荷兰先进疗法药物的退款途径和过去的做法
Jurriaan Gort1, Christine C van Hattem2, Floris Logman3
1Department of Epidemiology & Health Economics, Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.
Regenerative medicine
|December 1, 2025
概括
在荷兰,对先进治疗药物 (ATMP) 的报销很复杂. 营销许可证ATMP面临延迟,而医院豁免ATMP有不同的退款途径.
科学领域:
- 药物经济学 药物经济学
- 卫生政策 卫生政策
- 监管科学 监管科学
背景情况:
- 先进治疗药物 (ATMP) 面临着独特的市场准入挑战,特别是对于学术界和中小企业开发商来说.
- 导航国家退款路线对于ATMP市场准入和患者可用性至关重要.
- 荷兰对药品报销有特定的流程,需要详细了解.
研究的目的:
- 确定和绘制荷兰ATMP的报销路线.
- 评估ATMPs成功获得退款的机制.
- 为开发商,特别是中小企业和学术机构提供有关荷兰ATMP退款的见解.
主要方法:
- 对法律和政策文件进行了范围审查.
- 确定了在2008年1月至2024年3月期间获得欧盟范围的营销许可 (MA) 或国家医院豁免 (HE) 的ATMP.
- 评估了这些已识别的ATMP的报销途径.
主要成果:
- 荷兰的退款流程包括权利和资金阶段.
- 大多数经营许可的ATMP (MA-ATMP) 最初被排除在退款之外 ("锁定"),需要进行健康技术评估和谈判.
- 所有获得资格的MA-ATMP都通过附加代码 ("附加") 获得资金,而不是研究的单一HE-ATMP,该代码没有附加代码而被退还.
结论:
- MA-ATMP通常遵循与非ATMP可比的标准退款路线,涉及最初的排除和随后的权利和附加资金谈判.
- 医院豁免ATMPs (HE-ATMPs) 绕过了"锁"机制,并有一个不同的报销途径.
- 荷兰ATMP补偿的路线图突出了MA-ATMP和HE-ATMP的分歧路径,影响了市场准入战略.
相关概念视频
01:18Additional Routes of Drug Administration
Choosing the appropriate route of drug administration is significantly influenced by two key factors: the therapeutic objectives and the inherent properties of the drug being used.
Administering drugs via inhalation allows for the direct delivery of gaseous, volatile substances or droplets to different parts of the respiratory tract. One of the advantages of the inhalation route is the rapid absorption of drugs into the circulatory system, which is possible because of the large surface area of...
Administering drugs via inhalation allows for the direct delivery of gaseous, volatile substances or droplets to different parts of the respiratory tract. One of the advantages of the inhalation route is the rapid absorption of drugs into the circulatory system, which is possible because of the large surface area of...
01:18Routes of Drug Administration: Enteral
Medications can be administered through the enteral route using liquids, capsules, or tablets.
Enteral administration involves drug administration via the mouth in two ways: orally or sublingually.
Unlike sublingually drugs, drugs that are taken orally pass through the gastrointestinal (GI) tract and get metabolized by the liver. Once metabolized, the drug is absorbed into the systemic circulation, reaching different body parts via the bloodstream. However, while passing through the stomach,...
Enteral administration involves drug administration via the mouth in two ways: orally or sublingually.
Unlike sublingually drugs, drugs that are taken orally pass through the gastrointestinal (GI) tract and get metabolized by the liver. Once metabolized, the drug is absorbed into the systemic circulation, reaching different body parts via the bloodstream. However, while passing through the stomach,...
01:25Routes of Drug Administration: Parenteral
The administration of drugs via parenteral routes allows for direct drug introduction into the systemic circulation, resulting in high bioavailability because the medication bypasses the harsh conditions of the gastrointestinal tract and hepatic metabolism.
The intravenous route (IV) of drug administration can be further categorized into two types. The bolus injection administers the entire dose rapidly, while an intravenous infusion slowly delivers smaller doses steadily.
The IV route is often...
The intravenous route (IV) of drug administration can be further categorized into two types. The bolus injection administers the entire dose rapidly, while an intravenous infusion slowly delivers smaller doses steadily.
The IV route is often...
01:22Routes of Drug Administration: Overview
Drug administration involves delivering drugs to the body through various routes, such as enteral, parenteral, and topical.
Enteral administration refers to drugs absorbed through the gastrointestinal tract. They can be swallowed (perorally), placed under the tongue (sublingually), or on the inner lining of the cheeks (buccally). Perorally administered drugs take time to be absorbed and have a slower onset of action. The rectal route is another form of enteral administration, which allows for...
Enteral administration refers to drugs absorbed through the gastrointestinal tract. They can be swallowed (perorally), placed under the tongue (sublingually), or on the inner lining of the cheeks (buccally). Perorally administered drugs take time to be absorbed and have a slower onset of action. The rectal route is another form of enteral administration, which allows for...
01:22Drug Delivery: Miscellaneous Routes
Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection, and rectal administration provide localized effects with reduced toxicity.
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs through the...
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs through the...
01:15Non-Oral Extravascular Drug Absorption Routes
Non-oral extravascular routes, which encompass sublingual, buccal, topical, intramuscular, and inhalation methods, primarily utilize passive diffusion to transport drugs into the systemic circulation. The absorption rates and effectiveness of these routes depend on the drug's physicochemical properties, as well as the patient's anatomical and pathophysiological state.
Lipophilic drugs that are stable at salivary pH (6) and exhibit minimal binding to the oral mucosa are absorbed more effectively...
Lipophilic drugs that are stable at salivary pH (6) and exhibit minimal binding to the oral mucosa are absorbed more effectively...