Over 6,000 attendees are gathered this week in Las Vegas for Asembia 2022, a specialty pharmacy summit. We attended Tuesday’s keynote and industry outlook sessions, which took a hard look at specialty pharmacies and pharmaceuticals. More specifically, presenters examined what those numbers mean for the future of the industry and, most importantly, patient access to specialty medications.
Monday’s recap, “Legislation and Innovation for Specialty Pharmacy,” examined legislation that will affect specialty pharmacists and the impact digital and pipeline therapies will have in the coming year.
Session: "Keynote Session from Scott Gottlieb"
Presenter(s): Dr. Scott Gottlieb, former FDA commissioner; Adam Fein, CEO, Drug Channels Institute
Summary: What was discussed
The second day of Asembia kicked off with an extended keynote session and industry outlook, hosted by Adam Fein, CEO of Drug Channels Institute. Fein first interviewed former FDA Commissioner Scott Gottlieb about the state of the healthcare industry, especially as it relates to specialty pharmacy.
Gottlieb began by addressing the COVID-19 pandemic, noting the current small wave of the Omicron B2 variant. He said if COVID-19 mutations continue within the Omicron lineage, or forms of the Omicron variant of the virus, he expects an Omicron-specific vaccine in the fall. The virus will shift from pandemic status to endemic status, he said, when there are no longer continuous waves of infection. Ultimately, he expects COVID-19 to eventually be a winter pathogen, following the pattern of the seasonal flu.
The pair then switched to discuss the new trend of accelerated drug approvals by the FDA, using the controversial Alzheimer’s drug, Aduhelm, as an example. Gottlieb said the FDA’s approval of the drug was consistent with their guidance at the time. That guidance said an acceptable measure of the drug’s efficacy could be found by measuring plaque formation in the brain — rather than a cognitive patient test. Gottlieb pointed out the double-edged sword of drug accelerated approval pathways.
“We’re in an era now where the biology of how these drugs are developed is so well understood that we have clear markers for selecting patient populations who will benefit,” he said, noting this is where there’s been an increase in pipeline drugs coming through accelerated pathways.
However, while this means many drugs are proving efficacy early in clinical trials, there could be drawbacks. Regulatory and payer bodies may be hesitant to provide coverage and approval pathways for drugs that don’t have full, traditional outcomes results. Because of this, Gottlieb said, many large manufacturers may opt out of accelerated approval pathways. Instead, they may opt to go the longer route leading to full approval and a greater likelihood for reimbursement and formulary acceptance.
Gottlieb also noted the accelerated approval debate can at times become a proxy debate for drug pricing reform and noted a lack of understanding in some areas between list and net prices.
Key Takeaway: What's most important
When Fein asked for final thoughts, Gottlieb ended on a note of hope, saying, “We’re at an inflection point in science and medicine.” Especially, he said, regarding advances in cell and gene therapy. While innovation may be ahead of regulation and reimbursement, the potential impact of specialty pharmacy and pharmaceuticals is huge, particularly while eyes are on public health in unprecedented ways.
The kind of innovation that's going on right now is so profoundly different than what was going on 20 years ago. I think the biggest opportunities are going to be with cell and gene therapy. ... You're going to start to see cell and gene therapy used to attack a much larger subset of diseases.Scott Gottliebformer FDA commissioner
Industry call to action
Reimbursements and regulations must keep pace with the speed of advancement in specialty pharmacy. To do so, effective data sharing, including clinical data sets and patient data, will be critical. The industry is slowly evolving, and keeping patients at the center of decision-making, both within healthcare and in policymaking boardrooms and floors, will be important to reinforce.
Session: "The Specialty Pharmacy Industry Update & Outlook"
Adam Fein, CEO, Drug Channels Institute; Doug Long, VP, industry relations, IQVIA
Summary: What was discussed
During their session, Fein and Long explained the key trends reshaping specialty drug channels.
Fein noted the huge growth in specialty pharmacies, which grew 315% — from 378 in 2015 to 1,570 in 2021 — in six years. The fastest-growing category of specialty pharmacies are those owned by hospitals and health systems, which now account for a third of all specialty pharmacies. When it comes to dispensing and revenues, specialty pharmacies owned by pharmacy benefit managers (PBMs) represent over three-fourths of the total market.
Fein said emerging profit drivers for specialty pharmacies include:
- Copay maximizers
- Non-biologic specialty generic drugs
- White bagging
- Pharmacy benefit biosimilars
Fein also noted how one trend leads to another. In this case, the vertical integration of payers, pharmacies, health systems and provider practices is leading to hospitals driving volume through their own in-house specialty pharmacy.
