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クローン病 (CD)・潰瘍性大腸炎 (UC) の薬価・償還・アクセス

Crohn's Disease and Ulcerative Colitis Pricing, Reimbursement, and Access

発行 Datamonitor Healthcare 商品コード 633147
出版日 ページ情報 英文 204 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=113.38円で換算しております。
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クローン病 (CD)・潰瘍性大腸炎 (UC) の薬価・償還・アクセス Crohn's Disease and Ulcerative Colitis Pricing, Reimbursement, and Access
出版日: 2018年03月16日 ページ情報: 英文 204 Pages
概要

当レポートでは、クローン病 (CD) および潰瘍性大腸炎 (UC) の薬価・償還・市場アクセスの動向を調査し、主要国における承認ラベル、世界の保険者およびキーオピニオンリーダーによる各種考察、主要国別の動向分析、戦略的提言などをまとめています。

概要

エグゼクティブサマリー

法規制ラベル

  • 米国・日本・EU5カ国の上市済みクローン病製品
  • 米国・日本・EU5カ国の上市済み潰瘍性大腸炎製品
  • 文献

世界のアクセスレバーと障壁

  • 考察・戦略的提言
  • 生物学的製剤:IBD支出の大部分を占める
  • IBD治療薬へのアクセスを制限する保険者
  • IBD治療薬:より広範な炎症性疾患治療薬の一部
  • UC・CDの最大のアンメットニーズ:重篤患者の限られた治療オプション

近年上市された製品・パイプライン製品へのアクセス

  • 考察・戦略的提言
  • 保険者とStelaraのプラセボ対照試験
  • エトロリズマブ
  • 経口剤の差別化と直接的試験の不足
  • 皮膚科でのOtezlaのエクスペリエンス
  • JAK阻害剤:薬価設定戦略に左右される
  • Ozanimodの承認、など

価値・証拠

  • 考察・戦略的提言
  • 寛解ベースのエンドポイント:多くの保険者の鍵
  • KOLと保険者:臨床試験の継続試験を望まない
  • 米国・EUの保険者および医師:有効性の評価と薬価設定が行える直接対決の試験を求める

米国の薬価設定

米国の償還

  • 考察・戦略的提言
  • MedicareによるHumira・Remicadeの支払い
  • 炎症性疾患部門:もっとも高コストのカテゴリーに
  • Humira
  • Medicare Part Dフォーミュラリー
  • 複数の炎症性疾患を適応症とする承認済み薬剤:保険者に好まれる
  • 5種のTNFα阻害剤バイオシミラー:FDAで承認を得たが2種のみ上市済み
  • 保険者:バイオシミラーインフリキシマブよりRemicadeを好む
  • バイオシミラーインフリキシマブの利用推進には大幅な割引が求められる、など
  • 文献

日本

  • 薬価設定:クローン病・潰瘍性大腸炎の上市済み治療薬
  • 文献

EU5カ国市場におけるバイオシミラーTNFα阻害剤

  • 考察・戦略的提言
  • バイオシミラーTNFα阻害剤の導入:市場ごとに異なる
  • 保険者:導入推進のためバイオシミラーの割り当てを利用
  • スイッチング
  • 保険者によるバイオシミラー導入戦略:入札・医師へのインセンティブ・処方集からの除外
  • 保険者:バイオシミラーの導入推進のため、より積極的な戦略を実行したい、など

EU5カ国市場における薬価設定

フランス

  • 考察・戦略的提言
  • ASMRレーティング:薬価設定に影響
  • Stelara・Entyvioへのアクセスへの制限
  • EntyvioとTNFα不応性UC患者
  • EtrolizumabのASMR、など

ドイツ

  • 考察・戦略的提言
  • G-BAからのポジティブな評価:薬価設定交渉に影響する見通し
  • 直接的比較の不足とEntyvio
  • 新たなG-BAソフトウェア
  • Etrolizumab
  • Stelara、など

