{"id":10377,"date":"2026-06-30T10:41:44","date_gmt":"2026-06-30T02:41:44","guid":{"rendered":"https:\/\/regask.com\/?p=10377"},"modified":"2026-06-30T10:41:44","modified_gmt":"2026-06-30T02:41:44","slug":"drug-pricing-market-access-june-2026","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/drug-pricing-market-access-june-2026\/","title":{"rendered":"2026\u5e74\u306e\u533b\u85ac\u54c1\u4fa1\u683c\u3068\u5e02\u5834\u30a2\u30af\u30bb\u30b9\uff1a\u30e1\u30c7\u30a3\u30b1\u30a2\u306e\u4ea4\u6e09\u2026"},"content":{"rendered":"<p id=\"ember1956\" class=\"ember-view reader-text-block__paragraph\"><span class=\"TextRun SCXW232482172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><strong><span class=\"NormalTextRun SCXW232482172 BCX0\">Drug pricing and market access moved to the\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW232482172 BCX0\">centre<\/span><span class=\"NormalTextRun SCXW232482172 BCX0\">\u00a0of pharma regulation in mid-2026, as the focus shifted from registration to money<\/span><span class=\"NormalTextRun SCXW232482172 BCX0\">,<\/span><\/strong><span class=\"NormalTextRun SCXW232482172 BCX0\"><strong>\u00a0pricing, financing, and health technology assessment.<\/strong> The US advanced its Medicare price-negotiation framework, Spain opened a consultation on drug pricing, and Portugal\u00a0<\/span><span class=\"NormalTextRun SCXW232482172 BCX0\">formalized<\/span><span class=\"NormalTextRun SCXW232482172 BCX0\">\u00a0a national HTA regime, all in the same month. This is the part of the lifecycle where a perfectly approvable product can still fail commercially, and the gap between approval and access is widening.<\/span><\/span><span class=\"EOP Selected SCXW232482172 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-167104700\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-167104700 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3><strong><span class=\"TextRun MacChromeBold SCXW167568299 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW167568299 BCX0\">The US expanded Medicare drug price negotiation<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-1514234591\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1514234591 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW16343997 BCX0\">The Centers for Medicare &amp; Medicaid Services published a proposed rule covering the Medicare Drug Price Negotiation Program and the Medicare Prescription Payment Plan. Price negotiation has reshaped US commercial planning since its introduction, and each expansion widens the set of\u00a0<\/span><span class=\"NormalTextRun SCXW16343997 BCX0\">products,<\/span><span class=\"NormalTextRun SCXW16343997 BCX0\">\u00a0\u305d\u3057\u3066\u00a0<\/span><span class=\"NormalTextRun SCXW16343997 BCX0\">mechanics&#8217;<\/span><span class=\"NormalTextRun SCXW16343997 BCX0\">\u00a0manufacturers must model. Pricing strategy, launch sequencing, and lifecycle planning now\u00a0<\/span><span class=\"NormalTextRun SCXW16343997 BCX0\">must<\/span><span class=\"NormalTextRun SCXW16343997 BCX0\">\u00a0account for negotiation exposure rather than treating it as a distant edge case. The companies that adapt earliest build negotiation scenarios into their forecasts; the rest find their assumptions overtaken.<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW86240589 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW86240589 BCX0\">Spain moved on pricing and financing reform<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-1549987907\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1549987907 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW22514267 BCX0\">Spain&#8217;s Ministry of Health opened a consultation on a draft Royal Decree updating how medicines are priced and financed. Pricing-reform consultations are an opportunity as much as a risk\u00a0<\/span><span class=\"NormalTextRun SCXW22514267 BCX0\">(<\/span><span class=\"NormalTextRun SCXW22514267 BCX0\">the window to engage before rules harden<\/span><span class=\"NormalTextRun SCXW22514267 BCX0\">)<\/span><span class=\"NormalTextRun SCXW22514267 BCX0\">, \u3001 \u3057\u304b\u3057<\/span><span class=\"NormalTextRun SCXW22514267 BCX0\">\u00a0they also signal that the reimbursement bar is being reset. Companies in or approaching the Spanish market should read the draft closely, model the financing implications, and use the consultation period to make their case. Engagement now is far cheaper than repricing after the fact.