Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts

. 2018 ; 2018 () : 9597362. [epub] 20180110

Jazyk angličtina Země Spojené státy americké Médium electronic-ecollection

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid29546072

This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection.

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World Health Organisation. Life expectancy, 2015. http://apps.who.int/gho/data/view.main.SDG2016LEXv?lang=en.

Kaló Z., Annemans L., Garrison L. P. Differential pricing of new pharmaceuticals in lower income European countries. Expert Review of Pharmacoeconomics & Outcomes Research. 2013;13(6):735–741. doi: 10.1586/14737167.2013.847367. PubMed DOI

Kanavos P. G., Vandoros S. Determinants of branded prescription medicine prices in OECD countries. Health Economics, Policy and Law. 2011;6(3):337–367. doi: 10.1017/S1744133111000090. PubMed DOI

Elek P., Takács E., Merész G., Kaló Z. Implication of external price referencing and parallel trade on pharmaceutical expenditure: indirect evidence from lower-income European countries. Health Policy and Planning. 2017;32(3):349–358. doi: 10.1093/heapol/czw133. PubMed DOI

Inotai A., Petrova G., Vitezic D., Kaló Z. Benefits of investment into modern medicines in Central-Eastern European countries. Expert Review of Pharmacoeconomics & Outcomes Research. 2014;14(1):71–79. doi: 10.1586/14737167.2014.868314. PubMed DOI

Kaló Z., Landa K., Doležal T., Vokó Z. Transferability of National Institute for Health and Clinical Excellence recommendations for pharmaceutical therapies in oncology to Central-Eastern European countries. European Journal of Cancer Care. 2012;21(4):442–449. doi: 10.1111/j.1365-2354.2012.01351.x. PubMed DOI

Moorkens E., Jonker-Exler C., Huys I., Declerck P., Simoens S., Vulto A. G. Overcoming barriers to the market access of biosimilars in the European union: The case of biosimilar monoclonal antibodies. Frontiers in Pharmacology. 2016;7, article no. 193 doi: 10.3389/fphar.2016.00193. PubMed DOI PMC

Rémuzat C., Kapuśniak A., Caban A., et al. Supply-side and demand-side policies for biosimilars: an overview in 10 European member states. Journal of Market Access & Health Policy. 2017;5(1):p. 1307315. doi: 10.1080/20016689.2017.1307315. PubMed DOI PMC

Inotai A., Csanádi M., Vitezic D., et al. Policy Practices to Maximise Social Benefit from Biosimilars. Journal of Bioequivalence & Bioavailability. 2017;9(4):467–472.

Kaló Z., Vokó Z., Östör A., et al. Patient access to reimbursed biological disease-modifying antirheumatic drugs in the European region. Journal of Market Access & Health Policy. 2017;5(1, article no. 1345580) doi: 10.1080/20016689.2017.1345580. PubMed DOI PMC

Garrison L. P. Pharmacoeconomics and Drug Pricing. In: Ho R. J. Y., Gibaldi M., editors. Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs. 2nd. John Wiley and Sons; 2013.

Choy E., Jacobs I. A. Biosimilar safety considerations in clinical practice. Seminars in Oncology. 2014;41(1):S3–S14. doi: 10.1053/j.seminoncol.2013.12.001. PubMed DOI

Calo-Fernández B., Martínez-Hurtado J. L. Biosimilars: Company strategies to capture value from the biologics market. Pharmaceuticals. 2012;5(12):1393–1408. doi: 10.3390/ph5121393. PubMed DOI PMC

Emmanouilides C. E., Karampola M. I., Beredima M. Biosimilars: Hope and concern. Journal of Oncology Pharmacy Practice. 2016;22(4):618–624. doi: 10.1177/1078155215603232. PubMed DOI

Müller R., Renner C., Gabay C., Cassata G., Lohri A., Hasler P. The advent of biosimilars: Challenges and risks. Swiss Medical Weekly. 2014;144 doi: 10.4414/smw.2014.13980.w13980 PubMed DOI

Braun J., Kudrin A. Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health. Biologicals. 2016;44(4):257–266. doi: 10.1016/j.biologicals.2016.03.006. PubMed DOI

Schellekens H. Biosimilar therapeutics—what do we need to consider? NDT Plus. 2009;2, supplement 1:i27–i36. doi: 10.1093/ndtplus/sfn177. PubMed DOI PMC

Kudrin A., Knezevic I., Joung J., Kang H. N. Case studies on clinical evaluation of biosimilar monoclonal antibody: Scientific considerations for regulatory approval. Biologicals. 2015;43(1):1–10. doi: 10.1016/j.biologicals.2014.11.002. PubMed DOI

Markus R., Liu J., Ramchandani M., Landa D., Born T., Kaur P. Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community. BioDrugs. 2017;31(3):175–187. doi: 10.1007/s40259-017-0218-5. PubMed DOI PMC

Strand V., Balsa A., Al-Saleh J., et al. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review. BioDrugs. 2017;31(4):299–316. doi: 10.1007/s40259-017-0231-8. PubMed DOI PMC

Feldman S. R. Inflammatory diseases: Integrating biosimilars into clinical practice. Seminars in Arthritis and Rheumatism. 2015;44(6):S16–S21. doi: 10.1016/j.semarthrit.2015.04.003. PubMed DOI

Jeske W., Walenga J. M., Hoppensteadt D., Fareed J. Update on the safety and bioequivalence of biosimilars - Focus on enoxaparin. Journal of Drug, Healthcare and Patient Safety. 2013;5(1):133–141. doi: 10.2147/DHPS.S28813. PubMed DOI PMC

Kurki P., van Aerts L., Wolff-Holz E., Giezen T., Skibeli V., Weise M. Interchangeability of Biosimilars: A European Perspective. BioDrugs. 2017;31(2):83–91. doi: 10.1007/s40259-017-0210-0. PubMed DOI

