Transcript Issues in Oncology: A Payer
Provider Collaborations in Oncology
Finding Common Ground
ON76175 02/2012 © 2012, Lilly USA, LLC.
This program is sponsored by and the speaker is presenting on behalf of Lilly USA, LLC. It is being presented consistent with FDA guidelines and is not approved for continuing education credit.
Jim M. Koeller, MS
Professor and Eli Lilly/C.R. Sublett Endowed Fellow in Pharmacy Adjoint Professor of Medicine and Oncology Member of the Center for Pharmacoeconomic Studies Recipient of numerous awards, including an American Cancer Society National Merit award and an invitee of the American Society of Clinical Oncology Cancer Experts Serves on the editorial board of the journal
Pharmacotherapy
while serving as a reviewer for several other oncology- and pharmacy-related journals Research focuses on healthcare economics, pharmacoeconomics, and outcomes research primarily in cancer, but also in other disease areas 2
Meeting Considerations
During this meeting, we encourage you to
– – – Speak candidly Ask questions Share ideas
Our goal is to gain a better understanding of the most pressing issues in cancer care
Discussions regarding specific cancer agents or claims related to specific products or classes of medications should be avoided
Off-label product discussions are prohibited at all times
3
Presentation Overview
Oncology Care in a Changing Healthcare Environment
Current Oncology Practice and Reimbursement Landscape
Establishing Value in Cancer Care
4
The Current Oncology Landscape
Payers
• • • Controlling rapidly escalating cancer treatment costs 1,2 Managing off-label prescription use 3 Supporting cost effective quality cancer care 1,2
Providers
1,4
• • • Utilizing new agents and therapies Incorporating evolving standards of care into practice Efficiently operating an oncology practice
Patients
1,5
• • Accessing appropriate care in a timely manner Receiving high quality cancer care 1. Goldsmith M. Presented at: The Center for Business Intelligence 3rd Annual Effective Oncology Benefit Management Conference; October 6, 2008; Chicago, IL.
2. Kuzner W. Association for Value-Based Cancer Care Web site. http://www.valuebasedcancer.com/article/payer-trends-oncology challenges-and-solutions. Accessed January 20, 2012.
3. Reinke T.
Manag Care
. 2011;20(9):14-16. http://www.managedcaremag.com/archives/1109/1109.medmgmt.html. Accessed January 29, 2012.
4. Fuerst M.
Oncol Times
. 2010;32(16):20-22.
5. Healthreform.GOV Web site. http://www.healthreform.gov/reports/breastcancer/breastcancer3.pdf. Accessed January 23, 2012.
5
Oncology Care in a Changing Healthcare Environment
Oncology Care in a Changing Healthcare Environment
Healthcare reform 1-3 – The Affordable Care Act (ACA) contains a number of provisions that impact oncology practices • • • Patient-centered medical homes (PCMHs) Hospital value-based purchasing (VBP) Accountable care organizations (ACOs) Pathways 4 – Combine evidence-based practices and clinical community consensus to develop consistent treatment approaches Comprehensive medical home 5,6 – – Horizontal patient management system Includes evidence-based medicine, pathways, 7 nursing care, and end-of-life care 1. Healthcare.gov Web site. http://www.healthcare.gov/law/timeline/full.html. Accessed January 4, 2012.
2. Healthcare.gov Web site. http://www.healthcare.gov/prevention/nphpphc/advisorygrp/cmmi-prevention-health-promotion-10032011.pdf.
Accessed January 4, 2012.
3. AHRQ Web site. http://pcmh.ahrq.gov/portal/server.pt/community/pcmh__home/1483/what_is_pcmh_. Accessed February 13, 2012.
4. Butcher L.
Oncol Times
. 2010;32(12):11-13. http://journals.lww.com/oncology-times/Fulltext/2010/06250/Cancer_Care_Pathways_ Catching_on_with_Payers.1.aspx. Accessed January 4, 2012.
5. Nutting PA, et al.
Health Aff (Millwood)
. 2011;30(3):439-445.
6. Eagle D, Sprandio J.
Oncology (Williston Park)
. 2011;25(7). Cancer Network Web site. http://www.cancernetwork.com/practice/content/ article/10165/1875328. Accessed January 12, 2012.
7. Neubauer MA, et al.
J Oncol Pract
. 2010;6(1):12-18.
