{"id":6955,"date":"2025-07-22T17:47:04","date_gmt":"2025-07-22T15:47:04","guid":{"rendered":"https:\/\/value-dossier.com\/news\/"},"modified":"2025-09-21T18:14:09","modified_gmt":"2025-09-21T16:14:09","slug":"news","status":"publish","type":"page","link":"https:\/\/value-dossier.com\/en\/news\/","title":{"rendered":"News"},"content":{"rendered":"\n
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NEWS<\/div>\n

Recent Posts<\/h1>\n <\/div>\n <\/div>\n\n <\/div>\n
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Pediatric drug shortages<\/a><\/h3>\n

Pediatric drug shortages: has the situation really improved? In recent years, Germany has faced shortages of essential medicines for children, including antipyretics and antibiotics. To encourage manufacturers to increase production and supply, the GKV-SV (GKV-Spitzenverband, German SHI association)\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Start of EU-HTA: First Joint Assessments with IQWiG Involvement<\/a><\/h3>\n

Since the beginning of 2025, member states of the European Economic Area (EEA) have been working together on joint clinical assessments (JCA) of new medicines. Recently, the first 9 JCAs were announced, assessing 2 ATMPs with Orphan drug status and 7 oncologics. Germany, France, and Ireland are curr\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Pharmaceutical companies with R&D in Germany \u2013 Benefit for price negotiations<\/a><\/h3>\n

Products with initial market entry after January 1st, 2025 are now benefiting from less strict pricing guidelines if the studies used for AMNOG benefit assessment included \u2265 5 % German patients. The benefit will last for 3 years and can be maintained even afterwards for companies with active R&D\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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European Reference Pricing is discontinued in Germany<\/a><\/h3>\n

Changes to the German pricing system for innovative drugs are now in effect due to the Medical Research Act (Medizinforschungsgesetz, MFG). As of January 1st, 2025, European reference prices will no longer be included in the price negotiations according to \u00a7 130b SGB V following AMNOG benefit assess\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Confidential reimbursement amount \u2013 Only for pharmaceutical companies with R&D in Germany<\/a><\/h3>\n

Confidential reimbursement amounts are finally available in Germany. However, the medicinal product and the pharmaceutical company must meet several requirements. Above all, the confidential reimbursement amount will only be available for new medicinal products with initial market entry in Germany a\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Our new AMNOG Negotiation Guide is online now!<\/a><\/h3>\n

With the SHI Financial Stabilisation Act (GKV-FinStG), the framework conditions for price negotiations for medicinal products in Germany have been made more complex and have been systematically tightened by the legislator to the disadvantage of the pharmaceutical industry. On the one hand the extend\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Non-randomised studies and non-adjusted indirect comparisons<\/a><\/h3>\n

Overview of our services in the field of non-randomised studies and indirect comparisons Strategic consulting Systematic research Study design consulting Statistical consulting Non-randomised studies and non-adjusted indirect comparisons in benefit assessments Benefit assessments, at EU level as wel\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Introduction of confidential reimbursement prices sets the wrong incentives!<\/a><\/h3>\n

We are pleased to inform you that our analysis of confidential reimbursement prices in Germany has been published in the journal \u201cMarket Access & Health Policy\u201d: Schnorpfeil W, Kiehlmeier S. Einf\u00fchrung vertraulicher Erstattungsbetr\u00e4ge setzt falsche Anreize. Market Access & Health Policy. 202\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Transition to EU HTA \u2013 Consequences of an existence of national and EU HTA in parallel<\/a><\/h3>\n

Regulation (EU) 2021\/2282 Article 7 (1) of Regulation\u00a0(EU) 2021\/2282\u00a0specifies when a health technology must undergo a Joint Clinical Assessment (JCA). Paragraph 1a stipulates that the time of initial market authorization application (MAA) is decisive. A JCA of the new health technology only needs t\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Price negotiations with the SHI under consideration of the legal changes<\/a><\/h3>\n

SAVE THE DATE: 16.01.2024 From 10:00 am to 11:30 am Speakers: Dr. Willi Schnorpfeil, Dr. Angela Lammert We are offering a webinar on the topic of \u201cPrice negotiations with the SHI under consideration of the legal changes\u201d. The webinar is aimed at managing directors and employees of pharmaceutical com\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Our HospitalAnalyzer is now available!<\/a><\/h3>\n

Based on the quality assurance data of the G-BA, we provide analyses on German hospitals for your market planning. For example: What are the top hospitals for AML in remission (C92.01 according to ICD-10)? Top 5 Hospitals: University Medical Center of Johannes Gutenberg University Mainz University H\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Further specifications on the GKV-FinStG law<\/a><\/h3>\n

In their 2nd and 3rd reading, the German Parliament has decided further specifications of the new law on the financial stabilisation of the statutory health insurances (GKV-FinStG). As already outlined in the draft of the law, the outcome of the AMNOG benefit assessment will further gain importance \u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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Pharmabarometer Update<\/a><\/h3>\n

Have a look at our latest update of German price negotiations for drugs that went through the AMNOG benefit assessment. The mean price decrease after negotiations was 28 % for all analysed products, 23 % for orphan drugs and 30 % for non-orphan drugs. If you have any further questions or suggestions\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n

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EUnetHTA 21 – Open call for Joint Scientific Consultations<\/a><\/h3>\n

This month, the European Council adopted the regulation on the EU-wide assessment of health technologies (EU-HTA). At the same time, the first call for applications is now open for scientific advice within the framework of EUnetHTA. In the open call of the EUnetHTA 21 JSC Secretariat, pharmaceutical\u2026<\/p>\n <\/div>\n Read post<\/a>\n <\/article>\n\n \n <\/div>\n \n \n <\/div>\n<\/section>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6955","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/pages\/6955","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/comments?post=6955"}],"version-history":[{"count":1,"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/pages\/6955\/revisions"}],"predecessor-version":[{"id":6956,"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/pages\/6955\/revisions\/6956"}],"wp:attachment":[{"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/media?parent=6955"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}