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Janssen Pharmaceuticals ANZ (Johnson & Johnson)

Government funds new treatment for rare heart and lung disease

For immediate release


Government funds new treatment for

rare heart and lung disease

 

Sydney, Australia, 31 January 2021 - Federal Government funding for an oral treatment for a rare heart and lung disease, pulmonary arterial hypertension (PAH) is being welcomed by medical experts, patients and the Janssen Pharmaceutical Companies of Johnson & Johnson.

 

From 1 February 2021, Uptravi® (selexipag) will become available on the Pharmaceutical Benefits Scheme (PBS) for Australians with PAH, and will be used in combination with an endothelin receptor antagonist (ERA) and/or phosphodiesterase type 5 inhibitor (PDE-5i).1,2

 

Approximately 420 Australian patients commence for the first time on treatments for PAH each year3, and a number of these patients will be eligible for treatment with Uptravi. Eligible patients will now pay $41.30 (general patients) or $6.60 (concessional patients) for each treatment.4

 

Given the current Australian population, it is estimated that up to 3,800 Australians have PAH yet approximately only 2,300 are diagnosed.3,5

 

People living with PAH often present with symptoms such as shortness of breath, fatigue, dizziness, chest discomfort or pain – non-specific symptoms that can be indicative of any number of medical conditions.6

 

Dr Helen Whitford, Respiratory Physician, Department of Respiratory Medicine, Lung Transplantation Service, The Alfred said, “By having Uptravi available on the PBS clinicians now have a more complete arsenal of treatments available to tackle this disease.

 

“Our overall treatment goal for people living with PAH is to keep overall disease risk as low as possible.7 This translates into better long-term outcomes for patients”8, she said.

 

Lung Foundation Australia CEO Mark Brooke said this PBS listing was another step towards more equitable access for patients to receive the best treatment for their lung disease.

 

“Living with PAH can mean difficulty carrying out day-to-day tasks, work, travel and social opportunities. This can have a major impact on patients’ functioning and physical, psychological and social wellbeing 9”.

 

Dr Sophie Glover-Koudounas, Executive Director, Medical and Scientific Affairs, Janssen Australia and New Zealand, said: “We are proud as a company to have achieved a listing for Uptravi on the PBS for this rare disease that can go undiagnosed for too long and is in an area of significant unmet need.

 

We commend the Federal Government’s commitment to bringing about the best possible health and wellbeing outcomes for Australians living with a rare disease through its National Strategic Action Plan for Rare Disease10, with this listing being a tangible demonstration of this,” she said.

 

About Pulmonary arterial hypertension

Pulmonary arterial hypertension (PAH) is a rare, chronic and debilitating disease, affecting up to 150 people per million population.1 PAH causes the walls of the pulmonary artery to become thick and stiff, narrowing the space for blood to pass from the heart through to the lungs and increasing blood pressure.6 If left untreated, the disease progresses rapidly, leading to significant morbidity and mortality.11 PAH is not a lifestyle disease. PAH can be genetically inherited or idiopathic (unknown cause). PAH can be associated with connective tissue diseases, liver disease, congenital heart defects, HIV infection and certain drugs.12 

 

On average, it takes almost four years and up to eight doctors’ visits for people living with PAH to be correctly diagnosed.13 A longer diagnosis and delayed treatment can potentially shorten life expectancy. The median survival time without treatment is 2.8 years.14

 

About Uptravi

Uptravi is an oral, selective, prostacyclin receptor agonist. It was first registered on 18 March 2016 by the Therapeutic Goods Administration (TGA) as monotherapy and as an add-on, oral therapy for PAH: idiopathic PAH; heritable PAH; PAH associated with connective tissue disease (CTD); congenital heart disease (CHD) with repaired shunts; and drugs and toxins; in patients with WHO functional class II, III or IV symptoms.15

 

All medicines may have side-effects. Uptravi may cause headache, diarrhoea, nausea and vomiting, jaw pain, muscle pain, pain in extremity, reddening of the face, and aching joints. Other possible side effects may include wheezing, swelling of the lips/mouth/throat/face, difficulty in breathing or tightness in the throat, hives or rash, and fainting.15,16

 

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

 

Learn more at www.janssen.com/australia. Follow on Twitter @JanssenANZ. Janssen-Cilag Pty Ltd is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. 

