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AIS's Health Business Daily
Featured Story September 24, 2008 Health Plans Are Urged to Pay for Care Members Receive While Participating in Clinical Trials Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively. By Angela Maas, Managing Editor, (amaas@aispub.com) Some health plans are not paying for care that members are getting while they are participating in clinical trials despite the plans welcoming the research these trials yield. And with so many specialty drugs in the pharmaceutical pipeline that are going through trials, now more than ever health plans need to have a clear stance on their coverage of members participating in clinical trials. The American Cancer Society cites a study showing that "60% of patients said they feared having their insurance denied as a major reason for not signing up to take part in a clinical trial." To that end, 21 states have enacted laws requiring that insurers provide coverage for patients in clinical trials. As scientific research reveals more about not just the nature of illnesses but also that of potential cures, clinical trials that can shed some light on these situations are more important than ever. "We think clinical trials are absolutely essential," says Edmund Pezalla, M.D., national medical director at Aetna Pharmacy Management. Because the plan bases coverage and other health care decisions on the medical evidence available, Aetna also supports ways to get more of this evidence, he tells SPN. Oftentimes the therapy in the trial may be the only treatment for a particular condition. The past few years have seen FDA approval for numerous specialty pharmaceuticals, particularly oncology drugs, that are disease-altering therapies and may also provide options for patients who had very few therapeutic options before. According to Atheer Kaddis, M.D., vice president of managed markets at Diplomat Specialty Pharmacy, "It is important for members to be involved in clinical trials, especially for disease states that have limited treatment options or when there is a promising drug or drug regimen being investigated for a disease state." It is fairly standard, according to various industry sources who spoke with SPN, that the trial's sponsor covers the cost of the investigational drug or drug regimen before it is approved by the FDA. Plans will often cover "incidental health care costs for their members," says Kaddis. Once the drug or drug regimen is approved, he adds, "most health plans will cover the drug or drug regimen costs as well as incidental costs in post-marketing surveillance clinical trials." Pezalla says that Aetna's coverage is "compatible but not identical" with CMS's clinical-trial policy, which was updated in July 2007. According to CMS's national coverage determination, "Medicare covers the routine costs of qualifying clinical trials…as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials." Clear Policy Benefits Patients, Plans Aetna, says Pezalla, has "policies that are somewhat more generous" than those of other plans. "We've made it a point to have a clear policy," he says, which makes it easier for patients to get into clinical trials. It has been "developing and refining the policy for the last 10 years," he explains. "Like many of our policies, it is a work in progress" that reflects "our role in the health care environment and public sentiment and policy." According to Pezalla, Aetna covers "any routine health care costs that are incurred by a member in a clinical trial." This can include lab tests, surgical procedures, doctors' visits and medication, he explains. The plan also covers "any treatment of any complication from the clinical trial," he says. Members' coverage — including deductibles, copayments and in-network and out-of-network rates — during the trial is the same as it would otherwise be were they not participating in the clinical trial. If a treatment is considered experimental, Aetna covers some of these therapies, "but we try to encourage patients to be part of a trial," explains Pezalla. This "coverage with evidence development" usually occurs with some cancers. "We may end up covering the drug if that is needed to get the patient into a trial," he says. In many plans, he adds, such provisions are covered under end-of-life care. On the other hand, "if a manufacturer of a device or drug is giving it away for free, we expect our member to get it for free," Pezalla says. Also, "costs incurred as far as data collection that are not tied to the care of the patient are incurred by whomever is conducting the trial," he says. These are not routine health care costs or care that is normally covered. "Does Regence pay for members in clinical trials?" asks Jeff Robertson, M.D., executive vice president of health strategy for The Regence Group. "If you had asked me this about eight years ago, the answer would have been easy — no. But we had some events and incidents that caused us to pause and to reconsider." Regence has a research-urgent medical policy, which is also available online. It covers "medical costs in clinical trials related to situations that are likely to answer questions of the clinical value of a lifesaving measure or treatment," says Robertson. Plan coverage is usually for Phase III trials and sometimes for Phase II, he says, and for those trials on regimens for "severe conditions, not lifestyle-enhancing" therapies. The payer revisits the policy each year, he says. "Blue Cross and Blue Shield of Kansas members are eligible for research-urgent benefits if their circumstances meet a certain set of criteria," says Mary Beth Chambers, spokesperson for that plan. "We want to assure that all conventional treatments have been tried and failed or deemed medically inappropriate; that there is credible evidence that the treatment may provide a clinically significant and substantial improvement in the member's health outcome; that the drug, device, medical treatment or procedure is available to the member without regard for funding source; and that it will be provided within a well-designed clinical trial that meets all ethical standards of research and is in compliance with appropriate review organizations." The Kansas Blues plan, says Chambers, "understand[s] the importance of clinical trials for further advancing medical knowledge and improving outcomes for many, which is why we offer research-urgent benefits for those members that need this option. We will not drop coverage on those who participate in clinical trials without precertification, but they would be expected to pay themselves for medical services not covered by their contract if they were not approved to participate." Robertson says that while Regence continues to cover members enrolled in clinical trials for medically necessary conditions, if a member experiences a problem caused by the trial, coverage for the condition would be determined on a case-by-case basis. Make Sure Trials Are Ethical, Well-Designed When plans are considering a clinical-trial policy, they should keep in mind a couple of points, maintains Pezalla. First, "the member may benefit from being in the trial. Plans should give careful consideration of a member's request," he says. Participating in a trial "may be the only way for the member to get access to a lifesaving therapy." Second, plans should look to CMS and other plans for policies that ensure safeguards for patients. Make sure that clinical trials in which members are participating are ethical and that patients are monitored properly, he explains. The trial's approval by the FDA, another federal body or an institutional review board would ensure this, according to Pezalla. The health plan does not have to do such an investigation of the study itself, he says, "but it must make sure that someone else has." Kaddis points out that a potential challenge for health plans is when they do not have "information on patients involved in clinical trials since the data is usually blinded and the trial is going on outside of the knowledge of the health plan. In addition, the health plan is also then liable to cover costs associated with potential adverse outcomes of the patients in these trials." "Plans should be very mindful that there are risks as well as benefits" with clinical trials, says Robertson. "A well-designed clinical trial truly will answer questions about a procedure" and provide "community value," he says. "Unproven therapies are unproven," which can be risky, he explains. "You run the risk that the trial may be redirecting care away from established, known, effective therapies." Although it doesn't happen often, he adds, some clinical trials can be "Hail Mary pass attempts by pharmaceutical companies to get good results." Ultimately, by developing scientific knowledge, a situation such as what occurred with breast cancer patients undergoing bone-marrow transplants in the 1980s and 1990s hopefully could be avoided, says Robertson. Based on some preliminary but promising reports of success, patients and patient advocates began demanding then that plans cover the treatment, with some even filing lawsuits in order to achieve this. Many insurers did decide to cover the therapy, to the tune of sometimes more than $100,000 annually. Various journals say that about 12,000 women underwent the treatment, but only about 1,000 participated in clinical trials, which lessened the amount of data that could be gathered. "Without doing clinical trials to know the value" of the treatment, it was impossible to know which patients, if any, would benefit from the therapy, says Robertson. It turned out that
in some cases the therapy was "not only not helpful but harmful,"
and it contributed to some of these women undergoing "premature,
pretty gruesome deaths," says Robertson. "This is one of the
things that motivated us — care that showed promise but was not
yet proven."
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