Time From Marketing Authorization to Reimbursement of Medicines in Greece After the Introduction of the Health Technology Assessment Process From July 2018 to April 2022.

OBJECTIVES: This study aimed to quantify the median time from marketing authorization (MA) to the inclusion of medicines in the reimbursement list after the introduction of the health technology assessment process in Greece. METHODS: From July 2018 to April 2022, the Ministerial Decisions (MDs) and reimbursement lists, posted on the website of the Ministry of Health, were reviewed. The following information was collected for the medicines: the date that MDs and positive reimbursement lists were issued, the MA date, the date of the official price publication, and the type of the health technology assessment application. The time from MA to listing was calculated as the difference between the MA date and the date that the relevant reimbursement list was issued. RESULTS: During the study period, 93 MDs were issued, from which 79 (85%) were positive and 14 (15%) were negative. Focusing on medicines included in the positive list for the first time, the median time from MA to listing for the new molecules was found to be 34.8 (interquartile range 25.7-41.3) months. This time was statistically significantly shortened for fixed dose combinations (20.9 [15.3-45.4] months, P = .008), and biosimilars (23 [16.6-28.2] months, P = .001). For generics was 17.6 (interquartile range 10-30) months, statistically significantly lower than that of new molecules (P < .001). CONCLUSIONS: The time from MA to the inclusion of medicines in the reimbursement list in Greece is significantly long, especially for innovative medicines. Thus, policy makers should consider this point to optimize and improve patients' subsidized access.

Cost-Utility Analysis of Pegaspargase for the Treatment of Acute Lymphoblastic Leukemia in Greece.

BACKGROUND AND OBJECTIVE: Acute lymphoblastic leukemia (ALL) is an acute, rapidly progressing and life-threatening form of cancer involving immature lymphocytes called lymphoblasts. ALL is the most common subtype of leukemia in children and adolescents. The aim of the present study was to assess the cost-utility of pegaspargase versus L-asparaginase, both followed by Erwinase in the therapy sequence, as a treatment option for pediatric, adolescent, and adult patients with ALL in Greece. METHODS: A published cost-utility model comprising a decision tree and a state-transition Markov model was adapted from a public payer perspective to compare a pegaspargase treatment sequence with an L-asparaginase sequence. Efficacy and safety data, as well as utility values, were extracted from the published literature. Direct costs pertaining to drug acquisition, administration, and management of hypersensitivity were considered in the analysis (€2020). Model-extrapolated outcomes included quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICER). All future outcomes were discounted at 3.5% per annum. Sensitivity analyses were used to explore the impact of changing input data. RESULTS: The analysis showed that the pegaspargase sequence was estimated to produce 0.05 additional QALYs (18.12 vs. 18.07) and lower cost of - €1698 compared with L-asparaginase, indicating that the pegaspargase sequence was a dominant treatment strategy (improved outcomes with reduced costs) compared with L-asparaginase. Deterministic sensitivity analysis confirmed the cost-effective profile of pegaspargase. At the defined willingness-to-pay threshold of €54,000/QALY gained, probabilistic sensitivity analysis showed that pegaspargase had a 100% probability of being cost effective relative to the L-asparaginase sequence. CONCLUSION: The pegaspargase sequence was found to be less costly and more effective (in terms of QALYs) in relation to the L-asparaginase sequence, representing a dominant strategic option for Greek public payers in ALL.

Cost-effectiveness of trifluridine/tipiracil as a third-line treatment of metastatic gastric cancer, including adenocarcinoma of the gastrohesophageal junction, among patients previously treated in Greece.

OBJECTIVE: To evaluate the cost-effectiveness of trifluridine/tipiracil (FTD/TPI) compared with best supportive care (BSC) for the treatment of patients with metastatic gastric cancer(mGC), including gastroesophageal junction adenocarcinoma(GEJ), who have received at least two prior therapies for metastatic disease and are eligible for third-line treatment, in Greece. METHODS: A partitioned survival model was locally adapted from a public payer perspective over a 10-year time horizon. Clinical, safety and utility data were extracted from literature. Resource consumption data obtained from a panel of local experts using a questionnaire developed for the study was combined with unit costs obtained from official sources. All costs reflect the year 2020 (€). Outcomes of the model were patients' life years (LYs) and quality-adjusted life years (QALYs), total costs and incremental cost-effectiveness ratio (ICER) per QALY and LY gained. RESULTS: The total cost per patient was estimated to be €6,965 for FTD/TPI and €1,906 for BSC, while FTD/TPI was associated with 0.180 and 0.107 increments in LYs and QALYs, respectively, compared with BSC, resulting in an ICER of €47,144 per QALY gained and €28,112 per LY gained. CONCLUSION: FTD/TPI was estimated to be a cost-effective treatment option for eligible third line mGC patients, including GEJ in Greece.

