5 Misconceptions for MedTech Market Access Strategy

5 Misconceptions for MedTech Market Access Strategy

Market access in MedTech is a complex and rapidly evolving environment, with increasingly intense scrutiny on the costs and benefits of new technologies as the pressure on budgets increases globally. The ability to prepare for and navigate market access strategy is, now more than ever, crucial to the success of a new product, and is frequently assessed by potential partners and acquirers with the same priority as the scientific rationale or potential for favourable regulatory approval.

During the recent MedFit 2022 event in Grenoble, we discussed the most common pitfalls that may affect market access planning and strategy with leading European experts and start-up companies. Here are the top five misconceptions for market access strategy we identified.

“We want to get the approval first, then we will plan for market access”

Engagement with payers early in product development is essential. Companies should define a path to reimbursement, and understand how payers will assess their product, as early as the concept stage to use payers’ feedback to shape the technology into a marketable product and create patient and company value. Leaving engagement with payers until late in development, or after approval, can often lead companies to:

  • overlook crucial requirements
  • mistarget patient populations
  • fail to expectations to gain market access
  • fail to gain critical pricing insights to size the commercial potential

Missing the opportunity to treat payers as your sounding board can cause delays and significant restrictions in access, while timely and iterative payer engagement has the potential to speed up the development process.

“The evidence we are generating for regulators will be sufficient for our market access strategy”

Regulatory decisions are at the top of priority lists for MedTech entrepreneurs both in the US and Europe. Selection of the right pathway and preparation of required submission dossiers are time-consuming and costly and constitute a necessary condition for market access. Late-stage start-ups agree, nonetheless, that it is far from sufficient, and payers themselves corroborate this perspective. In a recent Kx Advisors study, 100% of interviewed executives for major US payers agreed going beyond the evidence required for regulatory approval is key for market access strategy. Payers increasingly require demonstration of patient value not only with differentiated clinical efficacy and safety but through increased compliance and improved patient outcomes and satisfaction. They are also seeking additional sources of data, such as real-world evidence, insurance claims, and adverse event reports. MedTech companies should plan and pre-empt these requirements by carefully designing their studies for a payer-targeted set of endpoints as early as possible and generating evidence with not only regulators but also payers in mind.

“There is an established price for devices like ours”

Existing pricing and reimbursement benchmarks provide valuable insights for market access strategy, as showing cost-effectiveness in comparison to the current standard of care is an important part of any MedTech company’s economic narrative. However, payers’ focus is shifting towards a more holistic view, with greater interest in:

  • improved patient outcomes
  • demonstrated longer-term value
  • ease of use
  • adherence to treatment
  • patient satisfaction

Four out of every five payers recently interviewed by Kx Advisors indicated a preference for increased value over purely lower cost of treatment and were ready to assess pricing based on a complete view of benefit for the patient and healthcare system. The approach MedTech companies take to frame, measure, and present this value becomes a tactical choice, and a key element of a broader commercialisation strategy, that should not be dismissed or made based on a simple competitive analysis.

“We will focus on a market we know and aim for broad market access”

Many MedTech companies decide to first target their home geographic market, building on their familiarity with it, knowledge of the local language and system, and network of contacts. This approach, while easier from a product development perspective, may not allow companies to fully capture their commercial potential. In conversations with Kx Advisors, start-ups with prior product launch experience highlighted the need for fast market deployment and the value of testing the product with first adopters (and getting the product paid for early on) typically outweighs the breadth of market access. The choice of the first markets in which to launch is a strategic decision, and market access becomes one of the key drivers that should be considered in careful prioritisation of the highest potential markets. Entrepreneurs should be aware of both regional (e.g., US vs EU) and intrinsic (e.g., openness to innovative technologies) differences among payers, as well as differing patient population structures and accessibility, and explore avenues that expedite first market access, such as targeting research institutions or venturing into new geographies.

“Payers are not willing to consider innovative reimbursement models”

Getting paid for innovative technologies is notoriously difficult, especially when there is no easy way to make them fit within the established market access pathways for medical devices. The emergence of digital therapies and connected health, as well as the ongoing shift towards at-home therapies accelerated by the COVID pandemic, have only made the landscape more complex. At the same time, the awareness and urgency to address these challenges is on the rise among payers. Approximately 60% of payers recently interviewed by Kx Advisors stated they are exploring value-based reimbursement options and new, alternative pricing models for medical technologies (e.g., subscriptions or device-as-a-service arrangements) will be an increasingly welcome element of future coverage decisions. Building a differentiated market access strategy that accounts for multiple possible business models and reimbursement scenarios and exploring those early with key stakeholders can allow MedTech companies to create and leverage these opportunities.

 

Has your commercialisation strategy ever been impacted by any of these common misconceptions? Or are you currently facing other strategic decisions that will be crucial for your MedTech company’s growth? Feel free to contact Kx Advisors for a follow-up discussion.

Contact Our Team Today

 

Jenna Riffell is a Managing Partner at Kx Advisors, based in London.

Przemek Czerklewicz is a Principal at Kx Advisors, based in London. During the recent MedFit Event 2022 he led an expert panel titled “Innovators’ checklist for market access”.

 

 

Using the Patient Journey to Understand Health Equity Challenges

Health Equity: Overview of Health Systems and Patient Pathway

Unequal healthcare access among different groups leads to less preventative care, and more urgent and intensive procedures. Such disparities in access currently cost the US healthcare system approximately $320 B annually and is projected to grow to as much as $1 trillion annually in 2040[1]. In economically and socially disadvantaged communities, patients face barriers that impact their ability to receive necessary and equal care.

For life sciences companies, inequities lead to patients receiving inadequate or delayed care, and in its worst form, causes patients to miss treatment opportunities that utilize their products.

Life science companies can begin to tackle some of the drivers and determinants of health equity by using a patient-centric approach, as patients’ primary point of interaction with the healthcare system is through their providers. A closer examination of those interactions can reveal how manufacturers and medical technology companies can create initiatives to support greater equity. Examining the patient pathway can reveal specific moments when inequities “add-up” causing significant treatment drop out.

Solutions to equity barriers are not static – companies need to set themselves on a continuous path to improvement. The place to start is understanding what drives friction between patients and their own healthcare and focusing on the patient-provider interaction to identify solutions and expand their presence in underserved markets.

Barriers Arise During Patient-Provider Interactions

In order to maximize patient access and health outcomes for life science companies and manufacturers, the patient-provider interaction is key to understanding barriers to treatment. Acute analysis of these barriers is the first step to understanding where life science teams have the most influence on health equity and patient treatment access.

