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การวิจัยเพื่อพัฒนานโยบายราคายา

วิโรจน์ ตั้งเจริญเสถียร; สุพล ลิมวัฒนานนท์; จุฬาภรณ์ ลิมวัฒนานนท์; อารีวรรณ เชี่ยวชาญวัฒนา; สมชาย สุริยไกร; นุศราพร เกษสมบูรณ์; ชะอรสิน สุขศรีวงศ์; เพชรรัตน์ พงษ์เจริญสุข; ศิริพา อุดมอักษร; สุรฉัตร ง้อสุรเชษฐ์; รุ่งเพ็ชร สกุลบำรุงศิลป์; อรอนงค์ วลีขจรเลิศ; นพคุณ ธรรมธัชอารี; อัญชลี จิตรักนที; อรลักษณ์ พัฒนาประทีป;
Date: 2555-08
Abstract
This report presents drug price control measures that have been implemented by government agencies in a number of developed countries and in Thailand. Findings from the Research Projects on Drug Prices (B.E. 2553-2555) funded by Health Systems Research Institute are included so as to recommend further policies on drug price control. In the developed countries, various drug price control policies have been implemented, especially in the step of reimbursement. The reimbursement price has been set according to therapeutic classes of drugs. Generally, healthcare purchasers seek to maximize several objectives, not limited to cost containment. Innovative products under patent protection would be reimbursable if their increasing effectiveness and decreasing significant adverse events were remarkable. In case of the narrow market drugs, such as orphan drugs and drugs used in special populations including infant and newborn, healthcare purchasers may be under pressure to provide the coverage and have limited power to bargain with drug manufacturers. The first launched generic product is allowed to set a price higher than other following products so as to increase an incentive for the manufacturers. VAT differential and mark up systems in supply chains are the important factors affecting drug price variation. Some countries require no VAT or relatively low VAT for the reimbursable drugs. External price benchmarking is a common measure for price control in the European Union. Price cap at 10% above an average of the three lowest-price countries has been used in Slovak Republic. The average price across France, Germany, the United Kingdom and the United States has been used in Japan. It is likely that manufacturers launch their products in the first countries where drug prices can be set freely or are controlled only for the reimbursable lists such as the United Kingdom and Germany. Such a measure may have positive impacts on market entry price convergence. There is evident that the market entry price among five big markets in Europe is similar. Profit control is an indirect form of price control regulation. This measure has been used in United Kingdom before 2008. Manufacturers sign an agreement capping the industry profits in exchange for a flexible framework for price setting. If the profit rate exceeds an authorized level, the manufacturers have to pay back excessive returns to government or they may not have the permission to increase the prices. In Thailand, drug price control has been implemented in government sector aiming for controlling the national health expenditure. Ministry of Public Health (MOPH) and National Health Security Office (NHSO) play a major role in drug price control. The MOPH’s Drug and Medical Supply Information Center (DMSIC) provides descriptive data on the purchasing prices of non-essential (NE) and essential drugs (ED) based on voluntary reports from the MOPH hospitals. In 2011, the MOPH announced the medium prices as a guide for procurement of 546 items of ED. Major limitations include lag-time, unregular data and under-representation of hospitals outside the MOPH.As mandated by the Cabinet Resolution on March 13, 2007, The MOPH’s Bureau of Health Administration has negotiated purchasing prices for single source products, covering 12 items and 45 items in fiscal years 2011 and 2012, respectively. However, price volume agreement was not used in the process. Therefore the price negotiation committee has limited bargaining power. At the MOPH regional level, group purchasing for high cost drugs is encouraged. However, this method is not well accepted because of variation in drug specification and rigidity of the price setting outcome. The group purchasing could reduce the purchasing price on average. However, large hospitals could obtain a price lower than the bidding one if they acted independently. In general, the group purchasing is acceptable for multisource products, of which the quality is not much an issue as for the high cost single source products. All three public insurance schemes cover drug products based on 783 items included in the current National Lists of Essential Medicines (NLEM). Therefore, the NLEM is considered as an important indirect price control. However, the three schemes vary in the degree of restrictiveness. Close ended provider payment used by the Universal Health Coverage (UC) scheme and Social Security (SS) scheme is the key incentive for hospitals in using ED. Another drug price control is price negotiation for