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Government Considering De-Listing Osteo-Paracetamol from PBS

Arthritis & Osteoporosis WA is deeply concerned by the Federal Government’s plans to delist over the counter medications, in particular osteo-paracetamol, from the Pharmaceutical Benefits Scheme and to allow biosimilars to be substituted for biologic medications.

We are urging our members and anyone with arthritis to contact their local Federal MP and the office of the Federal Minister for Health to let them know about your arthritis story and how this change will affect you.

The Minister for Health, the Hon Sussan Ley MP can be contacted on 02 6277 7220 or email at minister.ley@health.gov.au.

Eight percent of the Australian population suffer from osteoarthritis meaning there are more than 1.8 million people who will be affected by these changes.

We are urging the government to reconsider delisting over the counter medications like paracetamol from the PBS and to implement measures to protect patient safety with respect to the use of biosimilars in Australia.

Delisting of osteo-paracetamol

Over 80 percent of PBS scripts for paracetamol are for the ‘osteo’ slow-release formulation, available as a restricted benefit for the relief of persistent pain associated with osteoarthritis. This is currently the recommended first-line pharmacological therapy for this condition and is only available at pharmacies.

Delisting osteo-paracetamol will have a tremendous financial impact on concessional patients, whose co-payments currently stand at $6.10 for a one-month supply. The cheapest price we have been able to find for the same quantity of generic osteo-paracetamol was $7.98* through an online discount chemist, however, this does not include shipping fees of $6.90 meaning the overall cost to concessional patients would more than double if this product is delisted.

Many people with arthritis and chronic pain already struggle with the costs of doctor’s visits, medications, supplements and other services they need to manage their condition, and are unable to absorb additional costs that for others may seem minor.

Furthermore, the increased costs concessional patients are likely to face will create an incentive for them to seek (and for their GPs to prescribe) the next line PBS-listed therapies for osteoarthritis, such as non-steroidal anti-inflammatories. These therapies are associated with far less favourable safety profiles than paracetamol, especially for people with co-morbid conditions.

This shift in prescribing patterns is likely to reduce any savings to the PBS from delisting paracetamol and may even increase costs to both the PBS and the health system if more expensive products with greater side effects are prescribed. The Industry Commission in a 1996 report on the pharmaceutical industry noted that paracetamol was once delisted from the PBS, but this led to a shift to more expensive drugs, so it was relisted within 12 months^.

Substitution of biosimilars for biologic medications

Switching between a biologic and its biosimilar may increase the risk of adverse events and impede safety monitoring for those being treated for autoimmune forms of arthritis such as inflammatory arthritis. Clinical evidence on the safety and effectiveness of patients switching between a biologic and a biosimilar is currently limited, yet there is a move in Australia to allow these substitutions.

The position of Arthritis Australia and Arthritis & Osteoporosis WA is that, until more clinical evidence regarding the safety and efficacy of switching is available, people who are already receiving a biologic medication should not be switched to the biosimilar version without the informed mutual decision of the prescriber and the consumer. New patients or patients moving to a new biologic therapy, however, could be started on a biosimilar.

Biosimilars offer the potential to reduce health system costs and increase patient access to biologic medications. However, it is essential that measures to encourage uptake of biosimilars do not compromise patient safety in any way.

*http://www.myshopping.com.au/PR–481769_Paracetamol_Osteo viewed 01/05/2015
^Industry Commission Report no 51, 1996. The Pharmaceutical Industry Volume 1: The Report. http://www.pc.gov.au/ic/?a=31381

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