Pharmaceutical Launch Sequencing (PH219)

Establishing Patient Access and Understanding Global Pricing
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Published 2016
79 Pages
400+ Metrics
60+ Charts and Diagrams

Pharmaceutical Launch Excellence: Optimize Your Launch Sequence for Maximum Global Market Uptake

For pharmaceutical companies to maximize revenue and achieve global market access, setting a global launch sequence is critical. Pharmaceutical launch excellence requires extensive research and planning to coordinate the product launch effectively around the world.

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Cutting Edge Information’s benchmarking study, Pharmaceutical Launch Sequencing, is designed to help companies maximize their margins when launching products worldwide. This study provides executives with insights about pharmaceutical launch excellence and sequencing. It includes answers to specific questions on how to optimize launch sequencing and best allocate resources in this space. The report also identifies key trends in how companies approach launch sequences and in what drives decision making among internal and external stakeholders.

The report’s data were compiled from global, US and country-level teams for Top 10, Top 50, and small pharma companies. Armed with this information, market access teams can move forward with global launches and learn how small adjustments to launch sequences can result in a significant impact on revenue and overall market access.

Emerging trends examined in Pharmaceutical Launch Sequencing center on improving companies’ strategies for pharmaceutical product launch activities. Those trends include:

  • Assign final launch sequencing decisions to C-level executives.
  • Look to regulatory guidances to drive global launch decisions.
  • Prepare for the growing importance of BRIC markets as second wave launch targets.
  • Engage with regulatory teams throughout launch sequencing planning and execution.

 

Key Questions That This Study Answers About Pharmaceutical Launch Excellence and Sequencing

  1. What strategies can my company employ to improve cross-functional coordination of pharma launch excellence and sequencing tasks?
  2. What is the best approach for my product: an adjustable launch sequencing template or an individual plan customized to the product?
  3. What factors drive decision making in pharmaceutical product launch sequencing? Who should have final decision-making responsibility?
  4. How much should my company allocate to global launch sequencing spending?
  5. How does geography impact budget levels, and what studies/tools should be prioritized when setting launch sequencing budgets?
  6. How can my company boost communication and launch sequencing involvement from regulatory teams to facilitate a successful licensing cascade?
  7. What are the latest trends in pharmaceutical launch excellence and product sequencing that could affect launch strategies moving forward?

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Top Reasons to Read This Report

Establish and improve cross-functional coordination: Cross-functional coordination is crucial to managing launch sequences. It is especially important when working with regulatory teams to manage the licensing cascade. This study includes detailed best practices and strategies for how companies should work across functions within the organization to coordinate launch sequencing and provide important regulatory and market guidance to shape the product launch. It also includes global launch sequencing budgets and which US or global groups contribute the highest spend.

Involve C-suite executives in final launch sequence approvals: Because launch sequencing has such a large impact on a brand’s potential revenue, C-level executives are best positioned to review and approve plans. This benchmarking study provides detailed data on the composition of committees that determine pharmaceutical launch sequences. It also provides discussion on the advantages and disadvantages of employing dedicated launch sequencing committees.

Shift emerging markets to second wave launches: Large and comparatively wealthy US and European markets are typically high priorities for first launch waves. However, heavily populated emerging markets, such as the BRIC nations, are more commonly following in second wave launches. This report includes data analysis to support moving emerging market launches earlier in the launch sequence. Data include launch sequencing comparisons between 2012 and 2015.

Pharmaceutical Launch Sequencing Metrics

Chapter 1: Supporting Global Launch Sequencing through Structure and Spending

Major Takeaways

  • Begin launch sequencing tasks early — at least a year before launch — to position products optimally for market access and launch.
  • Establish and involve cross-functional teams in launch sequence planning — typically brand teams, market access, marketing and regulatory groups.
  • Consider geography when allocating GLS budgets; US groups report the highest spend, followed by global groups.

 
Chapter Data
26 charts detailing global launch sequencing timelines, distribution of responsibilities, tools, budgets and spending. Throughout the chapter, the data are broken down by company size (small, Top 50 and Top 10) and team region/scope of responsibility (US, EU, global and emerging markets).

  • Average number of months before launch companies begin launch sequencing
  • Current and ideal start time for launch sequencing
  • Business unit with ultimate responsibility for approving launch sequence
  • Organization of launch sequencing responsibilities (i.e., dedicated launch sequencing team or ad hoc committee)
  • Members of ad hoc launch sequencing committees
  • Number of FTEs on dedicated launch sequencing committees
  • Funding of dedicated launch sequencing committees
  • Spending in 2015 on global launch sequencing activities
  • Tools used in launch sequence development

 

Chapter 2: Coordinating Successful Launch Sequences

Major Takeaways

  • Carefully consider team resources and product revenue expectations when building launch sequences — customized launch sequences per product may be ideal, but not always possible.
  • Prioritize pricing study and payer research spending when setting launch sequences.
  • Ramp up communications with regulatory groups around product launch to ensure a successful licensing cascade.

 
Chapter Data
23 charts detailing life science companies’ strategies, tools and spending for global launch sequences. Throughout the chapter, the data are broken down by company size (small, Top 50 and Top 10) and team region/scope of responsibility (US, EU, global and emerging markets).

