The new “in” term among those looking to lower the cost of healthcare is “bundled payment” (BP). Although there is still disagreement about what it means, the bundling of  payments revolves around oncologists being paid a set fee for managing their patients’ care.

	“Five or 10 years ago, the oncology spend was not high on the payer’s priority list,” said Matthew Farber, MA, director of provider economics and public policy, at the Association of Community Cancer Centers in Rockville, Maryland. “As the number of patients goes up, the number of those who survive increases and the general demographic shifts, the cost of cancer care goes up. In addition, the recent run of new (and expensive) drug approvals has caused payer’s focus to turn toward oncology.”

	True bundled payments would give the oncologists a single amount of money per patient to cover all costs from initial visit through to discharge from care or to hospice. There are concerns that a BP system would not work in cancer treatment, and could cause disruptions in practices.

	One reason is that cancers are a very individualized and diverse group of diseases. To say that a payer will offer a set amount of money for 2 lines oftreatment will have to address who is responsible should a third be needed. There is enough variability in oncology that true BP is likely to be problematic.

	“Oncologists do not take care of large populations of patients where you can mitigate the risk of outliers who utilize a lot of costs, time, and energy,” noted Bruce J. Gould, MD, medical director of Northwest Georgia Oncology Centers in Marietta, Georgia. “Any payment system has to reflect this so that one or two expensive patients don’t break a practice.”

	The model that may be the best payment fit for oncologists is episode of care (EOC). As currently evolving, this transfers a specific part of the risk to the oncologists, but one that is easier to manage.

	Gould’s group is participating in an early pilot in cooperation with United Healthcare. The participants defined 19 categories for lung,breast, and colon cancers.

	“They have taken our margins for chemotherapy medications, added extra money for hospitalizations, and that is what we get when a patient is registered as an EOC fee,” said Gould. “We are still paid a fee-for-service when we see the patients in our offices and to administer the medications. The drugs are reimbursed at Average Sales Price.”

	The insurance company knows what its medicine costs will be and the most it has to spend for physician services should its enrollees need hospital treatment. It hopes tosave money by giving oncologists incentives to treat patients in the office (where they get paid) and not in the hospital. Hospital in-patient costs are still paid by the insurance company. The oncologists are only assuming the risk for their in-hospital services.

	How practices make their money is shifting, and getting the bulk of income from drug charges is past. Other responses by oncologists such as pay for administering medications and increasing in-office diagnostic radiology have come under greater scrutiny.

	“This gradual reduction in payment is a long-term trend that practices have to recognize to stay afloat,” said Farber. “I think eventually fee-for-service for both Medicare and private insurers is going down. Instead they will pay for better, more efficient, and less duplicative care.”

	Because of this, it is important for practices to take a long and close look at their processes and find ways to streamline them. Physicians, according to both experts, should look to implementing established clinical guidelines as a first step. But they will also need to update information-gathering abilities through use of electronic medical record (EMR) programs tracking both what they are doing well and where they need to improve.

	Compare current treatment modalities with guidelines from the National Comprehensive Cancer Network (NCCN) or other professional sources. Getting a physician to buy in is important, as just 1 opting out of the predetermined treatment regimens could harm the program for all. This also highlights the need for ways to monitor compliance.

	Full commitment to EMR technology is another important part of this puzzle. Both BP and EOC require practices to have the ability to monitor, document, and report treatment regimens. These systems help analyze costs, an important part of the process when negotiating your fee and managing your costs.

	Practice business management may play as big a role in profitability as the medical management side. For example, the efficiency and accuracy of your coding and billing staff will impact on your cash flow.

	“The investment in a strong management team is not cheap, but will pay dividends and keep practices strong and independent,” said Gould. “Over the last few years all of the fat has been removed from the system. If you don’t have a lean, mean practice that is collecting every penny due you on the first try, the chances the practice will  fold increase.”

	There is some disagreement on how long practices have to get themselves ready for whichever system wins out. Gould thinks the “ability to worry about tomorrow is gone,” with an immediate need to get the office in order.

	On the other hand, Mr Farber thinks there is still time for practices to watch the early adopters work out the kinks. Both agree that keeping track of the various models as they mature is important so that you are “leaning” the right way when approached. They also concur that things like establishing EMRs and familiarizing physicians with guidelines should begin immediately. 

 From KVU Communication, Inc, Carmel, IN.

Mr Ullman reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Drafting of the manuscript; critical revision of the manuscript for important intellectual content; and administrative, technical, or logistic support; and supervision.

Articles

Evidence-Based Oncology

As payment reform models continue to evolve, practitioners must determine which strategy makes the most sense for their practice. Although the idea behind bundled payments may be worth considering, there are some concerns that this system could causes disruptions in oncology practices. 

Bundled Payment: Practice Savior or Killer?

The full-court press toward comparative-effectiveness research and results reporting has compelled health plans and insurers to sharpen their focus on incorporating this information into coverage decision making. Managed care executives have long complained that too few evidencebased data of this type are available to improve coverage decisions. If the evidence were available and payers were ready to incorporate it, widespread development of value-based formularies might result.

Any pharmaceutical manufacturer whose small-molecule drug is the third or fourth product of a category to reach the market faces its own value-based quandary: How can it prove the value proposition of its agent in the face of heavy competition? Drug rebates and discounts can provide access to a plan’s membership, but this does not truly address the economic value of a drug. The question is even more difficult (and scrutinized) in the case of expensive biologic medications. A survey published in 2012 demonstrated that managed care executives are not satisfied with the current approach of contracting and discounts to obtaining formulary access.

 Only 4% indicated that they were “very satisfied” with this form of contracting.

One innovation that has yet to become mainstream involves manufacturers offering to back their product’s performance by taking some of the risk. This does not necessarily mean a “money-back guarantee,” but it certainly could. This is in stark contrast to the present situation, where the manufacturer’s “risk” has been defined by the difficulty in successfully navigating the drug development process from preclinical studies through US Food and Drug Administration (FDA) approval, and subsequently, the risk in marketing the drug successfully to payers. This risk must not be minimized—according to past reports from the Tufts Center for the Study of Drug Development (www. csdd.tufts.edu), the cost to develop biotechnology drugs was approximately $1.2 billion in 2006. In addition, the pharmaceutical industry spends hundreds of millions of dollars on marketing efforts to increase awareness and focus on their products’ benefits.

