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Regulation impact statement: Codeine re-scheduling

Version 1.1, December 2016

20 December 2016

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Individual options

Option 1: Status quo

Option 1 represents the status quo, that no changes to the scheduling of medicines containing codeine are made.

Codeine, under the status quo, will remain available 'over-the-counter' in low-dose preparations as cough and cold medicines (10* mg or less) and in combination analgesics with other pain relief medicines (12* mg or less) in pharmacies. High dose codeine preparations (greater than 30* mg) will continue to be available by prescription only.

Under this option there will be no change to the current scheduling of codeine, no change in pack size would be required, and the inclusion of an additional advisory warning statement on labels that 'codeine can cause addiction' would remain voluntary. The inconsistencies relating to the current scheduling of codeine (see 'Current scheduling inconsistencies' p. 36 and Table 7, below) would remain.

* The concentration of the codeine ingredient on the medicine pack may be different due to the salt component.

Table 7: Requirements for codeine in the current Poisons Standard
Dosage unit Maximum daily dose Pack Size Type

Schedule 2

(Pharmacy medicine)

10 mg or less[103] 60mg 6 days Cough and cold

Schedule 3

(Pharmacist Only medicine)

12 mg or less 100mg 5 days Analgesics

Schedule 4

(Prescription only medicine)

30 mg or less Not prescribed Not prescribed

Source: KPMG 2016, Table D2

Under the current scheduling status of codeine (Schedule 2 and Schedule 3), low-dose codeine preparations will be available in the pharmacy. Access to Schedule 3 low-dose codeine preparations is available after the consumer obtains adequate advice from a pharmacist (or licenced person).[104] However, industry consultation has suggested that this consultation process may be limited operationally by a lack of private consultation areas in most pharmacies,[105] subsequently resulting in consumers being inadequately informed of the risks of low-dose codeine preparations compared to alternatives (both pharmacological and non-pharmacological), and/or the inappropriateness of low-dose codeine medicines being used long term.

Under the status quo, it is likely that the significant public health issues such as codeine-related deaths (with and without other drug toxicity) associated with the misuse of codeine, and attributed to its wide accessibility,[38] will continue to rise by at least 9.3% each year.[10] For further details refer to 'Morbidity and death' (p. 21) and 'Health costs and benefits' for Option 1 (below).

Impacts

As Option 1 represents the status quo, there are no anticipated impacts on the medicine industry (such as direct compliance costs), consumers or healthcare professionals.

Regulatory costs

There are no direct costs associated with this option as the status quo has been used as a baseline with which to compare the regulatory costs associated with the implementation of the other options.

Health costs and benefits

Whilst Option 1 represents the business as usual scenario and therefore has no direct regulatory impact, this option does not address the range of concerns that has been identified with the current scheduling of codeine, such as lack of education and significant evidence of harm.

There are no net health benefits associated with Option 1; however the cost to the healthcare system over time will increase as health outcomes related to codeine misuse and abuse deteriorate. Furthermore, given the lack of efficacy in certain individuals, risk of dependency to codeine-containing medicines that can lead to an increase in the level of abuse or misuse, and safety concerns associated with rapid metabolisers of codeine, there is a significant net health burden that should not be dismissed.

Notwithstanding the re-scheduling of OTC codeine products from Schedule 2 to Schedule 3 in 2010, there have been numerous reports of adverse outcomes and codeine dependence suggesting that this re-scheduling has not been effective (see p. 33 'How effective were the scheduling changes for codeine in 2010?' and references therein).

While codeine-containing analgesics remain available OTC, it is less likely that patients using codeine for chronic pain will seek advice from GPs. Hence alternative treatment pathways and other treatment options, including referral to a pain management clinic, non-pharmacological interventions, or alternative pharmaceuticals, are less likely to be explored. Further, without changes to reduce the pack size to not more than 3 days' supply and include a label warning that 'codeine can cause addiction', no change in patient behaviour is likely for codeine-dependent individuals.

On this basis, for Option 1 (no change) it is anticipated that individual health outcomes would continue to deteriorate for consumers who abuse or misuse codeine. This option will not drive positive changes in consumer use behaviour, will not raise awareness of codeine dependency and will not encourage exploration of alternative treatment pathways.

As there is no catalyst for change under this option, the public will continue to access and self treat their conditions with codeine-containing medicines that are presumed to have no adverse health risks due to the relatively limited access restrictions. However, the most concern under this option is that the current identified public health issues of morbidity and deaths will remain.

Option 2: Reduce pack size of Schedule 2 and new label warning

Under Option 2 the current Schedule 2 entry for codeine in cough and cold medicine preparations would be amended to reduce the pack size to not more than 3 days' supply and include a label warning that codeine can cause addiction. The changes and regulatory impacts are summarised in Table 8.

Table 8: Regulatory impacts of Option 2
Current Proposed change Impact
Distribution model Schedule 2 Schedule 2 Nil
Label Advisory statement for addiction not required New advisory statement Update label
Pack Size 6 days' supply 3 days' supply Reduce pack size
Dosage 10 mg per dosage unit 60 mg per day No formulation change Nil
ARTG, CMI and PI Registered Update ARTG entry Updated ARTG entry

Source: KPMG 2016, Table D5

This option will affect 46[106] ARTG medicine entries (entirely OTC) across 15 sponsors (Table 4). The same baseline assumption has been used as outlined under Option 1.

As explained above, historically, changing the labelling and decreasing the pack size has not adequately addressed the problem of misuse, dependence or medicine misadventure. Of note, however, is that MHRA has incorporated these changes into a multi-faceted approach to the regulation of codeine-containing medicines and have noted a reduction in sales of these products since the changes were introduced in 2009. The significance of the reduction in sales of these medicines in addressing the public health issues is unclear.

MHRA have also limited indications for non-prescription use to short-term treatment of acute pain which is not relieved by paracetamol, ibuprofen or aspirin alone Further risk minimisation measures included the strengthening of the warnings in PI, CMI, labels and advertising, and educating consumers about the importance of not taking medicines for more than 3 days consecutively and the need to seek advice from a doctor if required for more than 3 days.

