isporeu_2015_filgrastims
1
• Additional biosimilars are expected to enter the US market within the next 1–2 years. – These include biosimilars of pegfilgrastim (Neulasta ® ), the pegylated, long-acting version of filgrastim, for which the US patent expired in October 2015. – Apotex submitted biosimilar applications under the 351(k) pathway for both pegfilgrastim (December 2014) and filgrastim (February 2015). 8 • US Payers will likely take advantage of new, lower priced biosimilars, accelerating uptake. Study Limitations • The underlying data from which the sample was drawn are not static and represent patient records from prescribers currently participating in the transcription service. New prescribers may join or leave the service at any time during the study period. • Filgrastim-sndz was available for less than 2 months of the study period, thus limiting the observation timeframe. – Next year’s follow-up data will be more revealing of uptake. • It is not clear how the 6-month delay to launch after FDA approval has affected market uptake of filgrastim-sndz. • Anticipation of the impending availability of filgrastim-sndz, the first official biosimilar in the USA, may have dampened prescriptions for tbo-filgrastim. • Payer coverage and formulary policy in California, both in commercial plans and in Medicare, entailed additional reauthorisation requirements for use of tbo-filgrastim not needed for filgrastim. 9,10 – These policies may have dampened provider use of tbo-filgrastim. – It is unknown to what extent such drug coverage policy may have affected provider reimbursement as well as patient costs, and how these might have influenced physicians’ tbo-filgrastim prescribing patterns. Uptake of Filgrastim ‘Biosimilars’ in the United States: Analysis of a Medical Transcription Database of Patient Office Visits Smoyer KE 1 , Jones CA 2 , Lane P 3 1 Envision Pharma Group, Philadelphia, PA, USA; 2 Envision Pharma Group, Hammersmith, UK; 3 Envision Pharma Group, Horsham, UK PCN345 Background • Filgrastim is a short-acting, recombinant granulocyte colony-stimulating factor (G-CSF) used to treat neutropenia (abnormally low neutrophil levels that can leave a patient susceptible to infections) in patients receiving chemotherapy. – Filgrastim was originally developed by Amgen and marketed under the trade name Neupogen ® . – Pegfilgrastim (Neulasta ® , Amgen), a long-acting G-CSF is also available. • Biosimilars of filgrastim have been available in Europe since 2008. • As of November 2015, 2 additional filgrastim products, tbo-filgrastim and filgrastim-sndz, are available in the USA. 1-3 – A timeline (Figure 1) and summary (Table 1) of these approvals are adjacent. • Amgen, the manufacturer of Neupogen, initiated litigation against the manufacturers of both tbo-filgrastim and filgrastim-sndz. – This litigation delayed the launch of filgrastim-sndz until September 2015. • Based on average wholesale price (AWP), pricing for both tbo-filgrastim and filgrastim-sndz is discounted approximately 15% versus Neupogen in US markets. 4,5 – In European markets, discounting of filgrastim biosimilars has ranged from 10–30%. 6 Methods • Physician records were extracted from RealHealthData (RHD), a US medical transcription database (Figure 2). – Data are available within 72 hours of each visit to a participating provider, enabling uptake of newly launched products to be observed with a limited lag time. – Records are in the form of physician-reported notes for office visits that document real-time data, without concern for recall or bias. – The data provide context about the physician’s intent-to-treat at the time of the visit. • Data were scanned over the study period from 1 November 2013 to 13 October 2015 and compared with online market reports. • Records were searched, with counts tabulated, for mention of filgrastim agents as follows: – Tbo-filgrastim: “tbo-filgrastim,” “Granix,” or “Neutroval” – Filgrastim-sndz: “filgrastim-sndz,” “Zarxio” or “Zarzio” – Filgrastim: “filgrastim” or “Neupogen” – Pegfilgrastim: pegfilgrastim” or “Neulasta.” References 1. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails 2. http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle_pf&ID=1877729 3. https://www.novartis.com/news/media-releases/sandoz-launches-zarxiotm-filgrastim-sndz- first-biosimilar-united-states 4. http://www.pharmacytimes.com/publications/health-system- edition/2014/march2014/tbo-filgrastim-granix 5. http://www.reuters.com/article/2015/09/03/ us-novartis-drug-idUSKCN0R30C220150903 6. Rovira J, et al. 2011. http://citeseerx.ist.psu. edu/viewdoc/download?doi=10.1.1.357.2218&rep=rep1&type=pdf 7. http://www.streetinsider. com/Analyst+Comments/Amgens+(AMGN)+On-Body+IMS+Sales+Starting+to+Pick+Up+- +RBC+Capital/10686091.html 8. http://www.apotex.com/global/about/press/20150217-2.asp 9. https://www.blueshieldca.com/sites/medicare/documents/PA_CY2015_NEUPOGEN_filgrastim_ MCweb.pdf 10. https://www.blueshieldca.com/sites/medicare/documents/PA_CY2015_GRANIX_tbo- filgrastim_MCweb.pdf Disclosures The authors are employees of Envision Pharma Group and developed the data extraction criteria. RealHealthData provided the data for this study at the authors’ request and without compensation. Acknowledgements The authors would like to thank Philip Howell of RealHealthData for his assistance in providing the patient counts. We also would like to thank our graphics and editorial divisions for their assistance in poster production. This study was funded by Envision Market Access Solutions, part of the Envision Pharma Group. Please scan this QR Code with your smartphone app to view an electronic version of this poster. Results Figure 1. Timeline of Filgrastim Approval and Launch 1 st Filgrastim biosimilar approved in Europe 2005 1991 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Neupogen approved by the FDA 1 st Biosimilar approved in Europe Tbo-filgrastim approved as a biologic by the FDA Filgrastim-sndz biosimilar application submitted to the FDA Filgrastim-sndz 1 st biosimilar approved by the FDA Filgrastim-sndz marketed in the USA Neupogen patent expiry Tbo-filgrastim launched in the USA Biosimilar approval pathway in Europe Biosimilar approval pathway in USA Litigation Study period Figure 3. Tbo-filgrastim Utilisation in RHD Sample Comprising Oncologists in California Tbo-filgrastim first-line treatment of neutropenia Tbo-filgrastim in place of filgrastim Tbo-filgrastim until pegfilgrastim is resumed Prophylactic, chemotherapy Interim, chemotherapy Treatment, no chemotherapy 33% 50% 17% Tbo-filgrastim use, n = 6 • Although RHD includes provider-reported data from all 50 states, approximately 86% of the available reports mentioning use of a G-CSF were from oncologists in California. • Counts of mentions of G-CSF by product name and by number of unique patients and prescribers are presented in Table 2. • Tbo-filgrastim was reported 6 times, for 5 unique patients, with all mentions referred to as “Granix”. • 59 Providers reported use of filgrastim, while only 4 reported use of tbo- filgrastim. – The 4 tbo-filgrastim providers were all located in the North of California. • Based on physician reports, tbo-filgrastim was utilised as follows (Figure 3): – Tbo-filgrastim, a short-acting G-CSF, was prescribed as an interim treatment for 2 patients undergoing chemotherapy who normally received pegfilgrastim, a long-acting G-CSF. › An example of patient chart notes showing this use is provided in a supplemental figure (Exhibit 2). – 1 Patient, who had no evidence of receiving chemotherapy, reported taking tbo-filgrastim, as needed, for neutropenia symptoms – Prophylactic tbo-filgrastim was prescribed in 3 visits for 2 chemotherapy patients – Only 2 of the 4 patients undergoing chemotherapy received tbo-filgrastim as their primary G-CSF therapy. • No mentions of filgrastim-sndz were identified. Scan the QR Code here to view an example of tbo-filgrastim use in patient chart notes (Exhibit 2) Table 2. Counts of Mentions and Number of Unique Providers for G-CSFs, 1 November 2013 to 13 October 2015 G-CSF Unique mentions Unique patients Unique providers Pegfilgrastim 2400 960 44 Filgrastim 566 351 59 Tbo-filgrastim 6 5 4 