Today’s price-volume agreements or patient-access initiatives (where patients would be given access to a drug at reduced cost to try to prove value to payers, in the hope of landing preferred formulary positioning) are a form of “value- based contracting,”

 but if outcomes are what the payers are after, these contracts are low on the evolutionary scale. “Outcomesbased contracting” represents the next evolution, encompassing risk-based agreements with performance guarantees or payment scales for attaining not utilization or market share benchmarks, but clinical status improvement or prevention of adverse events. This is truly value-based contracting. It boils down to the following: if the drug doesn’t provide the outcome that is expected, the manufacturer would be at risk in some way—reimbursement would be discounted or possibly even free, or the manufacturer would bear the cost of complications suffered by the patient. It may make it more palatable for payers to cover an expensive agent, and gain credibility for the maker of a specialty drug.

If the pharmaceutical companies will need to eventually move away from volume-based sales, it would be reasonable to expect “the industry to shift into a world in which outcomes-based contracting will be the standard reimbursement methodology,” according to one pharmaceutical executive.

Yet, this concept has not spread to date. Pay for performance has been utilized for provider reimbursement for a decade.

 Why not apply this concept to pharmaceuticals? Assuming one does not run afoul of federal anti-kickback statutes, and the remuneration, discounts, or incremental reimbursement resulting from an outcomes-based contract that can be coordinated under an accepted safe harbor,

 then one can explore some of the outcomes-based pharmaceutical contracting options being discussed today.

Specialty Pharmaceuticals Shine a Light on the Issue

The costs associated with specialty pharmaceuticals continue to concern payers and represent a difficult challenge for the years ahead. Specialty pharmaceuticals today account for 80% of the total drug spend in the medical benefit, and 8 of the top 10 drug categories in 2014 are forecast to be specialty drugs.

 In the future, specialty utilization is expected to grow rapidly, owing to new drug introductions and rising numbers of patients with chronic diseases for which specialty drugs may be indicated. Robert Kritzler, MD, deputy chief medical officer, Johns Hopkins HealthCare, Glen Burnie, Maryland, believes that “with the rising cost of specialty pharmaceuticals, especially those with variable outcomes based on patient selection, there will need to be a different way of contracting.”

Payers are not yet convinced of the value proposition behind these products. They are actively seeking reassurances that an agent that may cost $10,000 for each month of therapy is money well spent. This is partly behind the push for companion diagnostics, to help determine those patients who may optimally benefit from the use of specific specialty drugs. It is also responsible for the interest in performance guarantees and other ways to link a drug’s costs to its actual outcome in the patient.

“The pharmaceutical and biotech industries have done a bad job of clearly stating the value equation and lifesaving value of their products,” asserted Gerald Clor, MBA, of Clor Training & Consulting, LLC, Bethlehem Township, Pennsylvania. “Health plans do not want to be seen as ‘being too close’ to such a negative industry—especially when it is a business proposition.”

Clor continued, “This potential to help patients, improve care, and lower costs is partially lost owing to the ‘politics’ of the current state of affairs within the pharmaceutical industry. Too many big pharmaceutical companies have been caught behaving badly and brought into the public eye. How then can a health plan expect to partner with them? So politics and public sentiment trump good medicine in this case.”

In 2007, the prototype value-based or performance-based contract for a drug was introduced in the United Kingdom by Johnson & Johnson.

 The National Institute for Clinical Excellence (NICE) had deemed its product Velcade provided too little value for the cost to recommend coverage by the National Health Service. The company, worried about being locked out of the British market, offered a radical contract: The use of the drug must achieve a 50% reduction in serum paraprotein (M-protein) levels by the fourth cycle of therapy or the manufacturer would reimburse the National Health Service the full cost of the drug. Technically, this compensation was most commonly made in the form of additional free Velcade.

The decision makers at NICE took them up on their offer.

The first value-based pharmaceutical contracts in the United States were seen in 2009. One well-publicized contract was between Cigna and Merck for the diabetes products sitagliptin and sitagliptin/ metformin. Merck provided discounts if Cigna members with type 2 diabetes mellitus lowered their blood sugar levels, and also provided for additional discounts if people who were prescribed Merck’s drugs took their medications according to their physicians’ instructions. In return, Cigna placed the agents on a low copayment tier, in the hopes of optimizing adherence to the medication.

 According to a Cigna press release, “The results demonstrated improved blood sugar levels of more than 5% for those continuously enrolled in the program, regardless of which diabetes drug they were taking. There was also a 4.5% increase in blood sugar lab testing during the period.”

Also in 2009, Health Alliance Plan contracted with Procter & Gamble and sanofi-aventis on the osteoporosis drug Actonel (risedronate). In this deal, the manufacturers agreed to reimburse Health Alliance Plan for the costs of treating nonspinal, osteoporosis-related fractures in eligible postmenopausal women who were using the product, up to a predefined amount, which greatly limited their financial risk. This gamble worked well, as the effectiveness of the osteoporosis drugs in general were heavily questioned at this time, and the arrangement ensured health plan members had access to risedronate. Nine months after starting the program, the manufacturers found that they had paid far less (79% less) than the predefined limit established in the contract. In addition, the data gained corroborated Procter & Gamble’s original clinical trial data for risedronate’s efficacy in preventing nonspinal fractures.

Furthermore, it may have delayed the plan’s generic substitution for risedronate, as well as kept it in preferred position relative to the newer branded product Boniva (ibandronate).

In general, non-US payers are interested in seeking alternative methods of payment for pharmaceuticals. Although NICE is currently utilizing cost-effectiveness thresholds in making coverage recommendations, it is seeking to revamp its decision making as it applies to any new drug by 2014, and include other factors as well, such as unmet need, the burden of illness, degree of innovation associated with a new medicine, and additional societal benefits gained with the new medicine. This value-based pricing system will supplant the existing system used by the National Health Service when evaluating all new medications.

Australia, Germany, and Italy have all undertaken several initiatives aimed at increasing the number of outcomesbased pharmaceutical contracts.

 The Australian drug pricing authority has at least 90 contracts of this type on the books. There is no lacking for motivation among payers worldwide. It is only a matter of time before US payers are greater players in this area.

Hurdles to Overcome in Outcomes-Based Pharmaceutical Contracting

If 1 word characterizes the nature of outcomes-based contracting for pharmaceutical drugs, it is “complexity.” Gerald Clor believes that multidrug therapy, promoted by many clinical guidelines, muddies the waters quite a bit. “It becomes very difficult to measure the impact of clinical improvement when there is more than 1 single aspect to that improvement,” he said. “Few companies will want to enter into a riskshared contract if the measure of success goes past the drug monotherapy.”

Just coming to agreement on which outcomes measures are actually of importance is a notable obstacle. For example, according to one survey, payers focus on measures of longevity and quality of life, but pharmaceutical manufacturers are focused on specific units of clinical efficacy or the “cost-benefit implications of a new drug for overall treatment.” Furthermore, healthcare providers and patients may point to other preferred outcomes measures.

