Public Consultation for the Post-market Review of Opiate Dependence Treatment Program Medicines

A major challenge for the Australian ODT system, and the main focus for this review is to ensure that the cost of opioid treatment to the patient does not remain a barrier to participating in this treatment, as occurs with current funding models. If financial barriers are redressed, positive outcomes for the patient and the community will follow. It is also essential that the providers of this treatment, most notably community pharmacists, private medical practitioners and public sector services (e.g. Local Health Districts / Networks, hospitals, prisons) are compensated fairly to provide quality service provision and attract/retain service providers to be involved in this treatment.

ODT is a well-established treatment modality for opioid dependence arising from the use of illicit and pharmaceutical opioids. ODT involves a combination of
• structured opioid medication,
• psychosocial interventions,
• medical management, and ideally,
• interventions and co-ordination of services addressing a range of concurrent substance use, medical (e.g. hepatic disease, chronic pain), psychiatric (e.g. affective disorders, PTSD) and social (e.g. under-employment, homelessness, violence) conditions often experienced by clients with opioid dependence.

MEDICATIONS
In Australia, only methadone (oral liquid or syrup) and buprenorphine (sublingual film, tablets and depot subcutaneous long-acting injections) are licensed opioid agonist medications for the treatment of opioid dependence. Oral naltrexone is also licensed (but not reimbursed on PBS) for opioid dependence, and has little uptake due to concerns regarding poor efficacy. In other countries, injectable opioid medications (e.g. diamorphine in several European nations and Canada), and slow release oral morphine products (in Austria, Croatia, and Germany) are also licensed and used for this indication.

In Australia, methadone treatment was the only available medication for this indication from its introduction in 1970 until 2000, and the Australian treatment framework, including funding and clinical models of care, still largely reflects the systems established during the 30 year period when methadone was the only available treatment. Sublingual buprenorphine was introduced in 2000, sublingual buprenorphine-naloxone tablets were licensed in 2006, and in 2012-3 sublingual buprenorphine-naloxone film became available. Since the mid-2000’s SL buprenorphine products accounted for approximately 30-40% of the ODT population across Australia (AIHW 2021), although the trend is towards greater use of buprenorphine products – with the proportion of patients treated with methadone falling from 69% in 2011 to 58% in 2020 (AIHW 2021). This trend will most likely be accelerated with the introduction of depot buprenorphine in late 2019, which has led to considerable uptake (see Lintzeris, Dunlop et al 2019 NSW Guidelines for depot buprenorphine treatment), particularly in public sector and prison based programs, and in many public sector services now accounts for approximately half of the total client population. This has been driven in part by the COVID pandemic (with the benefits of patients attending only once a month for dosing), but also due to the popularity of depot buprenorphine within the client population. This was demonstrated by the findings of the DEBUT study (Lintzeris, Dunlop et al JAMA Open 2020) – a randomised controlled trial conducted in sites in NSW and Victoria comparing sublingual buprenorphine to depot buprenorphine (Buvidal®), which reported superior patient reported measures of satisfaction, convenience and effectiveness, further highlighted in qualitative research with participants in the study (Barnett et al 2021). The safety and effectiveness of the alternative depot product (Sublocade®) has also been demonstrated in Australian clinical settings in the recent COLAB study (publication submitted).

SERVICE SYSTEMS
In most of Australia, ODT is delivered by a combination of:
• Public sector (state funded) multidisciplinary specialist clinics, targeting clients with complex clinical presentations and treatment needs. These typically are free of charge to clients, and in most cases have the capacity for opioid dosing of clients. The reach of these services varies from between 30-60% of the state’s client population, and the ‘outlier’ is Victoria, which largely disbanded its state-funded opioid treatment system in the 1990’s, and has no public sector clinics that provide routine dosing for clients (AIHW 2021). Most public sector clinics also support suitable clients to be dosed in community pharmacy settings, with those clients having to pay community pharmacy dosing fees. An account of the role of public sector services (target client population and model of care) is described in the 2018 NSW Opioid Treatment Program Guidelines.
• Private practitioner programs – predominately provided by general practitioners and some Addiction Medicine and Addiction Psychiatry specialists. In most cases, clients are dosed at community pharmacy settings, although the advent of depot buprenorphine treatment has involved clients being administered their injections at the medical practice, without the involvement of a community pharmacy in the dispensing or supply of depot formulations. In NSW, twelve private clinics have also been established which are funded largely by Medicare (medical staffing) and client payment for dosing on site, with clients often paying in the range of $80-90 per week for dosing.
• Prison based programs, varying in their reach, with the greatest uptake in NSW prison settings (predominately through Justice Health). Prison based programs have historically provided mainly methadone treatment due to concerns regarding the diversion and workloads associated with SL buprenorphine, however, in NSW (and other states) this is largely transitioning more to the use of depot buprenorphine treatment, following demonstration of the safety and cost effectiveness of depot buprenorphine in correctional settings in the UNLOCT study (Dunlop, White et al 2021).