Comparing Use of Health Technology Assessment in Pharmaceutical Policy among Earlier and More Recent Adopters in the European Union.

OBJECTIVES: To examine and compare the use of health technology assessment (HTA) for the reimbursement of new medicines in selected European Union member states with decades of experience in the use of HTA and in countries that have used it regularly since 2000. METHODS: The selected countries were categorized into "earlier" adopters (group A: England, Germany, France, and Sweden) and more "recent" adopters (group B: Poland, Bulgaria, Hungary, and Romania). A systematic review of published literature was performed. The analysis and comparison of HTA procedures were done by using an analytical framework. RESULTS: In all countries, the assessment criteria used include effectiveness, safety, relative effectiveness, and economic data. In group A countries, the main objectives are improving quality of care, ensuring equal access, and efficient use of resources. Group B countries have established HTA organizations with official guidelines but often seek the decisions of other developed countries. They place considerable emphasis on the budget impact of new therapies, and HTA is also used as a cost estimation tool for state budgets. CONCLUSIONS: HTA organizations have been developed dynamically not only in high-income countries but also in countries with limited resources. The experience and evolution of both can be used by countries that are in the dawn of creating an HTA organization.

Economic evaluation of trimetazidine in the management of chronic stable angina in Greece.

BACKGROUND: To evaluate the cost-effectiveness of trimetazidine (TMZ) as add-on therapy to standard-of-care (SoC) compared to SoC alone in patients with chronic stable angina who did not respond adequately to first line therapy with b-blockers, nitrates or calcium channel antagonists in Greece. METHODS: A Markov model with 3-month cycles and 1-year time horizon was developed to assess the comparators. The analysis was conducted from a third-party payer perspective. The clinical inputs and utility values were extracted from the published literature. Resource consumption data were obtained from local experts, using a questionnaire developed for the purpose of the study and were combined with unit cost data (in €2016) obtained from official sources. Cost effectiveness was assessed by calculating the incremental cost effectiveness ratio (ICER). Probabilistic sensitivity analysis (PSA) was performed to account for uncertainty and variation in the input parameters of the model. RESULTS: The analysis showed that the cost of TMZ plus SoC was €1755.57 versus €1751.76 of SoC alone. In terms of health outcomes, TMZ plus SoC was associated with 0.6650 QALYs versus 0.6562 QALYs for SoC alone. The incremental analysis resulted in an ICER of €430.67 per QALY gained. PSA revealed that the probability of TMZ plus SoC being cost-effective over SoC was 89 %, at a threshold of €34,000 per QALY gained. CONCLUSION: The results indicate that TMZ as add -on treatment may be a highly cost-effective option for the symptomatic treatment of patients with chronic stable angina in Greece relative to SoC alone.

Economic evaluation of ivabradine in the treatment of chronic heart failure in Greece.

BACKGROUND: The objective of our study was to assess the cost-effectiveness of ivabradine plus standard care (SoC) in chronic heart failure (CHF) patients with sinus rhythm and a baseline heart rate ≥ 75 b.p.m. in Greece, in comparison with current SoC alone. METHODS: An existing cost-effectiveness model consisting of two health states, was adapted to the Greek health care setting. All clinical inputs of the model (i.e. mortality rates, hospitalization rates, NYHA class distribution and utility values) were estimated from SHIFT trial data. All costing data used in the model reflects the year 2013 (in €). An incremental cost effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained was calculated. Deterministic and probabilistic sensitivity analyses (PSA) were conducted. The horizon of analysis was over patient life time and both cost and outcomes were discounted at 3.5% per year. The analysis was conducted from a Greek third party-payer perspective. RESULTS: The Markov analysis revealed that the discounted quality-adjusted survival was 4.27 and 3.99 QALYs in the ivabradine plus SoC and SoC alone treatment arms, respectively. The cumulative lifetime total cost per patient was €8,665 and €5,873, for ivabradine plus SoC and SoC alone, respectively. The ICER for ivabradine plus SoC versus SoC alone was estimated as €9,986 per QALY gained. The PSA showed that the likelihood of ivabradine plus SoC being cost-effective at a threshold of €36,000/QALY was found to be 95%. CONCLUSIONS: Ivabradine plus SoC may be regarded as a cost-effective option for the treatment in CHF patients in Greece.