Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 169)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Letzter Kurs 01.08.23 Nasdaq
Neuigkeiten
20.07.23 · Business Wire (engl.)  |
30.06.23 · Business Wire (engl.) |
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,8000 | +45,45 | |
| 1,0000 | +42,86 | |
| 3,0000 | +42,18 | |
| 6,2500 | +24,75 | |
| 0,9600 | +18,93 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,9300 | -17,52 | |
| 23,700 | -19,52 | |
| 28,60 | -24,06 | |
| 1,3500 | -25,62 | |
| 0,7800 | -29,73 |
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Damit wäre Rajesh CC Aussage von 100 - 300 Mio mit Zevalin "easy" erreichbar mehr als bestätigt.
ZAHLT DIE US-REGIERUNG EINE BEHANDLUNG MIT ZEVALIN?!? 
Submission of OPPS ASP Data for Nonpass-Through Separately Payable Therapeutic
Radiopharmaceuticals and Radiopharmaceuticals with Pass-Through Status
Overview
Beginning in CY 2010, CMS provides payment for separately payable therapeutic
radiopharmaceuticals and pass-through radiopharmaceuticals using OPPS ASP data, if data are
submitted by all manufacturers of the radiopharmaceutical for a given calendar quarter. For
radiopharmaceuticals paid based on ASP data under the OPPS, we expect that OPPS ASP data
reported in a “patient-specific dose” or “patient ready form” would represent the sales price of all
of the component materials of the finished radiopharmaceutical product sold by the manufacturer
in terms that reflect the applicable HCPCS code descriptor. Manufacturers should report OPPS
ASP data in units that are compatible with the long code descriptor of the applicable HCPCS
code, such as “treatment dose” or “millicurie,” representing the manufacturer’s sales price for all
component materials. Component materials may include a “cold kit” (nonradioactive compound
or complex that is combined with a radioisotope and results in a radiopharmaceutical) and the
associated radioisotope. Manufacturers of radiopharmaceuticals may include in their calculation
of ASP for OPPS payment purposes, in addition to the prices for the component materials, the
portion of the sales price attributable to the production of the manufactured product as it is sold
by the manufacturer reporting OPPS ASP data, taking into account “bona fide service fees” for
radiolabeling or other services, as discussed in more detail in the examples.
Data Collection
ASP data submission procedures for therapeutic radiopharmaceuticals for payment purposes
under the OPPS are parallel to existing ASP data submission procedures for drugs and
biologicals for payment in the physician’s office setting under section 1847A of the Act and its
implementing regulations at §414.804. Information regarding timeframes and the instructions
and format for ASP reporting are available on the CMS ASP web site at:
http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/.
For therapeutic radiopharmaceutical payment under the OPPS, manufacturers may submit ASP
data for OPPS payment in any given calendar quarter on a quarter-by-quarter basis. For those
quarters where OPPS ASP data are not available for a therapeutic radiopharmaceutical (if a
manufacturer does not submit ASP data), CMS will pay for a therapeutic radiopharmaceutical
under the OPPS at the therapeutic radiopharmaceutical’s most recent mean unit cost derived
from hospital claims data.
In light of the imminent deadline for submitting ASP data for OPPS payment
beginning on January 1, 2010, we encourage manufacturers wishing to submit ASP
data for the January 2010 OPPS update to contact us immediately through the OPPS
mailbox at OutpatientPPS@cms.hhs.gov so we can facilitate the submission process.
October 30, 2010
2
Considerations Specific to OPPS ASP Reporting for Radiopharmaceutical Payment
1. As noted above, we expect manufacturers of therapeutic radiopharmaceuticals to report the
sales price of all of the component materials for the radiopharmaceutical as a “patient-
specific dose” or “patient ready form” in units that are compatible with the applicable
HCPCS code descriptor for OPPS ASP payment purposes. The submission should be
reported on the ASP Data Form (Addendum A) that may be downloaded from the CMS ASP
web site provided above.
2. Fees paid by the manufacturer under contract for the radioisotope and/or for the radiolabeling
process may be considered “bona fide service fees.” Under the ASP regulations, “bona fide
service fees” are fees paid by a manufacturer to an entity that represent fair market value for
a bona fide, itemized service actually performed on behalf of the manufacturer that the
manufacturer would otherwise perform (or contract for) in the absence of the service
arrangement, and that are not passed on in whole or in part to a client or customer of an entity
whether or not the entity takes title to the drug. “Bona fide service fees” are not deducted
from ASP (that is, they are not netted against the radiopharmaceutical price for purposes of
calculating ASP used for OPPS payment). Therefore, for purposes of the OPPS, if the
manufacturer pays a “bona fide service fee” for the services of a freestanding radiopharmacy,
hospital pharmacy, or other entity, and reflects that fee in its sales price for the
radiopharmaceutical, the amount of the “bona fide service fee” would be taken into account
in the reported OPPS ASP data. However, manufacturers are not required to pay for the
preparation of a radiopharmaceutical in a freestanding radiopharmacy, hospital pharmacy, or
other entity, and in that case, the cost of those services would not be taken into account in the
OPPS ASP data submitted to CMS.
