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ON-CONOMY
OBR


Payers Insights Into Future Oncology Management
By Rhonda Greenapple MSPH, President, Reimbursement Intelligence


  Reimbursement        Intelligence,    tumor type and staging is being                      Under the Affordable Care Act,
a nationally recognized market          used.                                              Accountable Care Organizations
research firm, conducted research                                                          (ACOs) are considered to be bring-
with 50 of the top-ranked man-          Quality Initiatives and                            ing a new model of care for Medi-
aged care health plans to better        New Care Models                                    care beneficiaries, and are, in effect,
understand the current and future          Payers recognize NCCN guide-                    an integrated system that attempts
dynamics in oncology management         lines in determining coverage for                  to eliminate fragmented care for
and evaluation of pipeline thera-       an oncology treatment with 90%                     Medicare beneficiaries. ACOs are a
pies relative to current treatment      using Category 1 and Category 2A                   group of providers and suppliers of
paradigms. This article reviews key     recommendations (Figure 1). Payers                 services (e.g., hospitals, physicians,
insights from the survey regarding      are also developing quality initia-                and others involved in patient care)
new care models and payer evalu-        tives where they work with oncol-                  that will work together to coordi-
ation of 3 new non-small cell lung      ogy practices to gather data and                   nate care for the Medicare Fee-For-
cancer (NSCLC) compounds.               outcomes based on accepted guide-                  Service (FFS) beneficiaries they
                                        lines. According to our survey, over               serve. They must agree to accept
   The RIQ 2011 ASCO Special
                                        half of the respondents indicated                  responsibility to serve at least
Report: Payer Reactions to Highly
                                        they implemented quality initia-                   5,000 Medicare beneficiaries for at
Anticipated Innovations and Clin-
                                        tives in oncology with either NCCN                 least 3 years.1
ical Data Presentations obtained
                                        Quality Measures (35%) or with
critical intelligence from both com-                                                         Patrick Cobb, MD, Chairman
                                        ASCO Quality Oncology Practice
mercial and government managed                                                             of Community Oncology Alliance
                                        Initiatives (25%).
care health plans covering over
100MM lives. Medical and Phar-
macy Directors were represented
equally to ensure both perspectives
in evaluating therapies.
  Four key tumor types: breast,
NSCLC, melanoma, and hemato-
logical malignancies were covered
by the respondents—all of whom
participate in their P&T commit-
tee meetings. This article will only
focus on the NSCLC section of the
report. Utilizing NCCN Guidelines
and other evidence-based medicine
guidelines, payers work towards
managing use of less costly thera-
pies and ensure that the most effi-
cacious treatment for a patient’s
                                        Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials
26 ONCOLOGY BUSINESS REVIEW • ONCBIZ.COM • JULY 2011
(COA) and the COA Policy Com-           ical costs and creation of a viable                the cost burden to payers. Unfortu-
mittee, and Ted Okon, Execu-            risk sharing structure.                            nately, the 5-year survival rate for
tive Director of COA, outlined the                                                         all patients with NSCLC was only
challenges for oncologists in the       Lung Cancer Management                             15% in the period 1995-2005.3 With
advent of ACOs, in a recent article       In certain cancer types such                     new treatment options and com-
on OncologyStat.com. According to       as NSCLC, treatment options are                    bination therapies, NSCLC thera-
Cobb and Okon, “An oncology pro-        expanding, but with these clinical                 pies will continue to be a focus for
vider participating in an ACO will      gains also come the expansion of                   oncology management (Table 2).
be under enormous pressure to sim-
ply control or reduce costs. Support-
ers argue that ACOs are different
from HMOs, in part because they
are not just about cost-savings—
quality measures must be satisfied.
However, there are no quality mea-
sures for cancer treatment. Fur-
thermore, although there is a nod
to quality, no one should kid them-
selves—ACOs are really all about
saving money.”2
   Our survey validates the COA
leaders’ concerns showing that
increasing use of lower cost treat-
ment alternatives ranks highly as
does improving overall spending
tracking (Table 1) when the respon-
dents were asked to rank in order       Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials
of importance primary drivers for
partnering or forming an ACO.
