03.22: White Paper
According to the World Health Organization, there are around 5,000 – 8,000 rare diseases that have been recognized across the world. In China, rare diseases are recognized in the National Rare Diseases List. In May 2018, the National Health Commission of China published the List of Rare Diseases (First List), covering 121 indications that affect up to three million patients to provide a reference for the rare disease drug review. Since 2021, the compilation of the second list of rare diseases is also in progress under the guidance of the National Health Commission.
Read in English.
Read in Chinese.
Biotech companies are a significant driver of innovation in drug development today, with a pipeline growing sharply in recent years. This growth provides hope for patients across many therapeutic indications. It also provides an avenue for future investment by financial institutions, industry partners, and investors. For the last two years, the financial market has supported biotechs with record-shattering funding.
10.21: MedTech Strategist
Novonate is a commercial-stage company dedicated to designing products that solve problems in neonatal care. The company is currently commercializing its first product, the LifeBubble, a novel device for the securement of umbilical cord catheters. Health Advances interviewed the co-founder and CEO of Novonate, Eric Chehab, PhD, to discuss the company’s progress to date and advice for pediatric device entrepreneurs.
09.21: White Paper
CRISPR-based gene editing technology is differentiated from other modalities, even traditional gene therapies, unlocking potential cures for a range of indications but also presenting unique developmental challenges. Devising a portfolio strategy for CRISPR-based gene editing therapies requires considering the novel therapeutic potential but also the technical, clinical, and commercial complexities. In this white paper, Health Advances proposes a framework for indication selection and portfolio strategy for CRISPR-based gene editing companies based on a range of factors including unmet need, level of competition, and addressable market size.
07.21: White Paper
The development and commercialization of novel biopharmaceutical products in recent years has continued to offer more safe and efficacious treatment options for patients across therapeutic areas. While a good proportion of the world’s transformative drug development and early commercial resources for novel therapies are focused in the United States, the level of drug innovation in the rest of the world has begun to shift. In the past decade, Japan and China have invested in regulatory reform and established policies to increase drug innovation within their respective countries.
03.21: Journal of Personalized Medicine
Personalized medicine (PM) approaches have revolutionized healthcare delivery by offering new insights that enable healthcare providers to select the optimal treatment approach for their patients. However, despite the consensus that these approaches have significant value, implementation across the US is highly variable. In order to address barriers to widespread PM adoption, a comprehensive and methodical approach to assessing the current level of PM integration within a given organization and the broader healthcare system is needed. A quantitative framework encompassing a multifactorial approach to assessing PM adoption has been developed and used to generate a rating of PM integration in 153 organizations across the US. The results suggest significant heterogeneity in adoption levels but also some consistent themes in what defines a high-performing organization, including the sophistication of data collected, data sharing practices, and the level of internal funding committed to supporting PM initiatives. A longitudinal approach to data collection will be valuable to track continued progress and adapt to new challenges and barriers to PM adoption as they arise.
12.20: White Paper
As tools that harness data to develop solutions for health applications, digital health technologies (DHTs) hold tremendous promise to transform the lives of patients and the management of diseases. This paper summarizes the value of DHTs in drug development and highlights the inherent challenges of the current regulatory paradigm in the US and Europe.
09.20: The MedTech Strategist
Eclipse Regenesis is developing a pediatric device for the restorative treatment of short bowel syndrome. In March 2020, the team was selected as the winner of the UCSF-Stanford Pediatric Device Consortium Accelerator competition. Health Advances interviewed two of the company founders to discuss the development of their mechanical solution and advice for pediatric entrepreneurs. Note, this content first appeared on The MedTech Strategist Community Blog.
Read the blog post here.
