ISELIN DAHLEN SYVERSEN, KEVIN SCHULMAN, AARON S. KESSELHEIM, WILLIAM B. FELDMAN
Policy PointsHealth care systems around the world rely on a range of methods to ensure the affordability of prescription drugs, including negotiating prices soon after drug approval and relying on formal clinical assessments that compare newly approved therapies with existing alternatives.The negotiation framework established under the Inflation Reduction Act is far more limited than other frameworks explored in this study. Adding elements from these frameworks could lead to more effective price negotiation in the United States.ContextIn 2022, Congress passed the Inflation Reduction Act, which allowed Medicare, for the first time, to begin negotiating the prices for certain high‐cost brand‐name prescription drugs. Many other industrialized countries negotiate drug prices, and we sought to compare and contrast key features of the negotiation process across several health systems. We focused, in particular, on the criteria for selecting drugs for price negotiation, procedures for negotiation, factors that influence negotiated prices, and how prices are implemented.MethodsWe included four G7 countries in our analysis (Canada, France, Germany, and the United Kingdom [England]), two Benelux countries (Belgium and the Netherlands), and one Scandinavian country (Norway) with long‐established frameworks for drug price negotiation. We also analyzed the Veterans Affairs Health System in the United States. For each system, we gathered relevant legislation, government publications, and guidelines to understand negotiation frameworks, and we reached out to key drug price negotiators in each system to conduct semistructured interviews. All interviews were recorded, transcribed, and coded, and data were analyzed based on an internal assessment tool that we developed.FindingsAll eight systems negotiate the prices of brand‐name prescription drugs soon after approval and rely on formal clinical assessments that compare newly approved drugs with existing therapies. Systems in our study differed on characteristics such as whether the body performing clinical assessments is separate from the negotiating authority, how added health benefit is assessed, whether explicit willingness‐to‐pay thresholds are employed, and how specific approaches for priority disease areas are taken.ConclusionsHigh‐income countries around the world adopt different approaches to conducting price negotiations on brand‐name drugs but coalesce around a set of practices that will largely be absent from the current Medicare negotiation framework. US policymakers might consider adding some of these characteristics in the future to improve negotiation outcomes.
{"title":"A Comparative Analysis of International Drug Price Negotiation Frameworks: An Interview Study of Key Stakeholders","authors":"ISELIN DAHLEN SYVERSEN, KEVIN SCHULMAN, AARON S. KESSELHEIM, WILLIAM B. FELDMAN","doi":"10.1111/1468-0009.12714","DOIUrl":"https://doi.org/10.1111/1468-0009.12714","url":null,"abstract":"<jats:label/><jats:boxed-text content-type=\"box\" position=\"anchor\"><jats:caption>Policy Points</jats:caption><jats:list list-type=\"bullet\"> <jats:list-item>Health care systems around the world rely on a range of methods to ensure the affordability of prescription drugs, including negotiating prices soon after drug approval and relying on formal clinical assessments that compare newly approved therapies with existing alternatives.</jats:list-item> <jats:list-item>The negotiation framework established under the Inflation Reduction Act is far more limited than other frameworks explored in this study. Adding elements from these frameworks could lead to more effective price negotiation in the United States.</jats:list-item> </jats:list></jats:boxed-text>ContextIn 2022, Congress passed the Inflation Reduction Act, which allowed Medicare, for the first time, to begin negotiating the prices for certain high‐cost brand‐name prescription drugs. Many other industrialized countries negotiate drug prices, and we sought to compare and contrast key features of the negotiation process across several health systems. We focused, in particular, on the criteria for selecting drugs for price negotiation, procedures for negotiation, factors that influence negotiated prices, and how prices are implemented.MethodsWe included four G7 countries in our analysis (Canada, France, Germany, and