------------------- | :--------------------- | :------------------------- | :----------------------------------------------- | :--------------------- | :------------------------- | | VICTOZA 6MG/ML SOLUTION FOR INJECTION | Brand (NCE) | Originator | %ALBUNORM 20 | Generic | Biosimilar | | STALORAL POLLENS MAINTENANCE | Brand (NCE) | Originator | VAXCEL HEPARIN SODIUM INJECTION | Generic | Biosimilar | | ACTEMRA 20 MG/ML SOLUTION FOR INJECTION/INFUSION | Brand (NCE) | Originator | ZELYSSA 18 MG PER 3 ML | Generic | Biosimilar | | ACTEMRA 20 MG/ML SOLUTION FOR INJECTION/INFUSION | Brand (NCE) | Originator | EVONANZ 18 MG PER 3 ML | Generic | Biosimilar | | ACTEMRA 20 MG/ML SOLUTION FOR INJECTION/INFUSION | Brand (NCE) | Originator | VALIUM TAB 2 MG | Generic | Brand (NCE) | | AVASTIN 400 SOLUTION FOR INFUSION | Brand (NCE) | Originator | VALIUM TAB 5 MG | Generic | Brand (NCE) | | AVASTIN 100 SOLUTION FOR INFUSION | Brand (NCE) | Originator | VALIUM AMP 10 MG-2 ML | Generic | Brand (NCE) | | FOSTIMON HP 75 IU VIAL (IM) USE | Generic | Biosimilar | GLUCOPHAGE 850MG TABLET | Generic | Brand (NCE) | | FOSTIMON HP 150 IU VIAL IM(WOMEN URIN) | Generic | Biosimilar | GLUCOPHAGE 500MG TABLET | Generic | Brand (NCE) | | HERCEPTIN 150MG VIAL | Generic | Originator | GLUCOPHAGE | Generic | Brand (NCE) | | TYSABRI 300 MG/15ML | Brand (NCE) | Generic | TIOMIST | Brand (NCE) | Generic | | SAXENDA 6 MG/ML SLOUTION FOR INJECTION IN PRE-FILLED PEN | Brand (NCE) | Originator | ACICLOVIR 250 MG/10ML | Brand (NCE) | Generic | | HUMIRA 40MG/0.4ML PRE-FILLED SYRINGE | Brand (NCE) | Originator | ACICLOVIR 500 MG/20ML | Brand (NCE) | Generic | | MENOPUR MULTIDOSE | Brand (NCE) | Originator | SANDOSTATIN LAR 20MG VIAL | Originator | Brand (NCE) | | MENOPUR MULTIDOSE | Brand (NCE) | Originator | SANDOSTATIN LAR 30MG VIAL | Originator | Brand (NCE) | | MENOPUR 75 IU POWDER FOR SOLUTION FOR INJECTION | Brand (NCE) | Originator | SANDOSTATIN 0.1MG-ML AMP | Originator | Brand (NCE) | | COSENTYX 150 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN | Brand (NCE) | Originator | OCRAN | Biosimilar | Generic | | ACTEMRA 162 MG/0.9 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | Brand (NCE) | Originator | SYNGRO | Biosimilar | Generic | | NEULASTIM 6MG-0.6ML PRE-FILLED SYRINGE | Brand (NCE) | Originator | BASAGLAR TEMPO PEN | Originator | Biosimilar | | HEPARINOL 5000 IU/ML INJECTION | Generic | Biosimilar | BASALOG ONE | Originator | Biosimilar | | HEPARINOL 1000 IU/ML INJECTION | Generic | Biosimilar | VIVARO | Originator | Biosimilar | | MENOPUR 75 IU POWDER FOR SOLUTION FOR INJECTION | Brand (NCE) | Originator | TRESIBA FLEXTOUCH 100 U/ML SOLUTION FOR INJECTION | Brand (NCE) | Originator | | | | | RYZODEG FLEXTOUCH 100 U/ML | Brand (NCE) | Originator | | | | | GLIPTAMET | Generic | Biosimilar | | | | | OZEMPIC | Generic | Biosimilar | | | | | RYBELSUS | Brand (NCE) | Originator | **ضمان** **مجلس الضمان الصحي** Council of Health Insurance 49 # Appendix 3 – Examples for Route of Administration Grouping | Trade Name | Scientific Name | Administration Route | grouped Administration Route | | :----------------------------------------------- | :-------------- | :------------------------------------ | :--------------------------- | | Epinephrine Inj | Adrenaline | Intravenous use | | | Dilute Adrenaline (Epinephrine) 1:10000 Solution For Injection | Adrenaline | Parenteral use | | | Adrenaline 0.1mg/MI Injection | Adrenaline | Intrathecal, Intravenous, Intramuscular | Parenteral use | | Adrenaline 1:1000 Inj | Adrenaline | Intravenous use | | | Adrenaline/Epinephrine Inj 1:1000 Injection | Adrenaline | Intramuscular use | | | Adijet | Adrenaline | Intramuscular and intravenous use | | | Aronep | Adrenaline | Intramuscular use | | | VIAGRA 50 MG ORODISPERSIBLE TABLET TURBO | Sildenafil | oral use | Oral use | | | Sildenafil | oromucosal use | | **ضمان** **مجلس الضمان الصحي** **Council of Health Insurance** 50 # Appendix 4 – List of Unchanged Route of Administration | | |---| | Dental use | | Rectal use | | Intravenous and Inhalation Use | | Intravenous, Oral | | Irrigation Use Only | | Transdermal use | | Auricular use | | Intradermal use | | Hemodialysis | | Intraperitoneal | | Intraarticular use | | Intratracheal use | | Oral use, Vaginal use | | Oral, Rectal | | Vaginal use | | Inhalation use | | Intrathecal use | | Subretinal use | | Intravitreal use | | Intraabdominal use | **ضمان** **مجلس الضمان الصحي** **Council of Health Insurance** 51 # Appendix 5 – CHI Harmonized Drug List Example The following tables present the classification of products as With Alternative or Without Alternative, based on the standardized drug type, strength, and route of administration. This classification reflects products that share the same scientific name but differ in drug type category (e.g., Brand vs. Generic, Originator vs. Biosimilar) following the standardization process. | Drug Type | Sub-Type | New Drug Type | Trade Name | Scientific Name | Scientific Description Code Root | Pharmaceutical Form | Administration Route | Strength | Strength Unit | Size | Size Unit | New Strength | New Strength Unit | Package Types | Package Size | Standardized Route | Alternat …(12,849 more chars)