Burden of Illness of Type 2 Diabetes Mellitus in the Kingdom of Saudi Arabia: A Five-Year Longitudinal Study.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is associated with huge clinical and economic burden in the Kingdom of Saudi Arabia (KSA) which can be curtailed by efficacious treatment. In order to achieve this, current treatment pathways for T2DM and associated costs need to be assessed. METHODS: A longitudinal cohort review was conducted to collect country-specific and patient-specific clinical data, over a minimum observation period of 5 years in the KSA. Patient demographics, clinical characteristics and treatment patterns were recorded. The IQVIA Core Diabetes Model (CDM) version 9.5 Plus was used to assess the burden of illness, which included long-term projections of clinical (life expectancy [LE], quality-adjusted life-years [QALYs], event rates of diabetes-related complications) and direct medical cost (per-patient annual or lifelong [50 years]) outcomes of the most commonly used first-line (1st-line) regimens for T2DM from a payer perspective in the KSA. RESULTS: Data were collected from a subpopulation of 638 patients from 15 participating centres. There was an equal gender representation with a majority of the patients belonging to Arabian/Saudi ethnicity (71.0%). Biguanides (81.5%), sulfonylureas (51.6%), dipeptidyl peptidase 4 (DPP4) inhibitors (26.2%) and fast-acting insulins (17.2%) were the most prescribed 1st-line agents. The most frequently used 1st-line regimens resulted in an estimated LE of 25-28 years, QALYs of 18-21 years and lifelong total cost of illness of 201,377-437,371 Saudi Arabian riyal (53,700-116,632 US dollars). CONCLUSION: Our study addresses gaps in the current research by providing a complete landscape of baseline demographic, clinical characteristics and treatment patterns from a heterogeneous group of patients with T2DM in the KSA. Additionally, the burden of illness analysis using CDM showed substantially higher cost of T2DM care from a payer perspective in the KSA.

The Saudi consensus recommendations for the management of psoriatic arthritis (2023).

Psoriatic arthritis (PsA) is a complex inflammatory disease characterized by musculoskeletal and non-musculoskeletal manifestations. It is a distinct disease entity at the interface between rheumatology and dermatology, making it challenging to manage. The diverse clinical presentation and severity of PsA require a multidisciplinary approach for optimal care. Early diagnosis and management are necessary to improving quality of life for patients. In Saudi Arabia, there is currently no unified national consensus on the best practices for managing PsA. This lack of consensus leads to debate and uncertainty in the treatment of the disease, resulting in over or under prescribing of biological agents. To address this issue, a multidisciplinary work group was formed by the Saudi Ministry of Health. This group, consisting of dermatologists, rheumatologists, and pharmacists, aimed to develop evidence-based consensus recommendations for he use and monitoring of biological therapy in PsA management. The work group conducted five consensus workshops between December 2021 to March 2022. Using the nominal group technique, they discussed various aspects of PsA management, including eligibility criteria for biological treatment, monitoring of disease activity, treatment goals, screening, precautions, and management of PsA with biologic therapies. The group also considered special considerations for patients with comorbidities, pregnant and lactating women, as well as pediatric and adolescent populations. The resulting consensus document provides recommendations that are applicable to the Saudi setting, taking into account international guidelines and the specific needs of PsA patients in the country. The consensus document will be regularly updated to incorporate new data and therapeutic agents as they become available. Key Points • In Saudi Arabia, there is a lack of unified national consensus on the optimal management of PsA, therefore, this article aims to provide up-to-date evidence-based consensus recommendations for the optimal use and monitoring of biologic therapy in the management of PsA in Saudi Arabia. • The consensus development process was undertaken by a multidisciplinary work group of 13 experts, including two dermatologists, six rheumatologists, and five pharmacists. • There is more than one disease activity tool used in PsA disease, depending on the disease domain - peripheral arthritis Disease Activity Index in Psoriatic Arthritis (DAPSA) or Minimal Disease Activity (MDA), axial PsA Ankylosing Spondylitis Disease Activity Score (ASDAS), and dactylitis and enthesitis MDA. • The main goal of therapy in all patients with PsA is to achieve the target of remission, or alternatively, low disease activity in all disease domains and improve quality of life (QoL).

Diagnosis and Management of Alopecia Areata: A Saudi Expert Consensus Statement (2023).

Alopecia areata (AA) is a complex autoimmune disease manifesting as a chronic inflammatory disease characterized by non-scarring patches of hair loss over the face, scalp, and body. Several treatments have been proposed for AA, but none are curative nor achieve a state of remission. The present consensus statement aims to present the evidence- and experience-based recommendations on the diagnosis and management of AA in Saudi Arabia. The Ministry of Health in Saudi Arabia has opted to initiate a meeting of a multidisciplinary group to discuss and concede on this topic. Eight dermatology experts and clinical pharmacists convened in eight consensus meetings. All content presented in this document was agreed upon by this working group, including diagnosis and severity assessment, prognostic indicators, and therapeutic options for AA. Special consideration was given to special patient populations including pediatric patients and patients with less frequent presentations of AA. Updates of the current recommendations will take place as new evidence evolves in the treatment of AA.

