April 26, Are Payers Getting Tougher? Essential Insights on How to Smooth Acceptance of New Genetic Tests?

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1 April 26, 2016 Are Payers Getting Tougher? Essential Insights on How to Smooth Acceptance of New Genetic Tests?

2 Outline Payer Trends/Dynamics Approaches to Reimbursement - Coverage, Coding, Payment, and Contracting Clinical Utility Evidence Development Case Studies - OncotypeDx Breast, OncotypeDx Colon Implications for Innovators 2016 Boston Healthcare Associates, Inc. 2

3 Payer Trends/Dynamics

4 The number, types, and costs of genetic tests are all rapidly rising The development and usage of genetic tests is one of the fastest growing areas in healthcare Increase in test offerings, per test cost, and complexity of testing have contributed to this upward trend Source: Boston Healthcare Associates, Inc. 4

5 Payers are Responding to the Rising Cost/Frequency of Clinical Diagnostics with Greater Scrutiny of Novel Tests Issue Area Implication Comments Increasing use of and revenue generation through misc coding Reductions in payments for laboratory testing Greater test scrutiny Continuing downward pricing pressure on laboratories Among the fastest-growing MDx test codes in 2014 was CPT (unlisted molecular pathology procedure) which jumped from $4.2 million in allowed Medicare charges in 2013 to $68.7 million in 2014 The growth in Part B spending on CPT occurred despite a stunning 88.8% denial rate for this code in 2014 Major commercial reference labs pursuing discounted contracts (in some cases 50-60% of Medicare amounts) Medicare shifting to commercial payment benchmarking (result of PAMA legislation) Changes to coding for MDx Greater test scrutiny Substantial changes to Medicare coding and payment for NGS tests with introduction of GSP codes Payers may not accept MPT1/2 codes in the long term for NGS assays Increasing payer scrutiny of laboratories/ diagnostics Suing plans for coverage Payers continue to believe that advanced diagnostics can potentially provide value, they are just more likely to question the evidence that supports that value Boston Healthcare Associates, Inc. 5 Higher clinical utility evidence requirements Increasingly contentious relationships Theranos and HDL laboratory scandals raise profile of industry Questions about high spend on pharmacogenomics (e.g., CYP2D6 and CYP2C19 genotyping) Under the radar payment strategies may become less viable moving forward Demand evidence of impact of test on clinical decision-making/outcomes Exact Sciences has filed lawsuits against Humana, etc. to demand coverage

6 Healthcare delivery is increasingly focused on improving quality, expanding access, and mitigating cost Historically, technologies were valued purely because they were innovative We are now moving into a world in which innovation is merely a tool to facilitate greater access and quality in a cost-effective manner In the US this has taken the form of the Patient Protection and Affordable Care Act (ACA), but payment reform and value seeking has always been an important trend Triple Aim Key Drivers of Healthcare Reforms Cost Control & Financial Stability Expanded Access Quality Improvement Increasing health expenditures Relatively poor outcomes in key indicators Significant numbers of uninsured and underinsured Inefficiencies and variability in care and associated costs Impact of shifting demographics Payment structures that incentivize overuse 2016 Boston Healthcare Associates, Inc. 6 Solution: Improvements in Care Through Valuable Laboratory Medicine

7 When placed in context, laboratory testing has the potential to show value that is disproportionate to its cost Percent Savings 35% 30% 25% 20% 15% 10% 5% Example Impact of a Care Improvement Program Baseline 1st Year of Program 0% Drugs Inpatient Surgical and Anesthesia Radiation Therapy Diagnostic Other Retail Pharmacy E&M Lab / Pathology ER Say, for example a new diagnostic technology is deployed to improve risk assessment and therapy selection for a particular patient population Lab costs usually are only a small part of the total cost of care, while the majority of savings will be seen in other areas (drug spending, inpatient care, etc.) So despite the premium pricing of the new product the net increase in lab costs is outweighed by the reduced spending elsewhere A focus on total costs of care will be able to show that increased spending on laboratory services can be offset by savings in other more costly areas 2016 Boston Healthcare Associates, Inc. 7

8 Approaches to Reimbursement

9 Reimbursement Reimbursement is payment to providers by third-party insurers (payers) in exchange for medical items and services The main components of reimbursement are:! Coverage - What is medically necessary and what is investigational/experimental?! Coding - How does the laboratory describe the test/ laboratory procedure?! Payment - How much is paid for the test?! Payer contracting (service providers only) - Is the lab service provider in-network or out-of-network? Coding Coverage Policy Contracting Payment System All components need to work together to achieve routine optimal payment 2016 Boston Healthcare Associates, Inc. 9

