New prostate cancer treatment subsidy breaks seven-year PBS listing drought

For the first time in seven years, a prostate cancer therapy will be added to the Pharmaceutical Benefits Scheme (PBS), providing affordable treatment access for the 1,000 Australian men with prostate cancer set to spread to other parts of the body.1,2

 

From 1 November, men with this high-risk form of the disease that no longer responds to traditional testosterone-lowering therapy (known medically as castration resistant prostate cancer [nmCRPC]) can access Nubeqa (darolutamide) with the support of a Federal Government subsidy.2

 

Eligible men will pay just $6.60 (concession) or $41.30 (general patients) each month for Nubeqa.3 Without a subsidy, the medicine would cost up to $44,000 per year.4

 

Nubeqa is an androgen receptor inhibitor that works to starve cancer cells of the hormones they need to grow and divide.5 Taken as tablets alongside traditional androgen deprivation therapy,5 it is the first medicine of its type to be included on the PBS for the treatment of nmCRPC.2

 

According to Associate Professor David Pook, a Medical Oncologist at Melbourne’s Cabrini Hospital, access to Nubeqa on the PBS will come as great news to men no longer responding to hormone therapy.

 

“This medicine offers an earlier line of treatment, allowing doctors to treat prostate cancer that no longer responds to traditional testosterone-lowering treatment and is likely to spread,” Dr Pook said.

 

“We no longer need to wait until we can see cancer spots on CT scan and bone scans before we initiate treatment,” he said. “We now have the option to act earlier with the goal of delaying the spread of prostate cancer.” 

 

The announcement comes as concerns grow among medical experts and advocates about the impact of COVID-19 lockdowns on prostate cancer screening and diagnosis,6 as well as Prostate Specific Androgen (PSA) blood tests and scans to gauge cancer activity in those already diagnosed.

 

“Protecting against COVID-19 must not be at the expense of timely diagnosis or appropriate monitoring of cancer activity,” Dr Pook said.

 

“Typically, men with nmCRPC are active and don’t display cancer symptoms, so we rely on regular PSA blood tests as well as medical imaging to monitor cancer. When PSA levels double within 10 months, the prospect of cancer becoming visible in lymph nodes and bones is more likely,”7 he said.

 

One-in-three men with nmCRPC will develop overt metastatic disease – where the cancer spreads to other parts of the body and is detected on CT or bone scans – within two years.8

 

While 95% of all men with prostate cancer will live at least five years after their diagnosis,9 Dr Pook explained that once prostate cancer is detected in lymph nodes, bones or other parts of the body (stage 4), and is not responding to testosterone suppression alone, the chance of a man being alive in five years’ time is only 36 per cent.9

 

“More treatment options in the earlier stages of prostate cancer highlights the importance of prostate cancer testing to support early diagnosis as well as routine PSA testing during the earlier stages of the disease to identify early cancer progression,” Dr Pook added.

 

It is estimated that more than 200,000 Australian men are currently living with prostate cancer.10 Each year, close to 17,000 men are diagnosed with the condition and approximately 3,200 lose their lives to the disease.10

 

Bayer Pharmaceuticals ANZ General Manager, Ashraf Al-Ouf welcomed the PBS listing for Nubeqa and commended the Federal Government for supporting affordable access to innovative cancer therapies.

 

“Recognising the seriousness of high-risk prostate cancer, Bayer has provided compassionate, early access to Nubeqa since August 2020. To date, approximately 200 Australian men with nmCRPC have received the therapy at no cost.11 We are pleased that so many more will be able to access the therapy upon PBS listing.”

 

As with all medicines, Nubeqa is associated with some side-effects. While uncommon, the most frequent adverse events are fatigue, rash, or pain in an extremity.5

 

Nubeqa is not suitable for patients with hypersensitivity to the medicine or other substances in the tablet, or in women who are or may become pregnant. Caution is required in patients who have recently suffered a cardiovascular event, or who have impaired liver or kidney function, and in those under 18 years of age.5 The following medicines may influence the effect of Nubeqa, or Nubeqa may influence the effect of these medicines: rifampicin (antibiotic), carbamazepine and phenobarbital (epilepsy), St. John's Wort (anxiety or low mood), rosuvastatin, fluvastatin and atorvastatin (high cholesterol), methotrexate (joint and/or skin inflammation, or cancer), and sulfasalazine (inflammatory bowel disease).12  

 

About Bayer in Australia

Bayer is a global enterprise with core competencies in the Life Science fields of healthcare and agriculture. Its products and services are designed to benefit people and improve their quality of life. It has operated in Australia since 1925 and has a long-term commitment to the health of Australians.  Locally, Bayer currently employs almost 900 people across the country and is dedicated to servicing the needs of rural Australia and the local community. Bayer is deeply committed to research and development and has a strong tradition of innovation. The company’s focus on people, partnerships and innovation underpins all aspects of its operations, consistent with its mission, “Bayer: Science For A Better Life.” www.bayer.com.au

 

From 1 November 2021: PBS Information:

PBS Information: This product is listed on the PBS. Authority Required (immediate/real-time assessment by Services Australia). Refer to PBS Schedule for more information.

 

Consumer Medicine Information for NUBEQA® is available here.

 

References

 

  1. Bayer Australia. Data on File. REF-NUB-AU-0061, October 2021.
  2. Schedule of Pharmaceutical Benefits. 2021. Available at: https://www.pbs.gov.au/pbs/home
  3. PBS: Fees, Patient Contributions and Safety Net Thresholds. 2021. Available at: https://www.pbs.gov.au/info/healthpro/explanatory-notes/front/fee
  4. Bayer Australia. Data on File. PP-NUB-AU-0157-2, October 2021.
  5. Bayer Australia. NUBEQA Product Information, 2020. 
  6. Te Marvelde, L. et al. Decline in cancer pathology notifications during the 2020 COVID‐19‐related restrictions in Victoria, Med J Aust 2021; 214 (6): 281-283.
  7. Howard, L., Moreira, D., DeHoedt, A., Aronson, W., et al. Thresholds for PSA doubling time in men with non-metastatic castration-resistant prostate cancer. BJU Int 2017;120: E80-E86. 
  8. Kirby M, et al. Characterising the Castration-Resistant Prostate Cancer Population: A systematic Review. Int J Clin Pract. 2011; 65: 1180-1192.
  9. Australian Institute of Health and Welfare. Cancer in Australia 2019. Available at: https://www.aihw.gov.au/getmedia/8c9fcf52-0055-41a0-96d9-f81b0feb98cf/aihw-can-123.pdf.aspx?inline=true 
  10. Cancer Australia. Prostate Cancer in Australia Statistics. 2020. Available at: https://www.canceraustralia.gov.au/cancer-types/prostate-cancer/statistics
  11. Bayer Australia. Data on File. PP-NUB-AU-0159-2, October 2021.
  12. Bayer Australia Consumer Medicine Information for Nubeqa, 2020

 

 

Forward-Looking Statements 

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

 

Bayer Australia Pty Ltd, ABN 22 000 1 38 714, 875 Pacific Highway, Pymble NSW 2073. Ph: (02) 9391 6000.

 

Date of Preparation: October 2021 / PP-NUB-AU-0146-2.