2011;17(10):784-93. BMC Health Serv Res. Health Policy. The first generic medicine is priced 35% lower than the pre-patent price of the original brand medicine, with subsequent generic medicines priced at least 10% lower, until the fourth generic medicine. Arabic. You may contact us at any time to opt-out. Southern Med Rev. Our reimbursement experts can assist you in finding the answers to coding and reimbursement questions. There was only one generic version of esomeprazole during the study period. Lucchesi S, Marcianò I, Panagia P, Intelisano R, Randazzo MP, Sgroi C, et al. Similarly, among generic medicines, the absolute price difference between the highest price generic medicine and other generic medicines and the price ratio of the highest price generic medicine to other generic medicines of the same molecule were calculated [23]. Author: Alian A Alrasheedy, BPharm(Hons), MPharm(Clin), PhD, MACP, RPh, Dean, Unaizah College of Pharmacy, Qassim University, Saudi Arabia. Saudi Pharm J. 4.1 Gulf Central Committee for Drug Registrations (GCC-DR) 4.2 Regulatory Review Process. This is applied mostly to generic drug products in Saudi Arabia. 22. 2011;1:141. In addition, only one dosage form of these products was analysed. 24. A price comparison between the original brand medicines and their generic versions was conducted for the top six selling medicines in Saudi Arabia during the period of 2010â2015. The study analysed the prices of only six medicines, which is considered a small number; although, these are the top selling products. 2015 [homepage on the Internet]. This paper mentions the prevalence of rare conditions in Saudi Arabia ⦠In: Babar ZUD, editor. Internal price referencing refers to the practice of determining the price of a medicine by considering the prices of its identical, similar, or therapeutically equivalent medicines within the same country. The Big Picture. Policies to enhance prescribing efficiency in Europe: findings and future implications. Approximately three quarters of the healthcare services are currently provided by the public sector. Vogler S, Martikainen JE. This is applied mostly to generic drug products in Saudi Arabia. 3.2 Procurement & Reimbursement Policies. 31. The generic medicine to original brand medicine price ratio was 0.86â0.31. 2020;9(1):14-21.DOI: 10.5639/gabij.2020.0901.003. The second registered generic medicine will be priced 10% lower than the set price of the first registered generic medicine. In the current study, large variations were noted among the generic medicines of the same molecule, with a generic medicine to generic medicine price ratio of 0.96â0.18. Medicine prices are determined according to pharmaceutical pricing rules and policies, which were approved by the Saudi FDA and have been implemented since November 2011 [36]. Provenance and peer review: Not commissioned; externally peer reviewed. Descriptive comparisons of medicine prices were made based on the official prices of medicines, i.e. The medicine prices were obtained from Saudi FDAâs official list of registered medicines and herbal products (available at https://www.sfda.gov.sa/en/drug/search/Pages/default.aspx) [, The study calculated the absolute price difference between the original brand medicine and the generic medicine in Saudi Arabian Riyals (SAR) and it calculated the generics to original brand medicine price ratio. The generic medicine to original brand medicine price ratio was 0.81â0.58. Browse or search our Report Store for the latest comprehensive reports, market data, analysis and survey findings alongside industry information on key companies, markets and financial deals. [Pharmaceutical institutions and products law 2004]. +44 20 7947 2745. Front Pharmacol. The "Saudi Arabia Diabetes Drug & Insulin Delivery Device Market Opportunity Outlook 2025" report has been added to ResearchAndMarkets.com's offering. Available from: https://www.sfda.gov.sa/ar/drug/drug_reg/Pages/drug_reg.aspx The current approach adopted for medicine pricing is the âprescriptive pricing approachâ for both original brand medicines and generic medicines. Apparel, Accessories, Luggage and Leather Goods (259), Cash and Carries and Warehouse Clubs (174), Drug Stores and Health and Beauty Stores (296), Hypermarkets, Supermarkets and General Merchandise Retailers (374). In addition, there was a large variation among the prices of the generic versions of diclofenac, where the generic medicine to generic medicine price ratio was 0.9â0.35. 