Pharmacoeconomics: theory and practice
№4, 2021, Vol.9

Kulikov A.Y., Protsenko M.V., Serpik V.G. 240

We conducted an budget impact analysis was made of the treatment of spinal muscular atrophy (SMA) with drugs Nusinersen and Risdiplam. Its results showed that from the point of view of the organization of drug provision for patients with SMA at current prices, treatment of patients under 18 years of age within the framework of the responsibility of the Circle of Kindness Foundation, given the current distribution of patients, in which 57.6% receive Nusinersen, and 42.4% Risdiplam, is characterized by a smaller budget already in the first year – 18.82 billion rubles, in comparison with the budget of the simulated distribution, in which 42.4% of patients receive Nusinersen, and 57.6% of Risdiplam – 19.27 billion rubles. Thus, with the current distribution over 5 years, budget savings in comparison with the simulated distribution reaches 3.24 billion rubles, excluding the discount factor, and 2.86 billion rubles, when discounting. Analyzing the long-term effect of the budget impact of the use of Nusinersen drugs per patient at the beginning of therapy at the age of two months, it was found that the total savings before the patient switches to provision through regional funding (reaching 18 years of age) can reach 59.72 million. rub. From the point of view of drug provision for patients with SMA at the regional level, that is, patients over 18 years old, the main pool of patients will be formed due to the successive transfer of patients from the Circle of Kindness Fund, since most of the patients (1039 people) are now provided precisely for the account of the Circle of Kindness Fund, and upon reaching the age of 18, this cohort of patients will be transferred to provision at the expense of the budgets of the regions of the Russian Federation. At the same time, it is noted that the costs of initiation of these patients with Nusinersen were covered by the Circle of Kindness Foundation, and therefore, from the point of view of the regions of the Russian Federation, savings on Nusinersen in comparison with Risdiplam will be noted already in the first year of therapy, based on the fact that the annual costs for Nusinersen maintenance mode are 16,957,680 rubles. per patient, and the annual cost of treatment with Risdiplam drug for one adult patient (weighing more than 20 kg) exceeds 20 million rubles. Thus, the stated results of the budget impact analysis revealed the economic feasibility of Nusinersen in the treatment of SMA in comparison with the Risdiplam.

Krylov V.A. 199

This article describes the differences in approaches to the reimbursement of IVF procedures in different countries. A comparative analysis of the regulatory framework has shown that in the EU countries there is a tendency to curb government spending by introducing restrictions on the total number of reimbursable cycles and the introduction of co-payments from patients. There is no federal law in the United States regulating the reimbursement of funds spent on assisted reproductive technologies, but 15 states have a mandate to cover infertility treatment. In Australia, financial support for married couples is provided when their own annual expenses for infertility treatment exceed one thousand Australian dollars. In Russia, a patient with infertility can receive two IVF cycles per year, but the total number of repeated cycles funded by the OMI is not limited.

Balykina Y.E., Kolbin A.S., Kurylev A.A., .., Proskurin M.A. 198

Glycemic control is a clinical goal in the treatment of diabetes mellitus. Currently available bolus insulin analogues do not follow the physiological pattern of insulin secretion after meals because they are slowly absorbed from the injection site. Insulin aspart+nicotinamide is an ultra-fast acting human insulin analog that can be administered before or after meals and the nicotinamide (vitamin B3) molecule provides optimal glycemic control. Aim. To evaluate clinical and economic efficacy of the drug insulin aspart+nicotinamide in comparison with insulin aspart in patients with diabetes mellitus. Materials and Methods. Clinical and economic analysis was performed in accordance with the standards and recommendations valid in the Russian Federation, the method of cost-effectiveness analysis for the first model population of patients with type 1 diabetes and the method of cost-minimization analysis for the second model population of patients with type 2 diabetes, modeling horizon was 26 weeks. Since the study is conducted from the per- spective of the health care system only direct medical costs were considered, that is, the cost of insulin therapy and the cost of complications treatment (hypoglycemia). During the budget impact analysis, the source of data on the target population was the registry of patients with diabetes mellitus of the Russian Federation. Probabilistic sensitivity analysis was performed to assess the impact of changes in the input parameters of the models. Results. Insulin aspart+nicotinamide has a clinical advantage in the effective- ness of HbA1c reduction in type 1 diabetes population. In patients with type 2 diabetes, the effectiveness of insulin aspart+nicotinamide and insulin aspart is comparable by a similar criterion. Direct medical costs of insulin aspart+nicotinamide are 10.64% lower in comparison with insulin aspart use in type 1 and type 2 diabetes patients’ population. The CER value in type 1 diabetes patient population for insulin aspart is 70% higher compared to insulin aspart+nicotinamide (7,410,353.83 and 4,348,513.94 RUR respectively). Budget impact analysis results are the following: that complete replacement of insulin aspart with insulin aspart+nicotinamide over 3 years is accompanied by a 5.3% re- duction of regional drug benefit budget costs. Conclusion. The clinical and economic analysis confirms the economic feasibility of insulin aspart + nicotinamide use