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Test patient response with initial 14 day fill
Although today’s emphasis seems to focus on patients not taking their medications as prescribed or forgetting refills, another concern is piquing interest: wasted medications resulting from an abandoned initial fill. Patients starting on a new drug might stop taking it prematurely-for a variety of reasons-resulting in waste and avoidable costs.
Insurers and pharmacy benefits managers (PBMs) are using innovative and established approaches to promote adherence to first-time prescriptions. Chief among them are partial fills, predictive modeling and patient counseling. The efforts aim to optimize drug selection for individual patients and reduce wasted medication.
For certain drugs, patient out-of-pocket cost, type of administration and side effects will impact patient adherence for first-fill prescriptions, says Jeremy Fredell, practice leader, Cardiovascular Therapeutic Resource Center for Express Scripts, a PBM based in St. Louis. For example, Fredell says, as many as 30% to 40% of patients do not respond satisfactorily to the first drug prescribed in the antidepressant class. Physicians often suggest patients try another drug in the class.
But tracking which medications are most likely to be abandoned is difficult. Last year, the Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy in Erie, Penn., partnered with the U.S. Drug Enforcement Administration to sponsor a National Drug Take-Back Day to obtain information regarding unused, first-fill prescriptions in Northwest Pennsylvania.
The top three categories of returned drugs were analgesics (34%), of which 84% were opioids; antibacterial agents (13%); and cardiovascular agents, such as statins (8%).
Since Jan. 1, 2013, rules from the Centers for Medicare and Medicaid Services (CMS) have required that in long-term care (LTC) facilities, prescribers write prescription cycles of 14 days or less for Medicare Part D benefits. In addition, pharmacies are no longer required to take back unused medications for credit and reuse or disposal. Pharmacies must collect data on drugs used by residents in LTC facilities and report the information to Part D plans.
CMS has proposed mandating Part D prescription drug plan sponsors outside of LTC facilities to offer a “trial size” of first-fill prescriptions for medications treating chronic conditions, along with prorated cost sharing based on the daily cost of the drug.
The savings are expected to be more than $1.8 billion by 2018
The two-week initial fill would test a patient’s response to and toleration of a specific drug.
A prescriber could write both an initial fill and a second prescription for the full supply at the same office visit, at the prescriber’s discretion. The latter prescription would be utilized if the enrollee and the prescriber agree the drug therapy should be continued after the trial period.
According to CMS, rationale for the proposals includes decreasing environmental waste, discouraging drug diversion, giving patients time to determine if they can tolerate a medication and savings for Medicare and Part D sponsors. The savings are expected to be more than $1.8 billion by 2018, assuming a rate of 32% discontinued first fills.
And short fills seem to be gaining traction in the commercial population as well.
Express Scripts uses short-fill programs for oncology, for example, providing a 15-day prescription rather than 30 days, complemented by nurse touch points at seven, fifteen and 30 days to determine if a patient is facing any barriers to adherence. If so, nurses recommend a therapy change and contact the patient’s physician.
Atheer Kaddis, senior vice president, sales and business development for Diplomat Specialty Pharmacy based in Flint, Mich., says non-adherence is more prevalent among refills than initial prescriptions.
Diplomat Specialty Pharmacy deploys partial fill strategies for 25 drugs, including oral oncology medications, as well as two drugs for hepatitis C, which are notorious for creating intense, flu-like symptoms. The prescription cycle is 14 days, but care coordinators check in with patients at 10 days for an assessment.
NEXT: Results of a nine-month study on partial fills >>>
Results of a nine-month study of a partial-fill program for 15 oral oncolytics authored by Kaddis, show that 41% of patients discontinued therapy after the first month of the prescribed therapy with nearly 20% stopping after one partial fill, attributed to adverse effects cited by patients.
While the percent of discontinued first-fill drugs is still relatively high despite the partial fill, the rate could reach as high as 70% otherwise, Kaddis says. Savings from the program, calculated from the waste minimization of 15 days of drug in the month that the drug was discontinued, could be in the range of $2,500 to $5,000 per patient per month.
Kimberly Burns, associate professor at the LECOM School of Pharmacy, supports the concept of partial fills for first time therapies. She says it is not always easy to predict how a patient will react even if a drug is prescribed according to standards of care.
She agrees with CMS’s suggestion that the cost of a partial fill be prorated to encourage patients to try medications. While she recognizes that patients would have to return for additional pills if the therapy works, causing additional dispensing fees, she believes a partial fill will prevent waste, diversion and environmental problems.
Burns would like to see CMS’s recommendation about trial fills go beyond just chronic disease medications.
Express Scripts also utilizes a proprietary predictive modeler to detect the risk of future non-adherence and develop techniques to address the problem. But Fredell says that the more common interventions, such as prior authorization and step therapy, also have an indirect beneficial impact on first fills by identifying optimal drug selection.
The common reasons behind non-adherence-cost, perceived lack of benefit and failure to meet patient expectations-also apply to first-fill prescriptions.
“When patients are asymptomatic, there is a higher rate of non-adherence because they don’t understand why they are taking a specific drug and if it will do anything,” says Kaddis at Diplomat. “Having high blood pressure is different than having heart burn, which a drug could address immediately.”
Kaddis notes that some seriously ill patients may reject prescribed drugs because they do not expect a benefit or because a medication may remind them of their illness.
Diplomat relies on patient-centered techniques, including partial fill, counseling, prior authorization and communication with physicians. It uses specialized care coordinators who are trained about specific drugs and diseases to work closely with patients in better understanding their medications and potential side effects.
“Our care coordinators are even given motivational and empathy training so they will know what or what not to say. The key is direct person-to-person contact,” Kaddis says.
He says if a drug is under the scrutiny of prior authorization, Diplomat expedites approvals by reaching out with patient profiles, historical data and diagnostic codes. The longer a prior authorization takes, the more possibility of non-adherence, Kaddis says.
Drug classes with the highest rate of discontinuation of the first-fill are protease inhibitors for hepatitis C and injectables such as interferon
Diplomat also mails out education materials to patients explaining how to take a specific drug and what to expect, along with starter kits outlining side effects and how to treat them. For example, Tarceva (erlotinib), an oral drug for lung cancer has a high probability of producing blistering and skin peeling. For erlotinib patients, Diplomat includes hydrocortisone cream and emollients with the education kits.
Kaddis says pharmacists defer to data on established drugs about side effects and drug alternatives to guide care coordinator and nurse outreach. “But it is difficult to determine exactly what a specific patient’s response to a drug will be,” he says.
Raulo Frear, general manager of OmedaRx, says large quantities of first-fills have gone to waste because of patients inability to tolerate certain medications. The PBM is working closely with its nurses and its specialty pharmacy vendor to help patients understand side effects, while also coordinating care with physicians.
Frear says the classes with the highest rate of discontinuation of the first-fill are protease inhibitors for hepatitis C and injectables such as interferon for multiple sclerosis. He anticipates that oral drugs for MS will provide potential for more adherence.
He says patients pay the same for two, 14-day prescriptions, as they would for one 30-day fill, so the cost structure makes sense.