Price Models for Multi-indication Drugs: A Systematic Review.

BACKGROUND: Marketing of new and existing drugs with new indications used alone or in combination is increasing. OBJECTIVE: To identify the advantages and disadvantages of indication-based pricing (IBP) systems for such drugs from the standpoint of economic theory, practical applications and international experiences. METHODS: We conducted a systematic review of published articles and reports using six bibliographic databases: PubMed, ASCO, Scopus, DARE, HTA and NHS EED. We also conducted a search of gray literature in Google Scholar. The same search terms were used as in Towse et al. (The debate on indication-based pricing in the U.S. and five major European countries. OHE Consulting Report, London, 2018). Articles and reports published from 1 January 2000 to 30 September 2018 were included. RESULTS: A total of 26 studies met the inclusion criteria. There are three main types of IBP: different brands with different prices for each indication, an averaged single price for all indications and a single price with differential discounts. The studies indicate that IBP systems are premised on the idea that charging a different price for different indications reflects the differences in their value and in social willingness to pay for each one and for the investment in R&D based on the indication's incremental clinical benefit. Some argue that a uniform price reduces access and increases the price for lower-value indications, while others contend that if IBP sets prices at the maximum threshold of social willingness to pay for each indication, all surplus is transferred to the producer and consumer surplus is reduced to zero. No practical applications of pure IBP were found. Single pricing for drugs is the most prevalent approach. The system that most closely approximates an IBP model consists of agreements that are generally confidential and linked to risk-sharing agreements. CONCLUSIONS: There are no applications of pure IBP systems and their practical consequences are therefore unknown. More economic theory-based assessments of the pros and cons of IBP and studies different from reviews are needed to capture their intricacies and specificities.

Evaluación del impacto de la utilización de medicamentos en dosis unitarias en 2 centros de atención primaria / Assessment of the impact of the use single-dose medications in 2 primary care centres

Objetivo: Evaluar el impacto económico de la utilización de medicamentos envasados en dosis unitaria (DU) independiente (Onedose®), en comparación con la prescripción de preparados en envase multidosis habitual. Diseño del estudio: Se ha realizado un análisis de minimización de costes desde la perspectiva del centro prescriptor. El diseño del estudio es observacional retrospectivo e incluye todas las prescripciones de los 23 productos analizados realizadas entre enero y abril de 2012.EmplazamientoEl estudio se ha realizado en 2 centros de atención primaria de la provincia de Barcelona. El primero urbano con 24.500 personas de cobertura y el segundo semiurbano que cubre a 10.000 personas. Mediciones principales: Para cada producto analizado se midió en el periodo de estudio y se extrapoló anualmente, en función de los resultados de los escenarios de sustitución definidos, el ahorro total en euros, ahorro derivado de precio y ahorro derivado de las dosis no prescritas. Resultados: El ahorro que en los centros analizados supondría haber utilizado Onedose® en vez de las presentaciones prescritas se sitúa en el período analizado sobre los 45.000 euros (24%) y anualmente en 133.000 euros. Se evitarían en el período estudiado unas 212.000 unidades galénicas (14%) de los medicamentos analizados y anualmente 669.000. Conclusiones: En los centros analizados la utilización de este tipo de medicamentos puede suponer reducción del gasto vinculado a la prescripción sin un incremento de costes de dispensación y podría reducir los stocks domiciliarios de aquellos medicamentos que objetivamente no es conveniente que sean aplicados sin un diagnóstico previo (AU)