<\/span><\/p>\n<h3><strong><span class=\"NormalTextRun SCXW80489494 BCX0\">\u30dd\u30eb\u30c8\u30ac\u30eb\u00a0<\/span><span class=\"NormalTextRun SCXW80489494 BCX0\">established<\/span><span class=\"NormalTextRun SCXW80489494 BCX0\">\u00a0a national HTA framework<\/span><\/strong><\/h3>\n\t<div id=\"gap-870306872\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-870306872 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW253334816 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW253334816 BCX0\">Portugal published Decree-Law 118\/2026\u00a0<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">\u78ba\u7acb\u3059\u308b<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">\u00a0a national health technology assessment regime,\u00a0<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">formalizing<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">\u00a0how new medicines and technologies are evaluated for reimbursement. HTA is increasingly the real gate to access in Europe: approval grants a\u00a0<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">license<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">, but HTA decides whether the system pays. A\u00a0<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">formalized<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">\u00a0framework means earlier, more structured\u00a0<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">evidence of<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">demands;<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SCXW253334816 BCX0\">health-economic data and comparative effectiveness must be planned into development, not assembled at launch when the trial design and comparators are already fixed.<\/span><\/span><span class=\"EOP SCXW253334816 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"NormalTextRun SCXW227434142 BCX0\">\u4f55\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW227434142 BCX0\">this<\/span><span class=\"NormalTextRun SCXW227434142 BCX0\">\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW227434142 BCX0\">means<\/span><span class=\"NormalTextRun SCXW227434142 BCX0\">\u00a0\u306e\u305f\u3081\u306b\u00a0<\/span><span class=\"NormalTextRun SCXW227434142 BCX0\">\u88fd\u85ac<\/span><\/strong><\/h3>\n\t<div id=\"gap-1637456174\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1637456174 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW97054545 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW97054545 BCX0\">Across the US, Spain, and Portugal, the message is consistent: getting approved is no longer the hard part<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">,\u00a0<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">getting paid is. Bring\u00a0<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">\u5e02\u5834\u30a2\u30af\u30bb\u30b9<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">\u00a0thinking forward. Model price-negotiation exposure in the US, engage with pricing consultations like Spain&#8217;s while\u00a0<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">they&#8217;re<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">\u00a0open, and build HTA-grade evidence early for markets\u00a0<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">formalizing<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">\u00a0assessment. Access strategy now belongs in development planning alongside the clinical program<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">s<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">, not in the post-approval scramble where\u00a0<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">evidence of<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">\u00a0options\u00a0<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">has<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">\u00a0already narrowed.\u00a0<\/span><strong><a href=\"http:\/\/regask.com\/ja\/\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW97054545 BCX0\">RegASK<\/span><\/a><\/strong><span class=\"NormalTextRun SCXW97054545 BCX0\">\u00a0monitors pricing, reimbursement, and HTA developments across global markets, helping regulatory and market-access teams\u00a0<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">\u30d7\u30e9\u30f3<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">\u00a0access barriers before\u00a0<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">launching<\/span><span class=\"NormalTextRun SCXW97054545 BCX0\">.<\/span><\/span><span class=\"EOP SCXW97054545 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Drug pricing and market access moved to the\u00a0centre\u00a0of pharma regulation in mid-2026, as the focus shifted from registration to money,\u00a0pricing, financing, and health technology assessment. The US advanced its Medicare price-negotiation framework, Spain opened a consultation on drug pricing, and Portugal\u00a0formalized\u00a0a national HTA regime, all in the same month. This is the part of the lifecycle where a perfectly approvable product can still fail commercially, and the gap between approval and access is widening.\u00a0 The US expanded Medicare drug price negotiation The Centers for Medicare &amp; Medicaid Services published a proposed rule covering the Medicare Drug Price Negotiation Program and the Medicare Prescription Payment Plan. Price negotiation has reshaped US&#8230;<\/p>","protected":false},"author":46,"featured_media":10378,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10377","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Drug Pricing and Market Access Explained in 2026<\/title>\n<meta name=\"description\" content=\"Explore the challenges of drug pricing and market access in a changing regulatory landscape. 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