high-cost ED. This is a mechanism to increase drug access implemented by the NHSO for the UC beneficiaries. Price volume agreement has been used for negotiating antiretrovirals, antipsychotics, and special class of the ED. Health Systems Research Institute (HSRI) has supported Drug Price Policy Research Program which focuses on specific target groups as the way to control drug expenditure for Civil Servant Medical Benefit (CSMB) scheme. The Program covers four major areas: (1) price setting strategies; (2) decision support system for improving drug acquisition price using the pharmaceutical acquisition capability (PAC) approach; (3) reference pricing system; and (4) the CSMBS beneficiaries’ preference and willingness-to-pay for expensive medications. For the first area (price setting strategies), the project suggests risk sharing by price volume agreement to be used for the innovative drugs because it could reduce expenditure better than the external price benchmarking. For a new drug with generics, brand premium for the first launched local generic should be used as the pricing strategy. After the patent expiration, price cutting should be applied for multisource drugs. For the second area, purchasing price data obtained from DMSIC was used to show substantial price variation across hospitals even after volume adjustment. With an implementation of the PAC approach, efficiency could be increased and the expenditure for purchasing drugs would decrease by 25%. For the third area, setting the reimbursed prices at the median values of drugs within the same therapeutic class could reduce drug expenditure by 50% of the CSMBS’ direct billing system in large hospitals. Setting the reimbursed prices using the price of same generics would decrease the expenditure by 20%. For the last area, the CSMB beneficiaries having hyperlipidemia have shown their willingness to pay of not more than nine Baht per day for switching simvastatin (ED) to rosuvastatin (NE). In addition, they were not willing to pay for any other NED antihyperlipidemics. In addition to the four major areas above, the Research Program supports the development of drug coding databases that link the MOPH’s 24-digit standard codes to the WHO’s Anatomical, Therapeutic and Chemical (ATC) code system and defined daily dose (DDD). Classification based on the NLEM classes and market status of the drug products were included. The database helps facilitate further data analyses and the monitoring and evaluation (M and E) system for controlling drug expenditure and utilization. Recommendation for drug price control Country should keep improving existing drug price control mechanisms as implemented by past and current governments. Use of the NLEM is a powerful indirect control measure. In the long run, manufacturers should be enforced for cost structure declaration as the criteria for selecting drugs on the NLEM. As market characteristics of drug products are matter, group purchasing and price negotiation should be the strategy of choice for the single source products. Capacity building for price negotiation techniques should be encouraged under the cooperation between MOPH and health insurance schemes because the comparative advantage of the MOPH on provider profiles and the schemes on demand information. Innovative methods such as risk sharing with price volume agreement, value-based pricing and cost effectiveness analysis should be used. In addition, the M and E system for the hospitals’ purchasing prices should be improved for timeliness and representation of the price information. For setting the reimburse price, use of branded and single-source NE products should be restricted for only the true candidates. The NLEM should be used as the reimbursed lists for all three insurance schemes. For the CSMBS, financial incentive should be made when setting the reimbursed price based on the generic ED. Standardization of the drug price data and coding is necessary for evidence-informed policy formulation. Therefore, an organization for maintaining drug price and use database and coding system should be established. System to feedback the demand information would help supporting decision during price negotiation and reimbursed price setting process. In the long run, structure for drug price monitoring should be developed. Drug price should be monitored for every step, from the NLEM process, hospital drug procurement, dispensing and reimbursement for insurance. The monitoring of drug prices across hospitals and time-trend comparison should be conducted. In addition, health care provider drug price index for both acquisition and reimbursement should be developed.
Copyright ผลงานวิชาการเหล่านี้เป็นลิขสิทธิ์ของสถาบันวิจัยระบบสาธารณสุข หากมีการนำไปใช้อ้างอิง โปรดอ้างถึงสถาบันวิจัยระบบสาธารณสุข ในฐานะเจ้าของลิขสิทธิ์ตามพระราชบัญญัติสงวนลิขสิทธิ์สำหรับการนำงานวิจัยไปใช้ประโยชน์ในเชิงพาณิชย์
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