The newest specialty therapies can offer significant improvements in outcomes for what have traditionally been difficult-to-treat disease states. But they are complex and often high-cost, and can present side effects that are hard for patients to tolerate. Find out how Burmans Medical Supplies, a family-owned pharmacy outside of Philadelphia, is meeting the challenges posed by the latest hepatitis C protocols by using a proprietary Web-based clinical treatment management software platform to support patients and prescribers and set the standard for managing complex specialty therapies.

Specialty therapies are a growing focus for drug companies, physicians, and pharmacies. They can offer significant improvements in outcomes for what have traditionally been difficult-to-treat disease states. But as these complex, often high-cost, and potentially difficult-to-tolerate treatments reach more patients, they bring new challenges for the pharmacies and physicians tasked with managing the therapies. Burmans Medical Supplies, a family-owned pharmacy outside of Philadelphia with a long-term commitment to clinical treatment programs, has met these challenges by developing its own Web-based therapy management platform.

A History of Care

John Regester, now a VP at Burmans
John Regester, VP, Burmans Medical Supplies

When Steve Burman took over the pharmacy from his father in 1989, he immediately started a full-service home healthcare company. Then, in 1997, Burman was looking to grow the respiratory supply business. He built clinical management programs around specific conditions such as asthma, COPD, chronic bronchitis, and emphysema, and hired respiratory therapists to implement them. These programs were not at all common at the time, according to John Regester, now a VP at Burmans and the first full-time therapists hired by Steve Burman. But this early commitment to clinical care at Burmans has formed the basis for a progressive approach to pharmacy services that has evolved through the founding of a specialty pharmacy division in 2001 and on to the recent creation of a technology platform for managing hepatitis C therapies.

“When we started the specialty pharmacy, we wanted to focus on patients with a chronic disease that at that point were underserved,” says Regester. “Around 2007 we really started to focus on the hepatitis C population because we saw this as a disease state where a strong pharmacy services program could have a major impact on outcomes.” In fact, clinical trials had shown that hepatitis C is a curable disease and offered excellent benchmarks against which Burmans could judge the success of its program. So, explains Regester, Burmans developed a clinical-treatment program centered on patient education, side-effects management, and the highest level of service to help patients be as compliant as possible and create the best chance of success in clearing the virus. The technology that drove this early program included Burmans’ pharmacy management software from QS/1 and such basic tools as Excel.

Improving Therapies, More Patients

At the time, from 2007 to 2009, patients were on a drug regimen for a year and had about a 50-50 chance of clearing the virus. But in 2009, Burman started hearing about clinical trials for drugs called protease inhibitors that were resulting in sustained viral response rates up to 70% or 80%, with a treatment duration of only six months. Logically enough, better therapy was going to mean more patients seeking treatment. And an increase in patients alone would be both a great opportunity and a challenge for the pharmacy and for physicians. But the new therapies also came with complex new rules, called response-guided therapy algorithms. “This means that a patient’s response to the treatment determines how the therapy continues,” explains Regester.

The leadership at Burmans looked at this combination of an expanding treatment group and an increasing complexity of therapy and saw the need to innovate. “With the prospect of the size of the treatment group tripling or quadrupling, we knew we weren’t going to be able to use Excel anymore to keep us organized,” says Regester. “We realized we were going to need something much more advanced to manage patients successfully on this new regimen.”

Investing in the Vision

As a result Burmans entered into a collaboration with Philadelphia’s Connexus Technology that resulted in its clinical treatment management software platform, HealthTrac. “We looked to see if there was existing hepatitis C clinical management software out there,” says Regester. “There wasn’t. So in December 2009, we began working with Connexus to build what we’d need to manage the therapies coming through the pipeline.”

When the new agents came to market in June 2011, Burmans had a technology that was much more advanced than anything anyone had seen for hepatitis C treatment management. The pharmacy was ready to handle the requirements of the newly available therapies. “For example,” says Regester, “if we had a treatment-naive patient that a doctor wanted to put on INCIVEK, which was by far the more popular of the two new medications, we needed to be able to track the patient to see if his or her viral load was negative at weeks four and 12.” If this was the case, the patient could stop treatment at week 24 and have the exact same chance of clearing the virus as a patient who stayed on treatment for another six months.

If there was a patient on the same regimen, but with a viral load at week 12 that was still positive and above a given threshold, the protocols dictated that he or she should stop the therapy as well. “This patient could stay on for the next five years, and they aren’t going to clear the virus,” explains Regester. “And we know this was happening with these drugs. Patients were staying on regimens that were not going to lead to a positive outcome, and they felt terrible, because these medicines aren’t easy to tolerate. So if you weren’t using HealthTrac or some system to track the response, and you have over 900 patients all hitting benchmarks at the same time, how are you going to keep track of them and what their needs are in the protocols? We were able to show doctors that we had the technology platform that was ready for the surge in patients and the increased complexity.”

Sharing the Data

And while the original motivation behind HealthTrac was to create a tool that improved Burmans’ capabilities to track the critical treatment data and milestones across a large and growing patient population, there turned out to be a benefit for payers and physicians, too. “Payers typically require prior auth for these medicines,” says Regester, “but if no one is watching a patient’s progress, then you can still be throwing money out the window every month paying for prescriptions that aren’t needed any longer or aren’t ever going to achieve the desired end result.”

And Burmans has been able to create a secure portal that puts important data from look at patients by alert status, therapy week, benchmark, pending authorizations, or just individual patient charts.

And even more impressively, the data in HealthTrac helps Burmans prove that it is delivering superior outcomes. This is a capability that attracted the attention of manufacturers of hepatitis C drugs. “They saw that we had the systems in place to demonstrate the real-world efficacy of the drug,” says Regester, “and so they worked with us to develop a study that looked at over 1,500 patients on service with us between June 2011 and November 2012 to show that these patients were responding just as well through the first 24 weeks of therapy as the patients did in the clinical trials.”

Being able to produce data that’s highly reliable and can be validated really puts Burmans out on the leading edge, notes Regester. “Every piece of data in HealthTrac can be reported on,” he explains. “So, for example, you can see how one drug compares against another, which is the basis of comparative effectiveness research, or CER, and that is a big focus right now.”

Some of the metrics and data that drive the success of HealthTrac come from Burmans’ QS/1 NRx pharmacy management system. This includes all patient demographics, insurance details, and authorization and fill histories. Then there’s data that’s more challenging to pull into the therapy management platform, such as clinical labs, previous therapy response information, and fibrotic score to measure liver cirrhosis. Pharmacy systems aren’t currently set up to manage this kind of clinical data, notes Regester, so Burmans has a team within its operations dedicated to making sure the critical data is available within HealthTrac.

Ready for What Comes

Burmans’ decision to invest in HealthTrac as a response to the improving therapies for hepatitis C bore further fruit when, in December 2013, two new agents came out. Sovaldi and Olysio offered even better outcomes — with rates of greater than 90% of clearing the virus on therapy for as few as 12 weeks — and once again there was another big spike in the number of patients being treated, which has now quadrupled. “We were ready for this,” says Regester, “because in HealthTrac we have a clinical-care system that can adapt to new rules and let us scale to the challenge of serving a large new patient population with the same attention to the patient and the same ability to demonstrate the effectiveness of our clinical care and the superior outcomes we can help achieve.” CT