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6Market Dynamics
Global cancer incidence rates vary by
regions and cancer types
2012 incidence rates (age-standardized incidence rate/100,000)
More developed regions Less developed regions
Lung ColorectalIncidence of all cancers Liver Gastric
Source: Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International
Agency for Research on Cancer; 2013. Available at: http://globocan.iarc.fr. Accessed 12/13/2013.
268
148
31
20
29
12
5
12
11
13
•• The degree to which cancer incidence rates
differ among countries can be quite substantial:
differences arise from both disease trends and
data availability.
•• Overall, cancer incidence rates are lower in less
developed regions; this may be the result of a
number of factors.
•• Populations in less-developed regions may
have diminished access to health care services,
and a higher probability of dying before being
diagnosed with cancer.
•• Public health organizations may be less likely
to track and record case information for
epidemiologic purposes, potentially resulting in
lower perceived incidences.
•• In terms of cancer type, lung and colorectal
cancer incidence tends to be higher in more
developed nations.
•• Conversely, liver and gastric cancer incidence
tends to be higher in less developed countries.
•• A causal link between hepatitis C infection
and liver cancer as well as higher likelihood of
exposure to environmental toxins may offer some
explanation of this phenomenon.
•• In developed countries liver cancers will be on
the rise due to life style. Obesity will take over as
the main cause of hepatocellular carcinoma (HCC)
in the U.S. (by 2030 forecasted) and in Europe
shortly after.
Innovations in cancer care and implications for health systems
Chart Notes:
More developed regions: all regions of Europe plus Northern America, Australia/New Zealand and Japan. Less developed regions: all regions of Africa, Asia (excluding
Japan), Latin America and the Caribbean, Melanesia, Micronesia and Polynesia.
7Market Dynamics
Cancer survival is improving steadily as detection and
treatment improve
Five-year U.S. relative survival by year of diagnosis
%alive
All sites NHL Breast RCC
2005200420032002200120001999199819971996199519941993199219911990
Source: National Cancer Institute. Surveillance, Epidemiology, and End Results Program.
Available at: http://www.seer.cancer.gov/csr/1975_2010/download_csr_datafile.php/. Accessed 3/11/2014
95
90
85
80
75
70
65
60
55
50
•• Survival has improved significantly over the past
two decades with published research suggesting
that 23% of the improvement is due to behavioral
changes, 35% is due to screening, 20% to advances
in treatment, and the remaining 22% attributed to
other factors.1
•• Non-Hodgkin’s lymphoma (NHL) provides an
example of one group of cancers where improving
survival is especially pronounced, due in part
to the adoption of new targeted and cytotoxic
therapies beginning in the 1990s.
•• Improvements in survival vary substantially
among cancers. Breast cancer, for example, has a
historically high survival rate, and has seen only
modest improvements despite new therapies
being approved.
Innovations in cancer care and implications for health systems
1. Cutler, David M. Are We Finally Winning the War on Cancer? Journal of Economic Perspectives. Volume 22, Number 4. 2008.
8
Innovations in cancer care and implications for health systems
Market Dynamics
Oncology drives major medicines spend in developed
and pharmerging markets
Spending by therapeutic area in 2017 (oncology does not include supportive care)
Source: IMS Health Thought Leadership, Sep 2013.