Adding to this measure of complexity is the desire to move toward new payment methods. “If a ‘bundled’ or ‘global’ payment is used, and the goal is to lower the total cost of care,” Clor wondered, “how do I measure my (pharmaceutical) impact on that cost parameter? This complication adds too many variables and components that the contract (or the drug company) cannot control.”

These challenges are difficult to overcome from a pharmaceutical manufacturer’s perspective. From the health plan perspective, the complexity of these arrangements is no less an issue. Dr Kritzler of Johns Hopkins Health Care explained, “Many plans, including our own, have considered some sort ofvalue-based contracting based on final outcome. Areas that many of us have considered are in the oncology, neurology, and the autoimmune space,” he commented, “but plans are having a rough time implementing this, as the details are extraordinarily complex.”

Not only are the details to implementation complex, but the administration of these types of contracts can be barriers to payers. Assume that they would need a tracking mechanism for particular patients’ clinical status over time. In some cases, they would save less money from the outcomes-based contract than it would cost to launch and manage the patient tracking system needed to analyze the intervention’s effects.

However, Dr Kritzler believes that once the ball begins rolling, it will be hard to stop. “As soon as a few of these arrangements gain traction, it is likely that this type of contracting will take off,” he said.

The idea of outcomes-based contracting for oncology products adds a new level of complexity to an already challenging issue. How to measure outcomes becomes not only a question about the value of overall survival versus progression-free survival or complete response versus clinical  response as a clinical or patient-related outcome, but consider the next stage of discussion: Would the terms of the outcomes- based oncology contract change for patients diagnosed at a different stage of cancer? For example, should the successful outcomes of a drug given in patients with stage III tumors be judged differently from the outcomes of a drug given in patients with stage I or II disease? These permutations can boggle the mind. In addition, how might a contract define objective result reporting?

With these questions in mind, it should not be surprising to see initial outcomes- or value-based contracting efforts focused on other diseases. Although oncology is an area that may optimally benefit from this approach— many primary drug treatments qualify as specialty pharmaceuticals&mdash;it may not be practical for many cancers.

Still, Johnson & Johnson successfully implemented and administered its Velcade contract with NICE, so there is some experience to build upon. In this example, M-protein may not be a good outcomes indicator of survival.

 Furthermore, up to 15% of all patients do not have measureable M-protein levels.

A value-based approach might help advance an approach that emphasizes biomarker testing before treatment, to help identify who would be most likely to benefit. Additionally, such contracting could be an incentive for manufacturers to engage in greater efforts to educate providers as to who might be the most appropriate subpopulations of patients for these expensive agents.

The industry has just begun to consider what payers mean when they say they want more value for the money they spend. A survey by a unit of 

found that the biopharmaceutical industry is a harsh critic of the progress made to date (Figure).

The survey report specifies that “More than one-half of respondents overall (55%) say that the sector is adjusting well to increasing demands for proof of value, but only 36% from traditional biopharmaceutical companies agree.”

 Furthermore, just over half (56%) believe that “The industry will introduce products with demonstrably more value than existing offerings in the next 3 years. Worse still, only 39% believe that the industry is more than just somewhat effective at creating such products.” Not insignificantly, the survey respondents didn’t believe that the industry does a good job of proving value, even when their products may be of real value. Only 25% of payers and government policy makers interviewed expressed a level of confidence about claims of value made by the industry.

Based on PriceWaterhouseCoopers’ analysis, it is imperative that payers and pharmaceutical manufacturers hold numerous discussions and hold them early in the contracting process “to determine what is of value to each stakeholder.”

 This may be augmented by developing formal, well-defined, consensus-driven value metrics, and by obtaining a consensus on a “common set of principles, policies, and technical methods for the data collection program.” Without this extremely high level of agreement on what constitutes an outcome of value to both payer and manufacturer, the vast effort to develop outcomes-based pharmaceutical contracts (for any disease category) will be destined to fail.

Outcomes-Based Contracting for Pharmaceuticals: A Health Plan Perspective

Outcomes-based contracting for pharmaceuticals has been discussed for years as an incentive to offer preferred formulary positioning for certain drugs and to lower costs. Drug categories and their associated outcomes have included diabetes agents and reductions in hemoglobin A1C; bisphosphonates and decreased fracture rates; statins and cholesterol lowering; and even guarantees against dose escalation in specialty categories like rheumatoid arthritis and psoriasis.

However, true outcomes-based contracting is elusive. Many healthcare plans are incapable of capturing, measuring, and reporting the data elements necessary to comply with the contract terms. Even integrated plans lack the information technology to adequately marry medical claims with pharmacy data. Furthermore, most contracts would require plans to manage down to the individual member level rather than use high-level aggregate data that are typically required for rebates.

It is also often difficult to identify and agree on what outcomes will be measured. It can be done with objective measures such as low-density lipoprotein and hemoglobin A1C levels, but when exploring more intriguing disease states, such as multiple sclerosis, rheumatoid arthritis, and oncology, the outcomes are often subjective. For example, a plan cannot be expected to define what is progression-free survival in a patient with metastatic prostate cancer or what is a clinically significant relapse in multiple sclerosis.

Plans also often find the investment in maintaining and complying with the contracts not worth the return warranted by the effort expended, partly because the pharmaceutical manufacturers have never gone truly at risk. Using a previously mentioned example, a bisphosphonate contract was touted as paying for the cost of a fracture if patients were compliant with the drug therapy. However, there was a cap on the exposure to the manufacturer—a maximum payment was set at a percentage of plan spend on the drug. This was substantially less than the total cost of any 1 fracture. For the diabetes and statin examples, the manufacturers offered a few extra percentage rebate points if a plan’s population met certain A1C or lipid goals. Often this results in a few thousand dollars in incremental rebates, which needs to be weighed against the effort required to code and measure the input data (not even considering the requests to stratify risk, which can’t be accomplished through claims databases). There is also the issue of how a plan addresses, and invests in, the education or incentives necessary to change both prescriber and member behavior to improve the respective lab values or outcome measures. These measures and activities would often have to be above and beyond what is occurring for quality measurements such as HEDIS or Medicare Star ratings.

Value-Based Contracting for Pharmaceuticals: Getting Ready for Prime Time?

The accountable care organization (ACO) has been the buzzword on the tip of everyone’s tongue. With January’s announcement by the Centers for Medicare & Medicaid Services of an additional 106 ACOs, the number joining the Medicare Shared Savings Program is now 259, serving 4 million beneficiaries.

An estimate by the consultant organization Leavitt Partners pegs the number of active ACOs at 428, operating in 49 states.

	The principal ideas underlying the ACO concept are (1) coordination of care through integrated services (or virtually integrated services) and (2) financial incentives for clinicians and hospitals to efficiently manage patients, saving money in the process, and in the Accountable Care Act’s Medicare Shared Savings initiative,

 sharing those savings with the provider-partners in the ACO. The majority of ACOs have focused on primary care. Policy makers agree that the ACO concept is most easily applied to primary care, which may have the highest payoff in terms of cost savings through disease prevention and early diagnosis and management.

