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فصولان
مجلس الفصلان الصحي
Council of Health Insurance
Webinar 1
DAMAN DRUG FORMULARY (DDF)
FRAMEWORK
Strategic Insights for Stakeholder Alignment and Effective Implementation
Survey Analysis
Usage of the Master Excel Sheet
Participants Profile
Yes
No
Others (e.g., sometimes, rarely)
Healthcare Providers
Healthcare Professionals
Pharma Industry
Insurance Companies
CHI Beneficiaries
Top 3 questions for the CHI Team
- “I would like to know more about how to access and use the formulary, and if there are any training materials”
- “How to use”
- “What is the plan to find solutions for the challenges
• What is the role of pharmacists in CHI?
Top Challenges mentioned
- What is the process and timeline for adding new molecules to the DDF formulary, and how does NPHIES integration impact this?
• Understand the ecosystem
جانس
مجلس الشمان الصحي
Council of Health Insurance
Webinar Objectives
01.
Understand the structure and governance of the CHI Daman Drug Formulary (DDF)
02.
Learn the process of indication reviews, drug submission, and approval timelines
03.
Gain a comprehensive understanding of the CHI drug monitoring process and its impact
04.
Get practical
guidance on using
the DDF Master
Excel Sheet
*Engage with CHI representatives and stakeholders on current challenges and improvements
شوان
مجلس الشمان المضي
Council of Health Insurance
3
DDF Educational Webinar
<table><tr><td>Time</td><td>Topic</td><td>Speaker</td></tr><tr><td>15:00- 15:05</td><td>Opening Keynote</td><td>Dr Ibrahim Al Juffali</td></tr><tr><td>15:05–15:25</td><td>Evolving DDF Toward a Value-Based Formulary</td><td>Dr Ibrahim Al Juffali and Dr Nada Alagil</td></tr><tr><td>15:25–16:05</td><td>DDF Maintenance and Monitoring</td><td>ITKAN</td></tr><tr><td>16:05–16:20</td><td>Panel of Experts: Insights and Interactive Q&A</td><td>ALL</td></tr><tr><td>16:20–16:30</td><td>Closing Remarks</td><td>Dr Nada Alagil</td></tr></table>
psom
مجلس الضمان الصحي
Council of Health Insurance
Webinar Panelists
Dr. Ibrahim Al-Juffali
CHI Pharmaceutical
Advisor
Chairperson of PTC
Dr. Nada Alagil
Senior Medical Advisor
CHI
psom
مجلس الشمان الصحي
Council of Health Insurance
5
Private Health Insurance Sector growth
100
Million
Visitors
Emergency coverage
psos
مجلس الضمان الصحيه
Council of Health Insurance
■ MOH ■ Other Govt. ■ Private
6
Council Of Health Insurance (CHI)
CHI SG
Dr. Shabab Alghamdi
■ By 2030, our estimates indicate that the Cooperative Health Insurance Scheme in Saudi Arabia will cover 22 million beneficiaries.
In financial terms; this will equate to a Gross Written Premium (GWP) of around SAR60 billion;
■ A full two per cent of the Kingdom’s Gross Domestic Product (GDP).
■ We draw upon the clearly established strategic objective of the Kingdom’s health care transformation agenda, to shift to Value-Based Health Care (VBHC)
■ We foresee a holistic approach within the framework of the CHI's VBHC strategy, involving extensive advocacy and stakeholder engagement activities to foster the change.
White Paper on Value-Based Payment
Council of Health Insurance (CHI)
Husein Reka, Senior Advisor Healthcare Finance, Policy & Innovation
Abdullah Almaghrabi, Policy Director
Dr. Shabab Alghamdi, Secretary General
Value-based Health Care in Saudi Health Insurance Market
As part of this strategy, CHI has devised the following strategic objectives:
1 Enable target population segments to be fully covered and protected
2 Enable payers and providers to improve their services to beneficiaries with progressive policies
3 Improve the sustainability and innovation of the sector
4 Operate as a reliable, lean and learning regulator
5 Catalyze the digital transformation of the sector
VALUE
Health Outcomes that Matter to Patients
Cost of Delivering Healthcare
psosun
مجلس الضمان المحي
Council of Health Insurance
8
العناصر الاستراتيجيه | تم تطوير الهيكل الاستراتيجي بناء علي الركايز الرييسيه لمجلس الضمان الصحي
<table><tr><td colspan="4">ان تكون جهه تنظيميه رايده في تمكن خدمات الرعايه الصحيه التي تتمركز حول المستفيد واللمنيه علي الجوده الكفاءه</td></tr><tr><td colspan="4">تسهيل وصول المستفيدين الي خدمات صحيه عاليه الجوده والكفاءه وتمكن مزودي الخدمات واصحاب العمل من خلال منظومه تثم بشفافيه والابتكار</td></tr><tr><td>التميز المؤسي</td><td>الابتكار والاستدامه</td><td>المرونه والتكيف</td><td>الشفافيه والصدقيه</td></tr><tr><td>جهه ميكركه ومستدامه ومتميزه رقميا</td><td>تعزيز الالتزام</td><td>رعايه صحيه معيه علي الجوده والكفاءه</td><td>تمكين اصحاب العمل</td></tr><tr><td>تبني حلول الذكاء الاصطناعي ودعم الابتكار</td><td rowspan="2">رفع معدل التغطيه التامينيه</td><td rowspan="4"> تاهيل مزودي الخدمات الصحيه لتبني الرعايه المبنيه علي الجوده والكفاءه</td><td rowspan="4"> تطوير قدره اصحاب العمل علي توفير رعايه صحيه للعاملين ومعالهم</td></tr><tr><td>الارتقاء بحوكمه وجوده البيانات وتعزيز مشاركتها</td></tr><tr><td>تعزيز كفاءه العمليات فيمجلس الضمان الصحي</td><td rowspan="2"> تطبيق الاشراف السلوكي علي مزودي الخدمات الصحيه</td></tr><tr><td>الاستدامه الماليه للمجلس</td></tr></table>
تم تحديد 9 برامج استراتيجيه
تم تطوير 47 مبادره استراتيجيه
خطه تنفيذيه موحده
موا نقي المبادرات التفصليه
الرؤيه
الرساله
القيم
المحاور الاستراتيجيه
الاهداف
الاستراتيجيه
البرامج
المبادرات
خطه التنفيذ
9
المحاور الاستراتيجيه | تم تحديد 5 محاور استراتيجيه لمجلس الضمان الصحي
10
Escalating Drug Costs: Global & Saudi Trends
- In 2022, approximately 1.48 trillion U.S. dollars had been spent on medicines, up from just 887 billion U.S. dollars in 2010.
