Q&A with Tina Fresta, Strategic Solutions Senior Manager at epocrates

Specialty-based drugs are dominating today’s pharmaceutical market—a statement healthcare leaders can all agree on. In the Q&A below, Tina Fresta, BA, MPH, Strategic Solutions Senior Manager at epocrates details how advancements in important therapeutic areas are continuing to drive the ongoing development of specialty drugs, while touching on how innovative platforms and technologies are being utilized in this evolution. Tina also details implications of the specialty landscape, including the increased number of specialty doctors, and how primary care physicians are adapting and becoming more knowledgeable about specialty drugs.

PharmExec: Can you set the stage on pharma’s trend towards specialty-based drugs? What has the evolution looked like over time?

Specialty-based drugs are consuming today’s pharmaceutical market. There are no ifs, ands, or buts about it, and while the exact definition of a specialty medication varies, industry experts agree they’re taking over the pharmaceutical market. These high-value drugs make up most novel FDA drug approvals and are often used to treat rare or complex conditions. In fact, according to a recent IQVIA report, these drugs comprise more than half of manufacturer revenue today with spending nearly doubled in the last decade.

With their high price tag, however, comes their ability to address specific and unmet needs in healthcare – a critical payoff. The evolution towards these drugs is far from over and in the next few years, leaders can expect continued medical breakthroughs in specialty-based therapeutic areas harnessing developing technology.

PharmExec: What are the key therapeutic areas to keep an eye on for the ongoing development of specialty drugs? Why these areas specifically?

There are a number of key specialty-based therapeutic areas to keep an eye on that could be revenue drivers in the next year, including: 

• Oncology is a quickly growing area, with immunotherapies showing great success in recent years. As experts are able to identify more genetic markers and create more personalized pharmaceutical treatments based on an individual patient’s genes, there will be more options available in previously untreated conditions.
• Immunology is another highly innovative area, with immunology specialty drugs continuing to take up market share, such as the success seen with Dupixent and its multiple indications. The recent patent expiration for Humira has also created market opportunity for a multitude of competitors as well as biosimilars.

• Neurology has seen great success with recent Alzheimer’s advancements. The approval of drugs such as Leqembi is expected to be followed with additional competitive entrants for a disease with currently limited treatment options. There are also multiple anticipated approvals next year in the multiple sclerosis space, a disease area in which the majority of patients experience relapses and can benefit from switching treatments. 
• Obesity has seen a huge increase in interest with the success of the Ozempic brand and recent market entrant Mounjaro. While these drugs are indicated for diabetes, their obesity counterparts (Wegovy and Zepbound, respectively) are expected to see continued uptake and increased prescriptions through 2024. The increased interest is driven partially by patient demand, in addition to disease prevalence and/or physician recommendation. 

PharmExec: Can you speak on the role of technology and innovative platforms in the specialty care arena?

As technology continues to evolve, it’s only natural the evolution will continue to make waves in healthcare. Which is why the shift to these specialty-based drugs didn’t come as a surprise to healthcare leaders. In fact, at epocrates, we’ve been seeing data that healthcare professionals are seeking increased knowledge on these drugs within the platform over the past several years as a result of technology and innovation. Specifically, technology including: 

• CRISPR, which has become a buzzword in the growing pharma world, with an emphasis on diseases with limited or no treatment options. There is a special focus on ongoing research in rare disease areas with the world’s first CRISPR therapy approved for the treatment of sickle cell disease in the UK in November (FDA review of this same drug for use in the US is expected by end of year).
• RNA based research has seen a heightened uptake thanks to the success of the mRNA COVID-19 vaccines Comirnaty (Pfizer/BioNTech) and SpikeVax (Moderna). There is now proven value in a vaccine technology, and the FDA approval indicates that new drugs utilizing RNA will have an established safety profile to build on. Additional therapeutics and vaccines are currently in development, including for RSV.
• Cell and gene therapy is an area with high investment and interest, especially in the oncology field with several already-approved CAR-T drugs available. CRISPR (mentioned above) is a type of gene therapy that can target more complex, rare diseases that currently have little to no treatment options. Continued advances in personalized medicine will continue to provide options to patients in need.

PharmExec: How has the increased focus on specialty drugs impacted primary care? Specifically, is specialty care eroding primary care?

The short answer is no. While there is a key focus on specialty care, primary care providers (PCPs) are not going anywhere. The increase in specialty drug development will in turn see a corresponding increase in PCP reliance. Essentially, PCPs are the gatekeepers for specialty care.

Think back to the last time you needed to see a specialty care provider: you first had to see your PCP, explain your symptoms, and eventually, get a referral. For most health plans today, you still need that initial primary visit to confirm a diagnosis and provide a referral. In the same vein, after the diagnosis and treatment, many chronic care patients are sent back to the PCP for ongoing care and monitoring. A great example is a patient with diabetes, who after being provided with a care plan are back with their PCPs for ongoing care.

PharmExec: As we move into 2024, what innovation can we anticipate to support the creation of specialty drugs and what will the ongoing impact on primary care physicians be? 

The role of the primary care physician is constantly evolving as these physicians are becoming increasingly familiar with specialty drugs. epocrates has seen through its own data that PCP viewership of drugs in a specialty-drug-dominated class is growing. The data shows PCPs are largely looking up information on these drugs for maintenance. As we chatted about, patients often have their long-term prescriptions and renewals managed by PCPs. As pharmaceutical developments continue to trend towards specialty care, primary care providers will see their role in medicine continue to expand as they will play a key role in treating—and prescribing—these increasingly focused specialty pharmaceuticals.

PharmExec: What advice would you give to healthcare leaders when it comes to tracking these trends and understanding the industry impact?

The trend of specialty drugs and care is not going away anytime soon – in fact, as we talked about, it’s going to surge. Pharmaceutical companies are continuing to invest at the early R&D levels to drive innovation and research in increasingly specialized medicines, advancements which we will see develop over the next decade. The recent innovations and technologies discussed above, and the FDA approvals seen in recent years, have paved the way for pharma to be able to focus on these new specialized therapeutic advancements. Further, an increase in competition reflects the demand to address unmet needs in the pharmaceutical market and continued rapid growth in these areas is to be expected in the coming years. For healthcare leaders, understanding these trends is critical in knowing how to best support physicians—and patients—as the evolution continues. Data is the most important asset we have when it comes to understanding the current landscape on a macro level, and individual physician trends on a micro level.