The FDA approval of Zytiga (abiraterone acetate) for men with advanced prostate cancer defines the men who qualify to receive the drug. To qualify you must have advanced prostate cancer and meet all of the three criteria below:
1- Men who are metastatic.
2- Men who failed hormone therapy also known as castrate resistant or hormone refractory.
3- Men who have had chemotherapy with taxotere
Zytiga is not considered chemotherapy, but is a second line hormone therapy.
The treatment involves taking four pills a day along with prednisone.
The main side effect is fluid retention, with about 1/3 of men on the treatment having this experience.
If you do not meet the qualifications set by the FDA approval, it still might be possible to get the drug “off label,” but you will probably not have insurance coverage for the treatment.
Joel T. Nowak, M.A., M.S.W.
While you’re right that the drug is taken once a day, the dose is actually four 250 mg pills.
This is very positive news. In terms of the patient criteria for this drug, I wonder about the patient who is in their 70s and is at great risk from the toxic effects of chemotherapy. Must they endure taxotere treatment just to gain access to abiraterone? Would insurance pay for this drug in the chemo-naive setting if the patient is too fragile to be treated with chemo?
My understanding is that this is a 2nd line hormonal treatment for metastatic castration-resistant prostate cancer. What does it matter whether a patient has had treatment with chemo or not? If it works after failed treatment with taxotere, it does not take a genius to figure that it would be just as effective in the pre-chemo setting. The ongoing clinical trials show that these new 2nd line hormone therapies (ie. mdv3100) are more effective in the chemo-naive setting in terms of time to PSA/radiographic progression. I guess I’m just frustrated at the distinction of stages of mCRPC based on previous treatment with chemo, a treatment with high risk and, generally, minimal rewards. The FDA should approve this drug for all “stages” of mCRPC.
I qualify to receive the drug, but will it be covered by insurance?
Hello,
This is indeed great news as my father fits the criteria for FDA approved abiraterone use.
As we live in New Zealand and it is not funded, how can we obtain this medicine. We are prepared to pay full costs and have an oncologist willing to provide prescription.
Ruth,
You are right, thanks for pointing out my error.
Joel
It should be covered by insurance. It is estimated that the treatment will cost $5,000 per month. – Joel
Andrea,
It will take a few months before it will be generally available. You would need an American doctor to write the prescription. I believe that the treatment will cost $5,000 per month on the retail market. – Joel
I have found out that since the drug is “Labeled” that insurance is required to pay. It will be distributed thru a Specialty Pharmacy. You might be able to buy it off-labeled. but you will probably have to pay full retail and your insurance probably won’t cover any of the cost….
Why the requirement for having previously done chemo? That seems like an unnecessary burden if this new drug is as good as they say. Why not do this one first, before Taxotere?
It is frustrating. I agree. The requirement results from the sample population that was used in the clinical trial. Most trials tend to initially be with those who are the sickest, especially trials in advanced prostate cancer. Because death does come relatively slowly as compared to other cancers and because the FDA wants survival numbers the trials can mature more quickly (more men will die). If they used men at an earlier stage we would need to wait more years for them to die, delaying the approval.
Joel
The issue seems to be for most men over 65-how to get Medicare to pay for pre chemotherapy patients. Not sure how this federal agency can be move. Might suggest a call in campaign directly to the White House. Thousands of calls would have an effect.
My dad is having trouble getting the drug….he has had keto but not taxotere…my mother’s insurance co. has approved paying for it, the doctor prescribed it and they signed all the paperwork, but the ZytigaOne line (or whatever that 1-800 number is called) is being very cagey, saying my dad’s request “is being processed.”
Is there any reason why he should not be able to get the drug right away?
Ashley – My understanding is that it often takes them a few days to process the request. I have seen the question raised that they are behind in the manufactoring process, but I do not know that as a fact. — Joel
I agree with Tom above– Zytiga should be approved for all stages. I had all the treatments including Taxotere and my PSA was doubling monthly after 3 months of taxotere. My PSA went down 40% after just two weeks on abiraterone and another 40% at the first month check. I am #2 in phase 3 trial at MD Anderson in Houston and my PSA has been below .2 for over 2.5 years. The metastatic lymph nodes are GONE as are the bone lesions after nearly 3 years on the drug. I wasted much energy and much worry when on Taxotere and in my opinion, it is cruel to make one go through Taxotere BEFORE Zytiga. It should be first line med, not last resort!
I agree with John D Palm . I’ve been on abiraterone now for 25 cycles [cycle is 28 days] my psa WAS AT 26 IN 4 WEEKS IT WENT DOWN TO 1.7 AT THE END OF THE 2ND CYCLE IT WAS.7 I am now at 1.1 I have 3spots of cancer in the bone, all 3 got smaller within the first 4cycles and have been stable ever since I did have cancer in the lymph nodes but they are now gone. I live in CANADA where health will cover the cost I’m sure I hope everyone who needs it can get this wonderful drug.
My husband has just commenced this drug. Can you tell me what dose of prednisolone he should be having in conjunction with Abiratone acetate? He also is suffering with huge taste alteration problems which is actually stopping him from eating hence he is in hospital having total parental nutrition.. now into his second week of hospitalization with TPN continuing. Will AA have the same side effects? If yes will this be ongoing? The answer will determine his descision whether to continue or stop treatment as this has been an ongoing problem with increased intensity for six months.Unless there is some form of medication which could improve this situation for him.
It would be sad for him to have to discontinue as the trial seems to be very successful but the medication could end his life before the cancer if he cannot eat by the normal route.
From the approved label for Zytiga:
———————–DOSAGE AND ADMINISTRATION———————–
Recommended dose: ZYTIGA 1,000 mg administered orally once daily in combination with prednisone 5 mg administered orally twice daily. ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. (2.1)
•
For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the ZYTIGA starting dose to 250 mg once daily. (2.2)
•
For patients who develop hepatotoxicity during treatment, hold ZYTIGA until recovery. Retreatment may be initiated at a reduced dose. ZYTIGA
As for the eating issue, he must find a way to eat. Add to his diet supplements like Ensure.
Joel
my uncle is 80 & has prostate cancer could you send me some information on the pill abiraterone & the cost as he is on old age penison & i am on ODSP both verry poor just proud he is my only living reletove & i would like him with me alive as long as possabull but the GOV dos not understand love of family only money please contact me soon thankyou Sandra Chalmers
Estoy en Argentina, necesito que me indiquen donde se puede comprar este medicamento, o el nombre de algun Oncologo de EEUU o Canada que pueda contactar mi oncologo para poder recetar este medicamento.
Ya la terapia con Taxtere no esta funcionando PSA 125
Saludos
Anibal
Hi,
My dad has just turned 68 and was diagnosed with advance prostate cancer last may 2010. He has tried hormone therapy, radiation and chemo. Hormone therapy worked for a short time but chemo didnt work just made him feel like he had only a short time to live. We were just advised that he could start arbiraterone but had to pass many test. Everything came back good except his heart. He has to be 50% and above and his came back 44%. He has never had problems with his heart and its so unfair that this is stopping him. My dads psa is starting to rise and has been told there is no other treatment. As his only daughter I am devastated. Any help out there whats this 50% heart thing??? By reading others comments it works so really what does my dad have to loose. Kylie
Is this medication covered by Medicaid?
Thank you
Lisa, See the question below from Walter Blicker and my response immediately below.
Joel
To Sandra: Regarding your uncle, look up Chronic Disease Foundation. With the story you tell, your uncle may well receive help from this organization. They are wonderful people.
Good Luck
Deb S