Executive Vice President

The annual Asembia Specialty Pharmacy Summit is the largest annual conference in the United States focused on specialty the specialty space. This year, the conference welcomed approximately 6500 attendees, including executives from pharmacies and health systems, pharma and biotech manufacturers, drug wholesal- ers, payers, technology innovators, and other industry stakeholders, filling both the Wynn and Encore hotels in Las Vegas, Nevada.

The growing portfolio of specialty products exceeds a value of $200 billion, and there were more than 1000 organizations representing various interests that support those products in attendance.

As has been our tradition, we are providing you this Asembia summit recap issue designed to provide a snapshot of the event and provide a quick reference until next year’s summit. Attendees this year received the inaugural 

 daily conference newsletters, which helped them stay on top of the events.

The Asembia summit lineup included business workshops, educational seminars,exhibits, and live continuing education (CE) credits, along with numerous networking and social events. There were more than 80 educational seminars over the 4-day event. Discussion topics focused on current and future trends in specialty pharmacy, including the rise of consumerism, emerging alliances, innovative technologies, and patient access solutions. Outside of the summit, there were ongoing private meetings of professionals in the hallway and in “high-roller” suites. It seems every year, this is the place the industry comes to meet, reviewing past and ongoing opportunities, and exploring potential new business and professional relationships.

Each year, the program attendance grows exponentially and now stretches to the investor, technology, distributor communities, as well as other areas that touch the specialty channel. Despite some of the divisive issues that accompany this emerging industry, such as direct and indirect remuneration fees and limited distribution products, all sides continue to collaborate in the spirit of our beloved profession. This year, the exhibit floor reached new heights as the focal point for many interactions between specialty pharmacies, manufacturers, and service providers. It’s been fun to watch this element of Asembia grow from a small handful of booths to a full-blown trade show.

For our early risers, there was a sunrise 5K run/walk on the Las Vegas strip and relaxing yoga sessions. Although the weather this year did not fully cooperate, thousands of hearty and thirsty folks attended the unparalleled Asembia Beach Club Party, protected from the rain and cool temperature under the cover of cabana rooms and walk in bars with heat lamps throughout.

David Gregory, CNN analyst and former moderator of NBC’s Meet the Press, hosted an expert panel following a comprehensive discussion of areas to watch in 2018 and beyond. The panel consisted of industry experts from UCB, OptumRx, CastiaRx, and Asembia, who offered insight into disruptive forces affecting the industry. This year, we were treated to a trio of kickoff speakers featuring Adam Fein, PhD, president of Pembroke Consulting, Inc; Doug Long, vice president of industry relations at IQVIA (formerly QuintilesIMS); and Lisa Gill, managing director of JP Morgan Securities. Just some of the hot topics they covered included:

		The battle among pharmacy benefit managers (PBMs), pharmacies, wholesalers, health plans, and providers for control of the specialty market and the patient journey.

		Manufacturer specialty networks becoming larger and more inclusive.

		The expanding channel control migrating from manufacturers to PBMs and payers.

		Coevolving economics affecting the continued consolidation of specialty pharmacies.

		The emergence of organized channels with new ownership and partnering relationships.

The CE session, “Preventing Crohn’s Disease and Ulcerative Colitis Progression With Biologic Therapies,” was headlined by a great group, including Rolf Benirschke, CEO of Legacy Health Strategies. Football fans will remember Benirschke as a for- mer National Football League placekicker, whose 10-year career was nearly derailed during his third season by a life-threatening battle with ulcerative colitis. Today, he has dedicated his life to supporting patients and is now a respected leader and speaker in the health care industry.

A session updating the specialty pharmacy pipeline featured Ray Tancredi, RPh, MBA, of Walgreens Specialty Pharmacy, who was joined by an expert panel to spotlight emerging specialty therapies on the horizon. I’ve attended this every year, and it’s packed with information and runs at a fast pace. The program identified select specialty drugs in the pipeline and highlighted some areas to watch within the top medication classes, described the trends in orphan drugs that target rare diseases, reviewed the growing focus on specialty and oral drugs, and examined recent specialty product approvals.

The session, “Forging Successful Managed Care Partnerships: Strategies That Positively Affect Patient Care,” explored hurdles to medication access to patients and how specialty pharmacies must develop collaborative relationships with payers. The lineup of leaders on the panel, who come from both the specialty and market access spaces, shared insights from their deep experience. The panel was led by the current National Association of Specialty Pharmacy (NASP) president, Mike Agostino, accompanied by Keith Cook, vice president of specialty operations for MedImpact Direct; Neil Minkoff, MD, chief medical officer and vice president of EmpiraMed, Inc; Jennifer Szumowicz, RPh, director of specialty for CareSource; and Jay Weaver, PharmD, MPH, divisional vice president of enterprise pharmacy for Health Care Service Corporation.

