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Pricing and Reimbursement P olicies

Pricing and Reimbursement P olicies. Pricing P olicies Patented Medicines. Maximum retail prices capped by Ministry of Economy (mainly for private sector) Use international reference pricing

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Pricing and Reimbursement P olicies

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  1. Pricing and Reimbursement Policies

  2. Pricing Policies Patented Medicines • Maximum retail prices capped by Ministry of Economy (mainly for private sector) • Use international reference pricing • Calculated on basis of the average ex-factory price of the previous quarter in the six largest markets for a given product globally • Governed by General Law on Health, Article 31 • Lack of across-the-board compliance by pharmacies, poorly regulated • Little competition in public sector prices for patented medicines (due to centralized purchasing price)

  3. Generic Pricing Policies • Pricing • Public sector: no central price control, wide variation in prices by state or insurance scheme • Private sector: generics/off-patent medicines no price control • Policies Promoting the Use of Generics • Federal Commission for the Protection against Sanitary Risks (COFEPRIS) creates Interchangeable Generics List • Listed by INN, includes both generic and original products • Public sector insurance schemes use list as well as National Formulary to encourage (but not require) generic prescription • Generic consumption through public insurance coverage still limited

  4. Reimbursement Policies • All public institutions and insurance schemes governed by National Formulary (CuadroBásico y Catálogo de Medicamientos) • Set by National Formulary Committee (CICBISS) of the General Health Council (CSG) • Dictates first, second and third lines of treatment • 4-5 months for review and decision • Listed by INN, each assigned a code • Limits medicines available to 932 INNs (2011) based on market authorization and Economic Evaluation Study (EEE) • Large majority are off-patent • Published annually

  5. HTA Policies • Economic Evaluation Study (EEE) compares current standard treatment with product proposed for inclusion in CuadroBásico • Mandated by CICBISS Internal Regulation, Article 24 • Submitted by company, CICBISS reviews according to CSG guidelines • Must include at least 1 of the following comparisons: • Cost-minimization – cost savings compared to equally effective comparators • Cost-effectiveness – incremental cost-effectiveness ratio relative to GDP per capita per additional years of life • Cost-utility – same as above, using QALY as denominator • Cost-benefit – rate of return relative to public debt issued by Federal Government

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