Specialty Pharmacy

Payer Demand for Disease Management, Therapy Management Programs Is on Rise

Reprinted from the March 3, 2005, issue of SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively.

Specialty pharmacies increasingly are jumping into disease management or therapy management, often at the behest of clients who are beginning to realize the benefits of SPs working to ensure compliance and persistence for complex specialty therapies. And many in the industry predict that the trend is likely to accelerate as specialty products are approved for such common diseases as diabetes.

"What we've tried to do is lay the groundwork for the explosion we expect through the pipeline," says Jane Havens, manager of specialty pharmacy for BlueCross BlueShield of Tennessee, which rolled out its specialty pharmacy management program in January 2004.

"The tide is turning, with people coming into us" looking for therapy management, adds Tony Zappa, executive vice president of operations at Chronimed, Inc. "Questions [in RFPs] are now being staged around adherence and persistence." In addition, the pharmaceutical manufacturers want distributors of specialty products to be able to provide programs, Zappa says. "Because these drugs have fairly significant side effects, they want to know you're managing them and not just distributing them."

Few specialty pharmacies offer full disease management programs. Most offer programs intended to manage drug treatment only, says Enoch Strollo, director of sales and marketing for BioPlus Specialty Pharmacy. "The term [disease management] is used a little loosely in our industry," says Strollo. "Truly, we usually talk about it as being pharmaceutical care or therapy care management. The doctors are really doing disease management — we just assist them." BioPlus, Strollo says, is "really trying to promote the term specialty care management, to let people know we're working with the doctors."

Zappa agrees. "For some of these disease states, we manage medications, certainly, but we don't get as involved in managing the actual disease. Diseases like multiple sclerosis and rheumatoid arthritis are a little more complicated because the disease state is more complicated." Also, few — if any — specialty pharmacies will accept risk when helping to manage these patients, unlike the model of disease management where the company providing DM services did accept financial risk, Zappa says.

Education on Side Effects, Administration Key

Specialty medications require greater side-effect education and also much more instruction about administration of the medication, says Jan Berger, M.D., senior vice president and chief medical officer for Caremark, Inc. "At Caremark, if a drug needs additional support, it fits in our own specialty pharmacy," says Berger. Caremark has therapy management programs for multiple sclerosis, cancer and hemophilia, she says.

"I agree that distribution of specialty medications has a different flavor than traditional PBM medication distribution," says Berger. "Medical management programs in a well-run specialty pharmacy really — in my mind — is very much a necessity as part of the distribution model."

Berger agrees that payers are getting far more interested in therapy management. "We do have a small proportion of clients who want us to do just distribution," she says, "but by and large, all of our participants and clients have therapy management associated" with specialty pharmacy services. "The great majority want that and want us to support that," she adds.

A subset also wants full-blown disease management services, which Caremark can provide for asthma (Xolair, for treatment of asthma, is a specialty pharmacy product). Accordant Health Services, Inc., a wholly owned subsidiary of Caremark, provides disease management for 15 or 16 conditions, including hemophilia, multiple sclerosis and rheumatoid arthritis, says Berger.

"The disease management subset is definitely growing," she says. "On the usual suspects — like asthma — we have well over 100 clients who have chosen to use the services." Berger adds: "What makes Caremark unique is we're able to integrate distribution of the meds with the disease management."

Adherence, Persistence, Compliance

Chronimed considers therapy management to include three parts: adherence, persistence and compliance, says Zappa. The company provides therapy management services for four conditions: transplant, hepatitis C, HIV and multiple sclerosis (a recent addition). Also, Chronimed is working on new programs for rheumatoid arthritis, psoriasis and Crohn's disease.

The program components vary by disease, Zappa says. For the transplant, hepatitis C and HIV programs, there are seven "touchpoints" with the patient in the first year. These touchpoints include a conversation with the patient in which he or she can opt out, a survey that gathers objective data such as refill history and lab results, and another survey that gathers subjective quality-of-life data.

"All the data is stored in the database, and we can use it to see such things as the side-effects rate," he says.

