HOW IS CURRENT PHARMACEUTICALS PRICING POLICY ON GENERICS PERFORMING IN TURKEY REGARDING PRICE EROSION?

Jenerik ilaçlar, ilaçların maliyetini aşağı çekerek hastalıkların daha ucuz ilaçlarla tedavi edilmesine büyük katkı sağlamaktadır. Orijinal bir ilacın patent süresinin dolması ile birlikte, jenerikler piyasaya girerek rekabet yaratıp fiyatları düşürmektedir. Bu çalışma, Türkiye'deki jenerik ilaç politikalarının ilaç fiyatlarını aşağı çekme konusunda ne kadar başarılı olduğunu ölçmeyi ve hem daha çok tasarruf sağlamak hem de fiyatları daha da aşağı indirmek için alternatif stratejiler geliştirmeyi amaçlamaktadır. 2009 Ocak ile 2013 Aralık ayları arasındaki Sosyal Güvenlik Kurumu (SGK) üzerinden ayaktan alınan tüm ilaçların aylık verileri MEDULA sisteminden derlenmiş ve seçilmiş 12 farklı eşdeğer grubunun jenerik ilaçların ilgili gruplara girmesinin sağladığı tasarruf bulunmuştur. Ayrıca, 2012 yılında ilk jenerik olarak geri ödemeye giren 15 jenerik ilacın fiyatları ne kadar düşürdüğü ölçülmüştür. SGK ilaç bütçesinin yaklaşık %7'sini oluşturan 12 eşdeğer grupta, jeneriklerin gruplarda bulunması fiyatları yaklaşık %41 düşmüştür, %8 ile %74 arasında tasarruf sağlanmıştır. Geri ödemeye giren 15 ilk jenerik ürünün, ilk yıl için sağladığı tasarruf ortalama %39 iken, bu ilaçların bulunduğu eşdeğer gruplarında kutu satışları %41 artmıştır. Bu analizler sonucunda, jenerik ilaçların fiyatları daha da aşağı çekmesi bağlamında, Türkiye için hala politika alanının mevcut olduğu sonucuna varılmıştır. Bu yüzden, daha fazla tasarruf sağlamaya yönelik; terapötik eşdeğerlik, ihale ve rekabeti artırıcı ve fiyatları daha da aşağı çeken saldırgan jenerik politikaları gibi uygulamaların yakın bir gelecekte hayata geçirilmesi önem arz etmektedir

FİYATLARI DÜŞÜRME AÇISINDAN TÜRKİYE’DEKİ JENERİK İLAÇ FİYATLAMA POLİTİKASININ PERFORMANS DEĞERLENDİRMESİ

Generics are commonly accepted to contribute significantly to treating disease by improving the affordability of pharmaceuticals. Once the patent expires for an originator brand, generics erode prices through creating fierce competition. The objective of this study is to investigate on Turkish pharmaceutical policies over generics through measuring how much they lower the prices, and then develop alternative strategies to maintain higher level of price reduction, and hence saving. Claims data from Turkish Social Security Institution (SSI) for all ambulatory care drugs reimbursed were collected monthly in the period of January 2009 to December 2013 and for selected 12 equivalent groups price erosion and saving impacts due to generic entry be computed. Moreover, the price erosion for 15 generics entering the reimbursement list in 2012 as first generics was measured. For 12 equivalent groups constituting nearly 7% of SSI drug spending, the price erosion was nearly 41% ranging from 8% to 74%. In the first year of the first generic entry, on average the prices were only shrank by 39% with an increase of 41% in units sold. As a result of those analyses, it is concluded that Turkey is not maximizing its full potential with respect to generic medicines. Therefore, it is of great importance that policies such as therapeutic equivalence, tendering, and aggressive generic pricing policy to stimulate higher savings need to be introduced in the near future

