TGA closes loophole on hyaluronic acid injections

The TGA has scheduled hyaluronic acid for intra-articular injection as a prescription medicine, closing a loophole that meant products used to treat arthritis were regulated as medical devices.

In its latest round of re-scheduling decisions, the TGA’s Advisory Committee on Medicines Scheduling announced that the Schedule 4 listing for hyaluronic acid would be amended to add “for intra-articular injection” to the existing indications of tissue augmentation, cosmetic use and for treatment of animals.

The committee noted that products containing hyaluronic acid designed for use as an intra-articular injection to treat knee osteoarthritis in humans were not specifically noted in the Schedule 4 listing for hyaluronic acid.

According to the Australian Register of Therapeutic Goods (ARTG), such products were regulated as medical devices, which were usually exempt from scheduling.

“Prescriptions are not used for these types of devices, as the product is not supplied directly to the patient but rather to a health care professional who would then directly administer it to the patient,” the TGA noted.

In its assessment, the TGA commented that hyaluronic acid posed little risk when used as recommended and had potential benefits for people not responding to other standard treatments for knee osteoarthritis and also those awaiting joint replacements.

“It is a one-off treatment lasting for six-nine months rather than having to take increased quantities of pain medication daily. The associated risks of this are especially so in the older population.”

It therefore decided to classify products for intra-articular injection as prescription only (Schedule 4), with an implementation date of 1 June 2018, the advisory committee noted.

A recent meta-analysis of eight randomised controlled trials involving almost 2200 patients with knee OA found a “modest but real” benefit of intra-articular hyaluronic acid. However NSW rheumatologist Dr David Hunter recently told thelimbic that he believed much of the benefit was a placebo effect, and the treatment was not widely recommended in guidelines

Products such as Synvisc-One (Sanofi) are currently offered by many sports medicine and orthopaedic specialists as a course of three weekly injections. It is not listed on the PBS and can cost around $500 for a course.

Product information for Synvisc One specifies that it can only be ordered by patients after consultation with a doctor and be delivered to a medical practice’s delivery address.

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