PHARMACOECONOMIC EVALUATION OF

RENACENZ (CEREBROLYSIN)

México, D. F., January 20, 2011

Stroke/Post-stroke

Cost – Effectiveness Study GENERAL OBJECTIVE

Perform a Pharmacoeconomic study to show clinical and economic benefits of using Renacenz in Mexican health units

Challenges (including questions) to further proceed: Acute treatment (within first hours of accident) vs rehab usage

Citicolina in Stroke? (not included in formulary If we have stroke approved by Cofepris, we can go to acute phase versus

what is used today at institutional level

Enough clinical support: demonstrated superiority vs identified competitors

There are No clinical treatment guidelines Limited information on costs and impact for México Health system Institutional data for Mexico is critical

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Stroke

Cost – Effectiveness Study SPECIFIC OBJECTIVES

Identify relevant alternatives for stroke in Mexico Quantify resource usage for each alternative treatment Estimate unitary costs for resource usage Identify treatment’s main effectivity measures based on

patient’s health impact Develop a decision tree considering health effects and

costs for each alternative Evaluate consistency of results through a sensitivity

analysis of critical variables of the model Interpret model’s results and discuss them

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Stroke

Sources to Estimate Treatment Effect

Measure effects depending on conference outcome Short term: Hours Mid-term: 10-30 days

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Sources up to now:

a) CASTA1. QUESTIONS Does not reflect Mexican population Short term to initiate treatment Less severe patients Lower dosage vs Adverse Reactions Measures vs placebo? In this case it means comparing to no

treatment? Opportunity for our model? Less deaths shown Indexed magazine publication

2. MORE SEVER SUB-GROUP ANALYSIS- CAN WE GET IT?

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Sources

b) Results of the multicenter prospective study of cerebrolysin safety and efficacy in acute stroke. Skwortsova VI, Stakhovskaia LV, Shamalov NA, Kerbikov OB. Zh Nevrol Psikhiatr Im S S Korsakova. 2006;Suppl 16:41-5.

Prospective multi-centric study for Cerebrolysin: efficacy and safety

Included 277 patients with ischemic CVA and age range of 55-85

Received treatment within first 12 hours after accident

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Sources

Treatment Group (Cerebrolysin) 10 ml per day + basic treatment during 10 days (138

patients).

Control Group Basic Treatment (139 patients)

Accelerated improvement in patients who received Cerebrolysin (days10 and 28) (p<0.05). : NIHSS score modified Rankin score Barthel index

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Sources

c) Clinical and pharmacoeconomic peculiarities of the treatment with cerebrolysin in the period of rehabilitation of ischemic stroke. Gusev EI, Gekht AB, Belousov IB, Pavlov NA, Galanov DV, Popov GR, Milchakova LE.; Zh Nevrol Psikhiatr Im S S Korsakova. 2007;107(10):26-33.

Clinical and Pharmacoeconomic study

Three groups for treatment 10ml/day 20ml/day Control

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Direct costs for each alternativeDepends on patient’s stage we decide in the conferenceMedicineHospitalizationLab tests/othr diagnosticRehab

Does not consider indirect costs and sequels

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Costs

Only one official source for costs: IMSS Licitations  “IMSS compró”, “compranet”. Published international or national studies. Resources usage: a sample case for a chosen

hospital in Mexico. Costs in IMSS for CVA (DRGs 2007- Diagnostic

Related Groups): Only referenced:

HEMORRAGIA INTRACRANEAL O INFARTO CEREBRAL $56,685 (Mex $)

(Intracranial hemorrhage or cerebral infarction)

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Source for costs

Comparators In accordance to institutional medical practice Current Mexican formulary (Cuadro Básico) includes:

Nimodipino. Indication: neurologic defic after a subaracnoides hemorage

Alteplasa: Indication: CVA

Others? NOT INCLUDED IN FORMULARY Citicolina (Somazina), Donepecilo (Eranz), r-TPA (Rapilysin), others

Time Horizon Will depend on chosen focus

Perspective Public Institutions in Mexico, particularly, IMSS

Sensitivity Analysis Univariate Probabilistic

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Other

Final Document including Economic Evaluation (in Spanish) following Consejo de Salubridad General guides Software versions of:

Final Document, pdf Executive Summary, pdf Results – slides presentation, ppt Full Text copy of used clinical studies (obeying copy rights) Model Data base Mathematical/Economical (if applies) format

based on software Support for Surveys, application and data base (if applies).

Support for dossier submittal (see proposal)

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Deliverables

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Time table

• To be updated or confirmed after this conference

Address:Insurgentes Sur 670 Piso 6-2Colonia Del ValleDelg. Benito Juárez México, D. F. 03100Tel: + 52(55)3640-0451Cel: +52(1)(55)5438-8849Contact: leonzapata@guiamark.comraulzambrano@guiamark.com

www.guiamark.com

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