	A few specialty models of ACOs are being piloted, but these are more dependent on secondary prevention of disease episodes or complications. For example, DaVita (www.davita.com), based in Denver, focuses on patients with kidney disease and owns more than 1900 outpatient dialysis centers.

Its Accountable Kidney Care Collaborative seeks to use the ACO model for patients with end-stage renal disease. The cost-saving potential of specialty or disease-specific ACOs can be huge, because of the existing costs associated with treating these patients, but it is unclear whether these specialty services are more efficiently provided through their own ACO or as ancillary to the burgeoning primary care ACO marketplace.

	The various common cancer types and multitude of therapies used to treat them may complicate the mission of an ACO. For patients with advanced kidney dysfunction, a specialty ACO may expect savings to be derived from lower hospitalization costs through improved patient care. Considering the cost of treating many neoplasms, should cost savings be a primary goal? Perhaps the principal mission of an oncology ACO would be to better standardize care pathways, use integrated care, and improve counseling of patients in how to manage the course of disease.

	If this is the case, oncology ACOs focused on the shared-savings model will likely come up short. In fact, the choice of whether to treat actively or simply monitor a cancer’s progress (ie, watchful waiting in prostate cancer) may be money saving to the ACO, but may seem to others as a sign that the organization is willfully withholding care in order to save money.

 This challenge ensures that the decision making and clinical pathways must be dictated by the clinicians, not the organization.

	Of course, the question of developing an oncology-based ACO should not imply that present ACOs do not provide oncology services through their networks. A survey conducted in 2011 found that health plans and health systems forming ACOs were indeed including oncology providers in their plans.

 According to health plan and health system executives who were forming ACOs, 65% indicated that oncology services were closely aligned or already employed by the organization (

). Another 30% had loose affiliations with oncology providers. Overall, the executives responding to the survey questioned whether a cancer-related ACO model would be the way forward. They indicated that because of the complex issues associated with oncology care (and other specialty-treated diseases, for that matter), most were more focused on learning how the ACO will perform in clinical areas that have more predictable costs, like primary care.

	Despite these challenges, Florida Blue (Blue Cross and Blue Shield of Florida) recently dove headlong into the oncology ACO arena. First, in May 2012, the insurer announced an agreement with Baptist Health South Florida and Advanced Medical Specialties, which provides oncology services in Miami, to form an oncology ACO. Next, in December 2012, Florida Blue unveiled an oncology ACO with Moffitt Cancer Center in Tampa.

 This collaboration will focus on common cancers and will “identify and select quality metrics for the program.” Slated to start this year, Florida Blue and Moffitt hope to improve patient care by sharing clinical and administrative claims data. It seems that this venture will seek to incorporate a value-based reimbursement system. Additionally, this agreement will emphasize patient engagement in their care and provide services for family members who care for the patients, in an effort to reduce costs Adoverall and improve outcomes.

 In the press release announcing the agreement, Dr Alan F. List, president and CEO of Moffitt, said, “This partnership with Florida Blue focuses on the value we provide our patients, and that becomes a positive for everyone. I anticipate that we will learn a lot from this new venture and that it will help us to continue to improve cancer care.”

	Aetna has been involved with oncology ACO model formation for the past few years. The health plan doesn’t view it simply as a new way to pay physicians. Aetna views it as necessary to try to move clinical pathways front and center in the oncologists’ offices. Ira Klein, MD, chief of staff to Aetna’s chief medical officer, and the head of its oncology strategy, told Evidence-Based Oncology, “Cancer care is among the top 3 highest medical cost categories in the United  States. Oncology also is an area of clinical care that is characterized by high variability in costs and treatment choices across the country. Given this large medical cost footprint and significant potential for clinical improvement, we believed and showed that applying evidence-based guidelines-pathways-to cancer care can help address the variability and get to equal or better health outcomes and lower costs.”

	He noted that widespread adoption of a pathways-based model requires changes in the approach to care, decision support, and payment. “Supporting oncologists through these changes is critical,” said Klein, “and new contractual relationships must drive positive change for their practices and their patients.”

	Aetna teamed with US Oncology Network’s Texas Affiliate, announcing the results of a shared savings model at the American Society of Clinical Oncology symposium in late 2012.

 According to Aetna, members in the program had at least the same clinical outcomes as members not under the shared savings program, but emergency department and hospital visits dropped significantly, as did hospital admissions and hospital days (

). This resulted in 12% lower costs overall for lung, breast, and colorectal cancers alone.

	“The concept for a shared savings model came from the understanding that oncology care is clinically complex in almost every case,” commented Klein. “A  comprehensive oncology management strategy starts with patients and the goal of adding value to their cancer therapies. But unless incentives are aligned, there’s no traction for the physicians and support staff to undertake the difficult work of practice change at the office level. We feel that to gain increased value,  you have to flip the coin to the other side and negotiate shared risk.

	“We replaced the traditional buy-and-bill model with a system that is rewarding in more appropriate ways, including payment redesign and use of a medical home model approach to patient care. We offer greater payment as an incentive for adherence to pathways, especially with regard to prescribing generic drug products when appropriate. The payment structure also focuses on what physicians do for patients in the office as well as what they do to keep them out of the need for care.”

	What, if any, early lessons have plans learned about developing the relationships necessary for an oncology ACO? According to Klein at Aetna, “Physicians are key component to the success of pathways implementation, and aligned incentives are a must. Having a trusted relationship with oncologists is critical as well, because they are providing the care. Without their input, no program can really be effective.”

	He also pointed out that “Physicians also have an important role in helping the insurer gather and analyze data, which can help in developing additional program goals going forward. We require some mechanism of data capture and strongly encourage interactive electronic clinical decision support tools. This gives us an unbiased activity reporting, which we can then use to feed the ‘plan, do, check, act’ cycle of quality improvement back to the physicians and offices at the practice level.” Klein noted that from earlier pilots, they realized that oncologists appreciated these tools as learning guides. “Process improvement reduces error while teaching about habits, both good and bad.”

	And what of Aetna’s long-term goals? “While we focus on tools used within practices for many reasons (workflow, precertification relief, error reduction), we will be looking to connect the inoffice environment with the care delivery ecosystem outside the oncology office in the future,” replied Klein. “Oncologists can be  ideal ‘medical neighbors’ in medical home—type integrated delivery systems. In an ACO, it’s all about working together. This can be parlayed into bundles of care, as well.”

	Additional pilot programs in oncology ACOs are being sponsored by Blue plans in California, Maryland, Michigan, New Jersey, Tennessee, and South Carolina.

