Kimberly Firtz, PharmD, MSPBA Candidate

Picture your childhood bicycle, banana seat and all; now picture the front wheel of that bicycle. That bicycle wheel can serve as a metaphor for the holistic specialty patient experience.

Around the outside of the wheel at the end of the spokes reside the patient, the physician/prescriber, the insurance provider/pharmacy benefit manager, the specialty pharmacy, and the pharmaceutical manufacturer.

Now, picture the same bicycle wheel without a hub in the center holding the spokes together. That’s a bit more challenging because of what the hub signifies within the specialty patient experience.

I remember how confusing the concept of a hub was when I first started my career in specialty pharmacy. I really wish someone had helped me out with a bicycle reference.

The concept of this connector, this interface between the stakeholders in the specialty pharmacy experience, was daunting at first. Once I began to understand the purpose of a hub as the experts that pharmaceutical manufacturers put in charge of streamlining access to their drugs and coordinating patient care, my mental picture got a little bit clearer.

, “Hubs have been around for over a decade, starting out as ‘reimbursement hubs,’ usually provided as a service by manufacturers to help patients and providers navigate the process of obtaining permission to use, and reimbursement for, expensive specialty therapies.”

Hub services have continued to evolve over the years to include big data collection and reporting, prior authorization and appeals, patient assistance programs, quick starts and bridge programs, e-prescription routing, and more. Pharmaceutical manufacturers depend on hubs to act as connectors between all of the “spokes” of the wheel.

Consider this patient example: A specialty patient visits their physician and is started on a new specialty therapy. In order to begin therapy, the physician fills out an electronic form that includes the prescription and patient information, such as benefits and clinical data.

This form is submitted to the hub. When the hub receives the form, they identify which specialty pharmacy is contracted with the patient’s insurance company and/or the pharmaceutical manufacturer to fill the medication.

The hub verifies the patient’s pharmacy or medical benefits to ensure coverage and submit for a prior authorization, if required. In the meantime, the hub contacts the patient and ships them a bridge supply of medication so that they have immediate access to begin therapy while their prior authorization is pending.

The hub also reaches out to the patient’s specialty pharmacy to enroll the patient and facilitate the transition from the bridge supply to the patient’s first order from their pharmacy. When the specialty pharmacy is able to fill the patient’s first order, they follow their standard process and send the dispense data back to the hub.

The hub then compiles these data for the patient, which are sent to the prescriber and manufacturer. This is a fairly common example of the activities performed within a hub to coordinate specialty pharmacy care for patients.

Consider a second example of the specialty pharmacy patient experience, in which a similar patient goes to their prescriber and is started on a new specialty therapy. The prescriber is not familiar with the patient’s specialty pharmacy benefits, so they submit a prescription form to their local specialty pharmacy.

The pharmacy enrolls the patient and during benefits verification, they must triage the prescription to the pharmacy that is contracted with the patient’s insurance company. The contracted pharmacy enrolls the patient and bills the claim to the insurance.

A prior authorization is required, so the specialty pharmacy calls the patient to update them on the status of their order and inform them that it may be up to 7 days before they can start their medication. This is an example of the bicycle wheel without the hub.

The above example demonstrates the potential benefits that hubs provide to the specialty patient experience. Hubs ensure that patients gain quick access to their medications and help to coordinate the transition for patients starting their specialty therapy through their contracted pharmacy.

They also perform benefits verification, frequently submit prior authorization data for patients to assist with coverage, and provide co-pay assistance and patient assistance programs when needed.

The patient experience without a hub is not always like the one described above. There are plenty of patients who are able to start specialty medications relatively seamlessly without intervention.

However, it is extremely beneficial to have the hub between the spokes of the wheel to function as the experts in coordinating patients starting on specialty therapies. The routing of prescriptions to the correct pharmacies, data collection and reporting, and patient assistance programs work in collaboration with the services offered by specialty pharmacies to ensure the best care for our specialty patients.

Kimberly Firtz earned her Doctor of Pharmacy degree from Duquesne University and is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. Kimberly has spent the last 5 years working in Specialty Pharmacy, initially as a clinical pharmacist and most recently working on a variety of high profile Specialty Operations Projects. Her current role is working with the Process Innovation team on an effort to transform Specialty Operations and optimize the stakeholder experience. 