Regulatory cost assumptions for Option 2

  • Several sponsors have recently implemented advisory warnings against codeine addiction as part of industry initiatives; however some additional labelling changes would likely be required as a result of the reduced pack size. Based on the baseline assumptions, 115 OTC medicines[107] currently marketed in Australia will be affected (Table 4).
  • As noted in the business-as-usual (BAU) costs, it is estimated that half of the product label updates can be rolled into already planned updates reducing the per product cost by 50% for that segment. Therefore the carry-forward figure is that 58 labels will need to be updated in addition to BAU labelling activities.
  • Based on BAU costs outlined in Option 1, the label pre-production and production costs are estimated to be $0.24 million.
  • Consultations have identified that approximately 50% of codeine sponsors already produce 3 day packs or have a production line that could accommodate this change across their impacted product portfolio, provided the implementation timeframe is sufficient. These sponsors will not need to implement new manufacturing arrangements for either the outer carton (apart from the printing) or inner blister pack. It is estimated that approximately 8 sponsors will incur costs to change their pack size.
  • For the impacted sponsors, it is estimated from industry consultations that the up-front cost to implement the required packaging changes is $30,000 per sponsor. This could include re-tooling to modify blister pack lengths or reduce packaging depth. It should be noted that these costs can vary depending on the location of the manufacturing facility being used. For example, changes can be implemented more quickly in domestic facilities but are more expensive, whereas changes in overseas facilities can be implemented at lower cost, but are subject to longer delays due to competing priorities.
  • The required changes fall under a C1 application level[108] based on a review of the applicable forms, and consultation with sponsors, it is estimated that 4 hours will be required to prepare and submit the relevant form. The cost of completing the required form is estimated to be $0.012 million.
  • Note that the estimated regulatory compliance costs do not account for the application fees that sponsors would have to pay (roughly $1,500 per listing update) as direct financial costs are outside the scope of the Regulatory Burden Measurement (RBM) framework.[109] Similar exclusions also apply to the other 4 options.

Impacts

Impact on the medicines industry

Current sponsors of Schedule 2 products with codeine-containing medicines would be required to update their labels to reflect the reduced pack size as well as include a new advisory statement that codeine can cause addiction (less those that already contain this advisory statement – currently voluntary). Current sponsors who do not already have a 3 day pack in their production portfolio would need to implement new manufacturing arrangements. All sponsors would need to complete the required documentation to effect the required change to their ARTG entries.

Impact on consumers and healthcare professionals

There are no predicted impacts on healthcare professionals.

Due to the reduction in pack size, consumers are expected to spend more to maintain current codeine use, including the use of codeine-containing cough and cold medicines, despite it being contraindicated for use in children under 6 years of age[110] and evidence to suggest that codeine has limited efficay for symptomatic relief of cough compared to placebo.[111,112,113,114,115]

As there are no expected changes in treatment or therapy for those consumers currently abusing low-dose codeine medicines, there are no predicted health gains under Option 2 for this subset of the population.

Due to the label changes and the reduction pack sizes, there may be a small increase in awareness of risks associated with the use of codeine-containing medicines. However, as pharmacist consultations are not required for Schedule 2 medicines, this increased awareness is likely to be minimal and limited to those consumers who read the label warning statements. The small health benefit is unlikely to be sustainable if a subset of these consumers go on to develop dependence to codeine.

Interestingly in a study that reviewed the gaps in consumers knowledge of cough and cold medicines[116], the main concerns for consumers were related to the potential for medicine interaction, side effects and delay in diagnosis. Consumers appeared to be poorly informed of the appropriate use, efficacy and safety of OTC medicines for respiratory symptoms despite the risks.[117] Most consumers believe that cough and cold medicines can cure or shorten the duration of an illness, rather than simply provide symptomatic relief. On this basis, greater awareness of the risks posed by codeine-containing cough and cold medicines may also encourage conversations about the use of such medicines in relieving symptoms.

The regulatory cost calculations (RBM) for Option 2 is reported in Table D7 of the KPMG Report (2016) in Annex 1 (and is provided below).

Impact on the government

No impact on government operations are expected from the implementation of Option 2.

Regulatory costs

The average annual regulatory costs (Table 9) for Option 2 when averaged over 10 years are estimated to be $0.05 million. This net regulatory cost accounts for BAU relabelling that occurs frequently. The total regulatory costs over 10 years (2017-2026) are $0.5 million.

Table 9: Average annual regulatory costs (from business as usual) for Option 2
Change in costs ($million) Business Community organisations Individuals Total change in costs
Total, by sector[a,b] 0.05 0.00 0.00 0.05

a From business as usual; b Change in costs ($millions); Source: KPMG 2016, Table D7

Health costs

The health economic costs for the period 2017-2026 for Option 2 are estimated to be $20.70 million; these costs are principally driven by the increase costs to consumers.

Health benefits

Under Option 2 the current Schedule 2 entries for codeine in cough and cold medicine preparations would be amended to reduce the pack size to not more than 3 days' supply and include a label warning that 'codeine can cause addiction'.

As detailed in the economic model, very limited health benefits are likely to be realized by the implementation of Option 2, and these would be principally driven by minor changes in consumer buying behaviour due to the label changes and the reduced pack sizes. Consumers would need to visit the pharmacy more often to source these medicines due to smaller pack size. It is unclear whether visiting the pharmacy more often will result in an increased awareness of the risks of codeine. The label warning statement is more likely to raise awareness of risks associated with codeine, leading to some health benefits for a small subset of the population that consume these products, especially for those consumers that may be unaware that their usual brand of cough and cold product contains low-dose codeine, and the inclusion of this may not have any substantial therapeutic benefit. No benefits are likely to be associated with consumers that are dependent on codeine.

From the health economic model, significant health benefits only arose when improved therapeutic pathways were taken by patients who are chronic users of low-dose codeine. For this improved therapeutic pathway to be realized the key enabler was a visit to a GP, which will not occur under this option.[118] Option 2 is likely to occur simultaneously with Option 5 (reduce the pack size for Schedule 3 medicines to not more than 3 days' supply and include a label warning that 'codeine can cause addiction') such that consistency in the packaging and labelling of all OTC codeine-containing medicines is achieved. This is discussed under Scenario 3.

Schedule 2 codeine-containing medicines represent the smallest subset of these medicines on the market, and thus reducing the pack size to not more than 3 days' supply is unlikely to have a substantial effect on health benefits for individuals or the broader community. Implementation of Option 2 is likely to have an impact similar to Option 1, which is the status quo. It is anticipated that individual health outcomes would continue to deteriorate for consumers who abuse or misuse codeine, and the resulting costs to the healthcare system over time will increase.

Option 3: Up-schedule Schedule 2 to 3, reduce pack size and new label warning

Under Option 3 the current Schedule 2 entries for codeine would be up-scheduled to Schedule 3, and the pack size would be reduced to not more than 3 days' supply and include a label warning that codeine can cause addiction. The changes and regulatory impacts are summarised in Table 10.

