COST MINIMIZATION ANALYSIS FOR THE TREATMENT OF PRIMARY IMMUNODEFICIENCY DISEASE (PIDD) IN THE MEXICAN SOCIAL SECURITY INSTITUTE (IMSS) IN 2016

Maciel-Hernandez Humberto1, Salazar-Alvarado Blanca2, Paladio-Hernandez Jose Angel3.

Background: Cost-minimization study examining the comparison of treatment with Human Subcutaneous Immunoglobulin 20% (Hizentra®) versus Intravenous Immunoglobulin 5% & 6% and Human Subcutaneous Immunoglobulin 16.5% under perspective of Mexican Institute of Social Security (IMSS). Objectives: Primary immunodeficiency disease (PIDD) is a large, heterogeneous group of disorders that weaken the immune system creating a pattern of repeated severe infections. These infections may attack Patients with PID require regular administration of immunoglobulin G (IgG) to prevent infection and maintain quality of life. The objective of this study is to compare the costs of using SCIG 20% (human subcutaneous immunoglobulin 20%, Hizentra®) in comparison to intravenous immunoglobulin (IVIG) in the IMSS in order to identify the cost-saving PIDD treatment. Methods: Since SCIG 20% and intravenous immunoglobulin (IVIG) have the same safety and efficacy profile, a cost-minimization analysis was conducted. The costs in the analysis are the treatment costs for a 72.65 Kg patient in a 5-year time horizon, applying a 5% discount rate on costs. The analysis is presented in 2 scenarios. The first scenario compared SCIG 20% vs IVIG 5% and 6%. The second scenario compared SCIG 20% vs SCIG 16.5%. All unitary costs are the IMSS acquisitions costs in 2016. Results: In the first scenario, monthly dose expected is 43.59 g, so the monthly treatment costs for IVIG 5% and 6% is 2,882.03 USD, meanwhile for SCIG 20% the monthly cost of treatment is 2,713.18 USD (a difference of 168.75 USD). Annual costs for IVIG 5% and 6% are 34,584.32 USD vs 32,559.36 USD. ISCG 20% leads to a saving of 2,024.96 USD per patient per year when compared to IVIG 5% and 6%. In the second scenario, the monthly dose is the same as scenario I, so expected monthly cost for IGSC 16.5% is 3,105.01 USD vs 2,713.28 USD per month IGSC 20% cost. Annual savings obtained by IGSC 20% compared to IGSC 16.5% are 4,700.80 USD per patient per year. In a 5-year time horizon, IGSC 20% savings vs IGIV 5% y 6% are $9,217.66 per patient. The savings to obtain from IGSC 20% when compared to IGSC 16.5% $21,325.80 Conclusions: IGSC 20% (Hizentra®) is a cost-saving alternative when compared to IGSC 16.5% and IVIG 5% and 6%. The use of IGSC 20% (Hizentra®) may lead to increase the number of PIDD patients treated at the IMSS. Keywords: primary immunodeficiency, cost minimization, human subcutaneous immunoglobulin, health care costs.

References: (1) Lim MS. Journal of Molecular Diagnostics, 2004; (2) Coria-Ramírez E. Rev Alerg Mex, 2010; (3) Ruggero P. Epidemiology Insights, Intech 2012; (4) Wasserman RL. Expert Review of Clinical

Immunology 2014; (5) Al-Herz W. Frontiers in Immunology, Primary Immunodeficiencies 2014; (6) LASID 2015. Registro de Inmunodeficiencias Primarias de la Sociedad Latinoamericana de

Inmunodeficiencias; (7) Notarangelo LD. J Allergy Clin Immunol 2010; (8) Contreras FA. Alergia, Asma e Inmunología Pediátricas 2014; (9) Bolli R. Biologicals 2010; (10) CSL Behring. Hizentra – IPPA 2014; (11)

Wasserman RL. Clin Pharmacokinet 2011; (12) Jolles S. Clinical Immunology 2011; (13) Hagan JB. J Clin Immunol 2010; (14) Melamed I. Int Rev Immunol, 2012. (15) Hagan JB. Expert Review of Clinical

