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市場調查報告書

免疫查核點抑制劑的醫療費償付、保險者管理

Reimbursement and Payer Management of Immune Checkpoint Inhibitors

出版商 Datamonitor Healthcare 商品編碼 858355
出版日期 內容資訊 英文 80 Pages
商品交期: 最快1-2個工作天內
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免疫查核點抑制劑的醫療費償付、保險者管理 Reimbursement and Payer Management of Immune Checkpoint Inhibitors
出版日期: 2018年11月28日內容資訊: 英文 80 Pages
簡介

本報告提供全球免疫查核點抑制劑市場相關調查,世界及主要國家的市場趨勢,獲取促進因素,各治療藥的評估,及國家、地方的醫療費償付的建議等。

概要

全球獲取促進因素

  • 保險者擔心免疫療法的預算影響
  • 標籤擴大到新的患者族群之後,往往要求降低價格
  • 競標作為未來的成本管理手段的可能性
  • 保險者需要管理癌症免疫聯合治療費用的新方法
  • 保險者對生物標記選擇的優點缺乏共識,但PD-L1 分層可能有利
  • Keytruda的價格遠高於整個歐洲的競爭性免疫療法
  • 美國、英國的保險者,更傾向於在不同的時刻的全存活率作為免疫查核點抑制劑的終點

美國

加拿大

日本

法國

德國

義大利

西班牙

英國

調查手法

目錄
Product Code: DMKC0200241

Payers are concerned about the budget impact of immunotherapies

As immune checkpoint inhibitors continue to gain approvals in expanded patient populations, interviewed payers express concern surrounding the potential budget impact of the drug class. Considering the high costs of these treatments in comparison to standard chemotherapy, HTA and reimbursement agencies stress the requirement for solid survival data and highlight that price will be a major factor during negotiations.

Price-volume and expenditure ceilings are frequently used across Europe

Price-volume and budget ceiling agreements are becoming increasingly popular for immunotherapies in France, Italy, and Spain, and payers in other European countries may follow suit in the future. These arrangements have been used in the past for high-impact indications such as hepatitis C; however, payers are imposing these spending caps more explicitly in the case of immunotherapies. Payers indicate that further cost-control mechanisms could be introduced for immunotherapies in the future, including per patient caps on pricing implemented at an indication-by-indication level.

Price reductions are frequently required following label expansions into new populations

Label expansions of immune checkpoint inhibitors into new treatment lines consistently trigger new pricing and reimbursement assessments across Europe, with many of these assessments leading to price reductions or new price-volume agreements based on increased patient numbers and budget impact. Furthermore, considering the rising competition among the immunotherapy drug class and the growing overlap in patient populations, companies are having to price their therapies strategically to facilitate reimbursement and patient access versus competitors, while maximizing overall revenue.

Immunotherapy drugs present an opportunity for contracting, but payers await more competition

Immune checkpoint inhibitors present an attractive target for future contracting due to the high budget impact of the class. However, products must be deemed therapeutically equivalent across a wide breadth of indications before these practices can take place. Therapies that gain approvals in the most prevalent indications are expected to be at a significant advantage when it comes to contracting, as payers will be able to negotiate higher discounts across more expansive patient populations.

Combination therapies pose challenges for payers as many markets do not have a clear path for HTA and price negotiation

Payers are likely to implement new strategies to manage price negotiations for immunotherapy combinations in the future. Mechanisms allowing for the negotiation of different prices for combinations are absent at the moment, but several payers report that the establishment of new tools is likely to emerge in the near future. The new tools will be used to ensure that the cost of individual components is lower when used in combination compared to use as a monotherapy, and as a result the maximum net price that can be achieved will be lower.

TABLE OF CONTENTS

OVERVIEW

GLOBAL ACCESS LEVERS

  • Payers are concerned about the budget impact of immunotherapies
  • Price reductions are frequently required following label expansions into new populations
  • Tendering is likely to be used as a method of cost control in the future
  • Payers want new methods to control the cost of immuno-oncology combinations
  • PD-L1 stratification is likely to be advantageous despite lack of payer consensus on the advantages of biomarker selection
  • Keytruda has maintained a significantly higher price than competing immunotherapies across Europe
  • Payers in the US and UK prefer overall survival rate at different time points as an endpoint for immune checkpoint inhibitors

US

  • Payers report minimal reimbursement controls for immunotherapies in the US
  • Clinical pathways may have an increasing influence on prescribing in the future
  • Contracting for immunotherapies is difficult under the current buy-and-bill reimbursement
  • Bibliography

CANADA

  • Immunotherapies are recommended under the conditions of improved cost effectiveness

