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; 

	Since pancreatic cancer is such a devastating disease, strategies for screening individuals at high risk would be beneficial. Two cost-effectiveness studies of screening high-risk individuals led researchers to conclude that early cancer can be detected by screening; however, until new biomarkers with high specificity and sensitivity become available, this strategy may not be cost-effective.

Owing to the poor outcomes of patients with pancreatic cancer, the evaluation of  cost-effective treatment strategies remains challenging. Alas, the survival of these patients is consistently short, and expressing incremental cost-effectiveness ratios (ICERs) in terms of years yields inadequate comparisons. For this reason, ICERs for pancreatic cancer interventions are often expressed in quality-adjusted life-months (QALMs), not life-years.

	A recent review examined 6 treatment strategies: no treatment, radiotherapy only, chemotherapy only, chemotherapy plus radiotherapy, surgery alone, and  surgery plus adjuvant therapy. The groups having surgery plus adjuvant therapy, chemotherapy alone, and no treatment were the only groups that were  considered costeffective. An ICER of $7663 per QALM was seen in the surgery plus adjuvant therapy group compared with the notreatment group, which was  primarily related to an increase in survival. Of note was that the ICER was most favorable in high-performing healthcare centers versus low-performing  centers ($5991/QALM vs $9144/QALM, respectively). This indicates that decreasing costs will be related to improved therapies and utilizing high-performing  care centers for providing the treatments.

	Another study examined the cost-effectiveness of gemcitabine monotherapy, gemcitabine plus conventional radiotherapy, gemcitabine plus  intensity modulated radiotherapy (IMRT), and gemcitabine with stereotactic body radio therapy (SBRT). The SBRT group had better results both clinically  and economically than each of conventional radiotherapy and SBRT groups, respectively, but only produced an increase of 0.20 quality-adjusted life-years (QALYs), at an incremental cost of $13,700 compared with gemcitabine alone. Using a willingness to pay of $50,000 per QALY as the threshold for  costeffectiveness, the probability of costeffectiveness was 78% for gemcitabine monotherapy and 21% for SBRT, while at a willingness-to-pay threshold of $200,000 per QALY, the probability of cost-effectiveness for SBRT was 73%.

	Another type of cost strategy evaluation was undertaken that determined the budget impact of adding erlotinib to gemcitabine therapy in patients with nonresectable pancreatic cancer. The budget impact was $0.02 per member per month; this small amount was primarily the result of the low incidence of pancreatic cancer among the hypothetical managed care organization of 500,000  members. It would be difficult to deny patients the additional drug being added to a gemcitabine regimen even with limited survival benefits.

	Both the National Cancer Institute (NCI) and pharmaceutical companies are investigating new modalities for treating pancreatic cancer. The NCI has  increased its budget for this disease by more than 50% since 2000. Yet, the complexity and variability of each tumor continues to challenge clinical treatment. As we learn more about the genetic makeup of pancreatic cancer, it will undoubtedly lead to new therapies, new combination therapy regimens, and biomarkers that will aid in the detection and monitoring of therapy. These advances will hopefully translate into better patient outcomes and economically sound treatment strategies. 

	EBO: Why is pancreatic cancer such a difficult problem today? Do we have sufficient information on its risk factors to be of use in prevention?

 Pancreatic cancer is the fourth-most common cause of cancerrelated deaths in the United States. There is little doubt that there are risk factors associated with pancreatic cancer. These include cigarette smoking, heavy alcohol intake, exposure to certain occupation-related chemicals, and obesity. Chronic pancreatitis has also been identified as a risk factor. A recent study demonstrated a 7-fold increase of pancreatic cancer for patients with a history of pancreatitis, and clinical studies are evaluating pancreatic cancer’s relationship with other risk factors. Truly familial pancreatic cancer is uncommon. However, there may be a genetic predisposition in up to 10% of patients with pancreatic cancer. There is also an increase of pancreatic cancer in families who have the BRCA2 gene mutation.

EBO: What do you see as the best value for our efforts to prevent, treat, or manage pancreatic cancer today?

: I believe our best efforts lie in educating our customers about their risk factors and how those risks can be reduced by changing lifestyle behaviors.

EBO: Pancreatic cancer is usually detected or diagnosed in the latter stages of the disease. What can health plans do to help improve this situation or is this more of an issue requiring better provider education?

 It is unclear whether screening high-risk individuals is beneficial. Studies are ongoing in an effort to answer this question.

