Budget impact model of avelumab in patients with metastatic merkel cell carcinoma in the US

Figures & data

Figure 1 Model structure.

Table 1 Patient population in 2019

Data description	Rate	Value	Source
Plan population	NA	30,000,000	User Input
MCC incidence rate (per 100,000)	0.84	252	4,52
mMCC (%)	37%	94	Calculated from Cowey et al, 2017^Citation14
Total number of patients receiving treatment (includes 1L and 2L+)	34%	32	Calculated from Cowey et al, 2017^Citation14

Abbreviations: MCC, merkel cell carcinoma; mMCC, metastatic merkel cell carcinoma; 1L, treatment-naïve, first line; 2L+, second-line or later.

Table 2 Market shares of therapies in the 1L and 2L+ settings

	2019–2021, without avelumab	2019–2021, with avelumab	Source
1L
IO Agents	80.0%	80.0%	Merck Healthcare KGaA/EMD Serono, Inc., data on file
Avelumab	0.0%	65.0%
Pembrolizumab	80.0%	28.0%
Nivolumab	20.0%	7.0%
Chemotherapy	20.0%	20.0%	^Citation14, Merck Healthcare KGaA/EMD Serono, Inc., data on file
Carboplatin	11.1%	11.1%
Carboplatin+  etoposide	11.1%	11.1%
Cyclophosphamide+  doxorubicin+  vincristine	33.3%	33.3%
Topotecan	44.4%	44.4%
2L+
IO Agents	25.0%	25.0%	Merck Healthcare KGaA/EMD Serono, Inc., data on file
Avelumab	0.0%	65.0%
Pembrolizumab	80.0%	28.0%
Nivolumab	20.0%	7.0%
Chemotherapy	75.0%	75.0%	^Citation14, Merck Healthcare KGaA/EMD Serono, Inc., data on file
Carboplatin	11.1%	11.1%
Carboplatin +  etoposide	11.1%	11.1%
Cyclophosphamide +  doxorubicin +  vincristine	33.3%	33.3%
Topotecan	44.4%	44.4%

Abbreviations: 1L, treatment-naïve, first line; 2L+, second-line or later; IO, immuno-oncology.

Table 3 Duration of treatment (months)

	Responders (CR+PR)	Non-responders (SD+PD)	Source
1L
Avelumab	9.1	9.1	^Citation32
Pembrolizumab	16.8	16.8	^Citation33
Nivolumab	16.8	16.8	^Citation33, same as pembrolizumab (assumed)
Chemotherapies	4.6	4.6	^Citation14
2L+
Avelumab	4.4	2.7	Responders: ^Citation35; Non-responders: ^Citation34
Pembrolizumab	4.4	2.7	Responders: ^Citation35; Non-responders: ^Citation34, same as avelumab (assumed)
Nivolumab	4.4	2.7	Responders: ^Citation35; Non-responders: ^Citation34, same as avelumab (assumed)
Chemotherapies	2.2	2.2	^Citation14

Abbreviations: 1L, treatment-naïve, first line; 2L+, second-line or later; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease.

Table 4 Summary of costs (per 4-week model cycle)

Treatments	Drug costs (USD)	HRU costs (USD)	AE costs (USD)
IO Agents
Avelumab	12,894	696	375
Pembrolizumab	12,953	464	67
Nivolumab	13,034	348	67
Chemotherapy
Carboplatin	39	331	433
Carboplatin+etoposide	152	766	1,334
Cyclophosphamide+doxorubicin+vincristine	1,173	442	886
Topotecan	207	1,214	3,287

Abbreviations: HRU, health care resource utilization; IO, immuno-oncology; AE, adverse event.

Table 5 Budget impact over 3 years, 2019–2021 (USD)

Costs	Scenario without avelumab (A)	Scenario with avelumab (B)	Cumulative budget impact (C = B – A)	% change in budget
Drugs	$11,178,202	$8,523,446	−$2,654,756	−23.8%
HRU	$478,837	$479,957	$1,120	0.2%
AEs	$53,076	$63,540	$10,463	19.7%
Total	$11,710,115	$9,066,942	−$2,643,173	22.6%
Cost per member per month	$0.0109	$0.0084	−$0.0025	22.6%

Note: Bold values indicate key conclusions of the analysis: total and per member per month costs. 

Abbreviations: HRU, health care resource utilization; AE, adverse event.

Table 6 Sensitivity analyses

		Incremental budget impact (USD)				Incremental PMPM (USD)
Scenarios	Change	Year 1	Year 2	Year 3	Total	Year 1	Year 2	Year 3	Average
Base case*	NA	−$764,287	−$935,720	−$943,166	−$2,643,173	−$0.0021	−$0.0026	−$0.0026	−$0.0025
Incidence	+20%	−$917,144	−$1,122,864	−$1,131,800	−$3,171,807	−$0.0026	−$0.0031	−$0.0031	−$0.0029
	−20%	−$611,429	−$748,576	−$754,533	−$2,114,538	−$0.0017	−$0.0021	−$0.0021	−$0.0020
Total number of patients receiving treatment (1L, 2L+)	+20%	−$917,144	−$1,122,864	−$1,131,800	−$3,171,807	−$0.0026	−$0.0031	−$0.0031	−$0.0029
	−20%	−$611,429	−$748,576	−$754,533	−$2,114,538	−$0.0017	−$0.0021	−$0.0021	−$0.0020
IO agent market share (1L, 2L+)	1L: 50%, 2L: 50%	−$764,647	−$647,611	−$587,928	−$2,000,186	−$0.0021	−$0.0018	−$0.0016	−$0.0019
	IO 100%; chemo 0%	−$760,505	−$1,123,745	−$1,175,855	−$3,060,105	−$0.0021	−$0.0031	−$0.0033	−$0.0028
Duration of 1L non-responders (both IO agents and chemo)	−50%	−$631,582	−$730,371	−$737,546	−$2,099,499	−$0.0018	−$0.0020	−$0.0021	−$0.0020
Duration of treatment for 1L IO agents	+100%	−$77,524	−$1,399,158	−$2,154,193	−$3,630,874	−$0.0002	−$0.0039	−$0.0060	−$0.0034
	−50%	−$533,432	−$535,328	−$543,291	−$1,612,051	−$0.0014	−$0.0015	−$0.0015	−$0.0015
	Based on avelumab data	$24,509	$24,666	$25,131	$74,306	$0.0001	$0.0001	$0.0001	$0.0001
	Based on pembroliz-umab data	$35,105	$37,567	$38,138	$110,810	$0.0001	$0.0001	$0.0001	$0.0001
Duration of treatment for 1L pembrolizumab and nivolumab	+300%	−$1,004,355	−$2,650,493	−$4,306,481	−$7,961,329	−$0.0028	−$0.0074	−$0.0120	−$0.0074
	−75%	$710,418	$712,822	$723,253	$2,146,493	$0.0020	$0.0020	$0.0020	$0.0020
Duration of treatment for IO agents (2L+)	+100%	−$764,060	−$935,492	−$942,935	−$2,642,487	−$0.0021	−$0.0026	−$0.0026	−$0.0025
	−50%	−$764,400	−$935,834	−$943,283	−$2,643,516	−$0.0021	−$0.0026	−$0.0026	−$0.0025

Notes:*Base case refers to the results of the main analysis without any additional scenarios and is presented for comparative purposes.

Abbreviations: PMPM, per member per month; NA, not applicable; IO, immuno-oncology; chemo, chemotherapy; 1L, treatment-naïve, first line; 2L+, second-line or later.

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