7
Healthcare Reform
The Affordable Care Act (ACA) of 2010 contains a number of provisions that will affect healthcare, including the practice of oncology 1-3 Examples of ACA provisions include – – – Accountable care organizations (ACOs) 1 Patient-centered medical homes (PCMHs) 2,3 Hospital value-based purchasing (VBP) 1 By 2014, state exchanges formed as a result of the ACA will begin offering medical insurance, 1 which will cover many Americans who previously may not have been covered 1. Healthcare.gov Web site. http://www.healthcare.gov/law/timeline/full.html. Accessed January 4, 2012.
2. Healthcare.gov Web site. http://www.healthcare.gov/prevention/nphpphc/advisorygrp/cmmi-prevention-health-promotion-10032011.pdf.
Accessed January 4, 2012.
3. AHRQ Web site. http://pcmh.ahrq.gov/portal/server.pt/community/pcmh__home/1483/what_is_pcmh_. Accessed February 13, 2012.
8
Pathways
Pathways combine evidence-based practices and clinical community consensus to develop consistent treatment approaches 1 Pathways from many sources are being integrated into the practice of oncology 1 Two studies of pathways showed cost advantages of on-pathway versus off pathway treatment, with outcomes consistent with the published literature 2,3 Pathways may enable oncologists and oncology practices to better position themselves to participate with ACOs, PCMHs, and other stakeholders 4 The impact of ACOs, PCMHs, and hospital VBP will likely be felt first in Medicare reimbursement, followed by private payers 1. Butcher L.
Oncol Times
. 2010;32(12):11-13. http://journals.lww.com/oncology-times/Fulltext/2010/06250/Cancer_Care_Pathways_ Catching_on_with_Payers.1.aspx. Accessed January 4, 2012.
2. Neubauer MA, et al.
J Oncol Pract
. 2010;6(1):12-18.
3. Hoverman JR, et al.
J Oncol Pract
. 2011;7(suppl 3):52s-59s.
4. D3 Oncology Solutions Web site. http://www.d3onc.com/pathways. Accessed January 4, 2012.
9
Comprehensive Medical Home
The Oncology Patient-Centered Medical Home ™ * (OPCMH) model provides a partial solution to fragmented delivery of care 1,2 Key features of OPCMH include 1,3 – Open access, enhanced care coordination, comprehensive care, and sustained personal relationships An oncology practice becomes the central coordinator of care throughout all phases of a patient’s treatment after a cancer diagnosis 1 – Surgery, radiation, chemotherapy, and survivorship OPCMH represents a logical platform to build a value-oriented, outcome-based system of delivering care by addressing important challenges 1 – Cost control, quality assurance, outcome measures, and process improvement *Oncology Patient Centered Medical Home™ is a trademark of the National Committee for Quality Assurance.
1. Eagle D, Sprandio J.
Oncology (Williston Park)
. 2011;25(7). Cancer Network Web site. http://www.cancernetwork.com/practice/content/article/10165/1875328. Accessed January 12, 2012.
2. Sprandio JD.
Commun Oncol.
2010;7:565-572. 3. Nutting PA, et al.
Health Aff (Millwood)
. 2011;30(3):439-445.
10
Survivorship and Chronic Care
Survivorship and chronic care are part of the national healthcare continuum of-care priority 1,2 The number of cancer survivors has more than tripled —to almost 10 million —over the past 30 years, and survival rates are increasing 3 Guidelines for survivorship and chronic care are included in accreditation standards established by the Commission on Cancer, representing 30% of all hospitals and more than 70% of newly diagnosed cancer patients annually 2 Primary care physicians seldom receive explicit guidance from oncologists 4 1. NQF Web site. http://www.qualityforum.org/projects/care_coordination.aspx. Accessed January 4, 2012.
2. Commission on Cancer Web site. http://www.facs.org/cancer/coc/cocprogramstandards2012.pdf. Accessed January 4, 2012.
3. IOM Web site. http://www.iom.edu/~/media/Files/Report%20Files/2005/From-Cancer-Patient-to-Cancer-Survivor-Lost-in-Transition/ factsheetfactsandfigures.pdf. Accessed January 9, 2012.
4. IOM Web site. http://iom.edu/Reports/2005/From-Cancer-Patient-to-Cancer-Survivor-Lost-in-Transition.aspx. Accessed January 4, 2012.