EBO: With regard to the direct costs of treating the disease, surgical procedures and hospital stays are responsible for the lion’s share (22% and 33%, respectively). Chemotherapy and radiotherapy account for only 13% combined. Do you expect that the chemotherapy costs will increase as more effective treatments are introduced?

The overwhelming share of costs do relate to surgical procedures, including the cost of inpatient hospital stays. Mortality in the United States for pancreatic cancer has not changed much over the past 20 years, despite the introductionof more chemotherapy drug combination treatments. Overall, costs likely will continue to increase as newer chemotherapy agents become available, especially the targeted agents that are being used to treat many other malignancies.

EBO: Do you think that other treatment-associated costs will become major contributors to this scenario in the future (eg, pancreatic enzyme replacement or biomarker testing)?

 Biomarker, molecular profiling, and gene array studies are currently in progress, and I believe this is the future—not only for pancreatic cancer, but for managing other malignancies as well. The results of these studies may enable us to take a novel and personalized approach to treat specific molecular targets that can be identified, and that will be predictive of chemotherapy sensitivity to treat pancreatic and other malignancies.

EBO: In terms of pancreatic cancer (or perhaps all cancers), what, if any, clinical guidelines do you encourage oncologists to follow?

Cigna encourages doctors who are treating our customers to follow evidence-based guidelines published by the NCCN and ASCO (American Society of Clinical Oncology). Cigna uses these guidelines to develop our coverage policies for pancreatic cancer and other malignancies.

EBO: Because of the limited success with current treatments of patients with pancreatic cancer, are you perhaps more lenient in your approval of investigational treatments?

Cigna covers experimental treatments for pancreatic cancer if the treatment is being done in conjunction with a listed clinical trial.

Articles

Evidence-Based Oncology

Searching for Clinical and Economic Value in Pancreatic Cancer

Prostate cancer is a common cancer in men that, once it progresses to the later stages, has serious morbidity and mortality consequences as well as burdensome financial issues for patients, the healthcare system, and society. Prostate cancer, second only to skin cancer, is responsible for about 10% of the deaths attributed to all of the cancers.

As a result, several strategies have been developed to reduce the morbidity, mortality, and costs associated with prostate cancer, inclusing the identification of patients at risk, chemoprevention regimens that prevent the development of the disease in those at risk, and the early diagnosis of patients with confirmed disease.

	According to the American Cancer Society, prostate cancer will be diagnosed in about 240,000 men in 2013, and it will be listed as the cause of death in 30,000.

 African Americans have a higher incidence of prostate cancer than Caucasians and are also more likely to die from the disease. Race, age, and family history are risk factors. Around 2.5 million men currently are prostate cancer patients.

	The majority of cases (approximately 60%) are diagnosed in men 65 years and older, and 97% of cases are diagnosed in men at least 50 years of age. The average age at diagnosis is approximately 67 years.

 Known genetic factors are linked to the disease in about 5% to 10% of patients.

	The disease usually has no symptoms and if diagnosed in the early stages, defined as being in the local or regional stages, it has an excellent 5-year survival (nearly 100%) and survival after 15 years is also very high (93%).

 Ironically, since patients with early-stage prostate cancer experience few or no symptoms, the cancer may not be diagnosed until it has spread to distant areas of the body, including lymph nodes, bones, and other organs. The 5-year survival for patients with metastatic disease is only 28%.

	Since the disease is usually diagnosed in older patients, men with slow-growing tumors are frequently monitored using a strategy termed “active surveillance,” monitoring the disease and delaying therapy until the disease demonstrates signs of being progressive.

	As would be expected, costs associated with the treatment of prostate cancer are greatest (approximately $34,000) in the last year of life. In 2006, the total estimated cost for all prostate cancer care was $9.86 billion.

 Newer treatments, such as sipuleucel-T, costing more than $93,000 for a full course of therapy, will undoubtedly increase these estimates.

	During the years from 2005 to 2009, the incidence of prostate cancer and number of deaths attributed to it decreased each year. Policy makers speculated that screening with the prostate-specific antigen (PSA) blood test was responsible for the decline.1 Interestingly, the US Preventive Services Task Force (USPSTF) issued a statement on PSA screening in May 2012 that recommended against PSA-based screening for prostate cancer in the general population. However, it did not apply this recommendation to men who had already been diagnosed with or were being treated for prostate cancer.

