Adapting In COVID-19: A Product Forecasting Framework

Adapting In COVID-19: A Product Forecasting Framework

Kx’s Key Takeaways For Product and Finance Teams   

  • Separate The Trough And Rebound: Modeling both the duration of the trough and the slope of the rebound, from peak COVID-19 infections to recovery, is critical to developing an accurate product forecast    
  • Layer In Regional Segmentation: Accurate forecasting requires more regional segmentation than most models demand due to the local variation in COVID-19 cases and varied government restrictions responding to the virus  
  • Expand Data Sources: Although COVID-19 is unprecedented in many respects, historical data can be used to model its impact. Utilizing a variety of data sources—analog regions that roll back restrictions earlier, patient and provider research, and prior economic downturns —can provide a valuable frame of reference to develop a more informed forecast  
  • Make It A Living, Breathing Model: With new restrictions and the medical community’s fast-paced response, it’s critical for companies to regularly monitor and update forecasting assumptions as the pandemic evolves   

COVID-19 Impacts Product Forecasting For Pharmaceutical and Medical Device Companies  

Dealing with significant evolving obstacles associated with COVID-19, businesses worldwide are adjusting their 2020 strategic plans. Pharmaceutical and medical device companies face particularly complicated hurdles, including procedure delays, office closures, and more that prevent patient access to their products. In this time of uncertainty, it’s critical to develop an informed view of future sales to establish a strategic plan and mitigate future risks to the business.  

Your Adaptable Product Forecasting Framework  

Kx Advisors created this framework to assist organizations in accurately forecasting sales during a time of high uncertainty with COVID-19. We recommend approaching the problem in two stages: the trough and the rebound. While organizations around the globe are currently in midst of the trough, understanding both stages is crucial for full-scale recovery. The questions we’ve identified for this framework can be split into three categories of barriers that COVID-19 presents: policy barriers, behavioral barriers, and economic barriers. Policy barriers are directly related to the pandemic management decisions of governments and medical associations, while behavioral barriers are driven by changes in industry competitor, physician, and patient behavior, and economic barriers are those created by changing economic conditions affecting willingness to pay.

 

COVID-19 Product Forecasting Framework Graphic Depicting Trough and Rebound

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Planning During COVID-19  

While no one can predict the future, this framework should help you gain critical insights to better project and respond to these challenges. Leveraging this tool to strategize is only step one; your product team must continually monitor the quickly evolving factors impacting the framework’s components and adjust your strategy as needed to stay ahead of the economic effect of this pandemic.  

Kx Is Here To Help  

Struggling with product forecasting during this crisis? With extensive forecasting experience, we’re experts at quantifying what is hard to quantify.  Our healthcare experts will rapidly analyze the changing field and build strategies with your team around the opportunities we identify. 

 

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3 Questions To Ask For Launch Planning During COVID-19

What Product Managers Must Do To Launch Successfully In This Pandemic

Launching Healthcare Products In Uncertain Times  

For many pharmaceuticals and medical device companies, the spread of COVID-19 has no doubt disrupted upcoming product launches. As prescribers treat and patients seek care in this highly variable environment, the landscape for a product launch looks different than just a few weeks ago. This crisis hampers months to years of planning, and we see a unique set of questions posed to product management leaders.  

What You Can Do Today – A Launch Planning Framework  

As the COVID-19 virus continues to spread, many companies must adjust different components of their upcoming launches. How do product managers decide what to adjust in their launch, how it impacts them, and where to go from here? Our experts created this framework to guide you through three critical questions for agile launch planning during this pandemic.   

Launch Planning Framework For Product Managers During COVID-19
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Moving Forward During COVID-19 

The uncertainty triggered by COVID-19 highlights the healthcare industry’s need for adaptability in pharmaceutical and medical device launches. Leveraging this framework, product managers can anticipate and meet any future challenges to launches due to COVID-19 or other rapidly-evolving events. Acting now can diminish any negative impact on your launch.  

Kx Advisors, Experts In Launching   

Are you planning a product launch that could be impacted by COVID-19? Kx Advisors can help. With launch planning expertise, our team of healthcare specialists will guide your team in identifying issues quickly and adapting your plans for whatever comes next. Our rapid assessments will build on this framework, examine market data, and evaluate your options to guide you through the crisis. Our tailored approach will empower your team to launch your product effectively. 

