Improving Care One Patient at a Time

Alex Ekstrom, PharmD, and Erika Kaplan, PharmD

For many, medications are an important part of daily life, and the burden is even more significant for patients with multiple chronic conditions and polypharmacy. Approximately 22% of Americans take five or more medications, and with more medications comes potential for risk, including adverse drug events.1

Adverse drug events, or the problems that stem from the use of medications, cause approximately 1.9 million emergency department visits and 768,000 hospitalizations annually.2 It is estimated that nearly 40% of these events are potentially avoidable.3 Patients often receive medications from multiple health care providers and may also be taking over-the-counter medications or herbal supplements that can further add risk and complexity to these regimens. Health care professionals, such as pharmacists, conduct comprehensive medication reviews (CMRs) to help coordinate overall care and avoid or resolve potentially preventable issues.

A CMR is a systematic and interactive approach to evaluating a patient's medication regimen and their understanding thereof. It involves, among other things, a thorough assessment of the patient's medical history, current health status, health literacy, and medication use. Broadly, the purpose of a CMR is to identify medication-related problems (MRPs) that the patient may have and resolve them. The benefits of a CMR are numerous for patients struggling with complex regimens. CMRs can improve a variety of patient outcomes, such as decreasing adverse drug events, improving control of chronic conditions, health literacy, and adherence to medications.4,5,6,7

Pharmacists and other health care professionals can also use the CMR process to address social determinants of health that may be affecting a patient's health outcomes.8 For example, a patient may be unable to adhere to their medication regimen due to transportation challenges or difficulty accessing health care. Accessibility of a pharmacist during these interactions can even help resolve issues that would at times be considered outside of the scope of a medication review, such as helping to obtain necessary durable medical equipment, ensuring access to adequate food or housing, or coordinating necessary provider appointments. In such cases, pharmacists can work with the patient to identify resources such as insurance plan case management, social workers, transportation services, or telehealth options that can help them manage their health conditions effectively.

At PerformRx, the Clinical Outcomes and Therapeutic Optimization team has developed criteria and programs in partnership with health plans to help better identify patients who may benefit from a CMR. The team focuses on individual patients with goals and outcomes tailored to the specific needs of the patient. Below is an actual case highlighting one of these patient interactions.

Patient Case

Background and discussion

A telephonic comprehensive medication review was completed with the caregiver of a 73-year-old female with a past medical history of atrial fibrillation, chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), coronary artery disease (CAD) with stent placement, diabetes, and hypertension.

The patient’s caregiver reported uncontrolled hypertension, CHF, and COPD. The caregiver explained they have not been able to monitor the patient’s blood pressure or weight at home following the addition of a new blood pressure medication. They have also had issues obtaining a higher dose of furosemide from the pharmacy to help with the patient’s increased swelling. The caregiver reported non-adherence to tiotropium bromide inhaler and vitamin D due to a processing issue at the pharmacy.

In addition, the patient had less symptom control with budesonide/formoterol inhaler as compared to mometasone/formoterol, which the patient was previously taking. The caregiver also requested assistance with obtaining a shower chair and seeing if the patient qualifies for a meal benefit. The patient’s atrial fibrillation, diabetes, and CAD were assessed during the call and determined to be controlled on current therapy.

Intervention

Following the discussion with the caregiver, the pharmacist made several interventions to help coordinate the care of the patient. First, the pharmacist contacted patient services to ensure the over-the-counter catalog was sent to the patient so a scale and blood pressure monitor could be ordered. Second, the pharmacist contacted the pharmacy to assist with processing the patient’s vitamin D prescription. Third, the pharmacist contacted the prescriber to recommend a new prescription for furosemide and tiotropium bromide inhaler, notify them of non-adherence to therapy with tiotropium bromide inhaler, and assist with the prior authorization process for mometasone/formoterol. Lastly, the pharmacist created a referral to case management to assist the patient in obtaining durable medical equipment and assess their eligibility for a meal benefit.

Outcome

As a result of the pharmacist’s intervention, many of the patient’s medication-related issues were resolved. The patient was given the tools needed to monitor her chronic conditions at home. New prescriptions for furosemide and tiotropium bromide inhaler were sent to and filled at the patient’s pharmacy. The pharmacist was also able to help the pharmacy process the patient’s vitamin D prescription. The prescriber submitted a prior authorization for mometasone/formoterol, and it was approved. All medications were filled consistently post intervention. The patient was also connected to a case manager who was able to help the patient with her durable medication equipment needs and meal benefit.

This is just one example of many, demonstrating how the PerformRx clinical outcomes and therapeutic optimization team can identify and resolve medication-related problems and adverse drug events, and help address social determinants of health. These interactions take place with over 14,000 patients each year, with services and populations expanding yearly. In 2021, the most recent year with data available, there were over 22,000 medication-related problems identified, and over 10,000 of those were resolved successfully. By taking the time to help patients on the individual level, we can continue to help drive improvements in care across the population.

