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Achieving product launch success in the biopharma industry

Executive Summary
Revenue for new biopharma launches often fall short of forecasts. In fact, an analysis of new prescription medications launched worldwide between 2009 and 2017 found that 40% of products failed to meet their 2-year sales forecasts.1 This is further complicated by an increasingly crowded competitive environment—the number of prescription medication launches increased by 60% from 2010 to 2019 compared to the yearly average of launches in the prior decade. Forecasts for the top launches have also increased dramatically, with average peak sales for these products doubling in the past decade compared to the decade before.2
In an environment of heightened competition and greater potential earnings, it is increasingly important for companies to identify the key reasons for missing launch forecasts and proactively address these downfalls when planning launches. Indegene has collaborated with Everest Group to conduct an in-depth study on biopharma product launches with this precise objective. The study included interviews with 15 experts in product launches and commercialization; each expert had more than 10 years of global launch experience and worked for one of the top 20 biopharma companies, based on revenue.
The study identified a number of common challenges encountered during a biopharma product launch, including:
Payer activation and reimbursement challenges
Regulatory obstacles and competition
Inadequate market adoption by healthcare professionals (HCPs)
Field force effectiveness and efficiency challenges
Patient engagement and adoption issues
A highly valued competitive characteristic of a new product is receiving regulatory approval with an appropriately differentiated product label. To achieve this, manufacturers must proactively shape the label early in the clinical trial design and mitigate any risks that could lead to a delay in approval, which not only prevent immediate sales but also provide opportunities for any competitors to be first to market. Manufacturers also must work to ensure a smooth reimbursement process by activating payers and overcoming related obstacles—this involves providing relevant education and product data to payers to support favorable reimbursement and coverage.
Gaining the confidence of HCPs is another key obstacle to achieving biopharma product launch success. Arguably, this has always been a challenge; however, it has become significantly more difficult for field sales representatives to reach HCP targets through traditional communication channels and respond to evolving preferences in a post-COVID world. As a result, it is essential for manufacturers of biopharma products to seek and address gaps in their HCP engagement strategy and move away from relying on face-to-face as the primary means to engage, educate and activate HCPs. In addition to earning the confidence of HCPs, launch success also hinges on engaging with and educating patients—and providing much-needed product support and assistance programs based on the complexity of the product and the disease area.
Based on the study findings, Indegene and Everest Group have developed a framework for improving biopharma product launch outcomes. Using this framework, biopharma manufacturers may be better prepared to identify and address gaps in their launch capabilities and maximize their chances of launch success.
Introduction
Along with R&D spend, market headwinds such as increasing competition, evolving regulations, and patent expirations are adding pressure on biopharma companies. The R&D budgets of biopharma enterprises have seen a CAGR of 6% growing from $137 billion in 2012 to $238 billion in 2021.3 At the same time, the number of new product launches increased by 60% between 2010 and 2019, in comparison to the yearly average of the previous decade.2 Most of these launches were unable to attain their expected commercial success.1
An analysis of new prescription medications launched worldwide between 2009 and 2017 found that 40% of products failed to meet their two-year sales forecasts.1
In this uncertain and risky environment, biopharma companies face a definitive need to achieve launch success and forecast attainment. The development and execution of a successful launch strategy is becoming increasingly critical with an evolving payer and commercial landscape post-pandemic, increasing regulatory complexity, and the discovery of new treatments with smaller patient populations.
Additionally, due to the COVID-19 pandemic and other economic pressures, the level of incremental differentiation required to be meaningful has changed, thus increasing the importance of effective communication that reflects changing customer behavior and preferences.
An analysis between February and August 2020 studied 86 launches with expected revenue of over $300 million from 2018 onward that ended with delays or lost revenues, or both.1 Although the biopharma industry has typically been resilient, it is likely to be impacted by the current macroeconomic environment and policy changes, adding more urgency to achieving launch success. High inflation rates can cause patients to reduce spending on treatments or switch to generic alternatives. The US market is also expected to observe a revenue squeeze with the anticipated onset of the Inflation Reduction Act (IRA). The impact of the IRA will be exacerbated by the impending patent cliffs, which could result in Losses of Exclusivity (LoE). LoE in the US is expected to be ~$141 billion through 2027.4
An effective strategy for successful new product launches is essential for biopharma companies to succeed in the current landscape.
Methodology
Everest Group interviewed 15 experts focused on product commercialization and launch domains. The experts are from the top 20 biopharma companies by revenue. They were asked to identify and rank, in order of decreasing impact, the major parameters and sub-parameters that posed challenges in product launches and provide their rationale for the ranking. The results from the 15 interviews were aggregated to arrive at the final order of challenges. For additional details on the profiles of experts, please refer to the appendix.
Results and Discussion
This research covers the major challenges that new products can encounter over the pre-launch, launch, and post-launch stages of commercialization. The key reasons for products missing launch forecasts were as follows.
The individual rankings provided by the experts on the primary challenges in product launches are listed below.
In the following sections, sub-challenges are identified for each of the five categories, as well as a high-level summary. See the Appendix for detailed descriptions of sub-challenges.
Payer activation and reimbursement challenges
The launch of a product does not stop at regulatory approval; it is complete only after attaining reimbursement at an acceptable level.
– Global Commercial Lead for Cell & Gene therapies, Top 10 Global Biopharma
DESCRIPTION
Payer activation and reimbursement was ranked highest by experts as a reason for products falling short of their launch expectations; in fact, 93% of experts identified this category as having high impact. Within this category, the top 7 sub-challenges were identified as follows.
