Prescription Medicines Reforms Medsearch App, PI Reformat, Priority Review, Provisional Approval Black Triangle Scheme and Orphans Adrian Bootes Assistant Secretary, Prescription Medicine Authorisation Branch, Department of Health 2017 Pharmaceutical Society of Australia Conference 30 July 2017
MedSearch™ The trusted source of medicine information in Australia • FREE app available from June 2017 • Consumer Medicine Information (CMI) or Product Information (PI) document • Sources directly from the Australian Register of Therapeutic Goods (ARTG) Prescription Medicines Reforms
MedSearch™ features Quickly access prescription medicine information from your phone: • Simply search the medicine name to find its CMI or PI • Favourites – bookmark medicine information in one place • Save medicine info documents and view them anytime • Share CMI/PI documents with family and carers Connects consumers, carers, doctors, nurses and pharmacists to trusted and current information about their prescription medicines
Changes to the Product Information (PI) • From January 2018 all new medicines will have a revised format that provides the important product information at the beginning of the PI, such as: • Indications • Contraindications • Warnings • Adverse events • Transition to this new format will be over 3 years • Medicines with new PI information – such as extension of their indication, new safety information - will be available in the new format • By end 2020 all medicine PIs will be in the new format 3 Prescription Medicines Reforms
Expedited pathways • Two new ‘expedited’ pathways for prescription medicines based on the government response to the recommendations of the MMDR review: • Priority Review of a complete data dossier within a reduced timeframe in certain circumstances (implemented in July 2017) • Provisional Approval on the basis of early data on safety and efficacy, where the immediate availability of the medicine outweighs the risk that more data is required (under development) • The key objective of the expedited pathways is to facilitate earlier access to medicines that address unmet clinical needs for Australian consumers, without compromising our standards for safety, efficacy and quality 4 Prescription Medicines Reforms
Eligibility criteria The medicine is a new prescription medicine or a new indication High level eligibility criteria for Priority Review and Provisional Approval: • serious condition • major therapeutic advance • comparison against existing therapeutic goods Eligibility for: • Priority Review will be based on ‘substantial evidence’ Provisional Approval based on ‘promising evidence from early clinical data ’ • Prescription Medicines Reforms
Priority Review • Introduced on 1 July 2017 through legislative and regulation amendments • New and flexible business processes to reduce the timeframe for assessing certain medicines with a full data dossier • Target of 150 working days for the registration process consistent with benchmarks set by international regulators • It is a ‘partnership’ and exit pathways to a standard pathway exist if the sponsor does not meet requirements for Priority Review • Full registration in the Australian Register of Therapeutic Goods (ARTG) Prescription Medicines Reforms
Priority Review Implementation Plan • Amendments to the Therapeutic Goods Act changes passed on 19 June 2017 June • TGA started to accept notifications of the intent to file/lodge for Priority Review designation applications or requests for pre- designation meetings • The new Priority Review regulation came into effect (1 July) July • TGA published Priority Review guidance prior to 1 July 2017 • TGA provides a new designation application e-form • TGA starts to accept Priority Review designation applications • First designation decisions under the Priority Review designation process are possible • Earliest opportunity to lodge Pre-submission Planning Form (PPF) with valid Priority Review designation Aug/Sep • TGA starts to accept submissions for registration with valid Priority Review designation for priority evaluation • Ongoing monitoring of the number of submitted designation applications and decision outcomes and the time from designation application lodgment to decision Dec • The impact of changes will be reviewed considering designation application numbers, designation outcomes and stakeholder July feedback. The guidance material will be reviewed and updated if required 2018 7 Prescription Medicines Reforms
More information on our website Priority Review: https:/ /www.tga.gov.au/priority-review-pathway- prescription-medicines 8
Provisional Approval pathway Provisional Approval is currently scheduled to be implemented in the first quarter of 2018 (subject to necessary legislative amendments) and will involve: • Allowing the TGA to provide provisional registration on the ARTG in the initial absence of full clinical data on safety and efficacy • Provisional registration granted for a specified period of time (currently proposed 2 years with a maximum of 2 extensions of 1-2 years each) • Sponsors will be required to collect and submit further clinical data to demonstrate efficacy and safety in order for the product to be granted full registration • Enhanced post-market monitoring and surveillance • Provisional registration will be subject to the provision of clear advice to consumers and healthcare professionals and any other conditions imposed by the TGA 4 Prescription Medicines Reforms
Outlook - Provisional Approval pathway • We recently conducted public consultation on the implementation arrangements for the proposed Provisional Approval pathway • Consultation outcomes will be published on the TGA website shortly • Stakeholder feedback will inform legislative amendments and TGA business processes • Further targeted consultation will be undertaken with industry on draft guidance for the Provisional Approval pathway later in 2017 • We will also work closely with consumer and healthcare professional representative groups to ensure appropriate messaging about provisionally registered medicines 4 Prescription Medicines Reforms
Other reforms - Orphan Drug Program The objective of the orphan drug program is to provide an incentive to sponsors to bring medicines for a small population to market and make medicines available to patients who would not otherwise be able to access them. • EMA alignment What’s changing? • Prevalence • New criteria • Designation validity • Transition period • Two pathways • Documentation Prescription Medicines Reforms 11
New dosage form medicine pathway An orphan designation for a medicine that is a new dosage form : • Life-threatening or seriously debilitating condition • Not financially viable • No refusal to approve overseas • Comparison against existing goods Definition of new dosage form: • has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register • has an indication in common with that other medicine does not have the same dosage form as that other medici ne • Benefits small patient populations, e.g. paediatrics
Criteria comparison Criteria Priority review Standard orphan New dosage form medicine orphan Life threatening or seriously debilitating Comparison against existing therapeutic goods Major therapeutic advance Prevalence threshold (now 5/10,000) OR Not financially viable Medical plausibility Prescription Medicines Reforms
More information on our website https://www.tga.gov.au/orphan-drug-program-reforms 14
Black Triangle Scheme • Provides a simple means to identify new medicines • Encourages the reporting of adverse events associated with their use • The symbol and text will appear on the PI and CMI, and TGA-related materials PI: ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events. CMI: CMI: ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. 15 Prescription Medicines Reforms
Black Triangle Scheme – inclusion criteria • All new medicines, except: • Biosimilars • Seasonal influenza vaccines • Medicines with a provisional extension of indications • Extensions of indication into significantly different conditions or patient groups may be included • example. from an oncology to rheumatology indication Prescription Medicines Reforms 16
Black Triangle Scheme • Provides a simple means to identify new medicines • Encourages the reporting of adverse events associated with their use • The symbol and text will appear on the PI and CMI, and TGA-related materials PI: ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events. CMI: CMI: ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. 17 Prescription Medicines Reforms
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