3. When submitting OPPS ASP data for radiopharmaceuticals, manufacturers should provide
their submissions under the most appropriate NDC number(s) for the radiopharmaceutical,
even if the NDC number(s) only represents the unique product-defining component material
for the final radiopharmaceutical product (such as the cold kit). As is standard with any ASP
submission, manufacturers should note any assumptions in their OPPS ASP submission to
CMS.
Examples
Scenario 1 A manufacturer sells a radiopharmaceutical with all component materials except the
radioisotope. The radioisotope is not provided by the manufacturer, but instead is furnished by
a freestanding radiopharmacy, hospital pharmacy, or other entity that goes on to prepare the
final product by radiolabeling the component materials provided by the manufacturer.
Result 1A If the manufacturer sells only a portion of the component materials to a
freestanding radiopharmacy, hospital pharmacy, or other entity that then proceeds
to prepare the radiopharmaceutical itself (as described by the HCPCS code)
through the addition of a radioisotope purchased from another source, the
manufacturer would be unable to report OPPS ASP data that reflect the sales of
all component materials necessary for the radiopharmaceutical. Therefore, the October 30, 2010
3
OPPS would not pay for this radiopharmaceutical based on ASP and would base
payment on mean unit cost.
Result 1B If the manufacturer pays “bona fide service fees” to a freestanding
radiopharmacy, hospital pharmacy, or other entity to obtain the radioisotope and
combine all of the component materials, the manufacturer would be able to report
OPPS ASP data for the radiopharmaceutical. OPPS ASP data submitted to CMS
would reflect the sales of all component materials necessary for the product
described by the HCPCS code, taking into account the “bona fide service fees”
incurred by the manufacturer to purchase the radioisotope and radiolabeling
services.
Scenario 2 A separately payable radiopharmaceutical is sold by the manufacturer with all
component materials included but not combined together in preparation for patient
administration. Therefore, the sale of all of the component materials (including the
radioisotope) could be included in the reported OPPS ASP data. However, further processing at
a freestanding radiopharmacy, hospital pharmacy, or other entity must occur to prepare the
radiopharmaceutical for ultimate patient administration in the hospital outpatient department.
Result 2 Manufacturers are not required to pay for the preparation of a
radiopharmaceutical at a freestanding radiopharmacy, hospital pharmacy, or other
entity after sale of the component materials and, in that case, the cost of those
services would not be reflected in the OPPS ASP data submitted to CMS. We
consider radiopharmaceutical processing services performed at a freestanding
radiopharmacy, hospital pharmacy, or other entity to be similar to pharmacy
overhead and handling services for other drugs and nonimplantable biologicals
paid under the OPPS. Payment for these costs would be made through the single
OPPS ASP-based payment for both the acquisition cost and associated pharmacy
overhead cost of the radiopharmaceutical.
Scenario 3 The manufacturer sells a radiopharmaceutical with all component materials
combined together to constitute the final radiopharmaceutical product (as described by the
HCPCS code) and this product is packaged into a single use vial that is shipped by the
manufacturer to a hospital. Upon receipt of the single use vial, the hospital draws up the
radiopharmaceutical into a syringe for administration and calibrates the radiopharmaceutical
immediately prior to patient administration.
Result 3 The OPPS ASP data submitted by the manufacturer would be reflective of the
sales of the component materials in the form provided (i.e., the single use vial),
but not the drawing up of the product into a syringe for administration and the
calibration performed by the hospital. In this case, the OPPS ASP data would
take into account the processing activities performed by the manufacturer but
would not take into account the hospital’s costs for the final preparation of the
dose for administration to the patient. Payment for the hospital preparation costs
would be made through the single OPPS ASP-based payment for both the
acquisition cost and associated pharmacy overhead cost of the
radiopharmaceutical.
Ne Menge zu lesen...
