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