oncology-report

The Future of the U.S. Oncology Market:Preparing for Healthcare 2.0AUTHORS: Jill E. Sackman, DVM, PhD; Michael N. Abrams, MA; Vince L. Ovlia, MBA

www.eyeforpharma.com/oncology

MARKET ANALYSIS

THE FUTURE OF THE U.S. ONCOLOGY MARKET MARKET ANALYSISPREPARING FOR HEALTHCARE 2.0

The Market Context 3

Market Access and Reimbursement 5in Oncology

Healthcare Provider Landscape 9for Oncology

Clinical Pathways in Oncology 12

Risk Sharing Agreements in Oncology 13

Implications for U.S. Manufacturers 15in Oncology

Great Opportunities Still Await 17

References 18

Contents

DISCLAIMER

This report has been produced by eyeforpharma (a division of FC Business Intelligence) in partnership with Numerof & Associates, Inc., a strategy consulting fi rm in St. Louis, MO. We like to thank the authors for the extensive primary research that went into the production. FC Business Intelligence has no obligation to tell you when opinions or information in this report change. FC Business Intelligence makes every effort to use reliable, comprehensive information, but we make no representation that it is accurate or complete. In no event shall FC Business Intelligence and its partners be liable for any damages, losses, expenses, loss of data, loss of opportunity or profi t caused by the use of the material or contents of this paper. No part of this document may be distributed, resold, copied, or adapted without our prior written permission.

AUTHORS

Jill E. Sackman, DVM, PhD

Michael N. Abrams, MA

Vince L. Ovlia, MBA

Numerof & Associates is a strategic management consulting fi rm focused on organizations in dynamic, rapidly changing industries. We bring a unique cross-disciplinary approach to a broad range of engagements designed to sharpen strategic focus, increase revenues, reduce costs, and enhance customer value.

EDITOR

Ulrich Neumann, MSc, MA

eyeforpharma is a global provider of pharmaceutical business insights. We serve as a respected hub for senior-level executives to exchange ideas and stay up-to-date with shifting trends and practices within the industry. Our mission is to help leaders defi ne future strategy and direction, develop growth opportunities and address commercial challenges through collaboration, networking and a host of market intelligence offerings. We produce high-level summits, bespoke industry research, strategy reports, white papers, global webinars, online platforms or customized digital solutions.


3

www.eyeforpharma.com/oncology ▲CONTENTS ▼ PRINT

U.S. Healthcare Landscape

Pressure on the healthcare industry to control costs and improve outcomes is intense, and growing. In 2010, the U.S. spent $2.6 trillion on healthcare, an average of $8,402 per person. The share of gross domestic product (GDP) devoted to healthcare has increased from 7.2% in 1970 to 17.9% in 2009 and 2010, and healthcare costs per capita have grown approximately 2.4 percentage points faster than the GDP since 1970.1 Despite this spending increase, the average life expectancy of Americans and the efficiency of the U.S. healthcare system are ranked near the bottom of countries with advanced economies.2 In fact, according to a 2013 study from the OECD, the U.S. ranks 26th overall in life expectancy – on par with Chile and the Czech Republic and just behind Slovenia.3 Not surprisingly, the entire healthcare industry has come under increased scrutiny from a concerned public that’s demanding better, more cost-effective solutions. Because of the breadth of its societal impact and the singularly high cost of treatment, oncology is shaping up to be a particular focus of the change that needs to occur.

U.S. Oncology Landscape

Historically, cancer drugs in the U.S. have enjoyed “special status” because they had been used to treat patients with generally incurable diseases whose life expectancies are often measured in months. This special status permeated clinical medicine, where new drugs and biologics have been rapidly adopted, even when the scientific rationale is weak. It has also affected regulatory approval processes, marketing authorization, and reimbursement policies. As a result, the cost of new cancer treatments has historically rarely been questioned. Payers typically deferred to oncologists in their networks when establishing coverage and reimbursement policy. Policy and common practice traditionally provided mostly unlimited access to drugs and biologics, as most of these products would only be used for very short periods of time and often only provided marginal benefit.4

However, as a result of an aging population, significant therapeutic innovation, nearly unlimited access to treatment options, and increasing patient survivorship, the cost of treating cancer – including drug costs – has skyrocketed in recent years.5 New therapies, along with earlier diagnosis and follow-up care, have allowed patients to live much longer and with improved quality of life, effectively turning cancer into a chronic disease for many in the U.S. Cancer survivorship in the U.S. has increased from 3 million in 1971 to 13.7 million in 2012.6 Today, two-thirds of cancer patients live at least five years after diagnosis, compared to half in the 1970’s.5 Survival rates have also increased. Breast, skin, prostate, testicular, and thyroid cancer now have 5-year survival rates of about 90% or greater.7

In parallel with these advancements in treatment, the inflation-adjusted median price of new cancer drugs has soared from $1,770 to $9,905 per month since the late 1990’s (see Figure 1). This steep trend is expected to continue with drug prices projected to increase by 25% annually.8 Given this environment, it’s not surprising that pharmaceutical companies continue to make large investments in oncology. As of 2014, there were nearly 800 medicines and vaccines for the treatment of cancer either in clinical trial or awaiting review by the FDA.6

In 2010, the U.S. spent $2.6 trillion on healthcare, an average of $8,402 per person

The Market Context


4


The Market Context

With cancer drug prices on pace to double every four to fi ve years in the U.S., key stakeholders from around the industry are acknowledging a disconnect between drug prices and value. Treatment cost increases are now considered unsustainable, and questions about new product value are being openly raised by physicians and payers alike. In this new environment, market access in oncology no longer simply includes the willingness of payers to reimburse, but also the relative power of provider organizations to enable or restrict the adoption of new and existing products. Going forward, manufacturers will be increasingly expected to demonstrate

the differentiated economic and clinical value of their products in order to justify market access and premium payments from payers as well as product adoption by physicians.