Submission of OPPS ASP Data for Nonpass-Through Separately Payable Therapeutic
Radiopharmaceuticals and Radiopharmaceuticals with Pass-Through Status
Overview
Beginning in CY 2010, CMS provides payment for separately payable therapeutic
radiopharmaceuticals and pass-through radiopharmaceuticals using OPPS ASP data, if data are
submitted by all manufacturers of the radiopharmaceutical for a given calendar quarter. For
radiopharmaceuticals paid based on ASP data under the OPPS, we expect that OPPS ASP data
reported in a “patient-specific dose” or “patient ready form” would represent the sales price of all
of the component materials of the finished radiopharmaceutical product sold by the manufacturer
in terms that reflect the applicable HCPCS code descriptor. Manufacturers should report OPPS
ASP data in units that are compatible with the long code descriptor of the applicable HCPCS
code, such as “treatment dose” or “millicurie,” representing the manufacturer’s sales price for all
component materials. Component materials may include a “cold kit” (nonradioactive compound
or complex that is combined with a radioisotope and results in a radiopharmaceutical) and the
associated radioisotope. Manufacturers of radiopharmaceuticals may include in their calculation
of ASP for OPPS payment purposes, in addition to the prices for the component materials, the
portion of the sales price attributable to the production of the manufactured product as it is sold
by the manufacturer reporting OPPS ASP data, taking into account “bona fide service fees” for
radiolabeling or other services, as discussed in more detail in the examples.
Data Collection
ASP data submission procedures for therapeutic radiopharmaceuticals for payment purposes
under the OPPS are parallel to existing ASP data submission procedures for drugs and
biologicals for payment in the physician’s office setting under section 1847A of the Act and its
implementing regulations at §414.804. Information regarding timeframes and the instructions
and format for ASP reporting are available on the CMS ASP web site at:
http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/.
For therapeutic radiopharmaceutical payment under the OPPS, manufacturers may submit ASP
data for OPPS payment in any given calendar quarter on a quarter-by-quarter basis. For those
quarters where OPPS ASP data are not available for a therapeutic radiopharmaceutical (if a
manufacturer does not submit ASP data), CMS will pay for a therapeutic radiopharmaceutical
under the OPPS at the therapeutic radiopharmaceutical’s most recent mean unit cost derived
from hospital claims data.
In light of the imminent deadline for submitting ASP data for OPPS payment
beginning on January 1, 2010, we encourage manufacturers wishing to submit ASP
data for the January 2010 OPPS update to contact us immediately through the OPPS
mailbox at OutpatientPPS@cms.hhs.gov so we can facilitate the submission process.
October 30, 2010
2
Considerations Specific to OPPS ASP Reporting for Radiopharmaceutical Payment
1. As noted above, we expect manufacturers of therapeutic radiopharmaceuticals to report the
sales price of all of the component materials for the radiopharmaceutical as a “patient-
specific dose” or “patient ready form” in units that are compatible with the applicable
HCPCS code descriptor for OPPS ASP payment purposes. The submission should be
reported on the ASP Data Form (Addendum A) that may be downloaded from the CMS ASP
web site provided above.
2. Fees paid by the manufacturer under contract for the radioisotope and/or for the radiolabeling
process may be considered “bona fide service fees.” Under the ASP regulations, “bona fide
service fees” are fees paid by a manufacturer to an entity that represent fair market value for
a bona fide, itemized service actually performed on behalf of the manufacturer that the
manufacturer would otherwise perform (or contract for) in the absence of the service
arrangement, and that are not passed on in whole or in part to a client or customer of an entity
whether or not the entity takes title to the drug. “Bona fide service fees” are not deducted
from ASP (that is, they are not netted against the radiopharmaceutical price for purposes of
calculating ASP used for OPPS payment). Therefore, for purposes of the OPPS, if the
manufacturer pays a “bona fide service fee” for the services of a freestanding radiopharmacy,
hospital pharmacy, or other entity, and reflects that fee in its sales price for the
radiopharmaceutical, the amount of the “bona fide service fee” would be taken into account
in the reported OPPS ASP data. However, manufacturers are not required to pay for the
preparation of a radiopharmaceutical in a freestanding radiopharmacy, hospital pharmacy, or
other entity, and in that case, the cost of those services would not be taken into account in the
OPPS ASP data submitted to CMS.
3. When submitting OPPS ASP data for radiopharmaceuticals, manufacturers should provide
their submissions under the most appropriate NDC number(s) for the radiopharmaceutical,
even if the NDC number(s) only represents the unique product-defining component material
for the final radiopharmaceutical product (such as the cold kit). As is standard with any ASP
submission, manufacturers should note any assumptions in their OPPS ASP submission to
CMS.
Examples
Scenario 1 A manufacturer sells a radiopharmaceutical with all component materials except the
radioisotope. The radioisotope is not provided by the manufacturer, but instead is furnished by
a freestanding radiopharmacy, hospital pharmacy, or other entity that goes on to prepare the
final product by radiolabeling the component materials provided by the manufacturer.