09.20: Future Medicine
Prior studies have established that broader incorporation of active surveillance, guided by additional prognostic tools, may mitigate the growing economic burden of localized prostate cancer in the USA. This study sought to further explore the potential of a particular gene expression-based prognostic tool to address this unmet need. Materials & methods: A deterministic, decision-analytic model was developed to estimate the economic impact of the Prolaris® test on a US commercial health plan. Results & conclusion: When adopted in patients classified by the American Urological Association as low or intermediate risk, the assay was projected to reduce costs by $1894 and $2129 per patient over 3 and 10 years, respectively, largely through the increased use of active surveillance.
Read the article here.
Read an interview with Gary Gustavsen, Partner at Health Advances, about the article.
05.20: :Journal of Vascular Surgery: Venous and Lymphatic Disorders
The purpose of this study was to define the current forms of treatment in lymphedema patients with breast cancer (BCRL) and venous leg ulcers (PLEDU). Our analysis of a large administrative claims database showed clear differences in treatment between each group, suggesting lymphatic therapy may be undervalued for treatment of chronic venous swelling and prevention and treatment of PLEDU.
04.20: Medtech Strategist
Software-based solutions for orthopedic surgeries have struggled to gain adoption. Will Augmented Reality prove indispensable to the musculoskeletal field, or be considered another useful but non-essential technology?
A strategic perspective on where digital therapeutics are today and what needs to happen next to unlock the full potential of digital therapeutics.
03.20: White Paper
Successful launch planning requires appropriate financial and resource planning. Launching a drug is a high-stakes and high-cost endeavor that requires the coordination and execution of many cost-intensive activities across different functional areas over multiple years, pre- and post-launch. Efficient and effective launch planning is critical to ensure the long-term commercial success of a new product. Health Advances conducted an extensive launch cost analysis based on products launched between 2012-2017.
18MM people live with T1D across the globe, yet there are no approved disease modifying therapies. This research report from the JDRF T1D Fund, JDRF International, and Health Advances seeks to answer why this is and more.
12.19: Future Oncology
Prior studies have established the economic burden of prostate cancer on society. However, changes to screening, novel therapies and increased use of active surveillance (AS) create a need for an updated analysis.
10.19: MedTech Strategist
Orthopedics and other device companies are exploring the newly invigorated remote patient monitoring opportunity as a way to adapt to increasingly rigid CMS reimbursement. This gives them an important role in the fast-moving world of healthcare big data, but leaves other key components of that world like aggregation, analytics, and systemic perspectives up for grabs.
09.19: Journal of Vascular Surgery: Venous and Lymphatic Disorders
Lymphedema (LE) has been called the forgotten vascular disease, given such scant knowledge about LE-associated comorbidities or causes. Such knowledge of the comorbidities and treatment of LE may assist in diagnostic decisions and health care planning.
05.19: Medtech Strategist
Growing experience with the use of 3D printing in orthopedics, plus declining cost differences between 3DP and traditionally manufactured implants, are enabling device manufacturers to expand the applications of 3DP in the musculoskeletal sector.
01.19: In Vivo
There is a wave of capital-intensive medical device companies that are challenging conventional wisdom of the razor-razor blade business model. Health Advances Co-Founder and Managing Director, Mark Speers, captures key insights from panelists representing Varian Medical Systems, INSIGHTEC, RefleXion Medical, and CyberHeart at the 2018 Wilson Sonsini Goodrich & Rosati Medical Device Conference.
01.19: MedTech Strategist
The pediatric patient population has been historically underserved, in part because designing and commercializing a pediatric device presents a host of unique issues. The Boston Children's Hospital Pediatric Device Strategic Partner Challenge was created to help develop novel pediatric device ideas, and Health Advances partnered with one of the winning teams of innovators to discuss their new heart valve device and the difficulties of pediatric device design and development.
To anyone watching, the story of rising healthcare costs in the US is not a new one. Prescription drug prices in particular have made headlines in recent years, from outrage over the 56-fold increase of anti-malarial drug daraprim, to controversy over the steady rise in price of EpiPen packs used to quell life-threatening allergic reactions.
