Dan Steiber, RPh, Specialty Pharmacy TimesÂ® Editor-in-Chief

Powerful economic forces continue to drive change in, which is clearly evident when examining the trends affecting hospital and institutional practices. We are seeing rising drug costs across all segments, for inpatient hospital in particular, but those same trends create opportunity on the outpatient side, specifically around oncology. Most hospitals are focusing on specialty pharmacy to improve continuity of care and generate significant new revenue. As mentioned in previous editorials, the number of specialty drugs entering the market is growing, with hundreds more in the pipeline. Although our politicians continue to debate ways to control escalating drug costs, each new product introduction seems to set a new pricing standard for these innovative therapies.

Oncology medical practices continue to evolve, and as a result of the changing dynamics of buy-and-bill drug reimbursement, many oncologists have left traditional community practice and integrated into hospitals or academic centers. Because of this remarkable trend, the importance of hospital specialty pharmacy has grown exponentially. This shift changes the practice of hospital pharmacy as well as the product and patient mix that flows through it. A greater number of patients with cancer are receiving infusions in outpatient facilities associated with the hospital instead of a community oncology practice.

Manufacturers of both oral and infused oncology products should see an increased demand for their products in the outpatient and inpatient hospital settings. The parameters for these companies are changing, as previously limited or closed distribution networks are being forced to be more open, expanding the opportunities for hospital specialty pharmacy. Hospitals that open a specialty pharmacy are challenged by access to these limited-distribution networks. In my experience, limited-distribution products and the ability to participate in these networks have restricted a majority of the fill opportunity.

Given that the distribution channel for most products entering the hospital space is via specialty drug distributors that may limit access to a drug under a contractual agreement with the manufacturer, a hospital pharmacy subsequently needs to approach both the distributor and the manufacturer to obtain access. Certain criteria may have been established by the manufacturer to gain access based on different clinical and reporting requirements; however, infrastructure and reporting capabilities do not always translate to drug access. Clearing all these hurdles takes time, effort, and investment.

Access to infused oncology specialty products tends to be less limited than access to orals. Therefore, a health-system specialty pharmacy should have access to approximately 75% of the necessary infused oncology products available on the market. Expanding a product mix will change financials because specialty drugs currently account for approximately 35% of the total drug spending from less than just 3% of prescription volume dispensed. Over the next several years, about 40% to 50% of the total US drug spend is expected to comprise specialty medications.

Upgrading to Health-System Specialty Pharmacy 

Hospital pharmacy has long been on the leading edge of the profession, and the bar continues to rise for graduates who may want to practice in the hospital setting. To get a clinical position in a hospital, most graduates enter 2-year residency programs after 6 to 8 years of both prepharmacy and pharmacy education. This expanding pool of talent bodes well for the future of hospital specialty pharmacy.

Several factors should come into play as hospitals continue to expand into oncology. The benefits of specialty pharmacy integration stretch beyond finances, with numerous opportunities to take patient care even further. Hospital specialty pharmacy is ideally positioned to expand clinical services with an integrated approach that includes oncology physician practices that interface as a component of an overall accountable care organization. Because a hospital-based specialty pharmacy can collect clinical data from a number of sources to demonstrate outcomes and quality of care, it can more accurately report adverse events, participate in clinical trials, and advance medication adherence, to name just a few benefits.

This unique portfolio of services, data sharing, and care coordination in the oncology space in particular is difficult to duplicate compared with standalone specialty pharmacies. This creates yet another set of circumstances that oncology manufacturers should pay attention to. Pharma needs to establish better channels of communication with hospital specialty pharmacies, especially to educate pharmacists on the attributes of their products and services they may provide. (

 has expanded our reader base to include this important audience.)

Reimbursement and Access to Payer Networks 

By and large, specialty pharmacies have grown as a result of the expertise developed through gaining access to payers and navigating the reimbursement landscape. As hospitals expand their product mix to include specialty products, they must also expand their skill sets to address these complicated areas. The buy-and-bill world of reimbursement and drug benefit programs for outpatient specialty products presents a newer set of needs that require hospital pharmacies to engage new resources for their personnel and internal systems. Manufacturers recognize the importance of providing resources that assist in the reimbursement process, often engaging the services of a hub or offering guidance from field-based reimbursement specialists. Additionally, nearly all specialty products have some form of patient assistance programs available to offset their cost.

Hospital specialty pharmacies are working hard to educate payers on their expanding access to products and services in this shift from community to institutional oncology. This transition requires that pharmacies participate in payer networks and expand their contractual access to be defined as a health-system center of excellence. Although a hospital specialty pharmacy can dispense products to patients with Medicare and Medicaid, the same cannot be said for commercial plans in most cases. This process is rapidly evolving as contracts increasingly shift their focus from the medical benefit to the pharmacy benefit, which is managed by a pharmacy benefit manager.

Additionally, most specialty product revenue from the pharmacy benefit flows through in-house, payer-owned specialty pharmacies. Although this is old news for traditional specialty pharmacies, it is likely a new experience for hospitals. This explains the large growth in specialty accreditations by hospitals, as they recognize that payer access is often gated by having obtained accreditation from 1 or more entities.

Approximately 10% of all specialty prescriptions are dispensed by 340B contract pharmacies, and nearly 50% of hospitals with more than 600 beds operate a specialty pharmacy, which highlights the importance of purchasing specialty drugs through the 340B program.