イタリア

  • 考察・戦略的提言
  • 新製品に対するAIFAの意思決定の遅れ
  • 限られた予算:生物学的製剤の利用の障壁
  • AIFAはCD・UCで承認されたすべての生物学的製剤を償還・しかしアクセスは限られている
  • AIFAで償還できるUC・CD治療薬:Emilia-Romagna地域の処方集に掲載のもの、など

スぺイン

  • 考察・戦略的提言
  • 国の償還に関する決定:アクセスの障壁とはならず
  • IPTによるEntyvioの制限
  • IPTによるStelaraの制限
  • UC・CD治療薬へのアクセス:地域により異なる、など

英国

  • 考察・戦略的提言
  • NICEによる承認:主なアクセスの障壁
  • Entyvio
  • Remicade
  • Xeljanz
  • 処方集の決定
  • 文献

調査手法

目次
Product Code: DMKC0189489

Overview:

Payers view spending on inflammatory bowel disease (IBD) drugs as significant, as there is a large patient base requiring expensive biologic therapies. The market has been long dominated by the TNF-alpha inhibitors Humira and Remicade, but more recent biologic launches such as Entyvio and Stelara have focused on novel mechanisms of action. Additionally, another alpha integrin, etrolizumab, is a further biologic of interest to clinicians.

The IBD pipeline is also expecting the launches of novel oral agents such as JAK inhibitors Xeljanz and filgotinib, as well as the S1P receptor antagonist ozanimod. Payers fully expect that these pipeline agents will continue to fuel the growth of the IBD market, and that the launches of TNF-alpha inhibitor biosimilars will not do much to temper growth. Consequently, payers have been restricting the prescribing of the non-TNF-alpha inhibitors to later lines of therapy - and after the TNF-alpha inhibitors whenever possible - to ensure biosimilar savings are realized. European payers are enacting national and regional restrictions: using start-and-stop criteria, delineating therapeutic lines, and requiring discounts in exchange for access to earlier lines of treatment. US payers mandate prior authorization, with most payers requiring failures with TNF-alpha inhibitors prior to accessing Entyvio or Stelara.

Table of Contents

OVERVIEW

EXECUTIVE SUMMARY

REGULATORY LABELS

  • Marketed Crohn's disease products in the US, Japan, and five major EU markets
  • Marketed ulcerative colitis products in the US, Japan, and five major EU markets
  • Bibliography

GLOBAL ACCESS LEVERS AND BARRIERS

  • Insights and strategic recommendations
  • Biologics comprise the majority of spend in IBD; new agents will continue to increase spend
  • Payers restrict access to IBD medications
  • IBD drugs are managed as part of the wider inflammatory class of drugs
  • The largest unmet need in UC and CD is severe patients at later lines of therapy, where options are limited

ACCESS TO RECENTLY LAUNCHED AND PIPELINE PRODUCTS

  • Insights and strategic recommendations
  • Payers are unimpressed by Stelara's placebo-controlled trials
  • Superiority data against infliximab are unlikely to push etrolizumab to be a first-line biologic
  • Oral compounds may struggle to achieve differentiation against one another due to the lack of head-to-head trials
  • Otezla's experience in dermatology could provide the best example for how oral IBD drugs will fare
  • Payers are skeptical that oral therapies can bridge the gap before biologics
  • Access for JAK inhibitors hinges on pricing strategy
  • A better safety profile matters to physicians, but is unlikely to move the needle from an HTA or payer perspective
  • Ozanimod's approval in UC could prove problematic for approval in MS
  • Some payers may elect to contract for selected oral inhibitors

VALUE AND EVIDENCE

  • Insights and strategic recommendations
  • Remission-based endpoints are key for most payers
  • Key opinion leaders and payers want longer clinical trials with extension studies
  • US and EU payers and physicians want head-to-head trials to directly assess efficacy and determine pricing