11
End-of-Life Care
Organizations such as the National Quality Forum (NQF) and NCCN have developed preferred practices and performance measures for palliative and end-of-life care 1,2 – Includes the coordination of multiple specialists More than 1 million people die each year without access to palliative and end-of-life services 3 Medicare paid for over 83% of all hospice care in 2009 4 – The median time in hospice is 17 days 5 1. NQF Web site. http://www.qualityforum.org/Projects/n-r/Palliative_and_Hospice_Care_Framework/Palliative___Hospice_Care__ Framework_and_Practices.aspx. Accessed January 4, 2012.
2. NCCN Web site. http://www.nccn.org/professionals/physician_gls/pdf/palliative.pdf. Accessed January 4, 2012.
3. NQF Web site. http://www.qualityforum.org/Topics/Palliative_and_End-of-Life_Care.aspx. Accessed January 4, 2012.
4. Senior Journal.com Web site. http://www.seniorjournal.com/NEWS/Eldercare/2010/20101011-HospiceCareIncreasingBut.htm. Published October 11, 2010. Accessed January 4, 2012.
5. Rau J.
New York Times
. June 28, 2011:D1.
12
Current Oncology Practice and Reimbursement Landscape
Current Oncology Practice and Reimbursement Landscape
Changing sites of care 1 – Shifting of patients from private clinics to hospital/health system care Alternate reimbursement models 2,3 – Pay for performance, episodes/segments of care Oral oncolytics 4,5 – Maintaining continuity of care with the use of outpatient oral agents 6 Risk evaluation and mitigation strategies (REMS) 7 – Potential risks of complex REMS with regard to patient care Biosimilars 8 – Approval of biosimilars may reduce cost and increase accessibility 1. COA Web site. http://www.communityoncology.org/UserFiles/files/87f3205e-ee73-4b03-85fb-094870cc430d/COA%20Community%20 Oncology%20Practice%20Impact%20Report%203-31-11(1).pdf. Accessed January 4, 2012.
2. ANCO Webinar. http://www.anco-online.org/P3InnoventANCOWebinar.pdf. Accessed February 13, 2012.
3. Burns J.
Manag Care
. 2011;20(1):12-14, 16. http://www.managedcaremag.com/archives/1101/1101.cancerdrugs.html. Accessed January 4, 2012.
4. CuraScript. http://www.curascript.com/bin_web/documents/08DrugTrendReportCuraScript.pdf. Accessed January 10, 2012.
5. EMD Serono. Rockland, MA: EMD Serono; 2011.
6. Partridge AH, et al.
J Natl Cancer Inst
. 2002;94(9):652-661.
7. DeMartino J. OncLive Web site. http://www.onclive.com/publications/obtn/2011/January-2011/impact-of-risk-evaluation-and-mitigation strategies-in-oncology. Accessed January 29, 2012.
8. Kozlowski S, et al.
N Engl J Med
. 2011;365(5):385-388.
14
Changing Sites of Care
Due mainly to cuts in chemotherapy reimbursement, the Community Oncology Alliance (COA) reports that from October 2007 to March 2011 1 – – – – – 241 clinics closed 442 struggling financially 48 practices sent patients elsewhere for chemotherapy 392 practices were acquired by hospitals 132 practices merged or were acquired by other corporate entities Between 2005 and 2008, the medical spend on specialty drugs, in general, shifted from physicians’ offices to outpatient facilities 2 – – For physicians, shifting from 76% to 63% of spend For outpatient facilities, shifting from 13% to 22% of spend 1. COA Web site. http://www.communityoncology.org/UserFiles/files/87f3205e-ee73-4b03-85fb-094870cc430d/COA%20Community%20 Oncology%20Practice%20Impact%20Report%203-31-11(1).pdf. Accessed January 4, 2012.
2. Express Scripts.
2010 Drug Trend Report
.
15
Pay-for-Performance (P4P)
Also known as P4P or VBP, this payment model rewards physicians, hospitals, medical groups, and other healthcare providers for meeting certain performance measures for quality and efficiency P4P can be integrated into pathways programs P4P seeks to generate cost-efficiencies through – – – – – Evidence-based, high-quality care Health information technology Outcomes measurement Clinical/financial analytics Patient support Abbreviation: VBP, value-based purchasing. Also called VBR, value-based reimbursement.
ANCO Webinar. http://www.anco-online.org/P3InnoventANCOWebinar.pdf. Accessed February 13, 2012.
