Budget Impact Analysis of prolonged-release buprenorphine depot-formulation for the management of patients affected by opioid use disorder


  • Michele Basile Università Cattolica del Sacro Cuore (UCSC), Facoltà di Economia, Sede di Roma and Alta Scuola di Economia e Management dei Sistemi Sanitari (ALTEMS), Roma - Italy
  • Lorenzo Somaini Servizio Dipendenze, Azienda Sanitaria Locale Biella (BI), Piemonte - Italy
  • Americo Cicchetti Università Cattolica del Sacro Cuore (UCSC), Facoltà di Economia, Sede di Roma and Alta Scuola di Economia e Management dei Sistemi Sanitari (ALTEMS), Roma - Italy




Budget Impact Analysis, Opioid use disorder, Disease management, Economic evaluation, Prolonged-release buprenorphine


Background: Opioid use disorder (OUD) is a disorder associated with significant rate of morbidity and mortality. Frequent clinic attendance for supervised consumption of sublingual buprenorphine is common. Prolonged-release buprenorphine (PRB) allows a management based on weekly or monthly subcutaneous injections, thus limiting the burdens of clinic attendance and the risks associated with sublingual formulations.

Objective: To determine the price level of PRB that allows to obtain a neutral impact from the point of view of the economic resources absorbed, in comparison with the alternatives currently available in the Italian context for the management of patients suffering from OUD.

Methods: The analysis assumes a daily PRB cost of €8.526 (neutral cost). The analysis aims to determine the economic impact associated with the introduction of PRB in the Italian context for the management of OUD patients. Results are expressed in terms of differential resourced absorbed in the alternative scenarios. A one-way sensitivity analysis was also carried out to test the robustness of the results.

Results: The introduction of PRB implies an increase in the drug acquisition costs over the 5-year time horizon of €19.563.019,13: such costs are fully compensated by the other cost driver considered in the analysis (drug tests provided, health professionals’ time destined to the provision of the treatment, indirect costs, for savings equal to €6.167.026,94, €9.106.824,67 and €4.289.167,53 respectively) demonstrating its effectiveness in particular by an organizational point of view. Lower price levels for PRB would imply significant savings for the SSN.

Conclusions: PRB resulted to be associated to a lower level of resources’ absorption in the Italian sector as compared with the available alternatives thus allowing to re-allocate health founds to other fields of the care sector ensuring greater safety for patients and a decreased misuse and diversion rate.


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Wermeling DP. Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access. Ther Adv Drug Saf. 2015;6(1):20-31. https://doi.org/10.1177/2042098614564776 PMID:25642320 DOI: https://doi.org/10.1177/2042098614564776

Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2095-2128. https://doi.org/10.1016/S0140-6736(12)61728-0 PMID:23245604 DOI: https://doi.org/10.1016/S0140-6736(12)61728-0

Fischer B, Rehm J, Patra J, Cruz MF. Changes in illicit opioid use across Canada. CMAJ. 2006;175(11):1385-1385. https://doi.org/10.1503/cmaj.060729 PMID:17116905 DOI: https://doi.org/10.1503/cmaj.060729

Fischer B, Cruz MF, Rehm J. Illicit opioid use and its key characteristics: a select overview and evidence from a Canadian multisite cohort of illicit opioid users (OPICAN). Can J Psychiatry. 2006;51(10):624-634. https://doi.org/10.1177/070674370605101002 PMID:17052030 DOI: https://doi.org/10.1177/070674370605101002

Dhalla IA, Mamdani MM, Sivilotti ML, Kopp A, Qureshi O, Juurlink DN. Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone. CMAJ. 2009;181(12):891-896. https://doi.org/10.1503/cmaj.090784 PMID:19969578 DOI: https://doi.org/10.1503/cmaj.090784

American Society of Addiction Medicine (ASAM), Definition of addiction. Online https://www.asam.org/docs/default-source/quality-science/asam's-2019-definition-of-addiction-(1).pdf?sfvrsn=b8b64fc2_2 (Ultimo accesso: 6/7/2021).

