Asset Potential and Growth Strategy
In today’s market, the commercial potential of innovative technologies is often complicated by the presence of multiple roadblocks to adoption. These may include limits to diagnosis, implicit resistance in prescribing behavior, and economic and physical flow drivers. Strategies that remove such roadblocks all contribute to maximizing the potential of new technology.
In managing to unleash your potential, it is essential to understand whether this potential lies in individual practitioners or organized centers for care; and in turn, if those centers act independently or in networks, and what route is required to provide patient care.
Manufacturers bringing technology to the marketplace must create business models that reflect the drivers of potential. Thus, they have to organize commercial models that allocate resources to the highest possible potential.
Case Study — Evaluation of market potential: building pre-launch positioning, medical, regulatory, market access strategies
First ex-US launch for a US biotech requires the establishment of both a strong team and organization, along with solid insights on which competitive, medical, regulatory and market access challenges the novel oncology drug will face—and which affect total market potential, and the possibility of a successful launch.
- Assess key requirements for a successful EU launch
- Estimate market potential and recommendations for targeting and distribution strategy
- Identify critical success factors for access and opportunities to expand clinical experience for market preparation
- Quantify potential gaps and risks in market and organizational preparation, and employ simulation of external scenarios.
A product’s market potential is based on a series of building blocks, which help define priorities and gaps that need to be addressed with an articulated pre-launch strategy.
The quantification of patient potential and dynamics from 2013 to 2020 required a deep understanding of the clinical claims of the product vs. competitors (100+ study meta-analysis), a detailed mapping of the current level of KOL experience and positioning of the drug, and a detailed quantification of the potential patient pool. Three alternative scenarios were modeled (best, base and worst) to reflect uncertainties in key assumptions, and a sensitivity analysis was performed to guide prioritization of interventions.
For 10 EU countries, a detailed review of market access (pricing and reimbursement) outcomes was performed to determine best, base and worst case pricing and reimbursement restrictions and launch delays. All these factors were considered in the model of potential to obtain a final cost result. We assessed possible timing delays and label restrictions at EMA, together with most probable outcomes of local payer negotiations (national, regional and local). A detailed review of past decisions on competitor and analog therapies provided key insights on payer thought processes.
- Onboarding the newly established EU management team on product market and access landscape
- Quantification of product market potential by label and by the scenario of 2013-2020
- Identification and quantification of key gaps in pre-launch strategy (positioning and market share, KOL engagement and medical, timing and regulatory strategy, and market access).
Case Study — Market expansion: working toward state-of-the-art oncology management in emerging markets
The launch of an innovative oncology drug requiring specific diagnostics and careful patient selection poses significant challenges in developing markets, where the healthcare system is not always able to provide and coordinate the required resources to ensure patient safety and optimal product utilization. As a consequence, not only could the product be subject to logistical challenges, but also local payers could take such deficiencies into account when assessing the drug’s reimbursability and pricing.
In that situation, real-life effectiveness will be estimated much lower than clinical trial efficacy, and the potential of the product will not be valued, with the result that patients will likely have no access to the innovative treatment.
The client needed to:
- Identify gaps in the delivery of care, and estimate their impact on the patient journey
- Leverage relationships with stakeholders to improve the management of the system
- Devise joint innovative initiatives to cover the gaps.
- We assessed the patient journey for the drug across hospitals in different institutions, both private and public, to identify gaps in reimbursement (including reimbursement of concomitant drugs, diagnostics and visits), access to resources and services, costs, waiting lists and capacity of resources.
- We leveraged epidemiology, literature and primary research data to quantify the size of each roadblock, its impact on the cost of the disease and the repercussion on the final QALY gained with the treatment.
- We selected and prioritized the areas of intervention, devising innovative strategies to reduce existing gaps, either through care management initiatives, commercial offerings and value added services.
- We liaised with stakeholders at different levels (physicians, hospital managers, payers, administrators) in order to integrate and further refine the proposed initiatives, to provide the client with a final “road to implementation.”
- 1,000 clinical records were analyzed, with 50 hospitals and 100 stakeholders involved
- The program helped the client list the product on the formularies of two major institutions
- The program helped ensure a faster uptake (more than 50% in the first year)
- Influenced the decision to change the organizational structure of the institutional affairs department.