 

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How Is COVID-19 Impacting Procedure Volume?

Understanding The Changing Healthcare Landscape Is Key For Commercial Strategy

Treating Patients During A Crisis

The spread of COVID-19 has disrupted the healthcare industry. With hospitals scrambling to prepare for an influx of patients and government officials enacting large-scale safety measures, the overall volume of medical procedures is decreasing dramatically. The Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and other healthcare thought leaders are recommending that providers limit non-essential and elective scheduled surgeries and procedures. However, not all procedures are equally impacted.

Graph depicting degree of impact on procedures based on setting and urgency

While COVID-19 is reducing treatment volume, the degree of impact varies depending on the urgency of the condition and the treatment setting. Procedure-focused companies must understand this evolving environment to forecast accurately and make crucial business decisions, such as resource deployment, commercial spending, and launch planning. Due to the fast pace of this pandemic and the corresponding response of the healthcare community, it can be difficult to predict the risks and disruptions organizations face. Without clear insight into the near-daily changes that medical professionals encounter, many companies’ strategic plans are no longer actionable.

How COVID-19 Impacts Orthopedics

The Kx team analyzed the consequences of COVID-19 for the orthopedic field, exploring trends that could inform expectations for the coming weeks and months. Our survey of orthopedic specialists across the US highlights that in most areas of the country, urgent and emergent procedures are still being performed, but elective procedures are being canceled.

US map depicting degree of impact on procedures by location

 

The only orthopedic procedures that are being performed treat truly urgent conditions: cases of infection and trauma. However, even critical treatments like these are being performed at a lower volume than before COVID-19 emerged in the US.

Graph depicting the volume by type of procedure

Lessons Learned For Other Specialties

Our case study in orthopedics serves as an opportunity for companies focused on other specialties to apply insights to their fields. With ~97% of orthopedic specialists only performing urgent procedures (if at all), healthcare professionals and companies can expect to see similar trends throughout the industry. As ~38% of orthopedic specialists are not rescheduling at this time, organizations throughout the healthcare industry must adjust their expectations and expect the repercussions of COVID-19 for an extended period.

Kx Advisors, Experts In Resilience

Is your organization impacted by the sharp decline in procedures due to COVID-19? Kx Advisors can help. Our experts offer tailored guidance in forecasting, commercial strategy, and launch planning, projecting future trends and empowering your organization to adapt during a global pandemic or another unpredictable event. Our team will continue to monitor trends over time to help predict which procedures are resuming and when, giving your organization current data to inform your key business decisions.

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Rare Diseases – Patient Advocacy

Patient Advocacy Groups (PAGs)

1 in 2 rare diseases do not have a dedicated foundation or research support group. In the US, that number translates to close to 15 million patients navigating a complex journey without a dedicated team supporting them and ultimately seeking out a life-changing treatment. As the rare disease market continues to grow and evolve, so will the focus on patient engagement and advocacy, led in part by patient advocate leaders and community patient advocacy groups (PAGs).

PAGs engage with three primary rare disease stakeholders

Caption: Patient Advocacy Groups work with stakeholders across the rare disease patient journey and can be a valuable partner to biotech companies.

Patient advocacy groups (PAGs) are at the crux of a highly complex healthcare landscape. They play a central role in connecting several stakeholders and work as liaisons between patients, physicians, biotech companies, and community leaders. Companies frequently team up with PAGs to engage patient populations and offer support – such as treatment access and care – to both patients and caregivers. Patient Advocacy Groups also work with community leaders and far-reaching KOL networks to raise disease awareness and influence legislation and / or local policy. Other valuable activities, such as patient identification, clinical trial recruitment, and R&D collaboration, also support the indispensable role of PAGs in the rare disease market.

PAGs come in different shapes and sizes

Caption: Rare disease patient advocacy groups come in all shapes and sizes, supporting patients of many rare diseases at various levels – national or global.