  1. Barriers limiting patient-provider interaction Before a patient walks into a doctor’s office, they may already face structural and socio-economic challenges impacting their interaction with the physician and their ability to follow a treatment plan. Such barriers include a lack of insurance, lack of transportation resources, and lack of availability. For example, Black Americans were 3x more likely to report loss of health insurance during the pandemic compared to white respondents. Structural and socioeconomic challenges also drive additional comorbidities, such as obesity and hypertension[2], which may limit treatment options.
  2. Patient perspectives and hesitancies during provider interaction When treating patients, providers interact with patient groups with differing attitudes towards the healthcare system, their diagnoses, and treatment options. For example, Black patients are more likely to mistrust the healthcare system due to long-standing racial inequalities. A nationwide poll by The Undefeated and the Kaiser Family Foundation found 7 out of 10 Black Americans say they’re treated unfairly by the healthcare system and 55% percent say they distrust it[3]. Lower trust among patients can lead to slower and less vigilant follow-up, and potentially patient drop-off from treatment. Patient groups also have varying awareness and understanding of their diagnosis due to education levels, and a patient’s perspective on the severity of a disease can be a major driver for urgency and vigilance with treatment follow-up
  3. Provider biases and pre-conceived notions Finally, physicians can also be impacted by racial bias, impacting the delivery of healthcare to racial minorities. Studies testing implicit association among physicians have found low to moderate levels of bias against racial minorities[4], and a public health study found 32% of Black Americans have reported being discriminated against when receiving healthcare treatment[5]. Although this bias may be unintentional, implicit bias from physicians negatively impacts patient behavior. A Journal of Family Practice study found patients who felt racial discrimination in a healthcare setting were less likely to follow physician recommendations and more likely to delay care[6]. Although many healthcare curriculums have developed to increase understanding of race-based impacts, negative impacts of bias on patient outcomes remain.

Health Equity Barriers to Patient Care

How can Kx Support Your Health Equity initiatives?

Research in Health Equity can be challenging. Understanding how to create a more equitable environment, and how to support underserved populations requires a nuanced and detailed approach to research supporting such initiatives. Kx Advisors helps clients frame research challenges using the patient pathway to understand where and how health equity initiatives should be targeted. To learn more about how Kx can support your Health Equity initiatives, contact Evelyn Tee at evelyn.tee@kxadvisors.com to learn more.

 

Contact Our Team Today

 

[1] McKinsey COVID-19 Consumer Survey as of June 8, 2020
[2] Akil L, Ahmad HA. Effects of socioeconomic factors on obesity rates in four southern states and Colorado. Ethn Dis. 2011;21(1):58-62.
[3] Common Wealth Fund: Medical mistrusts among Black Americans
[4] Sabin J, Nosek BA, Greenwald A, Rivara FP. Physicians’ implicit and explicit attitudes about race by MD race, ethnicity, and gender. J Health Care Poor Underserved. 2009;20(3):896-913. doi:10.1353/hpu.0.0185
[5] NPR/Robert Wood Johnson Foundation/Harvard T.H. Chan School of Public Health, “Discrimination in America: Experiences and views of African Americans,” 2017, Figure 1.
[6] Blanchard J, Lurie N. R-E-S-P-E-C-T: patient reports of disrespect in the healthcare setting and its impact on care. J Fam Pract. 2004;53(9):721–30.

Key Insights & Takeaways: American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo

The Clinical Chemistry Annual Meeting did not disappoint with great attendance, engaging talks, and some innovative exhibits. After digesting all our notes (and a bit of Chicago’s finest culinary fare) from the busy week, we walked away with five key takeaways:

Innovative culture on display

If new products and technologies capture your attention, the Clinical Expo did not disappoint. Headlined by the Disruptive Technology Award winner, Nanopath, who led with a solid-state biosensing platform that removes the need for nucleic acid amplification. However, the Clinical Expo was full of new product launches, with some breaking new ground, such as Angle, plc with a system for harvesting cancer cells from patients’ blood for analysis. As expected, a stream of Monkeypox virus controls and assays were starting to be announced to address the now declared public health emergency. With promising innovations come questions about their ability to displace existing technologies, improve testing workflows, the size of addressable markets, and go-to-market plans. Members of the Kx team support clients by answering these types of questions every day and can assist you in thinking through how best to tackle these issues.

Still have VALID fears

On the heels of Europe having a regulatory shakeup in diagnostics (In-Vitro Diagnostic Medical Devices Regulation (IVDR) implementation), it seems likely the United States is about to follow suit with the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) coming to a vote in Congress as early as next month. With so many clinical laboratorians converging on the conference, we expected to hear various positions and forecasts. AACC organizers did an excellent job putting forward an update through a session titled “Valid Vital LDTs: Current State of Regulation Legislation of Laboratory-Developed Tests.” However, we are left with the impression several laboratorians are upset with the impact this legislation could have on their business. Kx Advisors is keeping a close eye on this legislation and will be providing an update as the situation evolves. Get in touch if you would like to be kept informed and up to date on the latest developments.

Tech influences testing

Algorithms, connectivity, and smartphones were highlighted not only on the main stage, but across the Expo floor. Artificial intelligence and machine learning were featured in Dr. George Church’s plenary session discussing how machine learning will support a laboratory’s desire for multiplex testing, simultaneously gathering anywhere from tens up to billions of data points. On the show floor, we saw several connectivity products and features on display falling into two basic categories. First, solutions, such as Planet Innovation’s NeoSync(TM) and BrightInsight’s Connected Diagnostics Platform, focus on flexible configurations that may integrate into existing or future medical devices. The second category leverages smartphones as a connectivity conduit, with applications spanning from mobile phlebotomy to test analysis for blood clotting, infectious disease and more. Implementation of connectivity and algorithm-driven testing schemes as either products or product attributes require a strong understanding of testing behaviors and user segmentation. Kx Advisors utilizes novel behavioral modeling, and environment/user segmentation frameworks to support prioritizing the ideal tech-enabled features and products.

Character matters

As an industry, we all watched the collapse of Theranos, and the subsequent convictions of Elizabeth Holmes and Ramesh Balwani on fraud charges. These events surfaced discussions on the intersection of startup culture and clinical diagnostics, public trust in laboratory medicine, and the role of government oversight. AACC organizers wisely “read the room” and highlighted a discussion on ethics and accountability with Theranos whistleblowers, Erika Cheung, and Tyler Shultz. As a part of the diagnostics community, I applaud the efforts of AACC to facilitate these discussions.

Thank you, Chicago!

Chicago offers more than hot dogs and pizza – If you read our previous post about the hot topics of AACC, Bob Serrano and I voted for our favorite Chicago signature foods. Well, thank you Chicago for some amazing food and great hospitality— even if we missed grabbing a dog.

How Kx Can Help

Discuss more on the latest developments in diagnostics and life sciences or our key takeaways from the 2022 American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo. Contact Brian McNally, PhD brian.mcnally@kxadvisors.com.