THE ROLE OF SUPERVISED DOSING
A key issue that impacts upon costs of ODT for clients is the issue of supervised dosing at community pharmacies and private clinics. Australia established a methadone treatment framework relying on supervised daily dosing of methadone, with the opportunity for take-away doses (TADs) for clients considered at low risk of non-medical use of TADs. In most jurisdictions, methadone TADs are capped at 4 or 5 per week, based on a clinical risk assessment (as described in the National MATOD guidelines, and further described in the NSW OTP Guidelines (2018). The introduction of SL buprenorphine more or less replicated the supervised treatment system, although there is the capacity for ‘unsupervised’ Suboxone® treatment with clients allowed up to 30 days TADs of Suboxone, based on a the prescriber’s clinical risk assessment (Gowing et al, National MATOD Guidelines 2014). In practice, relatively few clients were accessing unsupervised Suboxone treatment – until the recent COVID pandemic. This is in contrast to most international models of sublingual buprenorphine treatment. The two countries with the largest buprenorphine treatment populations – the USA and France provide buprenorphine treatment without supervised dosing. Two RCTs examining the role of unsupervised SL buprenorphine treatment have been undertaken in Australia (Bell et al 2007; Dunlop, Brown et al 2017) – both of which demonstrated comparable safety and efficacy with unsupervised buprenorphine treatment, with improved consumer satisfaction and enhanced cost effectiveness.

One of the greatest concerns associated with unsupervised ODT medications is the risk of diversion and overdose related deaths. Whilst this is relevant for methadone (a potent full agonist), the safety profile of buprenorphine (a partial agonist) means it is associated with lower overdose related deaths and ‘all cause’ mortality than methadone (Marteau et al 2015; Hickman et al 2018; Komrowski et al 2021, Lam et al 2021, Santo et al 2021), further highlighting the opportunity to reconsider the reliance on supervised dosing for SL buprenorphine treatment. Yet despite the international experience and the evidence supporting unsupervised buprenorphine treatment, Australia has largely persisted with a supervised dosing model of care for buprenorphine – which is the major driver of the cost of this treatment for consumers dosed at community pharmacies.

The COVID pandemic has required ODT services to reconsider their models of care – as highlighted in the RACP Guidance document developed in April 2020 (Lintzeris et al 2020), and endorsed by a number of professional (Pharmacy Society Australia, RACGP, RANZCP, APSAD, Penington Institute) and consumer organisations (AIVL). These guidelines recommended greater use of unsupervised dosing (particularly with Suboxone) and uptake of depot buprenorphine as strategies to minimise transmission of COVID within this vulnerable population. The application of these guidelines in response to COVID were examined and evaluated by Drug and Alcohol Services at South East Sydney Local Health District, examining changes to services and related client outcomes in 429 clients before and 6-months after the onset of the COVID pandemic in 2020 (Lintzeris, Deacon et al 2021). This evaluation demonstrated a marked increase in the proportion of clients accessing weekly, fortnightly or monthly SL buprenorphine treatment (from 20% to 63% of clients), an increase in the number of weekly TADs for clients in methadone treatment (from 0% to 18%), and an increase in the use of depot buprenorphine (from 12% to 24% of total cohort). The authors reported that this TAD framework was able to be safely implemented in the vast majority of clients, without deterioration in client outcomes. Since that time, SESLHD D&A Services has revised its model of care using a co-design process (involving clinician and consumer input) which has now embedded many of these changes into its treatment model moving forward. A copy of the SESLHD Opioid Treatment Program Model of Care (Lintzeris et al 2021) is provided, and reflects the likely direction that many services will implement as we have to adapt opioid treatment in response to COVID. Given that the need for ongoing vigilance and systems to minimise COVID-19 transmission will most likely need to remain in place for several years, treatment programs across Australia will need to consider how treatment is adapted, with an increasing role for unsupervised SL buprenorphine treatment, greater flexibility with methadone TADs, and increased use of depot buprenorphine.