 

- Ends -

Issued by Provocate on behalf of Janssen Australia and New Zealand (Janssen-Cilag Pty Ltd).

 

For further information please contact:

Troy Bilsborough, Provocate

mobile +61 427 063 150; email: troy.bilsborough@provocate.com.au)

 

No compensation was provided to Dr Helen Whitford for her involvement in this media activity, and the opinions expressed are their own. The two individuals have been briefed by Janssen on the approved use of this product and the Medicines Australia Code of Conduct. Dr Helen Whitford has served on advisory boards and been involved in clinical trials sponsored by Janssen for which compensation was received.

 

Consumer Medicine Information is available at:

https://www.janssen.com/australia/sites/www_janssen_com_australia/files/prod_files/live/jccuptrv10720.pdf

 

References:

1.     Department of Health. Recommendations Made by the PBAC - July 2020. Available at: https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2020-07/positive-recommendations-07-2020.pdf

2.     Department of Health. Schedule of Pharmaceutical Benefits. Available at: http://www.pbs.gov.au/pbs/home

3.     Department of Health, Drug Utilisation Sub-Committee (DUSC), 2015. Pulmonary Arterial Hypertension (PAH) medicines utilisation analysis. Available at: http://www.pbs.gov.au/industry/listing/participants/public-release-docs/pulm-art-hypertension/pulmonary-arterial-hypertension-dusc-prd-2015-02-final.pdf [Accessed January 2021]. 

4.     Department of Health. Pharmaceutical Benefits: Fees, Patient Contributions and Safety Net Thresholds. Available at: http://www.pbs.gov.au/info/healthpro/explanatory-notes/front/fee

5.     Strange G et al. Survival of Idiopathic Pulmonary Arterial Hypertension Patients in the Modern Era in Australia and New Zealand. Heart Lung Circ 2018;27(11): 1368-1375

6.     Lung Foundation Australia, 2018. Factsheet: Pulmonary Arterial Hypertension. Available at: https://lungfoundation.com.au/wp-content/uploads/2018/09/PAH-Fact-sheet_Updated-Nov-2020-1.pdf [Accessed January 2021].

7.     Simons J et al Assessment of Risk of Disease Progression in Pulmonary Arterial Hypertension: Insights from an International Survey of Clinical Practice Advances in Therapy volume 36, pages 2351–2363(2019)

8.     Galiè N, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J 2016; 37:67-119.

9.     Pulmonary Hypertension US. The impact of pulmonary arterial hypertension (PAH) on the lives of patients and carers: results from an international survey, 2012.

10.  National Action Plan for Rare Disease, 26 February 2020. Available at: https://www.health.gov.au/sites/default/files/documents/2020/03/national-strategic-action-plan-for-rare-diseases.pdf [Accessed January 2021].

11.  Mak SM et al. Complications of pulmonary hypertension: a pictorial review. Br J Radiol 2017; 90:20160745

12.  Alves M, et al. Long-term survival of patients with pulmonary hypertension. Rev Port Pneumol. 2017;23(3):124-131.

13.  Strange G, et al. Time from symptoms to definitive diagnosis of idiopathic pulmonary arterial hypertension: The delay study. Pulm Circ 2013;3:89-94

14.  D’Alonza GE et al Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med 1991; 115: 343-349

15.  Janssen-Cilag Pty Ltd. UPTRAVI Product Information. December 2019.

16.  Janssen-Cilag Pty Ltd. UPTRAVI Consumer Medicine Information. December 2019.

 

Janssen-Cilag Pty Ltd, ABN 47 000 129 975, 1-5 Khartoum Road, Macquarie Park NSW 2113. Ph: 1800 226 334. Prepared January 2021. CP–203959

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