Case Study — Quantitative modeling for business decisions: an account-based go-to-market approach
The launch of an innovative drug for a “new disease,” significantly underdiagnosed and treated only with surgery, requires important changes to the current patient journey and physicians’ behavior. The drug’s potential will not be maximized unless a preparation of the key centers has been performed prior to launch.
- Identify specific roadblocks to the drug’s potential
- Estimate bottom-up uptake potential
- Develop tailored strategies and prioritize budget allocation
- Develop account plans to be used by the sales force.
In-depth assessment and modeling of key challenges to uptake allowed the client to estimate bottom-up forecasts and define specific interventions to maximize product launch. Each market was assessed through a standardized “waterfall” approach, which encompasses epidemiology (prevalence, incidence, diagnosis rates and referrals, and patient sub-groups), prescribing behavior (physicians’ knowledge of the drug, perceived value points, treatment algorithms and preferences by patient sub-group), local market access (local formularies, listing delays, administrative requirements, funding flows, caps and limitations), and logistics (delivery channel, storage, and availability and capacity of administration and storage facilities).
Information was collected through multiple internal and external sources, and complemented by in-depth working sessions with physicians and local stakeholders. Data was collected and analyzed to calculate the potential of the drug in each area, and to develop targeted local actions to accelerate drug adoption.
Center-by-center account plans were developed in close collaboration with the local team, in order to ensure full alignment of the internal actors on objectives and actions, as well as a clear definition of responsibilities.
Case Study — Quantitative modeling for business decisions: minimizing LoE erosion for a Primary Care blockbuster
Loss of exclusivity (LoE) is a highly challenging situation for any pharmaceutical company, especially when involving a multi-billion USD blockbuster.
The design and implementation of LoE strategies requires a high level of customization by market, as different regulations, healthcare system structures, culture and market environments exist. Emerging markets have peculiar challenges, and often represent an opportunity for experimenting with new business models and approaches.
- Quantify the expected loss following LoE estimating price elasticity and erosion rates in the market
- Identify the optimal positioning of a portfolio strategy (including also dual brands and branded Gx)
- Calculate the potential of such positioning and pricing strategy
- Adapt the promotional model and devise a medium-term strategy to address patients, physicians and distribution.
An initial market landscape was built, collecting all sources of information from the client, and integrated through primary research (e.g. price-elasticity analysis): products’ performance and prices, sales in private and public institutions, prescribing behavior influencers and outcomes, patients’ preferences, trade influence on decision making, current client’s strategies and tactics, and competitors’ strategies and tactics.
Quantitative modeling of stakeholders’ behavior (market response model) analyzed market data, plotted landscape evolution hypotheses, and estimated outcomes of strategies and tactics vs. competitors’ reactions.
Portfolio strategies and tactics were prioritized based on their potential and changes in the organizational structure. Promotional models were assessed in terms of field resources, targets, incentives and tools.
- The market response model was consistently used across markets to assess the value of opportunities
- Market-specific portfolio decisions were made, based on results of the project: new dual-brands and private label brands were launched as a consequence of the project’s outcomes
- The project was awarded as best project within the company’s emerging market division.
Physicians and HCP Engagement
The current selective adoption behavior of payers has forced manufacturers to concentrate on truly innovative technologies. As the new technologies reaching the market are the ones conveying a significant treatment breakthrough, physicians are very often challenged with the need to adopt entirely new treatment and disease paradigms. Manufacturers have to partner with physicians in helping identify the most suitable algorithms for their specific practice.
This is particularly true in the growing domain of specialty and acute care. Partnering must start well before the technology reaches the market, and involves the creation of opportunities to offer early and direct experience of the technology. Mastering the pre-launch phase is now just as crucial as an effective post-launch plan. Manufacturers must invest in significant planning early on, and carefully deploy these strategies.
Case Study — Developing levers of post-launch physicians engagement
Post-launch support. Maximization of a product’s performance after launch requires a thorough understanding of market drivers and, in particular, of physicians’ needs and behaviors.
