Dendreon er faldet 23% i afterhours efter Medicare nu indleder en formel analyse af kost benefit for Provenge. Og markeds første reaktion er åbenbart at der er tvivl om Medicare ønsker at betale for den meget dyre behandling. En behandling som koster $93.000
"The agency said it will determine if the treatment is "reasonable and necessary" for patients in Medicare"
http://online.wsj.com/article/SB10001424052748703426004575339451078637366.html?mod=googlenews_wsj
http://www.reuters.com/article/idUSN3025705620100630
"The agency said it will determine if the treatment is "reasonable and necessary" for patients in Medicare"
http://online.wsj.com/article/SB10001424052748703426004575339451078637366.html?mod=googlenews_wsj
http://www.reuters.com/article/idUSN3025705620100630
Hvis det bliver et tema er 23% meget biliigt sluppet.
1/7 2010 09:02 troldmanden 1
30891 Enig. Hvis først Medicare vælger ike at betale så kommer der til at blive delt seriøse smæk ud. For så stiger risikoen også for at en række af forsikrings selskaber måske heller ikke vil betale. Så det er meget alvorligt det her. Men der går et lille års tid inden dommen falder
Medicare har i mine øjne ikke noget reelt valg, men skal godkende når der er tale om "reasonable and necessary". Provenge er fundet significant bedre end Taxotere, og Taxotere er dækket under Medicare. Dvs. Provenge bliver selvfølgelig også dækket. Medicare er på den anden side forpligtet til at undersøge det.
lidt om Medicare: http://en.wikipedia.org/wiki/Medical_necessity#cite_note-0
Se iøvrigt pressemeddelelsen fra Dendreon, som bl.a. siger at Medicare dækker som hidtil: "NCAs do not impact existing coverage decisions, nor do they restrict local Medicare contractors from covering PROVENGE. Therefore, Medicare beneficiaries are still able to access PROVENGE and private payers can also still cover PROVENGE."
link: http://investor.dendreon.com/phoenix.zhtml?c=120739&p=irol-newsArticle&ID=1443313&highlight=
I mine øjne er det kun fabrikskapaciteten til fremstilling af Provenge, som i lang tid fremover begrænser salget af Provenge og antallet af patienter som bliver hjulpet.
Medicare dækker iøvrigt midlertidigt indtil den endelige godkendelse.
mvh
lidt om Medicare: http://en.wikipedia.org/wiki/Medical_necessity#cite_note-0
Se iøvrigt pressemeddelelsen fra Dendreon, som bl.a. siger at Medicare dækker som hidtil: "NCAs do not impact existing coverage decisions, nor do they restrict local Medicare contractors from covering PROVENGE. Therefore, Medicare beneficiaries are still able to access PROVENGE and private payers can also still cover PROVENGE."
link: http://investor.dendreon.com/phoenix.zhtml?c=120739&p=irol-newsArticle&ID=1443313&highlight=
I mine øjne er det kun fabrikskapaciteten til fremstilling af Provenge, som i lang tid fremover begrænser salget af Provenge og antallet af patienter som bliver hjulpet.
Medicare dækker iøvrigt midlertidigt indtil den endelige godkendelse.
mvh
1/7 2010 10:15 JørgenVarnæs 030894 Interessant pointe, du tager op der Pascal - vil myndighederne køre en LIFO eller en LIFO politik på de godkendte medikamenter? Hvis noget skal ud - skal det så være arzerra - eller skal Rituxan smides ud?
1/7 2010 10:19 Pascal 030896 Provenge er godkendt som first in line til behandling af svært fremskredenprostatacancer.
Det har dermed mig bekendt ikke nogen indflydelse på Azerra og Rituxan, som er noget helt andet
mvh
Det har dermed mig bekendt ikke nogen indflydelse på Azerra og Rituxan, som er noget helt andet
mvh
1/7 2010 10:16 1970 030895 Frit efter min hukommelse, som gerne må korrigeres, hvis jeg er galt på den, så har jeg forstået, at DNDN pga. mangel på kapacitet kun tilbyder 2000 behandlinger det første år og derfor har sat prisen højt. Måske uetisk, men de regner åbenbart ikke med at det vil blive et problem at få afsat behandlingerne. Det er mit indtryk, at man herefter vil udbyde behandlingen i større stil og til en lavere pris.
Jeg kan godt forstå, hvis Medicare og andre vil trække den lidt og få skubbet tilbuddet om behandling til prisen når ned i et mere overkommeligt leje og så er der vel også en slags forhandling mellem parterne om prisen i det, der sker p.t.
Det sørgelige er, at de første behandlinger så vil gå til pengestærke prostata-patienter, men jeg ser ikke den store fare for Dendreon, da der reelt ikke er nogen alternativer og 2000 behandlinger ikke rækker langt i dette marked.
Hvis ikke Medicare og DNDN kommer overens kan jeg godt se problemet i at få udbredt behandlingen om et års tid, men igen - manglen på alternativer og efterspørgslen skal ses i forhold til dette. Vil Medicare mfl. kunne tillade sig dette, hvis prisen kommer ned i et mere overkommeligt leje ?
Jeg beholder mine - ærgelig over ikke at have solgt, da den rundede 50 og genkøbt nu, men mine er købt med tidshorisont på 2-3 år og et target på 65 eller mere.
Jeg kan godt forstå, hvis Medicare og andre vil trække den lidt og få skubbet tilbuddet om behandling til prisen når ned i et mere overkommeligt leje og så er der vel også en slags forhandling mellem parterne om prisen i det, der sker p.t.
Det sørgelige er, at de første behandlinger så vil gå til pengestærke prostata-patienter, men jeg ser ikke den store fare for Dendreon, da der reelt ikke er nogen alternativer og 2000 behandlinger ikke rækker langt i dette marked.
Hvis ikke Medicare og DNDN kommer overens kan jeg godt se problemet i at få udbredt behandlingen om et års tid, men igen - manglen på alternativer og efterspørgslen skal ses i forhold til dette. Vil Medicare mfl. kunne tillade sig dette, hvis prisen kommer ned i et mere overkommeligt leje ?
Jeg beholder mine - ærgelig over ikke at have solgt, da den rundede 50 og genkøbt nu, men mine er købt med tidshorisont på 2-3 år og et target på 65 eller mere.
1/7 2010 10:21 Pascal 030897 Medicare må ifølge loven slet ikke skele til prisen på produktet
Iøvrigt, så dækker Medicare allerede Provenge - det er blot en midlertidig dækning frem til den endelige.
mvh
Iøvrigt, så dækker Medicare allerede Provenge - det er blot en midlertidig dækning frem til den endelige.
mvh
1/7 2010 10:32 1970 030899 Så godt du havde skrevet det efter jeg fik postet mit indlæg.
Tak for oplysning om dækning indtil videre - det var jeg ikke klar over.
mvh
ps: Hvis lovgivningen har den ordlyd, så virker den vist ikke heeelt i praksis
Tak for oplysning om dækning indtil videre - det var jeg ikke klar over.
mvh
ps: Hvis lovgivningen har den ordlyd, så virker den vist ikke heeelt i praksis
1/7 2010 11:19 troldmanden 030904 Er det sandt? Den nye lov har da netop inkluderet et prispres for at reducere de galoperende amerikanske sundhedsudgifter.