 This makes complete sense, as hospitals participating in 340B can access discounts on the cost of drug acquisition. These discounts provide significant economic benefits to the health system in reducing the drug spend and improving margins while supporting outreach and care for uninsured and underinsured patients.

The portfolio of specialty products will continue to expand as these products become increasingly complex, as seen with gene therapies, chimeric antigen receptor T-cell products, and customized treatments. Patients can access this level of unprecedented care only through the services of a complex integrated health care setting, most often the hospital—hence the broadening of hospital specialty pharmacy services. What an exciting time for the industry. We recognize this evolution, and as such, 

® is evolving our content to expand our readers’ access to information and education around oncology. We invite you to join us on this journey as the number of innovative oncology products grows.

A specialty pharmacy’s specific expertise and experience in supporting patients with cancer is among its most essential attributes. The very best of these entities combine professionals who have years of experience in oncology with supportive clinical capabilities and great data-driven decision making. The well-trained, compassionate professionals—and not just the products they dispense&mdash;are what truly makes a pharmacy special.

		Top 10 issues facing hospital pharmacy in 2019. Visante website. 

visanteinc.com/top-10-issues-facing-hospital-pharmacy-in-2019/

. Published December 11, 2018. Accessed June 3, 2019.

		Nezneski L, Shain C, Wilson, A. Understanding and navigating specialty and orphan drug challenges in the 340B program. 

Articles

A specialty pharmacyâ€™s specific expertise and experience in supporting patients with cancer is among its most essential attributes.

Importance of Hospital Specialty Pharmacies Grows Amid Shifting Oncology Landscape

The annual Asembia Specialty Pharmacy Summit has become the largest meeting in the specialty space, and this year it exceeded prior numbers in attendance and offerings in programing. Asembia, best known for its annual summit but also for its pharmacy network, hub services and technology solutions, has also established itself as a group purchasing organization (GPO) focused on specialty pharmaceuticals. 

Networking with others in our industry has become the No. 1 activity at the Asembia summit, by far, with seemingly every available space occupied at both the Wynn and Encore hotels. It seems only the casino was spared. There were nearly 100 educational seminars spaced out over the 4-day event. When we started 

® nearly 10 years ago, we foresaw a shift in the focus of research and development efforts from traditional to specialty therapies, so with the pharmaceutical industry indeed headed in this direction, Asembia has become the “must-attend” meeting for pharmacy.

To gauge how strong the attendance was at this year’s event, all you had to do was try navigating the crowd during the summit’s grand reception. A lap around the pool (not in it) created a welcome opportunity to visit many new and friends. Not only has the event grown around programming, but it has further expanded to include much of the investor community, technology, distributors, and anything and everything that touches the specialty channel. And those are just the attendees who were visible at the event. Every suite was occupied with private meetings. Taking the elevator up to a meeting suite at the Wynn often drew a line with all the activity. What is great is that all sides came together in the spirit of our beloved profession.

The exhibit hall was sold out again, and it sure has come a long way in just a short time, from table tops to monster displays. The floor is a focal point for many interactions between specialty pharmacy stakeholders, the pharma industry, and service providers. It’s been fun to watch this element of Asembia grow from a handful of booths to a full-blown trade show event. Thank you to those who came by the 

® booth to introduce themselves and share your insights. It was the highlight of the meeting for me and our staff.

The crescendo of the Asembia conference was the general session. Even with seating for more than 2000 people, if you were not there 15 minutes before it started, then you were left with standing room only. I got there 30 minutes early to secure a good spot in the front. The Wednesday kickoff speakers (Adam Fein, PhD, chief executive officer of the Drug Channels Institute; Lisa Gill, managing director of J.P. Morgan Securities; and Doug Long, vice president of industry relations at IQVIA) outlined several emerging trends for specialty pharmacy:

		Specialty drugs are the focus of the pharmacy and pharmacy benefit manager (PBM) industries, although the growth of total prescription revenue is slowing down.

		Bigger independent specialty pharmacies are growing at a faster pace than the overall specialty market.

		Small independent pharmacies are getting squeezed by the competition and may be looking to sell.

		Competition is increasing among hospitals, health systems, and PBMs over the specialty market, which has caused these players to look for partnership opportunities.

On this fourth trend, the fastest-growing and most progressive facet of specialty pharmacy has been the emergence of hospitals and health systems. The health-system specialty pharmacy continues to be the most significant segment of the industry. Given that hospitals are where our sicker patients end up, this integrated, collaborative clinical environment is at the forefront of growth. There are a few key drivers, such as 340B pricing or the tremendous shift we have seen during the past few years of community-based physician practices being absorbed by health systems. These large institutions have made significant investments in training, data systems, and payer access. Payers have recognized their value as they have a better view of the overall continuum of care, from inpatient through outpatient into the community.

Many of these hospital networks have combined resources through their collaboration with their GPO and formed key alliances. Manufacturers are seeing the value these large entities can bring to their products, particularly in the infusion space. Keep an eye on 

 as we refocus our content in the coming months on the emergence of specialty products in this space.

