Consider Enhancing your OBA with “Beyond the Pill” Interventions

It’s that time of year where we’re busy heading into the final quarter of the year. In 2018, we have witnessed a fundamental change in the concept of value, going far beyond pharmacological properties and clinical effects, to not only to include patient value, quality of life and patient management, but also to integrate systems and societal value dimensions more broadly.Where are we in our journey towards the new frontier in the ‘paying for value’ discussion in the US?

We decided to initiate a 15-part series on our blog, where our US access experts take us through the shifting landscape for innovative contracting. Come join us as we explore a new world where quality benchmarks and patient outcomes performance define reimbursement and risk, and where the ability to translate value from clinical trial results into the messy real world of clinical practice becomes the currency of market access success. We’d love to get your feedback on our thoughts below, come back every Wednesday and Friday for a new edition.

Consider Enhancing your OBA with “Beyond the Pill” Interventions

While the discussion above has focused on fairly straightforward OBAs structured around new therapies, there is tremendous interest in including non-pharmacological interventions that can enhance the performance and value of therapies.

As we’ve seen in practice, several factors can influence the effectiveness and safety of treatments in real-life and partners should investigate early-on what are these factors, how they are distributed in the health plan population, and what is their expected impact. Once the partners have this basis of shared understanding, there is a common interest in trying to add interventions that can steer the use of the therapy towards patients where it is most effective and safe, so that performance is maximized for the health plan’s members and the financial risk is minimized for the Biopharma company.

For example, contracts for therapies in diabetes or hypercholesterolemia consider including a disease management program to reinforce adherence, which is known to be a key driver of effectiveness in these diseases. As we have seen, an alternative is to include a provision where non-adherent patients are out of scope of the contract. Still, even with this type of provision, there is interest to minimize the proportion of these patients so that the OBA can deliver its full value to each partner and ultimately to the patients. Other interventions can include physician support programs to ensure that the treatment is given to patients who benefit the most from it (e.g., based on severity profile, prior treatment history, specific biomarkers, co-morbidities…)

Merck has reached agreements with Aetna for Januvia (sitagliptin) and Janumet (metformin/sitagliptin): If Aetna members with type-2 diabetes don’t meet certain clinical goals – such as hitting their hemoglobin A1C or bloodsugar targets – Merck pays a rebate which increases depending on the number of patients who miss the targets, measured by analyzing data from Aetna’s claims. But in addition to such a classic performance contract, Merck/ Aetna also worked out an agreement for commercial patients that involves predictive analytics to identify 500 at-risk patients diagnosed with hypertension or diabetes. The objective was to identify at-risk members with commercial insurance coverage who are participating in two accountable care organizations (ACOs) in northern New Jersey. For the payer, the data will be analyzed to create improved-care procedures that are aimed at helping patients improve adherence to therapy with social support such as phone calls and in-person visits from Aetna nurses on a regular basis. Merck agreed to provide adherence tools and educational resources.

So-called “beyond the pill” interventions are a key opportunity for insurers to maximize the outcomes in their patient population, while paying for the actual value of the treatment through the OBA. At the same time, they represent an opportunity for manufacturers to minimize their financial risk on the OBA, as well as to possibly enhance their volumes by optimizing adoption and use of their treatment by physicians and patients.

A recent survey revealed that, in the eyes of senior sector leaders, the biggest driver for the transformation in healthcare is pricing pressures over the next 5-10 years. 47% of C-level executives cited the “adoption of value-based or risk-sharing pricing models” as their top choice, compared with 38% of respondents who listed “scientific breakthroughs”.2

United HealthGroup, the largest health insurer in the US, released data showing that in 2017 about half of its $130 billion annual medical spending occurred through value-based models, a share the group seeks to increase to 60% over the next two years. UnitedHealth reports that nearly one in three of its plan members already receive care from providers in value-based arrangements.3

As health systems are driven to accept increasing accountability and downside risk, payers and providers are looking for the biopharmaceutical industry to share the risks around performance of their products – based on outcomes measured in the actual healthcare setting.

Meet Our Experts

Ulrich Neumann
Ulrich NeumannSr. Director & Head of US Value & Access
Ulrich Neumann is the Senior Commercial Director of Analytica Laser, a global research consultancy with offices in eight countries. In addition to client advisory in US-based market access, his responsibilities include corporate affairs, marketing, product development and customer-facing growth strategies across all of the company’s target markets. Analytica is part of Certara, the global leader in model-informed drug development with over 700 professionals in 20+ countries.

With a dual background in business management and public administration, Ulrich focuses his work as a pharmaceutical market access expert on reimbursement and pricing, as well as activities on the US political, legislative and regulatory landscape to assess policy drivers, enablers and challenges to market access. He has given conference keynotes and university seminars, published research in whitepapers and articles in the pharmaceutical press, as well as two books in the field of media and terrorism policy.

