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on the basis of interim data from an ongoing clinical trial, of three alogliptincontaining products. The medications are indicated for the improvement of glycemic control in adults with type 2 diabetes, and the relevant data were from the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) trial. The 5380-patient trial began in 2009, and final data on major adverse cardiac events were collected in April 2013. According to FDA, data from EXAMINE that were unblinded for a planned review before the study’s conclusion supported the preliminary finding that alogliptin improves glycemic control without any “offsetting” cardiovascular or other risks. FDA approved the drug products on the basis of that data, in part, but did not release the customary summary of that data or include the information in the products’ labeling. Instead, the agency released general background information about the trial, a summary indicating that the interim results were in line with FDA guidance on evaluating cardiovascular risks, and additional data unrelated to those risks. A March 2013 FDA memo emphasized that approval decisions are normally based on data from completed clinical trials, which was not the case for alogliptin. The memo stated that the approval of alogliptin thus raised “novel issues” about the release of data from unfinished studies but acknowledged that similar situations, though rare, may arise in the future. Big numbers. Cleveland Clinic cardiologist Steven Nissen, the lead author of the 2007 rosiglitazone meta-analysis, told hearing participants that 16 cardiovascular outcomes studies for diabetes drugs were initiated during the first three years after FDA’s 2008 decision. He said the planned recruitment for the studies exceeds 110,000 patients, and data from the studies, once they are completed, will provide major benefits to society. “This is a terribly important issue,” Nissen said.

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But Ratner noted that improvements in the care of patients with diabetes have caused a decline in cardiovascular event rates over the past 20 years, which makes it difficult to complete the type of study FDA requires. Ratner, like most presenters at the hearing, was leery of public disclosure of interim data because of the potential to further complicate the ability to complete clinical trials. University of Washington biostatistician Tom Fleming recalled that a confidential analysis of interim data from a study involving HIV-infected patients revealed 39 cases of death or progression to AIDS in patients treated with zalcitabine, compared with 19 such events in didanosine recipients. But by the end of the study a year later, adverse events had equalized between the groups. Although the interim adverse event data were within the study’s prespecified threshold, the data could well have alarmed clinicians, Fleming said. “If the early results were released, it would have been very misleading,” Fleming said. “There was essentially no chance that [the study] would have been completed.” FDA’s 2008 guidance on diabetes drugs allows for the possibility of early data disclosure to occur after accrual of 122 adverse cardiovascular events among clinical trial participants. This figure

represents about 20% of the total events needed for statistical validity. FDA allows drug sponsors to apply for product approval at this point during the study if the hazard ratio for the investigational diabetes drug does not exceed a predetermined threshold. If a drug sponsor files for approval using the interim safety data, FDA requires that the trial be continued to completion—with accrual of 620 adverse events—into the postmarketing period. Alternatively, drug sponsors may conduct a new cardiovascular outcomes study to obtain the required data. But several speakers at the hearing indicated that the latter option is not practical. Nissen said it’s critically important to avoid the disclosure of interim hazard ratios and other data that may prompt clinicians and patients to alter their medication decisions on the basis of statistical interpretations that may not hold up over the long term. “I believe that the agency is acting wisely,” Nissen said regarding the datadisclosure model FDA used for approving alogliptin. “It’s a tremendous benefit to society to have clarity about what these drugs do and what they don’t do,” he said. —Kate Traynor DOI 10.2146/news140069

CMS scales back prior-authorization policy for hospices

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he Centers for Medicare and Medicaid Services (CMS) on July 18 eased a weeks-old policy that had sent hospice programs scrambling to secure Medicare Part D coverage for medically necessary medications not included in the hospice benefit.

