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Formulating a specialty drug management playbook using expert insights

Using this playbook, healthcare organizations can better navigate the complexities of specialty drug management to optimize care, control costs, and improve patient outcomes.

Specialty drug management is a critical challenge for healthcare organizations. Still, by harnessing expert insights, organizations can better navigate specialty drug management, optimize care, control costs, and drive improved patient outcomes. This five-part playbook empowers healthcare organizations to confidently tackle specialty drug management's unique demands. 

1. Understanding the Role of Specialty Drugs 

Although specialty drugs are used by a small percentage of the population (1–5%), they represent roughly 50% of total drug spending in the United States. 

"Specialty has always been an interesting beast because it impacts a very small sliver of the population but drives a substantial amount of the cost in the healthcare system," confirmed Sana Hashmi, JD, MPA, Senior Vice President of Product at OptumRx.  

Due to their unique characteristics and therapeutic benefits, these drugs are often used to treat complex and chronic conditions — such as multiple sclerosis, HIV/AIDs, rare genetic disorders, and cancer — where patients may require multiple medications and face comorbidities. 

"For cancer, as an example, the FDA approves about 10–15 drugs a year. It’s a constantly evolving field, making it challenging to keep up. However, this dynamic nature is a positive aspect, indicating progress and advancements in therapy options," shared Tim Foley, MBA, Vice President of Oncology and Specialty Products at Optum. 

2. Addressing Challenges and Implications 

Specialty drug management presents a multitude of challenges for healthcare organizations, including high costs, limited availability, complex administration and monitoring, reimbursement complexities, data management and regulatory compliance. These challenges require collaborative efforts among stakeholders to enhance cost-effectiveness, improve patient access, streamline reimbursement processes, promote data interoperability, and develop evidence-based guidelines for appropriate utilization of specialty drugs. 

Hashmi pointed out that the advancements in rare disease therapies offer new opportunities while posing challenges. She highlights the delicate balance between the high cost of these therapies and their potential to provide cures, treatments, and improved longevity.  

“There are many new developments in rare diseases and therapies. Historically, these rare conditions didn’t get as much attention,” Hashmi said, emphasizing the latest treatment approved by the FDA for Duchenne muscular dystrophy, Duvyzat (givinostat). However, the high costs associated with these treatments may render them inaccessible to many patients. 

"The challenge lies in affording these needed therapies,” Foley added. “Health plans want to ensure that they can help the member and see the benefit over a multi-year period.”  

These high retail costs can strain healthcare budgets, create financial burdens for patients and insurers, and impact the affordability and accessibility of these life-saving treatments. 

3. Managing Access and Cost 

To effectively manage access and cost in specialty drug management, healthcare organizations are actively exploring innovative strategies, including optimizing the site of care for drug administration. By carefully considering the most appropriate location for drug administration, organizations can balance affordability and quality of care, ensuring that individuals receive the most cost-effective treatment available. 

Hashmi raised an important question: "How can individuals ensure they are receiving the drug in the most affordable way possible, considering that all sites of care are not created equal?" This question underscores the importance of healthcare organizations identifying the optimal site for drug administration to achieve the delicate balance between cost-effectiveness and high-quality care delivery.   

Foley highlighted Optum's Specialty Fusion solution, a unique, cross-benefit utilization management tool that provides real-time treatment recommendations aligned to health plan clinical policies and UM strategies. 

"The Specialty Fusion solution provides individuals with real-time information at the point of prior authorization, including all the tools a health plan can use to manage drug spending. This empowers them to make more informed and effective decisions, ultimately driving better decision-making and faster time to treatment for patients," explained Foley.  

Through Specialty Fusion, healthcare providers can choose the most effective and cost-efficient treatment options for their patients and get quick prior authorization approvals on treatments covered on both the medical and pharmacy benefits —  – all in one platform. This empowers providers to make better decisions, optimize patient outcomes, and promote cost-effective utilization of specialty drugs. 

These innovative approaches, driven by technology and data-driven insights, have the potential to transform specialty drug management, ensuring that individuals receive the most appropriate and affordable care while managing costs and enhancing overall healthcare delivery. 

4. Eliminating Waste and Abuse 

Reducing waste and abuse within the healthcare system is also crucial to specialty drug management. Optimizing medication supply duration can prevent overprescribing and minimize medication waste.  

Hashmi emphasized the importance of providing patients with an appropriate supply of medication based on their needs. For example, if a patient is still in the process of determining the right medication for their condition, it may be more suitable to give them a 15-day supply instead of a 30-day supply. This prevents the waste of medications that may no longer be needed if the drug is switched or adjusted after a shorter duration. By aligning the medication supply with the patient's treatment response, healthcare organizations can effectively reduce unnecessary waste.  

Another approach to reducing waste and abuse in specialty drug management is using real-world evidence to identify the most effective treatment regimens and the optimal dosage of each treatment. 

Foley emphasized the significance of leveraging real-world data to make informed treatment decisions.  

Foley mentioned that, through the analysis of real-world evidence, healthcare organizations have identified cases where certain indications or uses of drugs were initially approved but later found to be inappropriate based on the evidence gathered from real-world settings. By the FDA rescinding approval for certain indications, healthcare organizations can ensure that patients receive truly effective and appropriate treatments for their conditions. Additionally, using real-world evidence to highlight treatments associated with strong quality outcomes provides further decision guidance to providers. 

Continually evaluating and refining treatment approaches based on real-world evidence allows healthcare organizations to provide patients with the most effective and efficient care possible. 

5. Acknowledging Top Trends 

During the interview, Foley identified the following three key trends shaping the specialty drug management landscape:  

  1. Increasing diversity of cancer treatment options 
  2. Growing focus on managing autoimmune conditions 
  3. The challenge of balancing affordability and access to ultra-rare conditions 

"There are numerous types of systemic therapies that can be used for cancer patients,” explained Foley. “Chemotherapy, immune checkpoint inhibitors, CAR-T, bispecifics and more. For many cancers, there can be 10+ different treatment options.”  

The availability of a wide range of treatment options presents opportunities and challenges for healthcare organizations. 

Secondly, autoimmune conditions, such as rheumatoid arthritis and psoriasis, are gaining attention due to their impact on patients' quality of life and productivity. As these conditions become more prevalent, healthcare organizations must develop effective management strategies to address patients' needs. 

Lastly, the emergence of ultra-rare conditions necessitates frontier therapies, which come with exorbitant price tags. Healthcare organizations face the challenge of balancing the cost of these therapies with the imperative to provide patients with access to effective treatment options.  

"It's difficult to provide access while also ensuring affordability. Each challenge presents its own set of complexities.” Foley said, acknowledging these concerns. 

Specialty drug management remains a critical area of focus for healthcare organizations. Leveraging insights from experts, healthcare technology professionals can navigate the complexity of this landscape, optimize access, control costs, and improve patient outcomes.  

The playbook outlined by Hashmi and Foley serves as a valuable resource for healthcare organizations, enabling them to navigate the challenges and capitalize on the opportunities presented by specialty drug management. By leveraging technology and evidence-based decision-making, healthcare organizations can deliver high-quality, cost-effective care to needy patients. Organizations can meet the unique demands of specialty drug management and ensure the best possible patient outcomes by optimizing access, managing costs, eliminating waste, and staying attuned to emerging trends. 

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