Articles

Pharmaceutical manufacturers depend on hubs to act as connectors between various stakeholders across the specialty drug prescribing process.

The Benefits of the Hub for Specialty Patients

In an unprecedented unanimous ruling on June 12, 2017, the Supreme Court ruled that biosimilar drug manufacturers applying for approval from the FDA “may provide notice of commercial marketing to the branded biologic drug manufacturer before obtaining a license.”

This ruling was significant for all stakeholders in the health care space. From biologic and biosimilar drug manufacturers, to payers, providers, pharmacies, and, most importantly, patients requiring these medications, this ruling will have a lasting impact.

The precedent set during this case allows for an increase in the speed to market for biosimilar drugs by up to 180 days. To understand the impacts that this case will have on the future of biologics and biosimilars, let’s first take a step back and discuss biologic and biosimilar drugs.

According to the FDA website, “Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.”

Biologic medications differ from traditional medications in that they are isolated from natural living sources rather than being chemically synthesized. Biologics are produced by biotechnology methods and are typically very large mixtures of molecules.

Unlike simple chemical structures that can be drawn in an organic chemistry class, biologics are typically comprised of tens of thousands of atoms. They typically have strict storage and handling requirements, as many need to be stored at a certain temperature and may be injected or infused; therefore, they must remain sterile from manufacturing through delivery.

All of these attributes make biologic medications more difficult to manufacture, dispense, and deliver. It also makes them very difficult to replicate and reproduce.

Although biologics are extremely difficult to replicate, it is valuable to produce similar molecules with the same targets as these biologic drugs to bring additional competition to the market. The difficulties surrounding the manufacturing and handling of these drugs make them extremely expensive and the high cost makes it difficult for patients to gain access to them.

Introducing additional competition can greatly decrease cost and, therefore, improve patient access. In order to fulfill this need, many pharmaceutical manufacturers worked to create drugs similar to biologics, referred to as biosimilars.

As you can imagine from the description of biologic medications, biosimilars are different than traditional generic medications in that they are not an exact copy of the reference product. According to the FDA, “a biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.”

Similar to generic medications, there is an allowance by the FDA for small differences between the inactive ingredients in biosimilar and biologic products. Although biosimilars have been relatively slow to market in the United States, there are many biosimilars in the European market. It’s estimated that there were $4.8 billion dollars in sales of biosimilars in Europe in 2016.

Biosimilars Decrease Cost and Improve Access in Europe

An IQVIA (formerly QuintilesIMS) report released in June 2016 showed a drastic price decrease leading to increased patient uptake of biologic treatments.

“The increased competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class,” the report states. “In countries which used to have low usage/availability in the classes, the price reductions seem to have a significant impact on the increased access.”

This report tracked 4 classes of treatments for which biosimilar products were introduced in Europe: epoetins, granulocyte-colony stimulating factor, human growth hormone, and anti-tumor necrosis factor drugs.

The cost savings shown in these drug classes when biosimilars were brought to market were significant, upwards of 50% in some cases. Again, this incremental savings was not only seen for the reference product, but for the entire product class when the biosimilar product was introduced.

A separate report in March 2016 found that biosimilars could save health systems across Europe and the United States as much as $110 billion through 2020. If we see similar savings to what has been realized in Europe and bring additional biosimilars to market in the United States, it is clear that biosimilars could have a significant impact on drug costs in the United States.

Since 2006, the European Union has had more than 20 biosimilars approved, while only 5 have been approved in the United States. If the European Union is seeing drastic cost savings and improvements to access noted above, why is the United States lagging behind in approvals? Let’s take a look at the laws surrounding biosimilar approval in the United States so that we may get closer to this answer.

Biological Price Competition and Innovation Act

The Biological Price Competition and Innovation Act (BPCIA) was signed into law in 2010 by President Barack Obama as part of the Patient Protection and Affordable Care Act (ACA). Since the process to approve generic medications is predicated on the generic product having the same active compound as the drug, there was a need for additional legislation to allow a similar compound to go through an abbreviated pathway as well.

We wouldn’t want to force biosimilars through the full NDA process, so the BPCIA allows for this abbreviated licensure pathway for either biosimilar or interchangeable drugs. We discussed the definition of biosimilar above, but what is the difference between biosimilar and interchangeable?

