Outline. What HTA Represents in the Reimbursement Review. Principle and HTA Guideline. A Study of HTA PE Dossiers in Taiwan.

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1 New Trends of Health Technology Assessment Development and Value Evidence Requirement for Access and Reimbursement In Asia --PE Analysis Practice in Taiwan ISPOR FORUM (F3): Monday, May 22, 2017, 6:15-7:15 pm Chee Jen Chang, PhD Graduate Institute of Clinical Medicine Clinical Informatics and Medical Statistical Research Center Research Services Center for Health Information Chang Gung University Taiwan Outline What HTA Represents in the Reimbursement Review Principle and HTA Guideline A Study of HTA PE Dossiers in Taiwan Conclusions 1

2 Where HTA Sits in the Reimbursement Review Process HTA Proposal of new item listing NHIA 1 Expert meeting Publish HTA report (Drug Benefit Committee) Publish meeting Drug Benefit agenda 1 and Committee HTA report (DBC) Return to NHIA for revision No consensus 2 PBRS meeting Publish meeting minutes Submit to MOHW for approval Present both proposals Reach consensus Reject and close the case PBRS: Pharmaceutical Benefit Reimbursement Scheme PVA: Price Volume Agreement Reject and Close the case Approved cases: PVA* & temporary payment conditions Submit to MOHW for yearly announcement New Drug Classification & Pricing Principles Reimbursement cases will be assessed and categorized into 2 groups. Class I Breakthrough Drug New mechanism, first in treatment or remarkable improvement from current treatment. Priced at A10 median price Extra 10% mark-up with local R&D and clinical trials reaching up to a certain scale* Class 2A New drugs with moderate improvement Class II Same therapeutic group Class 2B New drugs that have similar clinical values 1) The lowest A10 price; 2) The price in the country of manufacturing; 3) International prices ratio; 4) Ratio to treatment course dosage (comparing with reference products) 5) Combination drugs (FDC) may be priced at 70% of the sum of the NHI payment price for each single ingredient, or at the payment price of the single active ingredient. 1) Extra 10% mark-up with local R&D and clinical trials reaching up to a certain scale* 2) Up to 10% mark-up with local pharmaco-economics (PE) study *Criteria of P&R mark-up with local R&D and clinical trials modified from the TFDA regulation for NCEs CPP-waiving requirements (so called, 38-1; 38-2 regulation) 2

3 Pricing Results of New Drugs: 60% of A10 Median *A10 countries: US, Canada, Japan, Australia, UK, France, Germany, Sweden, Switzerland, Belgium **I: breakthrough drug, IIA: moderate improvement of benefit, IIB: similar clinical benefit Source: Adopted from presentation by senior reviewer, Janice Chen, June HTA Methodological Guidelines -CDE HTA March 2014 Recommendations on CEA execution Recommendations on CEA report Quality assessment on CEA: a checklist Research topic vs reimbursement application Appropriateness of study design Quality and (local) application of parameter collection Execution quality Overall assessment Costs (A) Effects (A) Costs (B) Effects (B) Therapy A Therapy B 3

4 A Study of HTA Dossiers in Taiwan Aim: To review the current reimbursement approval process for new drugs using published HTA appraisals reports Data collection: HTA appraisal reports from NHI website New drug reimbursement application with HTA dossier Time Period : 2011~2017 Feb Information extracted from HTA appraisal report Drug name Ingredient HTA appraisal completion date Approval date (PBRS meeting date) Local PE (If applicable) Price marked up (If applicable) HTA Appraisal Download 8 4

5 Case No. Annual New Drug Applications with HTA Reports ~ Average Time for P&R Process HTA report date Average calendar days 161 CDE HTA Case: 95 Expert/PBRS Meeting Reimbursed case: 82 5

6 Applications vs Local PE Studies 2011~2016 With Local PE Case: 28 (30%) All Applications Cases: 95 Without Local PE Case: 67 (70%) Reimburse Cases by Local PE 2011~2016 Reimbursement Approval Rates 86% All case (82/95) 81% Without Local PE (54/67) 100% With Local PE (28/28) Fisher exact test: P-value=

7 Mark-up Premium Rates Local Local PE Cases: PE 1828 Markup percentage case % 1% 1 (4.2%) No 13 (46.4%) Yes 15 (53.6%) 2% 3 (12.5%) 3% 2 (8.3%) 4% 6 (25%) 5% 2 (8.3%) 6% 1 (4.2%) Conclusions Applications with local PE reports showed statistically significantly higher reimbursement rate than those without (100% vs. 81%, p-value=0.041). New drugs applied for reimbursement with local PE slightly increased since In 2016, the submission of PE studies became 50% among the new drug cases and maintained 100% reimbursed rate. Not all cases with local PE reports received marked up in unit price. 7

8 Limitations Studies focused on reports only, not categorized by diseases and drug types. Not all new drugs applied for reimbursement cases were included, we only collected and analyzed cases published in NHI website. Only CDE/HTA summarized appraisal reports can be extracted, but information from industry local PE assessment report can not be derived. Quality of local HTA PE reports were appraised, and quality of CDE/HTA appraisals can not be evaluated. THANK YOU FOR YOUR ATTENTIONS! ext RSCHI website: RSCHI 8