Jeg tror generelt vi de kommende 5 år vil se et kraftigt stigende pres på prisen for alle de meget dyre stoffer. Ingen regeringer har råd til at fortsætte med at øge sundhedsbudgettet i samme tempo som de seneste år. Så derfor vil vi fra tid til anen se specifikke big pharma og biotech selskaber få et gog i nødennår deres stoffer bliver presset ned i pris.
Jeg tror generelt vi de kommende 5 år vil se et kraftigt stigende pres på prisen for alle de meget dyre stoffer. Ingen regeringer har råd til at fortsætte med at øge sundhedsbudgettet i samme tempo som de seneste år. Så derfor vil vi fra tid til anen se specifikke big pharma og biotech selskaber få et gog i nødennår deres stoffer bliver presset ned i pris.
De galloperende udgifter er ganske rigtig noget som diskuteres meget.
En af årsagerne til de kraftigt stigende udgifter til Medicare er bl.a. at der alene kigges på det medicisk/faglige når behandlinger skal godkendes.
Iøvrigt er her et link til Obamas ændringer:
http://www.cms.gov/LegislativeUpdate/downloads/PPACA.pdf
Intet sted bliver godkendelseskriterierne for Medicare koblet sammen med prissætningen. Tværtimod udvides dækningen til også at omfatte flere mindre bemidlede personer - dvs. flere patienter får potentielt råd til Provenge (via Medicare til disse mindrebemidlede) ...
mvh
En af årsagerne til de kraftigt stigende udgifter til Medicare er bl.a. at der alene kigges på det medicisk/faglige når behandlinger skal godkendes.
Iøvrigt er her et link til Obamas ændringer:
http://www.cms.gov/LegislativeUpdate/downloads/PPACA.pdf
Intet sted bliver godkendelseskriterierne for Medicare koblet sammen med prissætningen. Tværtimod udvides dækningen til også at omfatte flere mindre bemidlede personer - dvs. flere patienter får potentielt råd til Provenge (via Medicare til disse mindrebemidlede) ...
mvh
1/7 2010 12:01 troldmanden 030908 Hej Pascal
Fik slet ikke sagt velkommen til ProInvestor som aktiv skribent. Og vel at mærke en rigtig velinformeret skribent
Jeg har ikke nærstuderet dokumenter på bagkandten af den nye sundhedsreform. Men der var da ret meget snak om at den vil betyde lavere priser. Til gengæld vil flere få mulighed for at blive behandlet. Så det undre mig hvis der intet er om en eller anden form for pris regulering. Selv Novo Nordisk har været ude at fortælle de venter lavere priser men flere som vil få deres medicin
Vh
T.
Fik slet ikke sagt velkommen til ProInvestor som aktiv skribent. Og vel at mærke en rigtig velinformeret skribent
Jeg har ikke nærstuderet dokumenter på bagkandten af den nye sundhedsreform. Men der var da ret meget snak om at den vil betyde lavere priser. Til gengæld vil flere få mulighed for at blive behandlet. Så det undre mig hvis der intet er om en eller anden form for pris regulering. Selv Novo Nordisk har været ude at fortælle de venter lavere priser men flere som vil få deres medicin
Vh
T.
1/7 2010 10:27 collersteen 030898 Prisen er ikke sat højt pga. manglen på kapacitet (som ganske rigtigt er omkring 2000 patienter de første 12mdr). Den er sat som en pris per overlevelsesmåned, der ligger i tråd med de alternative kræftbehandlinger (herunder chemo). Med 4,1 mdr giver det det så en pris omkring $23k per ekstra overlevelsesmåned....
En ganske kold og kynisk betragtning kan man mene....
Her er lige et citat fra deres CC ifm. den endelige FDA-godkendelse d. 29.april 2010.
"As you know, Provenge offers patients a unique treatment option. In addition to its survival benefit, Provenge also offers men a short course of treatment. As I just said, a full course of Provenge typically includes three infusions, which generally occur in one month. When you consider these benefits, the price for a full course of treatment equates to a cost per month of survival of just under $23,000, which compares very favorably to many other widely used oncology products in similar advanced disease settings."
Hans Bishop - Dendreon - EVP, COO
En ganske kold og kynisk betragtning kan man mene....
Her er lige et citat fra deres CC ifm. den endelige FDA-godkendelse d. 29.april 2010.
"As you know, Provenge offers patients a unique treatment option. In addition to its survival benefit, Provenge also offers men a short course of treatment. As I just said, a full course of Provenge typically includes three infusions, which generally occur in one month. When you consider these benefits, the price for a full course of treatment equates to a cost per month of survival of just under $23,000, which compares very favorably to many other widely used oncology products in similar advanced disease settings."
Hans Bishop - Dendreon - EVP, COO
Dendreon's Medicare Coverage Conundrum
http://www.thestreet.com/_yahoo/story/10796871/1/dendreons-medicare-coverage-conundrum.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
Adam Feuerstein
07/01/10 - 06:03 AM EDT
SEATTLE (TheStreet) -- The Dendreon(DNDN) drama continues.
The latest wicked twist hit Wednesday night after the Centers for Medicare and Medicaid Services, or CMS, said it had begun an evaluation process to determine national coverage of Dendreon's prostate cancer therapy Provenge.
Investors were already worried about Provenge reimbursement in the early days of the product's launch, so when the CMS news hit the tape, investors freaked out. Dendreon shares tumbled as much as 23% to $25 in Wednesday's after-hours trading session from their $32.33 close.
If you thought the tempest over Dendreon and insurance coverage of Provenge was going to end soon, I suggest grabbing a comfy chair, ordering another drink (or three) and settling in for a longer-than-expected wait.
Meantime, I'll try to answer the most pressing questions arising from Wednesday's surprising development:
What the heck is a National Coverage Determination?
Medicare is a health care insurance program for seniors administered by the federal government, but in fact, nearly all coverage and reimbursement decisions for products and services are made at the local level by states or private contractors that administer Medicare programs.
Sometimes, however, CMS chooses to unify coverage on a nationwide basis -- essentially telling all the individual Medicare providers how to cover a certain product or service. This top-down process is known as a National Coverage Determination (NCD).
Why is CMS starting an NCD for Provenge?
CMS almost never issues NCDs for cancer drugs, which is why investors were so surprised Wednesday.
From what I can surmise, there have been only three NCDs ever issued for cancer drugs -- Avastin and Erbitux (both for off-label uses) and another for the radio-immunotherapy drugs Bexxar and Zevalin. One additional and commonly cited NCD in the cancer arena is for the red blood cell stimulating drugs Epogen, Aranesp and Procrit.
The reasons for CMS wanting to place Provenge under an NCD are not clear, but a couple of guesses. Local Medicare providers may have asked for it because they want guidance from CMS on how to cover Provenge. Second, Provenge is not a run-of-the-mill cancer drug -- it's a cellular immunotherapy which stimulates the patient's own immune system to target and destroy cancer cells. Given the uniqueness of Provenge, CMS may think it best to coordinate coverage nationally.
Clearly, the market took this development as bad news, but please explain why.
