18th HTAi Global Policy Forum Considering and Communicating Uncertainty in HTA 22, 24, and 26 February 2021 Virtual
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Ground rules/housekeeping • Chatham House Rule: - Participants are free to use the information received, but neither the identity nor the affiliation of the speaker(s), nor that of any other participant, may be publicly revealed - This includes social media! #2021APF - Presentations, Zoom recordings, etc. can be shared within member organizations
New HTA system in Japan HTAi Asia Policy Forum December 6, 2021 Takashi Fukuda Center for Outcomes Research and Economic Evaluation for Health(CORE2-Health; C2H) National Institute of Public Health Japan Center for Outcomes Research and Economic Evaluation for Health
Insurance Coverage and Pricing of Medicines 1 and medical devices in Japan Health insurance coverage decision and reimbursement prices are determined by the Ministry of Health, Labour and Welfare (MHLW). MHLW has to consult with Central Social Insurance Medical Council (CSIMC; Chu-I-Kyo in Japanese). Almost all prescription medicines are covered by health insurance scheme. There exist pricing rules for new medicines and medical devices. Coverage and pricing decision should be made within 60days (90 days maximum) after approval. Those prices are revised every two years based on the repricing rules. Center for Outcomes Research and Economic Evaluation for Health
2 History on the discussion of cost-effectiveness evaluations Around 2010- Discussions at the Central Social Insurance Medical Council May 2012 (Chuikyo) on the introduction of cost-effectiveness evaluations June 2015 Special Committee on Cost-Effectiveness Evaluation April 2016 established under Chuikyo In the “Basic Policies on Economic and Fiscal Management and Reform 2015”, it was decided that cost-effectiveness evaluation would be introduced on a trial basis at the 2016 Revision of Medical Service Fees. Trial introduction of cost-effectiveness evaluations June 2018 In the “Basic Policies on Economic and Fiscal Management and Reform 2018”, it was decided that the full-scale introduction of cost-effectiveness evaluations continues to be considered, and a conclusion should be reached within FY 2018. April 2019 Full scale introduction of cost-effectiveness evaluations Center for Outcomes Research and Economic Evaluation for Health
Summary of new Cost Effectiveness Evaluation System 3 ・Started in April, 2019 ・Medicines and Medical devices ・After the approval, products are reimbursed under health insurance scheme in accordance with current pricing rules. The price may be adjusted after cost effectiveness evaluation. ・Products with large expected annual sales or prominently high price are subject to evaluation. ・Products only for rare diseases or children are exemption from evaluation. ・The price will be adjusted when ICER exceeds JPY 5 million /QALY. (JPY 7.5 million/QALY for such products as anti-cancer drugs.) Center for Outcomes Research and Economic Evaluation for Health
Selection criteria for products targeted for cost-effectiveness evaluations 4 Classification Similar Cost Selection Criteria Efficacy Calculation Comparison Method Method (Similar Function Classification) (i) New H1 •Peak sales (estimate): JPY 10 billion or Listed Products with more Products: H2 Products with premium(*), •Peak sales (estimate): JPY 5 billion or after full- H3 premium(*) or disclosure more, under JPY 10 billion scale rate of under implementati 50% •Products determined by the CSIMC on General Assembly, such as products with a prominently high price (ii) Already listed •products with sales of JPY 100 billion or more Products: •Products determined by the CSIMC before full- H4 Products with premium(*) General Assembly, such as products with a prominently high price scale implementati on •Medicine of which price is calculated in comparison with target products Similar H5 Similar products in the H1-H4 •Medical device of which price is calculated products Classification in comparison with target products, and that are categorized in the same functional classification (*) Products for which either an innovativeness premium, utility premium, or improvement premium (medical devices) was calculated will be targeted Center for Outcomes Research and Economic Evaluation for Health