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“We are all kind of breathing a sigh of relief ” after the July policy revision, said Pamela S. Moore, clinical lead pharmacist in pain and palliative care at Summa Health System in Akron, Ohio. The original policy, which went into effect May 1, 2014, had instructed Part D

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plan sponsors to subject all drug claims for hospice patients to prior-authorization requirements. “We have over 200 patients on our home hospice service, so it had a pretty significant impact,” Moore said. “It was very difficult to maintain continuity of those patients’ regimens.” Moore said each day at the hospice program began with “multiple physicians, multiple nurses, myself, hospice administrators, all in a room just going through the new admissions” to determine how to bill for each patient’s medications. She said patients with Part D coverage needed prior authorization to continue receiving medications for diabetes, dementia, and other common conditions. “It would take hours of the office staff time to get the forms filled out,” Moore said. “Each Part D company wanted something different, and they didn’t have a uniform way of accepting the information.” The original CMS policy was a response to instances in which Medicare Part D plans might have billed the agency for medications that should be covered under the Medicare Part A hospice benefit. This problem was described in a June 2012 report from the Health and Human Services department’s Office of Inspector General. The report had concluded that Part D plans “paid for prescription analgesic, antinausea, laxative, and antianxiety drugs that likely should have been covered under the per diem payments made to hospice organizations.” The July policy revision asked Part D plans to limit prior authorizations for hospice patients to those four drug categories. CMS acknowledged the “operational challenges” in the original policy and said it “created difficulties for Part D sponsors and hospice providers, and in some cases, barriers to access for beneficiaries.” The revised policy has an October 1 effective date, but CMS asked Part D plans to implement it as soon as possible. CMS requires hospice programs to cover the cost of drugs for conditions related to each patient’s terminal condi-

tion. Medications unrelated to that diagnosis may be covered by Medicare Part D or another third-party payer. But CMS has not precisely defined what the agency means by a “terminal condition” or “related conditions,” said Jason Kimbrel. Kimbrel is director of the HospiScript– Ohio State University College of Pharmacy postgraduate year 2 residency in hospice and palliative care and vice president of clinical services for HospiScript, a hospicefocused unit of the pharmacy benefits management company Catamaran. In the absence of clear guidance from CMS, Kimbrel said, decisions about a medication’s relation to the illness for which the patient is receiving hospice services are made by each hospice organization’s medical team, and there is no standardized approach to the process. And, Kimbrel explained, “there are legitimate medications that are unrelated to the terminal prognosis but are still medically necessary,” like eye drops for patients with glaucoma. “A patient could have glaucoma and they could have six months to live, and you don’t want them to have increased intraocular pressure and have vision issues,” Kimbrel said. “But there’s nothing about their glaucoma that’s going to cause them to pass away in the next six months. So it’s not a life-limiting illness at that point, but it’s medically necessary to still be managed.” Kimbrel said such medications should be eligible for Part D coverage. But when the prior-authorization policy first went into effect, he said, “those patients were unable to obtain their meds” from their Part D plans. For diabetes medications, identifying the correct payer can be difficult, Kimbrel said. If a patient is in hospice care because of Parkinson’s disease but also has wellcontrolled diabetes, the diabetes may not be contributing to the dying process. In this case, diabetes drugs could appropriately be covered under Medicare Part D, Kimbrel said. But Parkinson’s disease can make it difficult for patients to eat or swallow,

which may affect glucose control in patients with diabetes. “If you say hospice’s definitions of ‘related conditions’ are ‘any symptom that the patient needs to manage at the last six months of their life,’ well, then I would say hospice should cover the drug, because you would have to manage that person’s diabetes,” Kimbrel said. A rare but potentially difficult coverage decision could involve a patient who takes an analgesic for the treatment of a chronic condition, such as pain from a long-ago traffic accident. If that patient requires hospice care for a condition that causes little or no pain, Part D could conceivably cover the medication under a prior authorization, Kimbrel said. CMS in May solicited comments on the definitions of “terminal illness” and “related conditions” for future rulemaking. The agency stated that it will consider those comments and the effects the definitions may have on hospice services. Kimbrel said the initial policy on prior authorization “made sense, to some degree, on paper, but it didn’t necessarily actually come full circle on process.” He called the subsequent limiting of prior authorization “an interim solution” pending additional guidance from the agency about medication coverage determinations. “The intent is to limit patient harm and to ensure point-of-sale rejections don’t get in the way of patient care,” Kimbrel said. Moore said Part D plans’ policies on prior authorization have been “hit or miss” since CMS revised its policy. “Some of these Part D companies have reverted back. Some of them are still requiring prior authorizations for things; they haven’t quite gotten on board,” she said in mid-August. “So we’ve got a number of scenarios happening now, and we’re never sure which one we’re going to encounter” or when coverage will be denied. —Kate Traynor DOI 10.2146/news140070



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CMS scales back prior-authorization policy for hospices.

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