Two words: Risk and delay. The odds seems small given Provenge's clinical data, but yes, CMS could decide not to cover Provenge at all, or CMS could decide to place severe restrictions on the product's use. Either of these scenarios would be disastrous for Dendreon.
Now, again, I don't think this will happen but the risk is there, which adds another overhang to Dendreon in the early stages of the Provenge launch.
Second, the NCD process for Provenge is going to take a year! CMS plans on holding a meeting before the end of 2010 to review Provenge's clinical data, which will be followed by a proposed NCD being issued in March 2011. After more public comment, a final NCD will be announced in June 2011.
In other words, the Medicare reimbursement overhang is going to be around for quite some time.
Will this effect Dendreon's ability to sell Provenge today, or stop insurance carriers from reimbursing for Provenge?
We don't know. Last night, Dendreon said the NCD process does not impact existing coverage decisions. That's correct. Private insurers can continue to reimburse for Provenge as can local Medicare carriers. Nothing about CMS spending the next year on an NCD for Provenge changes that.
However, some local Medicare carriers may decide to hold off or delay making coverage decisions about Provenge pending the final NCD. If that happens, Provenge sales could be adversely affected.
This is crazy! Provenge prolongs the lives of prostate cancer patients? How could the government say no to that?
You're right. The Food and Drug Administration approved Provenge for the treatment of advanced prostate cancer based on data demonstrating a 4.1-month survival benefit for the therapy compared to the control group. No cancer drug with a proven survival benefit has ever been denied insurance coverage before, and I find it hard to see how Provenge becomes the first.
Haven't some insurance carriers already decided to cover Provenge?
Yes, which is another factor in Dendreon's favor as it makes the case for Provenge in front of CMS. Recently, Aetna(AET) and Humana(HUM) -- private insurers -- have announced positive coverage decisions of Provenge. Perhaps more importantly, one of the country's largest local Medicare contractors announced its intention to cover Provenge.
Treatment with Provenge has also received a strong endorsement from the National Comprehensive Cancer Network.
Do you think Provenge's high cost of $93,000 per treatment course has anything to do with all this?
Under CMS' own rules, the cost of therapy is not supposed to factor into coverage decisions. Do I think that rule is adhered to in all situations by CMS, especially with the red-hot focus lately on the high cost of cancer drugs and health care reform?
No, I don't.
Did the market over-react to the CMS announcement?
Ah, saving the tough question for the end. Let's not forget that Dendreon launched Provenge in May under manufacturing supply constraints and has already told us that only about 2,000 patients will be treated in the first year. It's hard to believe that Dendreon won't find 2,000 prostate cancer patients who want Provenge, especially given the reports of patient waiting lists.
By the time Dendreon expands Provenge manufacturing capacity in the middle of 2011, CMS will have already announced its tentative NCD decision. If the NCD is positive, then all the concerns about Provenge reimbursement will be put to bed and Dendreon is off to the races.
Aha! So, you're saying Dendreon in the mid-to-high $20s is a huge buying opportunity?
Objectively, I say yes, Dendreon looks very tempting down here, but...
But? Why does there have to be a but?
C'mon, you knew this was coming... The problem with going all-in on Dendreon today is that the stock doesn't trade on a cold, objective read of the fundamentals. You can't discount completely the possibility of CMS making an adverse coverage decision on Provenge. Fear matters. Risk matters. These overhangs may stick with Dendreon for a long time.
Investors don't like surprises. They like it when drug launches follow precedent. In Dendreon's case, unfortunately, CMS looks like it is breaking precedent. Now, this may turn out to be a great thing for Dendreon, but no one can predict the outcome with 100% accuracy.
And keep in mind, Dendreon doesn't trade in a vacuum. The volatility in the overall market -- more to the downside than up lately -- is also placing investors under enormous stress. Investors' appetite for risk, especially biotech-like risk around a first-of-its-kind drug launch, isn't at a high water mark these days.
I've talked to plenty of fund managers in the past weeks who really believe in the long-term blockbuster value of Provenge, but who nonetheless have no interest in owning Dendreon today because of the supply-constrained launch. Add in this new CMS coverage controversy and the stock looks even less appealing.
What a headache.
You got that right. The Dendreon drama never ends.
-- Reported by Adam Feuerstein in Boston.
http://www.thestreet.com/_yahoo/story/10796871/1/dendreons-medicare-coverage-conundrum.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
Adam Feuerstein
07/01/10 - 06:03 AM EDT
SEATTLE (TheStreet) -- The Dendreon(DNDN) drama continues.
The latest wicked twist hit Wednesday night after the Centers for Medicare and Medicaid Services, or CMS, said it had begun an evaluation process to determine national coverage of Dendreon's prostate cancer therapy Provenge.
Investors were already worried about Provenge reimbursement in the early days of the product's launch, so when the CMS news hit the tape, investors freaked out. Dendreon shares tumbled as much as 23% to $25 in Wednesday's after-hours trading session from their $32.33 close.
If you thought the tempest over Dendreon and insurance coverage of Provenge was going to end soon, I suggest grabbing a comfy chair, ordering another drink (or three) and settling in for a longer-than-expected wait.
Meantime, I'll try to answer the most pressing questions arising from Wednesday's surprising development:
What the heck is a National Coverage Determination?
Medicare is a health care insurance program for seniors administered by the federal government, but in fact, nearly all coverage and reimbursement decisions for products and services are made at the local level by states or private contractors that administer Medicare programs.
Sometimes, however, CMS chooses to unify coverage on a nationwide basis -- essentially telling all the individual Medicare providers how to cover a certain product or service. This top-down process is known as a National Coverage Determination (NCD).
Why is CMS starting an NCD for Provenge?
CMS almost never issues NCDs for cancer drugs, which is why investors were so surprised Wednesday.
From what I can surmise, there have been only three NCDs ever issued for cancer drugs -- Avastin and Erbitux (both for off-label uses) and another for the radio-immunotherapy drugs Bexxar and Zevalin. One additional and commonly cited NCD in the cancer arena is for the red blood cell stimulating drugs Epogen, Aranesp and Procrit.
The reasons for CMS wanting to place Provenge under an NCD are not clear, but a couple of guesses. Local Medicare providers may have asked for it because they want guidance from CMS on how to cover Provenge. Second, Provenge is not a run-of-the-mill cancer drug -- it's a cellular immunotherapy which stimulates the patient's own immune system to target and destroy cancer cells. Given the uniqueness of Provenge, CMS may think it best to coordinate coverage nationally.
Clearly, the market took this development as bad news, but please explain why.
Two words: Risk and delay. The odds seems small given Provenge's clinical data, but yes, CMS could decide not to cover Provenge at all, or CMS could decide to place severe restrictions on the product's use. Either of these scenarios would be disastrous for Dendreon.
Now, again, I don't think this will happen but the risk is there, which adds another overhang to Dendreon in the early stages of the Provenge launch.
Second, the NCD process for Provenge is going to take a year! CMS plans on holding a meeting before the end of 2010 to review Provenge's clinical data, which will be followed by a proposed NCD being issued in March 2011. After more public comment, a final NCD will be announced in June 2011.
In other words, the Medicare reimbursement overhang is going to be around for quite some time.
