Evaluating unmet needs in large-volume subcutaneous drug delivery: U.S. payer perspectives on a novel, large-volume on-body delivery system

Figures & data

Figure 1. Differences in cost of care by site of treatment.

Abbreviations: ASC = ambulatory surgery centres; HCPs = healthcare professionals; HOPD = hospital outpatient department.

Figure 2. Image of the novel on-body delivery device. A) Unbranded Product X demonstration device in packaging. B) Unbranded Product X demonstration device outside packaging. C) 20 mL vial of deionized water was utilized instead of a therapeutic. After taking off the purple cap, the vial is pushed into the circular transfer base to load the device with deionized water. D) Placement of the unbranded Product X demonstration device dispensing water into a plastic cup.

Table 1. Summary of relevant articles, by theme.

Administrative Method
Comparison	Quantity	References
Health-care resource utilization
IV vs. SC	18	Alsina 2022, Anderson 2019, Bittner 2018, De Cock 2016a, De Cock 2016b, Epstein 2021, Harvey 2022, Igarashi 2014, Kim 2021, Mallick 2018, McCloskey 2023, Olofsson 2016, Parra 2023, Perraudin 2020, Polinsky 2017, Ritchie 2022, Slavcev 2021, Wardley 2021
SC vs. OBDS	0
IV vs. OBDS	0
Other (non-comparative)	4	Bestsennyy 2022, Howard 2019, Schmier 2017, Townley 2018
Indirect costs
IV vs. SC	7	De Cock 2016b, Epstein 2021, Harvey 2022, Igarashi 2014, Olofsson 2016, Parra 2023, Slavcev 2021
SC vs. OBDS	0	None
IV vs. OBDS	0	None
Other (non-comparative)	0	None
Patient experience
IV vs. SC	16	Bell 2021, Bittner 2023, Dashiell-Aje 2018, Denys 2020, Gelhorn 2019, Gonzalez 2022, Mateos 2022, Mateos 2020, McCloskey 2023, Merz 2015, Moreau 2011, Mu 2018, O’Shaughnessy 2021, Overton 2021, Parra 2023, Yenerel 2023
SC vs. OBDS	1	Wasserman 2022
IV vs. OBDS	0
Other (non-comparative)	5	Alsbrooks 2022, Deeb 2022, Joshi 2017, Mahler 2017, Van den Bemt 2019

Table 2. Summary of studies comparing direct and indirect costs associated with transitioning from intravenous to subcutaneous administration within-hospital or in a home-based setting.

