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バイオシミラー:米国における保険者の展望

Biosimilars: US Payer Perspectives

発行 FirstWord 商品コード 328749
出版日 ページ情報 英文
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バイオシミラー:米国における保険者の展望 Biosimilars: US Payer Perspectives
出版日: 2017年04月01日 ページ情報: 英文
概要

当レポートでは、米国における国および民間の保険者10団体を対象にインタビューを行った結果から、米国におけるバイオシミラーの展望を調査し、主な導入推進因子・阻害因子の分析、現在の法規制環境に対する見解、薬価設定の展開に対する期待、スイッチング、適応症の外挿など市場を形成する主な課題に関する各種見解、将来の方向性に関する分析・期待など、保険者による各種展望をまとめています。

主要課題

  • 米国におけるバイオシミラー利用の推進因子・抑制因子と過去数年における変化
  • 保険者の現在の法規制上の手続きに対する賛否見解
  • 保険者による薬価設定に関する期待:バイオシミラーとの競合に対抗する先発医薬品の薬価について
  • スイッチング・自動代替・適応症の外挿・バイオシミラーの名称変更など市場を形成する主要課題についての保険者の見解
  • 米国におけるバイオシミラーの将来に関する検証

構成の例

  • 米国市場における進捗:概要
  • バイオシミラーに対する認知度と教育
  • 現在の法規制環境
  • バイオシミラーの商品化に関する主な考察
  • バイオシミラーの商品化:ケーススタディ
    • ケーススタディ1:Zarxio
    • ケーススタディ2:Inflectra
    • ケーススタディ3:Basaglar
  • 将来の課題と市場機会

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次

Will biosimilar provide a ‘magic bullet' to drug prices in the US? Payers speak out...

Biosimilars continue to be big business in the US, but has progress has been too slow? Not so, argue payers. While the number of biosimilar approvals in the US still lags behind Europe, a solid foundation continues to be laid by multiple key stakeholder groups. Successes have been seen in key areas, including the approval of the first monoclonal antibody (mAb) biosimilar, Inflectra, and regulatory refinement. But what of the critical opportunities and challenges in the US? How do payers perceive what's important, and what can companies do to ensure commercial success?

Report Overview

Ten expert US payers from government and commercial backgrounds, and all with experience with biosimilars, share their views on the evolution of the US biosimilars market and what challenges still remain. Biosimilars: US Payer Perspectives details their insights on the current status of the US biosimilars market and how they see things evolving.

Report Features

  • In-depth interviews reveal over 200 unique and candid insights from ten 10 expert US payers from government and commercial backgrounds
  • Overview of the key areas of progress in the US biosimilars market during the last year, including an analysis of critical market shaping issues such as clinical data, regulatory progress, commercialisation, legal and policy.
  • The key issues regarding how the US biosimilars market has evolved and where payers believe future efforts need to be focused, including pricing, market access and contracting.
  • Detailed case studies on the commercialisation of two biosimilars (Zarxio and Inflectra) and one follow-on biologic (Basaglar), and what payers believe has gone well and where improvements for subsequent launches need to be made.
  • Updated insights on what the critical challenges and opportunities within the US biosimilars market are today, and what companies can do to navigate these successfully.

Key Benefits

  • Understand how the US biosimilars market has evolved over the past year and what the stand- out developments were.
  • Gain insight into the trends that are set to drive high rates of biosimilar adoption in the US, and what issues could slow this adoption down
  • Gain insight into the role of focused and unbiased education has on biosimilars, and which key stakeholder group payers believe needs to be the key focus of these educational efforts.
  • Assess the current views on drug pricing in the US, and what impact biosimilars could have on lowering prices and improving patient access.
  • Critique payer views on the evolving arguments for switching from originator brands to biosimilars, and how FDA regulations and state-level legislation needs to work in concert for this to become a reality.
  • Navigate the critical opportunities and challenges within the US biosimilars market, and understand what payers see as must-win battles to ensure a successful US biosimilars market.