For a biological product to be deemed interchangeable with a reference product, it must be biosimilar and also meet the requirements set forth for interchangeability by the FDA. Once labeled as interchangeable, the drug “may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.”

This is the main difference between these designations. Products that are biosimilar, but not interchangeable, may not be substituted for the prescribed reference product without authorization to do so by the prescriber. Therefore, according to the FDA, “for products that will be administered more than once, the data and information must show that switching a patient back and forth between the reference product and the proposed interchangeable product presents no greater risk to the patient in terms of safety or diminished efficacy when compared to treating them with the reference product continuously.”

In other words, a patient would need to be able to switch back and forth between the reference product and the biosimilar with no significant change in efficacy or safety for it to be labeled interchangeable.

There have been 5 biosimilar products approved in the US market to date. In order to discuss the experience that has taken place in the United States around biosimilars coming to market, I’ll introduce you to a concept called “The Patent Dance.”

Sandoz’s Zarxio (filgrastim-sndz) was approved by the FDA on March 6, 2015, as biosimilar to Amgen’s Neupogen (filgrastim). As the first biosimilar approved in the United States, Zarxio’s approval was a milestone in the health care industry.

The internet was abuzz with articles expressing excitement regarding the drug, predictions about how this approval would change the future of biosimilars in the United States and, notably, a significant amount of confusion. Since the US biologic drug industry had no experience with an approved biosimilar, it seemed that nobody was sure what to do next. This led to the first “patent dance,” so to speak.

After Zarxio’s approval in March 2015, Sandoz sent full disclosure notification of the FDA’s decision to Amgen in accordance with the provisions in the BPCIA that require notification of the reference product manufacturer by the biosimilar manufacturer. Amgen felt that Sandoz violated the disclosure provisions, stating that Sandoz should have sent the information 6 months prior to filing for marketing.

Amgen took the matter to court and filed multiple other claims against Sandoz in the lawsuit, including unfair competition and conversion. Although the claims of unfair competition and conversion were dismissed, the court stated that Sandoz should have sent notification to Amgen 6 months prior to marketing Zarxio and ruled that Sandoz could begin marketing the drug after September 3, 2015, 6 months after the disclosure was received by Amgen.

This was relatively good news for Sandoz, as they were given the green light to take Zarxio to market. However, this 6-month waiting period delayed the cost savings and improvements in patient access to filgrastim that Zarxio would bring once marketed.

Now let’s circle back to the ruling made by the Supreme Court to bring it all together.

The data from the European Union around biosimilars is clear: there is a significant incremental cost savings opportunity for the US health care system tied to the approval of biosimilars. These cost savings will lead to improved patient access to these lifesaving therapies.

Patients will be able to finally start therapies that they need and could not previously afford; however, approval is only the first step in the process. These benefits cannot be realized until the biosimilar drugs come to market.

Therefore, the June 2017 Supreme Court ruling that allows for biosimilar manufacturers to notify the manufacturer of their reference product prior to licensing or approval is vital. This will enable biosimilar manufacturers to bring their drug to market at the time of FDA approval so that patients can gain access at a lower price as soon as possible.

Significant savings on biologic drugs from biosimilars may not be realized until litigation regarding patents is settled. 

Biosimilars: The Last 'Patent Dance'

With specialty drug costs projected to account for 50% of all drug spend by 2020, it is more important than ever that specialty pharmacies document and report positive clinical outcomes for patients. In an effort to identify the most effective therapies and justify the large costs associated with these therapies, specialty pharmacy systems that track patient data around clinical outcomes are now part of our core business model.

When clinically managing patients with complex, chronic disease states such as HIV, multiple sclerosis, and hepatitis C, pharmacies must continually enhance these systems to account for new specialty medications with additional clinical monitoring requirements. Once this information is captured within the specialty pharmacy system, it must then be reported to payers and pharmaceutical manufacturers to fulfill contractual requirements and demonstrate improved clinical outcomes for the drugs and patient lives that they manage. It makes sense, right?

As an employer group, if I’m paying $7000 for a Copaxone prescription, I need to make sure that it’s working. By the same token, if I’m a pharmaceutical manufacturer of an orphan drug, I need to demonstrate continued safety and efficacy for the medication, especially if my initial clinical trial size was limited.

