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市場調查報告書

到醫藥品上市所需時間的管理:超越醫藥品的商品化及業務能力上的框架的調整

Managing Market Access Launch Activities: Benchmarking Product Commercialization and Cross-Functional Coordination

出版商 Cutting Edge Information 商品編碼 353259
出版日期 內容資訊 英文 75 Pages
商品交期: 最快1-2個工作天內
價格
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到醫藥品上市所需時間的管理:超越醫藥品的商品化及業務能力上的框架的調整 Managing Market Access Launch Activities: Benchmarking Product Commercialization and Cross-Functional Coordination
出版日期: 2016年01月31日 內容資訊: 英文 75 Pages
簡介

本報告提供醫藥品的上市前後12個月間主要的市場進入活動相關基準,時間,保險者關係策略和價值的提案 (Value Dossier)、支援新產品的醫藥品的經濟性評估的專門知識,及醫藥品上市的優先順序等相關資料,調查分析 。

摘要整理

市場進入策略及活動時機的最佳化

  • 將內部專門知識合併到市場進入開始策略的通知
  • 最大化市場進入活動的影響的時機

上市時的保險者關係的管理

  • 健康技術評估的利用有助於歐洲的醫療費償付
  • 到市場進入為止的時間的管理市場的業務經理的調整

全世界的產品銷售的管理

  • 價格、醫療經濟學專家支持產品的銷售
  • 醫藥品的銷售的優先順序
目錄
Product Code: PH217

Market access teams in the launch window are responsible for several different aspects of a product's commercial success. However, they are not always positioned to make that juggling act easy:

  • Collecting and disseminating health economics data that do not always originate from the market access umbrella present a significant challenge for some groups.
  • Other companies struggle to appropriately resource product pricing and payer relationship groups that need to hit the ground running once a product is approved.
  • For some market access groups, coordinating with regulatory teams to maintain a successful launch sequence is a major hurdle.

This report presents benchmarks on key market access activities in the 12 months before and after product launch. For many surveyed groups, the scarcest resource is time, as a multitude of activities are compressed into tight 6- or 12-month planning windows that do not fit the workload. In light of this immense time pressure, starting early discussions on payer relationship strategy and value dossiers is crucial to product success. As a product launches, the market access team should have an appropriate level of pharmacoeconomic expertise to support new products. Finally, another essential element that determines a product's success is its launch sequence. Further benchmarks in this report include data on pricing teams and working with regulatory affairs teams on launch sequencing.

THREE KEY FINDINGS FOR SUCCESSFUL MARKET ACCESS LAUNCH WINDOWS

Cutting Edge Information's analysts synthesized the following three key findings and recommendations from the full breadth and depth of this project's research. These principles are signposts to help improve your company's strategy for market access launch activities. While these points are not inclusive of all elements in this report, they emphasize some of its central and most critical concepts.

BEGIN MARKET ACCESS LAUNCH ACTIVITIES EARLY IN THE PRODUCT LIFECYCLE TO MAXIMIZE IMPACT

Life science organizations must implement a number of market access activities - ranging from global launch sequencing to payer relationship management - leading up to brand commercialization. For successful product launches, firms should begin these activities well in advance to better meet fluctuating economic trends and evolving regulatory expectations. Market access teams must also have time to collect key supporting data - including health economics and outcomes research (HEOR), patient-reported outcomes (PROs) and comparative effectiveness research (CER). In today's regulatory environment, these data play a critical role in payer relationship management and market access discussions.

Surveyed pharmaceutical and device firms recognize the importance of beginning market access activities early in the product lifecycle. Figure E.1 shows surveyed companies' average current and ideal start times for specific market access activities relative to product launch dates. Across all activities, surveyed companies begin the task prior to product launch. Start times range from an average 3.3 months prior to launch for PROs to 15.1 months pre-launch for launch sequencing tasks.

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Surveyed life science organizations typically begin market access activities before product launch. However, current average start times are much later than reported ideal average start times. Ideally, companies surveyed would begin market access activities an average 20.6 months pre-launch with launch sequencing. This activity is particularly important as teams prepare to combat pricing referencing during global launches. Other key activities should begin by 18 months before product launch date, including general market access, product pricing and HEOR.

The reported differences between average current and ideal start dates vary across market access activities. Surveyed companies report the smallest variances between average current and ideal activity starts for general market access and CER - which begin 4.6 months and 3.2 months after their ideal start, respectively. However, surveyed firms report much larger variances for payer relationship management and patient-reported outcomes - at an average 7.1 and 7.2 months later than the ideal start date, respectively.