 This recommendation was based on the potential harms of screening, which included:

	• High false-positive rate—approximately 100 to 120 of every 1000 men screened may receive an incorrect diagnosis based on the PSA test result, subjecting them to unnecessary biopsies, which could result in undesirable side effects and unneeded worry or anxiety.

	• Overdiagnosis—most cancers of the prostate do not grow or cause symptoms. If the tumor does grow, it does so at a slow rate and usually does not cause health problems in the duration of the man’s life (based on the older age at diagnosis). The potential for overdiagnosis exists, as current technology cannot differentiate slow-growing tumors from aggressive tumors (a small minority of cases, but life threatening when they do occur).

	• Overtreatment—if more men are diagnosed, it is likely that some proportion of them will undergo active treatment, with potentially deleterious effects.

	The Task Force suggested that physicians should not offer PSA testing unless the patient raises the issue, and then the physician discusses with the patient the benefits and potential harms of PSA testing, as well as risks involved with the diagnostic testing and treatment.

	Recently, a computer model was used to assess alternative PSA screening strategies. The model evaluated 35 screening strategies that varied by the starting and ending age for screening, screening intervals, and thresholds for recommending a biopsy. Raising the PSA threshold in men aged 50 to 74 years being screened yearly was found to reduce the risk of prostate cancer and the risk for overdiagnosis. In even older men, the risk for prostate cancer was similar to that observed in the men aged between 50 and 74 years, but the risk for overdiagnosis was further reduced. Screening done every other year in men at low risk reduced the risk for prostate cancer and overdiagnosis; moreover, this strategy reduced the number of total tests by 59% and false-positive tests by 50%.

This study suggests that screening may not be needed in men older than 70 years, and thresholds for recommending biopsies could be raised in older men. Overall, men with normal PSA levels at baseline may need less frequent monitoring.

	Chemoprevention is the use of drugs, vitamins, or other agents (

) to try to reduce the risk of, or delay the development or recurrence of, cancer as defined by the National Cancer Institute.

 It is further classified as primary, secondary, and tertiary prevention. Primary prevention refers to preventing the development of cancer, usually in men who have an average or high risk for its occurrence. This includes men with a family history of cancer. Secondary prevention is aimed at individuals with known precancerous lesions. In this case, chemoprevention is used to deter the progression of these lesions to the cancerous state. Tertiary prevention is used in patients with diagnosed prostate cancer to prevent new cancers or metastasis.

The precancerous state is usually typified by the presence of intra-epithelial neoplasia, which is identified most commonly through biopsy or pathologic samples taken at surgery.

	In 2008, the American Society of Clinical Oncology (ASCO) and the American Urological Association (AUA) issued a clinical practice guideline for the use of 5-α-reductase inhibitors (eg, finasteride and dutasteride) for the chemoprevention of prostate cancer (primary prevention only). This guideline was developed based on the results of 15 randomized clinical trials, of which 9 included the prevalence of prostate cancer studies over 1 to 7 years (clinical trial data do not extend beyond 7 years). Only 1 completed trial, the Prostate Cancer Prevention Trial (PCPT), was randomized and was designed to show in a reduction in period-prevalence of prostate cancer. This trial, using finasteride as the intervention, had a very large study population of men who were being actively screened for prostate cancer. The clinical trial REDUCE (Reduction by Dutasteride of Prostate Cancer Events), in which men with a PSA >3 ng/mL were enrolled, was not yet completed at the time of review by the guideline development panel. Thus, the panel knew that additional information would be forthcoming from the REDUCE trial, and that the PCPT trial results would be further analyzed. Neither of these 2 trials was designed to assess the risk of death resulting from prostate cancer. The primary objective of both of these clinical trials was to study the safety and efficacy of drugs indicated for the treatment of benign prostatic hyperplasia (BPH).

	The panel concluded that therapy with a 5-α-reductase inhibitor during a 7-year period would lead to a 25% relative risk reduction (but only a 1.4% absolute risk reduction) for a prostate cancer diagnosis. The panel noted an increase in high-grade cancers, but they believed it was doubtful that this could occur while there was also a decrease in low-grade tumors. However, since men are prescribed 5-α-reductase inhibitors for BPH and male pattern baldness, they recommended that this potential finding should be discussed with these respective patients. Additionally, they knew that data from the REDUCE trial would support or dispute the findings of the presence of increased high-grade prostate cancer in men receiving a 5-α-reductase inhibitor.

	The suggestion from the panel was that men with a PSA level below 3.0 ng/mL who agreed to annual PSA screening might benefit from 5-α-reductase inhibitor therapy for a period of 7 years. Men should also be made aware of the potential benefits and risks of such therapy by their physicians.

