Substitute cost disadvantage ‘unjust’


Pharmacy body raises concerns that Actemra substitution issues will impact affordability and equity of access

The PSA has raised concerns about the news that community pharmacists are now able to substitute tocilizumab (Actemra) formulations without prior prescriber approval due to serious shortages.

Under the new Serious Scarcity Substitution Instrument (SSSI) for Actemra, the 162 mg/0.9 ml solution for injection in both pre-filled syringe and pre-filled pen autoinjector devices have been declared as “scarce and substitutable medicines”, making them effectively interchangeable at the pharmacy level.

However the PSA argues that as the substitute medicine is not subsidised by the PBS, it has concerns about affordability for patients.

This seems to be a carry-on from the previous Serious Shortages Substitution Notice (SSSN), which outlined that, “Medicines substituted under a SSSN will not be subsidised by the Pharmaceutical Benefits Scheme at this time.

“If a PBS subsidised medicine is required, the pharmacist will need to speak to the prescriber and obtain a new script in accordance with the PBS regulations.”

“PSA has been supportive of the policy intent of SSSIs (and previously the SSSNs) to promote timely access and continuity of care,” the organisation told the AJP.

“However, as the substitute medicine is not subsidised by the PBS, PSA remains concerned about the impact on affordability and equity of access for patients.

“We believe it is unjust that the patient who is caught up in a medicine shortage is further disadvantaged from a cost perspective,” they said.

“Further, we have heard from pharmacists previously that, rather than put patients in this unsatisfactory situation, they have opted to contact the prescriber for a new prescription for the alternative medicine – which defeats the original purpose of the SSSI.”

The PSA said it is aware that the Department of Health has been working towards a workable and equitable solution.

A spokesperson told AJP that the Department of Health is currently considering the PBS subsidy of tocilizumab (Actemra) products where these are substituted under the SSSI.

“To support this consideration, the Department has sought and is awaiting advice from stakeholders on its proposed approach to PBS subsidy for medicines subject to an SSSI,” they said.

The Actemra SSSI is in force from 7 August 2021 until 31 December 2021, in all states and territories, unless otherwise revoked.

Pharmacists have been advised to become familiar with information on the current SSSI on Actemra which can be accessed through the TGA website.

“Use your professional and clinical judgement to determine whether a patient is suitable for substitution and ensure the patient is fully informed and consents to the change,” said the TGA.

Community pharmacists should ensure the patient understands the differences between the products, said the TGA, as “both medicines are of the same strength and administered by subcutaneous injection, however the device to administer the medicine is different”.

“Ensure the patient has received instructions or will receive instructions on administration from their specialist, their rheumatology nurse or General Practitioner as outlined in the Specific permitted circumstances,” it said.

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