- That number is expected to increase to over 1.9 trillion by the year 2027.
- The Saudi pharmaceutical market is worth about $8.5 billion in 2021 and the market is estimated to touch $11 billion in 2026.
- Within all markets globally the top therapeutic class is oncology, followed by antidiabetics.
Recommendations from a recent National Academy of Sciences report, “Making Medicines Affordable: A National Imperative,” are to “refine methods for determining the 'value' of drugs and identify approaches to support ... formulary design and the selective exclusion of drugs.”
Global Spending on medicine in 2010,2022, and a forecast for 2027 (in billion U.S. dollars)
Global spending on medicines 2027 forecast | Statista
IQVIA Audited Data, MAT Q3 2021
11
CHI-Overall Healthcare and Pharmaceutical Spending
KSA's Private Sector Pharmaceutical Spending: Comparable to OECD Trends and Aligned with Saudi National Average
ACCESS TO THIS DATA IS RESTRICTED. FOR DATA REQUESTS, PLEASE CONTACT CHI'S DATA MANAGEMENT OFFICE AT THE EMAIL: DMO@chi.gov.sa
Global Benchmark
In OECD countries, about one-fifth of health spending is on medical goods (mostly pharmaceuticals). Compared to OECD countries, KSA's private sector pharmaceutical spending as a percentage of total healthcare expenditure is relatively close to the OECD average of 18%.
KSA's private sector pharmaceutical spending rate is similar to Saudi national numbers (19.85% of total healthcare expenditure)\( ^{2} \)
In 2023, total healthcare spending in KSA was 239.25 billion SAR3. Pharmaceutical spending for the same year amounted to 47.5 billion SAR2. Compared to 2022, healthcare spending increased by 5.11% growth3.
Comparison between Oct 2022-Sept 2023 and Oct 2023- September 2024.
شمان
مجلس الشان المحلي
Council of Health Insurance
OECD. Health at a Glance: Europe 2024.; 2024. https://www.oecd.org/en/publications/health-at-a-glance-europe-2024_b3704e14-en.html
SPIMACO. (August 11, 2024). Value of pharmaceutical market in Saudi Arabia from 2019 to 2023, with forecasts for 2027 (in billion Saudi riyal) [Graph]. In Statista. Retrieved January 22, 2025, from https://www.statista.com/statistics/1534881/saudi-arabia-value-
pharmaceutical-market/
Alpen Capital. (March 23, 2023). Healthcare expenditures in Saudi Arabia from 2011 to 2027 (in billion U.S. dollars) [Graph]. In Statista. Retrieved January 22, 2025, from https://www.statista.com/statistics/821018/saudi-arabia-healthcare-expenditures/
Formulary Definition
A formulary is a list of drugs approved for use in each setting, such as within:
• Hospitals and Health Systems
• Employer Groups
• Managed Care Organizations (MCO)
• Pharmacy Benefit Managers (PBM)
• Government agencies (Medicaid, VA system, CHI)
Dictates prescription drug/class coverage and/or the level of coverage (i.e. patient copayment)
psom
مجلس الضمان المحي
Council of Health Insurance
Different Types of Drug Formularies
CHI is moving into Value Based Formulary (VBF)
قسان
مجلس الضمان الصحيه
Council of Health Insurance
Formulary Management | AMCP.org. (2023). Amcp.org. https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/formulary-management
Goldberg R. B. (2020). PRACTITIONER UPDATE. Journal of managed care & specialty pharmacy, 26(4), 341–349. https://doi.org/10.18553/jmcp.2020.26.4.341a
Indication-Based Formulary Design Beginning in Contract Year (CY) 2020 | CMS. (2018, August 29). Cms.gov. https://www.cms.gov/newsroom/fact-sheets/indication-based-formulary-design-beginning-contract-year-cy-
2020#:~:text=What%20is%20Indication%2DBased%20Formulary,drugs%20predicated%20on%20specific%20indications.
Simon, G. E., Psaty, B. M., Hrachovec, J. B., & Mora, M. (2005). Principles for evidence-based drug formulary policy. Journal of general internal medicine, 20(10), 964–968. https://doi.org/10.1111/j.1525-1497.2005.0232.x
DDF Activities
2019-2022
مجلس الضمان المحيي
Council of Health Insurance
4 workshops with stakeholders
Post-workshops analysis
DDF Governance: Committees and Stakeholders Engagement and Interaction
2023+
DDF committees, composed of multidisciplinary experts, evaluate the clinical and economic value of medications and interventions to make informed decisions regarding their inclusion in formularies.
