Giving Patients Better Access to Oral Anticancer Drugs

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The use of oral oncolytics is increasing, with 14 approved already and nearly one-quarter of the oncology pipeline consisting of oral therapies. Despite this, the Community Oncology Alliance (COA), a nonprofit organization that advocates for patients and providers in the community oncology setting, said many patients still have difficulty getting access to targeted oral oncolytics. To find out why, COA commissioned a study with Avalere Health, a strategic healthcare advisory firm in Washington, DC. The finished report, “Oncolytics/Addressing the Barriers to Access and Identifying Areas for Engagement,” identifies several obstacles patients and providers face in prescribing oral oncolytics and proposes ways to address them.

Avalere’s researchers reviewed 2009 drug formularies for private insurance providers and Medicare, focusing on “formulary placement, utilization management, and coverage sharing” for 11 common oral anticancer agents. They also conducted a literature review and interviewed 54 professionals that provide community-based oncology care for their perspective on why some patients who need medications to treat cancer are not receiving them.

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Patrick Cobb, MD, president of COA and managing partner of Hematology-Oncology Centers of the Northern Rockies in Billings, Montana, and an Editorial Advisory Board member for , said, “Some of the most promising and effective drugs for cancer treatment are given orally. Unfortunately, we see patients who either can’t get the drugs due to inadequate insurance coverage, decline these treatments due to onerous copayments, or face inordinate delays in receiving the medications due to insurance problems.” He pointed out some of the challenges Avalere identified, such as “the bifurcated insurance benefit design and its effect on disparate patient cost-sharing.” Unlike intravenous drugs, which are typically covered under the medical plan, coverage for oral drugs is usually provided under the prescription drug plan. Oral drugs are also assigned to the highest tier, which means patients must pay a higher percentage of the cost—often as much as 25% to 50%. This adds up to thousands of dollars each year, or in some cases, each month. Patients with drug coverage under Medicare Part D often have a period between when they have exceeded standard benefits and when catastrophic coverage kicks in—the so-called donut hole—that requires them to pay the entire cost of their prescriptions. These high deductibles and co-insurance costs sometimes cause patients to request intravenous treatments, which may be less effective, or to skip pills or prescription refills.

Another barrier is the failure of healthcare plans and Medicare to compensate cancer treatment professionals for time spent managing adverse effects associated with oral therapies or monitoring patients for compliance. Cobb said, “It is an enormous problem that Medicare does not allow for compensation for the time and resources it takes to manage a cancer patient on oral chemotherapy drugs.” As the professionals interviewed for the study explained, patients receiving intravenous drugs typically visit the physician daily or weekly to receive the infusions but with oral drugs, the physician has less opportunity to monitor patients for adherence or adverse effects.

Many private insurers have implemented a variety of utilization management tools for prescriptions of oral oncolytics, such as prior authorization or step therapy requirements. The oncology professionals told investigators this required time-consuming paperwork, with forms varying from one insurer to the next. The authors cited a recent study that concluded “Physicians spend 2 to 3 hours per week working with health plans while their nurses spend nearly 20 hours per week and clerical staff nearly 30 hours per week on these tasks.” As an example of insurers’ increasing demand for prior authorization, the report cited the following statistics: “The percentage of PDPs requiring prior authorization for Gleevec increased from 40% to 76% between 2006 and 2009. Likewise, the use of prior authorization by PDPs for Tarceva increased from 41% to 68%.”

Because of the greater share of costs borne by patients for the oral drugs, practitioners also spend more time talking to patients about their out-of-pocket burdens before prescribing, and practices must help patients complete applications for Patient Assistance Programs (PAPs), all of which have different forms and different eligibility requirements. This often results in delays in treatment, the individuals interviewed said, making it more likely they would prescribe an intravenous drug for a patient who needs to start therapy immediately.

Cobb called the current reimbursement system “antiquated” and said that this system, coupled with the typically greater cost of the new oral oncolytics, “threatens to undermine the already financially-challenged community practice model.” He called for parity between how oral and intravenous cancer treatments are reimbursed. “[This] will both increase access to life-saving treatments and improve the quality of life for cancer patients,” he said.

The study outlined other ways in which oncology offices and healthcare insurers can work to guarantee patients have access to oral oncolytics. Avalere and COA suggested four Best Practices oncology practices and payers could implement immediately to help ensure patients have access to oral oncolytics:

1. Establishing an in-office pharmacy—Oncology offices should stock and dispense oral oncolytics and supportive drugs, reducing the administrative burden associated with tracking and monitoring side effects.

2. Health plan consultation with practicing Oncologist—Insurance payers should include a practicing medical oncologist among those determining drug coverage for patients.

3. Dedicated financial counselor—Oncology practices should provide a dedicated financial counselor to assist patients with their financial issues throughout treatment with oral drugs.

4. Health information technology (HIT)— Electronic medical records and other HIT tools can help address many of the complexities associated with oral drugs, including tracking of patient history, treatment planning, patient compliance, and side effects.

In addition, the study recommended several long-term changes, including creating a universal patient assistance program, private payer engagement, developing an oncology-specific benefit, establishing reimbursement policies that support efforts required to provide comprehensive cancer care, passing federal legislation to permit oncology providers to create in-office pharmacies, and redesigning Medicare Part D and private payer drug benefits. COA said it is already lobbying for adoption of some of the solutions proposed at the state and federal level.

“A movement to level the playing field for oral oncolytics is growing,” Cobb said. “Individual state legislation prohibiting health insurers from imposing additional limitations or financial requirements for the use of orally administered medications compared to those applied for the use of intravenously or injected chemotherapy is active in a number of states nationwide,” he explained. COA supports state efforts and hopes to see legislation requiring parity on a national level that encompasses Medicaid and insurers who are not subject to Congressional oversight.

Cobb said the changes are important because patients need to have access to the best available therapies. “Patients appreciate the convenience of these agents and oncologists are enthusiastic about these drugs’ potential to target cellular processes more specifically,” he explained. “But unless Congress and the Administration eliminate the barriers to the use of oral cancer therapy, patients will continue to be denied important weapons in their battle against cancer.” The full report is available at http://www.avalerehealth.net.