Objective: To evaluate the economical impact of using medications packaged in a single dose non-reusable container (Onedose®), compared to prescribing preparations in the usual multidose containers. Design: We performed a cost-minimization analysis from a prescribing center’s perspective. The observational study design is retrospective and analyzes 23 products in prescriptions made between January and April 2012. Setting: Two Spanish Primary Care Centers located in the province of Barcelona. The first covered an urban area with a population of 24.500 people, and the second a semi-urban area with 10.000 people. Primary outcome measures: Each examined product was measured between January and April 2012 and extrapolated annually, based on the defined substitution scenarios results of total Euro savings in non-prescribed doses and price differences. Results: The Savings related to the substitution of the prescribed packaging presentations with Onedose® were 45.000 Euros (24%) in the months of analysis and 133.000 Euros annually, avoiding the use of 212.000 doses (14%) in the period analyzed and 669.000 doses annually. Conclusions: The use of single dose non-reusable container packaging (Onedose®) in the analyzed health centers reduced prescription-related expenses without increasing dispensing costs, thus reducing the household stock of those medicines which are not objectively suitable to be used without a previous diagnosis (AU)

[Assessment of the impact of the use single-dose medications in 2 primary care centres]. / Evaluación del impacto de la utilización de medicamentos en dosis unitarias en 2 centros de atención primaria.

OBJECTIVE: To evaluate the economical impact of using medications packaged in a single dose non-reusable container (Onedose(®)), compared to prescribing preparations in the usual multidose containers. DESIGN: We performed a cost-minimization analysis from a prescribing center's perspective. The observational study design is retrospective and analyzes 23 products in prescriptions made between January and April 2012. SETTING: Two Spanish Primary Care Centers located in the province of Barcelona. The first covered an urban area with a population of 24.500 people, and the second a semi-urban area with 10.000 people. PRIMARY OUTCOME MEASURES: Each examined product was measured between January and April 2012 and extrapolated annually, based on the defined substitution scenarios results of total Euro savings in non-prescribed doses and price differences. RESULTS: The Savings related to the substitution of the prescribed packaging presentations with Onedose(®) were 45.000 Euros (24%) in the months of analysis and 133.000 Euros annually, avoiding the use of 212.000 doses (14%) in the period analyzed and 669.000 doses annually. CONCLUSIONS: The use of single dose non-reusable container packaging (Onedose(®)) in the analyzed health centers reduced prescription-related expenses without increasing dispensing costs, thus reducing the household stock of those medicines which are not objectively suitable to be used without a previous diagnosis.

[The use of the Framingham-REGICOR equation in a primary care centre. Impact on primary prevention of cardiovascular diseases]. / Utilización de la ecuación de Framingham-REGICOR en un centro de atención primaria. Impacto sobre la prevención primaria de las enfermedades cardiovasculares.

OBJECTIVES: To evaluate the adequacy of cardiovascular primary prevention by calculating cardiovascular risk (CVR) with 2 different equations and to evaluate the economic impact of the resulting drug expenditure. DESIGN. By means of a transversal study of all the new cases of lipaemia diagnosed, patients were classified in 2 CVR categories (> or =20% and <20%). The Framingham-Wilson (FW) and Framingham-REGICOR (FR) equations were used to analyse the difference between observed treatments (really prescribed) and expected treatments. Costs were compared. SETTING: Barceloneta PCC, Barcelona, Spain. PATIENTS: Ninety-two cases of lipaemia (2002 and 2003) that met the following inclusion criteria: no coronary history, no taking of lipid-lowering drugs, and age between 35 and 74. There were 10 losses in the 92 individuals through lack of a variable for calculating CVR. RESULTS: According to the clinical criterion, 22 of the 82 patients were treated with medication (26.82%). The expected proportion of patients treated when the FW equation was used was 24.39% (20/82); and was 0% (0/82) with the FR equation. On applying the FW equation, it was seen that 12 of 22 patients treated and 10 of 60 patients not treated did not receive the correct drug treatment. If the mean cost per patient treated and per year at the PCC is applied to the new cases, there is a 9.09% reduction (euro 479.2) for the FW equation and 100% (euro 5271.2) for the FR equation. CONCLUSIONS: The use of one or other algorithm for calculating CVR entails pertinent differences in clinical practice and expenditure. All patients in primary prevention must receive non-pharmacological treatment.