Immunology, 2012 (16) Gerth WC. Allergy, Asthma & Clinical Immunology 2014; (17) Igarashi A. Clinical Therapeutics, 2014; (18) Shapiro R. Clin Exp Immunol 2013; (19) Decamps-Solano GM. Alergia, Asma e

Inmunología Pediátricas, 2013. Disclosures: The study was supported by CSL Behring Mexico. Scientific information was obtained by published sources. Acknowledgments: Editorial and graphical support

was provided by CSL Behring Mexico. Presented: at the ISPOR 19th Annual European Congress, 29 October-2 November 2016, Austria Center Vienna, Vienna, Austria. Contact : Dr. Humberto Maciel.

hmacielh@cslbehring.com

Research Question: What the economic impact for introduction and use of Subcutaneous

Immunoglobulin 20% (IGSC 20% ) in the Mexican Social Security Institute is?

1. SCIG 20% and IVIG´s have

equivalent profiles of efficacy,

safety and tolerability.

2. SCIG 20% concentration

allows lower infusion volume

and better rate of

administration.

3. IGSC 20% is cost-saving

compared vs IVIG´s.

ECONOMIC MODEL

Type of Economic Evaluation: A Cost

Minimization was developed to evaluate

savings for Public Health Institutions due the

lower cost of Subcutaneous Immunoglobulin

therapy 20%.

Comparators: Subcutaneous Immunoglobulin

20% (SCIG) vs Endovenous Immunoglobulin

5% & 6% (IVIG)

Horizon: It was chosen an horizon of 5 years

to estimate impact on short-term use of IGSC

20% and make a conservative assessment.

However, since PID are a chronic illness,

horizon could also be developed for all

patient's life and extent the benefits for budget

analysis.

Perspective: Mexican Social Security Institute

Base Case:

- Annual cost of treatment with IVIG was USD

$36,025, and SCIG 20% was $ 33.903.

- Annual saving using IGSC 20% was USD

$2,122.

| IGIV 5% y 6% IGSC al 20% Savings

Year 1 $36,025 $33,903 -$2,122

Year 2 $70,249 $66,111 -$4,138

Year 3 $102,762 $96,708 -$6,053

Year 4 $133,649 $125,776 -$7,873

Year 5 $162,992 $153,390 -$9,601

Sensitivity Analysis:

- Considered a value of minimum weight of

20kg and maximum weight value of 120kg

- Used minimum monthly stable dose of

0.4g/kg and a maximum 0.8g/kg

- Used a discount cost rate minimum of 3%

and maximum 7%

The results of the probabilistic sensitivity

analysis allowed testing the robustness of

the model and showed that in all cases

generate savings for public health

institutions

Alternative Cost Incremental Cost

IGIV 5% & 6%$162,718

($146,922 a $178,515)

IGSC al 20%$153,133

($138,267 a $167,999)

-$9,586

(-$10,516 a -$8,655)

Sensitivity Analysis in 5 years

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3%

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5%

6%

7%

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Incremental Cost

Assumptions:

1. Derivated from Systematic Review

study, the model considered all

immunoglobulins therapies as

equivalents in efficacy and safety.

2. Based on the official anthropometric

study of size and weight (Mexico), it

was considered an average weight of

72.65 kg per patient.

3. According to prescribing information

for IGSC 20% and the mean dose

established in National Formulary for

IVIG 5% & 6%, monthly average dose

for treatment (0.6 g/kg) was used.

4. Prices of immunoglobulins were

obtained from consolidated national

tender (last published prices).

5. Discount rate per year was 5% for

costs, based on the Mexican Guidelines

for Economic Evaluations.

1 MD Master in Health Systems & Health Economics; 2 MD Pediatrician & Hematologist Pediatrician; 3 Health Economics Independent Consultant.

Budget Impact Analysis:

- It was considered a gradual substitution

(5% each year) from IVIG to SCIG 20%

- Based on incidence of patients in the

Mexican Social Security Institute, budget

impact analysis showed a 5-year savings

for USD $6.4 million.

- According to world experience,

substitution took place only in a

maximum of 25% of all cases.