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Dendreon vs CMS: Why the Provenge Coverage Controversy Is Bigger Than Just One Product
by Ramsey Baghdadi | CancerNetwork.com | 09.22.2010
It appeared that the controversy surrounding the prostate cancer immunotherapy Provenge ended with FDA approval in April. But now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.
Is $93,000 beyond the upper limit of what a drug company can charge for a non-curative cancer therapy when the government is the primary payer? That may be one interpretation of a recent action by the Centers for Medicare & Medicaid Services (CMS) to review its coverage policy for Dendreon’s prostate cancer cell-based immunotherapy Provenge.
Although the looming fight between Dendreon and CMS appears to be specific to the product in question, there is a larger lesson for other biopharmaceutical companies, particularly those operating in cancer drug development: as the government becomes an increasingly large payer, it is paying closer attention to what officials may see as exorbitant pricing practices.
And CMS has the tools at its disposal to force a de facto price negotiation—or go down fighting.
At the very least, the case of Provenge serves as another reminder that there are two regulators in Washington—not one—that are critical in determining a product’s commercial success. Approval by the Food & Drug Administration (FDA) remains, of course, a defining milestone for biotech companies and their investors, but satisfying CMS can be just as critical, especially in the field of oncology where Medicare is the dominant payer.
CMS may end up covering Provenge without limitation, or it may end up putting restrictions on coverage that have no real impact on a product that is going to be in relatively tight supply for the near future. But simply by initiating the review, the agency is encouraging public conversation about the value of the therapy.
That certainly has the attention of investors—and may be a sign of things to come for the biopharma sector overall.
Provenge Clears One Regulatory Hurdle, Faces Another
It’s almost never a good thing when your drug is the topic of daily conversations at CMS. That’s exactly the situation Dendreon found itself in with Provenge.
Investors cheered when Provenge was approved by FDA on April 29. The stock price rose as the days grew closer to Dendreon’s user fee date for Provenge as investors correctly anticipated that the product would complete its turnaround from a devastating “complete response” letter sent three years earlier. Even after the run-up, the stock increased by almost 35% the day the approval letter was disclosed, bringing its year-to-date increase to 100%. All that on top of a 10-fold price increase in 2009.
It looked to be the successful end of a long, up-and-down journey for the biotech company. During a same-day conference call announcing the Provenge approval, CEO Mitchell Gold declared that Dendreon had found the “Holy Grail of oncology” and that the company would begin a rollout of Provenge the following week.
The price? $93,000 for a three-course cycle; or $31,000 per infusion…
Even though breakthrough oncology therapies typically can garner an attractive premium compared with drugs in other therapeutic areas, the high price surprised even the most bullish Provenge watchers who had been following the progress of the cell-based immunotherapy.
Would reimbursement be a problem at that price, especially considering approximately 75% of patients who will use Provenge are Medicare beneficiaries?
Dendreon anticipated that Medicare and private payors would cover the costs of Provenge, Gold said, and a company official noted that the prostate cancer therapy Taxotere cost roughly $60,000 for a full treatment, making it “very close” to Provenge. The company also highlighted the cost advantage of Provenge as a defined, three-course regimen rather than a more typical open-ended course of therapy.
In the end, the price, Dendreon said, represented and “advantageous cost/value structure.”
Moreover, Dendreon planned to rollout Provenge to only 2,000 patients in the first 12 months, translating to a $110 million cost—not typically a sum that grabs a lot of attention when it comes to the large Medicare program.
CMS Opens a National Coverage Analysis
However, CMS was paying attention.
In a shocking move, CMS announced on June 30th that it had opened a national coverage analysis (NCA) for Provenge to determine whether the therapy is “reasonable and necessary.”
The Medicare agency said specifically: “CMS opens this NCA for autologous cellular immunotherapy treatment of prostate cancer. CMS is requesting public comments on the evidence regarding the effects of this treatment on health outcomes in patients with prostate cancer…CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the subject under review. CMS is commissioning a technology assessment from an external entity and plans to convene a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) in 2010.” The National Coverage Decision is expected in March 2011.
How big an impact did CMS’ announcement have? For Wall Street, it is simple: CMS’ decision to review coverage of the therapy erased all the gains from the approval of the product; with the stock dropping all the way back to the levels it had in January.
Put another way, investors seem to feel that the uncertainty surrounding the coverage policy means as much to the value of the company as did the uncertainty around FDA’s regulatory decision.
Using an alternative metric, based on Dendreon’s market cap of approximately $7.3 billion the day following FDA approval, Dendreon would have to give Provenge to more than 78,000 men with prostate cancer to meet the cap number. Following the CMS announcement, the number of prostate cancer patients dropped to just over 41,000 needed to meet the $3.9 billion market cap in early July.
And investors wondered: If CMS is taking on Provenge, will it take on other cancer therapies, like Roche AG’s Avastin, Herceptin and Rituxan?
The answer to that question is: it just might.
All indications are that the decision to review Provenge was triggered by specific circumstances surrounding what is, after all, a completely new type of therapy: a cell-based cancer “vaccine.” In that sense, it is probably an over-reaction to read into CMS’ decision a blanket review of coverage of all high-priced cancer therapies currently in use and in the pipeline.
But, having opened up the conversation in this specific context, there is nothing to stop CMS from expanding its reach and looking more broadly at what everyone in the healthcare policy world agrees is a key issue for the future: the exploding cost of cancer treatment in the U.S.
The Wrong Approach
It appears to have been a confluence of four factors that led to the NCA for Provenge: the price, Dendreon’s lack of communication with CMS, noise from private payers, and an agreement between FDA and CMS to facilitate the exchange of information.