مجلس الشمان الصحي
Council of Health Insurance
DDF Stakeholder's interactions
16
DDF Key Achievements
2023-2024
PTC Engagement
• 20 online meetings ensured continuous communication and progress.
• 10 email circulations efficiently disseminated information and gathered feedback.
- IPT workshop fostered collaboration, innovation, and in-depth discussions among members.
Indications Review
The PTC members meticulously reviewed and deliberated 200 indications. Among these, there were 60 new indications and 140 updated indications.
5700+
new
drug-indications
pairs
ADDED
3300+
molecules
MODIFIED
380+
molecules
DELISTED
شوان
مجلس الشمان الصحي
Council of Health Insurance
شوان
مجلس الشمان الصحي
Council of Health Insurance
DDF Update
2025
<table><tr><td>ICD-10: 133</td><td>ATC code: 4</td><td>Description code: 29</td><td>ICD-10/Prescribing edits/MDD/Notes: 107</td><td rowspan="2">Indication name/ICD-10/Prescribing edits/Notes: 26</td></tr><tr><td>Indication name/ICD-10: 122</td><td>ATC Code/Prescribing edits/Notes: 7</td><td>Drug pharmacological class/Drug pharmacological subclass: 9</td><td>ICD-10/Prescribing edits/MDD/Notes: 8</td></tr><tr><td>Indication name/ICD-10/MDD: 17</td><td>Drug pharmacological class/Drug pharmacological subclass/MDD adults: 5</td><td>Drug pharmacological class/Drug pharmacological subclass/ATC Code/Prescribing edits/Notes: 1</td><td>Indication name/ICD-10/MDD/Notes: 7</td><td>Note: 11Prescribing Edits: 373</td></tr><tr><td>Indication name/ICD-10/PE: 4</td><td></td><td>Drug pharmacological class/Drug pharmacological subclass/Prescribing edits/Notes: 4</td><td>Indication name/ICD-10/Notices: 12</td><td>Others: 112</td></tr><tr><td><img></td><td>Drug pharmacological class/Drug pharmacological subclass/MDD adults/MDD pediatrics: 5</td><td>Drug pharmacological class/Drug pharmacological subclass/Prescribing edits/Notes: 4</td><td>Indication name/ICD-10/Prescribing edits/MDD/Notes: 177</td><td></td></tr></table>
Daman Drug Formulary
2025 Updates
Daman Drug
Formulary (DDF)
Maintenance
Updating an existing indication
Adding a new indication to the formulary
Updating the Master Excel sheet
Monitoring of the
DDF Outcome
Monitoring reports on medication utilization in the private sector, trends, compliance with CHI regulations, inquiries complaints data and predefined KPI's
Medication Coverage Governance
Sustainable Adoption of Biosimilars in Saudi Private Sector
Value Assessment Framework
Market Education
Educate the Market on DDF and related components and policies
Publication
Develop manuscripts related to the DDF work.
Topics include Antibiotics and Diabetes, Biologics and Biosimilars Value based framework
مجلس fattمان المصي
Council of Health Insurance
Conclusion – Benefits of Value-based Formularies
PATIENTS
Lower costs and better outcomes
PROVIDERS
Higher patient satisfaction rates and better care efficiencies
PAYERS
Stronger cost controls and reduces risks
SUPPLIERS
Alignment of prices with patient outcomes
SOCIETY
Optimize healthcare
spending and better
allocation of resources
psosun
مجلس الضمان الصحي
26 council of Health Insurance
DDF Maintenance and Monitoring Process
ش Oman
مجلس الشمان الصحي
Council of Health Insurance
Monitoring Report Edition: August 2023
21
DDF Maintenance and Monitoring Process
مجلس الشمان المصدي
Council of Health Insurance
2
DDF Maintenance and Monitoring
<table><tr><td>Topic</td><td>Description</td></tr><tr><td>Triggers for Updates Horizon Scanning Sources</td><td>External SubmissionsDrug submissions by the pharmaceutical industryDrug submissions by healthcare providers (HCPs)Periodic Horizon ScanningIndication Prioritization Tool (IPT)New national and international clinical guidelinesNewly SFDA-registered drugsSafety alerts</td></tr><tr><td>Process Name</td><td>DDF Maintenance and Monitoring Process</td></tr><tr><td>Primary Output</td><td>DDF Master Excel Sheet</td></tr><tr><td>Update Frequency</td><td>Quarterly (Every 3 Months)</td></tr><tr><td>User Guidance</td><td>Master Excel Sheet Guidebook</td></tr><tr><td>Supporting Resources</td><td>Indications Review DocumentList of IngredientsSubmission Forms</td></tr></table>
شيدان
مجلس الشمان الصحي
Council of Health Insurance
Formulary Addition Request
المجله
مجلس الضمان الصحيه
Council of Health Insurance
CH Website
24
Priority Setting Using IPT Tool: Value Criteria Priority Setting
• Innovative Tool developed using AI algorithms with Nphies Real-World Data (RWD)
