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市場調查報告書

癌症免疫治療藥:保險者 (醫療費付款者) 的見解

Cancer Immunotherapy: Payer Insight

出版商 FirstWord 商品編碼 344328
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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癌症免疫治療藥:保險者 (醫療費付款者) 的見解 Cancer Immunotherapy: Payer Insight
出版日期: 2015年10月01日 內容資訊: 英文
簡介

本報告提供已上市及開發中的癌症免疫治療藥調查、美國及歐洲的主要保險者 (醫療費付款者) 的見解、新的癌症免疫治療藥的價值、藥價設定、償付、市場進入相關見解、對製藥公司的預期等、各種意見彙整。

調查專題

  • 醫療費的擴大:癌症免疫治療藥雖然被看好,不過預計將使已經高額的癌症治療藥更加上升。高成本化的醫療系統、保險者的負擔增加的機制為何?
  • 存取的限制性:由於高成本性促使EU及美國保險者獲取免疫療法受限制。保險者期待支援特定免疫療法候補藥的更佳資料及篩檢技術的理由為何?
  • 醫療改革的影響:EU醫療改革帶給高額治療的藥價設定/償付/市場進入大幅影響。據信美國根據「歐巴馬健保案」有同樣的影響。醫療改革的癌症免疫治療藥對相關保險者的決策的影響為何?
  • 價格的問題:製藥公司不提供保險者成本效益分析必要的臨床資料便進行癌症免疫治療藥的設定。對長期預算計劃的影響和保險者的對應為何?
  • 風險共享的複雜度:為了在沒有臨床數據下進行恰當的風險共享評估,保險者研究除了癌症免疫治療藥之外類型的契約。這些契約的類型為何?對新藥投入市場的影響為何?
  • 保險者的需求資料:保險者期待製藥公司願意證明免疫治療藥的高價格正當性,也就是,提供保險者的償付手續有效且支援市場進入的決策更佳,更多臨床資料。保險者尋求的資料類與其理由為何?

調查對象

  • 已受核准癌症免疫治療藥
    • Keytruda (pembrolizumab; Merck & Co.)
    • Opdivo (nivolumab; Bristol-Myers Squibb)
    • Provenge (Sipuleucel-T; Dendreon, Valeant收購)
    • Yervoy (ipilimumab; Bristol-Myers Squibb)
  • 開發平台藥物
    • 查核點抑制劑
      • MEDI4736 (durvalumab; AstraZeneca MedImmune)
      • MPDL3280A/RG7446 (atezolizumab; Roche, Genentech)
      • CP-675/CP-675,206 (tremelimumab, AstraZeneca)
    • 癌症疫苗
      • T-VEC (talimogene laherparepvec; Amgen BioVex)
      • PROSTVAC (rilimogene galvacirepvec-rilimogene glafolivec; Bavarian Nordic, Bristol-Myers Squibb)
    • CD19標的CAR-T細胞療法
      • Tisagenlecleucel-T (anti-CD19-CAR transduced T cells; Novartis)
      • KTE C19 (anti-CD19 chimeric antigen receptor transduced T cells; Kite)
      • JCAR 014 (anti-CD19/4-1BB/zeta modified CAR CD8+ central memory and CD4+ T lymphocyte therapy; Juno Therapeutics)
      • JCAR 017 (anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy; Juno Therapeutics)
      • JTCR 016 (WT1-sensitised allogeneic T-lymphocytes; Juno Therapeutics)
目錄
Product Code: 596200411

Immunotherapies are some of the most promising new weapons in the fight against cancer. But are they promising enough to justify their sky-high prices? Payers aren't convinced, and say they need better data to make effective market access and reimbursement decisions.

FirstWord's Payer Insight: Cancer Immunotherapy report explains why. This 111-page report gives you an in-depth account of how 12 leading payers in the US and Europe see the cancer immunotherapy landscape.

You'll discover payers' top concerns, find out how they assess the value of new cancer immunotherapy drugs, and get their candid thoughts on pricing, reimbursement, market access, and what they expect from pharma companies.

The report also includes analyses of 4 leading approved immunotherapies, and 10 pipeline drugs currently in clinical trials.