American Addition Center. The effects of opiates on the body. Online https://drugabuse.com/featured/the-effects-of-opiates-on-the-body/ (Ultimo accesso: 6/7/2021).

Alho H, Dematteis M, Lembo D, Maremmani I, Roncero C, Somaini L. Opioid-related deaths in Europe: strategies for a comprehensive approach to address a major public health concern. Int J Drug Policy. 2020;76:102616. https://doi.org/10.1016/j.drugpo.2019.102616 PMID:31855706 DOI: https://doi.org/10.1016/j.drugpo.2019.102616

Connock M, Juarez-Garcia A, Jowett S, et al. Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation. In: NIHR Health Technology Assessment programme: Executive Summaries. NIHR Journals Library; 2007. https://doi.org/10.3310/hta11090 DOI: https://doi.org/10.3310/hta11090

Fischer G, Nava F, Stöver H. Outcomes of opioid-dependence treatment across Europe: identifying opportunities for improvement. 2012. Heroin Addict Relat Clin Probl. 2012; 14(4):39-50 Online https://www.heroinaddictionrelatedclinicalproblems.org/download-magazine.php?idrivista=R0000047 (Ultimo accesso: 15/7/21)

World Health Organization. Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence. 2009. Online http://www.who.int/substance_abuse/publications/opioid_dependence_guidelines.pdf (Ultimo accesso: 6/7/2021).

De Maeyer J, Vanderplasschen W, Broekaert E. Quality of life among opiate-dependent individuals: A review of the literature. Int J Drug Policy. 2010;21(5):364-380. https://doi.org/10.1016/j.drugpo.2010.01.010 PMID:20172706 DOI: https://doi.org/10.1016/j.drugpo.2010.01.010

United Nations Office on Drugs and Crime. World Drug Report. 2016. Online https://www.unodc.org/doc/wdr2016/WORLD_DRUG_REPORT_2016_web.pdf (Ultimo accesso: 6/7/2021).

Fischer JA, Conrad S, Clavarino AM, Kemp R, Najman JM. Quality of life of people who inject drugs: characteristics and comparisons with other population samples. Qual Life Res. 2013;22(8):2113-2121. https://doi.org/10.1007/s11136-013-0350-8 PMID:23341173 DOI: https://doi.org/10.1007/s11136-013-0350-8

Srivastava, S., Bhatia, M. S., Rajender, G., & Angad, S. Quality of life in substance use disorders. Delhi Psychiatry Journal. 2009;12(1), 114-120;

FDA News Release: FDA approves first buprenorphine implant for treatment of opioid dependence. Online http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503719.htm

Istituto Superiore di Sanita (ISS) - Relazione annuale al parlamento sul fenomeno delle tossicodipendenze in Italia anno 2020 (dati 2019). Online https://www.iss.it/documents/20126/0/relazione-annuale-al-parlamento-2020-dati-2019.pdf/c5dd54ae-5e24-381d-7367-4ac427c2fc4b?t=1611899971308

Schottenfeld RS. Opioid maintenance treatment. In: Galanter M, Kleber Hd, eds. The American Psychiatric Publishing Textbook of substance abuse treatment. Arlington, VA: American Psychiatric Publishing, Inc; 2008:289308.

National Institute for Health and Care Excellence. Drug misuse in over 16s: opioid detoxifification. Clinical guideline 2007. Online https://www.nice.org.uk/guidance/cg52/resources/drug-misuse-in-over-16s-opioid-detoxification-pdf-975504131269

National Institute for Health and Care Excellence. Drug use disorders in adults. Quality standard 2012. Online https://www.nice.org.uk/guidance/qs23/resources/drug-use-disorders-in-adults-pdf-2098544097733

National Institute for Health and Care Excellence. Tackling drug use, 2014 Online http://publications.nice.org.uk/lgb18

Dennis BB, Naji L, Bawor M, et al. The effectiveness of opioid substitution treatments for patients with opioid dependence: a systematic review and multiple treatment comparison protocol. Syst Rev. 2014;3(1):105. https://doi.org/10.1186/2046-4053-3-105 PMID:25239213 DOI: https://doi.org/10.1186/2046-4053-3-105