Will this effect Dendreon's ability to sell Provenge today, or stop insurance carriers from reimbursing for Provenge?
We don't know. Last night, Dendreon said the NCD process does not impact existing coverage decisions. That's correct. Private insurers can continue to reimburse for Provenge as can local Medicare carriers. Nothing about CMS spending the next year on an NCD for Provenge changes that.
However, some local Medicare carriers may decide to hold off or delay making coverage decisions about Provenge pending the final NCD. If that happens, Provenge sales could be adversely affected.
This is crazy! Provenge prolongs the lives of prostate cancer patients? How could the government say no to that?
You're right. The Food and Drug Administration approved Provenge for the treatment of advanced prostate cancer based on data demonstrating a 4.1-month survival benefit for the therapy compared to the control group. No cancer drug with a proven survival benefit has ever been denied insurance coverage before, and I find it hard to see how Provenge becomes the first.
Haven't some insurance carriers already decided to cover Provenge?
Yes, which is another factor in Dendreon's favor as it makes the case for Provenge in front of CMS. Recently, Aetna(AET) and Humana(HUM) -- private insurers -- have announced positive coverage decisions of Provenge. Perhaps more importantly, one of the country's largest local Medicare contractors announced its intention to cover Provenge.
Treatment with Provenge has also received a strong endorsement from the National Comprehensive Cancer Network.
Do you think Provenge's high cost of $93,000 per treatment course has anything to do with all this?
Under CMS' own rules, the cost of therapy is not supposed to factor into coverage decisions. Do I think that rule is adhered to in all situations by CMS, especially with the red-hot focus lately on the high cost of cancer drugs and health care reform?
No, I don't.
Did the market over-react to the CMS announcement?
Ah, saving the tough question for the end. Let's not forget that Dendreon launched Provenge in May under manufacturing supply constraints and has already told us that only about 2,000 patients will be treated in the first year. It's hard to believe that Dendreon won't find 2,000 prostate cancer patients who want Provenge, especially given the reports of patient waiting lists.
By the time Dendreon expands Provenge manufacturing capacity in the middle of 2011, CMS will have already announced its tentative NCD decision. If the NCD is positive, then all the concerns about Provenge reimbursement will be put to bed and Dendreon is off to the races.
Aha! So, you're saying Dendreon in the mid-to-high $20s is a huge buying opportunity?
Objectively, I say yes, Dendreon looks very tempting down here, but...
But? Why does there have to be a but?
C'mon, you knew this was coming... The problem with going all-in on Dendreon today is that the stock doesn't trade on a cold, objective read of the fundamentals. You can't discount completely the possibility of CMS making an adverse coverage decision on Provenge. Fear matters. Risk matters. These overhangs may stick with Dendreon for a long time.
Investors don't like surprises. They like it when drug launches follow precedent. In Dendreon's case, unfortunately, CMS looks like it is breaking precedent. Now, this may turn out to be a great thing for Dendreon, but no one can predict the outcome with 100% accuracy.
And keep in mind, Dendreon doesn't trade in a vacuum. The volatility in the overall market -- more to the downside than up lately -- is also placing investors under enormous stress. Investors' appetite for risk, especially biotech-like risk around a first-of-its-kind drug launch, isn't at a high water mark these days.
I've talked to plenty of fund managers in the past weeks who really believe in the long-term blockbuster value of Provenge, but who nonetheless have no interest in owning Dendreon today because of the supply-constrained launch. Add in this new CMS coverage controversy and the stock looks even less appealing.
What a headache.
You got that right. The Dendreon drama never ends.
-- Reported by Adam Feuerstein in Boston.
1/7 2010 12:45 troldmanden 030914 Helt igennem genialt indlæg Hr Feuerstein der har fået lavet. Så godt spottet 1970
1/7 2010 14:36 1970 030917 tak - fandt også dette i den mere "lette" afdeling
http://www.thestreet.com/story/10796630/10/10-most-expensive-stocks-danger-ahead.html
10 Most Expensive Stocks: Danger Ahead
1. Dendreon(DNDN) is a biotechnology company. Its principle drug, Provenge, received Food and Drug Administration approval on April 29. Its stock has fallen 42% from its 52-week high on May 3. Dendreon trades at a price-to-projected-earnings ratio of 672, whereas its average peer trades at a multiple of 18. Although Dendreon remains a top pharma play, its stock is priced for unrealistic near-term growth.
This Dendreon item was written prior to news Wednesday that the Centers for Medicare and Medicaid Services said it had begun an evaluation process to determine national coverage of Provenge. Dendreon shares fell as much as 23% to $25 in after-hours trading Wednesday.
-- Reported by Jake Lynch in Boston
http://www.thestreet.com/story/10796630/10/10-most-expensive-stocks-danger-ahead.html
10 Most Expensive Stocks: Danger Ahead
1. Dendreon(DNDN) is a biotechnology company. Its principle drug, Provenge, received Food and Drug Administration approval on April 29. Its stock has fallen 42% from its 52-week high on May 3. Dendreon trades at a price-to-projected-earnings ratio of 672, whereas its average peer trades at a multiple of 18. Although Dendreon remains a top pharma play, its stock is priced for unrealistic near-term growth.
This Dendreon item was written prior to news Wednesday that the Centers for Medicare and Medicaid Services said it had begun an evaluation process to determine national coverage of Provenge. Dendreon shares fell as much as 23% to $25 in after-hours trading Wednesday.
-- Reported by Jake Lynch in Boston
1/7 2010 20:24 1970 030955 Nogen må være ærgelige over at have panikket i 20'erne
- og et par links fra dagen:
http://blogs.forbes.com/sciencebiz/2010/07/why-medicare-is-reviewing-provenge/?partner=yahootix
http://blogs.forbes.com/sciencebiz/2010/07/why-is-medicare-reviewing-dendreons-provenge/?partner=yahootix
http://finance.yahoo.com/news/Dendreon-Medicare-reviewing-apf-1623541772.html?x=0&.v=4
- og et par links fra dagen:
http://blogs.forbes.com/sciencebiz/2010/07/why-medicare-is-reviewing-provenge/?partner=yahootix
http://blogs.forbes.com/sciencebiz/2010/07/why-is-medicare-reviewing-dendreons-provenge/?partner=yahootix
http://finance.yahoo.com/news/Dendreon-Medicare-reviewing-apf-1623541772.html?x=0&.v=4
endnu en artikel:
http://www.fool.com/investing/high-growth/2010/07/01/is-dendreons-provenge-in-trouble-before-it-starts-.aspx
Is Dendreon's Provenge in Trouble Before It Starts? Not!
http://www.fool.com/investing/high-growth/2010/07/01/is-dendreons-provenge-in-trouble-before-it-starts-.aspx
Brian Orelli
July 1, 2010
Is a treatment that extends life by an average of 4.1 months "reasonable and necessary"?
Yes.
But the Centers for Medicare & Medicaid Services (CMS) isn't quite sure, yet. The agency has opened an analysis of the coverage of Dendreon's (Nasdaq: DNDN) recently approved prostate cancer treatment, Provenge.