the United Kingdom [England]), two Benelux countries (Belgium and the Netherlands), and one Scandinavian country (Norway) with long‐established frameworks for drug price negotiation. We also analyzed the Veterans Affairs Health System in the United States. For each system, we gathered relevant legislation, government publications, and guidelines to understand negotiation frameworks, and we reached out to key drug price negotiators in each system to conduct semistructured interviews. All interviews were recorded, transcribed, and coded, and data were analyzed based on an internal assessment tool that we developed.FindingsAll eight systems negotiate the prices of brand‐name prescription drugs soon after approval and rely on formal clinical assessments that compare newly approved drugs with existing therapies. Systems in our study differed on characteristics such as whether the body performing clinical assessments is separate from the negotiating authority, how added health benefit is assessed, whether explicit willingness‐to‐pay thresholds are employed, and how specific approaches for priority disease areas are taken.ConclusionsHigh‐income countries around the world adopt different approaches to conducting price negotiations on brand‐name drugs but coalesce around a set of practices that will largely be absent from the current Medicare negotiation framework. US policymakers might consider adding some of these characteristics in the future to improve negotiation outcomes.","PeriodicalId":501846,"journal":{"name":"The Milbank Quarterly","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142248850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"In the September 2024 Issue of the Quarterly","authors":"ALAN B. COHEN","doi":"10.1111/1468-0009.12716","DOIUrl":"https://doi.org/10.1111/1468-0009.12716","url":null,"abstract":"","PeriodicalId":501846,"journal":{"name":"The Milbank Quarterly","volume":"55 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142248852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The Orphan Drug Act (ODA) was the result of patient advocacy and by many measures has been strikingly successful. However, approximately 95% of the more than 7,000 known rare diseases still have no US Food and Drug Administration–approved treatment.
The ODA's success led to sustained criticism of high drug prices, often for products that have orphan drug indications. Critics misconstrue the ODA's intent and propose reducing its incentives instead of pursuing policies focused on addressing broader prescription drug price challenges that exist in both the orphan and nonorphan drug market.
Patients and their families will continue to defend the purpose and integrity of the ODA and to drive investments into rare disease research and clinical development.
政策要点《孤儿药法案》（ODA）是患者倡导的结果，从许多方面来看都取得了巨大成功。然而，在已知的 7,000 多种罕见病中，仍有约 95% 的罕见病没有得到美国食品药品管理局批准的治疗方法。ODA 的成功导致了对高药价的持续批评，而高药价往往是针对孤儿药适应症产品的。批评者曲解了 ODA 的初衷，并建议减少其激励措施，而不是推行侧重于解决孤儿药和非孤儿药市场中存在的更广泛的处方药价格挑战的政策。患者及其家属将继续捍卫 ODA 的宗旨和完整性，并推动对罕见病研究和临床开发的投资。
{"title":"The Orphan Drug Act at 40: Legislative Triumph and the Challenges of Success","authors":"PETER SALTONSTALL, HEIDI ROSS, PAUL T. KIM","doi":"10.1111/1468-0009.12680","DOIUrl":"https://doi.org/10.1111/1468-0009.12680","url":null,"abstract":"<div>\u0000<div>\u0000<h3>Policy Points</h3>\u0000<p>\u0000</p><ul>\u0000<li>The Orphan Drug Act (ODA) was the result of patient advocacy and by many measures has been strikingly successful. However, approximately 95% of the more than 7,000 known rare diseases still have no US Food and Drug Administration–approved treatment.</li>\u0000<li>The ODA's success led to sustained criticism of high drug prices, often for products that have orphan drug indications. Critics misconstrue the ODA's intent and propose reducing its incentives instead of pursuing policies focused on addressing broader prescription drug price challenges that exist in both the orphan and nonorphan drug market.</li>\u0000<li>Patients and their families will continue to defend the purpose and integrity of the ODA and to drive investments into rare disease research and clinical development.</li>\u0000</ul><p></p></div>\u0000</div>","PeriodicalId":501846,"journal":{"name":"The Milbank Quarterly","volume":"34 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138693355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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