Japan Pharma Regulatory Brief

Japan · 費用対効果評価 · C2H · Chuikyo · NHI price adjustment

Japan HTA (Cost-Effectiveness) Tracker

Every product Japan has designated for cost-effectiveness evaluation since 2019: class, dates, the ICER category Chuikyo approved and how much the NHI price moved — plus which products are next. Compiled from C2H (National Institute of Public Health) and Chuikyo (MHLW) documents; processed by the editor. Not an official translation.

Data as of 2026-09-29 · sources: C2H (NIPH), MHLW Chuikyo (PDL1.0); processed by Japan Pharma Regulatory Brief · CSV (aggregates) · 한국어 요약

83products designated since FY2019 (drugs 77, devices 6)
556.5 daysmedian from designation to Chuikyo result (H1–H4, n=50; IQR 532–605.5)
-4.08%median price adjustment (n=57); 79% got a cut, none an increase
-15%largest cut so far (LEQEMBI); cap is 10–15% of the price

Designations at a glance

By fiscal year of designation

FY2019
6
FY2020
8
FY2021
15
FY2022
13
FY2023
8
FY2024
13
FY2025
10
FY2026
10

By class

H1 — peak sales forecast ≥ ¥10bn
56
H2 — ¥5–10bn (Chuikyo selects)
11
H3 — notably high price / new evidence
2
H5 — similar product, follows its lead
14

H4 has never been used.

By status

Completed
50
In progress
20
H5 (follows lead product)
12
Analysis suspended
1

How long does a Japanese HTA take?

From designation to the Chuikyo general assembly approving the result: median 556.5 days (about 18 months; interquartile range 532–605.5 days, fastest 427, slowest 1204, n=50 H1–H4 products). That is longer than the official 15–18 month guide. The adjusted price then takes effect at the next quarterly window, usually 2–4 months later.

How much does the price change?

% change of the NHI price at the HTA price adjustment, first listed strength, including H5 similar products (n=57): median -4.08%, interquartile range -7.75% to -0.46%. Among H1–H4 products that were cut, the median is -4.29% (n=38).

MHLW’s own figure (2025-09 (Chuikyo HTA subcommittee; restated 2026-09-09 費-1)): 38 of 49 completed evaluations had a price change, median -4.29% of the whole price (PDF). Measured slightly differently from ours; comparable, not identical.

Distribution of price changes

increase (>0%)
0
no change (0%)
12
0 to -5%
24
-5 to -10%
15
-10 to -15%
6
below -15%
0

All 83 products designated for HTA

Newest designation first; click a column to sort. ICER category = the band approved by Chuikyo for each analysed population (healthcare payer view). Price adjustment = first listed strength (range shown when strengths differ). Days are counted to the Chuikyo result, not shown for H5 products. * = figures read from the Japanese PDFs by machine and not yet checked by hand (65 of 83 rows); 18 rows are hand-checked.