A product cannot reach the patient without swift and adequate coverage. Delays in obtaining access can significantly reduce HCP adoption, as can underestimating the timeline for obtaining access. Rebate strategy and unfavorable reimbursement and access can lead to restrictions, such as utilization management. Increasingly, payers are seeking evidence beyond efficacy and safety. The absence of a well-planned value communication strategy, backed by reliable data, can result in a larger cost to the company and delays in achieving the preferred formulary placement.
These challenges, along with inadequate bridge programs and affordability issues particularly in the US, mean that it is essential for manufacturers to develop a comprehensive strategy that considers payer needs and pain points. A strong launch package should contain the necessary information gathered during the development process, tailored to meet country-specific requirements.
Regulatory obstacles and competition
Without a strong label, you will start from a weak foundation. The label dictates the patient population to be targeted, as well as the information that can be promoted in front of the doctors.
– Global Franchise Lead, Top 10 Global Biopharma
DESCRIPTION
Eighty percent of experts ranked regulatory obstacles and competition as having a high impact on missing launch forecasts. Many challenges exist within this category; the top 7 were identified as follows.
The label with supporting evidence is an important determinant for product success and a major challenge to overcome amongst the regulatory obstacles and competition. Other activities allow for the marketing organization to reach the maximum potential of that product, but do not inherently change the product. A common downfall occurs when the development plan does not adequately incorporate both regulatory considerations and the likely competitive landscape. Additional regulatory reviews and unexpected delays further add to the challenge and can negatively impact key assumptions about launch timelines and forecasts.
Inadequate market adoption by HCPs
Key Opinion Leaders (KOLs) spread the word about the product and are an integral part of the HCP landscape. KOLs also provide feedback pertinent to the efficacy of products and collaborate with biopharma companies to improve the product and messaging activities. KOLs need to be included throughout the commercialization process and should be invited to participate in conferences, symposia, and roundtables, to express their opinions.
– Global Franchise Lead, Top 10 Global Biopharma
DESCRIPTION
Nearly half (47%) of experts ranked inadequate market adoption by HCPs as a high-impact challenge, and 40% ranked it as having medium impact. The experts’ rankings of the specific challenges in this area are listed below.
Securing product adoption by HCPs is crucial for successful patient onboarding and product adoption, which requires precise segmentation and targeting of HCPs—and continued omnichannel engagement throughout the product journey. HCPs are increasingly interested in data and outcomes beyond the regulatory data filing package submission. Establishing forums for HCPs to work with patients to generate real-world evidence and gain visibility into their patients’ experience with therapy is a critical early milestone in gaining HCP confidence—as is engaging continually with KOLs and providing them a uniform experience without a break in engagement from clinical trials through to approval and launch. In a post-COVID world, it is necessary to gain access to HCPs and achieve reach and frequency goals through hybrid engagement.
Field force effectiveness and efficiency challenges
Not having the right field force calling on the right people is one of the most expensive parts of SG&A expenses and can have a huge impact on the bottom line.
– Global Lead of Commercial Strategy, Top 10 Biopharma Organization
DESCRIPTION
Only 7% of experts ranked field force effectiveness and efficiency as having a high impact on missed launch forecasts, but over half (53%) ranked this category as having medium impact. The rankings provided by experts for the sub-challenges of field force effectiveness are listed below.
The expenditure on field force constitutes a major portion of biopharma companies' SG&A spend. Traditionally, field force sizing has been based on total HCP targets, behavioral, and attitudinal dimensions. However, in a post-COVID world, the majority of HCPs are seeking on-demand and digital information and are increasingly unable to see reps face to face. Biopharma companies need to rethink how they segment, target, and reach HCPs and move away from the traditional and now out-of-date HCP target lists with the rep as the primary channel. Effective field force training in product and disease in this evolving landscape necessitates adequate training on digital tools as well. To effectively handle these changes, it is important to strike a balance between the breadth and depth of deployment. Plus, it is critical to design incentive structures across rep-facing teams and internal teams to drive collaboration and delivery of the best possible HCP engagement strategy and execution, irrespective of channel.
Patient engagement and adoption issues
If patients fail to connect with the brand or do not find a convincing reason to use the product, physicians may discontinue its prescription.
– Global Lead of Commercial Strategy, Top 5 Biopharma Organization
DESCRIPTION
Sixty percent of experts ranked patient engagement and adoption issues as a medium impact reason for missing launch forecasts. The challenges within this category are listed below.
In certain specialty areas, patient engagement may not be necessary as patients typically follow the advice of their physicians. However, consumer-oriented products or rare disease products require much more patient engagement. To successfully reach the desired patient population, manufacturers must comprehend the patient's journey and their requirements, mapping out the path to diagnosis, reimbursement scenarios, and physician-referral dynamics.
Conclusion: Proactive planning and effective execution maximizes launch success
In today's world, biopharma companies need to navigate new product launch challenges while meticulously planning for factors and scenarios that can impede launch success. Although the possibility of unexpected setbacks is very high, the following initiatives are recommended to maximize launch success.
