Time to Reimbursement in Kazakhstan for Novel Biologic Medicines Approved during the Period 2013-2022

OBJECTIVES:

Biologic medicines are an effective and growing class of pharmaceuticals for the treatment and prevention of a broad range of non-communicable diseases. However, most middle-income countries have limited access to these innovative medicines. The objective of this study was to assess the availability of novel biologic medicines in Kazakhstan.

METHODS:

We collected novel biologic medicines (ATC code L04) approvals that were marketed in past decade in Kazakhstan, using the Registry of Approved Medicines. The primary outcomes were the rate of availability and the time to availability for Kazakhstan. The time to availability, measuring the average time between marketing authorization and availability, using days from the date of marketing authorization to the day of completion of reimbursement approval administrative processes.

RESULTS:

Of 65 novel medicines with ATC code L04 approved from January 2013 to December 2023, 32 (49%) obtained full availability in Kazakhstan, after inclusion in National Outpatient Medicines Benefit List and National Medicines Procurement List, with an average time to availability of 38.7 months (1 162 days). Additionally, 15 (23%) biologic medicines had limited availability, due to inclusion in the Kazakh National Formulary, with an average time to availability of 27.8 months (835 days). Limited availability meant being able to specific subpopulations of approved indication or individual patients.

CONCLUSIONS: Biologic medicines are poorly accessible to patients in Kazakhstan. Obviously, small molecules are more accessible than biologic medicines due to disparities in their costs and existing reimbursement policies. If their high costs persist, biologic medicines will remain relatively inaccessible. There is a significant unmet need for more affordable biologic therapies in Kazakhstan. The key concerns about the increased utilization of biosimilars were limited evidence on therapeutic equivalence and expected adverse immunologic reactions.