Oncology
Diabetes
Anti-TNFs
Pain
Asthma/COPD
Other CNS Drugs
Hypertension
Immunostimulants
HIV Antivirals
Dermatology
Antibiotics
Cholesterol
Anti-Epileptics
Immunosuppressants
Antipsychotics
Antiulcerants
Antidepressants
Antivirals excluding HIV
ADHD
Interferons
$74-84Bn
$34-39Bn
$32-37Bn
$31-36Bn
$31-36Bn
$26-31Bn
$23-26Bn
$22-25Bn
$22-25Bn
$22-25Bn
$18-21Bn
$16-19Bn
$15-18Bn
$15-18Bn
$13-16Bn
$12-14Bn
$10-12Bn
$8-10Bn
$7-9Bn
$6-8Bn
Pain
Other CNS Drugs
Antibiotics
Oncology
Hypertension
Diabetes
Dermatology
Antiulcerants
Cholesterol
Asthma/COPD
Anti-Epileptics
Antivirals excluding HIV
Immunosuppressants
Allergy
Antidepressants
Antiplatelet
Antipsychotics
Heparins
Erectile Dysfunction
Immunostimulants
$22-25Bn
$20-23Bn
$18-21Bn
$17-20Bn
$14-17Bn
$10-12Bn
$10-12Bn
$9-11Bn
$6-8Bn
$3-5Bn
$3-5Bn
$3-5Bn
$3-5Bn
$3-5Bn
$3-5Bn
$3-5Bn
$2-3Bn
$1-2Bn
$1-2Bn
$1-2Bn
Top 20 Classes = 71% of total Others, 29% Top 20 Classes = 45% of total Others, 55%
Developed Markets Pharmerging MarketsSales in
2017 (LC$)
Sales in
2017 (LC$)
•• Oncology is forecasted to be the number one
therapeutic area for developed nations in terms
of 2017 spending leading all other therapeutic
areas, even those associated with primary care.
•• Among pharmerging nations, oncology is
anticipated to be the fourth-largest therapeutic
area in terms of spending in 2017 and the largest
specialty area, only falling behind certain primary
care therapeutic areas.
Chart notes:
Pharmerging: China, Brazil, Russia, India, Mexico, Turkey, Venezuela, Poland, Argentina, Saudi Arabia, Indonesia, Colombia, Thailand, Ukraine,
South Africa, Egypt, Romania, Algeria, Vietnam, Pakistan and Nigeria.
Innovations in cancer care and implications for health systems
9Market Dynamics
Global spending on oncology drugs has grown
to $91Bn in 2013, including supportive care
Global oncology market dynamics 2003-2013
PreviousPeriodGrowthinConstantUS$
Global oncology (incl. supportive)
Source: IMS MIDAS, Dec 2013. Oncology includes therapeutic treatments as well as supportive care, radiotherapy, and immunotherapies.
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
0
10
20
30
40
50
60
70
80
90
100
0%
5%
10%
15%
20%
25%
Global therapeutic oncology growth
Global oncology growth (incl supportive)
Global overall pharma growth
SpendinginUS$Bn
•• From 2003 to 2008, growth was consistently
above 15% for therapeutic agents, reflecting the
launch of bevacizumab (Avastin) and expansion
of trastuzumab (Herceptin) into adjuvant breast
cancer.
•• Safety issues regarding the use of the
erythropoietin stimulating agents (ESA) in
2007 resulted in a dramatic drop in their use,
particularly in the U.S.
•• Most launches between 2005 and 2009 addressed
smaller patient populations and saw lower
adoption rates than earlier products.
•• 2012 featured a record number of FDA approvals,
particularly in oncology.
•• Meanwhile, the growth of Herceptin and
rituximab (MabThera/Rituxan) sales slowed in
2013.
•• Recent approvals for lymphomas,
immunotherapy agents for melanoma, PD-1
modulators, and anti-PD-L1 therapies represent
the next phase of targeted agents in oncology.
Innovations in cancer care and implications for health systems
11Market Dynamics
Oncology spending is still dominated by the U.S.
and EU5
Proportion of oncology spending by global market share, 2008-2013
U.S. EU5 ROW Japan Pharmerging
2008 $71.9Bn 2013 $90.8Bn
Source: IMS MIDAS, MAT Sep 2013. Pharmerging includes retail only for Brazil and Mexico.
Oncology includes Therapeutic treatments as well as supportive care, radiotherapy and immunotherapies.
10%
12%
27%
43%
8%
10%
13%
24%
41%
12%
•• U.S. share of total spending declined by 2% but
remains the largest oncology market.
•• The five largest European markets also reduced
their share of the global spending by 3%.
•• While the pharmerging share of total spending
has grown by 12%, 75% of total sales are
represented by the U.S., EU5, and Japan alone.
•• The U.S. relevance in global oncology extends
beyond its size but also because the access
and pricing associated with the U.S. health care
system have encouraged use of innovative
treatments.