• A list of criteria for prioritization based on research and contextualized to the Saudi healthcare
• Consensus Meeting with key stakeholders to approve scoring, criteria, and prioritized indications
<table><tr><td>Prioritization criterion #</td><td>Criterion</td><td>Measurement unit</td></tr><tr><td>1</td><td>Volume of patients corresponding to indication</td><td>Integer</td></tr><tr><td>2</td><td>Macro cost - total cost of managing indication</td><td>SAR</td></tr><tr><td>3</td><td>Total cost per member per month – PMPM of managing the indication</td><td>SAR PMPM</td></tr><tr><td>4</td><td>Total medications cost within indication</td><td>SAR</td></tr><tr><td>5</td><td>Total medications PMPM cost within indication</td><td>SAR PMPM</td></tr><tr><td>6</td><td>Proportion of “total medications cost” to total cost</td><td>%</td></tr><tr><td>7</td><td>Rejection rate</td><td>%</td></tr><tr><td>8</td><td>Qualitative criteria</td><td></td></tr></table>
Combined Multivariate Criterion
<table><tr><td colspan="3">Mahalanobis DistanceRank of Inverse Normal Transforms(Van Der Waerden)</td></tr><tr><td></td><td>ICD-10</td><td>Description</td></tr><tr><td>1</td><td>5.721</td><td>G35 Multi ple sclerosis</td></tr><tr><td>2</td><td>5.589</td><td>C50 Mallignant neoplasm of breast</td></tr><tr><td>3</td><td>5.392</td><td>C34 Mallignant neoplasm of bronchus and lung</td></tr><tr><td>4</td><td>5.222</td><td>C83 Non-follicular lymphoma</td></tr><tr><td>5</td><td>4.981</td><td>C75 Chronic obstructive heart disease</td></tr><tr><td>6</td><td>4.926</td><td>R18 Ascites</td></tr><tr><td>7</td><td>4.817</td><td>I64 Stroke, not specified as haemorrhage or infarction</td></tr><tr><td>8</td><td>3.995</td><td>M07 Psoriatic and enteropathic arthropathies</td></tr><tr><td>9</td><td>3.987</td><td>M45 Ankylosing spondylitis</td></tr><tr><td>10</td><td>3.917</td><td>E34 Other endocrine disorders</td></tr><tr><td>11</td><td>3.808</td><td>D57 Sickle-cell disorders</td></tr><tr><td>12</td><td>3.735</td><td>I10 Essential (primary) hyperntension</td></tr><tr><td>13</td><td>3.735</td><td>C16 Malignant neoplasm of stomach</td></tr><tr><td>14</td><td>3.728</td><td>E11 Type 2 diabetes mellitus</td></tr><tr><td>15</td><td>3.705</td><td>C92 Myeloid leukaemia</td></tr><tr><td>16</td><td>3.612</td><td>C64 Malignant neoplasm of kidney, except renal pelvis</td></tr><tr><td>17</td><td>3.593</td><td>C81 Hodgkin lymphoma</td></tr><tr><td>18</td><td>3.467</td><td>C61 Malignant neoplasm of prostate</td></tr><tr><td>19</td><td>3.452</td><td>Z99 Dependence on enabling machines and devices, not elsewhere classified</td></tr><tr><td>20</td><td>3.435</td><td>G70 Myasthenia gravis and other myoneural disorders</td></tr><tr><td>21</td><td>3.383</td><td>K50 Crohn's disease (regional enteritis)</td></tr><tr><td>22</td><td>3.369</td><td>C18 Malignant neoplasm of colon</td></tr><tr><td>23</td><td>3.325</td><td>M05 Seropositive rheumatoid arthritis</td></tr><tr><td>24</td><td>3.290</td><td>N18 Chronic kidney disease</td></tr><tr><td>25</td><td>3.176</td><td>C91 Lymphoid leukaemia</td></tr><tr><td>26</td><td>3.120</td><td>E10 Type 1 diabetes mellitus</td></tr><tr><td>27</td><td>2.944</td><td>C85 Other and unspecified types of non-Hodgkin lymphoma</td></tr><tr><td>28</td><td>2.893</td><td>C25 Malignant neoplasm of pancreas</td></tr></table>
<table><tr><td>C1</td><td>C2</td><td>C3</td><td>C4</td><td>C5</td><td>C6</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td>Volume of past 24 hours (1,000 ml)</td><td>Cost (million)</td><td>Mediterranean</td><td>Mediterranean</td><td>Mediterranean</td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td>1.5</td><td>2.4779</td><td>17.0</td><td>1.8828311</td><td>76%</td></tr><tr><td></td><td>4.8</td><td>1.6</td><td>4.1327</td><td>17.5</td><td>1.8429326</td></tr><tr><td></td><td>0.2</td><td>17.2901</td><td>8.5</td><td>6.1942364</td><td>36%</td></tr><tr><td></td><td>14.3</td><td>0.1</td><td>18.3592</td><td>5.6</td><td>7.198472</td></tr><tr><td></td><td>11.8</td><td>2.9</td><td>21.5885</td><td>21.7</td><td>0.7471750</td></tr><tr><td></td><td>29.1</td><td>0.2</td><td>30.4178</td><td>3.6</td><td>3.7719425</td></tr><tr><td></td><td>142.5</td><td>4.3</td><td>5.48249</td><td>12.9</td><td>0.4958635</td></tr><tr><td></td><td>3.4</td><td>0.5</td><td>11.6453</td><td>2.5</td><td>0.8726157</td></tr><tr><td></td><td>5.5</td><td>0.9</td><td>10.8753</td><td>4.0</td><td>0.7620371</td></tr><tr><td></