Standard Of Care Costs in Clinical Trials

An Oncology-Focused CRO Perspective

Presented by:

Donna BeardsworthFounder

Beardsworth – An Oncology-Focused CRO

• Since 1986• NJ-based, WEBENC-Certified, Woman-Owned

Business• Full Service CRO

– Serving Pharma, Biotech, Device, and Diagnostic Companies

– Phases I through 4– Regulatory Strategy Consulting, Project Management,

Clinical Monitoring, Data Management, Biostatistics, Medical Writing, Safety and Surveillance

• Global Services in Eastern and Western Europe via Beardsworth’s OncologyOne

Solid Tumors• Advanced Tumors• Brain• Breast• Colorectal• Esophagus• Head and Neck• Lung• Malignant Melanoma• Ovary• Prostate• Renal Cell

Therapeutic Area Expertise: Oncology

Hematologic Malignancies• Acute Myelogenous

Leukemia• Chronic Lymphocytic

Leukemia• Hairy Cell Leukemia• Multiple Myeloma

Oncology-Related • Associated Anemia• Associated Dysphagia• Associated Xerostomia• GvHD post BMT• Quality of Life

Oncology Trial Challenges Today

• Only 3% of adult cancer patients in the US participate in trials – There is tremendous competition for these patients– There is a crisis of perception regarding clinical trial

integrity and motivations– Most trials are NOT completed on time– US based CROs must have a Global Enrollment Solution

• Costs to Conduct Trials are Escalating– Trials are complicated and becoming more so– Endpoints generally require long-term follow-up– Sponsor, CRO, and Site Grant Costs increase reflecting

complexity and long-term nature

SOC Usage

• TTC recently surveyed 50 companies; asking them to rate the importance of Standard of Care.

Very Important 73%

Somewhat Important 23%

Not Very Important 3%

Not At All Important 1%

Total 100%

The Importance of Standard of Care Considerations in Your Company’s Approach to Developing Clinical Grants

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SOC Usage

• Companies are concerned about fair market value and more effective clinical grant management.

Percent

Avoid paying for procedures covered by third parties 85%

Insure paying fair market value by avoiding possible double payment 83%

Assist in protocol design 81%

Reasons for Using SOC to Incorporate SOC Considerations

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• Outside of oncology few companies attempt to achieve the cost savings possible through the incorporation of Standard of Care.

• Nearly two thirds of respondents feel the process is too time-consuming.

• Most express the need for more data.

• Most companies rely upon laborious processes and sources, e.g., sites and internal experts, for information.

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SOC Usage

Impediments to SOC Usage• It may be time-consuming to gather the SOC data

from sites, staff experts, and outside experts.

• It may hinder contract negotiations.

• It works in oncology.

• There is no evidence that it slows contract completion in clinical grant management.

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National Comprehensive Cancer Network

• NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) – Recognized standard for clinical policy in oncology

• Most comprehensive and most frequently updated clinical practice guidelines available in any area of medicine

• Covering 97 percent of all patients with cancer and updated on a continual basis

National Comprehensive Cancer Network

• Consortium of 21 not-for-profit US hospitals and institutions – Publishes 110 oncology guidelines that are “recognized and

applied as the standard of care in the United States” – Guidelines viewed by over 1 million unique visitors per

year.• According to surveys of oncologists conducted by

NCCN and other groups:– ~ 90 percent of oncologists in the US report that they

use the NCCN guidelines in their practice frequently or very frequently.

NCCN Guidelines and 3rd Party Payers

March 2010 – NCCN Meeting “Clinical and Economic Issues Impacting Cancer Care Delivery.”

• Aetna Inc. James D. Cross, MD– Spends upwards of $1.5 billion a year on cancer care– Uses the NCCN Guidelines as part of its care decisions

as well as reimbursement methodology• UnitedHealthcare

– Spends $3 billion annually on cancer care – Utilizes the NCCN Guidelines and NCCN Drugs &

Biologics Compendium (NCCN Compendium™) to make coverage decisions

Trial Design and Implementation Considerations

• Protocols – Patient Visits/Procedures are timed to reflect SOC

regimens– Concomitant Therapies are aligned with SOC

• Budgets and Grants – Contracts and Budget Grids are Fairly Straightforward

• Costs for the un- or under-insured must be delineated– Requires Detailed Grant Payment Work

• Procedure Based vs. Visit Based Payments to Sites• Costs to Process increase

Two Oncology Trials Analyzed

SOC Analysis – Acute Lymphoid Leukemia, Acute Lymphoblastic Leukemia, Leukemia

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Single Patient Duration 36 Months

Number of Visits 34

Number of Patients 22

Number of Procedures 42

Number of SOC Procedures 34

Number of Expensive SOC Procedures 2

Total Cost for Procedures Per Patient before SOC $52,264 USD

Total Cost for Procedures Per Patient after SOC $ 34,662 USD

Total SOC Savings Per Patient $ 17,602 USD

Total SOC Savings for All Patients $ 387, 244 USD

Total % of SOC Savings 34 %

SOC Analysis – Ovarian Cancer

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Single Patient Duration 89 Weeks

Number of Visits 163

Number of Patients 360

Number of Procedures 18

Number of SOC Procedures 12

Number of Expensive Procedures 2

Total Cost for Procedures Per Patient before SOC $ 109,423 USD

Total Cost for Procedures Per Patient after SOC $91,087 USD

Total SOC Savings Per Patient $ 18,336 USD

Total SOC Savings for All Patients $6,600,960 USD

Total % of SOC Savings 16.8%

Challenges

• The shift of oncology trial patients from US to other parts of the world– Different healthcare funding– Different motivators for trial participation

Why it Works in Oncology• In the US, Well-defined, Detailed, Generally

Accepted Guidelines exist and are: – Followed by US oncologists– Reimbursed by 3rd Party Payers

• Protocols are built in detail around the Guidelines that define SOC and are in Common Practice

• The Complexity and Duration of Oncology Trials drives costs up – The SOC impact is considerable

• Trivializes the additional steps required for contract and grant design and management