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Final decisions amending, or not amending, the current Poisons Standard, April 2018
Scheduling medicines and poisons
1.1 Hyaluronic acid
Part A - Final decisions on matters referred to an expert advisory committee (November 2017)
1. Advisory Committee on Medicines Scheduling (ACMS #22)
1.1 Hyaluronic acid
Delegate's final decision
The delegate's final decision is to amend the Schedule 4 entry for hyaluronic acid as follows:
Schedule 4 - Amend Entry
HYALURONIC ACID AND ITS POLYMERS in preparations for injection or implantation.
Implementation date: 1 October 2019
In view of the public submissions on the interim decision, the delegate has decided to delay the implementation date from 1 June 2018 to 1 October 2019.
The delegate notes the public submissions on the interim decision. However, as no new evidence has been received to alter the interim decision other than reconsidering the implementation date, the delegate has confirmed that the final decision and reasons for the final decision are identical to the interim decision.
Two public submissions on the interim decision suggested that supply of hyaluronic acid to doctors might have to be through a pharmacy, resulting in an increased cost to the patient. Making hyaluronic acid Schedule 4 for all injections or implantation would still allow the product to be directly supplied to the doctor and would not need to go through a pharmacy.
Public submissions on the interim decision
Three (3) public submissions were received that opposed the delegate's interim decision.
The main points opposed were:
- One submission acknowledged the delegate's rationale for the amendment to the Schedule 4 entry for hyaluronic acid to allow alignment with the existing subclause (e) of the Appendix A entry for medical devices. However, the proposal will not bring a positive benefit to the health of the Australian public and will not provide any additional risk reduction for patients. The reasons for the interim decision against the scheduling factors have confirmed the benefits of HA when used for its intended purpose and its lack of risks. Cosmetic or tissue augmentation use has a completely different benefit/risk framework, and is appropriately included in Schedule 4.
- Hyaluronic acid is not a dangerous drug.
- Based on consideration of the scheduling factors, the extensive experience of use in clinical practice and that the majority of supply already goes direct to the treating physician, the current method of product access is appropriate and does not pose any risks to public health that requires further mitigation.
- There was no consultation with stakeholders prior to this proposal being submitted. This step would have provided perspective on experience of use of the product in current clinical practice and an understanding of the impact on supply logistics and communication needs that would warrant a significantly longer transition time than indicated by the proposed implementation date of 1 June 2018.
- The implementation date of 1 June 2018 is unrealistic to allow for supply logistics, appropriate stakeholder communications, pack labelling changes. This could potentially lead to delaying or preventing market access to the products. A period of 12-18 months would be the minimum time period required.
- Hyaluronic acid products have been available for many years in other major markets including the EU, Canada and US. There are no restrictions on supply of the product and no evidence of any risk to public safety as a result of the current means of supply.
- The proposal is inconvenient for patients and may potentially increase costs for patients due to dispensing fees being incurred resulting in delayed access if the product is not routinely held in stock by the pharmacy, increased administrative burden for prescribers, and additional logistic impacts for wholesalers and suppliers.
- The product requires temperature control and currently is shipped from warehouse to temperature controlled clinics. Dispensing the product via a pharmacy to a patient could results in temperatures not being adequately controlled and increases the risk of the product being compromised. This in turn raises concerns for both the safety and efficacy of the product.
- Different hyaluronic acid products on the market are manufactured differently. Some products contain animal proteins that can cause adverse reactions to people who have allergies to avian products. There are concerns that these products may be perceived as biosimilar and may be substituted in the pharmacy.
The interim decision for hyaluronic acid was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 - 1.1. Hyaluronic acid.
The pre-meeting scheduling proposal for hyaluronic acid was published on the TGA website on 6 September 2017 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2017.