Launch planning is critical for the long-term commercial success of a drug product. Health Advances distills launch planning best practices learned from prior experience and illustrates the importance of those best practices with cases studies.
07.18: MedTech Strategist
Co-Founder and Managing Director Mark Speers points out some of the potential missteps that device
executives may not consider when caught up in the excitement of the M&A path.
07.18: Journal of Medical Economics
To assess the budget impact to a US commercial health plan of providing access to the Flexitouch (FLX) advanced pneumatic compression device (Tactile Medical) to lymphedema (LE) patients with either comorbid chronic venous insufficiency (CVI) or frequent infections.
06.18: Journal of Vascular Surgery
Phlebolymphedema (chronic venous insufficiency-related lymphedema) is a common and costly condition. Nevertheless, there is a dearth of evidence comparing phlebolymphedema therapeutic interventions. This study sought to examine the medical resource utilization and phlebolymphedema-related cost associated with Flexitouch (FLX; Tactile Medical, Minneapolis, Minn) advanced pneumatic compression devices (APCDs) relative to conservative therapy (CONS) alone, simple pneumatic compression devices (SPCDs), and other APCDs in a representative U.S. population of phlebolymphedema patients.
02.18: Biosimilar Development
In recent years, the growth in U.S. drug spending has become a hot-button issue. Data released in 2017 by the pharmacy benefit manager (PBM) Express Scripts illustrates which drugs account for the increased spending. In 2016, spend on so-called specialty drugs, a class that contains many biologics, grew by over 13 percent, while spend on traditional drugs actually declined by 1 percent. Five of the top 10 earning drug therapies in the U.S. in 2016 were biologics.
CAR-T cell therapy is currently one of the most exciting areas of clinical research. To create these living therapies, human T cells are genetically modified to express a CAR (chimeric antigen receptor) that has been programmed to target specific antigens found on the surface of cancer cells.
04.17: MedTech Strategist
At the recent MassMEDIC MedTech Investors Conference, Mark Speers, Co-Founder and Managing Director of Health Advances, interviewed John McDonough, CEO of medical diagnostics company T2 Biosystems, on the topic of capital fundraising.
While orphan drugs offer novel treatments for patients who previously had no options, the high price points they often command have resulted in restricted access by many European Health Technology Assessment (HTA) systems and intense discussions about how to determine their value.
Against this backdrop, manufacturers are eager to understand how to value their innovation and collect sufficient evidence to support a price that appropriately reflects the improvement in clinical outcomes versus the standard of care. The white paper indicates that patient prevalence is highly correlated with orphan drug pricing in Europe, highlighting the importance of budget impact to payer decision-making.
Over the past 15 years, the FDA and Congress developed several accelerated pathways to provide incentives for manufacturers to develop innovative new drugs to treat conditions with substantial unmet need. The objective of this white paper is to describe recent trends in the use of the FDA’s accelerated pathways and to examine the market advantage associated with these pathways, particularly in oncology.
03.16: Value in Health Journal
Intuitive Surgical’s da Vinci® surgical robot has often been accused of adding unnecessary costs to the healthcare system. The Company enlisted Health Advances to perform a rigorous and comprehensive study of the robot’s long-term economic impact to hospitals, payers and society when deployed to perform radical prostatectomies for prostate cancer patients. The resulting study, “A Multidimensional Analysis of Prostate Surgery Costs in the United States: Robotic-Assisted versus Retropubic Radical Prostatectomy,” was written in collaboration with leading researchers and clinicians at Mount Sinai Hospital in NYC and has been published in the well-respected Value in Health Journal. The study estimates that, when factoring in all the costs of a surgery, the robot usually saves hospitals money. In addition, payers and society benefit from treating fewer downstream complications and less lost days of employment.
08.15: MedTech Strategist
Simple insulin infusers are emerging as an important new tool to help people with type 2 diabetes gain better control of their disease. Although only one simple infuser product has been approved in the US to date, more are on the way and interest among physicians and payors is on the rise—all of which suggests a budding new market opportunity in the years ahead.