	One of the daunting challenges when considering shared savings methods for oncologists, as well as many other specialties, is the use of fee-for-service reimbursement, along with the “buy-and-bill” system for purchasing oncology medications, both sources of revenue for the oncology practice. Medicare and commercial plans have moved to average manufacturer price—based billing for drugs, which have limited buy-and-bill practices in recent years, but these issues need to be tackled before oncology ACOs can be developed in the mainstream.

	UnitedHealthcare, though not starting an oncology ACO per se, has a pilot program (more of a patient-centered medical home model) which may help set benchmarks as to how oncology providers can be paid in such an organization. In this pilot, providers are paid on an episode-of-care basis. This pilot involves 5 oncology practice sites.

The episodes of care were defined by the practices themselves for 19 cancer subcategories. This payment for cancer care is fixed, and drugs are reimbursed only at the manufacturer’s cost, discouraging buy-and-bill practices. Patient visits are billed separately, and UnitedHealthcare also pays oncology practices a case management fee, which may promote better coordination of care.

	In this move away from fee-for-service payments, which would be unworkable in an ACO or shared savings environment, the up-front episode-of-care fee covers the usual treatment period for a patient with breast, lung, or colon cancer. If the cancer recurs, this episode-of-care payment can be renewed every 4 months during the course of the disease. This provides the continuity of payment needed for oncologists to continue overseeing the patient’s care (regardless of whether drug therapy is utilized).

	This move is echoed by the efforts of others, such as those by Andrew Pecora, MD, president of the New Jersey—based Regional Cancer Care Associates, which was featured in the last issue of Evidence-Based Oncology.

 From the standpoint of building ACOs, it looks like a move in the right direction. 

Mr Mehr reports receiving payment for involvement in the preparation of this article.

Concept and design; drafting of the manuscript; critical revision of the manuscript for important intellectual content.	1. Accountable care organizations have more than doubled since 2011 (press release). Leavitt Partners, February 20, 2013. http://news.leavittpartners.com/newsrelease-cid-1-id-48.html. Accessed February 22, 2013.

		2. Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations. CMS-1345-P. Federal Register, Vol. 76, Issue 67. November 2, 2011.

		3. Stagg Elliott V. Disease-specific ACOs make their debut. American Medical News, January 28, 2013. www.ama-assn.org/amednews/2013/01/28/bisb0128.htm. Accessed January 31, 2013.

		4. Barkley R. Where does oncology fit in the scheme of accountable care? J Oncol Pract. 2012;8:71-74.

		5. Florida Blue and Moffitt Cancer Center Create Cancer-Specific Accountable Care Arrangement (press release). Florida Blue, December 20,2012. www3.bcbsfl.com/wps/portal/bcbsfl/newsroom?WCM_GLOBAL_CONTEXT=. Accessed January 31, 2013.

		6. Aetna, the US Oncology Network provide more evidence that clinically proven, integrated cancer care enhances quality and controls costs: positive outcomes from new study presented at ASCO Quality Care Symposium. Aetna, December 6, 2012. http://newshub.aetna.com/pressrelease/products-and-services/aetna-us-oncology-network-provide-more-evidence-clinicallyprove. Accessed January 12, 2013.

		7. Blum K. Episodic payment put to the test. Clinical Oncology News, December 2010. www.clinicaloncology.com/ViewArticle.aspx?d=Policy+and+Management&d_id=151&i=December+2010&i_id=685&a_id=16263. Accessed January 15, 2013.

		8. Focusing on clinical and economic outcomes—not guidelines: is it time for a new direction in oncology care? Am J Manag Care. 2013(1 Spec No.):SP43.

The cost-saving potential of specialty or disease-specific ACOs can be huge...but it is unclear whether these specialty services are more efficiently provided through their own ACO or as ancillary to the burgeoning primary care ACO marketplace.

Applying Accountable Care to Oncology: Developing an Oncology ACO

If there’s a “reset” button for oncology drug management, payers are ready to press it. For years, management of these agents has been the exception, not the rule. Although payers have restricted the use of these drugs, they have rarely denied coverage or required heavy cost sharing by patients. But that is poised to change as market dynamics shift and oncology becomes more of a management priority for health plans.

	According to research from Health Strategies Group’s Managed Care Complete service, oral oncolytics and officeadministered oncology agents are now among payers’ top 5 management priorities. The reasons for this refocusing include both market factors and new payer capabilities.

	The way health plans make decisions on oncology agents is changing in part because of their success containing costs in other complex drug categories comprising both self-injected and office-administered biologics, such as autoimmune and multiple sclerosis agents. Plans also have better information technology with expanded capabilities in data analysis, so they can identify inappropriate use and refine drug reimbursement. These improved capabilities—combined with the expanded choices afforded by new drug approvals and generic options, as well as a robust pipeline&mdash;are driving plans’ interest in using more management tactics.

	With their focus squarely on oncology agents, payers will take several management actions in the short term. For instance, newly approved oral oncolytics will face high cost-sharing requirements. Many plans will change their benefit designs—by adding more tiers or raising copay levels, for example&mdash; to increase cost sharing. Half of plans already require members to pay additional fees for office-administered drugs, and more plans will follow suit.

	Payers will also roll out clinical pathways that cover more tumor types and more oncologists in their networks. During this expansion, plans will rely on compendia guidelines from the National Comprehensive Cancer Network and other organizations to guide pathways. If successful, these pilots will help create the foundation for greater control of access. Health Strategies Group expects that after rolling out the additional pathways, plans will start narrowing pathway choice to specific first-line agents beginning in 2015.

	While these strategies are suited for the short term, they do not address payers’ goals over the long haul. Our research suggests that shifting management priorities are likely to generate 5 trends during the next 5 years (

	Plans say they will narrow prior authorization (PA) approval criteria to restrict use of oncology agents, particularly high-cost agents lacking substantial survival improvements. As they commonly do today, health plans will use PAs to ensure alignment with labeling and compendia (

). In addition, 60% of plans expect to influence treatment order by requiring trials of specific first- and second-line agents. As new therapeutic choices emerge to treat certain tumor types, such as metastatic breast cancer and prostate cancer, we expect more plans to adopt a similar “lines of therapy” strategy. In addition, more plans will manage therapy duration by not only prospectively confirming treatment plans but also requiring reauthorization for extended use of a product.

	Despite these efforts, plans recognize that PAs have a limited role and that pathways are a better long-term strategy to ensure appropriate use. As plans roll out clinical pathways, they will likely remove PA requirements.

	To encourage provider adherence to the new pathways, plans will likely ask oncologists for their input and provide technology that helps integrate the pathways into their process. In addition, plans will likely provide financial incentives to oncologists to encourage adherence.