On a broad level, biopharma companies must craft a comprehensive launch strategy that addresses the top obstacles that affect achieving a company’s revenue goals. Despite falling under discrete categories, these obstacles are consistently best addressed in prior phases of clinical and commercial development. Solutions for each category of obstacle are as follows:
Payer activation and reimbursement
During clinical development:
Define unmet need and clinical differentiation
Define the target patient, along with secondary endpoints captured in clinical trial or real-world studies
During market preparation:
Develop an impetus to modify natural obstacle by understanding the payer structure, with support from clinical and real world data
Regulatory obstacles and competition
During clinical development:
Think beyond regulatory endpoints to acquiring strong support for commercial communication
Understand the tradeoffs of getting approved efficiently versus getting approved with a strong label and supporting evidence
Inadequate market adoption by HCPs
Understand the way HCPs they want to be engaged and reach them through their preferred method of consumption
Create relevant, reliable, and consequential content to educate HCPs through targeted, customized methods and inspire a true change in behavior
Prioritize access for payers and patient support programs to complete the access landscape, enabling a change in attitude to result in a change in behavior
Field force effectiveness and efficiency challenges
Utilize technology to optimize promotion efforts, improving efficiency and economic perspectives
Patient engagement and adoption issues
Develop a cohesive patient engagement plan from mid-clinical development and early commercialization that includes HCPs and other important decision-makers
Utliize appropriate technology to engage patients through preferred channels
More specifically, the following targeted measures can be taken—from a people, process, and capability perspective—that work to address the identified challenges and minimize their impact.
Initiatives to address challenges from regulatory obstacles and competition
People :
Establish rapport with regulatory agencies from initial stages
Process :
Capture the right outcomes for obtaining the desired label
Respond to regulatory agencies agilely through well-defined systems and processes
Secure cross-functional alignment on label
Revise plans and targets based on scenario mapping of approvals
Capability :
Track competitor products with real-time intelligence on product characteristics, brand messaging, new data, etc.
Obtain information about differentiation drivers such as unmet need, novelty, efficacy, etc.
Track regulatory changes including labeling, data, and dossier requirements
Optimize Medical, Legal, and Regulatory (MLR) review via automation
Initiatives to address payer activation and reimbursement challenges
People :
Collaborate with payers to accelerate access timelines
Engage in early access discussions, up to 2 years prior to launch
Involve market access team in development phases to generate appropriate evidence, reimbursement coverage, etc.
Simulate price negotiations with a panel of experts
Process :
Incorporate local market nuances into global market access strategy
Use real-world evidence (RWE) to supplement clinical trial evidence
Capability :
Track launch metrics, including time to access and volume uptake
Devise a robust pricing strategy that considers budget impact on payers, current market, standard of care, and competitor offerings
Perform sensitivity analysis on payer coverage and physician prescribing rates
Perform robust patient population sizing
Gain payer intelligence through trend analysis of analogous cases
Initiatives to address inadequate market adoption by HCPs
People :
Engage with KOLs and medical societies early on to shape treatment guidelines
Continually engage with KOLs and arm them with necessary evidence from clinical trial through to launch and commercialization, avoiding a disjointed experience depending on their primary interaction point within the biopharma company
Process :
Integrate data sources (primary market research, medical and prescription, CRM, marketing, SDoH etc.) for holistic customer view
Model adoption rates through scenario planning to improve forecast accuracy
Enact granular segment level planning
Holistically generate and disseminate evidence throughout the product lifecycle and across markets
Capability :
Leverage data to segment HCPs based on their behavior, attitude, and communication preferences
Shape market perceptions through robust KOL mapping
Curate modular pre-approved content for dissemination and adapt content-related feedback from the field
Customize engagement with ongoing channel optimization
Initiatives to address field force effectiveness and efficiency challenges
People :
Invest in hiring the right talent and frequent upskilling
Process :
Synchronize field planning with latest market and HCP insights:
Cross-functional orchestration of face-to-face teams and digital channels to augment and amplify HCP engagement
Customize role planning and deliver an appropriate omnichannel experience
Design strategic incentive-based compensation programs
Capability :
Customize field force territory planning to HCP preferences, access, and affiliations
Track field performance metrics and field effectiveness
Provide dynamic field support
Integrate multiple channels into call planning
Initiatives to address patient engagement and adoption issues
People :
Collaborate with patient advocacy groups early and often to understand patient needs, issues and drivers
Educate HCPs and patient advocacy groups on patient support programs
Provide patient education and support
Process :
Capture patient-specific outcomes in clinical trials
Partner with health systems to improve the patient care journey
Design affordability/copay programs for financial access
Customize patient support programs with appropriate wrap-around services
Plan for potential disruptions from label changes
Capability :
Track the effectiveness of patient engagement efforts
Automate query management or use high-touch engagement based on patient preferences
Design an effective patient engagement strategy with persona mapping insights
See the appendix for more details on individual initiatives.
Key questions for biopharma companies to answer to maximize their product launch success
Knowing the product and corresponding market is the first step in creating a well-defined launch strategy and taking appropriate action to achieve initiatives. Early on, the following questions should be considered:
What problem does my product solve?
How important is that problem?
Who owns that problem?
Who has the authority to act on the problem?
Biopharma companies must also evaluate whether they have the required resources, capabilities, and expertise needed to achieve the initiatives outlined above. Bringing a new product to market requires an extensive and collaborative effort across multiple functions within biopharma companies to secure timely approval, gain adequate market access, and earn the trust of HCPs and patients. Some key questions to consider during this evaluation include:
Biopharma's commercial operations are intricate and demand a proficient workforce with extensive domain knowledge. Moreover, within a short period, the launch might expand to include multiple global markets and need to reach a large customer base. Hence, operational agility is important to fast-track timelines and aid in capturing market demand. Biopharma companies would also need to collect, integrate, process, and analyze vast amounts of data to extract valuable insights that can help optimize the launch strategy. With evolving customer preferences, purpose-built technological solutions that improve the effectiveness of the sales process and provide a personalized experience to HCPs and patients are increasingly important.
