NEW PBS LISTING FOR THE 760 AUSTRALIANS DIAGNOSED WITH RARE FORM OF CANCER EACH YEAR1-5

CONSUMER MEDIA RELEASE

EMBARGOED UNTIL 10AM FRIDAY 30th NOVEMBER 2018

 

NEW PBS LISTING FOR THE 760 AUSTRALIANS DIAGNOSED WITH RARE FORM OF CANCER EACH YEAR1-5

 

Somatuline® Autogel® (lanreotide) will be listed on the PBS from 1 December 2018 for the treatment of non-functional gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease.1

 

 

  • GEP-NETs are neuroendocrine tumours that originate in the gastrointestinal tract or pancreas.6
  • GEP-NETs can be indolent (slow-growing) or more aggressive and are associated with high morbidity.7,8

 

 

 

  • Somatuline Autogel is the first therapy of its kind to be listed on the PBS as a treatment for adult Australians with non-functional GEP-NETs. It is expected that on average, 760 Australians will have subsidised access to Somatuline Autogel each year through the PBS.1,2-5

 

 

22 NOVEMBER 2018, MELBOURNE: IPSEN Pty Ltd (IPSEN) is pleased to announce that Somatuline® Autogel® (lanreotide) will be listed on the Pharmaceutical Benefits Scheme (PBS) from 1 December 2018, as a first-line therapy for the treatment of non-functional gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease.1

 

Neuroendocrine tumours (NETs) are tumours that form from cells in the body, which have roles in both the endocrine and nervous systems. GEP-NETs, the most common form of NETs, originate from the gastrointestinal tract or pancreas.6,9 GEP-NETs can be indolent (slow-growing) or more aggressive, and are associated with high morbidity.7,8

 

“Until now, there has been no subsidised treatment option available for Australians diagnosed with nonfunctional GEP-NETs,” said Associate Professor Nick Pavlakis, Medical Oncologist from Northern Cancer Institute in Sydney.

 

“Due to the slow-growing nature of GEP-NETs and the presence of non-specific symptoms, the only course of treatment that has previously been available to clinicians has been ‘watchful waiting’ – where we continue to monitor the growth of the tumours in patients over a number of years, without administering anti-tumour therapy.  

“The addition of a new treatment option for GEP-NETs on the PBS is welcome news, as there is a strong unmet clinical need for therapies which can be introduced earlier in the treatment journey to help suppress the symptoms of this insidious disease and slow its growth,” Associate Professor Pavlakis said.

GEP-NETs are a relatively rare condition, with an estimated incidence of 3.3 newly diagnosed cases per 100,000 people each year.10 It is expected that on average, 760 Australians will have subsidised access to Somatuline Autogel through the PBS.2-5

 

“NET cancer patients will typically wait four to seven years for a correct diagnosis and see between four to six different doctors and specialists,” said Simone Leyden, CEO and Co-Founder of the Unicorn Foundation & President of the International Neuroendocrine Cancer Alliance (INCA).

 

“As a result of numerous misdiagnoses and lack of clear treatment pathways, many within our NET cancer community have become frustrated and disappointed in the medical system. Today’s PBS listing announcement demonstrates the Australian Government’s ongoing commitment to and support of rare cancers; and means patients with GEP-NETs will now have a viable treatment option available to them,” Ms Leyden said.

 

As a synthetic somatostatin analogue (SSA) therapy, Somatuline Autogel is the first treatment of its kind to be listed on the PBS for adult Australians with non-functional GEP-NETs.1

 

Somatostatin is a naturally occurring hormone in the body, which is responsible for inhibiting the release of other hormones, such as serotonin, insulin, glucagon and gastrin.7 In people with GEP-NETs, somatostatin may be ‘faulty’ and can lead to the overproduction of these other hormones.7

 

SSAs, like Somatuline Autogel, can be used in therapy to stop the overproduction of these hormones in people with GEP-NETs, while slowing growth of the tumour and treating the debilitating symptoms of the disease.6

 

“We are extremely pleased with the Australian Government’s decision to make Somatuline Autogel available on the PBS for Australian adults diagnosed with non-functional GEP-NETs,” said Peter Koetsier, General Manager for Australia and New Zealand at IPSEN.

