Implementation of an oral oncology repository program has the potential to help alleviate the financial toxicity burden for patients with cancer treated with these agents, according to a best practices summary published in JCO Oncology Practice.

Oral oncology drugs are commonly used as first-line treatment options for a number of cancer types, including lung cancer, renal cell carcinoma, and chronic myeloid leukemia. Furthermore, use of these agents in the treatment of cancer is expected to increase.

Nevertheless, the costs of these drugs can be very high, even for patients with medical insurance coverage, and patients may be responsible for out-of-pocket costs in the range of thousands of dollars per month.


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Although some pharmaceutical manufacturers and other organizations offer patient assistance programs to help defray the cost of these medications, many patients, including those covered by Medicare, are not eligible to receive coupons or discounts offered by drug manufacturer-sponsored programs.

“As a result of increasing out-of-pocket costs for oral oncology drugs, many patients experience financial toxicity, adding to their distress, hardship, and burden,” stated the authors of this paper.

Another indirect cost related to oral oncology drugs involves proper disposal of unused and/or discarded medications resulting from dose reductions or early treatment discontinuation.

“Annually, approximately $5 billion of unexpired drug is discarded, and the majority could be collected for reuse,” the authors noted.

The authors describe developing an oncology drug repository pilot program that centers on collecting unused oral oncology drugs. The program was put into practice at the James Cancer Hospital at The Ohio State University Wexner Medical Center (OSUWMC). It was designed to both provide oral oncology drugs to patients with cancer in need and to dispose of unusable oral oncology drugs safely.

Key steps in the successful implementation of the OSUWMC program, as outlined in this best practices summary, include the following:

  • Define patient eligibility requirements for the collected drug
  • Ensure patients have long-term availability to preferred treatment
  • Identify optimal oral oncology drugs to use
  • Provide safe drug collection with protocol
  • Calculate the amount of resources needed to provide services
  • Obtain adequate space to operate safely and efficiently
  • Establish safe disposal of the drug deemed inappropriate for use
  • Spread awareness to prospective patient participants

Although this pilot program was limited to 9 collections of capecitabine and 2 collections of temozolomide, it was an effective vehicle for providing an uninsured patient with access to capecitabine.  

Some of the challenges the authors faced in implementing their program included the need to conform to individual rules in states where these types of programs are allowed and to advocate for changes in states where they are not. In addition, funding sources for these programs need to be identified, and may include a handling fee charged to drug recipients.

“The full impact of oral oncology drug repository programs is unknown, but the programs have the potential to transform practice and significantly improve patient outcomes,” the authors commented.

They further added, “ultimately, the goal of this pilot project is to help provide a foundation for the development of novel oncology services within other health-system settings.”

Reference

Stanz L, Ulbrich T, Yucebay F, Kennerly-Shah J. Development and implementation of an oral oncology drug repository program. JCO Oncol Pract. Published online November 13, 2020.  doi:10.1200/OP.20.00513