Key Questions Answered By This Report

  • How have the key drivers and resistors of biosimilar usage in the US evolved over the past year?
  • Do payers agree with the current regulatory pathway for biosimilars in the US, and how do they perceive it changing moving forward, particularly in relation to interchangeability?
  • How do payers expect pricing dynamics within the US biosimilars market to evolve, and what are their expectations in relation to the pricing of originator biologics in response to biosimilar competition?
  • How have payer views in relation to the key market-shaping issues of switching, automatic substitution, extrapolation of indications, and biosimilar naming changed over the past year, and how have key events in these areas shaped and changed thinking?
  • What does the future hold for biosimilars in the US; is it a case that biosimilars need to succeed in order to support a more sustainable healthcare system, or will the biosimilars market crumble under the weight of its own expectations?

Expert Views

Each of our experts has a detailed understanding of the US pricing, reimbursement and market access landscape as it relates to biosimilars.

To enable them to express candid views, our experts have chosen to remain anonymous.

  • Clinical Advisor, Pharmacy Benefit Manager
  • Medical Director, Managed Care Organisation
  • Chief Medical Officer, National Health Plan
  • Clinical Pharmacist, Health Insurance Provider
  • Regional Clinical Manager
  • VP, National Health Insurance Provider
  • Chief Medical Officer, National Health Insurance Provider
  • Executive Director, Healthcare Services Organisation
  • Consultant, Payer Strategy
  • Consultant (former Pharmacy Director, Pharmacy Benefit Manager)

3 Key Quotes

“Physicians saw that Zarxio was highly similar and not inferior to Neupogen, so they're happy to use it. Cost then becomes an issue. Does it make sense for a health plan to adopt a product on formulary if the WAC [wholesale acquisition cost] is only slightly below that of the branded originator? In the end, nobody wants to lose money on biosimilars; the price has to be considerably lower versus where we are with a branded originator, otherwise nothing's going to change. There's lots of work to be done here. If the net/net price difference isn't worth it, then why go from the brand originator to a biosimilar?” Chief Medical Officer, National Health Plan.

“The FDA will need more data to approve a biosimilar as interchangeable. Companies will need to generate switching data, going from the originator to the biosimilar, and back again.” Regional Clinical Manager, National Health Plan.

“Huge! Enbrel and Humira are, across many plans, the number one drug by spend. If you combine them, it would be number one in the US, full stop. Humira and Enbrel biosimilars offer a huge opportunity for savings. It'll be interesting to see whether that materialises. It'll take a little bit of time, but it could be huge.” Consultant, Payer Strategy.

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Who Would Benefit from This Report?

  • Commercial teams negotiating biosimilar prices and discounts with payers
  • Marketing teams communicating the benefits and safety of biosimilars
  • Medical affairs teams, including medical science liaisons, who are building the evidence case for biosimilars with physicians and payers, and engaging with physicians about biosimilar safety and efficacy
  • Market research and HEOR teams analysing long-term real world data on biosimilar use and outcomes
  • Payer strategy teams tasked with the job of understanding what payers are looking for from biosimilars and originator brands, and how this thinking can be changed

Content Highlights

Overview of progress in the US market

  • Key insights
  • Biosimilars remain a critical element in the war against high drug prices in the US
  • Biosimilar awareness levels in the US remain below where they need to be, but educational efforts are improving
  • The biosimilar pipeline continues to advance, with positive clinical data being published for several key pipeline programmes
    • Non-monoclonal antibody (mAb) programmes
    • Anti-TNF programmes
    • Targeted oncology mAb programmes
  • Regulatory progress continues to be made, including new guidelines, more submissions and more approvals, but concerns remain regarding a potential lack of FDA resources
  • Litigation remains a key offensive and defensive strategy for companies involved in the biosimilars market
  • Commercially things are only just getting started in the US, but ground work is paying off for some products and commercial agreements are being struck
  • Policy and market access debates in the US remain focused on supporting the use of biosimilars, but critics say not enough is being done to support the industry
  • What next for the US biosimilars market?