The patient-focused nature of the rare disease space makes working with patient advocacy groups a necessity, not an option. While many companies may know the value that comes from PAG collaboration, they may not know how to go about having these conversations and develop a successful strategy. Companies should first thoroughly understand the various roles PAGs play in crafting an effective strategy and engage with these communities. Companies can take the knowledge they gain from these conversations to raise awareness, improve quality of life, and positively transform the treatment landscape for rare diseases. PAGs can support rare disease companies…

  • …as Patient Advocates

It’s in the name: Patient Advocacy Groups, or PAGs, are there first and foremost to be advocates for patients. PAGs are very close to the patient journey and have a unique perspective on it, including unmet needs and ongoing challenges. These organizations support patients and caregivers in seeking out treatment centers, navigating complicated access pathways, and obtaining financial assistance. PAGs are direct advocates, often lobbying in the public domain and influencing regulators to improve patient access. Biotech companies should invest in long term collaborations with PAGs to create an open dialogue about how to successfully engage with patients, such as marketing tactics or educational tools. These conversations may unearth existing challenges or unmet needs for patients that companies can capitalize on and use to differentiate themselves. Insight into patient unmet needs also provides perspective on what types of services and support patients require, and new product or support offerings can be directly informed by these conversations and custom-designed to meet patient needs. Feedback on existing support services and disease challenges can help companies also refine their customer-facing strategies. 

  • …as Educational Partners

With many rare diseases lacking educational resources, PAGs are crucial to minimize gaps in disease awareness. Besides providing patient and care education, they also work closely with COEs and KOLs to disseminate information about ongoing trials and new treatments, while encouraging patients to explore their options. The ongoing campaigns and awareness efforts often culminate in policy appeals and can even shift the treatment paradigm in the long term. Companies should consider this an opportunity to educate not only patients, but physicians as well, who are navigating a complicated diagnosis landscape with many unknowns. Diagnosis remains a large gap and could bring a big payoff to companies if they are able to develop new tools or tests to increase the diagnosis rate. Companies should strategically align themselves with PAGs to demonstrate a commitment to educating and supporting the patient population – a commitment that will reap impressive benefits later down the road.

  • …as Research Partners

PAG proximity to the patient journey makes them a valuable resource in not only selecting treatments, but in developing them. Like KOLs, PAGs support clinical trials by identifying patient populations and referring patients for recruitment. Furthermore, as the voice of the patient, PAGs are pivotal in pushing novel or first-in-class therapies through the pipeline. Their firsthand experiences with patients can inform clinical trial design, from determining best-fit patient profiles to establishing trial endpoints. As mentioned earlier in this series, an early-stage collaboration can set companies up for success as they think through treatment protocols and, eventually, product commercialization. Questions around clinical trial endpoints, treatment administration, and existing treatment protocols can be very valuable when preparing for drug development and design. Working directly with patients and physicians gives companies a first-hand understanding of their customer profile and can better inform the product and its strategy.

What questions should rare disease players be asking PAGs?

Caption: How should companies guide conversations with PAGS? Companies can look for gaps in the current landscape and identify opportunities to add value to stakeholders across the care continuum.

Patient advocacy groups will always be front and center in the rare disease space, focusing on their patients and advocating for new and effective treatments. Engaging in conversations around the treatment landscape, disease challenges, and unmet needs can present companies with an opportunity to establish a trusted presence in the market. Companies should be excited to partner with these groups and do so early; loyalty within the rare disease landscape benefits all stakeholders – not just the patients.

Rare Diseases – Stakeholder Education

The Role of Stakeholder Education in Rare Diseases

Despite the growing pipeline of orphan drugs, ~95% of rare diseases do not yet have an FDA-approved treatment. This increasing momentum in rare disease R&D has further highlighted the ever-present need for stakeholder education and engagement, which is critical to begin well before drug commercialization. Patients, key opinion leader (KOL) physicians, and other physician specialists supporting treatment are primary players in the rare disease space that influence treatment selection and access to novel therapies. Rare disease stakeholder education plays a critical role at every stage in drug development and commercialization and should be top of mind for rare disease companies regardless of whether they are designing clinical trials or preparing for product launch.

Caption: KOLs play an important role in the patient journey. From diagnosis to treatment access, KOLs support rare disease patients in making important decisions about managing their condition and obtaining the best possible care.