First off, there are indications that CMS was unhappy that Dendreon did not talk with agency officials much earlier in the development and review process, given the certainty that Medicare would be the primary payer for the new therapy. During the April 29 conference call, Dendreon essentially admitted it was not focused on CMS early on, saying it planned to meet with agency officials the week of May 3 to discuss reimbursement issues.
The lack of communication is one thing; the pricing decision is another. After hearing the price set by Dendreon for Provenge, some CMS officials became concerned about the high cost. At that point, the immunotherapy began being discussed regularly at the agency.
At the same time, CMS was hearing concerns from medical directors at private insurers who were complaining about the sticker-shock price.
Almost serendipitously from CMS’ point of view, a memorandum of understanding (MoU) was signed between the Medicare agency and FDA “to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between the federal partners.”
The MoU provides a framework for CMS medical experts and coverage analysis group to get full access to Dendreon’s study data of Provenge.
CMS’ decision to initiate an NCA may be nothing more than a back-door price negotiation.
It wouldn’t be the first time. Biogen Idec expected to get a payment code soon after launching its diagnostic/radiotherapeutic agent ibritumomab (Zevalin). The code was delayed for several months and then was set at 78% of Average Wholesale Price (AWP) as opposed to the much better rate of AWP-5%. Subsequently, Zevalin took another hit when CMS reclassified it as a procedure rather than a drug, giving it an even lower reimbursement rate.
What happened? CMS leadership became aware that Biogen had set Zevalin’s AWP at about $30,000 and communicated to the company that either there needed to be a price cut or Biogen could keep waiting for a coverage code. Eventually, the agency and Biogen were able to reach a compromise, but Zevalin never reached the commercial success that Biogen had hoped for.
CMS’ Options: Many or Few?
The Zevalin issue, however, took place outside of the “official” coverage process; with Provenge, CMS is going by the books, and that means there really isn’t much room for Dendreon to make an accommodation on price.
Here is how CMS officials see the options for a potential national coverage decision:
(1) Coverage
(2) Coverage with evidence development
(3) Coverage for on-label use only and blanket non-coverage for off-label use
(4) More restrictive coverage affecting even on-label use
(5) Blanket non-coverage
However, under the applicable Medicare statute, it appears as though CMS is relatively boxed in, and will have to cover, at the very least, the labeled uses of the therapy.
Sec. 1861(t)(2)(A) of the Medicare statute defines “drugs” to include “any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication.”
The description under the law of a medically accepted indication: “includes any use which has been approved by the Food and Drug Administration for the drug and such use is supported by one or more citations which are included (or approved for inclusion) in one or more of the following compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia-Drug Information, and other authoritative compendia as identified by the Secretary, unless the Secretary has determined that the use is not medically appropriate or the use is identified as not indicated in one or more such compendia, or the carrier involved determines, based upon guidance provided by the Secretary to carriers for determining accepted uses of drugs, that such use is medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this sub-clause by the Secretary.”
Still, there is ambiguity about whether CMS could in fact deem an FDA-approved drug to be not “reasonable or necessary” despite the definition, and some officials within CMS believe the therapy should not be covered, citing skepticism over the study data used to support FDA approval.
If CMS were to attempt to move away from routine coverage of cancer drugs, it would indeed have dramatic implications for the biopharma sector and the scientific inquiry and development of novel cancer therapeutics.
Copyright CancerNetwork.com 2010
Tuesday, September 28, 2010
CMS Payment Coverage Debate over Provenge
ABOUT PROSTATE CANCERGET INVOLVEDPROGRAMSRESEARCHPARTNERSSTOREABOUT US
Risk Factors
Prevention
Detection
Diagnosis
Treatment
New Prostate Cancer Research
Prostate Cancer Resources
Managing Bone Metastases and Pain
Side Effects of Prostate Cancer Treatment
Show All
Interests: -- Select a topic -- 2006 Prostate Cancer SymposiumAdvocacy and PolicyExpertsGeneral Health NewsInternational NewsPress/MediaProstate Cancer - The DiseaseProstate Cancer StoriesSponsors and PartnersVolunteersZERO in the News
Dendreon vs CMS: Why the Provenge Coverage Controversy Is Bigger Than Just One Product
by Ramsey Baghdadi | CancerNetwork.com | 09.22.2010
It appeared that the controversy surrounding the prostate cancer immunotherapy Provenge ended with FDA approval in April. But now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.
Is $93,000 beyond the upper limit of what a drug company can charge for a non-curative cancer therapy when the government is the primary payer? That may be one interpretation of a recent action by the Centers for Medicare & Medicaid Services (CMS) to review its coverage policy for Dendreon’s prostate cancer cell-based immunotherapy Provenge.
Although the looming fight between Dendreon and CMS appears to be specific to the product in question, there is a larger lesson for other biopharmaceutical companies, particularly those operating in cancer drug development: as the government becomes an increasingly large payer, it is paying closer attention to what officials may see as exorbitant pricing practices.
And CMS has the tools at its disposal to force a de facto price negotiation—or go down fighting.
At the very least, the case of Provenge serves as another reminder that there are two regulators in Washington—not one—that are critical in determining a product’s commercial success. Approval by the Food & Drug Administration (FDA) remains, of course, a defining milestone for biotech companies and their investors, but satisfying CMS can be just as critical, especially in the field of oncology where Medicare is the dominant payer.
CMS may end up covering Provenge without limitation, or it may end up putting restrictions on coverage that have no real impact on a product that is going to be in relatively tight supply for the near future. But simply by initiating the review, the agency is encouraging public conversation about the value of the therapy.
