payers

Podcast brought to you by the upcoming Personalized Medicine World Conference taking place in Mountain View, CA, January 28-29. Over 100 speakers in three tracks will discuss how best to navigate the changing landscape of personalized medicine.

Guest:

Ira Klein, MD, Chief of Staff, Office of the Chief Medical Officer, AETNA Bio and Contact Info

Listen (8:55) How do you determine when to pay for a Dx?

Listen (3:45) Are you opposed to covering a test before FDA approval?

Listen (2:56) How do you help physicians keep up with new Dx technology?

Listen (8:43) The problem of misaligned incentives

Listen (4:19) Are diagnostics way undervalued?

Our last show in the series, Commercializing Diagnostics, is from the payer's viewpoint. Reimbursement has become the biggest challenge for Dx companies, so we ask Ira Klein from Aetna to talk about the issues: How does Aetna go about deciding whether to cover a diagnostic? Do they always wait and follow the FDA's lead? What about the unregulated LDT's out there such as CardioDx's CAD test? Formerly a physician himself, Dr. Klein takes us into his world and explores the issues he faces as medicine changes. A fan of the new healthcare law, Klein sees diagnostics and personalized medicine as having a positive impact on the challenges of escalating costs and an aging population. Are diagnostics way undervalued, as Roche's Walter Koch asserted on the program? Tune in for Ira's answer.

Podcast brought to you by the upcoming Personalized Medicine World Conference taking place in Mountain View, CA, January 28-29. Over 100 speakers in three tracks will discuss how best to navigate the changing landscape of personalized medicine.

Guest:

Walter Koch, PhD, Vice President, Head of Research, Roche Molecular Diagnostics Bio and Contact Info

Listen (4:07) Why hasn't the sequencing of the human genome led to more therapeutics?

Listen (8:48) Every drug in development at Roche has to have a biomarker strategy

Listen (4:53) Barriers to clinical adoption vary by disease area

Listen (6:33) Dealing with unlevel regulatory playing field for CoDx and LDTs

Listen (6:02) Whole genome tests and the FDA

Listen (2:32) Diagnostics undervalued

We often use the term 'big pharma.' Will we one day be writing about 'big diagnostics' as well? As part of our series Commercializing Diagnostics, we're joined by the head of global research at Roche Molecular Systems, Walter Koch. Walter joined Roche in 1998 when the first drafts of the human genome were coming out. In today's interview he admits to his naivety at the time the human genome sequence was completed about how soon we'd realize therapeutic results. Walter dives into Roche's drug development and companion diagnostic strategy and in the end looks forward to clinical genome sequencing. Walter was formerly at the FDA and puts in his two cents about how to deal with the unlevel playing field between the regulation of CoDx and LDTs.

Podcast brought to you by: Genia Technologies - Makers of integrated circuits for "Last Gen" DNA sequencing. Biology . . . meet the integrated circuit.

Guests:

Deborah Kilpatrick, VP of Commercial, CardioDx Bio and Contact Info

Chapters: (Advance the marker)

0:40 Corus CAD™ - a diagnostic for a "huge cardiovascular market"

6:31 CardioDx - fusion between biotech, med device, high tech, and specialty pharma

10:11 The successful path toward reimbursement coverage

18:00 With Medicare approval and new funding, what is your focus now?

20:01 Diagnostics an answer to a troubled healthcare system

25:17 Selling to doctors with misaligned incentives

29:30 Personal journey from defense to diagnostics

Today we begin a series of shows about Commercializing Diagnostics. And we've chosen a company with some successes and great potential, CardioDx, based in Palo Alto, CA. They recently won Medicare coverage for their Corus CAD(™) test which can tell whether a blockage in your heart is causing symptoms such as chest pain or tiredness.

The challenge for diagnostic companies, according to Chief Commercial Officer, Deb Kilpatrick, is in demonstrating with data that the test is better than current methods. In this interview, Deb outlines the path that CardioDx took toward reimbursement and offers her insight for others pursuing what has become the holy grail for diagnostics companies. Indeed, there is now a conference devoted just to this issue of reimbursement. What next for CardioDx, we ask Deborah. This leads to a discussion about the role diagnostics companies can play in the challenges facing the healthcare system today. Will there be 'big diagnostics' along side 'big pharma?'