Key points

  • On 1 April 2021 adalimumab biosimilars became available on the PBS.
    In addition to the originator brand Humira, four biosimilar brands for adalimumab are now PBS-listed: Amgevita, Hadlima, Hyrimoz and Idacio.
  • The adalimumab biosimilars are ‘a’ flagged with the originator brand Humira
    ‘a’ flagging allows substitution between the biosimilar and originator products according to authority level, strength and dosage form.
  • New formulation and new strength for originator product
    From 1 April 2021, the adalimumab originator brand Humira will have new reduced-volume 20 mg and 40 mg formulations that are ‘a’ flagged to the existing formulations and new adalimumab biosimilar products. New 80 mg syringe and pen forms of Humira have also been listed on the PBS.
  • Original Humira formulations are now ‘Supply Only’
    Prescriptions for the original formulation written before 1 April 2021 can be dispensed if available. The original formulation can no longer be newly prescribed and will be completely removed from the PBS on 1 April 2022.
 

What’s changed?

Adalimumab biosimilars introduced

On 1 April 2021, four adalimumab biosimilars (Amgevita, Hadlima, Hyrimoz and Idacio) were added to the Pharmaceutical Benefits Scheme (PBS) General Schedule and Highly Specialised Drug (HSD) Program in the following strengths and forms:1

  • 20 mg/0.4 mL injection, prefilled syringe (Amgevita)
  • 40 mg/0.8 mL injection, prefilled syringe (Amgevita, Hadlima, Hyrimoz and Idacio)
  • 40 mg/0.8 mL injection pen device (Amgevita, Hadlima, Hyrimoz and Idacio)

Existing indications and clinical inclusion criteria for the use of adalimumab have not changed.1,2

All adalimumab biosimilars are ‘a’ flagged to the adalimumab originator Humira and each other, according to authority level (written/digital or streamlined), form (ie, syringe or pen) and strength (ie, 20 mg or 40 mg).1,2

Substitution is permitted between:

  • ‘a’ flagged adalimumab originator and biosimilar brands of the same strength and dosage form, where written/digital authority has been obtained under the Initial 1, Initial 2, Initial 3, First Continuing or Subsequent Continuing treatment phases2
  • ‘a’ flagged adalimumab biosimilars of the same strength and dosage form, where a streamlined authority prescription has been written under the Subsequent Continuing treatment phase.2

Prescribers should be aware of the different authority required restrictions for the different treatment phases:

  • when writing prescriptions for the Subsequent Continuing treatment phase, the four adalimumab biosimilar brands may use an Authority Required (STREAMLINED) code, while the originator brand Humira remains available as Authority Required (written/digital)2,3
  • all listings, for all brands of adalimumab, remain Authority Required (written/digital) when prescribed for use in the treatment phases Initial 1, Initial 2, Initial 3, and First Continuing.2,3

See the Schedule of pharmaceutical benefits 1 April (Addendum) for complete details for each item.

Reduced-volume formulations added

On 1 April, new reduced-volume formulations of adalimumab (Humira) were added to the PBS (General Schedule and HSD Program):1,2

  • 20 mg/0.2 mL injection, prefilled syringe
  • 40 mg/0.4 mL injection, prefilled syringe
  • 40 mg/0.4 mL injection pen device

The reduced-volume formulations deliver the active ingredient in equivalent doses to the existing 20 mg/0.4 mL and 40 mg/0.8 mL formulations of the originator brand.2,4,5

The reduced-volume formulations are ‘a’ flagged to the adalimumab originator Humira and to the newly listed adalimumab biosimilars, according to authority level (written/digital or streamlined), form (ie, syringe or pen) and strength (ie, 20 mg or 40 mg).1,2

Supply Only for original Humira formulations to 1 April 2022

With reduced-volume formulations for 20 mg and 40 mg Humira products now available on the PBS (General Schedule and HSD Program), the original formulations will become Supply Only for a 12-month period.1,2 Supply Only items/brands are available on the Schedule for dispensing but not for prescribing.1,6 Original Humira formulations will not be available for dispensing after 1 April 2022.2