That certainly has the attention of investors—and may be a sign of things to come for the biopharma sector overall.
Provenge Clears One Regulatory Hurdle, Faces Another
It’s almost never a good thing when your drug is the topic of daily conversations at CMS. That’s exactly the situation Dendreon found itself in with Provenge.
Investors cheered when Provenge was approved by FDA on April 29. The stock price rose as the days grew closer to Dendreon’s user fee date for Provenge as investors correctly anticipated that the product would complete its turnaround from a devastating “complete response” letter sent three years earlier. Even after the run-up, the stock increased by almost 35% the day the approval letter was disclosed, bringing its year-to-date increase to 100%. All that on top of a 10-fold price increase in 2009.
It looked to be the successful end of a long, up-and-down journey for the biotech company. During a same-day conference call announcing the Provenge approval, CEO Mitchell Gold declared that Dendreon had found the “Holy Grail of oncology” and that the company would begin a rollout of Provenge the following week.
The price? $93,000 for a three-course cycle; or $31,000 per infusion…
Even though breakthrough oncology therapies typically can garner an attractive premium compared with drugs in other therapeutic areas, the high price surprised even the most bullish Provenge watchers who had been following the progress of the cell-based immunotherapy.
Would reimbursement be a problem at that price, especially considering approximately 75% of patients who will use Provenge are Medicare beneficiaries?
Dendreon anticipated that Medicare and private payors would cover the costs of Provenge, Gold said, and a company official noted that the prostate cancer therapy Taxotere cost roughly $60,000 for a full treatment, making it “very close” to Provenge. The company also highlighted the cost advantage of Provenge as a defined, three-course regimen rather than a more typical open-ended course of therapy.
In the end, the price, Dendreon said, represented and “advantageous cost/value structure.”
Moreover, Dendreon planned to rollout Provenge to only 2,000 patients in the first 12 months, translating to a $110 million cost—not typically a sum that grabs a lot of attention when it comes to the large Medicare program.
CMS Opens a National Coverage Analysis
However, CMS was paying attention.
In a shocking move, CMS announced on June 30th that it had opened a national coverage analysis (NCA) for Provenge to determine whether the therapy is “reasonable and necessary.”
The Medicare agency said specifically: “CMS opens this NCA for autologous cellular immunotherapy treatment of prostate cancer. CMS is requesting public comments on the evidence regarding the effects of this treatment on health outcomes in patients with prostate cancer…CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the subject under review. CMS is commissioning a technology assessment from an external entity and plans to convene a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) in 2010.” The National Coverage Decision is expected in March 2011.
How big an impact did CMS’ announcement have? For Wall Street, it is simple: CMS’ decision to review coverage of the therapy erased all the gains from the approval of the product; with the stock dropping all the way back to the levels it had in January.
Put another way, investors seem to feel that the uncertainty surrounding the coverage policy means as much to the value of the company as did the uncertainty around FDA’s regulatory decision.
Using an alternative metric, based on Dendreon’s market cap of approximately $7.3 billion the day following FDA approval, Dendreon would have to give Provenge to more than 78,000 men with prostate cancer to meet the cap number. Following the CMS announcement, the number of prostate cancer patients dropped to just over 41,000 needed to meet the $3.9 billion market cap in early July.
And investors wondered: If CMS is taking on Provenge, will it take on other cancer therapies, like Roche AG’s Avastin, Herceptin and Rituxan?
The answer to that question is: it just might.
All indications are that the decision to review Provenge was triggered by specific circumstances surrounding what is, after all, a completely new type of therapy: a cell-based cancer “vaccine.” In that sense, it is probably an over-reaction to read into CMS’ decision a blanket review of coverage of all high-priced cancer therapies currently in use and in the pipeline.
But, having opened up the conversation in this specific context, there is nothing to stop CMS from expanding its reach and looking more broadly at what everyone in the healthcare policy world agrees is a key issue for the future: the exploding cost of cancer treatment in the U.S.
The Wrong Approach
It appears to have been a confluence of four factors that led to the NCA for Provenge: the price, Dendreon’s lack of communication with CMS, noise from private payers, and an agreement between FDA and CMS to facilitate the exchange of information.
First off, there are indications that CMS was unhappy that Dendreon did not talk with agency officials much earlier in the development and review process, given the certainty that Medicare would be the primary payer for the new therapy. During the April 29 conference call, Dendreon essentially admitted it was not focused on CMS early on, saying it planned to meet with agency officials the week of May 3 to discuss reimbursement issues.
The lack of communication is one thing; the pricing decision is another. After hearing the price set by Dendreon for Provenge, some CMS officials became concerned about the high cost. At that point, the immunotherapy began being discussed regularly at the agency.
At the same time, CMS was hearing concerns from medical directors at private insurers who were complaining about the sticker-shock price.
Almost serendipitously from CMS’ point of view, a memorandum of understanding (MoU) was signed between the Medicare agency and FDA “to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between the federal partners.”
The MoU provides a framework for CMS medical experts and coverage analysis group to get full access to Dendreon’s study data of Provenge.
CMS’ decision to initiate an NCA may be nothing more than a back-door price negotiation.
It wouldn’t be the first time. Biogen Idec expected to get a payment code soon after launching its diagnostic/radiotherapeutic agent ibritumomab (Zevalin). The code was delayed for several months and then was set at 78% of Average Wholesale Price (AWP) as opposed to the much better rate of AWP-5%. Subsequently, Zevalin took another hit when CMS reclassified it as a procedure rather than a drug, giving it an even lower reimbursement rate.
