- New brand of tiotropium listed for patients with COPD
Tiotropium 13 micrograms (Braltus) is listed on the General Schedule as an ‘a’ flagged alternative to tiotropium 18 micrograms (Spiriva).
- Tiotropium (Braltus) is delivered using the Zonda inhaler
The Zonda device should not be used with any other medicines and should be discarded after 30 doses.
- Braltus and Spiriva are equally effective at managing COPD
Braltus and Spiriva both deliver the same dose of tiotropium (10 micrograms) when used with their appropriate inhalation devices.
On 1 February 2020, a new brand of tiotropium was listed on the PBS General Schedule as a Restricted Benefit for the treatment of chronic obstructive pulmonary disease (COPD).1
At the March 2019 Pharmaceutical Benefits Advisory Committee (PBAC) meeting, tiotropium (Braltus) was recommended as an alternative to the currently listed brand of tiotropium (Spiriva).2
The PBAC advised that tiotropium 13 micrograms (Braltus) and tiotropium 18 micrograms (Spiriva) powder for inhalation capsules could be marked as equivalent for the purposes of substitution by the pharmacist at the point of dispensing (that is, ‘a’ flagged).2
Why was the new listing made?
Tiotropium 13 micrograms (as bromide) powder for inhalation (Braltus) is a generic form of the PBS-listed tiotropium 18 micrograms (as bromide monohydrate) powder for inhalation (Spiriva). In making their decision, the PBAC acknowledged that the TGA accepted tiotropium (Braltus) and tiotropium (Spiriva) are bioequivalent.2
Differences between the two products (ie, labelled metered doses and devices used to deliver the active ingredient) were not sufficient enough for the PBAC to consider them non-equivalent.2
Although Spiriva is delivered using the HandiHaler device and Braltus is delivered using the Zonda device, the PBAC considered the operational steps for the two devices to be similar.2
Patients also use the same inhalation technique with both inhalers.2,3
The PBAC considered any differences between the two medicines that may potentially lead to confusion for prescribers, pharmacists or patients can be managed in the course of regular patient education and counselling on correct device use. Information and education proposed by the sponsor also addresses key quality use of medicine concerns.2
In addition, Australian labelling requirements now specify that the delivered dose be disclosed on the label of all dry powder inhalers.2
Will the changes affect current prescribing?
The listing of tiotropium (Braltus) as an ‘a’ flagged equivalent to tiotropium (Spiriva) means that patients and prescribers can now choose a generic brand of tiotropium for patients with COPD.2,4
However, Braltus and Spiriva have different metered doses (13 and 18 micrograms, respectively), and require use with their own inhalation devices to deliver the same dose of tiotropium (10 micrograms).2
Braltus should only ever be taken using the Zonda inhaler device, and the Zonda device should not be used with any other medicines.5
If considering a switch from Spiriva to Braltus (or vice versa), prescribers should assess whether there is potential for patient confusion that may lead to non-adherence or harm (incorrectly using the Braltus medicine with the HandiHaler device, for example).2,6
As with all ‘a’ flagged medicines, if a prescriber is concerned that patient safety may be at risk with medicine substitution at the pharmacy, they can mark ‘substitution not permitted’ on the prescription.4,7
Prescribers and other health professionals are expected to understand the differences between the Zonda and HandiHaler devices, and be able to educate patients on their correct use.2
Health professionals can find information and resources for teaching inhaler technique on the NPS MedicineWise website.
What else should health professionals know?
The Spiriva HandiHaler device can be washed and reused, whereas the Zonda device should be discarded after 30 doses.2,5
As each pack of Braltus contains a new Zonda device, patients should be advised to discard the old Zonda device that came with their previous Braltus pack so that it is not mistakenly reused.5
If patients choose to switch from Spiriva to Braltus and are concerned about leftover Spiriva capsules, they may be advised to continue using the remaining Spiriva capsules with the HandiHaler device until they have been used up.3
If patients are finding it difficult to understand that while the metered dose is different between products the delivered dose is the same, health professionals can instead explain the dose in capsules (that is, ‘one capsule, once daily’ for either medicine).2
What should patients know?
Patients should be advised that tiotropium (Braltus) and tiotropium (Spiriva) differ slightly in their appearance and how they are used, but they are equally effective at managing COPD.2
Educate patients on correct inhaler technique and check they understand that Braltus should only be taken using the Zonda device, and the Zonda device should not be used with any other medicines – including Spiriva.2,5
To double-check that they are using the correct medicine with the correct inhaler, patients can use visual cues. Colours and logos associated with the Braltus and Spiriva brands can be matched to the Zonda and HandiHaler devices, respectively.2
Braltus capsules must not be swallowed or placed directly into the Zonda mouthpiece.5
Placing capsules into the mouthpiece of the Zonda device, rather than into the centre chamber, can potentially lead to aspiration and choking.2,6
Patients should be reminded to seek advice from a pharmacist or other health professional at any point during treatment if they are unsure how to use their medicines or inhalers correctly.
NPS MedicineWise has a CPD activity on inhaler technique, an inhaler checklist for most commonly used inhalers, and useful general information for consumers on inhaler devices for respiratory medicines.
- Pharmaceutical Benefits Scheme. PBS Schedule: Summary of Changes (February 2020). Canberra: Australian Government Department of Health, 2020 (accessed 31 January 2020)
- Pharmaceutical Benefits Scheme. Public Summary Document: Tiotropium Braltus (March 2019). Canberra: Australian Government Department of Health, 2019 (accessed 13 August 2019).
- NHS Thurrock Clinical Commissioning Group. Spiriva HandiHaler to Braltus Zonda: commonly asked questions. Grays, UK: NHS Thurrock CCG, 2018 (accessed 4 September 2019).
- Pharmaceutical Benefits Scheme. Public Summary Document: Tiotropium Spiriva (March 2019). Canberra: Australian Government Department of Health, 2019 (accessed 13 August 2019).
- Teva Pharma Australia Pty Ltd. Tiotropium (Braltus) product information. Macquarie Park, NSW: Teva Pharma Australia Pty Ltd, 2018 (accessed 16 August 2019).
- Medicines and Healthcare Products Regulatory Agency. Braltus (tiotropium): risk of inhalation of capsule if placed in the mouthpiece of the inhaler. UK: MHPRA, 2018 (accessed 14 August 2019).
- NPS MedicineWise. RADAR: Brand equivalence – ‘a’ flagging explained. Sydney: NPS MedicineWise, 2013 (accessed 27 August 2019).