2011;61(1):80-3. Prevalence of use and cost of biological drugs for cancer treatment: a 5-year picture from Southern Italy. Saudi security forces have foiled three attempts to smuggle banned drugs into the Kingdom, the Ministry of Interior said on Thursday. Saudi Arabia - Regulatory Aspects of Pharmaceutical Products . 2013;2(1):18-22. Therefore, the aim of this article was to provide an overview of the current pharmaceutical pricing policy of medicines in Saudi Arabia and to provide an evaluation of the impact of this policy on medicine prices, including both the original brand medicines and generic medicines. Innovative pharmaceutical pricing agreements in five European markets: a survey of stakeholder attitudes and experience. Decomposing changes in the growth of U.S. prescription drug use and expenditures, 1999-2016. Your data will never be shared with third parties, however we may send you information from time to time about related third party products that may be of interest to you. Use of genericsâa critical cost containment measure for all healthcare professionals in Europe? 29. In Norway, a stepped price model has been adopted. Currently, medicine prices are determined based on the pharmaceutical pricing policy approved by the Saudi FDA. J Generic Med. 2015;12(2):60-73. Saudi Arabia Pharmaceuticals & Healthcare Report Q3 2015. 16. Godman B, Shrank W, Andersen M, Berg C, Bishop I, Burkhardt T, et al. Journal of Generic Medicines. However, the private healthcare sector has grown in recent years and is now considered an essential component of the Saudi healthcare system [1–3]. Saudi Arabia Pharmaceuticals & Healthcare Report Q3 2019. The "Saudi Arabia Diabetes Drug & Insulin Delivery Device Market Opportunity Outlook 2025" report has been added to ResearchAndMarkets.com's offering. Generics and Biosimilars Initiative (GaBI), Healthcare in Saudi Arabia is provided via a dual system, i.e. The study compared the prices of the top selling medicines in Saudi Arabia, including six different medicines. However, the private healthcare sector has grown in recent years and is now considered an essential component of the Saudi healthcare system [, Pharmaceutical expenditures make up a large component of overall health expenditures [, In view of this tremendous increase in expenditure, which threatens the sustainability of healthcare systems, many countries have introduced strategies and policies, including pharmaceutical pricing policies, to control medicine prices, to ensure medicine affordability and accessibility, to ensure price stability, to promote innovation, and to maintain pharmaceutical production [, In Saudi Arabia, historically, medicine prices have been determined by the Ministry of Health. Roughead EE, Kim D-S, Ong B, Kemp-Casey A. In this study, there were significant differences in the prices of the generic medicines for the same molecule. Ministry of Health of Saudi Arabia. 2010;3(8):2470-94. World Health Organization. This paper mentions the prevalence of rare conditions in Saudi Arabia, discusses the current reimbursements methods and policies in ⦠The total healthcare expenditure is steadily increasing from US$23.641 billion in 2011 to US$40.657 billion in 2018 (66% of the total expenditure is currently funded by the governmental budget) [4, 5]. The study calculated the absolute price difference between the original brand medicine and the generic medicine in Saudi Arabian Riyals (SAR) and it calculated the generics to original brand medicine price ratio. The generic medicine to original brand medicine price ratio was 0.87â0.46. As shown in Table 6, the price comparison was conducted for atorvastatin (40 mg) film-coated tablets, available in a package size of 30 tablets. Saudi Pharm J. ... reimbursement policies for pharmaceuticals in the MENA region Describe and analyse the current use of ERP systems ... Drug product shortages Explores whether there are product shortages as a result of pricing policies Pricing policies for generic medicines in Australia, New Zealand, the Republic of Korea and Singapore: patent expiry and influence on atorvastatin price. Multiple policies to enhance prescribing efficiency for established medicines in Europe with a particular focus on demand-side measures: findings and future implications. In this approach, health authorities or regulators mandate price reductions that are necessary for the reimbursement price