 

“As an under-recognised disease with limited treatment options, today’s announcement is significant for the Australian NET cancer community, who have been waiting for many years for subsidised access to therapy.

 

“IPSEN is committed to advancing patient health and quality of life in areas with clear unmet need, such as NETs. We would like to acknowledge the work of the Australian Government, the Pharmaceutical Benefits Advisory Committee, and the Department of Health for making this therapy available on the PBS; as well as the healthcare professionals and the patient community who have been tireless in advocating for treatment access,” said Mr Koetsier.

 

Somatuline Autogel Safety Information11

Somatuline Autogel is available in a pre-filled syringe, fitted with an automatic safety system.11 For GEP-NETs treatment, Somatuline Autogel 120mg is administered every 28 days by a health care professional.11

 

INDICATIONS: Somatuline Autogel is a prescription medicine that is used for: the treatment and control of the growth of some advanced tumours of the intestine and pancreas that cannot be removed by surgery (i.e. GEP-NETs) in adult patients; the treatment of symptoms associated with carcinoid syndrome, such as flushing and diarrhoea; and the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy, or in patients who do not respond to therapy with drugs called dopamine agonists.11

 

CONTRAINDICATIONS: Somatuline Autogel should not be given to patients who are breastfeeding or during lactation; or who have a known hypersensitivity (allergy) to lanreotide or any of its ingredients.11

 

PRECAUTIONS: Somatuline Autogel should be used with precaution in diabetic patients; patients with liver, kidney, thyroid or gallstone problems; patients with heart problems, such as bradycardia (a slow heart rate); and those that are pregnant or breastfeeding. Somatuline Autogel is not recommended for use in children.11

 

INTERACTIONS:11 Some medicines and Somatuline Autogel may interfere with each other. Somatuline Autogel may reduce the intestinal absorption of other drugs administered at the same time (e.g. cyclosporin A) or increase the bioavailability of bromocriptine. The dose of other drugs which slows the heart rate (e.g. beta-blockers) may need to be reduced if Somatuline Autogel is administered.

Somatuline Autogel may interfere with the breakdown of some drugs by the liver enzymes (e.g. quinidine or terfenadine). Patients should consult their doctor or pharmacist for more information on medicines to be careful with or to avoid while taking Somatuline Autogel.

 

ADVERSE EFFECTS:11 Common and very common side effects include bowel problems (diarrhoea or loose stools, abdominal pain, passing wind or constipation), feeling sick, vomiting, heartburn, abdominal bloating or discomfort, gallbladder stones, changes in blood sugar levels, diabetes, slowing of heart rate, tiredness, headache, dizziness, hair loss or no hair growth, pain at injection site (sometimes with redness, swelling, itching or tenderness), changes in liver or pancreas test results, weight loss, lack of energy, feeling generally weak, decrease in appetite, pain in muscles, ligaments, tendons and bones, excess fat in stools, biliary dilatation.

 

Before taking Somatuline Autogel, please review the Consumer Medicine Information available from: http://www.guildlink.com.au/gc/ws/ipsen/cmi.cfm?product=iscsatgi

 

PBS INFORMATION: SOMATULINE® AUTOGEL® Authority required (Streamlined for Public Hospitals for all indications and Community Access for functional carcinoid tumours and acromegaly) Private Hospital Authority required. This product is a highly specialised drug listed on the PBS as a Section 100 item. Please refer to the PBS schedule for full authority information.

 

For further information about Somatuline® Autogel® contact Ipsen Pty Ltd. Level 2, Building 4, Brandon Office Park, 540 Springvale Road, Glen Waverley, VIC ,3150 Australia. ABN 47 095 036 909. T: (03) 8544 8100 | F: (03) 9562 5152 | E: info@ipsen.com.au. Somatuline® Autogel® is a registered trade mark. Date of preparation: November 2018 SOM-AU-000380.

 

# # ENDS # #

 

This media release has been distributed by opr health on behalf of IPSEN.

 

About IPSEN

IPSEN is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercialises innovative medicines in three key therapeutic areas – Oncology, Neurosciences and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumours, renal cell carcinoma and pancreatic cancer. IPSEN also has a well-established Consumer Healthcare business. With total sales close to €1.6 billion in 2016, IPSEN sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries.  IPSEN’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,100 employees worldwide. IPSEN is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on IPSEN, visit www.ipsen.com.