To effectively navigate global launches, biopharma companies must develop a comprehensive understanding of the unique market requirements in each region. With launches targeting specialized disease areas, these companies also require a profound understanding of the commercial landscape, regulatory and payer requirements, and market dynamics for the specific therapeutic area. Additionally, intelligence from past launches in the industry in similar areas can help direct the strategy through the implementation of key learnings.
Biopharma companies need to identify and address internal gaps to undertake targeted initiatives aimed at minimizing the impact of launch challenges and thereby maximizing launch success.
Appendix
Research methodology
Everest Group conducted primary interviews with 15 experts focused on the product commercialization and launch domains. The experts belonged to the top 20 biopharma companies by revenue. The experts’ profiles are as follows:
Expert #1
Ex Global Lead of Commercial Strategy, Top 5 European Biopharma Organization
The expert is based out of the US and possesses over 10 years of experience in commercial development strategy, pricing and reimbursement strategies, field force effectiveness, and execution across channels and segments in various top 10 global biopharma organizations. The expert has served as a commercial lead for supportive care oncology biosimilars across Belgium, India and various parts of United States and has led 5 product launch operations, with estimated annual sales of ~$1 billion.
Expert #2
Regional Medical Director, Top 5 European Biopharma Organization
The expert is based out of Netherlands and has more than 10 years of experience in global launch, forecasting, budget planning, and strategic marketing in various top 10 global biopharma organizations. The expert has been a commercial lead for a gene therapy solution for spinal muscular atrophy and has led and been a part of 5 product launches across France, Ireland, and Netherlands.
Expert #3
Senior Director for Value & Access Launch, Top 10 Global Biopharma Organization
The expert is based out of the US and is responsible for leading the overall US market access launch strategy. The current focus area of the expert is the development of an effective value proposition and integration of pricing across payer channels to optimize the business. The expert has led three product launches and has been an integral part of 10+ product launches with other top 10 global biopharma organizations across various parts of the US.
Expert #4
Global Commercial Lead for Cell & Gene therapies, Top 10 Global Biopharma Organization
The expert is based out of Germany and has over 7 years of experience in global launches, early asset commercialization, sales, and marketing across multiple therapeutic areas across the geographies of Europe and North America. The expert possesses experience working in American and European markets and has led four different product launches, with one of them having three separate indications. The value of the largest launch was ~€2 billion.
Expert #5
Vice President, Commercial, Top 20 Global Biopharma Organization
The expert is based out of the US and has experience in product supply, organizational readiness, brand marketing, scientific and medical affairs, and market access in the United States market. The expert has led 6 product launches, representing $6 billion in revenue, across the areas of diabetes, obesity, and other acute disease areas.
Expert #6
Ex Global Head of Decisions and Commercial Lead, Top 20 Global Biopharma
The expert is based out of the US and has nearly 15 years of experience with two top 20 global biopharma organizations. The expert has led five global product launches, representing over $15 billion in peak sales. The expert possesses experience in areas such as forecasting, sales force sizing, targeting, and field force compensation.
Expert #7
Global Franchise Lead, Top 10 Global Biopharma Organization
The expert is based out of the UK and manages a commercial strategy portfolio worth $5 billion. The major areas of focus include resource planning, pricing, and access, as well as launch and life cycle management. With over 10 years of experience at three different global biopharma companies, the expert has led three product launches and been an integral part of over seven more.
Expert #8
Commercial Launch Lead, Top 20 Global Biopharma Company based out of the UK
The expert is based out of Germany and has experience in strategic support, omni-channel marketing, and HCP engagement. The expert has led four product launches with estimated sales of approximately $5 billion. The expert possesses over 13 years of experience in go-to-market strategies, competitive analysis, and pricing strategies with multiple global pharma and medical device companies.
Expert #9
Director, US Value and Access Portfolio Strategy and Analytics, Top 5 Biopharma Company
The expert is based out of the US and has over 10 years of experience in pricing scenario planning, account management, and access strategy. The expert has been a part of 14 product launches with estimated sales of ~$40 billion. The expert has over 20 years of experience in pharma and biotech value and access across the US market.
Expert #10
Vice President, Global Commercial Strategy, Top 20 Global Biopharma Company based out of the USA
The expert is based out of the US and is responsible for leading a portfolio worth $3 billion. Over the course of 24 years, the expert has led 31 access and pricing strategies and possesses experience in real-world data, reimbursement, and marketing with multiple leading global biopharma companies across the geographies of Germany and US.
Expert #11
Global Commercial Director, Top 10 Global Biopharma Organization
The expert is based out of the US and has over 9 years of experience in managing launch readiness, long-range planning, financial forecasting, marketing strategy, and customer experience across United States. The expert has experience leading three product launches, with a portfolio worth $3 billion, and has been involved in all relevant aspects, such as pre-launch activities, payer discussions, research, and performance tracking.
Expert #12
Associate Director – Commercial Excellence for EU and LATAM region, Top 10 Global Biopharma Company
The expert is based out of Switzerland and has experience on patient advocacy, pricing, and access strategy, and has been involved in 25 launches. The expert has been serving as one of the leads in managing a portfolio worth >$350 million for close to 14 years across Australia, Europe, and Middle Eastern regions.
Expert #13
Global Launch Lead, Top 5 Global Biopharma Company
The expert is based out of the UK and has been involved in multiple launches with an estimated value of $2 billion across the UK and UAE and possesses 16 years of experience in the domain of global marketing, market access, insights and analytics, public affairs, communication, and supply chain.
