05 May, 2014 - THINGS ARE MOVING A BIT - 1. Petition Signature List has been presented to the Minister - 2. PBAC to consider a PBS subsidy but it is NOT ENOUGH!

 

 EVEN MORE PUBLIC INPUT IS VITAL OR MANY WILL STILL BE DENIED THIS ESSENTIAL DRUG. This updates my last post dated 7 April, 2014. In providing the following analysis I am motivated by a greater sense of urgency than ever before.  My own cancer has spread widely throughout my body as a result of failure of ADT therapy. I learned this bad news only last month. I have already started treatment on chemotherapy (Docetaxel) myself. 

 

There are two new events to note and one represents a new opportunity to move our case forward:

 

1. Last Thursday, 01 May, 2014 I submitted a copy of our Petition with a list of 5946 signatures and all the comments to date to a Ministerial Adviser. I have been assured the Petition will receive the Minister's personal consideration. While I continue to urge new supporters to add their signatures to this petition at http://chn.ge/QsuSHc . I believe it's time to step up the tempo to obtain maximum impact.

 

2. The current restrictions on abiraterone (Zytiga) are now under reconsideration. PUBLIC SUBMISSIONS to the Pharmaceutical Benefits Advisory Committee (PBAC) for consideration at its July, 2014 meeting have been invited by the committee.

 

The PBS listing request before the PBAC for consideration at its July, 2014 Meeting reads (see details:  http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda/07-2014 ):

"... To request extension of the current Section 85 Authority required listing for abiraterone  for the treatment of metastatic castration resistant prostate cancer (mCRPC) to include patients who have progressed following treatment with androgen deprivation therapy (ADT), who would not have benefit from immediate chemotherapy."

 

My comment: This is still very restrictive because, at present, chemotherapy has to fail before patients can have abiraterone via a PBS subsidy. It is axiomatic that chemotherapy is nasty because it kills normal body cells at the same time as it kills cancer cells - only less quickly (hopefully). Chemotherapy is supposed to kill cancer cells before it kills you (eg, from body organ failure or infection). Organ damage is also why chemo causes bad side-effects and why patients have to have cortisone to reduce these. Nevertheless, although all recipients will suffer from side-effects to a greater or lesser extent, most men do survive it and do obtain a benefit from immediate chemotherapy. The consequence of restricting subsidized Abiraterone to those who would not have benefit from immediate chemotherapy means that most mCRPC patients will still not be eligible. How are they defined? Hopefully the number that will have access under this new, somewhat obscure proposal will include those who cannot tolerate chemo (perhaps less than 10%). Indeed, to give access to even a few more is good and therefore it should be supported, but it doesn't go far enough.

 

The invitation by the PBAC to make public submissions is a good opportunity for all readers, including the 5,949 supporters who have now signed the Petition to influence the Minister's consideration of our request that the PBS pay the cost of abiraterone for all, repeat ALL, advanced prostate cancer patients whose condition has become incurable, without the requirement of failing chemotherapy first or being among the few who would not have benefit from immediate chemotherapy .

 

For information on how, please read on and thank you so much for your kind support (Tony):

 

 

NB: Your personal submission can made in, "... the PBAC online submission form or  http://goo.gl/z4gZpQ .

 

When you have completed the form and pressed the SUBMIT button, your form will be sent electronically to the PBAC Secretariat and you will receive email confirmation of receipt which will include a copy of your comments"."This form is also available in hardcopy on request from the PBAC Secretariat on (02 )6289 7099. (this information extracted from PBAC PDF (How Tos) located at http://goo.gl/EeqxOP .)

 

You could choose either, to draft your own individual submission to the PBAC or if you prefer to use a prepared email or letter you could avail yourself of the prepared the text below. Please read this anyway because it contains a resumé of the latest Therapeutic Goods Administration (TGA) approval status of Abiraterone (note that the TGA is separate from the PBAC). 

New readers can make both a public submission to the PBAC and also sign my petition on this site  http://chn.ge/QsuSHc . Every input will help at this stage.

 

Please go to http://goo.gl/z4gZpQ and fill out the submission form.

 

The form asks for your details first. Then, here is a SUGGESTED TEXT for copy and pasting in Q. 5 in the form in answer to the question, "Do you have any comments on the consumer input process?":

 

"Abiraterone (Zytiga manuf. Janssen-Cilag) has recently been approved by the Therapeutic Goods Administration (TGA) after failure of androgen deprivation therapy (ADT) for incurable metastatic castrate resistant prostate cancer (CRPC) patients. That's it. There is no condition requiring they have prior chemotherapy or that the chemo should fail before they qualify, or that they would not benefit from immediate chemotherapy.

