Specialty Pharmacy: The Trends Shaping Best Practices

Ongoing innovation in drug development is allowing patients managing one or more comorbidities to live longer and have an improved quality of life. Pacing much of that innovation are specialty medications, which are high-cost, complex therapies approved to treat a growing array of chronic conditions, rare diseases, and life-threatening illnesses. This includes cancer; HIV/AIDS; hepatitis C virus; rheumatoid arthritis and other immunology conditions; respiratory illnesses; multiple sclerosis; cystic fibrosis; hemophilia; and more.

What makes specialty medications so special? Such therapies typically have complicated dosing and administration requirements (often requiring self-administration of an injectable therapy at home or regular infusions in a clinical setting). They may engender unpleasant or debilitating side effects, and they often have premium prices that result in high out-of-pocket (OOP) costs for patients. Meanwhile, many require biomarker profiling or other types of genetic testing prior to initiation, along with ongoing lab testing over time.

Meanwhile, most specialty therapies must clear strict prior authorization (PA) requirements prior to prescribing. And many of these high-value drugs are temperature-sensitive, so they typically require complex cold-chain requirements and sophisticated chain-of-custody processes to ensure their stability throughout all stages of storage, distribution, and dispensing. With all of these factors at work, an array of wraparound services for both healthcare providers (HCPs) and patients is critical to ensure the most successful use of these therapies.

Commercialization efforts for all specialty therapies focus on three primary objectives: to ensure swift access to the drug for patients, to minimize OOP expenses, and to promote sustained adherence to therapy. The goal for today’s specialty pharmacies is to anticipate and then address all of the needs that individual HCPs and patients may have.

Specialty pharmacies play a direct role in helping HCPs and patients to manage many barriers that can undermine these critical objectives. They will also use data analytics to tailor the support as much as possible for both stakeholder groups while enabling ongoing improvement of the program offerings over time.

A growing share of the drug pipeline

Steady growth in the number and volume of specialty medications in recent years has drastically changed the healthcare and pharma/life sciences landscape. In 2023, 55 novel drugs received FDA approval¹—with 80% of those the specialty variety. Meanwhile, the pace continues; as of late August 2024, FDA has already approved 29 novel drugs.

Over the past decade, the specialty drug portion of total prescription dispensing in the US (by revenue) has also grown significantly—from 24% in 2013 to nearly 40% in 2023, according to a recent analysis by the Drug Channels Institute (DCI).² In 2023, US Rx dispensing revenues from specialty pharmaceuticals reached $243 billion, DCI finds.

The institute also notes that the largest six specialty pharmacies in the US (based on 2023 prescription revenues) are:

• CVS Specialty (owned by CVS Health): $73.3 billion
• Accredo/Freedom Fertility (owned by Cigna/Evernorth/ExpressScripts): $59.5 billion
• Optum Specialty Pharmacy (owned by United Health Group): $32.3 billion
• AllianceRx /Walgreens Pharmacy (owned by Walgreens/Boots Alliance):$8.4 billion
• CenterWell Specialty Pharmacy (owned by Humana): $6.2 billion
• Onco360 Oncology Pharmacy/CareMed Specialty Pharmacy (owned by BrightSpring Health Services): $4.6 billion

“One of the most important attributes for a brand team to consider is whether the potential specialty pharmacy partner has the experience and expertise that is needed to reach the target patient population, and whether they have the desired payer contracts in place to ensure the broadest possible market access at launch,” says Dave MacLeod, managing director, consulting, Syneos Health. The types of enhanced services offered by today’s specialty pharmacies—beyond traditional pick-pack-and-ship capabilities—are discussed ahead.

Addressing HCP needs to streamline patient access to therapy

With the rapid pace of innovation in specialty medications and their inherent complexity, physicians face challenges staying up to date on the latest approved options and associated evidence and guidelines. “The types of logistical and administrative barriers physicians face when considering prescribing a specialty drug are very real and brand teams need to think about all aspects of that,” says Lindsay Reel, PharmD, vice president, pharmacy practice and specialty solutions, EVERSANA.

Tailored educational outreach and training goes beyond just sharing clinical evidence related to safety and efficacy and comparative effectiveness. It also involves helping prescribers to understand the critical role that biomarkers and other types of genetic testing may play to inform proper diagnosis.

Managing the PA process is always arduous and creates delays (and frustration) for HCPs and patients, especially when a denial requires an appeals process.

“Many prescribers give up after a PA is denied because they do not have the time and resources to spend appealing the decision,” adds Reel. “When the specialty pharmacy designs a system to automate and streamline the PA process and provides trained clinicians to guide the HCP through the appeals process, the physician is more likely to prescribe the therapy.”

Creating a support ecosystem that enables different types of automated and personal communication options is critical to maximize HCP engagement, notes Meghan Pasicznyk, vice president, product, Accredo by Evernorth. Such options include a centralized message center that coordinates outgoing notifications, announcements, and pending actions (such as PA status), two-way chat that allows registered HCPs to contact clinical representatives when necessary, and e-prescribing/renewable capabilities that function seamlessly with multiple electronic health record systems.

Addressing issues patients face to ensure affordability and adherence

Given the niche treatment that specialty therapies provide, patients are often left to combat high OOP payments that go beyond their deductibles. Those costs can sometimes be in the hundreds of thousands or even millions. Many specialty pharmacies provide "patient advocates" to help individuals navigate their own insurance coverage and explore other options that may be available for financial support.

“The ability to centralize access to the various copay and charitable foundation options for patients, while providing clinical specialists who may be able to help the physician to find an alternative therapy option, is an essential value-added aspect of any specialty pharmacy offering,” says Renee St. Jean, senior director of pharmacy services, Innomar Strategies (part of Cencora, formerly AmerisourceBergen). “It takes a lot of hand holding to plot the next steps to ensure that patients are able to receive the specialty medications that are prescribed for them.”

