Budget impact of a 10% ready-to-use intravenous immunoglobulin in the treatment of primary immunodeficiency in Belgium

doi:10.4236/health.2009.13030

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Vol.1, No.3, 183-187 (2009)

doi:10.4236/health.2009.13030

SciRes

Health

Budget impact of a 10% ready-to-use intravenous

immunoglobulin in the treatment of primary

immunodeficiency in Belgium

Steven Simoens

Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit Leuven, Leuven, Belgium;

steven.simoens@pharm.kuleuven.be

Received 10 July 2009; revised 2 September 2009; accepted 5 September 2009.

ABSTRACT

The aim of this study is to compute the budget

impact of adopting Kiovig, a new ready-to-use

10% liquid immunoglobulin preparation, as a

treatment for primary immunodeficiency from

the perspective of the Belgian health care payer.

The analysis compared the “world with Kiovig”

to the “world without Kiovig” and calculated

how a change in the mix of immunoglobulins

used to treat primary immunodeficiency would

impact drug spending during 2010-2014. Data on

the number of patients, immunoglobulin market

shares and drug unit costs were derived from

the IMS Health hospital disease database and

from Belgian sources. The number of Belgian

patients suffering from primary immunodefi-

ciency is expected to increase from 2,378 pa-

tients in 2010 to 2,447 patients in 2014. The

budget impact of adopting Kiovig is likely to be

modest, raising the immunoglobulin drug bud-

get for this patient population by 0.4%-1.3% per

year. The budgetary increase originated from the

higher price of Kiovig as compared with other

products, although the impact of Kiovig was

limited by its anticipated slow market penetra-

tion. There is a need for more and better data on

the Belgian immunoglobulin market.

Keywords: Immunoglobulins; Intravenous; Primary

Immunodeficiency; Budget Impact; Belgium

1. INTRODUCTION

Primary immunodeficiency (PID) disorders are charac-

terised by low or undetectable immunoglobulin levels [1]

and are associated with an increased patient susceptibility

to recurrent respiratory tract and gastrointestinal infec-

tions [2]. Since the 1950s, immunoglobulin products have

been administered to treat infections in PID, and patients

often require lifelong therapy [3]. Immunoglobulin the-

rapy in PID replaces functionally deficient or absent

immunoglobulins, reduces the incidence of infections,

and prevents organ damage caused by infections [4].

Immunoglobulin therapy is administered via the intra-

muscular, intravenous or subcutaneous route.

Kiovig (Baxter International Inc.), a ready-to-use 10%

liquid immunoglobulin preparation, is medically indi-

cated for the treatment of, amongst other indications, PID

disorders [5]. This plasma-derived product consists of a

highly purified preparation of human immunoglobulin. It

is supplied as a ready-to-use liquid formulation with a pH

of 4.6 to 5.1. Three dedicated virus clearance steps are

integrated in the manufacturing process and the resulting

product exhibits an intact immunoglobulin molecule with

complete functional activity. Kiovig is supplied in sin-

gle-dose vials that nominally contain 1 g, 2.5 g, 5 g, 10 g

and 20 g protein per vial. The European Commission

granted a marketing authorisation valid throughout the

European Union for Kiovig in January 2006 [6].

With a view to assessing a drug reimbursement appli-

cation, regulatory agencies in an increasing number of

countries require data about, amongst other things, the

budgetary impact of the drug on national, regional or local

budgets [7]. A budget impact analysis examines the fi-

nancial impact of the adoption and diffusion of a drug

within a particular setting and, thus, considers the afford-

ability of a drug. Specifically, a budget impact analysis

explores how a change in the current mix of treatment

strategies by the introduction of a new drug will impact

spending on a disease. However, to date, budget impact

analyses have rarely been published in the international

literature [8].

In a context of spiralling health care costs and limited

resources, policy makers and health care payers are con-

cerned about the budget impact of Kiovig and other in-

travenous immunoglobulins. Therefore, the aim of this

study is to compute the budget impact of adopting Kiovig

as a treatment for PID from the perspective of the Belgian

health care payer.

S. Simoens / HEALTH 1 (2009) 183-187

184

Openly accessible at

2. METHODS

2.1. Analytic Technique

The methodology of budget impact analysis is still de-

veloping, although principles of good practice for budget

impact analysis have recently been proposed [9]. The

budget impact analysis assessed the financial conse-

quences of adopting Kiovig as a treatment for PID from

the perspective of the health care payer in Belgium.