Contact Our Team Today

Rare Disease Drug Development & Commercialization Learnings, Opportunities & Debates at World Orphan Drug Congress USA 2022

The Kx team attended the World Orphan Drug Congress (WODC) in Boston, MA last week and came away energized from three days of sharing ideas, inspirational stories, and panel discussions. This event brings together the full range of stakeholders who drive and support orphan drug development, regulatory approval, treatment delivery, and patient/caregiver support services. Here we discuss a few themes we heard across meetings and presentations:

Capturing the full market potential for a new orphan drug is a challenge; diagnosis and treatment gaps add to the unmet needs a new treatment needs to address

Repeatedly, newly approved treatments for rare diseases with a strong clinical profile (i.e., safe and effective) have not achieved the degree of adoption forecasted pre-launch. Why? With humility, drug developers acknowledged their own shortcomings in not building a comprehensive ecosystem of care for target patients, their caregivers, HCPs, and payers.

Unfortunately, there is no universal go-to-market (GTM) playbook for launching a treatment in an orphan indication; however, key questions to ask when GTM planning in rare diseases in have become clear:

  • What is the daily reality and emotional state of patients and caregivers?
  • What breakpoints exist in the patient journey, and how can we address those?
  • How can barriers to delivery be mitigated through just-in-time delivery infrastructure and treatment sites creation for gene therapies?
  • How should value be measured (to ensure access and coverage continuation)?

The term “beyond the pill” is still a popular idea, but there is a need to define what that means for meeting the needs of different patient, HCP, and payer populations. By establishing trusting, longitudinal relationships with the patients, caregivers, and HCPs they strive to serve, drug developers are successfully building tailored, comprehensive GTM strategies today for the next wave of orphan drug launches, building the foundation for “beyond the pill” to be more than a catchphrase. 

Value differentiation is best achieved through focus on simple, straightforward clinical endpoints

For over a decade, rare disease treatments have seen greater flexibility from regulators on primary endpoint designations than treatments for more prevalent indications; however, we consistently heard that leniency in clinical trial design may fade. Until now, drug developers could drive endpoints selection based on early trial results and carry these through to regulatory approval reviews. As noted by Simone Boselli, Public Affairs Director, EURODIS, during one of the panel discussions, too often today these endpoints are abandoned post-approval given challenges with continued tracking in real-world settings.

Going forward, drug developers should pursue greater prospective consideration and engagement to ascertain how regulatory bodies (FDA, EMA, health technology assessment (HTA) bodies) expect data packages to be constructed. Emphasis will be placed on using clinical endpoints that are simple to compare across studies by competing developers and straightforward to extrapolate to functional benefits for patients, as well as feasible to continue to measure in the real world as drug developers aim to build a real-world evidence base. In the future, drug developers presenting unique (rather than universally accepted) clinical endpoints may run into delays or rejections, costing time, revenue, and patient access to novel treatments.

Rare disease patients desire true partnership, including greater influence over the risk tolerance decisions and transparency on drug development setbacks

Appropriately, keynote presentation sessions often included patient advocates such as Allyson Berent, COO, GeneTx*, who shared her experience from her daughter’s Angelman Syndrome (AS) diagnosis at 6 months old. When she realized there were no approved treatments for the condition, she dedicated her time and energy to pursuing an effective treatment, ultimately becoming the Chief Science Officer of Foundation for Angelman Syndrome and co-founder of GeneTx.

(*note: GeneTx was acquired by Ultragenyx on 7/19/22)

We at Kx Advisors applaud the dedication of individuals, such as Allyson Berent, who work relentlessly to bring innovative therapies to patients. Also, we are telling her story here because her asks to industry were echoed by others at WODC:

  • Further elevate patients’ voices and requests – creating an ecosystem of care requires early and frequent patient input 
  • Consider that the risk-reward tolerance when patients are desperate for a lifeline may be different than industry’s view; many felt patients should have more influence on the calculus 
  • Increase transparency of critical feedback from the FDA to drug developers when reviewing clinical results, as patients are central to progress and deserve transparency on both advancements and setbacks; this sharing rarely occurs today, and collectively holds back innovation for the sake of competitive advantage

 

How Kx Can Help

Do you want to discuss further our takeaways from the World Orphan Drug Conference? Does your organization need to address specific challenges in rare disease asset planning and launch strategy? If so, please contact Brett Larson brett.larson@kxadvisors.com or Jenna Riffell at jenna.riffell@kxadvisors.com.

Contact Our Team Today

Q&A with Kx: Spotlight on AACC 2022

Q&A with Kx: Spotlight on AACC 2022

American Association for Clinical Chemistry (AACC)
2022 Annual Scientific Meeting & Clinical Lab Expo
July 24 -28, 2022
McCormick Place Convention Center
Chicago, Illinois USA

Before they head off to the Windy City for this year’s AACC Annual Scientific Meeting & Clinical Lab Expo, we asked Bob Serrano and Brian McNally for their insights on what they hope to learn, see, and are excited to discover at this year’s conference!

Q: What takes life science growth strategy consultants to the American Association for Clinical Chemistry Annual Meeting?

Bob: At Kx Advisors, we focus on partnering with life sciences clients to deliver actionable insights that fuel growth. Clinical diagnostics has always been a market with technical innovations, but now more than two years since the start of the COVID-19 pandemic, we see significant investments being made. Those investments are in a market where patients demand greater value from testing. Models that decentralize molecular diagnostics right into our homes or adding genome sequencing to doctor’s visits, are both examples of those new models. Conferences like AACC are a great venue for us to listen to various perspectives and share our own insights.

Brian: As a former bench scientist, I find myself drawn to new products and technologies. After all, new gadgets in clinical diagnostics hold the promise of a healthier future for all of us. With almost 300 new exhibitors since 2019, I’m excited to see the future of diagnostics in the lab and at home. So, you can expect to find me talking to exhibitors about their new study results and how they expect it will bring greater value to labs.

 

Q: What do you expect to be the hot topics in laboratory medicine?

Brian: While COVID testing is here to stay given the endemic-like nature of SARS-CoV-2, we see three outcomes of the pandemic impacting the labs. First, pandemic preparedness. We see this being tested with the spread of new SARS-CoV-2 variants as well as monkeypox. Second, advances in characterizing host-pathogen interactions, brings a new dimension to supporting clinical practice from diagnosis through treatment. Lastly, we expect labs will be sharing their perspectives on how to support patients with post-COVID syndromes.

Bob: I expect a hot topic for attendees will be what the inclusion of Verifying Accurate Leading-edge Development (VALID) into the Medical Device User Fee Amendments (MDUFA) will mean for innovation. VALID establishes a risk-based framework for in vitro clinical test (IVCT) regulation, which would give the FDA authority over LDTs (laboratory-developed tests). AACC has asked its membership to oppose VALID’s inclusion, while the industry group AdvaMed has endorsed VALID. So, while VALID’s language is not yet finalized, and there is a proposed five-year phase-in, we still expect to hear a lot from the Expo attendees on how VALID is going to impact them. Specifically, how will a risk-based regulatory structure be applied to new testing models that are less hypothesis-driven, and more proactive?