Dendreon's shares were down as much as 13% today because of the uncertainty the inquiry induces. Coverage of Medicare patients is essential to sales because most men don't get prostate cancer until an advanced age.
That uncertainty isn't going to end anytime soon, either. A proposed decision is expected by March 30, 2011, with a final ruling in June 2011. That's an awfully long time to have long-term sales uncertainty hanging over a company's head.
In the meantime, regional Medicare administrators are able to make their own decisions about coverage. Private insurers Aetna (NYSE: AET) and Humana (NYSE: HUM) have already announced that they're going to cover Provenge. Because Provenge is already under manufacturing constraints, and the company expects to work at full capacity for the near future, sales over the next year or so shouldn't be affected.
But once Dendreon gets its additional plants on line, the company needs CMS to be willing to foot the bill for the additional patients. The agency is only supposed to make its decisions based on the medical facts -- the reasonable and necessary quoted above -- but one has to wonder how much Provenge's pricey $93,000 cost has to do with the coverage inquiry. The cost-effectiveness train has left the station.
I'll go on the record and say there's no way CMS turns down Provenge completely. If it did, we'd see a revolt that would make the Greek riots look like an old folk's home. You'd see men with walkers marching on Washington asking for a few more months with their grandkids.
The bigger risk for Dendreon is that CMS limits coverage of Provenge for only certain men; perhaps some retrospective analysis shows that Provenge works best in men with certain characteristics. The agency has investigated changing the coverage of Johnson & Johnson (NYSE: JNJ) and Amgen (Nasdaq: AMGN) anemia drugs only for patients who drop below a certain red blood cell count.
The news and subsequent drop could make Dendreon a bad news buy, but we won't know for certain for another year. That's an awfully long time to wait.
http://www.fool.com/investing/high-growth/2010/07/01/is-dendreons-provenge-in-trouble-before-it-starts-.aspx
Is Dendreon's Provenge in Trouble Before It Starts? Not!
http://www.fool.com/investing/high-growth/2010/07/01/is-dendreons-provenge-in-trouble-before-it-starts-.aspx
Brian Orelli
July 1, 2010
Is a treatment that extends life by an average of 4.1 months "reasonable and necessary"?
Yes.
But the Centers for Medicare & Medicaid Services (CMS) isn't quite sure, yet. The agency has opened an analysis of the coverage of Dendreon's (Nasdaq: DNDN) recently approved prostate cancer treatment, Provenge.
Dendreon's shares were down as much as 13% today because of the uncertainty the inquiry induces. Coverage of Medicare patients is essential to sales because most men don't get prostate cancer until an advanced age.
That uncertainty isn't going to end anytime soon, either. A proposed decision is expected by March 30, 2011, with a final ruling in June 2011. That's an awfully long time to have long-term sales uncertainty hanging over a company's head.
In the meantime, regional Medicare administrators are able to make their own decisions about coverage. Private insurers Aetna (NYSE: AET) and Humana (NYSE: HUM) have already announced that they're going to cover Provenge. Because Provenge is already under manufacturing constraints, and the company expects to work at full capacity for the near future, sales over the next year or so shouldn't be affected.
But once Dendreon gets its additional plants on line, the company needs CMS to be willing to foot the bill for the additional patients. The agency is only supposed to make its decisions based on the medical facts -- the reasonable and necessary quoted above -- but one has to wonder how much Provenge's pricey $93,000 cost has to do with the coverage inquiry. The cost-effectiveness train has left the station.
I'll go on the record and say there's no way CMS turns down Provenge completely. If it did, we'd see a revolt that would make the Greek riots look like an old folk's home. You'd see men with walkers marching on Washington asking for a few more months with their grandkids.
The bigger risk for Dendreon is that CMS limits coverage of Provenge for only certain men; perhaps some retrospective analysis shows that Provenge works best in men with certain characteristics. The agency has investigated changing the coverage of Johnson & Johnson (NYSE: JNJ) and Amgen (Nasdaq: AMGN) anemia drugs only for patients who drop below a certain red blood cell count.
The news and subsequent drop could make Dendreon a bad news buy, but we won't know for certain for another year. That's an awfully long time to wait.
Endnu en - af de pessimistiske:
http://seekingalpha.com/article/213421-dendreon-and-provenge-what-if-we-lived-in-england?source=yahoo
Last week, Medicare created something of a stir when the agency announced that it would initiate a coverage determination on Provenge, an innovative but nevertheless expensive drug manufactured by Dendreon (DNDN), and approved for use in metastatic prostate cancer.
Given the context that surrounds Provenge - it is indicated for a disease with a poor prognosis, it has been demonstrated to extend life by about four months when compared to placebo, and it costs approximately $93,000 per treatment cycle - it seemed entirely reasonable that Medicare would, in the very least, take the time to examine exactly what it might be getting itself into before declaring the therapy worthy of taxpayer dollars. The initiation of a national coverage determination sounded simply logical, like measuring twice before cutting once.
The stock market, however, did not appear to count itself a fan of either reason or logic. DNDN shares plunged immediately after the Medicare announcement, and though it recovered some of its value as the day progressed, the sentiment that surrounded the trading declared itself clearly: If public health insurers so much as entertain the idea of rationing cancer care; if the days of Medicare virtually rubber-stamping all FDA-approved cancer therapies, regardless of cost and relative efficacy, really are over; if our federal healthcare payors are under so much financial strain that acting judiciously is even more important than acting compassionately - well, the market seemed to say one day last week, if all this is true, Provenge just might be doomed.
As DNDN's shares fell and then climbed back up a little, it all got me wondering: Is Provenge a drug that is going to succeed or fail on its merit alone? Or is it a marginal, albeit inventive, medication whose future hinges more on the philosophical direction of healthcare in this country than any other factor?
And then I got to thinking some more: What would happen to Provenge if the United States were more like Europe? What would become of its prospective market if Medicare were run like England's National Health Service (NHS), and cost-efficacy actually figured into coverage determinations for our various medical therapies? It seemed like a fun exercise to embark upon, and so I did.
So the first thing I looked at was the quality-adjusted life year (QALY), which is a measurement used by NHS's National Institute for Health and Clinical Excellence (NICE). Simply put, QALY applies a value to the amount of life that a therapy procures. For example, if Provenge can provide its average patient with an extra four months of a fully functional life, than it has a QALY of 0.33. If, however, Provenge delivers four more months of a life that now has to endure bone pain due to metastases, and in those four months the patient might have a prolonged hospital stay, then it might be reasonably argued that the four months in question are lived only half as well as a healthy person's life - and thus the QALY would only be 0.17 (or half of 0.33).
And so, I thought, it was reasonable to argue that Provenge would provide a QALY of somewhere between 0.17 and 0.33 - though for some patients, the number might be considerably lower than that.
The next thing that NHS and NICE would do in assessing a coverage determination on Provenge would be the assignment of a monetary cost to its QALY. This concept is pretty easy: If, as in the example of Provenge, the cost of procuring four extra months of life is $93K, then the cost of obtaining an extra year of a life well-lived is about $282K, or $93K/0.3. If, however, the extra life that is procured is only half as good as that of a completely healthy person's, then the monetary cost of Provenge and its four extra weeks of life would be $93K/0.17, or $547K.