16
Episodes of Care
This payment model reimburses for an “episode of care” by bundling payments to groups for the full cost of care for each cancer patient The payer may freeze drug margins in an episodes-of-care model, which would replace the buy-and-bill approach The payer may continue to pay for drug costs, office visits, and administration fees on a fee-for-service (FFS) basis, allowing for inflation In an episodes-of-care model, quality and outcomes are closely monitored Burns J.
Manag Care
. 2011;20(1):12-14, 16. http://www.managedcaremag.com/archives/1101/1101.cancerdrugs.html. Accessed January 4, 2012.
17
Oral Oncolytics
New oral oncology agents are coming into a market historically dominated by infused/IV medications, with many oral agents in the product development pipeline 1 More than 90% of payers reimburse for oral oncology agents under the pharmacy benefit as opposed to the medical benefit 2 – Payers can more easily track pharmacy claims, which may give them more control over drug utilization. Although about three-fourths of payers now track drug spend and cost trends under the medical benefit, as well In general, cancer treatment places a greater financial burden on patients than the cost of treatment for other chronic conditions 3 1. CuraScript. http://www.curascript.com/bin_web/documents/08DrugTrendReportCuraScript.pdf. Accessed January 10, 2012.
2. EMD Serono. Rockland, MA: EMD Serono; 2011.
3. Bernard DS, et al.
J Clin Oncol
. 2011;29(20):2821-2826.
18
Risk Evaluation and Mitigation Strategies (REMS)
In 2007, the FDA received the authority to require a REMS from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks 1 Some oncology drugs and supportive-care medications (eg, opioids for pain management) have associated REMS 2 Drugs with complex REMS create significantly more work for prescribers and dispensers, which may reduce the likelihood of their use and patient access to appropriate care 2 The results of a 2010 NCCN Trends Survey found that 2 – – 55% of respondents believed REMS will interfere with the provision of care 60% of respondents agreed REMS will drive utilization toward drugs without REMS REMS programs should not overburden the healthcare system, drive utilization to less effective drugs, or increase or create healthcare disparities for cancer patients 2 Abbreviation: FDA, Food and Drug Administration; NCCN, National Comprehensive Cancer Network.
1. FDA Web site. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm. Accessed January 4, 2012.
2. DeMartino J. OncLive Web site. http://www.onclive.com/publications/obtn/2011/January-2011/impact-of-risk-evaluation-and mitigation-strategies-in-oncology. Accessed January 29, 2012.
19
Biosimilars
Biologics are costly because they are complex to develop and manufacture 1 Biosimilars may increase the affordability and access to biologic medications for patients 1 – Primary reason for the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which is part of the 2010 Affordable Care Act Biosimilars present multiple challenges, particularly in determining how similar is similar enough when substituting complex biologics in clinical practice 2 Biosimilars must meet a higher standard of similarity to a reference product (ie, “interchangeability”) 2 – Must produce the same clinical result in any given patient with no greater safety risks when switching from a biologic to a biosimilar Uncertainty exists about how biosimilars will be covered, reimbursed, and handled in the United States 1 1. Zelenetz AZ, et al.
J Natl Compr Canc Netw
. 2011;9(suppl 4):S1-S22. 2. Kozlowski S, et al.
N Engl J Med.
2011
;
365(5):385-388.
20
Establishing Value in Cancer Care
Establishing Value in Cancer Care
Measuring outcomes and endpoints 1 – Quantitative and qualitative measures Measures versus process – Utilizing electronic medical records (EMRs) and pathways to improve practice efficiencies and establish treatment patterns 2,3 – Selective outcome measures 1,2,4 1. FDA Web site. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf. Accessed January 29, 2012. 2. Kanas G, et al.
ClinicoEconomics Outcomes Res
. 2010;2:1-14.
3. Lau EC, et al.
Clin Epidemiol.
2011;3:259-272.
4. CMS.gov. https://www.cms.gov/EHRIncentivePrograms/30_Meaningful_Use.asp. Accessed January 29, 2012.
22
Outcome Measures or Clinical Endpoints in Oncology
Clinical trials measure the safety and efficacy (or clinical benefit) of interventions used against a disease • Quantitative endpoints in clinical oncology studies include – Overall survival (OS) – – Symptom endpoints (patient-reported outcomes) Surrogate endpoints are based on tumor assessment • Disease-free survival (DFS); Progression-free survival (PFS); Response rate (RR); Time to Treatment Failure (TTP) Are these measures practical in community practice?