Innovations in cancer care and implications for health systems
15Innovation and Launch
Preclinical
3,088
Phase I
1,082
Phase II
1,438
Phase III
449
Pre-Reg/
Registered
177
1,026
33%
352
33%
369
26%
102
23%
16
9%
Number and % of oncology products in phase Total drugs in pipeline
Non biologics (small molecules) Biologics
56% 44% 63% 37%62% 38% 59% 41% 62% 38%
Source: IMS Institute for Healthcare Informatics, Feb 2014
Oncology is the largest area of focus in R&D,
with almost 2000 products in the pipeline
Number of active products in the pipeline to date = 6,234
Chart notes:
Chart notes: Chart counts the number of unique products in R&D for the most-advanced phase they are being researched for. Many cancer drugs are investigated for
multiple indications and counting only unique products may understate late-stage cancer research.
•• Oncology represents the largest cluster of
R&D activity, with over 30% of preclinical and
phase I activity.
•• Fewer cancer drugs are progressing to phase
II and III which indicates both the high levels
of early phase activity and the difficulties in
generating successful results in the clinic.
•• While only 9% of drugs pending with regulators
were for cancer, over a quarter of NME launches
in the past three years in the U.S. were cancer
medicines, and cancer medicines are more likely
to be fast-tracked by regulators and progress
rapidly from phase III to approval.
•• The first drug launched with an FDA
breakthrough designation was a cancer drug
(obinutuzumab; Gazyva), and many of the others
pending with FDA with this designation are also
cancer treatments.
•• In 2013, 17 new drugs were launched to treat
orphan diseases, rare conditions affecting less
than 200,000 people and for which few therapies
are effective. Eight of the new orphan drugs were
for the treatment of cancer, and many were fast-
tracked by the FDA.
Innovations in cancer care and implications for health systems
23
Innovations in cancer care and implications for health systems
Innovation and Launch
R&D focus appears to be based on factors other than
disease prevalence or potential treatment populations
Phase III trials by cancer type and 5-year disease prevalence
Source: IMS R&D Focus, Globocan
7
6
5
4
3
2
1
0
0 5 10 15 20 25 30 35 40
Breast
CRC
Prostate
Bladder
NHL Kidney
Liver
Stomach
Melanoma
Leukemia
Ovarian
Cervical
Uterine
Thyroid
Lung
5-yearGlobalPrevalence(Millions)
Number of phase III trials
•• While it is not surprising that higher prevalence
tumors have more late-stage pipeline
development, another key driver of innovation
is unmet needs, which are not always tied to
prevalence.
•• Although prostate cancer has approximately twice
the 5-year global prevalence, the number of trials
investigating agents for the treatment of lung
cancer is more than twice that for prostate cancer.
•• This is presumably due to the fact that molecular
targets in non-small cell lung cancer—particularly
epidermal growth factor receptor (EGFR)—have
been long-since identified and extensively studied.
•• Similar phenomena likely play a role in the
relatively high number of agents being
investigated for colorectal, breast, and ovarian
cancer, specifically those targeting KRAS, BRAF,
and ALK mutations and human epidermal growth
factor receptor 2 (HER-2).
•• So in a pipeline overwhelmingly populated by
targeted therapies, agents with well characterized
molecular targets and accompanying biomarkers
appear to be high potential investments.
•• Conversely, six key tumor types (thyroid, uterine,
cervical, bladder, NHL, and kidney) with lower
prevalence and corresponding lower numbers of
clinical trials evaluating investigational therapies,
represent an opportunity for R&D efforts in
the future.
•• It is also important to note the impact of immune
therapy and recent success in clinical trials. This
is expected to enhance focus in lung cancer
and melanoma, and has already impacted
gastrointestinal cancers.
Chart notes:
Phase III numbers refers to counts of drugs in clinical trials
Innovations in cancer care and implications for health systems
33
Innovations in cancer care and implications for health systems
Value of Treating Cancer and Pricing Trends
CostinUS$
Cost per month Average cost per month for drugs over a period of 5 years
201320122011200920062003
Source: 1. Adapted from Bach PB. N Engl J Med. 2009;360:626-633. 2. IMS MIDAS ex-manufacturers sales data.
