WASHINGTON – While the intrinsic value of using companion diagnostics to target the right drugs to the right patients is recognized by all components of the health care system, including drugmakers, diagnostic developers, clinician and patient interest groups and payers, more cohesion is needed among all those parties – and at earlier stages in development – for personalized medicine to reach its potential value.

A conference last week organized by the Personalized Medicine Coalition (PMC) and the Biotechnology Industry Organization (BIO) was convened to encourage dialogue between the technology providers (diagnostic/pharma industries) and the broader stakeholders, especially the payers who could ensure swift market benefit from the new tools.

"We wish to ensure that the personalized medicine train keeps moving, as the advancement of personalized treatments is best for the patient community, the physicians and the payers alike." Edward Abrahams, president of PMC, explained to BioWorld Today.

That sentiment was echoed by Paul Sheives, director of diagnostics and personalized medicine policy at BIO. "The diagnostic industry is delivering breakthrough technology, and as a community, we must now ensure that the industry's advances in R&D, and toward effective clinical data, will lead to market acceptance, in terms of compelling value and reimbursement," he said.

Companion diagnostics validate (or reject) the use of specific drugs on specific patients, and hence dramatically affect the patient's treatment protocol. Though it is debatable how many highly valuable companion diagnostics tests are currently in the U.S. market – based on definitions, the numbers vary between five and 20 such tests – many more are expected, thanks to technological developments and economic requirements.

But what emerged during the discussion was the need for greater collaboration and trust between stakeholders. While operating within diverse disciplines, and with different expertise and financial goals, diagnostics and pharma players need to find a way of working creatively to allow the sharing of positive outcomes. They can then approach the clinical, regulatory and payer communities with a more powerful, validated and unified tone.

"Pharma companies are in need of a companion diagnostic today, more so than previously, in order to market their drug." Stephen Eck, vice present and global head of oncology medical sciences at Astellas Pharma Inc., told BioWorld Today, adding that "the companion diagnostic is a key ingredient of our R&D plans."

Presenters also touched on other "misalignments" within the industry, with a particular focus on return and reimbursement.

"Is the allocation of payment fair," asked one participant, "if a diagnostic determines that a $40,000 drug be ordered, yet it is reimbursed at less than 1 percent of that figure?"

Paul Landauer, senior director of health care policy and market access at Abbott Molecular, also pointed to a need for a "model whereby there is alignment between the diagnostic and pharma companies across the world markets. Some European states, for example, will pay for the drug, but see the allied diagnostic test merely as an adjunct that should be covered by the drug company, a sort of rite of passage. To date, the industry is not set up to handle this type of consideration, nor to fully recompense the diagnostic player for his role in the partnership."

Marc Boutin, executive vice president of the National Health Council in Washington, offered a more colorful description of that imbalance. "Diagnostics are the loss leader, like the turkey on Thanksgiving Day. Everyone needs one, but no one wants to pay, or be the one to bring it to the table."

Boutin further explained that his group is supporting legislation that would encourage biopharma investment in diagnostic technology, by means of regulatory protection for the pharma that brings a drug-diagnostic bundle to the market. "We need to incentivize improved collaboration between drug/diagnostics groups, and this model may be a suitable approach," he told BioWorld Today.

Collaboration with pharma on integrating data would be a first step in creating a more powerful bloc, and would lead to improved cohesion on data issues toward FDA approvals.

"The pace of innovation in personalized medicine diagnostics is often slowed by the demands of clinical utility in FDA submissions," Tadd Lazarus, chief medical officer of Qiagen's Global Molecular Diagnostics Group, explained to BioWorld Today. "There needs to be a fast track for the approval of a companion diagnostic where clinical utility has already been demonstrated."

Once that alignment is in place, earlier engagement of the payer elements will be the next step.

"It would be best," suggested Tamara Syrek Jensen, deputy director of the Center for Medicare & Medicaid Services' (CMS) coverage and analysis group, "to integrate the CMS [or other payer] perspective into early stages of biomarker clinical testing, rather than receiving clinical outcomes, and then have us address the value of the data from a reimbursement angle."

She added that by also "broadening the discussion regarding clinical outcomes and needs at an earlier stage, there would be increased trust among all stakeholders, which is not quite there today."