   Under an ACO structure, our
survey indicates that health plans
anticipate more increased price
concessions, including more aggres-
sive contracting with manufactur-
ers (35% of respondents) or more
aggressive pursuit of manufactur-
er rebates (10% of respondents).
Health plans designing ACOs
acknowledge that managing oncol-
ogy therapies will have challenges
including reduction of overall med-

                                        Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials
                                                                   JULY 2011 • ONCBIZ.COM • ONCOLOGY BUSINESS REVIEW 27
OBR
   ON-CONOMY
   Most new oncology molecules are      results showed a median survival of                   Another product in the pipeline,
priced at $5,000 per month or more,     30.6 months with Stimuvax vs 13. 3                 [crizotinib; Pfizer, Inc], is an oral,
and recently one newly approved         months with best supportive care.                  selective, small molecule inhibi-
cancer therapy broke the $100,000                                                          tor for patients with NSCLC who
                                           Payers reviewed both products’
per year threshold. Several NSCLC                                                          express the EML4-ALK gene muta-
                                        trial data and Stimuvax effica-
clinical studies involve combina-                                                          tion. Approximately 3%-5% of
                                        cy rated higher than emepepimut
tion therapy with biologics as well                                                        individuals with NSCLC have this
                                        (Figure 2).
as second- and third-line therapies.                                                       mutation (which represents about
In a recent New England Journal of         More important, 80% of pay-                     6,000 to 10,000 patients in the
Medicine article, Thomas Smith,         ers rated Stimuvax survival data                   United States). Most recent data
MD, and Bruce Hillner, MD, con-         significant or highly significant.                 presented at the 2011 ASCO meet-
sider whether patients who have         However, the majority of payers                    ing from a nonrandomized, retro-
progressive disease after 3 consec-     expect these products to be priced                 spective Phase 1 trial showed that
utive regimens should be switched       equal to or higher than Avastin                    patients who are ALK+ receiving
to palliative care specifically where   (Table 3).                                         crizotinib as second- or third-line
there are lung and breast cancer
guidelines.4
   However, payers understand
despite the drug cost that there is
still a need for effective treatment
options for NSCLC. In our RIQ
2011 ASCO special report, 80%
of payers cover the use of Tarceva
[erlotinib; Genentech] and Avastin
[bevacizumab; Genentech] in non-
squamous NSCLC with only 5%
placing any restrictions.
  The report also provided feed-
back on 2 new targeted therapies:
astruprotimut and empepepimut.
Astuprotimut [MAGE-A3 ASCI;
GSK] is a targeted immunother-
apeutic agent designed to trigger       Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials
a specific response against tumor
cells expressing MAGE-3 antigen,
presenting in 30%-50% of NSCLC
patients. In a Phase 2 trial, there
was a 27% reduction in relative risk
of cancer recurrence following sur-
gery vs placebo.
   Emepepimut [Stimuvax; Mer-
ck] is a vaccine against cancer cells
expressing MUC-1 antigen, which
is present in 74%-86% of NSCLC
patients. In a Phase 2b trial with
advanced NSCLC (stage IIIB and IV)
                                        Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials
28 ONCOLOGY BUSINESS REVIEW • ONCBIZ.COM • JULY 2011
therapy vs ALK+ patients in the                   ing quality of care while reducing            ceivable that lung cancer can
control group who had previous-                   costs. According to the report, pay-          become a chronic disease with long-
ly received standard of care chemo-               ers recognize that diagnostic tests           term maintenance therapy. With
therapy (pemetrexed or docetaxel)                 will reduce use of ineffective drugs          more treatment options and combi-
or erlotinib had a 1-year overall                 and increase appropriate treatment            nation therapies, guidelines and
survival of 70% vs 44%, respective-               (Table 4).                                    evidence-based medicine will be
ly; and 2-year overall survival of                                                              critical in containing costs and
55% vs12%, respectively.                          In Conclusion                                 ensuring appropriate care. RI
                                                     Payers have traditionally not
  Payers project using crizotinib
                                                  managed oncology treatment choic-
with 23% indicating first-line ther-                                                            1
                                                                                                 Summary of Proposed Rule Provisions for
                                                  es since care is so individualized            Accountable Care Organizations Under the
apy for EML-ALK gene fusion
                                                  and many patients face life-threat-           Medicare Shared Savings Program, Center for
positive patients, and 42% for sec-
                                                  ening conditions. However, payers             Medicare & Medicaid Services, April 2011.