Table 10: Regulatory impacts of Option 3
Current Proposed change Impact
Distribution model Schedule 2 Schedule 3 Consumer must now speak with pharmacist
Label Advisory statement for addiction not required New advisory statement Update label
Pack Size 6 days' supply (Schedule 2) 3 days' supply Reduce pack size
Dosage 10 mg per dosage unit, 60 mg per day No formulation changea Nil
ARTG, CMI and PI Registered Update ARTG entry Updated ARTG entry including new CMI and PI

a The implementation of Option 3 would result in the creation of two classes of codeine products within Schedule 3: 10 mg/dose, 60 mg/day and 12 mg/dose, 100 mg/day; Source: KPMG 2016, Table D8.

This option will affect 46[119] ARTG medicine entries (entirely OTC) across 15 sponsors (Table 4). The same baseline assumption has been used as outlined under Option 1.

Regulatory cost assumptions for Option 3

  • Several sponsors have recently implemented advisory warnings for codeine addiction as part of industry initiatives; however, some additional labelling changes would likely be required as a result of the reduced pack size. Based on the baseline assumptions, 115 OTC medicine products currently marketed in Australia will be affected (Table 4).
  • It is estimated that all Schedule 2 sponsors will migrate their products to Schedule 3, but with a rationalisation of their product portfolio by 50% to reflect the reduced range that would be expected as products move behind the pharmacy counter, which faces stronger competition for space. Therefore the carry-forward total into the model is 58 products. As noted in the BAU costs it is estimated that half of the product label updates can be rolled into already planned updates reducing the per product cost by 50% for that segment; therefore the carry forward figure is 29 labels that will need to be updated in addition to BAU labelling activities.
  • Based on BAU costs outlined in Option 1, the label pre-production and production costs are estimated to be $0.33 million.
  • Consultations have identified that roughly 50% of codeine sponsors already produce 3 day packs or have a production line that could accommodate this change across their impacted product portfolio, provided the implementation timeframe is sufficient. These sponsors will not need to implement new manufacturing arrangements for either the outer carton (apart from the printing) or inner blister pack. It is estimated that approximately 8 sponsors will incur costs to change their pack size.
  • For the impacted sponsors, it is estimated from industry consultations that the up-front cost to implement the required packaging changes is $30,000 per sponsor. This could include re tooling to modify blister pack lengths or reduce packaging depth. It should be noted that these costs can vary depending on the location of the manufacturing facility being used. For example, changes can be implemented more quickly in domestic facilities but are more expensive, whereas changes in overseas facilities can be implemented at lower cost, but are subject to longer delays due to competing priorities.
  • Based on BAU costs outlined in Option 1, and the factors listed above, packaging transition costs are estimated to be $0.24 million.
  • The required changes fall under a C2 application level,[120] based on a review of the applicable forms, and consultation with sponsors, it is estimated that 12 hours will be required to prepare and submit the relevant forms (including the creation of PI and CMI documentation). This estimate assumes that current Schedule 2 sponsors will adopt the efficient practice of replicating the PI documentation of a generic product already in the market. It is also possible that a core PI would be available from similar medicines already available and this would assist industry with an efficient migration of these products, which would further reduce costs. The cost of completing the required form and provision of supporting materials is estimated to be $0.036 million.
  • The re-scheduling of Schedule 2 medicines to Schedule 3 would require individuals to speak with a pharmacist prior to making a purchase of codeine-based cough and cold products. In the absence of data it has been estimated this will consume an additional 30 seconds of time for both the individual and the pharmacist.
  • Current sales data indicates roughly 4.4 million packets of codeine-based Schedule 2 cough and cold products are sold every year in Australia. In the absence of data to forecast the market responses to Option 3, it is estimated that aggregate demand for Schedule 2 products would drop by 25% if re-scheduled to Schedule 3. It is therefore estimated that there will be an additional 3.3 million Schedule 3 transactions/conversations per year in response to the Schedule 2 to Schedule 3 re-scheduling.
  • The regulatory cost calculations (RBM) for Option 3 is reported in Table D9 of the KPMG Report (2016) in Annex 1, with overall regulatory costs presented below in Table 11.

Impacts

Impact on the medicines industry

Current sponsors of Schedule 2 products with codeine as an active ingredient would be required to update their labels to reflect the change from Schedule 2 to Schedule 3 and the reduced pack size, in addition to including a new advisory statement that codeine can cause addiction (less those that already contain this advisory statement – currently voluntary). Current sponsors who do not already have a 3 day pack in their production portfolio would need to implement new manufacturing arrangements. All sponsors would need to complete the required documentation to effect the required change to their ARTG entries.

Impact on consumers and healthcare professionals

The change from Schedule 2 to Schedule 3 would require customers to speak to a pharmacist prior to making a purchase of codeine-containing cough and cold products. Due to the reduction in pack size, consumers are expected to spend more to maintain current codeine use. For the individual who is dependent on codeine and consumes Schedule 2 products, there may be localised health benefits for the individual (from speaking with a pharmacist). At a higher level however, only very minimal gains in health outcomes are expected for those consumers currently abusing low-dose codeine as there will be only minimal changes in treatment for these consumers. (For further details see p. 54 'How many additional GP visits?'). This conclusion is consistent with the outcomes of the 2011 re-scheduling of codeine from Schedule 2 to Schedule 3, which did not achieve the required reduction in harm to affected individuals. Although inclusion in Schedule 3 may have initially decreased abuse of codeine-containing products, the number of patients presenting for codeine detoxification have continued to grow since 2010.

Impact on the government

No impact on government operations are expected from the implementation of Option 3.

Regulatory costs

The average annual regulatory costs (Table 11) for Option 3 are estimated to be $10.14 million when averaged over ten years. Total regulatory costs for 2017-2016 are $101.40 million. This net regulatory cost accounts for BAU relabelling that occurs frequently.

Table 11: Average annual regulatory costs (from business as usual) for Option 3
Change in costs ($million) Business Community organisations Individuals Total change in costs
Total, by sector [a,b] 6.95 0.00 3.19 10.14

a From business as usual; b Change in costs ($millions); Source: KPMG (2016) Table D10

Health costs

The health economic costs for Option 3 are estimated to be $14.49 million for the period 2017 2026 (7% discounted); these costs are principally driven by the increased costs to consumers.