A Study in Specialty Pharmacy Care for MS Patients

It has been proven that specialty pharmacy care significantly improves clinical outcomes for patients. Clinical management of patients’ drug therapy through proactive outreach for renewal prescriptions—as well as prior authorization renewals, consistent patient counseling, clinical monitoring, and refill reminder communication&mdash;has been found to improve patient outcomes on both a quantitative and qualitative basis.

To demonstrate this impact, a retrospective cohort study conducted through 2016 followed multiple sclerosis patients for 3 years to track adherence and clinical outcomes when receiving specialty pharmacy care versus traditional community pharmacy care. The study examined the prevalence of MS relapse in a cohort of patients receiving each type of pharmacy care.

The results were clear: The patients with MS receiving specialty pharmacy care had a significantly lower risk of disease relapse than the patients receiving traditional community pharmacy care.

The outcomes reporting from the specialty pharmacies in this study made it possible for these positive clinical results to be demonstrated. In an era in which cost savings are king and new specialty medications are hitting the market with prices more than $40,000 per month, it is essential to continue to show the ways that we, as specialty pharmacies, manage these medications responsibly.

If we can identify the most efficient and effective ways to clinically manage these patients and back up these findings with data, we can ensure mutually beneficial outcomes for our patients and payer partners and gain a competitive advantage in the marketplace.

Outcomes Beyond Clinical Trials for Orphan Drugs

When new specialty medications come to market, especially those with indications for rare diseases with extremely small patient populations, the outcomes data collected by the specialty pharmacies with contractual access to these drugs are required for pharmaceutical companies to prove continued drug safety and efficacy.

In order to ensure positive patient clinical outcomes, we first must insure that our patients are taking their medications correctly. Once the patient starts the medication, we must monitor their adherence and track key clinical indicators associated with the drug over time.

Compiling and reporting these data gives the pharmaceutical manufacturer key insight into the real-world application of their drug as opposed to data compiled in a controlled clinical trial setting. Since many orphan drugs are approved by the FDA based on small clinical trials due to small overall patient populations, these real-world data are necessary to allow patients continued access to the medication.  

Typically, there are also specific storage and handling requirements associated with these drugs, so being able to consistently confirm stability data is directly related to the integrity of the drugs and, therefore, patient safety.

Payers and Pharma Rely on Specialty Pharmacy Outcomes Data 

Outcomes reporting has really become a core competency of the specialty pharmacy. It is a quintessential part of the specialty pharmacy model and is required for every payer and pharma contract.

Payers depend on specialty pharmacies to demonstrate that they are fluent with cost savings measures while providing excellent care to patients. This care must include attention to clinical details, such as adherence metrics and any additional clinical markers required for the specialty drugs taken by their patients.

Payers must be able to trust that the care provided by the specialty pharmacy will improve their patients’ quality of life and decrease costs associated with hospital admissions and absenteeism. Therefore, the pharmacy must provide patient data back to the payer to prove that their care fits these criteria.

Pharmaceutical manufacturers of specialty medications also depend on specialty pharmacy outcomes data to ensure that their drugs are safe and effective, and that patients can continue to gain access to them.

Kimberly Firtz earned her Doctor of Pharmacy degree from Duquesne University and is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines.  Kimberly has spent the last 5 years working in Specialty Pharmacy, initially as a clinical pharmacist and most recently working on a variety of high profile Specialty Operations Projects.  Her current role is working with the Process Innovation team on an effort to transform Specialty Operations and optimize the stakeholder experience. 

http://www.ahdbonline.com/issues/2016/november-2016-vol-9-no-8/2230-effects-of-specialty-pharmacy-care-on-health-outcomes-in-multiple-sclerosis

https://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2015/october-2015/analytics-for-specialty-managing-patient-outcomes

Collecting data that show the most efficient and effective ways to clinically manage patients is becoming more important than ever in specialty pharmacy.

Outcomes Reporting: A Specialty Pharmacy Core Competency

In our current health care landscape, it has become more important than ever for specialty pharmacies to focus on quality and value-based care. The increased costs surrounding specialty medications, paired with the payer shift toward outcomes-based reimbursement models, have made tracking and reporting pharmacy data—as well as decreasing costs through quality and efficiency measures&mdash;critical to our success.