• Besides OS, most of these measures are probably not practical in every-day practice • Measurements would not be consistent or reproducible FDA Web site. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf. Accessed January 29, 2012. 23
Outcome Measures or Clinical Endpoints in Oncology
Measures that may ‘represent’ good/bad care (also referred to as down-stream endpoints) ~ Surrogate Markers
Transfusions
Return clinic visits
ER visits
Hospitalizations
Infections
Hydration
Cancer care by inference
To conclude from certain premises or evidence
FDA Web site. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf. Accessed January 29, 2012. 24
Electronic Medical Records (EMRs)
The use of EMRs in clinical medicine can help improve the quality of patient care, reduce the cost of healthcare, and facilitate the transfer of patient information among providers 1,2 – Easier to analyze and typically more cost-effective than chart reviews 3 Large increases in the use of EMRs have been reported by community cancer programs —84% in 2009 vs 65% in 2008 4 – 54% of them use more than 1 software program A 2010 survey found that EMRs were adopted by about 50% of office-based physicians —an increase of more than 30% from 2009 2,5 – Unfortunately, only 10% of EMR systems were considered fully functional Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs provide a financial incentive for the "meaningful use" of certified EHR technology 6 – Providers must use the technology in ways that can be measured significantly in quantity and quality 1. Kanas G, et al.
ClinicoEconomics Outcomes Res
. 2010;2:1-14.
2. Mehta NB, Partin MH.
Cleve Clin J Med
. 2007;74(11):826-830. 3. Lau EC, et al.
Clin Epidemiol.
2011;3:259-272.
4. Eastman P.
Oncol Times
. 2010;32(16):19-20.
5. Hsiao CJ, et al. NCHS Health E-Stat. 2010.
6. CMS.gov. https://www.cms.gov/EHRIncentivePrograms/30_Meaningful_Use.asp. Accessed January 29, 2012.
25
Bibliography
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Association of Northern California Oncologists (ANCO). Realizing pay for performance: moving from fee-for-service to value-based reimbursement. ANCO Webinar, October 26, 2010. http://www.anco-online.org/P3InnoventANCOWebinar.pdf. Accessed February 13, 2012.
Bernard DS, Farr SL, Fang Z. National estimates of out-of-pocket health care expenditure burdens among nonelderly adults with cancer: 2001 to 2008.
J Clin Oncol
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Manag Care
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Butcher L. Cancer care pathways catching on with payers. Accessed January 4, 2012.
Oncol Times
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Commission on Cancer.
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Community Oncology Alliance (COA). Community oncology cancer care practice impact report. COA Web site. http://www.communityoncology.org/UserFiles/files/87f3205e-ee73-4b03-85fb-094870cc430d/COA% 20Community%20Oncology%20Practice%20Impact%20Report%203-31-11(1).pdf. Accessed January 4, 2012.
CuraScript.
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27
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Oncology (Williston Park)
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Eastman P. ACCC Survey: economic recession slows cancer centers’ equipment purchases, hiring.
Oncol Times
. 2010;32(16):19-20.
EMD Serono. EMD Serono Specialty Digest, 7th ed. Rockland, MA: EMD Serono; 2011.
Express Scripts.
2010 Drug Trend Report
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Clin Epidemiol.
2011;3:259-272.
Mehta NB, Partin MH. Electronic health records: a primer for practicing physicians.
Cleve Clin J Med
. 2007;74(11):826-830.
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Neubauer MA, Hoverman JR, Kolodziej M, et al. Cost effectiveness of evidence-based treatment guidelines for the treatment of non-small-cell lung cancer in the community setting.
J Oncol Pract
. 2010;6(1):12-18.
Nutting PA, Crabtree BF, Miller WL, et al. Transforming physician practices to patient-centered medical homes: lessons from the National Demonstration Project.
Health Aff (Millwood)
. 2011;30(3):439-445.
30
Bibliography
(cont) Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to therapy with oral antineoplastic agents.
J Natl Cancer Inst
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Rau J. Concerns about costs rise with hospices’ use.
New York Times
. June 28, 2011:D1.
Reinke T. Plans and oncologists don't see eye to eye on prior authorization.
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Sprandio JD. Oncology patient-centered medical home and accountable cancer care.
Commun Oncol.
2010;7:565-572. Zelenetz AZ, Ahmed I, Braud EL, et al. NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives.
J Natl Compr Canc Netw.
2011;9(suppl 4):S1-22.
31