What happened? CMS leadership became aware that Biogen had set Zevalin’s AWP at about $30,000 and communicated to the company that either there needed to be a price cut or Biogen could keep waiting for a coverage code. Eventually, the agency and Biogen were able to reach a compromise, but Zevalin never reached the commercial success that Biogen had hoped for.
CMS’ Options: Many or Few?
The Zevalin issue, however, took place outside of the “official” coverage process; with Provenge, CMS is going by the books, and that means there really isn’t much room for Dendreon to make an accommodation on price.
Here is how CMS officials see the options for a potential national coverage decision:
(1) Coverage
(2) Coverage with evidence development
(3) Coverage for on-label use only and blanket non-coverage for off-label use
(4) More restrictive coverage affecting even on-label use
(5) Blanket non-coverage
However, under the applicable Medicare statute, it appears as though CMS is relatively boxed in, and will have to cover, at the very least, the labeled uses of the therapy.
Sec. 1861(t)(2)(A) of the Medicare statute defines “drugs” to include “any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication.”
The description under the law of a medically accepted indication: “includes any use which has been approved by the Food and Drug Administration for the drug and such use is supported by one or more citations which are included (or approved for inclusion) in one or more of the following compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia-Drug Information, and other authoritative compendia as identified by the Secretary, unless the Secretary has determined that the use is not medically appropriate or the use is identified as not indicated in one or more such compendia, or the carrier involved determines, based upon guidance provided by the Secretary to carriers for determining accepted uses of drugs, that such use is medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this sub-clause by the Secretary.”
Still, there is ambiguity about whether CMS could in fact deem an FDA-approved drug to be not “reasonable or necessary” despite the definition, and some officials within CMS believe the therapy should not be covered, citing skepticism over the study data used to support FDA approval.
If CMS were to attempt to move away from routine coverage of cancer drugs, it would indeed have dramatic implications for the biopharma sector and the scientific inquiry and development of novel cancer therapeutics.
Copyright CancerNetwork.com 2010
Risk Factors
Prevention
Detection
Diagnosis
Treatment
New Prostate Cancer Research
Prostate Cancer Resources
Managing Bone Metastases and Pain
Side Effects of Prostate Cancer Treatment
Show All
Interests: -- Select a topic -- 2006 Prostate Cancer SymposiumAdvocacy and PolicyExpertsGeneral Health NewsInternational NewsPress/MediaProstate Cancer - The DiseaseProstate Cancer StoriesSponsors and PartnersVolunteersZERO in the News
Dendreon vs CMS: Why the Provenge Coverage Controversy Is Bigger Than Just One Product
by Ramsey Baghdadi | CancerNetwork.com | 09.22.2010
It appeared that the controversy surrounding the prostate cancer immunotherapy Provenge ended with FDA approval in April. But now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.
Is $93,000 beyond the upper limit of what a drug company can charge for a non-curative cancer therapy when the government is the primary payer? That may be one interpretation of a recent action by the Centers for Medicare & Medicaid Services (CMS) to review its coverage policy for Dendreon’s prostate cancer cell-based immunotherapy Provenge.
Although the looming fight between Dendreon and CMS appears to be specific to the product in question, there is a larger lesson for other biopharmaceutical companies, particularly those operating in cancer drug development: as the government becomes an increasingly large payer, it is paying closer attention to what officials may see as exorbitant pricing practices.
And CMS has the tools at its disposal to force a de facto price negotiation—or go down fighting.
At the very least, the case of Provenge serves as another reminder that there are two regulators in Washington—not one—that are critical in determining a product’s commercial success. Approval by the Food & Drug Administration (FDA) remains, of course, a defining milestone for biotech companies and their investors, but satisfying CMS can be just as critical, especially in the field of oncology where Medicare is the dominant payer.
CMS may end up covering Provenge without limitation, or it may end up putting restrictions on coverage that have no real impact on a product that is going to be in relatively tight supply for the near future. But simply by initiating the review, the agency is encouraging public conversation about the value of the therapy.
That certainly has the attention of investors—and may be a sign of things to come for the biopharma sector overall.
Provenge Clears One Regulatory Hurdle, Faces Another
It’s almost never a good thing when your drug is the topic of daily conversations at CMS. That’s exactly the situation Dendreon found itself in with Provenge.
Investors cheered when Provenge was approved by FDA on April 29. The stock price rose as the days grew closer to Dendreon’s user fee date for Provenge as investors correctly anticipated that the product would complete its turnaround from a devastating “complete response” letter sent three years earlier. Even after the run-up, the stock increased by almost 35% the day the approval letter was disclosed, bringing its year-to-date increase to 100%. All that on top of a 10-fold price increase in 2009.
It looked to be the successful end of a long, up-and-down journey for the biotech company. During a same-day conference call announcing the Provenge approval, CEO Mitchell Gold declared that Dendreon had found the “Holy Grail of oncology” and that the company would begin a rollout of Provenge the following week.
The price? $93,000 for a three-course cycle; or $31,000 per infusion…
Even though breakthrough oncology therapies typically can garner an attractive premium compared with drugs in other therapeutic areas, the high price surprised even the most bullish Provenge watchers who had been following the progress of the cell-based immunotherapy.
Would reimbursement be a problem at that price, especially considering approximately 75% of patients who will use Provenge are Medicare beneficiaries?
Dendreon anticipated that Medicare and private payors would cover the costs of Provenge, Gold said, and a company official noted that the prostate cancer therapy Taxotere cost roughly $60,000 for a full treatment, making it “very close” to Provenge. The company also highlighted the cost advantage of Provenge as a defined, three-course regimen rather than a more typical open-ended course of therapy.