 

Therefore, the request for consideration by the PBAC at its July 2014 meeting is too restrictive. As the existing TGA approval does not require prior chemotherapy wealthy patients can already have it by paying $3,500 pm. The vast majority cannot afford this cost and so are denied access to a PBS subsidy until after they fail treatment with chemotherapy. Their only alternative choice is a toxic chemotherapy drug. The government requires this even though the alternative, abiraterone, is safer, kinder and effective. They could access abiraterone if it had a PBS subsidy. Currently, the only alternative to chemotherapy is an earlier, more painful death using the palliative care option to ease their passing.

 

Chemotherapy is nasty because it kills normal body cells at the same time as it kills cancer cells - only less quickly (hopefully). Chemo is supposed to kill cancer cells before it kills the patient (eg, from body organ failure or infection). Organ damage is also why chemo causes bad side-effects and why patients have to have cortisone to reduce these. Nevertheless, although all recipients will suffer from side-effects to a greater or lesser degree, most men do survive and obtain a benefit from immediate chemotherapy.

 

The request that the PBAC will consider in July has some merit. It will possibly help a few and therefore should be supported but it still falls far short of the need. The consequence of restricting subsidized abiraterone to those "who would not have benefit from immediate chemotherapy" means that most mCRPC patients will still not be eligible. The condition as worded is somewhat obscure. How is this group defined? Hopefully it includes a number who simply cannot tolerate chemotherapy (perhaps fewer than 10%). Making more patients eligible is good and the request will possibly help a few and so it should be supported. It just doesn't go far enough.

 

The cost to the Government might be another $30 million or so. There would be obvious offset savings because abiraterone is given as tablets at home with no need for expensive chemotherapy, which imposes a heavy burden on hospital in-patient resources and takes over much of the valuable time remaining in patients' lives, lives that are already diminished by their cancer. At present I am spending four hours every Monday (3 weeks in every 4) in order to have monitoring blood tests and IV infusions of three or four different drugs including Docetaxel. This has given me a refreshing insight into how costly the chemotherapy alternative to abiraterone is. The expense involves all the hospital infrastructure costs including the physical and service side of maintaining, a day hospital bed, plus an oncology nurse, and aide, a medical oncologist, the drugs, infusion fluids and equipment. I reckon there wouldn't be much change out of $3,500 (the monthly cost of abiraterone tablets, self-administered at home. Even if it is a bit cheaper, the other costs, medical and humanitarian, have to have a value if we are a compassionate society.

 

Effectively, the choice is either, to live on for a while without pain and the side-effects of chemo, or actually to die sooner. This choice is being directly affected by recommendations to and decisions by the government and its agencies. These are not medical decisions. In the light of the TGA approval referred to above there is no medical reason for withholding a PBS subsidy permitting access to abiraterone by all incurable CRPC patients. Not providing a subsidy is discrimination between equally deserving sufferers on the basis of means. This is unfair.

 

I urge the PBAC to exercise compassion as well as scientific and economic scrutiny in formulating its recommendation, so that:

 

 All incurable CRPC ADT resistant patients (metastatic and pre-metastatic) should qualify for a PBS subsidy of abiraterone after failure of androgen deprivation therapy (ADT), giving all an equal chance for the best possible outcome, irrespective of their financial means

 

This information also appears in my Facebook post dated 04 May, 2014, see: https://www.facebook.com/tony.pcm.5

  

05April14 IMPORTANT NEWS - IF YOU CAN AFFORD TO PAY, Zytiga (Abiraterone) is now approved for mCRP patients before chemotherapy

05April14  IMPORTANT NEWS - Zytiga (Abiraterone) is now approved by TGA for "pre-chemo" metastatic castration resistant prostate cancer (mCRP) patients. Yet they still have to pay a small fortune for this drug that has now been accepted as an effective, low risk treatment and often preferable to chemotherapy. This is because it has not yet been recommended for a PBS subsidy by the PBAC. The new Minister for Health is urged to fix this so that several thousand Australian men might live longer without pain or the ill-effects of chemotherapy. 

 

 (Please sign my petition to the Minister at http://chn.ge/QsuSHc )

 

 

Here is a very brief summary of the Current TGA Regulatory Status of Abiraterone. (The following are key brief excerpts from the original document¹ which has has 31 pages - see: http://www.tga.gov.au/pdf/auspar/auspar-abiraterone-acetate-140122.pdf ) (There is some highlighting of significant words).

 

"The product received initial Australian Register of Therapeutic Goods (ARTG) Registration on 27 February 2012."

 

"Clinical findings (a summary) ...

 

The Overall Survival (OS) and Radiographic Progression-Free Survival (rPFS) data are supported by convincing results on the secondary endpoints, particularly those relating to the initiation of cytotoxic chemotherapy and opiate analgesia. The other endpoints suggest that abiraterone is likely to be also associated with maintenance of functional status/quality of life.

