Context
On 1 October 2015, the Therapeutic Goods Administration (TGA) published an Interim Decision by the medicines scheduling delegate (the delegate) to adopt the proposal that all medicines containing codeine currently available over-the-counter (Schedule 2 and Schedule 3) be up-scheduled to Schedule 4, prescription-only medicines. See the TGA website for further detail regarding this decision, including the reasons for the decision.
The TGA undertook a series of public consultations regarding the interim decision, as well as seeking comment on alternative courses of action. Subsequently, on 19 November 2015, the Delegate announced that a final decision on the rescheduling of codeine would be deferred to allow a more thorough consideration of the numerous submissions and broader implications to current products in the market. See the TGA website for more information regarding this decision.
The TGA will be undertaking a regulatory impact review and producing a Regulation Impact Statement (RIS). To assist with production of the RIS, on 2 August 2016, TGA engaged KPMG to undertake economic, social and regulatory impact modelling on the range of codeine scheduling options as developed through the public submission process. The KPMG modelling will be provided to the TGA in late August 2016 to support the development of the RIS.
KPMG is engaging with codeine sponsors to better understand the potential impacts on industry, understand potential implementation considerations and inform the development of modelling to support the development of a RIS.
Scenarios
Formally, the options being considered for the purposes of constructing the RIS are presented in a step-wise manner, as follows:
| Option 1 | No change - the current scheduling of codeine remains appropriate. |
|---|---|
| Option 2 | The current Schedule 2 entry for codeine in cough and cold medicine preparations be amended to reduce the pack size to not more than 3 days' supply and include a label warning that codeine can cause addition. |
| Option 3 | The current Schedule 2 entries for codeine in cough and cold medicine preparations be up-scheduled to Schedule 3, and that the pack size be reduced to not more than 3 days' supply, and include a label warning that codeine can cause addiction. |
| Option 4 | To up-schedule the current Schedule 2 entries for codeine to Schedule 4 and amend the current Schedule 4 and 8 entries. |
| Option 5 | The current Schedule 3 entries for codeine (including, but not limited to codeine containing analgesics) be amended to reduce the pack size to not more than 3 days' supply and include a label warning that codeine can cause addiction. |
| Option 6 | To up-schedule the current Schedule 3 entries for codeine to Schedule 4 and amend the current Schedule 4 and 8 entries. |
In practice, these options could result in the following scenarios:
|
Scenario 1 (Option 1) |
No change to the status quo. |
|---|---|
|
Scenario 2 (Options 2 and 5) |
Schedule 2 and Schedule 3 entries for codeine (including, but not limited to, cough and cold medicine preparations and codeine containing analgesics) be amended to reduce the pack size to not more than 3 days' supply and include a label warning that codeine can cause addition. Summary
|
|
Scenario 3 (Options 3 and 5) |
The current Schedule 2 entries for codeine in cough and cold medicine preparations be up-scheduled to Schedule 3, and then all Schedule 3 entries (i.e. those currently Schedule 2 and those previously Schedule 2) for codeine (including, but not limited to, cough and cold medicine preparations and codeine containing analgesics), be amended to reduce the pack size to not more than 3 days' supply, and include a label warning that codeine can cause addiction. Summary
|
|
Scenario 4 (Options 4 and 6) |
Schedule 2 and Schedule 3 entries for codeine (including, but not limited to, cough and cold medicine preparations and codeine containing analgesics) be up-scheduled to Schedule 4. Summary
|
Topic 1 – Product strategy
- How would your product strategy respond to an up-scheduling decision (i.e. Scenarios 3 or 4)?
- Would you rationalise your codeine portfolio?
- Would the current S2 and S3 product lines be reformulated?
- Would you substitute this share of the market with non-codeine containing S2 and S3 products and/or increased production of S4 product lines?
Topic 2 – Market response
- (Contextual) How is the market for your S2 and S3 codeine products composed; i.e. principally individual patients or does this also include bulk institutional customers?
- What are the anticipated impacts on demand for your products in the following scheduling scenarios? Consider impacts to individual patients (including different types of patients, i.e. acute / chronic users, dependent / non-dependent etc.), prescribers, institutional customers, and any other relevant demand groups.
- Scenario 3 (S2 up-scheduled to S3)
- Scenario 4 (for S2 up-scheduled to S4)
- Scenario 4 (for S3 up-scheduled to S4)
- In the case of a rescheduling decision (i.e. Scenarios 3 and 4), what segment of patients currently consuming your codeine-containing S2 and S3 product lines do you anticipate will substitute these for other, non-codeine containing S2 and S3 products (rather than seek a prescription for the S4 products?)
- Are there any other market responses that you are anticipating?
Topic 3 – Reduced pack sizes
- (Contextual) How are changes to your packaging (outer and inner) implemented for your products?
- In terms of physical pack sizes, what would be required to conform with a decision regarding limiting pack sizes to no more than three days' supply?
- Does this differ for types of packaging for all codeine containing products, i.e. blister pack inserts and boxes, liquid preparations, tablet bottles etc.?
- Do you have product lines currently in production that would meet the reduced pack size requirements, i.e. through placing a reduced number of blister pack inserts in existing boxes?
- What upfront costs would be incurred to implement changes in outer or blister packs per ARTG listing? (Either in dollar terms or FTE resources.)
- What are the timeframe involved in making these changes?
Topic 4 – New warning labels
- (Contextual) How are changes to labelling (outer and, where required, inner) implemented for your products?
- What would be required to conform with a decision regarding mandatory warning labels?
- Consider for all types of packaging for all codeine containing products, i.e. blister pack inserts and boxes, liquid preparations, tablet bottles etc.
- Consider all key steps in the process (i.e. design, manufacture, printing etc.), including which of these are managed internally and which are outsourced.
- What upfront costs would be incurred? (Either in dollar terms or hours of FTE resources.)
- What are the timeframes involved in making these changes?
Topic 5 – Updated listings
- How many hours or FTE resources would usually be required to complete and submit an ARTG change application to the TGA?
- If required under the decision made, would you anticipate creating a new PI/CMI (i.e. 'from scratch') or copying and modifying an existing PI/CMI as needed?
- How many hours or FTE resources would usually be required to undertake this task?
- What are the timeframe involved in making these changes?
- If S2 and S3 product lines were up-scheduled to S4 (i.e. Scenario 4), would you seek reimbursement under the PBS?
- If so, what costs would be incurred as a result? (Either in dollar terms or FTE resources.)
Topic 6 – Implementation timeline
(Contextual) Consideration has already been given (above) to timeframes required for changes to pack size, labelling, and updating listings.
- Please indicate any other key considerations in relation to a projected implementation timeline.