In the end, the price, Dendreon said, represented and “advantageous cost/value structure.”
Moreover, Dendreon planned to rollout Provenge to only 2,000 patients in the first 12 months, translating to a $110 million cost—not typically a sum that grabs a lot of attention when it comes to the large Medicare program.
CMS Opens a National Coverage Analysis
However, CMS was paying attention.
In a shocking move, CMS announced on June 30th that it had opened a national coverage analysis (NCA) for Provenge to determine whether the therapy is “reasonable and necessary.”
The Medicare agency said specifically: “CMS opens this NCA for autologous cellular immunotherapy treatment of prostate cancer. CMS is requesting public comments on the evidence regarding the effects of this treatment on health outcomes in patients with prostate cancer…CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the subject under review. CMS is commissioning a technology assessment from an external entity and plans to convene a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) in 2010.” The National Coverage Decision is expected in March 2011.
How big an impact did CMS’ announcement have? For Wall Street, it is simple: CMS’ decision to review coverage of the therapy erased all the gains from the approval of the product; with the stock dropping all the way back to the levels it had in January.
Put another way, investors seem to feel that the uncertainty surrounding the coverage policy means as much to the value of the company as did the uncertainty around FDA’s regulatory decision.
Using an alternative metric, based on Dendreon’s market cap of approximately $7.3 billion the day following FDA approval, Dendreon would have to give Provenge to more than 78,000 men with prostate cancer to meet the cap number. Following the CMS announcement, the number of prostate cancer patients dropped to just over 41,000 needed to meet the $3.9 billion market cap in early July.
And investors wondered: If CMS is taking on Provenge, will it take on other cancer therapies, like Roche AG’s Avastin, Herceptin and Rituxan?
The answer to that question is: it just might.
All indications are that the decision to review Provenge was triggered by specific circumstances surrounding what is, after all, a completely new type of therapy: a cell-based cancer “vaccine.” In that sense, it is probably an over-reaction to read into CMS’ decision a blanket review of coverage of all high-priced cancer therapies currently in use and in the pipeline.
But, having opened up the conversation in this specific context, there is nothing to stop CMS from expanding its reach and looking more broadly at what everyone in the healthcare policy world agrees is a key issue for the future: the exploding cost of cancer treatment in the U.S.
The Wrong Approach
It appears to have been a confluence of four factors that led to the NCA for Provenge: the price, Dendreon’s lack of communication with CMS, noise from private payers, and an agreement between FDA and CMS to facilitate the exchange of information.
First off, there are indications that CMS was unhappy that Dendreon did not talk with agency officials much earlier in the development and review process, given the certainty that Medicare would be the primary payer for the new therapy. During the April 29 conference call, Dendreon essentially admitted it was not focused on CMS early on, saying it planned to meet with agency officials the week of May 3 to discuss reimbursement issues.
The lack of communication is one thing; the pricing decision is another. After hearing the price set by Dendreon for Provenge, some CMS officials became concerned about the high cost. At that point, the immunotherapy began being discussed regularly at the agency.
At the same time, CMS was hearing concerns from medical directors at private insurers who were complaining about the sticker-shock price.
Almost serendipitously from CMS’ point of view, a memorandum of understanding (MoU) was signed between the Medicare agency and FDA “to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between the federal partners.”
The MoU provides a framework for CMS medical experts and coverage analysis group to get full access to Dendreon’s study data of Provenge.
CMS’ decision to initiate an NCA may be nothing more than a back-door price negotiation.
It wouldn’t be the first time. Biogen Idec expected to get a payment code soon after launching its diagnostic/radiotherapeutic agent ibritumomab (Zevalin). The code was delayed for several months and then was set at 78% of Average Wholesale Price (AWP) as opposed to the much better rate of AWP-5%. Subsequently, Zevalin took another hit when CMS reclassified it as a procedure rather than a drug, giving it an even lower reimbursement rate.
What happened? CMS leadership became aware that Biogen had set Zevalin’s AWP at about $30,000 and communicated to the company that either there needed to be a price cut or Biogen could keep waiting for a coverage code. Eventually, the agency and Biogen were able to reach a compromise, but Zevalin never reached the commercial success that Biogen had hoped for.
CMS’ Options: Many or Few?
The Zevalin issue, however, took place outside of the “official” coverage process; with Provenge, CMS is going by the books, and that means there really isn’t much room for Dendreon to make an accommodation on price.
Here is how CMS officials see the options for a potential national coverage decision:
(1) Coverage
(2) Coverage with evidence development
(3) Coverage for on-label use only and blanket non-coverage for off-label use
(4) More restrictive coverage affecting even on-label use
(5) Blanket non-coverage
However, under the applicable Medicare statute, it appears as though CMS is relatively boxed in, and will have to cover, at the very least, the labeled uses of the therapy.
Sec. 1861(t)(2)(A) of the Medicare statute defines “drugs” to include “any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication.”
The description under the law of a medically accepted indication: “includes any use which has been approved by the Food and Drug Administration for the drug and such use is supported by one or more citations which are included (or approved for inclusion) in one or more of the following compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia-Drug Information, and other authoritative compendia as identified by the Secretary, unless the Secretary has determined that the use is not medically appropriate or the use is identified as not indicated in one or more such compendia, or the carrier involved determines, based upon guidance provided by the Secretary to carriers for determining accepted uses of drugs, that such use is medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this sub-clause by the Secretary.”
Still, there is ambiguity about whether CMS could in fact deem an FDA-approved drug to be not “reasonable or necessary” despite the definition, and some officials within CMS believe the therapy should not be covered, citing skepticism over the study data used to support FDA approval.