 

Overall the data from the pivotal study are considered to provide convincing evidence of the efficacy of abiraterone in chemotherapy-naïve patients with mCRPC. ...

 

The safety profile of the drug appears more favourable than that of taxane chemotherapy. ... "

 

"Benefit-risk assessment -

 

First round assessment of benefits

The benefits of abiraterone in the proposed usage are:

• A decreased risk of disease progression as assessed by bone scan/magnetic resonance imaging (MRI)/computed tomography (CT);

• A delay in the need for chemotherapy and opiate analgesia;

• Maintenance of functional status/quality of life.

 

First round assessment of benefit-risk balance

 

The benefit-risk balance of abiraterone, given the proposed usage, was considered to be favourable."

 

"First round recommendation regarding authorisation

 

It was recommended that the application be approved. ...  restriction (in symptomatic patients in whom chemotherapy is not yet clinically indicated ) seems unnecessary since the risks of chemotherapy are likely to exceed the benefits in asymptomatic or mildly symptomatic patients and therefore chemotherapy is unlikely to be clinically indicated.

 

The benefit-risk balance of abiraterone in the proposed indication was considered to be positive."

 

"Indications ...  the TGA Clinical Evaluator’s and TGA Delegate's recommendations to approve abiraterone for the extended indication (the sponsor agreed) (were):

 

“ZYTIGA is indicated with prednisone or prednisolone for the treatment of patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mCRPC):

 

• who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) or

 

• who have received prior chemotherapy containing a taxane.” ...

 

"Janssen (the manufacturer) concurred with the Clinical Evaluator’s and Delegate’s assessment that efficacy has been established in the proposed indication. The EU, whose guidelines TGA adopts, also agreed that efficacy had been established as evidenced by their approving of the extension of indications. The new indication has also been approved in the USA, Canada and New Zealand.

 

The safety profile in Study COU–AA-302 (the definitive research study reported in N Engl J Med 2013; 368:138-148 / http://www.nejm.org/toc/nejm/368/2/ ) was consistent with abiraterone’s well established favourable toxicity profile, especially when compared to chemotherapy. For a patient with incurable mCRPC, treatment with an oral medication as an outpatient, without the side effects of cytotoxic chemotherapy, is clinically meaningful in the context of the limited available treatment options."

 

"Outcome

Based on a review of quality, safety and efficacy, TGA approved the registration of Zytiga/Janssen Abiraterone tablets (250 mg abiraterone acetate) for oral administration, indicated for (additional indication):

Zytiga is indicated with prednisone or prednisolone for the treatment of patients with metastatic castration resistant prostate cancer (mCRP) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT).10F11"

 

 

¹ EXTRACTED from SOURCE Document (See the full text in the following):

 

"AusPAR Zytiga Abiraterone acetate Janssen-Cilag Pty Ltd PM-2012-02706-3-4 Final 22 January 2014"

 

click on:  http://www.tga.gov.au/pdf/auspar/auspar-abiraterone-acetate-140122.pdf

 

 

Therapeutic Goods Administration

PO Box 100 Woden ACT 2606 Australia

Email: info@tga.gov.au

Phone: 1800 020 653

Fax: 02 6232 8605

http://www.tga.gov.au

 

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 )

 

 

Incurable prostate cancer patients denied new medication on the PBS

Chemotherapy-naïve (never had chemo) patients also deserve Zytiga “free” on the PBS

 
Prostate cancer (PC) is the most common male cancer in Australia and the third most common cause of death from cancer in males (Australian Cancer Database 2007). It was the most common type of newly diagnosed cancer among males in 2007 (19,403 cases), ahead of breast cancer in females (12,567 cases).°  Many men die from PC every year, most from advanced stages in its castrate resistant (hormone resistant) form. Metastatic prostate cancer occurs in most of these men after a period of treatment with LHRH agonists (drugs which suppress male hormone) and the cancer eventually becomes hormone-refractory (ie, resistant to this treatment). These patients are incurable. Inevitably they will die from their cancer. Currently, once metastases (secondary cancer deposits) are present, chemotherapy and palliative measures for the relief of pain are needed until the time of death.

 Abiraterone acetate (Zytiga, Janssen Cilag Pty., Ltd.) is one of the few effective new drugs proven to prolong life and delay the onset of pain and the need for opiates in patients with advanced prostate cancer. Abiraterone arrests cancer progression and inhibits the development of distant metastases for a significant period. It postpones the need for unpleasant chemotherapy drugs. Evidence for this was presented at the annual meeting of the American Society of Clinical Oncology in June, 2012.¹ ² This followed publication of the original clinical trial COU-AA-302 in the New England Journal of Medicine on May 26, 2011.¹

 On 1^st March, 2012 (under Section 28 of the Therapeutic Goods Act 1989), abiraterone was approved for treatment of castrate resistant metastatic prostate cancer (mCRPC) but only after patients have already been treated with chemotherapy.³  It is not approved for “chemotherapy-naïve”patients (those who have not yet had chemotherapy) even though they also have advanced cancer and are incurable. They are the “excluded ”group. It has been recommended but not yet approved for subsidy via the Pharmaceutical Benefits Scheme (PBS).