Factors that can hinder the performance of an innovative product include:
- Inconsistencies and delays in the diagnosis and care pathway
- Insufficient medical education regarding a new technology
- Lack of experience.
- Identify drivers to maximize drug potential
- Develop a consistent strategy to prioritize investments
- Organize the product strategy into clear and powerful tactical plans, ready to be put into operation.
- Care pathways were analyzed in depth through secondary and primary research, to identify and quantify bottlenecks in the patient flow that limit the patient base that can benefit from the client’s drug.
- Physicians’ choices were discussed through in-depth focus groups and interviews, in order to identify the main reasons of dissatisfaction with the drug— as well as the criteria for decision making that were leading to underutilization in selected and approved (i.e. in label) categories of patients.
A revised market penetration strategy was built based on:
- Ensuring expansion of the physicians’ base with direct experience of the drug and its use
- Building patient segmentation based on efficacy and safety criteria, as well as rationale for patient treatment
- Improving referral from primary care to specialty care institutions/HCPs, where treatment decisions related to the pathology are taken
- The overarching strategy was transformed into a series of selected tactics, which were built into a comprehensive tactical plan (by country). Tactics were adapted by market to ensure consistency with local care pathways and maximization of their impact on patients’ access to treatment.
- Rapidly revamped the go-to-market strategy and its execution across countries
- Significantly increased market potential for the drug and patient access to treatment
- Ensured consistency of the strategic approach, together with localization of strategic drivers.
Case Study — Building pre-launch physician engagement plans to support product strategy
Market preparation in Europe requires significant pre-launch activities. In particular, KOL engagement is vital to achieve the correct positioning of a product in the market before launch. This will affect both chances of approval and actual recognition of the product’s value by the final users.
- Identify key physicians to engage in pre-launch medical activities
- Select activities to be deployed in the EU market before launch
- Develop and track individualized plans for each selected physician, based on their needs and professional goals.
In-depth understanding of physicians’ objectives and interests is the key to building a targeted medical affairs plan. Our approach leveraged to this objective all the available information inside the company, as well as additional research (e.g. publications, public relations, media releases, and social media public information), building and analyzing a comprehensive and unique database of information.
Based on a panel of several activities that medical affairs functions can rely upon (e.g. ph3b-4 studies, registries, CME, congresses and symposia, and MSL activities), we associated each physician’s profile and interests to a potential “set of interactions” that would cover mutual interests of the company and the KOL. The approach was adapted in a center-by-center fashion, ensuring that all detailed local knowledge of a single center and physician was actually incorporated into planning.
Center-by-center plans were then transformed into country-by-country plans. They were associated with metrics and tools to help medical affairs track the progress in implementation of the activities, as well as understand and evaluate the benefit that such activities generated to physicians, and their feedback.
- A database with comprehensive information on more than 600 hospitals and physicians in the EU was built, ensuring cross-functional understanding of the medical community in the therapeutic area
- Monthly engagement plans for more than 150 centers were drafted, with a multi-functional view. Ease of access and in-depth analysis ensured all activities’ plans were fully informed
- The project helped set up the medical affairs function in the EU, providing objectives and training.
Case Study — From obstacle to opportunity: RMP implementation as a go-to-market strategy
Regulatory agencies require product initiation, and use is subject to safety measures (i.e. RMP) to minimize risks to patients due to the drug’s AEs. The implementation of the RMP requires structures, resources and activities normally not conducted by neurologists.
For this reason, the RMP might cause significant delays in the drug’s uptake, as well as risks to the benefit/risk profile of the product, if not properly implemented.
- Identify roadblocks to RMP implementation
- Devise and implement solutions to minimize these hurdles and ensure optimal adoption of the product.
Hospitals were assessed through field visits aimed at understanding: availability, location and capacity of resources; knowledge of the product and RMP procedures; required training and education; and administrative, local payment and logistics hurdles.
All assessments were collected and analyzed to determine the ability to implement the RMP on a center-by-center basis, in order to design local solutions. Solutions designed were divided between local “quick wins” (e.g. identify resources and explain RMP requirements, write hospital RMP protocols, and efficiently divide RMP activities among HCPs) and more global “Long-term” actions (e.g. RMP Outsourcing Network).
