Fatma Betul Yenilmez

Impact of Health Policy Changes on Trends in the Pharmaceutical Market in Turkey

BACKGROUND The implementation phase of the Turkish Health Transformation Program (HTP) began in 2003, with the aim of organizing, financing, and delivering health care services effectively, efficiently, and equally. The HTP impacted all clinical and economic outcomes of health, including pharmaceutical sales, by improving access to health services. OBJECTIVES To understand the impact of five selected major policy changes that made an impact on supply, demand, or price in the pharmaceutical market between 1998 and 2012. METHODS Monthly sales data (in units and value in US

General Assessment Of Unlicensed Medicine Usage In Turkey.

) of a total of 180 pharmaceuticals covering the period between 1998 and 2012 were used for statistical analysis. Five major policies that could affect health expenditures and the demand and supply of pharmaceuticals were selected and led by the Ministry of Health. A P value of less than 0.05 was considered as the cutoff value for statistical significance. RESULTS There was a growing trend in pharmaceuticals value and units in years, possibly as a result of the HTP implementation. Supply- and demand-related policies had a negative impact on the trends for value, whereas the pricing policy had a positive impact. CONCLUSIONS It could be said that the HTP had an impact on units for improved access to health care services. Although this access increased the consumption of pharmaceuticals in units, the policies implemented were successful in controlling pharmaceutical expenditures.

Discount Distribution Analysis of Original Medicines Which Has No Generics In Turkey

Pharmaceuticals can be used in un-approved or unlicensed indications or dosages apart from their licensed use. This is called off-label use. In principle, a drug can be considered to be off label under three conditions: (i) if the approval have not been extended, although evidence of efficacy is available; (ii) if it falls into the so-called ‘grey zone’ of evidence-based medicine, within which high-level evidence is difficult to reach even for treatments which are likely to be effective and (iii) if the drug is ineffective or at least there is no reason to believe it is effective (Koçkaya et al., 2011). Off-label use is defined by the Turkish Ministry of Health (MoH) as the use of licensed pharmaceutical products in doses outside of or exceeding the scope of the registered indication and the use of unlicensed medicinal products that are imported for the purpose of individual treatment. Hence, off-label use covers both licensed and unlicensed products (Koçkaya et al., 2012). The Turkish Medicines and Medical Devices Agency (TMMDA) gives the permission of unlicensed medicine use on patient basis. Authorized wholesalers including Turkish Pharmacists’ Association (TPA) can import the drugs based on the TMMDA`s permission. These medicines are reimbursed by the Social Security Institution (SSI), the main reimbursement agency in Turkey. Until 2014, , pharmaceuticals under this status could only be imported by the Turkish Pharmacists’ Association (TPA) when wholesalers were also authorized. This study aims to understand the trends in unlicensed medicine consumption between 2011 and 2013 when the TPA was the only authorized supplier.

A Cost-Effectiveness Evaluation for a New Therapy in HIV Treatment.

In the analysis, “Detailed Price List” data published on the website of the Ministry of Health’s Turkish Medicines and Medical Devices Agency(TMMDA) and “Annex 4-A Funded Medicines List” data published by Social Security Institution (SSI) were used. The lists were merged using the Excel software and generic medicine including genericized original medicines with different pricing and payment conditions compared to original medicines with no generics and other specific medicines such as blood products, enteral nutrition products, etc. and specific conditions such as medicines with no reimbursement were excluded. The analysis was made with a total of 568 original medicines with no generic. Exfactory prices were used in the analysis. The reference prices of all original medicines (100 %) are calculated by multiplying their actual reference price values with the periodic Euro value in the price list used in Turkey. In this analysis the mandatory discount rate for original drugs of 41% discount is mostly implemented by SSI. In rare cases, higher or lower discount rate can be applied. This is compatible with the implementation of the original drug reimbursement policy rules. However, further analysis should be done to obtaining more detailed information. Results

Impact of Health Policy Changes on the Growth Locally Manufactured and Imported Pharmaceutical Markets In Turkey

