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
Arthritis Australia