ProductIngredientCompanyClassDesignatedChuikyo resultDaysICER category (healthcare payer view)Price adjustmentEffectiveC2H
SARCLISA*
サークリサ
IsatuximabH1
In progress
2026-08-05not yetC2H2610
list only
MERCILON*
マルシロン
Desogestrel, ethinylestradiolH2
In progress
2026-08-05not yetC2H2609
list only
Cobalt XT HF Quad CRT-D MRI* device
Cobalt XT HF Quad CRT-D MRI
Cardiac resynchronization therapy defibrillatorH2
In progress
2026-07-22not yetC2H2608
list only
Cobalt XT DR MRI* device
Cobalt XT DR MRI
Implantable cardioverter defibrillatorH2
In progress
2026-07-22not yetC2H2607
list only
SAPIEN 3 Ultra RESILIA systetm* device
エドワーズ サピエン3 Ultra RESILIA システム
Transcatheter heart valveH1
In progress
2026-07-22not yetC2H2606
list only
ADSTILADRIN*
エドスチラドリン
nadofaragene firadenovecH1
In progress
2026-07-08not yetC2H2605
list only
JASCAYD*
ジャスケイド
NerandomilastH1
In progress
2026-07-08not yetC2H2604
list only
Zolgensma IT*
ゾルゲンスマ髄注
Onasemnogene abeparvovecH5
In progress
2026-05-13follows lead productnot yetC2H2603
list only
EXDENSUR*
エキシデンサー
DepemokimabH1
In progress
2026-04-08not yetC2H2602
list only
AQUIPTA*
アクイプタ
Atogepant hydrateH5
In progress
2026-04-08follows lead productnot yetC2H2601
BLENREP*
ブーレンレップ
Belantamab mafodotinH1
In progress
2026-03-11not yetC2H2510
list only
PLUVICTO*
プルヴィクト
Lutetium (177Lu) vipivotide tetraxetanH1
In progress
2025-11-05not yetC2H2509
list only
IZERVAY*
アイザベイ
Avacincaptad pegol sodiumH1
In progress
2025-11-05not yetC2H2508
list only
NEXLETOL*
ネクセトール
Bempedoic acidH1
In progress
2025-11-05not yetC2H2507
list only
Nurtec*
ナルティーク
Rimegepant sulfate hydrateH1
In progress
2025-11-05not yetC2H2506
list only
YORVIPATH*
ヨビパス
PalopegteriparatideH1
In progress
2025-10-15not yetC2H2505
list only
TALVEY*
タービー
TalquetamabH1
In progress
2025-08-06not yetC2H2504
list only
AIRWIN*
エアウィン
SotaterceptH1
In progress
2025-08-06not yetC2H2503
list only
WELIREG*
ウェリレグ
BelzutifanH1
In progress
2025-08-06not yetC2H2502
list only
IMDELLTRA*
イムデトラ
TarlatamabH1
In progress
2025-04-09not yetC2H2501
LUNSUMIO*
ルンスミオ
MosunetuzumabChugai Pharmaceutical Co., Ltd.H5
H5 (follows lead product)
2025-03-12follows lead product-2.73%
H5 of C2H2307
2025-08-01C2H2413
list only
TECVAYLI*
テクベイリ
Teclistamab(株)H5
H5 (follows lead product)
2025-03-12follows lead product0%
H5 of C2H2403
C2H2412
list only
DATROWAY*
ダトロウェイ
Datopotamab deruxtecan(株)H5
H5 (follows lead product)
2025-03-12follows lead product-11.00%
H5 of C2H2409
2026-11-01C2H2411
list only
Zepbound
ゼップバウンド
TirzepatideEli Lilly Japan K.K.H1
Completed
2025-03-122026-08-26532<2M yen/QALYpendingC2H2410
TRODELVY
トロデルビ
Sacituzumab govitecanGilead Sciences K.K.H2
Completed
2024-11-132026-05-13546≥15M yen/QALY-11.00%2026-11-01C2H2409
Awiqli
アウィクリ
Insulin icodecNovo Nordisk Pharma Ltd.H1
Completed
