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PBAC sets conditions for Xofigo (Radium-223) on the PBS

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Jim Marshall (not a doctor) said ...

Xofigo (Radium-223) has been recommended to go on the PBS.

The conditions just published include:

Previous Docetaxel, or unsuitability for Docetaxel;

No previous enzalutamide (Xtandi) (or intolerance);

No previous abiraterone (Zytiga) (or intolerance);

 

So if a man has 2 or more bone metastases (mets) on the PBS his doctor will have to choose only one of:

Xtandi (enzalutamide);

Zytiga (abiraterone);

Xofigo (Radium-233).

If a man does not qualify for PBS Xofigo, doses cost about $7,000, with up to 6 doses the normal treatment.

... end Jim

From the Public Summary Document – November 2017 PBAC Meeting 

Patients must have ≥ 2 skeletal metastases
AND
Patient must have a WHO performance status of 2 or less
AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; OR Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel
AND 

The treatment must not be used in combination with chemotherapy. 

AND 

The patient must not receive PBS-subsidised 223Ra if progressive disease develops while on 223Ra 

AND
The patient must not have received prior treatment with abiraterone or enzalutamide; OR
The patient must have developed intolerance to enzalutamide requiring permanent withdrawal AND
The patient must have developed intolerance to abiraterone requiring permanent withdrawal. 

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Charles (Chuck) Maack

The restrictions to Xofigo prescribing make little sense.  There is no relation between Xofigo/alpharadin/radium 223 and enzalutamide or abiraterone acetate.  Xofigo is designed to treat cancer metastases to the bone as well as accompanying pain from that metastases.  Enzalutamide is designed to hopefully totally block the multitude of androgen receptors on cancer cells from testosterone/dihydrotestosterone access.  Abiraterone acetate is designed to shut down the three sources of testosterone production - testicular, adrenal glands, and that cancer cells can produce within themselves from fueling cancer cell growth and proliferation.   Thus, neither enzalutamide nor abiraterone are designed to treat bone metastases and pain.  The explained reasoning for restrictions identified seem amiss. 

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Chris Fuhrmeister

What does WHO status mean ?

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Admin

Jim Marshall (not a doctor) said ...

Who status is about how healthy you are.

For Xofigo:

Black below is OK.

Red is NOT OK - basically in bed or chair for more than half the waking day.

... end Jim

The Eastern Cooperative Oncology Group (ECOG) score (published by Oken et al. in 1982), also called the WHO or Zubrod score (after C. Gordon Zubrod), runs from 0 to 5, with 0 denoting perfect health and 5 death:[2] Its advantage over the Karnofsky scale lies in its simplicity.

  • 0 – Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
  • 1 – Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
  • 2 – Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)
  • 3 – Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours)
  • 4 – Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)
  • 5 – Death

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Chris Fuhrmeister

Whoa ok this ones a new one for me. Looks like I'm a zero. Thanks Jim

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whatmeworry1941

So does this mean it still hasn't been approved?

 

Saw the oncologist last month with my Dad and his PSA has gone down from ~800 last year to under 1 with Zoladex, so his pain from his bone mets have gone down. I asked the oncologist about Radium-223 versus Lutetium-177. He said Raduim-223 still hasn't been approved and it faces much competition from other drugs.

 

He also said Radium-223 might be better in some situations then Lutetium-177 eg. Radium-223 maybe be better earlier on and Lutetium-177 might have some toxicity issues but Lutetium-177 might have some better results in some people but he said they are still debating the pros and cons of both.

 

For both Ra-223 and Lu-177, some Doctors suggest these two medications should maybe be used earlier on.

 

I would love my father to receive Ra-223 if it becomes available to try to get rid of his mets, but because his PSA's have gone down it looks like waiting is the thing to do.

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Admin

Only one step remains - for Cabinet to approve the recommendation.

Hopefully, this will be weeks, rather than months.

Cabinet has never (to my knowledge) turned down a PBAC recommendation for a cancer drug.

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Patrick Turner
23 hours ago, Chris Fuhrmeister said:

Whoa ok this ones a new one for me. Looks like I'm a zero.

Chris, what cruel thing to say about yourself :-/  But I am also a zero and far too healthy to get what might be the best treatment early as I might wish. There are a few reasons why we just can't have what we wish are reading how miraculously Ra223 and Lu117 seem to work. We need to be very sick to qualify to get these things and from what I read, they do not cure, they just prolong life, and they don't always work the same way in all men. Why would I say that?

1. I watched a few videos Jim made about Psa numbers and Gleason scores and other things and it seems Jim is doing well after being diagnosed with Gleason 9 quite some time ago, bit I am not doing that well, and after only 7 mths, the Zytiga abiraterone appears to be not so effective and Psa is beginning to rise again after getting psa from 7.2 to 2.0.