Utilización de la ecuación de Framingham-REGICOR en un centro de atención primaria. Impacto sobre la prevención primaria de las enfermedades cardiovasculares / The use of the Framingham-REGICOR equation in a Primary Care Centre. Impact on primary prevention of cardiovascular diseases

El estudio que aquí se presenta corresponde a un trabajo de tesina del Máster de Salud Pública de la UPF (edición 2002-2004). Este estudio no ha sido presentado ni publicado en ninguna revista científica y únicamente ha sido expuesto al tribunal del Máster. Objetivos. Evaluar la adecuación de la prevención primaria cardiovascular mediante la estimación del riesgo cardiovascular (RCV) según 2 ecuaciones diferentes y evaluar el impacto económico del gasto farmacológico consecuente. Diseño. Estudio transversal. Emplazamiento. Centro de atención primaria de la Barceloneta (CAP Barceloneta) en Barcelona. Pacientes. Se incluyó a 92 casos incidentes de dislipidemia (años 2002 y 2003) que cumplían los siguientes criterios de inclusión: sin antecedentes coronarios, no tomar fármacos hipolipidemiantes y edad entre 35 y 74 años. De los 92 individuos se produjeron 10 pérdidas por falta de alguna variable para calcular el RCV. Mediciones. Los pacientes se clasifican en 2 categorías de RCV (≥ 20% y < 20%) mediante la aplicación de las ecuaciones de Framingham-Wilson (FW) y Framingham-REGICOR (FR). Se analiza la diferencia entre tratamientos observados (realmente prescritos) y esperados según una u otra ecuación. Se compara el coste. Resultados. Se observa que, según el criterio clínico, 22 de los 82 pacientes incidentes son tratados con fármacos (26,82%). La proporción esperada de pacientes tratados si se aplica la ecuación de FW es del 24,39% (20/82), y del 0% (0/82) para la ecuación FR. Al aplicar la ecuación FW se observa que 12 de los 22 pacientes tratados y 10 de los 60 pacientes no tratados no reciben correctamente el tratamiento farmacológico. Si el coste medio por paciente tratado y año en el CAP se aplica a los casos nuevos, se observa una reducción del 9,09% (479,2 euros) para la ecuación FW y del 100% (5.271,2 3 euros) para la ecuación FR. Conclusiones. La aplicación de uno u otro algoritmo de cálculo del RCV comporta diferencias relevantes en la práctica clínica y en los costes derivados. Todos los pacientes en prevención primaria deben recibir tratamiento no farmacológico

Objectives. To evaluate the adequacy of cardiovascular primary prevention by calculating cardiovascular risk (CVR) with 2 different equations and to evaluate the economic impact of the resulting drug expenditure. Design. By means of a transversal study of all the new cases of lipaemia diagnosed, patients were classified in 2 CVR categories (≥20% and <20%). The Framingham-Wilson (FW) and Framingham-REGICOR (FR) equations were used to analyse the difference between observed treatments (really prescribed) and expected treatments. Costs were compared. Setting. Barceloneta PCC, Barcelona, Spain. Patients. Ninety-two cases of lipaemia (2002 and 2003) that met the following inclusion criteria: no coronary history, no taking of lipid-lowering drugs, and age between 35 and 74. There were 10 losses in the 92 individuals through lack of a variable for calculating CVR. Results. According to the clinical criterion, 22 of the 82 patients were treated with medication (26.82%). The expected proportion of patients treated when the FW equation was used was 24.39% (20/82); and was 0% (0/82) with the FR equation. On applying the FW equation, it was seen that 12 of 22 patients treated and 10 of 60 patients not treated did not receive the correct drug treatment. If the mean cost per patient treated and per year at the PCC is applied to the new cases, there is a 9.09% reduction (€479.2) for the FW equation and 100% (€5271.2) for the FR equation. Conclusions. The use of one or other algorithm for calculating CVR entails pertinent differences in clinical practice and expenditure. All patients in primary prevention must receive non-pharmacological treatment