Insurers, accountable care organizations, and manufacturers increasingly look for demonstrable clinical outcomes as proof for reimbursement or access to limited distribution networks.
You know the old riddle, “If a tree falls in a forest and no one is around to hear it, does it still make a sound?”
That also can be applied to specialty pharmacies today, especially those based in hospitals and health systems. We all know that these pharmacies do a great job caring for patients and getting them quick access to needed, sometimes life-saving medications.
They also score high in patient satisfaction. But if they can’t quantify the impact of their efforts through clinical outcomes data, can they truly demonstrate their differentiation in the market?
With their access to health records as well as patients, health-system specialty pharmacies are uniquely positioned to deliver high-value care. But it’s paramount that they can prove their value to engage external stakeholders.
Insurers, accountable care organizations, and manufacturers increasingly look for demonstrable clinical outcomes as proof for reimbursement or access to limited distribution networks. How can health systems demonstrate impact on disease progression, disease control, and cure rates? It all comes down to data.
This need was highlighted during the American Society of Health-System Pharmacists specialty pharmacy summit in February 2021. As spending on high-cost medication continues to grow, the meeting concluded that health-system leaders should anticipate an increased focus on outcomes and value. Proving how health-system specialty pharmacies can help improve clinical results while reducing costs will be key to broader adoption.
Unfortunately, there are still barriers to overcome. There has been limited progress defining standardized clinical outcomes measures and benchmarks, which are needed to ensure all health-system specialty pharmacies deliver a best-in-class experience to patients.
Compounding the problem, many health systems do not have the necessary technology to consistently collect and report on data, much less to apply insights from data to impact patient care in real time. Some rely on electronic health records (EHRs) alone, whereas others use software solutions not designed to leverage the clinical data health-system specialty pharmacies can uniquely access.
Clinical results published to date have mainly been in retrospective research studies focused on single clinical areas, by individual medical centers. There has been some movement among academic medical centers to expand this portfolio.
For example, members of the Health System Specialty Pharmacy Consortium at Vanderbilt Specialty Pharmacy’s Health Outcomes and Research Program have been collaborating to demonstrate the benefits of the health-system specialty pharmacy model. One recent study of 3530 patients across 20 health systems found that adherence to self-administered biological disease-modifying antirheumatic drugs (bDMARDs) was 95%,1 which is significantly higher than the 44%-83% ranges reported in previous studies. Few patients required a change in therapy during the study time period, potentially as a result of high touchpoints from integrated health-system pharmacists.
Trellis Rx also has been working to address the data gap and advance the health-system specialty pharmacy practice by establishing clinical outcomes measures based on results from our partner health systems across the country. A patient impact report we released in January demonstrates the valuable clinical results that can be achieved by health systems that have embedded pharmacists and pharmacy liaisons in care teams supporting patients with chronic, complex conditions.
Our partners represent a diverse group of health systems in rural and urban areas across the country. Working locally under our partners’ brands, pharmacists and pharmacy liaisons use standardized clinical protocols to interact with patients and a common technology platform to collect and analyze data. The report shared our outcomes across 9 specialty and common chronic conditions.
Take rheumatoid arthritis as an example—biologics and DMARDscan reduce symptoms and stop or slow the progression of rheumatic diseases. However, we currently cannot determine the efficacy of therapy for patients with such conditions using biomarkers.
Instead, we must rely on patient-reported outcome measure surveys, such as RAPID3, in combination with lab results, to assess health status. Although many health-system specialty pharmacies collect RAPID3 results, few have figured out how to consistently apply these data in real time to impact patient care.
Our evidence-based clinical protocol for patients with rheumatic diseases focuses on 3 arms:
1. therapy adherence;
2. proactively monitoring patients between appointments; and
3. using RAPID3 results to assess therapy efficacy and make timely interventions.
We deploy the protocol to pharmacists and pharmacy liaisons working on-site at our partner health systems through our EHR-integrated specialty pharmacy technology platform, which enables consistent patient care and documentation of clinical data including RAPID3 results. The platform’s advanced algorithms alert pharmacists of patients potentially requiring additional support so they can proactively intervene to improve outcomes.
I’m pleased to share with you that 99% of 3533 patients had a RAPID3 assessment collected and documented, compared with 61% in another study.3 Additionally, some 88% of 3052 patients showed an improved or maintained RAPID3 score between baseline and follow-up, and nearly 98% of patients with worsening RAPID3 scores received pharmacist intervention.
Health-system pharmacies also make a difference in common chronic conditions, such as diabetes. Drugs to manage these conditions are not necessarily considered specialty medications. However, patients who rely on them face many of the same challenges, including barriers to adherence.
Diabetes medications such as insulin, GLP-1 agonists, SGLT2 inhibitors, meglitinides, and DPP-4 inhibitors all have a common goal: reducing A1c levels to prevent disease progression and reduce the risk of adverse events and hospitalizations. Many patients struggle to afford these therapies.
Knowing this, our evidence-based clinical protocols focus on improving medication access and adherence, ensuring high-risk patients achieve target A1c levels as quickly as possible, and ensuring low-risk patients maintain target A1c levels over time.
Our report demonstrates these efforts are working. The rolling 6-month average medication adherence was 92% from May-October 2021, compared with 36%-84% in the overall market.4 Reductions in A1c levels also have been notable.
Reviewing data from 214 patients from July 2020-September 2021, high-risk patients achieved a 20% reduction in A1c levels compared to baseline, and low-risk patients achieved an 8% reduction, compared to an average 2% decline in a random sample of patients filling medications with external pharmacies.
With a growing number of patients with chronic conditions relying on complex therapies, offering integrated pharmacy services should be a critical part of every health system’s strategy—whether academic or community-based, rural or urban, small or large. However, as they establish or expand these services, health system leaders must prioritize using data to optimize patient care.
Doing so will ensure their organizations can drive measurable clinical outcomes while reducing costs for their stakeholders, which will be critical to success in an increasingly value-focused health care landscape.
To begin, use data from peer organizations or research studies to determine what clinical benchmarks exist in the literature. Can your pharmacy measure it the same way? If not, how else could you measure these data, or what infrastructure would you need to do so? Establish clinical goals or re-evaluate your existing ones.
Finally, make needed investments in your clinical and operational infrastructure to achieve these goals, whether developing evidence-based protocols, hiring additional personnel, or implementing a new technology platform. Even data on 1 or 2 metrics can start you on the right path, yielding beneficial outcomes for your teams, and ultimately, your patients.
A copy of our report, “Elevating Impact: Outcomes Measures for Health System Specialty Pharmacy Services,” is available for download.
About the Author
Brandon Newman, PharmD, MMHC, CSP, is chief operating officer at Trellis Rx.