Launch Sequence Strategy and Coordination

  • Approach to building launch sequence (i.e., launch sequence is built from scratch, adjusted from a template or unchanged from one product to another)
  • Number of working hours to develop custom launch sequences
  • Frequency of launch sequence group communication with regulatory teams
  • Number of meetings per month with regulatory group about launch sequences
  • Frequency of launch sequence reassessments

Launch Sequence Spending

  • Spending on specific launch sequencing tools (all companies surveyed, by company type and by company):
    • Pricing studies
    • Regulatory guidance
    • Payer advisory boards
    • Market research
  • Total spending on a single launch sequence
  • Allocation of spending on a single launch sequence

 

Chapter 3: Trends and Practices for Global Launch Sequencing

Major Takeaways

  • Build individual launch sequences based on product indication, available evidence, geographic considerations and regulatory approval.
  • Consider market size, potential and regulatory hurdles when coordinating launch sequences and licensing cascades to facilitate a smooth launch:
    • Major Western markets (US and EU) are crucial both in terms of price and early launch.
    • Some markets, such as Japan, have specific regulatory pathways that must be followed for a launch to be successful.

 
Chapter Data
12 charts detailing trends in global launch sequencing.

  • Percentage of companies launched in US and major five EU markets, by launch wave
  • Division of countries by launch wave
    • US and major developed markets
    • Asian markets
    • Latin American markets
  • First wave launches and second wave launches among all companies: 2012 and 2015 data
  • Percentage of companies per launch wave
    • US launches
    • UK launches
    • Germany launches
    • France launches
    • Spain launches
    • Italy launches

Pharmaceutical Launch Sequencing Excerpt

 
The following is excerpted from Chapter 3, Trends and Practices for Global Launch Sequencing.

LAUNCHING IN EUROPEAN MARKETS
As the integration of Europe under EU regulations continues, more streamlined approval processes are available to many launching pharmaceutical products. That being said, each country within the EU represents a unique challenge in terms of the dominant payer system and varying degrees of regionalization within each market. Many of the major five EU countries — UK, Germany, France, Spain and Italy — are common reference points for other countries in Europe and surrounding areas.

Generally, companies have prioritized the UK and Germany first among the European markets and then moved on to France, Spain and Italy. According to the launch sequencing director at Company B, “We know what we’re going to need in the UK and Germany: EMEA approval and 6–18 months to actually get the local negotiations done.” Once physician networks and local investigators have access to the drug, then companies will move further into the European market.

 

LAUNCHING PRODUCTS IN THE UK
The UK has historically been one of the primary European markets. But downward pressure on prices was expected to decrease the number of companies launching there in their first launch wave. Contrary to expectations, the percentage of surveyed companies launching in the UK in their first wave has actually grown from 47% in 2012 to 58% in 2015. Forty-two percent of surveyed companies launch in the UK during their second launch wave.

The implementation of NICE and further budget cuts to the UK’s NHS healthcare delivery system have changed the pricing landscape in the UK significantly. The UK’s position as a common price reference point means that many companies are acutely aware of the pricing situation.

Ultimately, the price a company sets in its initial launch provides a benchmark to which future launch markets will compare. For instance, India looks toward the US and UK markets for guidance as it develops its international reference-pricing scheme.

Companies already have the tools in place to maximize price referencing systems knowledge. In anticipation of price referencing schemes among countries, companies should take a top-down approach. Global teams must develop and implement launch sequences with price referencing at the forefront. Affiliate teams must then set prices in accordance with the globally determined launch sequence. These plans must favorably balance market entry costs and anticipated profit margins from a selected price. By adhering to this strategy, companies can prevent affiliate-determined prices from adversely affecting prices in later launch stages.

Global Launch Sequencing Key Finding

The following is excerpted from the full report's Executive Summary:

 

Do Not Allow Reference Pricing to Diminish Drug Value

Companies must consider price referencing prior to launch.  The fact that two-thirds of surveyed companies rank price referencing highest among launch-determining factors highlights its importance.  Companies that fail to anticipate pricing schemes lose valuable time and potentially sacrifice revenue.  Drafting a launch plan with reference markets in mind can ensure that companies do not settle for lower prices by prioritizing launches in low-paying countries.  This is especially true if higher-priced markets reference those initial markets.

Companies must become aware of the changing face of price referencing markets.  Proximity is no longer the sole reference-pricing determinant.  Previously, European countries maintained a relatively isolated referencing system.  More and more countries are expanding their price referencing beyond their geographical neighbors, however.  According to one executive, Latin American markets are looking toward Canada for referencing.

Formal and informal referencing systems prove equally influential as emerging markets look increasingly toward developed markets.  Ultimately, the price a company sets in its initial launch provides a benchmark to which future launch markets will compare.  For instance, India looks toward the US and UK markets for guidance as it develops its international reference-pricing scheme.

Companies already have the tools in place to maximize price referencing systems knowledge.  In anticipation of price referencing schemes among countries, companies should take a top-down approach.  Global teams must develop and implement launch sequences with price referencing at the forefront.  Affiliate teams must then set prices in accordance with the globally determined launch sequence.  These plans must favorably balance market entry costs and anticipated profit margins from a selected price.  By adhering to this strategy, companies can prevent affiliate-determined prices from adversely affecting prices in later launch stages.