OUR AUTHORS

References

1. Hales CM, Servais J, Martin CB, Kohen D. Prescription Drug Use Among Adults Aged 40–79 in the United States and Canada. NCHS Data Brief. 2019;347.

2. Budnitz DS, Shehab N, Lovegrove MC, Geller AI, Lind JN, Pollock DA. US Emergency department visits attributed to medication harms, 2017–2019. JAMA. 2021;326(13):1299-309. doi: 10.1001/jama.2021.13844

3. Institute of Medicine. Committee on Identifying and Preventing Medication Errors. Preventing Medication Errors, Washington, DC: The National Academies Press 2006

4. Zillich, A. J., Snyder, M. E., Frail, C. K., Lewis, J. L., Deshotels, D., Dunham, P., Jaynes, H. A., & Sutherland, J. M. (2014). A Randomized, Controlled Pragmatic Trial of Telephonic Medication Therapy Management to Reduce Hospitalization in Home Health Patients. Health Services Research, 49(5), 1537–1554. https://doi.org/10.1111/1475-6773.12176

5. Miller E., Roane, T. E., & Mclin, K. D. (2016). Reduction of 30-day hospital readmissions after patient-centric telephonic medication therapy management services. Hospital Pharmacy, 51(11), 907-914. doi:10.1310/hpj5111-907

6. Skinner, J. S., Poe, B., Hopper, R., Boyer, A., & Wilkins, C. H. (2015). Assessing the effectiveness of pharmacist-directed medication therapy management in improving diabetes outcomes in patients with poorly controlled diabetes. The Diabetes Educator, 41(4), 459-465. doi:10.1177/0145721715587563

7. Pinto, S. L., Kumar, J., Partha, G., & Bechtol, R. A. (2013). Improving the economic and humanistic outcomes for diabetic patients: Making a case for employer-sponsored medication therapy management. ClinicoEconomics and Outcomes Research, 153. doi:10.2147/ceor.s40735

8. Amanda Foster et al., “Addressing Social Determinants of Health in Community Pharmacy: Innovative Opportunities and Practice Models,” Journal of American Pharmacists Association, 2021.

Commentary by Megan Coder, PharmD, MBA, Chief Policy Officer, Digital Therapeutic Alliance

In 2017, Digital Therapeutic Alliance (DTA) launched with the goal of creating a strong foundation for this new category of medicine. With digital therapeutics (DTx) being used in patients’ homes and clinical settings around the world to directly treat and alleviate diseases and disorders, it was imperative for industry leaders to align around product development principles [dtxalliance.org], ethical standards [dtxalliance.org], and medical device best practices to ensure that meaningful, safe, and effective therapies are delivered to patients.

As such, DTA continues to deliver on our mission by developing DTx evaluation frameworks [dtxalliance. org] for payers and clinicians to use, supporting the passage of a DTx Medicare benefit category [dtxalliance.org], and clarifying how these products are incorporated into health-system workflows [dtxalliance.org]. Digital therapeutics are becoming a core component of health care delivery.

What are digital therapeutics?

Digital therapeutics (DTx) is an emerging class of therapeutics within digital health solutions. The Digital Therapeutics Alliance (DTA) defines DTx as delivering evidence-based therapeutic interventions to patients that are driven by high quality software programs to treat, manage, or prevent a disease or disorder.

DTx can be used independently or concurrently with medications or other therapies to optimize patient care and outcomes.3 DTx interventions are delivered to patients through digital devices such as a smartphone or tablet. Food and Drug Administration (FDA)authorized digital therapeutics, a subcategory within DTx known as prescription digital therapeutics (PDTs), are evaluated for safety and efficacy and require a prescription from a licensed health care practitioner. The Digital Health Trends 2021 report by IQVIA reported that there were 137 DTx products in the pipeline with 25 DTx products being marketed globally in at least one country.4 Currently in the U.S., 16 DTx products are authorized, of which eight need a prescription.5

Digital health is an all-encompassing term that includes mobile health, health information technology, wearable devices, telehealth, telemedicine, and personalized medicine.1 As stated by the World Health Organization, digital health solutions are an integral part of our daily lives and can be leveraged for global attainment of health and well-being.2 Digital health solutions empower individuals to participate in and manage their health. Fueled by limited access to in-person visits during the COVID-19 pandemic, there has been an increase in utilization of virtual care and other digital health solutions. As comfort levels have increased with the use of digital health at the provider and patient level, we can anticipate that this field of health care will continue to expand.

Like conventional medicines, DTx products treat a range of chronic conditions that include substance use disorders, insomnia, pain, and behavioral health disorders, such as attention deficit hyperactivity disorder (ADHD), depression, and anxiety. Instead of solely relying on medications, DTx uses softwarebased algorithms and machine learning to provide personalized therapy that is tailored for the patient based on their progress, preferences, and feedback. DTx also enables the collection of real-time data allowing for population health management.

