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 2

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 3

Stroke Sources to Estimate Treatment Effect  Measure effects depending on conference outcome  Short term: Hours  Mid-term: days 4

Sources up to now: a) CASTA 1. 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? 5

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  Received treatment within first 12 hours after accident 6

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 7

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):  Clinical and Pharmacoeconomic study  Three groups for treatment  10ml/day  20ml/day  Control 8

 Direct costs for each alternative  Depends on patient’s stage we decide in the conference  Medicine  Hospitalization  Lab tests/othr diagnostic  Rehab  Does not consider indirect costs and sequels 9 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 Diagnostic Related Groups):  Only referenced: HEMORRAGIA INTRACRANEAL O INFARTO CEREBRAL $56,685 (Mex $) (Intracranial hemorrhage or cerebral infarction) 10 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 11 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) 12 Deliverables

13 Time table To be updated or confirmed after this conference

Address: Insurgentes Sur 670 Piso 6-2 Colonia Del Valle Delg. Benito Juárez México, D. F Tel: + 52(55) Cel: +52(1)(55) Contact: 14