Introduction
3. What is the name of your organisation?
Organisation
Mayne Pharma
Terms of Reference
1. Describe and compare essential elements of models of service delivery for opioid dependence treatment (ODT) in Australia (and internationally) including best practice guidelines and current models (including models developed in response to the COVID-19 pandemic) that support timely access to ODT medicines through both pharmacy and non-pharmacy settings*.
Terms of Reference One
Best practice guidelines and current models of service delivery in international programs, including the recent update in May 2021 in Canada(Ref:1), include providing different forms of opioid agonist therapy in order to make the best choice for the patients and minimise harms. This includes in select countries the option of Slow Release Oral Morphine (SROM) specifically recommended when buprenorphine/naloxone (bup/nlx) and methadone are ineffective, contraindicated or refused (refer to recommendation B4, Prescribing slow-release oral morphine (Ref:1)). Experimental studies show that benefits of SROM over methadone include less heroin craving, better tolerability, higher patient satisfaction and mental stability (Ref:2). SROM is not available in Australia for ODT.
In Europe, SROM was first approved for use in ODT in Austria in 1998. Bulgaria and Slovenia added approval in 2009, Switzerland in 2013 and since 2015, SROM has had authorisation in Germany (Ref: 3,4).
Recent publications from Austria show retention rates favouring SROM over methadone and bupenororphrine (Ref:5); two publications reporting data from a naturalistic noninterventional study from Germany (Ref:2,3). This study (SROMOS) investigated the efficacy and safety of SROM in patients previously treated with methadone or buprenorphine who were switched to morphine because of dissatisfaction, something that is not possible in the current Australian ODTP.
Randomised clinical studies have been undertaken globally to evaluate success of maintenance treatment (Ref:6) and Mayne Pharma is actively working with a European partner for the registration of KAPANOL (sustained-release morphine sulfate pentahydrate for oral administration) for this indication in select EU-member states and Switzerland.
Mayne Pharma has also supported a clinical trial in Canada for this research where an opioid crisis, exacerbated by the SARS-CoV-2 pandemic, continues to worsen. Abuse factor of SROM compared with other more traditional substitutes is not as high and as detailed in the combined Canadian guidelines, SROM is recommended (Ref:1). Mayne Pharma is in ongoing discussions with Australian researchers well recognised in Australia and internationally to explore this unmet medical need. The long-term plan is to register KAPANOL for this indication in Australia and to have an ODTP ready to support this option, for patients treated in a non-pharmacy setting, would be advantageous and offer more options for Australian dependant patients.
References
1. OPIOID AGONIST THERAPY: A SYNTHESIS OF CANADIAN GUIDELINES FOR TREATING OPIOID USE DISORDER, May 2021 Available at https://www.camh.ca/-/media/files/professionals/canadian-opioid-use-disorder-guideline2021-pdf.pdf
2. Lehmann K, Kuhn S, Baschirotto C, Jacobsen B, Walcher S, Görne H, Backmund M, Scherbaum N, Reimer J, Verthein U. Substitution treatment for opioid dependence with slow-release oral morphine: Retention rate, health status, and substance use after switching to morphine. J Subst Abuse Treat. 2021 Aug;127:108350. doi: 10.1016/j.jsat.2021.108350. Epub 2021 Mar 4. PMID: 34134867.
3. Cinzia Baschirotto, Kirsten Lehmann, Silke Kuhn, Jens Reimer, Uwe Verthein, Switching opioid-dependent patients in substitution treatment from racemic methadone, levomethadone and buprenorphine to slow-release oral morphine: Analysis of the switching process in routine care, Journal of Pharmacological Sciences, Volume 144, Issue 1, 2020, Pages 9-15, ISSN 1347-8613, https://doi.org/10.1016/j.jphs.2020.06.004.
4. European Monitoring Centre for Drugs and Drug Addiction. 2009 Annual Report on the State of the Drugs Problem in Europe. Lisbon: European Monitoring Centre for Drugs and Drug Addiction; 2009. Available at http://www.emcdda.europa.eu/publications/annual-report/2009.
5. Busch et al. Harm Reduct J (2021) 18:25 doi: 10.1186/s12954-021-00473-9
6. Klimas J, Gorfinkel L, Giacomuzzi SM, et al, Slow release oral morphine versus methadone for the treatment of opioid use disorder BMJ Open 2019;9:e025799. doi: 10.1136/bmjopen-2018-025799
In Europe, SROM was first approved for use in ODT in Austria in 1998. Bulgaria and Slovenia added approval in 2009, Switzerland in 2013 and since 2015, SROM has had authorisation in Germany (Ref: 3,4).
Recent publications from Austria show retention rates favouring SROM over methadone and bupenororphrine (Ref:5); two publications reporting data from a naturalistic noninterventional study from Germany (Ref:2,3). This study (SROMOS) investigated the efficacy and safety of SROM in patients previously treated with methadone or buprenorphine who were switched to morphine because of dissatisfaction, something that is not possible in the current Australian ODTP.
