SUPERIORITY OF NASAL SPRAY COMPARED TO ORALLYADMINISTERED METOCLOPRAMIDE IN REDUCINGHEALTHCARE COSTS FOR TREATING DIABETICGASTROPARESIS PATIENTS
October 2023

Richard McCallum1, Michael Cline2, Mostafa Shokoohi3, Sumaiya Marium3,David C. Kunkel4
1Texas Tech University Health Sciences Center, El Paso, TX, United States;
2Cleveland Clinic, Cleveland, OH, United States;
3Eversana, Burlington, ON, Canada;
4University of California San Diego, La Jolla, CA, United States;1© 2023 EVERSANA. All Rights Reserved. CONFIDENTIAL.

Background on Gastroparesis

DiabeticGastroparesis(DGP) is a chronic
disorder of thestomachcharacterized bydelayed gastric
emptying which
results in nausea,vomiting, earlysatiety, bloating, andsevere abdominal
pain.1•

Gastroparesis is common with a prevalence of 3% of US adults, and 57.4% of
all cases have an etiology of Type 1 or 2 diabetes mellitus.2•

DGP leads to poorly controlled diabetes impacting quality of life and increasing
the risk of mortality.3•

Symptom management includes dietary restrictions, antiemetics, and treatment
with the only US approved medication, metoclopramide (MCP) and surgery.4•

In 2017, in a survey of 1,423 GP patients, 60% were dissatisfied or somewhat
dissatisfied with available treatment options (sponsored by IFFGD).5•

DGP patients have two to three times greater healthcare costs compared tonon-GP diabetic patients (inpatient, ED and outpatient visits).6•

In June 2020, MCP nasal spray (NMCP) became the first non-oral FDAapproved treatment* for patients with acute and recurrent DGP in the US.7
* Domperidone is approved for DGP in Canada.

2References: 1. Horowitz et al. Diabetologia. 1989; 32:151-159. 2. Ye Y et al. Gastroenterology. 2022 Jan;162(1):109-121. 3. Shakhatreh M et al. Expert Rev Gastroenterol Hepatol. Aug;13(8):711-721. 4. Lata PF et al. AnnPharmacother. 2003 Jan;37(1):122-6. 5. Yu D et al. Dig Dis Sci. 2017 Apr;62(4):879-893. 6. Chen YJ et al. Am J Gastroenterol. 2020;115(Supplement):686-687. 7. Gajendran M et al. Expert Rev Endocrinol Metab. 2021; 16(2):25-35

Recent Real-World Study Presented at DDW 2023 Showed Significant
Reductions in Healthcare Resource Utilization (HCRU) in Patients Treatedwith Nasal vs Oral MCPIn a matched comparison of HCRU in 6 months post initiation of therapy:

3•

Patients treated with Nasal MCP (NMCP) had significantly fewer DGP-related office, ED, and inpatient
hospital visits, compared to Oral patients.

•Similar reductions in all-cause healthcare utilization equated to an avoidance of 124 physician officevisits, 167 fewer ED, 37 fewer inpatient, and 55 fewer outpatient visits for NMCP patients versus
OMCP patients.

•The likelihood of a DGP patient treated with NMCP experiencing a visit to the ED or hospital outpatientfor any cause was less than half that of patients treated with OMCP during the same period.1

Reference: 1. Kunkel et al. Oral plenary presentation at the Digestive Disease Week; 2023 May 6-9; Chicago, IL

Rationale & Objective• Moderate to severe patients taking Nasal Metoclopramide (NMCP) in a phase 3 double-blind, placebo-controlled
trial experienced a significant reduction in nausea and upper abdominal pain (P<0.05) compared to placebo.1• Given the high burden DGP places on patients, we hypothesized that symptom control in patients treated withNasal MCP may result in lower healthcare costs compared to patients treated with Oral MCP (OMCP).

Research Objective
To compare healthcare costs associated with inpatient hospitalization (IH), emergency
department (ED), hospital outpatient (HO), physician office (PO), lab/home/telehealth(LHT), and pharmacy for DGP patients treated with NMCP vs. OMCP.

4

Reference: 1. McCallum RW et al., Poster presented at: Digestive Disease Week 2017; Washington, DC

Study Design: Cohort Selection
IBM MarketScan®
database
IBM MarketScan®
Research Database isa comprehensive
administrative claims
database.

Cohort Selection Criteria
Patients receiving
NMCP or OMCP
between June 2020and December 2021

It includes adjudicatedand paid insurance
claims for individuals*.
Payments are actual
costs and not estimatedmean costs.