	The results of the REDUCE trial were similar to those seen in the PCPT trial (

). There was a decrease in relative risk and absolute risk for developing prostate cancer when using 5-α-reductase inhibitor therapy, but there was in increase in the absolute risk for the development of high-grade prostate cancer. The original publication of the trial did not show an increased risk for high-grade prostate cancer, but the FDA mandated a reanalysis of the data using a modified scoring scale which resulted in an increase in high-grade prostate cancer.

	In December 2010, the Oncologic Drugs Advisory Committee voted against approving dutasteride and finasteride for the prevention of prostate cancer based on the findings of the REDUCE and PCPT trials. The FDA followed the committee’s recommendation in January 2011.

Since the FDA did not approve the drugs for the prevention of prostate cancer, ASCO and AUA subsequently archived the 2008 clinical guideline on the use of 5-α reductase inhibitors for prostate cancer chemoprevention. However, the guideline is available in the “Archived Guides” section of the AAU website.

	The AUA communicated that it believes some urologists and urologistoncologists would continue to prescribe these medications for men at potentially high risk for prostate cancer and that these agents should be used with caution. It believed the decision was controversial and still debatable.

	The Southwestern Oncology Group (SWOG) disagreed with the FDA’s decision, saying that it believed the PCPT reanalysis demonstrated that the use of 5-α-reductase inhibitors could significantly reduce the risk of prostate cancer.

 Even the USPSTF concluded that additional studies were needed to determine the impact of 5α-reductase inhibitors on the mortality of men with prostate cancer.

 Furthermore, a reanalysis of the data from the PCPT and REDUCE trials for mortality suggested there may have been a small increase in deaths due to therapy, but that there could have also been a modest decrease.

	Coupled with the clinical analysis of the use of 5-α-reductase inhibitors for the chemoprevention of prostate cancer, several investigators examined the cost-effectiveness and cost utility of using these drugs specifically for chemoprevention. A study in the mid-2000s utilizing a Markov decision analysis model concluded that prescribing finasteride in a lower-risk population ≥50 years would not be cost-effective; however, if it were used in men with a high risk for prostate cancer (defined as at least 50 years of age with a probability of at least 30% for developing prostate cancer), the chemoprevention strategy could be cost-effective. If the lifetime prevalence were to be increased, the costs per life-year saved would be reduced; moreover, the cost of the chemoprevention strategy would also affect the costs.

 Another study utilizing a Markov decision analysis model also concluded that finasteride would not be likely to be cost-effective for use in the general population, but that it would be cost-effective to prescribe it in high-risk men (defined as ≥50 y and a ≥30% chance of developing prostate cancer), especially if quality-of-life issues (erectile dysfunction, loss of libido, and incontinence) were considered. The sensitivity analysis showed a cost-effectiveness ratio of <$50,000 per QALY with a 25% risk reduction in the men at high risk.

There appears to be a level of agreement that utilizing these medications in low-risk populations would not be cost-effective, but that there is a cost benefit to their use in high-risk men.

	Age alone (ie, men older than 50 years) does not appear to be the only criterion for initiating chemoprevention. Assuming that finasteride use resulted in a constant risk reduction for all tumor grades, the drug was found not cost-effective because of the costs associated with side effects (urinary and bowel incontinence, impotence, and erectile dysfunction).

 A Markov model has been developed that shows high-risk men, defined as those having a positive family history and the presence of genetic markers for prostate cancer, would benefit from chemoprevention.

	There is little question that PSA testing at present is a useful tool, but has been an overused one, in our limited arsenal to screen for prostate cancer. And when it is used appropriately, there is little consensus (except in cases of extreme readings) on how to interpret the results. Many even argue that the logic in favor of screening is faulty, owing to the relatively slow growth of earlystage prostate tumors. However, few would not want to prevent late-stage prostate cancer and seek to improve its poor 5-year survival.

	Therefore, the real debate seems not to address the value of preventing prostate cancer but whether our technologies for prevention (both screening and treatment) are efficient enough to yield cost-effective outcomes. If 5-α-reductase inhibitors are not sufficiently effective in preventing the development of prostate cancer, or if the side effects of the medications are such that the costs to treat (or in terms of reduced quality of life) result in inadequate cost-effectiveness, are there specific patients where the drugs may be useful and are there more effective chemoprevention strategies available or on the horizon?