Benyamina A. The current status of opioid maintenance treatment in France: a survey of physicians, patients, and out-of-treatment opioid users. Int J Gen Med. 2014;7:449-457. https://doi.org/10.2147/IJGM.S61014 PMID:25228817 DOI: https://doi.org/10.2147/IJGM.S61014

Guillou Landreat M, Rozaire C, Guillet JY, Victorri Vigneau C, Le Reste JY, Grall Bronnec M. French experience with buprenorphine: do physicians follow the guidelines? PLoS One. 2015;10(10):e0137708. https://doi.org/10.1371/journal.pone.0137708 PMID:26479400 DOI: https://doi.org/10.1371/journal.pone.0137708

Istituto Superiore di Sanità (ISS). The ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 Focused Update. Online https://www.iss.it/documents/20126/0/Linee-Guisa-ASAM_2020.pdf/b4a81d64-374c-fb54-302d-e77460bc3ab2?t=1588167692291 (Ultimo accesso: 6/7/2021).

Istituto Superiore di Sanità (ISS). Oppiacei: trattamenti di mantenimento. Online https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwit1aC5t8_xAhW-_rsIHRbpAA4QFjAAegQIBBAD&url=https%3A%2F%2Fwww.iss.it%2Fdocuments%2F20126%2F2344091%2Foppiacei_mantenimento.pdf%2F8a44ed15-c97a-3227-f72b-0506e871f700%3Fversion%3D1.1%26t%3D1575731388988%26download%3Dtrue&usg=AOvVaw3IXrcmNPCn-DyoPQSDzpDt (Ultimo accesso: 6/7/2021).

Dematteis M, Auriacombe M, D'Agnone O, et al. Recommendations for buprenorphine and methadone therapy in opioid use disorder: a European consensus. Expert Opin Pharmacother. 2017;18(18):1987-1999. https://doi.org/10.1080/14656566.2017.1409722 PMID:29183228 DOI: https://doi.org/10.1080/14656566.2017.1409722

Bonhomme J, Shim RS, Gooden R, Tyus D, Rust G. Opioid addiction and abuse in primary care practice: a comparison of methadone and buprenorphine as treatment options. J Natl Med Assoc. 2012;104(7-8):342-350. https://doi.org/10.1016/S0027-9684(15)30175-9 PMID:23092049 DOI: https://doi.org/10.1016/S0027-9684(15)30175-9

Mégarbane B, Hreiche R, Pirnay S, Marie N, Baud FJ. Does high-dose buprenorphine cause respiratory depression?: possible mechanisms and therapeutic consequences. Toxicol Rev. 2006;25(2):79-85. https://doi.org/10.2165/00139709-200625020-00002 PMID:16958555 DOI: https://doi.org/10.2165/00139709-200625020-00002

Wolff K. Substance Misuse: Substitution Drugs. In Encyclopedia of Forensic and Legal Medicine: Second Edition. Elsevier Inc. 2015;436-441. DOI: https://doi.org/10.1016/B978-0-12-800034-2.00357-8

Whelan PJ, Remski K. Buprenorphine vs methadone treatment: A review of evidence in both developed and developing worlds. J Neurosci Rural Pract. 2012;3(1):45-50. https://doi.org/10.4103/0976-3147.91934 PMID:22346191 DOI: https://doi.org/10.4103/0976-3147.91934

Gowing LR, Farrell M, Bornemann R, Sullivan LE, Ali RL. Brief report: methadone treatment of injecting opioid users for prevention of HIV infection. J Gen Intern Med. 2006;21(2):193-195. https://doi.org/10.1007/s11606-006-0258-x PMID:16336624 DOI: https://doi.org/10.1007/s11606-006-0258-x

Gronbladh L, Ohlund LS, Gunne LM. Mortality in heroin addiction: impact of methadone treatment. Acta Psychiatr Scand. 1990;82(3):223-227. https://doi.org/10.1111/j.1600-0447.1990.tb03057.x PMID:2248048 DOI: https://doi.org/10.1111/j.1600-0447.1990.tb03057.x