More specifically, the budget impact analysis compared

the “world with Kiovig” to the “world without Kiovig”

and calculated how a change in the mix of immunoglo-

bulins used to treat PID would impact the trajectory of

drug spending on this condition. The general model for

conducting the budget impact analysis of Kiovig is out-

lined in Figure 1.

The budget impact analysis consisted of four modules.

First, the Market Size was estimated by identifying the

number of PID patients requiring immunoglobulin

treatment. Second, the Market Distribution module esti-

mated the market share of Kiovig as well as the impact

of the adoption of Kiovig on the market shares of other

immunoglobulins. Third, the Drug Costs scenario calcu-

lated annual immunoglobulin costs per patient. Fourth,

the Budget Impact module calculated total drug costs in

the reference scenario (“world without Kiovig”) and the

new drug scenario (“world with Kiovig”). The cost dif-

ference between these two scenarios revealed the budget

impact of adopting treatment with Kiovig. The time ho-

rizon of the budget impact analysis was five years from

2010 until 2014.

2.2. Market Size

The number of Belgian people suffering from PID was

derived from the IMS Health hospital disease database

and was expressed as a proportion of the Belgian popu-

lation. The analysis assumed that the percentage of the

Belgian population who suffers from PID would remain

constant over time. This implies that, in line with the

growing size of the Belgian population over time [10], the

number of PID patients is expected to increase.

2.3. Market Distribution

Based on the reimbursement value of intravenous immu-

noglobulins in 2007 as derived from the IMS Health hospi-

tal disease database, the market share of intravenous im-

munoglobulin products was estimated at 50% for Multigam,

45% for Sandoglobuline, 5% for Gammagard S/D, and 0%

for Octagam. No data were available on the market shares

of other intravenous immunoglobulins (i.e. Nanogam) and

subcutaneous immunoglobulins (i.e. Subcuvia and Vivag-

lobin) available on the Belgian market. The analysis as-

sumed that immunoglobulin market shares observed in

2007 would persist in the future in the reference scenario.

Market size

Market Distribution

Historical market share distribution of IGs

Forecasted market share of IGs without Kiovig

Forecasted market share of IGs with Kiovig

Drug Cost

Cost per patient

Budget Impact

Direct cost in Reference Scenario Direct cost with Kiovig

Scenario

Number of Belgian PID patients requiring IG

treatment Size of Belgian IG market

Incremental Costs (savings) over Reference Scenario

Notes: IG = immunoglobulin; PID = primary immunodeficiency.

Figure 1. Model structure of budget impact analysis.

Table 1. Intravenous immunoglobulin market shares in new drug

scenario.

2010 2011 2012 2013 2014

Gammagard

S/D 4.84% 4.75% 4.67% 4.59% 4.49%

Kiovig 3.20% 5.00% 6.60% 8.10%10.20%

Multigam 48.40%47.50% 46.70% 45.95% 44.90%

Sandoglobuline 43.56%42.75% 42.03% 41.36%40.41%

Total 100% 100% 100% 100% 100%

In the new drug scenario, Baxter expects Kiovig to

gain a market share of 3.2% in 2010, 5% in 2011, 6.6%

in 2012, 8.1% in 2013, and 10.2% in 2014. Kiovig was

assumed to take its market share evenly from Gamma-

gard S/D, Multigam and Sandoglobuline (see Table 1).

The associated number of patients in the reference

scenario and in the new drug scenario was calculated by

multiplying the estimated market share of each immu-

noglobulin product by the size of the target population.

2.4. Drug Costs

Hospital prices (including value-added tax of 6%) per

patient were calculated assuming an immunoglobulin

consumption of 24 g for a patient weighing 60 kg. This

was based on an average monthly dose of 0.4 g per kg of

body weight [1,3]. The average hospital price per gram

was calculated based on the different doses available for a

particular immunoglobulin product. Immunoglobulin unit

cost data for 2008 originated from Belgian sources and

were assumed to persist in the future. Table 2 presents the

cost per gram, monthly costs and annual costs for im-

munoglobulin products on the Belgian market.

2.5. Budget Impact

This study estimated the market size by identifying the

number of PID patients requiring immunoglobulin treat-

S. Simoens / HEALTH 1 (2009) 183-187

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Table 2. Intravenous immunoglobulin costs per patient in 2008.