Expert #14
Ex Executive Director and Head, Global Commercial Assessment, Top 5 Global Biopharma Company
The expert is based out of the US and has experience in areas such as global launch preparation, marketing, budgeting, business development, licensing, etc. and has led commercial assessment for more than 9 products across US and Canada. The expert has experience with two global top 5 biopharma organizations for 20+ years.
Expert #15
Director – Launch Excellence, Commercial Strategy and Operations, Top 20 Global Biopharma Company
The expert is based out of the US and has been involved in 5 launches with estimated sales of $10 billion in gross sales and possesses 10 years of experience in the domain of strategic planning, cross-functional problem solving, direct-to-patient selling, CRM etc.
Payer activation and reimbursement sub-challenge descriptions
Based on the aggregated rankings, the key issues in payer activation and reimbursement, in the order of decreasing impact are:
Slowness to gain access at launch (6 months-12 months)
Delays in obtaining access can significantly reduce HCP adoption, as can underestimating the timeline for obtaining access. Negotiations at the national level must be accompanied by reimbursement discussions at the regional level, to ensure successful access for the product. For specialty products, additional account-based negotiations and coverage discussions may also be necessary.
Unfavorable price negotiations/rebates
Rebates can have an adverse effect on the product's revenue. Favorable formulary placement and the time taken to gain access may be determined by the biopharma company's rebate strategy among other factors.
Unfavorable formulary placement
The positioning in the formulary can lead to restrictions, such as utilization management, that can affect the prescription and usage of the product. The consequences of unfavorable positioning can be compounded if the product has limited differentiation and if competing products have a more favorable placement.
Lack of evidence-based value (RWE, HEOR, etc.)
Payers are increasingly seeking evidence beyond efficacy and safety. The absence of a well-planned value communication strategy, backed by reliable data, can result in a larger investment and delays in achieving the preferred formulary placement. This is especially pertinent for products in competitive markets and specialty areas.
Absence of bridge programs for patients until access is in place
Bridge programs are essential, especially in the US, to facilitate onboarding of patients while formal coverage is in process.
Patient affordability challenges
Patient affordability challenges can affect the usage of the product in countries such as the US.
Unfavorable value-based payment arrangements
The therapeutic area and site of service are key drivers in determining value-based payment arrangements. When the product is in rare disease areas with potentially higher costs and resulting patient out-of-pocket expenses, value-based payment arrangements become increasingly significant. Negotiating an optimal payment arrangement based on outcomes while addressing data and operationalization issues is essential.
Regulatory obstacles and competition sub-challenge descriptions
Based on the aggregated rankings, the key issues from a regulatory and competitive perspective, in the order of decreasing impact, are as follows.
Regulatory setbacks in approval
Regulatory delays can cause adverse financial impact, especially if the groundwork for the launch has already been laid. Additionally, these setbacks can also damage the brand's reputation and the HCPs' trust in the product.
Gaps in product safety profile
Absence of a favorable side-effect profile can affect treatment guidelines and protocol adoption and lead to lower acceptance from HCPs and patients.
Divergence between expected and approved label claims
The lack of an expected differentiated label with strong claims impairs the product's competitive position in the market which in turn can slow market adoption and launch success. Furthermore, it can limit the intended patient population for the usage of the product.
Inability to bring about product differentiation (benefits, pricing, etc.) in alignment with competition
Product differentiation is essential for gaining favorable access from payers and increased traction with HCPs. Without differentiation, it becomes difficult to communicate the product's benefits, and it could be perceived as a commodity which will reduce market adoption.
Inadequate planning for new regulatory changes (like labelling impact)
It is necessary to be aware of any changes in regulatory requirements that may occur as a product is being developed, which requires biopharmas companies to keep up with the regulatory landscape and anticipate potential changes with scenario planning.
Delays to campaign approval
Delays can affect the timeline for field force execution as it can be difficult to clearly articulate the product's benefits with just the label. Suboptimal message delivery can occur when campaigns are not approved and deployed as planned which can slow market adoption and launch uptake.
Rework and evolution delay due to changes between the original strategy & final approved campaign
Rework can slow launch campaign approvals, and the final campaign may end up being very different from the base-case campaign. Additionally, market adoption and launch success can be impacted if core claims that highlight differentiation and create a distinct brand are not approved.
Inadequate market adoption by HCPs sub-challenge descriptions
Based on the aggregated rankings, the key issues for inadequate market adoption by HCPs, in the order of decreasing impact, are:
Inefficient HCP segmentation and targeting
Inaccurate segmentation and targeting of HCPs can lead to poor product uptake, along with inefficient use of time and resources, as the right message needs to be delivered to the right audience to increase market and HCP adoption. In a post-COVID world, many HCPs are harder to reach, and segmentation and targeting based only on accessibility by the field force can result in an ineffective and partial HCP reach.
Ineffective KOL advocacy programs
Engagement and co-creation with Key Opinion Leaders (KOLs) from an early stage is critical, as they hold a high degree of expertise and knowledge that can inform treatment guideline updates, build markets, and shape prescribing habits of HCPs. Inconsistent engagement can pose a significant challenge and hamper the KOLs experience, particularly when there are gaps in engagement between the development and launch phases. It can also result in disjointed interactions where the engagement occurs with the clinical team during development, followed by involvement from the medical and commercial teams without a smooth transition.
Delays in treatment guideline updates/adoption to drive trial and usage
The absence of timely product inclusion in treatment guidelines can hinder efforts to increase product utilization based on the importance placed on guidelines in the therapeutic area.
