In an interview with First Report Managed Care, Carmine DeNardo, Vice President and General Manager at Omnicell emphasizes the critical role of specialty pharmacies in patient care and highlights payers' increasing coverage of high-cost biologics and oncology medications, driven by value-based contracts and real-world effectiveness data.

Mr DeNardo also discusses the integration of patient-reported outcomes (PROs) into payer coverage plans, which are essential for evaluating treatment impact and improving adherence. He underscores the importance of multidisciplinary collaboration in gathering comprehensive patient data.

Please introduce yourself by stating your name, title, organization, and relevant professional experience.

Carmine DeNardo: My name is Carmine DeNardo, and I serve as Vice President and General Manager, leading the specialty pharmacy business for Omnicell. I am also the past Board Chairman for National Association of Specialty Pharmacy (NASP) and currently serving/representing Omnicell as a Board Member and Executive Committee for NASP. Prior to joining the Omnicell family, I was the President and Chief Executive Officer of ReCept Pharmacy, which I joined in 2009. In this role, I was responsible for overseeing the company’s long-term national growth, developing a multi-disciplined team focused on patient care and integration of strategic initiatives to expand specialty pharmaceutical care to large health systems.

I am a pharmacist by trade, and I have more than 35 years of executive leadership experience in both retail and specialized pharmacy services, and was a key industry contributor in defining the “specialty” pharmacy model. Prior to founding ReCept, I served as Chief Operating Officer for TheraCom, a service division of CVS Caremark, and Vice President of CVS Caremark Specialty Operations, overseeing all specialty retail locations across 25 states. I earned my Bachelor of Science degree in Pharmacy from Northeastern University.

What are the current trends in specialty pharmacy coverage by payers, and which medications are receiving the most coverage?

Carmine DeNardo: Recent trends in specialty pharmacy coverage by payers have gained traction over the last 20 years, and are today, taking off. Nearly 60% of newly developed medications are in specialty with oncology leading the way. The oncology market is projected to be worth more than $110 billion by 2025.

Focus also remains on high-cost biologics and therapies for chronic conditions such as multiple sclerosis, rheumatoid arthritis, and hepatitis C, which contribute to a total drug spend of almost $600 billion with $133 billion put back into R&D by manufacturers.

Payers are increasingly implementing value-based contracts and outcomes-based pricing models to ensure cost-effectiveness and therapeutic efficacy. Medications with strong clinical evidence and real-world effectiveness data are more likely to receive extensive coverage.

How do payers incorporate patient-reported outcomes (PROs) and outcome measures into their coverage plans for specialty pharmacy?

Carmine DeNardo: Payers incorporate PROs and outcome measures by integrating these data into value-based contracts and performance-based reimbursement models. PROs provide insights into the patient's perspective on treatment effectiveness, quality of life, and symptom management, which are critical for evaluating the true impact of therapies. Payers can use medication possession ratio (MPR) and proportion of days covered (PDC) to gauge medication adherence, as well as medication turnaround time to measure performance. This information helps payers to determine coverage decisions and align incentives with patient-centric care for specialty pharmacy.

Overall, when payers align themselves toward the common goal of getting patients on critical therapies, educating patients about their therapy adherence, and helping patients stay on therapy, better outcomes ensue.

What are the main insights from Penny Surratt and Sarah Kester's presentation "PROs and PROMs – It’s More Than Just a Chat" at Asembia? What do you expect the audience to take away from this session?

Carmine DeNardo: The main insights from the presentation covered objectives including: outlining the definition of PROs and patient reporting outcome measures (PROMs) for recognition of use in specialty pharmacies, recognizing that a specialty pharmacy’s setting lends itself to capturing PROs and incorporating PROMs for addressing nonadherent-prone patients, and illustrating how the application of PROs in a practice setting facilitates the design for optimal strategies in addressing patient adherence.

For reference, PROMs are standardized and validated tools and instruments used to capture or measure patient-reported outcomes that provide relevant information regarding health status, quality of life, symptomology, and functional status.

The presentation walked the audience through specialty pharmacy program development considerations including recognizing an underserved patient population, staffing concerns, and workflow disruptions.

The session also included a case study with Bausch Health that outlined a plan of action for improving medication non-adherence for patients with chronic comorbid conditions, such as HE. To improve patient outcomes, Omnicell’s Specialty Pharmacy Team worked with 1701 enrolled patients along with payers and physicians to start patient therapies, educate patients on how to remain adherent to medication, and conduct ongoing follow-up with the patient to ensure they are compliant with therapy plans. The audience should walk away with an understanding of how to build trust with patients and engage in quality reporting to enable an ongoing improvement process.

How do patient-reported outcomes and outcome measures contribute to addressing unmet needs and providing real-world evidence for payer coverage? Is collaboration with other health care professionals necessary to gather this data?

Carmine DeNardo: Patient-reported outcomes and outcome measures are essential in decreasing hospitalizations and improving quality of life, as well as addressing unmet needs by highlighting gaps in treatment efficacy and patient satisfaction. PROs provide insight into the patient’s understanding of their disease process and facilitates patient engagement for accessing adherence roadblocks.

These measures provide real-world evidence that complements clinical trial data, offering a more comprehensive view of a therapy’s impact. Collaboration with other health care professionals, including physicians, pharmacists, and nurses, is crucial to collect, analyze, and interpret this data. Such multidisciplinary efforts ensure accurate and holistic patient assessments, driving informed payer coverage decisions and improving patient care outcomes.

What is one key takeaway you hope the audience gains from this interview?

Carmine DeNardo: Specialty pharmacies play a critical role in a patient’s continuum of care and are a critical support to enhance patient quality of life. With specialty medications expected to eclipse $316 billion in spending by 2025, launching or optimizing an entity-owned specialty pharmacy is a compelling way for hospitals and health systems to improve patient care while driving financial growth.

However, launching a specialty pharmacy is a heavy lift, requiring significant resources and expertise to manage operational and site logistics, secure accreditations, gain access to specialty drugs, contract with payers, and more. An experienced partner can help navigate these challenges, allowing health systems to launch, operate, and optimize a specialty pharmacy program quickly and cost effectively. At Omnicell, we help pharmacies overcome specialty pharmacy barriers like accreditation, provider engagement, and payer/drug access, which results in improved specialty growth, increased cost savings, and amplified patient care.