Traditional randomized clinical trials rarely provide a complete understanding of real-world product performance in patients. However, payers are increasingly resistant to footing the bill to fi gure this out.10 As a result, post-market real-world evidence (RWE) is gaining acceptance as are companion diagnostics that identify which patients are most likely to respond to a specifi c drug or treatment.

FIGURE 1: U.S., Median Monthly Cost of New Cancer Drugs for Each 5-Year Period*

*Note: Prices are adjusted for infl ationSource: Peter B. Bach, Memorial Sloan-Kettering Cancer Center, Center for Health Policy & Outcomes9

$129 $430$1,097 $1,199 $1,770

$4,716

$7,000

$9,905

2010-20142005-20092000-20041995-19991990-19941985-19891980-19841975-1979


5


Market Access and Reimbursement in the U.S.

In the U.S., drug coverage and reimbursement for approved oncology indications has historically been virtually assured. Medicare is required to cover all on-label indications, and has limited ability to control pricing for patented drugs. Additionally, Medicare covers off-label applications included in various compendia. Although laws vary by state, commercial payers often have more flexibility to restrict access in the off-label setting by requiring prior authorization or large co-pays for high-priced drugs.

Additionally, the FDA offers a number of options to expedite a product’s regulatory approval process based on certain criteria, including unmet clinical need as well as preliminary clinical evidence. Novartis’ Gleevec (imatinib mesylate) was approved in just two and a half months as a result of the accelerated approval process, and Millennium Pharmaceuticals’ Velcade (bortezomib) went through the accelerated process in only two months. In 2012, the FDA’s Breakthrough Therapy Designation was enacted to provide yet another mechanism to accelerate the path of critical therapeutics to market. As of December 2014, the regulatory agency had awarded 59 such designations, with cancer drugs accounting for 26 (44%) of these products.11

It is not surprising that cancer patients in the U.S. receive faster access to more oncology drugs than patients in other countries

Taking these programs into account, it is not surprising that cancer patients in the U.S. receive faster access to more oncology drugs than patients in other countries. For instance, new oncology drug approvals in the U.S. outpaced European approvals by 33% between 2000 and 2011.12 This strong push for drug approval has contributed to the U.S. being a laggard in implementing cost-containing measures and ensuring that the outcomes from these products justify their premium price. “Although more oncology drugs are available in the U.S., and the costs for a higher share of them are reimbursed, the evidence-based approach adopted by European systems has improved the affordability of drugs in Europe that are considered to be cost-effective,” says Dr. Joshua P. Cohen, Deputy Director of the Center for the Evaluation of Value and Risk in Health.12

In a recent white paper on the subject, the Institute of Medicine (IOM) described cancer care in the U.S. as in crisis, largely because of poor care coordination, the lack of evidence-based medicine (EBM) care paths, inconsistency in treatment, and accelerating costs.13 Such criticism has spurred more public and private payers to adopt a value-based approach to coverage. Spurred by increased competition and enabled by improved IT capabilities, managed care organizations (MCOs) and other payers are using a variety of tools to help manage oncology costs and trends (see Table 1). These tools include, but are not limited to, requiring prior authorization and/or companion diagnostics, limited drug quantities, and copays or coinsurance.

Market Access and Reimbursement in Oncology


6



Targeted Therapies and Oral Oncologics

Targeted therapies represent a major focus of cancer research today. In fact, four oncology drugs approved in 2013 alone are indicated for patients that have a specifi c genetic mutation.15 As personalized medicines continue to proliferate in the oncology space, indications for available treatments have become narrower and drug labels more complex. Consequently, payers are now more likely to restrict market access of these products through prior authorizations (PAs). “The FDA labels for specialty medications are becoming increasingly detailed. We try to manage these medications in line with their approvals, so prior authorization is expanding,” says Dr. Estay Greene, Director of Pharmacy Programs at Blue Cross Blue Shield of North Carolina.16 The data reported in Table 1 support Dr. Green’s statement, as does a recent study reporting that 93% of the 47 major health plans routinely employed PA to manage utilization of oncology agents.17

Simultaneously, payers are requiring use of companion diagnostic tests where they exist before approving certain therapies, in an effort to focus expensive drugs on the most appropriate patients. “The ability to avoid the unnecessary administration of expensive therapies – which can cost upwards of $10,000/month or more – that will provide no clinical benefi t and may incur a lot of side effects (and even ER or hospital visits) provides tremendous opportunities for cost savings to plans and to the overall healthcare system, so there’s a lot of interest in this,” adds Dr. Michael Kolodziej, National Medical Director for Oncology Solutions for Aetna.18 Kolodziej also warns manufacturers that as premium-priced oral cancer drugs continue to penetrate the market, PAs and companion diagnostic requirements will become an even greater access barrier for these products. He states, “With these two drivers in place, many community oncologists have been less willing to prescribe oral oncolytics when a suitable IV option exists.”19

TABLE 1: Tools Used to Control Oncology Drug Costs and Trend

*Note: AWP = average wholesale price; ASP = average sales price; WAC = wholesale acquisition costSource: The 2013 Genentech Oncology Trend Report14