td><td>13.7</td><td>3.6</td><td>0.64425</td><td>8.9</td><td>0.4148751</td></tr><tr><td></td><td>63.5</td><td>3.7</td><td>2.88867</td><td>9.8</td><td>0.4434187</td></tr><tr><td></td><td>304.0</td><td>109.9</td><td>0.4625</td><td>78.0</td><td>0.1186216</td></tr><tr><td></td><td>8.6</td><td>0.1</td><td>11.5728</td><td>1.6</td><td>2.1967436</td></tr><tr><td></td><td>504.8</td><td>166.2</td><td>0.50757</td><td>156.2</td><td>0.156999</td></tr><tr><td></td><td>3.2</td><td>0.1</td><td>3.85537</td><td>1.6</td><td>1.9977777</td></tr><tr><td></td><td>5.3</td><td>0.2</td><td>3.86729</td><td>2.2</td><td>1.6368114</td></tr><tr><td></td><td>3.8</td><td>0.2</td><td>3.56327</td><td>1.8</td><td>1.7225534</td></tr><tr><td></td><td>5.6</td><td>0.4</td><td>2.3443</td><td>2.5</td><td>1.0226575</td></tr><tr><td></td><td>14.7</td><td>0.4</td><td>5.63725</td><td>2.8</td><td>1.0882062</td></tr><tr><td></td><td>2.5</td><td>0.2</td><td>1.94474</td><td>1.5</td><td>1.1666747</td></tr><tr><td></td><td>10.1</td><td>1.3</td><td>1.29175</td><td>5.0</td><td>0.6436201</td></tr><tr><td></td><td>19.6</td><td>0.7</td><td>4.66025</td><td>3.8</td><td>0.9070036</td></tr><tr><td></td><td>8.0</td><td>2.1</td><td>0.62593</td><td>4.9</td><td>0.3804829</td></tr><tr><td></td><td>75.2</td><td>5.3</td><td>2.38075</td><td>8.4</td><td>0.2663571</td></tr><tr><td></td><td>4.5</td><td>0.1</td><td>5.41941</td><td>1.3</td><td>1.6069502</td></tr><tr><td></td><td>64.3</td><td>11.8</td><td>0.91102</td><td>12.8</td><td>0.1818069</td></tr><tr><td></td><td>3.0</td><td>0.1</td><td>4.36788</td><td>0.9</td><td>1.3405713</td></tr><tr><td></td><td>5.0</td><td>0.1</td><td>6.39034</td><td>0.9</td><td>1.1799178</td></tr></table>
جلس الشمان الصحي
Council of Health Insurance
Lauvrak V, Bidonde J, Peacocke E. Topic identification, selection and prioritisation for health technology assessment (HTA) - A report to support capacity building for HTA in low- and middle-income countries [Internet]. Norwegian Institute of Public Health. 2021 [cited 2023 Feb 15].
DDF Maintenance and Monitoring Process
مجلس الشمان الصحيه
Council of Health Insurance
2
Topic Review
السلام
مجلس الضمان المحي
Council of Health Insurance
Scope Definition
Evidence Generation
Report Development
DDF Master Sheet Update
Topic Review
<table><tr><td>Question Type</td><td>Databases</td></tr><tr><td>National Guidelines</td><td>Saudi Ministry of Health (MOH)Saudi Health CouncilSaudi Professional Organizations</td></tr><tr><td>North American- European- major international clinical guidelines (Japanese, Australian)</td><td>PubMed</td></tr><tr><td>Systematic Reviews and Meta-analysis</td><td>PubMed, Cochrane</td></tr><tr><td>Secondary resources</td><td>Google ScholarOvid Health Technology Assessment Database GuideNational Institute for Health and Care Research Journals Library</td></tr><tr><td>Tertiary resources</td><td>UpToDate</td></tr><tr><td>Local Data as priority guideline – SFDA StatusFDA, EMA, MHRA, & PMDA-approved medications</td><td>FDA: CenterWatchEMA: European Pharmaceutical ReviewMHRA: MHRA websitePMDA: PMDA website</td></tr><tr><td>Health Technology Assessment</td><td>NICE (UK)- CDA (Canada)- HAS (France)- IQWIG (Germany)- PBAC (Australia),HTAi database, INAHTA database, EUnetHTA database, ICER database</td></tr><tr><td>Drug Monograph/Prescribing Information</td><td>LexicompMedscapeBNF</td></tr><tr><td>Maximum Daily Dose</td><td>EMC</td></tr></table>
مجلس الشمان الصحي
Council of Health Insurance
Scope Definition
Evidence Generation
Report Development
PDF Master Sheet Update
DOCUMENTATION
PDF-FR-F-06-01
Indication Review
Checklist
CHI Indication Review
Transparency & Standardization
econ
مجلس الشمان الصحي
Council of Health Insurance
eServices
Knowledge Center
The Council
Media Center
Contact Us
Report to Damar
الدييه
ASTHMA
CHI Formulary Development Project
مجلس الضمان المحي
Council of Health Insurance
Introduction
User Guide
Medication
Indication Review
Appendix
Search...
<table><tr><td></td><td>Name</td><td>Date</td></tr><tr><td></td><td>Abdominal Spasm-Indication Update</td><td>2023-11-01</td></tr></table>
CHI Formulary Development Project
INDICATION UPDATE
ADDENDUM- March 2025
To the CHI Original Asthma Clinical
Guidance- Issued January 2020
مجلس العمان المصري
Council of Health Insurance
eServices
Knowledge Center
The Council
Media Center
Contact Us
Report to Daman
الغربيه
نقيس
Introduction
User Guide
Medication
Indication Review
Appendix
Search...
