Cost-effectiveness analysis of tofacitinib for the treatment of moderate to severe rheumatoid arthritis: a systematic review and meta-analysis.

BACKGROUND: As rheumatoid arthritis (RA) is a chronic and progressive disease that requires lifelong therapeutic intervention, it represents a considerable economic burden on those affected. This study investigated whether tofacitinib is a cost-effective therapeutic alternative to other DMARDs for treating moderate-to-severe RA. RESEARCH DESIGN AND METHODS: All economic evaluation studies of tofacitinib compared to other DMARDs were identified. Using random-effects meta-analysis, we pooled incremental net benefit (INB) in (purchasing power parity) adjusted US$ with 95% confidence intervals. The modified economic evaluation bias checklist and Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) instrument for quality appraisal were used. The subgroup analysis was done based on the comparator regimen. RESULTS: Of the selected 11 studies, the number of studies from high-, upper-middle- and lower-middle-income countries was 7, 3, and 1, respectively. The subgroup analysis showed that tofacitinib with an INB of 19,180 US$ [95% CI, -34520 to -3840; p-value = 0.01] was not statistically cost-effective compared with cDMARDs (p-value > 0.0001). Compared to other DMARDs, the estimated pooled INB of tofacitinib was US$ 7260 [95% CI, 3030 to 11,480; p-value < 0.001], but there was substantial heterogeneity among the included studies, and the observed publication bias. CONCLUSION: While tofacitinib shows potential as a cost-effective treatment, tailored economic evaluations are needed to account for the diverse and evolving contexts of RA treatment. REGISTRATION: PROSPERO: CRD42023405970.

Evaluating the affordability of asthma, chronic obstructive pulmonary disease, and cystic fibrosis medicines in a middle-income country.

BACKGROUND: A heavy financial burden is imposed on patients suffering from chronic diseases due to medicine out-of-pocket payments. OBJECTIVES: This study focuses on assessing the affordability of medications used for chronic respiratory diseases (CRDs) such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF) in Iran, specifically on the category R medicines listed in the 2017 Iran drug list (IDL) that are used for the treatment of these diseases, based on the anatomical therapeutic chemical (ATC) drug code. METHODS: The affordability of medicines in mono and combination therapy approaches was assessed in CRDs using the World Health Organization/Health Action International (WHO/HAI) methodology. Accordingly, if out-of-pocket payment for 30-days of pharmacotherapy exceeds one day for the lowest-paid unskilled government worker (LPGW), it's considered non-affordable. RESULTS: Based on the monotherapy approach, our finding demonstrates that all generic medicines of category R were affordable. However, branded drugs such as Symbicort®, Pulmicort Respules®, Flusalmex®, Seretide®, Fluticort Plus®, Seroflo®, and Salmeflo® cost between 1.2 and 2.5 days' wage of LPGW and considered unaffordable despite 70% insurance coverage. Moreover, based on the affordability ratio in the combination therapy approach, all medicines used in asthma, COPD, and CF patients with mild respiratory problems are affordable except omalizumab (inj), which is non-affordable due to its high price and no insurance coverage. CONCLUSION: Results showed that the existing insurance coverage does not protect households from hardship, so more considerations are needed such as different insurance schedules and patient support programs.

How Do Iranian Stakeholders Think About Pharmaceutical Managed Entry Agreements?

Background: Uncertainty in real-world product profiles is the main barrier to pharmaceutical market access. Managed entry agreements (MEAs) are the formal arrangements to overcome these uncertainties. Despite the extensive experience of developed countries in implementing such agreements, the experience of developing countries is minimal. As health decision-makers in Iran have moved towards implementing MEAs since 2020, seeking stakeholders' insights is crucial for filling this experience gap and facilitating the optimal implementation of these new policies. Methods: Our research was done in three phases: (1) Focus group interviews to disclose the main objectives of implementing MEAs in Iran, (2) the AHP approach to prioritize uncertainties, and (3) individual semi-structured interviews to carry out strengths, weaknesses, opportunities, and threats (SWOT) analysis. Results: Based on our stakeholders' views, increasing flexibility in improving patients' access to innovative and expensive drugs and responding to budget impact uncertainty seems highly prioritized for conducting MEAs in Iran. The SWOT analysis showed that although MEAs have the chance for success due to their strengths and opportunities, such as providing early and assured access, allocating resources efficiently, and enhancing the efficiency of post-marketing studies, policymakers should consider the weaknesses and threats such as difficulty in defining outcomes, high transaction cost, and lack of suitable infrastructure to increase the success rate. Conclusions: Efficient implementation of MEAs depends on the weaknesses and threats and considering the views of relevant stakeholders. Constructive interaction among all stakeholders is essential for adequately executing MEAs.

Country Pharmaceutical Situation on Access, Quality, and Rational Use of Medicines: An Evidence from a middle-income country.

Evaluation of pharmaceutical systems performance is an essential prerequisite for promoting evidence-based policy-making and improvement in health system performance. This study attempts to evaluate the performance of Iran pharmaceutical system based on the world health organization (WHO)'s indicators, including access, quality, and rational use of medicines. In this cross-sectional descriptive study, inspired by the instructions proposed by WHO, public and private pharmaceutical service-providers were evaluated in three dimensions and 16 indicators. Accordingly, eleven separate checklists were developed and, in terms of translation, face and content validity were certified by pharmaceutical sector's experts. Sampling was randomly carried out in five cities. Depending on the type of indicators, retrospective or prospective approaches was determined for data collection. The data were collected from April to November 2018 and analyzed by SPSS 24. The availability of targeted key medicines in various cities as well as in public and private pharmacies was 97.5% with no significant difference. Although the medicines cost was higher in private sectors than in public ones, they were affordable in both sectors. In quality indicators, public sectors enjoyed a higher level than the private sectors did. The average number of medicines per prescription in public pharmacies was 3.2 and it was 3.4 in private ones. On average, in public sectors 33% and 32% of outpatients received antibiotics and injectable medicines, respectively. Finally, 77% of medicines were prescribed by using their generic names and 25% of prescriptions were in accordance with key medicines list. This study reveals that the availability and affordability of targeted key medicines in Iran are in good condition; however, in terms of rational use of medicines, Iran fails to meet the standard levels.

Synthesis and biological evaluation of quinoline analogues of flavones as potential anticancer agents and tubulin polymerization inhibitors.

A new series of 2-aryl-trimethoxyquinoline analogues was designed and synthesized as tubulin inhibitors using methoxylated flavones as the lead compounds. The cytotoxic activity of the synthesized compounds was evaluated against four human cancer cell lines including MCF-7, MCF-7/MX, A-2780, and A-2780/RCIS. All the alcoholic derivatives (6a-6e) showed significant cytotoxic activity with IC50 in the range of 7.98-60 µM. The flow cytometry analysis of the four human cancer cell lines treated with 6e and 5b showed that 6e induced cell cycle arrest at G2/M phase and apoptosis as well. The effect of quinolines on tubulin polymerization was also evaluated. Compound 6e that demonstrated the best antiproliferative activity in the series was identified as the most potent inhibitor of tubulin polymerization as well. Molecular docking studies of 6e into the colchicine-binding site of tubulin displayed possible mode of interaction between this compound and tubulin.