2024-11-132026-06-24588Cost increase (no added benefit); Equivalent effect and cost-0.34%
-0.42 to -0.34%
2026-11-01C2H2408
TEPEZZA
テッペーザ
TeprotumumabAmgen K.K.H1
Completed
2024-11-132026-05-135467.5M–10M yen/QALY-5.51%2026-11-01C2H2407
Kisunla
ケサンラ
DonanemabEli Lilly Japan K.K.H1
Completed
2024-11-132026-08-26651Cost-saving (dominant); ≥10M yen/QALYpendingC2H2406
Briviact
ブリィビアクト
BrivaracetamUCB Japan Co., Ltd.H1
Completed
2024-08-072026-04-08609≥10M yen/QALY-4.29%
-4.29 to -4.28%
2026-08-01C2H2405
Vyloy*
ビロイ
ZolbetuximabAstellas Pharma Inc.H1
Completed
2024-05-152025-10-15518Cost increase (no added benefit); ≥15M yen/QALY-4.29%2026-02-01C2H2404
Elrexfio*
エルレフィオ
ElranatamabPfizer Japan Inc.H1
Completed
2024-05-152025-11-145482M–7.5M yen/QALY0%C2H2403
Truqap*
トルカプ
CapivasertibAstraZeneca K.K.H1
Completed
2024-05-152025-12-1057411.25M–15M yen/QALY-10.67%2026-06-01C2H2402
Reblozyl*
レブロジル
LuspaterceptBristol-Myers Squibb K.K.H1
Completed
2024-04-102025-09-10518Cost increase (no added benefit); ≥10M yen/QALY-8.30%2026-02-01C2H2401
LEQEMBI
レケンビ
LecanemabEisai Co., Ltd.H1
Completed
2023-12-132025-07-09574≥10M yen/QALY-15.00%2025-11-01C2H2308
EPKINLY*
エプキンリ
EpcoritamabGenmab K.K.H1
Completed
2023-11-152025-04-235257.5M–11.25M yen/QALY-2.73%2025-08-01C2H2307
Wegovy
ウゴービ
SemaglutideNovo Nordisk Pharma Ltd.H1
Completed
2023-11-152025-05-14546≥10M yen/QALY-8.27%
-8.30 to -7.30%
2025-11-01C2H2306
LEQVIO*
レクビオ
Inclisiran sodiumNovartis Pharma K.K.H1
Completed
2023-11-152025-05-145465M–7.5M yen/QALY; Cost increase (no added benefit)-11.00%2025-11-01C2H2305
PHOZEVEL*
フォゼベル
Tenapanor hydrochlorideKyowa Kirin Co., Ltd.H1
Completed
2023-11-152025-05-145462M–5M yen/QALY; Cost increase (no added benefit)-11.02%
-11.02 to -10.99%
2025-11-01C2H2304
Litfulo*
リットフーロ
Ritlecitinib tosilatePfizer Japan Inc.H1
Completed
2023-08-232025-01-295252M–7.5M yen/QALY; Cost increase (no added benefit)-3.76%2025-06-01C2H2303
GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System* device
ゴア®CTAG胸部大動脈 ステントグラフト システム
Thoracic Stent GraftW. L. Gore & Associates G.K.H2
Completed
2023-07-052025-01-29574Cost-saving (dominant)0%C2H2302
Besremi*
ベスレミ
Ropeginterferon Alfa-2bPharmaEssentia Japan K.K.H1
Completed
2023-05-172024-10-09511-8.30%2025-02-01C2H2301
XOCOVA
ゾコーバ
Ensitrelvir fumaric acidShionogi & Co., Ltd.H1
Completed
2023-03-082024-10-09581Cost increase (no added benefit)-4.28%2025-02-01C2H2213
Mounjaro*
マンジャロ
TirzepatideEli Lilly Japan K.K.H1
Completed
2023-03-082024-09-115532M–5M yen/QALY0%C2H2212
Paxlovid
パキロビッド
Nirmatrelvir / ritonavirPfizer Japan Inc.H1
Completed
2023-03-082026-06-241204Cost increase (no added benefit)-4.29%2026-11-01C2H2211
Tezspire*
テゼスパイア
TezepelumabAstraZeneca K.K.H1
Completed
2022-11-092024-06-12581Cost increase (no added benefit); ≥10M yen/QALY-4.08%
-4.08 to -4.04%
2024-11-01C2H2210