Name
Abdominal Spasm treatment algorithm
Date
2023-11-01
Topic Review
Full Review
DDF-FR-F-04-01 New Indication Review Report
Key Sections
Executive Summary
Summary of Reviewed Clinical Guidelines and Evidence
Drug Therapy
Key Recommendations Synthesis
Conclusion
References
Appendices
SCD
Example
Executive Summary
SCD has been recognized as a global health issue by multiple key organizations such as the World Health Organization (WHO) and the United Nations (UN). \( ^{12} \) It affects millions of people around the world with KSA being among the country. \( ^{13} \) High prevalence where more than 4.51% adults and 0.24% children are to have SCD.
The disease course could be a symptoms to severe complications necessitating hospitalization and the increase in bed stays in readmissions of SCD patients around $2,400,000. The life of the life of the life of the life of the life of the life of the life of the life of the life of the life of the life of the life of the life
Executive Summary
This report compiles all clinical and economic evidence related to sickle cell disease (SCD) and associated complications according to the relevant sources. The ultimate objective of issuing SCD guidelines by the Council of Health Insurance is to update the IDF (CHI Drug Formulary) with the best available clinical and economic evidence related to drug therapies, ensuring timely and safe access to SCD patients in Saudi Arabia. The main focus of the review was on Saudi, North American and European guidelines issued within the last five years in addition to recent systematic reviews and Meta-Analysis.
The management of SCD involves a multidisciplinary approach and is focused on preventing and treating resultant complications. Management of the disease and its complications based on recent guidelines are summarized in section 2.
New therapies are emerging to help provide more options for patients with this rare disease. Targets include the reduction in Vaso-occlusive episodes, increase in hemoglobin levels, prevention of end organ damage, and improvement in patient quality of life. \( ^{19-19,19,21-24} \)
There are four current medication options on the global market, and KSA has access to three of them. Section 3 provides full description of each with final statement on the placement of therapy. All recommendations are well supported by reference guidelines, Grade of Recommendation (Go), Level of
Evidence (OE) and Strength of Agreement (SOA) reflecting specific drug class role in the SCD therapeutic management.
Main recommendations issued by different Health Technology Assessment (HTA) bodies on the use of the current medications in sickle cell disease were reviewed and summarized. These include the National Institute for Health and Care Excellence (NICE), the Canadian Agency for Drugs and Technologies in Health, Haute Autologie de Sante (HAS), Institute for Quality and Efficiency in Healthcare (IQWIG), and the Pharmaceutical Benefits Advisory Committee (PBAC).
Section 3 lists the key recommendations synthesis for SCD treatment.
Drugs Recommended for Formulary Inclusion with level of evidence
Page | 8
- Major clinical outcomes reported for treatment of SCD patients with hydroxyurea include: reduction in mortality, stroke prevention, reduction of VOC, reduction in pain episodes, and improvement in quality of life.
- Hydroxyurea remains standard of care for management of patients with SCD in all reported global evidence-based guidelines
Page | 9
Rational of Recommendations
Transfusion Support
Main Recommendations are provided belowK17
• Transfusion support remains a mainstay for management of patients with SCD.
- Red blood cells are subject exhaustive profiling and matching, before receipt of blood rather than old techniques of blood-type testing.
Use only Phenotypically-matched RBCs.
o Determine extended phenotype (Rh, Kel), Duffy, Kidd and MNS blood groups) at first visit.
- In patients with no previous alloantibodies, select RBCs matched for the patient's Rh (D,C,c,E,e) and Kell (KI) antigens.
- If known alloantibodies, select RBCs that are matched for the patient's Rh (D, C, c, E, e), Kell (KI), Kidd (Dka, Jkb), Duffy (Fyra) and S (Ss) antigens, as well as any antigens to which the patient is immunized.\(^{6,8}\)
Health Maintenance
Recommendations are provided below
• Pneumococcal infection prevention\( ^{5,6} \)
- Penicillin prophylaxis especially for pediatric patients ≤ 5 years old (conditional
- vaccination, low quality evidence)\( ^{5,6} \)
• Transic
• Transic
• Proteinuria screening (antihypertensive)
• Systemic blood pressure control to target < 130
• Ophthalmic exams and audiometry especial
parameters for some iron chelating agents \( ^{10} \) .
When a range of clinically suitable and equivalent treatment
equally effective in the management of SCD related complications, treatment
should be started with the least expensive medication, taking into account
administration costs, dosage, price per dose and commercial arrangements if
any.
[Non-Text]
Evidence (OE) and Strength of Agreement (SOA) reflecting specific drug class role in the SCD therapeutic management.
Main recommendations issued by different Health Technology Assessment (HTA) bodies on the use of the current medications in sickle cell disease were reviewed and summarized. These include the National Institute for Health and Care Excellence (NICE), the Canadian Agency for Drugs and Technologies in Health, Haute Autologie de Sante (HAS), Institute for Quality and Efficiency in Healthcare (IQWIG), and the Pharmaceutical Benefits Advisory Committee (PBAC).
Section 3 lists the key recommendations synthesis for SCD treatment.
Therapies are presented below.
