Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensure that patient access to medicines of therapeutic value is not delayed. As part of an ongoing study to monitor regulatory and HTA performance, CIRS has been collecting data on new active substances (NASs) appraised between 2014 and 2017 by eight health technology assessment (HTA) agencies, analysing synchronisation between the regulatory decision and first HTA recommendation in timing and outcome.

Recommendations were collected from the Australian Pharmaceutical Benefits Advisory Committee (PBAC), Canadian Agency for Drugs and Technologies in Health (CADTH; both Common Drug Review [CDR] and pan-Canadian Oncology Drug Review [pCODR]), English National Institute for Health and Care Excellence (NICE), French Haute Autoritéde Santé (HAS), German InstitutfürQualitätund WirtschaftlichkeitimGesundheitswesen(IQWiG), Polish Agencja Oceny Technologii Medycznych iTaryfikacji (AOTMiT), Scottish Medicines Consortium (SMC) and Swedish Tandvårds-& läkemedelsförmånsverket(TLV), for NASs approved 2012-2017 by the respective jurisdictional regulatory agencies, the Australian Therapeutic Goods Administration (TGA), Health Canada and European Medicines Association (EMA).

The idea of conducting HTA assessments concurrent with regulatory reviews or used as a means of priority setting, therefore, has been actively discussed.

To gain a more detailed understanding of the evolution of the relationship between regulatory and HTA decision-making processes, CIRS undertook a research project to investigate “How might the sequence of regulatory and HTA decision making influence patient access to new medicines?” This study focused on the effect of sequence on medicines and not other treatment technologies.

Two-part study design:

  • A literature review of the published literature and grey literature was conducted to understand regulatory and HTA decision-making sequences, to inform hypothetical effects of potential changes, and to examine the implications and consequences for healthcare stakeholders.
  • A survey was also undertaken across patient representatives and agencies (regulatory and HTA) to explore perceptions and understandings regarding the current and potential evolution of review sequences and relationships between regulatory, HTA and payer assessments on access.