JAPAN

  • Price premiums are awarded for added benefit or innovation
  • Opdivo received a 60% pricing premium
  • Opdivo's price was cut dramatically following its label expansion into NSCLC
  • Reimbursement reforms in 2018 crack down on drug pricing
  • Opdivo and Keytruda subject to further price decreases in 2018
  • Bibliography

FRANCE

  • Price-volume and budget ceiling agreements are used to control the cost of immunotherapies in France
  • Exclusion from the liste en sus is the biggest threat for immunotherapies
  • Tecentriq is not yet available on the French market
  • Pricing and HTA decisions in France
  • Bibliography

GERMANY

  • Pricing negotiations are the main access lever in Germany
  • Each immunotherapy has received at least one considerable added benefit rating
  • Pricing and HTA decisions in Germany
  • Bibliography

ITALY

  • Immunotherapies benefit from innovative status
  • AIFA uses expenditure ceilings and price-volume agreements to control spend on immunotherapy drugs
  • Pricing and HTA decisions in Italy
  • Bibliography

SPAIN

  • Immune checkpoint inhibitors tend to be recommended for reimbursement nationally
  • Regional and local authorities can introduce further reimbursement requirements
  • Bibliography

UK

  • Immune checkpoint inhibitors are recommended by NICE under the conditions of a patient access scheme
  • Many immune checkpoint inhibitors gain initial funding through the Cancer Drugs Fund
  • Keytruda's approval in NSCLC triggered the £20m budget impact test
  • Immunotherapy prices are determined by their cost effectiveness in the lowest-value indication
  • Contracts for immunotherapies are likely to be introduced in the next 12 months
  • Treatment algorithms will have an increasing influence on prescribing in oncology in the future
  • NICE frequently imposes stopping criteria for immune checkpoint inhibitors

METHODOLOGY

  • Primary research
  • Price assumptions
  • Exchange rates
  • Bibliography

LIST OF FIGURES

  • Figure 1: Opdivo pricing changes in Japan
  • Figure 2: Additional medical benefit of immunotherapies in different patient populations/indications versus liste en sus inclusion
  • Figure 3: Immunotherapy patient populations versus ASMR ratings, by drug
  • Figure 4: HAS assessment dates and pricing changes for Opdivo
  • Figure 5: HAS assessment dates and pricing changes for Keytruda
  • Figure 6: HAS assessment dates and pricing changes for Yervoy
  • Figure 7: Results of G-BA added benefit assessments for immunotherapies
  • Figure 8: G-BA assessment dates and pricing changes for Opdivo
  • Figure 9: G-BA assessment dates and pricing changes for Keytruda
  • Figure 10: G-BA assessment dates and pricing changes for Yervoy
  • Figure 11: AIFA assessment dates and pricing changes for Opdivo
  • Figure 12: AEMPS reimbursement recommendations for immune checkpoint inhibitors
  • Figure 13: Reimbursement restrictions used by NICE for immune checkpoint inhibitors
  • Figure 14: Funding routes for immune checkpoint inhibitors approved in bladder cancer and NSCLC
  • Figure 15: Immunotherapies recommended for reimbursement by NICE with a two-year stopping rule
  • Figure 16: Price sources and calculations, by country

LIST OF TABLES

  • Table 1: Pricing strategies for PD-1/PD-L1 inhibitors, by country
  • Table 2: Future use of contracts/tenders for immunotherapies across the US and five major EU markets, by country
  • Table 3: Current and future cost-management techniques for combination therapies across the US and five major EU arkets, by country
  • Table 4: Relative yearly treatment costs of key immunotherapies across the five major EU markets, by drug and country ($)
  • Table 5: Bladder cancer clinical pathway used by Anthem's Cancer Care Quality Program
  • Table 6: Pricing premiums given to medicines that can demonstrate benefit over comparators
  • Table 7: Price calculation methodologies for immune checkpoint inhibitor drugs in Japan
  • Table 8: Price cuts required for products exceeding specific sales thresholds
  • Table 9: Yearly treatment costs of immune checkpoint inhibitors in Japan, by drug ($), 2014-18
  • Table 10: HTA and pricing decisions for Opdivo in France
  • Table 11: HTA and pricing decisions for Keytruda in France
  • Table 12: HTA and pricing decisions for Yervoy in France
  • Table 13: G-BA assessments of Opdivo
  • Table 14: G-BA assessments of Keytruda
  • Table 15: G-BA assessments of Yervoy
  • Table 16: G-BA assessments of Tecentriq
  • Table 17: AIFA decisions and pricing changes for Opdivo
  • Table 18: AIFA decisions for Keytruda
  • Table 19: AIFA decisions for Tecentriq
  • Table 20: National and regional reimbursement recommendations for Opdivo in renal cell carcinoma
  • Table 21: Exchange rates used for calculating branded drug prices
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