Real-world analysis of the economic and therapeutic burden in advanced breast cancer patients in Italy

ABSTRACT

Background

This real-world analysis evaluated drug utilization focusing on wastage and healthcare costs for treatment of patients with advanced breast cancer (aBC) hormone receptor-positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) in Italy.

Methods

A retrospective analysis was conducted on administrative data covering about 13.3 million health-assisted individuals. Across January/2017–June/2021, all patients with HR+/HER2-aBC were identified by ≥ 1 prescription for cyclin-dependent kinase 4/6 inhibitors (CDK 4/6i). Cost analysis was performed and updated referring to the prices of November 2021.

Results

Overall, 3,647 HR+/HER2-aBC patients were included (2,627 palbociclib treated, 729 ribociclib treated, and 291 abemaciclib treated). After 12 months of follow-up, 35% of palbociclib patients had a dose reduction (on average 8.9 wasted pills/patient), 44.7% of abemaciclib patients had a dose reduction (on average 6.7 wasted pills/patient), 22.1% of ribociclib patients had a dose reduction (no wasted pills). Therapy wastage added up to 528,716€ for palbociclib-treated patients (524€/patient) and 5,738€ in abemaciclib-treated patients (151€/patient). No wastage was attributed to ribociclib.

Conclusions

Dose reduction was associated with drug wastage in palbociclib and abemaciclib-treated patients, but not in ribociclib-treated ones. These findings might be helpful to policy decision-makers who, for healthcare strategies implementation, among several variables should consider the possible restraining of drug wastage.

KEYWORDS:

• Advanced breast cancer
• cyclin-dependent kinase 4/6 inhibitors
• real-world evidence
• dose reduction
• drug wastage
• healthcare cost analysis

Article highlights

• Drug wastage is an unsolved issue for public health services and payers. This is particularly true in oncology area since the frequent necessity of progressing through therapeutic schemes or dose adjustments can cause a costly discard of unused medications.

• This real-world analysis assessed drug utilization and wastage in women with HR+/HER2- advanced breast cancer treated with CDK 4/6 inhibitors currently approved in Italy, namely palbociclib, ribociclib and abemaciclib. The economic analysis highlighted that the expenses for CDK 4/6 inhibitors were by far the weightiest cost item accounting for 65–75% of the overall healthcare expenditures.

• After one-year from the start of therapy with CDK 4/6 inhibitors, dose reductions were seen in 35% of women on palbociclib resulting in nearly 9 wasted pills per patient, 44.7% of those on abemaciclib resulting in average 6.7 wasted pills per patient, and 22.1% of those on ribociclib with no pill wastage. Discarding leftover drugs with dose adjustments occurs when the high dosage strengths prevent pill splitting and preservation for later use. The therapy with ribociclib did not imply wastage because this drug is available with a unique formulation of 200 mg, thus dosage can be modulated on the number of pills without requiring a new prescription.

• In the era of rising healthcare costs especially in the oncology setting, all strategies to keep drug wastage phenomenon under control are highly desirable. The data emerging from this analysis suggest that future efforts of pharmacological research should target dose strengths to facilitate dose adjustments and minimize until to cancel wastage of unused medications.

Declaration of interest

S Palladino, E Premoli, D Valsecchi and MSuter are employees of Novartis Farma Italy. This manuscript was developed with Novartis Farma Italy and CliCon S.r.l. Società Benefit. The agreement signed by Clicon S.r.l. Società Benefit and Novartis Farma Italy does not create any entity, joint venture or any other similar relationship between the parties. Clicon S.r.l. Società Benefit is an independent company. Neither Clicon S.r.l. Società Benefit nor any of its representatives are employees of Novartis Farma Italy in any purpose. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Study conception: S Palladino, E Premoli, D Valsecchi, M Suter, V Perrone, L Degli Esposti. Acquisition/analysis/interpretation of data: V Perrone, E Giacomini, D Sangiorgi, L Degli Esposti. Final approval of the publication: all authors.

Data sharing statement

All data used for the current study are available upon reasonable request next to CliCon s.r.l. which is the body entitled of data treatment and analysis by Local Health Units.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14737167.2023.2234637

Additional information

Funding

Novartis Farma Italy purchased the study report, which is the basis for this manuscript.