TOOLTOOLPercentage of MCOs reported to use tool Percentage of MCOs reported to use tool Percentage of MCOs reported to use tool Percentage of MCOs reported to use tool Percentage of MCOs reported to use tool Percentage of MCOs reported to use tool Percentage of MCOs reported to use tool Percentage of MCOs reported to use tool Percentage of MCOs reported to use tool

with respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugswith respect to cancer drugs

Prior authorization protocolsPrior authorization protocolsPrior authorization protocolsPrior authorization protocolsPrior authorization protocolsPrior authorization protocolsPrior authorization protocols 89.1%89.1%

Drug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitationsDrug quantity/days’ supply limitations 81.2%81.2%81.2%81.2%81.2%81.2%

Member cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsuranceMember cost sharing via dollar copays and percent coinsurance 67.3%67.3%

Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures*Adjusted drug reimbursement (e.g., AWP-, ASP-, or WAC-based) to lower expenditures* 56.4%56.4%56.4%56.4%56.4%56.4%

Step therapyStep therapyStep therapyStep therapy 55.4%55.4%

Closed specialty pharmacy networkClosed specialty pharmacy networkClosed specialty pharmacy networkClosed specialty pharmacy networkClosed specialty pharmacy networkClosed specialty pharmacy networkClosed specialty pharmacy network 52.5%52.5%52.5%

Specialty drug benefi t design recommendationsSpecialty drug benefi t design recommendationsSpecialty drug benefi t design recommendationsSpecialty drug benefi t design recommendationsSpecialty drug benefi t design recommendationsSpecialty drug benefi t design recommendationsSpecialty drug benefi t design recommendationsSpecialty drug benefi t design recommendationsSpecialty drug benefi t design recommendationsSpecialty drug benefi t design recommendations 40.6%40.6%40.6%

Preferred drug therapyPreferred drug therapyPreferred drug therapyPreferred drug therapyPreferred drug therapyPreferred drug therapy 39.6%39.6%

Limited fi rst fi ll (i.e. short fi ll)Limited fi rst fi ll (i.e. short fi ll)Limited fi rst fi ll (i.e. short fi ll)Limited fi rst fi ll (i.e. short fi ll)Limited fi rst fi ll (i.e. short fi ll)Limited fi rst fi ll (i.e. short fi ll) 33.7%33.7%


7



Biosimilars

With looming patent cliffs for blockbuster biologics like Avastin and Rituxan as well as the increased need of key stakeholders to counterbalance rising drug costs, the use of biosimilars in oncology has the potential to increase significantly over the next few years. Thus far, the U.S. has lagged in adopting a formal path to approval for biosimilars, with the FDA currently finalizing its guidelines. Nonetheless, recent events signal that the landscape may be quickly changing.20 Of particular note in oncology are monoclonal antibody (mAb) biosimilars. Although relatively new, there are over 600 mAb biosimilars currently in development in oncology.21 In addition, an FDA advisory panel recently endorsed a biosimilar for Neupogen, a white blood cell booster used in cancer treatment, paving the way for the expanded use of biosimilars in oncology.22

The spiraling cost of cancer drugs is also forcing payers to reevaluate their payment model for reimbursing physicians

The Emergence of New Payment Modelsfrom PayersThe spiraling cost of cancer drugs is also forcing payers to reevaluate their payment model for reimbursing physicians. In an effort to move away from a buy-and-bill system that rewards oncologists for prescribing higher-priced drugs, payer organizations such as UnitedHealthcare have begun to experiment with “bundled payments” (also called “episode payments”) in the treatment of cancer. Although these

models are still in their early stages, they indicate an increased willingness by payers to experiment with new reimbursement strategies in oncology.

Under a three-year pilot program from UnitedHealthcare, oncologists were reimbursed upfront based on the expected cost of treating patients with breast, colon, and lung cancer, using regimens defined by the physicians. Payments to physicians were made by calculating the anticipated drug profits they would be expected to receive using the selected regime. These payments were made at the beginning of a patient’s treatment, eliminating the connection between physician income and the choice of drugs prescribed during treatment. In describing this payment model, Lee N. Newcomer, Senior Vice President of Oncology at UnitedHealthcare, states,

“All the drug profit margin went up to a single payment on the first day. And then we drew a line in the sand. We said, ‘Look, from here forward science is going to change, new drugs are going to come out. We will always pay you the cost of the drug but we will not pay you any more profit margin.’” Essentially, under this program, the only way for physicians to increase their profits is to either achieve better outcomes or reduce the total cost of care. So far, the results from this pilot program have been positive. Although more was spent on chemotherapy drugs in the bundled price group, this group cost 34% less to treat overall than the control group.23

UnitedHealthcare recently announced an even more expansive bundled payment program with MD Anderson Cancer Center in Houston. Under this program, which focuses on newly diagnosed patients with head and neck cancer, UnitedHealthcare agrees to make a pre-negotiated annual payment that covers almost all aspects of a patient’s treatment, including surgery, chemotherapy, and imaging scans. The program actually consists of eight separate bundles, with a different price for each. Patients are assigned to bundles based on their individual wants and needs as well as other patient-specific considerations.24


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New Payment Models from OtherStakeholdersIn addition to payers, other key stakeholders are also experimenting with new payment models in oncology, providing further evidence that the existing fee-for-service model is being increasingly challenged. Indicating a continued focus on cost and quality, the American Society of Clinical Oncology (ASCO) recently released its own proposed payment approach – structured around fi ve fl exible “bundled payments”– that would reimburse physician practices for many of the services related to cancer treatment as a single or monthly payment.25 Furthermore, providers are also launching their own programs to provide fully transparent, bundled care in cancer. For example, at Cancer Treatment Centers of America, patients are guaranteed a diagnosis and treatment plan at a fi xed cost for several leading types of cancer.26

