The Use of the SF-36v2® Health Survey (SF-36), SF-12v2®, and SF-6D® in Health Technology Assessments

OBJECTIVES: The SF-36v2®, SF-12v2®, and SF-6D® (SF-instruments) are commonly used generic health-related quality of life (HRQoL) and health-state patient reported outcomes (PRO) measures in clinical trials, but little is known about how they are being used in health technology assessment (HTA) evaluations. This study aims to describe the use of SF-instruments in HTA across four therapeutic areas (TAs).

METHODS: A systematic search of all global HTA records submitted to national and regional HTA bodies (e.g., NICE, HAS, CADTH, AEMPS, AETSA, AHRQ) between 2013-2024 for Infectious/Parasitic Disease (ID), Blood/Immune System (Blood), Skin, and Oncology was conducted using the HTA Accelerator^TM. Search criteria included keywords of any generic PRO (e.g., SF-36, SF-12, SF-6D, EQ-5D-5L, EQ-5D-3L, WHOQOL), “health technology assessment” type, and “completed” assessment status. Any records reporting use of one or more SF-instruments were manually reviewed to determine which score(s) were reported, statistical significance, and final recommendations from the HTA body.

RESULTS: 1,822 (23.1% of all) HTA applications for the four TAs reported used any kind of generic PRO findings. Of those, 246 (13.5%) included an SF-instrument, though inclusion varied by TA (e.g., 55.7% ID, 54.9% Blood, 51.2% Skin, 4.4% Oncology). The use of an SF-instrument alone also varied by TA (32.1% ID, 36.6% Blood, 0% Skin, 1.3% Oncology). 30.0% of SF-instrument scores assessed reached statistical significance in the target population. Across all TAs, over 65% of HTA reports where an SF-instrument was used resulted in a “Positive” or “Positive with Restrictions” recommendation.

CONCLUSIONS: Generic PROs such as the SF-36v2® can provide key information to stakeholders on the impact of treatment on HRQoL and can provide a utility score that can be used in HTA appraisals.