To secure payer and pharma contracts necessary for continued growth in the marketplace, specialty pharmacies must continually improve operational procedures and invest in increasingly complex technology. With new specialty pharmacies arriving on the scene and existing pharmacies continually evolving, how is it possible for payers and pharma to see each pharmacy’s “report card,” so to speak, to ensure they are a viable partner? The answer, of course, is specialty pharmacy accreditation.

There are many accrediting bodies for specialty pharmacies. According to URAC, their accreditation programs are considered the premier choice in the industry. URAC is also 1 of only 2 approved accreditations for health plans as part of the Affordable Care Act.

 However, URAC isn’t the only game in town when it comes to specialty pharmacy accreditation.

The Accreditation Commission for Health Care, The Joint Commission, Center for Pharmacy Practice Accreditation, and Community Health Accreditation Program are also very commonly utilized for accreditation by specialty pharmacies.

In order to show payers and pharmaceutical manufacturers that your pharmacy is dedicated to quality, controlling costs, and documenting positive patient outcomes, accreditation is now all but mandatory, if not truly mandatory, when competing for contracts. It is now considered part of the cost of doing the business of specialty pharmacy. Accreditation has become so commonplace in our current landscape that many contracts are now requiring not only 1, but 2 specialty pharmacy accreditations.

If accreditation is so common, and pharmacies now need multiple accreditations to be competitive, the accreditation process must be fairly simple, right? Wrong.

The accreditation process is extremely complex and each accrediting body has a slightly different focus and, therefore, different expectations. For this discussion, let’s focus on URAC accreditation.

According to the URAC website, a specialty pharmacy with URAC accreditation:

·       Has policies and procedures in place to ensure consumers have access to appropriate drugs/medications.

·       Maintains methods to measure customer satisfaction.

·       Protects consumer health information.

·       Has policies and procedures that ensure adherence to drug safety protocols.

·       Follows a logical blueprint for quality management, maintenance, and reporting.

·       Meets rigorous performance measures for accuracy and turnaround time of dispensed prescriptions.

·       Has a patient-centered strategy for its patient management program that includes coordination of care, communication and education, patient rights and responsibilities.

·       Ensures the timeliness and performance of customer service center operations, including time to answer telephone inquiries.

·       Reports mandatory performance measures to URAC.

These attributes of a URAC-accredited pharmacy are anchored on 4 elements of specialty accreditation. The first element is 

customer service, communications, and disclosure

. The quality measures included for this element are all related to patient satisfaction metrics and patient privacy. It is always of the utmost importance that patients are satisfied with their pharmacy services, and it becomes increasingly important with specialty patients.

In the world of retail pharmacy, many patients are utilizing pharmacy services on an acute or temporary basis. Most specialty patients will require service through a specialty pharmacy for their entire lives.

The second element of URAC accreditation is 

. We must track quality data when dispensing specialty medications to ensure proper resolution and documentation of any quality errors that may occur to demonstrate adherence to quality standards. According to Aaron Turner-Pifer, URAC’s director of government relations and policy, “This quality data can and should be used as a competitive tool that exhibits a specialty pharmacy’s expertise.”

URAC also adds a sixth right to the “Five Rights” of medication administration, which includes right patient, right drug, right dose, right time, and right route. The sixth right that URAC includes is “the right result for the patient,” in demonstrating the importance of tracking patient outcomes.

This falls under the third element for accreditation: 

. Tracking and reporting patient outcomes is increasingly important as CMS regulations are following outcome-based reimbursement models, as mentioned above.

The final element of specialty accreditation through URAC is 

. The goal of tracking operations metrics is to ensure adherence to key performance indicators such as turnaround time and average speed of answer, and to identify opportunities to gain efficiencies where possible.

Tracking and working to decrease the average speed of answer, which is the average time that it takes a representative to answer an inbound call, is critical to patient satisfaction. The turnaround time is directly related to the speed with which patients can gain access to their specialty medication. When managing complex disease states, including HIV and cancer, a small decrease in turnaround time can significantly improve patient outcomes.

