Table 2.
Overview of early tripartite dialogues and parallel submission interactions.
| Region/country | Stakeholders | Name of program |
|---|---|---|
| Australia | TGA (regulator) PBS (HTA user/payer) | Scientific advice on development (pilot) (54) |
| Australia | TGA (regulator) PBAC (HTA user/payer) | Parallel submission/review (55) |
| Canada | Health Canada (regulator) CADTH (HTA user/payer) | Parallel submission/review (56) |
| England and Wales | MHRA (regulator) NICE (HTA user/payer) | NICE Scientific Advice Programme (57) |
| Sweden | MPA (regulator) TLV (HTA user/payer) | Scientific advice on development (58) |
| The Netherlands | MEB (regulator) ZIN (HTA user/payer) | Parallel submission/review (Pilot) (59) |
| Europe | EMA (regulator) EUnetHTA (multinational HTA network) | Parallel consultation (23) |
| Europe | Multiple stakeholders, including EMA, MHRA, MPA, BfArM, AFSSAPS, AIFA (regulators) NICE, TLV, G-BA, CEPS, AIFA (HTA user/payer) EUNetHTA (as observer) FDA (as liaison) | Tapesty Network (Scientific advice on development) (60) |
| US | FDA (regulator) CMS (HTA user/payer) | Parallel submission/review (61, 62) |
| Global | Multiple stakeholders | Green park collaborative (scientific advice on development) (40) |
TGA, Therapeutic Goods Administration; PBS, Pharmaceutical Benefits Scheme; PBAC, Pharmaceutical Benefits Advisory Committee; CADTH, Canadian Agency for Drugs and Technologies in Health; MHRA, Medicines and Healthcare products Regulatory Agency; NICE, The National Institute for Health and Care Excellence; MPA, Medical Products Agency; TLV, The Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket); MEB, Medicines Evaluation Board; ZIN, The National Health Care Institute (Zorginstituut Nederland); EMA, European Medicines Agency; FDA, Food and Drug Administration; AIFA, Italian Medicines Agency (L'Agenzia Italiana del Farmaco); BfArM, The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte); CMS, Centers for Medicare & Medicaid Services.