Advocacy Focuses On Pharmaceutical Issues
Arthritis Australia’s Franca Marine reflects on the major national advocacy campaigns of 2015
Parmaceutical issues have been at the forefront of advocacy efforts by Arthritis Australia and the state and territory arthritis foundations in recent months. Key issues with major implications for people with arthritis have been the delisting of paracetamol from the Pharmaceutical Benefits Scheme and the introduction of biosimilar medicines for autoimmune forms of arthritis to the Australian market.
Subsidies for paracetamol to be removed
In April 2015, the Minister for Health, the Hon Sussan Ley, foreshadowed that a number of over the counter medicines, including paracetamol, would no longer be subsidised by the Pharmaceutical Benefits Scheme. She claimed that people could buy these medicines more cheaply from the supermarket.
Analysis by Arthritis Australia, however, found that the Minister’s claims about paracetamol were misleading and that people with arthritis on concession cards would end up paying up to three times more for their pain relief medication.
“Most of these scripts are for concession card holders who currently pay $6.10 for two boxes of 96 tablets. To buy the same quantity without a script costs at least $10 and up to $18, which adds up to an extra $50 to $140 over a year. People who need lots of medicines will be even worse off as these medications will no longer count towards their Safety Net.
“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,” Ainslie added. “They just can’t absorb additional costs that may seem minor to others.”
Making the voices of their members heard, state and territory arthritis foundations together with Arthritis Australia raised their concerns with the Minister, the Pharmaceutical Benefits Advisory Committee, and the Department of Health.
We encouraged our members to share their stories and write to Sussan Ley, and worked with other organisations to publicly highlight the impact on people with arthritis.
Unfortunately, while acknowledging that some people would indeed pay more for pain relief medication, the Minister has decided to proceed with the delisting in order to free up funds for new medications. The delisting of paracetamol takes effect from 1 January 2016.
The introduction of biosimilars
As the government introduces measures to support the uptake of biosimilars, Arthritis Australia is actively working to ensure that safety and efficacy issues for consumers are given paramount importance.
The first biosimilar medicine for the treatment of autoimmune forms of arthritis – a copy of the biologic infliximab – is now available in Australia, heralding a new era in biologic therapy for these conditions. Other biosimilars are expected to come onto the market in the next couple of years.
The advent of biosimilars is exciting because they will reduce the cost of expensive biologic medicines and increase treatment choices for doctors and consumers. However, the complex nature of biologic medicines suggests the need for caution around some of the measures being adopted to support their uptake.
A key focus of our advocacy efforts has been the Government’s decision to allow the option of pharmacy-level substitution for biosimilars. This means your pharmacist may ask you whether you would consider a biosimilar medicine (if one is available) rather than your usual biologic brand, as they do with generic medicines.
Consumer and clinician groups however are wary about allowing pharmacy level substitution for biosimilars.
Associate Professor Susanna Proudman, Medical Director of Arthritis Australia, explains why we need to tread carefully when considering pharmacy-level substitution for biosimilars.
“Biosimilars are copies of biologic medicines but they are not generics. Biologic medicines are grown in living cells and are extremely complex,” explained Susanna. “They are virtually impossible to copy exactly, unlike generics of simple small molecule medicines such as aspirin.
“We know biosimilars are safe and effective in patients who are new to that therapy and we support their use in these cases.
“At present, however, less is known about about whether biosimilars and biologics can be used interchangeably in people who are stable on their current therapy, as could happen if pharmacy-level substitution was allowed.
“Switching and especially multiple switching between a biosimilar and a biologic may affect patient safety by triggering an immune response or it may make the medicines less effective,” Susanna warned. “If something does go wrong, it also makes it much harder to work out which product is causing the problem, because an immune response can take a while to surface.”
In the case of the biologic infliximab, switching from the original brand (Remicade®) to the biosimilar brand (Inflectra®) has been shown to achieve comparable treatment results. However, less is known about the impact of switching between these products many times. For this reason we recommend you talk to your rheumatologist about which brand is right for you.
Arthritis Australia has prepared an information sheet for consumers on biosimilar infliximab that provides information and advice on how to ensure you get the right medicine.
This information sheet is available at www.arthritisaustralia. com.au/biosimilar_infliximab.
As a result of advocacy efforts by Arthritis Australia and other stakeholders, the Government is adopting a more consultative approach in developing and implementing its biosimilars policy, including an education campaign for consumers, prescribers and pharmacists.
Biologic: A complex medicine grown using living organisms. They have been used in Australia since 2003 to treat autoimmune forms of arthritis such as rheumatoid arthritis and juvenile arthritis. Biologics can reduce disability and improve quality of life for many. Familiar brands include Enbrel, Humira and Remicade.
• Biosimilar: A copy of a biologic medicine that is very similar, but not identical to, the original medicine.
• Conventional medicine: A simple, chemically-manufactured medicine such as aspirin.
• Generic medicine: An identical copy of a conventional medicine.
By Franca Marine
National Policy & Government Relations Manager