In summary,
• the emphasis upon supervised dosing of sublingual buprenorphine is likely to diminish given the generally positive experience of unsupervised buprenorphine treatment in many services following COVID, and bringing Australian treatment models of care more in line with international approaches. This is likely to have a significant impact upon how medications are accessed and paid for by clients (see below)
• we can expect further uptake of depot buprenorphine treatment across Australia given its high levels of satisfaction and convenience for many clients, and it is not unrealistic that depot buprenorphine will become the predominant form of ODT in Australia within several years, having achieved this status already in a number of public clinics across the country.
• we can expect a gradual decline in the role of methadone treatment, a trend that has been occurring in recent years with the advent of depot buprenorphine products. Indeed, the demographics of patient in methadone treatment indicates it is increasingly used by ‘older’ ODT clients, with younger clients being treated more often with buprenorphine products (73.4% of methadone treated patients are aged 40 years or older compared to 56.7% of buprenorphine treated patients). The transition of prison programs from predominately methadone to increasingly depot buprenorphine, will most likely further hasten the ‘demise’ of methadone treatment, as a big driver of methadone treatment was the prioritisation of methadone in prison treatment systems.

An important principle of effective ODT is informed choice for consumers regarding their ODT medication. Consumers should be able to choose their medication type, based on available evidence of safety and effectiveness, and also on the logistics and practical considerations of treatment with the medications. For example, depot buprenorphine has comparable safety and efficacy to sublingual buprenorphine, but the greater convenience of once a month dosing, often at a lower cost to the consumer, means we are seeing greater uptake of this treatment approach.

The impact of a supervised dosing model for methadone and SL buprenorphine impacts considerably on the consumer experience. The current S100 schedule of these medications (appropriately instituted in the 1970’s when methadone treatment was provided only in state-funded clinics and hospitals) is no longer consistent with medications supplied at community pharmacies. Community pharmacies first became involved in dispensing ODT in the late 1980’s in Victoria (in response to the need to expand ODT quickly to address the HIV epidemic), and the S100 schedule did not provide any mechanism for reimbursing the labour of community pharmacists, and this cost was shifted to consumers. This appears to have been a historical oversight – in that the there was no attempt to amend the S100 schedule to reflect the increasing role of community pharmacies. Most clients now pay approximately $40-50 per week for their methadone or sublingual buprenorphine medication. This is an inordinate burden on many clients – particularly given the low levels of employment in this client population, and that many are reliant on Jobseeker or Disability pension payments. This is particularly problematic for clients with other social and health conditions. The increasing age of ODT clients also means that they are increasingly experiencing a range of social and health problems – such as social isolation, homelessness, falls, cognitive impairment, mobility problems and chronic health conditions - as highlighted in a study of older clients in opioid and other AoD treatment (Lintzeris, Rivas et al 2016).

The supervised dosing model is particularly burdensome in regional and rural areas, where clients have to travel considerable distances to pharmacies for dosing – further adding to the expense of treatment. In many regional and rural areas, the lack of suitable public transport means that many clients must drive long distances to access treatment – which not only increases the cost and inconvenience of treatment, but also endangers community safety given a proportion of these clients are still using alcohol or other drugs.

In most jurisdictions, state funded programs are designed to address the treatment needs of clients with more severe social and health conditions, and this can alleviate the burden on consumers of community pharmacy dosing fees. However, most public sector programs have not had any significant funding enhancements in 10-20 years, and indeed in NSW where state sector funding has transitioned to activity based funding models, funding for opioid treatment programs has actually reduced by 20-30% in most services in the past 3 years! Furthermore, state funded programs need to be able to transition clients to private services (including community pharmacies) in order to avoid becoming ‘silted up’ with long term patients. The cost of pharmacy dosing is a major barrier to clients transitioning from public clinics to community pharmacies, and jeopardises the capacity of these programs to provide services to the next cohort of vulnerable clients seeking treatment (e.g. following release from prison, following hospital admission, or for vulnerable clients such as those experiencing domestic violence or homelessness). The need to be able to match consumer needs with appropriate services requires removal of the obstacle of cost to the consumer with community pharmacy dosing.

Another key development in the past decade has been the increasing emergence of prescription opioid dependence, with increasing proportions of patients entering ODT with a background of prescription opioid dependence, usually for the treatment of chronic pain. The current funding models highlight the inequity of the current system. For example, a patient who has developed dependence to oxycodone in the context of chronic pain treatment, may be appropriately treated with SL buprenorphine to address both pain and dependence issues. When treated with oxycodone, the patient can expect to pay $6.60 if a Health Card Holder or $41.30 for a month’s supply of medication, and the medication costs go towards the annual PBS ‘cap’ for the patient. However once treated with Suboxone, the patient will now have to pay on average $40 a week - $160 a month – 5 times more for a patient and 25 times more if they are a Health Card holder. This financial disincentive is a barrier to optimal patient care and patient outcomes, and highlights the problems of the current funding models.