Filgrastim-sndz 0 0 0 Discussion • Data from this small sample show that tbo-filgrastim is mentioned in slightly more than 1% of provider records that report a short-acting G-CSF. – In comparison, tbo-filgrastim is reported to have captured approximately 15–16% of the overall market for short-acting G-CSF in the USA based on IMS sales data. 7 • There may be several reasons why uptake of tbo-filgrastim in the study sample was much lower than the reported market share: – The sample was small and highly localised, and therefore is not representative of US prescribing patterns – Differences between sales data and utilisation data – Providers may have had service contracts in place for filgrastim that could delay adoption of competing agents. Conclusions • Among nearly 3000 records reporting a G-CSF in this snapshot of primarily Californian oncologists, uptake of subsequent filgrastim agents was limited and highly concentrated in 1 region in the North of California. – Only 6 mentions of tbo-filgrastim were noted in the 18 months since launch. – No mentions of filgrastim-sndz were identified in the more than 2 months since launch. • As educational initiatives increase physician awareness of alternate G-CSFs, existing supply contracts with originator manufacturers expire, and the length of time on the market increases, uptake of new filgrastim agents in the USA is expected to accelerate. Table 1. Approval and Launch of Additional Filgrastim Products in the USA Tbo-filgrastim (Granix®, Teva) Filgrastim-sndz (Zarxio®, Sandoz) FDA approval pathway 1 351(a) Biologic License Application (BLA) Considered a biologic; biosimilars pathway did not exist at time of application 351(k) Biosimilar application, BPCIA First biosimilar in the USA; submitted under the biosimilars pathway Indications Only 1 of the Neupogen ® indications: reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia All 5 approved Neupogen ® indications as of March 2015 (including neutropenia treatment and prophylaxis but excluding the newest Neupogen ® indication for acute radiation exposure, approved March 2015) FDA approval date 1 August 2012 March 2015 US launch date November 2013 2 September 2015 3 AWP Discounting Approximately 15% from Neupogen ® 4 Approximately 15% from Neupogen ® 5 Abbreviations: AWP, average wholesale price; BPCIA, Biologics Price Competition and Innovation Act. Figure 2. Data Capture Process Structured Data Set Patient visits physician Physician dictates notes Transcription company processes audio overnight and delivers back to clinic after multiple quality control tiers Physician revises document with any additions or comments and provides final E-signature Details about the visit including medical history, examinations and prescription according to specialty Record Name Year of Visit Specialty State Unique Provider ID Zip Code Patient 1 2013 Oncology California 47321 123XX Patient 2 2014 Gastroenterology California 24389 123XX Patient 3 2014 Oncology Nevada 54320 567XX Patient 3B 2014 Cardiology California 54320 123XX Patient 4 2014 Oncology California 94627 456XX Patient 5 2014 Oncology Nevada 35165 567XX Patient 6 2014 Oncology Nevada 39182 567XX Patient 7 2015 Oncology California 72345 456XX Patient 8 2015 Geriatrics Florida 99142 234XX Patient 9 2015 Cardiology Virginia 37890 345XX “Note: Provided as an example, not actual data”. To view an animated, descriptive timeline, scan the QR Code here Objective • The objective of this study was to assess the uptake of ‘biosimilar’ filgrastim by identifying physician documentation referencing use of tbo-filgrastim and filgrastim-sndz in the USA during patient office visits. Presented at the 18th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research, 7–11 November 2015, Milan, Italy
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Transcript of isporeu_2015_filgrastims
• Additional biosimilars are expected to enter the US market within the next1–2 years. – These include biosimilars of pegfilgrastim (Neulasta®), the pegylated,
long-acting version of filgrastim, for which the US patent expired in October 2015.