These examples of quality and service metrics are just a snapshot of the increasingly complex expectations for specialty pharmacy accreditation. To gain the competitive advantage to win business in the current marketplace and to ensure that patients are achieving the best possible outcomes, it is critical to get a passing grade on our accreditation report card.

https://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2016/april-2016/accreditation-in-specialty-pharmacy-no-longer-optional

https://www.urac.org/accreditation-and-measurement/accreditation-programs/all-programs/specialty-pharmacy/

https://cdn2.hubspot.net/hubfs/2297879/Specialty%20Pharmacy%20Industry%20Insight%20Report%20/URAC%20Specialty%20Pharmacy%20Report.pdf?t=1501279274271

Kimberly Firtz earned her Doctor of Pharmacy degree from Duquesne University and is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines.  Kimberly has spent the last 5 years working in Specialty Pharmacy, initially as a clinical pharmacist and most recently working on a variety of high profile Specialty Operations Projects.  Her current role is working with the Process Innovation team on an effort to transform Specialty Operations and optimize the stakeholder experience.

 With new specialty pharmacies emerging and existing pharmacies evolving, accreditation has become more important. 

Accreditation: The Specialty Pharmacy 'Report Card'

There are many daily conversations in our pharmacies about the importance of the stakeholder experience—patients, customers, physicians, and pharma&mdash;not to mention shareholders and wholesalers…the list goes on. These stakeholders all play a clear and vital role in the success of the business of specialty pharmacy.

However, there’s a key area missing from the above list. What about our internal teams? Doesn’t employee engagement impact our success as well?

Gallup’s “State of The American Workplace” survey from 2016 states that 51% of US employees are not engaged, and haven’t been in some time.

 This statistic shows that more than half of our workforce is not performing at their highest level.

Although the employee engagement numbers have grown throughout the years, this growth has been sluggish. In the past 5 years, employee engagement has grown a total of 4%, from 29% in 2012 to 33% in 2016.

As leaders, it is our job to develop strategies to drive the business forward, and in the world of specialty pharmacy, these strategies are constantly evolving. Due to the unpredictable nature of our current health care landscape, as well as the challenges that come with managing specialty drugs and therapies, leaders must be extremely creative and flexible when making daily decisions.

It seems that in specialty, we never fully get our footing from an operational change before another takes place. We all know that when we come back from vacation, it is not uncommon to return to our desks and have the business feel a bit different than it did when we left.

This begs the question: If we feel this way as leaders, how does this constant evolution and uncertainty affect our teams? How does this impact, in turn, affect our customers’ experience?

I’ve spent most of my specialty pharmacy career working on operational projects. Each time we roll out a large-scale project, we work very hard on the change management component.

We must ensure that our new initiatives are promoted and carried out by pharmacy teams who are informed and engaged. Without the team’s full engagement, our implementation will not be successful.

Our change management campaigns include a great deal of engaging communication. From posters to newsletters to games and prizes, we take every avenue possible to notify our teams of the upcoming changes and to be sure that they feel included throughout the process.

Through the development of internal change champions, we work 

 our teams to implement changes, rather than simply cascading the changes 

Why is it that we place such a large emphasis on change management when rolling out large-scale changes, but we don’t perform these activities with our smaller day-to-day changes? With our operations evolving daily, should we have more of a consistent focus on change management within pharmacy operations?

If we expect our teams to deliver efficient, quality care to our patients and physicians to execute on service goals that may be a moving target, how do we ensure they know exactly where this target currently is?

In researching employee engagement at a high level in the health care sector, and it’s clear that engagement is likely even lower in health care than in other segments of the market. According to Kristin Baird of Baird Group, a healthcare consulting firm, this is due to “the stress, angst, and pressure associated with delivering health care today.”

This quote reflects the current atmosphere around working in health care, and the high-stress environment that currently exists in the segment.

I’d take this a step further, and suggest that engagement is even lower in specialty pharmacy than in other areas of health care. Why, you ask? The answer is simple.

When strategies must change as frequently as ours do, it is difficult to consistently communicate these changes, as well as the way that they’ve impacted our goals, to our teams. When the teams lack this information, it can be very difficult for them to understand their expectations.

Employees who are continually switching gears with a limited understanding of the “why” behind the changes will struggle with engagement; however, hope is not lost.

There are many things that we can do as specialty pharmacy leaders to improve employee engagement, and in discussing our employee engagement, we are already on the right track.

Acknowledging the Current State of Engagement 

It was clear by researching engagement that the number one thing that leaders can do to improve employee engagement is to acknowledge the current state of engagement in their organization, and know that it can improve. This seems fairly straightforward, but it is easy to let our own experiences and biases fog up our view of the current state.

