Facts speak for themselves on drug listings

Australia has a world-class Pharmaceutical Benefits Scheme.

Page last updated: 23 September 2015

PDF printable version of Facts speak for themselves on drug listings (PDF 456 KB)

23 September 2015

Australia has a world-class Pharmaceutical Benefits Scheme.

It is supported by world-class drug approval systems that balance fast access to the latest drugs for patients with strict public safety protections that are based on clinical evidence, not just the claims of drug companies. I make no apologies for this.

Our approval systems also include safeguards to ensure taxpayers are not overpaying for drugs that do not deliver on what they promise patients.

This has allowed our Government to deliver on our promise to list new drugs quickly, with 798 new and amended listings added to the PBS since we came to office in 2013. This is the more than double the 331 new and amended drug listings delivered in Labor’s final term in half the time.

Unfortunately Australia is disadvantaged because drug companies often delay bringing new medicines down under – sometimes by up to 15 months – in favour of making applications in more-lucrative markets such as the US and Europe first.

For example, the recent independent Expert panel review of medicines and medical device regulation found Australians waiting on average about six months longer than the US and Europe for drug companies to apply to list new medicines here. This includes:

    • 148 days (or about five months) for anti-cancer medicines
    • 231 days (or about seven months) for cardiovascular medicines
    • 467 days (or about 15 months) for nervous system medicines
This is despite Australia being on average 90 days – or three months – faster to approve new drugs as safe than world-leaders such as Europe.

The same independent expert report therefore found:
      These submission gaps may be contributing to a perception that the TGA (Therapeutic Goods Administration) is slow to approve new drugs for market, as observers will not necessarily be aware the dossier was not submitted in Australia at the same time as it was submitted in, for example, the US.
This delay is something I am determined to overcome and I am currently working with the entire pharmaceutical chain, including consumers, to institute reforms.

This includes current consideration of recommendations of an independent review into strengthening and streamlining Australia’s world class drug approval systems so that they deliver even more for patients.

Discussions about drug listings are often a difficult and emotive issue and its important patients are able to access the facts, not just perceptions and propaganda.

CASE STUDY:
Europe is one of the biggest medicine markets in the world.

Earlier this year, an independent review found that when comparing drug safety approval systems like for like, Australia is on average 90 days faster than Europe:
    • Australia (TGA) – takes an average of 391 days to approve a new drug as safe
    • Europe (European Medicines Agency or EMA) – takes an average of 481 days to approve a new drug as safe
However, the review also found Australia receives drug applications on average six months after the US, compared to just 20 days on average for Europe. Therefore, when factored in, this leads to a significant blow out in Australia’s approval times for new drugs when compared to the rest of the world.
    • Australia (TGA) – total approval times of 572 days (lag-time of 181 days compared to US)
    • Europe (EMA) – total approval times of 501 days (lag-time of 20 days compared to US)
VERDICT:
**Direct Quotes from the Review**
    • “The TGA outperforms the EMA (European Medicines Agency) and a number of medium sized regulators in terms of its median approval time.
    • In terms of predictability of approval times, the TGA, along with the EMA, is setting the benchmark for other NRAs (National Regulatory Authorities for Drug Safety & Approvals).
    • These submission gaps may be contributing to a perception that the TGA is slow to approve new drugs for market, as observers will not necessarily be aware the dossier was not submitted in Australia at the same time as it was submitted in, for example, the US.
A copy of the review can be found on the TGA website.

EXAMPLES OF DRUG LISTINGS:
Since coming to office in September 2013, the Commonwealth has listed the following medicines, among others, on the PBS:
    • Keytruda (2015) – Melanoma – $57 million – $150,000 per patient if not subsidised through the PBS
    • Soliris (2014) – Atypical Haemolytic-Uraemic Syndrome (rare immune disease) – $63 million – $500,000 per patient if not subsidised through the PBS
    • Kayldeco (2014) – Cystic Fibrosis – $174 million – $300,000 per patient if not subsidised through the PBS
    • Mekinist (2015) – BRAF-positive Metastatic Melanoma – $594 million – $131,000 per patient if not subsidised through the PBS
    • Adcetris (2014) – Lymphoma – $15.2 million – over $110,000 per patient if not subsidised through the PBS
    • Perjeta, Herceptin and Kadcyla (2015) – Breast Cancer – $191 million combined – $82,000 per patient if not subsidised through the PBS
    • Crizotinib (2015) – Lung Cancer – $60 million – $80,000 per patient if not subsidised through the PBS
    • Lemtrada (2015) – Relapsing, Remitting Multiple Sclerosis – $50 million – $70,000 per patient if not subsidised through the PBS
    • Abraxane (2014) – Pancreatic Cancer – $92 million – $16,000 per patient if not subsidised through the PBS
    • Lucentis (2015) – Retinal Vein Occlusion (RVO) and Diabetic Macular Oedema (DME) (blindness) – $541 million – $10,000 per patient if not subsidised through the PBS
Listing these medicines on the PBS means patients pay just the PBS co-payment, with taxpayers covering the difference in the cost of treatment. For example, a patient using Soliris – which costs $500,000 per patient – now pays just $6.10 if they are a concession card holder or $37.70 if they are a general patient as a result of the drug being listed on the taxpayer-funded PBS.


ENDS

Media Contact: James Murphy 0478 333 974

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