Long’s overview focused more on the specialty drug market, which now account for 55% of the share of net spending in the market. Long also noted the upcoming growth of biosimilars over the next year. This continues the growth trend of immunology specialty drugs, which have seen the largest five-year growth of all specialty drug classes.
We've reached a fertile ground with biosimilars, and the future is bright as we expect $100 billion in potential savings in the next five years.Doug LongVP of Industry Relations, IQVIA
With these launches come some challenges for patients in accessing and affording medications. Long noted that in 2021, only 1 in 4 new-to-brand patients who tried to fill a launched brand were successful due to payer controls. Additionally, as many as 70% of patients on newly launched brands are on a patient assistance program through a biopharma company, he said.
Key takeaways: What’s most important
According to Fein, the increase in vertically integrated organizations and specialty drug use will lead to a battle for control of specialty patient. It'll be tough for organizations who aren’t part of a vertical integration to get access to the market. These vertically aligned channels are also creating new market access risks for products, companies and pharmacies, Fein said. On the drug revenue side, Long noted that by 2026, oncology and immunology net spending growth will slow due to biosimilars in the market.
Industry call to action
Transparency and education, for patients, providers and care teams, will be critical as specialty pharmacy systems continue to evolve. As payers, pharmacies and health systems continue to consolidate, it'll be critical to integrate workflows and systems, rather than create one-off or point solutions. That way, all stakeholders can have a consistent view of the pharmaceutical and patient journey and understand who's responsible for what costs.
ICYMI: Monday’s Asembia recap, “Legislation and Innovation for Specialty Pharmacy,” examined legislation that will affect specialty pharmacists and the impact digital and pipeline therapies will have in 2022.
Session: "Pharmacy Leadership Panel"
Presenters: Rina Shah, Group VP, Pharmacy Operations & Services, Walgreens; Natalie Bedford, SVP, Specialty Pharmacy, Humana; Lucille Accetta, SVP, Pharmacy Benefit Management and Specialty Product Development, CVS Health; Michael Einodshofer, Chief Pharmacy Officer, SVP, Optum; Bruce Japsen, senior contributor, healthcare, Forbes
Summary: What was discussed
Bruce Jaspen, Forbes healthcare contributor, led a panel of PBM and pharmacy leaders on specialty medication costs, disruption in the industry and addressing health inequities.
Jaspen first asked the panel what their company is doing to help patients and plan sponsors manage the costs of specialty medications. Panelists were in consensus that reducing waste in prescribing, access and adherence processes was critical to keeping costs down for all involved. This includes making sure the patient is on the right drug to begin with and at the right time in their healthcare journey. Lucille Accetta noted that at CVS Health, this includes capturing a holistic view of patients and helping them manage side effects, comorbidities or mental health conditions that could impact patient adherence. She noted that a lack of adherence could increase costs to the entire system over time, as these patients can become sicker and require more costly care.
As for where change or disruption will come from for the specialty healthcare industry, panelists had their thoughts. They noted trends in biosimilar competition, value-based compensation considerations and leveraging the strengths of multivariate healthcare partners to get ahead of medicines of the future. Rina Shah emphasized that the future will be about data and technology and implementing both effectively to understand patients and their habits better.
“It's not only on the pharmacy side but also consumer behavior,” Shah said. “Decisions patients make dictate what the next five to 10 years look like.”
Several panelists adjacently mentioned health inequities and capturing the holistic view of the patient in answering other questions. So, Jaspen drew attention to the topic by asking panelists what their companies are doing to address social determinants of health. Answers included efforts such as partnering with community organizations to address underserved populations, locating pharmacists centrally to areas without ready access to healthcare and screenings to better understand patient populations.
Key takeaway: What's most important
Data is important to driving decisions around formulary inclusions, benefit design and the creation of auxiliary programs to help address multiple subsets of patients. Reducing waste and administrative burden can not only make the medication access process smoother but also reduce costs from the top down, helping more patients afford their medications and stay on them.
Industry call to action
Great opportunity exists for healthcare with integration of primary care within pharmacies, vertical consolidation of PBMs and health systems and general connectedness to better understand patient populations. The impact could be felt from a public health standpoint of larger trends, down to microcosms of regional-level issues that impact access to care. And what’s more, efforts that help patients find the path of least resistance to accessing and staying on their medications also reduce waste and costs in the system.