PBS LISTING OF FIRST MEDICINE TO TREAT ADULT AUSTRALIANS WITH A COMMON GENETIC KIDNEY DISEASE

JINARC® (TOLVAPTAN) PBS REIMBURSED FROM 1ST JANUARY 2019 FOR ADPKD •

JINARC is the first drug treatment for ADPKD which is the fourth most common cause of kidney failure1.
• The majority of people with ADPKD will eventually need dialysis or a kidney transplant by 60 years of age2.
• The disease has a significant impact on families due it its hereditary nature and complications3.
Eligible Australians living with the most common life-threatening genetic disease of the kidneys1 from January 1st 2019 will have reimbursed access to the first drug treatment indicated to the slow progression of their condition4.
JINARC (tolvaptan) will be listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of eligible adult patients with autosomal dominant polycystic kidney disease (ADPKD), a progressing and sometimes painful disorder in which fluid-filled cysts grow in the kidneys causing them to enlarge, up to four times their normal size. Patients can suffer high blood pressure, infections and in some cases intracranial aneurysms. As kidney function declines due to enlarging cysts, people with ADPKD face dialysis or transplant5,6.
ADPKD affects approximately 10,000 Australians (based on European prevalence data)7 and impacts families across multiple generations, because a parent with the disease has a 50 percent chance of passing it on to their children3.
Nephrologist Carol Pollock, Professor of Medicine at the University of Sydney and Chair of Kidney Health Australia, said: “Doctors will now have access to the first PBS listed treatment for patients who are living with this difficult disease. If we can slow the decline in kidney function in these patients we can give them more time until they face dialysis and transplant, which is important for the patients and their families and could save significant healthcare costs.”
JINARC is approved in Australia for ADPKD patients who have stage 1 to 3 kidney disease and evidence of rapid progression4,8. It has been PBS listed for adults with rapidly progressing ADPKD who have stage 2 to 3 chronic kidney disease (CKD).
JINARC blocks the activity of the naturally occurring hormone vasopressin which is elevated in ADPKD patients. Abnormally elevated levels of vasopressin contribute to the proliferation and growth of cysts on the kidneys5. JINARC counteracts this and has been studied in two pivotal clinical trials, TEMPO 3:4 lasting three years and REPRISE lasting one year1,4,9. More than 100 Australian patients took part in these trials at 14 hospital sites10.
PKD Australia Manager Charmaine Green said, “As a parent of a child with PKD I vividly remember seeing the ultrasound that confirmed tiny cysts growing on my son’s kidneys. People with this disease live with uncertain futures as their kidney function deteriorates. Research and clinical trials that deliver new treatments are welcome.”
/Public Release.