DIFFERENTIATE HTA AND VALUE DOSSIER PLANNING FOR INNOVATIVE AND FOLLOW-ON PRODUCTS

In a price-sensitive payer marketplace, pharmaceutical companies are being asked to provide increasingly detailed pharmacoeconomic data on new products. In Europe and other highly structured markets, health technology assessments (HTAs) are increasingly important. In countries such as the US where there are few formalized HTA guidelines, the value story is still an important part of any successful launch. However, not all products require the same kind of support, and market access groups should plan their activities around launch accordingly.

HTA and value dossier support for innovative products typically begins over a year before launch as data are collected on cost-effectiveness and budget impact models. In European markets where payers are particularly cost sensitive, many companies indicate that value discussions for innovative products start up to three years before launch. Surveyed companies typically start preparing value stories for follow-on products around three to six months before product launch.

HTAs and value dossiers require support from a skilled team of managed markets account managers or market access field forces to deliver data to payers and work with payers through the pricing and negotiation process. Managed markets account managers are best able to disseminate crucial HEOR data with support from health outcomes liaisons and medical science liaisons. Among groups interviewed for this study, the pharmacoeconomic support provided to account managers was crucial in making sure that payers understood the true value of a newly launched product.

CONSISTENT MARKET ACCESS AND REGULATORY COMMUNICATION HELPS MAINTAIN LAUNCH SEQUENCES

Launch sequences are typically determined well in advance of a product launch. But inevitably, teams encounter the real world, where part of a licensing cascade may not go perfectly according to plan. In some cases, this reality is a delayed regulatory approval that requires an adjustment to the overall launch sequence. However, in some cases, the potentially good news of an early regulatory approval can turn sour if a local business unit presses ahead with a launch in a lower price market that jeopardizes the planned reference pricing baskets.

Many companies try to avoid this problem altogether by maintaining constant contact with regulatory groups to make sure that licensing cascades stay in step with the planned launch sequence. As shown in Figure E.2, surveyed global market access groups tend to have monthly meetings with regulatory groups as early as one year before launch. As the product gets closer to launch, 67% of those surveyed have weekly meetings. At the start of the first launch wave, 67% of surveyed global market access groups are meeting with regulatory groups daily to make sure that both groups remain in lockstep. Once the product has been on the market for up to a year, the regularity of meetings slows until the next product launch.

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Outside of regulatory groups, a good launch sequence can be derailed by an overeager country-level business unit that presses ahead with an early launch. Interviewed companies that have dealt with this detail the way such an early move can ripple through an entire product's profits. Companies can preempt this problem by actively engaging local groups on the importance of maintaining the planned launch sequence and working to make sure that processes are in place to prevent rogue local launches.

Table of Contents

Executive Summary

  • Figure E.1: Current and Ideal Start Time for Market Access Activities Relative to Product Launch Date: All Companies
  • Figure E.2: Frequency of Launch Team Meetings with Internal Regulatory Groups: Global Teams

Optimizing Market Access Strategies and Activity Timing

Combine Internal Expertise to Inform Market Access Launch Strategies

  • Figure 1.1: Market Access Group Involvement in Launch Activities
  • Figure 1.2: Managed Markets Group Involvement in Launch Activities
  • Figure 1.3: Marketing Group Involvement in Launch Activities

Timing Market Access Activities to Maximize Impact

  • Figure 1.4: Current and Ideal Start Time for Market Access Activities Relative to Product Launch Date: All Companies
  • Figure 1.5: Current Market Access Activity Start Time, by Company Type and Portfolio Size: General Market Access
  • Figure 1.6: Ideal Market Access Activity Start Time, by Company Type and Portfolio Size: General Market Access
  • Figure 1.7: Current Market Access Activity Start Time, by Company Type and Portfolio Size: Product Pricing
  • Figure 1.8: Ideal Market Access Activity Start Time, by Company Type and Portfolio Size: Product Pricing
  • Figure 1.9: Current Market Access Activity Start Time, by Company Type and Portfolio Size: Payer Relationships
  • Figure 1.10: Ideal Market Access Activity Start Time, by Company Type and Portfolio Size: Payer Relationships
  • Figure 1.11: Current Market Access Activity Start Time, by Company Type and Portfolio Size: Launch Sequencing
  • Figure 1.12: Ideal Market Access Activity Start Time, by Company Type and Portfolio Size: Launch Sequencing
  • Figure 1.13: Current Market Access Activity Start Time, by Company Type and Portfolio Size: Health Economics
  • Figure 1.14: Ideal Market Access Activity Start Time, by Company Type and Portfolio Size: Health Economics
  • Figure 1.15: Current Market Access Activity Start Time, by Company Type and Portfolio Size: Comparative Effectiveness
  • Figure 1.16: Ideal Market Access Activity Start Time, by Company Type and Portfolio Size: Comparative Effectiveness
  • Figure 1.17: Current Market Access Activity Start Time, by Company Type and Portfolio Size: Patient- Reported Outcomes
  • Figure 1.18: Ideal Market Access Activity Start Time, by Company Type and Portfolio Size: PROs