If CMS were to attempt to move away from routine coverage of cancer drugs, it would indeed have dramatic implications for the biopharma sector and the scientific inquiry and development of novel cancer therapeutics.
Copyright CancerNetwork.com 2010
Sunday, August 29, 2010
Using Finasteride Sor PCa Prevention?
Few Doctors Prescribe Finasteride to Prevent Prostate Cancer, Despite Effectiveness
by Thomas H. Maugh II | Los Angeles Times | 08.11.2010
Most physicians are reluctant to prescribe the drug finasteride to prevent prostate cancer in older men with elevated risk of the disease, despite evidence that the drug can reduce risk by about a quarter, researchers said Tuesday.
"There are no other proven ways of reducing yours risk of prostate cancer -- this is the only one," Dr. Ian M. Thompson of the University of Texas Health Science Center in San Antonio, told Bloomberg. Its use could reduce new diagnoses by "tens of thousands," he said.
Thompson was the lead author of a 2003 report that showed that the drug, sold by Merck under the brand name Proscar, could reduce the risk of prostate cancer among such men from 24% to 18%. Another study earlier this year showed that a second drug, dutasteride, might be even slightly more effective.
About 217,730 men will be diagnosed with prostate cancer this year, according to the National Cancer Institute, and about 32,000 will die from it. That makes it the second-leading cause of cancer death among men, following only lung cancer.
Risk factors for prostate cancer include being over the age of 65, having elevated levels of prostate-specific antigen (PSA), a family history of the disease and being African American.
In the new study, Dr. Linda S. Kinsinger of the Veterans Health Administration National Center for Health Promotion and Disease Prevention and her colleagues surveyed a random sample of 325 VHA urologists and 1,200 VHA primary care physicians to determine how their prescribing practices changed from 2000 through 2005, a period that included the widely heralded finasteride trial.
The researchers reported in the September issue of the journal Cancer Epidemiology, Biomarkers & Prevention that the use of finasteride did increase somewhat during the period, but to treat benign prostatic hyperplasia, not to prevent prostate cancer. Fully 64% of urologists and 80% of primary-care physicians said they never prescribed the drug for prevention, and 52% of the latter group said they did not even know that the drug could be used for that purpose.
One concern among urologists was that the 2003 study suggested that, even though finasteride reduced the risk of prostate cancers, those who did develop the disease might be more likely to develop a highly aggressive form of the disease. Researchers have subsequently shown, however, that that was an artifact of the study and that the drug doesn't increase the risk of such tumors.
"The prospect of chemoprevention is a difficult one for patients and physicians," Kinsinger said in a statement. She compared using finasteride to ward off prostate cancer to using statins to ward off heart disease.
The primary difference between the two, she added, is that the effects of statins can be monitored by measuring cholesterol levels, but there is no analogous marker to show that finasteride is working. The only marker is not developing cancer.
The primary side effect of finasteride is that it increases hair growth. In fact, the drug is also sold under the brand name Propecia to promote new hair growth in the balding. The amount of drug in Propecia is about 20% of that in Proscar.
Copyright Los Angeles Times 2010
Initial Savings May Hide True Cost of Prostate Cancer Care
U.S. News & World Report | 08.23.2010
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© Copyright 2010, ZERO - The Project to End Prostate Cancer. All rights reserved.
by Thomas H. Maugh II | Los Angeles Times | 08.11.2010
Most physicians are reluctant to prescribe the drug finasteride to prevent prostate cancer in older men with elevated risk of the disease, despite evidence that the drug can reduce risk by about a quarter, researchers said Tuesday.
"There are no other proven ways of reducing yours risk of prostate cancer -- this is the only one," Dr. Ian M. Thompson of the University of Texas Health Science Center in San Antonio, told Bloomberg. Its use could reduce new diagnoses by "tens of thousands," he said.
Thompson was the lead author of a 2003 report that showed that the drug, sold by Merck under the brand name Proscar, could reduce the risk of prostate cancer among such men from 24% to 18%. Another study earlier this year showed that a second drug, dutasteride, might be even slightly more effective.
About 217,730 men will be diagnosed with prostate cancer this year, according to the National Cancer Institute, and about 32,000 will die from it. That makes it the second-leading cause of cancer death among men, following only lung cancer.
Risk factors for prostate cancer include being over the age of 65, having elevated levels of prostate-specific antigen (PSA), a family history of the disease and being African American.
In the new study, Dr. Linda S. Kinsinger of the Veterans Health Administration National Center for Health Promotion and Disease Prevention and her colleagues surveyed a random sample of 325 VHA urologists and 1,200 VHA primary care physicians to determine how their prescribing practices changed from 2000 through 2005, a period that included the widely heralded finasteride trial.
The researchers reported in the September issue of the journal Cancer Epidemiology, Biomarkers & Prevention that the use of finasteride did increase somewhat during the period, but to treat benign prostatic hyperplasia, not to prevent prostate cancer. Fully 64% of urologists and 80% of primary-care physicians said they never prescribed the drug for prevention, and 52% of the latter group said they did not even know that the drug could be used for that purpose.
One concern among urologists was that the 2003 study suggested that, even though finasteride reduced the risk of prostate cancers, those who did develop the disease might be more likely to develop a highly aggressive form of the disease. Researchers have subsequently shown, however, that that was an artifact of the study and that the drug doesn't increase the risk of such tumors.
"The prospect of chemoprevention is a difficult one for patients and physicians," Kinsinger said in a statement. She compared using finasteride to ward off prostate cancer to using statins to ward off heart disease.