 

Q: What technologies do you see making headlines on the Expo floor?

Bob: While the headlines might be from earlier this year, the news surrounding decreasing costs of next generation sequencing will resonate with clinical laboratories. Costs are a key barrier to the recent push we see for comprehensive genomic profiling (CGP). At this past month’s American Society of Clinical Oncology meeting, Illumina hosted a networking event where a panel of clinicians shared case studies where CGP was transformational for the patient. The panelists went on to describe reimbursement as a barrier to adoption; so obviously, if costs keep decreasing, we could see CGP’s growth accelerate.

Brian: AACC does a fantastic job of providing some built-in technology headlines with the Disruptive Technology award. This year, there are three finalists who we expect will be getting a lot of attention moving forward. First, the Verita™ lab-on-a-chip platform by Biological Dynamics offers a nanoparticle-based isolation solution for streamlined multi-omic testing. This type of platform technology should garner broad appeal with biomarker discovery groups as well as assay developers. Next, Nanopath has focused their attention on women’s infectious diseases and looks to use their expertise in nanotechnology to offer a compelling physician office testing platform. Lastly, Visby Medical has launched a palm-size PCR testing platform for COVID and sexually transmitted infections. All these finalists are great representatives for the trends we have seen coming in the molecular diagnostic space, so now we need to find what’s next.

 

Q: What do you expect to share with your clients when you get back from the Meeting & Expo?

Brian: With COVID bringing diagnostic testing into our homes, we have all participated in the adoption of decentralized diagnostic testing. Now we are looking at the next wave of patient-focused testing, both in the home as well as distributed throughout the healthcare setting. The innovations we see coming are not only from the test technology, i.e., how fast can PCR be done, but how the tests fit into these new environments, and how they communicate with the broader healthcare system.

Bob: An event like AACC is a great way to share perspectives and gather experiences firsthand from the clinical laboratory. The insights I expect to share with our clients will then be focused on how laboratories are going to deliver value to patients. As an example, how can labs deliver greater clinical insights in a post-VALID environment? And what impact will greater competition in the genomics space have? So, we look forward to hearing perspective of the labs, the diagnostic developers and partnering with them to help identify the best way to help patients and clinicians.

 

Q: Last question for you both, Deep Dish Pizza or Chicago Dog?

Brian: Chicago Dogs for me. No way to pass up all those toppings.

Bob: Deep Dish all the way! More specifically, Deep Dish from Pizzeria Due, the original chain restaurant of Pizzeria Uno. This is the true pride and soul of Chicago. 🍕

 

How Kx Can Help

Discuss more on the latest developments in diagnostics and life sciences (or the great pizza vs. hot dog debate of 2022), join us in Chicago for AACC Annual Scientific Meeting & Clinical Lab Expo.  Contact Bob Serrano bob.serrano@kxadvisors.com or Brian McNally, PhD brian.mcnally@kxadvisors.com

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Cell and Gene Therapy: The Next Frontier in Healthcare

Cell and Gene Therapy: The Next Frontier in Healthcare 

Executive Summary

  • Cell and gene therapies (CGTs) have become one of the most promising technology categories in biopharma with the global market expected to grow from ~$7B in 2021 to ~$58B in 2026
  • CGT treatments are broad and can be categorized into three technology approaches: 1) Cell & gene-modified cell therapies, 2) Gene therapy & genome editing, and 3) DNA & RNA therapeutics
  • The main drivers of anticipated growth of the sector are CAR-T and cell therapies in oncology as well as gene therapies targeting rare diseases
  • CGT development has accelerated with M&A and licensing deals, which have been strong over the last 5 years, in particular after FDA approvals of Luxturna and Kymriah in 2017
  • Despite significant optimism, CGT has faced a number of commercial, clinical, and regulatory hurdles that have dampened expectations in the last year

Introduction

Cell and Gene Therapy (CGT) is one of the most promising new frontiers in advanced therapies with the potential for transformational disease-modifying outcomes. As an example, Luxturna, approved by the FDA in 2017, can restore vision in children and young adults with a rare disease that would otherwise lead to blindness. The promise of CGT is potentially very broad, holding hope for treating or even reversing many currently uncurable and more common genetic diseases like hemophilia A or Parkinson’s.

Current State of Cell & Gene Therapy

Although the space is constantly expanding in breadth and application, CGTs can be grouped into three broad types of technologies: cell and gene-modified cell therapies, gene therapy and genome editing, and DNA and RNA therapeutics.

The first CGT was approved by the FDA in 2017 (Kymriah ‒ developed by Novartis and indicated for acute lymphoblastic leukemia and diffuse large B-cell lymphoma). Since then, only 17 CGTs have launched in the US through 2021.

 

Despite a relatively low market size of $7B in 2021, CGT is forecast to grow to a market size of $58B by 2026 at a 52% CAGR, compared to only 5% for small molecules and 1% for non-CGT biologics (incl. vaccines) markets. This forecast is underpinned by a growing interest in CGT with total financing in regenerative medicine doubling from ~$10 billion in 2019 to ~$20 billion in 2020, according to the Alliance for Regenerative Medicine.[i] Interest stems from Big Pharma as well as from private equity and venture capital. In 2020, 16 out of 20 largest biopharma manufacturers had CGT products in their portfolio, although CGT account for more than 20% of pipeline assets for 2 of the 16 manufacturers.[ii] Out of all private investment made in life sciences, roughly a third is directed toward CGT ($68 billion in 2021).[iii]

Approximately 46% of the cumulative worldwide sales in CGT ($70.5 billion) is expected to come from assets currently in clinical trials. Significant growth in this segment is expected to be driven by gene therapies, which account for half of the top 10 assets with the highest projected sales. These include Valoctocogene Roxaparvovec (valrox) by BioMarin and Etranacogene Dezaparvovec by uniQure, targeting Hemophilia A and B, respectively.

Overall, CGTs have accounted for just over 14% of the 63 biologics approved and marketed in the US in 2020 and 2021. In 2021, out of 130 conventional drugs and biologics approved by the FDA, only 6 were CGTs. However, the clinical-stage pipeline is very strong with 1,183 assets across all three clinical phases. Cell therapies and gene-modified cell therapies (incl. CAR-T) account for almost two thirds of the pipeline.

In evaluating CGT assets in the pipeline, there are clear patterns that emerge with respect to therapeutic areas with more substantial investment within each technology category. Cell and gene-modified cell therapy assets predominantly focus on oncology (62% of all clinical stage programs), while assets from gene therapy and genome editing, in addition to oncology, concentrate on central nervous system (CNS) and ophthalmology applications. Over a quarter of DNA and RNA therapeutics in the pipeline focus on oncology and ~10% each target CNS and GI indications.