 An application from (Janssen Australia) has recently been recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) but only on behalf of mCRPC patients whose cancer has progressed in spite of enduring the unpleasant side effects of chemotherapy with a“taxane”.³  This means that those patients in the “excluded” group will not be permitted the more effective treatment when it will do the most good and without the side effects of the alternative, chemotherapy.

 The PBAC has already acknowledged that abiraterone has a better safety profile and is more convenient to administer (oral administration) than cabazitaxel. ³ Janssen R&D in the USA has announced it will seek a new indication for abiraterone in chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) in the second half of 2012.²

 Therefore, in order to survive longer and postpone the ravages of secondary cancer the mCRPC “excluded”group would to pay the full price to receive treatment with abiraterone. Information from the supplier puts the approximate cost at $3,300 per month, thus placing it out of reach of all but the richest Australians.

Why is this group of cancer sufferers forced to endure the pain of advancing metastatic cancer in the bones, brain and liver before they are allowed to receive abiraterone funded by the PBS? When chemotherapy fails (and this is inevitable) they will be much closer to death and only then might the PBS pay for the medication. Why should they be denied a significant extension of life pain-free when this new drug Abiraterone can achieve this?

 These restrictions derive from criteria set by the PBAC designed to minimize financial cost.³  The rules are oppressive. Cost savings are to be achieved at the expense of the pain and suffering and the faster track to death determined by government edict for mCRPC sufferers.

Already, there is excellent evidence that abiraterone can delay progression of the cancer, minimize symptoms and lengthen life.¹ ²   Surely, Australian men with incurable prostate cancer are just as worthy of receiving costly treatment as others, eg, HIV aids, renal dialysis, organ transplants, etc.. The cost of chemotherapy and “best supportive care” treatment, alternatives to abiraterone that are already approved for subsidy for PC patients, can themselves be very expensive. Therefore the current restrictions on the availability of abiraterone are unreasonable and oppressive. Budgetary restrictions need to be lifted, otherwise many more men will die before they can get this new drug

 

STOP PRESS  08Feb'12: Extracts from Updated Research and Reports

 In November 2012 the Pharmaceutical Benefits Advisory Committee (PBAC) recommended listing Abiraterone on a cost-minimisation basis with cabazitaxel and cost‑effectiveness basis when compared with best supportive care (see URL http://goo.gl/UhVu1 ).

It may take several months to receive Ministerial and Cabinet approval, which could still be denied. Even if a PBS subsidy is approved, it will benefit only those patients with incurable prostate cancer who have failed treatment with chemotherapy. Those who have not had chemo first will not be eligible. Unlike the FDA in the USA, The Therapeutics Goods Administration (TGA) in Australia has not given approval for these patients. Without such approval no application for PBAC consideration is possible under the "rules". As a consequence about 2,000 Australian men will inevitably develop painful secondaries forcing them onto chemotherapy. They are being left without access to this effective treatment that offers a pain-free extension of life. If the Government so decided, this process could and should be expedited)

 Support for: Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy

from: National Cancer Institute UPDATE of December 11, 2012 Report:   "FDA Approval for Abiraterone Acetate"  (See WEB: http://www.cancer.gov/cancertopics/druginfo/fda-abirateroneacetate  )  URL abbreviated to: http://goo.gl/i3PBi

EXTRACT  " ... abiraterone acetate was approved by the FDA*  on December 10, 2012 for the treatment of mCRPC patients prior to receiving chemotherapy."

* Food and Drug Administration - USA
Reference:  ¹Charles J. Ryan, et al. (for the COU-AA-302 Investigators). "Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy." N Engl J Med. 2013; 368:138-48 doi: 10.1056/NEJMoa1209096   (report updated January 17, 2013)
________________________________________________________________________________

from N Engl J Med. 2013; 368:138-48 (UPDATE 17Jan13) : "Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy"  (See WEB: http://www.nejm.org/doi/full/10.1056/NEJMoa1209096 )  URL abbreviated to: http://goo.gl/39YeM

EXTRACT  "Conclusions: Abiraterone 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."

_______________________________________________________________________________

from: UroToday (Urology News) published on Friday, 08 February 2013 16:19 (referring to the above): "Abiraterone in metastatic prostate cancer without previous chemotherapy (from study COU-AA-302)"

(See WEB: http://www.urotoday.com/Treatment-of-mCRPC/abiraterone-in-metastatic-prostate-cancer-without-previous-chemotherapy-from-cou-aa-302.html  )  URL abbreviated to: http://goo.gl/D2NGm

EXTRACT  " ... In summary, 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. ..."