View: US Payers, EU Payers, Approved drugs, Pipeline drugs

“The financial burden of the prices of these drugs is putting a very high strain on the overall budget for CMS and managed care.” - US Payer

Order the report and you'll also receive three quarterly FirstWord Therapy Trends Update Bulletins absolutely free!

Answering key questions:

Get answers to key questions about approved and pipeline immunotherapies:

  • Checkpoint Inhibitors: how will competition affect pricing negotiations as late-stage pipeline checkpoint inhibitors come on the market?
  • Cancer Vaccines: how will new market entrants escape the shadow of Provenge-a costly early cancer vaccine that overpromised and underdelivered, leaving payers feeling sceptical?
  • CD19-targeted CAR-T Treatments: with only preliminary data available, how will payers evaluate these new treatments?
  • Combination therapies: how will changes to policy and legislation help payers accommodate complex and extremely costly combination therapies?

Top Takeaways

  • Rising Costs: though promising, cancer immunotherapies are set to increase the already high cost of oncology drugs. Find out how higher costs are straining healthcare systems and challenging payers.
  • Restricted Access: high costs are prompting payers in both the US and EU to restrict access to immunotherapies. Find out why payers expect better data and screening techniques to help identify candidates for immunotherapy treatment.
  • Effect of Health Reforms: in the EU, healthcare reforms are having a big impact on pricing, reimbursement and market access for expensive treatments. In the US “Obamacare” is expected to have a similar effect. Learn how these reforms affect payer decision-making for cancer immunotherapies.
  • Pricing Problems: pharma companies are setting prices for cancer immunotherapies without giving payers the clinical data they need for cost-benefit analyses. Find out how this affects long-term budgeting, and how payers are responding.
  • Risk Sharing Too Complex: without the clinical data they need to properly assess risk-sharing, payers are considering other types of agreements for cancer immunotherapies. Find out what those are and how they affect the way new drugs are brought to market.
  • Payers Demand Data: payers expect pharma companies to justify the high prices they charge for cancer immunotherapy drugs. That means providing more and better clinical data to help payers make reimbursement and access decisions. Find out what kind of data payers want and why.

Key Issues Explored

  • Costs for cancer treatments are rising, and will continue to rise as regulators approve more immunotherapies. Governments are bearing a larger share of these costs.
  • Payers use a variety of data to evaluate new drugs and make reimbursement and access decisions. The lack of real-world data about the clinical benefits of cancer immunotherapies is a growing challenge.
  • Recent healthcare reforms (e.g., the US's Obamacare, the UK's EAMS and Cancer Drugs Fund, Germany's AMNOG law, France's law of formal HAS assessment) are having a significant impact on reimbursement and access decisions for cancer immunotherapies.
  • Payers believe that pharma companies do not properly appreciate their budget limitations. Reducing the costs of immunotherapy drugs is a top priority.
  • Bottom line: to justify the high cost of cancer immunotherapies, pharma companies must give payers more and better clinical data. Payers see increasing competition in the immunotherapy space as an opportunity to demand it.

A report based on expert knowledge

US Payers*

  • Medical Director; Policy, Formulary Management, Managed Care Organisation
  • Chief Medical Officer and Chair of the P&T (Pharmacy and Therapeutics) in charge of Medical and Quality; Managed Care Organisation
  • Pharmacy Director; Community Health Plan
  • National Managing Senior Medical Director; Managed Care Organisation
  • Medical Director; Managed Care Organisation
  • Director of Clinical Pharmacy Services; Pharmacy Benefit Manager

EU Payers*

  • Leading Health Economist (France)
  • Medical Director; Association of Statutory Health Insurance Physicians (Germany)
  • G-BA member (Germany)
  • Chief Pharmacist; Specialist Oncology Hospital (UK)
  • Formulary Pharmacist; large teaching hospital focused on oncology (UK)
  • Transparency Committee Member (France)

* Due to the sensitive nature of the interviews and comments made, respondents requested that their identities remain confidential.

