Opioid reforms: information for sponsors

Nearly 150 people are hospitalised in Australia every day as a result of the adverse effects of opioids.

The TGA is implementing reforms to reduce harm to patients while providing continued access to this important class of medicines where it is medically necessary.

These reforms are:

• tightening the indications (therapeutic uses) for fentanyl patches to:
  • For the management of pain associated with cancer, palliative care, and other conditions in opioid-tolerant patients where:
    • other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and
    • the pain is opioid-responsive, and
    • severe enough to require daily, continuous, long term opioid treatment.
  • Not for use in opioid-naïve patients.
• tightening the indications for immediate release products* to:
  • [Product] is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.
• tightening the indications for modified release products* to:
  • [Product] is indicated for the management of severe pain where:
    • other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and
    • the pain is opioid-responsive, and
    • requires daily, continuous, long term treatment.
  • [Product] is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.
  • [Product] is not indicated as an as-needed (PRN) analgesia.
  • Not for use in opioid naïve patients. (Hydromorphone and fentanyl patches only)
• requiring sponsors to add a boxed warning and class statements to their Product Information (PI) documents;
• introduction of smaller pack sizes for certain immediate release opioids; and
• updates to Consumer Medicine Information (CMI) to align with the revised Product Information.

*Some sponsors of products that already have appropriately tight indications may not be required to make changes.

More information about these reforms, including the consultation undertaken and how they were developed, is available on the prescription opioids hub.

Implementation

Implementation of the reforms started in October 2019 and will finish in 2021.

We will write to all innovators in December 2019 requesting they update product indications and include the boxed warning and class statements.

We will write to generic sponsors throughout 2020 with the same requests to align Product Information with that of the innovator products.

We will write to those sponsors affected by pack size changes in early 2020.

Sponsors: what you need to do

Key steps for affected sponsors during initial implementation are:

• Receipt of a letter from TGA advising you of required changes for each product
• Submission of the appropriate application, or applications, to address the required changes (see below).

Lodging opioid reforms applications

Opioid reforms applications are lodged via our standard pathways for varying register entries or the Category 1 application process. You may lodge an application in response to a request from TGA as a stand-alone application, or bundled with other applications.

However, the way you lodge these applications may impact on eligibility for the fee waiver or refund incentive as set out in the fee waiver or refund section below.

You are requested to identify an opioid reform application whether it is lodged by itself or bundled with other applications. 

Include:

• opioid reforms application and the type of change you are seeking in the cover letter; AND
• include the following text in the comment section of the variations e-form, OR section 1.4 of the Pre-submission Planning Form under the heading 'Overview of the Application'
  • This SRR application is at the request of SIU-PSAB relating to Opioid Reforms (PSAB Issue No.: XXXX; TRIM Ref.: XXX-XXXXXX)
• the opioid reforms specific code 'PM-OP-19-1', in the submission number element within the XML envelope of the eCTD or NeeS application. This should be included in addition and on a separate line to the application number as the envelopes are designed to accommodate multiple submission number tags. For example: <submission-number>PM-2019-xxxxx-1-1</submission-number>

Extension of the fee waiver or refund period

There has been a fee-waiver or refund for applications that are made in response to changes requested as part of the opioid reforms, in the circumstances given below. The Therapeutic Goods Regulations 1990 include provisions for waivers of fees (Reg 45). This incentive applies to affected sponsors and was initially available until 31 December 2020.

Through an amendment in the Therapeutic Goods Regulations 1990, the fee waiver period has been extended for an additional 12 months and it will continue until 31 December 2021.

A fee waiver or refund will apply where:

• the applicant is only seeking (has sought) a change that directly relates to the reforms, as requested by TGA and has not bundled any other applications as part of the submission; and
• the application was lodged on or after 15 December 2020 and before 31 December 2021.

As per standard billing processes, your company will still receive an invoice for an application relevant to all changes, including those exclusively relating to prescription opioid reforms. We ask you to inform your billing department to withhold payment of this invoice as a subsequent credit note will be generated and provided to the sponsor which will nullify the invoice (i.e. the TGA will not be seeking payment of this invoice). If your organisation did proceed to pay an invoice and your application is eligible for a refund, you would be contacted by the Application Entry Team.

Pack size review

The pack size review concluded that a number of existing pack sizes for immediate release opioids used following an acute episode of care frequently exceed the clinically necessary amounts. Generally, patient need for opioids following an acute episode have decreased by day two or three, with pain subsequently adequately managed by non-opioid products. There is a risk that the remaining, unused opioids will either be inappropriately re-used by the patient, or people known to them, or could be diverted to other inappropriate uses via theft.

Only some opioid sponsors will be requested to register additional pack sizes, in cases where an appropriately small pack sizes is either not registered or not marketed. More information regarding changes required for individual products will be published as it is finalised.

Consumer Medicine Information (CMI)

It is the responsibility of sponsors to ensure that safety information, including the relevant warnings, is prominently displayed in the Consumer Medicine Information (CMI) to ensure consistency of language and information across all classes of prescription opioids.

The documents must be lodged in the TGA eBusiness Services system. Information on how to lodge these documents is available at www.ebs.tga.gov.au. The documents must be in text PDF format – scanned PDF documents will not be accepted by the system.

More information

Visit our prescription opioid hub for more information.

Contact: opioidreforms@health.gov.au if you have further questions.