_____________________________________________________________________________
My Goal: Make Abiraterone acetate (Zytiga) available immediately via the Pharmaceutical Benefits Scheme for ALL patients who have metastatic castration-resistant prostate cancer, without the current requirement for prior treatment with chemotherapy.

 Your support for this proposal would be much appreciated. How? simply click on the following URL (or paste it into the address pane in your web browser). Then "sign" the prepared email petitioning the federal minister for health to cover the cost for the excluded patients under the PBS:  https://www.change.org/en-GB/petitions/pbs-should-pay-for-abirterone-for-all-incurable-prostate-cancer-patients#.html

 
Footnotes and References:
 
° Australian Institute of Health and Welfare (AIHW):

Cancer in Australia 2010: in brief. ISSN 1039-3307; ISBN 978-1-74249-081-6; Cat. no. CAN 55; 28pp.

http://www.aihw.gov.au/publication-detail/?id=6442472454

 

¹  American Society of Clinical Oncology (ASCO):

 
ASCO Daily News June 1-5, 2012 > Abstract LBA4518, Charles J Ryan,“Abiraterone Delays Progression in Patients with Chemotherapy-Naïve CRPC” Jun1-5’12 ASCO Annual Meeting >

J Clin Oncol 30, 2012 (suppl; abstr LBA4518) “Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)” URL:

http://chicago2012.asco.org/ASCODailyNews/LBA4518.aspx?et_cid=29383386&et_rid=463667997&linkid=http%3a%2f%2fchicago2012.asco.org%2fASCODailyNews%2fLBA4518.aspx

 
EXTRACTS of KEY POINTS:

 “ … In patients with asymptomatic or mildly symptomatic chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), abiraterone acetate (AA) plus prednisone produced a statistically significant benefit in radiographic progression-free survival (rPFS) over placebo plus prednisone, according to a planned interim analysis of a phase III study. … “

 “ …AA plus prednisone delayed disease progression, increased survival, and extended time with minimal or no symptoms, said Charles J. Ryan, MD, of the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco. In addition, no important new safety signals were seen in the randomized, multicenter COU-AA- 302 study, added Dr. Ryan,

 “ …the co-primary endpoints of overall survival (OS) and rPFS and secondary endpoints all favored the AA arm and unanimously recommended unblinding the study and crossing patients over from placebo to AA treatment, Dr. Ryan said.

 “ …the objectives of therapy development in this disease state have been met, … “

 “ … These data merit consideration as providing a new standard approach in this highly prevalent patient population faced with an unmet medical need.”

“… However, a reality is that much of the life of a patient with mCRPC is lived before chemotherapy, and in fact a large proportion of patients never receive it,” he said.

 "The natural history of progressive mCRPC can be prolonged, and can appear over a period of years. Therefore, several hallmarks of disease progression (time to opiate use as a surrogate for cancer-related pain, time to initiation of chemotherapy, time to Eastern Cooperative Oncology Group performance status deterioration, time to PSA progression) were used as secondary endpoints, to provide “a comprehensive assessment of the magnitude of the clinical benefit conferred by AA,” Dr. Ryan said. “Therapy with AA delayed, to a clinically significant degree, the onset of these meaningful events,” he said. … “

 

¹ (additional reference) Original article (Clinical Trial COU-AA-302) published in:

 N Engl J Med 2011; 364:1995-2005May 26, 2011 Abiraterone and Increased Survival in Metastatic Prostate Cancer. “Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)”

Johann S. de Bono, M.B., Ch.B., Ph.D., Christopher J. Logothetis, M.D., Arturo Molina, M.D., Karim Fizazi, M.D., Ph.D., Scott North, M.D., Luis Chu, M.D., Kim N. Chi, M.D., Robert J. Jones, M.D., Oscar B. Goodman, Jr., M.D., Ph.D., Fred Saad, M.D., John N. Staffurth, M.D., Paul Mainwaring, M.D., M.B., B.S., Stephen Harland, M.D., Thomas W. Flaig, M.D., Thomas E. Hutson, D.O., Pharm.D., Tina Cheng, M.D., Helen Patterson, M.D., John D. Hainsworth, M.D., Charles J. Ryan, M.D., Cora N. Sternberg, M.D., Susan L. Ellard, M.D., Aude Fléchon, M.D., Ph.D., Mansoor Saleh, M.D., Mark Scholz, M.D., Eleni Efstathiou, M.D., Ph.D., Andrea Zivi, M.D., Diletta Bianchini, M.D., Yohann Loriot, M.D., Nicole Chieffo, M.B.A., Thian Kheoh, Ph.D., Christopher M. Haqq, M.D., Ph.D., and Howard I. Scher, M.D. for the COU-AA-301 Investigators

http://www.nejm.org/doi/full/10.1056/NEJMoa1014618#t=abstract

http://www.nejm.org/doi/full/10.1056/NEJMoa1014618

 