Trend #2: Management of Office- Administered Agents

	Office-administered agents will face more access barriers. In the past 18 months, many plans rolled out changes to their infrastructure to improve management of these drugs. One of the newest changes is claims adjudication by National Drug Code (NDC) data. Widespread plan requirements to collect NDC data in claims submissions by 2014 will improve plans’ ability to enforce use of low-cost agents. With the data specificity provided by NDC codes, plans can set different reimbursement amounts for generic and branded options, reducing physicians’ incentive to use high-priced choices.

	Oncologists should expect even greater communication with payers around alignment as more practices implement electronic medical records (EMRs). Automatic payer precertification through EMRs will save time and reduce financial risks for practices. Plans will also benefit from greater alignment as oncologists are able to view pathways and PA criteria in “real time.” This technology will provide plans with more opportunities to build tools that can help them manage office- administered agents.

	Moving forward, plans will take steps to influence site of care and move administration of office-administered oncology agents away from hospitals. Their goal will be to drive patients to the most cost-effective setting, which may be a specialty pharmacy manager. However, plans are somewhat limited in how they can drive the local market dynamics that determine where patients receive these agents. Of late, these dynamics include more hospitals buying up oncology practices, a trend that has driven steady increases in hospital outpatient infusions in some markets. In addition, diminishing profit margins on drugs have prompted some oncology groups to refer patients to hospital outpatient departments for infusions. Accountable care organization growth may accelerate this trend.

	For now, the best tool for plans is to ratchet down hospital reimbursement, which 46% of plans will try in 2014 (

). In addition, many plans will pilot reimbursement models, including episodic payments that encourage providers to select low-cost administration locations. Integrated health plans with strong relations with oncology groups cover will likely lead this effort. Plans may also consider more fundamental network design changes, such as only offering “preferred” or “in-network” status to hospitals with reasonable infusion charges.

	Recognizing that oncologists are key partners in their efforts to provide better value and higher quality care, plans will introduce new financial incentives to influence provider decisions. These will include oncologist-specific pay-for- performance (P4P) programs, which will reward oncologists for cost-of-care reductions, quality improvements, increased generic prescribing, reduced hospital infusions, and other goals. Plans are in a better position than ever before to implement P4P with oncologists—building on their experience designing P4P for primary care providers, plans can refine their approaches for the unique challenges of oncologists. These challenges include the availability of new generics as well as the wide variation in prescribing in oncology.

	Plans have yet to develop an effective solution for managing the high costs of care at the end of life (EOL). Given the sensitive nature of this topic, plans aren’t likely to deny therapy to patients with advanced cancer. For their part, oncologists are often reluctant to have EOL discussions with their patients. One possible solution for plans would be to utilize case managers and social workers to initiate advance care planning, although they would need to be careful not to overstep their bounds. Another possibility is for plans to increase payments to oncologists for holding counseling sessions and include a counseling metric in their P4P programs, thereby paying oncologists for discussing the options with their patients.

	As part of their long-term management strategy, plans will take more aggressive steps to maximize oral generic use. Multisource availability of Gleevec (imatinib), likely in 2014, will provide a significant cost-saving opportunity. Almost two-thirds of plans intend to reimburse Gleevec on a higher copaying Sprycel (dasatinib) or Tasigna (nilotinib) (

). These intended moves demonstrate payers’ increasing willingness to influence therapy order—fewer plans were interested in taking such actions as recently as 2010.

	Plans will also take steps to increase use of generic alternatives for officeadministered agents in the next few years, primarily by embedding recommendations in clinical pathways or PA criteria. But encouraging use of these lower-cost infused agents is a little trickier for plans. Coding and current fee schedules need to be refined to neutralize profit incentives associated with brands and encourage generic use.

	Payer adoption of these emerging trends will vary greatly. In the short term, health plans will likely focus on improving patient and physician support, rather than implementing penalties and coverage denials. Over time payers will be more interested in advanced management strategies that require collaboration with providers to ensure appropriate use.

		All figures and statistics in this article are based on the 2012 findings of Health Strategies Group’s Managed Care Complete research series, which reports on 10 categories, including oral oncolytics and office- administered oncology agents. Managed Care Complete provides future-oriented, strategic insights on the decisions that all relevant managed care customers and business lines make that affect brand access. Health Strategies Group offers syndicated research and client-private consulting, which focus on understanding the pharmaceutical and biotech industry’s key customers and influencers.

From Health Strategies Group, Redwood City, CA.

 The author reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

 Concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; administrative, technical, or logistic support; and supervision.

Susan Weber, Research Director, Health. Strategies Group, 303 Twin Dolphin Dr, Ste 600, Redwood City, CA 94065. E-mail: sweber@healthstrategies.com.

Market Dynamics Change How Plans Manage Oral and Office-Administered Agents

Five Trends Emerge in Payer Management of Oncology

Two of my favorite activities are running and salt-water fishing. Both are very precise and numbers-oriented activities. Running is about time, pace, distance, calorie burn rates, and heart rate zones, among other factors. When talking with runners it does not take long for the conversation to come around to the essential questions: “What is your PR (personal record) for a half (or full) marathon?” or “What is your average weekly miles?” Both of these questions reflect standard benchmarks of the level of accomplishment in the sport.

Fishing, or as we say in the South, “fishin’,” has its own set of standards. Before we graduate to the point of hoping the fish do not bother us, we are watchful of length, weight, creel limit, and also making sure the catch falls within season. Measurement is serious business, to the point that the fishing industry has its own “Golden Rule”—an official calibrated tool to measure the length of a fish. Woe to the person who is caught with a fish under or over the size requirements. The fisherman strives to have the best answer to the routine question, “Did you catch anything?” If that is answered in the affirmative the next question will hopefully be answered with a boast: “Any size?”

Both of these activities have finite and very specific criteria of what is considered “good” or “excellent.” Why is it we struggle with the similar concepts in healthcare and particularly cancer care? It is interesting that healthcare accounted for 15.2% of GDP in 2008.

Fishing (even when included in the category of agriculture, hunting, forestry, and fishing) is only 1.1% of GDP.

The running industry is not even high enough to score a 1/100 of a percent. If healthcare  consumes so much of our world, why is it then that we focus so little attention on the specifics of quality or value or outcomes in healthcare?

Defining Quality, Value, and Outcome Measures

The lack of attention in systematically measuring quality and value in cancer care became particularly obvious when working with the Oncology Medical Home (OMH) Steering Committee on its objective of defining 16 quality, value, and outcomes measures for cancer care. This cross-section and balanced approach to defining key determinants to patient care, resource utilization, survivorship, and end-of-life care may prove challenging, but its time is past due. For example, as an outdoor enthusiast my hope is that I will be called home while running, fishing, or simply walking on a trail. For a cancer patient the hope is that they may leave this earth among family or friends and surrounded by a known and friendly environment—peacefully and quietly. Dying at home would seem to be the choice for all, if we had a choice. And there is no better indicator of the quality of life, at end of life, than the place of death. However, it seems that the national death registry does not record a “place” of death. The standard death certificate includes the following choices for place of death:  “Hospital inpatient, ER/Outpatient or DOA; Nursing home, Residence or Other (Specify).” It would seem that it would be beneficial to include these data in the national death registry and to recognize same as a quality and value indicator for all of healthcare, not just cancer care. This seems to be an easy fix.