One of the favorite programs I attended was, “Pharma Contracting: 2017 Year in Review and 2018 Forecast,” in which a team of experienced attorneys, Mike Hess, Kirk Hunt, Abby Kaplan, and Dan Tardiff, provided their real-world experience in the increasingly complex arrangements between manufacturers and specialty pharmacies while under the intense scrutiny of regulators. They also reviewed key legal concepts and missteps in specialty pharmacy contracting and how stakeholders can apply the requirements. Attendees gained insights from these specialty pharma legal industry veterans as they recapped everything you need to know about the intricate world of specialty pharma contracting.

ON THE HORIZON: NASP CONFERENCE IN WASHINGTON, DC

In addition to Asembia, there is also the NASP 2018 Annual Meeting and Educational Conference, taking place September 24 to 26, 2018, in Washington, DC. Both feature a 1-stop shop for specialty programs. The sixth annual NASP meeting will provide comprehensive information regarding all aspects of specialty pharmacy, including the evolution of the market, how specialty pharmacies impact patient care, and national legislative and regulatory policy. The meeting will also feature the Specialty Pharmacy Law Conference, which offers CE credits to attendees, and a 1-day preparation course for phar- macists studying for October examinations given by the Specialty Pharmacy Certification Board for Certified Specialty Pharmacist certification. For more information, visit 

NASPMEETING.COM/GENERAL- INFORMATION?LINK=AGENDA#AGENDA

MARK YOUR CALENDAR FOR NEXT YEAR’S SUMMIT 

Asembia just published the dates for next year, so mark it down on your calendar, as the event again will be held at the Wynn and Encore beginning April 29, 2019, through May 2, 2019.

Articles

The annual Asembia Specialty Pharmacy Summit is the largest annual conference in the United States focused on specialty the specialty space.

Key Takeaways from Asembia 2018

® tradition of focusing on oncology in our midyear edition, timed to the American Society of Clinical Oncology (ASCO) conference in Chicago, continues this month. Never has there been a more exciting time in the development of specialty products for the treatment of cancer. Our industry is developing treatments that are eradicating cancers or extending life at higher rates than ever before. These therapies are felt across the spectrum of health care delivery, from the community oncologist to the high-touch Cancer Centers of Excellence.

However, new oncology products typically come at a price and at a time in which the cost of health care is front-page news on a daily basis, the question that remains is whether our system can afford it. We must find solutions to provide quality health care with economics that don’t force individuals to be hit with tremendous premiums or tough choices. The cost of treating cancer is a huge burden on our current economic infrastructure. Market access and health care professionals must work to find the balance to provide solid treatment without burdening the system to a point of collapse, and this balance must recognize that we cannot slow down the advancement of care.

The 21st Century Cures Act was signed into law on December 13, 2016. The legislation provides the National Institutes of Health (NIH) with critical tools and resources to advance biomedical research across the spectrum, from foundational basic studies to advanced clinical trials of promising new therapies. The act allocates a total of $4.8 billion to the NIH over 10 years and authorizes $1.8 billion in funding for cancer. An initial $300 million was appropriated in fiscal year 2017 to fund cancer initiatives. This funding is largely tied to the Cancer Moonshot, a government-sponsored program designed to accelerate oncology research to help make more therapies available to more patients while also improving the ability to prevent cancer and detect it at an early stage. Let’s probe a bit deeper into one of the most challenging areas in the market today, that of reimbursement, by focusing on one of the newest categories of products, chimeric antigen receptor T-cell therapy (CAR T).

CAR T products were approved for commercial use only recently. This immunotherapy is intended to enable the immune system to detect and destroy cancer cells. The process begins with the removal of T cells from a patient that are then reengineered in a laboratory. In doing so, the T cells are genetically changed so they will destroy the cancer cells once injected back into the patient. Typically, CAR T therapy is injected just once into the patient’s body, where the cells multiply and the efficacy of the treatment increases over time.

In late 2017, the FDA approved 2 new CAR T therapies, with several more currently in development. Kymriah (tisagenlecleucel) is indicated for the treatment of children and adults 25 years and younger with relapsed/refractory B-cell precursor acute lymphoblastic leukemia and is priced at $475,000. Yescarta (axicabtagene ciloleucel) is indicated for adults with relapsed/refractory diffuse large B-cell lymphoma and is priced at $373,000. These products have begun to force a paradigm shift in the way that market access professionals manage their oncology portfolio.