Rare diseases make up a significant portion of clinical stage programs, in particular for gene therapy and genome editing. Almost half of gene therapy and genome editing assets in the pipeline are targeting rare diseases, while cell and gene-modified therapies focus on non-rare diseases, many of which are in oncology.

Pipeline Category Spotlight: Gene Therapy & Genome Editing

Within CGT, gene therapy and genome editing is highly diverse, as biopharma companies are pursuing a range of therapeutic area applications. The goal of gene therapy is to treat a disease by either replacing, inactivating or including new genes into cells, either inside (in vivo) or outside patient’s body (ex vivo). This process is conducted using vectors, of which viruses are the most popular form (e.g., adenovirus, adeno-associated virus, lentivirus and retrovirus). Currently, there are only two FDA-approved gene therapies (Zolgensma and Luxturna). These two gene therapies target rare diseases, but as popularity of the technology grows, it is expected that gene therapy will be used to address more common conditions such as hemophilia A or stubbornly high LDL cholesterol.

Recent Challenges

Despite significant optimism and investment, CGTs have faced substantial hurdles to approval and access, in particular for treatments with long-term or potentially lifetime efficacy. While the effects of RNA interference are transient, gene therapy treatments and gene editing therapies like CRISPR-Cas9 are intended be permanent solutions. This raises the bar for long-term data – both for regulators seeking extended safety data for approvals and payers seeking validation of long-term efficacy to justify $1-2M+ single treatment pricing.

Bluebird bio received EMA approval for two gene therapies—Zynteglo (severe beta thalassemia) and Skysona (cerebral adrenoleukodystrophy)—but subsequently exited EU operations in 2021 due to difficulties gaining payer reimbursement. Bluebird has also encountered several clinical holds and extended FDA reviews. With these hurdles, bluebird’s future is in doubt as it faces the possibility of running out of cash with its stock trading 98% below its March 2018 peak despite the potential for three gene therapy approvals in the next two years, signaling a more challenging environment than anticipated for the sector moving forward.

Cell and Gene Therapy Deals Landscape

Only a small portion of launched CGTs originated or were owned by large biopharma companies. Licensing agreements are understandably more common than acquisitions. However, the promise of CGT has led to significant large consolidator interest and investment in pipeline assets.

 

When looking at deals >$1B in value in the last two years, licensing agreements are about as frequent as M&A.

The deals landscape around CGT has been very active in the last five years as large biopharma companies look to expand capabilities in rare diseases, hematology, immunology, and oncology. Notable deals post-pandemic include Bayer acquisition of Asklepios Biopharmaceuticals (Askbio) in December 2020 for $4B ($2B upfront) to strengthen its emerging gene therapy business through its adeno-associated virus (AAV)-based technology platform and Eli Lilly adding its first gene therapy to its portfolio through the purchase of Prevail Therapeutics in January 2021 for $1B.

When looking for partners, large biopharma often evaluates particular cell and gene therapy technology potential and strategic fit of a target. Companies are often either looking to expand existing CGT capabilities (e.g., Sanofi-Translate Bio deal to strengthen Sanofi’s mRNA center of excellence), to build up a CGT portfolio (e.g., Astellas buying Audentes to develop expertise in AAV), or to access a specific technology platform (e.g. Sumitomo acquisition of Spirovant). Large biopharma is also spreading its bets and investing in early-stage biopharma companies that are looking for ways to make cell and gene therapies address a wider range of diseases, to reduce potential side effects, or to streamline the manufacturing process. One example is Takeda’s collaboration with Code Bio to develop liver-directed gene therapy using lipid nanoparticles (LNP). LNPs are an alternative to virus-based vectors that should not trigger immune response and can carry a larger load than AAV, thus enabling gene therapy to tackle disorders where a larger gene is affected.[1]

Conclusion

These are exciting times for cell and gene therapies. “These concepts are no longer the stuff of science fiction,” noted the former FDA Commissioner Scott Gottlieb. The technologies have potential for breakthrough innovations across a wide range of therapeutic areas and conditions. Some companies choose to engage by developing capabilities in-house, while many others have chosen M&A, licensing agreements, or partnership deals with smaller companies and startups. Given the plethora of investment opportunities and multiple directions in which the CGT space is currently growing, it is even more important for the overall commercial success to choose the right deal partner and the right format for collaboration.

How Kx Can Help

Our experts evaluate business opportunities, deliver top-notch expertise, and make data-driven recommendations to our healthcare clients. Kx can support your growth strategy from opportunity assessments for pipeline investment through commercialization. Contact Sean Vander Linde at sean.vanderlinde@kxadvisors.com to learn more. 

Contact Our Team Today

References

[i] Alliance for Regenerative Medicine, Annual Report 2020
[ii] Toby AuWerter, Jeff Smith and Lydia The, “Biopharma portfolio strategy in the era of cell and gene therapy,” McKinsey & Company, April 2020
[iii] Steve Kemler, Adam Lohr, “Cell & Gene Therapy Investment Outlook in 2022 & Beyond,” Feb. 21, 2022, https://www.cellandgene.com/doc/cell-gene-therapies-investment-outlook-in-beyond-0001
[1] Madeleine Armstrong, “Genetic Medicine: The Next Generation,” Evaluate Vantage, April 2022

Strategizing for Your First Drug Launch

Strategizing for Your First Drug Launch

Part 1 of Kx’s 3-part series

Introduction

“We have 12 months to either make it or break it post-launch”. This sentiment has echoed from one pharmaceutical board room to the next for years. And though it may be overused, for pre-revenue pharmaceutical companies planning to directly launch their first product, the idiom couldn’t be truer.

With increasing payer scrutiny, heightened competition in specialty drug markets, and more restrictive in-person access to HCPs due to COVID-19, achieving commercial success out of the gate is crucial for pharmaceuticals. In an analysis of 149 new drug launches, roughly 64% of drugs met or beat expectations in their launch years. Of those, 86% continued to meet or beat analyst expectations in year 2. For the drugs that missed expectations in year 1, 70% went on to miss again in year 2. Only about 30% managed to reverse course by year 3. (Deloitte, 2020). In other words, winning in Year 1 is paramount to a drug’s long-term success and ROI.

Unfortunately, drug research and development costs are on the rise (an estimated 8.5% YoY over general price inflation) (Joseph A DiMasi 1, 2016), and pre-revenue drug companies rarely have the resources and cash flow to mimic the commercial strategies of Big Pharma and legacy incumbents. Further, these “cookie-cutter” commercial strategies applied to the wrong market or product can kill a launch before it even begins. Still, there are unique competitive advantages held by commercial leaders at smaller pharmaceutical companies that cannot be matched by larger peers and incumbents:

  • The full might of your commercial team is able to focus on one product
  • Leaner organization size and operations enable nimbler post-launch commercial tactics

Kx’s blog series on Strategizing for your First Drug Launch is intended to support late-stage, pre-revenue pharmaceutical companies who are planning to directly commercialize their first product capitalize on these competitive advantages. Kx’s 3-step approach draws on concepts from academic experts such as James Collins and Jerry Porras and on our direct, real-world expertise consulting clients through launch planning. It is designed to help your company build a dynamic commercial strategy tailored to your drug:

  1. Cast a launch vision
  2. Build a brand plan and supporting operating plan around your drug
  3. Utilize a dynamic launch P&L model to refine your launch strategy to meet internal constraints

This first post in our 3-part blog series will focus on Step 1: the launch vision.