* individuals and their dependents, who receive health5

insurance coverage through their employers• ≥18 years of age at index date• ≥2 insurance claims with adiagnosis for GP >30 days apart

NMCP cohort(N=45)NMCP cohort(N=45)OMCP cohort(N = 3,040)

1:4 Matched
OMCP cohort(N=180)(ICD-10: K31.84)• >1 insurance claim for diabetes
with gastroparesis(E8.43, E9.43, E10.43, E11.43)

Study Design: Statistical Analysis Plan

• NMCP patients were matched against OMCP patients in a 1:4 ratio, using propensity score matching.
• Healthcare Resource Utilization (HCRU) categories of inpatient hospitalization, ED, hospital outpatient (HO),office, lab/home/telehealth and was analyzed using generalized linear model between the two cohorts• Mean (SD) real-world cost and mean differences were reported for both cohorts, and 95% confidenceintervals obtained from appropriate generalized linear model.
Study period
Matching period

Index period

Comparison period≥6 months of pre-index
claims history

Index = Date of firstdispense of NMCP (n=45)
or OMCP (n=180)≥6 months of post-index
claims history

Jun 2020

6Abbreviations: SD = Standard Deviation

Dec 2021

Using Propensity Score Matching 45 NMCP Patients were Matched against
180 OMCP Patients for Statistical Analysis• 1:4 match Nasal vs Oral
Metoclopramide

SMD---

18-35yrs

15.6%

11.1%

0.044

36-55yrs

55.6%

62.2%

-0.067• Age56-65yrs

26.7%

26.7%

0• Sex66-95yrs

2.2%

0%

0.022

Male sex
Region at index
Northcentral

24.4%

25%

-0.0066.7%

7.2%-0.006

Northeast

8.9%

7.8%

0.011

South

73.3%

73.9%

-0.006

West

2.2%

2.2%

0Missing
Insurance at index
Commercial

8.9%

8.9%

088.9%

90.6%-0.017

Medicaid

8.9%

8.9%

0Medicare

2.2%

0.6%

0.017

DGP Severity*

44.4%

47.2%

-0.028Comorbidity Score**, Mean (SD)

2.2 (2.3)

2.3 (2.2)-0.045• Cohorts were well-matched across:• Region• Payer• DGP Severity*• Comorbidity index*** DGP Severity was defined as having experienced emergency department orinpatient hospitalization in the 6 months pre-index** Comorbidity Score measured using the Charlson Comorbidity Index (CCI). The
severity of comorbidity is typically considered mild with CCI scores of 1–2,moderate with CCI scores of 3–4, and severe with CCI scores ≥5.
7

Post Propensity Score Matching (1:4 ratio)
NMCP
Matched OMCP
(N=45)(N=180)Age at index, yrs.
47.7 (11.8)
49.3 (9.9)
Mean (SD)

Abbreviations: DGP: Diabetic Gastroparesis; MCP: Metoclopramide; SD: Standard deviation; SMD:
Standard mean difference;

A Significantly Smaller Proportion of NMCP Patients versus OMCP had an
Inpatient, Outpatient and ED visit% of Patients with ≥1 visit in the
6 months post-index period

Healthcare Resource Use in DGP Patients
p=0.001p=0.018100%

p=0.085

93%
81%

79%
75%

98%

64%
p=0.006

p=0.00550%53%

p=0.813p=0.586

43%
26%

25%

24% 23%

20%

13%

17%

4%
0%Inpatient
HosptialEDOutpatient
Hospital

Lab/Home/Telehealth

NMCP (n=45)

OMCP (n=180)

OfficeClinic

Other

The proportion of NMCP-treated patients who experienced an inpatient, outpatient, ED and/or lab/home/telehealthvisits were significantly lower than patients treated with Oral MCP, in the six months post-treatment index8Patients Treated with NMCP Had Significantly Lower All-Cause Healthcare
Costs Compared to OMCP Patients
Mean Healthcare Cost per Patient in DGP Patients

Mean Cost per Patient in the6 Months Post-Index Period$30,000

p=0.005$27,309
P<0.001$21,325$20,000

p=0.01

P<0.001p=0.004

p=0.014p=0.274$10,136$10,000$1,203$115
Inpatient$12,082$7,564$5,320$0p=0.276$277
ED$2,074$366

Outpatient
Hospital$4,518$3,693$973$1,686††

Lab/Home/Telehealth

NMCP (n=45)$5,984†

Office/Clinic

OMCP (n=180)

Total
MedicalPharmacy

TotalHealthcare(Medical + Pharmacy)

Lower healthcare costs in NMCP versus Oral MCP patients are driven by lower costs for Inpatient, ED and Outpatient
Hospital visits. NMCP pharmacy cost was higher than generic OMCP, but not statistically significant.
9† Includes Laboratory, Ambulatory, Image, Home, Telehealth and Other†† Office is a location, other than a hospital, skilled nursing facility, State/local public health clinic, where the health professional routinely provides health examinations, diagnosis, and treatment of illness or injury on an ambulatory basis.
Clinic includes walk-in health clinic, independent clinic and public/rural health clinic, that is not part of a hospital and that is organized and operated to provide preventive, diagnostic, therapeutic, rehabilitative, or palliative services to outpatients only.Conclusions
In a matched Healthcare Resource Utilization cost comparison study based on 6 months
post initiation of therapy in DGP patients:• NMCP patients had significantly lower medical and overall healthcare
costs for all-cause encounters compared to Oral MCP patients• Lower real-world costs for NMCP versus OMCP patients were driven bymarkedly reduced spendings across key sites of care, including inpatient,emergency department and outpatient visits.
• These data offer real-world evidence for healthcare providers and payers,emphasizing the substantial benefits of the NMCP route for treating
patients with DGP.

10THANK YOU

11© 2023 EVERSANA. All Rights Reserved. CONFIDENTIAL.