CeQur: Overcoming Barriers with PaQ Simple Insulin Infuser.
Value-Based Care (VBC) initiatives are capturing a lot of attention, and in some cases capturing scarce IT budget allocations, as health industry stakeholders prepare for what some believe is an inevitable shift in the way care will be financed and delivered. For Health Information Technology (HIT) vendors,
this shift presents a double-edged sword of both new opportunity and risk.
Health Advances analyzed key hospital cost metrics for two implant configurations in the surgical treatment
of AIS: all pedicle screw constructs and hybrid constructs consisting of pedicle screws and sublaminar bands.
The T1D prevention landscape evaluation validated that numerous efforts to date have resulted in many important
advances that will set the stage for future progress. Over 25 observational and intervention studies have been completed
or are ongoing across primary and secondary prevention, with the majority of these in secondary prevention.
09.14: American Journal of Managed Care
Health Advances published the results of its system economic analysis of bioTheranostics’ Breast Cancer Index, a second-generation gene expression test that predicts risk of breast cancer recurrence and likelihood of benefit from extended endocrine therapy. The study showed that the test has the ability to lower costs for third-party payers which will be an important consideration as they seek to establish medical policy surrounding the test.
Selling health IT (HIT) solutions to hospitals and other healthcare providers has never been easy. HIT companies have always faced long, arduous sales cycles and the very real risk that growth will never extend beyond a few early adopters to the broader market.
03.14: IN VIVO
As traditional specialty drug markets have become increasingly crowded, large pharmaceutical companies and biotech companies alike have successfully turned previously ignored rare diseases into a robust business model. Are these first-mover products protected from competition by virtue of being in orphan markets? Here, we argue that meaningful product differentiation is required for new drugs to enjoy rapid clinical development and commercial success traditionally associated with orphan markets.
06.13: Personalized Medicine Journal
The increasing complexity of the personalized medicine field necessitates an entirely new roadmap to success in the sector. The article provides a resonating agenda to innovators who realize that strong partnerships are absolutely vital to a future in personalized medicine as well as a truthful forecast for companies that do not.
05.13: Age of Personalized Medicine
Kristin Pothier, Partner at Health Advances and contributing writer for the Age of Personalized Medicine, broke down her recent panel at the PMC/BIO Solutions Summit, “Evidentiary Standards and Data Requirements for Payer Coverage”. Kristin explains the frustrations around data requirements for coverage and voices the opinions of her respected panelists on key issues and most importantly, solutions.
04.13: InVivo Magazine
Nontraditional molecular diagnostic buyers, including pharmaceutical companies, life science tool companies, and diversified conglomerates, are driving molecular diagnostics M&A. The needs of these buyers dictate the assets targeted, premium paid and integration strategy pursued.
03.13: Science Translational Medicine
This article explores the root causes of the vicious cycle leading to the pronounced undervaluation of tumor-biomarker tests, and the resulting failure to become standard clinical practice. A roadmap to break the cycle is described, recommending changes in processes across the board to stakeholders nationwide.
12.12: InVivo Magazine
The current crop of molecular diagnostics acquisitions – especially those made by nontraditional buyers – must mature prior to the commencement of additional M&A activity. Historical data suggest this could occur starting in the 2014-2015 timeframe. Health Advances provides a contrarian view to the negative press surrounding Molecular Diagnostics M&A, and suggests a new window of opportunity could open in the near future.
09.12: InVivo Magazine
Health Advances outlines commercialization options for emerging medtech companies and the potential valuation and exit implications. Susan Posner, Vice President and Mark Speers, Partner and Managing Director, describe challenges that are emerging in the current industry climate that make early sales and commercialization decisions a critical component of a company’s overall strategy. Ultimately the strategy will not only drive sales and revenue but have a direct impact on exit valuations.