PDF

___

Adamski, J., Godman, B., Ofierska-Sujkowska, G., Osińska, B., Herholz, H., Wendykowska, K., … Gustafsson L. L. (2010). Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Services Research, 10(153), 1-16.
Cameron, A., Ewen, M., Ross-Degnan, D., Ball, D., & Laing, R. (2009). Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis. Lancet, 373, 240-249.
Cameron, A., Mantel-Teeuwisse, A. K., Leufkens, H. G., & Laing, R. O. (2012).
Switching from originator brand medicines to generic equivalents in selected developing countries: How much could be saved. Value Health, 15(5), 664-673.
Carone, G., Schwiertz, C., & Xavier, A. (2012). Cost-containment policies in public pharmaceutical spending in the EU. European Economy. Economic papers. Economic Papers 461. Brussels: European Union.
Cook, J. P., Vernon, J. A., & Manning, R. (2008). Pharmaceutical risk-sharing agreements. Pharmaco Economics, 26(7), 551-556.
Danzon, M. P., & Ketcham, J. D. (2004). Reference pricing of pharmaceuticals for Medicare: Evidence from Germany, the Netherlands, and New Zealand. Forum for Health Economics and Policy, 7, 1-47.
Dylst, P., Vulto, A., & Simoens, S. (2011). Tendering for outpatient prescription pharmaceuticals: What can be learned from current practices in Europe? Health Policy, 101, 146-152.
FDA. (2015). FDA center for drug evaluation and research. Office of generic drugs. What are generic drugs? Retrieved from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm144456.htm in August 15, 2016.
Ferrario, A., & Kanavos P. (2013). Managed entry agreements for pharmaceuticals: The European experience. Brussels: Eminet.
Galizzi, M., Ghislandi, G., & Miraldo, M. (2011). Effects of reference pricing in pharmaceutical markets. Pharmaco Economics, 29(1), 17-33.
Generic Pharmaceutical Association. (2015). Generic Drugs Savings in the US Report 2015. Seventh Annual Edition:2015. Retrieved from http://www.gphaonline. org/media/wysiwyg/PDF/GPhA_Savings_Report_2015.pdf .
Godman, B., Shrank, W., Wettermark, B., Andersen, M., Bishop, I., Burkhardt, T., … Gustafsson, L. L. (2010). Use of generics –a critical cost containment measure for all healthcare professionals in Europe. Pharmaceuticals, 3, 2470-2494.
Godman, B., Wettermark, B., Bishop, I., Burkhardt, T., Fürst, J., Garuoliene, K., … Gustafsson, L. L. (2012). European payer initiatives to reduce prescribing costs through use of generics. Generics and Biosimilars Initiative Journal, 1, 22-27.
IMS Health. (2005). IMS National Sales Perspective (TM), 1999-2004, extracted February 2005. Retrieved from http://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/ucm129385.htm in September 21, 2016.
Kanavos, P., Seeley, L., & Vandoros, S. (2009). Tender systems for outpatient pharmaceuticals in the European Union: Evidence form Netherlands, Germany and Belgium. Brussels: European Commission.
Leopold, C., Habl, C., & Vogler, S. (2008). Tendering of pharmaceuticals in EU member states and EEA countries. Results from the country survey. Retrieved from http://whocc.goeg.at/Literaturliste/Dokumente/BooksReports/Final_Report_ Tendering_June_08.pdf .
MOH. (2015). Notification on the pricing of medicinal products for human use. Retrieved from http://www.resmigazete.gov.tr/eskiler/2015/12/20151211-3.htm in June 15, 2016.
Seeley, E., & Kanavos, P. (2008). Generic medicines from a societal perspective: Savings for health care systems? Eurohealth, 14(2), 18-22.
Sermet, C., Andrieu,V., Godman B., Van Ganse, E., Haycox, A., & Reynier, J. P. (2010). Ongoing pharmaceutical reforms in France: implications for key stakeholder groups. Applied Health Economics and Health Policy, 8(1), 7-24.
SGK. (2016a). Regulation on Drug Reimbursement. Retrieved from http://www. resmigazete.gov.tr/eskiler/2016/02/20160210-7.htm in August 13, 2016.
SGK. (2016b). Health implementation practice. Retrieved from http://www. saglikaktuel.com/mwg-internal/de5fs23hu73ds/progress?id=sQRhI-ssJ1gQo6DBC c8xvP3DoRIsum3YvR9U8ExxShI in September 20, 2016.
Sheppard, A. (2010). Generic medicines: Essential contributors to long-term health of society. Retrieved from http://www.medicinesforeurope.com/ wpcontent/uploads /2016/03/IMS_Generic_Medicines_Essential_contributors.pdf .
Simoens, S. (2012). A review of generic medicines pricing in Europe. Generics and Biosimilars. Initiative Journal, 1, 8-12.
Simoens, S., & De Coster, S. D. (2006). Sustaining generic medicines market in Europe. Journal of Generic Medicines, 3, 257-268.
Simoens, S. (2013). Sustainable provision of generic medicines in Europe. Retrieved from http://www.generikusegyesulet.hu/mwginternal/de5fs23hu73ds/ progress?id=EiS+Vact7.
TITCK. (2005). Registration regulation of human medicinal products. Retrieved from http://www.titck.gov.tr/PortalAdmin/Uploads/UnitPageAttachment/459e11 9d86725.pdf in August 30, 2016.
Tootelian, D. H., Gaedeke, R. M., & Schlacter, J. (1988). Branded Versus Generic Prescription Drugs: Perceptions of Risk, Efficacy, Safety, and Value. Journal of Health Care Marketing, 8(3), 26-29.
Vogler, S. (2012). How large are the differences between originator and generic prices? Analysis of five molecules in sixteen European countries. Farmeconomia. Health economics and therapeutic pathways, 13, 29-41.
WHO. (1988). How to develop and implement a national drug policy. Retrieved from http://apps.who.int/medicinedocs/pdf/s2283e/s2283e.pdf.
WHO. (1988). Guidelines for developing national drug policies. Geneva: World Health Organization.
WHO. (1996). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth Report. WHO Technical Report Series No.863, Annex 9. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. Geneva: World Health Organization.
WHO. (1998). Marketing authorization of pharmaceutical products with special reference to multisource (generic) products. A manual for a drug regulatory authority. Regulatory Support Series No.5. Geneva: World Health Organization.