US PRICING

US REIMBURSEMENT

  • Insights and strategic recommendations
  • Medicare pays $2.9bn for Humira and Remicade at an average of over $25,000 per beneficiary
  • The inflammatory conditions segment has been the most expensive specialty drug category for eight consecutive years
  • Humira is the drug with the highest spend in the specialty category for all Express Scripts' payers
  • Rising per member per year spend for Humira is mostly due to unit cost increases
  • Commercial formularies vary in their tier positioning for IBD drugs
  • Exclusions are more common within Medicare Part D formularies than in commercial plans
  • Medicare Part D covers first-generation biologics, but with high out-of-pocket costs for members
  • State Medicaid programs are largely in consensus on their IBD preferred drug formulary lists
  • Prior authorization is the key utilization management tool used in IBD for all payers in the US
  • Drugs with approvals in multiple inflammatory indications are favored in payer contracting
  • Five TNF-alpha inhibitor biosimilars have been approved by the FDA, but only two have launched
  • Payers continue to prefer Remicade over biosimilar infliximab
  • Larger discounts are required to promote biosimilar infliximab use
  • Bibliography

JAPAN

  • Pricing of launched treatments for Crohn's disease and ulcerative colitis
  • Bibliography

BIOSIMILAR TNF-ALPHA INHIBITORS IN THE FIVE MAJOR EU MARKETS

  • Insights and strategic recommendations
  • The uptake of biosimilar TNF-alpha inhibitors varies across EU markets, as the EMA does not determine interchangeability
  • Payers resort to biosimilar quotas to promote uptake
  • High quotas requiring biosimilar use prompt many physicians to switch patients
  • Switching costs have led to reservations among some payers, meaning switching among multiple biosimilars is unlikely
  • Discounts are not the only strategy to facilitate switching among biosimilars
  • Payers use tenders, physician incentives, and formulary exclusions to drive biosimilar uptake
  • Payers are willing to implement more aggressive measures to promote biosimilar uptake
  • Bibliography

PRICING IN THE FIVE MAJOR EU MARKETS

FRANCE

  • Insights and strategic recommendations
  • ASMR rating has an impact on pricing
  • In the absence of head-to-head trials versus TNF inhibitors, later entrants largely receive no added benefit
  • Access to Stelara and Entyvio is restricted to TNF-failure patients in CD and UC respectively
  • Entyvio gets added benefit in TNF-alpha-refractory UC patients
  • Etrolizumab's ASMR hinges on efficacy data demonstrating absolute improvement over infliximab
  • Bibliography

GERMANY

  • Insights and strategic recommendations
  • A positive assessment from the G-BA will impact pricing negotiations
  • Lack of head-to-head comparisons results in no added benefit for Entyvio
  • Certain sickness funds subject TNF-alpha inhibitors to indicative budget limits, but the relevance of this may change under ongoing reforms
  • New G-BA software will make added benefit assessments and prices for competing drugs more visible to prescribers
  • Etrolizumab may have mixed pricing due to an anticipated added benefit in some patient populations
  • Stelara is expected to bypass benefit assessment in CD despite approval post-AMNOG
  • Bibliography

ITALY

  • Insights and strategic recommendations
  • Delays in AIFA decisions for newly launched drugs hamper regional and local access
  • Limited budgets present the greatest barrier to biologics use
  • AIFA reimburses all biologics approved for CD and UC, but with access restrictions
  • UC and CD drugs reimbursed by AIFA are found in the regional formulary of Emilia-Romagna
  • Bibliography

SPAIN

  • Insights and strategic recommendations
  • National reimbursement decisions are usually not a barrier to access
  • IPT restricts Entyvio in UC and CD to patients who have failed TNF-alpha inhibitors
  • IPT restricts Stelara for CD to patients who have failed on or who are contraindicated to TNF-alpha inhibitors
  • Regional access to UC and CD treatments varies in Spain
  • The Catalonian therapeutics committee has outlined a pathway for CD
  • Moving towards a flat fee per patient will incentivize use of the least expensive IBD therapy
  • Bibliography

