Information intended for UK healthcare professionals only. 

This formulary decision guide was developed from content provided by Accord Healthcare Limited in a format developed by Guidelines in Practice. See below for full disclaimer.

View prescribing information and adverse event reporting information.   

Key points

  • Sixmo®:
    • is the longest acting buprenorphine formulation available in Europe, providing uninterrupted treatment for 6 months1
    • has a sustained release implant formulation developed to help problems with adherence, diversion, and misuse2,3
    • offers a discreet treatment, which may help reduce stigma and pharmacy visits4
    • implants can be removed early by a trained physician if there is a clinical need.3

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Drug name

Sixmo® (buprenorphine) 74.2 mg implant

Indication

  • Sixmo® is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social, and psychological treatment.1,3

Prevalence

  • The UK has the highest prevalence of high-risk opioid use in Europe, in people aged between 15–64 years5
  • Rates of drug poisoning deaths involving opiates in 2020 was 49.6%.6

Dosage and method of administration

  • Sixmo® should only be used in patients who are opioid tolerant3
  • Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine3
  • Each dose consists of four implants, for subcutaneous insertion in the inner side of the upper arm3
  • Sixmo® implants are intended to be in place for 6 months3
  • Treatment must be under the supervision of a healthcare professional experienced in the management of opioid dependence/addiction3
  • Insertion and removal of the implant must be performed by a physician competent in minor surgery and trained to conduct the insertion and removal procedure.3

Training

  • Sixmo® implantation and removal training is approximately 4.5 hours virtually and spread across 2 days covering Sixmo® additional risk minimisation measures, practical demonstration, Q&A, and an individual practical test to demonstrate insertion and removal of implants in the model provided
  • For further information on training, please email: enquiries_specialitybrands@accord-healthcare.com

Clinical stability

  • Achieving clinical stability is an important step in recovery and can influence the choice of maintenance therapy7
  • Supervised administration of opioid substitution therapy (OST) may interfere with patients’ daily activities, especially those who live rurally, have cormorbidities, or are in employment8–11
  • Some patients with an OUD believe a slow-release OST would improve their quality of life vs current OST10
  • Extended release medications, such as Sixmo®, may help overcome poor treatment adherence to daily medications.12

Clinical evidence

  • Sixmo® has demonstrated clinical effectiveness in a controlled clinical study PRO-81413
    • non-inferior to sublingual buprenorphine + naloxone on the primary end point,[A] with superiority also demonstrated in a subsequent analysis (Intention To Treat population). 
    • at month six, 85.7% cumulative abstinence (n=72/84) with Sixmo® and 71.9% (n=64/89) for sublingual buprenorphine + naloxone.

[A] primary efficacy end point was the difference in proportion of responders, defined as participants with at least 4 of 6 months without evidence of illicit opioid use (based on urine test and self-report composites) by treatment group.

Safety profile3

  • Sixmo® is contraindicated for:
    • hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics
    • severe respiratory insufficiency
    • severe hepatic impairment
    • acute alcoholism or delirium tremens
    • concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence
    • patients with a history of keloid or hypertrophic scar formation should not undergo subcutaneous insertion, as difficulties in retrieving the implant are possible
    • patients who have contraindications for MRI should not be allowed to receive the implant.

References

  1. Chappuy M, et al. Therapies 2020; 75: 397–406.
  2. Ling W, et al. JAMA 2010; 304: 1576–1583.
  3. Accord Healthcare Limited. Sixmo 74.2 mg implant–summary of product characteristics. 
  4. Neale J et al. Drug Alcohol Depend 2018; 189: 1–7.
  5. European Monitoring Centre for Drugs and Drug Addiction. European Drug Report 2020: Trends and Developments. Luxembourg, 2020. Available at: www.emcdda.europa.eu/publications/edr/trends-developments/2020_en
  6. Office for National Statistics. Deaths related to drug poisoning in England and Wales: 2020 registrations. Available at: www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsrelatedtodrugpoisoninginenglandandwales/2020
  7. NICE. Drug misuse in over 16s: opioid detoxification. Clinical Guideline 52. NICE, 2007. Available at: www.nice.org.uk/cg52
  8. Notley C et al. Drug Alcohol Rev 2014; 33: 64–70.
  9. Wogen J et al. Health and Human Rights Journal 2020; 22: 51–60.
  10. Gillman M et al. Patient Preference and Adherence 2018; 12: 2123–2129.
  11. Metrebian N et al. Contemp Clin Trials Commun 2020; 17: 100506.
  12. National Academies of Sciences, Engineering, and Medicine 2019. Medications for Opioid Use Disorder Save Lives. Washington, DC: The National Academies Press. https://doi.org/10.17226/25310.
  13. Rosenthal RN et al. JAMA 2016; 316: 282–290.

This formulary decision guide was developed from content provided by Accord Healthcare Limited in a format developed by Guidelines in Practice. It was commissioned by Accord Healthcare Limited, who carried out full medical approval to ensure compliance with regulations.

 UK-03417

Date of preparation: October 2021