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Old 09-09-2015, 01:25 PM   #1
Debbie L.
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Pertuzumab not "cost effective"?!

“The addition of pertuzumab to a standard regimen of TH for treatment of metastatic HER2-overexpressing breast cancer is unlikely to provide reasonable value for money spent in the United States compared with other interventions generally deemed cost effective,” the authors wrote. “This analysis highlights the economic challenges of extending life for patients with noncurable disease.” Here's the link to the whole article.

This is sure to be provocative and controversial. Perhaps initially specifically to pertuzumab, but eventually for all the expensive new cancer drugs.

What do those of you who are savvy about reimbursement think? Could insurance and medicare/medical use this to deny coverage for an FDA-approved drug indication?

I'm about as frugal as one can get, but even I find this shocking. If we're going to develop and approve drugs, then any needed action on their cost should happen much sooner than when they're already out there, benefiting people. Am I overreacting?

Debbie Laxague
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Old 09-09-2015, 09:49 PM   #2
SoCalGal
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Re: Pertuzumab not "cost effective"?!

Why does it cost so friggin' much?

"The total cost of cancer care in the United States is projected to be between $173 and $207 billion by 2020".
This preceding sentence triggers my fear of big pharma suppressing cures and maintaining treatments.

Now with the insurance weighing in, they don't want to pay for said treatment. It is a mess. It is horrible to be reduced to a statistic, and even so, I don't fit the mold. It's hard enough to fight a disease for which there is no cure, only treatments, and the potential of treatments denied by insurance just adds to the stress and burden. Very frustrating.
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1996 cancer WTF?! 1.3 cm lumpectomy Er/Pr neg. Her2+ (20nodes NEGATIVE) did CMF + rads. NED.
2002 recurrence. Bilateral mastectomy w/TFL autologous recon. Then ACx2. Skin lymphatic rash. Taxotere w/Herceptin x4. Herceptin/Xeloda. Finally stops spreading.
2003 - Back to surgery, remove skin mets, and will have surgery one week later when pathology can confirm margins.
‘03 latisimus dorsi flap to remove skin mets. CLEAN MARGINS. Continue single agent Herceptin thru 4/04. NED.
‘04 '05 & 06 tiny recurrences - scar line. surgery to cut out. NED each time.
1/2006 Rads again, to scar line. NED.

