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リアルワールドデータ (RWD):保険者ニーズへの対応

Real World Data -- Meeting payer needs

発行 FirstWord 商品コード 509320
出版日 ページ情報 英文
納期: 即日から翌営業日
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リアルワールドデータ (RWD):保険者ニーズへの対応 Real World Data -- Meeting payer needs
出版日: 2017年05月01日 ページ情報: 英文
概要

当レポートでは、リアルワールドデータ (RWD) に関する現況および保険者ニーズへのより良い対応などについて考察しており、保険者の態度を形成する動向とRWD需要の水準、RWDを用いる際に保険者が直面する課題、保険者がRWDから求めるもの、および医薬品会社にとっての新たなアイデアと次のステップなどについて、まとめています。

目次

  • エグゼクティブサマリー
  • 調査目的・調査手法
  • リアルワールドデータ (RWD) の定義
  • リアルワールドデータ (RWD) はどのように医薬品予算への圧力を緩和できるのか
  • 米国において保険者のリアルワールドデータ (RWD) への態度を形成する動向
  • 欧州は薬剤価格の上昇に選択肢を比較検討
  • 米国におけるパフォーマンスベースの医薬品コンバージェンスは依然として低水準
  • パフォーマンスベース契約に対して変化しやすいEU5のサポート
  • 米国における保険者のリアルワールドデータ (RWD) に対する需要
  • EU5は様々なリアルワールドデータ (RWD) への関心を示す
  • 保険者が求めるRWDの種類は?
  • リアルワールドデータ (RWD)を使用する問題
  • 保険者はRWDから何を求めているか
  • 保険者のRWD使用の将来、ほか
目次

How to adjust your Real World Data provision to address the real needs of payers

Drug costs are spiralling upwards and so too are frustration levels. Payers with stretched budgets are still struggling to make the case for ‘big ticket' drugs. Whereas pharma is keen to prove that higher cost drugs are justified and will ultimately save money. But are payers listening? And just how convinced are payers by Real World Data (RWD)? Is the evidence being provided matching their needs - or is it missing the point?

Report Overview

Real World Data: Meeting Payer Needs offers a clear and practical assessment of the current mood regarding RWD, along with insight into what is needed to better meet payer needs and improve impact. In this revealing report, 10 senior-level European and US payers and payer influencers share their frank and honest professional views. The pros and cons of current RWD provision are covered in depth, along with thoughts on how pharma can better address payer challenges with RWD.

Report Features

  • A robust assessment of the trends shaping payer attitudes and levels of demand for RWD.
  • Insight into the challenges facing payers when using RWD. What are their key issues and concerns? What specific factors are hindering uptake?
  • A clear assessment of what payers want from RWD, including a range of views from the US and across Europe.
  • New ideas and next steps for pharma, taking account of the full spectrum of payer needs, how to respond to specific challenges, and potential future scenarios to consider.

Key Benefits

  • Remove the guesswork: Gain clarity on what payers say they want to see from RWD if it is to be embraced and fully utilised. Focus finite RWD resources on addressing real needs.
  • Results-oriented: Understand how to better integrate payer needs into the design and roll-out of RWD collection projects in the short- and long-term.
  • Build positive relationships: Stand out from the rest by understanding the practicalities from the payers' perspective and responding with more relevant, timely and usable RWD.
  • Take action: Review a comprehensive set of recommendations and find out exactly what action is required to move RWD to the next level with payers.

Why is it so important for pharma to change its Real World Data approach?

Although a handful of risk sharing schemes are bearing fruit, the industry has a long way to go before Real World Data is widely accepted and used as a matter of course by payers. Payment for performance makes sense for patients, payers and drug companies - but achieving this will not be easy whilst there is an underlying lack of trust in the evidence provided. Pharma can and must find new ways to close the gap between what payers want, what is provided, and how it is perceived. If not, following established routines for drug pricing will continue to be the easiest option.

Key Questions Answered By This Report

  • How do payers regard RWD as a means of substantiating drug pricing, reimbursement and uptake?
  • Are payers prepared to embrace outcomes-oriented budgeting, supported by RWD?
  • What are the weaknesses in the currently available sources of RWD?
  • What are the most important components of RWD for payers, in relation to drug effectiveness, cost-effectiveness, safety, budget impact and adherence rates?
  • At what point in the budget cycle do payers want to receive RWD, how often, and for how long?
  • How will RWD change the way market-access decisions are made by payers over the next five years?

Who Will Benefit from this Report?

  • Corporate leaders looking to position their company in niche orphan disease opportunity areas
  • Business development teams profiling potential acquisition or collaboration opportunities
  • Research managers planning clinical research programmes
  • Regulatory teams applying for and monitoring trends in FDA and EMA orphan drug designation
  • Competitive intelligence professionals tracking the activity of key competitors in their field of interest
  • Financial and consultancy professionals identifying investment opportunities.

Expert Views

The 10 experts interviewed for this report are senior payers and payer influencers based in the US and Europe. Each has significant experience of RWD and how it is being used currently. To enable them to express candid views, our experts have chosen to remain anonymous.