Let’s all take a step back and consider what it’s like to work on the front lines of today’s specialty pharmacy:

Back-to-back calls are coming in. My supervisor is likely in a meeting, but is managing to send me messages to try to take more calls. I am seeing emails coming in informing me of new specialty medications that are coming to market, and whether they may be handled by a separate team, or whether I need to learn specifics for helping patients taking these medications. As much as I love taking care of patients, this is becoming exhausting.

This is clearly an oversimplification, but I think we can all see where I’m going here. We’re busy. We’re scurrying around to help our extremely sick patients, and things are constantly changing. It’s exhausting for everyone involved.

Thankfully, once we acknowledge the current state of our employee engagement, there are steps that we can take to empower our teams to become more engaged.

There are many lists that detail potential steps to improve employee engagement. I’ve compiled a few, and provided some highlights through the lens of the specialty pharmacy experience.

Clarify expectations and relate them to your vision

	A frequent complaint heard across specialty pharmacies is that things change so quickly that it’s hard to keep your eye on the ball, so to speak. In our fast-paced culture, it is easy to get bogged down in day-to-day stressors, and lose sight of the bigger picture. Every pharmacy has a vision for the future, and clarifying employee expectations to align with this vision is of the utmost importance. This helps employees to understand the “why” behind what they are doing, and helps them feel part of something bigger than just their piece of the process.

Ensure clear communication pathways so that all are informed

	When there is constant change, there needs to be constant change management. As I discussed previously, we tend to focus on change management during times of large change, such as a shift in vision or rebranding of the business. However, if we are changing small processes and procedures on a weekly or daily basis, it is critical to engage the team in these changes. Simply getting the team together in a huddle to communicate the changes may work, or someone on the team could take charge of putting together a newsletter for communication. Simply making sure that each member of the team understands the changes that are occurring and what to expect next will greatly improve engagement.

Arrange teams so that each employee can do what they do best

	I think all of us would say that we do our best when we feel motivated about our work, but I would turn this around and propose that we are the most motivated when we are able to demonstrate our best work. If there are 2 employees on a team, and 1 is best at resolving customer service issues and the other is best at drafting written communications, why not empower them to do these things if there is a need to do so? They will immediately feel more engaged in their work.

Provide positive and constructive feedback

	When providing feedback to employees during monthly, quarterly, or yearly performance reviews, make sure that you include recognition for the things that the employee has done well, along with constructive feedback on ways that the employee can improve their performance. Many of the templates that we are given for feedback include the opportunities for improvement, but lack the recognition of accomplishments. It’s simple psychology and classical conditioning that we will do more of the things for which we receive praise, so this is a critical part of a performance review.

Make sure everyone has what they need to be successful 

	The foundation of our role as leaders is to provide our teams with the tools that they need for success. Whether this includes physical tools, such as access to software to perform job duties or assistance with learning a new task, it is critical that we are available to provide these things for our employees. As leaders in specialty pharmacy organizations, we wear multiple hats. Many of us are involved in a variety of projects and initiatives on top of our duties to our teams, but if we can facilitate the success of our teams by being available when they need us, they will be more engaged.

Once we acknowledge our current state of employee engagement and resolve to empower our teams to become more engaged in their roles in our pharmacies, we can begin to implement positive changes. These changes will enable our employees to provide a better customer experience for all specialty pharmacy stakeholders.

http://www.gallup.com/reports/199961/state-american-workplace-report-2017.aspx

http://www.beckershospitalreview.com/hospital-management-administration/engaged-empowered-and-enthused-the-link-between-employee-engagement-and-the-patient-experience.html

Leaders in specialty pharmacy must work to improve employee engagement in order to boost the customer experience.

Meeting the Challenge of Employee Engagement in the Ever-Changing Specialty Pharmacy

Throughout my time in pharmacy school, I loved my role as a retail pharmacy intern, and I was immediately drawn to the innovative nature of the world of pharmacy. I hadn’t even heard of specialty pharmacy, but when I decided to sign up for a Specialty APPE rotation in my fifth year of pharmacy school, I was intrigued by the concept.

“What is specialty pharmacy, and what’s so “special” about it?” I asked.