Choices and New Market Access Strategies 

How does the health care system absorb these new high-cost therapies? CAR T therapies present a whole new set of challenges for payers that cross the spectrum of reimbursement. Typically, the patient is treated in an institutional oncology setting where the T cells are removed from the body. After being sent to the manufacturer’s lab and engineered into the final product, the drug is subsequently frozen, shipped back, and finally infused into the patient. There are costs associated with the facility, the medical staff, and the drug. Given that CAR T-cell products are complex compared with community oncology-administered products, manufacturers are seeking creative mechanisms to access the market.

On the CMS front, Novartis, whose CAR T product, Kymriah, was the first to be approved, announced an outcomes-based arrangement designed to create efficiencies in the health care system. According to an agreement between Novartis and CMS for Kymriah, CMS will not pay for patients who fail to respond within the first 28 days of treatment. The nondrug costs are typically tied to a patient’s hospital stay.

Expect that under the current system of CMS reimbursement, these products will be reimbursed at average sales price plus 6%. Manufacturers of these high-cost, onetime therapies must consider creative strategies that often lead to putting “skin in the game,” in which drug coverage is, in part, based on the positive outcome of the patient.

Government-sponsored programs such as CMS place legal restrictions on what a manufacturer may do to gain market access, but the game plan varies with commercial coverage. It is likely that commercial payers will see a combination of value-based pricing/contracting, potentially using similar thresholds as those of the CMS agreement. The commercial payer market is estimated to comprise 50% to 60% of CAR T patients. The CAR T manufacturers’ websites offer patients, payers, and providers a host of assistance programs to help assure that patients who are prescribed the drug are able to access it. These programs offer co-pay assistance and patient assistance programs, including transportation and accommodations for eligible patients and up to 2 caregivers to support compliance with the safety monitoring period.

Treatment Pathways: Oncology’s Tool for Optimal Therapy 

Patient care should always come first in the therapy decision process; however, cost cannot be ignored. Given the complexity of cancer treatment, clinical practice guidelines have been developed to review and construct data to facilitate therapy decisions. Pathways provide guidelines that can standardize oncology care. Although several oncology organizations have developed guidelines, the best-known include the National Comprehensive Cancer Network and ASCO. The process these organizations follow to develop their respective guidelines varies, using a combination of literature review, clinical trial results, and modalities of treatment comprising panels of experts who work in collaboration. Guidelines are continually updated to reflect the evolving landscape and new drug approvals. Stakeholders, including market access decision makers, can access these guidelines through the respective websites.

Clinical oncology pharmacists have become active participants in the process of treating cancer. Given the advancements we have seen, the clinical pharmacist is often working in institutional settings, managed care, specialty pharmacies, and community oncology clinics. They play an instrumental role in determining which therapies a patient receives using the tools described above, as well as in the preparation, administration, and reimbursement of products both infused and oral. The clinical pharmacist has played an evolving role in managed care settings, particularly given the increased importance of oncology, which is the third-highest category of specialty drug spending.

Using traditional utilization management tools, these professionals have expanded their duties to include oversight of a health plan’s coverage of both oral and infusible oncology products. Many of these products are billed under a medical benefit in which, unlike the drug benefit, clinical pharmacists often use manual systems to review oncology spend. To assure appropriate use and coverage, prior authorization is viewed as the most effective method to drive access based on the approved labeling. Treatment pathways also are important tools.

Another common strategy is to use a short-fill or short-cycle dispensing program. In this case, the specialty pharmacy will ship a 1- or 2-week supply of a new medication, communicate with patients about their ability to tolerate the medication, and allow for discontinuation of subsequent refills, as appropriate. The patient is charged a co-pay or coinsurance on the first fill, while subsequent refills adjust for any additional coinsurance, as needed. Industry estimates suggest that a 25% savings in drug cost can be achieved with this type of program.

Specialty pharmacies help control cost with such services as patient support and education to ensure compliance and monitor adverse effects, as well as specialized handling and distribution of medications directly to the patient or care provider. Specialty pharmacy continues to lead the process of patient care and of assuring that value is created and that there is a return in the health care investment dollar. We welcome your feedback on this topic and on any topics you would like us to cover in future editions of 

®ï¡¿. Please reach out to me at dsteiber@pharmacytimes.com. We also encourage you and your colleagues to subscribe to this unique journal by logging on to specialtypharmacytimes.com. &ensp;

Market access and health care professionals must work to find the balance to provide solid treatment for cancer without burdening the system to a point of collapse.