For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess its value to the system, their informational needs differ. Two different but potentially aligned dossiers are therefore required: the regulatory dossier and the HTA submission dossier. The medical writer must be prepared to contribute to both. Herein we review the basic elements of the regulatory dossier, the Global Value Dossier and the HTA submission dossier. For the medical writer, an important challenge is how to determine whether there can be alignment and synergies between regulatory data and HTA data to support the respective decision-making processes. Practical approaches to the construction of the submission documents are provided here. These approaches bring consistency to the documents, serve as a checklist for relevant information, and facilitate the review by the assessor.
Liberti L & Wang T. The regulatory-HTA decision-making interface: What the medical writer should know. Medical Writing 2021; 30(3):50-55.