Prescribers and dispensers should let their patients know of this change. Some patients may be concerned about how the change could affect current management of their condition. Discuss active ingredients with them and explain that the reduced-volume Humira formulations are considered clinically equivalent to the original formulations for the purposes of substitution.2,4,5

New strength for Humira added

A higher strength dose (80 mg/0.8 mL) of adalimumab (Humira) is now listed on the PBS General Schedule as Authority required for the treatment of people living with severe Crohn disease (Tables 1a and 1b), fistulising Crohn disease (Table 2), moderate to severe ulcerative colitis (Table 3), moderate to severe hidradenitis suppurativa (Table 4) or chronic severe plaque psoriasis (Table 5).1

Adalimumab (Humira) in 80 mg/0.8 mL forms is not equivalent or ‘a’ flagged to any other adalimumab products.2

Information about the treatment and clinical criteria for prescribing this dose to the patient groups described above can be found in the Schedule of pharmaceutical benefits 1 April (Addendum).

Table 1a. PBS listings for 80 mg/0.8 mL adalimumab (Humira) for severe Crohn disease adult

Treatment phases

Forms available

Item codes

Max qty packs

No of repeats

Initial treatment

  • Initial 1 (new patient)
  • Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
  • Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

adalimumab 80 mg/0.8 mL injection, pen device

adalimumab 80 mg/0.8 mL injection, prefilled syringe

12419P

12372E

3

3

-

-

Table 1b. PBS listings for 80 mg/0.8 mL adalimumab (Humira) for severe Crohn disease – paediatric patients with refractory disease

Treatment phases

Forms available

Item codes

Max qty packs

No of repeats

Initial treatment

  • Initial 1 (new patient)
  • Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
  • Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

adalimumab 80 mg/0.8 mL injection, pen device

adalimumab 80 mg/0.8 mL injection, prefilled syringe

12426B

12409D

3

3

-

-

Table 2. PBS listings for 80 mg/0.8 mL adalimumab (Humira) for complex refractory fistulising Crohn disease

Treatment phases

Forms available

Item codes

Max qty packs

No of repeats

  • Initial treatment (new patient or recommencement of treatment after more than 5 years break in therapy – Initial 1)
  • Change or recommencement of treatment after a break in therapy of less than 5 years (Initial 2)

adalimumab 80 mg/0.8 mL injection, pen device

adalimumab 80 mg/0.8 mL injection, prefilled syringe

12360M

12393G

3

3

-

-

Table 3. PBS listings for 80 mg/0.8 mL adalimumab (Humira) for moderate to severe ulcerative colitis

Treatment phases

Forms available

Item codes

Max qty packs

No of repeats

Initial treatment

  • Initial 1 (new patient)
  • Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
  • Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

adalimumab 80 mg/0.8 mL injection, pen device

adalimumab 80 mg/0.8 mL injection, prefilled syringe

12374G

12339K

3

3

-

-

Table 4. PBS listings for 80 mg/0.8 mL adalimumab (Humira) for the treatment of moderate to severe hidradenitis suppurativa

Treatment phases

Forms available

Item codes

Max qty packs

No of repeats

Initial treatment 1 – New patient or

Initial treatment 2 – Recommencement of treatment – balance of supply

adalimumab 80 mg/0.8 mL injection, pen device

adalimumab 80 mg/0.8 mL injection, prefilled syringe

12449F

12395J

2

2

2

2

Continuing treatment

adalimumab 80 mg/0.8 mL injection, pen device

adalimumab 80 mg/0.8 mL injection, prefilled syringe

12448E

12408C

2

2

5

5

Initial treatment 1 – New patient

Initial treatment 2 – Recommencement of treatment

adalimumab 80 mg/0.8 mL injection, pen device

12450G

3

-

Table 5. PBS listings for 80 mg/0.8 mL adalimumab (Humira) for the treatment of chronic severe plaque psoriasis

Treatment phase

Forms available

Item code

Max qty packs

No of repeats

Initial treatment

  • Initial 1, Face, hand, foot (new patient)
  • Initial 1, Whole body (new patient)
  • Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)
  • Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)
  • Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)
  • Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)

adalimumab 80 mg/0.8 mL injection, pen device

adalimumab 80 mg/0.8 mL injection, prefilled syringe

12447D

12394H

1

1

-

-

 

What is adalimumab?