Pricing Rule of New Medicine 5 Similar Efficacy Comparison Method Innovative Premium 5 to 120% Useful Premium Price New medicine Similar medicine Center for Outcomes Research and Economic Evaluation for Health
6 Cost Calculation Method Premiums Premium= Total Cost Consumption tax × Premium Rate × Premium Factor Distribution Profit Industry Transparency >80% 50 - <50% Average Index 1.0 80% 0.2 Research & Development Premium 0.6 Factor Production cost Submitted by Transparency Index : Proportion of detailed manufacturer structure of total production cost reported to the drug pricing organization Center for Outcomes Research and Economic Evaluation for Health
7 Peak Sales Estimation Manufacturer has to declare its estimation of annual peak sales when to apply for reimbursement. Actual sales of each product are monitored by the government. When the actual sales exceeds the criterion for selection, even though the initial estimation by the manufacture was under the threshold, those products will be designated at that point. Center for Outcomes Research and Economic Evaluation for Health
Selected Products for Evaluation in FY2019-2020 # ID Brand name Generic name Category Designated day 1 C2H1901 Trelegy Fluticasone, Umeclidinium, Vilanterol H1 2019/05/15 2 C2H1902 Kymriah Tisagenlecleucel H3 2019/05/15 3 C2H1903 Ultomiris Ravulizumab H1 2019/08/28 4 C2H1904 Breztri Budesonide, Glycopyrronium, Formoterol H5 2019/08/28 5 C2H1905 Trintellix Vortioxetine H1 2019/11/13 6 C2H1906 Coralan Ivabradine H2 2019/11/13 7 C2H2001 Noxafil Posaconazole H1 2020/4/8 8 C2H2002 Cabometyx Cabozantinib H1 2020/5/13 9 C2H2003 Enhertu Trastuzumab Deruxtecan（Genetical H1 2020/5/13 Recombination） 10 C2H2004 Zolgensma Onasemnogene abeparvovec H3 2020/5/13 11 C2H2005 Entresto Sacubitril Valsartan H5 2020/8/19 12 C2H2006 Enerzair Indacaterol, Glycopyrronium, Mometasone H5 2020/8/19 13 C2H2007 Rybelsus Semaglutide (Genetical Recombination) H1 2020/11/11 14 C2H2008 Trelegy200 Fluticasone, Umeclidinium, Vilanterol H5 2021/2/10
Selected Products for Evaluation in FY2021 (as of October) # ID Brand name Generic name Category Designated day 15 C2H2101 Emgality Galcanezumab 16 C2H2102 Yescarta Axicabtagene ciloleucel H1 2021/4/14 17 C2H2103 Polivy Polatuzumab Vedotin H5 2021/4/14 18 C2H2104 Darzquro Daratumumab, Vorhyaluronidase Alfa H1 2021/5/12 19 C2H2105 Arikayce Amikacin sulfate H1 2021/5/12 20 C2H2106 Breyanzi Lisocabtagene maraleucel H1 2021/5/12 21 C2H2107 Verquvo Vericiguqat H5 2021/5/12 22 C2H2108 Ajovy Fremanezumab (Genetical Recombination) H5 2021/8/4 23 C2H2109 Aimovig Erenumab (Genetical Recombination) H5 2021/8/4 24 C2H2110 Revestive Teduglutide (Genetical Recombination) H5 2021/8/4 25 C2H2111 Veklury Remdesivir H2 2021/8/4 26 C2H2112 Micra AV Transcatheter pacing system H1 2021/8/4 H2 2021/10/13 Total: 26 H1: 12 H2: 3 H3: 2 H5: 9
Process for cost-effectiveness evaluations 9 months (manufacturer’s analysis)*1 Standard 3 to 6 months*1 3 to 6 months*1 3 months or 6 months timeline (determine analytical framework) (Academic analysis) 3 months (manufacturer’s analysis based on the determined analytical framework) Manufacturers (medicines, medical devices) Actual price adjustmentsPreliminary consultationManufacturerAcademic CSIMC <Approval of evaluation / New price determination>conducts analysisAnalysis Expert Committee (iii) <Appraisal>• Manufacturer submits proposal for based on the • Verification of Expert Committee (ii) <Confirms manufacturer analysis>analytical frameworkanalyticalmanufacturer framework analysis Expert Committee (i) <Determines analytical framework, etc.>• Consultation based(review) on the proposed Consultations, CSIMC <Target Selection>framework, if needed • Re-analysis Listing summarize main issues Consultations, if needed • Content of the consultation recorded Ministry of Health, Labor and Welfare, National Institute of Public Health (Center for Outcomes *1 The total time Research and Economic Evaluation for Health: C2H) from the “preliminary consultation” to Clinical specialists (2)⑥ Academic analysis group “completion of manufacturer submission” shall not exceed 9 months.