Health benefits

Under Option 3 the current Schedule 2 Pharmacy Only entries for codeine in cough and cold medicine preparations would be up-scheduled to Schedule 3 Pharmacist Only, and the pack size would be reduced to not more than 3 days' supply and include a label warning that 'codeine can cause addiction'.

The label changes and the reduced pack size is likely to result in an increased number of pharmacy consultations at the time of dispensing, and therfore a small increase in awareness of risks associated with codeine is likely. This will be limited to those consumers that experience adequate consultations with pharmacists, or who read the product label. The small health benefit is unlikely to be sustainable if a subset of these consumers goes on to develop dependence to codeine, due to the subsequent public health issues.

As detailed in the economic model, no significant health benefits will be realized by the implementation of Option 3. As described earlier in the report, the only projected significant health benefits arose from improved therapeutic pathways taken by patients who are chronic users of low-dose codeine. For an improved therapeutic pathway to be realized the key enabler was a visit to a GP, which would unlikely occur under this option. Option 3 (up-schedule Schedule 2 to 3) is likely to occur simultaneously with Option 5 (reduce the Schedule 3 pack size to not more than 3 days' supply and include a label warning that 'codeine can cause addiction'). This combination is discussed under Scenario 3.

Schedule 2 codeine-containing medicines represent the smallest subset of OTC codeine-containing medicines on the market. Making these medicines Pharmacist Only, reducing the pack size (3 days' supply) and including a label warning is likely to have a small effect on health benefits for the consumer. For this option, the requirement to consult with a pharmacist to purchase codeine-containing cough and cold medicines may have a positive impact on the consumer. However, as with Options 1 and 2, it is anticipated that individual health outcomes would continue to deteriorate for consumers who abuse or misuse codeine, and the resulting costs to the healthcare system over time will increase.

Option 4: Up-schedule Schedule 2 to Schedule 4

Under Option 4, current Schedule 2 entries for codeine would be up-scheduled to Schedule 4. The changes and regulatory impacts are summarised in (Table 12). This option will affect 46 ARTG medicine entries (entirely OTC) across 15 sponsors ( Table 4). The same baseline assumptions have been used as outlined under Option 1.

Table 12 : Regulatory impacts of Option 4
Current Proposed change Impact
Distribution model Schedule 2 Schedule 4 Consumer must see doctor for prescription
Label Advisory statement(s) as per RASML Insertion of 'prescription only' medicine Update of label
Pack Size 6 days' supply Not prescribed Nil
Dosage 10 mg per dosage unit, 60 mg per day No formulation change Nil
ARTG, CMI and PI Registered OTC medicine on ARTG Register prescription medicine on ARTG ARGPM: Category 1/2 application (Type G or J) including new PI/CMI + GMP conformity assessment (if required for sponsor)

Source: KPMG 2016, Table D11

Regulatory cost assumptions

  • There are no packaging or supply restrictions for Schedule 4 products.
  • Up-scheduling Schedule 2 medicines to Schedule 4 will require sponsors to apply to register a prescription medicine. Consultations have identified significant commercial and practical barriers to migrating low-dose codeine products to a prescription-only market. Further, it is not clear whether there is a market for former Schedule 2 medicines in this scenario. For this reason it is estimated that only 15% of current Schedule 2 sponsors, would migrate their products to Schedule 4. Due to the need for portfolio rationalisation, it is estimated that each sponsor will migrate two products. As there are currently 15 sponsors with Schedule 2 medicines, the total number of medicines to be carried forward into the model is therefore 4 medicines (15% of 15 sponsors and 2 products per sponsor) which will incur costs to update labels. It has been assumed that each product to be up-scheduled relates to a separate ARTG entry.[121]
  • Based on BAU costs outlined in Option 1, the label pre-production and production costs are estimated to be $0.017 million.
  • The required changes fall under a major variation (Category 1 application – maximum processing time of 255 days) but TGA have advised that since these applications do not relate to a new chemical entity or a new indication(s) then the actual processing time (and associated data requirements) is likely to be considerably less than that required for a standard Category 1 application. Based on a review of the applicable forms it is estimated that 12 hours will be required to prepare and submit the relevant forms (including the creation of PI and CMI documentation). This estimate assumes that current Schedule 2 sponsors will adopt the efficient practice of replicating the PI documentation of a generic product already in the market. It is also possible that a core PI would be created to assist industry with an efficient migration of these products which would further reduce costs. The cost of completing the required form and provision of supporting materials is estimated to be $0.003 million.
  • This analysis has not accounted for reformulation in response to Option 4 as consultation has indicated that, due to costs and potential regulatory barriers to the redeployment of branding, there should be no reformulation.
  • Registered prescription (Schedule 4) medicines have the site of manufacture of the active pharmaceutical ingredient(s) [API] recorded in the ARTG. Moving to Schedule 4 will require more detailed ARTG records for the products, with the addition of the site of API manufacture. This is a minor administrative process that can be combined with any other application type (e.g. an application to amend the labels).
  • For new prescription medicines, evidence of Good Manufacturing Practice (GMP) at API manufacturing sites is assessed by the TGA. Schedule 2 medicine sponsors currently self-certify that they are compliant with GMP principles; subsidiary GMP requirements encompass supplier (e.g. API) qualification. The TGA can seek evidence of GMP compliance from sponsors of medicines at any time. Sponsors who already have a related Schedule 4 medicine containing codeine made at the same medicine manufacturing site are assumed to be compliant with API GMP requirements and possess all necessary GMP evidence (it is noted that this applies to 3 of the current 15 Schedule 2 sponsors). For other products, where Schedule 2 medicines are converted to Schedule 4 medicines on the ARTG due to the up-scheduling of codeine, the TGA may seek GMP evidence. It is estimated that the engagement of GMP professionals, development of documentation, and implementation of staff and managerial processes would cost $34,500 per impacted sponsor.
  • Similarly for new prescription medicines, the manufacturing process and controls for the API(s) are reviewed. Any up-scheduling is a change to a currently supplied medicine: the extent of review at the time of up-scheduling is a matter of judgement by TGA. The TGA might require assurances from the sponsor that no changes have been made to the existing Schedule 2 products that would move to Schedule 4, including the API manufacturing site(s). If a sponsor changes API details for these products in the future, the required documentation to demonstrate compliance will be required.
  • Sponsors who already have a Schedule 4 medicine manufactured at the same manufacturing site are assumed to be compliant with GMP requirements and possess all necessary certification (it is noted that this applies to three of the current 15 Schedule 2 sponsors). As detailed above, 3 sponsors are estimated to undertake this process. The upfront cost of demonstrating GMP compliance is estimated to be $0.069m.
  • The reclassification of Schedule 2 medicines to Schedule 4 will require patients to visit a doctor to obtain a prescription for any product containing codeine. This will increase the compliance burden on individuals. The costs to the healthcare system, in the form of GP payments via MBS, are outside the scope of regulatory modelling as they are considered a direct financial cost and not a compliance cost. These are instead considered in the economic modelling. It is estimated that consumers will require 15 minutes (each way) to drive to their local doctor (therefore a total of 30 minutes). It is also estimated, based on consumer behaviour survey data, that individuals will spend an average of 30 minutes in a waiting room before being able to see their doctor and that they will have a standard 15 minute consult (therefore a total of 1.25 hours).[122] The time taken for the pharmacist to process the script and talk to the consumer regarding the prescription medicine is estimated to be 2 minute (please note that no adjustment was made in relation to the estimated pharmacist wage rate for whether the processing of the script is undertaken by a pharmacist's assistant rather than the pharmacist as not all pharmacies will have this business model).
  • Based on the economic modelling undertaken for this RIS it is estimated that Option 4 will generate an additional average of 200,000 GP appointments per annum over the next ten years. This estimate accounts for the modelled behaviour of consumers in these scenarios (demand side), factors in supply side assumptions, and assumes no repeats due to Schedule 2 codeine medication being indicated for cough and colds. In addition, the economic modelling shows that there are 599,000 per annum existing visits to GPs (that is, would have occurred in the absence of the proposed regulatory change) where a script for codeine would be requested. For the latter category it is assessed that this does not increase the time taken to visit the GP by consumers (as they were undertaking a GP visit anyway) but does result in a slight incremental increase in the duration of the consultation because the GP now needs to prepare a script for codeine (it is assessed that no additional time is required by GPs compared to the average consultation for writing a script for codeine for the additional GP appointments). The increase in the time taken by pharmacists to respond to the regulatory change is the net of the two populations (additional GP appointments plus existing GP appointments with a codeine script requested).

