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MANAGED CARE AND NEW TEST FOR HCV TREATMENT RESPONSE
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Melissa Palmer, MD posted:

10/27/2010
- Time gap could appear between protease inhibitor approval and creation of new AASLD practice guidelines, committee member says - Managed care might ask for testing at week 4 and 12, may interrupt treatment regimens - IL-28B genotype testing to possibly play a role in reimbursement algorithms - If a patient displays eRVR, then SOC would likely be sufficient, some physicians said Merck's (NYSE: MRK) boceprevir and Vertex's (NASDAQ: VRTX) telaprevir, first generation protease inhibitors in development for HCV, will necessitate both professional treatment algorithms to be updated and managed care reimbursement algorithms to be created to define eligibility criteria for triple therapy, physicians said. The current treatment regimen for the treatment of hepatitis C (HCV) involves a 24 or 48-week course of a combination of pegylated alpha interferon and ribavirin. There is concern that there will be a disconnect between the time when these protease inhibitors become available, the next annual review of the American Association for the Study of Liver Diseases (AASLD) practice guidelines, and the implementation of managed care reimbursement algorithms, according to Dr Nancy Reau, a member of the AASLD Practice Guidelines Committee and associate professor of medicine at the University of Chicago. The annual review is typically not a complete overhaul, said Reau, but there is concern that the association will have to change the whole algorithm. This might include four week viral load testing, which the European Association for the Study of Liver (EASL) guidelines currently indicate, she said. In practice, this means that the current EASL guidelines are set up to "use week four as a decision making point, but ours are not," she said. The lack of a four week testing point conflicts with the four week assessment to see if a patient has achieved early rapid virologic response (eRVR), which might indicate that a patient is eligible for response guided therapy as is done in some clinical study protocols, according to Reau. "We don't think our practice guidelines are going to mirror [clinical> practice the day this becomes available. We think these are going to come out, and our guideline review will lag a bit," said Reau. However, she said she remains confident that academic institutions will be able to adequately treat patients with triple therapy until the guidelines are updated. Although there are currently guidelines for the use of interferon and ribavirin, use is not uniform - as it is tailored to an individual patient, Reau said. The lag time in the guideline review will be most difficult for physicians who are less experienced in the treatment of HCV, like virologists and gastroenterologists, she said. Reau has previously had to show 12 week viral load data to managed care companies demonstrating sufficient viral load in order for them to continue authorizing even SOC treatment, she said. "That's probably going to become more common with triple therapy, because it's going to be so much more expensive," she said. "You could see some treatment interruptions," as a result of possibly needing four week or 12 week data, she said. The appropriate tests need to be performed and analyzed, with results then sent to a managed care company to review. The company then needs to reauthorize treatment and appropriately notify the physician, who will then need to reorder the proper therapy. It will be "nearly impossible" for this to happen in a timeline
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which will not interrupt the proper time course of therapy, said Dr Paul Gaglio, medical director of the Liver Transplant Center at Montefiore Medical Center and professor of clinical medicine at Albert Einstein College of Medicine. Gaglio said he would like to use protease inhibitors in all of his patients - regardless of whether an individual presents with a positive prognostic profile who would likely achieve SVR with SOC. The improved SVR results in a patient like this would merit use of triple therapy, he said. Another option outlined by Gaglio was the use of a four week SOC lead-in and subsequent viral load test to then determine if a patient should receive triple therapy, which is the protocol used by Merck in its boceprevir trials. If a patient displays eRVR, then SOC would likely be sufficient, whereas if the viral load still remained high, the patient would be eligible for triple therapy, he said. If managed care mandates these four week and 12 week decision making points, it might "mandate a minimum standard," said Reau, with practitioners ordering these tests because they have to for reimbursement purposes. The IL-28B genotype test may also be used to guide treatment selection, said Gaglio. Dr Andrew Muir, director of gastroenterology and the hepatology research program at Duke, and co-author on the article in Nature which reported on the predictive value of the IL-28B genotype and a patient's likelihood of responding to the SOC, said "IL-28B appears to be the strongest predictor of your response to standard of care." The test is available from LabCorp (NYSE: LH) after it licensed the technology from Merck. Current turnaround time on the test is usually around 10 days, said Muir. Gaglio outlined a possible scenario of how IL-28B genotyping could be used in a managed care algorithm. If IL-28B testing is favorable, a patient will get SOC first, he explained. If patients have a lack of response or an unfavorable genotype to start, then they will start on triple therapy, he added. "I think IL-28B testing might be the way that companies stratify which way patients are treated," he said. The "worst case scenario," according to Gaglio, would be one in which managed care only pays for triple therapy if a patient is a null responder or relapser, he said. Muir also cautioned, however, that IL-28B is neither the only predictor of response, nor always a predictor of response. Other predictive indicators beyond IL-28 genotype include race, viral load, and degree of fibrosis. "As with many other tests, it could be misused," said Dr Melissa Palmer, medical director of hepatology at New York University Hepatology Associates. Virologic response to treatment is still a stronger indicator than IL-28B, Reau added. IL-28B data could be used to truncate the treatment window of patients with an unfavorable genotype if they do not demonstrate a reduced viral load on therapy, she said. Additional studies are currently being done to verify that the IL-28B genotype is also predictive of a patient's response to therapy with a protease inhibitor, said Muir. This data is expected around EASL next year, said Reau. "Boceprevir seems like it will cost more because in trials it was in continuous therapy for longer than telaprevir," said Dr Silvia Degli Esposti, director of the Center for Women's Gastrointestinal Services at Women and Infants Hospital of Rhode Island. Additionally, the side effect profile associated with boceprevir, namely anemia, may limit the extent of its managed care reimbursement and thus use in patients, as a patient may require erythropoietin stimulating agents (ESAs) in addition to their triple therapy regimen, she said. This could confer an advantage to the use of telaprevir, she noted. "I have the feeling it is too complicated for managed care to tackle, because it's too complicated for us, as individualized therapy is very difficult," said Degli Esposti. "I don't think they want to know about patient details to decide what should be reimbursed. I think they will just go for a general guideline," she said.
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When historically presented with only guidelines, patients have a hard time receiving reimbursement without a defined algorithm, as there is often no rationale behind an insurance provider's choice for w
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