Reaching coverage and universal access for expensive drugs and medical devices in chile abg july...
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Transcript of Reaching coverage and universal access for expensive drugs and medical devices in chile abg july...
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Reaching Coverage and Universal Access for Expensive Drugs and Medical Devices in Chile
Andrea Basagoitia, PhD
Chief of Studies and HTA
Scientific Affairs Department
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Institute of Public Health, ANAMED, keeps the registry of pharmaceutical products, allowing
national distribution or international commerce
ISP CHILE
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Since
July 1, 2016
PAHO Audit ISP-MoH-SEREMI
National Regulatory
Authority of Regional Reference
for drugs and biologicshttp://iris.paho.org/xmlui/handle/123456789/28521
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Chile (2015)
• Estimated Population (app.) 18.000.000
• 97% is covered under the health system.
• 76% covered by public funding.
• Expenditure on health: 7,8 % of GDP
• OOP Expenditure: 33% (2013), 31 % (E 2015)
• Pharmaceutical sales: MM US$3.887 (PPP)
• Generic Market: 80% (vol.), 59% (value)
http://stats.oecd.org/index.aspx?DataSetCode=HEALTH_STAT#
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Medication Coverage
• Medication National Formulary. Since 1985
– (2005) 720, 484 and 232 (needs an update)
• AUGE 80. Since 2004 (need revision)
• FOFAR. Since 2014 (needs auditing)
• Ley Ricarte Soto. Since 2015. Financial Protection for High Cost Treatments (drugs,
feeding form. IVD or medical devices).
“UNIVERSAL”http://stats.oecd.org/index.aspx?DataSetCode=HEALTH_STAT#
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Progressive Funding
• CL$ 100.000 Millions
• In 2017
US$ (today)
148,148,148.148
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STATUS of LEY RICARTE SOTO:First Decree December 4th 2015 until31/12/2016
• Continuity of treatments was guaranteed. More than 2.000 Patients are getting their meds.
• CPGs for treatments. 11 Conditions. • Implementing with minimum
regulations.• 85% Execution of the Projected
Budget by March 2016… However isonly 6.000 of 90.000
IMPLEMENTING A FINANCIAL PROTECTION SYSTEM FOR HIGH COST TREATMENTS: INCLUDED MEDS - LEY 20.850
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Pricing
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Pricing
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STATUS of LEY RICARTE SOTO:Second Decree should be coming outthis month.
• Verifying Provider Network• Still negotiating new acquisitions• 78% in 2 Health Problems. Breast Ca.
Preemies with BPD
IMPLEMENTING A FINANCIAL PROTECTION SYSTEM FOR HIGH COST TREATMENTS: INCLUDED MEDS - LEY 20.850
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Still greyThreshold to define High
Cost updated every 3
years
Prioritizing
Process
http://leyricartesoto.fonasa.cl/index.html
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Prioritizing
Decreto Ley N° 20.850: Publicado el 4 de Diciembre de 2015
1. Threshold to define High Cost
2. Safety and Efficacy
3. Immediate Availability
4. Readiness of Providers Network
5. Total Annual Cost less than 80% (MMCL$72.000)
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Usual HTA Process
Recommendation Decision
& Implementation
¿Qué evidencia?
¿Quién es el
responsable?
¿Quién lo ejecuta?
¿Cuáles métodos?
¿Quién demanda?
¿Cuál es el producto?
¿Cuánto demora?
¿En base a qué elementos?
¿Quién lidera?
¿Quién participa?
¿Cómo se toma la decisión?
¿Cuánto demora?
¿Qué incluye la recomendación?
¿Quien toma la
decisión?
¿Cómo se financia?
¿Cómo se implementa?
¿Quién monitoriza?
¿Qué se monitoriza?
¿Cómo se monitoriza?
¿Quién revisa y
actualiza la decision?
Assessment
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HTA with a new focus
Eficacia Relativa
y Seguridad
Efectividad
Relativa
Evaluación Económica
¿funciona?
¿funciona en la realidad?
¿vale la pena pagar por ella?
Implementación
Impacto
presupuestario
¿Se puede asegurar acceso?
¿Puede el presupuesto de salud pagar la intervención?
Reevaluación y revisión
Evaluación de
mecanismos de pago¿Cuál es el máximo precio que se debiera pagar y
cuáles son las oportunidades de condicioinar el pago?
¿Real World Evidence?
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2 Key points (1)
¿Qué evidencia?
¿Quién es el
responsable?
¿Quién lo ejecuta?
¿methods?
¿Quién demanda?
¿Cuál es el producto?
¿Cuánto demora?
Principle:
Characterization of benefits, risks, financial
costs and opportunity costs.
Consensus:
-RCTs y meta-analysis
-CEA
-Characterization of first and second degree of
uncertainty
Re - define:
-“Relevant evidence”
- Equity and social values
Assessment
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Assessment
¿Qué evidencia?
¿Quién es el
responsable?
¿Quién lo ejecuta?
¿Cuáles métodos?
¿Quién demanda?
¿Cuál es el producto?
¿How long is it going to take ?
Principle:
It has to be defined
Assessment time:
-2 weeks– 1 month for fast reports
-3-6 months for simple comparison
-6-12 months for multiple comparisons
2 Key points (2)
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ISP BPR BID
To improve efficiency in high cost medication management
http://www.omaif.org/
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http://www.omaif.org/medicamentos-observados
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http://www.omaif.org/herramientas/taller-costa-rica
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Coming soon!
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Andrea Basagoitia, PhD
Chief of Studies and HTA
Scientific Affairs Department
Reaching Coverage and Universal Access for Expensive Drugs and Medical Devices in Chile