Mattick RP, Ali R, White JM, O'Brien S, Wolk S, Danz C. Buprenorphine versus methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent patients. Addiction. 2003;98(4):441-452. https://doi.org/10.1046/j.1360-0443.2003.00335.xPMID:12653814 DOI: https://doi.org/10.1046/j.1360-0443.2003.00335.x

European Monitoring Centre for Drugs and Drug Addiction. Perspectives on drugs. Strategies to prevent diversion of opioid substitution treatment medications. 2016. Online http://www.emcdda.europa.eu/system/files/publications/2936/OST%20medications_POD2016.pdf (Ultimo accesso: 6/7/2021).

Strang J, Hall W, Hickman M, Bird SM. Impact of supervision of methadone consumption on deaths related to methadone overdose (1993-2008): analyses using OD4 index in England and Scotland. BMJ. 2010;341(sep16 2):c4851. https://doi.org/10.1136/bmj.c4851 PMID:20847018 DOI: https://doi.org/10.1136/bmj.c4851

Auriacombe M, Fatseas M, Franques-Reneric P, Daulouede JP, Tignol J. Substitution therapy in drug addictions. Rev Prat. 2003;53(12):1327-1334. PMID:12920942

Cook C, Bridge J, McLean S, et al. The funding crisis for harm reduction: Donor retreat, government neglect and the way forward. London: International Harm Reduction Association; 2014.

Adfam. Medications in drug treatment: tackling the risks to children; 2014. Online https://adfam.org.uk/files/docs/adfam_ost_fullreport_web.pdf

Frauger E, Nordmann S, Orleans V, et al; reseau des CEIPs. Which psychoactive prescription drugs are illegally obtained and through which ways of acquisition? About OPPIDUM survey. Fundam Clin Pharmacol. 2012;26(4):549-556. https://doi.org/10.1111/j.1472-8206.2011.00950.xPMID:21564282 DOI: https://doi.org/10.1111/j.1472-8206.2011.00950.x

Hansen RN, Oster G, Edelsberg J, Woody GE, Sullivan SD. Economic costs of nonmedical use of prescription opioids. Clin J Pain. 2011;27(3):194-202. https://doi.org/10.1097/AJP.0b013e3181ff04ca PMID:21178601 DOI: https://doi.org/10.1097/AJP.0b013e3181ff04ca

European Monitoring Centre for Drugs and Drug Addiction. European Drug Report: Trends and Developments, 2017. Online http://www.emcdda.europa.eu/system/files/publications/4541/TDAT17001ENN.pdf

Dale-Perera A, Goulao J, Stover H. Quality of care provided to patients receiving opioid maintenance treatment in Europe: results from the EQUATOR analysis. Heroin Addict Relat Clin Probl. 2012;14(4). 23-38;

European Medicine Agency (EPAR). Buvidal - Assessment report. Online https://www.ema.europa.eu/documents/assessment-report/buvidal-epar-public-assessment-report_en.pdf (Ultimo accesso: 6/7/2021).

Advisory Council on the Misuse of Drugs. How can opioid substitution therapy (and drug treatment and recovery systems) be optimised to maximise recovery outcomes for service users? 2015. Online http://www.rcpsych.ac.uk/pdf/ACMD_RC_OPTIMISING_OST_REPORT_231015.pdf

National Institute for Health and Care Excellence. Methadone and buprenorphine for the management of opioid dependence. Technology appraisal guidance, 2007. Online https://www.nice.org.uk/guidance/ta114/resources/methadone-and-buprenorphine-for-the-management-ofopioid-dependence-pdf-82598072878789

Faggiano F, Vigna-Taglianti F, Versino E, Lemma P. Methadone maintenance at different dosages for opioid dependence. Cochrane Database Syst Rev. 2003;2003(3):CD002208. https://doi.org/10.1002/14651858.CD002208 PMID:12917925 DOI: https://doi.org/10.1002/14651858.CD002208

Stöver H. Assessing the current state of public-health-related outcomes in opioid dependence across Europe: data from the EQUATOR analysis. Heroin Addict Relat Clin Probl. 2012;14(4):51-64.