After the kickoff speakers came Scott Gottlieb, MD, former FDA commissioner who is also a physician and investor. He is presently a resident fellow at the American Enterprise Institute, the conservative think tank, and a contributor to CNBC. Gottlieb spoke extensively on his experience at the FDA and the great path that it is on; specifically their core focus on specialty products. Wrapping up the eventful program was Maria Shriver, renowned journalist, author, and former first lady of California. Shriver has received a Peabody Award and was co-anchor for NBC’s Emmy-winning coverage of the 1988 Summer Olympics. Fein did a nice job interviewing her about her passion, The Women’s Alzheimer’s Movement, which she founded. The movement is a global alliance of individuals, organizations, researchers, foundations, influencers, and industry leaders committed to finding out why Alzheimer disease prevalence is higher in women. Shriver believes that by answering the question of why women are disproportionately affected by Alzheimer disease, society can unlock the other mysteries surrounding this condition, and that will lead to a cure for all.

Award-Winning Continuing Education (CE) Programs 

 Continuing Education™ team for staging 15 programs offering over 30 credits of CE and, as usual, a great list of topics. In addition to the sessions that offered CE credits, there were dozens of great topics reviewing technology, law, professional practice, new therapies, and so many more. 

Next Up: National Association of Specialty Pharmacy (NASP) Annual Meeting 

We will be in full force at the NASP annual meeting this fall in Washington, DC. The 6th annual 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 include the annual Specialty Pharmacy Law Conference offering CE credits to attendees, plus a 1-day preparation course for pharmacists studying for October examinations given by the Specialty Pharmacy Certification Board for Certified Specialty Pharmacist status. 

For more information, visit naspnet.org/annual-meeting/ and check out our live coverage of the NASP meeting at our new website at pharmacytimes.com.

The annual Asembia Specialty Pharmacy Summit has become the largest meeting in the specialty space, and this year it exceeded prior numbers in attendance and offerings in programing. 

Looking Back at Another Blockbuster Asembia Meeting

June brings the annual American Society of Clinical Oncology meeting in Chicago and our ninth oncology-focused edition of 

. The sheer volume of specialty products in the oncology space creates the greatest opportunity for our field. Developments in oncology therapy dominate the number of approvals coming out of the FDA and shadow other disease states. If you want to be a player in specialty pharmacy, oncology is the place to be.

Traditionally, specialty pharmacy has focused on oral or self-injectable oncology products; however, there has been a significant shift as specialty pharmacies become increasingly involved in infused oncology products, which are often administered to patients in the clinic, at home, or in the hospital.

Given the cost and complexity of oncology products, payers have considered specialty pharmacy as the main channel of dispensing and leverage the drug benefit to better manage the economics. Because of the US system for drug reimbursement, virtually 100% of oncology products are covered by some form of insurance or sponsored coverage. With rare exceptions, all specialty pharmacies touch the payer system through either ownership or contracting.

Because payers control reimbursement, the most significant dollar volume of oncology products flows through payer-owned specialty pharmacies. For accredited specialty pharmacies, the focus is on not just cost but also the optimization of pharmaceutical care outcomes, which are accomplished by ensuring appropriate medication use and maximizing adherence. Economics are important, but if the drug is not managed appropriately, the value created by that therapy can be negatively affected. Patient satisfaction also plays a key role and is measured by specialty pharmacy with a focus on continuous improvement. A close interaction with the patient’s caregivers is critical, because nearly all these products are dose adjusted to tweak their efficacy and minimize adverse effects (AEs). This leads to ongoing communication with the patient to make sure they are doing the right thing with their therapy.

Oncology products by nature are most often cytotoxic and kill off faster-growing tumor cells. However, the human body also has many fast-growing nontumor cells, which are frequently affected by treatment, leading to AEs. Treatment involves an ongoing battle between efficacy and managing these AEs, making adherence to therapy an art in the practice of specialty pharmacy. The complexity of instructions makes patient education paramount. Specialty pharmacies raise the bar on education and reinforcement, using a multifaceted strategy designed to envelop the patient with care. The specialty pharmacy team must be great listeners, probing for issues and providing recommendations that keep patients on therapy to ensure the best outcomes, which correlate highly with adherence. Specialty pharmacies work to empower patients with knowledge about their condition, treatment, and potential AEs. Pharmacists and other specialists supporting the pharmacy counsel patients before the initiation of therapy, reinforcing and complementing the information received from physicians and other caregivers.

Making sure the patient always has necessary medication on hand requires strategically timed communications so that the patient receives refills before running out of their current supply. A specialty pharmacy employs several techniques to ensure adherence to the dosage regimen and asks questions with each interaction to determine how much of the drug has been consumed. Because most specialty pharmacies deliver medications to the patient’s home, there must be adequate lead time to obtain the approval and secure reimbursement. Technology often comes into play, and several resources can assist in determining the timing of a patient’s next refill. For example, a text message reminder to take their medication is very powerful with some patients. Patients are busy and tend to forget to take their drug, and a text message offers a gentle, minimally intrusive prompt. These texts often request a response to validate they were received and acted on. Some specialty pharmacies use smart vials that remind the patient when to take their medication and have feedback technology to determine if a dose was taken. Some of these devices connect to the internet to provide real-time feedback to the pharmacy. 