His business experience lies in defining product strategy, value messaging and brand development. The founder of several ventures, Ulrich has worked on go-to-market projects for close to 15 years and most recently ran the US division of a respected global provider of pharma market insights, b2b networking and conferences. Ulrich is a graduate of the London School of Economics (MSc), University of Southern California (MA), University Twente (BSc) and University of Muenster (BA). At USC, he held the Roger Silverstone Fellowship, the Annenberg School’s highest-sponsored grant, conducting quantitative and qualitative research on the economics of digital platform markets, competitive strategy as well as marketing and communications strategies. Active in the NY health tech community, Ulrich is a supporter of the open health data movement and member of ISPOR and DIA. He is a nominated Fellow of the Royal Society of Arts and Commerce since 2014.

Isha Bangia
Isha BangiaUS Access Specialist
Isha brings a combination of clinical and strategic experience to Analytica. She holds a PharmD from Rutgers University and an MBA from Johns Hopkins. Her background as a pharmacist provides clinical perspective into retail and hospital settings where she has been involved in market access and clinical care at the provider level. Her managed care expertise includes work at Hunterdon Medical Center, Bayshore Community Hospital, Princeton Houser Psychiatry, Hackensack University Medical Center, Bayonne Medical Center. Isha has also participated in P&T committee meetings for formulary decisions. Prior to joining Analytica, Isha was a consultant at Prescient Healthcare Group, focused on competitive landscaping and go-to-market strategies. She has past experience from Zitter Health Insights where her work focused on payer primary and secondary market research to better understand market access barriers (e.g. step therapies and prior authorizations) for manufacturers. She has worked across multiple therapeutic areas including oncology, biosimilars, diabetes, vaccines and rare diseases.

Roman Casciano
Roman CascianoGeneral Manager of Analytica Laser & SVP, Market Access, HEOR and Real-world Evidence, Certara
Roman Casciano is the General Manager of Analytica Laser, leading Certara’s Market Access, HEOR and Real-world Evidence Group in the capacity of Senior Vice President. Based in New York City, Roman’s role comprises the executive management of all strategic and scientific teams across the company’s eight offices and three divisions. Roman continues to actively participate in client engagements as a market access strategist, ensuring that customers can leverage all of the benefits of our multidisciplinary team and integrated offer.

Roman was one of the founding members of the Analytica Group in 1997 and remained with the company for over 14 years, serving in various capacities during his tenure ultimately serving as President from 2008 onwards. Prior to joining Analytica, Roman worked for 4 years as an environmental engineering consultant with HDR Engineering Inc. in White Plains, NY. Roman went on to participate in the founding of the Analytica Group in 1997, initially serving as Director of Operations and subsequently serving as General Manager for the German subsidiary from 2004-2006. After returning to the US from his tenure as General Manager in the German subsidiary and prior to taking on his role as President of Analytica, Roman worked for 2 years in Analytica’s previous parent company, Accentia Biopharmaceuticals as the Sr Vice President and head of the NY-based product development team with full responsibility for the conduct of its two on-going phase III clinical programs.

As an applied health economist and market access strategist, Roman has personally led hundreds of engagements in the international market access and HEOR context related to product value demonstration and has deep experience in the management of multidisciplinary teams of scientific and strategic consultants across continents. Roman’s experience ranges from analytical activities such as economic modelling and database studies, to strategic activities such as developing product pricing and market access plans and communicating evidence internally and externally for our customers. Roman has experience across the product lifecycle, including assessment of early phase assets, licensing due diligence, and go/no-go decision-making support, as well as launch planning and commercialization activities.

Roman received both a Bachelor of Science degree in Mechanical and Aerospace Engineering and a Master of Engineering Degree in Mechanical Engineering and Engineering Decision Making from Cornell University.

Lee Stern
Lee Stern Global Vice President, Business Development
Lee Stern is a Vice President at ANALYTICA LASER, formerly Senior Vice President of Analytica International. In this role, she is responsible for all health economic and market access engagements for global clients. She also oversees the full operations of the New York office. Lee is a strategic and actionable leader managing highly qualified and scientifically robust cross-functional and geographically disparate teams.

Her expertise in solving client issues via action-oriented deliverables is a strong asset in the context of a cost conscious payer environment. She has extensive experience in global market access and launching products in competitive landscapes. As a strong operations leader, Lee is able to deploy a team of specialized scientists to ensure timely, relevant and scientifically robust deliverables for her clients. Her 10+ years of experience in the industry enables her to draw upon a vast repertoire of project deliverables to produce solutions for complex study designs and market access issues. For example, she has coordinated multiple local country submissions for major oncology products, managed international payer research in diabetes, and published numerous retrospective data analyses, models and literature review studies in peer-reviewed journals.

Prior to joining ANALYTICA LASER, Lee served as the primary nutritionist in a large physician practice, closely affiliated with NYU Langone Medical Center where she has maintained close ties.

Lee received her Bachelor of Arts degree in Neuroscience at The University of Pennsylvania. She also completed her Masters in Clinical Nutrition at New York University School of Education.

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