2. Charles Mack was diagnosed 25 years ago at 60. He still contributes to our collective wisdom here.

3. A friend of mine is having his 3rd dose of Docetaxel after being diagnosed 2.5 years ago, after RP failed, and following fancy-smancy Calypso IMRT failed, and he has soft tissue mets. ADT failed after 4 mths. Cosadex made his Psa rise alarmingly to 40. Doctors concluded his cancer could not respond to any anti-testosterone drugs like abiraterone or enzalutamide. so he went straight to chemo. Docetaxel reduced Psa 40 to 7 after 2 doses. But if he has 6 doses, his Psa may well be 1.0, but that does not mean he is cured, and in 12 months, if he is alive, Docetaxel may have little effect because what he may have then is Pca that is resistant to it.

 

These realities are part of the reason why about 30% of all men diagnosed will die from Pca. 

We like to think that what works for one man works for another but sadly this is just not always true.

If Govt and Big Pharma made Ra223 and Lu117 easily available then all hospitals would have hundreds of guys pounding on the door demanding these medicines which the medical experts say should be limited to "end stage patients" and unfortunately, Pca is a cancer for which NO CURE has been found. The Ra and Lu is radiation, and usually after radiation is done there are survivor Pca cells, The Fugly Ones, and these cannot be killed. Immune therapy is the 4th weapon to be perfected and holds some hope because it can be made to work for longer than any chemo or radiation and where surgery is useless. Much is researched on ImT, but sipulucel and other ImT is yet to be proven to cure anyone.

 

(( But a Texas doctor says apple skins, turmeric, and red grape skins kills all cancers, but does not say who has been cured yet, or how many tonnes per week you have to eat before a Psa test shows a reduction. Maybe the doc owns a vineyard and nobody wants his horrid tasting wine, and he's gotta make a $$$ some how. There's fake news, fake information, fake cures. Is it all a Russian Plot? ))

 

If surgeons do not remove a PG when a Gleason score is less than about 5, there is a large chance there is some Pca left behind, perhaps in micro mets, and the man has a battle lasting years. if no Pca is left behind, but some PG cells are left behind, those cells have similar DNA to the ones which developed Pca so they go on to become cancerous and the long battle is ahead.

I will be very surprised if I am still alive in 3 year's time.

 

Meanwhile my Melbourne friend says he can still play competition tennis after 2 chemo doses. But he's about 60, and otherwise positively health conscious like I am, and week before last I cycled 220km. I just ain't sick enough to get what seems like would be very good treatment to reduce my many small lymph node and bone mets. But If I had mets in my liver like my friend, I think docs might allow the more aggressive treatment. My friend was playing tennis after 2 chemo doses but side effects may take time to develop, and I will be surprised if he is playing tennis after 6 doses.

Some guys easily withstand 2 doses of Lu117, likely to be good for soft tissue mets. But if the scans show no mets it does not mean they ain't still there. The may well be there, only smaller, and below the scans limits for detectability, and possibly resistant to whatever killed the other Pca cells so it is never over until its over, and years have gone by without Pca being big enough to pop into view in scans.

Both Ra223 and Lu117 are absorbed into tear and saliva glands so you get dry eyes and dry mouth, and the other drugs make it likely that if you do have all teeth removed after becoming badly infected, the jaw bone does not want to heal, and wants to die.

Fact is, when cancer and the treatment has weakened you up, other shit happens, and we just don't here much from those guys.

If the Ra223 "cures" the bone mets, does it not mean that radium atoms have replaced calcium atoms where mets were? if so, what is the bone structure like? Like chalk maybe? So you'd live, but what if a fracture occurs? does it mend? if it does, its going to be slow, because none of us are young, and many of us are seriously ADT affected and have had zelodronic acid or denosumab.  

The weather here is extremely pleasant today, and autumn looks good so far, to be sure.

Patrick Turner. 

 

 

 

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Charles (Chuck) Maack

To the best of my knowledge "WHO" actually means "World Health Organization" with that organization a supporter of Traditional medicine.  As noted: Traditional medicine has a long history. It is the sum total of the knowledge, skill, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.

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whatmeworry1941

Are we still waiting for approval?

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Admin

Yes. I'm afraid so.

New legislation is needed to be adopted by parliament for this to happen.

The latest we have is that Prime Minister Turnbull told me in May that he hoped approval would be in place by Christmas.

 

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Patrick Turner

Someone here posted that he had six Xofigo infusions ( Ra223 ) and said they seemed to still be in good shape. I forget who it was, and he didn't get much response from group, but methinks there are bothers with radium.