Quick wins were directly implemented by LSC in hospitals, while a long-term RMP development map was recommended, country by country or region by region. Authorization and market access implications were also considered, in order to ensure a consistent and synergistic approach within each region.
- Project was considered a company-wide best practice for launch excellence and the assessment framework was used consistently across markets by MSLs to assess hospitals’ ability to run the RMP
- More than 300 hospitals were assessed through field visits—and the activity was very well received by customers
- Over 50 hospitals directly prepared for the RMP—and prepared centers saw faster product uptake
- Implementation of the RMP was transformed from a hurdle into a go-to-launch program, enabling pre-launch interactions with customers and institutions (e.g. on guidelines and budget impact)
- The program had additional benefits in emerging markets, in terms of developing specialty medicines used (e.g. local registries for access and controlled distribution to reduce misuse, parallel trade and fakes).
Access and Healthcare Ecosystems
The worldwide life sciences market is struggling with the exploding cost of healthcare and treatment technologies.
The challenges of pricing new technologies and granting access to patients now require manufacturers to possess superior ability to innovate in the way they price their therapies, as well as outstanding skills in demonstrating value.
Among the most interesting trends we see on a daily basis: the increasing role of the private/OOP market as ultimate payer for care, the creation of new commercial strategies and pricing systems for manufacturers to engage payers, the surge of new payers, and payer archetypes in US, EU and emerging markets.
Case Study — Innovative commercial deals: outcome and capitation-based offerings in diabetes
Diabetes is a major concern for public payers, who are looking at ways to improve control of disease while limiting and maintaining spending. Economic conditions and generic drugs’ entry into the market put our client’s diabetes portfolio at risk, despite significant benefits in terms of clinical outcomes when compared to competitors. Major public institutions increase pressure on drugs’ margins, an easy-to-control budget item.
- Identify opportunities/initiatives to maximize penetration and revenue in the public market.
- Leverage its complete portfolio of treatments for diabetes.
An innovative population-based offering was developed for the client, encompassing the whole drug portfolio, complemented by value-added services, population management systems and a benefit-maximizing pricing scheme. The offering had clear benefits for payers/accounts, in terms of cost control and improved clinical outcomes.
We supported the client through a four-phase program in all markets:
- Offering design and optimization based on extensive epidemiology, cost and clinical data review
- Epidemiology and economic modeling for each target account, to determine costs and benefits
- Targeting, offering adjustment and negotiation support with all identified accounts
- Detailed design and implementation of the negotiated program with each account.
- Discussion and offering presentation to more than 40 accounts across markets
- The offering was used to develop additional solutions, and spread to all emerging markets
- Transformation of a few countries’ commercial structure through a deal-oriented approach
- Deals above $20 million USD were reached with three accounts during the project.
Case Study — Captive population-based MEAs: develop actuarial and pricing models, and gauge account interest on deals
A top five pharmaceutical firm was facing unique competition and payer pressures—both on price levels and market share—for one of its most important products. The opportunity to assess the viability of an innovative, closed population-based agreement would have the potential to lead to transformational organizational change (from traditional go-to-market into a deal-making organization).
- Assess arbitration opportunities and viability of captive population-based MEAs
- Gather feedback from internal stakeholders on design of pricing schemes, and evaluate business case for the pharmaceutical company and payer, and associated risks
- Identify a sample of “suitable” payers/accounts for real-life testing, and define pilot offering alternatives according to different account archetypes
- Evaluate the interest of selected payers/accounts.
A deep understanding of the product, competition and therapeutic area cost drivers was fundamental to discover arbitration opportunities underlying a successful deal. It was also important to demonstrate to each country affiliate how this scheme was superior to any current deal or any other non-population-based deals.
The deal also had to be simple and clear to communicate internally and externally; core concepts were isolated from other add-on components. We were thus able to develop several offering structures based on the same core concept, but which could be attractive to different account archetypes (i.e. those interested in financial benefits vs. improved outcomes). A clear and tangible business case was also necessary, and had to build on sources of value truly appreciated by the payer: a win-win agreement.
