Nearly a year after the commercial launch of Roche’s AmpliChip CYP450 microarray diagnostic in the United States, it seems the bellwether test still has not caught fire in the marketplace.
As the first microarray-based pharmacogenomic diagnostic to hit the market, the AmpliChip is blazing a trail that might be followed by a host of new devices, although demand for the test — at least in the short term — appears to be low.
Following the US Food and Drug Administration’s clearance of the AmpliChip for in vitro diagnostic use last January, the test was added to the product menu of its first provider, Spectrum Laboratory Network, in September. Since then, only three clinical reference laboratories have added the test to their offerings, and there is no evidence that testing with the microarray is regularly reimbursed by insurance companies.
Specialty Laboratories, Laboratory Corporation of America, Spectrum Laboratory Network, and Georgia Esoteric and Molecular Lab are the only four labs that currently offer the microarray test. Georgia Esoteric and Molecular Lab became the most recent to offer the test in January.
Quest Diagnostics has yet to add AmpliChip to the product menu of any of its US laboratories, even though the company conducted the validation studies that Roche submitted to the FDA when it filed for IVD approval. A Quest spokesperson told Pharmacogenomics Reporter last August that the company would begin offering testing with the chip later in 2005. It is not clear why Quest has not added the test, and company spokespeople were not able to respond before deadline.
There is reason to believe that AmpliChip may gain momentum in the clinical lab market, however. In May, Washington G-2 Reports published a survey of molecular diagnostics labs that found a “substantial number” of 294 responders intended to offer AmpliChip CYP450 testing within the next five years.
Like its adoption by clinical labs, AmpliChip CYP450 reimbursement appears to be moving slowly as well, but it is difficult to determine for certain. “The thing about reimbursement is that there is no one person that makes the decision, and then — poof! — it’s reimbursed,” said Lucy Sannes, president of Sannes & Associates, a biotechnology consultancy. “It goes: one small insurance company by another insurance company by another. So, it’s impossible to track how many insurance companies are reimbursing for a specific test at any one second,” she said. While she said that reimbursement for new products like AmpliChip tends to advance slowly, she noted that she has not tracked the progress of that particular test.
An informal survey of large insurers did not reveal any providing AmpliChip reimbursement. WellPoint, the largest health benefits company in the United States, does not cover the diagnostic under its Blue Cross-Blue Shield plans. Similarly, Cigna HealthCare and Aetna do not cover AmpliChip CYP450 testing because the firms consider it “experimental and investigational,” according to company documents. The Centers for Medicare and Medicaid Services’ coverage database does not contain any entries for AmpliChip, microarrays, cytochrome P450, or CYP450. Kaiser Permanente was unable to respond before deadline.
Kaiser Permanente will offer AmpliChip CYP450 testing in “some unusual cases, but not routinely,” said a company spokesperson in an interview this week. Like many diagnostic procedures, the company will review expert evaluations of the test, and will decide whether to offer it routinely at some point, she added.
Specialty Labs “tend[s] to bill clients, not third parties,” so it does not have much information on AmpliChip reimbursement, Keith Laughman, the firm’s CEO, said last week in an interview. Specialty lists six CPT codes for clients to use in reimbursement, none of which are directly related to microarray testing — the codes were originally established for nucleic acid isolation, cystic fibrosis testing, and the use of nucleic acid probes.
The use of older CPT codes or codes adapted from another procedure can complicate reimbursement and decrease the likelihood of payment.
Pam Lowder, technical manager at Spectrum, said she did not have access to reimbursement information for tests performed by the company, but said that the lab had received very few orders for AmpliChip CYP450 testing. “I think we’ve only done four,” she said. However, before Spectrum added AmpliChip to its menu, the company’s researchers were able to get testing reimbursed using a collection of older CPT codes, such as those for nucleic acid isolation, probe labeling, and interpretation, said Lowder.
A LabCorp spokesperson said the company treated reimbursement of its tests as confidential information, and could not share it.
Working Toward Coverage
“Coverage of a new diagnostic technology rests with each individual insurer and we do not track who covers our technology on an insurance-company-by-insurance-company basis," said John Ridge, head of reimbursement services at Roche Diagnostics, in an e-mail message to Pharmacogenomics Reporter this week.
“Coverage of a new diagnostic technology rests with each individual insurer and we do not track who covers our technology on an insurance-company-by-insurance-company basis."
But Roche is working toward coverage. “As we receive new evidence and information from studies and trials, we are forwarding it to the appropriate decision-making bodies for their review,” said Ridge.
One source of new evidence Ridge mentioned is a US Centers for Disease Control and Prevention “task force” that is evaluating the “value of pharmacogenomic tests to healthcare.” It was not immediately clear what project he was referring to, but most likely Ridge meant the Evaluation of Genomic Applications in Practice and Prevention
project ongoing at the CDC Office of Genomics and Disease Prevention.
Part of EGAPP’s goal is to establish whether CYP450 testing improves outcomes for adults beginning treatment with selective serotonin reuptake inhibitors, including technical parameters of testing, harms of testing, and patient management options. The CYP450 EGAPP effort is expected to conclude by “late 2006,” according to documents from the group.
Roche is also conducting a phase 3 clinical trial using AmpliChip as another likely source of data that the company might feed to insurance companies. The trial, “Genetic Study of Liver Enzymes in Patients With Side Effects From Antidepressants,” is being conducted at the Medical College of Georgia in Augusta, Ga., which houses the Georgia Esoteric and Molecular Lab, and is expected to finish in March. It hypothesizes that patients exhibiting adverse events from antidepressant treatment will carry CYP450 2D6 and 2C19 alleles associated with poor-metabolizer status more often than patients who do not experience adverse events.
It was not immediately clear whether the trial is associated with the EGAPP CYP450 effort.