How to Implement Rare Disease Stakeholder Education

Rare disease companies need to engage with different stakeholders to address various pain points along the patient journey and maximize the opportunity for their orphan drug. KOL communities will be especially valuable throughout the drug development process. As a part of tight-knit medical communities, KOLs collectively influence treatment standards and typically have a deep understanding of how access to care and treatment varies across global markets. KOLs will be play important roles in:

  • Diagnosis: Timely diagnosis remains a major challenge for rare diseases; on average, patients wait close to 5 years and visit over 7 physicians before an accurate diagnosis is made. Delayed diagnosis can further complicate the patient pathway, often increasing the number of interventions required after the disease has progressed. Dedicated education efforts targeting physicians and patients, as well as improved testing access, can ensure accurate and earlier diagnoses.  Companies should look at this as an opportunity to educate stakeholders and develop genetic tests to increase diagnosis rates and maximize patient adoption. While there are currently no genetic tests available for many rare conditions, competition to develop effective diagnostic tests will increase after a disease modifying treatment is introduced to the market. KOLs can also support development of innovative screening techniques, including using artificial intelligence or predictive analytics with electronic health record data to identify patients at high risk of an undiagnosed rare disease. 
  • Drug development: KOLs play an integral role in drug development, ranging from supporting animal model design, clinical trial design, and designing clinical endpoints (e.g., novel disease severity / quality of life scales). As disease experts, KOLs understand needs, market access challenges, and adoption drivers and should be considered an asset to pre-commercialization efforts for rare disease companies. KOL in-depth expertise and knowledge should be leveraged for refining target product profiles (in particular via advisory boards), understanding treatment barriers across markets, estimating the size of local patient populations, selecting sites and recruiting patients for clinical trials, and supporting market access and reimbursement decisions for regulatory bodies and payers. Companies will greatly benefit from early and global KOL engagement throughout the drug development process – whether as consultants or scientific investigators.
  • Launch planning: KOLs are very familiar with the gaps in the existing patient pathway, and, post drug launch, can provide insights on ideal future-state diagnosis and referral patient pathways. Rare disease companies should continue to collaborate with KOLs to streamline the access pathway and demonstrate their long-term commitment to a given patient population. Post-launch trials also offer an opportunity for KOLs to disseminate information and develop stakeholder education deliverables about achieved health outcomes and / or pivotal trial results with physicians and patient advocacy groups (PAGs). Over time, KOLs become strong advocates for drugs, especially those that they have supported through development, and can be important allies as companies move towards commercialization. 

Caption: Companies looking to launch a new drug should focus on how they can work with KOLs and other stakeholders to best understand local market opportunities, including disease prevalence/incidence, frequency of diagnosis, and likelihood of treatment adoption.

Centers of Excellence (COEs) are another critical component of rare disease stakeholder education. COEs, in conjunction with KOLs and their reference networks, offer rare disease patients specialized care and expertise. COEs combine clinical research, knowledge, and treatment services to become a regional or global “hub” for undiagnosed or recently diagnosed patients. The multidisciplinary approach they take is not only valuable to patients, but also biopharma companies as they enter commercialization stages. COEs are a reliable source of support for companies, referring patients from their centers and supporting commercial activities later down the road. A strong relationship with COEs and their KOLs can mean success for rare disease companies looking to work closely with patient populations and demonstrate long term commitment.

Caption: Centers of Excellence are a critical component of the rare disease patient pathway. Patients seek diagnosis support, treatment advice, and care coordination from experts at COEs across the globe.

KOLs and COEs are key stakeholders in the rare disease space and should be top of mind for companies looking to enter the space. As competition within the market increases, how companies work with KOLs to leverage their expertise and best understand the treatment landscape will become a key differentiator. KOLs, though critical to the market, are not the only stakeholders that companies should keep an eye on. In the next part of these series, we will share why patient advocacy groups are an important ally for both patients and rare disease companies, and how they can successfully work together to introduce new treatments to the market.

 

Rare Diseases – Market Access

AN ORPHAN DRUGS JOURNEY: COMMERCIALIZING RARE DISEASE DRUGS

In this series, Kaiser will explore how rare disease drug companies can develop commercial growth strategies to succeed against the challenges of a high cost and highly specialized market.