Flow of cost effectiveness evaluation and the role of C2H 11 Target selection at CSIMC Central Social Insurance Medical Council(CSIMC) Preliminary Consultation Role C2H Preliminary consultation with manufacturer Manufacturer’s submission Consultation with manufacturer upon request Review and Re-analysis Conduct review and re-analysis process with academic groups Final report of review and re-analysis Appraisal Expert committee under CSIMC Price adjustment Central Social Insurance Medical Council(CSIMC) Center for Outcomes Research and Economic Evaluation for Health
Role and members of Expert Committee on Cost-Effectiveness Evaluation 12 CSIMC General Assembly Special Committee on Cost- Expert Committee on Cost- Effectiveness Evaluation Effectiveness Evaluations Role •Approve rules of cost- •Discuss on rules of cost- •Discuss on contents of preliminary effectiveness evaluations effectiveness evaluations consultation and determine analytical framework •Approve target products, Public determine price •Discuss on manufacturer analysis adjustments •Appraisal Meeting Public Private Members •7 members from the •6 members from the payer •Health economist payer •6 members from the •Clinical specialist •Biostatistician/Epidemiologist •7 members from the healthcare provider •Bioethicist healthcare provider •4 members from the public •6 members from the interest public interest •4 expert members •2 academics •10 expert members Center for Outcomes Research and Economic Evaluation for Health
Guideline for Preparing Cost-Effectiveness Evaluation to the 13 Central Social Insurance Medical Council, Version 2.0 1. Objectives 2. Analysis perspective 3. Target population 4. Comparator(s) 5. Additional benefit 6. Methods of analysis 7. Time horizon 8. Choice of outcome measure 9. Sources of clinical data (except costs) 10. Calculation of healthcare costs 11. Public long-term care costs and productivity loss 12. Discounting 13. Modelling 14. Uncertainty (downloadable form C2H website) Center for Outcomes Research and Economic Evaluation for Health
Method of price adjustments according to ICER, setting reference values, 14 and price adjustments for products requiring special consideration JPY 5 million/QALY, JPY 7.5 million/QALY and JPY 10 million/QALY are used as reference values for price adjustments. The reference values for products requiring special consideration in the appraisal process, such as medicines for rare diseases, pediatric diseases, and cancer, shall be JPY 7.5 million/QALY, JPY 11.25 million/QALY, and JPY 15 million/QALY. <standard price adjustment methods> < price adjustment method for products requiring special consideration> Rate of price adjustments within premium Rate of price adjustments within premium 1.0 1.0 0.7 0.7 0.4 0.4 0.1 0.1 5 million 7.5 million 10 million ICER 7.5 million 11.25 million 15 million ICER Center for Outcomes Research and Economic Evaluation for Health
Rate of price adjustment 15 Figure 1: Rate of Price Figure 2: Rate of Price Adjustments for Premium Adjustments for Operating Profit Rate of price adjustments Rate of price adjustments 1.0 1.0 0.7 0.4 0.83 0.1 0.67 5 million 7.5 million 10 million 0.5 ICER 5 million 7.5 million 10 million ICER Center for Outcomes Research and Economic Evaluation for Health
Multiple Indications or Populations 16 The case of Drug X, indicated for Disease A and Disease B Percentage of Adjustment rate population Population A ICER= JPY 3 million → No adjustment 0.8 0% x 0.8 Population B ICER = JPY 6 million + → Price 0.2 30% x 0.2 adjustment 30% Reference value = 6% (entire adjustment rate) (JPY 5 million) Center for Outcomes Research and Economic Evaluation for Health
17 C2H1902 Kymriah (tisagenlecleucel) B-ALL: B-cell acute lymphoblastic leukemia DLBCL: Diffuse large B-cell lymphoma HSCT: Hematopoietic stem cell transplantation Center for Outcomes Research and Economic Evaluation for Health
18 C2H1902 Kymriah (tisagenlecleucel) Because ICER values were beyond reference values of price adjustment for some populations, price of the product was adjusted. Original price JPY 34,113,655 Adjusted price JPY 32,647,761 (4.3% reduction) Center for Outcomes Research and Economic Evaluation for Health
