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BIOCOM :: Reimbursement

BIOCOM's Reimbursement & Market Access committee's second education offering of 2011 was a panel discussion of Healthcare Reform. Each of the business sectors represented in BIOCOM - diagnostics, device and drug - presented their view on why we have Healthcare Reform and what it means to that share of the market. With 19% of the federal budget being spent on Medicare and Medicaid programs, increasing costs and decreasing quality issues are helping to drive reform.

The panel discussion was moderated by Kathleen Juniper, Partner, from Hooper, Lundy and Bookman, P.C.
A summary of key points along with presentations from the speakers are below:

Drug - Jennie Best, Amylin

• New rule for BioSimilars for prescription drugs. Comparative Effectiveness research must be conducted with active patient reported outcomes (PRO).
• Improvements have been made in Part D prevention coverage but payment s will be affected
o Payers impacted by program cuts and new fees
• Cost to the pharma industry estimated to be 78 billion

Diagnostic - Darron Segall, Quidel Corporation

• Impact seen as decreasing pricing pressure
• New decision makers with variations of who those people are across payers
• Paradigm shift as payers are being viewed as a partner not an adversary by diagnostic companies
• Reimbursement was based upon effacy and safety, but it is shifting to value for patient outcomes
o Payers view is the clinical outcomes is a good measure of ACO success
• Market Access is difficult for a new product
o Need better defined evidence based requirements
o Keys to success are HEOR and Reimbursement integration, Corporate objectives need to be aligned at the top with commercial operations, pricing and reimbursement

Devices - Richard Strobridge, Entra Health Systems

• As a manufacture of wireless blood glucose monitors, this company looked deeply at what Health Care Reform would mean to them as a new company.
• They asked two questions when looking to put a new device on the market - Who will pay and Did we have market access?
• Entra feels strongly that payers are partners and they plan to work formularies with private payers to be able to obtain payment

Question and Answer Session
1. What's different about the formularies?
a. They apply to drugs and devices. Tier 1 is O co-pay, tier 2 is 10% and tier 3 is 20%

2. When going to market, should one focus on the US or Europe?
a. Look outside of the US as the primary option to get more data to substantiate US FDA requirements

3. How does each of you feel about the impact of Health Care Reform on your respective industries?
a. Drug - increase in fees, but increase in market access
b. Device - neutral to good - new ACO opportunities
c. Diagnostic - neutral to good - New ACO opportunities

4. What have you changed because of Health Care Reform?
a. Drug- No placebos but better, comparative effectiveness for clinical trials
b. Device - more hard dollar data ROI
c. Diagnostic - increased efforts to engage insurances, include more studies and funding for HEOR

5. In 2014, non-covered lives become covered (approximately 85 million)....are you planning on capturing these lives?
a. All answered yes. Medicaid plans will increase in scope as managed care organizations increase quality care and decrease cost. Important for companies to know how to present your company to the insurance companies

6. How do you start the partnering process?
a. Hire people with connections at the insurance companies
b. Network
c. Join advocacy societies
d. Reach out to provider organizations - if they want it, they can bring it to the insurance company's attention

Feeling lost, want to learn more? Your company is not alone. In this session, changes enacted by the recent passage of The Patient Protection and Affordable Care Act, were explored. Part 3 of our 5 part series will feature a discussion on Risk-Sharing programs as a means to achieving market access and will be held June 14, 2011. Register at www.biocom.org.

By:
Carol Stoyla
Millenium Laboratorie

BIOCOM's Reimbursement & Market Access committee kicked off their 2011 seminar series with a successful and well-attended session on "Understanding Global Market Access and Reimbursement" on February 8. All too often, manufacturers of drugs, devices or diagnostics fail to adequately understand and address the market access and reimbursement needs of the marketplace and consequently fail to leverage the value and optimize the commercial success of their products. Featured speakers, Bruce Quinn, MD, MBA, Senior Health Policy Specialist at Foley Hoag, LLP and Michael Pollock, President of Reynolds, Pollock & Associates provided attendees with a well-rounded introduction to US reimbursement strategies and global market access.

A summary of key points from their topics follow below:

• Achieving optimal pricing, reimbursement and utilization should be the goal for any new product development or commercialization team; unfortunately, this is missing in many companies and is a disservice to the product itself and to patients
• To succeed in the maze, companies that consider barriers to entry beyond just the FDA and CMS will be better positioned to gain market access for their products
• A firm understanding of the target patient population for a product is integral in understanding which payors, or insurance carriers, will most influence market access
• Keen knowledge of coding systems and how reimbursement and pricing play into a product will assist in further developing market strategies
• Generating the evidence necessary to meet clinical and health outcome benefits that result in positive coverage or technology assessments are crucial; non-coverage policies and negative technology assessments among major payers can have a tremendous effect on utilization
• Economic value (cost-effectiveness and cost-utility) and budget impact is increasingly becoming a focus of payors within the US as is already the case outside of the states; this is an essential component of achieving market access and is typically demonstrated by using an economic model based on pivotal Phase III studies

Michael Pollock Slides

Bruce Quinn Slides

Feeling lost, want to learn more? Your company is not alone. In this session, ISPOR was cited in this as a tremendous resource for those seeking information on health economic and outcomes research for pharma, therapeutic and diagnostic devices.

Part 2 of our 5 part series will feature a panel from all sectors that will speak on the potential impact of health reform on their business so that you can learn from their mistakes and emulate their successes. Health Reform: Legislative Overview and Impact on Market Access will be hosted by BIOCOM on Tuesday, April 12. Click here www.biocom.org to register today.