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Analyzes an executive-order–driven proposal to “end the distortion,” and evaluates implications for patient affordability, access, and dermatology treatment reliance. Models potential Medicare spending increases if the small-molecule window extends to 13 years, discusses risks to savings, disparities, and adherence, and concludes that legislative changes are required.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/access-deferred-is-access-denied-small-molecule-drug-pricing-and-the-future-of-dermatology/468144/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/access-deferred-is-access-denied-small-molecule-drug-pricing-and-the-future-of-dermatology/468144.png","ImageObject",300,407,{"name":92,"@type":93},"Oliver","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-07","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":81},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What does the Inflation Reduction Act allow Medicare to do regarding drug prices?","Question",{"text":112,"@type":113},"For certain high-cost medications, Medicare can negotiate drug prices with manufacturers, aiming to lower out-of-pocket costs and reduce government spending after defined exclusivity periods following FDA approval.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Why are small-molecule therapies criticized under the current IRA framework?",{"text":117,"@type":113},"Small molecules become eligible for negotiation after 9 years, while biologics are eligible after 13 years. Critics argue the longer biologic protection discourages investment in small molecules that are often cheaper and serve broader populations.",{"name":119,"@type":110,"acceptedAnswer":120},"How might extending the small-molecule negotiation window affect Medicare spending and dermatology patients?",{"text":121,"@type":113},"Extending eligibility from 9 to 13 years could increase Medicare spending and delay access to more affordable alternatives. In dermatology, that may worsen affordability and access for patients relying on small-molecule therapies, affecting adherence and contributing to disparities.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},468144,1793155066,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":81,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":14,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":24,"preview_page_count":4},8796095461610,"https://ap-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","International Journal of Dermatology  \nAccess Deferred Is Access Denied: Small Molecule Drug Pricing and the Future of Dermatology  \nNikhita J. Perry1  | John S. Barbieri2,3 | Lee A. Fleisher1,4  \n1Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA | 2Harvard Medical School, Boston, Massachusetts,  \nUSA | 3Department of Dermatology, Brigham and Women's Hospital, Boston, Massachusetts, USA | 4Rubrum Advising, Philadelphia, Pennsylvania, USA  \nCorrespondence: Nikhita J. Perry ([perryn@pennmedicine.upenn.edu](perryn@pennmedicine.upenn.edu)) Received: 22 July 2025 | Revised: 30 July 2025 | Accepted: 4 August 2025  \nFunding: The authors received no specific funding for this work.  \nKeywords: drug pricing | inflation reduction act | small molecule therapies  \nOn April 15, President Trump signed an Executive Order (E.O.) directing the United States Department of Health and Human Services (HHS) to propose legislative changes to the Inflation Reduction Act (IRA), including addressing what some have called the “pill penalty.” Passed in 2022, theIRA allows Medicare, the US federal health insurance program for adults aged 65 and older, to negotiate drug prices with pharmaceutical manufacturers for certain high-cost medications with the goal of lowering out-of-pocket costs and reducing government spending. This authority is notable because, unlike many other high-income countries, the US government historically has not regulated or directly negotiated drug prices, leaving prices largely set by the private market. These negotiations occur only after an exclusivity period following Food and Drug Administration (FDA) approval: currently, small molecule drugs become eligible after 9 years, while biologics are eligible after thirteen [1] . Critics argue that this longer protection for biologics, which are more expensive and target rare diseases, disincentivizes investment in small molecule drugs that are typically cheaper and serve broader populations.  \nThe E.O. directs HHS Secretary Robert F. Kennedy Jr. to work with Congress to “end the distortion.” [2] E.O.s are instructions to the executive branch to implement policies, but do not have the force of law. Addressing this issue would ultimately require legislative action, as modifying the current incentive structure for pharmaceutical investment falls within Congress's authority. Although no legislation has yet enacted these changes,  \nthe E.O. signals a major policy shift with potentially serious consequences.  \nIf small molecule drugs were granted the same 13-year exemption as biologics, more than half of the drugs selected for Medicare negotiation—representing $61 billion USD in Part D spending—would have been excluded. These include Eliquis, Jardiance, Farxiga, Entresto, and Ozempic/Rybelsus/Wegovy [3] . In dermatology, many patients rely on small molecule therapies for chronic inflammatory diseases. This includes not only systemic oral medications but also topical small molecules, which play a critical role in dermatologic care. Extending the timeline under the guise of supporting innovation may instead limit affordability and access for patients while increasing government spending.  \nFor example, extending the small molecule negotiation window from 9 to 13 years could cost Medicare an estimated $350 million to $2.1 billion USD in lost savings across just the three most expensive drugs in dermatology (Table 1) .  \nWhile many of these small molecule drugs are not yet scheduled for negotiation, the policy shift could affect future candidates by allowing high-cost therapies to stay at full price longer, delaying access to more affordable alternatives and exacerbating the financial burden on older adults. The resulting out-of-pocket costs from prolonged ineligibility for negotiation could exacerbate health disparities and undermine treatment adherence.  \nThis is an open access article under the terms of the Creative Commons Attribution License, which pe","cbCaiag7npyUx1gv","https://ap.wps.com/l/cbCaiag7npyUx1gv","pdf",112034,"English","# Background and IRA negotiation timing\n## Exclusivity periods for small molecules vs biologics\n# Policy shift and legislative pathway\n## Executive order scope and need for congressional action\n# Expected impact on drug access and affordability\n## Patient out-of-pocket costs and treatment adherence\n## Dermatology focus and topical/systemic therapies\n# Medicare spending projections\n## Cost estimates for three high-spend drugs\n# Considerations and stakeholder arguments\n## Supporters vs critics on innovation incentives","[{\"question\":\"What does the Inflation Reduction Act allow Medicare to do regarding drug prices?\",\"answer\":\"For certain high-cost medications, Medicare can negotiate drug prices with manufacturers, aiming to lower out-of-pocket costs and reduce government spending after defined exclusivity periods following FDA approval.\"},{\"question\":\"Why are small-molecule therapies criticized under the current IRA framework?\",\"answer\":\"Small molecules become eligible for negotiation after 9 years, while biologics are eligible after 13 years. Critics argue the longer biologic protection discourages investment in small molecules that are often cheaper and serve broader populations.\"},{\"question\":\"How might extending the small-molecule negotiation window affect Medicare spending and dermatology patients?\",\"answer\":\"Extending eligibility from 9 to 13 years could increase Medicare spending and delay access to more affordable alternatives. In dermatology, that may worsen affordability and access for patients relying on small-molecule therapies, affecting adherence and contributing to disparities.\"}]","Access Deferred Is Access Denied - Small Molecule Drug Pricing and the Future of Dermatology | PDF",1790773809]