Price Adjustment based on Cost Effectiveness Evaluation # ID Brand Generic name Designated Price New price name date Adjustment starts 1 C2H1901 Trelegy Fluticasone, Umeclidinium, 2019/5/15 0.5% reduction 2021/7/1 Vilanterol 4 C2H1904 Breztri Budesonide, 2019/8/28 0.5% reduction 2021/7/1 Glycopyrronium, Formoterol 12 C2H2006 Enerzair Indacaterol, Glycopyrronium, 2020/8/19 0.5% reduction 2021/7/1 Mometasone 14 C2H2008 Trelegy200 Fluticasone, Umeclidinium, 2021/2/10 0.5% reduction 2021/7/1 Vilanterol 2 C2H1902 Kymriah Tisagenlecleucel 2019/5/15 4.3% reduction 2021/7/1 16 C2H2102 Yescarta 4.3% reduction 2021/4/21 20 C2H2106 Breyanzi Axicabtagene ciloleucel 2021/4/14 4.3% reduction 2021/5/19 3 C2H1903 Ultomiris 4.2% reduction 2021/8/1 5 C2H1905 Trintellix Lisocabtagene maraleucel 2021/5/12 4.3% reduction 2021/11/1 6 C2H1906 Coralan no adjustment Ravulizumab 2019/8/28 - Vortioxetine 2019/11/13 Ivabradine 2019/11/13
Case of lacking enough data for analysis 20 For products determined to be “impossible to analyze” due to lack of data, upon deliberation by the expert committee, the evaluation process may be interrupted by final approval of the CSIMC General Assembly. If the evaluation process is interrupted, the CSIMC General Assembly can ask the manufacturer to accumulate the necessary data by predetermined deadline. If the data cannot be acquired, the CSIMC General Assembly will conduct price adjustments similarly with products with the poorest cost-effectiveness, based on deliberations by the expert committee. Center for Outcomes Research and Economic Evaluation for Health
21 Publication of results We release the following documents on our website after evaluation. Disease description [Japanese] Summary reports [Japanese][English] Full reports [Japanese][English] Company’s submission [Japanese] Center for Outcomes Research and Economic Evaluation for Health
Some Issues under discussion at CSIMC 22 Evaluation Process ・Length of evaluation process ・Preliminary consultation ・Re-evaluation ・Additional indications Evaluation Methods ・Proportion of multiple populations ・Long term care cost Human Resource Development ・Education program ・Capacity in C2H and academic groups Center for Outcomes Research and Economic Evaluation for Health
Possible Re-evaluation 23 Classification Similar Cost Selection Criteria Efficacy Calculation Comparison Method Method (Similar Function Classification) (i) New H1 •Peak sales (estimate): JPY 10 billion or Listed Products with more Products: H2 Products with premium(*), •Peak sales (estimate): JPY 5 billion or after full- H3 premium(*) or disclosure more, under JPY 10 billion scale rate of under implementati 50% •Products determined by the CSIMC on General Assembly, such as products with a prominently high price (ii) Already listed •products with sales of JPY 100 billion or more Products: •Products determined by the CSIMC before full- H4 Products with premium(*) General Assembly, such as products with a prominently high price scale implementati on •Medicine of which price is calculated in comparison with target products Similar H5 Similar products in the H1-H4 •Medical device of which price is calculated products Classification in comparison with target products, and that are categorized in the same functional classification (*) Products for which either an innovativeness premium, utility premium, or improvement premium (medical devices) was calculated will be targeted Center for Outcomes Research and Economic Evaluation for Health
Selection Criteria for H3 24 Products determined by the CSIMC General Assembly, such as products with a prominently high unit price, products of which new findings that would have a major impact on the evaluation were discovered after the completion of the evaluation and other products that a re-evaluation was required. Under Consideration C2H will monitor such data as the results of other HTA agencies and publication of medical journals. When the new findings are monitored, CSIMC General Assembly will judge if the product needs to be re-evaluated. When a new indication is approved, CSIMC General Assembly will also judge if the product needs to be re-evaluated. Center for Outcomes Research and Economic Evaluation for Health
More Information 25 https://c2h.niph.go.jp/en/ Center for Outcomes Research and Economic Evaluation for Health
HTA IN THE POST-PANDEMIC ERA INAHTA PERSPECTIVE PROFESSOR TRACY MERLIN CHAIR, INTERNATIONAL NETWORK OF AGENCIES FOR HEALTH TECHNOLOGY ASSESSMENT (INAHTA) DIRECTOR, ADELAIDE HEALTH TECHNOLOGY ASSESSMENT (AHTA) HEAD, SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF ADELAIDE, AUSTRALIA
OUTLINE What is INAHTA? What perspective are we coming from? How has HTA been impacted by the pandemic? What does HTA look like in a post-COVID future? www.inahta.org
WHAT IS INAHTA?