– Apotex submitted biosimilar applications under the 351(k) pathway for both pegfilgrastim (December 2014) and filgrastim (February 2015).8
• US Payers will likely take advantage of new, lower priced biosimilars,accelerating uptake.
Study Limitations• The underlying data from which the sample was drawn are not static and
represent patient records from prescribers currently participating in thetranscription service. New prescribers may join or leave the service at anytime during the study period.
• Filgrastim-sndz was available for less than 2 months of the study period, thuslimiting the observation timeframe. – Next year’s follow-up data will be more revealing of uptake.
• It is not clear how the 6-month delay to launch after FDA approval hasaffected market uptake of filgrastim-sndz.
• Anticipation of the impending availability of filgrastim-sndz, the first officialbiosimilar in the USA, may have dampened prescriptions for tbo-filgrastim.
• Payer coverage and formulary policy in California, both in commercial plansand in Medicare, entailed additional reauthorisation requirements for use oftbo-filgrastim not needed for filgrastim.9,10
– These policies may have dampened provider use of tbo-filgrastim. – It is unknown to what extent such drug coverage policy may have affected
provider reimbursement as well as patient costs, and how these might have influenced physicians’ tbo-filgrastim prescribing patterns.
Uptake of Filgrastim ‘Biosimilars’ in the United States: Analysis of a Medical Transcription Database of Patient Office Visits Smoyer KE1, Jones CA2, Lane P3
1Envision Pharma Group, Philadelphia, PA, USA; 2Envision Pharma Group, Hammersmith, UK; 3Envision Pharma Group, Horsham, UK
PCN345
Background• Filgrastim is a short-acting, recombinant granulocyte colony-stimulating factor
(G-CSF) used to treat neutropenia (abnormally low neutrophil levels that canleave a patient susceptible to infections) in patients receiving chemotherapy. – Filgrastim was originally developed by Amgen and marketed under the
trade name Neupogen®. – Pegfilgrastim (Neulasta®, Amgen), a long-acting G-CSF is also available.
• Biosimilars of filgrastim have been available in Europe since 2008.• As of November 2015, 2 additional filgrastim products, tbo-filgrastim and
filgrastim-sndz, are available in the USA.1-3
– A timeline (Figure 1) and summary (Table 1) of these approvals areadjacent.
• Amgen, the manufacturer of Neupogen, initiated litigation against themanufacturers of both tbo-filgrastim and filgrastim-sndz. – This litigation delayed the launch of filgrastim-sndz until September 2015.
• Based on average wholesale price (AWP), pricing for both tbo-filgrastim andfilgrastim-sndz is discounted approximately 15% versus Neupogen inUS markets.4,5
– In European markets, discounting of filgrastim biosimilars has rangedfrom 10–30%.6
Methods• Physician records were extracted from RealHealthData (RHD), a US medical
transcription database (Figure 2). – Data are available within 72 hours of each visit to a participating provider,
enabling uptake of newly launched products to be observed with a limited lag time.
– Records are in the form of physician-reported notes for office visits that document real-time data, without concern for recall or bias.
– The data provide context about the physician’s intent-to-treat at the time of the visit.
• Data were scanned over the study period from 1 November 2013 to 13October 2015 and compared with online market reports.
• Records were searched, with counts tabulated, for mention of filgrastimagents as follows: – Tbo-filgrastim: “tbo-filgrastim,” “Granix,” or “Neutroval” – Filgrastim-sndz: “filgrastim-sndz,” “Zarxio” or “Zarzio” – Filgrastim: “filgrastim” or “Neupogen” – Pegfilgrastim: pegfilgrastim” or “Neulasta.”