35000
30000
25000
20000
15000
10000
5000
0
The average monthly cost of branded oncology drugs
has doubled over the past decade
U.S. cost per month of branded oncology drugs (2003-2013)
•• The average monthly cost of branded oncology
drugs was ~$5,000 in 2003 compared with
~$10,000 in 2013.
•• Certain individual branded oncology agents cost
upwards of $30,000 per month.
•• These costs do not include discounts, or patient
payment shares.
Innovations in cancer care and implications for health systems

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Oncology Market Dynamics

  • 1. 6Market Dynamics Global cancer incidence rates vary by regions and cancer types 2012 incidence rates (age-standardized incidence rate/100,000) More developed regions Less developed regions Lung ColorectalIncidence of all cancers Liver Gastric Source: Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available at: http://globocan.iarc.fr. Accessed 12/13/2013. 268 148 31 20 29 12 5 12 11 13 •• The degree to which cancer incidence rates differ among countries can be quite substantial: differences arise from both disease trends and data availability. •• Overall, cancer incidence rates are lower in less developed regions; this may be the result of a number of factors. •• Populations in less-developed regions may have diminished access to health care services, and a higher probability of dying before being diagnosed with cancer. •• Public health organizations may be less likely to track and record case information for epidemiologic purposes, potentially resulting in lower perceived incidences. •• In terms of cancer type, lung and colorectal cancer incidence tends to be higher in more developed nations. •• Conversely, liver and gastric cancer incidence tends to be higher in less developed countries. •• A causal link between hepatitis C infection and liver cancer as well as higher likelihood of exposure to environmental toxins may offer some explanation of this phenomenon. •• In developed countries liver cancers will be on the rise due to life style. Obesity will take over as the main cause of hepatocellular carcinoma (HCC) in the U.S. (by 2030 forecasted) and in Europe shortly after. Innovations in cancer care and implications for health systems Chart Notes: More developed regions: all regions of Europe plus Northern America, Australia/New Zealand and Japan. Less developed regions: all regions of Africa, Asia (excluding Japan), Latin America and the Caribbean, Melanesia, Micronesia and Polynesia.
  • 2. 7Market Dynamics Cancer survival is improving steadily as detection and treatment improve Five-year U.S. relative survival by year of diagnosis %alive All sites NHL Breast RCC 2005200420032002200120001999199819971996199519941993199219911990 Source: National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Available at: http://www.seer.cancer.gov/csr/1975_2010/download_csr_datafile.php/. Accessed 3/11/2014 95 90 85 80 75 70 65 60 55 50 •• Survival has improved significantly over the past two decades with published research suggesting that 23% of the improvement is due to behavioral changes, 35% is due to screening, 20% to advances in treatment, and the remaining 22% attributed to other factors.1 •• Non-Hodgkin’s lymphoma (NHL) provides an example of one group of cancers where improving survival is especially pronounced, due in part to the adoption of new targeted and cytotoxic therapies beginning in the 1990s. •• Improvements in survival vary substantially among cancers. Breast cancer, for example, has a historically high survival rate, and has seen only modest improvements despite new therapies being approved. Innovations in cancer care and implications for health systems 1. Cutler, David M. Are We Finally Winning the War on Cancer? Journal of Economic Perspectives. Volume 22, Number 4. 2008.
