With Richard Schilsky, MD, Chief Medical Officer and Executive Vice President of ASCO
By Sarah DiGiulio
Earlier this year the American Society of Clinical Oncology issued its first position statement on drug repository programs. (The statement, published in January, is available as a pdf that can be accessed via asco.org.)
Due to the high cost of cancer drugs, members of the oncology team need to explore many options to reduce drug waste and increase access and affordability, according to the statement. That's why ASCO has decided to publish this statement on drug repository programs now.
"ASCO members have expressed interest in drug repository programs as a means to alleviate some of the challenges associated with drug affordability, access, and waste; the society was asked to explore this issue in the format of a position statement that would help guide our state affiliates," Richard Schilsky, MD, Chief Medical Officer and Executive Vice President of ASCO, told Oncology Times.
Here's what Schilsky said about the statement and how drug repository programs could work.
1. The statement includes some specific recommendations on how these drug repository programs would work. Can you explain how they would work and how they would be cost-saving?
"ASCO supports drug repository programs solely for oral medications provided that are maintained within a closed system. A closed system is defined as one in which the delivery to and/or return of prescription medicines from a health care or other institutional facility is maintained in a controlled environment under the supervision of a health care practitioner and not the patient. Drug repository programs within a closed distribution system are compliant with FDA policy on the return of unused prescriptions and ensure that the surplus medicines are maintained in a safe, effective, and private manner and can then be dispensed in accordance with the prescribing clinician's guidance.
"Costs for prescription drugs have risen to the point where many patients cannot afford them, leading to treatment non-compliance, drug abandonment, and resultant negative health outcomes. Research has shown that prescriptions with such high cost sharing for patients often are not filled because of inability for patients to absorb such high out-of-pocket costs. Drug abandonment such as this can have a serious effect on patient health, leading to hospitalizations, extensive health care costs, and even death. The abandonment rate for brand-name drugs accounts for 40 percent of all abandoned claims for new patients, in contrast to new patient abandonment rates for generics, which are three times lower.
"One recent study found that distributing essential medicines at no charge led to increased adherence to treatment and some improvement in health outcomes. Therefore, while drug repository programs are no substitute for affordable and accessible prescription drug coverage for patients, they can help some patients access otherwise unattainable treatments while helping physicians do their part to reduce waste associated with unused drugs."
2. What leads to those drugs going unused in the first place?
"For their part, providers seek to restrain costs and growth in expenditures in their practice through quality improvement and efficient scheduling practices that help reduce waste. A prescription may go unused at a doctor's office for a variety of reasons, including drug discontinuation because of disease progression or patient intolerance (toxicity).
"Factors such as pricing, vial size availability, and drug shortages are fueling the demand to reduce costs associated with drug waste. Unfortunately, many pharmaceuticals used in the treatment of cancer-related care are not eligible for drug repository programs. Injection and infusion drugs are generally ineligible for state-level donation programs because they: 1) do not meet the program's unopened packaging requirements; and 2) can have very short time frames in which the leftover drug would be safe for use.
"ASCO's position is that drug repository programs are appropriate in cancer care, but only for oral medications and provided the drugs are maintained within a closed distribution system. Widespread use of these programs may incentivize all stakeholders to effect change that could result in decreased costs to patients and unused medications in the outpatient setting. Therefore, while many pharmaceuticals used in cancer care may not fit the mold of a drug repository program, we saw no reason to prevent those that can be donated safely from being provided to a patient in need."
3. What is the most important takeaway for practicing oncologists and cancer care providers to know about this statement and drug repository programs?
"The cost of pharmaceutical drugs and resulting strain on patients' ability to afford them has become a pervasive issue in the health care system. The cost of drugs represents a large and increasing portion of the financial burden of cancer care. While pharmaceutical drug repository programs, also known as 'drug donation and reuse' programs are not new, there is new focus on their potential as a practical way to increase access to prescription drugs for patients.
"We encourage all cancer care providers to educate themselves about the programs available to them in their state. Many details and links current as of its publishing are available in the tables at the end of our statement (at asco.org). If a provider is practicing in a state with no such program, we encourage them to get in touch with their ASCO state affiliate (where available) to learn more about what they can do in support of safe and effective drug donation."