Value-Based Healthcare Model of Medical and Pharmaceutical Care for Patients With Coronary Artery Disease with Comorbid Conditions: Cost- Benefit Analysis in the Healthcare Setting of Ukraine

Technical Summary: Value-Based Healthcare Model for Coronary Artery Disease in Ukraine

Problem Statement
The management of Coronary Artery Disease (CAD) with comorbid conditions in Ukraine faces a critical dual challenge: clinical inefficiency due to poor patient adherence and economic strain exacerbated by the ongoing war. The current standard of care relies heavily on the "Affordable Medicines" reimbursement program, which primarily covers monocomponent generic drugs. This approach often results in severe polypharmacy, complex dosing regimens, and low adherence, leading to a high incidence of Major Adverse Cardiovascular Events (MACE). Furthermore, the war has introduced specific barriers, including pharmaceutical staff shortages, data fragmentation within the national eHealth system, and disrupted supply chains. These factors have created a situation where the existing model, while minimizing initial drug costs, shifts a significant financial burden to the healthcare system through emergency hospitalizations and rehabilitation, while simultaneously forcing patients to bear substantial out-of-pocket expenses for effective, non-reimbursed original medications.

Methodology
The study employs a Cost-Benefit Analysis (CBA) to evaluate a proposed "New Model" of integrated pharmaceutical care against the existing "Comparator" model. The analysis is grounded in A. Donabedian's theory of structure, process, and outcome, and adheres to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS).

• Study Design: A pharmacoeconomic model was constructed for a hypothetical cohort of 100 adult patients with stable CAD and comorbidities (e.g., hypertension, diabetes, heart failure) over a one-year time horizon.
• Intervention (New Model): This model integrates clinical and community pharmacists into patient care pathways. Key components include:
  • Prescription of original Fixed-Dose Combinations (FDCs) not currently in the reimbursement program to simplify regimens.
  • Active pharmacist involvement in monitoring, deprescribing, and motivational interviewing.
  • Use of combined portable test systems for outpatient monitoring.
• Comparator (Standard Care): Represents the current Ukrainian practice involving outpatient use of monocomponent generic drugs via the "Affordable Medicines" program without systematic pharmaceutical support.
• Data Sources: Clinical probabilities (adherence rates and MACE incidence) were derived from the EUROASPIRE V, CLARIFY, and Stimul studies. Cost data utilized National Health Service of Ukraine (NHSU) tariffs, external price referencing, and specific Ukrainian regulatory resolutions (CMU №854, №955, №1503).
• Perspectives: The analysis was conducted under three distinct scenarios:
  1. State Payer Perspective: Focusing solely on Ministry of Health (MoH)/NHSU budget funds.
  2. Combined Medical Perspective: Including patient out-of-pocket expenses (estimated at 58.6% of total costs in the comparator).
  3. Societal Perspective: Incorporating indirect economic benefits related to preserved human capital and GDP contribution.
• Sensitivity Analysis: A one-factor deterministic sensitivity analysis was performed to test the stability of results against variations in drug prices and MACE avoidance rates.

Key Contributions
The paper contributes a conceptual framework and quantitative evidence for transitioning to a Value-Based Healthcare (VBHC) model in a resource-constrained, war-torn environment.

• Conceptual Model: It proposes a three-level (primary, secondary, tertiary) pharmaceutical care model that operationalizes the "Pharmacist of 10 stars" concept within the Ukrainian context, detailing specific stages from information collection to outcome evaluation.
• Economic Justification: It provides the first comprehensive CBA demonstrating that investing in original FDCs and pharmacist services generates a net economic benefit, challenging the assumption that cheaper generics are always more cost-effective in the long term.
• Policy Roadmap: The study identifies specific legislative and structural barriers (e.g., lack of pharmacist rates in staffing, eHealth data fragmentation) and proposes concrete regulatory amendments, such as updating the Law on eHealth and expanding the "Affordable Medicines" program to include original FDCs.

Results
The modeling indicates that the New Model is clinically superior and economically advantageous across all three scenarios.

• Clinical Outcomes: The intervention reduced the absolute risk of MACE by 19.3% compared to the comparator (8.6% incidence in the New Model vs. 27.9% in the Comparator). This corresponds to an Odds Ratio (OR) of 22.67 for improved adherence when pharmacists are involved.
• Scenario 1 (State Payer): The New Model generated a net benefit of UAH 1.56 million. The Benefit-Cost Ratio (B/C Ratio) was 2.24 for the New Model versus 1.84 for the Comparator. While the New Model required an initial net cost increase of UAH 127,911 for original medicines, this was offset by savings from avoided hospitalizations.
• Scenario 2 (Combined Perspective): When patient out-of-pocket costs were included, the New Model became less expensive overall than the Comparator, with a net cost saving of UAH 149,606. The B/C Ratio for the New Model remained stable at 2.24, while the Comparator dropped to 1.69.
• Scenario 3 (Societal Perspective): Including the preservation of human capital (GDP contribution for patients over 60), the net benefit increased to UAH 2.39 million, with a B/C Ratio of 2.78 for the New Model versus 2.15 for the Comparator.
• Sensitivity Analysis: The results demonstrated high stability; the B/C Ratio remained greater than 1 across all parameter variations (±10–20%), confirming the robustness of the investment case.

Significance and Claims
The authors claim that the developed Conceptual Model represents a "self-paying and highly effective investment" for the Ukrainian healthcare system, even under martial law. The study argues that the traditional reliance on cheap generics constitutes an "imaginary economy" that merely shifts financial burdens to acute care settings and patient budgets.

The paper asserts that the transition to a VBHC model involving pharmacists and FDCs is not only clinically necessary to reduce MACE but is also fiscally responsible. It concludes that implementing this model requires specific political and regulatory actions: amending eHealth legislation to recognize clinical pharmacists, introducing specific staffing rates for pharmacists in healthcare facilities, developing interprofessional standards, and expanding the reimbursement program to cover original FDCs. The authors position these findings as a reliable basis for future Budget Impact Analysis and macro-level management decisions in Ukraine's healthcare sector.