27Jul13: Prostate cancer (PC) patients still can't have Abiraterone (Zytiga) on PBS before chemo fails

Did you see Channel 9 News on 26July - Abiraterone ( Zytiga ) to be funded by the Pharmaceutical Benefits Scheme ( PBS ) from 01 August? Good news for some but bad for many others.

 

The news report featured a healthy looking man who stated that he now has prostate cancer in his bones. but is overjoyed that he now has an effective and kinder drug, available from 1st August and that it will cost pensioners only $5 instead of $3,500 per month. In the presentation of this “good news” it required close attention not to miss the brief comment that Zytiga would be available only for those who had already ceased to respond to treatment with Docetaxel (chemotherapy).

 

The fear is that most viewers will now believe (wrongly) that all advanced PC patients will have access to this drug. It is simply not so. Unlike in the USA, in Australia the large proportion who could benefit from Zytiga still cannot get it. They must suffer the side-effects of chemotherapy first. Chemotherapy has to fail, meaning that these sufferers will be facing their "end-game" before the government subsidy cuts in. Because this drug delays the appearance of secondary cancer in the bones and extends life pain-free, withholding the subsidy until they are on their last legs is unjust and unfair and not much more cost-saving than treatment with chemotherapy.

 

If you have not yet done so, please add your signature to the 5,500 already on my petition to the Minister for Health seeking to rectify this by approving a subsidy for Zytiga for the "pre-chemo" group as well - see:  http://chn.ge/QsuSHc  

 

30Jun13: Minister for Health Tanya Plibersek approves Abiraterone subsidy but only for some (under PBS from August 2013)

TOO MANY ARE MISSING OUT - see: http://goo.gl/5QEhe  EXTRACT FROM MINISTER'S STATEMENT:

 

Ms. Plibersek, (quote), “The PBS listing of abiraterone will benefit more than 1,000 Australians each year who would otherwise have to pay around $27,000 a year to access the drug. This medicine offers an important treatment option for patients who are not well enough to tolerate further chemotherapy.”

 

Minister, only terminal patients having failed chemotherapy will be eligible for a PBS subsidy for Abiraterone. The rest face the ordeal of chemo and qualify only when it fails. This is illogical because chemotherapy requires hospital resources and is costly itself. Abiraterone (tablets) can substantially delay metastases, cause them to regress and is well tolerated. It extends life, pain-free.

 

The FDA in USA recognizes this and approves its use in the pre-chemotherapy group. The TGA in Australia still needs to do so and the PBAC to recommend PBS subsidy. This would be humane and cost-effective.

 

My petition with 5,400 signatures seeks to achieve this and needs the signatures (urgently) of all supporters and of the contacts of those who have already signed. Please ask everyone to sign it at http://chn.ge/QsuSHc .

16 May 2013 After the FEDERAL BUDGET - Will the Minister approve Abiraterone acetate (Zytiga)?

16 May 2013 Abiraterone acetate (Zytiga) – The FEDERAL BUDGET and The Pharmaceutical Benefits Advisory Committee (PBAC) 'Public Summary Document' Nov12 – SEE URL: http://goo.gl/WdAOo  (Document as PDF: http://goo.gl/UPc8B ).

 

Ministerial and Cabinet approval are the remaining requirements for some desperately ill prostate cancer patients to receive this drug under the Pharmaceutical Benefits Scheme (PBS). The manufacturer’s restrictions and the PBAC’s rationalization of cost containment pose significant constraints on who will be eligible.

 

These are the issues:

1. The prospect of chemotherapy is an awful one.
2. The Government could easily approve a PBS subsidy a lot sooner if it were not for all the bureaucratic process involving application, assessments, changes of position and repeated revisions.
 

On the one hand, the “Public Summary Document” states that as a prerequisite to receiving a PBS subsidy for its own drug, the manufacturer (Janssen-Cilag) required that,

- Abiraterone must not be used with chemotherapy before it is subsidized
- a patient must have failed chemotherapy with Docetaxel?
- a patient must have a WHO performance status of 2 or less?
- a patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone?

 

On the other there is the cost-saving versus life-saving comment by the PBAC,

“… The PBAC therefore reaffirmed its decision from July 2012 that a risk share agreement would be required to mitigate the financial risk to Government of treatment beyond progression (ie, progression of the cancer after treatment with abiraterone) and use (of abiraterone) in patients who had not previously been treated with docetaxel.”

These and other caveats restrict the options for patients who could otherwise receive a life extending benefit .

 

These restrictions are at odds with the recommendations of Ryan et al ( N Engl J Med 2013; 368:138-148 January 10, 2013 ) who recommend providing the drug for all advanced prostate cancer sufferers without requiring that they have to have chemotherapy first. In the USA this restriction has now been removed by the TGA. The baffling thing is why both the advisory committee and the manufacturer should seek to impose such severe restrictions on the availability of this vital drug when its use would reduce the need for other severe and costly treatments, as well as giving lots of patients a pain-free extension of life.