The costliest form of care today involves ending up in the emergency department. Having access to trained specialty pharmacy oncology professionals with strong clinical experience may help prevent emergencies caused by AEs and nonadherence. A well-trained specialty pharmacy clinician can often help patients recognize or mitigate AEs that demand medical attention and instruct the patient to seek medical attention, often contacting their oncology team. To achieve the highest level of care, some pharmacies employ staff who have obtained specialized certifications. Having credentialed professionals ensures that patients receive qualified services. One of the better-known programs is by the Board of Pharmacy Specialties, a division of the American Pharmacists Association. Leading specialty pharmacies frequently offer some form of 24/7 clinical support. If a specialty pharmacy has an oncology focus, it is imperative that they employ staff who possess extensive knowledge about oncology products and their AEs. 

Many specialty pharmacies that work closely with oncologists engage in research by enrolling in clinical studies. By adhering to strict research protocols, providing timely access to specialty products, coordinating dose modifications and patient information, and reporting AEs, specialty pharmacies can play a significant role in advancing the approval of new products and indications. The specialty pharmacy also can contribute to the clinical research process by facilitating the aggregation of data augmented by collecting additional information through patient communication and disease management information.

Arm Patients With Co-pay Assistance Information 

Oncology products usually come at a high price and for many patients, co-pays for specialty drugs are prohibitive. Most manufacturers sponsor programs that assist with co-pays or provide financial assistance programs so that high out-of-pocket costs do not prevent patients from accessing therapy. Several foundations around oncology products also offer support but are very complex programs and require a great deal of experience to navigate. Many patients and prescribers are often unaware of these resources and those who are aware are frequently overwhelmed by the applications and enrollment processes.

Specialty pharmacy staff should have solid knowledge about the products they dispense and the programs that can assist patients in accessing these products. For patients to obtain insurance coverage, nearly all available oncology products require a specialty pharmacy to obtain prior authorization. The specialty pharmacy must be adept at obtaining coverage and clearly communicating the status during the process until authorization is received or denied.

A specialty pharmacy’s expertise in supporting oncology patients is among its most essential attributes. Well-trained, compassionate professionals, not just the products dispensed, make a pharmacy special. Specialty pharmacies are also expected to obtain multiple accreditations and provide superior data-driven decision making. Developing partnerships with manufacturers to produce data that are timely, accurate, and comprehensive helps the manufacturer better understand their product’s performance, including how patients respond to therapy.

If you want to be a player in specialty pharmacy, oncology is the place to be.

Oncology: The Gateway to Success in Specialty Pharmacy

The FDA continues to crank out approvals in record fashion. Although the government shutdown resulted in several pending approvals being sidelined, things appear to be back on track. Hopefully, our politicians can appreciate the consequences to health care of their high-stakes gamesmanship. We are in the health care business, and decisions they make have an impact on the lives of patients. 

The FDA website can be a treasure trove of information on recently approved products or products in development. For example, I searched for new molecular entity FDA approvals in 2018 and there were 59 search results. Every newly approved product clearly met the definition of specialty and can be categorized as innovative, and they have never been used in clinical practice as listed.

The FDA has prioritized from the top down seeking new treatment options for patients. More specialty products expand the relevance of specialty pharmacy. These approvals feed the lifeline of our industry.

What I found interesting in the list of approvals was the ratio of oral products to infused. Nearly half of all new approvals were for infused specialty products. For the traditional specialty pharmacy, we often think of oral or self-injectable products being sent to the patient’s home. But what about specialty infused products? How might a specialty pharmacy expand their practice? How can an existing practice expand into specialty infused products?

Although many infused products are administered in the acute care or hospital setting, several products lend themselves to being administered in the patient’s home or in an ambulatory infusion center or free-standing infusion center. The clinical, lifestyle, and economic attributes of a product play a factor in choosing the administration setting. 

Traditionally, many of these products were administered in the physician’s clinic and often defined as “buy and bill.” However, there has been a significant trend of declining physician-administered drug reimbursement rates driving these products into home infusion and ambulatory infusion centers. Many hospitals have jumped on this and established accredited specialty pharmacies, for both oral and infused specialty products.

In support of these trends, several specialty pharmacy operations have added infusion centers to their portfolio or an infusion suite to their opera- tion. This is not new, however, as our neighbors in Canada have offered community-based infusion suites for many years. Ambulatory infusion centers can be beneficial to manufacturers, patients, and providers. Many serve as the host pharmacy for home-infusion service providers, in which nurses secure access to the products and devices necessary to administer treatment in the patient’s home.

Some patients may also receive their therapy in a physician’s infusion clinic, where treatment is administered in a familiar setting under the care of their usual physician. Insurers often prefer the ambulatory infusion center option because they may have to pay higher rates for hospital-based medical infusion services. This will likely continue to encourage the use of outpatient infusion centers. Despite the similarities between in-home infusion (trained professionals go into the patient’s home) and ambulatory (patients come to the medical facility), the operational costs and reimbursement are quite different.

Ambulatory infusion centers must strictly adhere to Centers for Medicare and Medicaid Services (CMS) supervisor requirements. The owners and operators of ambulatory infusion centers must be prepared to understand and follow CMS rules in this area. The rules for physi- cian supervision for infusion are more stringent in the freestanding centers and physician offices than in hospital out- patient departments in this area. CMS requires direct supervision by physicians, which means that the physician, not an advanced provider, must be “immediately available” and “interruptible” for help and direction throughout the infusion. However, the physician does not need to be in the infusion room when the infusion is given.

