A new R&D alliance between national pharmacy benefit manager Medco and Laboratory Corporation of America to determine if Roche’s AmpliChip can help physicians prescribe a safer and more efficacious dose for the widely prescribed breast cancer drug tamoxifen could eventually convince health insurers to cover the test.
Despite having received the US Food and Drug Administration’s stamp of approval nearly three years ago, large insurers like Aetna still consider the AmpliChip CYP450 test an investigational product and have refused to reimburse for the test pending additional outcomes data [see PGx Reporter 04-25-2007
Still, the study partners, which announced their collaboration last week, said the AmpliChip will help their project “advance the field of pharmacogenomics.”
“This agreement is between two industry leaders that are at the forefront of the movement toward personalized medicine,” Myla Lai-Goldman, LabCorp executive vice president said in a statement. Companion diagnostics, such as AmpliChip, “can help physicians determine which drug will be most effective for particular patients [and] will benefit patients and lower healthcare costs by improving outcomes, enhancing safety, and reducing ineffective drug regimens.”
Tamoxifen, a selective estrogen receptor modulator, is currently the most widely prescribed drug for breast cancer. However, according to Medco, approximately 10 percent of women using tamoxifen do not receive the full benefit from the drug due to variations in their CYP2D6 genes, causing them to metabolize the drug too slowly.
Knowing this, the FDA plans to update tamoxifen’s label with information about genetic testing that could help identify women likely not to fully respond to the drug. Last October, an FDA advisory committee recommended that the agency update the label for the breast cancer drug to include information about CYP2D6 genotype testing [see PGx Reporter 11-15-2006
Equally important to Medco/LabCorp, their study might show whether using AmpliChip to dose tamoxifen has economic benefits. “The adoption of new technologies needs to accelerate when there is clear evidence of clinical and financial benefit,” Medco Chief Medical Officer Robert Epstein said in a statement. “New [diagnostic] tests can help ensure patients are getting the right medication at the right dosage, while also assisting to avoid adverse drug events.”
The agreement with LabCorp “is part of Medco's strategy to partner with established leaders in the area of personalized medicine to bring the most advanced approaches to pharmacy care to our clients and their members,” Epstein added.
When it comes to pharmacogenomics from the perspective of a pharmacy benefit manager, Medco, the second-largest PBM in the US with 60 million beneficiaries, has typically been ahead of the curve. Last December, eight months before the FDA updated warfarin’s label to include genetic testing information, Medco partnered with the Mayo Clinic to study the clinical and economic utility of using molecular diagnostics to help physicians dose the popular anticoagulant [see PGx Reporter 12-06-2006
When the Medco/Mayo alliance launched last year, a Medco official suggested that results from the study may be the “value proposition” payors need to cover genetic tests. Now, a collaborative project around tamoxifen could yield similar data to help insurers make coverage decisions about CYP2D6 testing, particularly with Roche’s AmpliChip, for that indication.
Medco did not return requests for an interview prior to deadline. However, “both LabCorp and Medco believe strongly in the importance of companion diagnostics,” Eric Lindblom, senior vice president of investor and media relations told Pharmacogenomics Reporter last week. “We shared a common interest with them and were able to collaborate utilizing our expertise in testing and their expertise in pharmacy care.”
LabCorp will be responsible for testing patients on the AmpliChip. Meanwhile, the patients for the study will be recruited from Medco’s enrollees.
According to Roche, the Medco/LabCorp study will raise awareness for the availability of AmpliChip, something the test needs in the marketplace.
“Pharmacogenetics is still in its infancy. We are pleased with the progress and continued interest shown in AmpliChip from various clinicians, laboratories, researchers and the healthcare industry,” a Roche spokesperson told Pharmacogenomics Reporter this week. “Any studies that assist in increasing awareness of AmpliChip among clinicians help advance pharmacogenetics and the CYP450 test market as a whole.”
AmpliChip was approved as an IVD in the US in 2004. Since then, industry observers have described adoption rates for AmpliChip as lackluster. However, as physicians became more comfortable with genetic testing and data from emerging outcomes studies, that may now be old news.