The primary difference between the two, she added, is that the effects of statins can be monitored by measuring cholesterol levels, but there is no analogous marker to show that finasteride is working. The only marker is not developing cancer.
The primary side effect of finasteride is that it increases hair growth. In fact, the drug is also sold under the brand name Propecia to promote new hair growth in the balding. The amount of drug in Propecia is about 20% of that in Proscar.
Copyright Los Angeles Times 2010
Initial Savings May Hide True Cost of Prostate Cancer Care
U.S. News & World Report | 08.23.2010
About Prostate Cancer | Donate | Get Involved | Programs | Research | Partners | Store | About Us | Site Map | Contact Us | Privacy Policy
© Copyright 2010, ZERO - The Project to End Prostate Cancer. All rights reserved.
Friday, August 27, 2010
National Cancer Institute's Clinical Trials
Click Here for more information and links to surveys
Multiple trials
Prostate cancer trials at the NIH Clinical Center in Bethesda, MD [080706]
NCI currently conducting trials for patients with prostate cancer -- The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), conducts more than 150 clinical trials at the NIH Clinical Center in Bethesda, MD. NCI is currently conducting clinical trials for patients with prostate cancer.
Visit http://bethesdatrials.cancer.gov/prostate for a listing of prostate cancer clinical trials that are currently enrolling patients at the NIH Clinical Center.
There is no charge for medical care received at the NIH Clinical Center. Study participants will be responsible for travel costs for their initial screening visits. Once participants are enrolled in a trial, NCI will pay for the transportation costs for all subsequent trial-related visits for participants who do not live in the local area. In addition, these participants will receive a small per diem for food and lodging expenses if they are being treated as outpatients.
For more information on clinical trials conducted at NCI, please visit http://bethesdatrials.cancer.gov or call the Clinical Trials Referral Office (formerly Clinical Studies Support Center) at 1-888-NCI-1937 (1-888-624-1937).
The National Cancer Institute also sponsors clinical studies at cancer centers nationwide. To learn more about these studies, call 1-800-4-CANCER (1-800-422-6237).
Multiple trials
Prostate cancer trials at the NIH Clinical Center in Bethesda, MD [080706]
NCI currently conducting trials for patients with prostate cancer -- The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), conducts more than 150 clinical trials at the NIH Clinical Center in Bethesda, MD. NCI is currently conducting clinical trials for patients with prostate cancer.
Visit http://bethesdatrials.cancer.gov/prostate for a listing of prostate cancer clinical trials that are currently enrolling patients at the NIH Clinical Center.
There is no charge for medical care received at the NIH Clinical Center. Study participants will be responsible for travel costs for their initial screening visits. Once participants are enrolled in a trial, NCI will pay for the transportation costs for all subsequent trial-related visits for participants who do not live in the local area. In addition, these participants will receive a small per diem for food and lodging expenses if they are being treated as outpatients.
For more information on clinical trials conducted at NCI, please visit http://bethesdatrials.cancer.gov or call the Clinical Trials Referral Office (formerly Clinical Studies Support Center) at 1-888-NCI-1937 (1-888-624-1937).
The National Cancer Institute also sponsors clinical studies at cancer centers nationwide. To learn more about these studies, call 1-800-4-CANCER (1-800-422-6237).
Hormone refractory/hormone resistant PCa
AFFIRM (A Study Evaluating the EFFicacy and Safety of Investigational DRug MDV3100 in Men with Advanced Prostate Cancer) [012010]
Now enrolling patients, this trial will evaluate the efficacy and safety of the investigational drug MDV3100 as a treatment for advanced prostate cancer – specifically a type known as hormone-resistant prostate cancer. The study will evaluate the impact of MDV3100 on survival and other factors, including quality of life.
The first triple-acting, oral anti-androgen, MDV3100 has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than the most commonly used anti-androgen, bicalutamide. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone from binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells and inhibits binding to DNA. Preclinical data published in Science demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.
Patients who were previously treated with the chemotherapy drug docetaxel may be eligible for the study. Two-thirds of patients will randomly be assigned to receive MDV3100 while 1/3 will receive placebo (sugar pill), which does not contain active medicine.
For more information on eligibility and enrollment, patients can call the AFFIRM study hotline toll-free at 1-888-782-3256 or visit www.affirmtrial.com
Now enrolling patients, this trial will evaluate the efficacy and safety of the investigational drug MDV3100 as a treatment for advanced prostate cancer – specifically a type known as hormone-resistant prostate cancer. The study will evaluate the impact of MDV3100 on survival and other factors, including quality of life.
The first triple-acting, oral anti-androgen, MDV3100 has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than the most commonly used anti-androgen, bicalutamide. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone from binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells and inhibits binding to DNA. Preclinical data published in Science demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.
Patients who were previously treated with the chemotherapy drug docetaxel may be eligible for the study. Two-thirds of patients will randomly be assigned to receive MDV3100 while 1/3 will receive placebo (sugar pill), which does not contain active medicine.
For more information on eligibility and enrollment, patients can call the AFFIRM study hotline toll-free at 1-888-782-3256 or visit www.affirmtrial.com
Dr Patriclk Walsh on Selectiing Your Surgeon
Dr. Patrick Walsh, former director of Johns Hopkins's Brady Urological Institute, shares his insights on choosing a doctor for your cancer surgery.
Dr. Patrick Walsh, dean of prostate cancer surgeons, has performed the technically challenging radical prostatectomy procedure thousands of times, and has personally schooled hundreds of surgeons in the finer points of the difficult nerve-sparing cancer operation. He certainly knows what it takes to be an expert in curing a man of cancer, preserving bladder function, and maintaining the nerves responsible for erections. What about the doctor you're considering for your own prostate cancer surgery?