UK

  • Insights and strategic recommendations
  • NICE approval is a key market access barrier
  • Entyvio is restricted to the third line in CD after failure with a TNF-alpha inhibitor, and requires a patient access scheme
  • Entyvio is reimbursed in the full patient population for UC with a patient access scheme and a one-year stopping rule
  • Remicade is reimbursed for pediatric UC patients, as per its marketing authorization, despite failing the cost-effectiveness test
  • Xeljanz's pricing will largely be dictated by its cost in RA, which will need to be comparable to Olumiant
  • Managing spend for IBD drugs will revolve around start-and-stop criteria
  • Regional formulary decisions
  • Bibliography

METHODOLOGY

  • Primary research
  • Price assumptions
  • Exchange rates
  • Bibliography

LIST OF FIGURES

  • Figure 1: Price sources and calculations for the US and EU, by country

LIST OF TABLES

  • Table 1: Marketed products and approved indications for Crohn's disease drugs in the US, Japan, and five major EU markets
  • Table 2: Marketed products and approved indications for ulcerative colitis drugs in the US, Japan, and five major EU markets
  • Table 3: Levers impacting access to IBD drugs in the US and five major EU markets, by country
  • Table 4: US pricing of key marketed IBD drugs, 2017
  • Table 5: Top anti-inflammatory drug prescriptions filled by Medicare beneficiaries participating in Part B and D programs, 2015
  • Table 6: Specialty drug spend by Express Scripts commercial members (inflammatory diseases market), 2016
  • Table 7: CVS Caremark and Express Scripts' formulary exclusions for IBD drugs, 2016-18
  • Table 8: Formulary placement of IBD medications in selected commercial formularies
  • Table 9: Formulary placement of IBD medications in selected Medicare formularies
  • Table 10: Selected formulary practices of top 10 Medicare Part D and Medicare Advantage IBD drugs
  • Table 11: Formulary placement of IBD medications in selected state Medicaid formularies
  • Table 12: Prior authorization criteria for Crohn's disease drugs with major health insurers and pharmacy benefit managers
  • Table 13: Prior authorization criteria for ulcerative colitis drugs with major health insurers and pharmacy benefit managers
  • Table 14: Japan - pricing premiums given to medicines that can demonstrate benefit over comparators
  • Table 15: Pricing of key marketed Crohn's disease and ulcerative colitis drugs in Japan, 2017
  • Table 16: Market access tools used to promote biosimilar TNF-alpha inhibitor uptake in the five major EU markets, by country
  • Table 17: Pricing of key Crohn's disease drugs in the five major EU markets, by country, 2017
  • Table 18: Pricing of key ulcerative colitis drugs in the five major EU markets, by country, 2017
  • Table 19: Transparency Committee's ASMR ratings and pricing implications
  • Table 20: Transparency Committee's SMR ratings and pricing implications
  • Table 21: Transparency Commission's assessment of Crohn's disease treatments
  • Table 22: Transparency Commission's assessment of ulcerative colitis treatments
  • Table 23: G-BA assessment of key Crohn's disease therapies
  • Table 24: G-BA assessment of key ulcerative colitis therapies
  • Table 25: Spending regulations for TNF-alpha inhibitors in the five largest physicians' associations in Germany
  • Table 26: Reimbursement conditions for Crohn's disease treatments in Italy
  • Table 27: Reimbursement conditions for ulcerative colitis treatments in Italy
  • Table 28: Italian regional formulary decisions for Crohn's disease drugs
  • Table 29: Italian regional formulary decisions for ulcerative colitis drugs
  • Table 30: Therapeutic positioning reports for IBD drugs in Spain
  • Table 31: Spanish Society of Hospital Pharmacy ratings
  • Table 32: Regional MADRE assessments for Crohn's disease drugs
  • Table 33: Regional MADRE assessments for ulcerative colitis drugs
  • Table 34: NICE assessments of key Crohn's disease therapies
  • Table 35: NICE assessments of key ulcerative colitis therapies
  • Table 36: Exchange rates used for calculating drug prices
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