or for determining the price [15, 29]. This article discusses the pharmaceutical pricing policies and the impact of health drug prices on the public in the Kingdom of Saudi Arabia. Policies to promote use of generic medicines in low and middle income countries: a review of published literature, 2000â2010. Alkhuzaee FS, Almalki HM, Attar AY, Althubiani SI, Almuallim WA, Cheema E, et al. Pharmaceutical pricing and reimbursement in the Middle East and North Africa region A mapping of the current landscape and options for the future Panos Kanavos, ... SFDA Saudi Food and Drug Authority (Saudi Arabia) SHI Social Health Insurance SLR Systematic Literature Review TDL Tender Drug ⦠the price will be reduced to the level of the WADP) [16, 27]. By comparison, the study by Zeng (2013) reported that in China the difference was 0.34 and 0.98 [23]. 2016 [homepage on the Internet]. The original brand of atorvastatin is currently not marketed; hence, the prices for its generic versions were compared to the first registered generic version. Hence, educational campaigns need to highlight the facts regarding generic medicines, which are clinically interchangeable with the original brand medicines, with the same quality, safety, and effectiveness, (the only difference is their cheaper prices). It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Saudi Arabia. There was only one generic version registered in the same dosage form. 2015;23(2):143-6. 2014;117(3):297-310. 52. active ingredients, in which their products were listed in the top 10 products sold in Saudi Arabia during the period of 2010â2015 [37]. However, the retail pharmacy prices of medicines, i.e. No medication, either brand or generic, can be registered without being priced first by the SFDA [42] . Cancer drug expenditure in British Columbia and Saskatchewan: a trend analysis. reportstore@globaldata.com In: Babar ZUD, editor. Similarly, the third generic medicine will be priced at least 10% lower than the second registered generic medicine. the association between low price and low quality and effectiveness, as reported in the literature [49–52]. Market for Saudi Arabia Pharmaceuticals projected to reach US$ 8,465 Mn by 2023. The report provides information on the healthcare, regulatory, and reimbursement landscape in the Saudi Arabia, and includes: • An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers, • Profiles and SWOT analyses of the major players in the pharmaceutical market (GlaxoSmithKline, Novartis, Pfizer, Tabuk Pharmaceuticals and Saudi Arabian Pharmaceutical Industries & Medical Appliances Corp) and profiles and SWOT analyses of the major players in the medical device market (Cardinal Health, Fujitsu, AstraZeneca, GE Healthcare, and Kimberly-Clark Corporation), • Detailed analysis about recent completed deals in the pharmaceutical and medical device market of Saudi Arabia, • Porter’s five forces analysis for pharmaceutical and medical devices market of Saudi Arabia, • An insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the regulatory agencies and the approval processes for new drugs, • Information regarding recent healthcare policies along with healthcare infrastructure and healthcare expenditure, • An overview of the opportunities and challenges to growth in the Saudi Arabian healthcare market. Saudi Arabia - Diabetes Drug Market . For example, pharmaceutical expenditure increased from US$4.894 billion in 2011 to US$7.897 billion in 2018 [4, 5]. In Saudi Arabia, public drug prices are strictly regulated by the SFDA. Due to this large difference, the cost savings will depend on the product prescribed or procured by the health organization. 2019;54(4):752-63. To ensure the accuracy of the comparisons, only medicines of the same properties were included [38]. 2015;6:14-21. 2019:1-8. In Europe, particularly France, the first generic medicine is required to be at least 55% lower than the price of the original brand medicine to be reimbursed. Albarraq AA. 18. 2010;3(3):471-81. In addition, some generic medicines imported from high income countries were cheaper than the medicines manufactured locally or from other countries within the Middle East. J Pharmacy Pract Comm Med. The products compared had to be in the same dosage form, with the same strength and the same package size. Sermet C, Andrieu V, Godman B, Van Ganse E, Haycox A, Reynier J-P. In addition, some generic medicines imported from high income countries were cheaper than the medicines manufactured locally or from other countries within the Middle East. Hence, to promote generic medicines, especially low-priced generic medicines, demand-side policies particularly educational activities and campaigns are needed to promote the cost-effective use of medicines. 