Adalimumab is a disease-modifying biological medicine. It is a recombinant, fully human immunoglobulin (IgG1) monoclonal antibody that recognises and binds to the cytokine protein tumour necrosis factor (TNF-alpha), which is present at higher levels in some inflammatory diseases.7,8

The originator brand Humira was TGA-approved for use in Australia in 2003, initially for the treatment of patients with rheumatoid arthritis.7,8 Since 2017, four new adalimumab medicines have also been TGA-approved and determined to be biosimilars to the originator brand Humira.9-12

 

What else should health professionals know?

In alignment with the Government’s commitment to the uptake of biosimilars, prescribers are encouraged to prescribe a biosimilar brand for treatment-naïve patients where appropriate.3

Biological medicines are medicines derived from a living source.13

These medicines now contribute to the management of several chronic diseases, including a range of autoimmune and inflammatory conditions.13 In recent years, primary care practitioners will have noted increasing numbers of patients with more severe forms of rheumatoid arthritis, ulcerative colitis, Crohn’s disease, psoriasis and other inflammatory conditions who are using these medicines, usually prescribed by specialists.

Biological medicines are, however, expensive to develop and manufacture. As patents on these products expire, competing manufacturers are able to develop highly similar versions of originator biological medicines, referred to as biosimilar medicines, or simply, ‘biosimilars’. The introduction of biosimilar medicines into the market prompts price reductions and potential savings for the PBS.13

A biosimilar has demonstrable similarity to the originator in physicochemical, biological and immunological characteristics, efficacy and safety, based on comprehensive comparability studies.14,15

The current practice of ‘a’ flagging in the Schedule of Pharmaceutical Benefits denotes that brand substitution may be undertaken by pharmacists at the point of dispensing without differences in clinical effect. When dispensing, attention must be paid to the selection of the correct PBS item code to ensure the correct product is claimed. Applying incorrect item codes may result in a rejection warning message from Services Australia.2

As with all ‘a’ flagged medicines, if prescribers are concerned that patient safety may be at risk from medicine substitution at the pharmacy, they can mark ‘substitution not permitted’ on the prescription.

Pharmacovigilance is important to establish the long-term safety and efficacy of all medicines, including biosimilars. No safety signals have emerged following a single switch from reference to biosimilar medicines.16 Data on repeat switching for any biosimilar, including adalimumab, are currently limited.17

Patients should be educated on brand substitution and informed of any potential differences in appearance or use of ‘a’ flagged medicines eg, different injector devices.

Changes to Humira pack sizes

Pharmacists are advised that pack sizes for adalimumab (Humira) have changed to better match pack sizes available for adalimumab biosimilar products.2

The changes affect 11 PBS item codes.

Find details of the changes and a table summarising the impacted codes (p 3).2

For information about reporting adverse reactions to the TGA, or to report suspected adverse reactions online, see the TGA website.

Changes to prescribing information and processes

Active ingredient prescribing

On 1 February 2021 the inclusion of active ingredient information became mandatory for most PBS and RPBS prescriptions. Active ingredient prescribing is part of a wider government strategy to ensure consistent and standardised medicines information.

Under the regulations, prescribers:

  • 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 or to ensure medicine continuance where a patient is familiar with a particular brand of their regular medicine.

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

To support pharmacies, and ensure consumers have continued access to PBS/RPBS subsidised medicines during the transition, the Department has agreed to provide a six-month grace period for pharmacy, ceasing 31 July 2021.

Find out more about active ingredient prescribing.