ABOUT INAHTA International Network of Agencies for HTA Founded in 1993. Now a global network of 50 agencies (2020) Member agencies support health system decision making that affects over 1 billion people in 31 countries Agencies by region: • 31 Europe • 5 Latin America • 5 Canada & USA • 5 Asia • 3 Australia & New Zealand • 1 Africa Agencies by country economic status: • 41 in high income countries • 8 in upper-middle income countries • 1 lower-middle income country www.inahta.org
INAHTA’S MISSION Bring agency leadership and expertise to the global HTA community to advance the science and practice of HTA. Demonstrate the value of HTA agencies as key components of modern health systems to support robust decision-making based on the best available scientific evidence. Support best practice and innovation for building and maintaining thriving HTA agencies. Enable continuous exchange of knowledge and learning among member agencies. www.inahta.org
HTA-HTA KNOWLEDGE SHARING What we do at INAHTA INAHTA congress • Sharing methods, processes • Impact stories • COVID-19 impact Listserv Surveys and report back Learning groups and webinars Position statements Task groups www.inahta.org
INAHTA MEMBERS All INAHTA members are publicly-funded HTA agencies that: Assess technology in health Are funded at least 50% by care public sources Are non-profit organizations Provide access to publicly- available reports to other Relate to a regional or members upon request national government www.inahta.org
INAHTA Members (2020) Australia: AHTA, ASERNIP-S Malaysia: MaHTAS Australia & New Zealand: HTRG Norway: NIPH Austria: GOeG, LBI-HTA Peru: IETSI Argentina: IECS Poland: AOTMiT Belgium: KCE Russian Federation: CHQAC Brazil: CONITEC Singapore: ACE Canada: CADTH, HQO, IHE, INESSS Spain: AETS, AETSA, AQuAS, AVALIA-T, Colombia: IETS IACS, OSTEBA Denmark: DEFACTUM Sweden: SBU France: CEDIT, HAS Switzerland: SFOPH Finalnd: FinCCHTA Taiwan, Republic of China: CDE Germany: G-BA, IQWiG The Netherlands: ZIN, ZonMw Ireland: HIQA Tunisia: INEAS Italy: Agenas, ASSR, UVT-Gemelli Ukraine: SEC (Candidate Member) Kazakhstan: RCHD United Kingdom: HIS, HTW, NIHR, NICE South Korea: NECA Uruguay: HAD-MSP U.S.A.: AHRQ INAHTA – Global Networking for Effective Healthcare www.inahta.org
GLOBAL COLLABORATION Memoranda of understanding with: • WHO • HTAi • EUnetHTA • HTAsiaLink • RedETSA • G-I-N • i-HTS (formerly EuroScan) www.inahta.org
HTA DURING COVID
www.inahta.org
Tests Vaccines www.inahta.org
Treatments https://database.inahta.org/ www.inahta.org
Preventive measures https://database.inahta.org/ www.inahta.org
WHAT WAS PRODUCED? FAST! Rapid reviews www.inahta.org HTA reports Roadmaps to recovery Recommendations Guidelines Transmission models Horizon scanning assessments Interactive Assessing Tools Decisions Press statements, press conferences and interviews
HTA RESPONSE Accelerated collaboration Accelerated information gathering Ultra-rapid HTA Use of uncertain evidence Value for money?? “Living HTA” www.inahta.org
Living HTA “A multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The technology is re-assessed in an iterative manner as new information becomes available. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system.” HTA Glossary
HTA POST-COVID
HTA RESPONSE Accelerated collaboration Accelerated information gathering Ultra-rapid HTA Use of uncertain evidence Special circumstances only Value for money?? “Living HTA” www.inahta.org
CONTACT INAHTA www.inahta.org Chair: Prof Tracy Merlin Secretariat Executive Manager: Tara Schuller Tel (Canada): +1 780 401 1770 Email: [email protected] www.inahta.org
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