Drug Cost per gram Monthly costs Annual costs

Gammagard S/D 44.86 € 1,076.64 € 12,919.68 €

Kiovig 49.01 € 1,176.24 € 14,114.88 €

Multigam 41.29 € 990.96 € 11,891.52 €

Sandoglobuline 45.58 € 1,093.92 € 13,127.04 €

Table 3. Estimated target population.

2010 2011 2012 2013 2014

Number of Belgian people 10,807,396 10,886,032 10,965,473 11,044,878 11,123,330

Percentage of people with pri-

mary immunodeficiency 0.022% 0.022% 0.022% 0.022% 0.022%

Number of primary immunode-

ficiency patients 2,378 2,395 2,412 2,430 2,447

Table 4. Estimated patient numbers.

Reference scenario New drug scenario

2010 2011 2012 2013 2014 2010 2011 2012 2013 2014

Gammagard

S/D 119 120 121 121 122 Gammagard

S/D 115 114 113 111 110

Kiovig 76 120 159 197 249

Multigam 1,189 1,197 1,206 1,215 1,224 Multigam 1,151 1,138 1,126 1,117 1,099

Sandoglobuline 1,070 1,078 1,085 1,094 1,101 Sandoglobuline1,036 1,023 1,014 1,005 989

Total 2,378 2,395 2,412 2,430 2,447 Total 2,378 2,395 2,412 2,430 2,447

Table 5. Budget impact of adopting Kiovig.

Total drug costs in reference scenario (€) Total drug costs in new drug scenario (€)

2010 2011 2012 2013 2014 2010 2011 2012 2013 2014

Gammagard

S/D 1,537,442 1,550,362 1,563,281 1,563,281 1,576,201Gammagard

S/D 1,485,763 1,472,844 1,459,924 1,434,084 1,421,165

Kiovig 1,072,7311,693,786 2,244,266 2,780,6313,514,605

Multigam

14,139,017 14,234,149 14,341,173 14,448,197 14,555,220Multigam 13,687,14013,532,550 13,389,852 13,282,828 13,068,780

Sandoglobu-

line 14,045,933 14,150,949 14,242,838 14,360,982 14,452,871Sandoglobu-

line 13,599,613 13,428,962 13,310,819 13,192,67512,982,643

Total

29,722,392 29,935,460 30,147,293 30,372,460 30,584,292Total

29,845,247 30,128,141 30,404,860 30,690,21930,987,193

Budget impact of adopting Kiovig

2010 2011 2012 2013 2014

Absolute budget impact

(€) 122,855 192,681 257,567 317,759 402,900

Relative budget impact

(%) 0.41 0.64 0.85 1.05 1.32

ment. Annual costs for a specific immunoglobulin product

were calculated by multiplying the number of patients

taking that product with the annual cost of that product.

Summing annual costs over all immunoglobulin products

generated total drug costs.

3. RESULTS

Table 3 presents estimates of the Belgian number of pa-

tients suffering from PID over the 2010-2014 time hori-

zon. The number of Belgian PID patients is expected to

increase from 2,378 patients in 2010 to 2,447 patients in

2014. Multiplying the estimated market share of each

immunoglobulin product by the size of the target popu-

lation generates estimates of the number of PID patients

taking a particular immunoglobulin product in the refer-

ence scenario and in the new drug scenario (see Table 4).

In both scenarios, the highest number of patients would

S. Simoens / HEALTH 1 (2009) 183-187

186

be expected to take Multigam, followed by patients tak-

ing Sandoglobuline and patients taking Gammagard S/D.

In the new drug scenario, the number of patients treated

with Kiovig is expected to increase from 76 patients in

2010 to 249 patients in 2014.

Table 5 shows total drug costs in the reference sce-

nario (“world without Kiovig”) and the new drug sce-

nario (“world with Kiovig”), respectively. In the refer-

ence scenario, total drug costs are expected to increase

from 29.7 million € in 2010 to 30.6 million € in 2014. In

the new drug scenario, total drug costs would rise from

29.8 million € in 2010 to 31 million € in 2014. The esti-

mated budget impact of treatment with Kiovig is the

difference in total drug costs between the new drug sce-

nario and the reference scenario. Table 5 demonstrates

that the absolute budget impact of adopting treatment

with Kiovig increases from 0.1 million € in 2010 to 0.4

million € in 2014. Overall, treatment with Kiovig raises

the 2010-2014 budget by 1.3 million € (or 0.86% of the

reference drug budget).