Little did I know, I was about to experience the fastest growing segment of the pharmaceutical market. A landscape in which the opportunities are virtually endless for anyone with a desire for innovation, an appetite for trailblazing, and the grit necessary to create disruptive change.

An innovative spirit has been at the core of specialty pharmacy since its inception in the late 1970s. One of the quintessential stories of the birth of specialty pharmacy took place in my hometown of Pittsburgh, PA. 

In a time when many patients began to travel to Pittsburgh to receive organ transplant surgery, it became apparent that many of their local pharmacies didn’t have the expertise required to clinically manage their medication when they returned after discharge. Stadtlanders Pharmacy—a small local pharmacy outside of Pittsburgh&mdash;identified the need for enhanced clinical management of these patients’ medications.

They were also keenly aware of the challenges that these patients often faced when working with their insurance companies for drug coverage. The last thing that these patients needed after their transplant surgery was worrying how they were going to be able to pay for their medication, and filling out the paperwork to do so.

In an effort to mitigate these challenges, Stadtlanders began to service many of these patients—developing enhanced clinical training for staff and teaching them the skills necessary to efficiently navigate the complex payer landscape. 

The model that Stadtlanders created to satisfy these needs shaped much of the foundation for our current specialty pharmacy model. Stadtlanders, as well as other early specialty pharmacies, worked with discharge planners to coordinate patient care and deliver medications to their homes to ensure immediate access after discharge.

According to Scott Kober in an article from 2008, “these pharmacies grew through word of mouth; nurses and physicians heard from their patients about the ‘special services’ provided by these pharmacies and started to refer patients in similar predicaments.”

As the pharma research and development pipelines began to pivot toward innovative biotech compounds that required increased clinical management and carried extremely high price tags, the specialty pharmacy model became critical to the successful coordination of care for patients requiring these therapies.

There is currently no universal definition of a specialty pharmacy. Many of the definitions of specialty pharmacy specifically mention the cost of the medications being serviced, as specialty medications are typically priced at more than $600 per month. Though there are many financial hurdles that we must help the patient overcome throughout their medication therapy, there is certainly more to a specialty pharmacy than cost-mitigation strategies.

I like the definition put forth by Kevin Alder in an article from 2014 that defines specialty as a pharmacy that incorporates the following synergistic components First, a service model that is “structured to include the patient as an integral member of the care team through ‘high-touch’ patient-centric therapy management and support services.”

Second, the pharmacy must have “an environment of continuous quality improvement” that meets or exceeds the specialty patient’s clinical and administrative needs. Lastly, the standard of care in the pharmacy must be “structured to support expert and reliable therapy fulfillment according to rigid quality and patient safety standards, and the efficient resolution of administrative and financial barriers to access.”

This definition demonstrates many of the aspects of specialty pharmacy that go above and beyond managing the cost of the medications. The development of disease state management programs that focus on patient safety and quality is truly central to the specialty model. 

Collaboration with the patient and prescriber to ensure positive clinical outcomes for these high-touch patients is essential, and specialty pharmacies work diligently to continue to implement increasingly effective clinical programs. 

Even if there was a universal definition of specialty pharmacy, there’s really no textbook in which to put it. If a specialty pharmacy textbook was to be written, the strategies therein would likely be outdated by the time the book went to print. 

With our business segment showing double-digit yearly growth in a health care landscape that is as unpredictable as ours, the strategies need to continually scale while meeting stakeholder expectations that are constantly evolving. The amount of diligent creativity and flexibility required to thrive in the specialty pharmacy space may be at an all-time high. What an exciting place to be.

1. Kober, S. The Evolution of Specialty Pharmacy, 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2706163/

2. Alder, K. The Evolution of the Specialty Pharmacy Effectively Partnering for Persistence, February 2014. 

https://www.pm360online.com/the-evolution-of-the-specialty-pharmacy-effectively-partnering-for-persistence/

Kimberly Firtz earned her Doctor of Pharmacy degree from Duquesne University and is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. Kimberly has spent the last 5 years working in specialty pharmacy, initially as a clinical pharmacist and most recently working on a variety of high profile Specialty Operations Projects. Her current role is working with the Process Innovation team on an effort to transform Specialty Operations and optimize the stakeholder experience. 

The current specialty pharmacy landscape is constantly evolving, requiring a collaborative environment to meet the needs of patients.