3/07 Heartbreaking news - mets! lungs.sternum. Try Tykerb/Xeloda. Tykerb/Carbo/Gemzar. Switch Oncs.
12/07 Herceptin.Tykerb. Markers go stable.
2/8/08 gamma knife 13mm stupid brain met.
3/08 Herceptin/tykerb/avastin/zometa.
3/09 brain NED. Lungs STABLE.
4/09 attack sternum (10 daysPHOTONS.5 days ELECTRONS)
9/09 MARKERS normal!
3/10 PET/CT=manubrium intensely metabolically active but stable. NEDhead.
Wash out 5/10 for tdm1 but 6/10 CT STABLE, PET improving. Markers normal. Brain NED. Resume just Herceptin plus ZOMETA
Dec 2010 Brain NED, lungs/sternum stable. markers normal.
MAR 2011 stop Herceptin/allergy! Go back on Tykerb and switch to Xgeva.
May-Aug 2011 Tykerb Herceptin Xgeva.
Sept 2011 Tykerb, Herceptin, Zometa, Avastin.
April 2012 sketchy drug trial in NYC. 6 weeks later I’m NED!
OCT 2012 PET/CT shows a bunch of freakin’ progression. Back to LA and Herceptin.avastin.zometa.
12/20/12 add in PERJETA!
March 2013 – 5 YEARS POST continue HAPZ
APRIL 2013 - 6 yrs stage 4. "FAILED" PETscan on 4/2/13
May 2013: rePetted - improvement in lungs, left adrenal stable, right 6th rib inactive, (must be PERJETA avastin) sternum and L1 fruckin'worsen. Drop zometa. ADD Xgeva. Doc says get rads consultant for L1 and possible biopsy of L1. I say, no thanks, doc. Lets see what xgeva brings to the table first. It's summer.
June-August 2013HAPX Herceptin Avastin Perjeta xgeva.
Sept - now - on chemo hold for calming tummy we hope. Markers stable for 2 months.
Nov 2013 - Herceptin-Perjeta-Avastin-Xgeva (collageneous colitis, which explains tummy probs, added Entocort)
December '13 BRAIN MRI ned in da head.
Jan 2014: CONTINUING on HAPX…
FEB 2014 PetCT clinical “impression”: 1. newbie nodule - SUV 1.5 right apical nodule, mildly hypermetabolic “suggestive” of worsening neoplastic lesion. 2. moderate worsening of the sternum – SUV 5.6 from 3.8
3. increasing sclerosis & decreasing activity of L1 met “suggests” mild healing. (SUV 9.4 v 12.1 in May ‘13)
4. scattered lung nodules, up to 5mm in size = stable, no increased activity
5. other small scattered sclerotic lesions, one in right iliac and one in thoracic vertebral body similar in appearance to L1 without PET activity and not clearly pathologic
APRIL 2014 - 6 YRS POST GAMMA ZAP, 7 YRS MBC & 18 YEARS FROM ORIGINAL DX!
October 2014: hold avastin, continue HPX
Feb 2015 Cancer you lost. NEDHEAD 7 years post gamma zap miracle, 8 years ST4, +19 yrs original diagnosis.
Continue HPX. Adding back Avastin
Nov 2015 pet/ct is mixed result. L1 SUV is worse. Continue Herceptin/avastin/xgeva. Might revisit Perjeta for L1. Meantime going for rads consult for L1
December 2015 - brain stable. Continue Herceptin, Perjeta, Avastin and xgeva.
Jan 2016: 5 days, 20 grays, Rads to L1 and continue on HAPX. I’m trying to "save" TDM1 for next line. Hope the rads work to quiet L1. Sciatic pain extraordinaire :((
Markers drop post rads.
2/24/16 HAP plus X - markers are down
SCIATIC PAIN DEAL BREAKER.
3/23/16 Laminectomy w/coflex implant L4/5. NO MORE SCIATIC PAIN!!! Healing.
APRIL 2016 - 9 YRS MBC
July 2016 - continue HAP plus Xgeva.
DEC 2016 - PETCT: mets to sternum, lungs, L1 still about the same in size and PET activity. Markers not bad. Not making changes if I don't need to. Herceptin/Perjeta/Avastin/Xgeva
APRIL 2017 10 YEARS MBC
December 2017 - Progression - gonna switch it up
FEB 2018 - Kadcyla 3 cycles ---->progression :(
MAY30th - bronchoscopy, w/foundation1 - her2 enriched
Aug 27, 2018 - start clinical trial ZW25
JAN 2019 - ZW25 seems to be keeping me stable
APRIL 2019 - ONE DOZEN YEARS LIVING METASTATIC
MAY 2019 - progression back on herceptin add xeloda
JUNE 2019 - "6 mos average survival" LMD & CNS new single brain met - one zap during 5 days true beam SBRT to cord met
10/30/19 - stable brain and cord. progression lungs and bones. washing out. applying for ds8201a w nivolumab. hope they take me.
12/27/19 - begin ds8401a w nivolumab. after 2nd cycle nodes melt away. after 3rd cycle chest scan shows Improvement, brain MRI shows improvement, resolved areas & nothing new. switch to plain ENHERTU. after 4th cycle, PETscan shows mostly resolved or improved results. Markers near normal. I'm stunned but grateful.
10/26/20 - June 2021 Tucatinib/xeloda/herceptin - stable ish.
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Old 09-10-2015, 01:04 AM   #3
Pamelamary
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Re: Pertuzumab not "cost effective"?!

Thanks Debbie - things seem to be getting a bit hairy! Pertuzumab has just been approved for funding in Australia for ABC women, but only first line. If you have had more than 12 months of herceptin alone, no go! Plenty of women like me who hope to use Pertuzumab eventually, are feeling a bit challenged!
Regards..... Pam
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Diagnosed 2004: Lumpectomy - 2 tumours, both grade 1 infiltrating duct carcinoma, about 12mm. ER+,
C-erbB-2 status 3+.
Clear margins, no nodal involvement.
Radiotherapy, i year Tamoxifen, 4 years Arimidex.
Rediagnosed 2012: Multiple bone metastases.
3/12: began on Marianne trial - T-DM1 + Pertuzamab/Placebo.
5/12:Unexpected development of numerous bilateral liver mets. Came off trial.
Started Docetaxol/ Herceptin + Zometa.
8/12:Bones stable +major regression in liver (!)
9/12:Can't take any more Docetaxol! Start on Herceptin and Tamoxifen. Cross fingers!
Changed to Denosumab.
11/12: Scan shows stable - yay!
11/13: Still stable :-) !!!
1/16: All stable, but lowered calcium, so switched to Zometa 3 monthly.
2/19: Happily still stable on Herceptin, Letrozole and 3 monthly Zometa.
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Old 09-12-2015, 07:10 AM   #4
Mtngrl
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Re: Pertuzumab not "cost effective"?!

