Outcomes Register – Active ingredient prescribing

Trade names Ozempic® and Wegovy®

The sponsor asked that the decision made by the Australian Commission of Quality and Safety in Health Care’s advisory group in October 2022, that semaglutide does not meet principles for inclusion in either list, is re-considered. 

The AIPWG did not have sufficient detail as to why the sponsor is requesting a re-consideration of the Commission’s decision. The Department will clarify with the sponsor it’s reasons for reconsideration against published principles.

Trade name Aci-Jel® Balance Vaginal Gel 

Product is available through the RPBS under ‘other gynecologicals’. There are similar items listed in the LEMI for practicality. 

Trade name Orabase® 

Product is available through the RPBS under ‘emollients and protectives’. There are similar items listed in the LEMI for practicality. 

Semaglutide products were reconsidered in July AIPWG. Trade names, Ozempic® and Wegovy® have different devices, i.e., multi use and single use pens and

for different indications, i.e., weight loss and diabetes

There is a risk of confusion and patient safety

Include in LMBC on basis of principle 8, differences in administration/delivery devices

Include in LMBC

Ciclosporin eye drops 

Available in  0.09%, 0.1%, 0.05%

Trade names Cequa®, Ikervis®, Restasis®

Confusion can occur while prescribing and dispensing.

Include in LMBC on basis of principle 7, similarity of active ingredient names

Trade name: Bijuva® 1/100

There is potential for confusion with other hormone replacement therapy (HRT) products.

All hormonal contraceptive pills are on LMBC

Trade name: Angusta®

There is a risk of confusion between misoprostol brands. Other higher strengths, misoprostol 200mcg products, Cytotec and Gymiso, are already on LMBC

Angusta® meet principle 7, similarity of active ingredient names

Include in LMBC

Lenalidomide capsule

and pomalidomide capsule

Each company/brand are having a separate risk management program, to ensure that pregnant women are not prescribed or supplied the medicine.

At its out of session October 2022 meeting, the Pharmaceutical Benefits Advisory Committee recommended that bioequivalent brands of lenalidomide and equivalent brand of pomalidomide should not be considered equivalent for the purposes of substitution on the PBS for practicality reasons. (Not ‘a’ flagged)

Lenalidomide and pomalidomide meet principle 9, Highly Specialised Drugs.

Include in LMBC 

Trade names: Estalis Continuous 50/140 and Estalis Continuous 50/250

Estalis Sequi 50/140 and 50/250 are on LMBC.

Estalis continuous 50/140 and 50/250 have same active ingredient and within the same product range of Estalis Sequi that can be confused with. 

Trade name: Femoston-Conti

Femoston 1/10 mg and 2/10 mg tablets are both on the LMBC

Femoston-Conti has same active ingredient and within the same product range of Femoston that can be confused with.

Trade names: Diprosone ointment and cream

Eleuphrat ointment and cream

Diprosone OV ointment and cream are on the LMBC.

Diprosone  and Eleuphrat ointment and cream has same active ingredient and within the same product range of Diprosone OV that can be confused with.

Trade names: Symbicort Turbuhaler, Rilast Turbuhaler, Biresp Spiromax and Duoresp Spiromax

Spiromax® and Turbuhaler® devices are both dry powder inhalers but they are designed differently and have different instructions for use

200 microgram-6 microgram strength of these inhalers is on the LMBC

Delivery device continuity required

Trade names: Amphotericin Liposomal RAN, Amphotericin Liposomal RBX and Amphotericin Liposomal SUN

AmBisome amphotericin B (liposomal amphotericin 50 mg) and Amphotericin B Mylan (amphotericin B 50 mg) are on the LMBC. Rules apply to all TGA registered brands of amphotericin 

Trade names: Levothox, Levothyroxine Sandoz, Levothryoxine GH, Thyrox,  

Oroxine, Eutroxsig, Levoxine and Eltroxin are on the LMBC

Rules apply to all TGA registered levothyroxine brands

Trade names: Mycophenolic Acid ASTRON, Mycophenolic acid INTAS, Mycophenolic acid Accord, Mycophenolic acid ARX

Myfortic brand of mycophenolate mofetil 180 mg and 360 mg enteric coated tablets is also available on the LMBC

Rules apply to all TGA registered Mycophenolate brands

Abiraterone acetate 125mg and

methylprednisolone 4 mg tablet

Trade names: Yonsa Mpred

Rules apply to only the TGA registered Yonsa Mpred brand. 

Availability of the single and composite pack may cause confusion. 

Trade names: Fleet Ready-To-Use enema

Rules apply to all TGA registered Fleet brands

Does not meet principles for inclusion in the LEMI; recommended to be included in LMBC.

Trade names: Actonel EC Rules apply to only the TGA registered Actonel EC brand

Differences in release characteristics between brands with the same active ingredient and strength. 

Betacarotene 0.0002 g +

Ispaghula Husk Dry 3.5 g sachet

Trade names: Fybogel

Apart from the product being an RPBS item, no other principles were met for inclusion in the LEMI. There are no patient safety risks. 

Psyllium Husk Powder 3.4g/7 g powder for oral liquid, 504 g

Trade names: Metamucil Natural Granular 

Apart from the product being an RPBS item, no other principles were met for inclusion in the LEMI.

There are no patient safety risks

Trade names: OsmoLax

Apart from the product being an RPBS item, no other principles were met for inclusion in the LEMI.

There are no patient safety risks.

Trade name: Slenyto

Different formulation exists for different indications, with the same strength (Voquily immediate release capsules 5mg indicated for children 6-18 years while Slenyto prolonged release tablet 5 mg is indicated for children 2 – 18 years). The active ingredient of melatonin meets the principles for inclusion in the LMBC - different formulation, same active, different indications or dosing regimens or different release characteristics.