And so that's what Provenge appears to cost - somewhere between $282K (in an absolute best-case scenario) and $547K (in a middle-of-the-road scenario) for every year of life it extends, at least as they see it in England. Of course, for those less fortunate, who might have to spend part of those four extra weeks receiving 24-hour hospice care, the cost of a QALY might come out to considerably more than that - perhaps over $1 million for four months of a life that can boast only one-quarter the quality of an average healthy person's. For argument's sake, however, I will take the lowest number, $282,000, which assumes four months of a life lived in good health.
The last step that NHS and NICE would take is the most difficult: the determination of what a year of life is worth - or, at least, what a QALY is worth. For the most part, NHS does not cover the expense of medical technologies that cost more than the equivalent of $30K per QALY. In special circumstances, in which patients have little in the way of options, that number may go as high as $60K, but a QALY is rarely valued as more than that.
And so Provenge, with a cost per QALY of at least $282K, would probably not be designated as a covered expense by NHS, as its cost in the best-case scenario well exceeds the $60K threshold.
If, in fact, the United States ever administered its public health benefits in a manner similar to our counterparts across the Atlantic, Provenge would never, ever be covered. It is just too expensive for what it does. In fact, Provenge is quite unlikely to find a market in many of the countries within Western Europe, who are more apt to perform cost-benefit analyses on their most expensive drugs. And certainly Provenge will have no market at all in the developing world, where absolutely no one can afford it.
But what are the chances that such a day would ever come to our soil? What are the chances that the United States, of all places, would emulate the socialistic healthcare practices of Western Europe and Canada?
I am not sure. But I look around and I see a country whose healthcare expenditures, if maintained at the rate we have seen in the last decade, will grow larger than our tax base within the next 15 years. I look around and I see a country that is spending more to pay the interest on its debt than it spends on some of its most important national security and social programs. I look around and see a recently signed healthcare bill that provides for the establishment of an Office of Comparative Effectiveness - which sounds an awful lot like the American version of NICE - and see further that our president is serious about funding it, to a tune of over $1 billion.
And I look around and see that Medicare is giving itself a full year to decide on whether it should pay for a drug that extends a terminal illness by four months, and I wonder what else might go down, economically, during those 12 months. I look at all of this, and after a while I don't feel so good about Provenge.
Disclosure: No positions
http://seekingalpha.com/article/213421-dendreon-and-provenge-what-if-we-lived-in-england?source=yahoo
Last week, Medicare created something of a stir when the agency announced that it would initiate a coverage determination on Provenge, an innovative but nevertheless expensive drug manufactured by Dendreon (DNDN), and approved for use in metastatic prostate cancer.
Given the context that surrounds Provenge - it is indicated for a disease with a poor prognosis, it has been demonstrated to extend life by about four months when compared to placebo, and it costs approximately $93,000 per treatment cycle - it seemed entirely reasonable that Medicare would, in the very least, take the time to examine exactly what it might be getting itself into before declaring the therapy worthy of taxpayer dollars. The initiation of a national coverage determination sounded simply logical, like measuring twice before cutting once.
The stock market, however, did not appear to count itself a fan of either reason or logic. DNDN shares plunged immediately after the Medicare announcement, and though it recovered some of its value as the day progressed, the sentiment that surrounded the trading declared itself clearly: If public health insurers so much as entertain the idea of rationing cancer care; if the days of Medicare virtually rubber-stamping all FDA-approved cancer therapies, regardless of cost and relative efficacy, really are over; if our federal healthcare payors are under so much financial strain that acting judiciously is even more important than acting compassionately - well, the market seemed to say one day last week, if all this is true, Provenge just might be doomed.
As DNDN's shares fell and then climbed back up a little, it all got me wondering: Is Provenge a drug that is going to succeed or fail on its merit alone? Or is it a marginal, albeit inventive, medication whose future hinges more on the philosophical direction of healthcare in this country than any other factor?
And then I got to thinking some more: What would happen to Provenge if the United States were more like Europe? What would become of its prospective market if Medicare were run like England's National Health Service (NHS), and cost-efficacy actually figured into coverage determinations for our various medical therapies? It seemed like a fun exercise to embark upon, and so I did.
So the first thing I looked at was the quality-adjusted life year (QALY), which is a measurement used by NHS's National Institute for Health and Clinical Excellence (NICE). Simply put, QALY applies a value to the amount of life that a therapy procures. For example, if Provenge can provide its average patient with an extra four months of a fully functional life, than it has a QALY of 0.33. If, however, Provenge delivers four more months of a life that now has to endure bone pain due to metastases, and in those four months the patient might have a prolonged hospital stay, then it might be reasonably argued that the four months in question are lived only half as well as a healthy person's life - and thus the QALY would only be 0.17 (or half of 0.33).
And so, I thought, it was reasonable to argue that Provenge would provide a QALY of somewhere between 0.17 and 0.33 - though for some patients, the number might be considerably lower than that.
The next thing that NHS and NICE would do in assessing a coverage determination on Provenge would be the assignment of a monetary cost to its QALY. This concept is pretty easy: If, as in the example of Provenge, the cost of procuring four extra months of life is $93K, then the cost of obtaining an extra year of a life well-lived is about $282K, or $93K/0.3. If, however, the extra life that is procured is only half as good as that of a completely healthy person's, then the monetary cost of Provenge and its four extra weeks of life would be $93K/0.17, or $547K.
And so that's what Provenge appears to cost - somewhere between $282K (in an absolute best-case scenario) and $547K (in a middle-of-the-road scenario) for every year of life it extends, at least as they see it in England. Of course, for those less fortunate, who might have to spend part of those four extra weeks receiving 24-hour hospice care, the cost of a QALY might come out to considerably more than that - perhaps over $1 million for four months of a life that can boast only one-quarter the quality of an average healthy person's. For argument's sake, however, I will take the lowest number, $282,000, which assumes four months of a life lived in good health.
The last step that NHS and NICE would take is the most difficult: the determination of what a year of life is worth - or, at least, what a QALY is worth. For the most part, NHS does not cover the expense of medical technologies that cost more than the equivalent of $30K per QALY. In special circumstances, in which patients have little in the way of options, that number may go as high as $60K, but a QALY is rarely valued as more than that.
And so Provenge, with a cost per QALY of at least $282K, would probably not be designated as a covered expense by NHS, as its cost in the best-case scenario well exceeds the $60K threshold.
If, in fact, the United States ever administered its public health benefits in a manner similar to our counterparts across the Atlantic, Provenge would never, ever be covered. It is just too expensive for what it does. In fact, Provenge is quite unlikely to find a market in many of the countries within Western Europe, who are more apt to perform cost-benefit analyses on their most expensive drugs. And certainly Provenge will have no market at all in the developing world, where absolutely no one can afford it.
But what are the chances that such a day would ever come to our soil? What are the chances that the United States, of all places, would emulate the socialistic healthcare practices of Western Europe and Canada?
I am not sure. But I look around and I see a country whose healthcare expenditures, if maintained at the rate we have seen in the last decade, will grow larger than our tax base within the next 15 years. I look around and I see a country that is spending more to pay the interest on its debt than it spends on some of its most important national security and social programs. I look around and see a recently signed healthcare bill that provides for the establishment of an Office of Comparative Effectiveness - which sounds an awful lot like the American version of NICE - and see further that our president is serious about funding it, to a tune of over $1 billion.