Global Trends and Future Implicationsin the U.S.Understanding how other countries have controlled the cost of healthcare is crucial for manufacturers. Coverage and reimbursement decisions in many countries are increasingly based on clinical and cost-effectiveness data, especially throughout the European Union (EU). For several years, commercial success for oncology products outside the U.S. has required more than regulatory approval. In these developed markets, real-world data, patient relevant outcomes, health economic and budget impact analyses, as well as comparative effectiveness have become the standard for market access.27

Historically, manufacturers in the U.S. have been held to a less-demanding reimbursement standard because of the large role of private insurers. While there are still some unique forces at play in the U.S market, including the recently passed Affordable Care Act (ACA), differences between developed markets are rapidly closing. As such, manufacturers should expect oncology to be treated by payers no differently than other diseases, especially with the arrival of key generics and biosimilars.27

Understanding how other countries have controlled the cost of healthcare is crucial for manufacturers


9


Increased Pressure on Providers

Payers are not the only stakeholders looking for ways to improve cancer patient care quality and reduce medical expenditures. Provider organizations (e.g., hospitals and physician groups) in the U.S. are becoming increasingly focused on costs as well – a trend that is largely driven by declining reimbursement rates, the enforcement of financial penalties related to clinical metrics, and increased regulation. The ACA has a number of provisions that propose to address cost and efficiency in healthcare. As an example, the ACA includes demonstration and implementation of new payment and care delivery models, such as accountable care organizations (ACOs). With the ACA’s endorsement of ACOs, there is a clear focus on moving more of the risk associated with the quality and cost of healthcare to the provider. Healthcare providers are being forced to adapt to these external pressures and are choosing to do so, at least in part, through consolidation.27

Consolidation and Partnerships

Consolidation in healthcare is having significant implications for manufacturers selling into the delivery sector. With respect to purchasing power, fewer, larger health systems increase the leverage of buyers with all suppliers, including pharmaceutical companies. Beyond that, the integration of insurers with delivery organizations potentially increases the power of administrative perspectives in purchasing decisions relative to clinical perspectives. The likely consequence of this is accelerated pricing pressure. Massive consolidation also poses a threat to product adoption. Treatment decisions that historically were made at the physician-level are being institutionalized through evidence-based care paths, with management’s role growing at the expense of clinicians. Enterprise-level senior executives and hospital administrators increasingly are making decisions about what drugs will be on the formulary, and which will not.27

Hospitals are also creating partnerships with payers, with several interesting examples in oncology (see Table 2). For instance, Florida Blue recently partnered with two separate healthcare institutions, including Moffitt Cancer Center, to launch initiatives aimed at better integrated, higher quality care and improved patient outcomes. These trends in payer-provider partnerships are expected to continue with the full implementation of the ACA.

Treatment decisions that historically were made at the physician-level are being institutionalized through evidence-based care paths, with management’s role growing at the expense of clinicians

Healthcare Provider Landscape for Oncology


10



Like payers, providers are also starting to demand evidence of a product’s economic and clinical value. Moving forward, hospital administrators, who are under increased pressure to control costs and justify reimbursement rates, will rely on published evidence as well as the experience of their clinical teams to determine a product’s value. In oncology, this will mean a more rigorous assessment of drugs that are included in treatment protocols.

This, in fact, is already happening. In 2012, in an unmistakably public forum – the editorial page of the New York Times – oncologists at Memorial Sloan-Kettering Cancer Center (MSKCC) decided not to include Sanofi ’s Zaltrap in their treatment protocols because it wasn’t worth the cost. The available data indicated that Zaltrap was no better at

extending life than the product currently used, Avastin, and it cost more than twice as much (an average of $11,063 per month for Zaltrap vs. about $5,000 per month for Avastin.34 These actions eventually led to a 50% reduction in the price of Zaltrap.35

Even Pharmacy Benefi t Managers (PBMs), like Express Scripts and CVS/Caremark, have been getting involved. In 2015, Express Scripts will exclude 66 brand-name drugs from its main formulary, while CVS will exclude 95. This represents an increase over the number of exclusions in 2014.36 While no oncology agents have been removed as of yet, cancer drugs may be next on the chopping block. Sixteen of the 33 cancer drugs introduced since 2010 cost $10,000 or more per month, and all cost more than $5,000 per month.37

TABLE 2: Innovative Payer/Provider Cancer Care Initiatives in the U.S.

Source: Multiple Sources 28, 29, 30, 31, 32, 33

Partnership Constituents (Payer/Provider)Partnership Constituents (Payer/Provider)Partnership Constituents (Payer/Provider)Partnership Constituents (Payer/Provider)Partnership Constituents (Payer/Provider)Partnership Constituents (Payer/Provider)Partnership Constituents (Payer/Provider)Partnership Constituents (Payer/Provider)Partnership Constituents (Payer/Provider) Focus of InitiativeFocus of InitiativeFocus of InitiativeFocus of InitiativeFocus of Initiative

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11



Growth of Retail Medicine

With the increasing focus on cost of care, one of the biggest “curve benders” is the growth of high-deductible health plans that force consumers to be better shoppers of healthcare. Savvy consumers – carrying higher deductibles and copays – now expect the price transparency, access, convenience, and value common to the retail sector. The use of retail clinics continues to expand in oncology, especially as the market for alternative-site infusion centers grows. Leading pharmacy retailers as well as non-traditional entrants, like the St. Louis-based Schnucks grocery chain, are increasingly making their presence felt in this market. Walgreens currently has more than 1,600 clinicians offering infusion services to patients in their homes and at care centers.38 Manufacturers should take note of this fast-evolving market, as potential consolidation creates new, commercially-savvy entities to deal with – unless manufacturers choose to enter into this market themselves.