27. This report will enhance your decision-making capability by allowing you to: • Develop business strategies by understanding the trends shaping and driving the Saudi Arabian healthcare market, • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the healthcare market in the future, • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors, • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnership, • Identify, understand, and capitalize on the opportunities and challenges in the Saudi Arabian healthcare market, 2.3 Key Events: Saudi Arabian Pharmaceutical History, 2008–2019, 2.4 Key Events: Saudi Arabian Pharmaceutical Market, 2.5 Key Events: M&A, VC & PE Deals, Global Pharmaceutical Market, 2018–2019, 3.4 Pharmaceutical Market – Market Segments, 3.5 Pharmaceutical Market – Supply Channels, 3.6 Pharmaceutical Market – Top Five Disease Areas, 3.7 Pharmaceutical Market – Major Players, 4.2 Medical Device Market – Top Five Segments, 4.3 Medical Device Market – Diagnostic Market, 4.4 Medical Device Market – Major Players, 5 Pharmaceutical and Medical Device Market – Drivers and Barriers, 6.1 Deal Analysis: M&A, VF and PE Deals, Pharmaceutical Market, Saudi Arabia, 6.2 Deal Analysis: M&A, VF and PE Deals, Medical Device Market, Saudi Arabia, 7 Pharmaceutical and Medical Device Market – Porter’s Five Forces Analysis, 7.1 Pharmaceutical Market, Saudi Arabia – Porter’s Five Forces Analysis, 7.2 Medical Device Market, Saudi Arabia – Porter’s Five Forces Analysis, 8.1 Overview of Healthcare System, Saudi Arabia, 8.1.2 Healthcare Transformation, Saudi Arabia, 8.2.1 Overview of Insurance, Saudi Arabia, 8.2.2 Healthcare Spending and Medical Products Price Index, Saudi Arabia, 8.3.1 Market Authorization for Pharmaceutical Drugs, Saudi Arabia, 8.3.2 Market Authorization for Medical Devices, Saudi Arabia, 8.3.3 Pharmaceutical Establishment Regulations, Saudi Arabia, 8.3.5 Intellectual Property Rights, Patent, Saudi Arabia, 8.3.6 Intellectual Property Rights, Trademark, Saudi Arabia, 8.3.7 Clinical Trial Regulations, Saudi Arabia, 8.3.8 Pharmaceutical Advertising Regulations, Saudi Arabia, 8.3.9 Labeling and Packaging Regulations, Saudi Arabia, 9.7.2 Share of Public and Private Sectors, Table 1: Opportunities in Pharmaceutical and Biotech Clusters, Saudi Arabia, 2019, Table 2: Pharmaceutical Market, Saudi Arabia, Sales of Patented Drug Products by Major Therapeutic Class (%), 2010–2015, Table 3: Medical Device Market, Saudi Arabia, Revenue by Segment, Table 4: Nephrology and Urology Device Market, Saudi Arabia, Revenue ($M) and Market Share (%) of Major Companies, 2017, Table 5: Drug Delivery Devices Market, Saudi Arabia, Revenue ($B) and Market Share (%) of Major Companies, 2017, Table 6: Healthcare IT Market, Saudi Arabia, Revenue ($M) and Market Share (%) of Major Players, 2017, Table 7: Ophthalmic Devices, Saudi Arabia, Revenue ($M) and Market Share (%) of Major Companies, 2017, Table 8: Hospital Supplies Market, Saudi Arabia, Revenue ($M) and Market Share (%) of Major Companies, 2017, Table 9: Market Shares of Health Insurance Companies, Saudi Arabia, 2017, Table 10: Total Performance Target, Saudi Arabia, 2019, Table 11: MDMA Evaluation Fees, Saudi Arabia, 2016, Table 12: License Or Renewal Fee ($), 2019, Saudi Arabia, Table 13: Profit Margin (%), 2019, Saudi Arabia, Table 14: Customs Ports, 2015, Saudi Arabia, Table 15: Patent Fees ($), 2019, Saudi Arabia, Table 16: Trademark Fees ($), 2019, Saudi Arabia, Table 17: Label of a Pharmaceutical Product, Saudi Arabia, 2019, Table 18: Minimum Particulars to Appear on Blisters or Strips , Saudi Arabia, 2019, Table 19: Minimum Particulars to Appear on Small Immediate Packaging, Saudi Arabia, 2019, Table 20: Recommendations for Using Color, Saudi Arabia, Table 21: Recommendations for Primary Packaging, Saudi Arabia, Table 22: Recommendations for Secondary Packaging, Saudi Arabia, Figure 1: Pharmaceutical Market, Saudi Arabia, Revenue ($B), 2013–2018, Figure 2: Medical Device Market, Saudi Arabia, Revenue ($B), 2015–2020, Figure 4: 2018–19 Deal Overview By Region, Figure 5: Country Profile, Saudi Arabia, 2018, Figure 6: Pharmaceutical Market, Saudi Arabia, Revenue ($B), 