Equipment and staffing need to be carefully considered prior to establishing an ambulatory infusion center. The physical space for the ambulatory infusion center should have an adequate comfort structure. Some centers might be as simple as a single infusion chair with an intravenous (IV) pole compared with other facilities decked out with 20 high-tech leather recliners, each with its own TV and massage unit. At a minimum, the ambulatory infusion center should have 2 infusion chairs, infusion pumps, blood pressure monitors, patient entertainment equipment, and general supplies (eg, locking refrigerator, IV tubing, needles, gloves, and medications to handle complications).

In addition to well-trained pharmacists, staffing should include infusion nurses with adequate training. An ambulatory infusion center must have skilled, competent, and knowledgeable nurses and pharmacists. Consideration of the total time spent giving infusions as well as whether the staff will be involved in helping to obtain authorizations for specialty infused products can be a considerable time outlay. Therefore, ambulatory infusion centers must have the correct state licensing requirements and accreditation and be able to verify that these are met by the infusion nurse or other personnel involved with the infusion of medications to patients in addition to their pharmacy requirements and accreditations.

Obtaining and billing for specialty infused medications are usually done by ambulatory infusion centers in 1 of 2 ways. There may be a pass-through type of arrangement or buy-and-bill:

		In a pass-through situation, a specialty pharmacy delivers the drug— and possibly infusion equipment&mdash;to the ambulatory center and then the pharmacy bills the insurer directly. The pharmacy is also responsible for the authorization and collection of co-pays.

		In buy-and-bill, the ambulatory infusion center establishes an account with a wholesaler/distributor. The infusion center then bills the patient’s insurance plan or Medicare directly. This method requires caution and diligence by the infusion center in several areas. It is the center’s responsibility to comply with insurance company and CMS rules, ensure correct and necessary authorizations are obtained, and collect patient co-pays.

Coding and billing for outpatient infusion services is a key component for any ambulatory infusion center. It is critical that the ambulatory infusion center has competent coders and billers and a clear understanding of the most recent current procedural terminology (CPT) codes to assure the ambulatory infusion center is receiving the appropriate reimbursements. Each insurer may also have their own policies regarding infusion payment.

There are specific rules regarding infusion coding, and they can be complex. It is also very important to record the timing of the entire infusion. For example, the CPT code for the infusion of 1 product may cover the administration and IV infusion techniques for a certain number of hours, whereas another code may cover each additional hour. In addition, codes are listed separately for primary and additional procedures.

The Healthcare Common Procedure Coding System is used to supplement the CPT codes. In the case of infusions, this would cover the drug, IV tubing, syringes, and other supplies for the infusion that are not included in the CPT code. Coding coverage may vary by insurer or between plans with the same insurer. The ambulatory infusion center may need to consult each payer for specific coding policies.

In addition to the steps above, it is important to establish which infused specialty products are available and in your market that may be in demand by providers and patients. To get started, there are several open-distribution infused products available from your specialty distributor or wholesaler. Because many physician practices are assessing their continued participation, reach out to oncologists, rheumatologists, hematologists, neurologists, and immunologists, and other practices, that currently perform in-office infusions to seek guidance and/or a partnership.

Also, stay on top of new product developments via FDA.gov. Your local specialist might be participating in a clinical trial, and following approval of the drug, they will be looking for commercial access to the product as well as infusion services. Get a head start by leveraging those relationships to reach out to manufacturers well before the anticipated approval of a product. Review your payer portfolio, and get on the right provider panels for infusion services, as these will be different than your traditional pharmacy agreements.

We will continue to see a tidal wave of new product approvals and infused specialty products strongly represented. Position your business for that growth. 

For the traditional specialty pharmacy, we often think of oral or self-injectable products being sent to the patientâ€™s home. But what about specialty infused products? 

Infused Specialty Pharmacy and Expanded Opportunities

Another year is behind us, and what an eventful one it was for specialty pharmacy. Health care was the No. 1 focus in virtually all political campaigns during last year’s election season. In 2019, the outcome of those elections will likely affect the specialty space.

Not a day goes by without a health care—related headline, and our industry continues to be influenced by change, some positive and some less so. However, our mantra stays the same: Take care of the patient and we all win.

Some great way to stay on top of the latest trends include registering on SpecialtyPharmacyTimes.com, following any of our social media channels, and signing up to receive our industry-focused emails and continuing education resources. At 

, our readers are among the most informed in the industry; in this issue, we will review the top specialty trends to watch in the year ahead.

In the FDA’s own words, “innovation drives progress.” Under Commissioner Scott Gottlieb, MD, the FDA has made it very clear that when it comes to innovation in the development of drugs and therapeutic biological products, the agency’s Center for Drug Evaluation and Research supports the pharmaceutical industry at every step of the process. This is a change from the past, when the pharma industry and the agency were often at odds. It’s not that the core group of people at the FDA changed; it is, rather, “under new management.” There is a deeper understanding that the agency’s commitment is to provide the scientific and regulatory advice needed to bring new therapies to market.