  • US Payer 1: Pharmacy director at a US health maintenance organisation
  • US Payer 2: Chief pharmacy officer and business director at a US pharmacy-benefit organisation
  • US Payer 3: Manager of specialty and pharmacy contracts at US full-service health-benefits company
  • US Payer 4: Clinical adviser at large US pharmacy and healthcare provider
  • US Payer 5: US clinical pharmacist
  • French Payer: Hospital pharmacologist with key influence on pricing and reimbursement committee
  • German Payer: Budget manager, pharmaco-economic expert and adviser to the Federal Joint Committee (G-BA)
  • Italian Payer: Regional payer and member of Technical and Scientific Committee (CTS) at Italian Medicines Agency (AIFA)
  • Spanish Payer: Payer and pharmacoeconomic expert, adviser to the Spanish Agency for Medicines and Health Products (AEMPS) and the Inter-Ministerial Pricing Commission (CIPM)
  • UK Payer: Commissioning Lead Pharmacist for clinical commissioning group in NHS England

3 key quotes:

“It will definitely increase. I think everybody is interested in it conceptually across the field. We are getting good value for the dollars we are spending, and as those dollars continue to grow dramatically, we are trying to justify what we're doing. From a management perspective, we are under a lot of pressure: drug costs go up and people don't believe we are managing.” US Payer.

“Because we can have one-year, two-year data, we are starting to look at the frequency compared with the licence ..... and affordability. We are using those data then to assess how much things are really costing us and potentially reviewing patients that aren't benefiting.” UK Payer.

“Horizon-scanning is something we have been doing for many years, but independent of the industry. And interaction, but more on access questions, market access, reimbursement and pricing - not so much on real-world evidence. It needs to be independent data from independent institutions, scientific institutions, independent databases. And if not, then we don't trust it, because it's difficult to manipulate an RCT but very easy to manipulate real-world evidence.” German Payer.

Who Would Benefit from This Report?

  • Market access teams evolving payer-centric strategies
  • Payer liaison specialists seeking to meet all requirements and fill gaps
  • Senior leadership teams looking for a return on RWD project development and investment
  • IT teams responsible for data collection, processing and access
  • R&D planning trial conversion into real world data collection points
  • Health economics and outcomes research (HEOR) professionals creating robust, relevant analyses

Table of Contents(Content Highlights)

  • Executive Summary
  • Research objectives and methodology
    • Experts interviewed for this report
  • Defining real-world data
  • How real-world data could ease pressure on drug budgets
    • Key insights
    • Pharmaceutical innovation is weighing on health systems
    • Costs are skewed to specialty medicines
    • Niche indications are commercially attractive
    • Concerns are building over high-cost drugs
      • Case Study 1: Squaring cost-effectiveness with affordability: direct-acting antivirals for hepatitis C
    • Cost pressures from oncology
    • Do the benefits of new drugs justify the costs?
    • Specialty drugs dominate US payer concerns
    • EU5 payers' drug-budget concerns
  • Trends shaping payer attitudes to real-world data in the US
    • Key insights
    • US political impact on RWD is hard to gauge
    • Questions raised over PBM strategies
  • Europe weighs options for drug-price escalation
    • Key insights
    • EU trends with implications for RWD uptake
    • Risk-sharing schemes are not widely used across the EU5
    • EU collaboration is more about cost-containment
    • Payers are already clamping down on costs
      • Cost-containment mechanisms applied to medicines in the US
      • Case Study 2: NHS England gets tough with high-cost medicines
    • Pharma is keen to push the value of RWD
  • Performance-based coverage of medicines still at a low level in the US
    • Key insights
    • Question mark over outcomes-based contracting in the US
  • Variable EU5 support for performance-based contracts
    • Key insights
  • Payer demand for real-world data in the US
    • Key insights
    • US payers prefer their own internally generated RWD
  • EU5 payers show varying interest in RWD
    • Key insights
    • Italy
    • Spain
    • UK
    • Germany
    • France
    • EU5 payers can tap into public-health systems
  • What type of RWD do payers look for, and are they generating their own?
    • Key insights
    • US payers data-mine only selectively
    • The role of digital technology in US data-gathering
    • EU5 payers are not proactive about generating RWD either
    • EU5 payers are equivocal on health wearables
    • How much data do US payers need, and how broad should RWD be?
    • EU5 opinions vary on suitable RWD population
  • Local conditions play into RWD demand and access
    • Key insights
  • The challenges of using real-world data
    • Key insights
    • Problems with incompleteness, lack of integration, quality, integrity
    • European payers are more concerned about RWD quality
    • Would global standardisation of RWD help?
    • National autonomy complicates RWD standardisation in the EU5
    • Technical and practical challenges to RWD uptake
    • Budget cycles, discontinuity complicate US RWD uptake
    • Data privacy, budget cycles, siloed datasets are common concerns in EU5
  • What payers want from RWD
    • What payers want from RWD in the US
      • Key insights
      • RWD can show where and how a drug is best used
      • When to deliver RWD in the US, and how often
      • Horizon-scanning and talking to industry
    • What payers want from RWD in Europe
      • Key insights
      • RWD in the EU5 markets targets co-morbidities, budget impact, adherence
    • When to deliver RWD in Europe
    • Trust issues but some interaction with pharma in EU5
  • Future scenarios for payer use of RWD
    • Key insights
    • RWD will gain traction in the US, but slowly
    • EU5 payers envisage selective use of RWD
  • Conclusion
  • Recommendations for industry action