Health Advances team members are actively engaged in thought leadership across the healthcare spectrum. We speak at conferences, participate in panels, and contribute to specialized journals on a wide range of topics, including commercialization strategies, emerging technologies, the changing delivery and reimbursement landscape, and implications of healthcare reform. Our white papers provide detailed perspectives and insights regarding issues of interest to healthcare executives.

Orphan Drug Pricing in Europe

Kelly Cockerill, Andrew Funderburk, Sheela Hegde and Julia Gaebler

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.

Leveraging FDA’S Accelerated Pathways for Market Advantage

Andrew Funderburk, Partner, Sheela Hegde, Partner

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

A Multidimensional Analysis of Prostate Surgery Costs in the United States: Robotic-Assisted versus Retropubic Radical Prostatectomy

Mike Davitian, Associate; Holly May, Consultant; and Mark Speers, Partner

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

Market Outlook: Simple Infusers: Unlocking the Potential of Insulin in Type 2 Diabetes

Marie Schiller, Arushi Agarwal, and Sheela Hegde

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. Also Included: CeQur: Overcoming Barriers with PaQ Simple Insulin Infuser.

Big Bets on Value-Based Care

Bruno Nardone, MHSA, FACHE

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.

Type 1 Diabetes Prevention Landscape: A Guide for Navigating Emerging Opportunities

Health Advances

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

Economic Study Published for Novel Breast Cancer Test

Gary Gustavsen, Vice President and Patrick Kennedy, Consultant

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.

The Rising Importance of Quantifying the Value of Health IT

Bruno Nardone, Vice President and Andrew Matzkin, Manager

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

Established Orphan Disease Markets: Innovators Wanted

Soren Peterson, PhD, Senior Analyst; Michelle Lerman, Senior Analyst; Vivek Mittal, PhD, Partner

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.


Publications Archive
06.13: Personalized Medicine Journal

Combating Complexity: Partnerships in Personalized Medicine

Kristin Pothier, Partner and Gary Gustavsen, Manager

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

Balancing the Need for Guidance, Communications, and Education to Support Personalized Medicine Diagnostics

Kristin Pothier, Partner

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

Matchmaking and Integration In The New World of Diagnostics M&Ao

Soren Peterson, PhD, Senior Analyst; Vivek Mittal, PhD, Vice President; Kristin Pothier, Partner

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

Breaking a Vicious Cycle: Commentary on Tumor-Marker Diagnostics

Gary Gustavsen, Manager

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

Molecular Diagnostics M&A: Dormant But Not Done

Vivek Mittal, PhD,, Vice President, Soren Peterson, Senior Analyst, and Kristin Pothier, Partner

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

Commercialization Alternatives in the New Medtech World

Susan Posner, Vice President and Mark Speers, Partner and Managing Director

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

Next Generation Combination Therapy in Oncology

Contributing Authors: Aidan Finley, Consultant; Vivek Mittal, PhD, Manager

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

Oral Molecules in an Injectable World: What Developers Need to Do Now

Contributing Authors: Andrew Funderburk, Vice President; Kimberly Howland, Vice President; Kate McLaughlin, Consultant

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.

The Reimbursement Landscape for Novel Diagnostics: Current Limitations, Real-World Impact, and Proposed Solutions

Contributing Authors: Kristin Pothier, Partner; Gary Gustavsen, Associate; Kerry Philips, Senior Analyst with support from BIO

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

Continuous Glucose Monitoring: A Case Study for Commercializing Products in the Era of Patient-Driven Health Care

Contributing Authors: Marie Schiller, Partner, Sheela Hegde, Vice President, and Brittany Carroll, Associate

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

Has Point-of-Care Come of Age?

Contributing Authors: Health Advances: Kristin Pothier, Vice President and Sonia Gupta, Former Consultant LipoScience: Mark Kirtland, Vice President of Strategy and Business Development

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

Advocacy in Personalized Medicine: A Developing Strength in a Complex Space

Contributing Authors: Health Advances: Kristin Pothier, Vice President and Michael Dunn, Senior Analyst bioMérieux: Iain Miller, Senior Director, Oncology Strategy and Theranostics Business Unit

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

Manufacturing Obstacles in IVD Product Development — Perspectives from Health Advances and KMC Systems Inc. (an Elbit Systems of America company)

Contributing Authors: Health Advances: Donna Hochberg, Ph.D., Manager KMC Systems: Walter Gilde, Business Development Manager

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

Medical Devices Deserve More Respect

By Mark Speers, Partner and Managing Director, Susan A. Posner, Vice President, and Jennifer Kim Cutie, MD, Professional Development Manager

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.

Maintaining Attractive Biopharma Returns in the Face of Healthcare Reform

Contributing Authors: Health Advances: Marie Schiller, Sheela Hegde, Kerry Phillips, and Urvesh Shelat Cowen Healthcare Royalty Partners: Greg Brown M.D., Paul Hadden, and Wendy Liu

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

By Susan A. Posner, Jennifer Kim Cutie, MD, and Anna Chen

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

How to Earn the Economic Payback Diagnostics Companies Deserve

By Gary Gustavsen and Kristin Pothier

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

Will Simpler Devices Tap the Largest Diabetes Market?

By Marie Schiller, Andrew Funderburk, Sheela Hegde, and Kathryn Strayer-Benton

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

Taking the High Road: Building the Right Foundation for a Medtech Product Launch

By Mark Speers, Managing Director and Partner, and Susan Posner, Vice President; Health Advances

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: Place Your Bets Wisely

By Kristin Pothier and Donna Hochberg

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.