11.11: InVivo Magazine
Traditional cancer development in the 1970s and 1980s focused on individual druggable targets and combinations were developed empirically post-approval. In the new age of molecular medicine, this incremental empiricism is no longer acceptable to patients, physicians, and payers. Drug developers need to seize upon the FDA's combination therapy guidance to accelerate the development of rational combinations.
02.11: InVivo Magazine
Therapeutic areas currently dominated by injectable or infused therapeutics are beginning to see competition from oral therapies intent on taking market share because of their perceived delivery advantages. However, the head starts enjoyed by injectables in these markets – and the physician, payer, and patient familiarity they create – translate into higher efficacy and safety hurdles for oral therapies. Oral delivery is not without downsides – including poorer compliance and reimbursement challenges in specialty markets dominated by injectable competitors. Companies willing to face these issues head-on and engage constituents early about the drawbacks and advantages of their new oral agents can fully realize the value of their therapies.
Personalized medicine has the potential to revolutionize patient care. The fundamental goal in advancing our healthcare system through personalized medicine is to deliver the right treatment to the right patient at the right time. Novel diagnostics hold great promise as tools that allow physicians to differentiate patient-specific characteristics, design personalized treatment approaches, and ultimately improve patient outcomes. The successful delivery of novel diagnostics is the foundation of personalized medicine in our evolving healthcare system.
11.10: InVivo Magazine
While continuous glucose monitoring offers significant value to a broad range of patients, the technology has still not fulfilled its market potential. Many hurdles to adoption still exist including product accuracy issues, ease-of-use hurdles, and insufficient payer coverage. However, for patients who have successfully built CGM into their therapeutic plan, the results have been impressive. So why is a technology that can have such a meaningful impact on some individuals gaining traction so slowly?
09.10: Point-of-Care Journal
The prospect of point-of-care (POC) testing, enabling near immediate diagnosis and subsequent treatment, has been alluring to clinicians for years. Science and technological progression, evidence based clinical and economic drivers for POC use, and the current health care system's demand for streamlined options suggest that POC products should be instrumental in today's diagnostic paradigm. Nevertheless, relatively few POC tests have attained commercial success. The article reviews the current barriers to the use of POC, the emerging success factors, and the evolving future of this space.
04.10: Future Medicine Journal
Multiple stakeholders play a role in the adoption of personalized medicine, including payers, patients, policy makers, diagnostic manufacturers and providers, and clinicians. These stakeholders span multiple positions, institutions and points of view, and are interested in making sure that each diagnostic launch covers a particular, sometimes contradictory, market need. A growing number of advocacy groups have emerged to unify these stakeholders in this increasingly complex marketplace. This article identifies examples of these advocacy efforts in personalized medicine today. It discusses how far these groups have been able to go, what they are currently pursuing, and how they and others can continue to work to move personalized medicine from concept to reality.
03.10: IVD Technology Magazine
With the IVD market changing rapidly, the pressure to deliver new products to market less expensively and more efficiently is mounting. The changes in the IVD industry are being driven by increased laboratory test volumes and growing pressure to lower turnaround times (TAT) with fewer skilled lab technicians. Any new product launch must be able to address this demanding environment. Such sweeping demands in the industry are accelerating the development of three specific areas of advancement: point-of-care (POC) technologies, automation, and graphical user interfaces. To reduce costs and shorten product development cycles, some OEMs and start-up companies have been turning to contract instrument developers and manufacturers for their guidance and relevant experience to overcome common development challenges. This article will examine these trends, outline common obstacles associated with them, and discuss how working with contract partners can overcome product development challenges by showing examples of instruments that were introduced to the market with the help of a contract partner. Also available is an audio discussion with Donna Hochberg and Walter Gilde.
