Tom Reinke

Advanced therapy management may lead to physician acceptance of additional medications infused at home

Tom Reinke

Home infusion has been around for over 30 years, but it is a service that has never really taken off. Effective infusion drugs have been developed for acute conditions, but home infusion has been relegated to less glamorous uses such as parenteral nutrition, analgesics, and antibacterials for chronic situations.

Part of the problem may be that home infusion is perceived as a service coming from providers that might have inadequate controls and variable quality.

“The challenge has been to get the medical community’s acceptance of this as a safe and effective method of care,” says Paul Mastrapa, president of Walgreens Infusion Services. Walgreens claims to be the country’s largest home infusion provider.

Home infusion will not become widespread until physicians feel that the procedure is safe for their patients, says Don Liss, MD, a senior medical director at Independence Blue Cross in eastern Pennsylvania.

The company sees potential for home infusion to overcome its narrow role but there are also important hurdles that stand in the way.

Emerging growth

Walgreens says home infusion is expanding. “Home infusion is targeting a wider range of medications for acute situations like pain management, chemotherapy, and hydration. We also take care of patients awaiting transplantation and those in late-stage heart failure,” says Mastrapa.

He says his company has been credentialed by Elan Pharmaceuticals to administer Tysabri (natalizumab), which is restricted by an FDA REMS (risk evaluation and mitigation strategy) program. The company also administers Remicade (infliximab), another biologic.

Greg Gambescia, who manages the self-injection and infusion therapy programs at Independence Blue Cross (IBC) in the Philadelphia area says that additional medications, some of them complex, are working their way into home infusion, but that usage is not yet significant.

A move to complex medications, particularly for acute conditions, would be a step up for home infusion.

Walgreens is trying to demonstrate that taking that step is feasible and that alternate settings, including the home, are a viable alternative to costly hospital outpatient departments and doctors’ offices. The company has implemented an intensive pharmacist-led therapy management program for intravenous immunoglobulin therapy, one of the few high-cost complex medications in home infusion.

Obstacles

While Walgreens paints a positive picture of home infusion, the treatment’s future depends on several critical factors, including acceptance by prescribing physicians.

“Over the past couple of years, several new infusion drugs have been introduced for chronic diseases, but they have been used primarily in controlled settings,” says Don Liss, MD, a senior medical director at IBC.

“As physicians gain experience with these drugs, we may see them used in the home, but that change will occur primarily because physicians have become comfortable with the safety of the home setting.”

Another critical factor is Medicare, which does not cover home infusion for most patients. The medications are covered under Part D and the infusion pumps are covered under Medicare’s durable medical equipment benefits, but the nursing services are not covered. “It’s a broken benefit,” says Mastrapa.

A 2010 GAO report reviewed coverage of home infusion services by health plans and found that they effectively managed these services. It recommended that Medicare “conduct a study of home infusion therapy to inform Congress regarding potential program costs and savings, payment options, quality issues, and program integrity associated with a comprehensive benefit under Medicare.”

Unsuccesful lobbying

The home infusion trade association has consistently but unsuccessfully tried to get Congress to pass home infusion legislation.

Most private payers cover hands-on home infusion, which is the cost of a nurse. Mastrapa says that health plan benefit structures often encourage infusion in a higher-cost setting. “A patient may have a 20 percent [coinsurance] requirement for home infusion but only an office visit copayment for infusion services in a doctor’s office,” says Mastrapa.

Private health plans do not pay for the expanded pharmacist services that Walgreens has brought to IVIG therapy.

The expansion of home infusion will depend on acceptance by prescribing physicians and on well-thought-out coverage policies by Medicare and private health plans.

Walgreens expands pharmacist role for IVIG home infusion

Intravenous immunoglobulin (IVIG), one of the few high-cost, complex medications administered through home infusion, presents coverage problems.

IVIG was initially approved for primary immunodeficiency but neuro-immunological diseases now account for 73 percent of IVIG therapy, according to Ashar Hasan, RPh, immunoglobulin program director at Walgreens.

Much IVIG use is off label. In some cases off-label use is covered by health plans based on peer-reviewed literature and publications from physician specialty societies and from professional organizations such as the American Hospital Formulary Service.

Off-label use also includes a long list of very diverse conditions, and the coverage policies of the national health plans go to great lengths to list conditions that are not covered.

The cost of IVIG at home can range from $5,000 to $15,000 per month and the cost in a hospital can be $40,000 to $50,000 per month.

In other words, off-label use can be expensive and wasteful. The cost of IVIG at home can range from $5,000 to $15,000 per month and Hasan says the cost in a hospital can be $40,000 to $50,000 per month.

Managing IVIG therapy is a thorny challenge.

“The diseases in which IVIG is used are not fully understood, and immunoglobulin’s mechanism of action is not known. There are no clinical guidelines for certain conditions. It’s like the wild, wild West,” says Hasan.

The lack of clear treatment guidelines places an additional burden on health plans. In addition to figuring out if there is evidence to support IVIG in disparate situations, they have to go one step further to determine appropriate therapy for conditions with scant supporting literature.

Hasan says that the challenge is made more complicated by frequent IVIG non-response in patients.

A common utilization management technique of health plans is to limit authorizations to three months of therapy.

He says the treatment protocols for different diseases vary greatly. “Medication for immunodeficiency is low-dose therapy, but in neuro-immunology it is high-dose therapy, requiring 8 to 10 hours of infusion. So, 65 to 70 percent of the use of IVIG is in hospital outpatient departments because physicians don’t understand how to dose or infuse this medication,” says Hasan.

But that isn’t always the best choice. “In the hospital setting, I have found it used for chronic fatigue syndrome, severe back pain, and post-chemotherapy nausea, which are not recognized,” says Hasan.

Walgreens has analyzed the IVIG claims for several health plans and found that there is no indication of the effectiveness of IVIG therapy for 7 to 10 percent of claims.

“Therapy management can be improved in several ways,” says Hasan. “The starting point is better patient assessment. We have adopted the majority of the recognized assessment tools for various diseases, and we request lab and renal function tests for comorbidities to help in treatment planning.

Pharmacists are part of the home infusion team, conducting a patient assessment and then designing a treatment plan to offer the phsician.

Another area requiring attention is product selection. That’s because there are five or six different products from several manufacturers, so if the patient has diabetes, you have to use one product, and if it is compromised renal function, it’s another product.”

Product selection is important because manufacturers use different processes for selecting and purifying antibodies.

A third area is premedication of patients.

“We want to make sure we tailor the drug or the therapy in such a way that patients get the maximum benefit. Some patients may have comorbidities like congestive heart failure or edema, and we arrange Lasix, hydration, or steroids.”

The company published a study of home IVIG therapy that found that patients with neuroimmunological disorders who received premedication had significantly fewer adverse reactions than non–premedicated patients (18.2 percent compared with 29.3 percent, P = 0.02).

Walgreens has incorporated these services into its home infusion division by involving pharmacists in patient assessment at the outset of a referral and in the design of an evidence-based treatment plan that is offered to the doctor for approval.

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