There are more ways than one to run a specialty pharmacy - and success can be found with any of them.
Specialty pharmacy, the niche that focuses on high-cost medications and high-touch care, is now practiced in all types of healthcare settings - clinics for specific disease states, health systems, community pharmacies, and ambulatory care sites, as well as dedicated specialty pharmacy providers.
As more specialty medications enter the market, the reach of this type of pharmacy practice is expected to expand.
“It’s one of the fastest-growing areas of our profession today,” said Elizabeth Cardello, BPharm, RPh, senior director of corporate alliances for the American Pharmacists Association (APhA).
More pharmacies are beginning to explore specialty pharmacy and the opportunity it has created in the industry. As more specialty pharmaceuticals hit the market, the need for knowledgeable pharmacists grows.
Tim Affeldt“Many or even all health systems right now are either getting involved in specialty pharmacy or they are already involved in specialty pharmacy,” said Tim Affeldt, PharmD, director of specialty/infusion operations for Fairview Specialty Pharmacy, LLC.
But while the opportunity is large, specialty pharmacy is an area that requires the management of complex medications and disease states, and it brings with it a series of challenges and obstacles. These include competition with pharmacy benefit managers (PBMs) that restrict patient access to outside specialty pharmacies, the lack of existing technology programs to support specialty pharmacy efforts, and maintenance of quality in an ever-changing market.
Affeldt and two other pharmacists from specialty pharmacies across the country led a roundtable discussion of those challenges at APhA’s annual meeting this spring.
During the session, which was moderated by Cardello, the panelists recounted their companies’ progression into specialty pharmacy, described how their specialty pharmacies operate, and outlined potential roadblocks.
Each path to specialty pharmacy is unique, and the examples of the three pharmacies highlighted during the session made that clear.
For Fairview Specialty Pharmacy, a business unit of Fairview Health System and a partner of the University of Minnesota Medical Center, the interest in specialty pharmacy began about two decades ago.
It originated in a need to provide better service to the 300 to 400 patients each year who received solid organ transplants at the University of Minnesota Medical Center.
“There was a need from that group that they felt they weren’t getting from their pharmacies at the time,” Affeldt said.
Today, Fairview Specialty Pharmacy serves approximately 12,000 specialty pharmacy patients a year and has 55 specialty clinics within its health system. In addition, the specialty pharmacy serves other specialty clinics outside the health system.
“We have access to more than 90 limited-distribution drugs, which can be very important for your specialty pharmacy,” Affeldt said. “We have a little more than 200 different payer contracts.”
Brian KomotoBrian Komoto, PharmD, president and chief executive officer of Komoto Healthcare, began his journey in 1981 when he purchased a small community pharmacy in Delano, Calif.
Komoto Healthcare - which has expanded to include a custom-care pharmacy with a compounding facility, a synergy pharmacy solutions company, and a family foundation created to help patients obtain access to medications - entered the specialty market in 2000 after teaming with a local managed care plan to find a better way to meet the needs of hepatitis C patients.
“We came up with the novel idea of having our own nurses track and work with the patients on a monthly basis to help them through the patient-service issues,” Komoto said. “We felt that nursing was a good complement to the pharmacist.”
The company now has several areas of specialty pharmacy, Komoto said, including respiratory syncytial virus (RSV), rheumatology, oncology, hepatitis C, and intravenous immunoglobulin (IVIG). It serves between 200 to 400 patients each month.
With 19 locations across the United States, Diplomat Pharmacy is the nation’s largest independent specialty pharmacy. In 2015, Diplomat dispensed 911,000 prescriptions throughout all 50 states and Puerto Rico, but there was a time when the company’s reach wasn’t nearly so expansive.
Claire LeeThe company began about 40 years ago as a small retail pharmacy in Flint, Mich., said Claire Lee, PharmD, CSP, CPHQ, clinical quality improvement supervisor at Diplomat. Between 2005 and 2012, the pharmacy expanded, adding locations in Michigan, Ohio, Illinois, California, and Florida. In 2013, the company expanded again through a series of acquisitions.
Diplomat now has a hospital specialty Rx program that encompasses a partnership with hospital outpatient pharmacies to provide 340B limited distribution and accountable care support; a retail specialty network, created to bridge the gap between community pharmacies and the specialty pharmacy market, which provides back-end services to its community pharmacy partners; specialty infusion services; and EnvoyHealth, a company division that offers patients individualized services such as clinical care management, reimbursement support, or patient-access management.
“Diplomat is unique because of our singular focus on specialty,” Lee said. “We also have a high-touch model, which makes us unique from some of our partners that dispense on a scale similar to what we do.”
While all three specialty pharmacies have been established for at least a decade, the speakers acknowledged that getting established posed some unique challenges.
Networks. As a regional player in the specialty pharmacy space, Komoto said, his company faced the serious challenge of being locked out of networks. He said that in some cases, patients who had been referred to his company were forced to go through the mail-order system. While his company was working to establish itself, Komoto said, it relinquished these patients to the mail-order system, although it still worked with patients’ physicians’ offices to help manage their care.
“The physician’s office still wanted us involved in following the patient, because we would help order labs; we would also provide the end result, the outcome, back to the office after treatment, and so we were still involved,” he said.