	The debate about the use of 5-α-reductase inhibitors as chemoprevention for prostate cancer continues, as does the utilization of PSA testing to screen men for the disease. Based on the sheer numbers of men who develop prostate cancer and the cost burden of the disease, it seems that the need exists for both a useful screening tool and a chemoprevention strategy. Appropriate application of this strategy will be the key to success. Evolving and improved technology will be paramount in making this happen.

 Mr Mehr reports receiving payment for involvement in the preparation of this article. Ms Zimmerman reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

	1. American Cancer Society. Cancer Facts & Figures 2013. Atlanta: American Cancer Society;

	2. American Cancer Society. Prostate Cancer 2013. Atlanta: American Cancer Society; 2013. www.cancer.org/cancer/prostatecancer/ detailedguide/prostate-cancer-key-statistics. Accessed January 29, 2013.

	3. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. www.nccn.org/professionals/ physician_gls/pdf/prostate.pdf. Accessed January 29, 2013.

	4. Roehrborn CG, Black LK. The economic burden of prostate cancer. BJU Int. 2011;108(6):806-813.

	5. Mulkhy N. Medicare already paying for Provenge for some patients: national coverage analysis still important. Medscape Medical News, January 6, 2011. www.medscape.com/viewarticle/735366. Accessed January 30, 2013.

Chemoprevention in Prostate Cancer: Identifying Patients at Greatest Risk May Provide Greatest Value

	In 2011, the Medicare Electronic Health Record (EHR) Incentive Program began paying physicians and hospitals for the measurement and reporting of performance metrics through the utilization of certified electronic medical record software. This epic program began in earnest the irrevocable shift in the provision of healthcare from an individual craft-based art to a structured, evidence-based system. The EHR Incentive program has 3 specific phases that progressively build from data capture and reporting, through clinical process refinement, to the final goal of achieving measurably improved healthcare outcomes.

 Currently, we are in the first phase of this transition, and in oncology, trends are emerging about what metrics are important to 3 important groups—patients, payers, and providers. Each seeks improvements to quality and lower, or at least stable, costs for cancer care. The broad utilization of electronic medical record technology has, for the first time in history, enabled systematic measures of care delivery on a broad scale.

	While management of clinical care using modern information technology is important to providers and payers of oncology care, it is critical to those of us who have a cancer diagnosis in our family or in our future— and that is just about everyone. Providers must participate in the move to active measurement of clinical variables or become obsolete. They must also integrate reporting and measurement of important process measures into routine clinical management. Payers have a critical role in promoting this technology adoption. They are positioned to promote payment methodologies that support and reward clinical measurement. Without such support, innovative practices suffer economically as they push toward rational care. We all should expect basic quality process measures that are indicative of good clinical management of cancer care for our families and ourselves. Successful payers and providers will encourage patients to seek care where these quality indicators are available and exemplary.

	Three visions of performance metrics in oncology were presented at the Cancer Center Business Summit held October 11-12, 2013, in Fort Worth, Texas. The theme of the conference was transitioning to value-based oncology and most of the program content, including the full program that is summarized in this article, is available online.

While the 3 perspectives are different, there were consistent themes throughout. All speakers endorsed the use of available data, keeping metrics simple, delivering measurements to the care providers who can affect the numerator, and showing these providers how they compare with peers. The speakers all understand that current payment methodology does not support process optimization, yet view that as a transitional barrier that will not persist.

	I presented the 3 criteria that are generally accepted for choosing clinical performance measures.

 To be successful, measures must be important, scientifically sound, and feasible. Importance is measured by the relevance of the measure to patients and providers and the promise that being measured offers for improvement. To be scientifically sound, there must be substantial, explicit evidence with validity, reliability, and sufficient specificity to patient factors to be clinically useful. Feasibility requires an explicit definition of the numerator and denominator needed for the measure from data that are available at low cost and with low administrative burden. Today the fact is that payment drives process measurement and most systematic data are about billing, not about medical care. The EHR incentive program, coupled with many providers and payers seeking a departure from fee for service, are factors driving oncology data feasibility toward important, scientifically sound measurements.

	The presence of specific, essential clinical information as structured data in the clinical database is necessary for oncology care management. These data support pathway and guideline adherence, reduce treatment variability, take advantage of emerging companion treatment diagnostics, and promote cost savings through the avoidance of valueless care. In oncology, 6 basic elements are needed to enable such measurement. For every patient, we need to have structured data in the electronic medical record for stage, intent of therapy, toxicity, disease status, patient status, and line of therapy. When there is substantial data density for these 6 process measures, the foundation is in place to begin to measure clinical outcomes across large populations of patients and then, in real time, see what is working.