Result 1A If the manufacturer sells only a portion of the component materials to a
freestanding radiopharmacy, hospital pharmacy, or other entity that then proceeds
to prepare the radiopharmaceutical itself (as described by the HCPCS code)
through the addition of a radioisotope purchased from another source, the
manufacturer would be unable to report OPPS ASP data that reflect the sales of
all component materials necessary for the radiopharmaceutical. Therefore, the October 30, 2010
3
OPPS would not pay for this radiopharmaceutical based on ASP and would base
payment on mean unit cost.
Result 1B If the manufacturer pays “bona fide service fees” to a freestanding
radiopharmacy, hospital pharmacy, or other entity to obtain the radioisotope and
combine all of the component materials, the manufacturer would be able to report
OPPS ASP data for the radiopharmaceutical. OPPS ASP data submitted to CMS
would reflect the sales of all component materials necessary for the product
described by the HCPCS code, taking into account the “bona fide service fees”
incurred by the manufacturer to purchase the radioisotope and radiolabeling
services.
Scenario 2 A separately payable radiopharmaceutical is sold by the manufacturer with all
component materials included but not combined together in preparation for patient
administration. Therefore, the sale of all of the component materials (including the
radioisotope) could be included in the reported OPPS ASP data. However, further processing at
a freestanding radiopharmacy, hospital pharmacy, or other entity must occur to prepare the
radiopharmaceutical for ultimate patient administration in the hospital outpatient department.
Result 2 Manufacturers are not required to pay for the preparation of a
radiopharmaceutical at a freestanding radiopharmacy, hospital pharmacy, or other
entity after sale of the component materials and, in that case, the cost of those
services would not be reflected in the OPPS ASP data submitted to CMS. We
consider radiopharmaceutical processing services performed at a freestanding
radiopharmacy, hospital pharmacy, or other entity to be similar to pharmacy
overhead and handling services for other drugs and nonimplantable biologicals
paid under the OPPS. Payment for these costs would be made through the single
OPPS ASP-based payment for both the acquisition cost and associated pharmacy
overhead cost of the radiopharmaceutical.
Scenario 3 The manufacturer sells a radiopharmaceutical with all component materials
combined together to constitute the final radiopharmaceutical product (as described by the
HCPCS code) and this product is packaged into a single use vial that is shipped by the
manufacturer to a hospital. Upon receipt of the single use vial, the hospital draws up the
radiopharmaceutical into a syringe for administration and calibrates the radiopharmaceutical
immediately prior to patient administration.
Result 3 The OPPS ASP data submitted by the manufacturer would be reflective of the
sales of the component materials in the form provided (i.e., the single use vial),
but not the drawing up of the product into a syringe for administration and the
calibration performed by the hospital. In this case, the OPPS ASP data would
take into account the processing activities performed by the manufacturer but
would not take into account the hospital’s costs for the final preparation of the
dose for administration to the patient. Payment for the hospital preparation costs
would be made through the single OPPS ASP-based payment for both the
acquisition cost and associated pharmacy overhead cost of the
radiopharmaceutical.
Ne Menge zu lesen...
Zum 2. Quartal haben die Zevalin Umsätze im Vergleich zum Vorjahr um 25% angezogen. Ich bin gespannt was im November bei den Zahlen zum 3. Quartal herauskommt. Ich hoffe mal das dann die 4 Dollar endgültig der Vergangenheit angehören 
Sollte Spectrum in ein paar Jahren wirklich in den Bereich von 100 bis 300 Mio USD Zevalinverkäufe "easy" vorstoßen können, wie Raj es gestern prognostiziert hat, so sind 4 USD Kurs definitiv ein super Einstieg.
Wir werden quartalsweise sehen, was diese Ansage wert war und ob sie aus der Bedrängung der Fusilev Ablehnung heraus recht unbedarft gesagt wurde oder ob da wirklich Hand und Fuß dahinter ist. Logisch erklären kann man es ja, das Medikament ist ohne Zweifel sehr wirksam und sicher.
Klar muss einem werden, dass auch die Kosten wegen der mit 50-70 Mann nochmal verdoppelten Salesforce das nächste Quartal massiv nach oben gehen werden.
Wir werden quartalsweise sehen, was diese Ansage wert war und ob sie aus der Bedrängung der Fusilev Ablehnung heraus recht unbedarft gesagt wurde oder ob da wirklich Hand und Fuß dahinter ist. Logisch erklären kann man es ja, das Medikament ist ohne Zweifel sehr wirksam und sicher.