Sotyktu
ソーティクツ
DeucravacitinibBristol-Myers Squibb K.K.H1
Completed
2022-11-092024-04-245325M–7.5M yen/QALY-8.57%2024-08-01C2H2209
Lagevrio*
ラゲブリオ
MolnupiravirMSD K.K.H1
Completed
2022-08-102024-03-13581Cost increase (no added benefit)-8.18%2024-07-01C2H2208
Ondexxya*
オンデキサ
Andexanet alfaAstraZeneca K.K.H2
Completed
2022-05-182023-10-115112M–5M yen/QALY; <2M yen/QALY0%C2H2207
Kerendia
ケレンディア
FinerenoneBayer Yakuhin, Ltd.H1
Completed
2022-05-182024-03-136655M–7.5M yen/QALY-2.70%
-2.74 to -2.70%
2024-07-01C2H2206
Dysval*
ジスバル
Valbenazine tosilateMitsubishi Tanabe Pharma Corp.H2
Completed
2022-05-182023-10-115115M–7.5M yen/QALY-1.43%2024-02-01C2H2205
Vyvgart*
ウィフガート
Efgartigimod alfaargenx Japan K.K.H1
Completed
2022-04-132023-10-11546Cost increase (no added benefit); ≥15M yen/QALY-7.75%2024-02-01C2H2204
Bimzelx*
ビンゼレックス
BimekizumabUCB Japan Co., Ltd.H1
Completed
2022-04-132023-09-13518<2M yen/QALY0%C2H2203
Pivlaz*
ピヴラッツ
Clazosentan sodiumIdorsia Pharmaceuticals Japan Ltd.H1
Completed
2022-04-132023-09-135182M–5M yen/QALY0%C2H2202
Lyfnua*
リフヌア
Gefapixant citrateMSD K.K.H1
Completed
2022-04-132023-06-14427≥10M yen/QALY-7.73%2023-11-01C2H2201
Expedium Verse Fenestrated Screw system* device
Expedium Verse Fenestrated Screwシステム
Screw for spinal fusionJohnson & Johnson K.K.H2
Completed
2021-12-082023-06-14553Cost increase (no added benefit)-3.07%2023-11-01C2H2115
Padcev*
パドセブ
Enfortumab vedotinAstellas Pharma Inc.H1
Completed
2021-11-172023-02-15455≥15M yen/QALY-8.18%2023-06-01C2H2114
Retevmo*
レットヴィモ
SelpercatinibEli Lilly Japan K.K.H1
Completed
2021-11-172023-08-236442M–7.5M yen/QALY; 7.5M–11.25M yen/QALY-0.16%2024-02-01C2H2113
Micra AV* device
Micra AV
Transcatheter pacing systemsMedtronic Japan Co., Ltd.H2
Completed
2021-10-132023-06-14609≥10M yen/QALY-8.55%2023-11-01C2H2112
Veklury*
ベクルリー
RemdesivirGilead Sciences K.K.H1
Completed
2021-08-042023-01-18532<2M yen/QALY; Cost increase (no added benefit); ≥10M yen/QALY-2.12%2023-06-01C2H2111
Revestive*
レベスティブ
TeduglutideTakeda Pharmaceutical Co., Ltd.H2
Completed
2021-08-042023-01-185327.5M–11.25M yen/QALY; ≥10M yen/QALY-7.09%2023-06-01C2H2110
Aimovig
アイモビーグ
Erenumabン(株)H5
H5 (follows lead product)
2021-08-04follows lead product-5.04%
H5 of C2H2101
2023-06-01C2H2109
list only
Ajovy
アジョビ
FremanezumabOtsuka Pharmaceutical Co., Ltd.H5
H5 (follows lead product)
2021-08-04follows lead product-5.05%
H5 of C2H2101
2023-06-01C2H2108
list only
Verquvo*
ベリキューボ
VericiguatH5
H5 (follows lead product)
2021-08-04follows lead productnot foundC2H2107
list only
Breyanzi*
ブレヤンジ
Lisocabtagene maraleucelH5
H5 (follows lead product)
2021-05-12follows lead productnot foundC2H2106
list only
Arikayce*
アリケイス
Amikacin sulfateInsmed G.K.H1
Completed
2021-05-122022-12-14581≥10M yen/QALY-9.36%2023-06-01C2H2105
Darzquro*
ダラキューロ