OK, it goes where calcium activity is high at bone mets and is absorbed to replace Ca. Maybe goes to other Ca intake places. But what is the condition of bone structure where Pca is killed, assuming it is, and the bone tries to heal, or recover? If the bone mets are large, there's  the danger of easy fractures, no? - Especially verterbre compressions, a real generator of high chronic pain.

One wonders what Lu177 does to bone mets, assuming it happens to work as scans show it does for some blokes. Maybe body patches up holes in bones, but of course I guess patch up jobs in old blokes ( like me for example ) will occur at glacial pace. 

I am very likely to want Xofigo if I could get it because I have countless small bone mets. 

I am due for chemo No 3 in 10 days,  and in about 4 weeks will find out if chemo is working, or if Psa is going up, and Psa is ignoring the Docetaxel, or my body is blocking its effectiveness, wotevva. I have choice of Cabizataxel or Lu177, and I read report from fellow who said Cabizataxel gave worse side effects and Psa still went up. I have read reports saying the opposite. So it is time to gamble. No certainty of outcome at all.

Waddawee want? A cure, wennawee wannit? 3 years ago. Please don't hold your breath waitin for magic. 

Patrick Turner.

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Nev Black

Patrick, I think this is probably the posting you are referring to by Worried Man on 26 July 2018.

Keep in mind not all members reside in this country, Australia. 

 

'It's Worried Man from Fountain Hills, AZ with an update.  I was diagnosed with advanced prostate cancer on 12-1-2016.  My PSA was 283 and I began treatments with Eligard.  I am still on Eligard every six months.  Last September I was told I had a bad lesion on my left femur.  They wanted me to have that spot treated with external radiation.  Because I stayed up with the latest treatments, I knew about Xofigo (radium 223), I suggested that to my oncologist and he referred me to a radiation oncologist.  I received six injections of Xofigo ending in Feb. 2018.  Subsequent bone scan showed no new lesions in the bones, Doctor said that means we got the cancer, at least in the bones.

Recently I received some info on the Latitude and Stampede studies.  They show a remarkable extension of life if Zytiga (Abiraterone) is given before a man becomes castrate resistant.  I am not.  I will begin my treatment with Zytiga along with prednisone on this coming Monday.

I want to share this with you and your members to show how important it is to be your own advocate.  Don't hesitate to call if you have question.'

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Patrick Turner

Hi Nev, yeah, that's the post. Lord Noze what the cost was.

Anyway, I think it probably will be quite a while before Lu177 or Ra 223 are available from a public hospital, with patients getting all things for free under Medicare. 

Patrick Turner.

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whatmeworry1941
On 8/21/2018 at 5:18 AM, Admin said:

Yes. I'm afraid so.

New legislation is needed to be adopted by parliament for this to happen.

The latest we have is that Prime Minister Turnbull told me in May that he hoped approval would be in place by Christmas.

 

 

What happens if we have a new PM tomorrow?

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Nev Black

Unfortunately, I do not think Xofigo is in the forefront of the politicians, in Canberra, minds at the moment.

 

During Question Time in the Federal Parliament in Canberra today, the cross bench member for Mayo, Rebekha Sharkie asked the health minister Greg Hunt about the listing of a particular drug on the PBS. (Nothing to do with prostate cancer)

In his reply he mentioned a number of other members of the House of Representatives had canvased him about the listing date on the PBS of this particular PBAC approved drug.

 

Maybe, we have to get a number of men waiting for Xofigo (Radium 223) to approach their local federal member to make representation, to the health minister, on their behalf to move this forward. 

 

 

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Patrick Turner

The present Liberal "government" has become a rabble.

IMHO, Dutton has charisma rating of -275. Un-charismatic leaders have little chance to be elected, and Malcolm once had fire in belly, but that went out long ago, so you may have to ask Shorten's Crew to give you your Xofigo, and don't hold your breath waiting. Could take years. The only ppl I have heard about who have had Ra223 must have paid for it all themselves. Maybe they can get it because they are rich, and get it well before they become bedridden and nearly dead, when, IMHO, it may be just too late. In my mind, when chemo fails, then what? Lu177, Ra223? its all there seems to be, and bring your money to the doc, because at present, Unkel Medicare is not willing to pay.

If there was some wonder drug for a chidren's cancer, sure, they make a fast decision. But for old men?

But its old men who leave their wealth to following generations, and you never see the Treasurer give credit for those payments back to society. 

Patrick Turner.

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whatmeworry1941

Just saw my Dads Oncologist the other day. Bad news on the Radium decision for now. He said any news on Ra223 has gone quiet but Lutetium is now the more favoured choice.