Community level electronic prescriptions

On 31 October 2019, Commonwealth legislation changed to recognise electronic prescriptions as a legal prescription for the purpose of PBS-listed medicine supply. Electronic prescribing is part of a wider government strategy to support safer medicine management and improve the efficiency of the PBS. It will not be mandatory but provides prescribers and their patients with a safe and secure alternative choice to paper prescriptions.

Electronic prescribing aims to:

  • improve efficiency in prescribing and dispensing medications
  • remove the need for handling and storing a physical paper prescription
  • support digital health services such as telehealth services to ensure continuity of patient care

To support the legislative changes, technical upgrades are currently underway to ensure safe, secure and seamless transmission of information of electronic prescriptions between prescribing and dispensing clinical software and to PBS payment systems.

Once in place, two models will be available to support electronic prescription; Token and Active Script List.

More information about electronic prescriptions is available:

 

References

  1. Pharmaceutical Benefits Scheme. PBS Schedule: Summary of changes (addendum) 1 April 2021. Canberra: Australian Government Department of Health, 2021 (accessed 1 April 2021).
  2. Department of Health. Adalimumab Pharmaceutical Benefits Scheme changes – 1 April 2021 Canberra: Australian Government Department of Health, 2021 (accessed 30 March 2021).
  3. Department of Health. Information for Healthcare Professionals Biosimilar Uptake Drivers – ADALIMUMAB Canberra: Australian Government, 2021 (accessed 12 April 2021).
  4. Pharmaceutical Benefits Scheme. Public Summary Document: adalimumab (Humira) July 2018 PBAC Meeting. Canberra: Australian Government Department of Health, 2018 (accessed 10 April 2021).
  5. Pharmaceutical Benefits Scheme. Public Summary Document: adalimumab (Humira) December 2017 PBAC Meeting. Canberra: Australian Government, 2017 (accessed 15 April 2021).
  6. Pharmaceutical Benefits Scheme. PBS Frequently Asked Questions: What is Supply Only? Canberra: Australian Government Department of Health, 2021 (accessed 15 April 2021).
  7. Australian Prescriber. New Drug. Adalimumab. Australian Prescriber 2004;27:101-5.
  8. Therapeutic Goods Administration. Australian Public Assessment Report for Adalimumab (rch) Proprietary Product Name: Humira. Canberra: Australian Government Department of Health, 2013 (accessed 1 April 2021).
  9. Pharmaceutical Benefits Scheme. Public Summary Document: adalimumab (Amgevita) July 2018 PBAC Meeting. Canberra: Australian Government Department of Health, 2018 (accessed 10 April 2021).
  10. Pharmaceutical Benefits Scheme. Public Summary Document: adalimumab (Hadlima) July 2018 PBAC Meeting. Canberra: Australian Government Department of Health, 2018 (accessed 10 April 2021).
  11. Pharmaceutical Benefits Scheme. Public Summary Document: adalimumab (Hyrimoz) March 2020 PBAC Meeting. Canberra: Australian Government Department of Health2020 (accessed 30 March 2021).
  12. Pharmaceutical Benefits Scheme. Public Summary Document: adalimumab (Idacio) November 2020 PBAC Meeting. Canberra: Australian Government Department of Health, 2020 (accessed 30 March 2021).
  13. Department of Health. Biosimilar Awareness Initiative. Canberra: Australian Government, 2021 (accessed 12 April 2021).
  14. Therapeutic Goods Administration. Acronyms & glossary. Canberra: Australian Government Department of Health, 2020 (accessed 15 April 2021).
  15. Therapeutic Goods Administration. Biosimilar medicines regulation. Canberra: Australian Government Department of Health, 2018 (accessed 14 April 2021).
  16. Barbier L, Ebbers HC, Declerck P, et al. The efficacy, safety, and immunogenicity of switching between reference biopharmaceuticals and biosimilars: A systematic review. Clin Pharmacol Ther 2020;108:734-55.
  17. Feagan BG, Marabani M, Wu JJ, et al. The challenges of switching therapies in an evolving multiple biosimilars landscape: A narrative review of current evidence. Adv Ther 2020;37:4491-518.