Informing a cost-effectiveness threshold for Saudi Arabia.

BACKGROUND: Saudi Arabia's Vision 2030 aims to reform health care across the Kingdom, with health technology assessment being adopted as one tool promising to improve the efficiency with which resources are used. An understanding of the opportunity costs of reimbursement decisions is key to fulfilling this promise and can be used to inform a cost-effectiveness threshold. This paper is the first to provide a range of estimates of this using existing evidence extrapolated to the context of Saudi Arabia. METHODS AND MATERIALS: We use four approaches to estimate the marginal cost per unit of health produced by the healthcare system; drawing from existing evidence provided by a cross-country analysis, two alternative estimates from the UK context, and based on extrapolating a UK estimate using evidence on the income elasticity of the value of health. Consequences of estimation error are explored. RESULTS: Based on the four approaches, we find a range of SAR 42,046 per QALY gained (48% of GDP per capita) to SAR 215,120 per QALY gained (246% of GDP per capita). Calculated potential central estimates from the average of estimated health gains based on each source gives a range of SAR 50,000-75,000. The results are in line with estimates from the emerging literature from across the world. CONCLUSION: A cost-effectiveness threshold reflecting health opportunity costs can aid decision-making. Applying a cost-effectiveness threshold based on the range SAR 50,000 to 75,000 per QALY gained would ensure that resource allocation decisions in healthcare can in be informed in a way that accounts for health opportunity costs. LIMITATIONS: A limitation is that it is not based on a within-country study for Saudi Arabia, which represents a promising line of future work.

Healthcare in Saudi Arabia is undergoing wide-ranging reform through Saudi Arabia's Vision 2030. One aim of these reforms is to ensure that money spent on healthcare generates the most improvement in population health possible. To do this requires understanding the trade-offs that exist: funding one pharmaceutical drug means that same money is not available to fund another pharmaceutical drug. This is relevant whether the new drug would be funded from within the existing budget for healthcare or from an expansion of it. If the drugs apply to the same patient population and have the same price, the question is simply, "which one generates more health?" In reality, we need to compare pharmaceutical drugs for different diseases, patient populations, and at a range of potential prices to understand whether the drug in question would generate more health per riyal spent than what is currently funded by the healthcare system. This paper provides the first estimates of the amount of health, measured in terms of quality adjusted life years (QALYs), generated by the Saudi Arabian healthcare system. We find that the healthcare system generates health at a rate of one QALY produced for every 50,000­75,000 riyals spent (58­86% of GDP per capita). Using the range we estimate to inform cost-effectiveness threshold can aid decision-making.

Recommendations for the treatment of rheumatoid arthritis in Saudi Arabia: adolopment of the 2021 American College of Rheumatology guidelines.

BACKGROUND: The 2021 American College of Rheumatology (ACR) rheumatoid arthritis (RA) guideline considers the specific context of the United States which differs from that of Saudi Arabia in many aspects that may impact recommendations. The objective of this project was to adapt a set of prioritized recommendations from the 2021 ACR guideline for the treatment of rheumatoid arthritis RA for the context of Saudi Arabia, by the Saudi Society for Rheumatology (SSR). METHODS: The process followed the GRADE-ADOLOPMENT methodology, and the reporting adhered to the RIGHT-Ad@pt checklist. Working groups included a coordination group and a 19-member panel representing different stakeholder groups. The Evidence to Decision (EtD) tables included evidence on health effects from the source guideline and contextual information from the Saudi setting. RESULTS: The panel prioritized and adapted five recommendations from the source guideline. The process led to modifying two out of the five prioritized recommendations, all listed here. In naive patients with low disease activity, methotrexate (MTX) is conditionally recommended over sulfasalazine (SSZ) (modified direction); hydroxychloroquine (HCQ) is conditionally recommended over SSZ (unmodified). Initiation of csDMARDs with short-term glucocorticoids is conditionally recommended over csDMARDs alone in naive patients with moderate to high disease activity (modified direction). Switch to subcutaneous MTX is conditionally recommended over addition/switch to alternative DMARD(s) in patients taking oral MTX who are not at target (unmodified). Discontinuation of MTX is conditionally recommended over gradual discontinuation of the bDMARD or tsDMARD for patients taking MTX plus a bDMARD or tsDMARD who wish to discontinue a DMARD (unmodified). CONCLUSION: Rheumatologists practicing in Saudi Arabia can use the adoloped recommendations generated by this project while adopting the rest of the recommendations from the 2021 ACR guidelines.

