Public insurance programs and private insurance plans must develop criteria for deciding which drugs to cover, for which patients, and under which conditions. For this they need to assess the incremental clinical and social contribution of new products and compare them to the products already on the market. These assessments then must be weighed against the incremental spending likely to be incurred. Implicitly, if not explicitly, insurers must conduct a health technology assessment (HTA). In the multi-payer US system, each public program, private insurer, and self-insured employer conducts its own assessments. Most are done without explicit attention to the quality of the evidence and without providing the documentation that would be needed for stakeholders to understand what has been decided and on which grounds. None are coordinated with the others, generating a duplication of effort and an increase in administrative burden for physicians and patients. European nations have developed a much more formal approach to HTA, with governmentally managed or mandated bodies that evaluate new drugs and issue recommendations for insurance coverage and pricing. While the national assessments typically devote more explicit attention to the quality of the evidence than do their US counterparts, they too suffer from lack of coordination, duplication of effort, opacity for physicians, and uneven access to care for patients. In recognition of the problems caused by the diversity of technology assessments, the European Union has been engaged in a 20-year process of harmonization, with the hope of moving towards a single process and outcome for each innovative therapy. This effort has run into fiercely held opinions on methods and a jealous regard for local prerogatives. The voluntary harmonization initiative, dubbed EUnetHTA, produced a framework (i.e., HTA Core Model) and some joint assessments for individual drugs, but never achieved standardization. This year the European Union put the voluntary effort out of its misery and mandated a new approach.
Harmonization of health technology assessment across the European Union: lessons for the United States
Tarricone, Rosanna;Robinson, James
2021
Abstract
Public insurance programs and private insurance plans must develop criteria for deciding which drugs to cover, for which patients, and under which conditions. For this they need to assess the incremental clinical and social contribution of new products and compare them to the products already on the market. These assessments then must be weighed against the incremental spending likely to be incurred. Implicitly, if not explicitly, insurers must conduct a health technology assessment (HTA). In the multi-payer US system, each public program, private insurer, and self-insured employer conducts its own assessments. Most are done without explicit attention to the quality of the evidence and without providing the documentation that would be needed for stakeholders to understand what has been decided and on which grounds. None are coordinated with the others, generating a duplication of effort and an increase in administrative burden for physicians and patients. European nations have developed a much more formal approach to HTA, with governmentally managed or mandated bodies that evaluate new drugs and issue recommendations for insurance coverage and pricing. While the national assessments typically devote more explicit attention to the quality of the evidence than do their US counterparts, they too suffer from lack of coordination, duplication of effort, opacity for physicians, and uneven access to care for patients. In recognition of the problems caused by the diversity of technology assessments, the European Union has been engaged in a 20-year process of harmonization, with the hope of moving towards a single process and outcome for each innovative therapy. This effort has run into fiercely held opinions on methods and a jealous regard for local prerogatives. The voluntary harmonization initiative, dubbed EUnetHTA, produced a framework (i.e., HTA Core Model) and some joint assessments for individual drugs, but never achieved standardization. This year the European Union put the voluntary effort out of its misery and mandated a new approach.
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