Featured Health Business Daily Story, March 23, 2011

Managing Side Effects and Waste Is Critical With Oral Oncology Drugs

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers contain costs and improve outcomes related to high-cost specialty products.

By Angela Maas, Managing Editor
March 2011Volume 8Issue 3

As the number of FDA-approved oral cancer drugs continues to climb and their labels expand to include more indications, many payers are implementing programs to manage this class of drugs.

“In terms of the marketplace, there is a growing number of oral oncology agents approved and on the market in the U.S., plus a large pipeline…and a pattern of expanded indications” for already-approved therapies, says Stephen Cichy, senior vice president of managed care sales, marketing and product development at BioScrip, Inc.

Oral oncology regimens, including adjunctive therapies, can range from $1,000 to $10,000 per month, Cichy explains. “Treatment costs are likely to expand as they are taken over larger periods of time and with additional products.…From a payer perspective, the oral oncology category has grown exponentially over the last three to five years.”

With infused oncology regimens, a physician sees the patient more often, so there is close monitoring. But with oral oncolytics, a physician may not see the patient for weeks. “You get a prescription and that’s sort of it,” says Brian Solow, M.D., vice president and senior medical director for clinical services at Prescription Solutions.

Side Effects Can Be ‘Significant’

Because patient “compliance is very vital,” adherence monitoring is crucial, contends Solow. According to Rhonda Letwin, director of specialty reporting and analytics for Walgreens Specialty Pharmacy, “people think that because these are oral drugs, they won’t have significant side effects, but certain ones do.” In fact, says Cichy, many oral oncology regimens have toxicity levels that “are as bad as or worse than their IV counterparts.”

For these reasons, management programs that focus specifically on the oral oncolytics are becoming more common across the industry. Payers are asking specialty pharmacies to support them in three areas, Cichy tells SPN:

(1) Help maximize therapy adherence for patients,

(2) Assist in educating patients about medication tolerance, and

(3) Actively monitor regimen compliance and persistency.

Walgreens Specialty Pharmacy, for instance, has a drug-specific program for Tarceva (erlotinib), Sutent (sunitinib malate) and Nexavar (sorafenib) — drugs chosen for their patient compliance issues — as well as a general oncology program for drugs that need relatively less management. Letwin tells SPN that the company will soon expand the program to more oral oncolytics, but she declines to say what they are.

Company Grades Adverse Events

“When we originally built the program, we did so under the guidance of an oral oncology advisory board,” explains Letwin. “We looked at the National Cancer Institute grading scale for different adverse events.”

That scale offers four grades of toxicity. For example, Grade 1 nausea is the least severe and describes “loss of appetite without an alteration in eating habits,” Letwin says. Grade 2 means the “oral intake has declined without significant weight loss, dehydration or malnutrition.” But Grade 3 indicates “inadequate oral caloric or fluid intake,” and Grade 4 means “life-threatening consequences.”

Walgreens will do 10- and 20-day assessments of patients on these drugs, asking them a series of questions specific to each therapy. For instance, with Nexavar, “one of the questions we ask is if they are experiencing any nausea, vomiting or diarrhea,” says Letwin. A “yes” response on nausea triggers a series of questions to help determine how severe it is and whether the patient is still able to eat.

Once the patient’s adverse reaction is graded, “we then go to a drug-specific algorithm,” she explains. With Nexavar, if a patient reports Grade 1 nausea, Walgreens will counsel him or her on how to manage it, including suggestions for reducing it. But with Grade 2 nausea, Walgreens holds off on dispensing more of the drug and contacts the patient’s doctor. All of the information is also documented in an adherence report that is faxed to the physician around day 20 of the regimen.

“Another key piece of the program is waste management,” says Renee Clark, Ph.D., a senior data analyst for Walgreens. “The savings can be so significant for the payer,” as well as for patients who have copayments, if five days into a treatment regimen the patient finds he or she can’t take a $9,000-per-month drug, she says.

Patient out-of-pocket costs can be daunting, and they can have a tremendous impact on compliance. “It’s not only incumbent for a specialty pharmacy to provide proper dispensing and patient management services but also services that can correctly identify [patient-assistance] funding services” to help patients meet their copays, Cichy says.

Prescription Solutions, the PBM unit of UnitedHealth Group, sends out a patient questionnaire each time there is a refill. “We see if we can identify any issues and provide additional support,” says Solow. “We have claims data, so we can see who’s compliant and who’s not.”

Monitoring patients for side effects is also a big part of that PBM’s management of these patients. The company has oncology-trained pharmacists assess the severity of adverse events. “Depending on the side-effect severity, they might provide side-effect management tips, instruct the patient to talk with their physician or recommend calling 911,” Solow says. “We reach out to physician offices as well.” In addition, when these drugs are dispensed, Prescription Solutions “looks at provider instructions to make sure the patient is receiving the recommended dose.”

Oncology management company Biologics, Inc. has a “focus on quality patient care, which leads to cost containment. Everything falls into place from there,” says Tania Boardman, a spokesperson for the company.

Dan Duffy, executive vice president and general manager of oncology pharmacy services at Biologics, says the company focuses on three areas to manage patients on oral oncolytics: (1) care teams and patient care plans, (2) rapid response and communication, and (3) relationships with clinicians and patients.

Firm Designs Individualized Care Plans

Pam Smith, director of pharmacy services at Biologics, adds that “typically we will assign a patient to a care team” that will “develop an individualized care plan for that patient” that includes “tailored customized proactive touch points — based on the particular drug, disease and patient — by all members of the team to reach out to the patient.” Patients are given the option to opt out of the program, but more than 95% choose to participate, she tells SPN.

Biologics will also ask patients about any anxieties or concerns they have that could cause noncompliance. And midway through a treatment cycle, the company makes adverse event monitoring calls to make sure patients understand the regimen and see if they are experiencing any side effects, says Smith. “We also do compliance calls when it’s time to receive the next round of therapy” that include asking for a pill count and making sure the patient plans to continue with the therapy.

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