Account feedback during the design process was fundamental, to ensure market receptivity to the agreement and establish first contacts to actual follow-up negotiations. Accounts were short-listed; we supported local teams with training and workshops to successfully engage with accounts during the meetings. Results of account discussions defined recommendations to top management on a proposed plan forward.
- Over a quick six-month timeframe, a product population-based MEA was drafted, studied and shared with global pricing, country affiliates and selected accounts
- Definition of profitable commercial offerings
- Effective support to training and facilitating account discussions
- First two deals were closed in Spain.
Case Study — Achieving premium pricing in a generic market: identifying differential value drivers and go-to-market strategy
Currently, market access negotiations in Europe can be a daunting task, due to the increasing budget pressures on healthcare expenditures. This is especially the case if the market of reference is mainly generic and widely perceived as being undifferentiated.
- Identify key value drivers that could be used to build a value story
- Analyze the viability of the drug business case with innovative commercial agreement schemes
- Conceptualize a country-specific go-to-market strategy involving innovative commercial agreements.
In-depth comparators’ clinical data analysis was key to identifying the unique value proposition of the drug that was previously regarded as undifferentiated. A proprietary model was developed based on the identified value drivers, which translated the product’s superior profile—as a stand-alone agent as well as relative to the competitors—into the value in economic terms.
The theoretical value calculated by the model was subsequently adjusted for claim strength and probability of value capture, resulting into the product’s price for each of the six EU markets. Based on the resulting prices and a thorough understanding of local payers’ profiles and archetypes, we assessed the viability of drug commercialization.
Country-by-country payers’ profiling and archetyping was transformed into country-by-country go-to-market strategies, which would serve as the foundation for market access discussions in Phase II of the project.
- A proprietary model was developed to define the inherent value of the product
- The claims strength analysis model translated the value into the price to be captured by the client
- High-level country-specific innovative commercial offerings were developed for each of the top six EU countries
- The project served as the foundation for top management’s positive decision on the commercialization of the product.
Patient Experience and Empowerment
Relationships with patients challenge manufacturers in several ways. Today, efficacy of new products is often coupled with increasing safety challenges.
Patient education must be provided by manufacturers, which in turn face more stringent compliance requirements.
Similarly, real-life efficacy requires strict adherence to therapy, but manufacturers are struggling to identify compliant and effective ways to support patients and providers.
Digital media pose additional threats to integrity of communication and quality of information.
When devising new patient support programs, global managers now must consider multiple and sometimes conflicting regulatory environments, identify unique value propositions and complement services with incumbent providers’ activities.
Case Study — Patient support program: design a global franchise strategy and enable consistent local execution by affiliates.
Launching a biosimilar product in a crowded, undifferentiated and highly relationship-driven market, where competitors have traditionally offered extensive patient and HCP support programs for over 15 years, is not an easy task. That’s especially true if one needs to establish such a presence in order to prepare the market for a follow-on game-changing product.
- Prevent barriers to prescription and ensure successful initiation of therapy
- Enhance adherence and retention
- Drive choice of prescription and attract new patients through differentiation (in selected cases)
- Reinforce the franchise image
- Untap synergies through a Pan-EU services model.
Effective concept design required a profound understanding of the market landscape, which was achieved through the analysis of the patient journey and needs, as well as benchmarking competitors’ core offerings. With this input, we developed both core and advanced service model strategic frameworks—and an actionable implementation plan.
The support for implementation of the concept across 12 EU markets required customizations and integrations, without losing the sight of overall Pan-EU service model core objectives. We closely followed country affiliates along each step of concept implementation, assessed their alignment and readiness, and designed measures of success (KPIs).
Service model design evolution required the selection of longer term service model objectives to support the franchise, and to leverage the availability of new digital channels. We developed a framework of selection criteria, designed functionalities of each new offering, facilitated internal compliance approval and developed a global toolbox for country affiliates
- Implemented more than 20 types of services in 12 EU countries
- Significant improvement of patient outcomes and reduction in therapy discontinuations
- Continuous support was provided to the franchise over five consecutive years, to design and implement global and country affiliate service models at launch, and their evolutions and upgrades over time.