Randomised clinical studies have been undertaken globally to evaluate success of maintenance treatment (Ref:6) and Mayne Pharma is actively working with a European partner for the registration of KAPANOL (sustained-release morphine sulfate pentahydrate for oral administration) for this indication in select EU-member states and Switzerland.
Mayne Pharma has also supported a clinical trial in Canada for this research where an opioid crisis, exacerbated by the SARS-CoV-2 pandemic, continues to worsen. Abuse factor of SROM compared with other more traditional substitutes is not as high and as detailed in the combined Canadian guidelines, SROM is recommended (Ref:1). Mayne Pharma is in ongoing discussions with Australian researchers well recognised in Australia and internationally to explore this unmet medical need. The long-term plan is to register KAPANOL for this indication in Australia and to have an ODTP ready to support this option, for patients treated in a non-pharmacy setting, would be advantageous and offer more options for Australian dependant patients.
References
1. OPIOID AGONIST THERAPY: A SYNTHESIS OF CANADIAN GUIDELINES FOR TREATING OPIOID USE DISORDER, May 2021 Available at https://www.camh.ca/-/media/files/professionals/canadian-opioid-use-disorder-guideline2021-pdf.pdf
2. Lehmann K, Kuhn S, Baschirotto C, Jacobsen B, Walcher S, Görne H, Backmund M, Scherbaum N, Reimer J, Verthein U. Substitution treatment for opioid dependence with slow-release oral morphine: Retention rate, health status, and substance use after switching to morphine. J Subst Abuse Treat. 2021 Aug;127:108350. doi: 10.1016/j.jsat.2021.108350. Epub 2021 Mar 4. PMID: 34134867.
3. Cinzia Baschirotto, Kirsten Lehmann, Silke Kuhn, Jens Reimer, Uwe Verthein, Switching opioid-dependent patients in substitution treatment from racemic methadone, levomethadone and buprenorphine to slow-release oral morphine: Analysis of the switching process in routine care, Journal of Pharmacological Sciences, Volume 144, Issue 1, 2020, Pages 9-15, ISSN 1347-8613, https://doi.org/10.1016/j.jphs.2020.06.004.
4. European Monitoring Centre for Drugs and Drug Addiction. 2009 Annual Report on the State of the Drugs Problem in Europe. Lisbon: European Monitoring Centre for Drugs and Drug Addiction; 2009. Available at http://www.emcdda.europa.eu/publications/annual-report/2009.
5. Busch et al. Harm Reduct J (2021) 18:25 doi: 10.1186/s12954-021-00473-9
6. Klimas J, Gorfinkel L, Giacomuzzi SM, et al, Slow release oral morphine versus methadone for the treatment of opioid use disorder BMJ Open 2019;9:e025799. doi: 10.1136/bmjopen-2018-025799
2. Examine the consumer experience, focussing on equity of access, geographical barriers to access, cultural safety, and affordability of ODT medicines across the different models of service delivery. This will include consideration of access to ODT for at risk population groups including people living in rural and remote areas, Aboriginal and Torres Strait Islander peoples and other populations who may have limited access to health care services, including ODT.
Terms of Reference Two
The current available treatment options for patients in Australia are limited should buprenorphine/naloxone (bup/nlx) and methadone be ineffective, contraindicated or refused. Even through the availability of modified release buprenorphine injections (when approved and listed), this is still within an already existing class of treatment. The availability of Slow Release Oral Morphine (SROM) for when there is a true need due to contraindication or refusal would be advantageous and provide further equity of access.
3. Explore the utilisation of PBS ODT medicines in Australia, including funding, benefits (health system and societal) and costs incurred in the supply and dispensing of Opiate Dependence Treatment Program (ODTP) medicines in pharmacy and non-pharmacy settings. This will include examination of current PBS restriction criteria and the impact of listing of modified release buprenorphine injections on the PBS ODTP.
Terms of Reference Three
Having new medicines that meet the need for Australian patients on the PBS is paramount to access and equity. However the process and cost of submissions to the PBAC can at times be prohibitive for small organisations. The overtime time to successfully achieve PBS reimbursement can lead to delays in patients accessing new and effective alternative treatment options.
4. Propose improved service delivery arrangements for access to ODT medicines, with an aim of identifying an ODTP that is equitable, timely, reliable and affordable for consumers and stakeholders involved in the supply and delivery of ODT medicines and cost-effective for the Australia Government.
Terms of Reference Four
Having Slow Release Oral Morphine (SROM) approved for ODT for Australian patients, made by an Australian pharmaceutical manufacturer, and developed in collaboration with Australian researchers, may present a suitable option for these ‘at-risk’ patients and the Australian Government.