Biosimilar awareness and education

  • Key insights
  • Lack of hands-on, real-world experience with biosimilars is preventing all key stakeholder groups from improving their knowledge and acceptance of biosimilars in the US
  • No stone should be left unturned in relation to educating key stakeholders about biosimilars, with payers, physicians and patients being the key audiences

The currently regulatory environment

  • Key insights
  • Payers are supportive of the FDA guidelines, arguing the data requirements are fair and sufficient enough to get biosimilars on formulary
  • Payer comfort with extrapolated indications has improved rapidly over the last 12 months, but physicians might represent a different challenge
  • Differentiated names for biosimilars won't impact payer decision making at all, but could help improve traceability
  • Payers predicted correctly what the FDA would require in its interchangeable biosimilar guideline, but also propose other avenues to gaining the much-coveted designation
  • While the commercial impact of interchangeable biosimilars could be considerable, some concerns remain, particularly from a patient safety and regulatory perspective
  • For the most part, payers don't believe interchangeable biosimilars are better than non-interchangeable biosimilars, but some mention a willingness to pay more for them

Key considerations in the commercialisation of biosimilars

  • Key insights
  • Payers are now leveraging multiple strategies to drive better adoption of biosimilars in the US
  • Formulary exclusions have grown in prominence as a tactic used by payers to drive better adoption of biosimilars, but they won't be used for all biosimilars
  • Payers express concern about how patients will be able to afford a biosimilar if something isn't done about filling the ‘donut hole' for self-injected products reimbursed via Medicare Part D
  • The ‘rebate trap' remains an issue for some payers, while others argue it would become a moot point if biosimilar companies discounted their products aggressively
  • Value added services are a waste of money and don't influence decision making, but biosimilar companies will need to offer something
  • Payers do have a lot of influence over the future of the US biosimilars market, but biosimilar companies must always consider physicians in their go-to-market strategy

Biosimilar commercialisation case studies

  • Key insights
  • Introduction
  • Case study 1: Zarxio
    • Sandoz's early go-to-market strategy for Zarxio has not been well received by payers
    • Amgen's response to Zarxio has ranged from implementing various commercial and 3 developmental lifecycle management tactics to simply manipulating the rebate for Neupogen
    • Payers scoff at the suggestion that a 15 percent WAC discount is enough to drive high rates or biosimilar adoption, and expect higher discounts in the future
    • Payers opine that unless Sandoz is more aggressive with its pricing for Zarxio, market share gains could stall in the high teens
  • Case study 2: Inflectra
    • Payers perceive a balanced and considered go-to-market strategy for Inflectra, with portfolio positioning, education and rational pricing all forming key elements
    • Inflectra has launched into a class with high sales, high utilisation and high price rises, and payers have become tired of attempted profiteering
    • While Pfizer's end-game for Inflectra is unknown, payers believe this first anti-TNF biosimilar will bring much needed change to the US market
    • Janssen Biotech's US defense strategy for Remicade seems fairly low key at this point, but Inflectra is on Janssen's radar and signs are that Janssen is keen to compete
    • Switching data for Inflectra will have a positive influence on the uptake of Inflectra
    • Inflectra's future market share will be shaped by aggressive discounting and a balanced reliance on newly diagnosed and established patients
    • Do payers believe indication-specific pricing in the anti-inflammatory space will become a common strategy?
  • Case study 3: Basaglar
    • While the opportunities for cost-effective options in the basal insulin category are significant, competition is fierce and payers are allowing more flexibility
    • Early suggestions are that Sanofi's response to Basaglar has been muted, but payers are seeing signs of commercially and clinically focused arguments

Future challenges and opportunities

  • Key insights
  • Payers provide mixed views on the evolution of biologic prices in the US, but argue that prices need to come down to drive sustainability
  • Payers believe that portfolios will become critical to the future success of biosimilars and could improve the value propositions of other high-cost therapies
  • All eyes are on the next wave of anti-TNF biosimilars, including biosimilars of Enbrel and Humira
  • Significant challenges remain for therapeutic oncology mAb biosimilars, but payers remain optimistic that oncologists can be convinced of their benefits
  • Biosimilar can't offer a ‘magic bullet' solution to the current issues being debated in the US healthcare system, but can provide much-needed relief if they're able to succeed
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