Cast a holistic launch vision with a guiding ‘north star’ and quantifiable goals before you start commercial planning

In a 1996 publication of the Harvard Business Review, James Collins and Jerry Porras asserted that “a well-conceived vision consists of two major components: core ideology and envisioned future. Core ideology, the yin in our scheme, defines what we stand for and why we exist. Yin is unchanging and complements yang, the envisioned future. The envisioned future is what we aspire to become, to achieve, to create – something that will require significant change and progress to attain” (James C. Collins, 1996). Kx agrees that the exercise of determining the core ideology of a company (i.e., its core values combined with its core purpose) should take place at a company’s inception, well before commercialization. However, because of the outsize impact a first drug launch can have on a pharmaceutical company’s holistic success, we recommend that executives revisit and repurpose three modified components of Collins’ and Porras’ framework to cast a “Launch Vision” specific to your leading asset:

1. Launch Purpose

The launch purpose should be distinct from the core purpose of a company. For instance, Pfizer’s corporate core purpose is to “deliver breakthroughs that change patients’ lives” (Pfizer, 2022). Yet, for their SARS-CoV2 vaccine launch in 2020, Pfizer consistently messaged a more focused launch purpose to “move with the same level of [timely] urgency to safely supply a high-quality vaccine around the world” (Pfizer, 2020). This launch purpose is both more specific, and also directly linked to the unique characteristics and launch environment of the drug itself. Because Pfizer launched a first-to-market vaccine, swift distribution and broad market access were necessary cornerstones of the launch to combat the pandemic.

To align on principles for the launch purpose, executives should consider a number of questions:

  • What did we set out to achieve with this drug during R&D?
  • What makes my drug unique as a product? What is my drug solving that is different?
  • What are the characteristics of the market environment into which our drug is launching?

2. Lofty Launch Goal (LLG)

It is imperative for executives to define what launch success means before fleshing out the commercial strategy. Far too often, leaders across the healthcare industry communicate that their #1 goal in launch is to “maximize revenues” or “maximize profits” when communicating to their commercial organizations and investors. But these goals are fundamentally flawed in that they are not measurable. A commercial team should have the ability to know when it has achieved its goals.

Collins and Porras specifically state that companies should define a “Big, Hairy, Audacious Goal” or BHAG that serves as the 10-year or even 30-year measurable goal for the company. They classify BHAGs into four broad categories: target, common-enemy, role-model, and internal-transformation (James C. Collins, 1996). For drug launch planning, Kx recommends developing a goal or set of goals similar to a BHAG, and typically segments these lofty launch goals (LLGs) into three buckets:

  • Financial:
    • E.g., reach $200M of US revenue by end of Year 2
    • E.g., achieve simple payback before 2025
  • Competitive
    • E.g., become the #2 drug in our indication by Year 3 of launch
    • E.g., knock off Competitor X as the #1 drug company in our target indication
  • Brand
    • E.g., become brand with highest unaided awareness among our target HCPs
    • E.g., become the Apple of our target therapeutic category
    • E.g., introduce the first premium drug to cash-pay market

3. The Vivid Description of Launch Success

The vivid description of launch success should answer the question, “what would the environment around our drug look like if we achieve our goal and fulfill our purpose”? The answer to this question could include anything related to your first drug, but typical elements may include:

  • Market & competitive position
  • Paradigm shifts in provider practices
  • Quality of relationships with prescribers
  • Brand awareness
  • Prescriber reach and conversion
  • Patient quality of life
  • Patient access to your drug

The primary utility of the vivid description is to motivate and inspire the commercial team with something tangible to which they can aspire during the strategic planning phases ahead of launch. Often even more than the LLG, it has the ability to ground the commercial organization in a common, tangible envisioned future of success.

The Launch Purpose (your “north star”) combined with the Lofty Launch Goal and Vivid Description of Success (your “finish line”) together form the holistic Launch Vision to support your commercial and executive teams throughout the pre-launch planning process. With the Launch Vision in place, commercial leadership can pivot to building out the backbone of the first drug launch strategy: the brand plan and ideal operating plan. Read more about our end-to-end launch strategy capabilities in Steps 2 and 3 of this blog series!

How Kx Advisors can support you in building your first drug’s “Launch Vision”

The “Launch Vision” stage of first drug launch planning is typically executed internally by commercial and executive leadership. However, Kx Advisors’ pharmaceutical launch excellence team supports clients during this initial phase by facilitating workshops and discussions with senior leadership, providing relevant in-market and out-of-market insights from decades of launch strategy experience, and much more. To learn more about Kx’s launch planning capabilities, contact Chris at chris.waybill@kxadvisors.com.

Contact Our Team Today

References

Deloitte. (2020, March 26). Key factors to improve drug launches. Retrieved from Deloitte Insights: https://www2.deloitte.com/us/en/insights/industry/life-sciences/successful-drug-launch-strategy.html

James C. Collins, J. I. (1996). INNOVATING TO BRING IMPORTANT NEW THERAPIES TO PATIENTS. Harvard Business Review, 65-77.

Joseph A DiMasi 1, H. G. (2016, March 21). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 1. Retrieved from Policy & Medicine: https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html#:~:text=Developing%20a%20new%20prescription%20medicine,the%20Journal%20of%20Health%20Economics.

Pfizer. (2020, December 02). Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19. Retrieved from Pfizer: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-achieve-first-authorization-world

Pfizer. (2022). INNOVATING TO BRING IMPORTANT NEW THERAPIES TO PATIENTS. Retrieved from Pfizer: https://www.pfizer.com/science/research-development/breakthroughs

Digital Priorities of the C-Suite

Digital Priorities of the C-Suite

How Vertical Solution Providers Can Support Health System Competitiveness  

Since the onset of COVID-19, health system C-Suites’ view of “digital” has rapidly evolved from latest buzzword to cause for concern, then call to action, and ultimately exciting, but existential, imperative. Health system leaders recognize the myriad of new entrants vying to “own” the patient relationship as serious competition. As evaluations continue of the direct-to- consumer, virtual-first options, and omni-channel capabilities offered by big-box stores, leaders are comparing their own internal capabilities and options for next steps. With this emergence of digitally enabled competitive threats, Kx wanted to better understand the prevailing approach(es) of health systems to vendor evaluation and solutioning. We recently conducted in-depth interviews with CIOs, CMIOs, and Digital Strategy executives from some of the nation’s most progressive enterprises. Compilation of our findings revealed a nearly unanimous perception of opportunities and boundaries regarding horizontal vs. vertical options in healthcare digital technology.