²  OncologyStat (a subscriber medical journal scanning and news service)

“Abiraterone Delays Progression in Patients with Chemotherapy-Naïve CRPC,” ASCO 2012: Conference Coverage Roundup: Abstract from: IMNG Medical Media. 2012 Jun 11, P Wendling “Abiraterone Blocks Chemo-Naïve Prostate Cancer” 

http://www.oncologystat.com/news/Abiraterone_Blocks_Chemo-Naive_Prostate_Cancer_US.html

(Note: to read the full article it is necessary to sign up to this professional cancer news publication, OncologyStat; it takes only a few seconds on this URL and membership is free).

 
EXTRACTS of KEY POINTS:

“CHICAGO (EGMN) - Abiraterone acetate plus prednisone significantly delays progression and initiation of chemotherapy in asymptomatic or mildly symptomatic, chemotherapy-naive, metastatic, castration-resistant prostate cancer, according to much-anticipated data from a pivotal clinical trial. >

The second preplanned interim analysis of the COU-AA-302 trial also revealed a strong overall survival trend favoring abiraterone (Zytiga) over prednisone and placebo, leading to unblinding of the phase III trial in March 2012 and crossover treatment for the control arm. … “

 “… This is the first trial to show progression and overall survival benefits in this setting. Janssen Research & Development announced it will seek a new indication for abiraterone in chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) in the second half of 2012. >

The combination of abiraterone plus prednisone has already demonstrated an overall survival benefit in patients with prior chemotherapy, leading to its approval in April 2011 for mCRPC that had previously been treated with docetaxel (Taxotere) chemotherapy.…”

(author’s note: From the expert commentaries extracted above two compelling reasons emerge as to why a PBS subsidy should apply without further delay for chemo-naïve mCRPC patients. One derives from the evidence that abiraterone is effective and “safer …” and this has been acknowledged by the PBAC (plus Janssen-Cilag is seeking FDA approval in the USA for this group on the same basis). The other is that the strength of this evidence led the COU-AA-302 clinical trial to be unblinded early so as to permit the control group to receive the obvious benefits of the drug. Their lives would otherwise have been sacrificed, arguably unjustifiably in order to keep the trial “pure”. This is the moral and ethical dilemma that can sometimes arise and it serves as a timely reminder that real people are affected for better or worse by decisions made in the name of scientific purity. Other trials are also ongoing in the USA to confirm the safety of abiraterone. The outcomes will be very important. Nevertheless, there is already sufficient evidence in its favour to permit eligible patients to make an informed decision on the balance of risks to benefits of receiving this drug now instead of chemotherapy. It should be their choice.)

 
³  Pharmaceutical Benefits Advisory Committee (PBAC)

EXTRACTS of KEY MILESTONES:

Nov, 2011     Pharmaceutical Benefits Advisory Committee (PBAC) Public Summary Document

http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-abirateronee-nov11

“… 2. Background

The Rule of Rescue:
There are four factors which when applied concurrently in exceptional circumstances, are called the ‘rule of rescue’ as follows.

• No alternative exists in Australia to treat patients with the specific circumstances of the medical condition meeting the criteria of the restriction. This means that there are no nonpharmacological or pharmacological interventions for these patients.
• The medical condition defined by the requested restriction is severe, progressive and expected to lead to premature death. The more severe the condition, or the younger the age at which a person with the condition might die, or the closer a person with the condition is to death, the more influential the rule of rescue might be in the consideration by PBAC.
• The medical condition defined by the requested restriction applies to only a very small number of patients. Again, the fewer the patients, the more influential the rule of rescue might be in the consideration by PBAC. However, PBAC is also mindful that the PBS is a community-based scheme and cannot cater for individual circumstances.
• The proposed drug provides a worthwhile clinical improvement sufficient to qualify as a rescue from the medical condition. The greater the rescue, the more influential the rule of rescue might be in the consideration by PBAC.

(author’s note: the italics are mine)

“ … 11. Estimated PBS Usage and Financial Implications

The net financial cost to the PBS was estimated by the submission to be between $30 – $60 million in Year 5 of listing. The estimate was considered uncertain because of the potential of extended use beyond disease progression given the safety profile and ease of administration of abiraterone.”


