Some estimates now put the cost of developing a new drug at nearly $2.9 billion. Adding to this financial pressure, pharmaceutical companies have little control over what CMS, health plans and PBMs will agree to pay for approved drugs, or if their new drugs will be listed on formularies—often because the value of new drugs is still an unknown.
To overcome some of these challenges, pharma companies are increasingly leveraging digital therapeutics in tandem with pharmacotherapy to optimize the therapy and to efficiently collect real-world evidence of efficacy, outcomes and ROI—as well as data on adherence and quality of life. This approach helps prove value for better reimbursements and formulary inclusion in an emerging value-driven environment.
Digital therapeutics, according to the Digital Therapeutics Alliance, “deliver to patients evidence-based therapeutic interventions that are driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.” Broadly defined, digital therapeutics could include the thousands of health and wellness wearables and apps available to consumers, but the technology that’s leveraged to demonstrate the value of drug therapy and for drug development is far more sophisticated.
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Ideally, data collection occurs via FDA-cleared, clinical-grade wearables that patients wear continuously to capture vital signs and other biometrics. Data from the sensors is integrated with patient-reported data collected via a mobile app. These data are linked with a massive “data lake,” and an FDA-cleared analytics engine identifies trends and provides clinical decision support that signals to providers where adjustments in pharmacotherapy may be needed.
Active and passive data collection and predictive analytics powered by artificial intelligence (AI) and machine learning can offer timely insights into efficacy and outcomes as well as quality of life measures such as functional capacity. When digital therapeutics are leveraged, drug therapy can be titrated for optimal effectiveness—and a worsening condition can be predicted well in advance of when it would have otherwise occurred, enabling earlier interventions.
Here are five ways that digital therapeutics are being leveraged by pharma, managed care, providers and clinical researchers to demonstrate value, to improve R&D, and to ultimately benefit health plan members:
- Maximizing the value of drug regimens: The analytic and predictive capabilities of digital therapeutics demonstrate value to drive reimbursement levels. The technology also can provide insights to inform ongoing monitoring and improvements in drug therapy recommendations.
A digital therapeutics platform paired with medication therapy captures data from clinical-grade wearables and uses AI and advanced machine learning to derive dozens of physiology biomarkers. When that data is fed into a data analytics engine, the efficacy—and value—of the medication can be measured.
Digital therapeutics prescribed in tandem with pharmacotherapy can enable payers to reduce costs by leveraging active and passive data collected from patients to optimize medication therapy to achieve guideline-directed targets that improve outcomes. Based on predictive analytics from biometrics captured from wearables and patient-reported data, providers have valuable information about whether a medication may need to be adjusted, and how likely the patient is to be adherent based on symptom improvement and quality of life.
Digital therapeutics also can help providers flag members who are non-adherent to their drug therapy; this approach enables providers to intervene in a timely manner for improved chronic condition management and patient satisfaction. After all, medication only works if the patient actually takes it.
- Paying for value, not pills—especially for newer drugs: Data on patient outcomes is crucial when launching a new drug. Being able to capture clinical outcomes as well as information about patients’ levels of satisfaction and well-being while being treated are important to health plans and PBMs that need to evaluate the value of specific types of drug therapy, especially for drugs that are newer to the market and that may carry higher price tags.
Digital therapeutics platforms—due to their automation and advanced AI, machine-learning and analytical capabilities—offer clinically relevant data to payers and PBMs on outcomes, so the value the medication is delivering can be evaluated and quantified.
- To monitor and optimize drug therapy for chronic and complex conditions: Increasingly, digital therapeutics are being prescribed as companion therapy when certain medication regimens are prescribed. When a patient is prescribed the drug, the provider explains that it comes with companion wearable sensors and a smartphone app that will capture physiologic data and allow them to report potential changes in their health.