  • 3. 8 Innovations in cancer care and implications for health systems Market Dynamics Oncology drives major medicines spend in developed and pharmerging markets Spending by therapeutic area in 2017 (oncology does not include supportive care) Source: IMS Health Thought Leadership, Sep 2013. Oncology Diabetes Anti-TNFs Pain Asthma/COPD Other CNS Drugs Hypertension Immunostimulants HIV Antivirals Dermatology Antibiotics Cholesterol Anti-Epileptics Immunosuppressants Antipsychotics Antiulcerants Antidepressants Antivirals excluding HIV ADHD Interferons $74-84Bn $34-39Bn $32-37Bn $31-36Bn $31-36Bn $26-31Bn $23-26Bn $22-25Bn $22-25Bn $22-25Bn $18-21Bn $16-19Bn $15-18Bn $15-18Bn $13-16Bn $12-14Bn $10-12Bn $8-10Bn $7-9Bn $6-8Bn Pain Other CNS Drugs Antibiotics Oncology Hypertension Diabetes Dermatology Antiulcerants Cholesterol Asthma/COPD Anti-Epileptics Antivirals excluding HIV Immunosuppressants Allergy Antidepressants Antiplatelet Antipsychotics Heparins Erectile Dysfunction Immunostimulants $22-25Bn $20-23Bn $18-21Bn $17-20Bn $14-17Bn $10-12Bn $10-12Bn $9-11Bn $6-8Bn $3-5Bn $3-5Bn $3-5Bn $3-5Bn $3-5Bn $3-5Bn $3-5Bn $2-3Bn $1-2Bn $1-2Bn $1-2Bn Top 20 Classes = 71% of total Others, 29% Top 20 Classes = 45% of total Others, 55% Developed Markets Pharmerging MarketsSales in 2017 (LC$) Sales in 2017 (LC$) •• Oncology is forecasted to be the number one therapeutic area for developed nations in terms of 2017 spending leading all other therapeutic areas, even those associated with primary care. •• Among pharmerging nations, oncology is anticipated to be the fourth-largest therapeutic area in terms of spending in 2017 and the largest specialty area, only falling behind certain primary care therapeutic areas. Chart notes: Pharmerging: China, Brazil, Russia, India, Mexico, Turkey, Venezuela, Poland, Argentina, Saudi Arabia, Indonesia, Colombia, Thailand, Ukraine, South Africa, Egypt, Romania, Algeria, Vietnam, Pakistan and Nigeria. Innovations in cancer care and implications for health systems
  • 4. 9Market Dynamics Global spending on oncology drugs has grown to $91Bn in 2013, including supportive care Global oncology market dynamics 2003-2013 PreviousPeriodGrowthinConstantUS$ Global oncology (incl. supportive) Source: IMS MIDAS, Dec 2013. Oncology includes therapeutic treatments as well as supportive care, radiotherapy, and immunotherapies. 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 0 10 20 30 40 50 60 70 80 90 100 0% 5% 10% 15% 20% 25% Global therapeutic oncology growth Global oncology growth (incl supportive) Global overall pharma growth SpendinginUS$Bn •• From 2003 to 2008, growth was consistently above 15% for therapeutic agents, reflecting the launch of bevacizumab (Avastin) and expansion of trastuzumab (Herceptin) into adjuvant breast cancer. •• Safety issues regarding the use of the erythropoietin stimulating agents (ESA) in 2007 resulted in a dramatic drop in their use, particularly in the U.S. •• Most launches between 2005 and 2009 addressed smaller patient populations and saw lower adoption rates than earlier products. •• 2012 featured a record number of FDA approvals, particularly in oncology. •• Meanwhile, the growth of Herceptin and rituximab (MabThera/Rituxan) sales slowed in 2013. •• Recent approvals for lymphomas, immunotherapy agents for melanoma, PD-1 modulators, and anti-PD-L1 therapies represent the next phase of targeted agents in oncology. Innovations in cancer care and implications for health systems
  • 5. 11Market Dynamics Oncology spending is still dominated by the U.S. and EU5 Proportion of oncology spending by global market share, 2008-2013 U.S. EU5 ROW Japan Pharmerging 2008 $71.9Bn 2013 $90.8Bn Source: IMS MIDAS, MAT Sep 2013. Pharmerging includes retail only for Brazil and Mexico. Oncology includes Therapeutic treatments as well as supportive care, radiotherapy and immunotherapies. 10% 12% 27% 43% 8% 10% 13% 24% 41% 12% •• U.S. share of total spending declined by 2% but remains the largest oncology market. •• The five largest European markets also reduced their share of the global spending by 3%. •• While the pharmerging share of total spending has grown by 12%, 75% of total sales are represented by the U.S., EU5, and Japan alone. •• The U.S. relevance in global oncology extends beyond its size but also because the access and pricing associated with the U.S. health care system have encouraged use of innovative treatments. Innovations in cancer care and implications for health systems