The regulatory cost calculations (RBM) for Option 4 is reported in Table D12 of the KPMG Report (2016) in Annex 1, with the regulatory costs presented below in Table 13. When averaged over ten years the total regulatory cost for Option 4 is $10.24 million per annum.

Impacts

Impact on the medicines industry

Current sponsors of Schedule 2 products containing codeine would be required to update their labels to reflect the change from Schedule 2 to Schedule 4. All sponsors would need to complete the required documentation to effect the required change to their ARTG entries.

Consultations with industry stakeholders have indicated that rationalisation of current Schedule 2 products is likely to occur with this regulatory option. Some industry members indicated that Schedule 4 product lines would not be feasible as they currently did not have a prescription medicine arm to their business model. This feedback provided support to the assumptions used in determining the regulatory costs associated with this option.

Impact on consumers and healthcare professionals

The change from Schedule 2 to Schedule 4 would require patients to visit a doctor to obtain a prescription for any product containing codeine. This would result in a slight increase in time for doctors to write out the script. The requirement to see a doctor might generate health gains compared with the existing situation by driving changes in treatment and therapy. However in the case of Schedule 2 these gains are expected to be small and were not quantified in the economic model. There is also projected to be a net reduction in out of pocket expenses for the consumer as a consequence of patients substituting the Schedule 2 medicine with another OTC rather than visit their GP for a prescription.

Impact on the government

Increased visits to general practitioners will result in increased costs to MBS, however patients are also expected to incorporate obtaining a prescription with other visits that would otherwise occur.

The present value predicted additional costs to MBS for option 4 for the period of 2017-2026 is $56.03 million, all relating to GP consultation costs for treatment and source a prescription for low-dose codeine medicine.

Regulatory costs

The average annual regulatory costs (Table 13) for Option 4 are estimated to be $10.24 million per annum when averaged over ten years.

Table 13: Average annual regulatory costs (from business as usual) for Option 4
Change in costs ($million) Business Community organisations Individuals Total change in costs
Total, by sector [a,b] 2.53 0.00 7.71 10.24

a From business as usual; b Change in costs ($millions); Source: KPMG 2016, Table D12

Health costs

Under Option 4, current Schedule 2 entries for codeine in cough and cold medicine preparations would be up-scheduled to Schedule 4. The economic health costs are estimated to be $56.03 million for the period of 2017-2026 (7% discounted), primarily driven increases to MBS for a greater number of GP visists related to treatment and sourcing a prescription.

In addition, consumers will experience out of pocket expenses by purchasing the medicine (time and cost) and seeing their doctor ($7.71 million).

Some key clinical stakeholders noted that the initial increase in the number of people who are additionally treated and experience a health benefit is likely to decline over a few years until the system recalibrates. That is, patients who are currently using low-dose codeine medicines and who, following up-scheduling, will pursue therapeutic pathways that improve health outcomes, are part of a cohort. They will receive additional treatment and care for the following year, but this additional treatment, compared to what they would otherwise have received, will reduce each year. The economic model captures this factor by assuming, in the base case, a 30% annual reduction on previous year's treatment and health gains. This factor was incorporated into the model by using an average (over ten years) number of additional GP appointments (200,000 additional appointments per year for Option 4 and 51,000 additional appointments per year for Option 6). The additional regulatory compliance costs for doctors and pharmacists are likely to occur over the entire ten-year period used for the regulatory modelling, and is predicted to be $2.53 million.

The cohort of consumers changing their behaviour from status quo is likely to reduce over time. These additional health costs should be considered in conjunction with the health benefits provided for this option ($243.95 million) for the same period.

Health benefits

As detailed in the economic model in the KPMG report (2016), some health benefits may be realized by the implementation of Option 4, estimated to be $243.95 million for the period 2017-2026. The requirement to see a doctor would likely generate health gains compared to the existing situation by driving changes in diagnosis and treatment.

Schedule 2 codeine-containing cough and cold preparations represent the smallest subset of OTC codeine-containing medicines on the market. Hence, the up-scheduling of Schedule 2 (cough and cold) medicines to prescription medicines is likely to lead to an increase in awareness of risks associated with codeine due to health practitioner intervention, but on a lesser scale when compared to Option 6. One significant public health benefit is the exploration of alternative treatment pathways for a persistent cough.