Cost of cardiovascular diseases and renal complications in people with type 2 diabetes mellitus in the Kingdom of Saudi Arabia: A retrospective analysis of claims database.

BACKGROUND: The burden of macro- and microvascular complications in patients with Type 2 diabetes mellitus (T2DM) is substantial in Middle East countries. The current study assessed the healthcare resource utilization (HCRU) and costs related to cardiovascular and renal complications among patients with T2DM. METHODOLOGY: This non-interventional, longitudinal, retrospective, cohort study collected secondary data from three insurance claims databases across Kingdom of Saudi Arabia (KSA) of patients diagnosed with T2DM. The study included adult patients aged ≥18 years diagnosed with first cardiovascular disease (CVD) during index time period and at least one T2DM claim anytime during the study time period. The primary analyses were conducted per database, stratified by three cohorts; patients with at least one claim every six months during the 1-year pre-index and 1-year post-index period (cohort 1), patients with at least one claim every six months during the 1-year pre-index, and two years post-index period (cohort 2) and patients with at least one claim every six months during the 1-year pre-index and 3-year post-index period (cohort 3). For each Payer database, demographics, CVD subgroups, HCRU, and costs were analysed. Descriptive statistics were used to analyse the data. RESULTS: The study sample comprised of 72-78% male and 22-28% female T2DM patients with CVD and renal complications. Patients in the age group of 35-65 years or above contributed to the significant disease burden. Nearly 68 to 80% of T2DM patients developed one CVD event, and 19 to 31% of patients developed multiple CVD events during the follow-up period. For most patients with comorbid CVD and renal disease, the average HCRU cost for post­index periods was higher compared to 1-year pre-index period across the different visit types and activities. CONCLUSION: The study findings elucidates the need for early initiation of therapies that would reduce the long-term cardiovascular and renal outcomes and the associated costs in patients with T2DM.

Restriction on antimicrobial dispensing without prescription on a national level: Impact on the overall antimicrobial utilization in the community pharmacies in Saudi Arabia.

BACKGROUND: High rates of non-prescription dispensing of antimicrobials have led to a significant increase in the antimicrobial overuse and misuse in Saudi Arabia (SA). The objective of this study was to evaluate the antimicrobial utilization following the enforcement of a new prescription-only antimicrobial dispensing policy in the community pharmacy setting in SA. METHODS: Data were extracted from the IQVIA database between May 2017 and May 2019. The antimicrobial utilization rates, based on sales, defined daily dose in grams (DDD), DDD/1000 inhabitants/day (DID), and antimicrobial-claims for the pre-policy (May 2017 to April 2018) and post-policy (June 2018 to May 2019) periods were assessed. RESULTS: Overall antimicrobial utilization declined slightly (~9-10%) in the post-policy versus pre-policy period (sales, 31,334 versus 34,492 thousand units; DDD, 183,134 versus 202,936), with higher claims (~16%) after policy implementation. There was a sudden drop in the utilization rate immediately after policy enforcement; however, the values increased subsequently, closely matching the pre-policy values. Utilization patterns were similar in both periods; penicillin was the most used antimicrobial (sales: 11,648-14,700-thousand units; DDD: 71,038-91,227; DID: 2.88-3.78). For both periods, the highest dip in utilization was observed in July (sales: 1,027-1,559 thousand units; DDD: 6,194-9,399), while the highest spike was in March/October (sales: 3,346-3,884 thousand units; DDD: 22,329-19,453). CONCLUSION: Non-prescription antimicrobial utilization reduced minimally following policy implementation in the community pharmacies across SA. Effective implementation of prescription-only regulations is necessary.

Saudi consensus statement on biologic treatment of chronic plaque psoriasis (2020).

Psoriasis is a common chronic and complex inflammatory skin disease that affects over 125 million people worldwide. Management of psoriasis in daily clinical practice in Saudi Arabia is variable. Local preferences for management differ, which may have a bearing on the treatment selection. Biologic therapy is now a well-established strategy for managing moderate-to-severe plaque psoriasis. There is a clear need for national consensus statements due to the extended role and high availability of literature on these agents. As a result of an initiative of the Ministry of Health, a multidisciplinary expert panel of dermatologists and pharmacists with practical experience in the clinical management of psoriasis were invited to be part of a work group to update the previous practical guidelines on the biologic treatment of psoriasis published in the Journal of Dermatological Treatment, 2014. The overall aim of this consensus document is to deliver evidence-based recommendations on the use, screening, and monitoring of biologic therapy in patients with moderate-to-severe plaque psoriasis. These recommendations also address the use of biologic therapy in special patient populations. They were developed after rigorous evaluation of existing international guidelines as well as the latest emerging evidence. Updates of the present consensus document will be provided as needed to incorporate new data or agents.