 

 

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Patrick Turner

There's an election soon. Ra223 is only going to help several hundred older men, so the huge funds for Ra223 won't buy many votes.

My doc from Theranostics Australia said that Ra223 may work better on Pca bone mets than Lu177, but there is a serious risk for bone fractures. This is due to Ra replacing Ca where there is high traffic of Ca, as there is at a bone met site. Bone structure at met sites and surrounding bone volume becomes less able to withstand compression and tension forces, ie, the bone becomes chalky, so after Ra 223, one might become largely free of Pca, at least for a year or longer, but you'd need to be sedentry and not do much so you'd suffer due to inactivity,

especially if you've had ADT for 10 years.

 

The other thing is that Govt is slow to fund sicknesses and home improvements like solar panels and batteries because Govt knows many could reverse mortage their house for cancer funding, or downsize from family mansion to a smaller house, give the kids and grand kids less in their will, and spend the balance on solar panels and batteries, PLUS a BIGGER air con system to over come greenhouse warming and make life bearable in old age. But many ppl expect Govt to give enormous handouts for numerous expenses, but Liberal philosphy is "if ya wannit so much, youse can pay for it" Labour might not be any better on Ra223.

 

Meanwhile, there is some serious research going on in Vic for Pca and I guess there is some Govt funding.

But even without Govt funding the research would go on because people are prepared to pay for expensive fixes like Lu177 to get a few years more life. Those who bear the cost of research pass the cost on to medical companies who provide the treats.

Last Friday at Macquarie Uni hospital in Sydney, I had my second Lu177 infusion and there were 4 other men being done. There was $50,000 gross takings by Theranostics Australia just for that day and that procedure. There were other patients and other things being done, but it was no wonder the doc could afford his nice bow tie.

 

If Govt funds more research and herds old men towards prostate examination earlier when Psa is 3.0, not 5.0, Govt then should pay far lower amounts for later expensive treats. It is impossible to enforce lower prices charged by private enterprize doctors.

I had regular yearly Psa tests from about age 46, in 1994. Psa was about 3.0 in 2004 at 56 when I probably had Pca with low Gleason score so PG could have been removed safely / easily. I'd have dodged the estimated gross cost to me and Medicare of maybe $200,000 so far for trying to catch a horse after it has bolted.

Gleason score was 9 in 2009, at 62 when Psa went above 5.0, and Pca had spread, and was inoperable.

Diagnosis was Too Late.

Idiots suggest watchful waiting, or abolishing Psa tests, but I think if a man wants to have his PG removed WITHOUT ANY PCA present, he should be able to have it done, and all paid by Medicare to get more men to do it. 

Most nerves can be spared and so most men will recover to have continence and good sex function, plus keep his testosterone so his bones stay strong without bone density reduction by ADT, and all that allows a more cost free old age, and less medical expense borne by Govt.

Try telling all this to a Pollie; its like talking to zombie.  

However, even with premptive surgical prevention of Pca, its always possible a few men will still get Pca because surgeons cannot always remove every little bit of tissue containing prostate gland DNA, and even if 2% remains after surgery, it may become cancerous over time. But these cases would be a minority, and more treatable by IMRT etc, or preferably by immune therapy if it is made to become beneficial. 

However, many men will never get Pca and Psa remains < 0.7 at 40, and > 1.0 at 60. No need for preamptive strikes. Some have Psa that is high due to BPH but they need investigation because BPH can precede Pca.

 

I heard Peter Mac was going to try Lu177 with Keytruda, and also with Olaparib PARP inhibitors and Pembrozilumab, so not just Lu177 alone. It seems there'd be a lot to gain by combinations of drugs and nucleides like Lu177. The idea is that the if Pca is rendered punch drunk by Lu177, it cannot hide so easily from keytruda.

Getting a fix for Pca, one of The Most Difficult cancers to cure would lead to fixes for other cancers.

 

Meanwhile, my Psa was 25 before Lu177, is slightly down to 20 after first Lu177 shot. After second Lu177 last Friday, there is some bone pain without me taking any prednisolone or other pain killers, I think its due to activity and bone mets causing inflammation. But it remains to be seen if Lu177 is effective for me. I never count chickens before they hatch.

I was given my No2 infusion in a small room with another patient getting Lu177. This man was from NZ, and I had previously talked with him on HeathUnlocked discussion group. So we had a lot to talk about that made the 4 hour stay at hospital very pleasant. What we both faced was a fast rising Psa and the question was "would the speed of applied treatment stop the speed of Psa rise?"

Patrick Turner. 

 

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