PIN77 A Cost-EffECtIvENEss EvAluAtIoN for A NEw thErAPy IN hIv trEAtmENt Malhan S.1, Kockaya G.2, Elbir Zengin T.2, Dalgic C.2, Yenilmez F.B.3, Cerci P.3, Oksuz E.1, Tayfun K.2, Unal S.3 1Baskent University, Ankara, Turkey, 2Gilead Science, Istanbul, Turkey, 3Hacettepe University, Ankara, Turkey Objectives: Economical evaluation of Stribild in Turkey, which is a single tablet regimen indicated for the treatment of HIV-1 infection in adults aged 18 years and over who are antiretroviral treatment naive or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in it. MethOds: STRIBILDTM was compared with various treatment options; tenofovir DF+emtricitabine+efavirenz (FTC/TDF+EFV), tenofovir DF+emtricitabine+ ritonavir+lopinavir (FTC/TDF+LPV/r), tenofovirDF+emtricitabine+nevirapine (FTC/ TDF+NVP), tenofovir DF+emtricitabine+darunavir (FTC/TDF+DRV+r), tenofovir DF+emtricitabine+raltegravir (FTC/TDF+RAL), lamivudine+zidovudine+efavirenz (3TC/AZT+EFV), lamivudine+zidovudine+ritonavir+lopinavir (3TC/AZ+LPV/r), lam ivudine+zidovudine+nevirapine (3TC/AZT+NVP). The adherence rates were calculated from the increase rate in CD4 cell count and the risk of hospitalization as the effectiveness values. The data were taken from patient files from Hacettepe University that consists of 252 patients and 12 year follow-ups with an outpatient clinic, interventions, laboratory and imaging tests, medication usage, side effects, comorbidity’s diseases and their treatments and complications. The costs of treatment of diseases were calculated by cost of disease methodology. Average annual cost per patient is calculated for health care technologies. Health technology effectiveness values are found from the literature review. Incremental cost-effectiveness ratio (ICER) was used for the comparison. Results: According to comparison of rate of compliance to treatment, STRIBILDTM was cost effective against 3TC/AZT+EFV (2157.2 TL), FTC/TDF+LPV/r (612.7 TL), FTC/TDF+NVP (951.9 TL), FTC/TDF+DRV+r (544.28 TL) and cost saving aganist FTC/TDF+RAL (-166,22 TL). According to the rate of risk of hospitalization, STRIBILDTM was cost effective against 3TC/AZT+EFV (517.7 TL), FTC/TDF+LPV/r (318.6 TL), FTC/TDF+NVP (495 TL), FTC/TDF+DRV+r (283 TL), 3TC/ AZT+EFV (632,4 TL), 3TC/AZ+LPV/r (425.6 TL), 3TC/AZT+NVP (591.2 TL). According to the increase rate in CD4 cell count and over 95% of compliance rate, STRIBILDTM was cost effective against FTC/TDF+EFV (392.2 TL) and cost saving against FTC/TDF+RAL (-308.7 TL), respectively. cOnclusiOns: HIV is a life-threatening disease with in terms of major public health problem globally.. In this study, STRs in comparison of combination treatment strategies, has higher compliance rates, better outcomes and lower health care costs.

Introduction to the Market Access

PHP32 ImPact of HealtH PolIcy cHanges on tHe growtH locally manufactured and ImPorted PHarmaceutIcal markets In turkey Hilal Vural E.1, Kockaya G.2, Yenilmez F.B.3, Saylan M.2, Safak Yilmaz E.1, Tatar M.3, Vural I.M.1, Akbulat A.1, Gursoz H.1, Artiran G.1, Kerman S.1 1Turkish Medicines and Medical Devices Agency, Ankara, Turkey, 2Health Economics and Policy Association, Ankra, Turkey, 3Hacettepe University, Ankara, Turkey Objectives: Turkish Ministry of Health (MoH) initiated Health Transformation Program (HTP) in 2002. HTP impacted all clinical and economic outcomes of health including pharmaceutical sales by improving access to health services. The objective of this analysis is to to understand the impact of selected 5 major policy changes by MoH to sales of locally manufactured and imported pharmaceutical products in the respective periods. MethOds: 132 months sales data with segmented regression analysis for interrupted time series were used. International reference pricing of pharmaceuticals (RF), mandatory reimbursement dossier submission for new molecules, new indications and line extensions with medical and economic evaluations (MRDS), auditing for good manufacturing practice (GMP), family physician system (FP) and compulsory medical service for physicians (CMS) were selected as five major policies that may affect cost, demand and supply of pharmaceuticals. The analysis was conducted for total imported pharmaceutical (IP) sales and total locally manufactured pharmaceutical (LMP) sales. The Durbin-Watson d statistics of SPSS version 20.0 was used as serial correlation. Shift in slope with p< 0.05 was considered as statistically significant. Results: The negative effect of RF policy change on CS trends was more prominent for IP than LMP sales. However, the shift in CS due to other 4 policy changes was lower for IP when compared with LMP sales. The differences reached statistical significance level except for CMS policy. Although not significant, positive shift of US due to RF policy change was higher for LMP than IP sales. There was a decreasing slope of LMP unit sales following MRDS and GMP policies but an increasing slope of IP unit sales. cOnclusiOns: Policy changes may effect at differently direction and amount the unit and cost sales of LMPs and IPs. Cost control mechnism such as RF has a more negative effect on imported product as expected.