Messaging and content not delivered to HCPs in the market as planned
The likelihood of product adoption by HCPs decreases if they do not receive the right information at the right time, leading to lower-than-expected demand. It is therefore critical to deliver the right messages across multiple channels, including face-to-face and digital, to reach HCPs in a coordinated and personalized way.
Overestimation of switching rates
Overestimation of HCP adoption and patient switching rates can lead to missed forecasts, particularly for products entering a competitive environment. This is because encouraging HCPs to prescribe a new product can be challenging, which can limit market adoption.
Lack of evidence-based marketing with RWE feedback loop from patients
HCPs are increasingly interested in data and outcomes beyond the regulatory data filing package submission. Establishing forums for HCPs to work with patients to generate real-world evidence and gain visibility into their patients’ experience with therapy is a critical early milestone in gaining HCP confidence.
Challenges in reaching HCPs given the shifts in office dynamics (e.g., limited access, new ownership, etc.)
Limitations in reaching HCPs increased significantly in a post- COVID world. The limited access can slow the ability to achieve the desired reach and frequency targets, which can further affect the speed of HCP activation. Achieving the target reach and frequency are essential for HCPs to become familiar with the product to begin prescription.
Gaps in omni-channel activation and content personalization
Challenges in omnichannel activation and personalization can lead to reduced engagement with HCPs, which may affect the adoption of the product by HCPs. Gaps in omnichannel capabilities need to be solved as executing suboptimal omnichannel is insufficient to achieve intended results. Today there are many options to close gaps in omnichannel including partnering, selective integration, and building internal capabilities.
It is essential to create personas based on HCP behavior and engagement patterns for effective omnichannel outreach with personalized content. HCPs are seeking relevant, personalized, and on-demand information and experiences, so it is important to execute and optimize accordingly.
Field force effectiveness and efficiency challenges sub-challenge descriptions
Based on the aggregated rankings, the key issues in field force effectiveness and efficiency, in the order of decreasing impact, are:
Inefficient field force deployment
Difficulties in communicating the value of the product arise when biopharma companies are unable to get the appropriate reach in the right customer segment. Proper sizing and deployment of efficient resources in alignment with HCP preferences are essential for translating the value of the product and driving sales.
Inefficient field force training/coaching
Without sufficient training, the field force may face challenges in effectively communicating and building trust with HCPs, which can lead to issues with product adoption. In the post-COVID world, the field force needs adequate training to effectively use digital tools, in addition to equipping them with product and disease knowledge for them to be fully effective.
Reduced/unoptimized HCP access with multiple field force interactions (e.g., Medical Science Liaison (MSL), Field Reimbursement Manager (FRM), sales reps)
Inadequate coordination between field force teams can have a negative effect on the HCP experience and impede product adoption. The field force teams must be organized to make the most of limited HCP time, creating positive experiences across multiple channels to build trust.
Lack of robust incentive-based compensation programs
Lack of motivation sets in when incentive-based compensation plans are not adjusted in a timely manner according to updated changes in forecasts. This can cause a loss of momentum and result in unproductive HCP engagement. Additionally, prioritization challenges can arise when the field force is managing multiple products and must balance between maximizing sales for existing products and new products.
Call file completion rate below expectations
Call file completion rates below the desired target can lead to a disconnect between the product and HCPs, which can have a significant impact on the commercial success of the product. Biopharma companies use predicted and modeled reach and frequency to base their forecasts, and if the field force is unable to reach HCPs as intended, it can jeopardize the forecast.
Lack of real-time sales enablement tools
Lack of robust sales enablement tools that can integrate data from multiple siloed systems to provide details on appropriate target HCPs, their engagement history, and preferences can make it difficult to reach and activate HCPs.
Increase in field force turnover
Along with a loss of talent, which can result in lower HCP reach and uptake, field force turnover can also lead to the erosion of established relationships. The likelihood of turnover increases if the forecasts are incorrect and the incentive plans are not adjusted accordingly. In highly competitive categories, the field force can turnover more quickly.
Patient engagement and adoption issues sub-challenge descriptions
Based on the aggregated rankings, the key issues for inadequate patient engagement and adoption, in the order of decreasing impact, are:
Execution of tactics not as planned based on the patient journey
A lack of comprehension of the patient’s journey and barriers to care can cause difficulties in the implementation of the correct messaging throughout the care journey. This is especially the case for a product that is the first entrant in a disease category.
Limited patient advocacy activity
A lack of proactive engagement with patients and advocates can lead to inadequate support within patient communities, thereby risking the launch. For products focused on rare diseases with a small patient population, patient-advocacy groups become even more critical, as it can be difficult to engage patients without the assistance of these groups as they are close-knit communities, which hinders the ability to capture important insights and outcomes.
Inadequate/inefficient patient support programs (e.g., clinical support, adherence, affordability)
Patient support programs play a critical role in facilitating access to products, especially for products with complicated reimbursement mechanisms. Additionally, these programs provide education and motivation to patients in complex therapies. If these programs are not available or lack sufficient support, patients may face difficulties in accessing the product or may discontinue treatment, ultimately limiting the product's uptake. Additionally, HCPs may reduce prescriptions if they believe their patients may not have access to the product.
Delays in going live with patient materials (websites, search results, in-office brochure, etc.)
Delays can have a negative impact on early product recognition and awareness, potentially leading to lower brand demand as well as delayed or weaker brand recall among patients.