Most of the new specialty approvals can be categorized as innovative products that have never been used in clinical practice. Others are the same as or related to previously approved products and will compete with them in the marketplace. From the top down, the emphasis is on seeking new treatment options for patients and advances in health care for the American public. For our industry, this means more specialty products and the subsequent expansion of our footprint and relevance. Drug approvals are the lifeline of our industry and the key driver of growing a successful specialty practice. Several specialty drugs are expected to be approved in the first half of 2019 (

Below are some examples of specialty products approved in late 2018:

		Patisiran (Onpattro)—a small interfering ribonucleic acid therapeutic for treating polyneuropathy caused by hereditary transthyretin-mediated amyloidosis

		Migalastat (Galafold)—an α-galactosidase A pharmacological chaperone indicated for adults with a confirmed diagnosis of Fabry disease and an amenable GLA gene variant

		Duvelisib (Copiktra)—a first-in-class, oral, dual phosphoinositide-3-kinase (PI3K)—δ/PI3K-γ inhibitor for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and relapsed or refractory follicular lymphoma

		Talazoparib (Talzenna)—an oral poly (ADP-ribose) polymerase inhibitor indicated for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2- negative locally advanced or metastatic breast cancer.

In late 2018, the FDA initiated the expanded access (EA) program, providing a pathway for patients to access investigational drugs, biologics, and medical devices for serious diseases and immediately life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available. Although there is work to be done, expect that specialty pharmacy will play a key role in the FDA-administered. Requests for individual patients are made using newly developed access applications. Some requests are granted immediately by phone, whereas nonemergency requests are generally processed within a few days. There is a close interplay between the FDA, the provider, the patient, and the pharma industry.

Because these are patient-specific requests, a manufacturer often relies directly on their hub services and contracted specialty pharmacy to provide fulfillment services. The manufacturer is at the center of ensuring that the patient receives ongoing therapy under specific conditions as granted by the approval. Working together with the physician, the pharmacy facilitates the process. All stakeholders are engaged to help review the safety data generated by using an investigational drug or biologic through the EA pathway.

It is hoped that the improvements to this program will not only provide immediate therapy to the patient but also help accelerate the approval process as warranted. The EA program can be another great pathway to a specialty pharmacy obtaining early access to a drug—even prior to an approval. Seek out the right folks in the industry or any service providers working on their behalf.

3. Price Controls and the Cost of Specialty Products

The administration continues to play a prominent public role in chipping away at health care spending, and the high cost of specialty products is at the center of that process. The administration will likely find willing partners in both the Congress and Senate; however, President Donald Trump has the power to bypass the House and Senate, if necessary, by using a pilot program to test 3 ways to lower the cost of drugs—including negotiating for some drugs directly administered by doctors under Part B.

					Given the growing role of specialty pharmacy with infused and injectable products, these initiatives will affect the specialty business model. The goal is to keep pricing in line with the far lower prices paid in many other countries, in which governments often take an active role in setting prices.

					Expect the administration to empower private sector vendors to negotiate pricing, similarly to what has been done with Medicare Part D. The whole rebate mechanism is greatly in flux, with a large pharmacy benefit manager (PBM) recently launching a rebate-free formulary solely based on efficacy and wholesale acquisition cost. It just might take a presidential decree or an act of Congress to revamp our pricing system of reimbursement, and this could be the year it happens.

Early in 2018, the administration presented a plan addressing the entire spectrum of drug pricing in America: “American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.”

We expect to see the administration chipping away at pricing using various tactics, including the following:

		Remove some of the gaming of the regulatory and patent processes by brands that inhibit the approval of generics and biosimilars to boost price competition.

		Include prices in drugmaker advertising to enhance price competition.

		Increase the use of value-based pricing by expanding outcome-based payments.

		Enforce the prohibition of the gag rules that prevented pharmacists from informing patients when they could pay less out of pocket by not using insurance.

		Reserve Part D incentives only for manufacturers that stop raising prices.

		Expand the use of co-pay discount cards in Medicaid.

		Require that beneficiaries be informed about their out-of-pocket costs prior to receiving a Part B drug or a Part D drug prescription and whether lower-cost alternatives exist.

		Require safety net hospitals paid under Medicare Part B to use their 340B drug discounts to provide care to more low-income and vulnerable patients.

		Require the FDA to issue a guidance to address some of the ways in which manufacturers use risk evaluation and mitigation strategy programs to delay or block competition from generics.

		Review the imbalance on reimbursement based on the site-of-care for patients to ensure site neutrality between the inpatient and outpatient settings. This will allow providers to be reimbursed appropriately with care provided in the least expensive setting.

It seems the push to manage the cost of specialty products has been based mainly on drug prices, ignoring value. Expect to see an even greater emphasis in the specialty industry turning to value-based contracting (VBC), which seeks to link the price of a prescription drug to its clinical or economic performance. Specialty pharmacy plays an integral role in ensuring that the patient receives an optimal outcome when using a specialty pharmaceutical; therefore, specialty pharmacy’s role will be even more important as new reimbursement schemes, such as VBC, roll out. However, the expanded use of value-based payment models will require a higher tolerance for financial risk, regulatory change, and the willingness and flexibility to collaborate closely with payers, specialty pharmacy, PBMs, and patients.

The US biosimilar market continues to lag other global markets, much of which is a result of the bureaucratic approval process. The FDA’s leadership has shown a commitment to biosimilars via increasing competition across specialty pharmacy classes and launching more biosimilars. There are some potential blockbusters in 2019, such as bevacizumab-awwb (Mvasi) and trastuzumab-dkst (Ogivri). The FDA is seeking to raise the educational bar with providers about the safety and efficacy of biosimilars.

