Pharmacy Shows Savings, Improved Outcomes Under Chronic Kidney Disease

December 28, 2007

Diplomat Specialty Pharmacy Shows Savings, Improved Outcomes Under Chronic Kidney Disease Pilot

Reprinted from 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.

As the number of Americans with chronic kidney disease continues to rise, one specialty pharmacy is reporting success with a pilot program focused on managing CKD.

Diplomat Specialty Pharmacy managed CKD patients for Michigan's McLaren Health Plan in a one-year pilot that began in September 2006, in which 80 patients were randomly assigned to either a control or study group. The company utilized disease management (DM) and medication therapy management (MTM) techniques in its CKD Navigator program.

Diplomat — which worked on the pilot with McLaren, The National Kidney Foundation of Michigan and manufacturer Genzyme Corp. — tracked these patients' medical and prescription cost data for six months and compared their data to those of the control group. The company reports that it reduced medication and medical costs by $300 per patient per month (PPPM) compared with the control group. Diplomat also says that it achieved savings of $150 per patient per day in delaying the onset of dialysis.

Diplomat President and CEO Phil Hagerman tells SPN that the pilot has shown that the company can provide up to a 6-to-1 return on investment (ROI).

Diplomat Focuses on Stage-Three CKD Patients

Out of the five stages of CKD, as determined by glomerular filtration rate (GFR), Diplomat focused on stage three as the best level of intervention. At this point, patients "are getting fairly close to a slippery slope. If they are caught early in stage three," they could remain at that level or could even revert to stage two, says Hagerman. The "most important thing" for CKD patients is to halt the progress of their disease so they do not suffer renal failure, he says.

The combined prescription and medical costs for the control group of stage-three patients totaled $999 monthly, according to Hagerman. The same costs for the Diplomat-managed group were $639 PPPM, demonstrating an average savings of $360, he says. After the cost of Diplomat's services (about $60 per month) was factored in, this meant a net average savings of about $300 PPPM. "As we expand the program and add some additional educational pieces, we anticipate an ongoing cost for a health plan or employer group would be in the $60 to $90 per enrolled patient per month, depending on the services involved," Hagerman says. "This works out to be an ROI between 4 and 6 to 1, which is a tremendous return for a DM program."

According to an article in the Nov. 7 issue of the Journal of the American Medical Association, a study at Johns Hopkins University showed that between 1994 and 2004, CKD prevalence among U.S. adults rose from 10% to 13%. National Kidney Foundation data show that 20 million Americans have CKD, and another 20 million more are at increased risk. The organization says that diabetes and high blood pressure are responsible for two-thirds of the cases of CKD. Because of this link, Diplomat focused on managing not only CKD but also these comorbid conditions.

Estimates put the number of people on dialysis or who have undergone a kidney transplant — those who have reached stage five of CKD, which is kidney failure — at between 300,000 and 500,000, a number expected to increase to about 750,000 by 2015. Average annual dialysis patient costs are approximately $70,000.

Keeping patients from going on dialysis "is an interesting and exciting part of the study," says Hagerman in relation to the $150 per-patient per-day savings. "Our original goal when we designed this program was to show the cost savings from keeping patients from progressing to dialysis.…We were very surprised to find we could show this much savings per month by keeping the stage-three patients healthier and not factoring in any costs of the savings for delaying the onset of dialysis."

He adds that the small number of patients in the study group and the short length of time that the data were based on means the company cannot "accurately determine how much 'extra' savings we have gained from delaying the onset of dialysis. But the improved health of the patient as reflected by their reduced medical costs is a clear indication that the continued slide downward in health seen in many CKD patients had been stabilized to some extent."

Hagerman points to various reasons for the outcomes. Diplomat nurses followed up monthly with patients through telephone calls. "When our nurses contacted the patients, we verified all medication access issues to support compliance," he says. Diplomat also performed full medication reviews and recommended any therapy adjustments or changes to patients' primary care physicians.

MTM Process Found Many Medication Problems

Through the MTM process, Diplomat found that some patients were taking drugs that were nephrotoxic or were at levels that needed to be reduced, says Ron Alexander, vice president of clinical services at Diplomat. Some patients who were seeing both a specialist and their primary care physician were on duplicate medications, he adds. And drug-drug interactions were detected as well.

"This level of detail and intervention with patients is by far and away not the norm," says Maurie Ferriter, director of programs and services at the National Kidney Foundation of Michigan, who is on dialysis himself. "But it is exactly what needs to be done. The [Diplomat] program is not unique" - he notes that Baxter Health Care, DaVita, Inc. and the American Association of Kidney Patients have similar offerings - "but it is the best, most thorough program I've seen. A lot of people could benefit from this, but they're not getting it."

Focus on Insurer, Physician Education

Diplomat wants its educational efforts to reach beyond the patient population.

"If we can convince managed care to spend some money, there is a tremendous opportunity to impact a large amount of patients," maintains Alexander, and to keep them productive members of society.

Many patients, says Ferriter, "don't understand the ramifications of not complying with their treatment..They haven't been educated on what they need to do."

In addition, says Atheer Kaddis, vice president of managed markets at Diplomat, there is "an opportunity to educate physicians on tracking GFRs." There is generally a "lack of follow-up," he says, with testing often done once a year. While the amount of testing should also depend upon what CKD stage the patient is in, as a general rule testing should be done a minimum of twice a year, says Alexander, who adds that three times a year is better. "This is not a costly test," he says. GFR can be calculated when a complete blood count, which costs less than $25, is done. In fact, many states now mandate that standard lab work include GFRs.

Diplomat Is Expanding Program

Aside from adding some further educational aspects to the pilot, Diplomat is expanding the program, with a goal of enrolling 1,000 patients by midyear 2008, says Hagerman. McLaren, he says, will identify more patients within its plan, and Community Choice Michigan, a division of CareSource Management Group, has just signed on. The insurer will begin to enroll patients in the first quarter of 2008.

Diplomat, says Hagerman, is "in discussions with several other health plans in Michigan" to expand the program. "We hope to have a health plan that will combine the CKD DM program with a carve-out of the prescription drug benefit," he says. "While Diplomat filled the prescriptions for some of the patients in the first phase of the pilot, that was not a requirement for the plan."

According to Hagerman, "we believe the success we have had with the MTM portion of the program can be even more improved when medication delivery is integrated into the program. Plus we expect a larger patient population will allow us to develop the statistics about the delay of onset of dialysis and the associated savings."

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