Unawareness due to lack of direct-to-consumer marketing
The ability to go direct-to-consumer varies depending on country regulations. In the US, it is particularly critical for products that are in a competitive market and serve a large patient base; it raises the Rx for all therapies, resulting in the advertising product receiving its share. In Europe, however, branded marketing to patients is not allowed, and disease-focused campaigns are used to raise awareness for a product.
Lack of personalized engagement
Patient engagement should be tailored to individual preferences for maximum effectiveness. A higher level of personalization and easily consumable content can help in gaining a higher level of adoption from patients.
Initiative Details and Categorization Definitions
The people, process, and capability initiatives have been categorized with the below intent:
People initiatives: Invest in appropriate talent through each phase of commercialization to establish understanding, advocacy, and a network across various stakeholders.
Process initiatives: Incorporate proactive planning and risk assessment to foster cross-functional coordination, and to adapt to changing circumstances in real-time.
Capability initiatives: Develop data, technological and skill-based competencies to gain valuable insights and optimize launch strategy and execution.
Initiatives to address challenges from regulatory obstacles and competition
People :
Establish regulatory rapport: Interact frequently with regulatory agencies (spanning the US FDA, MHRA, EMA, etc.) from the initial stages to ensure the robustness of data requirements, and identify possible approval issues and any upcoming regulatory changes.
Process :
Capture the right outcomes for obtaining the desired label: Ensure adequate measurement of the right outcomes during the development phases to obtain the label claims as per the target product profile by prioritized country and region.
Agility in responding to regulatory agencies: Respond promptly to regulatory authorities by utilizing efficient and well-defined systems and processes, which enable quick turnaround of regulatory queries at every stage.
Cross-functional alignment on label: Secure alignment from cross-functional teams such as medical, market access, and commercial when the label is drafted and on all subsequent updates; ensure the label is commercially viable in prioritized launch markets.
Revise planning basis scenario mapping of approvals: Revise plans and targets based on scenario mapping of approvals limited to certain segments or indications. Design decision trees with all possible outcomes for go/no-go decisions, along with risk mapping and mitigation/management plans. Additionally, promote awareness among cross-functional teams on the best-case and worst-case scenarios during label negotiations, to plan accordingly based on multiple potential scenarios and label approvals.
Capability :
Track competitor products: Obtain real-time intelligence on competitor products including products in pipeline, characteristics (such as safety profile, labelling strategy, pricing, differentiation offered), brand messaging, new data, publications, and changing stakeholder perceptions.
Obtain intelligence on differentiation drivers: Secure intelligence on levers such as unmet need, novelty, efficacy, or higher convenience (usage for patient or administration for HCP) that can differentiate in a particular disease area and how they are evolving with new product launches.
Track regulatory changes: Track regulatory changes such as labelling requirements, dossier requirements, data requirements, promotional guidance changes, therapeutic area updates, and accessibility requirements such as the ADA website requirement in the US and across various markets. This should be coupled with impact assessment.
Optimize Medical, Legal, and Regulatory (MLR) review: Optimize MLR review of medical and promotional content from varied functions via automation. Test marketing and launch campaign assumptions with medical, legal, and regulatory teams early and frequently to ensure effective MLR reviews and avoid surprises.
Initiatives to address payer activation and reimbursement challenges
People :
Collaborate with payers: Accelerate timelines for access through collaboration with payers starting from protocol design to understanding evidence requirements and identifying value concerns if any.
Engage in early access discussions: Conduct early access discussions with payers by showcasing how treatment is better than current standard of care/competition (access discussions can start up to 2 years prior to launch for treatments that have a high budget impact).
Early involvement of market access team: Involve market access teams in the development phases to generate payer-relevant evidence and appropriate indication sequencing for cost-effectiveness claims, reimbursement coverage, and net price maximization.
Simulate price negotiations with a panel of experts: Arrive at a price threshold by testing the pricing with an expert panel containing payers, Integrated Delivery Networks (IDNs), and Pharmacy Benefit Managers (PBMs).
Process :
Incorporate local market nuances: Incorporate local nuances in the overall global market access strategy and craft evidence generation plans for locations that were not a part of clinical trials.
Use RWE to supplement clinical trial evidence: Include RWE sources in evidence packages where large trials can be challenging due to smaller population sizes (especially for rare diseases). Additionally, craft evidence-generation plans to collect patient feedback and engagement data to demonstrate treatment effectiveness.
Capability :
Track launch metrics: Track metrics such as time to access and volume uptake to devise trade-offs needed with rebates or patient assistance programs.
Robust pricing strategy: Devise a robust pricing strategy in alignment to budget impact on payers, current market situation, standard of care, and competitor offerings.
Perform sensitivity analysis: Measure the impact of payer coverage on physician prescribing rates and patient price sensitivity impact on fill rates.
Robust patient population sizing: Accurately size the patient population to quantify budget impact and accelerate access.
Payer intelligence: Gain insights into payer evidentiary needs and requirements and perform a trend analysis based on payer decisions in analogous cases involving relevant products and competitors. Keep track of policy and reimbursement updates for products across various markets.
Initiatives to address inadequate market adoption by HCPs
People :
Continual engagement with KOLs: Design a uniform KOL experience with regular interactions from development to the commercial phase, avoiding any disconnects between the development and commercial phases, as well as during the transition from the clinical to medical and commercial teams spanning pre-launch to launch/approval to post-launch (especially for rare diseases).
Early engagement with KOLs and medical societies to shape treatment guidelines: Invest early in engaging and educating KOLs and medical societies to facilitate the evolution of treatment guidelines and ensure timely updates.
