Growing patient involvement in Health Technology Assessment (HTA)

Health technology assessment (HTA) agencies such as National Institute for Health and Care Excellence (NICE – UK), Scottish Medicines Consortium (SMC – Scotland), Pharmaceutical Benefits Advisory Committee (PBAC – Australia) and Pan-Canadian Oncology Drug Review (pCODR – Canada) have been at the forefront of incorporating user input and feedback in drug reviews. Patient and caregiver perspective are crucial in understanding disease burden, defining what value means in the real world and helping the pharmaceutical industry holistically target the needs. For similar reasons, social listening—a tool that equips pharmaceutical companies with first-hand and unbiased social media exchanges between patients, physicians or caregivers—has been gaining traction in the industry.

While most of the South-East Asian markets such as Taiwan and the Philippines are strengthening their drug review process by steadily introducing HTAs, their more developed counterparts are refining drug assessments by offering a platform for discourse between various stakeholders. The focus is on taking a collaborative and problem-solving approach to expedited patient access and improving transparency in the drug recommendation process.

Germany’s HTA stakeholders, the G-BA (Gemeinsamer Bundesausschuss) and IQWIG (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen), already include patient input for assessment and decision making. Further, in December 2018, France’s HTA agency the Haute Autorité de Santé (HAS) announced its intention to create a Council for User Engagement for its drug recommendations. The Council would constitute members from patient advocacy groups as well as those with academic or professional expertise. It would be responsible for supporting and evaluating all actions of the HAS while also participating in ethical reflections as part of HAS assessments. Industry experts expect the adoption of this practice in other European Union member states. Additionally, the potential of a common HTA platform such as EUnetHTA in Europe would ensure increased patient engagement at a national and EU level.

There are a number of benefits to incorporating this type of data into drug review processes. Active involvement of patient groups and experts in discussion forums or meetings has the potential to have a substantial effect on drug review decision-making. Besides empowering patients, it endorses value-based experiences and helps to develop a greater understanding of disease-specific gray areas. Engagement at various stages of drug assessment promotes transparency and familiarizes patients or patient associations with the complexities of the review process.

Comprehensive drug assessments are certainly the need of the hour but what’s also important is integration of patient engagement with robust clinical or pharmacoeconomic evidence and derivation of maximum benefit for all parties concerned. Even with incorporation of patient involvement in HTAs, the industry is beginning to understand the challenges and complexities associated with optimum utilization of patient experiences. Studies have demonstrated that patient involvement, as of now, is a one-way street with rare exceptions. In most scenarios, feedback is collected passively from patient groups via questionnaires or templates and the impact on decision-making is not substantiated. Feedback on patient submissions from HTA agencies is also not a general practice but would be likely to strengthen future collaboration in this area. Gaps in communication and ambiguity in terms of purpose are only a few of the noteworthy concerns that have been highlighted when looking at this development. While patient engagement is gaining the favor of HTA agencies globally, its functional value has yet to be fully recognized.


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