10 Strategic Reimbursement Options The reimbursement strategy needs to be closely aligned with the overall commercial strategy (business/market entry model, regulatory, clinical development, market opportunity, etc.) FEE SCHEDULE BASED, BELOW THE RADAR APPROACH Go below the radar by doing the following: Working within existing reimbursement framework as a low-profile test Using an existing code Securing payment rate relative to Medicare fee schedule rate Providing the test through a contracted lab MINIMAL INVESTMENT OF RESOURCES 2016 Boston Healthcare Associates, Inc. 10 FEE SCHEDULE BASED, ABOVE THE RADAR APPROACH Some combination of the below the radar approach with the following elements: Creation of a new code Driving payer coverage Working to secure higher payment (cross-walking, gapfilling process, or RVU RUC analysis process for anatomic pathology tests) STILL IN A COST BASED SYSTEM BUT WORKING TO ALTER REIMBURSEMENT ENVIRONMENT VALUE BASED APPROACH Consider going above the radar by becoming a highprofile test that can do the following: Interest payers in explicit positive coverage Use a miscellaneous code Receive value-based premium payment (usually in 1000s of dollars) Often in sole-source lab ACTIVE ENGAGEMENT

11 Impact of Clinical Positioning on Coverage: Roles of Tests Position Examples Description Payer Implications Screening Diagnosis Therapeutic Selection Monitoring 2016 Boston Healthcare Associates, Inc. 11 HIV, Pap smears, Prostate Specific Antigen culture, red blood cell count HER2/ Herceptin T-cell counts, ATL for liver disease Performed in the absence of signs, symptoms, or personal history of disease or injury Used to provide opportunity for early intervention Used to differentiate possible causes of symptoms Test indicates whether a patient is a candidate for a particular therapy Used to track disease progression or improvement Also used to identify side effects or complications, monitor drug levels or assess prognosis Payers concerned about overutilization in a large population, especially if in the hands of a primary care provider (PCP) as a point of care test Not typically covered by Medicare Most familiar to payers Sensitivity and specificity are most important Biggest opportunity for tangible immediate cost offset Payers concerned that volume/ cost of repeat testing may not be justified First question by payers is always: How does this change treatment? For example, if you run the test but prescribe the same drug you would have used empirically, then why run the test?

12 Clinical Utility Evidence Development

13 Categorization of Payer Clinical Utility Evidence Needs Typical Need Type Critical Beneficial Analytic validity studies Test analytic accuracy Clinical validity studies Clinical utility studies: change in treatment decision-making Clinical utility studies: outcomes Clinical utility studies: health economic impact Concept verification Initial validation study Publication of chart review to define current approaches to care Decision impact study Payer cost impact assessment 1-year prospective trial interim results Physician survey publication 2-year prospective trial outcomes Patient registry tracking outcomes? Cost-effectiveness analysis (not a requirement in US) 2016 Boston Healthcare Associates, Inc. 13

14 A prospective, non-randomized, multi-site, observational study to show utility for test will also be a critical to strengthen supporting evidence Chart Review Study Historical Comparison Group (Chart Review Data) The historical utilization rates of biopsy and other imaging tools at the chart review sites can be used as a comparison group of patients that did not receive Test Single-arm, Prospective Observational Study Test Group Record the treatment plans for patients receiving Test. Evaluate the utilization rates biopsy and other imaging tools Follow-up Period = ~ Six months* Number of Sites: Three to four sites (25-35 patients per site). Using the same sites as the chart review will provide the most comparable data Number of Patients: N = ~100 patients (50 Test patients, 50 chart reviews)** Primary Endpoints: Comparison of diagnostic utilization rates with Test vs. without Test Secondary Endpoints: Comparison of malignancy rates for patients who receive a biopsy *Overall study duration will depend on speed of Test uptake at chosen breast cancer centers and endpoints measured **Based on expected biopsy reduction of 54%. Sample size necessary for statistical significance will depend on current and expected utilization rates 2016 Boston Healthcare Associates, Inc. 14

15 Case Studies

16 Case Study: OncotypeDx Breast showed success because of a simple strong value story (and financial support) 2007: Coverage by 70% U.S. private insurance, positive BCBC TEC review and Medi-Cal coverage Feb 2009: More than 90% of all U.S. insured lives covered through contracts, agreements, or policy decisions 2005: Kaiser adopts test : Genomic Health goes public 2004: Oncotype DX is launched 2006: Aetna, National Heritage, United Healthcare reimburse (in total, over 100 million lives) *Revenue, SG&A, and R&D figures are in Millions of Dollars High-dollar investments and a good clinical story have driven revenue growth, although it took five years from launch to achieve optimal coverage for OncotypeDx Boston Healthcare Associates, Inc. 16