It was not long ago that traditional generics were introduced with a good deal of skepticism regarding their efficacy, which changed when economic pressure from payers forced compliance and conversion. We expect to see the same process evolve for biosimilars. There is too much money on the table with potential new approvals to let this opportunity pass. These factors indicate that 2019 could be a big year for biosimilars.

The strategy behind the merger of CVS Health and Aetna was laid out from the beginning. Larry Merlo, chief executive officer of CVS, said that the combined company will emphasize lowering medical costs by increasing adherence to prescription regimens, broadening its membership base, and providing more services through its brick-and-mortar stores. The combined company also plans to close gaps in care, reduce unneeded emergency department trips, and shift costly therapies to less expensive care sites. With the growth in infusion specialty pharmacy, we also expect to see the increased emergence of stand-alone infusion care in retail settings. The platform is already in place with the Coram acquisition, and CVS Caremark currently has the highest revenue-producing specialty pharmacy. Combining platforms means this giant could be an even more dominant force in specialty.

Prime Therapeutics and Walgreens and their joint venture, AllianceRx, bring together a pharmacy, PBM, and health plan. This partnership has combined the largest national retail network with a central specialty pharmacy and mail service company. Like the abovementioned CVS initiatives, these well-established organizations drive lives and use to the specialty arena. To round out their play, Walgreens partnered with Humana on several strategic ventures, including taking equity stakes in each other. And the plot thickens: The market has already speculated on Walmart purchasing Humana.

As Express Scripts and Cigna begin their integration, how will that partnership affect specialty pharmacy? Clearly, these companies will enhance their purchasing power by both the increase in lives under management and exposure to differing biopharmaceutical manufacturer rebates across their books of business. Both organizations have well-run specialty pharmacies and have shown a willingness to be tough negotiators when they hold leverage. It can be expected that Express Scripts and Cigna will be emboldened by the expanding specialty portfolio of second-generation products and biosimilars.

These mergers and future acquisitions in the specialty industry will undoubtedly have a profound impact on patients, providers, and the overall health care industry. In the world of limited distribution products, manufacturers will increasingly be pressured to include payer-owned specialty pharmacies in their networks or risk greater access barriers to their products from these payers. Non-payer-owned specialty pharmacies will face even greater challenges from these factors.

In early 2018, Amazon, Berkshire Hathaway, and JPMorgan Chase announced plans to collaborate on a new health care company seeking to both provide high-quality care and reduce costs. The 3 organizations hope to pool their resources to take an innovative and disruptive approach to health care. One area of their focus involves developing a more effective way to manage specialty drug spending. Thus far, not much information has leaked from this entity; however, they have staffed their leadership and, combined with PillPack, should be a closely watched group in 2019.

The health system specialty pharmacy continues to be the most significant segment of the industry. Given that hospitals are often where our sicker patients end up, this integrated, collaborative, and clinical environment is at the forefront of growth. Key drivers include 340B pricing and the past few years’ tremendous shift toward community-based physician practices being absorbed by health systems. These large institutions have made significant investments in training, data systems, and payer access. As such, payers recognize the value of these systems in providing a better view into the overall continuum of care from inpatient through outpatient and into the community. Many hospital networks have combined resources through a collaboration with their group purchasing organizations to form key alliances. Manufacturers are seeing the value in these large entities can bring to their products, particularly in the infusion space.

8. Community Specialty Pharmacy Rediscovered

Despite the drivers mentioned above, the opportunities for community specialty pharmacy remain strong. The reality is that health care is still a relationship business. People need to interact with people, and face-to-face will always be the baseline—that is how humans are wired. Services provided by the community pharmacy and pharmacist have played a very active role as a key component of the health care delivery system. Community pharmacy has a strategic advantage, with the broadest network of outlets in the US market today. Plus, consumers generally know and trust their community pharmacist.

It stands to reason that when given the opportunity to maintain a professional relationship with their local pharmacist on specialty products, patients will chose their community pharmacy over other providers. The big chains, such as CVS and Walgreens, have already built integrated hybrid systems to network specialists into their traditional pharmacy locations, in addition to several community-based specialty pharmacy locations that are in place.

Specialty products not of limited distribution often serve as the entry point for emerging specialty pharmacies. If these pharmacies are able to prove professional excellence, they can use their established competency to gain access to new niche products. The big 3 wholesalers already take pride in their independent networks claiming them as chains. If distributors successfully gain access to products on behalf of emerging networks, the playing field stands a better chance of increasing fairness.

 has withstood the test of time and evolved with the industry: 2019 marks 9 years since our launch. We hope the insights you find in this journal will help you be more informed and successful in the year ahead.

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Not a day goes by without a health careâ€“related headline, and our industry continues to be influenced by change, some positive and some less so. 

Top Trends for 2019 In Specialty

As we approach the end of 2018, analysts are predicting this year may break records for new drug approvals, especially in the specialty space. The Trump administration has been bullish on pushing for faster and more efficient approvals; therefore, the pipeline of specialty products is robust. Each product approval has a story and opportunity built around it. If a specialty pharmacy wants to participate in providing products and services to patients, they must prepare. Your approach to managing the complex environment of specialty products must be both strategic and tactical if you want to compete. It takes hard work and thoughtful preparation to develop a plan that assures the best possible patient outcome, and each product requires a unique strategy. That’s why we call it specialty.