Our targeted stakeholder consultations have indicated that product rationalisation is a likely consequence of this regulatory option and therefore may result in less choice of cough and cold preparations. However, noting that consumers appear to be misinformed of the risks, benefits and proper use of these preparations[123], consumers are likely to make an informed choice on how to use such preparations when this information is conveyed to patients at the time of consultation.[124] On this basis, greater awareness of the risks posed by codeine-containing cough and cold medicines may also encourage conversations about the use of such medicines in relieving symptoms.

In isolation, an up-schedule from Schedule 2 to Schedule 4 is likely to have a small positive effect on health benefits for individuals. Indeed, the economic modelling estimated the health benefit to be $243.95 million for the period 2017-2016, a small benefit in comparison to Option 6 ($5,353.17 million). Consumers misusing or abusing codeine-containing medicines in Schedule 2 may shift to Schedule 3 medicines. Hence, for any health benefits to be realised, Option 6 (up-schedule of Schedule 3 medicines to Schedule 4) will need to occur simultaneously with Option 4 to prevent diversion of the misuse problem to Schedule 3 medicines. This is discussed in Scenario 4.

Option 5: Reduce pack size of Schedule 3 and new label warning

Under Option 5 the current Schedule 3 entries for codeine products would be amended to reduce the pack size to not more than 3 days' supply and include a warning label that codeine can cause addiction. The changes and regulatory impacts are summarised in Table 14.

This option will affect 168 ARTG medicine entries (entirely OTC) across 22 sponsors ( Table 4 ).

Table 14: Regulatory impacts of Option 5
Current Proposed change Impact
Distribution model Schedule 3 Schedule 3 Nil
Label Advisory statement for addiction not required New advisory statement Update label
Pack Size 5 days' supply 3 days' supply Reduce pack size
Dosage 12 mg per dosage unit 100 mg per day No formulation change Nil
ARTG, CMI and PI Registered OTC medicine on ARTG Update ARTG OTC entry Updated ARTG entry

Source: KPMG 2016, Table D14

Regulatory cost assumptions

  • As part of industry initiatives several sponsors have recently implemented advisory warnings to warn consumers of codeine addiction. However, some additional labelling changes would likely be required as a result of the reduced pack size. Based on the baseline assumptions, 420 OTC products currently marketed in Australia will be affected.
  • As noted in Option 2, it is estimated that half of the product label updates can be rolled into already planned updates reducing the per product cost by 50% for that segment. Therefore the carry forward figure of 210 labels will need to be updated in addition to BAU labelling activities.
  • Based on BAU costs outlined in Option 1, the label pre-production and production costs are estimated to be $0.88 million.
  • Consultations have identified that roughly 50% of codeine sponsors already produce 3 day packs or have a production line that could accommodate this change across their product portfolio (provided the implementation timeframe is sufficient). These sponsors will not need to implement new manufacturing arrangements for the outer carton (apart from the printing) nor inner blister pack. It is estimated that approximately 11 sponsors will incur costs to change their pack size.
  • It is estimated from industry consultations that up-front costs for the impacted sponsors to implement the required packaging changes is $30,000 per sponsor. This may include re tooling to modify blister pack lengths or reduce packaging depth. It should be noted however, that these costs can vary depending on the location of the manufacturing facility being used. For example, changes can be implemented more quickly in domestic facilities but are more expensive, whereas changes in overseas facilities can be implemented at lower cost, but are subject to longer delays due to competing priorities.
  • Based on BAU costs outlined in Option 1 and the factors listed above, packaging transition costs are estimated to be $0.33 million.
  • The required changes fall under a C1 application level.[125] Based on a review of the applicable forms and consultation with sponsors, it is estimated that 6 hours will be required to prepare and submit the relevant form (including updates to the PI and the CMI). The cost of completing the required form is estimated to be $0.066 million.
  • The regulatory cost calculations (RBM) for Option 5 is reported in Table A15 of the KPMG Report (2016) in Annex 1, with the regulatory costs presented below in Table 15.

Impacts

Impact on the medicines industry

Current sponsors of Schedule 3 products containing codeine would be required to update their labels to reflect the reduced pack size and include a new advisory statement that codeine can cause addiction (less those that already contain this advisory statement – currently voluntary). Current sponsors who do not already have a 3 day pack in their production portfolio would need to implement new manufacturing arrangements. All sponsors would need to complete the required documentation to implement the required change to their ARTG entries.

Impact on consumers and healthcare professionals

Healthcare professionals are not predicted to be impacted by the implementation of Option 5. Due to the reduction in pack size consumers are expected to spend more to maintain current codeine use. Health gains are not predicted as there is not expected to be any change in treatment or therapy for those consumers currently using low-dose codeine when other therapies might be more effective or as effective but with reduced side effects.

Impact on the government

No impact on government operations are expected for this option.

Regulatory costs

When averaged over ten years the average annual regulatory cost (Table 15) for Option 5 is $0.13 million; this net regulatory cost accounts for BAU relabelling that occurs frequently. The total regulatory cost for the period 2017-2026 is $1.3 million.

Table 15: Average annual regulatory costs (from business as usual) for Option 5
Change in costs ($million) Business Community organisations Individuals Total change in costs
Total, by sector [a,b] 0.13 0.00 0.00 0.13

a From business as usual; b Change in costs ($millions); Source: KPMG 2016, Table D16

Health costs

Under Option 5 the current Schedule 3 entries for codeine would be amended to reduce the pack size to not more than 3 days' supply and include a label warning that 'codeine can cause addiction'. The economic health costs are estimated to be $409.87 million for the period of 2017-2026 (7% discounted), primarily driven by the out of pocket expenses to consumers by purchasing the medicine more frequently due to smaller pack size.

Health benefits

Limited health benefits could be realized by the implementation of Option 5, and these would be principally driven by minor changes in consumer buying behaviour due to the label changes and the reduction pack size. Consumers would need to visit the pharmacy more often to source these medicines due to smaller pack size, leading to an increased probability that consumers will be adequately informed of the risks of codeine and provided alternative products for their specific condition. Given the busy pharmacy environment, and the lack of referral pathways associated with pharmacies, these consultations are unlikely to encourage the exploration of alternative treatment pathways that would be required for significant gains in QALYs. As codeine-containing analgesics will remain available OTC, it is less likely that consumers using codeine for chronic pain will seek advice from GPs. Hence further diagnosis and other treatment options, including referral to a pain management clinic or other non-pharmacological interventions, are less likely to be explored.

