ATMP in Sweden: New HTA and payment approaches identified by the TLV

The Swedish Government has requested that the Dental and Pharmaceutical Benefits Agency (TLV) develop new methods for health economic evaluation and payment methods for Advanced Therapy Medicinal Products (ATMP). The current system and payment methods present challenges, as ATMP often have limited evidence and high upfront one-time costs.
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The Joint Clinical Assessment (JCA) and its implication for the industry
The European (EU) Regulation on Health Technology Assessment (HTA) came into force in January 2022 and creates a permanent framework for cooperation between member states in JCA regarding certain new therapies. This article aims to provide an overview of the current understanding time frame of implementation and some implications for the JCA industry.
The long road to EU HTA: An update to the current status of implementation
The European Union’s new Regulation (EU) 2021/2282 on health technology assessment creates the legal and organizational framework for cooperation between member states in joint scientific consultations (JSCs) and joint clinical assessments (JCAs) of certain new therapies for the first time. The joint assessments will impact all centrally authorized medicines and some medical devices and serve as the basis for national value assessments and price negotiations. This regulation is now in force and will bring important and wide-reaching changes that pharmaceutical companies need to understand.
The P&R landscape of Orphan Drugs in Spain
The PHAROS network member Omakase Consulting shares their last report, in collaboration with the ObserveMHe platform, about the Pricing and Reimbursement situation in Spain of Orphan Drugs approved by the European Commission until 2021 (included).