Managing Payer Relationships at Launch

Using Health Technology Assessments to Aid European Reimbursement

  • Figure 2.1: Time Before Launch that Groups Begin Preparatory HTA Discussions for Innovative Products at Top 10 and Top 50 Companies: US Payers
  • Figure 2.2: Time Before Launch that Groups Begin Preparatory HTA Discussions for Innovative Products at Small Companies: US Payers
  • Figure 2.3: Time Before Launch that Groups Begin Preparatory HTA Discussions for Follow-On Products at Top 10 and Top 50 Companies: US Payers
  • Figure 2.4: Time Before Launch that Groups Begin Preparatory HTA Discussions for Follow-On Products at Small Companies: US Payers
  • Figure 2.5: Time Before Launch that Groups Begin Preparatory HTA Discussions for Innovative Products: EU Payers
  • Figure 2.6: Time Before Launch that Groups Begin Preparatory HTA Discussions for Follow-On Products: EU Payers

Coordinating Managed Market Account Managers in the Launch Window

  • Figure 2.7: Total Number of Managed Markets Account Managers at Launch Among US Groups, by Company Type
  • Figure 2.8: Number of Managed Markets Account Managers per Product at Launch Among US Groups, by Company Type
  • Figure 2.9: Total Number of Managed Markets Account Managers at Launch Among US Groups, by Portfolio Size
  • Figure 2.10: Number of Managed Markets Account Managers per Product at Launch Among US Groups, by Portfolio Size
  • Figure 2.11: Average Number of Meetings with Private Payers Among US Groups, by Time Around Launch
  • Figure 2.12: Average Number of Meetings with Government Payers Among US Groups, by Time Around Launch
  • Figure 2.13: Average Duration of Meetings with Private Payers Among US Groups, by Time Around Launch
  • Figure 2.14: Average Duration of Meetings with Government Payers Among US Groups, by Time Around Launch
  • Figure 2.15: Timing of First Formal Contact with Payers Among Top 10 and Top 50 Companies
  • Figure 2.16: Timing of First Formal Contact with Payers Among Small Companies

Managing Global Product Launches

  • Figure 3.1: Percentage of Time and Spending Dedicated to Single Product in First 12 Months on Market, by Portfolio Size
  • Figure 3.2: Number of Pricing FTEs Supporting a New Product Around Launch: Global and US Groups

Supporting Product Launches with Pricing and Health Economics Expertise

  • Figure 3.3: Number of Pricing FTEs Supporting a New Product at US Groups Around Launch: Innovative vs Follow-on Products
  • Figure 3.4: Number of Pricing FTEs Supporting a New Product at Global Groups Around Launch: Innovative vs Follow-on Products
  • Figure 3.5: Number of Pricing FTEs Supporting a New Product at US Groups Around Launch: Blockbuster vs Niche Products
  • Figure 3.6: Number of Pricing FTEs Supporting a New Product at Global Groups Around Launch: Blockbuster vs Niche Products
  • Figure 3.7: Minimum and Maximum HEOR Expenditure per Product, by Time Around Launch: US Groups
  • Figure 3.8: Minimum and Maximum HEOR Expenditure per Product, by Time Around Launch: Global Groups

Product Launch Sequencing

  • Figure 3.9: Team with Final Responsibility for Approving Launch Sequence
  • Figure 3.10: Organization of Launch Sequencing Responsibilities: All Companies
  • Figure 3.11: Organization of Launch Sequencing Responsibilities: By Company Size
  • Figure 3.12: Organization of Launch Sequencing Responsibilities: By Portfolio Size
  • Figure 3.13: Frequency of Launch Team Meetings with Internal Regulatory Groups: Country-Level Teams
  • Figure 3.14: Frequency of Launch Team Meetings with Internal Regulatory Groups: Global Teams
  • Figure 3.15: Launch Sequencing Preferences Among Surveyed Companies, by Wave of Launch: Major Markets
  • Figure 3.16: Launch Sequencing Preferences Among Surveyed Companies, by Wave of Launch: Asia Pacific
  • Figure 3.17: Launch Sequencing Preferences Among Surveyed Companies, by Wave of Launch: Latin America
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