Specialty Pharmacy

Featured Health Business Daily Story May 2008

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.

By Angela Maas, Managing Editor, (amaas@aishealth.com)

While putting patients in charge of administering their own self-injectable therapies is a critical part of specialty pharmacy, giving patients adequate training to do so is crucial to their compliance with these costly drugs. And with a large number of injectables in the drug pipeline, payers should take the time now to make sure that their specialty pharmacy programs are successfully meeting this need.

"Specialty medications require significant education in order for the patients to feel confident self-injecting and achieve a successful outcome. For many patients, injecting a medication into the skin or muscle can be very intimidating," says Kari Amundson, director of specialty pharmacy services at Fairview Pharmacy Services LLC. "Because of the expense and the complexity of the medication, we cannot assume that the patient is just going to figure it out on their own."

For some disease states, including rheumatoid arthritis and multiple sclerosis (MS), the only currently available specialty drugs are self-injectables, although that may change, as some oral formulations are in the pipeline. Still, according to BioMedical Insights, Inc., more than 90% of the 111 unique biopharmaceuticals in late-stage development in the United States as of May 2006 would require administration by either injection or infusion.

"Patients' education is the starting point that can make or break a specialty therapy," maintains Enoch Strollo, vice president of sales and marketing for BioPlus Specialty Pharmacy Services. He points to statistics showing that more than half of patients on specialty drugs are not compliant within the first 90 days of therapy. "Most likely, they were not educated by the provider as to what to expect and given a full detailed explanation of their treatment," he says.

While some physicians may administer the initial dose of a self-administered therapy in their office, it is not a given that this will occur. Specialty pharmacies are often called on to educate patients from the outset of a therapy. According to Mark Leeper, staff vice president, market and clinical program development, for PrecisionRx Specialty Solutions, WellPoint, Inc.'s specialty pharmacy, "outcomes are now showing that a centralized, coordinated approach is more beneficial for the member. Specialty pharmacies are providing this coordination." He says this might involve sending a patient back to his or her physician if needed; employing a home care agency, nutritional specialist or other health care professional for patient education; and utilizing pharmaceutical manufacturer-provided services.

Combine Drug-Specific, General Information

Patient education should cover a variety of topics. "Proper administration varies between drugs, so the patient must know how to administer their specific drug, as well as how to follow proper general injection techniques," points out Amundson. For example, she says, patients should inject subcutaneous drugs under the skin, as opposed to into the skin, which "can cause unnecessary pain, resulting in poor adherence to the medication regimen."

Likewise, patients should not inject drugs just taken out of the refrigerator, so patients need to know how soon they can take them and how they can warm them up. Mark Rubino, chief pharmacy officer at Aetna Inc., notes, for instance, that patients can rub an insulin shot between their hands to get it to room temperature so it's ready to be injected.

Rotating the injection site ensures that the skin remains healthy, says Amundson, especially since many of these patients will be injecting the drugs for the rest of their lives. "Repeated injections in the same site can cause scarring and impair the ability for the body to absorb the drug," she explains.

Specialty pharmacies should also educate patients about their drugs' storage. Many of these pharmaceuticals require special handling, such as refrigeration. Some drugs may be stable at room temperature for a while, but others may not, notes Rubino. "Improperly stored medications can result in damage to the active ingredient, impairing efficacy and resulting in wasted medication," says Amundson.

Patients may also need to mix their drugs before they are ready to be administered. Hemophilia therapy, for instance, must be reconstituted, says Leeper, and patients will need to know how to do this.

Specialty pharmacies also should prepare patients for the side effects that come with their disease and their medication. "Many of these medications can produce adverse reactions or events, which prevent a positive clinical outcome for the patient. Patients can actually feel worse on the therapy than they do with the symptoms associated with the condition being treated," says Leeper. For instance, flu-like side effects are common with hepatitis C therapies. Not preparing patients for what lies ahead, says Strollo, can result in payers getting hit with "an emergency room bill for something that may be normal."

Drug-drug interactions may also potentially occur, and a specialty pharmacist can identify issues with prescriptions and contact the physician if needed. He or she can also warn the patient about other potential effects to keep an eye out for.

While some medications may have an immediate impact on patients' well-being, other drugs may not show obvious improvements so quickly. Patients should be educated up front, says Strollo, on when they should start seeing results. Otherwise, patients may incorrectly assume that the drug isn't working and stop taking it. For example, the psoriasis drug Humira (adalimumab) does not immediately prompt a patient response. "Providing a patient with three months of Humira" — roughly $4,100 worth of injectable medication — "with minimal follow-up can be dangerous," he says.

Some specialty pharmacies also contact patients when they don't call in a refill at the expected time.

Beyond cutting down on waste, educating patients can also help payers realize cost savings through better outcomes. Leeper says that hepatitis C therapy can cost from $10,000 to $50,000. If a patient is compliant with the therapy and the therapy is effective, the virus is eliminated. This can avoid the need for a liver transplant, which can be about $300,000 in initial costs, followed by a lifelong regimen of costly drugs.

"We're focused on outcomes," says Rubino. If patients are noncompliant with their therapy and potentially incurred additional costs because of this, it's a "double whammy to the plan sponsor," he says.

Amundson adds that "encouraging the patient to take the drug as prescribed for the intended duration is an important component of the education," as is explaining the goal of the therapy. Specialty pharmacies should explain why keeping physician and lab appointments is necessary - for example, to monitor viral loads for hepatitis C, she says. When a therapy isn't effective, physicians can discontinue or change patients' medication. "In this case, payer costs are positively affected because they are getting more value for their investment when [the specialty pharmacy] helps ensure the ongoing appropriateness of the medication," says Amundson. She says that Fairview has shown a 12-to-1 return on investment through using pharmacist therapy management services.

In addition, says Amundson, "a component of education that is easily forgotten is making patients aware of available options if they cannot afford the medication. Compliance issues often stem from financial problems." Specialty pharmacies should remind patients to review any impending benefit design changes early, so higher copayments don't take them by surprise, she says.

Patient Education Is Ongoing Process

Patient education does not stop once the initial training is completed. "Patient education should never be a one-time deal," asserts Strollo. "It must be ongoing." Adds Leeper, "most of these disease states [treated with self-injectables] can be progressive in nature or have exacerbations of symptoms. As the disease changes, treatment regimens need to be monitored and altered."

According to Amundson, "often patients may not be ready for the education until the side effect occurs or their disease starts progressing." They may also forget information. "For certain safety issues, we believe it important to include reminders with every order. For example, at the request of our rheumatologists, we send out a brightly colored insert reminding the patient to contact their physician if they have signs of a more serious infection," she says.

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