Although Roche does not break out its sales figures by product, a company spokesperson told Pharmacogenomics Reporter this week that it is projecting 2007 AmpliChip sales to be 113 percent higher than in 2006.
Other than LabCorp, genetic testing services using AmpliChip are offered by Affymetrix Clinical Services Laboratory; the Center for Molecular Medicine; Veteran’s Affairs Hospital in Tampa, Fla.; Georgia Esoteric and Molecular Diagnostics Laboratories; Specialty Laboratories; Spectrum Laboratory Network; and UCI Pathology Services.
“[AmpliChip’s] volume is really picking up.”
Michigan-based Center for Molecular Medicine, which became the first laboratory in the Midwest to offer the AmpliChip, said there has been strong growth in demand for the test since the lab began offering it in April. “We’ve gotten a lot of interest from pharmacists, internists, and mostly psychiatrists and oncologists,” Daniel Farkas, executive director of CMM, told Pharmacogenomics Reporter this week. “The test volume is really picking up.”
Farkas estimated that the lab has been doubling its test volume month-over-month, and in October CMM performed between 15 and 20 tests on the AmpliChip.
In contrast, the head of another national genetic testing laboratory that does not offer the test but has researched the product told Pharmacogenomics Reporter on the condition of anonymity that AmpliChip’s high cost and complexity have deterred many laboratories from offering it.
The list price for the instrument, according to this official, is $219,000, and each fluid station adds another $55,000. Each patient needs a chip, which has a list price of $400. Comparatively, other 2D6 tests cost under $90 per sample. Labs charge between $600 and $1,200 for testing.
Another downside to AmpliChip is its low throughput, the official said. Only four samples can be run at a time during an eight-hour period. With the additional of the fluidics station, the throughput can be ramped up to 32 samples per run.
FDA approval of AmpliChip also means that the methodology for the test cannot be changed. “This can be a problem if the test fails for a sample or a whole run, it's hard to figure out why, and all you can do is run the sample again the same way as before,” the official said. “For lab-developed tests, there is some optimization that can be done on a repeat run to increase success rate.”
Finally the AmpliChip format means that both the 2D6 test and the CYP 2DC19 test must be run. “This is a problem cost-wise, since you are paying for a test you don't want, and also ethically, since if the physician didn't order CYP 2DC19, then a result will be generated that wasn't ordered,” the official noted.
On the plus side, however, the official noted that the software generating the genotype result also gives a predicted phenotype and that the 2D6 assay tests for more variants than other platforms.
The lack of exact usage data from Roche and contrasting opinions from lab-service providers make it difficult to gauge how AmpliChip is performing in the market. In addition, a difficult and inconsistent reimbursement environment for genetic tests further confounds projections for AmpliChip adoption rates.
While insurers like Aetna and Cigna still consider the test investigational and do not reimburse for it, others, like Humana, do cover the test.
The Roche spokesperson maintained that laboratories offering the test have not reported difficulty gaining insurance reimbursement. Farkas said CMM had opened up constructive dialogues with local insurers, particularly Priority Health and Blue Cross Blue Shield of Michigan. “We’ve had very positive conversations. We’re talking about pilot demonstration projects so we can determine what subset of patients this test is most useful for,” he said.
Still, expressing frustration at some payors’ reluctance to reimburse AmpliChip, a Roche official previously told Pharmacogenomics Reporter
that payors are holding diagnostics developers to the same evidence standards as pharmaceutical companies, which may end up hindering the development of innovative tests [see PGx Reporter 04-25-2007
]. In its 2006 policy bulletin, Aetna notes that prospective, randomized, controlled clinical trials may be required before it starts considering the AmpliChip for coverage.
It could be to Roche’s benefit if the Medco/LabCorp study can provide the kind of data payors are seeking. Roche has also begun studying the test with payors in mind. In an effort to prove the utility of AmpliChip to skeptics, the company is conducting studies to establish the test’s clinical validity and utility. The company spokesperson would not reveal any more details about these studies, but said that “any health economics study has the potential to impact an insurer’s decision.”