Technology. One of the biggest challenges that Fairview faced, Affeldt said, was related to technology and the need not only to collect but also to report necessary data to payers or pharmaceutical companies. He said a successful program requires an IT infrastructure with a data warehouse or central repository of data from multiple sources, which stores dispensing data but also has the functionality for the pharmacist to pull reporting information.
“That’s something that certainly was a challenge when we started, and it continues to be a challenge. How do you [the specialty pharmacy] put all the data points together that they want?” he said.
Lee added that another challenge related to technology is the lack of existing programs to support everyday functions in specialty pharmacy.
“As we move beyond a pure dispensing role, we are looking for ways to track the care management of our patient populations,” she said.
To address the problem, Diplomat has had to develop its own proprietary software that allows the company to track data about patient interventions and outcomes.
At Fairview, gathering the necessary compliance data from patients is usually done with assistance from outside software solutions. For instance, Fairview uses McKesson’s EnterpriseRx to track dispensing data necessary to calculate various adherence metrics. Pharmacist nurses, care coordinators, and account managers also interact regularly with patients to gather and collect patient information.
Pharmacy staff also play a key role in gathering compliance data at Komoto Healthcare.
“We’re high touch, so that’s where our medical assistants and pharmacy technicians get involved,” Komoto said. “They usually have their list of patients, or family members of that patient, that they are communicating with on a personal basis, so we know if they are on target or if they are actually taking medications.”
In addition to company software that helps collect data, said Lee, Diplomat collects its compliance data through patient interviews it conducts before each billing cycle.
“Prior to every dispense, we ask the patient not only about the quantity on hand, but also the number of missed doses that have occurred, so we have two data points to evaluate whether or not the fill date is in alignment with the number of pills or the number of injections the patient still has on hand,” she said.
If the patient-care coordinator identifies a discrepancy in the data, the patient is routed to a pharmacist for an evaluation to determine whether an intervention may be needed.
Every quarter, Diplomat conducts a retrospective analysis of its data on all its clinical management programs and evaluates the average medication-possession ratio and the proportion of days covered. This enables the company to determine whether it is meeting its own established benchmarks.
All three specialty pharmacies stressed the importance of collaboration, between pharmacy team members and with outside physicians and care managers, to better meet the needs of each patient.
At Diplomat, every time the company receives a prescription order from a pharmacy, a member of Diplomat’s patient-access team contacts the patient to outline what the patient can expect from the specialty pharmacy.
The prescription will then go through the member benefit management team, which assesses whether the patient has coverage for the medication and whether a prior authorization is needed.
“If the patient is not covered, or if the prior authorization still leaves the patient with a very high copay that the patient may not be able to afford, then the patient will go to our funding assistance team,” Lee said.
Once payment challenges have been addressed, the patient receives a call to set up delivery of the prescription, and patient background information is gathered and assessed by a pharmacist before any medication is sent to a patient.
The process at Fairview usually starts in the clinic, where the specialty pharmacy works with the provider, care coordinator, or nurse manager working with the patient to set up and chose the appropriate therapy. The prescription order then follows a process similar to Diplomat’s, with identification of the treatment, prior authorization, and identification of any obstacles to care, Affeldt said.
An electronic medical record seen by all involved in a patient’s care helps the pharmacists communicate with other members of the healthcare team in real time to speed up the approval process and address any obstacles to patient care.
Specialty pharmacy is an area rich in opportunity; however, those in the field say challenges and obstacles are also a prevalent part of the industry.
When asked to identify the biggest challenge facing the industry today, the panel speakers brought up issues already discussed, such as access and technology, but they also cited the importance of having the necessary cash flow on hand, maintenance and establishment of quality check points in a rapidly growing market, and the role significant costs can play in dictating which therapies are approved for treatment.
Access has been a growing problem for his pharmacy, said Komoto, as increasing numbers of PBMs own their own mail-order companies and often require patients to use them for specialty services. Whereas four years ago, 10% of business in his service area went to mandatory mail-order, he said, more than 70% does so today.
Komoto said he has tried to address the problem by going to state and national pharmacy associations, but he believes that ultimately legislation will be needed in order to bring about real changes.
According to Affeldt, the industry is starting to see more instances of a large payer or payer organization working with a pharmaceutical company to negotiate the cost of a specific product. This can have implications for patient therapy, he said, if pharmacists and physicians need to look at a specific product rather than all available therapies.
“I think that is one of the biggest challenges and concerns, but it’s also certainly understandable when you are looking at costs and how can you reduce costs,” he said.
The speakers concluded their presentation with advice for pharmacists interested in pursuing specialty pharmacy.
Lee recommended that pharmacists take advantage of resources that would give them a better understanding about the nature of specialty pharmacy, whether that is done by reaching out to a specialty pharmacy, going through a certification program, visiting the Specialty Pharma Education Center online, or reading specialty pharmacy publications.
Affeldt made the point that pharmacies don’t have to try to be everything right away, but instead should focus on what they can be good at initially.
“How can you fill a gap that’s possibly being seen in your marketplace or how can you possibly partner with a provider in your marketplace?” he said.
Regardless of the challenges that exist, said Komoto, pharmacists need to keep the focus where it belongs – on the patient.
“When you get involved in these areas of specialty, you can really make a huge difference in the lives of that patient,” he said.