Reference	Comparison	Design and Population	Findings
Parra 2023	IV versus SC	A systematic review of 34 publications on costs, HCRU, patient preferences, and administration time associated with daratumumab, rituximab, and trastuzumab in SC and IV presentations for patients with cancer	Compared with IV formulations, SC formulations of daratumumab, rituximab, and trastuzumab reduced preparation costs by 6.6%-50.1% and administration costs by 4.5%-95.3% when provided by a HCP in a clinical setting SC administration of rituximab and trastuzumab resulted in reduced productivity loss, including reduced travel expenses and time of informal caregivers
McCloskey 2023	IV versus SC	A systematic review of 72 publications of oncology biologics in a hospital setting	SC administration in a hospital setting reduced HCP time and resource use SC administration was associated with substantial time savings in the preparation and administration of treatment
Alsina 2022	IVIg versus SCIg	A cost-minimization model of annual costs per patient with PID from the Spanish National Healthcare System perspective (inpatient versus at home)	Annual costs per patient with PID were €4,266 ($4,731 USD) lower with SCIg versus IVIg, with differences primarily attributed to dosage (€1,927; $2137) and hospital administration costs (€2,688; $2,981), although SCIg was associated with training costs for home administration (€695; $771)
Harvey 2022	IV versus SC	A decision-analytic cost model assessing the incremental cost difference between IV and SC rituximab in a simulated cohort of patients with NHL in the US	20% transition rate in a cohort of 157 patients (769 total drug administrations) was predicted to save $153,000 from the payer perspective Increased provider capacity by 270 h At the cohort level, 20% transition freed 470 h of patient time
Ritchie 2022	IV versus SC	A population-based cohort study of 7,890 patients who received IgG for the treatment of immunodeficiency diseases in Canada	Average administration cost per year of self-administrated SC Ig was $5,386 lower than clinic-administered IVIg ($817 vs. $6,204) Switching just 50% of the patients from clinic-administered IV Ig to self-administered SC Ig could translate into $19.4 million in cost savings annually related to medical laboratory staff, nursing time, and ambulatory care visits
Slavcev 2021	IV versus SC	A prospective, cross-sectional, time-and-motion survey of relapsed/refractory multiple myeloma patients treated with daratumumab in Brazil, Greece, Israel, Japan, Poland, Sweden, Taiwan, and Ukraine	SC formulation reduced median total active HCP time by 63.8% for the first treatment and 49.5% for subsequent treatments Results extrapolated to two years estimated active HCP time per patient was reduced by 50% when using SC in comparison to IV Estimated chair time for SC administration was 97% lower than IV administration for initial (from 456.9 to 13.3 min) and subsequent treatments (238.0 to 8.1 min)
Perraudin 2020	IVIg versus SCIg	Swiss cost-minimization analysis for chronic inflammatory demyelinating polyneuropathy	Hospital-based IVIg cost health insurance payers 114,747 CHF over 48 weeks, versus SCIg costs of only 86,558 CHF ($126,221 USD vs. $95,213 USD)
Anderson 2019	IV versus SC	A systematic rapid evidence assessment of 63 publications assessing biologics for the treatment of malignancies	SC administration of biologics for the treatment of malignancies significantly reduced provider time spent on drug preparation and administration, resulting in lower costs compared to IV administration of the same agents
Mallick 2018	IVIg versus SCIg	Pooled analysis of six phase 3 studies of patients with Primary Immunodeficiency who switched from IVIg to SCIg	Patients in European and Japanese studies who switched from IVIg to SCIg reported significant and meaningful improvements in health status and IgG-specific HRQoL perception across all time points as measured by Life Quality Index domains (p < 0.0001)
De Cock 2016a	IV versus SC	A non-interventional time-and-motion study of patients across eight countries who received rituximab for the treatment of NHL	Significantly less mean active HCP time required to prepare and administer SC rituximab versus IV formulation (32% reduction; p < 0.0001) Mean chair time for patients was significantly lower with SC versus IV administration (74% reduction, p < 0.0001)
De Cock 2016b	IV versus SC	A prospective, observational time-and-motion study of patients across eight countries who received trastuzumab for the treatment of HER2-positive early breast cancer	Mean patient chair time was significantly reduced with SC single-use injection device (57 min saved; p < 0.0001) and with SC handheld syringe (55 min saved; p < 0.0001) versus IV formulation Mean active HCP time was significantly reduced with SC single-use injection device (13 min; p < 0.0001) and SC handheld syringe (17 min p < 0.0001) versus IV formulation
Olofosson 2016	IV versus SC	An observational study of HCRU among 195 patients (101 IV, 94 SC) with HER2-positive breast cancer in Sweden	IV trastuzumab requires 14 min & 23 min more for nurses and patients versus SC Significantly more patients treated with IV trastuzumab took time off from work compared to those on the SC regimen (14% vs. 5%; p = 0.0223) Personal and caregiver productivity loss and lost leisure time were also higher with IV versus SC delivery for initial and subsequent trastuzumab treatments (€140 higher and €16 higher, respectively) Societal costs were €897 lower per treatment with SC versus IV trastuzumab
Igarashi 2014	IV Ig versus SC Ig	A prospective phase 3 single-arm study of 24 Japanese patients with Primary Immunodeficiency who transitioned from IVIg to SCIg treatment	Switching to SCIg treatment was associated with a median productivity loss reduction of 60% from baseline to Week 12 and 24, resulting in a reduction in costs of JPY 10,875 per patient per month (approximately $80 USD) The number of patients, parents, or guardians who were not absent from work or housework duties and had no reduction in working time increased from 17.4% with IVIg treatment to 39.1% with SCIg treatment

Abbreviations: CHF = Swiss franc; HCP = Healthcare professional; HCRU = Healthcare resource utilization; HRQoL = Health-related quality of life; Ig = Immunoglobulin; IV = Intravenous; JPY = Japanese Yen; NHL = Non-Hodgkin lymphoma; SC = Subcutaneous; US = United States; USD = United States Dollar.

Figure 3. Overview of payer characteristics.

Abbreviations: IDN = Integrated Delivery Network; MCO = Managed Care Organization; PBM = Pharmacy Benefits Manager.

Figure 4. US payers’ (N = 17) ratings of the most important novel OBDS product attributes in payer coverage decision-making.

*Prompt: “On a scale from 1 to 5, where 1 = not important at all and 5 = extremely important, how important are the following attributes in your coverage decision-making?”. Abbreviations: HCP = healthcare professional; Med = median; NSI = needle stick injury; OBDS = on-body delivery system.

Figure 5. The evolution and relative benefits of drug delivery technologies.

^aFeasibility dependent on syringe volume and number of needle pricks/injection sites.

^bVaries by product (e.g. flexible [Enable Injections enFuse] versus fixed dosing [West SmartDose]).