01.10: Medical Device & Diagnostic Industry Magazine
Should devices be considered earlier in the treatment paradigm? Devices are often reserved for patients who have already failed multiple drug therapies, but in some cases, devices may ultimately provide better long-term outcomes more cost-effectively than drugs. In order to pursue these opportunities, manufacturers must effectively develop technologies that can surmount traditional therapeutic hurdles, including physician perceptions of drugs and devices and the short-term payer outlook. Health Advances Medtech Practice Group shares their insights on the potential paradigm shift that would move devices to an earlier position in the treatment pathway, potentially expanding the market opportunity for devices and the medtech industry.
Healthcare reform is the Obama Administration’s top domestic priority. Although the Administration’s original goal was to have a reform bill passed in October, it now appears that a final vote will not take place before December. The rigorous debates have focused on three key components: access to care, cost of care, and value of care in the US healthcare system.
09.09: Medtech Insight
Value Proposition is Key to New Product Success in a Cost-Conscious Medtech Market
Management teams are well aware of the need to demonstrate compelling economic data, but can a product still be successful without an economic benefit in the increasingly cost-conscious health care marketplace? Overcoming negative economics requires a combination of positive attributes; many compelling advantages like clinical or safety benefits are well-known, but other key attributes may be overlooked. Recognizing all of these potential advantages is crucial for appropriate planning to compile relevant data and position the product accordingly, thereby optimizing product success. Health Advances Medtech Group shares its thoughts and observations on current products that have overcome negative economics, highlighting the keys to their success and lessons learned for emerging products.
03.09: InVivo Magazine
For most diagnostics companies, the prospect of premium pricing has been an evasive dream. The health care landscape is peppered with expensive novel drugs priced to underscore their clinical impact on patient care. A similar strategy for pricing novel diagnostics with significant clinical impact makes sense, especially since many of them are driving the decisions to deploy novel drugs in the first place. But logic has only recently translated into reality for most novel diagnostics. The existence of an antiquated CPT code system which bases reimbursement for diagnostics largely upon the cost of their underlying laboratory procedures, rather than on their benefit, made for a slow start. In addition, many diagnostic companies did not fund studies to document their products' ability to affect clinical outcomes. However, strong system economics arguments are becoming more mainstream and payers are beginning to reward companies with reimbursement of their premium priced tests. Rewards are based upon rigorous clinical arguments supporting the diagnostics' benefits to clinical decision-making and compelling economic arguments customized to each major payer. Identifying and documenting these arguments for each product is the key to attaining sustainable premium pricing in diagnostics.
12.08: Start-Up Magazine
Historically, technological advances to the insulin pump market have concentrated on slow but steady improvements to the pump's functionality, size and design. What the market hasn't yet experienced are dramatic improvements that would embrace the needs of both type 1 and type 2 diabetes patients while keeping costs low. This may be changing as companies expand their focus on developing simpler, lower cost insulin pumps that will benefit a broad spectrum of diabetes patients and providers. Health Advances Diabetes Practice Group shares its thoughts on the push to move insulin pump therapy into the larger type 2 diabetes population and some of the hurdles that will need to be overcome.
09.08: MDDI Magazine
Many companies launch products onto the medtech market concurrent with their initial FDA approvals in an effort to realize revenue as soon as possible. Delaying a market launch may seem counterintuitive, however having the fortitude to delay revenue may lead to far greater returns. Executives must be careful to differentiate between their regulatory and commercialization strategies. Each device company should carefully consider whether it has amassed the critical clinical and/or economic data necessary to catalyze purchase decisions by physicians and payers before launching. The article describes an analytic approach to optimizing the commercialization plan including launch timing.
01.08: InVivo Magazine
Biomarker diagnostics are critical to achieving the promise of personalized medicine. Unfortunately, building a successful business around such tests is difficult, given the complexities associated with both their development and commercialization. Many biomarkers present the risks of drug development and only the profitability of devices. Therefore, molecular diagnostic companies need to think carefully before they choose a "go it alone" strategy. It may make far more sense to forge a partnership with another diagnostic company or a drug developer with the goal of sharing costs, risks and profits.