Benyamina A, Stöver H. Barriers to treatment access and informed patient choice in the treatment of opioid dependence in Europe. Heroin Addict Relat Clin Probl. 2012;14(4):65-80.

Bacha J, Reast S, Pearlstone A. Treatment practices and perceived challenges for European physicians treating opioid dependence. Heroin Addict Relat Clin Probl. 2010;12(3):9-19.

Riassunto delle Caratteristiche del Prodotto (RCP). European Medicine Agency (EMA). Online https://www.ema.europa.eu/en/documents/product-information/buvidal-epar-product-information_fr.pdf (Ultimo accesso: 6/7/2021).

Lofwall MR, Walsh SL, Nunes EV, et al. Weekly and monthly subcutaneous buprenorphine depot formulations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: a randomized clinical trial. JAMA Intern Med. 2018;178(6):764-773. https://doi.org/10.1001/jamainternmed.2018.1052 PMID:29799968 DOI: https://doi.org/10.1001/jamainternmed.2018.1052

Istituto Italiano di Statistica (ISTAT). Popolazione e famiglie. Online https://www.istat.it/it/popolazione-e-famiglie (Ultimo accesso: 6/7/2021).

Liste di Trasparenza dell'Agenzia Italiana del Farmaco (AIFA). Online https://www.aifa.gov.it/-/liste-di-trasparenza-del-17-06-2019 (Ultimo accesso: 6/7/2021).

Parsons G, Ragbir C, D'Agnone O, Gibbs A, Littlewood R, Hard B. Patient-Reported Outcomes, Experiences and Satisfaction with Weekly and Monthly Injectable Prolonged-Release Buprenorphine. Subst Abuse Rehabil. 2020;11:41-47. https://doi.org/10.2147/SAR.S266838PMID:33173372 DOI: https://doi.org/10.2147/SAR.S266838

D'Agnone O. Successful Treatment of opioid dependence with flexible doses of injectable prolonged release buprenorphine. Case Rep Psychiatry. 2019;2019:9381346. https://doi.org/10.1155/2019/9381346 PMID:31360572 DOI: https://doi.org/10.1155/2019/9381346

Comer S., Cunningham C., Fishman MJ et al. National practice guideline for the use of medications in the treatment of addiction involving opioid use. Am Soc Addicit Med, 2015; 66.

Ruggeri M, Basile M, Armuzzi A, Cicchetti A. Activity-based costing and budget analysis of vedolizumab versus conventional treatments in ulcerative colitis and Crohn's disease. Global & Regional Health Technology Assessment. 2017;4(1):88-99. DOI: https://doi.org/10.5301/grhta.5000258

Ministero della Salute - Tariffario delle Prestazioni Specialistiche Ambulatoriali; Online http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=3662&area=programmazioneSanitariaLea&menu=vuoto

Job Pricing: All About Rewards - Salary Outlook 2019: L'analisi del mercato retributivo Italiano - dati aggiornati al secondo semestre 2018;. Online https://www.jobpricing.it/blog/project/salary-outlook-2019-prima-edizione/

Ministero della Salute (MdS). Rapporto Tossicodipendenze. Analisi dei dati del Sistema Informativo Nazionale delle Dipendenze. 2018. Online https://www.salute.gov.it/portale/documentazione/p6_2_2_1.jsp?lingua=italiano&id=2968

Xu X, Grossetta Nardini HK, Ruger JP. Micro-costing studies in the health and medical literature: protocol for a systematic review. Syst Rev. 2014;3(1):47. https://doi.org/10.1186/2046-4053-3-47 PMID:24887208 DOI: https://doi.org/10.1186/2046-4053-3-47

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How to Cite

Basile, M., Somaini, L., & Cicchetti, A. (2021). Budget Impact Analysis of prolonged-release buprenorphine depot-formulation for the management of patients affected by opioid use disorder. Global and Regional Health Technology Assessment, 8(1), 96–104. https://doi.org/10.33393/grhta.2021.2237



Original Research Articles


Received 2021-01-29
Accepted 2021-07-06
Published 2021-07-22


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