1. COST-EFFECTIVENESS ASSESSMENT OF TWO BOTULINUM TOXIN TYPE A COMMERCIAL BRANDS, IN THE MANAGEMENT OF SPASTICITY IN CEREBRAL PALSY. Vega G (1), Idrovo J (1,2), Rivas R (1), Zapata L* (1), Rico-Alba I (1,2,3). 1 Guia Mark S.A. de C.V. 2 Instituto Nacional de Salud Pública, México. 3 Universidad Anáhuac Norte, México Introduction Objective Discussion Table 1. COSTS FOR PROCEDURES AND TREATMENT OF SPASTIC SYNDROME Resource: Centro de Rehabilitación Integral Querétaro (CRIQ), Mexico Note: BtA= Botulinum toxin type A Figure 1. ALGORITHM FOR CARE IN PATIENTS WITH SPASTIC SYNDROME SECONDARY TO CP Methods Results Cerebral palsy (CP) is a broad concept, used to describe different non- progressive motor and postural deterioration syndromes, and it is considered as the main cause for severe disability among children worldwide (1-3). In Mexico, in 2003, there were 500,000 individuals with some degree of CP (2). There are different treatments available to manage spasticity in CP, and one of them is the use of botulinum toxin type A (4). Currently, two commercial brands are available in Mexico (Dysport® and Botox®) which differ in their manufacturing process, protein association and doses used (19). The equivalence between the presentation doses has been a widely discussed topic, and it is a limitation to define if there is or not any difference in the effectiveness of these compounds. The estimated annual treatment cost per patient was USD $3,844 (± $673) for Botox and USD $3,441 (± $602) for Dysport. Therefore, the use of Dysport represents annual savings of USD $406 (± $73) in the base case scenario. An increase in the dose ratio from 1:2.5 to 1:3 and 1:4 still showed annual treatment savings per patient favoring Dysport, for USD $290 (± $52) and USD $58 (± $10) respectively. To perform a cost-effectiveness analysis of the use of botulinum toxin type A (Dysport® vs Botox®) to treat spasticity in Mexico According to the effectiveness equivalence, the procedures used to treat SCP are the same for both alternatives, therefore, the differences are only given by the cost. Therefore, in the Mexican context, Dysport ® is the institutional cost-minimization alternative in the treatment of patients with spasticity, and this advantage is maintained in a dose ratio from 1:2.5 to 1:4. Implementation of Dysport® is recommended as the therapy of choice for SCP treatment, with important savings for institutions that follow formal care protocols, such as the protocol used in CRIQ. A systematic literature review was performed in order to find the effectiveness variables that would be used as the input for the economic model. From this review, it was inferred that the effects generated by both alternatives are equivalent, therefore, it was necessary to adjust the analysis to the cost- minimization type. Doses and use of resources for spasticity treatment were estimated from an institutional perspective, through an algorithm based on observations performed in a specialized health care unit (Centro de Rehabilitación Infantil de Querétaro (CRIQ) and validated by an independent neurological specialist. It was assumed that the patient treatment process is similar with any of the botulinum toxin formulations (Fig 1). The study was performed from an institutional perspective. The cost analysis model includes: treatment with Botox® or Dysport® and physical therapy. Costs were estimated in Mexican pesos (year 2006) and were converted to dollars at an exchange rate of $10.81 MXP/$1 USD. The time horizon was 1 year. A sensitivity analysis was performed. References: (1) Koman LA, Paterson-Smith B, Shilt JS. Cerebral Palsy. Lancet 2004; 363: 1619-31. (2) APAC. Hay en Mexico 500 mil personas con parálisis cerebral. In the web [available at: http://www.cimacnoticias.com/noticias/03may/03050511.html [Revised on February 15, 2007]. http://www.cimacnoticias.com/noticias/03may/03050511.html (3) Sevilla-Castillo RA, et al. Utilización de toxina botulínica A en las extremidades inferiores en niños con parálisis cerebral. Bol Med Hosp Infant Mex 1996; 53: 318-25. (4) Augustí A, Bosch M. Usos terapéuticos de la toxina botulínica. Butlletí d'informació terapèutica del Departament de Sanitat i Seguretat Social de la Generalitat de Catalunya 2003; 15:11-4 Pre- ) Rehabilitation Consultation Rehabilitation Consultation 2-3 times/week for 3-4 months Preconsultation (General Surgeon, Pediatrician, Neurologist, Internist Physician) 1st Consultation for application of botulinum toxin (BtA) 2nd Consultation BtA Subsequent Figure 2. RESULTS OF THE SENSITIVITY ANALYSIS Medical Care ProcedureUnitTotal Cost Consultation for diagnostic of spastic syndrome Consultation with general surgeon, internist, pediatrician or neurologist 1449.36 Specialist consultation, first BtA* application and rehabilitation. Specialist Consultation1$1,142.50 Computerized Axial Tomography 1$7,379.75 RMN1$8,214.42 Electromyography1$212.80 Electroencephalogram1$212.80 Evoked Potentials1$212.80 Rehabilitation Consultation 49$4,150.59 Dysport®225.4$1,893.36 Botox®90.16$3,220.58 Dysport® Subtotal $23,419.22 Botox® Subtotal $24,746.23 Specialist consultation, second BtA* application and rehabilitation. Specialist Consultation1$1142.498 Rehabilitation Consultation 32$2,710.59 Dysport®225.4$1,893.36 Botox®90.16$3,220.58 Dysport® Subtotal $5,746.45 Botox® Subtotal $7,073.67 Specialist consultation, third BtA* application and rehabilitation. Specialist Consultation1$1142.498 Rehabilitation Consultation 16$1,355.30 Dysport®225.4$1,893.36 Botox®90.16$3,220.58 Dysport® Subtotal $4,391.15 Botox® Subtotal $5,718.37 Resource: Unit Costs for Medical Care IMSS 2005, using prices of 2006, Mexico. IMSS purchased: therapeutic assets. Available at: http://200.34.143.57:8080/wijsp/PDF_IMSS/IMSSComproBienesTerapeuticos.pdfIMSS purchased: therapeutic assets. Available at: http://200.34.143.57:8080/wijsp/PDF_IMSS/IMSSComproBienesTerapeuticos.pdf Note:: BtA= Botulinum toxin type A All procedures are taken based on the algorithm validated by experts. Alternatives In general, a dose equivalence ratio of 1:3 is accepted between Botox® and Dysport®. Equivalences from 1:2 to 1:5 have been used and approved, according to the indication 4. The above was modeled using a sensitivity analysis, in order to measure the impact of the equivalence change on the final results. Therapies Contents Unit Cost 1 Botox ® Botulinum toxin type “ A ”. Solution for injection. Each powder vial contains: botulinum toxin type “ A ” 100u. $330.44 USD 2 Dysport ® $388.53 USD ISPOR 1st Latin American Conference, Cartagena, Colombia. September 2007. Project sponsored by Beaufour Ipsen México, S. de R. L. Contact: contactenos@guiamark.com PND2 Botulinum toxin type “ A ”. Solution for injection. Each powder vial contains: botulinum toxin type “ A ” 500u. Rehabilitation Consultation 1-2 times/week for 3-4 months 3rd Consultation BtA Rehabilitation Consultation 1 time/week for 3-4 months Rehabilitation Consultation 1 time/week for 3-4 months