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Barriers to Initiating Oral Oncolytics by Specialty Pharmacy or Payers Can Affect Patient Outcomes

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Delaying medication processing is common, especially when it comes to oral cancer therapies. Oncologists at 3 oncology clinics looked at such barriers and the potential impact on patient outcomes.

In their recent study, Jennifer L. Niccolai, PharmD, BCOP, Clinical Pharmacy Specialist, Allegheny Health Network, Jefferson Hills, PA, and colleagues analyzed the time it takes for a specialty pharmacy to process and deliver oral anticancer medications to a patient, which was the most time-consuming barrier in initiating oral oncolytic therapy.

High copays were another barrier to acquiring oral anticancer drugs, although the majority of patients who were included in the study considered their out-of-pocket costs to be affordable. These barriers may affect the clinical outcomes for patients by delaying the initiation of treatment, the study results suggest.1

“Oral therapy is an increasingly popular treatment option for individuals diagnosed with cancer. However, several potential barriers to oral therapy acquisition exist, and our findings suggest that these barriers may affect patients’ time to treatment initiation,” observed Dr Niccolai and colleagues.

Study Population

The patients’ mean age was 68.4 years, and the most common tumor types included in the study were breast cancer (20.5%) and multiple myeloma (8.8%).

The majority of the patients had insurance coverage for their prescription drugs through Medicare (55.9%), and 35.3% of patients had additional prescription insurance coverage, such as a low-income grant from Medicare Part D or Medicaid. Overall, 2 patients had no prescription coverage.

Steps Affecting a Patient Initiating an Oral Drug

To define the steps needed for patients to get their oral anticancer drugs, and to quantify the time it takes to complete each of these steps, the investigators selected 34 patients who had been prescribed an oral oncolytic at 1 of the 3 outpatient oncology clinics included in the study. These steps, whittled down to a succinct 6, include:

  1. Prescription for an oral drug
  2. Submission of the prescription to the insurance company
  3. Attainment of prior authorization (if necessary)
  4. Receipt of private funds or grants (when applicable)
  5. Processing of the prescription by a specialty pharmacy
  6. Patients receiving their prescribed drug.

The time in hours per prescription spent by clinic staff was captured to describe the effect that the acquisition of these oral drugs has on the staffing needs of the ambulatory oncology clinic.

The researchers also identified financial and logistic barriers that affect the likelihood of oral anti­cancer therapies being selected for treatment regimens.

Drug Acquisition

At the oncology clinics included in the study, nurses and pharmacists were the primary staff members relied on to complete the required paperwork and to communicate with pharmacies, drug and insurance companies, and private foundations that provide funding.

In addition, although each of the 3 clinics has a designated oncology clinical pharmacist whose responsibilities include creating and verifying chemotherapy orders, offering supportive care management, and providing education about chemotherapy, none of the clinics house on-site pharmacies for dispensing oral medications. Therefore, oral anticancer drugs are typically acquired from an off-site specialty pharmacy.

Because of a lack of information regarding the drug delivery date and a refusal of medication at the time of prescription, 7 patients were excluded from analysis of the time it takes to complete each acquisition step. Among the remaining 27 patients, the median time from prescription to acquisition of medication was 10 days.

The processing of the prescription by the specialty pharmacy was found to be the rate-limiting step for 18 patients, and took a median of 6 days. Prior authorization was required for 18 patients, and it took a median of 1 day for prior authorization approval. It took a median of 3 days for the 8 patients who were eligible for financial assistance to receive their funds through a private foundation or a grant.

Cost and Affordability Concerns

In addition, Dr Niccolai and colleagues found that among the 18 patients who required a prior authorization from their insurance company, the majority had copays of up to $50. Overall, 7 patients had out-of-pocket costs that exceeded $1000, 2 of whom chose not to start therapy because of the increased drug costs.

“Affordability is a highly individualized concept and was defined based on patient perception and decision to initiate treatment,” the team noted, adding that although copays are often on the high end for patients receiving specialty drugs, there are programs that generously provide copay assistance, and to which patient accessibility is vital.

The researchers stressed the need for clinic staff to identify patients who qualify for financial assistance, and to communicate pertinent information about obtaining this assistance.

Time Delay

With regard to the amount of time clinic staff spend processing prescribed oral anticancer therapy regimens, Dr Niccolai and colleagues reported that a median of 2 hours was spent on completing the fulfillment requirements of each prescription.

A median of 10 days is a reasonable time between the plan to start therapy and the attainment of an oral anticancer drug, according to Dr Niccolai and colleagues. However, they suggest that in certain situations, the time to treatment initiation can affect a patient’s clinical outcomes, including the risk for disease progression.

In addition, treatment delays can influence anxiety in patients and caregivers, and can lead to issues in scheduling follow-up appointments and laboratory monitoring.

“Pharmacy processing was the rate-limiting step for the majority of patients during the acquisition process. Improved communication between the various health care professionals and a standardized process for prescription submission, processing, and delivery will continue to facilitate timely receipt of oral anticancer medications,” the investigators concluded.


  1. Niccolai JL, Roman DL, Julius JM, Nadour RW. Potential obstacles in the acquisition of oral anticancer medications. J Oncol Pract. 2017;13:e29-e36.

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