Качественная клиническая практика (May 2018)
Pharmacoeconomic analysis of Cocarnit® complex as treatment for diabetic polyneuropathy
Abstract
Diabetic polyneuropathy (DP) occupies the third place among the most common neurological disorders, affecting a significant portion of diabetes patients, and is characterized by progressive lesions of nervous fibers. While normalizing carbohydrate metabolism is crucial for treating DP, metabolic compounds that integrate into nervous tissue metabolism have received considerable attention. Despite their therapeutic attractiveness and significant spread in clinical practice, the amount of data pertaining to pharmacoeconomic properties of these compounds remains limited. Given significance of this problem and due to availability of new clinical data on comparative effectiveness of two of such drugs, a research effort was undertaken to evaluate the pharmacoeconomic properties of Cocarnit combination drug compared to Milgamma drug, as well as with components of Cocarnit purchased separately. Aim. To evaluate comparative pharmacoeconomic performance of therapy using Cocarnit combination drug, Milgamma, and Cocarnit components purchased and administered separately in the context of Russian healthcare. Methodology. Current analysis was performed from perspective of Russian state healthcare system within context of mandatory medial insurance system. Modelling horizon was 3 years. Randomized clinical trial directly comparing the safety and efficacy of investigated drugs (Cocarnit and Milgamma) as well as long-term randomized clinical trials of other metabolic drugs for treatment of diabetic neuropath and general dynamic of diabetic neuropathy response to metabolic treatment were used as data sources for this PHe. The number of patients in each simulated group was 1000 people. A Markov model was constructed to assess the costs and utility effects of treating diabetic neuropathy with comparator compounds, with simulated treatment protocols being based on existing Russian standards of diabetic neuropathy treatment. The model accounted for existing data regarding long-term outcomes and recurrence rates of diabetic neuropathy undergoing metabolic treatment. Model did not account for mortality resulting from diabetes proper and treatment costs associated with addressing the underlying primary condition (Type I and Type II diabetes). The cycle length was 1 week. QALY improvements were used as surrogate endpoints, since the existing clinical trial data indicates that the only significant difference between the drugs being compared is their quality of life effects. Since clinical trial data contained only SF-36 quality of life data, a widely used mapping algorithm found in peer-reviewed literature was utilized to convert from SF-36 to EQ-5D in order to properly evaluate QALY differences. Upon completion of modelling, the following types of analysis were performed: cost minimization analysis (CMA) for “Cocarnit/Cocarnit components purchased separately” comparator pair (CMA was used here since utility, efficacy and safety values for this case will be strictly equal), budget impact analysis (BIA) for “Cocarnit / Cocarnit components purchased separately” comparator pair, Cost-utility analysis for “Cocarnit / Milgamma” pair. Sensitivity analysis was used to verify the robustness of the results. Discounting was performed at rate of 5%. Results. Cocarnit has demonstrated promising results, showing superiority over separately purchased and administered components in CMA (with CMA factor of -2 752 082 rubles) and budget impact analysis, which indicated that use of Cocarnit instead of separate metabolite components would result in reduction of budget burden totaling 1 458 603 per 100 000 of Russian Federation population (accounting for prevalence of diabetic neuropathy) within 3 years. During cost-utility analysis it was found that Cocarnit is superior to Milgamma demonstrating greater overall quality of life and a CUR of 552,34 rubles (while Milgamma has a less favorable CUR of 555,41 rubles) per patient. It also had ICUR of 208,88 rubles per patient, indicating a low cost per one QALY gained and high pharmacoeconomic expediency within context of pharmacoeconomic expediency analysis. Sensitivity analysis has shown that results remain robust to price increases up to 25%. Conclusion. These results demonstrate that Cocarnit has favorable pharmacoeconomic characteristics and indicates high expediency of using it in Russian healthcare system, and allows us to recommend further research into clinical and pharmacoeconomic properties of this drug.