The MS program is "more basic," and doesn't delve into quality-of-life data, Zappa says. "That's mostly an adherence and persistence program."

Adherence and persistence form the bedrock of all Chronimed's therapy management programs, he says. "During the first-time counseling, we spend a fair amount of time talking to them about what happens if they don't adhere." Therapy managers can suggest ways to improve adherence, such as tying pill-taking to a daily television show or to a meal, and can discuss ways to deal with problems such as travel that involves time-zone changes, he says.

On persistence, the Chronimed therapy managers discuss with each patient the importance of knowing lab results and what they mean. "For hepatitis C, 80% of the time we can get the patient to both get the data from the doctor and to understand what it means," Zappa says.

Chronimed also does retrospective reviews on the refill side, and if a patient is flagged with a late refill, therapy managers can make an unscheduled call to try and get that patient back on track, he says.

BioPlus Works to Win Doctors' Trust

According to Strollo, BioPlus considers the first part of therapy management to be office management, which means "trust, and no hassle, for the doctors." For example, if a physician's office sends BioPlus a patient, and the specialty pharmacy finds that the patient's insurance doesn't include BioPlus, "our job is to help that doctor help that patient get their medication," he says. Therefore, BioPlus will initiate referrals to other specialty pharmacies in an effort to help the physicians.

Second, BioPlus's concept of therapy management includes compliance management and side-effects management, says Strollo. "A lot of doctors and a lot of major payers look at medications on a per-unit basis. We look at it as an investment in the patient's life," he says. BioPlus spends a great deal of time working with the patient to manage side effects and to ensure compliance, because the costs of noncompliance — both to the patient and to the health plan — are so great, he says.

BioPlus patients have access to doctors of pharmacy who are trained in their specific conditions 24 hours a day, seven days a week via a toll-free phone line, Strollo says. If the toll-free hotline can get a patient the information he or she needs, then that patient won't have to contact his or her physician.

"True therapy management should be able to eliminate doctors' visits" by eliminating compliance issues, says Strollo. "Our job is to know everything about a few medications." BioPlus deals with about 20 to 30 medications, he says, and provides therapy management for hepatitis C, psoriasis, Crohn's disease, rheumatoid arthritis, and cancer.

Reimbursement Still an Issue

Many insurance companies don't take into consideration the risks they might run by failing to provide therapy management for patients at high risk of discontinuing therapy, Strollo says. He adds, "In the long run, these insurance companies have to see the value of true therapy management for the cost."

For example, an average of 50% of hepatitis C patients complete therapy, but of BioPlus hepatitis C patients, an average of 62% complete therapy, he says. The specialty pharmacy achieves this through intensive counseling of patients aimed at teaching them about their medications and their laboratory results, he explains, adding that "hepatitis is probably one of the toughtest and one of the most important [therapy areas] to manage."

Hepatitis C therapy costs $30,000, so patients who get halfway through the therapy and then quit cost their insurers $15,000, Strollo says.

Getting reimbursed for therapy management services "is still a battleground right now on our end," says Strollo, who says that some insurers want to pay specialty pharmacies average wholesale price (AWP) -20%. "We're saying, 'You can't do it for that.' Usually what happens in that situation is we submit information back to the payer and explain therapy management. If you're accepting AWP -20, you're not going to be able to have the staff" to do therapy management.

"Most of [the payers contracting with BioPlus] have an understanding of what we provide from the front end and are willing to give it a try," says Strollo, who adds that the specialty pharmacy still is pricing at AWP -15% to AWP -17%. "Two percent makes a big difference," he says.

Chronimed is offering programs on a per-member, per-month basis, says Zappa, who adds that "we try not to tie it to the drug." The specialty pharmacy provider did its first couple of therapy management programs with strategic partners at no cost, he says.

"This is a different type of sell," Zappa notes. "It's not like selling disease management at the PBM level. Most people have not dealt with transplant before, where one poor adherer that leads to a lost transplanted organ can cost $200,000 or $300,000 because of retransplantation or dialysis."

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