Arm KOLs with necessary evidence: Equip KOLs with the necessary evidence, as they are thought leaders around the world. Arming them with evidence will not only facilitate the use of the product, but also help in gaining timely access and driving advocacy for the product among key stakeholders.
Process :
Integrate data sources for holistic customer view: Integrate data from different sources (primary market research, medical and prescription, CRM, marketing, SDoH etc.) to build a holistic view of the customer.
Scenario planning to improve forecast accuracy: Model adoption rates based on scenarios with labelling, indication, and age group approval to arrive at switching rates and forecasts. Refresh the forecast numbers as new information from market/competition becomes available.
Granular segment level planning: Design brand planning, objectives, and executional tactics at a segment level, and optimize them regularly based on the response from the segments.
Holistic evidence generation and dissemination: Incorporate a holistic strategy to generate impactful evidence from clinical trials, real-world data, and patient data throughout the product lifecycle and across markets.
Capability :
Evidence-based segmentation and targeting: Segment HCPs based on their behavior, attitude, and communication preferences by leveraging data from pharmacies, payers, HCPs, and labs, as well as communication preferences and ability to access across channels including face-to-face (F2F) and digital so that the segmentation and targeting is actionable in a post-COVID world.
Robust KOL mapping: Identify and prioritize KOLs to shape market perceptions and understanding including digital KOLs to account for shifting preferences.
Modular content curation and adaptation: Curate modular pre-approved content for dissemination. Track product performance and feedback from the field, omnichannel, marketing, and other functions by indication and region to inform rapid evolution and adaptation of content at an individual level wherever feasible.
Customized engagement with ongoing optimization: Identify optimal channel coupled with timing, frequency, and content for HCPs.
Initiatives to address field force effectiveness and efficiency challenges
People :
Invest in hiring the right talent and frequent upskilling: Hire top talent and provide them with the right level of training and coaching to instill knowledge in the product and disease area and confidence in handling customer-facing conversations. Additionally, upskill them to effectively use new digital and communication tools in alignment with the evolving HCP preferences.
Process :
Synchronize field planning with latest market and HCP insights: Ensure alignment between sales and marketing teams to optimize field deployment based on latest market and HCP insights in a timely and agile manner.
Cross-functional orchestration of F2F teams: Ensure coordination between the various field force teams and integration in the overall effort to maximize customer and market insights and deliver a superior customer experience.
Customize role planning: Plan for the right mix of field force for customer-facing activities as per product complexity and market access and reimbursement landscape (generally more reliance on MSLs for more differentiated and first to market products). Actively plan to deliver an omnichannel experience where the rep/MSL is one of the channels planned.
Design strategic incentive-based programs: Design and customize compensation plans so that the behavior and execution of the field force and marketing teams are aligned with and share the business targets
Capability :
Customize territory planning: Configure field force sizing and deployment in consideration with HCP preferences, access, and affiliations. Lead the design of territories with a broader view of channels beyond just planning territories based on rep as primary channel to reach HCPs to maximize coverage while balancing efficiency and effectiveness.
Track field performance metrics: Assess field performance metrics against the actual plan.
Track field effectiveness: Assess performance of field force at an individual level on pre-defined KPIs.
Dynamic field support: Equip field force with data and insights to direct their efforts on the right opportunities at the right time.
Integrate call planning: Incorporate multiple channels (including rep as a channel) into call plans and optimize frequently to drive performance across all channels deployed to optimize reach and frequency across all channels.
Initiatives to address patient engagement and adoption issues
People :
Collaborate with patient advocacy groups: Establish long-term partnerships with patient advocacy groups based on mutual goals (especially for rare diseases).
Educate HCPs and patient advocacy groups on patient support programs: Provide information to HCPs and patient advocacy groups about the various support programs available for patients.
Provide patient education and motivation: Deploy patient support professionals to educate and motivate patients (especially for specialty products and for rare diseases).
Process :
Capture patient-specific outcomes: Incorporate patient perspectives in clinical trials to ensure the outcomes captured are relevant to patients.
Partner with health systems to transform care journey: Establish partnerships with health systems to reconfigure care pathways for transformational treatments based on bottlenecks identified in patient journey and treatment dynamics.
Design affordability programs for financial access: Design robust patient affordability/copay programs based on internal communications with the market access team on the formulary positioning scenarios and plan for differences by plan(s) at a national, regional, and local level.
Customize patient support programs: Design a right mix of affordability and wrap-around services such as hub/adherence for products that require support.
Plan for potential disruptions: Engage in early preparation for patient support in case of potential disruptions stemming from label changes (if any).
Capability :
Track the effectiveness of patient engagement: Track the impact of patient engagement efforts and design appropriate course correction actions if needed.
Automated/high touch query management based on patient preferences: Automate inquiry management or use high-touch engagement based on patient preferences to aid in medical information, refills, reimbursement queries, enrollment, and approval status etc.
Design an effective patient engagement strategy: Craft effective messaging via the best channels that resonate with the patient throughout critical touchpoints in patient journey. Glean insights into access, affordability, and adherence barriers based on persona mapping to design corrective actions.

References

1.
"Ready for launch: Reshaping pharma’s strategy in the next normal", McKinsey, 2020
2.
Congressional Budget Office
3.
Statista
4.
"Global Use of Medicines 2023", IQVIA, 2023

Authors

Nancy Phelan
Nancy Phelan
Jeff Rothstein
Jeff Rothstein
Kevin Patterson
Kevin Patterson
Milesh Gogad
Milesh Gogad
Emily Huegler
Emily Huegler

Insights to build #FutureReadyHealthcare