Get Payer Insights Into

Approved Cancer Immunotherapy Drugs

  • Keytruda (pembrolizumab; Merck & Co.)
  • Opdivo (nivolumab; Bristol-Myers Squibb)
  • Provenge (Sipuleucel-T; Dendreon, now acquired by Valeant)
  • Yervoy (ipilimumab; Bristol-Myers Squibb)

Cancer Immunotherapy Pipeline Drugs

Checkpoint Inhibitors:

  • MEDI4736 (durvalumab; AstraZeneca [MedImmune])
  • MPDL3280A/RG7446 (atezolizumab; Roche, Genentech)
  • CP-675/CP-675,206 (tremelimumab, AstraZeneca)

Cancer Vaccines:

  • T-VEC (talimogene laherparepvec; Amgen [BioVex])
  • PROSTVAC (rilimogene galvacirepvec-rilimogene glafolivec; Bavarian Nordic, Bristol-Myers Squibb)

CD19-targeted CAR-T Treatments:

  • Tisagenlecleucel-T (anti-CD19-CAR transduced T cells; Novartis)
  • KTE C19 (anti-CD19 chimeric antigen receptor transduced T cells; Kite)
  • JCAR 014 (anti-CD19/4-1BB/zeta modified CAR CD8+ central memory and CD4+ T lymphocyte therapy; Juno Therapeutics)
  • JCAR 017 (anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy; Juno Therapeutics)
  • JTCR 016 (WT1-sensitised allogeneic T-lymphocytes; Juno Therapeutics)

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Table of Contents(SAMPLE)

Executive Summary

Research Objectives

Research focus

Cancer Immunotherapy market overview

  • Financial burden of cancer
  • Targeting the immune system to develop cancer treatments
  • Approved cancer immunotherapy drugs
    • Opdivo(nivolumab; Bristol-Myers Squibb)
    • Keytruda(pembrolizumab; Merck & Co.)
    • Yervoy(ipilimumab; Bristol-Myers Squibb)
    • Provenge(Sipuleucel-T; Dendreon, now acquired by Valeant)
  • Pipeline Cancer immunotherapy drugs
    • Checkpoint inhibitors
    • Cancer vaccines
    • CD19-targeted CAR-T treatments

Pricing, reimbursement (PR) and market access (MA)

  • Current processes of reviewing new drugs
    • Process of drug review in the US
    • Process of drug review in the EU
  • Key influences over reimbursement decision making
    • Key data for PR and MA decision making
  • Current scenarios for managing PR and MA
    • Current ways of providing access to drugs in the US
    • Current ways of providing access to drugs in the EU

Perspectives on future drug launches

  • How do payers assess the value of new drugs ?
  • Payer awareness and key concerns about new drugs
    • Checkpoint inhibitors
    • Cancer vaccines
    • CD19 targeted CAR-T treatments

Perspectives on pricing, reimbursement and market access for future drug

  • Impact of healthcare reforms in shaping PR and MA strategies
    • Impact of Obamacare
    • Future of the CDF and impact of EAMS
    • Impact of AMNOG law and sickness fund
    • Impact of formal health assessment in France
  • Payer's sentiments and challenges in making reimbursement and access decisions
    • Pharma's insensitivity to pricing excess and payer's difficulty planning long-term budgets
    • Cancer immunotherapies as first line therapy will not reduce costs in the longer term
    • Challenges in PR and MA decisions for cancer immunotherapy drugs
  • Future strategies for controlling reimbursement & access to new drugs
    • Payers' perspective on the future of cancer immunotherapy drugs market
    • Payer opinions on outcome-based risk sharing contracts
    • Discounting and rebating expectation
    • What payers will, and will not, pay for
  • Past mistakes, lessons learned and advice for pharmaceutical companies
    • Past mistakes and lessons learned
    • Advice to pharmaceutical companies

Appendix

  • Payers interviewed for this report
    • US payers
    • EU payers
  • Cancer Immunotherapy Drugs: Key Clinical Trials
    • Opdivo
    • Keytruda
    • Yervoy
    • Atezolizumab
    • Durvalumab
    • T-VEC
    • CD19-targetd CAR-T treatments
    • Cancer Immunotherapy Combinations
  • Abbreviations
  • Glossary
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