Schedule 3 codeine-containing medicines represent the largest subset of low-dose codeine medicines on the market. Reducing the pack size of these products is likely to result in modified behaviour in individuals who are dependent on codeine. For example, 'pharmacy shopping' is likely to increase as consumers attempt to source codeine.

As detailed in the economic model, no significant health benefits are likely to be realized by the implementation of Option 5. As noted earlier in the report, the only projected health benefits factored into the economic model arose from improved therapeutic pathways taken by patients who are chronic users of low-dose codeine. For an improved therapeutic pathway to be realized the key enabler was a visit to a GP, which will not occur under this option. Given the level of concern for public health and safety, it is anticipated that this option could not occur in isolation of Option 2 (amend Schedule 2 entries to reduce the pack size to not more than 3 days' supply). This is discussed under Scenario 3).

Therefore, if Option 5 is implemented it is anticipated that individual health outcomes would not improve for consumers who abuse or misuse codeine, and the resulting costs to the health care system over time will increase.

Option 6: Up-schedule Schedule 3 to Schedule 4

Under Option 6, current Schedule 3 entries for codeine would be up-scheduled to Schedule 4 and current Schedule 4 and 8 entries for the Poisons Standard would be amended to reflect this change. The changes and regulatory impacts are summarised in Table 16.

This option will affect 168 ARTG medicine entries (entirely OTC) across 22 sponsors ( Table 4).

Table 16: Regulatory impacts of Option 6
Current Proposed change Impact
Distribution model Schedule 3 Schedule 4 Consumer must see doctor for prescription
Label Advisory statement(s) as per RASML Insertion of 'Prescription Only' medicine Update of label
Pack Size 5 days' supply Not prescribed Nil
Dosage 12 mg per dosage unit 100 mg per day No formulation change Nil
ARTG, CMI and PI Registered OTC on ARTG Register prescription medicine on ARTG ARGPM: Category application (Type G/J) including new PI/CMI + GMP conformity assessment (if required for sponsor)

Source: KPMG 2016, Table D17

Regulatory cost assumptions

  • The packaging options (reduced pack size and mandatory warning statements) are not relevant to Schedule 4 products, as prescription medicines already have packaging restrictions.
  • Up-scheduling Schedule 3 products to Schedule 4 will require sponsors to apply to register a prescription medicine. It is estimated that 50% of current Schedule 3 sponsors will seek to migrate their products to Schedule 4. Further, it is estimated that Schedule 3 sponsors will rationalise their portfolio to two products per sponsor given the challenging commercial realities of the prescription-only market. As there are currently 22 sponsors of Schedule 3 products, the total number of products to be carried forward into the model is therefore 22 medicine products (50% of 22 sponsors (therefore 11 sponsors) and 2 products per sponsor) which will incur costs to update labels. It has been assumed that each product to be up-scheduled relates to a separate ARTG entry.[126]
  • Based on BAU costs outlined in Option 1, the label pre-production and production costs are estimated to be $0.092 million.
  • The required changes fall under a minor variation (Category 3 application) level. Based on a review of the applicable forms, it is estimated that 4 hours will be required to prepare and submit the relevant form. The cost of completing the required form is estimated to be $0.005 million.
  • This analysis has not accounted for reformulation as consultation has indicated there will be no reformulation in response to Option 6 due to costs and potential regulatory barriers to the redeployment of branding.
  • As outlined in Option 4, registered prescription (Schedule 4) medicines have the site of manufacture of the active pharmaceutical ingredient(s) [API] recorded in the ARTG. Moving to Schedule 4 will require more detailed ARTG records for the products, with the addition of the site of manufacture of the API. This is a minor administrative process which can be combined with any other application type (e.g. an application to amend the labels).
  • For new prescription medicines, evidence of Good Manufacturing Practice (GMP) at API manufacturing sites is assessed by the TGA. Schedule 3 sponsors currently self-certify that they are compliant with GMP principles; subsidiary GMP requirements encompass supplier (e.g. API) qualification. The TGA can seek evidence of GMP compliance from sponsors of medicines at any time. Sponsors who already have a related Schedule 4 medicine containing codeine made at the same medicine manufacturing site are assumed to be compliant with API GMP requirements and possess all necessary GMP evidence (it is noted that this applies to 3 of the current 22 Schedule 3 sponsors). In addition, 14 of the remaining 22 Schedule 3 sponsors also have a product in Schedule 2. To avoid double counting with Option 4, it is assumed that only 3 sponsors[127] will incur costs to obtain GMP certification from the TGA. Where Schedule 3 medicines are converted to Schedule 4 medicines on the ARTG due to the up-scheduling of codeine, the TGA may seek GMP evidence. It is estimated that the engagement of GMP professionals, development of documentation, and implementation of staff and managerial processes would cost $34,500 per impacted sponsor.
  • Similarly for new prescription medicines, the manufacturing process and controls for the API(s) are reviewed. Any up-scheduling is a change to a currently supplied medicine: the extent of review at the time of up-scheduling is a matter of judgement. The TGA might require assurances from the sponsor that no changes have been made to the existing Schedule 2 products that would move to Schedule 4, including the API manufacturing site(s). If a sponsor changes API details for these products in the future, the required documentation to demonstrate compliance will be required.
  • It is estimated that the engagement of GMP professionals, development of documentation, and implementation of staff and managerial processes would cost $34,500 per impacted sponsor.
  • The reclassification of Schedule 3 products as Schedule 4 will require that patients visit a doctor to obtain a prescription for any analgesic product containing codeine. This will increase the compliance burden on individuals. As noted in Option 4 this will require 1.33 hours to travel to and from a doctor's, attend an appointment, and then visit a pharmacy to obtain the medicine. As per Option 4, it is also assumed doctors spend an additional 30 seconds to process the prescription for these new visits and that pharmacists will take an additional 1 minute to process the script and talk to the consumer when providing them the medicine.
  • Based on the economic and social impact modelling undertaken for this RIS it is estimated this option will generate an additional average of 51,000 GP appointments per annum over the next ten years. This estimate accounts for the modelled behaviour of consumers in these scenarios (demand side), factors in supply side assumptions, and assumes a maximum of five repeats (therefore up to 6 packs per script). In addition, the economic modelling shows that there are 152,000 existing visits to GPs (that is, would have occurred in the absence of the proposed regulatory change) where a script for codeine would be requested. For the latter category it is assessed that this does not increase the time taken to visit the GP by consumers (as they were undertaking a GP visit anyway) but does result in a slight incremental increase in the duration of the consultation because the GP now needs to prepare a script for codeine ((it is assessed that no additional time is required by GPs compared to the average consultation for the writing of script for codeine for the additional GP appointments). As this option relates to up-scheduling Schedule 3 to Schedule 4 there is assessed to be no additional time required by pharmacists (assuming a 2 minute time interaction for the processing of Schedule 3 transactions).
  • The regulatory cost calculations (RBM) for Option 6 are reported in Table A18 of the KPMG Report (2016) in Annex 1, with the regulatory costs presented below (Table 17).

