Genomic Health, Inc. Oncotype DX Colon Cancer Assay Clinical Compendium March 30, 2012

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1 Economic Validity Eligibility and Addressability for Use of the Assay An important distinction should be made between the total population of patients eligible for the Oncotype DX Colon Cancer assay, and the subset within this population for whom the Oncotype DX Colon Cancer Assay should be appropriately used. For instance, the Oncotype DX Colon Cancer Assay may not be appropriate for patients who are not candidates for adjuvant chemotherapy on the basis of advanced age, comorbidities, shortened life expectancy, or inability to tolerate treatment. These patients would not be considered addressable, even though they are eligible. Table 1. Eligible vs. addressable patients Eligible Patients All patient populations for whom Oncotype DX could be used, without exclusions Current eligible patients include those with stage II, T3, mismatch repair proficient (MMR P), colon cancer Addressable Patients The addressable population would exclude all stage II patients who are not candidates for adjuvant chemotherapy, because of age, comorbidities or personal preference against systemic therapy Patients who have T3, MMR P lesions Figure 1 outlines the annual estimated number of patients likely to be addressable for Oncotype DX Colon Cancer Assay. Page 1 of 13

2 Figure 1. Addressable population for the Oncotype DX Colon Cancer Assay *Applying a 22% discount to adjust for chemotherapy eligibility and life expectancy, plus 18% filter for life expectancy extremes. Page 2 of 13

3 Cost Effectiveness Analysis Economic validity refers to the completeness, quality, and reliability of the analyses used to assess the economic implications of novel technologies. The economic impact of the Oncotype DX Colon Cancer Recurrence Score in the treatment of stage II, T3, mismatch repair proficient (MMR P) colon cancer patients has been evaluated by Meropol et al. 1 This study used a state transition (Markov) model to compute the utility and economic implications of assay adoption from a US societal perspective (Figure 2). Figure 2. Decision tree Source: Meropol et al. Gastrointestinal Cancers Symposium The cost effectiveness analysis modeled a treatment paradigm, which combined the prognostic benefit of Recurrence Score documented by the QUASAR validation study combined with anticipated life years remaining. This model framework produces a continuous curve with moving cut point. The recommendation for treatment versus observation is modeled when the quality adjusted life years Page 3 of 13

4 gained from chemotherapy is greater than the quality adjusted life lost from 6 months of adjuvant chemotherapy (Figure 3). Figure 3. Proposed Treatment Decision Illustration Consider Observation Consider Adjuvant Chemotherapy Legend: Red No chemotherapy, where QALY loss during treatment is greater than overall gain; Yellow Treatment decision dependent on individual patient s view of quality of life associated with chemotherapy; Green Yes chemotherapy, where the QALY loss during treatment is less than overall gain. Source: Meropol et al. Gastrointestinal Cancers Symposium Regardless of the number of lymph nodes sampled after surgery or high risk pathological features, use of the assay results in a decrease in chemotherapy use (Figure 4). Results show that the Recurrence Score would reduce adjuvant chemotherapy use by 17% and increase quality adjusted life expectancy by an average of years compared with current treatment patterns. Thus, using the Page 4 of 13

5 assay results in a net savings ( $2,971 USD 2010 ), and a dominant incremental cost effectiveness ratio (ICER). Figure 4. Cost effectiveness results by status of high risk pathologic features These results support the clinical use of a 12 gene RS to assess risk of recurrence in stage II T3 MMR proficient colon cancers. Sensitivity analyses (1 way) show the assay to be cost saving under a variety of conditions. The cost saving result was robust through a range of variables. It was not sensitive to the cost of the assay, chemotherapy costs or type, or complication costs or frequency. The results are sensitive to the benefit of chemotherapy in patients over 60 years of age, and the utility loss due to chemotherapy. Details of this abstract are available in the Economic Validity: Article Summaries section. Page 5 of 13