Increased Role of Technology and Big Data

One important aspect of the ACA is its mandate for improvements in the way clinical data is exchanged and transmitted to electronic health records (EHRs). Health IT (HIT) expansion, along with a proliferation of provider alliances, M&As, and partnerships, is promoting the collection and use of big data. Specifically with respect to oncology, IBM joined with WellPoint and MSKCC to train a supercomputer to process and interpret oncology data.39 According to Dr. Harlan Levine, Executive Vice President for Comprehensive Health Solutions at WellPoint, such technology “will bring the best clinical information about effectiveness to the doctor’s office… [and] empowers the doctor with the collective knowledge of the oncology community.”40

As the use of EHRs continues to become more common in the U.S., there are new and unique opportunities for manufacturers to collaborate with both providers and payers. One example is Optum Labs, a joint collaboration between the Mayo Clinic

and UnitedHealthcare, which brings together vast arrays of clinical and claims data from the two organizations. Through its Claims Linked Registry for Oncology, Optum provides linked medical records and claims data for breast and lung cancer patients in the U.S. Pfizer and Merck have already announced official partnerships with Optum.

Also of note is the work of Dr. Patrick Soon-Shiong, CEO of NantHealth. Blackberry and NantHealth recently announced the release of the NantOmics Cancer Genome Browser, the world’s first clinical genome browser. Leveraging a multitude of data sources – including a patient’s own genetic information – this cloud-based, big data platform enables physicians to create personalized treatment protocols, tailored to the unique genetic makeup of each patient’s cancer. The platform also allows physicians to track patients remotely to ensure that they’re properly taking their medications. Dr. Soon-Shiong plans to launch the first pilot program for the platform in January 2015 in collaboration with Providence Health and Services.41

With the increasing focus on cost of care, one of the biggest “curve benders” is the growth of high-deductible health plans that force consumers to be better shoppers of healthcare


12


The Trend Toward Clinical Pathways

Clinical decision-making represents one of the last bastions of cost that has remained untouched by administrators. Hospitals have typically operated with a strict division of activities such that decisions impacting clinical care were exclusively made by clinicians, and all other decisions were made by administrators. As organizations seek to manage shrinking profi t margins due to falling reimbursement rates, their ability to reduce costs has become even more critical. What was once considered “off limits” is now a legitimate and necessary target. Only by addressing the clinical and cost implications of physician decision-making can clinicians and administrators maintain organizational growth and ensure future viability.27

It’s not surprising, then, that payers, provider organizations, and professional societies have all shown growing interest in establishing treatment guidelines and developing pathways as a way to ensure greater consistency and the use of evidence-based medicine. In addition to reducing the variability of treatment between facilities, guidelines and clinical pathways may also reduce overall costs by decreasing the use of less effective therapies.

In the past several years, a number of programs between pathway vendors and payers/providers have begun yielding results. In 2013, an alliance between Cardinal Health Specialty Solutions and CareFirst BlueCross BlueShield was found to have helped reduce overall breast, lung, and colon cancer treatment costs by 15%.42 The decline in costs was primarily attributed to fewer emergency room visits, shorter hospital stays, increased use of generic drugs, and more appropriate use of chemotherapy. Importantly, reimbursement to physicians increased for both branded and generic drugs, despite the fact that overall drug expenditures were reduced.

“…when implemented collaboratively, with physician input and buy-in, clinical pathways can create a new paradigm for the delivery of cancer care – one in which all stakeholders can win,” maintains Dr. Bruce Feinberg, Vice President and CMO of Cardinal Health Specialty Solutions.43

Future Expectations for Clinical Pathways

It’s expected that these collaborative efforts will continue as physicians are increasingly employed by hospitals and healthcare systems, and payers push to reduce cost and increase quality. By 2015, clinical pathways could expand to cover 25% of the oncology market, up from about 10% in 2010.44 Recent evidence also suggests that broader considerations – beyond product effi cacy and safety – will increasingly be factored into clinical pathways. In new guidelines for metastatic prostate cancer, the ASCO indicated that clinicians needed to be conscious of cost and, signifi cantly, tied cost to a broader consideration of quality of life. A leader of the guidelines committee explained that “including quality of life data in the guideline helps people understand how the different treatments will make them feel.”45 Thus, clinical pathways may still include costly oncologics, but only when the costs are justifi ed by broad and differentiated economic and clinical value.

Clinical Pathways in Oncology


13


Global Risk Sharing Agreements

Demonstrating the overall value of a new oncologic agent is particularly challenging. Cancer treatment is complex, and new drugs may only have incremental clinical benefi t for a subset of the patient population. It can be diffi cult or impossible to accurately predict a drug’s effectiveness for a given patient in a “real world” scenario before it is administered. As a result, payers around the world are increasingly looking to “hedge” their reimbursement decisions with risk sharing agreements (RSAs), pricing controls, or negotiated price cuts in order to control costs.46

Through RSAs, public and private payers are able to respond to patient and physician pressure for new and more costly drug treatments, while attempting to mitigate the uncertainties around these drugs. There are a number of risk sharing schemes that have been used, and they can broadly be separated into fi nancial-based and performance-based (or outcomes-based)

agreements. Financial-based agreements have historically included price-volume agreements, price-capping, volume-capping, free or discounted drugs, and rebates. The shift to value is focused on outcomes-based agreements and refers to instances where the manufacturer provides free or discounted pricing if desired health outcomes are not achieved.