“ … 12.  Recommendations and Reasons … ”

“ … Whilst the PBAC considered that there are uncertainties inherent from indirect comparisons, it accepted the submission’s clinical claims:  … 3) abiraterone plus prednisone/prednisolone is non-inferior in terms of comparative effectiveness and superior in terms of comparative safety over cabazitaxel plus prednisone/prednisolone alone. … ”
 
(author’s note: this assertion stands in contradistinction to those in the key points in reference¹ above, in particular, “ … AA plus prednisone delayed disease progression, increased survival, and extended time with minimal or no symptoms” … and “…“Therapy with AA delayed, to a clinically significant degree, the onset of these meaningful events, … ” ie, Abiraterone is better than non-inferior. It is acknowledged by the PBAC as safer.)
 
“ … The PBAC therefore rejected the submission on the basis of an unacceptably high incremental cost-effectiveness ratio and due to uncertainty regarding the clinical place in therapy.”

“ … 14. Sponsor’s Comment

The sponsor has no comment.“

(author’s note: in reference ² above, third key point, see: “ … Janssen Research & Development (USA)  announced it will seek a new indication (ie, FDA approval) for abiraterone in chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) in the second half of 2012. … “  In view of this more recent announcement by the sponsor’s USA parent one hopes that this situation has changed since November, 2011. I am seeking more information on Janssen Australia’s intentions. )

 
March 2012     PBAC Outcomes - Positive Recommendations:

http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2012-03/positive-recommendations

“PBS Listing requested by the sponsor (Janssen-Cilag Pty Ltd):

Authority Required listing for the initial and continuing treatment, in combination with prednisone or prednisolone, of patients with metastatic advanced prostate cancer (castration resistant prostate cancer) in whom disease progression has occurred following treatment with docetaxel”
 
“PBAC Recommendation:

Recommended on a cost-minimisation basis with cabazitaxel. The PBAC noted that abiraterone has a better safety profile and is more convenient to administer (oral administration) than cabazitaxel.”

(author’s notes: 

a) “cost-minimization” !

b) in reference ² above, third key point, see: “ … Janssen Research & Development announced it will seek a new indication for abiraterone in chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) in the second half of 2012. … “ but this is in the USA, not in Australia.

Janssen Australia would need to obtain a similar approval from the Therapeutics Goods Administration (TGA) in Australia as well as succeed with a further request to the PBAC to include chemotherapy-naive mCRPC patients in a listing for PBS subsidy before this “excluded” group could get any access to abiraterone. All this regulatory process eats up precious time, time that these patients don’t have)

 
July 2012     Agenda for the July 2012 PBAC Meeting

http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-agenda

                                                                                                                                                                     

Listing requested by Sponsor (Janssen-Cilag Pty Ltd ) /  Purpose of Submission: 

“Re-submission to request a review of the March 2012 PBAC recommendation for an Authority Required listing for the initial and continuing treatment, in combination with prednisone or prednisolone, of patients with metastatic advanced prostate cancer (castration resistant prostate cancer) in whom disease progression has occurred following treatment with docetaxel.”

(author’s note:  It is still not being considered for “chemotherapy-naïve”patients (those who have not yet had chemotherapy) even though they also have advanced cancer and are incurable. The “excluded ” group  are still being left to get worse and condemned to chemotherapy.)

26 Sep12  Agenda for the November 2012 PBAC Meeting

http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-agenda

“Resubmission

ABIRATERONE, tablet, 250 mg (as acetate), Zytiga^®

Prostate cancer

Requests a review of the PBAC’s March 2012 recommendation to list abiraterone on a cost‑minimisation basis to cabazitaxel as an Authority Required benefit for the treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who meets certain criteria.”

(author’s note:  The request by Janssen to the PBAC for consideration at it November, 2012 meeting (see extract above), basically reverting to the wording used in March, including a rider, viz., “ … of castration resistant metastatic carcinoma of the prostate in a patient who meets certain criteria.” construed to mean those who have failed chemotherapy and to still exclude the chemotherapy-naive  “excluded” group that I have identified (see above).)

______________________________________________________________________________

 On 08 October, 2012 I submitted the following comment to the PBAC for consideration at its November, 2012 meeting:
Copy:

 

"My Consumer Comment (also my clinical comment as a retired medical practitioner and medical administrator in community and public health)

Following radical prostatectomy and radiotherapy I have been treated with IM Lucrin depot which kept my PSA down for three years but I am now “hormone refractory”

 

The real new hope for "post-chemotherapy" mCRPC and "chemotherapy-naïve" mCRPC patients (like me) resides in two seminal events:

1. In September 2012 the final analysis of the COU-AA-301 study was published online in Lancet Oncology confirming that abiraterone significantly prolongs overall survival in patients with metastatic castrate resistant prostate cancer (mCRPC) who have progressed after docetaxel treatment. No new safety signals were identified with increased follow-up, and

 

2. The highly significant comments made in June, 2012 at the ASCO Conference in Chicago, viz.,

"Abiraterone Delays Progression in Patients with Chemotherapy-Naïve CRPC: In patients with asymptomatic or mildly symptomatic chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), abiraterone acetate (AA) plus prednisone produced a statistically significant benefit in radiographic progression-free survival (rPFS) over placebo plus prednisone, according to a planned interim analysis of a phase III study"

 

More than a year ago the EU, UK and USA approved the subsidy of abiraterone basically on the same terms as the Australian Sponsor’s request for listing in March 2012. Meanwhile it is still not listed on the PBS despite repeated consideration by the PBAC since November 2011.