	So how do we get from low density, as presently observed in oncology electronic medical record data, to high density on these process measures? 

 shows data from an Oncology Metrics survey performed in 2009 and reveals that physicians directly enter most of these data as part of their clinical management activity.

	There is ample evidence that peer review does alter physician behavior. Oncologists who received feedback about the amount of chemotherapy that they were giving at the end of life reduced from 50% of patients to 20% of patients in only 6 months.

 Structured clinical data offer the opportunity to show individuals how they compare with named physicians in their own practice. Additionally, this lets the physician know that others see his score too (

	Deb Hood, vice president of the national oncology service line of Catholic Health Initiatives (CHI), spoke about the experience of her institution in beginning to establish what she called value-based care metrics. While there are 5 dimensions to their hospital perspective, she emphasized improvement in quality and reduction of cost. Although there are many quality metrics in oncology, CHI has decided to focus on data that are readily available and easy to audit. The best data source for them is registry data, as they are extracted in real time, and encompass more that 30,000 new cases each year. From these data, they have created “dashboards” for breast cancer, exception reporting for chemotherapy and radiation therapy, readmission tracking for all oncology patients, and pharmaceutical expense tracking. To leverage these reports to create measurable improvement in care, they are presenting comparative measures at the institutional level with color coding to promote easy understanding. Green is compliant, yellow is nearly in range, and red is out of compliance standard. A sample of such a report card is shown in 

	Wes Chapman, president and CEO of PCD Partners, provided an overview of the application of ISO 9001 and Lean Six Sigma in 2 large-scale projects.

 Noting that outcome metrics are only viable in the context of a uniform process, and understanding that healthcare provision is not at all a uniform process, useful metrics are limited to process metrics (

	To adequately measure processes in large systems, the integration of documents and data into a single system is necessary. Chapman said that this novel functionality could be created in a cloud-based relational database but noted that these 2 types of information are not standardized. This shortcoming limits the ability of process measurement to provide compelling information about problems addressed and determine if improvements are realized. To achieve process control and improvement, it is necessary to define the process and train process operators, collect process performance data, and then audit process for compliance. None of this functionality is present in large-scale systems today and this is a limiting reality to the application of tested process management technology that is used in the manufacturing environment. To no small degree, this fractioning of healthcare is part of the payment methodology. Fee for service provides incentives for more process steps and leads to variable endpoints, uncoordinated care, and undocumented outcomes. When healthcare delivery and payment more closely resemble typical manufacturing environments, characterized by a drive to reduce process steps and maximize value, then the tools from that sector will become applicable.

The author reports employment with Altos Solutions, which produces electronic health records.

Concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis; provision of study materials or patients; and obtaining funding.

Thomas R. Barr, MBA, 520 Hopkins St, Neptune Beach, FL 32266. E-mail: tbarr@oncomet.com.	1. EHR incentive programs. Centers for Medicare & Medicaid Services website. www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/index.html. Accessed December 6, 2012.

	2. Cancer Center Business Summit website. www.cancerbusinesssummit.com/program.htm. Accessed December 6, 2012.

	3. Center for Health Policy Studies, Harvard School of Public Health, Center for Quality of Care Research and Education. Understanding and choosing clinical performance measures for quality improvement: development of typology: final report. Rockville, MD: Agency for Healthcare Research and Quality; 1995.

	4. Blayney DW, McNiff K, Hanauer D, et al. Implementation of quality practice initiative at a university comprehensive cancer center. J Clin Oncol. 2009;27(23):3802-3807.

	5. Bloomberg highlights Vermont cancer pilot; PCD partners plays key HIT role. PCD Systems website. http://pcdsys.com/bloomberg-highlights-vermont-cancer-pilot/. Published August 24, 2012. Accessed December 6, 2012.

	6. Decreasing complexity, improving care quality, and reducing cost in oncology. http://pcdsys.com/care-quality-in-oncology/. PCD Systems website. Published July 5, 2012. Accessed December 6, 2012.

Performance Metrics in Oncology

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.

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

March/April

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Performance Metrics in Oncology

Applying Accountable Care to Oncology: Developing an Oncology ACO

Five Trends Emerge in Payer Management of Oncology

Measuring Quality Cancer Care

Bundled Payment: Practice Savior or Killer?

The Future of Melanoma Treatment

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