2011–2018, Figure 7: Pharmaceutical Market, Saudi Arabia, Revenue Forecast ($B), 2019–2025, Figure 8: Pharmaceutical Market, Saudi Arabia, Pharmaceutical Exports, Figure 9: Pharmaceutical Market, Saudi Arabia, Top Export Partners, Figure 10: Pharmaceutical Market, Saudi Arabia, Pharmaceutical Imports, Figure 11: Pharmaceutical Market, Saudi Arabia, Top Import Partners, Figure 12: Innovation Centers, Saudi Arabia, 2019, Figure 13: Biosimilars, Saudi Arabia, 2019, Figure 14: Major OTC Drug Classes (Share %), Saudi Arabia, 2018, Figure 15: Pharmaceutical Market, Supply Chain, Saudi Arabia, Figure 16: Pharmaceutical Market, Saudi Arabia, Sales of Patented Drug Products by Major Therapeutic Class, 2010–2015, Figure 17: Pharmaceutical Market, Major Players, Saudi Arabia, Figure 18: Medical Device Market, Saudi Arabia, Revenue ($B), 2015–2020, Figure 19: Medical Device Market, Saudi Arabia, Revenue Forecast ($B), 2021–2025, Figure 20:Medical Device Market, Saudi Arabia, Revenue by Segment ($B), 2018, Figure 21: Nephrology and Urology Device Market, Saudi Arabia, Revenue ($B), 2015–2022, Figure 22: Nephrology and Urology Device Market, Saudi Arabia, Market Share of Major Players (%),2017, Figure 23: Drug Delivery Devices Market, Saudi Arabia, Revenue ($B), 2015–2022, Figure 24: Drug Delivery Devices Market, Saudi Arabia, Market Share of Major Players (%), 2017, Figure 25: Healthcare IT Market, Saudi Arabia, Revenue ($B), 2015–2022, Figure 26: Healthcare IT Market, Saudi Arabia, Market Share of Major Players (%), 2017, Figure 27: Ophthalmic Devices, Saudi Arabia, Revenue ($B), 2015–2022, Figure 28: Ophthalmic Devices, Saudi Arabia, Market Share of Major Players (%), 2017, Figure 29: Hospital Supplies Market, Saudi Arabia, Revenue ($B), 2015–2022, Figure 30: Hospital Supplies Market, Saudi Arabia, Market Share of Major Companies (%), 2017, Figure 31: Diagnostic Market, Saudi Arabia, Revenue ($B), 2015-2020, Figure 32: Diagnostic Market, Saudi Arabia, Revenue ($B), 2021–2025, Figure 33: Medical Device Market – Major Players, Figure 34: Deal Value and Deal Count Quarterly, Pharmaceutical Market, Saudi Arabia, 2018–2019, Figure 35: Deal Value and Deal Count Sub-Types, Pharmaceutical Market, Saudi Arabia, 2018–2019, Figure 36: M&A Deals by Therapy Area, Pharmaceutical Market, Saudi Arabia, 2018–2019 (by value and by number), Figure 37: Structure of the Healthcare Sectors, Saudi Arabia, Figure 38: Organizational Chart of Ministry of Health, Saudi Arabia, Figure 39: NTP Strategy to Transform Healthcare, Saudi Arabia, 2018, Figure 40: Formulary Additions, Saudi Arabia, Figure 41: Insurance System of GOSI, Saudi Arabia, 2019, Figure 42: Health Insurance Market, Revenue ($B), Saudi Arabia, 2018, Figure 43: OOP Expenditure (% of total expenditure on health), Saudi Arabia, 2010–2016, Figure 44: Annual Rate of Change (%), Health Price Index, Saudi Arabia, 2010–2018, Figure 45: SFDA, Organizational Structure, Saudi Arabia, 2018, Figure 46: MAA Submission Process, Saudi Arabia, Figure 48: Drug Licensing Renewal, Saudi Arabia, Figure 49: Patent Application Process, Saudi Arabia, 2018, Figure 50: Number of Hospitals, Saudi Arabia, 2010–2018, Figure 51: Diagnostic Equipment, Saudi Arabia, 2015–2018, Figure 52: Hospital Beds (per 10,000 population), Saudi Arabia, Figure 53: OBS/Gyn and Pediatric Hospital Beds of MoH (per 10,000 population), Saudi Arabia, Figure 54: Psychiatric Hospital Beds of MoH (per 10,000 population), Saudi Arabia, Figure 55: Life Expectancy (Years), 2010–2018, Saudi Arabia, Figure 56: Immunization Rate (%), 2010–2018, Saudi Arabia, Figure 57: PM2.5 (µg/m3), Saudi Arabia, 2010–2017, Figure 58: CO2 Emissions (Million of Tons), Saudi Arabia, 2010–2018, Figure 59: Physicians (per 10,000 population), Saudi Arabia, 2010–2018, Figure 60: Dentists (per 10,000 population), Saudi Arabia, 2010–2018, Figure 61: Nurses (per 10,000 population), Saudi Arabia, 2010–2018, Figure 62: Pharmacists (per 10,000 population), Saudi Arabia, 2010–2018, Figure 63: Major Causes of Mortality (number of deaths), Saudi Arabia, Figure 64: Major Causes of Male Mortality (number of deaths), Saudi Arabia, Figure 65: Major Causes of Female Mortality (number of deaths), Saudi Arabia, Figure 66: DALYs by Major Disease (‘000), Saudi Arabia, Figure 67: Healthcare Expenditure as Percentage of GDP (%), Saudi Arabia, 2010–2016, Figure 68: Public-Private Share (%), Saudi Arabia, 2010–2016. 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