And somewhat related is the entire discussion surrounding end-of-life care discussions. The patient and their family need open and honest dialogue regarding their current status, their wishes, and how their wishes are to be carried out. This goes beyond the simple question of asking a patient if they are ready to meet their maker. One of several programs that attempt to remedy this issue is the “5 Wishes” program.

 This program asks 5 probing questions regarding assigning decision makers, medical treatment preferences, preferred comfort levels, preferences on interactions with others, and last wishes. This  program provides specific guidance on how to conduct these conversations. Dr John Sprandio (Pennsylvania) and Dr John Fox (Michigan) have indicated that when these discussions occur, and at the right time, patients have made decisions to discontinue aggressive cancer treatment.The end result is more comfortable end-of-life care. Although some patients (or family members) may resist these discussions, they should be required for any healthcare team  charged with managing any terminal disease. When done properly, the door is left open for miracles, but the patient and family are able to make informed decisions regarding their care. Electronic medical record vendors will need to enhance their data capture fields from a simple “Advanced directive on file — Y or N” to a more detailed and comprehensive approach to this question if we are to raise the bar in care and compassion. There should be similar guidelines for the specifics of care plans and cancer survivorship plans.

Another milestone by the COA Oncology Medical Home Steering Committee was the endorsement that all cancer care providers should calculate their own 5-year survival rates for breast, colon, and lung cancers. This is completely logical and is a measurement whose time has come. As a former manager of a cancer center, I often wondered what I would say when asked for our own 5-year survival rate for stage 3 breast cancer. It would seem to be a logical and  reasonable question but one that currently has no answer— at least not for an individual cancer center. “Survival” rates, when they are the only measure, are  not necessarily a good indication of quality, particularly if a patient is being kept alive through artificial means and against the wishes of the patient or  family. But, when combined with other standards and educational requirements, this information can be very helpful to the patient and their families in  planning and in the celebration of significant milestones.

One of the more elusive measures but one that has great significance in the value department is the use, or overuse, of hospital services. Some patients and healthcare providers are quick to utilize these expensive inpatient, outpatient, or emergency department (ED) resources over a less expensive setting such as the exam or procedure room of their medical home. Governmental and commercial payers all agree that the overuse of these resources represents a  significant expense and an opportunity to realize savings in time and dollars to the payer and patient. The challenge with curbing this misuse of resources is that the person who should know of these encounters, the patient’s medical home physician, does not always know when they occur. The hospital staff will be the first to know, the patient’s payer may be the second to know, but the person who should know first, the patient’s physician, may never know if or when  this event occurs. Some commercial insurance companies are providing financial incentives to curb unnecessary ED visits or hospitalizations. This is why the COA OMH Steering Committee has endorsed this measure. Perhaps we need to revise this notion of “precertification” and insert the patient’s medical home provider as the “mother may I” authority before these services are rendered. This procedural change would allow the patient’s main care team to intervene with, hopefully, a more efficient solution and it would also assist in nurturing the relationship between the patient and his medical home physician. Only then will we be able to measure and benchmark the utilization of these valuable resources and reward those care teams that use them appropriately.

Other industries seem to have a head start on defining quality statements. Healthcare, and particularly cancer care, seems to be the last industry to define, measure, benchmark, and promote quality, value, and positive outcomes. Perhaps it is because we have been busy taking care of others that we have not been able to focus on such a mammoth undertaking. Now may be the time to apply our own “Golden Rule” to measuring quality and value in cancer care. After all, and as I am sometimes reminded, there is more to life than running and fishing. 

The author reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

 Concept and design; analysis and interpretation of data; drafting of the manuscript; administrative, technical, or logistic support; and supervision.1. Healthcare in the United States. http://en.wikipedia.org/wiki/Health_care_in_the_United_States. Accessed January 3, 2013.

2. OECD. StatExtracts. http://stats.oecd.org/Index.aspx?DatasetCode=SNA_TABLE1. Accessed January 3, 2013.

3. Aging with Dignity website. www.agingwithdignity.org/five-wishes.php. Accessed January 3, 2013.

Measuring Quality Cancer Care

Pancreatic cancer is an extremely aggressive tumor type that continues to carry a dismal prognosis. Research regarding the cause of the cancer has continued, but important breakthroughs have been slow in coming. Additionally, pancreatic tumors demonstrate a resistance to chemotherapy, which has contributed to clinicians’ frustration in obtaining remission, or even a firm foothold in managing it. This may also be related to the relatively late stage of the tumor at thetime of diagnosis. Therefore, early diagnosis and the future discovery of an effective screening method could change the clinical picture and alter the search for value in managing this deadly cancer.

Mortality Increasing Unlike for Other Cancers

	Death rates for most cancers have trended downward over the past 10 years; however, this has not been the case for pancreatic cancer. The incidence rate has increased by 0.9% per year in Caucasian men and women and African American men, while remaining stable in all others.

 illustrates the likelihood of developing pancreatic cancer over one’s lifetime.

 The majority of patients (74%) diagnosed will die within 1 year of diagnosis, whereas only 6% will survive for 5 years—this is the lowest relative survival of any cancer tracked by the American Cancer Society and the National Cancer Institute. Patients’ average life  expectancy after diagnosis of metastatic disease is only 5 to 7 months.

 It is not one of the top 5 cancers in men or women in terms of incidence, yet it is the  fourth leading cause of cancer death among men and women. More than 45,000 Americans will be diagnosed with pancreatic cancer in 2013, and over 38,000 will die this year.

	The incidence of pancreatic cancer increases with age, with the median age at diagnosis being 71 years. More men than women are diagnosed with the disease.

	Pancreatic cancer typically refers to a ductal adenocarcinoma (exocrine pancreatic cancer). A less common type is a neuroendocrine tumor (endocrine pancreatic cancer). The public profile of pancreatic cancer has been raised in recent years with the chronicled cases of Patrick Swayze (who had exocrine pancreatic cancer) and Steve Jobs (who had endocrine pancreatic cancer).

 In fact, the dire prognosis for patients with pancreatic cancer has driven people like Jobs to seek unorthodox treatment and unproven therapies.

	Patients with pancreatic neuroendocrine tumors have a somewhat better median overall survival than those with ductal adenocarcinomas. Unfortunately, the incidence of these tumors appears to be increasing.