17 Case Study: Oncotype Colon: Oncotype Dx Colon has yet to be endorsed by guidelines and covered by payers because its clinical relevance is unclear In summary, the information from these tests can further inform the risk of recurrence over other risk factors, but the panel questions the value added. Furthermore, there is no evidence of predictive value in terms of the potential benefit of chemotherapy to any of the available multigene assays. The panel believes that there are insufficient data to recommend the use of multigene assays (Oncotype Dx colon, ColoPrint, ColDx) to determine adjuvant therapy With no studies rated as low or medium risk of bias (RoB), we found no reliable data to inform conclusions about the impact of the Oncotype DX Colon test on treatment decisions United Health Coverage based on secondary research Aetna Cigna Kaiser Permanente Humana Health Net Enrollment 45m 22m 14m 9.6m 9.8m 6m Coverage Oncotype Dx colon is not included in clinical guidelines because of a lack of predictive value resulting in non-coverage Boston Healthcare Associates, Inc. 17

18 Implications for Innovators

19 The diagnostics industry is confronting a changing sales model and customer type and evolving evidence needs Diagnostics Historically Site of Care: Hospital Customer: Laboratorian Value messages: cost avoidance, platform feature improvement (turnaround time, sample processing capacity, broader test menu, footprint) Evidence development: minimal, focus on demonstrating analytical validity/ accuracy meeting regulatory requirements (e.g., concordance studies) Diagnostics in the Future Site of Care: hospital systems and centralized reference laboratories, private clinics Customer: strategic sale to multiple stakeholders including lab, physician, hospital administration, and payer Value messages: Improvements in workflow/testing capabilities translate into meaningful clinical impact and efficiencies in care delivery Evidence development: focused on defining clinical utility (clinical/cost impact), showing improvements in care delivery in head to head comparisons with existing technologies To avoid race to the bottom diagnostics we must focus on value propositions which extend beyond traditional laboratory value messages/sale 2016 Boston Healthcare Associates, Inc. 19

20 Refine Value Proposition: In the evolving health care value environment, innovators must combine both technologies and processes to deliver clinical, economic, and practice success for customers Analytical Framework: Value Dimensions Care Delivery: Clinical Impact Care Delivery: Economic Impact / Revenue and Cost Stakeholders are seeking value through managing increased access, improved quality, and financial stability Training / Education Connectivity / Performance Measurement and Documentation Strategic Solutions that address Customer Value Perspectives Distribution / Logistics Patient Satisfaction / Experience / Others Stakeholders will demand more than novel tools: Customers will need the tools to effectively integrate these technologies into clinical practice and demonstrate value 2016 Boston Healthcare Associates, Inc. 20

21 Real-world data comes from a variety of sources, each their own strengths and limitations Social media Payer claims databases Consumer data Test results, lab values, pathology results Observational Clinical Trials Real- World Evidence Hospital Visit Data Electronic medical and health records Health Care Utilization Surveys Patient Registries Real World Evidence Strengths + Can provide answers to important clinical and economic questions without the cost and complexity of RCT prospective clinical trials + Reflects actual behavior of physicians and patients in real-life care settings + Once a real world data set is organized it can potentially be used for multiple purposes Limitations - No one data source can address all needs - Data aggregation/organization and quality can be a challenge - Data mining can lead to identification of relationships which are correlations rather than causative Real-world evidence can be drawn from a variety of sources. Data integration and quality can be a real challenge. Clear research questions and a comprehensive plan for collection are needed Boston Healthcare Associates, Inc. 21

22 Key Takeaways 1) Innovators must look for opportunities to align technical capabilities/ market opportunities with a reasonable pathway to reimbursement 2) Payer reimbursement environment is increasingly complicated and evidence demands are increasing 3) Innovators can successfully launch premium priced products as long as they have strong clinical and economic value propositions 4) Innovators must first focus on non-traditional value messages like overall improvement and care and clinical utility 5) Laboratory innovators should look for opportunities to show value in situations where providers are assuming greater responsibility for episodes of care and patient populations (ACOs) and use real world evidence (RWE) to show that value 2016 Boston Healthcare Associates, Inc. 22

23 Thank You Charles Mathews Vice President Boston Healthcare (617)