And I look around and see that Medicare is giving itself a full year to decide on whether it should pay for a drug that extends a terminal illness by four months, and I wonder what else might go down, economically, during those 12 months. I look at all of this, and after a while I don't feel so good about Provenge.
Disclosure: No positions
Den fik han godt nok nogle kommentarer på:
http://seekingalpha.com/article/213421/comments#comment-1101303
Og hvis man vil se en, der er meget positiv:
http://seekingalpha.com/instablog/567205-saulk/80523-dendreon-fear-is-our-friend
http://seekingalpha.com/article/213421/comments#comment-1101303
Og hvis man vil se en, der er meget positiv:
http://seekingalpha.com/instablog/567205-saulk/80523-dendreon-fear-is-our-friend
20/7 2010 15:08 1970 031413 Det er ikke kedeligt...
http://blogs.forbes.com/sciencebiz/2010/07/anonymous-email-slams-dendreon-stockholders/?partner=yahootix
Anonymous Email Slams Dendreon StockholdersJuly 16, 2010 - 12:58 pm
The Dendreon saga keeps getting stranger. An anonymous email circulated among investors led to a sell- off in shares of Seattle-based Dendreon yesterday, but the arguments it made about the company's prostate cancer treatment Provenge don't appear to hold up to scrutiny.
The 27-page email, embedded below, does focus in on one of the biggest vulnerabilities in the studies that resulted in Provenge being approved by the Food and Drug Administration: the nature of the placebo group to which the treatment was compared. But the email's reason's for doubting Provenge seem unlikely at best - and are actually less believable than similar worries about the Provenge data that were brought up before the FDA approved it.
Provenge is a cell therapy. Some of the patient's own immune cells are removed from his blood using a process called apheresis. They are sent to a factory, where they are treated in a way meant to teach them to attack prostate cancer cells, then sent back to the doctor and injected back into the patient. In Provenge clinical trials, patients had cells removed whether or not they were going to get the treatment or placebo; placebo patients had a fake version of Provenge injected into them.
This kept either doctors or patients from knowing who got what treatment, but it did mean that instead of getting nothing at all, the patients in the control group received apheresis and the fake Provenge. One worry, brought up before the drug was approved, was that both real and fake Provenge were increasing the incidence of stroke. That didn't stop the FDA from approving the treatment.
The new wrinkle in the 27-page email is the idea that removing the immune cells and then not replacing them somehow compromised the immune systems of the placebo patients, and that this alone accounted for the impressive 4 month survival benefit seen in the average Provenge patient. David Miller of Biotech Stock Research, one of the smartest and most long-term Dendreon bulls, did a pretty good job demolishing this idea in a note last night. The core of his argument: the apheresis process removes only 0.3% of the immune cells in question, called lymphocytes.
"Effectively, the author claims that a change in 0.15% of the body's total lymphocytes is [the] real explanation for Provenge's benefits," Miller writes. "Sure."
Christopher Raymond, an analyst at R.W. Baird, labeled the note "a new level of absurdity in the Provenge saga.." He wrote: "While we hesitate to justify this with a response, we feel compelled given the facts strongly contradict the author's conclusion."
Another, related argument that has circulated at times - and makes more sense - is that patients in the control group of the study received Provenge after they got worse, before receiving Taxotere, a chemotherapy which has been proved top extend survival in prostate cancer patients. This could mean, in effect, that patients in the Provenge arm got Taxotere before those in the control arm, which might account for some of the survival benefit.
But this criticism doesn't seem to bear out, either. Daniel Petrylak, a respected Columbia University prostate cancer expert, was first author on an analysis looking at the Taxotere question that was presented at this year's meeting of the American Society of Clinical Oncology. His conclusion, which I've changed only by replacing generic names with brand ones:
"A [Provenge] treatment effect was observed both in patients who did and did not receive subsequent [Taxotere]. The overall [Provenge] treatment effect remained robust when adjusting for [Taxotere] use. There was no evidence to suggest that subsequent [Taxotere] use explains the observed [Provenge] effect."
I'd be interested in arguments that the single big Provenge trial might have overestimated the effect of the treatment; that happens with a lot of new drugs. But I think any argument that Provenge is worthless or harmful should be approached with some skepticism. I wish there were more data, but what is there is pretty convincing, and, after all, the drug is already approved.
http://www.scribd.com/doc/34285499/Provenge-Trial-Alternative-Explanation-for-Observed-Survival-2
http://blogs.forbes.com/sciencebiz/2010/07/anonymous-email-slams-dendreon-stockholders/?partner=yahootix
Anonymous Email Slams Dendreon StockholdersJuly 16, 2010 - 12:58 pm
The Dendreon saga keeps getting stranger. An anonymous email circulated among investors led to a sell- off in shares of Seattle-based Dendreon yesterday, but the arguments it made about the company's prostate cancer treatment Provenge don't appear to hold up to scrutiny.
The 27-page email, embedded below, does focus in on one of the biggest vulnerabilities in the studies that resulted in Provenge being approved by the Food and Drug Administration: the nature of the placebo group to which the treatment was compared. But the email's reason's for doubting Provenge seem unlikely at best - and are actually less believable than similar worries about the Provenge data that were brought up before the FDA approved it.
Provenge is a cell therapy. Some of the patient's own immune cells are removed from his blood using a process called apheresis. They are sent to a factory, where they are treated in a way meant to teach them to attack prostate cancer cells, then sent back to the doctor and injected back into the patient. In Provenge clinical trials, patients had cells removed whether or not they were going to get the treatment or placebo; placebo patients had a fake version of Provenge injected into them.
This kept either doctors or patients from knowing who got what treatment, but it did mean that instead of getting nothing at all, the patients in the control group received apheresis and the fake Provenge. One worry, brought up before the drug was approved, was that both real and fake Provenge were increasing the incidence of stroke. That didn't stop the FDA from approving the treatment.
The new wrinkle in the 27-page email is the idea that removing the immune cells and then not replacing them somehow compromised the immune systems of the placebo patients, and that this alone accounted for the impressive 4 month survival benefit seen in the average Provenge patient. David Miller of Biotech Stock Research, one of the smartest and most long-term Dendreon bulls, did a pretty good job demolishing this idea in a note last night. The core of his argument: the apheresis process removes only 0.3% of the immune cells in question, called lymphocytes.
"Effectively, the author claims that a change in 0.15% of the body's total lymphocytes is [the] real explanation for Provenge's benefits," Miller writes. "Sure."
Christopher Raymond, an analyst at R.W. Baird, labeled the note "a new level of absurdity in the Provenge saga.." He wrote: "While we hesitate to justify this with a response, we feel compelled given the facts strongly contradict the author's conclusion."
Another, related argument that has circulated at times - and makes more sense - is that patients in the control group of the study received Provenge after they got worse, before receiving Taxotere, a chemotherapy which has been proved top extend survival in prostate cancer patients. This could mean, in effect, that patients in the Provenge arm got Taxotere before those in the control arm, which might account for some of the survival benefit.