The obvious remaining factor denying access to abiraterone for the “post-chemotherapy”   patients is “cost-minimization”. Compared with the evident benefit in regard to significant extension of life and amelioration of symptoms cost should not be a consideration. It isn’t in other diseases such as HIV aids where lives are also at stake.

 

A second group excluded from receiving the obvious benefits of abiraterone comprises“chemotherapy-naïve” mCRPC patients (excluded ones including myself). Just like “post-chemotherapy”  patients these men also have advanced cancer. They too are incurable and the outcome for them is invariably fatal.  The TGA approval of March 2012 did not include them but they also are on death row like those who have had docetaxel, mitoxantrone and cabazitaxel. It’s just they are at an earlier stage. They will have to get worse even though there is an effective and less harmful remedy available, abiraterone, all because of “cost-minimization”.

 

The TGA has already approved abiraterone for patients in the “post-chemotherapy”  group. There is an urgent need for the TGA to approve the drug for the“chemotherapy-naïve” mCRPC group as well. The benefits and safety for the latter group were declared at the ASCO Conference in Chicago in June 2012. These patients urgently need a reprieve before their condition worsens. TGA approval would clear the way for the PBAC to recommend a PBS subsidy for this group as well.

 

As for cost-effectiveness, the base price of abiraterone seems to compare favourably with published costs of taxane chemotherapeutic drugs and “best supportive care” (BSC) both of which have known costly components. Oral administration gives abiraterone a cost advantage. BSC and chemotherapy attract additional costs including IV administration, use of hospital beds and staff, treatment of side effects, analgesia and palliative care radiotherapy. In any case, to weigh some residual cost-saving against a patient’s best interests goes against a fundamental principle of justice in our society.

 

Neither should cost-saving become a lottery where some diseases are permitted high-cost treatments while others are not. Just as Burroughs Wellcome was induced (by popular protest) to offer a 36% lower price for AZT in 1989, price negotiation remains a further tool in the process of cost-minimization. Agreement on price by sponsor and government must be achieved. It should not be allowed to roll over for further reconsideration at future PBAC meetings which would mean more delay while lives are literally at stake.

 
Until TGA approval is given for inclusion of the“chemotherapy-naïve”  mCRPC group, saving money will continue to have greater weight than delaying the development of overt metastases and painful complications like spontaneous fractures of vertibrae and spinal nerve compression. Who could look even one patient in the eye and say, you can have chemotherapy with all of its downside but no, you may not have the drug abiraterone that could delay all this suffering and extend your life, all because it costs too much.
 

I therefore ask the PBAC at its November 2012 meeting to recommend an immediate subsidy for abiraterone on the PBS for the “post-chemotherapy”  group and do what is necessary to press the TGA to broaden its current approval to include“chemotherapy-naïve” mCRPC patients, this to be followed by an immediate subsidy for them also. For those of us with the disease this is a matter of life or death.

 

Yours sincerely, ”

November 2012    PBAC Outcomes - Positive Recommendations

LISTING REQUESTED BY SPONSOR

http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2012-11/positive-recommendations

 Requests a review of the PBAC’s March 2012 recommendation to list abiraterone on a cost minimisation basis to cabazitaxel as an Authority Required benefit for the treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who meets certain criteria.

PBAC RECOMMENDATION

 The PBAC recommended listing on a cost-minimisation basis with cabazitaxel and cost‑effectiveness basis when compared with best supportive care

 (author’s notes: 

 

It may take several months to receive Ministerial and Cabinet approval, which could still be denied. Even if a PBS subsidy is approved, it will benefit only those patients with incurable prostate cancer who have failed treatment with chemotherapy. Those who have not had chemo first will not be eligible. Unlike the FDA in the USA, The Therapeutics Goods Administration (TGA) in Australia has not given approval for these patients. Without such approval no application for PBAC consideration is possible under the "rules". As a consequence about 2,000 Australian men will inevitably develop painful secondaries forcing them onto chemotherapy. They are being left without access to this effective treatment that offers a pain-free extension of life. If the Government so decided, this process could and should be expedited)

________________________________________________________________________________ 

Blog updated 17Feb13