There are several excellent sources of information that look ahead at pending approvals. Many of these are produced by leading pharmacy benefit managers (PBMs), payers, the FDA, and subscrip- tion services. Also, most of the national conferences carve out a presentation that covers the pipeline. Leverage these resources whenever possible. To put your organization’s best foot forward, it is important to do this type of planning. Below is a list of some of the potential approvals over the next several months.

From the list, it is highly likely that most of these specialty products will fall into either the open or limited distribution category. Although open distribution products create access to revenue opportunities, a specialty pharmacy may need to dig a little deeper with manufacturers to seek compensation for services and data in exchange for the value these pharmacies provide back to the manufacturers and the patients prescribed their drugs.

There are several reasons why a manufacturer may choose to distribute its product through a limited specialty pharmacy or network of pharmacies. Whatever those reasons are, your pharmacy must convince the manufacturer that your services meet the need of the product based on their selection criteria and understanding of their distribution methodology. Typically, the distribution plan is driven by several questions:

		Is the product oral, self-injectable, or infused?

		Are there special storage, handling, and administration requirements?

		Does the product come at a significantly higher cost?

		Is there a small target audience of patients (5000-100,000)?

		Are the patients typically treated in an institutional or ambulatory setting?

		Is there a risk evaluation and mitigation strategy (REMS) or patient registration program in place?

		Are there atypical reimbursement challenges?

		How can the standards of data collection and analysis be raised?

High-touch, focused pharmacy solutions have emerged that seek to maximize patient outcomes for specialty products. Specialty pharmacy offers a greater level of patient care and understanding to dial in on the right solution for complex challenges. Once your organization best understands the needs of the product and the patient, as well as the tactics of the manufacturer, you are ready to build your plan.

The business of specialty pharmacy has evolved over the last several years into a $150-billion plus enterprise. Because of that growth, the rules of engagement have shifted and become more complex. A handful of PBM-owned specialty pharmacies dominate the landscape of limited-distribution products. If a specialty pharmacy wants to compete, it must have all of the elements in place to participate in the selection process. Successful specialty pharmacies invest in business development and work hard at having people in the market who tell their story. Having the relationships to be considered for distribution is equally critical. Our industry is blessed with several national meetings, to establish these relationships, such as the recent National Association of Specialty Pharmacy conference, which more than 1200 individuals and dozens of pharma organizations attended. Meeting the right decision-makers or networking with attendees to get to those folks is of utmost importance if you want to get invited to the party, better known as the request for proposal (RFP).

Once a pharma company has decided on its model and plan, the industry standard is to use the RFP process to document a company’s viability. While each product may have unique characteristics that determine viability, many of the essentials that will be covered in the RFP are below:

		Quality: metrics, standard operating procedures

It has been my experience with the emergence of more complex products that having the right resources to support clinical services for patients is most important. The cost of specialty products continues to escalate as we find great new therapies that often treat a smaller population for complex diseases. Therefore, reimbursement and access are equally important. The rules of engagement with a manufacturer and a payer on these products, like the diseases they treat, are becoming more complex.

We are seeing more value-based contracting in the market. Value-based contracting involves payment, or reimbursement, based on indicators of value, such as patient health outcomes, efficiency, and quality. This is distinct from volume-or fee-for-service—based contracting, which involves payment for every unit of service delivered, often without terms related to outcomes, quality, or cost per- formance. In the world of value-based contracting, the specialty pharmacy is an essential partner to the manufacturer in ensuring the patient receives the best possible clinical outcome in order for the product to be fully reimbursed.

Specialty pharmacies must have the right resources to provide services and have the tools in place to measure outcomes. Earlier this year, our elected and appointed leaders published American Patients First (APF), which is a plan for bringing down the high price of drugs and reducing out-of-pocket costs for the American consumer. Whatever the outcome of these initiatives, expect that they will have an impact on the decision-making process of distribution selection. I predict that APF will enhance access to specialty products as the value of services will be better recognized beyond just their price.

Do your best to get in front of the decision-makers; create your case studies and win them over on the fact that what you do is best for the patient and their product. Many pharmacies subspecialize in in key therapeutic areas and are experts at providing services for products that treat specific disease states. Specialty pharmacists must strive to become the best at managing patients with their medications in those disease states. Access to recently launched products is awarded to pharmacies that have a more defined focus on disease- and product-specific services. Look to other health professionals in your market, as they often have a degree of influence over patients’ choice of a specialty pharmacy. Physicians and their support staff are very aware of the specialty pharmacies that offer comprehensive support services, therapeutic expertise, and access to a specific product. Having strong relationships with local physicians is a great asset, because they often provide feedback to the manufacturer’s representatives who share this up the chain with their decision makers.

As you review the pipeline, understand the profile of the product and the manufacturer. A manufacturer’s website is a great source of information to best understand both. This is big business and manufacturers must raise capital to bring these products to the market. In doing so, they post a great deal of information you can use to understand their product and plan of action. Look for presentations they may have posted digitally, as well as press releases and financial filings, including their annual reports. The information is there.

Opportunities are out there for those who prepare. The shift from traditional to specialty products is the future of our profession.

With the record number of pending and soon to be approved products, find those that you can do best with. Please continue to use 

® as a key resource to participate in the future. Also, check out the 

® site where you’ll find additional resources at www. specialtyrxaccess.com/strategic-planning.

If a specialty pharmacy wants to participate in providing products and services to patients, they must prepare.