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市場調査レポート

癌免疫治療薬:保険者 (医療費支払者) の見解

Cancer Immunotherapy: Payer Insight

発行 FirstWord 商品コード 344328
出版日 ページ情報 英文
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=106.02円で換算しております。
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癌免疫治療薬:保険者 (医療費支払者) の見解 Cancer Immunotherapy: Payer Insight
出版日: 2015年10月01日 ページ情報: 英文
概要

当レポートでは、上市済みおよび開発中の癌免疫治療薬について、米国および欧州の主要保険者 (医療費支払者) の見解を調査し、新たな癌免疫治療薬の価値、薬価設定・償還・市場アクセスに関する見解、製薬会社への期待など、各種意見をまとめています。

調査トピック

  • 医療費の拡大:有望視される癌免疫治療薬だが、すでに高額な癌治療薬をさらに上昇させる見通し。高コスト化による医療システム・保険者への負担増の仕組みとは?
  • アクセスの限定性:高コスト性からEUおよび米国の保険者による免疫療法へのアクセスへの制限が促される。保険者が免疫療法候補薬の特定を支援するより良いデータおよびスクリーニング技術に期待する理由とは?
  • 医療改革の影響:EUでは医療改革が高額治療の薬価設定・償還・市場アクセスに大きな影響を及ぼしている。米国では「オバマケア」により同様の影響があると考えられている。医療改革の癌免疫治療薬に関する保険者の意思決定への影響とは?
  • 価格の問題:製薬会社は保険者に費用対効果分析に必要な臨床データを提供しないまま癌免疫治療薬の設定を行っている。長期的予算計画への影響と保険者の対応とは?
  • リスク共有の複雑さ:臨床データなしで適切なリスク共有の評価を行うために、保険者は癌免疫治療薬に関する他のタイプの契約を検討している。これらの契約のタイプとは?新薬の市場投入への影響とは?
  • 保険者の需要データ:保険者は製薬会社が免疫治療薬の高価格性を正当であると証明してくれること、つまり、保険者による償還手続きに有効で市場アクセスへの決定を支援するより良い、より多くの臨床データを提供をしてくれることを期待している。保険者が求めるデータの種類とその理由とは?

調査対象

  • 承認済み癌免疫治療薬
    • Keytruda (pembrolizumab; Merck & Co.)
    • Opdivo (nivolumab; Bristol-Myers Squibb)
    • Provenge (Sipuleucel-T; Dendreon, Valeantが買収)
    • Yervoy (ipilimumab; Bristol-Myers Squibb)
  • パイプライン薬
    • チェックポイント阻害剤
      • MEDI4736 (durvalumab; AstraZeneca MedImmune)
      • MPDL3280A/RG7446 (atezolizumab; Roche, Genentech)
      • CP-675/CP-675,206 (tremelimumab, AstraZeneca)
    • 癌ワクチン
      • 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)
目次
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

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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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