"Your doctor may be nice and personable," says Dr. Walsh, "a practitioner whose empathy for your condition appeals to you, which is great. But what do you know about him? He's got a terrific bedside manner, but is he a board-certified urologist? What training has he had? Does he know and use the nerve-sparing cancer surgery techniques -- the anatomical approach to radical prostatectomy? How many of these cancer surgeries does he perform annually? What success has he had in preserving potency and continence? If he can't or won't give you his rate of success as compared to reports from other surgeons, or to results published in medical journals, this may be a red flag, and perhaps you should look elsewhere for your cancer surgeon.
"You should be able to get a good idea of his success rate in numbers or percentages. In addition, if he hasn't done very many of these cancer operations -- ideally, hundreds -- you might want to find a more experienced surgeon. Look at it this way: Do you want to be one of the patients he's learning on? Do you want to be part of someone's learning curve?
"Remember: You don't want a surgeon who's "pretty good" at removing the prostate. There are no second chances here: This is a one-shot operation. You are looking for the one surgeon who will perform the one radical prostatectomy you will ever receive in your life, the one operation that will cure your cancer.
"You want a surgeon who is going to make sure that no cancer is left behind, and who knows how to minimize trauma to your body during surgery so you don't wind up with incontinence, erectile dysfunction, or both.
"Finding the right surgeon may mean that you must travel to a major medical center in another city. This may mean that you'll be away from home for four days. But after that, even though you may need to wear a catheter for a week or two, the recovery from the operation is usually speedy, and follow-up communication can be carried out over the telephone."
Dr. Patrick Walsh, dean of prostate cancer surgeons, has performed the technically challenging radical prostatectomy procedure thousands of times, and has personally schooled hundreds of surgeons in the finer points of the difficult nerve-sparing cancer operation. He certainly knows what it takes to be an expert in curing a man of cancer, preserving bladder function, and maintaining the nerves responsible for erections. What about the doctor you're considering for your own prostate cancer surgery?
"Your doctor may be nice and personable," says Dr. Walsh, "a practitioner whose empathy for your condition appeals to you, which is great. But what do you know about him? He's got a terrific bedside manner, but is he a board-certified urologist? What training has he had? Does he know and use the nerve-sparing cancer surgery techniques -- the anatomical approach to radical prostatectomy? How many of these cancer surgeries does he perform annually? What success has he had in preserving potency and continence? If he can't or won't give you his rate of success as compared to reports from other surgeons, or to results published in medical journals, this may be a red flag, and perhaps you should look elsewhere for your cancer surgeon.
"You should be able to get a good idea of his success rate in numbers or percentages. In addition, if he hasn't done very many of these cancer operations -- ideally, hundreds -- you might want to find a more experienced surgeon. Look at it this way: Do you want to be one of the patients he's learning on? Do you want to be part of someone's learning curve?
"Remember: You don't want a surgeon who's "pretty good" at removing the prostate. There are no second chances here: This is a one-shot operation. You are looking for the one surgeon who will perform the one radical prostatectomy you will ever receive in your life, the one operation that will cure your cancer.
"You want a surgeon who is going to make sure that no cancer is left behind, and who knows how to minimize trauma to your body during surgery so you don't wind up with incontinence, erectile dysfunction, or both.
"Finding the right surgeon may mean that you must travel to a major medical center in another city. This may mean that you'll be away from home for four days. But after that, even though you may need to wear a catheter for a week or two, the recovery from the operation is usually speedy, and follow-up communication can be carried out over the telephone."
Wednesday, August 18, 2010
IDing Which of the 24 Types of PCa You Have
Some 218,000 American men will be diagnosed with prostate cancer this year.
An estimated 85% of those
tumors will grow so slowly that they will never cause problems. But the rest
are aggressive and lethal. As of now,
there's no way to tell early on which cancers are which, so tens of
thousands of men undergo surgery or radiation
each year for cancers that never needed treatment, risking impotence or
incontinence in the process.
Several recent genetic discoveries could help doctors evaluate how
aggressive a man's prostate cancer is much
earlier. Scientists at the University of Michigan have identified at least
24 different kinds of prostate cancer of
varying virulence whose DNA signatures can be read like a bar code. Memorial
Sloan-Kettering Cancer Center
researchers have identified other genetic subtypes of prostate cancer that
seem to predict whether the tumor will
be low or high risk. And Harvard Medical School scientists have found a
specific gene that causes prostate
cancers to spread. Some of the discoveries also could lead to new
treatments, tailored specifically for the kind of
prostate tumor a man has.
.
An estimated 85% of those
tumors will grow so slowly that they will never cause problems. But the rest
are aggressive and lethal. As of now,
there's no way to tell early on which cancers are which, so tens of
thousands of men undergo surgery or radiation
each year for cancers that never needed treatment, risking impotence or
incontinence in the process.
Several recent genetic discoveries could help doctors evaluate how
aggressive a man's prostate cancer is much
earlier. Scientists at the University of Michigan have identified at least
24 different kinds of prostate cancer of
varying virulence whose DNA signatures can be read like a bar code. Memorial
Sloan-Kettering Cancer Center
researchers have identified other genetic subtypes of prostate cancer that
seem to predict whether the tumor will
be low or high risk. And Harvard Medical School scientists have found a
specific gene that causes prostate
cancers to spread. Some of the discoveries also could lead to new
treatments, tailored specifically for the kind of
prostate tumor a man has.
.
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