Contributed Commentary by Lev Gerlovin, Brooke Bonet, and Inderpreet Kambo, CRA 

March 26, 2020 | In recent years, several pharmaceutical companies have shifted their research and development to target personalized medicines including novel cell and gene therapies, many of which offer the prospect of first-time treatments and even curative benefit for patients. While these therapies represent important and historic advances in medicine, they also require regulators, healthcare providers (HCPs), payers, and manufacturers to consider new value-based care principles and payment models to enable their commercialization and affordability. Value-based care can offer a number of advantages including the ability to align payer and industry incentives and the potential to improve patient outcomes and lower long-term healthcare costs. But some of these models may be accompanied by substantial and even onerous requirements to monitor patient efficacy and safety data, often over many years, to validate sustained performance. Payers often point to a gap in manageable and reliable processes for data capture when considering value-based care models. 

To understand how digital health technologies can play a role in mitigating payer concerns about patient data management for personalized therapies, life sciences experts from the global consulting firm CRA recently reviewed the use of several new and emerging digital health platforms. Findings showed that adoption of digital technologies can enhance the capture of real-world data related to patient outcomes and treatment compliance, and thereby facilitate broader use of value-based care models. The key to success is adopting the right technology at the right time. 

Facilitating the transition to value-based care 

There are several digital health solutions that both payers and drug developers must consider as the application of value-based care models and payment agreements, including outcomes-based agreements, expands. These solutions can be categorized as follows:
1. Data generation and storage to collect insights from various patient populations
2. Data analytics that demonstrate the impact of treatment decisions
3. Remote monitoring tools to observe patients and track data in real-time
4. Secure messaging between HCPs and patients to improve workflow and overall quality of care 

Electronic medical records (EMRs), one of the most well-known and widely available types of digital health technology, may be used to track and store patient information related to treatment progress and compliance. These data are critical to implementing value-based care models, understanding different patient populations, and supporting treatment decisions. For example, EMR data could help identify patients at a higher risk of adverse events and allow HCPs to tailor care plans accordingly, striving to improve outcomes. While HCPs can leverage EMR data to support patient care, privacy guidelines make it difficult to share this information with other stakeholders, potentially hindering the ability to holistically map the patient journey and provide optimal levels of care. 

Many manufacturers also use data analytics developed based on EMRs to forecast long-term drug efficacy. These analyses can support value-based care models by aligning payments to actual or validated product performance. But some payers question the reliability of these forecasted data and as a result are hesitant to switch to value-based care models. Companies such as Change Healthcare and Clarify Health Solutions are now integrating data analytics within value-based care models in an effort to provide greater clarity on drug efficacy and cost expectations over the long term. According to Change Healthcare, their analytics platform has provided cost benefit data that has resulted in improvements in quality of patient care as reported by about 80% of payers in their network. 

Digital technologies also are being used to collect more comprehensive data in real time. Remote monitoring tools and techniques, from implanted devices to more complex sensors, machines, and adherence devices, have made it easier for HCPs to observe and communicate with patients. Providers and payers can now monitor treatment compliance remotely. These tools can provide valuable insights and added convenience, but they also have been shown to lead to better and more cost-effective outcomes. In a recent six-month study (doi: 10.1097/00005650-200111000-00010) of patients with congestive heart failure (CHF), those who were on treatment and monitored through electronic stethoscope and video conferencing experienced significantly fewer CHF-related emergency room visits. 

As the use of remote monitoring increases and patient information becomes more readily available, especially in real time, it will become essential for many HCPs to adopt technologies that support secure and streamlined communication related to these data among care delivery teams and other key stakeholders. This approach will allow HCPs, hospital staff, and other medical professionals to quickly and reliably address patient requests, track progress and treatment adherence, and improve overall workflow, which can potentially improve quality and reduce costs for the entire healthcare chain. 

The role of stakeholder partnerships 

Developing strategic partnerships with different healthcare stakeholders could be beneficial when presenting value-based care models and payment agreements to payers. Many manufacturers are now finding ways to collaborate with digital health companies to gain access to advanced technologies and analytics tools to support real-world data capture and patient monitoring. In 2018, Roche purchased Flatiron Health, in part, to access their oncology-specific electronic health records to optimize patient outcomes and collect real-world evidence to support research, product pricing, and a value-based approach to patient care. 

Stakeholder partnerships can also help change payer perceptions of value-based care models and better demonstrate the potential benefits they can offer to healthcare systems, patients, clinicians, and others. The Health Transformation Taskforce is one example of a stakeholder consortium involving digital health companies, payers, and healthcare systems created to shape care delivery ecosystems and policies to encourage more HCPs and payers to participate in value-based care models. In 2017, the Duke-Margolis Medical Center formed the Value-Based Payment Consortium, giving drug manufacturers including Allergan, Novartis, Bluebird Bio, and Spark Therapeutics the opportunity to connect with patients, advocates, payers, providers, and experts from regulatory affairs, law, and policy to address challenges in transitioning to and executing value-based care arrangements. 

Conclusion 

By partnering with digital health companies and a range of other industry stakeholders, drug developers can create more competitive and effective payment agreements based on value-based care models. To ensure that payers are comfortable with the structures and requirements of these new and emerging models, manufacturers should consider having more frequent and holistic discussions with them and work to highlight how use of digital health technologies can be effective in making the transition from traditional care models. In addition, manufacturers should organize regular forums to review the evolving role of digital technologies in supporting value-based care and access to high-value treatments, which can help build broader awareness and acceptance of value-based care models among payers moving forward. 

Lev Gerlovin is a Vice President in the Life Sciences Practice at CRA with more than 12 years’ experience in life sciences strategy consulting, focused on commercial and market access strategies. He can be reached at lgerlovin@crai.com. Brooke Bonet is an Associate Principal with more than 10 years’ experience in life sciences, specializing in commercial strategy. Inderpreet Kambo is an Associate Principal with eight years’ experience focusing on analytical tool development and new product design. The views expressed herein are the authors’ and not those of Charles River Associates (CRA) or any of the organizations with which the authors are affiliated.