Prolia should be on PBS
Mainly for anyone who is er+ post menopausal and taking Aromatase Inhibitors but guess the more that join in the better as is a bit of a focus on bc atm with the passing of Connie and Olivia's recurre...
Forum Discussion
Oral bisphosphonates are on PBS for osteoporosis with T score being sole criteria . I tried two different ones pre- bc. The first one caused an oesophageal ulcer as one needs to be fully upright for at least 30 minutes after ingestion. I was prescribed another one but later needed a tooth extraction whereupon only Prof Alastair Goss would take the risk after crosslaps due to fear of osteonecrosis of the jaw and being sued. Oral bisphosphonates stay in the body indefinitely Prolia exits rapidly at the end of 6 months enabling opportunity for serious dental between injections without risk of onj. Two of the oncs suggested Prolia has benefits also for prevention of bc recurrence am not sure bisphosphonates afford the same.I wrote to the distributor Agen about it at the suggestion of the AMA and here is their response and a copy of my original email to them .
"Thank you for your email. Amgen has conducted Prolia® (denosumab) clinical trials for a number of indications, including in patients with non-metastatic breast cancer receiving hormone therapy. However, at present, Prolia is unapproved for this indication in Australia.
Whilst we obtained registration and reimbursement in some of these patient populations, the pathways to registration and subsequent reimbursement can be quite complex. It requires extensive negotiations with government departments, and the exact criteria for reimbursement is not a decision that can be made solely by the manufacturer of the medicine.
We do appreciate your concerns regarding the issue, and the time taken to write to us. Additionally, I have passed your email on to the appropriate internal departments for their reference.
If you have any additional questions, please do not hesitate to contact the Amgen Australia Medical Information Service on 1800 803 638.
Kind Regards,
Leigh Brown, PhD
Medical Information Manager – JAPAC
"Many women who have estrogen receptor positive breast cancer - the most common form of breast cancer- are prescribed hormone therapy to prevent recurrence .Post- menopausal women are prescribed drugs called Aromatase Inhibitors.Many of these women have also experienced chemotherapy prior to commencement of hormone therapy. Aromatase Inhibitors are taken usually for 5 years and whilst considered highly effective in preventing recurrence of breast cancer do have the side effect of thinning bones and causing fractures. In addition those women who have had chemotherapy prior to commencing Aromatase Inhibitors have lowered bone density at the outset of this treatment due to the chemotherapy .Administration of Denosumab injections(trade name Prolia) six monthly counteracts this effect and in addition further reduces recurrence of breast cancer significantly. http://www.breastcancer.org/research-news/prolia-reduces-recurrence-risk-for-somehttp://www.breastcancer.org/tips/bone_health/breast_cancer Currently Prolia is only available on the PBS to women over 70 or those who have an existing fracture. The cost of Prolia to those unable to access the PBS price is high- $275 for each 6 monthly injection - and difficult for many to afford especially as the costs of breast cancer treatment has already been substantial. Could not women suffering breast cancer who are placed on Aromatase Inhibitors -and at the outset of hormone therapy are osteoporotic as indicated by low T scores also be granted access to Prolia at the PBS price rather than wait to suffer the severe pain of a fracture and in addition receive the benefit of a further reduction in the risk of breast cancer recurrence this drug provides?"