ond-line therapy for EML-4-ALK
                                                  are looking to new models like qual-          2
                                                                                                 Cobb P, Okon T. Just ‘who’ is the oncologist
gene fusion positive patients after
                                                  ity initiatives to allow for better use       accountable to in an accountable care organi-
failure on chemotherapy alone.                                                                  zation? September 7, 2010. www.oncologystat.
                                                  and adherence to guidelines to pre-
                                                  vent unnecessary or ineffective               com/viewpoints/cancer-policy-forum/Just_Who_
Diagnostic Value                                                                                Is_the_Oncologist_Accountable_to_in_an_
                                                  care. Many branded lung cancer
   Manufacturer’s research and                                                                  Accountable_Care_Organization.html
                                                  therapies are over $50,000 per year
development will continue to iden-                                                              CDC and Prevention, Cancer Incidence and
                                                                                                3
                                                  which is an increasing burden for
tify biomarkers and gene selectiv-                                                              Mortality Rate, 1995-2005.
                                                  health plans. However, pipeline
ity to increase targeted therapies                                                              4
                                                                                                 Smith T and Hillner B. Bending the cost curve in
                                                  therapies for NSCLC are offering
in NSCLC. New diagnostics will be                                                               cancer care. N Engl J Med. 2011;364:2060-2065.
                                                  the hope for breakthrough thera-
valued by payers as the tests help
                                                  pies that can improve the overall
ensure the right treatment reach-
                                                  survival for patients. It is not incon-
es the right patient thus increas-



                                                                                                    About the Contributor

                                                                                                    Reimbursement Intelligence is a nation-
                                                                                                    ally recognized market research firm
                                                                                                    specializing in Managed Markets and
                                                                                                    reimbursement. Our clients include biotech,
                                                                                                    pharma, and medical device as well as
                                                                                                    financial analysts and institutional
                                                                                                    investors. To obtain a copy of the RIQ Special
                                                                                                    Report, please call 973 805 2300 or email
                                                                                                    rgreenapple@reimbursementintelligence.
                                                                                                    com.
Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials


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                                                                               JULY 2011 • ONCBIZ.COM • ONCOLOGY BUSINESS REVIEW 29

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Payers Insights Into Future Oncology Management