To date, RSAs have been mostly confi ned to Europe, where payers have been more restrictive in their coverage of cancer drugs and have used value calculations based on comparators and QALYs (quality-adjusted life-years). In particular, these agreements have gained traction in Italy and the UK (see Table 3). Traditionally, RSAs have typically been ad-hoc, varying across treatment, drug type, and country. For example, in the case of Votrient, GSK negotiated somewhat different agreements in Italy and the UK.

Risk Sharing Agreements in Oncology

TABLE 3: Examples of Risk Sharing Agreements in Oncology from Italy and the UK

*Note: NICE revised this agreement in 2013, removing the head-to-head trial componentSource: Ernst & Young Biotechnology Industry Report 201347 and “List of Technologies with Approved Patient Access Schemes” from the offi cial site of NICE48

CountryCountryCountry DrugDrug IndicationIndicationIndication CompanyCompanyCompanyCompany YearYearYear DetailsDetails

ItalyItaly VidazaVidazaVidazaMyelodysplastic syndromesMyelodysplastic syndromesMyelodysplastic syndromesMyelodysplastic syndromesMyelodysplastic syndromesMyelodysplastic syndromesMyelodysplastic syndromesMyelodysplastic syndromesMyelodysplastic syndromesMyelodysplastic syndromesMyelodysplastic syndromes

chronic myelomonocytic leukemiachronic myelomonocytic leukemiachronic myelomonocytic leukemiachronic myelomonocytic leukemiachronic myelomonocytic leukemiachronic myelomonocytic leukemiachronic myelomonocytic leukemiachronic myelomonocytic leukemiaacute myeloid leukemiaacute myeloid leukemiaacute myeloid leukemiaacute myeloid leukemiaacute myeloid leukemiaacute myeloid leukemia

CelegeneCelegeneCelegeneCelegene 201020102010Manufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebateManufacturer provides an 11% rebatefor patients not responding to three for patients not responding to three for patients not responding to three for patients not responding to three for patients not responding to three for patients not responding to three for patients not responding to three for patients not responding to three

cycles of the treatmentcycles of the treatmentcycles of the treatmentcycles of the treatmentcycles of the treatmentcycles of the treatment

Italy VotrientVotrient Advanced renal cell carcinomaAdvanced renal cell carcinomaAdvanced renal cell carcinomaAdvanced renal cell carcinomaAdvanced renal cell carcinomaAdvanced renal cell carcinomaAdvanced renal cell carcinoma GSKGSK 201120112011Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not

responding after 24 weeks of treatmentresponding after 24 weeks of treatmentresponding after 24 weeks of treatmentresponding after 24 weeks of treatmentresponding after 24 weeks of treatmentresponding after 24 weeks of treatmentresponding after 24 weeks of treatmentresponding after 24 weeks of treatment

UKUKUK RevlimidRevlimidRevlimid Multiple myelomaMultiple myelomaMultiple myelomaMultiple myelomaMultiple myeloma CelgeneCelgeneCelgene 2009Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not

responding after 26 cycles of treatmentresponding after 26 cycles of treatmentresponding after 26 cycles of treatmentresponding after 26 cycles of treatmentresponding after 26 cycles of treatmentresponding after 26 cycles of treatmentresponding after 26 cycles of treatmentresponding after 26 cycles of treatmentresponding after 26 cycles of treatment

UK VotrientVotrient Advanced renal cell carcinomaAdvanced renal cell carcinomaAdvanced renal cell carcinomaAdvanced renal cell carcinomaAdvanced renal cell carcinomaAdvanced renal cell carcinomaAdvanced renal cell carcinoma GSKGSK 2011201120112011

Manufacturer provides an initial 12.5% Manufacturer provides an initial 12.5% Manufacturer provides an initial 12.5% Manufacturer provides an initial 12.5% Manufacturer provides an initial 12.5% Manufacturer provides an initial 12.5% Manufacturer provides an initial 12.5% Manufacturer provides an initial 12.5% rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebate with the possibility of future rebates based upon the results of arebates based upon the results of arebates based upon the results of arebates based upon the results of arebates based upon the results of arebates based upon the results of arebates based upon the results of arebates based upon the results of ahead-to-head trial against Sutent*head-to-head trial against Sutent*head-to-head trial against Sutent*head-to-head trial against Sutent*head-to-head trial against Sutent*head-to-head trial against Sutent*head-to-head trial against Sutent*head-to-head trial against Sutent*

UKUKUK YondelisYondelisYondelis Advanced soft tissue sarcomaAdvanced soft tissue sarcomaAdvanced soft tissue sarcomaAdvanced soft tissue sarcomaAdvanced soft tissue sarcomaAdvanced soft tissue sarcoma PharmaMarPharmaMarPharmaMar 2010Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not Manufacturer pays for patients not responding after fi ve treatmentsresponding after fi ve treatmentsresponding after fi ve treatmentsresponding after fi ve treatmentsresponding after fi ve treatmentsresponding after fi ve treatmentsresponding after fi ve treatmentsresponding after fi ve treatments


14


Risk Sharing Agreements in Oncology

Risk Sharing Agreements in the U.S.

In the U.S. today, the incentives for pharmaceutical companies to negotiate risk sharing agreements with payers are limited. Medicare, for example, is required by law to reimburse cancer drugs, thereby limiting the program’s negotiating leverage. However, because of mounting concerns from key stakeholders over costs and the perceived success of European schemes, the pressure to use cost containment measures has been building.