Debbie, I share your unease about this conclusion, and you raise an important question about treatment costs.

When I broached the subject of "is it worth it?" with my oncologist a couple of years ago, she said, "The US spends $1 million per year per soldier in Afghanistan. Somebody apparently thought that money is well spent." That highlights a critical public policy issue. The NCI budget hasn't been raised in 10 years. In that time the budget for warfighting has doubled. We now spend around $1 trillion per year, all told, on "defense." How much is that costing per quality-of-life-adjusted year of additional life (and for whom?)

I'm not saying there should be no attention paid to medical costs. Quite the opposite. Let's start with our for-profit healthcare system in the US. Healthcare is a right, and it's something everyone needs. It should be publicly funded. Then there's the cost of research and development for new therapies. Is our system really the best one for doing that? Then there's "intellectual property" and how "the market" prices new drugs and creates monopolies. One economist has suggested that we, the people, could buy out drug patents and then have a competitive system for licensing their production. In the long run, that would be much less expensive.

Per capita costs for healthcare in the US are double what other OECD countries pay, and our results are worse, including the fact that millions of people still don't have any healthcare. Instead of focusing on one stunningly expensive new drug, we should be talking about the entire byzantine, awkward, irrational system.
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4/19/11 Diagnosed invasive ductal carcinoma in left breast; 2.3 cm tumor, 1 axillary lymph node, weakly ER+, HER2+++
4/29/11 CT scan shows suspicious lesions on liver and lungs
5/17/11 liver biopsy
5/24/11 liver met confirmed--Stage IV at diagnosis
5/27/11 Begin weekly Taxol & Herceptin for 3 months (standard of care at the time of my DX)
7/18/11 Switch to weekly Abraxane & Herceptin due to Taxol allergy
8/29/11 CT scan shows no new lesions & old lesions shrinking
9/27/11 Finish Abraxane. Start Herceptin every 3 weeks. Begin taking Arimidex
10/17/11--Brain MRI--No Brain mets
12/5/11 PET scan--Almost NED
5/15/12 PET scan shows progression-breast/chest/spine (one vertebra)
5/22/12 Stop taking Arimidex; stay on Herceptin
6/11/12 Started Tykerb and Herceptin on clinical trial (w/no chemo)
9/24/12 CT scan--No new mets. Everything stable.
3/11/13 CT Scan--two small new possible mets and odd looking area in left lung getting larger.
4/2/13--Biopsy of suspicious area in lower left lung. Mets to lung confirmed.
4/30/13 Begin Kadcyla/TDM-1
8/16/13 PET scan "mixed," with some areas of increased uptake, but also some definite improvement, so I'll stay on TDM-1/Kadcyla.
11/11/13 Finally get hormone receptor results from lung biopsy of 4/2/13. My cancer is no longer ER positive.
11/13/13 PET scan mixed results again. We're calling it "stable." Problems breathing on exertion.
2/18/14 PET scan shows a new lesion and newly active lymph node in chest, other progression. Bye bye TDM-1.
2/28/14 Begin Herceptin/Perjeta every 3 weeks.
6/8/14 PET "mixed," with no new lesions, and everything but lower lungs improving. My breathing is better.
8/18/14 PET "mixed" again. Upper lungs & one spine met stable, lower lungs less FDG avid, original tumor more avid, one lymph node in mediastinum more avid.
9/1/14 Begin taking Xeloda one week on, one week off. Will also stay on Herceptin and Perjeta every three weeks.
12/11/14 PET Scan--no new lesions, and everything looks better than it did.
3/20/15 PET Scan--no new lesions, but lower lung lesions larger and a bit more avid.
4/13/15 Increasing Xeloda dose to 10 days on, one week off.
7/1/15 Scan "mixed" again, but suggests continuing progression. Stop Xeloda. Substitute Abraxane every 3 weeks starting 7/13.
10/28/15 PET scan shows dramatic improvement everywhere. All lesions except lower lungs have resolved; lower lungs noticeably improved.
12/18/15 Last Abraxane. Continue on Herceptin and Perjeta alone beginning 1/8/16.
1/27/16 PET scan shows cancer is stable.
5/11/16 PET scan shows uptake in some areas that were resolved on the last two scans.
6/3/16 Begin Kadcyla and Tykerb combination
6/5 - 6/23 Horrible diarrhea from K&T together. Got pneumonia.
7/15/16 Begin Kadcyla only every 3 weeks.
9/6/16 Begin radiation therapy on right lung lesion that caused the pneumonia.
10/3/16 Last of 12 radiation treatments to right lung.
11/4/16 Huffing and puffing, low O2, high heart rate, on tiniest bit of exertion. Diagnosed as radiation pneumonitis. Treated with Prednisone.
11/11/16 PET scan shows significant improvement to radiated part of right lung BUT a bunch of new lung lesions, and the bone met is getting worse.
11/22/16 Begin Eribulin and Herceptin. H every 3 weeks. E two weeks on, one week off.
3/6/17 Scan shows progression in lungs. Bone met a little better.
3/23/17 Lung biopsy. Tumor sampled is ER-, PR+ (5%), HER2+++. Getting Herceptin and Perjeta as a maintenance treatment.
5/31/17 Port placement
6/1/17 Start Navelbine & Tykerb
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Old 09-12-2015, 11:46 AM   #5
kk1
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Re: Pertuzumab not "cost effective"?!