6 Budget Impact Model The Financial Implications of Oncotype DX Colon Cancer Assay, v2.0, Budget Impact Model is designed to estimate the direct costs to a payer of adopting the technology. The cost of the assay is considered in the context of the savings from avoiding unnecessary, or overly intense, chemotherapy. The model user interface allows input of plan characteristics to customize the results to an individual plan (Figure 5). Buttons allow the user to see the base case, lower bound, and upper bound. Breakeven analyses and sensitivity analyses are also provided. Figure 5. User interface Note: The values above represent the default base case. Base case inputs Payer mix These inputs allow the user to choose whether the considered population is covered by Medicare Advantage, a private payer, or a mix of the two. The particular proportions can be set by the user, though the default is 10% Medicare Advantage, and 90% privately payer. The results below are reported for two scenarios in which all the patients are insured by Medicare, or all patients are insured by a private payer. Page 6 of 13

7 Plan demographics The number of covered lives in the plan can be adjusted to reflect the number of people in any particular plan. The default plan size is set to 2 million members. An analysis of the Surveillance Epidemiology and End Results (SEER) program indicated a per 100,000 incidence rate of colon cancer, of which 27.4% is stage II colon cancer. 2 Out of the stage II population, 87.0% are T3, 89.0% are mismatch repair proficient (MMR P) and 60.0% are chemotherapy eligible. Test utilization Out of the eligible stage II, T3, MMR P colon cancer population (100%), the assay should only be ordered for the addressable patient subset (patients for whom chemotherapy is an option). Because physicians and patients might or might not choose to use this new technology, only 30% of all stage II, T3, MMR P colon cancer patients are conservatively estimated to use the assay. Cost of Oncotype DX per patient The default cost of the assay is the list price, $4,175. Chemotherapy use (chemo eligible) The values for chemotherapy use and distribution of chemotherapy regimens before and after Oncotype DX were presented by Cartwright et al. in 2012 at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. 3 Adjuvant chemotherapy costs The Medicare costs of chemotherapy drugs, administration, and supportive care were calculated using the Centers for Medicare and Medicaid (CMS) ASP file, and physician fee lookup weighted by use rates reported in the OncoReport T published by Interactive Clinical Intelligence. 4,5 The adverse event costs are from published literature (cost of death is based on expert opinion). 6 8 These costs are separated by chemotherapy type (oxaliplatin or non oxaliplatin), and payer (Medicare or private). Page 7 of 13

8 Results The calculations in the model are based on simple algebra and the results are shown directly to the right of the inputs used to calculate them (Figure 5). Outputs The model results show the patient populations expected to be diagnosed in the plan per year. The eligible population includes patients who have stage II, T3, mismatch repair proficient [MMR P] colon cancer. The addressable subpopulation includes those patients in the eligible population who are considered for chemotherapy. Of the addressable patients, there is a smaller subset of patients for whom the assay will be ordered. The effect of the assay on chemotherapy use is shown as an overall change, and by chemotherapy type. The two chemotherapy type categories are oxaliplatin containing regimens, and non oxaliplatin containing regimens. The average costs for chemotherapy, administration, supportive care, and adverse events are computed for each chemotherapy type. These costs are weighted averages of the Medicare and private payer input costs. The overall costs to the plan before and after the Oncotype DX Colon Cancer Assay are calculated for the assay, chemotherapy drugs, administration, supportive care and adverse events. The financial implications of the assay are shown as the differences in costs with or without the assay. This is shown in red in the results section of the BIM (Figure 6). The overall impact to the plan is computed as the total costs and the cost per member per month (PMPM). These two values are provided in bold font. Key findings The model can estimate the financial impact of adopting the Oncotype DX Colon Cancer Assay to a plan with 2 million members to Medicare and to a private payer separately, or for a population covered by a mix of the two. Figure 6 shows the financial implications of the assay for these two types of plans separately. To calculate these results, all inputs other than those pertaining to the payer mix were held equal to the default base case values. At base case, the assay is cost saving regardless of payer type. Page 8 of 13

9 Figure 6. Model results by payer A. Medicare B. Private Page 9 of 13

10 The user interface includes tools to return all inputs to the default base case, to conduct scenario analyses (lower bound, upper bound and breakeven) and to conduct 1 way sensitivity analyses (Figure 5). The lower bound and upper bound buttons vary the cost of chemotherapy (±25%) and the proportion of patients for whom the Oncotype DX Colon Cancer Assay is used (±50%). The 1 way sensitivity analysis shows that the three most influential inputs on the difference in total costs are, in order, the change in use of oxaliplatin chemotherapy due to the assay, the cost of oxaliplatin chemotherapy, and the cost of the assay. This remains true regardless of payer. Page 10 of 13

