Dan Steiber, RPh Specialty Pharmacy Times Editor-in-Chief

The National Association of Specialty Pharmacy (NASP) hosted its seventh annual meeting in Washington, DC, from September 9-12. NASP maintains a strong focus on policies affecting the national, legislative, and regulatory landscape of specialty pharmacy year round. Subsequently, the annual event has become vital for stakeholders if they want to stay abreast of rapid developments in the field. As always, the meeting was highly instructive for attendees and offered numerous opportunities to interact with peers and leaders in the profession.

NASP originated from the exponential growth of specialty pharmacy with a mission to elevate the profession by developing and promoting continuing education and the certification of specialty pharmacists while advocating for public policies that ensure patients have access to specialty medications and critical services. Uniquely, NASP is the only national association representing all stakeholders in the specialty pharmacy space.

In addition to NASP officers and board members, the audience included senior executives, pharmacy directors, pharmacists, consultants, and other management-level personnel from specialty pharmacy providers. Attendees also included pharma and biotech manufacturers, managed care organizations, group purchasing organizations, distributors, and suppliers. Given the magnitude and growth of specialty infusion and the nuances in the laws affecting specialty, there were 2 special sessions on this area.

The NASP meeting has become the second largest annual event in the specialty space. Although the meeting heavily focuses on education, networking opportunities are abundant. The exhibit hall was packed with participants walking the floor and meeting with various service providers to gain a face-to-face perspective.

Two awards were given at this year’s event: the Distinguished Service Award and the Specialty Pharmacy of the Year Award. The Distinguished Service Award is given to the individual who has made a sustained contribution to leadership within NASP. To be eligible, a candidate must be nominated by an active NASP member with a statement about why the individual merits the award, their contributions to both NASP and the specialty pharmacy industry as a whole. This year’s award was given to Tim Safley, clinical manager at the Accreditation Commission for Health Care, Inc. Safley distinguished himself with his exceptional and sustained leadership within the specialty pharmacy industry and NASP.

Selection criteria for the Specialty Pharmacy of the Year Award comprise community involvement, patient satisfaction, cost management, quality and performance improvement initiatives, and innovation in the field, including patient care, outcomes, disease state and therapy management, and patient engagement. This year’s award went to Fairview Specialty Pharmacy.

The meeting kicked off with introductions from NASP President Carmine DeNardo, RPh, and Executive Director Sheila Arquette, RPh. Next to take the podium was Boomer Esiason, former NFL star and current media personality who cofounded The Boomer Esiason Foundation after his son Gunnar received a diagnosis of cystic fibrosis (CF). The foundation funds research to find a cure for CF and provides scholarships, transplant grants, hospital grants, and education and awareness to help provide a higher quality of life for patients with CF. Esiason discussed his family’s personal journey and experiences prior to taking questions from the audience and spending time in the exhibit hall taking photos.

The second day featured Andy Slavitt, former acting administrator for the Centers for Medicare and Medicaid Services (CMS). In that role, Slavitt oversaw Medicaid, Medicare, the Children’s Health Insurance Program, and the Health Insurance Marketplace programs. His tenure at CMS was marked by the successful execution of several large new programs, including the shift to value-based payment models and implementation of the bipartisan Medicare Access and CHIP Reauthorization Act of 2015 and the Affordable Care Act. Slavitt discussed the prospects of health care and its potential impact on specialty.

This year, 44 abstracts were submitted and reviewed by volunteers from the NASP Educational Committee for presentation. During the meeting, judges recognized the top posters most relevant to specialty pharmacy. In addition, the attendees iden- tified the poster most relevant to specialty pharmacy. These were the winners:

1. Delivery of Specialty Pharmacy Products or Services

Understanding Purchasing Patternsand Product Access of Newly Launched Specialty Generics

Appropriate Prescribing of Antiemetics With Oral Oncolytic Therapy a Single Center Experience

Development of a Collaborative Pharmacy Practice Agreement to Improve Efficiency and Management of Prescribing in a Renal Transplant Clinic

Integrating High-Touch Specialty Pharmacy Services Within a Neurology Clinic to Improve Medication Access and Affordability

NASP’s focus on education really shined this year, and many unique and relevant programs were offered to standing room— only crowds in many cases. Sessions included state-of-care seminars for several disease states, an examination of the effect reimbursement has on patient care, insight on the Trump administration’s Blueprint to Lower Drug Prices in Medicare, and challenges and opportunities for employers in managing specialty drugs.