Many DTx products on the market today are based on cognitive behavioral therapy (CBT) delivered through a smartphone or tablet. CBT is a form of psychosocial treatment provided over a set period and has demonstrated to be effective for multiple disorders including depression, substance use disorder, insomnia, irritable bowel syndrome, and chronic pain. At present there are five DTx products using CBT as the primary interventions that are FDA-authorized and require prescription.5

Opportunities and challenges in digital therapeutics

DTx can play a significant role in advancing health equity. A Pew research study indicated that 80% of U.S. adults living in rural areas own a smartphone.6 As most DTx interventions are delivered through a smartphone, this treatment modality is uniquely positioned to help lower rural health inequalities by increasing access to care in rural areas. In addition to this, DTx enables patients to have timely access to personalized care when they need it most, such as when they are experiencing symptoms. DTx may also help increase accessibility of care by mitigating the impact of the current shortage of health care practitioners. DTx may also help fill the gap for segments of the population that are looking for alternate ways to manage their health rather than traditional provider office visits.

Unfortunately, even as the number and diversity of products in this category continue to increase, widespread adoption for these products is not following the same trend. The reasons for this include regulation, legislation, coverage, and reimbursement.

At present, digital therapeutics are reviewed under the FDA medical device pathway, including premarket notification [510(k)] and De Novo classification requests.7

De Novo review requires clinical trial data, but it is not as rigorous as what is required for pharmaceutical agents. 510(k) review must demonstrate that the new device is “substantially equivalent” to a predicate device. As the evidence needed for these approval pathways is not as rigorous as the evidence required for pharmaceutical products, real world evidence is needed to drive acceptance and use of these products. The FDA has also created the Digital Health Center of Excellence to guide the review of digital health technology, which will inform future direction for all digital health solutions, including DTx, by supporting the regulatory review of digital health solutions.8

Legislation is needed to pave the path for widespread adoption and continues to evolve. In April 2022, the Centers for Medicare & Medicaid Services (CMS) established new Healthcare Common Procedure Coding System (HCPCS) codes for FDA-authorized PDTs providing CBT interventions, enabling reimbursement through medical benefits.9 On March 8, 2023, a bipartisan bill, Access to Prescription Digital Therapeutics Act of 2023, was introduced to the House of Representatives.10 If passed, the bill will authorize, but not require, CMS to cover digital therapeutics for Medicare and Medicaid beneficiaries. The bill also directs CMS to develop reimbursement and coding practices appropriate to the unique nature of digital therapeutics.

Reimbursement for DTx is not well defined and may fall under pharmacy, medical, behavioral health, or employer-sponsored wellness benefits.11 To promote the use of these products, value-based agreements and pilot projects are also in play. Reimbursement for these products under the pharmacy benefit offers some additional benefits by utilizing established and validated formulary management tools. However, as this a new category of product, currently accepted drug review processes through the pharmacy and therapeutics committee will have to be updated to capture elements relevant to DTx.

Payers, manufacturers, and health care practitioners also must address digital health literacy, cultural considerations, and unique patient circumstances during the development and evaluation process of DTx.

New horizon

DTx has paved the path to a new horizon in health care combining digital technology and evidence-based treatment regimens. If implemented appropriately, DTx has the potential to improve patient outcomes, reduce the cost of care, and advance health equity. There is still work to be done to provide access. The industry must streamline operational steps that are needed to prescribe, and implement care coordination and assessments for patients who need these interventions to assure efficacy and safety. DTx has the potential to empower patients to engage in their personal health care.

OUR AUTHORS

Binal Patel MPharm, BCGP PerformRx

REFERENCES

1. “What is Digital Health”, U.S. FDA, https://www.fda.gov/medical-devices/ digital-health-center-excellence/what-digital-health

2. "Digital Health.” WHO, https://www.who.int/health-topics/digital-health#tab=tab_1

3. “Understanding DTx,” Digital Therapeutics Alliance, https://dtxalliance.org/ understanding-dtx/what-is-a-dtx/

4. "Digital Health Trends 2021,” IQVIA, July 22, 2021, https://www.iqvia.com/insights/ the- iqviainstitute/reports/digital-health-trends-2021

5. "Digital Therapeutics Using Cognitive Behavioral Therapy” IPD Analytics, January 9,2023, http://www.ipdanalytics.com

6. “Mobile Fact Sheet,” Pew Research Center, April 7, 2021, https://www.pewresearch.org/ internet/fact-sheet/mobile/

7. “The Current Landscape and Complexities of Digital Therapeutics” IPD Analytics, August 24, 2021, http://www.ipdanalytics.com

8. “Digital Health Center of Excellence”, U.S. FDA, https://www.fda.gov/medical-devices/ digital-health-center-excellence/about-digital-health-center-excellence

9. “Update - CMS Establishes New Level II HCPCS Code for Certain Digital Therapeutics,” March 2022, http://www.ipdanalytics.com

10. “Prescription Digital Therapeutics.” AMCP, March 9, 2023, https://www.amcp.org/ policy-advocacy/legislative-regulatory-issues/prescription-digital-therapeutics

11. “Prescription Digital Therapeutics: Software-Based Treatments,” IPD Analytics, June 2020, http://www.ipdanalytics.com