Drugs Recommended for Formulary Inclusion with level of evidence
[Non-Text]
<table><tr><td colspan="4">Main Recommendations are provided below</td></tr><tr><td colspan="4">Management of Sickle Cell Disease</td></tr><tr><td>Medication</td><td>Indication</td><td>Line of Therapy</td><td>Recommendation</td></tr><tr><td>Reduce VRRocclusive crises, frequency of pain (HYDROXYUREA)\( ^{®} \)</td><td>10%</td><td>A</td><td>1</td></tr><tr><td>Hydroxycarbamide (HYDROXYUREA)\( ^{®} \)</td><td>10%</td><td></td><td></td></tr><tr><td>Crizantuzumab\( ^{®} \)</td><td>Reduce SCD-related VRRocclusive crises (acute conditions) and VRRof patients ≥ 6 years of age through the end of VRRof patients ≥ 4 years of age through the end of VRRof patients ≥ 6 years of age through the end of VRRof patients ≥ 6 years of age through the end of VRRof patients ≥ 6 years of age through the end
Rationale of Recommendations are provided below
Major clinical outcomes reported for treatment of SCD patients with hydroxyurea include: reduction in mortality, stroke prevention, reduction of VOC, reduction in pain episodes, and improvement in quality of life.
- Hydroxyurea remains standard of care for management of patients with SCD in all reported global evidence-based guidelines
Page | 8
Page 19
Rational of Recommendations
Transfusion Support
Main Recommendations are provided below
• Transfusion support remains a mainstay for management of patients with SCD.
- Red blood cells are subject exhaustive profiling and matching, before receipt of blood rather than old techniques of blood-type testing.
Use only Phenotypically-matched RBCs.
o Determine extended phenotype (Rh, Kel), Duffy, Kidd and MNS blood groups) at first visit.
o In patients with no previous alloantibodies, select RBCs matched for the patient's Rh (D.C.C.E.e) and Kell (KI) antigens.
• If known alloantibodies, select RBCs that are matched for the patient's Rh (D, C, c, E, e), Kell (KI), Kidd (Dka, Jkb), Duffy (Fyra) and S (Ss) antigens, as well as any antigens to which the patient is immunized. \( ^{6,8} \)
Health Maintenance
Main Recommendations are provided below
• Pneumococcal infection prevention
- Penicillin prophylaxis especially for pediatric patients ≤ 5 years old (conditional
- vaccination, low quality
• Transic
• Transic
• Transic
• Proteinuria screening (anti-
[Non-Text]
• Systemic blood pressure
• Systemic blood pressure control to
• Ophthalmic exam
• Ophthalmic exam
parameters for some iron chelating agents
parameters for some iron chelating
[Non-Text]
When a range of clinically
equally effective in
should be started
administration cost
any.
1. Summary of Reviewed Clinical Guidelines and Evidence
a. KSA Guidelines
In the 2015 SCD guidelines published by Saudi expert panel, the following recommendations were provided \( ^{2} \) :
1- Nonpharmacologic management:
○ Cognitive behavioral therapy (CBT) is suggested in the presence of pain. (Conditional recommendation, low certainty)
- Patient education on adequate hydration, avoiding harsh weather and avoiding intensive exercising is suggested for patients with chronic pain. (Conditional recommendation, low certainty)
2- Blood transfusions:
- Use of simple preoperative transfusion is suggested over no transfusion or aggressive transfusion. (Conditional recommendation, low certainty)
- Aggressive transfusion, like transfusion, can be considered in patients at high risk of SCD related complications and those with high baseline Hgb levels. (Conditional recommendation, low certainty)
tion is recommended in addition, low certainty)
tion is recommended for patients with pain crises. (Strong recommendation, low certainty)
Management of SCD complications
When a range of clinically suitable and equivalent treatment equally effective in the management of SCD related complications, treatment should be started with the least expensive medication, taking into account
administration costs, dosage, price per dose and commercial arrangements if any.
- ox is suggested for
mentation, very low
- chelating agent plus
- a combination of
- oxyurea). (Conditional
(1) 2017年1月1日
(1) Adequate hydration is re
(Strong recommendation, low certainty)
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DRUG LIST
DRUG FORMULARY
DDF Output
[Non-Text]
CHI Drug Formulary Master Excel Sheet User Guide
June 2023
CLICK
1528 DDF LIST OF INGREDIENTS
CLICK
DDF INDICATION & DRUGS MASTER
EXCEL SHEET – MARCH 2025
شوان
مجلس الضمان المحي
Council of Health Insurance
Scope Definition
Evidence Generation
Report Development
DDF Master Sheet Update
31
DDF Prescribing Edits
Master Excel Sheet
شوان
مجلس الشمان الصحي
Council of Health Insurance
32
DDF Maintenance and Monitoring Process
مجلس الشمان الدعي
Council of Health Insurance
2
DDF Monitoring
DDF is monthly monitored for Clinical, Safety, Compliance, & Users' Feedback
- DDF innovative tool generating monthly dynamic report sheet using dynamic visualization matrix
- Specific Indicators built with validated methods using Nphies RWD
- A simulation and predictive analysis is developed to validate and monitor policies, utilization trend, and financial risks
HORIZON SCANNING TEAM
New drugs registered
New clinical guidelines
Saudi Food & Drug Authority
Saudi Health Council
Horizon
Scanning
Drug Safety Alert
DDF
Monitoring
DATA TEAM
Dashboard illustration and utilization trends
Looking a high-risk drugs and indications taken from score-card prioritized drug indication pairs balance score-card (DDF-FR-F-19-01)