The robust lineup will only improve as we move forward, so make sure you visit naspmeeting.com to reserve your spot for next year’s NASP Annual Meeting, again to be held in Washington, DC.

Articles

NASP maintains a strong focus on policies affecting the national, legislative, and regulatory landscape of specialty pharmacy year round.

NASP Meeting Shines Light on Challenges, Opportunities in Specialty Pharmacy

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.

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.

Market Access in Oncology: Shooting for the Moon

If you are in the specialty pharmacy space, there are 2 major annual can’t miss-events: the Asembia Specialty Pharmacy Summit and the National Association of Specialty Pharmacy (NASP) Annual Meeting and Educational Conference. These meetings are strategically spaced out, occurring every May and September, respectively. The Asembia—formerly known as Armada&mdash;summit, has become the largest meeting in our space, and it was perfectly situated at the Wynn and Encore hotels in Las Vegas from April 30 to May 3 this year.

The planning group made sure that there were plenty of places to meet, while dozens more meetings were held in private suites throughout the facilities. There were more than 5000 attendees, with just the right mix of business, education, and social/networking functions, in addition to nearly 100 educational seminars spaced over the 4-day event.

It seems like the summit’s attendance increases every year. It has now stretched across the investor community, technology, distributors, and anything and everything that touches the specialty channel.

Despite some of the hot issues that come with an emerging industry—such as direct and indirect remuneration (DIR) fees and limited distribution products&mdash;all sides came together in the spirit of our beloved profession. The summit’s exhibit floor has grown immensely, becoming the focal point for many interactions among specialty pharmacies, pharma, 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 event.

Three speakers&shy;&shy;—Adam Fein, PhD, of Pembroke Consulting, Inc; Doug Long, of Quintiles IMS; and Eric Percher, of Barclays&shy;&mdash;kicked off the event and outlined several emerging trends for specialty. In a follow-up post on his Drug Channels blog [drugchannels.net/2017/05/the-state-of-specialty-pharmacy-2017.html], Dr Fein noted several themes that were at the forefront of the summit, including

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

• Manufacturer specialty networks are becoming larger and more inclusive.

• The continued migration of channel control from manufacturers to PBMs and payers.

• Consolidation of specialty pharmacies due to evolving economics.

• The emergence of more organized channels as a result of new ownership and partnerships.

If you are in pharmacy, specialty or otherwise, DIR fees are a growing issue that represents a significant concern among stakeholders. DIR fees have hit specialty even harder due to the high cost of product, combined with highly competitive reimbursement rates to gain network access to payers. There were many presenters who discussed the topic, while the exhibit hall this year featured a half-dozen legal firms, all of whom were eager to support clients in their quest to reduce or eliminate DIR fees.

Specialty Pharmacy Patient Choice Awards 

Keeping the patient in mind, this year marked the first annual Specialty Pharmacy Patient Choice Award™ ceremony, held in a first-class setting thanks to the MJH Live Events team. Zitter Health Insights (ZHI) conducted the survey, while the 

 team assisted with the event. The ZHI survey was designed to identify and recognize the top-performing specialty pharmacies for their achievements in customer satisfaction. It was a good first start and will continue to improve over time.

With the slow-to-improve lack of consumer and media understanding of the great work that specialty pharmacies perform, it was time for specialty pharmacies to leverage information that highlights their services to patients, raising the bar even higher in the industry. The award is about recognizing the patient’s choice, first and foremost, with a focus on excellence. The awards were judged in 2 categories, PBM/Payer Specialty Pharmacy and Non-PBM/Payer Specialty Pharmacy, with US Specialty Care and PANTHERx Specialty Pharmacy, respectively, receiving top honors.  

We will be out again in full force at the NASP annual meeting this fall in Washington, DC, September 18 to 20. The 5th Annual NASP Meeting will provide comprehensive information regarding all aspects of specialty pharmacy, including the evolution of the market, impact of specialty pharmacy on patients, and national legislative and regulatory policy.

The meeting will also offer a Specialty Pharmacy Law Conference, continuing education credits to attendees, and a 1-day preparation course for pharmacists studying for October examinations given by the Specialty Pharmacy Certification Board for Certified Specialty Pharmacist certification.&ensp;

For more information, visit naspmeeting.com/general-information.

The first of 2 showcase events in the specialty space brings thousands of stakeholders from pharmacies, manufacturers, and service providers.