Environmental Shifts

Almost overnight, the pandemic shifted consumers’ ideas about digital experience in healthcare. Consumers now expect convenient, personalized, tech enabled care, and providers must adapt their processes, adopt new tools, and transform their mindset to more closely mirror other industries that focus on the consumer. With nearly $30B in U.S. venture capital funding introduced in 20211, upstarts, larger solution providers, and Big Tech (e.g., Microsoft, Google, Amazon, Apple) are all well-capitalized and rapidly mobilizing to introduce consumer-friendly tools and capture market share.   The proliferation of both vertical solutions and horizontal (Big Tech) offerings is prompting health system buyers to commit to a vision of their digital transformation end-state and whom they will partner with along the way. There’s broad acknowledgment of the imperative to pursue digital strategies that progress the quality and efficiency of care and strengthen their connection with the patient beyond and in between each episode of care. Nothing less than convenient, consumer-friendly experiences will suffice in our digitally saturated post-pandemic world. Given these requirements – which match so closely to some of Big Tech’s core competencies – Big Tech seems like the obvious answer. However, despite the variety of foundational capabilities that Big Tech brings to the health system enterprise, we uncovered a tech partnership “line in the sand” in the minds of health system leaders.  

Necessity of Specificity   

Apart from Microsoft (due to the Nuance acquisition), our conversations found that health systems leaders generally preferred vertical vendors over horizontal technology providers for impact areas such as the EHR, clinical workflows and patient engagement. The lack of explicit enterprise strategy from Big Tech in healthcare is a significant detractor, characterized by one health system leader as “[the company] floating around like a rudderless ship, with no commitment, support, or strategy around healthcare.” Other reasons include the overall lack of expertise, the perception of healthcare opportunities as potentially lower-margin than other industries, and likely pushback from EHRs to interact with Big Tech solutions.  Even so, horizonal tech players remain a contender in the areas where they lead across industries. The key drivers of health systems considering a Big Tech purchase or co-development partnership include the following:   

  • Proven and well-regarded cloud infrastructure and data migration capabilities from Amazon and Microsoft that are trusted in regulated industries (Google’s solution in this space is negatively perceived across the provider market) 
  • Stated interest and initial positive results from Amazon, Microsoft, and Google to create the necessary data ecosystems for developing and running analytics, and deriving actionable insights to support the delivery of efficient, high-quality care  
  • Broad success in the consumer wearables market (Apple’s Watch, Google’s FitBit) and the acknowledgement that patient-generated data will become more relevant and useful over time   

Implications for Vertical Players  

This conclusion from health system enterprise decision makers – that vertical solution vendors are better positioned than horizontal tech players to support their digital transformation initiatives – is good news for Digital Health companies but comes with caveats.  An academic medical center CMIO stated “there are plenty of interesting startups that offer more intricate solutions, but they may go out of business and leave us without a solution.”  Despite the risk factors, digital health solutions are instrumental, highly visible components of health systems’ enterprise strategies and are typically considered on a different plane than Big Tech.  To capitalize on the positives and mitigate some of those negative considerations, digital health companies can understand and prepare for expectations that health systems have of them, including:  

  • Configuration Flexibility: Flexibility and willingness to configure the solution to meet unique health system needs  
  • Security Commitment: Readily available security documentation and a willingness to meet enterprise-specific security and compliance requirements 
  • Clear ROI Story: A competitive pricing model and the ability to speak to both near-term and downstream ROI implications of the product (including being able to “sell” this storyline to a variety of health system stakeholders – clinical, IT, Finance, etc.) 
  • Understanding of Competitive Implications: A thoughtful analysis of the health system’s competitive landscape and perceived advantages gained via user adoption of the solution 
  • Credible Implementation Plan: A thorough implementation plan that forecasts a reasonable timeline, strategies for end-user change management support, and EHR integration plans  
  • Team-wide Subject Matter Expertise: Consistent exhibition of deep expertise in the subject matter addressed by the solution – credentialing and reinforcing trust in the solution’s capabilities throughout the sales, implementation, and stabilization cycles 
  • Ability to Measure Impact: A plan to show impact through easily digestible, configurable, self-service reports accessible upon go-live 

Our interviews concluded that as long as vertical vendors continue satisfying the true needs of health systems, health system leaders will continue preferring to partner with vertical solution vendors. Keeping pace with morphing buzzwords and emerging external threats are daily challenges faced by every health system C-Suite. By reliably performing as expected, vertical solution vendors will maintain their preferred status with health systems, simplify aspects of each organization’s digital transformation journey, and support the overall goals of the health system business.  

How Kx Can Help You  

Kx Advisors’ Digital Health and Health IT team partners with digital health solutions companies so they can outshine the competition, delight their customers and end users, and maximize their growth potential. Ready to start winning against your competition and achieving your growth goals? Contact Rachael at rachael.england@kxadvisors.com to learn more. 

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Six Considerations to Evolve Your Capital Equipment Pricing Strategy

Six Considerations to Evolve Your Capital Equipment Pricing Strategy  

Capital Equipment Pricing Models  

As the world of capital equipment changes rapidly, manufacturers must find innovative ways to stay competitive. With new technology and enhancements, such as software upgrades and digital and connectivity solutions, as a crucial part of the value proposition of capital equipment, manufacturers can offer alternative pricing solutions to provide greater customer customization. Flexible pricing is especially pertinent for highervalue equipment on the market, such as AI-assisted imaging equipment, roboticallyassisted surgical equipment, and advanced monitoring equipment. With the shift in procedures from hospitals to smaller office-based labs and ambulatory surgical centers, manufacturers can also capture new business opportunities with these alternative models.  

New Pricing Models for Capital Equipment  

The traditional pricing models offered three options: an upfront purchase with each component sold separately, a consumable upcharge model, or a leasing model. A combination of new technology and more customized pricing improves a manufacturer’s value proposition. With new pricing models, manufacturers can boost revenues, increase penetration, and build long-term relationships with clients by offering greater flexibility.  