  • 6. 15Innovation and Launch Preclinical 3,088 Phase I 1,082 Phase II 1,438 Phase III 449 Pre-Reg/ Registered 177 1,026 33% 352 33% 369 26% 102 23% 16 9% Number and % of oncology products in phase Total drugs in pipeline Non biologics (small molecules) Biologics 56% 44% 63% 37%62% 38% 59% 41% 62% 38% Source: IMS Institute for Healthcare Informatics, Feb 2014 Oncology is the largest area of focus in R&D, with almost 2000 products in the pipeline Number of active products in the pipeline to date = 6,234 Chart notes: Chart notes: Chart counts the number of unique products in R&D for the most-advanced phase they are being researched for. Many cancer drugs are investigated for multiple indications and counting only unique products may understate late-stage cancer research. •• Oncology represents the largest cluster of R&D activity, with over 30% of preclinical and phase I activity. •• Fewer cancer drugs are progressing to phase II and III which indicates both the high levels of early phase activity and the difficulties in generating successful results in the clinic. •• While only 9% of drugs pending with regulators were for cancer, over a quarter of NME launches in the past three years in the U.S. were cancer medicines, and cancer medicines are more likely to be fast-tracked by regulators and progress rapidly from phase III to approval. •• The first drug launched with an FDA breakthrough designation was a cancer drug (obinutuzumab; Gazyva), and many of the others pending with FDA with this designation are also cancer treatments. •• In 2013, 17 new drugs were launched to treat orphan diseases, rare conditions affecting less than 200,000 people and for which few therapies are effective. Eight of the new orphan drugs were for the treatment of cancer, and many were fast- tracked by the FDA. Innovations in cancer care and implications for health systems
  • 7. 23 Innovations in cancer care and implications for health systems Innovation and Launch R&D focus appears to be based on factors other than disease prevalence or potential treatment populations Phase III trials by cancer type and 5-year disease prevalence Source: IMS R&D Focus, Globocan 7 6 5 4 3 2 1 0 0 5 10 15 20 25 30 35 40 Breast CRC Prostate Bladder NHL Kidney Liver Stomach Melanoma Leukemia Ovarian Cervical Uterine Thyroid Lung 5-yearGlobalPrevalence(Millions) Number of phase III trials •• While it is not surprising that higher prevalence tumors have more late-stage pipeline development, another key driver of innovation is unmet needs, which are not always tied to prevalence. •• Although prostate cancer has approximately twice the 5-year global prevalence, the number of trials investigating agents for the treatment of lung cancer is more than twice that for prostate cancer. •• This is presumably due to the fact that molecular targets in non-small cell lung cancer—particularly epidermal growth factor receptor (EGFR)—have been long-since identified and extensively studied. •• Similar phenomena likely play a role in the relatively high number of agents being investigated for colorectal, breast, and ovarian cancer, specifically those targeting KRAS, BRAF, and ALK mutations and human epidermal growth factor receptor 2 (HER-2). •• So in a pipeline overwhelmingly populated by targeted therapies, agents with well characterized molecular targets and accompanying biomarkers appear to be high potential investments. •• Conversely, six key tumor types (thyroid, uterine, cervical, bladder, NHL, and kidney) with lower prevalence and corresponding lower numbers of clinical trials evaluating investigational therapies, represent an opportunity for R&D efforts in the future. •• It is also important to note the impact of immune therapy and recent success in clinical trials. This is expected to enhance focus in lung cancer and melanoma, and has already impacted gastrointestinal cancers. Chart notes: Phase III numbers refers to counts of drugs in clinical trials Innovations in cancer care and implications for health systems
  • 8. 33 Innovations in cancer care and implications for health systems Value of Treating Cancer and Pricing Trends CostinUS$ Cost per month Average cost per month for drugs over a period of 5 years 201320122011200920062003 Source: 1. Adapted from Bach PB. N Engl J Med. 2009;360:626-633. 2. IMS MIDAS ex-manufacturers sales data. 35000 30000 25000 20000 15000 10000 5000 0 The average monthly cost of branded oncology drugs has doubled over the past decade U.S. cost per month of branded oncology drugs (2003-2013) •• The average monthly cost of branded oncology drugs was ~$5,000 in 2003 compared with ~$10,000 in 2013. •• Certain individual branded oncology agents cost upwards of $30,000 per month. •• These costs do not include discounts, or patient payment shares. Innovations in cancer care and implications for health systems