And such effort pays dividends. Consider, for instance, that in 2023, Accredo helped to coordinate $3 billion in copay assistance on behalf of its enrolled patients, according to Pasicznyk.

As for adherence challenges, the stakes are higher than ever when it comes to treatments for rare, chronic, and often life-threatening conditions. “The goal is to meet patients where they are, and provide personalized support to help them get on and stay on their prescribed therapy regimens,” adds MacLeod.

This includes helping patients and their caregivers to understand the disease; how the therapy works; how it is administered; what potential side effects they may experience and how to manage them; and what is needed to coordinate regular lab testing. St. Jean explains: “When trained personnel—who have deep clinical knowledge about the rare condition and the therapy in question—can be accessed through a centralized platform, it provides invaluable knowledge and reassurance to both patients and HCPs.”

Incorporating real-world evidence can also benefit specialty pharmacies. Gathering and analyzing such data helps identify patterns of non-adherence. This enables potential delivery of personalized interventions, such as, for example, condition-specific outreach by a clinical coach, notes Pasicznyk. She adds that in a recent pilot program to test such interventions related to chronic inflammatory conditions, “patients receiving at least one targeted outreach had up to 9% higher adherence rates.”³

Despite ongoing advances in automation and digital efficiency, individual patients will need to speak with a person (i.e., nurse, pharmacist, benefits specialist) at certain points in their journey. “It’s about leveraging all of your data-driven insights and then deciding where to leverage technology versus the human touch,” says MacLeod. “This is something that the best specialty pharmacies are doing very well—truly understanding individual behaviors and preferences down to the patient level and then meeting them where they are.”

Hallmarks of a world-class specialty pharmacy offering

Specialty pharmacies play an integral role in bridging the gap between clinical trial data and real-world practice. To that end, data analytics is a differentiator. “By collecting longitudinal information on medication adherence, disease progression, side effects, clinical outcomes, and quality of life, the specialty pharmacy can help the brand team to assess the real-world effectiveness, value, and impact of their therapies over time and evaluate the effectiveness of the program offerings,” says Reel.

According to MacLeod, the best specialty pharmacies are those that build out their data-analytics capabilities to address three key objectives:

1. Tracking operational efficiency: This includes specific metrics that track the time required for each service that is provided.
2. Monitoring the health of the business: This includes tracking start/conversion rates, days to first fill, days on therapy, refill rates, etc.
3. Optimizing the experience for stakeholders: For medications that must go through several steps (and, hence, delays between prescribing and initiation on therapy), the specialty pharmacy should not only track each step of the process but should create protocols to communicate clearly along the way.

“Increasingly, specialty pharmacies are using their own integrated data to predict patients who face a greater risk of non-adherence so that brand team resources can then be focused in the most efficient way to help patients overcome the barriers they face,” adds St. Jean.

Advanced data analytics can help to segment patients according to specific attributes of their patient experience, for instance, recognizing those who are experiencing cost challenges versus those who are experiencing side effects or struggling with other social determinants of health. “This helps the specialty pharmacy to direct targeted messaging or support options that resonate much more directly,” says MacLeod. "Such targeted outreach helps to improve outcomes and reduce frustration for patients."

Patient engagement and support efforts aside, having strong cold-chain capabilities in place during product transport, is, of course, paramount in the handoff to pharmacies. In managing temperature-sensitive specialty therapies, the need to ensure failsafe door-to-door distribution is a top priority. “It’s important to choose a specialty pharmacy partner with extensive cold chain infrastructure and expertise,” says Reel. She adds that brand teams should verify that the pharmacies and distribution facilities they are partnering with have an up-to-date and comprehensive business continuity planthat will prevent any drug loss or delays.

“Sophisticated processes are needed to safeguard today’s high-value, temperature-sensitive therapies so they can remain stable and not jeopardize the potency and purity of the therapy throughout all stages of storage, distribution, and delivery,” says St. Jean. “Specialty pharmacies that developed a robust infrastructure during the height of the COVID-19 pandemic will benefit as a higher volume of specialty therapies continues to come to market.”

According to MacLeod, delivering specialty products to HCPs on a "near-real-time basis" helps to reduce risk for HCPs, who often don't have the infrastructure in place to guarantee maintaining the exact temperature specifications for storing high-value, fragile immunotherapies and cell and gene therapies onsite.

As for Accredo, the pharmacy believes in widespread testing of the temperature-sensitive products it handles, with SOPs to accommodate specific therapies.

“To support the unique requirements of specific ultra-low-temperature products, we customize our clinical and fulfillment models and establish drug-specific processes,” says Pasicznyk. “As part of our implementation process for new therapies, we also conduct extensive testing of ultra-cold-chain products. Test shipments are sent to multiple locations so that temperatures can be monitored, and appropriate packaging and overall product integrity can be validated.”

For specialty pharmacies and their distribution partners, the goal is to anticipate and address every issue that may arise for HCPs and patients—and then make the experience for both as seamless and as transparent as possible.

References

1. Advancing Health Through Innovation: New Drug Therapy Approvals 2023. FDA’s Center for Drug Evaluation and Research. https://www.fda.gov/media/175253/download?attachment

2. The Top 15 Specialty Pharmacies of 2023: Market Shares and Revenues at the Biggest PBMs, Health Plans, and Independents. Drug Channels Institute. April 16, 2024. https://www.drugchannels.net/2024/04/the-top-15-specialty-pharmacies-of-2023.html

3. How to Improve Specialty Drug Adherence for Patients with Inflammatory Conditions. Evernorth Health Services. November 3, 2023. https://www.evernorth.com/articles/improving-medication-adherence-inflammatory-conditions