Financial Impact of Integrated Specialty Pharmacy Efforts to Avoid Oral Oncolytic Waste

1 Study details

1.1 Study title

Oncology Waste Avoidance

1.2 Background

A growing number of oral oncolytic agents have been developed in recent decades. Though newer agents provide more options for patients to treat cancer using self-administered therapy, they may pose burdens on patients, including high cost and side effects. Patients receiving oncolytic therapy require frequent follow-up with scans, laboratory tests, and clinic visits, for healthcare providers to monitor drug safety and disease progression. Treatment plans are often adjusted at the time of planned follow-up, leading to changes in medications or dosing. As a result of these changes, medications are often wasted, which poses a high economic burden on healthcare systems.

1.3 Objectives

The purpose of this study was to describe an integrated health-system specialty pharmacy’s efforts to reduce medication waste for patients prescribed oral oncolytic medication.

1.4 Methods

Retrospective review of patients filling oral oncolytic medications prescribed by a Vanderbilt University Medical Center (VUMC) provider with medication dispensed by the Vanderbilt Specialty Pharmacy (VSP) between January 1, 2020 and January 31, 2021.

Data was gathered from the electronic health record (EPIC/EStar), VSP dispense software (EnterpriseRx), and the specialty pharmacy patient management software (Atlas).

Specialty pharmacy staff received a system-generated renewal request for oral oncolytic medications when the final prescription refill was dispensed, prompting the pharmacist to review the patient’s medical record for continued therapy appropriateness and to request a new prescription. With access to the electronic health record, the pharmacist would review upcoming appointments and clinic notes. If the patient had a sufficient supply on hand to last until after an upcoming follow-up, the pharmacist postponed the renewal until after the scheduled follow-up.

1.4.1 Inclusion criteria

Patients were included if the refill renewal request was postponed after review of the amount of medication on hand and presence of an upcoming follow-up.
And if patients had a clinic visit between 01/01/20 to 01/31/21.

1.4.2 Exclusion Criteria

Treatment regimens consisting of multiple strengths of the same medication to reach the prescribed dose were only included as a single refill renewal request postponement. (i.e., If the patient had prescriptions for temozolomide 100mg and temozolomide 5mg to reach a total dose of 310mg and the specialty pharmacist postponed the refill renewal request for both prescriptions because the patient had sufficient quantity to make it through until after an upcoming follow-up, this would be counted as a single refill renewal request postponement even though 2 refill renewal requests were postponed.)
Postponed renewal requests were excluded from analysis if:
- They were part of a multi-strength regimen (explained above) labeled as duplicate
- Patient did not complete clinical follow-up
- Patient transferred care before clinical follow-up
- Medication was discontinued or the patient died before clinical follow-up

1.5 Outcomes of interest

1.5.1 Outcomes

Frequency at which medication refills/renewals were postponed until after a patient clinic visit
Frequency at which medications were changed (dose change, drug discontinuation, or new drug prescribed) at clinic visits after refill/renewal was postponed.
Cost savings associated with postponing a refill/renewal until after a clinic visit which resulted in a medication change.
- Total cost savings were calculated as the manufacturer wholesale price of the prescription fill postponed that would subsequently not be needed due to medication being changed at appointment.

1.5.2 Determining Outcomes

Waste Avoidance

No Waste Avoidance
- Medication continued as previously prescribed after follow-up
Medication Waste Avoidance
- Medication was discontinued, changed or held after follow-up
- Multi-strength drug regimens were counted as 1 refill postponement
Financial Waste Avoidance
- Medication discontinuation, change or hold would have resulted in
  - The patient having medication on hand that could not be used
  - The patient having excess quantity of medication on hand

Assigning Cost

Medication Discontinuation or Change
- Quantity of medication that would have been refilled x AWP per unit
Dose Change or Medication Hold
- Quantity of medication, if refilled, that could not be used x AWP per unit
- Quantity of medication, if refilled, that would have been in excess x AWP per unit
Excluded from the financial analysis
- Medication could have been used to make the new dose
- Medication could have been used if restarted after a medication hold

2 Descriptive Statistics

2.1 Patient Characteristics

The sample size indicates the number of patients.

	N=139
Patient Characteristics.
Age	50 64 72
Gender
Female	0.56 (78)
Male	0.44 (61)
Ethnic group
Not Hispanic, Latino/a, or Spanish origin	0.91 (126)
Other Hispanic, Latino/a, or Spanish origin	0.01 ( 2)
Unknown	0.02 ( 3)
Decline to Answer	0.01 ( 1)
NA	0.05 ( 7)
Patient race
White	0.86 (119)
Black or African American	0.04 ( 6)
Other Asian	0.02 ( 3)
Unknown	0.01 ( 2)
Other	0.03 ( 4)
NA	0.04 ( 5)
Patient status
Alive	0.86 (119)
Deceased	0.14 ( 20)
a b c represent the lower quartile a, the median b, and the upper quartile c for continuous variables. Numbers after proportions are frequencies.

2.2 Outcome of follow-up

The sample size indicates the number of renewal requests.

	N=167
Outcome of follow-up.
Reason for medication postponement
Clinic visit	0.88 (147)
Labs needed	0.05 ( 8)
Imaging needed	0.01 ( 1)
Other	0.07 ( 11)
Outcome of follow-up
No change to postponed medication	0.02 ( 3)
Medication change	0.06 (10)
Dosing change	0.31 (52)
Medication discontinued	0.56 (94)
Medication held	0.05 ( 8)
Formulaton change	0.00 ( 0)
Numbers after proportions are frequencies.

2.3 Medication holds

The sample size indicates the number of renewal requests with a medication hold as an outcome.

	N=8
Medication hold outcomes.
Hold outcome
Patient restarted original medication	0.25 (2)
Dose change	0.25 (2)
Discontinuation	0.50 (4)
Numbers after proportions are frequencies.

2.4 Cost avoidance analysis

Cost savings were calculated by first filtering out all rows that are not classified as cost savings as defined in the previous section. The AWP/unit (cost per pill) was obtained for each medication based on drug name, strength and if the brand or generic formulation had been dispensed on the previous fill. To calculate the potential cost avoidance the AWP/unit was multiplied by the number of units that would have been wasted if the medication had been refilled prior to the patients upcoming follow-up.

2.4.1 Cost avoidance per fill

The sample size indicates the number of fills.

The patients with a medication hold for their outcome of follow-up were reclassified to discontinuation or dose change, according to final outcome of the medication hold.

	Dosing change N=59	Medication change N=12	Medication discontinued N=104	Combined N=175
Cost savings per fill by outcome in dollars.
Cost avoidance per fill	366 2820 8477	3957 10038 16768	986 1951 5295	986 2417 8215
a b c represent the lower quartile a, the median b, and the upper quartile c for continuous variables.

2.4.2 By Outcome

Parentheses indicate column percentages

Table 2.1: Cost savings by outcome
	Brand		Generic		Total
Outcome of Follow-up	Cost savings	n	Cost savings	n	Cost savings	n
Dosing change	$147,432 (22.6%)	16	$146,641 (46.5%)	42	$294,073 (30.4%)	58
Medication change	$94,790 (14.5%)	9	$18,245 (5.8%)	3	$113,035 (11.7%)	12
Medication discontinued	$344,060 (52.7%)	36	$145,784 (46.2%)	64	$489,843 (50.6%)	100
Medication held	$66,259 (10.2%)	3	$4,612 (1.5%)	2	$70,871 (7.3%)	5
Total	$652,540.41	64	$315,281.33	111	$967,821.74	175