Insulin glargine 100 IU/mL injections: PBS listing changes

• On 1 January 2020 a new brand of insulin glargine 100 IU/mL formulation was listed on the PBS General Schedule
  It is available in two delivery methods: prefilled disposable injector pen (Optisulin Solostar) and cartridges for use in reusable injector pens (Optisulin).

• From 1 July 2020 Lantus Solostar and Lantus insulin glargine 100 IU/mL products will be unavailable on the Australian market and, as a result, delisted from the PBS
  Patients using either of the two Lantus products have until 1 July 2020 to transition to another insulin glargine injection.

• When Optisulin Solostar was listed on 1 January 2020 it was added to Lantus Solostar and Semglee as an ‘a’ flagged medicine
  Optisulin Solostar, Lantus Solostar and Semglee (a biosimilar) are marked as equivalent for the purposes of substitution by pharmacists at the point of dispensing.

• When Optisulin was listed on 1 January 2020, it was ‘b’ flagged on the PBS General Schedule with Lantus
  Optisulin and Lantus are the same formulation of insulin glargine 100 IU/mL, using the same cartridges for reusable injector pens.

Optisulin

On 1 January 2020, a new brand of insulin glargine 100 IU/mL formulation was listed on the Pharmaceutical Benefits Scheme (PBS) General Schedule (Section 85).¹

It is listed as an insulin glargine 100 IU/mL formulation using two delivery methods:^2,3

• insulin glargine 100 IU/mL (Optisulin SoloStar) prefilled disposable injector pen
• insulin glargine 100 IU/mL (Optisulin) cartridges for use in the AllStar, JuniorStar and ClikStar reusable injector pens.

Lantus

From 1 July 2020, the Lantus brand of insulin glargine 100 IU/mL formulation will be delisted from the PBS General Schedule.¹

Until then, it is listed as an insulin glargine 100 IU/mL formulation using two delivery methods:

• insulin glargine 100 IU/mL (Lantus SoloStar) prefilled disposable injector pen
• insulin glargine 100 IU/mL (Lantus) cartridges for use in the AllStar, JuniorStar and ClikStar reusable injector pens

Optisulin SoloStar, Lantus Solostar and Semglee are ‘a’ flagged medicines

On 1 January 2020, Optisulin Solostar was added to Lantus Solostar and Semglee as an ‘a’ flagged medicine on the PBS General Schedule. They are marked as equivalent for the purposes of substitution by pharmacists at the point of dispensing.^1,4,5

Semglee, a biosimilar medicine, has been listed and marked as equivalent for the purposes of substitution for Lantus Solostar on the PBS since 1 October 2019.⁶ Optisulin SoloStar is the same formulation and delivery device as Lantus SoloStar (prefilled disposable injector pen).^7,8

Optisulin and Lantus ‘b’ flagged

On 1 January 2020, Optisulin was listed with Lantus as ‘b’ flagged medicines and marked as equivalent for the purposes of substitution by pharmacists at the point of dispensing on the PBS General Schedule.^1,4

Optisulin is the same formulation and delivery device as Lantus (cartridges for reusable injector pen devices).⁸

Read more about ‘a’ flagging and ‘b’ flagging.

See the PBS website for complete details about each item.

Semglee is a biosimilar medicine. It was listed, and marked as equivalent for the purposes of substitution with Lantus Solostar, on the PBS General Schedule on 1 October 2019, following a positive recommendation for listing at the July 2018 meeting of the Pharmaceutical Benefits Advisory Committee.^6,10

The manufacturer of Lantus products announced last year that, with the ongoing shift in Australia to more biosimilar, generic and second brand medicines, it would launch a second brand medicine of insulin glargine 100 IU/mL, Optisulin, on 1 January 2020.⁷

It also decided that from 1 July 2020 all Lantus products will be taken off the market in Australia for commercial reasons, according to the Therapeutic Goods Administration (TGA) Medicine Shortages Information Initiative.¹¹

In anticipation of the removal of Lantus products from the Australian market on 1 July 2020, their delisting from the PBS General Schedule was set for the same date. The Optisulin products were listed on the PBS General Schedule as a new brand of an existing pharmaceutical item because they are the same formulation and use the same delivery devices as the Lantus products.^7,8

Transition until 1 July 2020

On 1 January 2020, a 6-month period commenced for prescribers to transition their patients from Lantus products to other insulin glargine products by 1 July 2020. During this period patients will be able to use up their remaining prescriptions and see their healthcare providers for new prescriptions.^7,8

The PBS-listed options for patients using Lantus Solostar are Optisulin Solostar or Semglee. For patients using Lantus, there is only one option, Optisulin.^1,4

Optisulin SoloStar

Optisulin SoloStar is the same formulation and its prefilled disposable injector pens use the same delivery method as Lantus SoloStar.^7,8

No dose adjustments are required when transitioning from Lantus SoloStar insulin glargine to Optisulin SoloStar insulin glargine.^7,8