	The cause(s) of pancreatic cancer are unknown. Family history is a positive risk factor and is identified in 5% to 10% of those diagnosed; the risk increases as the number of family members diagnosed with the disease increases. Smoking is also a risk factor, with a 2.5% to 3.6% increase in risk compared with  non-smokers. As the number of life-years of smoking increases, so does the risk for pancreatic cancer.

 Other potential risk factors include age; obesity;  alcohol use; consumption of red and processed meat, and fructose sweeteners; chronic pancreatitis; diabetes; chronic infections (eg, hepatitis B virus, hepatitis C virus, and Helicobacter pylori); some surgeries (eg, partial gastrectomy, cholecystectomy); cystic fibrosis; and periodontal disease.

	Pancreatic cancer is usually not detected or diagnosed in the early stages of the disease, as there are no specific symptoms. Symptoms that bring patients to the physician’s office include: nausea, vomiting, abdominal discomfort, abdominal pain that is localized to the tumor area, anorexia, weight loss, generalized weakness, and fatigue. The majority of the tumors develop in the head of the pancreas, which leads to obstructive cholestasis, rather than the tail of the pancreas. Overall, most tumorsare found when only about 15% to 20% of patients are still candidates for surgery.

	As would be expected, costs for treating patients who undergo surgery are greater than costs for patients who have nonresectable tumors (either locoregional or metastatic). A Surveillance, Epidemiology, and End Results (SEER) Medicare database study that included patients diagnosed between 2000 and 2007  found the mean total costs for those 3 patient groups to be $134,000 (surgical candidates), $65,300 (patients with locoregional tumors), and $49,000 (patients with metastatic disease), with an average cost of $61,700. The largest portion of the costs was related to hospitalizations and cancer-related procedures (

 Undoubtedly, improved treatment strategies may increase the cost of treating patients with pancreatic cancer by increasing their lifespans.

	Pancreatic cancer is genetically heterogeneous. One study analyzing 24 tumors found 63 genetic abnormalities in each tumor that were believed to be likely relevant for the disease. It has been determined that there are always at least 1 or more genetic defects involving 4 genes in patients with pancreatic cancer.

 Recent research has determined that germline mutations in 

2 predispose women to pancreatic cancer, doubling their risk for developing it. The 5-year survival for these individuals was no greater than 5%.

) overexpression has been  identified in 40% to 65% of pancreatic tumors. This overexpression leads to tumors being resistant to chemotherapy and an even poorer prognosis.

Since pancreatic tumors vary so much between patients, a highly individualized approach to treating the disease will probably be needed to improve patient outcomes.

	Currently, only 1 biomarker is approved by the US Food and Drug Administration for pancreatic cancer, serum Ca-19-9 (carbohydrate antigen 19-9, also known as cancer antigen-GI and CA-GI).

This marker is useful for identifying the tumor location, stage, and resectability.

 However, not all pancreatic tumors produce Ca-19-9; therefore, it is not sensitive or specific enough to be used as a screening test.

However, the test does have value for evaluating effectiveness of treatment and early detection of recurrent disease.

	Other frequently used tests include endoscopic ultrasound, helical computed tomography, magnetic resonance imaging, and endoscopic retrograde cholangiopancreatolography. To confirm the diagnosis, fine-needle aspiration biopsy is standard procedure.

	Staging of the disease guides the type of treatment that will be the most effective. The 4 stages associated with pancreatic cancer are differentiated by the location of the tumor and whether it has spread to lymph nodes and distant organs. Stage I indicates that the tumor is restricted to the pancreas, and stage IV describes cancer that has spread to a distant organ, such as the liver or lungs. Patients with stage III or IV tumors are generally not candidates for surgical resection, and this comprises about 80% of patients.

 The lethality of this cancer in late stages cannot be overemphasized; survival is somewhat greater when diagnosed at an earlier stage. When a patient has surgery after being diagnosed with stage I or stage II cancer, the 5-year survival is 20% to 25%, whereas a patient diagnosed with stage IV cancer has a 5-year survival that is below 1%.

	Surgery is the only treatment option that can cure early-stage disease. However, a small percentage of patients present with stage I pancreatic cancer, because of the difficulty in diagnosing it. Surgical procedures most commonly performed include cephalic pancreatoduodenectomy (also known as the Whipple procedure), distal pancreatectomy, and total pancreatectomy. Predictors of improved survival include younger age and early-disease stage.5,16 After surgery, adjuvant chemotherapy either alone or in combination with radiation therapy has been shown to improve survival. Neoadjuvant therapy, both chemoradiation or chemotherapy in combination or alone, are also options, especially when the patient has locally advanced or borderline rescectable disease. In patients undergoing surgery, the chemotherapy regimens initiated after the surgery usually include gemcitabine, 5-fluorouracil (5-FU) with leucovorin, or capecitabine.

	Since surgery for pancreatic cancer can involve several organs in the digestive system in addition to an already diseased organ, several potential morbidities  should be considered. Up to 80% of patients undergoing surgical procedures for pancreatic cancer will require oral pancreatic enzyme  replacement therapy (PERT). The dose of lipase required usually ranges from 160,000 to 400,000 units daily. A proton pump inhibitor may be added to  improve the efficacy of the PERT, if there is adequate gastric acid secretion.

Since at least a portion of the pancreas is removed during surgery, the body’s ability to produce insulin is compromised. As a result, up to 50% of patients develop diabetes and require insulin therapy postsurgery.

 Other complications  observed after surgery include gastroparesis, dumping syndrome, and vitamin and mineral deficiencies.

	For the majority of patients whose tumor is not resectable, the therapeutic options are chemoradiation and/or chemotherapy. Gemcitabine has been the  mainstay of therapy since the late 1990s, when the drug was shown to increase median survival to 5.7 months compared with 4.4 months for those taking  5-FU (

 = .0025), but the 1-year survival was worth noting (18% versus 2%, respectively).

Capecitabine is a pro-drug of 5-FU, and it has also demonstrated benefit in treating patients with pancreatic cancer.

 A combination therapy regimen, FOLFIRINOX (oxaliplatin, irinotecan, fluorouracil, and leucovorin), was compared with gemcitabine in patients with stage IV metastatic disease that involved up to 6 distal sites. The combination therapy group showed an improved median overall survival (11.1 vs 6.8 mo, respectively; 

 <.0001). Median progression-free survival was also longer in the combination therapy group (6.4 vs 3.3 mo, respectively; 

Targeted EGFR therapy using erlotinib plus gemcitabine led to a marginally longer overall survival than gemcitabine alone (6.2 vs 5.9 mo, respectively; 

March/April

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Searching for Clinical and Economic Value in Pancreatic Cancer

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