 

MEDIA CONTACTS

Tania Jayesuria | E: tania@opragency.com.au | M: 0404 094 744

Eliza Roel | E: eliza.roel@opragency.com.au | M: 0404 950 315

 

REFERENCES

  1. Department of Health, Pharmaceutical Benefits Scheme. Available at: www.pbs.gov.au [Date accessed: August 2018].
  2. Yao J, Hassan M, Phan A, Dagohoy C, Leary C, Mares J et al; One hundred years after “carcinoid”: Epidemiology of an prognostic factors for neuroendocrine tumours in 35,825 cases in the United States”; Journal of Clinical Oncology; 26(18): 3063-3072, 2008
  3. Oberg K, Knigge U, Kwekkeboom D; Perren A; Neuroendocrine gastro-enteropancreatic tumours: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up; Annals of Oncology, 23 (suppl 7): 4656-4633; 2012
  4. Frilling AG: Neuroendocrine tumour disease: an evolving landscape; Endocrine-Related Cancer; 19: R163-R185; 2012
  5. Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P for the CLARINET Investigators; Lanretodie in Metastatic Enteropancreatic Neuroendocrine Tumours; The New England Journal of Medicine; 371: 224-33.
  6. Leyden, J. for the Unicorn Foundation. Neuroendocrine tumours: A guide for patients and carers. 2015 (First Edition).
  7. Leyden, J. for the Unicorn Foundation. Neuroendocrine tumours: A guide for healthcare professionals. 2015 (First Edition).
  8. Harring TR, Nguyen NTN, Goss JA, O’Mahony CA. Treatment of liver metastases in patients with neuroendocrine tumors: a comprehensive review. Int J Hepatol. 2011;2011:154541.
  9. Kos-Kudła, B. et al. Current treatment options for gastroenteropancreatic neuroendocrine tumors with a focus on the role of lanreotide. Contemp Oncol (Pozn) 2017;21 (2):115–122.
  10. Luke, C. et al. Cancer Causes Control. 2010 Jun;21(6):931-8. Epidemiology of neuroendocrine cancers in an Australian population. Cancer Causes Control. 2010 Jun;21(6):931-8.
  11. Somatuline Autogel (lanreotide) Approved Consumer Medicine Information.

 

Date of preparation November 2018. SOM-AU-000380.  

  1. Department of Health, Pharmaceutical Benefits Scheme. Available at: www.pbs.gov.au [Date accessed: August 2018].
  2. Yao J, Hassan M, Phan A, Dagohoy C, Leary C, Mares J et al; One hundred years after “carcinoid”: Epidemiology of an prognostic factors for neuroendocrine tumours in 35,825 cases in the United States”; Journal of Clinical Oncology; 26(18): 3063-3072, 2008
  3. Oberg K, Knigge U, Kwekkeboom D; Perren A; Neuroendocrine gastro-enteropancreatic tumours: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up; Annals of Oncology, 23 (suppl 7): 4656-4633; 2012
  4. Frilling AG: Neuroendocrine tumour disease: an evolving landscape; Endocrine-Related Cancer; 19: R163-R185; 2012
  5. Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P for the CLARINET Investigators; Lanretodie in Metastatic Enteropancreatic Neuroendocrine Tumours; The New England Journal of Medicine; 371: 224-33.
  6. Leyden, J. for the Unicorn Foundation. Neuroendocrine tumours: A guide for patients and carers. 2015 (First Edition).
  7. Leyden, J. for the Unicorn Foundation. Neuroendocrine tumours: A guide for healthcare professionals. 2015 (First Edition).
  8. Harring TR, Nguyen NTN, Goss JA, O’Mahony CA. Treatment of liver metastases in patients with neuroendocrine tumors: a comprehensive review. Int J Hepatol. 2011;2011:154541.
  9. Kos-Kudła, B. et al. Current treatment options for gastroenteropancreatic neuroendocrine tumors with a focus on the role of lanreotide. Contemp Oncol (Pozn) 2017;21 (2):115–122.
  10. Luke, C. et al. Cancer Causes Control. 2010 Jun;21(6):931-8. Epidemiology of neuroendocrine cancers in an Australian population. Cancer Causes Control. 2010 Jun;21(6):931-8.
  11. Somatuline Autogel (lanreotide) Approved Consumer Medicine Information.
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