11 Summary These economic analyses of Oncotype DX Colon Cancer Assay support the assay s ability to direct more appropriate adjuvant treatment in stage II colon cancer. Both the cost effectiveness analysis by Meropol et al. and the Financial Implications Budget Impact Model, detailed above, show the assay to be cost saving. Treatment algorithms proposed for the use of the 12 gene Oncotype DX Colon Cancer Assay highlight the compatibility of the assay with a diversity of clinical practices. They suggest that the assay has added value in the current practice. Two proposed algorithms are described below (Figure 7). Figure 7. Treatment algorithm This assay has been rigorously validated to estimate the risk of recurrence in patients with stage II colon cancer and provides value independent beyond the existing criteria for risk assessment. When adopted into the current practice, the Colon Cancer Recurrence Score can direct more appropriate, individualized and effective adjuvant treatment. Furthermore, economic analyses indicate that the adoption of the Colon Cancer Assay would be highly cost effective, if not cost saving. Page 11 of 13

12 Article Summaries Meropol N, Lyman G, Chien R, Hornberger J. Use of a multigene prognostic assay for selection of adjuvant chemotherapy in patients with stage II colon cancer: Impact on quality adjusted life expectancy and costs. Abstract no In: Gastrointestinal Cancers Symposium. San Francisco, CA; Specific Aim: To determine the utility and cost effectiveness of a multi gene expression prognostic assay in guiding use of adjuvant therapy in patients with stage II, T3, MMR P colon cancer. Summary: The utility and economic implications of assay adoption from a US societal perspective were computed using a state transition (Markov) model. Risk of recurrence by RS was based on the QUASAR validation study. Risk of mortality and risk of recurrence were derived from US Vital Statistics and Surveillance Epidemiology and End Results, respectively. Costs of treatment were computed from Medicare Part B average sales price (April 1st, 2010). Incidence and costs of adverse events were obtained from literature and hospital utilization databases. Utilities for remission, relapse, and during treatment were derived from the literature. Results of the base case analysis show that treatment decisions based on RS and a patient's years of life remaining without cancer recurrence would reduce adjuvant chemotherapy (actx) use by 17% compared with current treatment patterns, and increase quality adjusted life expectancy by an average of years. With lower use of actx, direct medical costs are expected to decrease by an average of $2,971 per patient. Sensitivity analyses also show the assay to be cost saving under a variety of conditions. These results support the clinical use of a 12 gene RS to assess risk of recurrence in stage II T3 MMR proficient colon cancers. Clinical application of 12 gene RS may improve quality adjusted life expectancy and be cost saving from a societal perspective. To view this abstract please visit: =71079 Page 12 of 13

13 References 1. Meropol N, Lyman G, Chien R, Hornberger J. Use of a multigene prognostic assay for selection of adjuvant chemotherapy in patients with stage II colon cancer: Impact on qualityadjusted life expectancy and costs. Abstract no In: Gastrointestinal Cancers Symposium. San Francisco, CA; SEER Cancer Statistics Review, (Colon Cancer) (Accessed June 15, 2009, at 3. Cartwright TH, Chao C, Lopatin M, Bentley TG, Broder MS, Chang E. Effect of Oncotype DX colon cancer test results on treatment recommendations in patients with stage II colon cancer: Preliminary results. Abstract no In: Gastrointestinal Cancers Symposium. San Francisco, CA; Interactive Clinical Intelligence. OncoReport: Medical Oncology, 3rd Trimester Payment Allowance Limits for Medicare Part B Drugs, Effective January 1, 2012 through March 31, In: Centers for Medicare and Medicaid Services, ed. 6. Chu E, Schulman KL, Zelt S, Song X. Costs associated with complications are lower with capecitabine than with 5-fluorouracil in patients with colorectal cancer. Cancer 2009;115: Elting LS, Lu C, Escalante CP, et al. Outcomes and cost of outpatient or inpatient management of 712 patients with febrile neutropenia. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2008;26: Healthcare Cost and Utilization Project (Accessed at Page 13 of 13

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