RSAs have been generally viewed in the U.S. as a recent export from Europe, although, several such agreements have previously existed in the U.S.49 Of particular note in oncology is a scheme developed by Genentech for Avastin in 2006. After receiving signifi cant negative publicity over the market price of Avastin in the treatment of several forms of cancer, Genentech launched a program to make Avastin free of charge for patients who reached an annual dosage of 10,000 mg, essentially capping the annual price at approximately $55,000 for all payers.50, 51

Also of note is an agreement between UnitedHealthcare and Genomic Health in 2007 that allowed Oncotype DX – a genetic test that can predict the likelihood of chemotherapy benefi t for early-stage breast cancer patients – to be reimbursed at a predetermined price. However, if too many women with low-risk scores were still receiving chemotherapy, then UnitedHealthcare would have the ability to re-open the contract at a lower price.49 The agreement appears to have been a success. In discussing it in the March 2010 edition of Oncology Business Review, Newcomer states, “After the fi rst round we found that 16 percent of doctors were using the tests incorrectly. That number has since gone down dramatically, so we have not had to re-open the contract and re-price it.”52

Like most risk sharing schemes, these examples highlight the importance of individual negotiations between manufacturers and payers. Also, the relatively high number of payers in the U.S. means that risk sharing will be much more varied compared to a country like the U.K. Therefore, it is more likely that risk sharing in the U.S. will grow as a trend rather than as a result of policy shift.49


15


What Manufacturers Should Expect

Manufacturers in oncology are currently facing a number of internal and external barriers to traditional premium pricing and market success in the U.S. Because of greater market power by providers as well as tougher measures by payers and PBMs to moderate the utilization of higher cost products, manufacturers in oncology are increasingly at risk for lower sales, slower uptake, and squeezed profit margins. With costs growing across the board, the financial assumptions that underlie the rush to oncology bear a second look, if not revision. Going forward, manufacturers in oncology must be prepared to move beyond old business models to ensure success in the market place.

The Potential for Risk Sharing in the Future

Reduced reimbursement for providers translates to higher risk for buyers, especially when it comes to expensive oncology therapeutics. Given the increased market power conferred by consolidation, manufacturers should plan on a future in which they may be asked – or even required – to take on some of those risks related to the performance and cost of their products. As a result, there are specific steps that manufacturers must take now to ensure that they’ll be ready for this new environment.

Focus on Economic and Clinical ValueAcross the Product LifecycleIn order to compete for premium pricing, manufacturers must have a clear understanding of their products’ ability to deliver economic and clinical value (ECV). Without clearly-defined product ECV, manufacturers are effectively “flying blind” and will be unable to define outcomes for risk based agreements. However, if manufacturers are confident that they can show differentiated value and relevant outcomes, then RSAs can provide a mechanism for achieving market access and favorable reimbursement.46

Regardless of what happens with RSAs in the U.S. oncology market, payers and providers will continue to use various tactics, including prior authorization and evidence-based clinical pathways, to control drug utilization. As a result, manufacturers must focus on the ability of their products to improve current treatment regimens, save costs, and improve outcomes when compared against less costly alternatives.

As payers and providers continue to demand greater demonstrated value in oncology, manufacturers should develop a more robust value story that includes considerations for adherence, quality of life, access to treatment, and broader stakeholder requirements. As part of this, manufacturers should take the time to address such considerations as the long-term cost-benefit of their products, the relative value of their products compared to other (potentially non-pharmacological) options, the impact of their products on care delivery (e.g. nursing, diagnostics), the ability of their products to reduce or eliminate medical costs (e.g. fewer hospitalizations, lower readmissions), and the impact of their products on the overall quality of life for patients.27 For manufacturers, it is crucial for these considerations to be integrated throughout the entire product lifecycle – from R&D to commercialization – with the decision to move forward on a product regularly assessed against the strength of its value story.

It should be noted that premium-priced innovative products can still achieve placement on formularies and inclusion in clinical pathways if real value has been demonstrated. For instance, despite the fact that Genentech’s Perjeta (pertuzumab) costs $180,000 per patient for a course of therapy covering an 18-month period, UnitedHealthcare added the drug to its bundled price program based on positive clinical results. Based on a recent phase III clinical trial, pertuzumab (when combined with trastuzumab) boosted progression-free survival rates by six months over the control group (trastuzumab plus docetaxel) for patients who had not received any chemotherapy for metastatic HER2-positive breast cancer.53

Implications for U.S. Manufacturers in Oncology


16



Build a Framework for Capturing Real World Evidence

In light of demands by payers and providers, manufacturers must build the analytic framework and capabilities to structure, collect, analyze, and report on real-world evidence (RWE) from multiple sources, including non-interventional observational studies, retrospective database studies, patient reported outcomes, and electronic health records. More broadly, because of the serious limitations of randomized clinical trial data, payers are increasingly shifting their focus to RWE when making decisions on reimbursement and market access. With the inclusion of RWE, manufacturers should be prepared to engage payers earlier and in higher-level, strategic conversations (vs. discussions about product-specific features). This will require manufacturers to identify and define the capability set, accountabilities, deliverables, key interfaces, and decision-making authority of individuals responsible for engaging key decision-makers in payer organizations.10

Expand Your IT and Data Analytics Capabilities

With the increasing need to accurately track and assess outcomes – not only for potential RSAs but also more widely across the market – manufacturers must have the appropriate IT and data analytics capabilities to ensure that they aren’t hindered by issues related to the collection, monitoring, or assessment of data. Payers and providers are rapidly adopting or developing their own analytic capabilities to track outcomes and understand the value associated with specific practices and products. Manufacturers will need to keep pace.