References1. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails2. http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle_pf&ID=18777293. https://www.novartis.com/news/media-releases/sandoz-launches-zarxiotm-filgrastim-sndz-first-biosimilar-united-states 4. http://www.pharmacytimes.com/publications/health-system-edition/2014/march2014/tbo-filgrastim-granix 5. http://www.reuters.com/article/2015/09/03/us-novartis-drug-idUSKCN0R30C220150903 6. Rovira J, et al. 2011. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.357.2218&rep=rep1&type=pdf 7. http://www.streetinsider.com/Analyst+Comments/Amgens+(AMGN)+On-Body+IMS+Sales+Starting+to+Pick+Up+-+RBC+Capital/10686091.html 8. http://www.apotex.com/global/about/press/20150217-2.asp9. https://www.blueshieldca.com/sites/medicare/documents/PA_CY2015_NEUPOGEN_filgrastim_MCweb.pdf 10. https://www.blueshieldca.com/sites/medicare/documents/PA_CY2015_GRANIX_tbo-filgrastim_MCweb.pdf
DisclosuresThe authors are employees of Envision Pharma Group and developed the data extraction criteria. RealHealthData provided the data for this study at the authors’ request and without compensation.
AcknowledgementsThe authors would like to thank Philip Howell of RealHealthData for his assistance in providing the patient counts. We also would like to thank our graphics and editorial divisions for their assistance in poster production.
This study was funded by Envision Market Access Solutions, part of the Envision Pharma Group.
Please scan this QR Code with your smartphone app to view an electronic version of this poster.
Results
Figure 1. Timeline of Filgrastim Approval and Launch
1st Filgrastim biosimilar approved in Europe
20051991 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Neupogen approved by the FDA
1st Biosimilar approved in Europe
Tbo-filgrastim approved as a biologic by the FDA
Filgrastim-sndz biosimilar application submitted to the FDA
Filgrastim-sndz 1st biosimilar approved by the FDA
Filgrastim-sndz marketed in the USA
Neupogen patent expiry
Tbo-filgrastim launched in the USABiosimilar
approval pathway in Europe
Biosimilar approval pathway in USA
LitigationStudy period
Figure 3. Tbo-filgrastim Utilisation in RHD Sample Comprising Oncologists in California
Tbo-filgrastim first-line treatment of neutropenia
Tbo-filgrastim in place of filgrastim
Tbo-filgrastim until pegfilgrastim is resumed
Prophylactic, chemotherapy Interim, chemotherapy Treatment, no chemotherapy
33%
50%
17%
Tbo-filgrastim use, n = 6
• Although RHD includes provider-reported data from all 50 states,approximately 86% of the available reports mentioning use of a G-CSF werefrom oncologists in California.
• Counts of mentions of G-CSF by product name and by number of uniquepatients and prescribers are presented in Table 2.
• Tbo-filgrastim was reported 6 times, for 5 unique patients, with all mentionsreferred to as “Granix”.
• 59 Providers reported use of filgrastim, while only 4 reported use of tbo-filgrastim. – The 4 tbo-filgrastim providers were all located in the North of California.
• Based on physician reports, tbo-filgrastim was utilised as follows (Figure 3): – Tbo-filgrastim, a short-acting G-CSF, was prescribed as an interim
treatment for 2 patients undergoing chemotherapy who normally received pegfilgrastim, a long-acting G-CSF. › An example of patient chart notes showing this use is provided in a supplemental figure (Exhibit 2).
– 1 Patient, who had no evidence of receiving chemotherapy, reported taking tbo-filgrastim, as needed, for neutropenia symptoms
– Prophylactic tbo-filgrastim was prescribed in 3 visits for 2 chemotherapy patients
– Only 2 of the 4 patients undergoing chemotherapy received tbo-filgrastim as their primary G-CSF therapy.
• No mentions of filgrastim-sndz were identified.
