METHODS: The guidance document was developed over two face-to-face workshops, in addition to an online survey, a face-to-face interview and pragmatic search of literature. The specific focus was on what, where and how to collect RWD/ RWE.
RESULTS: All 11 REALISE member jurisdictions participated in the online survey and the first in-person workshop, 10 participated in the second in-person workshop, and 8 participated in the in-depth face-to-face interviews. The guidance document was iteratively reviewed by all working group members and the International Advisory Panel. There was substantial variation in: (a) sources and types of RWD being used in HTA, and (b) the relative importance and prioritization of RWE being used for policy-making. A list of national-level databases and other sources of RWD available in each country was compiled. A list of useful guidance on data collection, quality assurance and study design were also compiled.
CONCLUSION: The REALISE guidance document serves to align the collection of better quality RWD and generation of reliable RWE to ultimately inform HTA in Asia.
METHODS: A quasi-experimental economic evaluation comparing CPE impact on 6-month CKD mortality was conducted on the basis of payer perspective. The experimental group (n = 63) received care by health care providers who were given CPE on drug-related problems and dose adjustment. The control group (n = 80) was based on the historical cohort of patients who received care before the CPE. Measure of clinical outcome applied in this study was number of lives saved/100 patients treated. Cost-effectiveness ratios for CKD stages 4 and 5 patients without CPE and with CPE and incremental cost-effectiveness ratios (ICERs) for CKD stages 4 and 5 patients were analyzed.
RESULTS: Lives saved (%) in the treatment of CKD without CPE: CKD stage 4, 78.57; CKD stage 5, 57.58. Lives saved (%) in the treatment of CKD with CPE: CKD stage 4, 88.89; CKD stage 5, 65.45. Cost-effectiveness ratios for stage 4 with and without CPEs were Rp3,348,733.27 and Rp3,519,931.009, respectively. Cost-effectiveness ratios for stage 5 with and without CPEs were Rp7,137,874.93 and Rp7,871,822.27, respectively. ICERs were Rp2,045,341.22 for CKD stage 4 and Rp1,767,585.60 for CKD stage 5.
CONCLUSIONS: Treatment of CKD stages 4 and 5 with CPE was more effective and cost-effective compared with treatment of CKD stages 4 and 5 without CPE. The ICERs indicated that extra costs were required to increase life saved in both stages.