where's the like button for mountain girl's comment! It is spot on in my opinion.
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KK1
April 2004 de novo metastatic left breast 1.5cm her2++,er+/pr+ with 2 small liver mets
weekly taxotere,herceptin, xeloda
Sept 2004 NED-3 herceptin, zoladex,aromasin
Dec 2006 recurrence in liver
Feb. 2007 liver resection left lobe removed-herceptin, zoladex, switch to Arimidex
NED 16 months added zometa
May 2008 new lesion in liver 15mm Tykerb/Xeloda/Herceptin
July 2008 stable...yeah!
Sept 2008 NED again !!!
Jan 2009 fell off the wagon again spot back in the liver and fell out of menopause.
Feb 2009 RFA and 2nd liver resection to remove spot ---back on the NED wagon again continue Tykerb, Herceptin.
March 2009- oophrectomy added Femara and bi-annual Zometa
May 2009- scans clear but suspect lung nodule
June 2009- Lung VAT wedge resection to remove nodule---fungus ball not cancer!! phew
Aug 2009- NED
Nov 2009-scans again clear YAHOO!
March 2010- scans clear continue Tykerb, Herceptin, Femara, Zometa Q6mo
Nov 2009-Nov 2019 scans clear done every 6 months


Feb 2020 - Fell out of the NED wagon hard! single liver lesions and large infect cyst. 3 weeks in ICU.
March 2021- 5 cycles perjeta, herceptin, navelbine. lesion stable.
June 2021 - 3rd liver resection to remove single liver lesion. Continued perjeta, herceptin.
Nov. 2021- PET scan show 5 hot nodes near liver. 9 cycles Kadcyla
June 2021- PET scan shows progression. nodes size unchanged but even more SUV uptake.

July 2021- start ENHERTU
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Old 09-12-2015, 12:27 PM   #6
donocco
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Re: Pertuzumab not "cost effective"?!

As a pharmacist who owned his own small pharmacy I know something about drug prices. The increase in price is unbelelievable. There is no word in the english language to describe the situation. Words like "outrage", "sinful" etc do not do the situation justice. In 1987 the most expensive drug for chronic use was Mevacor (Lovostatin) and this was the first of many statin drugs. The price: about 95 dollars for 60 tablets. In those pre-insurance days this was outrageous. People payed for the drugs themselves. I dont know how many arguments I got into when people would accuse me of getting wealthy off their illness. My pharmacy was in Fontana, California, a small blue collar town and I knew the people pretty well. The relationship was very personal. Eventually I was able to convince them that the drug cost me more than I was charging them. People over 55 got a 5% discount. Not much but it helps.

How about today's costs. The drug Harvoni for Hepatitis C costs close to or more than 100,000 dollars for 84 tablets. Brand Donnatal, which was one of the cheapest drugs (costing say 20 dollars per hundred) now cost 800 dollars per hundred. You all know about the outrageous price of anti-cancer drugs.