� Scan the QR Code here to view an example of tbo-filgrastim use in patientchart notes (Exhibit 2)
Table 2. Counts of Mentions and Number of Unique Providers for G-CSFs, 1 November 2013 to 13 October 2015G-CSF Unique mentions Unique patients Unique providersPegfilgrastim 2400 960 44Filgrastim 566 351 59Tbo-filgrastim 6 5 4Filgrastim-sndz 0 0 0
Discussion• Data from this small sample show that tbo-filgrastim is mentioned in slightly
more than 1% of provider records that report a short-acting G-CSF. – In comparison, tbo-filgrastim is reported to have captured approximately
15–16% of the overall market for short-acting G-CSF in the USA based on IMS sales data.7
• There may be several reasons why uptake of tbo-filgrastim in the studysample was much lower than the reported market share: – The sample was small and highly localised, and therefore is not
representative of US prescribing patterns – Differences between sales data and utilisation data – Providers may have had service contracts in place for filgrastim that could
delay adoption of competing agents.
Conclusions • Among nearly 3000 records reporting a G-CSF in this snapshot
of primarily Californian oncologists, uptake of subsequentfilgrastim agents was limited and highly concentrated in 1region in the North of California.
– Only 6 mentions of tbo-filgrastim were noted in the 18 monthssince launch.
– No mentions of filgrastim-sndz were identified in the more than 2 months since launch.
• As educational initiatives increase physician awareness ofalternate G-CSFs, existing supply contracts with originatormanufacturers expire, and the length of time on the marketincreases, uptake of new filgrastim agents in the USA isexpected to accelerate.
Table 1. Approval and Launch of Additional Filgrastim Products in the USA
Tbo-filgrastim (Granix®, Teva)
Filgrastim-sndz (Zarxio®, Sandoz)
FDA approval pathway1
351(a) Biologic License Application (BLA)Considered a biologic; biosimilars pathway did not exist at time of application
351(k) Biosimilar application, BPCIAFirst biosimilar in the USA; submitted under the biosimilars pathway
Indications Only 1 of the Neupogen® indications: reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia
All 5 approved Neupogen® indications as of March 2015 (including neutropenia treatment and prophylaxis but excluding the newest Neupogen® indication for acute radiation exposure, approved March 2015)
FDA approval date1
August 2012 March 2015
US launch date November 20132 September 20153
AWP Discounting
Approximately 15% from Neupogen® 4
Approximately 15% from Neupogen® 5
Abbreviations: AWP, average wholesale price; BPCIA, Biologics Price Competition and Innovation Act.
Figure 2. Data Capture Process
Structured Data Set
Patient visits physician Physician dictates notes
Transcription company processes audio overnight and
delivers back to clinic after multiple quality control tiers
Physician revises document with any additions or
comments and provides final E-signature
Details about the visit including medical history,examinations and prescription according tospecialty
Record Name Year of Visit Specialty State Unique Provider ID Zip Code
Patient 1 2013 Oncology California 47321 123XXPatient 2 2014 Gastroenterology California 24389 123XXPatient 3 2014 Oncology Nevada 54320 567XXPatient 3B 2014 Cardiology California 54320 123XXPatient 4 2014 Oncology California 94627 456XXPatient 5 2014 Oncology Nevada 35165 567XXPatient 6 2014 Oncology Nevada 39182 567XXPatient 7 2015 Oncology California 72345 456XXPatient 8 2015 Geriatrics Florida 99142 234XXPatient 9 2015 Cardiology Virginia 37890 345XX“Note: Provided as an example, not actual data”.
To view an animated, descriptive timeline, scan the QR Code here �Objective • The objective of this study was to assess the uptake of ‘biosimilar’
filgrastim by identifying physician documentation referencing useof tbo-filgrastim and filgrastim-sndz in the USA during patientoffice visits.
Presented at the 18th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research, 7–11 November 2015, Milan, Italy
MA ISPOR Poster no1 Filgrastim Biosimilars_tc12.indd 1 04/11/2015 11:08