  • 1. ON-CONOMY OBR Payers Insights Into Future Oncology Management By Rhonda Greenapple MSPH, President, Reimbursement Intelligence Reimbursement Intelligence, tumor type and staging is being Under the Affordable Care Act, a nationally recognized market used. Accountable Care Organizations research firm, conducted research (ACOs) are considered to be bring- with 50 of the top-ranked man- Quality Initiatives and ing a new model of care for Medi- aged care health plans to better New Care Models care beneficiaries, and are, in effect, understand the current and future Payers recognize NCCN guide- an integrated system that attempts dynamics in oncology management lines in determining coverage for to eliminate fragmented care for and evaluation of pipeline thera- an oncology treatment with 90% Medicare beneficiaries. ACOs are a pies relative to current treatment using Category 1 and Category 2A group of providers and suppliers of paradigms. This article reviews key recommendations (Figure 1). Payers services (e.g., hospitals, physicians, insights from the survey regarding are also developing quality initia- and others involved in patient care) new care models and payer evalu- tives where they work with oncol- that will work together to coordi- ation of 3 new non-small cell lung ogy practices to gather data and nate care for the Medicare Fee-For- cancer (NSCLC) compounds. outcomes based on accepted guide- Service (FFS) beneficiaries they lines. According to our survey, over serve. They must agree to accept The RIQ 2011 ASCO Special half of the respondents indicated responsibility to serve at least Report: Payer Reactions to Highly they implemented quality initia- 5,000 Medicare beneficiaries for at Anticipated Innovations and Clin- tives in oncology with either NCCN least 3 years.1 ical Data Presentations obtained Quality Measures (35%) or with critical intelligence from both com- Patrick Cobb, MD, Chairman ASCO Quality Oncology Practice mercial and government managed of Community Oncology Alliance Initiatives (25%). care health plans covering over 100MM lives. Medical and Phar- macy Directors were represented equally to ensure both perspectives in evaluating therapies. Four key tumor types: breast, NSCLC, melanoma, and hemato- logical malignancies were covered by the respondents—all of whom participate in their P&T commit- tee meetings. This article will only focus on the NSCLC section of the report. Utilizing NCCN Guidelines and other evidence-based medicine guidelines, payers work towards managing use of less costly thera- pies and ensure that the most effi- cacious treatment for a patient’s Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials 26 ONCOLOGY BUSINESS REVIEW • ONCBIZ.COM • JULY 2011
  • 2. (COA) and the COA Policy Com- ical costs and creation of a viable the cost burden to payers. Unfortu- mittee, and Ted Okon, Execu- risk sharing structure. nately, the 5-year survival rate for tive Director of COA, outlined the all patients with NSCLC was only challenges for oncologists in the Lung Cancer Management 15% in the period 1995-2005.3 With advent of ACOs, in a recent article In certain cancer types such new treatment options and com- on OncologyStat.com. According to as NSCLC, treatment options are bination therapies, NSCLC thera- Cobb and Okon, “An oncology pro- expanding, but with these clinical pies will continue to be a focus for vider participating in an ACO will gains also come the expansion of oncology management (Table 2). be under enormous pressure to sim- ply control or reduce costs. Support- ers argue that ACOs are different from HMOs, in part because they are not just about cost-savings— quality measures must be satisfied. However, there are no quality mea- sures for cancer treatment. Fur- thermore, although there is a nod to quality, no one should kid them- selves—ACOs are really all about saving money.”2 Our survey validates the COA leaders’ concerns showing that increasing use of lower cost treat- ment alternatives ranks highly as does improving overall spending tracking (Table 1) when the respon- dents were asked to rank in order Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials of importance primary drivers for partnering or forming an ACO. Under an ACO structure, our survey indicates that health plans anticipate more increased price concessions, including more aggres- sive contracting with manufactur- ers (35% of respondents) or more aggressive pursuit of manufactur- er rebates (10% of respondents). Health plans designing ACOs acknowledge that managing oncol- ogy therapies will have challenges including reduction of overall med- Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials JULY 2011 • ONCBIZ.COM • ONCOLOGY BUSINESS REVIEW 27