Daratumumab / vorhyaluronidase alfaJanssen Pharmaceutical K.K.H1
Completed
2021-05-122023-02-156442M–7.5M yen/QALY; Cost-saving (dominant)0%C2H2104
Polivy*
ポライビー
Polatuzumab vedotinChugai Pharmaceutical Co., Ltd.H1
Completed
2021-05-122022-11-095462M–7.5M yen/QALY0%C2H2103
Yescarta*
イエスカルタ
Axicabtagene ciloleucelH5
H5 (follows lead product)
2021-04-14follows lead productnot foundC2H2102
list only
Emgality
エムガルティ
GalcanezumabEli Lilly Japan K.K.H1
Completed
2021-04-142023-01-186442M–5M yen/QALY; 5M–7.5M yen/QALY; ≥10M yen/QALY-5.05%2023-06-01C2H2101
Trelegy200*
テリルジー200
Fluticasone, Umeclidinium, VilanterolH5
H5 (follows lead product)
2021-02-10follows lead product-0.55%
H5 of C2H1901
2021-07-01C2H2008
list only
Rybelsus*
リベルサス
SemaglutideNovo Nordisk Pharma Ltd.H1
Completed
2020-11-112022-07-20616Cost increase (no added benefit); Cost-saving (dominant)-2.51%
-2.55 to -2.51%
2022-11-01C2H2007
Enerzair*
エナジア
Indacaterol, Glycopyrronium, MometasoneスファーマH5
H5 (follows lead product)
2020-08-19follows lead product-0.55%
-0.57 to -0.55%
H5 of C2H1901
2021-07-01C2H2006
list only
Entresto*
エンレスト
Sacubitril valsartan sodium hydrateファーマ(株)H5
H5 (follows lead product)
2020-08-19follows lead product0%
H5 of C2H1906
C2H2005
list only
Zolgensma*
ゾルゲンスマ
Onasemnogene abeparvovecH3
Analysis suspended
2020-05-13n/aC2H2004
Enhertu*
エンハーツ
Trastuzumab deruxtecanDaiichi Sankyo Co., Ltd.H1
Completed
2020-05-132022-03-2367911.25M–15M yen/QALY; 7.5M–11.25M yen/QALY; Cost increase (no added benefit)-2.15%2022-07-01C2H2003
Cabometyx*
カボメティクス
CabozantinibTakeda Pharmaceutical Co., Ltd.H1
Completed
2020-05-132022-05-187352M–7.5M yen/QALY; Cost-saving (dominant)0%C2H2002
Noxafil*
ノクサフィル
PosaconazoleMSD K.K.H1
Completed
2020-04-082021-11-105817.5M–10M yen/QALY; <2M yen/QALY-0.46%2022-02-01C2H2001
Coralan*
コララン
Ivabradine hydrochlorideOno Pharmaceutical Co., Ltd.H2
Completed
2019-11-132021-05-265602M–5M yen/QALY0%C2H1906
Trintellix
トリンテリックス
Vortioxetine hydrobromideTakeda Pharmaceutical Co., Ltd.H1
Completed
2019-11-132021-05-26560Cost increase (no added benefit)-4.26%
-4.30 to -4.26%
2021-11-01C2H1905
Breztri*
ビレーズトリ
Budesonide, Glycopyrronium, FormoterolH5
H5 (follows lead product)
2019-08-28follows lead product-0.55%
H5 of C2H1901
2021-07-01C2H1904
list only
Ultomiris
ユルトミリス
RavulizumabAlexion Pharma G.K.H1
Completed
2019-08-282021-04-14595Cost increase (no added benefit)-4.29%2021-08-01C2H1903
Kymriah
キムリア
TisagenlecleucelNovartis Pharma K.K.H3
Completed
2019-05-152021-03-2467911.25M–15M yen/QALY; 2M–7.5M yen/QALY; 7.5M–11.25M yen/QALY-4.30%2021-07-01C2H1902
Trelegy*
テリルジー
Fluticasone, Umeclidinium, VilanterolGlaxoSmithKline K.K.H1
Completed
2019-05-152021-03-24679<2M yen/QALY; Cost increase (no added benefit); Cost-saving (dominant); Unable to evaluate-0.54%
-0.55 to -0.54%
2021-07-01C2H1901