As stated in Point 1, the existing S100 funding models for ODT medications are no longer appropriate, and undermine the uptake and viability of this treatment approach given the inordinate burden upon consumers, and its impact upon state funded specialist services to target clients based upon clinical need rather than affordability of medications.

A legitimate problem with methadone are the safety concerns of this medication, with demonstrated risks of overdose deaths, particularly when TADs are diverted to people not in treatment and without tolerance to methadone. Furthermore, the oral liquid formulation requires TADs to be individually packaged and labelled by pharmacists, which increases the labour and cost associated with this treatment. Indeed, the labour for a pharmacist is comparable irrespective of whether the client attends for supervised dosing or receives a TAD. Hence, some form of reimbursement for pharmacists is required for each dose administered or packaged as a TAD.
In contrast, SL buprenorphine is a considerably safer medication, and we can expect increasing levels of unsupervised treatment (e.g. weekly, monthly supplies) in coming years, hastened by the experiences of the COVID pandemic. An advantage of SL buprenorphine formulations when provided as TADs is that daily doses do not need to be individually packaged by a pharmacist, and up to a month of TADs can be supplied as one dispensed item. This provides the opportunity for markedly reduced cost to the consumer, as the pharmacist labour is not substantially different to that involved in supplying a month’s supply of another S8 medication (e.g. oxycodone) to a patient. However, despite the reduced labour for pharmacists with unsupervised Suboxone treatment, most community pharmacies continue to charge patients the same weekly price ($40-50 a week) irrespective of whether the patient attends daily for supervised dosing, or attends once a month with TADs. The justification for this practice is unclear, and there needs to be better alignment between the labour involved for the pharmacy and cost to consumer.

The re-imbursement of depot buprenorphine raises different challenges and opportunities. Depot buprenorphine cannot be supplied to the client, but mist be administered by a health care practitioner (e.g. nurse, doctor, pharmacist). Increasingly we are seeing four models for this treatment:
• Public sector (and correctional) treatment settings – with the client attending services once a month and being administered injections free of charge to the consumer.
• Private medical practices – with the medical practitioner or practice nurse administering the depot injection, having been supplied directly from the wholesaler, without any community pharmacy involvement. At present, the health care provider (doctor or nurse) can access Medicare payments for this work, and/or introduce a fee for the client. Anecdotally, many medical practitioners are charging between $20 and $50 for each monthly injection.
• Private medical practices – with the medication dispensed by a community pharmacy and supplied to the medical practitioner or practice nurse, who administers the dose at the medical practice. At present, there is no clear payment framework for the community pharmacist, and indeed the client may never actually attend the pharmacy. Anecdotally, some pharmacists are charging clients between $20 and $50 for each monthly injection, however the justification for this charge remains unclear. There needs to be a mechanism for community pharmacists to be reimbursed for their labour under such a model, and this should be consistent with the cost of dispensing other S8 medications.
• Depot doses being administered at community pharmacies. Increasingly, a small number of pharmacies have commenced administering depot buprenorphine at the pharmacy. It is unlikely that this will become widespread practice – given the need for private dosing areas, training and medical record keeping required for this practice, however it will have an important role, particularly as we expand telehealth models of care, where the prescribing medical practitioner may be in an urban setting (e.g. Melbourne, Sydney or Brisbane) for a client in a remote or rural setting who access their dose once a month at a community pharmacy in the nearest town.

The different range of services involved in dispensing ODT medications highlights that neither S85 nor the existing S100 schedule can be implemented universally. S100 systems need to be available to ensure ODT can be delivered in prison, hospital and public clinics, as removal of a S100 listing would make these treatment systems untenable. Similarly, routine S85 schedule does not adequately reimburse community pharmacies for the labour of supervised dosing (and TAD preparation for methadone).