  • 3. OBR ON-CONOMY Most new oncology molecules are results showed a median survival of Another product in the pipeline, priced at $5,000 per month or more, 30.6 months with Stimuvax vs 13. 3 [crizotinib; Pfizer, Inc], is an oral, and recently one newly approved months with best supportive care. selective, small molecule inhibi- cancer therapy broke the $100,000 tor for patients with NSCLC who Payers reviewed both products’ per year threshold. Several NSCLC express the EML4-ALK gene muta- trial data and Stimuvax effica- clinical studies involve combina- tion. Approximately 3%-5% of cy rated higher than emepepimut tion therapy with biologics as well individuals with NSCLC have this (Figure 2). as second- and third-line therapies. mutation (which represents about In a recent New England Journal of More important, 80% of pay- 6,000 to 10,000 patients in the Medicine article, Thomas Smith, ers rated Stimuvax survival data United States). Most recent data MD, and Bruce Hillner, MD, con- significant or highly significant. presented at the 2011 ASCO meet- sider whether patients who have However, the majority of payers ing from a nonrandomized, retro- progressive disease after 3 consec- expect these products to be priced spective Phase 1 trial showed that utive regimens should be switched equal to or higher than Avastin patients who are ALK+ receiving to palliative care specifically where (Table 3). crizotinib as second- or third-line there are lung and breast cancer guidelines.4 However, payers understand despite the drug cost that there is still a need for effective treatment options for NSCLC. In our RIQ 2011 ASCO special report, 80% of payers cover the use of Tarceva [erlotinib; Genentech] and Avastin [bevacizumab; Genentech] in non- squamous NSCLC with only 5% placing any restrictions. The report also provided feed- back on 2 new targeted therapies: astruprotimut and empepepimut. Astuprotimut [MAGE-A3 ASCI; GSK] is a targeted immunother- apeutic agent designed to trigger Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials a specific response against tumor cells expressing MAGE-3 antigen, presenting in 30%-50% of NSCLC patients. In a Phase 2 trial, there was a 27% reduction in relative risk of cancer recurrence following sur- gery vs placebo. Emepepimut [Stimuvax; Mer- ck] is a vaccine against cancer cells expressing MUC-1 antigen, which is present in 74%-86% of NSCLC patients. In a Phase 2b trial with advanced NSCLC (stage IIIB and IV) Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials 28 ONCOLOGY BUSINESS REVIEW • ONCBIZ.COM • JULY 2011
  • 4. therapy vs ALK+ patients in the ing quality of care while reducing ceivable that lung cancer can control group who had previous- costs. According to the report, pay- become a chronic disease with long- ly received standard of care chemo- ers recognize that diagnostic tests term maintenance therapy. With therapy (pemetrexed or docetaxel) will reduce use of ineffective drugs more treatment options and combi- or erlotinib had a 1-year overall and increase appropriate treatment nation therapies, guidelines and survival of 70% vs 44%, respective- (Table 4). evidence-based medicine will be ly; and 2-year overall survival of critical in containing costs and 55% vs12%, respectively. In Conclusion ensuring appropriate care. RI Payers have traditionally not Payers project using crizotinib managed oncology treatment choic- with 23% indicating first-line ther- 1 Summary of Proposed Rule Provisions for es since care is so individualized Accountable Care Organizations Under the apy for EML-ALK gene fusion and many patients face life-threat- Medicare Shared Savings Program, Center for positive patients, and 42% for sec- ening conditions. However, payers Medicare & Medicaid Services, April 2011. ond-line therapy for EML-4-ALK are looking to new models like qual- 2 Cobb P, Okon T. Just ‘who’ is the oncologist gene fusion positive patients after ity initiatives to allow for better use accountable to in an accountable care organi- failure on chemotherapy alone. zation? September 7, 2010. www.oncologystat. and adherence to guidelines to pre- vent unnecessary or ineffective com/viewpoints/cancer-policy-forum/Just_Who_ Diagnostic Value Is_the_Oncologist_Accountable_to_in_an_ care. Many branded lung cancer Manufacturer’s research and Accountable_Care_Organization.html therapies are over $50,000 per year development will continue to iden- CDC and Prevention, Cancer Incidence and 3 which is an increasing burden for tify biomarkers and gene selectiv- Mortality Rate, 1995-2005. health plans. However, pipeline ity to increase targeted therapies 4 Smith T and Hillner B. Bending the cost curve in therapies for NSCLC are offering in NSCLC. New diagnostics will be cancer care. N Engl J Med. 2011;364:2060-2065. the hope for breakthrough thera- valued by payers as the tests help pies that can improve the overall ensure the right treatment reach- survival for patients. It is not incon- es the right patient thus increas- About the Contributor Reimbursement Intelligence is a nation- ally recognized market research firm specializing in Managed Markets and reimbursement. Our clients include biotech, pharma, and medical device as well as financial analysts and institutional investors. To obtain a copy of the RIQ Special Report, please call 973 805 2300 or email rgreenapple@reimbursementintelligence. com. Source: Reimbursement iQ: 2011 ASCO Special Report to Latest Clinical Trials OBR DAILY NEWS FLASHES ??? JULY 2011 • ONCBIZ.COM • ONCOLOGY BUSINESS REVIEW 29