Semglee

Semglee is considered bioequivalent to Lantus and non-inferior in terms of both efficacy and safety.¹⁰ Like Optisulin SoloStar and Lantus Solostar, it is administered using a prefilled disposable pen.⁵

Optisulin

Optisulin is the same formulation and its cartridges for reusable injector pens are the same as Lantus.^7,8 Optisulin cartridges can be used in the AllStar Pro, JuniorStar and ClikStar reusable injector pens.^2,7,8

No dose adjustments are required to transition from Lantus insulin glargine cartridges to Optisulin insulin glargine cartridges.⁸

Active ingredient prescribing

On 31 October 2019, active ingredient prescribing regulations were introduced by the PBS under the National Health Act 1953. Active ingredient prescribing is part of a wider government strategy to ensure consistent and standardised medicines information.¹²

Active ingredient prescribing aims to:¹²

• ensure the identification of active ingredient names on all PBS prescriptions
• increase patient understanding of the medicines they are taking
• promote the uptake of generic and biosimilar medicines.

Under the regulations, prescribers:¹²

• are required to include the active ingredient on all PBS prescriptions (excluding handwritten prescriptions, paper-based medication charts in residential aged care settings, and medicines with four or more active ingredients).
• can include a brand after the active ingredient on a prescription, if the medicine prescribed is likely to pose a patient safety risk if the brand is not specified to ensure medicine continuance where a patient is familiar with a particular brand of their regular medicine.

A 12-month transition period has been arranged to ensure prescribers have sufficient time to update prescribing software to versions which meet the new active ingredient prescribing requirements.¹²

Patients should be advised that:

• from 1 July 2020, the Lantus brand of insulin glargine 100 units/mL will no longer be on the market in Australia nor available on the PBS,
• other insulin glargine 100 units/mL products are currently available on the PBS, and
• they have until 1 July 2020 to transition to another product.

During the transition, patients should be instructed to use up their remaining supply of Lantus or Lantus SoloStar as usual, before starting the new insulin glargine product that they have chosen together with their prescriber.

Choosing and using another insulin glargine product

Here are some discussion points that prescribers who are helping patients transition from Lantus to another insulin glargine product may wish to cover.

If you have been using Lantus SoloStar prefilled disposable injector pen

• You can choose to start using Optisulin SoloStar or Semglee.
• Lantus SoloStar and Optisulin SoloStar are produced by the same manufacturer, using the same manufacturing process.⁷
• Semglee is a biosimilar. This means it has been assessed by the TGA as ‘highly similar’ (biosimilar) and equivalent to Lantus SoloStar.^10,13 This means that Semglee is as safe and effective as Lantus SoloStar and Optisulin SoloStar, and provides the same health outcomes.¹⁰
• Semglee uses a prefilled disposable injector pen.⁵
• If you agree to transition to Semglee, your pharmacist may offer Semglee instead of Lantus SoloStar on your current prescription, before Lantus products go off the market.^4,10
• Your pharmacist may not substitute a medicine if your prescribing doctor has ticked the ‘brand substitution not permitted’ box on the prescription.¹⁴
• No dose adjustments are required when you transition from Lantus SoloStar insulin glargine to Optisulin SoloStar insulin glargine.⁸

If you have been using Lantus cartridges in a reusable injector pen

• You can choose to transition to Optisulin.
• Optisulin insulin glargine cartridges for reusable injector pens are the same as Lantus cartridges.⁸
• The cartridges can be used in the AllStar Pro, JuniorStar and ClikStar reusable injector pens.^2,8
• No dose adjustments are required when you transition from Lantus insulin glargine cartridges to Optisulin insulin glargine cartridges.⁸

If you have been using Semglee prefilled disposable injector pen

• If you have been using Semglee prefilled disposable injector pen, you can continue using this product as before without any need to change anything.

Discuss the Optisulin, Lantus or Semglee Consumer Medicine Information (CMI) leaflet with the patient.

• Community pharmacists have a role in patient education about PBS listing changes and biosimilar medicines.
• Check that the patient has been informed about the Lantus delisting from the PBS and removal from the Australian market, and the need to transition to another insulin glargine 100 IU/mL product.
• Check if the ‘brand substitution not permitted’ has been ticked on the patient’s prescription.
• If the ‘brand substitution not permitted’ has been ticked, dispense the brand specified on the prescription.
• If the ‘brand substitution not permitted’ has not been ticked, inform the patient that a biosimilar insulin glargine is available for substitution.
• If the patient agrees, dispense the biosimilar medicine and ensure the patient knows how to use the medicine.
• Check that the patient has a diabetes management plan.
• For treatment-naïve patients, provide guidance on the use of the insulin injector device if necessary.
• Check that the patient is aware of hypoglycaemic signs and symptoms and understands how to manage a hypoglycaemic event.

• NPS MedicineWise Brand equivalence – ‘a’ flagging explained
• Department of Health Information for consumers: What are biosimilar medicines?
• Department of Health Information for health professionals: What are biosimilar medicines?
• Australian Medical Association: Changes to the way you prescribe – Electronic and active ingredient prescribing