User's compliance
Formulary
Complaints
SAFETY COMMITTEE
Safety report
Search methodology for monitoring drug safety alert (DDF-FR-F-15-01)
Safety alert-based recommendations reports (DDF-FR-F-15-01)
DATA TEAM
Compliant report
Complaints-based recommendations (DDF-FR-14-01)
Drug related complaints received from DDF-stakeholders and users
جانس العمان الصحي
Council of Health Insurance
34
Performance Metrics of General Reports
1. Spending Dynamics & Impact: Unveiling Costs Within Total Healthcare and Pharmaceutical Spending
• Proportion of Indication Healthcare Spending
• Proportion of Indication Pharmaceutical Spending out of Total Healthcare Spending
• Proportion of Indication Pharmaceutical Spending out of Indication Healthcare Spending
• Proportion of Indication Pharmaceutical Spending out of Pharmaceutical Spending
• Pharmaceutical Breakdown: Spending and Utilization of Brand vs Generic vs Biosimilar vs Originator
• Healthcare Spending Trend Metrics
• Healthcare Spending Per Member Per Month (PMPM)
4. Claims Stratification: Insights by Payer, Provider, and Geographical Region
• Utilization & Spending by Payer
• Utilization and Spending Intensity by Region (per 1,000 insured)
• Utilization & Spending by Provider Type
• Top Drugs by Spending per Provider Type
5. Exploring Specialty (when applicable)
• Specialty Drug Utilization Rate (%)
• Specialty Drug Spending Rate (%)
• Quarterly/Annual Trends in Utilization and Spending
• Mean Specialty Drug Spending PMPM (SAR)
• Comparison of Specialty vs. Non-Specialty PMPM
8. Access Challenges: Trends in Rejection Rates
• Medication Rejection Rate
• Rejection Rate by Geographic Area
• Rejection Rate by Payer
• Rejection Rate by Provider
2. Spending Patterns Analysis: Highlighting Cost Drivers and Trend Dynamics
• Top 10 Drugs by Spending
• Pharmaceutical Quarterly Spending Trend (in SAR)
• Pharmaceutical Percentage Change in Spending (in %)
• Pharmaceutical Spending Per Member Per Month (PMPM)
• Member Out-of-Pocket Costs
• Top 10 Spending by Indications
6. Generics Trends and Impact
- Brand vs. Generic Split (% Claims and % Spending)
• Generic Utilization Trend Over Time
• Generic Uptake Rate (%) by Scientific Name
• Generic Penetration by Therapeutic Class
• Current Savings Achieved by Generics (SAR)
• Potential Additional Savings from Increased Generic Utilization (SAR)
3. Utilization Patterns Analysis: Uncovering Prescribing Trends and Claim Dynamics
• Utilization Trend: Total Claims Processed Per Quarter
• Percentage Change in Claim Volume (in %)
• Top 10 Drugs by Utilization
• Average Claims Per Member
• New vs. Repeat Prescriptions Ratio
• Utilization Rate by Pharmacological Classes
7. Biosimilar Trends and Impact
• Originator vs. Biosimilar Split (% Claims and % Spending)
• Biosimilar Utilization Trend Over Time
• Biosimilar Uptake Rate (%) by Scientific Name
• Biosimilar Penetration by Therapeutic Class
• Current Savings Achieved by Biosimilars (SAR)
• Potential Savings from Increased Biosimilar Utilization (SAR)
9. Insights on Policy and Process Improvements
مجلس الشمان المصري
Council of Health Insurance
35
خسوان
الشراك الايستاني
(2024)
Medication Utilization - استهلاك الاندويه
(2024)
Detailed View
CHI
Monitoring
Dashboard
قسلان
مجلس الضمان الصحيه
Council of Health Insurance
Data & AI Department: data@chigov.sa
"Excluding Unlistened & Other Medication Codes Due to Unclear Classification
Co-Pay and Generics Policy in the DDF
<table><tr><td>Medication Type</td><td>Copayment</td></tr><tr><td>1. Generic medications (prescription or OTC)</td><td>0 to 20% with a maximum pay of 30 SAR, for the total prescription</td></tr><tr><td>2. Brand medications (prescription or OTC): With available registered generics</td><td>Copayment for brands is 0 to 50% for each medication</td></tr><tr><td>3. Brand medications (prescription or OTC): Without available registered generics</td><td>0 to 20% with a maximum pay of 30 SAR, for the total prescription</td></tr></table>
Beneficiary must be given the choice between generics and brands with explanation on the coinsurance impact to them.
Medications that should not be replaced as per the SFDA, bylaws, will be considered as generics in term of coinsurance (point 1 above)
جانس العمان الصحي
مجلس العمان الصحي
Council of Health Insurance
Insurance Drug Formulary Implementation Guide for the updated Essential Benefit Package
(1 October 2022- 30 September 2023)
37
Expected Impact of Co-Pay Policy on Stakeholders
- Address Moral Hazard
- Cost-Saving
- Lead the way to preferred generics
Patient
Prescribers
Pharmacies
National level
Local
Manufacturer
Brand
Manufacturer
- Address Moral Hazard
- Cost-Saving
- Lead the way to preferred generics
- Reasonable payment cap
- Better allocation of budget to enhance basic plan (treat more health conditions)
- Reduce conflict of interest with pharmaceuticals
- Encourage medical practice ethics
- Plan of purchase/deals based on preferred generics
- Encourage competition and repricing
• Incentivizing Local Manufacturing
• Better allocation of budget to cover innovative treatments
• Encourage R&D/Pharmaceutical Innovation
psolans
مجلس الشمان المضي
Council of Health Insurance
38
Panel of Experts
Insights and Interactive
Q&A
ش Oman
مجلس الشمان الصحي
Council of Health Insurance
39
DDF Prospects – Stay Tuned
01.
Biosimilar Policy & Impact
03.
Nphies Intelligence
02.
Drug Dictionary
04.
Value Based Framework
Scan Here
Survey QR Code
شامن
مجلس الضمان المضي
Council of Health Insurance