We propose systems that ensure equitable access for consumers, without the inordinate cost burden of current reimbursement models for clients and their families.
We would like to recommend consideration of a 4 tier approach to funding ODT dosing, reflecting the different treatment arrangements most commonly used in Australia

A. Systems that reimburse methadone dosing and supervised SL buprenorphine dosing (defined here as at least 2 supervised doses per week, with up to 5 TADs per week) at community pharmacies. An equitable and simple approach is to extend current funding models in place for Staged Supply of other medications (e.g. S8 opioids, benzodiazepines), in which the pharmacist is reimbursed directly a daily fee ($8.10 per day in the first week then $4.12 per day thereafter) by the Commonwealth for each dose administered – separate to the dispensing fee for the prescription. Hence for clients accessing methadone (irrespective of the number of TADs) or where SL buprenorphine is predominately supervised e.g. (1-5 TADs per week), the pharmacist would be reimbursed $56.84 in the first week and then $28.84 per week for dosing, plus an S8 dispensing fee per prescription. The existing Staged Supply model was designed to assist people who are at risk of drug dependency or who are otherwise unable to manage their medicines safely, however has explicitly excluded methadone and SL buprenorphine from the system. This exclusion could easily be amended.
B. A reimbursement model for unsupervised SL buprenorphine (ie weekly, fortnightly or monthly dispensing, with no more than 1 supervised dose within the interval) and for pharmacists dispensing depot buprenorphine to another health care practitioner (e.g. doctor, nurse) to administer. In this model, pharmacists should be reimbursed an appropriate weekly or monthly dispensing fee (e.g. $20 for either a weekly or monthly dispensing interval), which adequately compensates for their labour – most likely greater than current reimbursements for other S8 medications, and reflects the increased workloads (record keeping, communicating with prescribers) associated with ODT. This would require an amendment to the S100 listing, as it is not consistent with routine S85 payment schedule.
C. A reimbursement model for pharmacists administering depot buprenorphine (e.g. $20 per injection administered) – over and above the dispensing fee referred to point ‘B’ above, that reflects the workload for pharmacists in administering the injection, separate to dispensing.
D. A reimbursement model for medical practitioners or practice nurses administering depot buprenorphine which has been supplied directly to their practice from a wholesaler, with no pharmacist involvement. This can be reimbursed by Medicare fees charged by the doctor / nurse, with individual patient contributions where the practitioner does not ‘bulk bill’, and consistent with current practice.

These are summarised in Table 1 (included as attachment as online process does not support tables).

In order to model the cost of these options to the Australian government, we suggest we need to model future service models rather than looking back at historical trends. For example, the following conditions could be used to develop a costings model:
• Approximately 30% of ODT clients remain dosed at public sector or correctional settings where dosing is funded by state governments (not considered further in below model, but recognising the need to retain some S100 listing to ensure continuity in these essential settings)
• Of the remaining 70% of clients dosed at non-public sector services, we will most likely see shifts in the make-up of ODT in Australia, with a reduction in the proportion of patients in methadone treatment (to approximately 25-40% of client population within 5-10 years), an increase in the use of depot buprenorphine to approximately 40-50% of the treatment population, and the remaining 15-25% in SL buprenorphine, of which half will be able to be treated in an unsupervised dosing model (attending a pharmacy once a week, once a fortnight or once a month), and the other half having some mix of supervised dosing and regular TADs (e.g. 0-5 TADs per week). Furthermore, we assume that half of depot buprenorphine in private settings will be supplied by a medical practitioner without pharmacy involvement, and half will be dispensed by a pharmacist, of which half will be administered by the pharmacist, and half supplied to the doctor to administer.

With these assumptions, Table 1 (attachment) describes the range of treatment conditions and potential funding for reimbursing health care providers for their labour, and ensures no cost to the consumer for accessing ODT medication – consistent with the original intent of the S100 listing of methadone in the 1970’s when provided in state run services.

See Table 1 (attachment). Framework for funding ODT medication supply

It would be possible for the Committee to develop costing models to the Commonwealth based on these assumptions, and projected client numbers, or to revise modelling accordingly.

We also believe that the variation in prices to the consumer currently charged by different between community pharmacies (some as low as $30 / week, others charge $50 / week) should be addressed, with standard reimbursement for pharmacies, as described in this above reimbursement framework.

In summary, the existing S100 listing is no longer suitable for ODT, reflecting that practice has largely shifted to community pharmacy settings and there is no reimbursement for pharmacist labour (except for patient payment which is inequitable); whilst a standard S85 listing does not reflect the workloads for pharmacists in supervised dosing or methadone TAD preparation. We recommend that a revised S100 listing be developed that reflects contemporary clinical practice, as summarised in Table 1, and that the exclusion of methadone and SL buprenorphine from the Staged Supply funding for pharmacists be removed.