Pharmaceutical innovativeness index: methodological approach for assessing the value of medicines - a case study of oncology drugs.

BACKGROUND: We propose a framework to assess the value of pharmaceutical innovations, with explicit clinical and methodological parameters, based on the therapeutic value and health needs. RESEARCH DESIGN AND METHODS: The study was based on the adaptation of health technology assessment methods documented in the literature, which was applied to a sample of oncological drugs. Difficulties and issues during the application of those tools were identified and addressed to develop a new framework with new and revised domains and clear classification criterion for each domain. Scores were assigned to each level and domain according to their relevance to generate the final score of innovativeness. RESULTS: The Pharmaceutical Innovation Index (PII) includes four domains, two related to clinical and social dimensions - Therapeutic Need and Added Therapeutic Value - and other two about methodological features - Study Design and Quality (risk of bias). The scores combined after assigned to each domain results Index of the Innovativeness of the medicines represents the degree of pharmaceutical innovation. CONCLUSION: This work proposes a transparent methodology with well-defined criteria and script; the algorithm developed with authors' weightings and criteria may be switched to best adjust to other applications, perspective or clinical indications, while keeping the transparency and objectiveness.

Access to medicines in the Brazilian Unified Health System's primary health care: assessment of a public policy.

In 2008, the Programa Rede Farmácia de Minas (RFM, literally translated: 'Minas Gerais Pharmacy Network' program) was created as a strategy to expand access to medicines. Aim: Measure access to medicines in public pharmacies through comparison between municipalities that joined or not the RFM. Materials & methods: Cross-sectional, evaluative study, gathering information from a representative sample of the municipalities in Minas Gerais between July 2014 and May 2015. The Poisson regression results were obtained by calculating the prevalence ratios. Results: Adequate access to medicines in Minas Gerais was 69.9%, being 75.8% in municipalities with and 69.2% without the RFM. The municipalities with the RFM showed statistically higher percentages in the Availability, Adequacy/Accommodation, and Acceptability dimensions. Conclusion: RFM appears an efficient strategy for promoting access to medicines.

Strategies to improve the availability of medicines in primary health care in Brazil: findings and implications.

Aim: Access to essential medicines is a key component of managing patients in ambulatory care. In 2008, the State of Minas Gerais, Brazil, created the Pharmacy Network of Minas (Rede Farmácia de Minas [RFM]) program to improve access to medicines, increasing availability and restructuring the infrastructures. The aim was to assess the current situation, comparing municipalities with and without RFM. Materials & methods: Descriptive survey study, data collected from 2014 July to May 2015. Availability was verified by stock levels. Results: The drug availability index was 61.0%, higher in municipalities with RFM. Most physicians considered the pharmaceutical services as good/very good. The main reasons for medicines shortage were 'financial transference problems', 'insufficient financial resources' and 'budget'. Conclusion: Strategies, such as the RFM can promote improvements in medicine availability.

Medication Persistence of Disease-Modifying Antirheumatic Drugs and Anti-Tumor Necrosis Factor Agents in a Cohort of Patients With Rheumatoid Arthritis in Brazil.

OBJECTIVE: To assess the use and persistence of anti-tumor necrosis factor (anti-TNF) versus disease-modifying antirheumatic drug (DMARD) therapies in patients with rheumatoid arthritis (RA) in Brazil. METHODS: This was a new-user cohort study of RA patients from 2003 to 2010, using administrative data. Individuals were classified as being persistent using a drug at the first year and the first 2 years after cohort entry, if they did not discontinue that drug during that period. Cox regression was used to identify potential determinants of discontinuation of therapy in each medication group. RESULTS: Among 76,351 patients, 14,313 were using anti-TNF (+/- DMARD) therapy. At the end of the first year of followup, 48.2% continued using anti-TNF (+/- DMARD) therapy compared to 42.6% who persisted with DMARDs only. At the end of the second year, 23.1% of anti-TNF (+/- DMARD) users and 19.3% of DMARD-only users continued with therapy. Infliximab users had the lowest persistence rates. Multivariate Cox regression analysis showed that among anti-TNF (+/- DMARD) users, higher discontinuation rates were observed in female patients, in patients with lower income (only at the first 2 years of followup), in nonresidents of the region with the highest Human Development Index (HDI) rates, in those with a higher comorbidity score, and in those enrolled in the 2003-2006 period. Among DMARD-only users, younger patients, patients with lower income, nonresidents in regions with high HDI, those with a higher comorbidity score, and those enrolled in the 2003-2006 period were also more likely to discontinue therapy. CONCLUSION: Brazilian patients with RA showed low rates of medication persistence for DMARDs and anti-TNF agents, particularly at the first 2 years of followup. Future work could determine what other factors might contribute to drug persistence in RA.