But this criticism doesn't seem to bear out, either. Daniel Petrylak, a respected Columbia University prostate cancer expert, was first author on an analysis looking at the Taxotere question that was presented at this year's meeting of the American Society of Clinical Oncology. His conclusion, which I've changed only by replacing generic names with brand ones:
"A [Provenge] treatment effect was observed both in patients who did and did not receive subsequent [Taxotere]. The overall [Provenge] treatment effect remained robust when adjusting for [Taxotere] use. There was no evidence to suggest that subsequent [Taxotere] use explains the observed [Provenge] effect."
I'd be interested in arguments that the single big Provenge trial might have overestimated the effect of the treatment; that happens with a lot of new drugs. But I think any argument that Provenge is worthless or harmful should be approached with some skepticism. I wish there were more data, but what is there is pretty convincing, and, after all, the drug is already approved.
http://www.scribd.com/doc/34285499/Provenge-Trial-Alternative-Explanation-for-Observed-Survival-2
Og Bavarian blev lige nævnt der...
Dendreon Gets Some Respect
http://blogs.forbes.com/sciencebiz/2010/07/dendreon-gets-some-respect/?partner=yahootix
The biggest study of Dendreon's prostate cancer treatment Provenge has been published in the current issue of the New England Journal of Medicine. This is an important milestone for the Seattle-based biotech firm.
For most pharmaceutical companies, publishing already presented data in a medical journal isn't that big a deal, even if it is the most august medical periodical there is. Investors have already seen the data, and top doctors probably saw the original presentation or got the gist from either the lay press or specialty publications.
But Provenge elicits stronger emotions from investors and researchers than just about any other treatment. On the one hand, it is a breakthrough that trains the immune system to attack tumor cells, and doctors and investors are passionate about its potential. On the other, Dendreon's initial attempts at garnering regulatory approval seemed premature to many experts, and that bred distrust.
Seeing the Provenge results in black and white in the New England Journal is likely to clear up lots of remaining doubts. It helps that Philip W. Kantoff, a well-respected prostate cancer researcher at the Dana Farber Cancer Institute, is the study's lead author.
One of the strongest factors in Provenge's favor is the consistency of the data. No matter what subgroup of patients one looks at, Provenge increased survival.
Particularly important is an analysis of patients who received Taxotere, a Sanofi-Aventis chemotherapy that extends life in prostate cancer. If you adjust for Taxotere use, the results barely change. Overall, Provenge patients had a 22% decrease in the risk of death and a 4.1 month increase in median survival compared to those on a placebo.
An editorial, by Dan L. Longo, another prostate cancer researcher, calls the result "an important step" but then goes on to raise potential problems with the study. He lists the following issues:
The placebo group: Provenge is a cell therapy meant to stimulate the immune system to attack prostate cancer cells. The placebo group got cells that had not been incubated with any immune stimulant. That, Longo argues, leaves open the possibility that just stimulating the immune system, and not teaching it to attack prostate cancer cells, led to the benefit.
Provenge had no measurable effect on tumors. This makes the survival results harder to explain, Longo writes. The Taxotere data are useful, but it is also necessary to look at other data, like the use of cholesterol-lowering statin drugs, to make sure that accidental differences between the Provenge and placebo groups did not account for some of the survival advantage.
Provenge is expensive, and that may, in Longo's words, "affect use." He notes that it currently costs $1,800 per month to treat a patient with prostate cancer. At its current cost of $93,000, Provenge costs $23,000 per month of additional survival.
Other therapies could surpass Provenge. Longo points in particular to Prostvac-VF, currently being developed by Bavarian Nordic, a Kvistgård, Denmark, biotechnology firm.
Investors worried competition should take solace in this: the original maker of Prostvac-VF, Therion Biologics, went out of business, allowing Bavarian Nordic to scoop up the rights. Dendreon, despite long odds, managed to keep the lights on and hold onto Provenge.
Dendreon Gets Some Respect
http://blogs.forbes.com/sciencebiz/2010/07/dendreon-gets-some-respect/?partner=yahootix
The biggest study of Dendreon's prostate cancer treatment Provenge has been published in the current issue of the New England Journal of Medicine. This is an important milestone for the Seattle-based biotech firm.
For most pharmaceutical companies, publishing already presented data in a medical journal isn't that big a deal, even if it is the most august medical periodical there is. Investors have already seen the data, and top doctors probably saw the original presentation or got the gist from either the lay press or specialty publications.
But Provenge elicits stronger emotions from investors and researchers than just about any other treatment. On the one hand, it is a breakthrough that trains the immune system to attack tumor cells, and doctors and investors are passionate about its potential. On the other, Dendreon's initial attempts at garnering regulatory approval seemed premature to many experts, and that bred distrust.
Seeing the Provenge results in black and white in the New England Journal is likely to clear up lots of remaining doubts. It helps that Philip W. Kantoff, a well-respected prostate cancer researcher at the Dana Farber Cancer Institute, is the study's lead author.
One of the strongest factors in Provenge's favor is the consistency of the data. No matter what subgroup of patients one looks at, Provenge increased survival.
Particularly important is an analysis of patients who received Taxotere, a Sanofi-Aventis chemotherapy that extends life in prostate cancer. If you adjust for Taxotere use, the results barely change. Overall, Provenge patients had a 22% decrease in the risk of death and a 4.1 month increase in median survival compared to those on a placebo.
An editorial, by Dan L. Longo, another prostate cancer researcher, calls the result "an important step" but then goes on to raise potential problems with the study. He lists the following issues:
The placebo group: Provenge is a cell therapy meant to stimulate the immune system to attack prostate cancer cells. The placebo group got cells that had not been incubated with any immune stimulant. That, Longo argues, leaves open the possibility that just stimulating the immune system, and not teaching it to attack prostate cancer cells, led to the benefit.
Provenge had no measurable effect on tumors. This makes the survival results harder to explain, Longo writes. The Taxotere data are useful, but it is also necessary to look at other data, like the use of cholesterol-lowering statin drugs, to make sure that accidental differences between the Provenge and placebo groups did not account for some of the survival advantage.
Provenge is expensive, and that may, in Longo's words, "affect use." He notes that it currently costs $1,800 per month to treat a patient with prostate cancer. At its current cost of $93,000, Provenge costs $23,000 per month of additional survival.
Other therapies could surpass Provenge. Longo points in particular to Prostvac-VF, currently being developed by Bavarian Nordic, a Kvistgård, Denmark, biotechnology firm.
Investors worried competition should take solace in this: the original maker of Prostvac-VF, Therion Biologics, went out of business, allowing Bavarian Nordic to scoop up the rights. Dendreon, despite long odds, managed to keep the lights on and hold onto Provenge.
30/7 2010 15:19 1970 031642 Dendreon's Provenge Costs the Same as Chemotherapy
http://www.minyanville.com/businessmarkets/articles/dendreon-provenge-cost-taxotere-sanofi-aventis/7/29/2010/id/29371?camp=syndication&medium=portals&from=yahoo
http://www.minyanville.com/businessmarkets/articles/dendreon-provenge-cost-taxotere-sanofi-aventis/7/29/2010/id/29371?camp=syndication&medium=portals&from=yahoo