Inotai A., Prins C. P., Csanádi M., Vitezic D., Codreanu C., Kaló Z. Is there a reason for concern or is it just hype? – A systematic literature review of the clinical consequences of switching from originator biologics to biosimilars. Expert Opinion on Biological Therapy. 2017;17(8):915–926. doi: 10.1080/14712598.2017.1341486. PubMed DOI

Annese V., Vecchi M., Bossa F., et al. Use of biosimilars in inflammatory bowel disease: Statements of the Italian Group for Inflammatory Bowel Disease. Digestive and Liver Disease. 2014;46(11):963–968. doi: 10.1016/j.dld.2014.07.019. PubMed DOI

Atzeni F., Sebastiani M., Ricci C. Position paper of Italian rheumatologists on the use of biosimilar drugs. Clinical and Experimental Rheumatology. 2014;33(1):1–4. doi: 10.1007/s10067-013-2463-4. PubMed DOI

Barosi G., Bosi A., Abbracchio M. P., et al. Key concepts and critical issues on epoetin and filgrastim biosimilars: a position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation. Haematologica. 2011;96(7):937–942. doi: 10.3324/haematol.2011.041210. PubMed DOI PMC

Gomollón F. Biosimilars: Are they bioequivalent? Digestive Diseases. 2014;32:82–87. doi: 10.1159/000367833. PubMed DOI

Gulácsi L., Brodszky V., Baji P., Rencz F., Péntek M. The Rituximab Biosimilar CT-P10 in Rheumatology and Cancer: A Budget Impact Analysis in 28 European Countries. Advances in Therapy. 2017;34(5):1128–1144. doi: 10.1007/s12325-017-0522-y. PubMed DOI PMC

Rémuzat C., Dorey J., Cristeau O., Ionescu D., Radière G., Toumi M. Key drivers for market penetration of biosimilars in Europe. Journal of Market Access & Health Policy. 2017;5(1):p. 1272308. doi: 10.1080/20016689.2016.1272308. PubMed DOI PMC

Swartenbroekx N., Farfan-Portet, Espín J., Gerkens S. Incentives for market penetration of biosimilars in Belgium and in five European countries. Journal de Pharmacie de Belgique. 2014;(4):36–46. PubMed

Dylst P., Vulto A., Simoens S. Barriers to the uptake of biosimilars and possible solutions: A Belgian case study. PharmacoEconomics. 2014;32(7):681–691. doi: 10.1007/s40273-014-0163-9. PubMed DOI

Kawalec P., Stawowczyk E., Tesar T., et al. Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries. Frontiers in Pharmacology. 2017;8 doi: 10.3389/fphar.2017.00288. PubMed DOI PMC

Kaló Z., Holtorf A.-P., Alfonso-Cristancho R., et al. Need for multicriteria evaluation of generic drug policies. Value in Health. 2015;18(2):346–351. doi: 10.1016/j.jval.2014.12.012. PubMed DOI

Parkinson B., Sermet C., Clement F., et al. Disinvestment and Value-Based Purchasing Strategies for Pharmaceuticals: An International Review. Pharmacoeconomics. 2015;33(9):905–924. PubMed

Rencz F., Pentek M., Bortlik M., et al. Biological therapy in inflammatory bowel diseases: Access in Central and Eastern Europe. World Journal of Gastroenterology. 2015;21(6):p. 1728. doi: 10.3748/wjg.v21.i6.1728. PubMed DOI PMC

Celltrion Remicade biosimilar gathers momentum in EU, 2015. http://www.pharmatimes.com/news/celltrion_remicade_biosimilar_gathers_momentum_in_eu_971086.

Lunddahl B. Pharmacovigilance on biologicals and biosimilars: A Danish perspective. GaBI Journal. 2016;5(3):123–124. doi: 10.5639/gabij.2016.0503.030. DOI

Papamichael K., Van Stappen T., Jairath V., et al. Review article: Pharmacological aspects of anti-TNF biosimilars in inflammatory bowel diseases. Alimentary Pharmacology & Therapeutics. 2015;42(10):1158–1169. doi: 10.1111/apt.13402. PubMed DOI

McKeage K. A Review of CT-P13: an Infliximab Biosimilar. BioDrugs. 2014;28(3):313–321. doi: 10.1007/s40259-014-0094-1. PubMed DOI

Ebbers H. C., Muenzberg M., Schellekens H. The safety of switching between therapeutic proteins. Expert Opinion on Biological Therapy. 2012;12(11):1473–1485. doi: 10.1517/14712598.2012.711308. PubMed DOI

Biologics in the Polish health system, 2015. http://www.infarma.pl/assets/files/innowacje/Biologics_in_the_Polish_health_system.pdf.

Pinheiro A. V., Vithlani M., Sarnataro K., et al. Impact of market access factors in the adoption of biosimilar anti-TNFs across Europe. Precision for Value report, 2016. http://www.precisionforvalue.com/wp-content/uploads/2016/05/Impact-of-Market-Access-Factors-Across-Europe.pdf.

Pacte d’avenir pour le patient avec l’industrie pharmaceutique, 2015. http://www.deblock.belgium.be/sites/default/files/articles/20150727%20Pacte%20d’avenir.pdf.

ANSM report, État des lieux sur les médicaments biosimilaires, 2016. http://ansm.sante.fr/var/ansm_site/storage/original/application/c35f47c89146b71421a275be7911a250.pdf.

Hemmington A., Dalbeth N., Jarrett P., et al. Medical specialists' attitudes to prescribing biosimilars. Pharmacoepidemiology and Drug Safety. 2017;26(5):570–577. doi: 10.1002/pds.4186. PubMed DOI

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