These new models include:   

  • Risk-based or outcomes-based model: Risk-sharing pricing strategies factor in a cost savings component from any operational efficiencies gained and clinical outcomes achieved in this model 
  • Recurring revenue stream model: Instead of the traditional transfer of ownership model, manufacturers offer a subscription with a recurring fee. The purchaser or user is granted access to a set number of capital equipment devices for the subscription period. This fee may or may not include unlimited usage in the number of consumables 
  • Patient usage pricing model: Based on patient usage, manufacturers can offer a per-patient fee for the equipment over a period of time with this model 
  • Enterpriselevel model: This model bundles the customers capital equipment needs across entire care units and multiple hospitals within the network. The bundle would normally include both equipment and services components. Payment schedules could be yearly or bi-yearly

Six Considerations for Identifying the Right Pricing Model  

With so many pricing models emerging, it can be challenging to identify the right one for your product offerings. As your organization moves towards a new pricing model, like the ones above, there are six key considerations to keep in mind to identify the most effective model for your team: 

  1. Set clear objectives: With an identified goal, your organization can better evaluate the potential models. Objectives can include increasing revenue, expanding the adoption rate, smoothing revenue, maximizing profit, and expanding account use of a suite of products and services. For example, if a manufacturer’s goal is to increase the use of a full suite of products, the recurring revenue stream model may be a better fit for their goal 
  2. Identify the value drivers of your product:  Drivers, such as clinical efficacy, payment model, ROI, and the strength of existing relationships, impact pricing and the manufacturer’s ability to customize the pricing model  
  3. Determine the decision-maker: Sometimes the end-user who makes the purchase decision is different from the purchaser who chooses the pricing model. Broadly, there are three types of capital equipment buyers: economic, clinical, and operational. The economic buyer’s sole focus is to improve their organization’s profit. In contrast, the clinical buyer is more focused on the clinical value of the product offerings, like patient outcomes or improved patient experienceOperational buyers typically focus on other factors such as department workflow, device integration with key clinical systems, or maintenance and uptime. Knowing the levels of influence and priorities for each buyer type will help determines which pricing model to offerIf the buying decision is more committee-basedthe pricing model will need to consider all stakeholder needs  
  4. Consider the impact on clients’ budgets: Pricing structure might impact where a client categorizes a purchase (i.e., capital expenses or operational expenses). Often capital expenses will fall under the hospital’s capital budget while operational expenses fall under the department’s budget, which may sway some clinicians towards a capital expense model  
  5. Understand clients’ financial health: Innovative recurring pricing models might be a better fit for clients working under capital restraints. This consideration is crucial overseas, especially in countries where COVID-19 has ravaged hospitals, which would seek to reduce the upfront cost of purchasing capital equipment  
  6. Establish benchmarking metrics: This consideration is the most important for risk-based or outcomes-based pricing, as identifying the equipment’s impact on patient outcomes or operational efficiencies dictates price. These metrics could include hospital readmission rates or the number of adverse events related to the equipment. When determining these benchmarks manufacturers must ensure they are measurable and that clients have the right infrastructure system in place to measure them 

How Kx Can Help You  

With our expertise in pricing strategy, Kx Advisors can guide your team through developing an optimized capital equipment business model. Our team of healthcare experts will help you evaluate your base, identify your customer segments, effectively appeal to your ideal customer, and position your organization for long-term success.  

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Using Your Product Launch Forecast as a Strategic Tool

Using Your Product Launch Forecast as a Strategic Tool 

Forecasting as a Decision-Making Tool

Too often, commercial planning teams approach revenue forecasting as a required financial exercise rather than a strategic planning activity. The highest performing teams, however, develop revenue models to drive decision-making and reinforce strategy. The forecasting process – designing the model, understanding the demand funnel, gathering insights, aligning on assumptions, and analyzing results – can drive decisions and deliver more value than the output itself. Elevating a revenue forecast to a powerful decision-making tool requires careful planning and thoughtful design considerations.

Crafting Your Product Launch Forecast to Inform Strategy

While revenue models are commonly designed to inform resource allocation, investor communications, or inventory planning, the most robust and accurate models are also designed to inform commercial strategy.  With the correct design considerations, your commercial planning team can learn more about the patient segments driving forecast value, identify opportunities in the patient journey to drive product adoption, and pinpoint the investments needed to drive share. Further, the most effective models consider multiple scenarios to plan for key unknowns.

Unfortunately, many project teams jump into forecasting with unclear objectives, insufficient data sources, or too many scenarios, and ultimately fail to develop a useful decision-making tool. Your team can avoid common modeling pitfalls by following best practices in three critical planning steps:

  1. Create the decision-making framework  
  2. Find the applicable data for the model   
  3. Define the scenarios    

Create the Decision-making Framework

The first step of any model should be aligning on the end goals (i.e., defining the decisions model will inform).  An end goal could be, for example, determining the focus and magnitude of commercial investments, evaluating strategic options in the face of a new market force, or determining supply need for a quarterly production plan. After identifying the overarching question(s), your team can determine how to approach the model.  

Your team can use the end goal to decide on the type of model. The type of model, from market share model to launch planning to production demand, determines the model’s specificity. Analyzing the structure before gathering data to ensure the model aligns with the end goal will save your team time and effort.  For example, is an annual model sufficient to calculate net revenue, or does the organization need monthly/weekly sales granularity to inform production planning? Is there a need (and reliable data) to support international country-level forecasts, or would a regional forecast be more accurate and equally actionable? Once you understand the key questions the model is answering, the desired output, and the aligned model type, your team will have the clarity to move to the next step: finding the data.     

Find the Applicable Data for the Model    

First, your team should identify and classify relevant data sources about your product and market, such as epidemiology studies, claims data sets, qualitative interviews, quantitative surveys, historical product sales, and competitor sales, among others, for input. Forecasting teams should take a “best source” approach –evaluating every assumption individually for the highest confidence source. Without pinpointing potential knowledge gaps, models can provide incorrect or incomplete information, impacting the outputs of the model, and ultimately, the launch’s success.  

If the data does not exist in the public domain or within research resources, it can often be collected. Kx specializes in designing and executing market research with key stakeholders (e.g., providers, patients, and payers) to inform quantitative forecasts.   When designing primary market research, it is important to start with the model structure and work backward to design the research to fit the model. Designing for the model’s purpose will lead to a more accurate forecast. Finally, research should be designed to enable a “living, breathing” forecast. Research approaches such as choice-based conjoint surveys can allow forecasters to simulate new market conditions as they arise and update key assumptions without conducting additional market research. 

Define the Scenarios  

After outlining the criteria for the data, the next step is to determine which scenarios need to be analyzed. Often teams will initially attempt to investigate and list all possible options, but if the model becomes too complex, it will lose its effectiveness. Instead, the best practice is to define a base case or most likely scenario. A base case typically uses a consensus estimate or confidence-based weighting along key assumptions to drive forecast outputs. Once your team identifies the most likely scenario, define the parameters you want to test. Identifying priorities and areas of uncertainty will help determine which scenarios to test. For example, breadth of market access or coverage, varying price points, the impact of future clinical study outcomes on adoption, and changes to competitor mix are some of the most frequently explored scenarios.  

How Kx Can Help With Your Product Launch Forecast

Over the last four decades, our team has developed proven modeling and forecasting approaches that produce accurate, insightful outputs and drive strategic decision making. Our team acts as strategic partners to help guide you through the entire process, including developing the product launch forecast, gathering the underlying data and insights, aligning internal stakeholders, and ultimately preparing the model for you to run.  

 

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