Likely next HTA results and designations

Since April 2024 every new-drug pricing sheet states whether the product falls under HTA (“費用対効果評価への該当性:該当する(H1)”). We read 145 sheets from 16 listing rounds: H1 21, H2 2, H5 4, not applicable 116. Below: products designated at listing whose Chuikyo result is still to come, soonest first. The window is the Chuikyo listing meeting + the interquartile range of designation-to-result days in this tracker (532–606 days, median 556.5, n=50). Estimates, not official dates.

ListedProduct (ingredient)CompanyClassPeak sales forecastChuikyo result expected (est.)
2025-04-16Imdelltra (tarlatamab)
イムデトラ
Amgen K.K.H1¥24.7bn2026-09 – 2026-12
2025-08-14Airwin (sotatercept)
エアウィン
MSD K.K.H1¥54.4bn2027-01 – 2027-04
2025-08-14Welireg (belzutifan)
ウェリレグ
MSD K.K.H1¥40.4bn2027-01 – 2027-04
2025-08-14Talvey (talquetamab)
タービー
Janssen Pharmaceutical K.K.H1¥25.6bn2027-01 – 2027-04
2025-10-22Yorvipath (palopegteriparatide)
ヨビパス
Teijin Pharma LimitedH1¥12.9bn2027-03 – 2027-06

Showing 5 of 13 pending results. Peak sales = company forecast quoted in the Chuikyo pricing sheet.

What subscribers get

  • All 13 pending results with expected windows, plus H5 products that will follow their lead product.
  • 9 products that met the numbers (usefulness premium + peak forecast ≥ ¥5bn) but were not designated at listing — usually the rare-disease / paediatric exclusion — and could still be designated if annual sales pass ¥35bn.
  • 7 already-listed products on our market-expansion watch list (possible H1 after expansion, the “equivalent category” or the never-used H4).
  • An email the week a product is designated, its result is approved, or its adjusted price takes effect.

Part of the team / company plan (Market Access Team). Join the free weekly email ↓

What Japan’s HTA is

Rule changes in 2026

  • New notice: “Handling of cost-effectiveness evaluation of drugs, medical devices and regenerative products” (産情発0213第3号 / 保発0213第7号, 13 Feb 2026), in force 1 Apr 2026 for drugs and 1 Jun 2026 for devices. Chuikyo outline: 16 Jan 2026 (PDF). Price formula: Drug Pricing Standards, Annex 12 (draft PDF). The notice’s own MHLW URL is not yet confirmed.
  • Thresholds unchanged: ¥10bn / ¥5bn / ¥35bn / ¥100bn and the ICER bands.
  • “Cost increase, no added benefit” results: adopted in principle to adjust the whole price (comparator daily cost ÷ product daily cost), with a floor of 85% of the price still under discussion. Results approved from April 2026 will be re-adjusted once the implementing notice is issued (verification report to Chuikyo 9 Sep 2026; not issued as of this build).
  • Re-designation route: after an evaluation ends, new evidence (e.g. foreign HTA) can lead to an H3/H4 re-designation proposed directly to Chuikyo.
  • A price increase now needs “a clinically useful new mechanism of action”; the analysis guideline moves to its 5th edition; long-term-care costs are still not used for pricing.
  • What’s next: the 2026 “honebuto” policy calls for wider product and price-adjustment scope, with conclusions due for the FY2027 price revision. H4 (large pre-2019 products) has never been used.

Sources & attribution

Sources: C2H, National Institute of Public Health (c2h.niph.go.jp) and MHLW Chuikyo materials (Public Data License 1.0) — processed by Japan Pharma Regulatory Brief.

  • C2H (Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health): products selected since 2019 (English) / 日本語 and each product page. Terms of use (PDL1.0). Company-submitted analysis PDFs on C2H belong to the companies; we do not reproduce them.
  • MHLW Chuikyo general assembly papers: “医薬品等の費用対効果評価案について” (results, ICER category by population) and “…の費用対効果評価結果に基づく価格調整について” (prices before/after, effective date); new-drug pricing sheets (HTA flag).
  • Rules: 医薬品、医療機器及び再生医療等製品の費用対効果評価に関する取扱いについて(令和8年2月13日 産情発0213第3号・保発0213第7号).

Used under the Public Data License 1.0 (compatible with CC BY 4.0) — processed, translated and analysed by Japan Pharma Regulatory Brief (unofficial). See the MHLW terms of use. This page is not made by, affiliated with or endorsed by MHLW, Chuikyo, the National Institute of Public Health or C2H. The Japanese originals prevail.

出典:「費用対効果評価 制度化以後に選定された品目」(国立保健医療科学院 保健医療経済評価研究センターホームページ)(https://c2h.niph.go.jp/results/item.html)、厚生労働省 中央社会保険医療協議会 総会の資料(医薬品等の費用対効果評価案について、費用対効果評価結果に基づく価格調整について)を加工して Japan Pharma Regulatory Brief が作成

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