4. DISCUSSIONS

The budget impact analysis compared the “world with

Kiovig” to the “world without Kiovig”. The analysis took

into account the market size, immunoglobulin market

shares and unit costs with a view to estimating the budget

impact of Kiovig. The findings showed that, from the

perspective of the Belgian health care payer, the budget

impact of adopting Kiovig in the treatment of PID is

likely to be limited.

The adoption of Kiovig would raise the immunoglobulin

drug budget by 0.4%-1.3% per year. The budgetary in-

crease originated from the higher price of Kiovig as com-

pared with other intravenous immunoglobulins, although

the impact of Kiovig was limited by the slow market

penetration of Kiovig as predicted by Baxter. The analysis

used conservative estimates of the market share of Kiovig

over time given that similar products are expected to enter

the market in the future.

The budget impact analysis was based on a number of

assumptions in the absence of data. First, the analysis

focused on some, but not all intravenous immunoglobulin

therapies available on the Belgian market and did not

include subcutaneous immunoglobulin therapies. Second,

the immunoglobulin market evolves so that, even though

the most recent market share data relating to 2007 were

used, the data may no longer reflect the current market

situation. Third, the assumption was made that a patient

would require an immunoglobulin consumption of 24 g

per month. This is in line with estimates used by the

Belgian Commission for Drug Reimbursement [11]. In

light of these assumptions, the findings give an idea of the

order of magnitude of the budget impact of Kiovig, but do

not represent the exact budget impact. These shortcom-

ings highlight the need for more and better data on the

Belgian immunoglobulin market size and the market

distribution.

It should be noted that the budget impact is only one of

the factors informing the decision whether to reimburse

Kiovig. Other factors that are taken into account in Bel-

gium are the therapeutic value, price, importance in

medical practice in terms of therapeutic and social needs,

and cost-effectiveness.

Kiovig has a favourable pharmacokinetic, safety and

effectiveness profile in the treatment of PID patients. Three

prospective, open-label, multi-centre studies 160001 [12],

160101 [13] and 160002 [14] have demonstrated that

Kiovig attains the required minimum trough levels and

pharmacokinetic parameters in PID patients. The Euro-

pean Public Assessment Report of Kiovig reveals no

special risk for humans based on the exploration of safety

pharmacology and toxicity [15]. The outcome measures

of incidence of infections, antimicrobial use and the

number of days off school or work were similar to those

of other intravenous immunoglobulins.

In Belgium, Kiovig tends to be more expensive than

other intravenous immunoglobulins, amounting to an

increase in the hospital price per gram (excluding VAT of

6%) of 0%-18% as compared with Gammagard S/D,

5%-27% as compared with Multigam, -4% to 21% as

compared with Nanogam, and 8%-28% as compared with

Octagam in 2008.

In addition to Kiovig, other intravenous immu-

noglobulins are available on the Belgian market, in-

cluding Gammagard S/D, Multigam, Nanogam, Octa-

gam and Sandoglobuline. Furthermore, Subcuvia and

Vivaglobin are available for subcutaneous administra-

tion. As compared with other immunoglobulins, Kiovig

benefits from: a manufacturing process consisting of

three dedicated virus reduction steps; a formulation

containing no sucrose or sodium and containing more

than 98% immunoglobulin G; a ready-to-use liquid

presentation obviating the need for reconstitution; the

ability to store at room temperature; a faster infusion

speed and lower infusion volume; and the potential for

home-based administration [4,5].

To date, the cost-effectiveness of Kiovig as compared

with other intravenous immunoglobulins is unknown.

The previous sections point to a similar effectiveness and

higher price of Kiovig as compared with other products.

To determine the cost-effectiveness of Kiovig, there is a

need for an economic evaluation alongside a head-to-

head clinical trial comparing Kiovig with other intrave-

nous immunoglobulins.

5. ACKNOWLEDGEMENTS

Financial support for this research project was received from Baxter.

The author has no conflicts of interest that are relevant to the content of

this manuscript.

S. Simoens / HEALTH 1 (2009) 183-187

187

Openly accessible at

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