As electronic health records (EHR) continue to gain significant traction in the U.S., manufacturers should look to enter into alliances with providers and EHR platforms as a way of accessing de-identified patient data. In preparation for dealing with patient data, which tends to be more “messy” and less controlled, manufacturers should take steps to ensure that they have the appropriate clinical and HE&OR capabilities to effectively leverage this data.

Several manufacturers have also taken big steps to embrace data and analytics internally. In a recent article in InformationWeek, Pfizer stands out as a market leader in healthcare analytics, bringing together large, diverse sets of genomic, clinical trial, and EHR data. As part of its Precision Medicine Analytics Ecosystem, Pfizer worked with several data partners to build a cloud-based clinical data repository, capable of collecting clinical data from multiple sources, including data from its own clinical studies, data from research partners, and data acquired through mergers and acquisitions.54

Develop a Market-Based Commercial Model

As payer organizations become more powerful and decision-making moves further from physicians, manufacturers should focus on a more strategic approach to their commercial efforts. Manufacturers must also understand that the needs of individual stakeholders are unique, so it is crucial to identify the business drivers, risk profile, and key decision-makers for each organization, rather than using a “one size fits all” approach. Specifically, manufacturers should focus on creating strategic sales teams directed at evolving healthcare delivery and payment models (e.g. ACOs and bundled pricing) and payers. Manufacturers should also look to expand the core competencies of these sales teams, so that they can engage decision-makers in sophisticated conversations regarding the medical and financial benefits of their products.55

Explore Value Added Services

With key stakeholders increasingly focused on improving long-term outcomes, opportunities for broader approaches to managing wellness and disease have never been greater. One approach is value added services, which may include service wraps around particular products that seek to promote adherence, improve outcomes, or reduce medical costs.


17



Great Opportunities Still Await

Given the complex nature of treating cancer as well as the increased pressure on drug pricing and reimbursement, product service wraps and related services are likely candidates for consideration as manufacturers look to enhance profitability and competitive positioning.

Prepare for Stakeholders’ Demands for NewTherapies and Companion DiagnosticsWith the rise of targeted therapies, companion diagnostics will play a significant role in future market access decisions. Manufacturers, like Roche, are responding to this by making big bets in companion diagnostics. According to Roche CEO Severin Schwan, “More than 60% of our pharmaceutical pipeline projects are coupled with the development of companion diagnostics in order to make treatments more effective.”56

The FDA has already approved multiple targeted drug cancer therapies, with many additional therapies currently being studied either as stand-alone products or in combination with other treatments. Because these targeted drugs usually involve multiple drug combinations, manufacturers should prepare for more complex and multifunctional considerations, including patient screening, drug matching with tumor molecular etiology, safety and quality of life, overall cost, and patient adherence.27

Traditionally, companion diagnostics have been developed separately and approved after the therapeutic treatment. This is due, at least in part, to the fact that payers have placed restrictions on the reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. As a result, manufacturers should engage payers in early discussions to better understand the clinical evidence necessary to bring targeted therapy-companion diagnostic pairs to market.27

Payers, providers, and researchers are all planning increased scrutiny of expensive cancer treatments in today’s marketplace. Yet, despite these ongoing challenges, the oncology space continues to provide enormous opportunities for manufacturers, especially as our understanding of cancer, focus on personalized medicine, and development of more targeted diagnostics continue to increase.

Going forward, manufacturers that commit to focusing on economic and clinical value, capturing real-world evidence, making strategic investments and partnerships in IT and data analytics, exploring alternative revenue sources like value added services, and preparing for stakeholder demands based on new therapies and diagnostics will have a significant advantage over their competitors.

18


References


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2 Squires, D. A. Issues in International Health Policy. (2011, July). Retrieved December 2014 from The Commonwealth Fund: http://www.commonwealthfund.org/~/media/Files/Publications/Issue%20Brief/2011/Jul/1532_Squires_US_hlt_sys_comparison_12_nations_intl_brief_v2.pdf

3 Kliff, S. The U.S. Ranks 26th for Life Expectancy, Right Behind Slovenia. The Washington Post. (2013, November 21).

4 Sackman, J., Rothenberg, S. Global Challenges for Oncology Drugs. PM360 Online. (2014, May 13).

5 Marchione, M. Cancer’s Growing Burden: The High Cost of Care. USA Today. (2012, February 27).

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9 Cost of Cancer Drugs. Retrieved December 2014 from Center for Health Policy & Outcomes – MSKCC: http://www.mskcc.org/research/health-policy-outcomes/cost-drugs

10 Numerof, R. Avoid Another Vioxx – Making the Case for Real World Evidence in Market Access. (2012, Aug 1). Retrieved December 2014 from eyeforpharma: http://social.eyeforpharma.com/column/real-world-evidence-making-case-market-access

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12 U.S. Offers Patients Faster, Greater Access to Cancer Drugs than Europe. (2012, July/August). Retrieved December 2014 from Tufts Center for the Study of Drug Development: http://csdd.tufts.edu/files/uploads/jul-aug_2012_ir_summary.pdf

13 Institute of Medicine. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. (2013).

14 The 2013 Genentech Trend Report. Retrieved December 2014 from Genentech – Forum: http://www.genentech-forum.com/files/documents/2013-oncology-trend-report.pdf

15 Hematology/Oncology (Cancer) Approvals & Safety Notifications. Retrieved December 2014 from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm

16 Reinke, T. Plans and Oncologists Don’t See Eye to Eye on Prior Authorization. Managed Care Magazine. (2011, September).

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19


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