Klar muss einem werden, dass auch die Kosten wegen der mit 50-70 Mann nochmal verdoppelten Salesforce das nächste Quartal massiv nach oben gehen werden.
Ich habe heute angefangen meine Pos weiter zu verstärken.
Trading Spotlight
Gut, so neg. ist der Artikel auch nicht. Für mittelfristig bis langfristig sicher nun gute Einkaufskurse um die 4 Dollar.
Antwort auf Beitrag Nr.: 38.266.003 von walk_on am 27.10.09 23:09:45Super - und heute gehts wieder runter (aktuell 4,05 Dollar)
Vielleicht deswegen??
http://community.smallcapnetwork.com/Speculating-on-Spectrum…
Vielleicht deswegen??
http://community.smallcapnetwork.com/Speculating-on-Spectrum…
Hallo ,
nur noch Jammer hier ?
Also ich habe heute gekauft (4,10 US$). Ole.
Die USA habe nicht mehr viel.
Biotec, Militär, ihr Ego und die Flexibilität sind die letzten Pluspunkte.
Der nächste Hype wird hier kommen.
Finanzplatz USA ist nach meiner Meinung 90 % Psychologie und Geld ist dort wirklich nur ein Rechenfaktor.
Gruß
w_o
nur noch Jammer hier ?
Also ich habe heute gekauft (4,10 US$). Ole.
Die USA habe nicht mehr viel.
Biotec, Militär, ihr Ego und die Flexibilität sind die letzten Pluspunkte.
Der nächste Hype wird hier kommen.
Finanzplatz USA ist nach meiner Meinung 90 % Psychologie und Geld ist dort wirklich nur ein Rechenfaktor.
Gruß
w_o
WoW! Da ist er wieder unser Rajesh
Zevalin ist der Hammer und Spectrum bekommt das gebacken, wo Biogen und Cell Therapeutics gnadenlos gescheitert sind.
Wer braucht da noch Fusilev?!
Fazit: KAUFEN!!!!
Zevalin ist der Hammer und Spectrum bekommt das gebacken, wo Biogen und Cell Therapeutics gnadenlos gescheitert sind.
Wer braucht da noch Fusilev?!
Fazit: KAUFEN!!!!
Antwort auf Beitrag Nr.: 38.264.761 von Ville7 am 27.10.09 20:01:09und auf dem board wurde weiter ergänzt:
Raj stated 1400 patients now enrolled for phase 3 clinical trials of Eoquin and enrollment w/b completed end of 2009
2) Partner Allergen pays 65% of trial costs.
3)primary endpoint as agreed upon with fda consultation, is "Relapse rate of bladder cancer at end of 2 years"
4) Eoquin for bladder cancer is an unmet medical need.
5) 2.7 million bladder patients worldwide.... up to 85% of bladder cancer patients are eligible for Eoquin use, if fda approval is issued.
6) Raj stated $500 Million in USA ALONE, for Eoquin, if fda approved.
7) Sppi to obtain Row partner for ex usa (china,india,japan) sppi retains 100 % rights to Asia and sppi shares equal USA rights with Allergen...
8) Eoquin is a one dose treatment (4mg) . It is injected into the bladder to prevent cancer regrowth/relapse....because during surgery, if bladder is punctured, some cancer cells or other toxins can get iside the bladder and fester, so as to perhaps let cancer grow anew/relapse..... and the Eoquin injection into bladder at time of surgery is to prevent such from happening.
9) Bladder cancer is most expensive bladder cancer of all cancers to treat, said Raj
Raj stated 1400 patients now enrolled for phase 3 clinical trials of Eoquin and enrollment w/b completed end of 2009
2) Partner Allergen pays 65% of trial costs.
3)primary endpoint as agreed upon with fda consultation, is "Relapse rate of bladder cancer at end of 2 years"
4) Eoquin for bladder cancer is an unmet medical need.
5) 2.7 million bladder patients worldwide.... up to 85% of bladder cancer patients are eligible for Eoquin use, if fda approval is issued.
6) Raj stated $500 Million in USA ALONE, for Eoquin, if fda approved.
7) Sppi to obtain Row partner for ex usa (china,india,japan) sppi retains 100 % rights to Asia and sppi shares equal USA rights with Allergen...
8) Eoquin is a one dose treatment (4mg) . It is injected into the bladder to prevent cancer regrowth/relapse....because during surgery, if bladder is punctured, some cancer cells or other toxins can get iside the bladder and fester, so as to perhaps let cancer grow anew/relapse..... and the Eoquin injection into bladder at time of surgery is to prevent such from happening.
9) Bladder cancer is most expensive bladder cancer of all cancers to treat, said Raj
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