 

The apparent focus of this report is its economic analysis of the relative value of Abitaterone compared with other damaging or “end-game” treatments. It is astounding that figures such as $100,000 per patient or overall costs of $30 million (to budget) in a given year should be agonized over, overlooking the fact that for a national budget these are paltry sums of money for keeping advanced prostate cancer patients alive pain-free for a substantially longer time (as they have a right to expect from their government).

 

It is time that the Health Minister and Federal Cabinet approve a PBS subsidy without further delay (the Federal Budget last Tuesday provided $691 million, allocated over five years for new listings or amendments to the Pharmaceutical Benefits Scheme (PBS)).

 

To date 4,790 interested persons, patients and their friends and families, have signed my petition. It would be a great help if everyone could circulate this request to their other friends and contacts seeking even more support for this cause by asking them to sign the petition to the Minister at http://chn.ge/QsuSHc .

 

Footnote: I have been told that Janssen-Cilag is negotiating with the TGA to have Abiraterone registered and listed for PBS subsidy for the treatment of mCRPC patients who have not received chemotherapy (but this process is very slow).  

 

Prostate Cancer: Not much hope for new drug but ...

Prostate Cancer: Not much hope yet for new drug but …

 

01May13: There is not much hope yet for Australian men with incurable prostate cancer who need Abiraterone unless they are rich and chemotherapy is not working

 

The approval process for the new drug, also called Zytiga, appears to have stalled. There is no positive news, just one small ray of hope for the future.

 

I am reliably informed that the manufacturer, Janssen-Cilag is currently working with the TGA to have Abiraterone registered for the treatment of mCRPC patients who have not received chemotherapy (as is now the case in the USA) and intends to seek PBS subsidy for this indication. Unfortunately, this process can seem interminable.

 

This has to succeed to save Australian patients from a premature painful death.

 

All who have not yet signed the petition to the Minister for Health, Tanya Plibersek, are urgently invited to do so at: http://chn.ge/QsuSHc . Read more below.

 

 

 

Government Inaction on New Prostate Cancer Drug Abiraterone (Zytiga) Gets Media Attention

 

In “The International News Magazine” on Thursday, 28 March 2013 Greg Rogers published and article,  “Prostate Cancer Treatment Zytiga Needs Listing on the Pharmaceutical Benefits Scheme”  (URL for article: http://goo.gl/saNM9  ).

 

Greg also provided the following link to a letter from The PCFA (Prostate Cancer Foundation of Australia) to the Minister urging immediate action. Read that letter here.

 

This issue was also explored by Rachael Brown on 31 March 2013 in an article in the Sydney Morning Herald, "Prostate cancer drug tied up in red tape" (See: http://goo.gl/hEgFl ).

 

You can help change the discrimination against many incurable prostate cancer patients in Australia by signing the petition to the Minister for Health, "PBS should pay for Abiraterone for all incurable prostate cancer patients" and broadcast this request to all your contacts asking them to sign this petition (see URL:  http://chn.ge/QsuSHc ). All such help is much appreciated.

 

Here is a bit of further clarification. Only half the story is getting publicity. Even when the government eventually approves PBS listing there are many more incurable mCRPC patients who are not be eligible and so they are going to die painfully sooner than they should.

 

This is happening in Australia because the PBAC recommendation for a PBS subsidy for this drug is only for those patients who have failed a course of chemotherapy and are on their last legs. For this (first) group to get the drug the Federal Minister now only needs to give approval. So far she hasn't and the process is dragging on while patients suffer and die.

 

In USA the FDA has now approved Abiraterone acetate (Zytiga) for a second group of men with advanced prostate cancer without demanding they first fail a course of chemotherapy to qualify.

 

In Australia, because of the huge cost of Abiraterone and a lack of anyone seeking a PBS subsidy, those in this second group of incurables are doomed to suffer the ongoing ravages of their cancer and the side effects of chemotherapy until they also are "death's door". Only then, with little time left, may they hope to join the first group.

 

At present there is no such recommendation even being considered for pre-chemotherapy patients – seemingly not even from the manufacturer; not from the medical profession; not from involved community organizations. Several thousand incurables who could have a useful and pain free extension of life "pre-chemo" are being denied this effective treatment and an earlier death is guaranteed by the inaction. Please sign and get your friends to sign this petition at:  http://chn.ge/QsuSHc , and what about an email to your local member and the Leader of the Opposition  tony.abbott.mp@aph.gov.au .

 

References and supporting articles:

In the New England Journal of Medicine (NEJM) on 17 January, 2013 researchers concluded that, "Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy" improved radiographic progression-free survival, showed a trend toward improved overall survival, and significantly delayed clinical decline and initiation of chemotherapy in patients with metastatic castration-resistant prostate cancer." (see URL:  http://www.nejm.org/doi/full/10.1056/NEJMoa1209096 )

 

A review in UroToday (Urology News) published on 08 February 2013 interprets the (NEJM) report above as, "this shows that the patients can live longer without disease progression, can live longer without symptoms, can live longer until performance status deteriorates, can live longer until receiving chemotherapy, can live longer until starting opiates for pain, and probably live longer overall."  (see URL:   http://goo.gl/D2NGm )