For a long time I couldnt understand why th insurance companies put up with this. They are very powerful and they pay for the drugs. A course of Harvoni for hepatitis C is 100,000 dollars. Suppose CVS/Caremark, Blue Cross, Blue Shield, Health Net etc said to Gilead. " We know each Harvoni tablet is worth less than a penny in ingredients. Yet we are paying you close to 2000 dollars for each tablet. Tell you what. From now on well pay you 20 dollars a tablet." What would and could Gilead, the drug company do? Absolutely nothing. Its a take it or leave it situation.
So why dont the insurance companies do this to save money which is so important them and their stockholders.

I dont know but Ill offer a suggestion. The high obscene drug prices benefit the insurance companies as much as the drug companies. On the surface this statement sounds like the ranting of a schizophrenic. But think about it. The obscene drug prices make everybody absolutely dependent on having health insurance. The insurance companies make much mnore money on their premiums (which are going up and up) than they lose paying for drugs. If they wanted to, the Insurance companies could force the drug companies to drastically lower tomorrow. They could have done that yesterday. Im sorry if this sounds to simplistic.

Paul
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Old 09-12-2015, 02:29 PM   #7
Juls
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Re: Pertuzumab not "cost effective"?!

The same goes for Health Boards here - why can't they negotiate cheaper prices?
It is a concern here as well - as UK Medicine Boards are cancelling or not approving drugs on cost basis. Just last week in England 3 cancer drugs cancelled (Eribulin,Lapatinib & Everolimus). I am in Scotland & currently in a Pertuzumab trial. Scottish Medicine Board has turned Pertuzumab down twice already. It is worrying to think that others may not get this drug purely on a cost basis!

Paul - Just wondering - Was Herceptin as expensive when first introduced? Is it still as expensive or has it reduced (in relative terms) because its the drug of choice for Her2? I don't know how drug companies work - but just wondering if Pertuzumab became standard treatment would price change?
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Old 09-12-2015, 04:02 PM   #8
donocco
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Re: Pertuzumab not "cost effective"?!

Juls

I cant answer you about Herceptin. I closed my pharmacy in 1994 and Herceptin started being used around 2000. Besides I had a reetail pharmacy and herceptin, Perjeta etc are injectables. The Hospital pharmacists could tell you much more than I could.

As far as why doesnt the UK negotiate prices Ill give you a very inadequate answer based on info Ive skimmed over. You have to think of the political term "sphere of Influence." The United States and the United Kingdom are in each others "Sphere" so
politically there is a fear of "stepping on toes." Egypt is not in this sphere. Eighty Four tablets of Sovoldi (related to Harvoni for hepatitis C-Harvoni is Sovaldi plus another drug) costs about 900 dollars. Cost in the USA, 95,000 dollars.

From what Ive skimmed theses countries say to the Drug companies " Here is what we will pay, take it or leave it. If you wont take it well forget your patent and make it ourselves." If teens can make methamphetamine from Pseudoephedrine Im sure professional chemists in the various cointries can make Lapatanib, Xeloda whatever. What could be done to Nepal, Burma, Albania, Egypt etc. They are not in our economic sphere of influence. The UK is, Singapore might be, some countries in Europe. This is why these drugs are sold so cheaply.

I was thinking of you and the Metaclopropamide ve Prolactin.
Its something to be aware of but I wouldnt worry too much about it. They have used Metaclopropamide to stimulate milk secretion in nursing women by increasing Prolactin. The dosage of Metaclopropamide used is 30-40mg, much than you were probably taking.

They found increases of breast cancer in women working night shifts. They thin it is because these nurses dont get the melatonin surge in the blood from being in the dark at night. Melatonin has definite anti cancer action, definitely in breast cancer. Yet Melatonin stimulates prolactin secretion. Yet my guess is the beneficial action of melatonin against cancer outweighs any "it increases prolactin effect. The whole subject is very complicated and there is a lot of things not clear.

Paul
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Old 09-12-2015, 05:37 PM   #9
Juls
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Re: Pertuzumab not "cost effective"?!

Paul
Thank you again!! I understand what you are saying!

Just read it costs about £45,000 approx. per year of treatment for Pertuzumab here. A sum I would be hard pushed to find if they don't approve it.

Regarding Metoclopramide - as you say not worth worrying about.

Once again Paul -Thank you for the info!
Take care
Juls
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