Impacts

Impact on the medicines industry

Current sponsors of Schedule 3 products with codeine as the active ingredient would be required to update their labels to reflect the change from Schedule 3 to Schedule 4. All sponsors would need to complete the required documentation to effect the required change to their ARTG entries.

Impact on consumers and healthcare professionals

The change from Schedule 3 to Schedule 4 would require patients to visit a doctor to obtain a prescription for any product containing codeine. This would result in a slight increase in time for doctors to write the script. The requirement to see a doctor would likely generate health gains compared to the existing situation by driving changes in treatment and therapy. Also predicted is a net reduction in out of pocket expenses for the consumer as a consequence of patients substituting the Schedule 3 medicine with an OTC rather than visit a GP for a prescription.

Impact on the government

An increase in the number of GP visits will results in an increase in MBS costs. For some patients however, there will be a health gain if they access cost effective therapies, including more suitable prescription medicines or specialist referrals for pain management.

Regulatory costs

The average annual regulatory costs for Option 6 (Table 17) are estimated to be $2.21 million per annum when averaged over ten years. The total regulatory costs for the period of 2017-2026 is $22.10 million (not discounted).

Table 17: Average annual regulatory costs (from business as usual) for Option 6
Change in costs ($million) Business Community organisations Individuals Total change in costs
Total, by sector a,b 0.24 0.00 1.97 2.21

a From business as usual; b Change in costs ($million); Source: KPMG 2016, Table D19

Health costs

Under Option 6, current Schedule 3 entries for codeine would be up-scheduled to Schedule 4. The economic health costs, estimated to be $209.87 million for the period of 2017-2026, are primarily driven by out of pocket expenses for consumers as a result of purchasing the medicine and making an appointment to see their doctor.

Health benefits

As detailed in the economic model, substantial health benefits ($5,353.17 million for the period of 2017-2026, 7% discounted) will be realized by the implementation of Option 6. The only projected health benefits factored into the economic model arose from improved therapeutic pathways including changes in treatment and therapy in patients who are chronic users of low dose codeine medicines. For this improved therapeutic pathway to be realized, the key enabler was a visit to a GP, which is highly likely to occur under this option. It is anticipated that this option could not occur in isolation of Option 4 (Schedule 2 entries would be up-scheduled to Schedule 4). This is discussed under Scenario 4 (p. 93).

Schedule 3 codeine-containing medicines represent the largest subset of codeine-containing OTC medicines on the market. If low-dose codeine-containing analgesics are no longer available OTC in pharmacies, it is more likely that patients using codeine for chronic pain will seek advice from GPs. Hence further diagnosis and other treatment options, including referral to a pain management clinic or other non-pharmacological interventions, are more likely to be explored, and quality of life years (QALY) gains are realised. The broad options for acute and chronic users of Schedule 3 codeine products and their relationship to potential health benefits under Option 6 are illustrated in Figure 5.

The substantial health benefits are driven by the gain in QALY of 9,208 in 2017 as patients receive treatment they would otherwise not have accessed that leads to more effective therapy compared to low-dose codeine combination medicines. This gain is offset by the QALY loss of 134 experienced by a small proportion of clients for whom low-dose codeine combination medicines are the most effective option available to them and who do not attend a GP to obtain a prescription under Scenario 4. This situation was identified by some stakeholders. Systematic reviews indicate[128] that, on average, current acute users and chronic users of low-dose codeine combination medicines who change to OTC only paracetamol and/or ibuprofen will experience no change in pain relief and hence do not experience a QALY loss.

The monetary valuation of a QALY ($182,000) was used to ensure consistency with OBPR guidelines.[129] This resulted in a gain of $1,651.5 million (in 2017) and a gain (present value) of $4,399.5 million over 2017-26. The ten year result is not simply ten times the first year result, as the majority of the QALY gains occur in the first two years as customers pursue different options as a consequence of attending a GP consultation. Stakeholders stated that this initial activity would reduce over time. The model assumes the reduction in the number of patients participating in additional therapy occurs at a rate of 30% per year. (The QALY gained is assumed conservatively to occur only in the year that treatment occurs).

Some health benefits associated with dependent users may not be realised due to abusers of codeine entering into 'doctor shopping' behaviour. However, the potential increase in this type of behaviour may be offset by raising awareness through an education campaign and encouraging best prescribing practices with GPs. Further, dependent users of codeine may divert to other readily available substances (other medicines or illegal substances) to provide relief to their addiction.

The positive net benefit for Option 6 is robust to a wide range of sensitivity analyses, including:

  • Number of deaths prevented;
  • the costs of gaining any quality of life improvements through improved treatment for chronic pain, for example, are increased by 80%; and
  • the quality of life gain from treatment is reduced by 80%.

The variables that net benefit was most sensitive to were the average QALY gain resulting from additional treatment received and the number of repeat scripts. The result was only moderately sensitive to the discount rate, number of deaths prevented, and the co-payment for GP and specialist consultations.

The economic modelling accounts for additional health costs such as out-of-pocket expenses for consumers cost to the MBS through increased GP and/or specialist consultations and the additional costs to the Government (MBS and PBS; see net benefit for scenarios). These health costs are assumed to begin 12 months after a scheduling decision is made.

Figure 5

Figure 5: Option 6 outcomes for acute and chronic users of current Schedule 3 codeine

Acute users are the only consumer group expected to have some users who continue to use low-dose codeine at the same rate over the ten years of the model (Outcome 1.1). This assumption is based on discussions with stakeholders, some of whom indicated that it was unlikely that GPs would continue to prescribe low-dose codeine for chronic users. Stakeholders instead indicated that GPs would likely prescribe higher dose codeine, or a range of other therapeutic options that may not have been otherwise suggested (Outcomes 1.3 and 2.2) had the consumer not seen a GP and instead continued to use OTC low-dose codeine. These are the outcomes that could result in health gains for consumers.

Therefore, if Option 6 is implemented, it is anticipated that individual health outcomes would improve for consumers who abuse or misuse codeine, and the related costs to the healthcare system over time will decrease.

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