2018 saw 91 orphan drug approvals by the FDA – nearly 3 times greater than in 2013 and the highest number of approvals yet – along with over 400 designations for the candidates in development. 2019 is expected to bring even more orphan drug approvals as more companies begin to realize R&D investments in rare diseases. Driven by high pricing potential, significant unmet needs, and favorable regulatory policy, orphan drug sales are expected to balloon to reach $262B in the next 5 years. The market continues to grow more competitive and new technologies are emerging, such as Spark Therapeutics’ Luxturna, which marks the first FDA approval in a new class of one-time gene therapy treatments targeting inherited diseases. In this environment, companies will need to shift their focus to how they can play strategically and optimize the value of their orphan therapies.

 

Caption: Orphan drug approvals are expected to reach a similar level as 2018, with new tissue agnostic cancer therapies poised for approval and increasing market opportunities for emerging gene therapies, especially those enabled by advances in CRIPSR gene-editing. Source: FDA Orphan Drugs Data

 

Caption: Orphan drug sales are expected to grow at an ~11 % CAGR over the next five (5) years and continue to gain share of the overall drug market as sales growth outpaces non-orphan drugs, despite expected introduction of newer generics and biosimilars for non-rare conditions. Source: EvaluatePharma

 

Launching an orphan drug is very different from launching a standard, non-rare disease drug. For companies to successfully commercialize rare disease drugs, they need to understand the critical differences between traditional and non-traditional (orphan) commercial models and rely on a new playbook to capture and maintain market share.

Caption: Rare disease companies face different challenges in effectively deploying their commercial budget, namely in developing the market by identifying patients, targeting leading treatment centers of excellence, and establishing KOL partnerships. 

What makes commercializing rare disease drugs different? Rare disease drug companies need to consider launch from a patient-focused mindset rather than a traditionally physician-focused one. While traditional drugs depend on physician adoption and assume widely educated and diagnosed patient populations, the opposite is true for orphan drugs. Rare disease companies will have to manage their commercial budgets very differently, focusing on patient needs and setting the stage for:

  • Targeted sales force development: In the rare disease drug space, quantity does not mean quality. Sales teams need to address patient populations specifically, ensuring they are reaching the right customers with the right messaging. Small, agile, and cross-functional commercial teams will contrast with the larger, specialized sales teams used for traditional big-name therapies.
  • Stakeholder education: Identifying the right physicians, patients, and care settings is a challenge unique to the orphan drug market. Companies should expect to develop a market where limited educational resources, physician training, and diagnostics tools regularly inhibit accurate diagnoses of patients with rare conditions. Rare disease companies must be ready to develop their markets through targeted educational efforts and be armed with a thorough understanding of the addressable space. Many rare disease companies have established one-on-one nurse case management services to provide “personalized product support” to patients with treatment information, coverage options and authorizations, financial assistance, and care navigation. Examples of these services include Alexion’s OneSource Treatment Support and Shire’s OnePath program.
  • Patient advocacy: Physicians and patient advocacy groups (PAGs) are often an essential part of care management for many patients. By sharing educational resources, helping to address financial issues, and creating awareness for patients to enroll in clinical trials, PAGs present themselves as a necessary resource not only to patients but to orphan drug companies as well.  Drug companies should strategically align themselves with these types of groups to locate and engage patients throughout the drug approval process.
  • Effective KOL partnerships: In orphan diseases, it is common for a small group of specialized physician researchers and Key Opinion Leaders (KOLs) to manage and determine treatment for a significant portion of an orphan disease population through reference centers of excellence. Companies should consider involving KOLs with late stage clinical studies to engage patients early and potentially jumpstart early access initiatives, such as compassionate use. KOLs are also valuable assets during drug development; a collaborative approach, for example via advisory boards, fosters trust and confidence in the product all the way through launch.
  • Pricing and market access: For US companies, outcomes-based pricing and value-based contracting will become a primary focus for rare disease companies moving forward. Last year, Alnylam announced a value-based selling strategy for Patisiran, an increasingly popular approach to make the high cost of these drugs more palatable. In contrast, companies launching in Europe will face challenges as the market prepares for continued high cost drug launches and a higher bar is set for outcomes in rare diseases with one or more marketed therapies.                                                 

 

Rare disease drug companies must be ready to actively engage in market development and support targeted efforts within this fragmented arena. In the next part of this series, we will understand why stakeholder education plays a critical role in market development for rare disease drug companies and how they can successfully capitalize on the opportunity despite the unique challenges it presents.