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PDUFA reauthorization moves toward resolution

BY Alaric DeArment

Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


On May 24, the Senate voted 96-1 to approve the reauthorization and modification of the user fee program, with Vermont independent Sen. Bernie Sanders casting the sole dissenting vote with the assertion that it wouldn’t do enough to bring down drug prices. The House followed suit, overwhelmingly approving its own version of PDUFA legislation May 30.


Both versions include new provisions that would create, for the first time, a user fee program for generic drug makers. The generic industry would pay $299 million a year in user fees for the next five years — beginning Oct. 1, 2012 — for new FDA staff, faster generic approvals that could help clear a backlog of some 2,500 applications and more inspections of manufacturers’ production plants.


In another key change, the PDUFA proposals would create a user fee program for makers of biosimilar drugs. 


The House and Senate must still hammer out any differences in legislation. Some members of Congress predict that will happen before the July 4 recess.


Both the branded and generic drug industries hailed the moves in Congress. Ralph Neas, president and CEO of the Generic Pharmaceutical Association, said they’ll move Americans “one step closer to receiving faster access to … generic medicines.”


Said John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, “by casting a positive vote to reauthorize PDUFA, members of both the House and the Senate … have acted in the best interests of America’s patients.” The new funding, he added, also will “provide the FDA with the resources necessary to help build new scientific and regulatory capabilities … and promote ongoing biopharmaceutical innovation.”


One provision of the Senate’s version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, did raise alarm bells among pharmacy groups, however. Five organizations — including the American Pharmacists Association, National Association of Chain Drug Stores and National Community Pharmacists Association — registered opposition to an amendment by Sen. Joe Manchin, D-W.Va.


Manchin’s proposal would make it tougher for patients to obtain common pain relief remedies containing hydrocodone by raising them from schedule III to the more restrictive schedule II classification. The change would “result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation’s healthcare costs with no assurance of a reduction in diversion and abuse,” the pharmacy groups warned.

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Study: Mobile reminders improve adherence

BY Alaric DeArment

Medication adherence rates are higher among patients who receive text message prescription reminders than among those who don’t, according to a new study. The study — conducted by OptumRx, part of UnitedHealth Group, and published in the May issue of the journal Clinical Therapeutics — found that patients taking chronic oral medications showed higher medication adherence if they took part in a text message prescription reminder program offered through OptumRx’s pharmacy benefit management organization. The company said this was the first large-scale study in the United States to determine if a text message program providing medication-specific reminders could increase adherence. Previous studies included smaller patient pools, often with fewer than 100 patients, and were focused on homogenous patient groups, such as those being treated for the same disease.


“Text messages and emerging technologies offer new opportunities to educate and engage patients so they can improve their health and ultimately rein in their healthcare costs,” OptumRx pharmacist and lead author Kalee Foreman said. “A study in the New England Journal of Medicine found that nearly 70% of medication-related hospital admissions in the United States are due to poor medication adherence, costing the healthcare system roughly $100 billion per year.”


The study, which enrolled 580 members of employer-sponsored Medicare programs, found that patients who received text message reminders had adherence rates of 85%, compared with 77% of those who did not receive the reminders. Among patients who had diabetes, adherence rates were even higher, with a rate of 91% among those who received reminders and 82% among those who didn’t.


Among patients taking beta blockers, similar rates were observed, with 88% adherence among those receiving messages and 71% among the control group. The study measured adherence by “proportion of days covered,” or PDC, which examined each day between Jan. 1, 2011, and Aug. 1, 2011, to determine if the patient had the drug on hand. 


“This research provides strong evidence that technology can play a vital role in improving medication adherence, even among older patients,” OptumRx chief medical officer Brian Solow said. “This is of great importance to all stakeholders in health care because poor medication adherence can lead to inferior treatment outcomes, higher hospitalization rates and increased healthcare costs.”

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Pinpointing the cause of nonadherence

BY Alaric DeArment

It’s been cited as one of the biggest health crises facing the United States and, if solved, the equivalent dollar value of a blockbuster drug. According to the latest statistics from pharmacy benefit manager Express Scripts, poor medication adherence costs the country $317 billion per year, an upgrade from the $290 billion calculated in a study released in 2009 by the New England Healthcare Institute.


Of course, solving medication nonadherence is no simple task. It’s one of those issues like alcoholism and crime, the result of a complex mix of economic, personal and societal factors that combine to create one big social problem. Everything from concerns about cost and fears of side effects and efficacy to simple forgetfulness conspire to keep people from taking their medications as prescribed.


In May, for example, CVS Caremark released results of a study showing that Food and Drug Administration warnings about drug efficacy — even those that aren’t safety-related — can adversely affect medication adherence. The study cited one high-profile FDA communication that questioned the efficacy of the cholesterol drug ezetimibe, sold by Merck under the Zetia and Vytorin (ezetimibe and simvastatin) brands, after which the monthly level of patients who stopped filling their prescriptions increased by nearly 6%, while only 16.5% of those who stopped taking the drug switched to another, clinically appropriate therapy.


But like alcoholism and crime, even if it can’t be solved overnight with some magic panacea, it and its effects can be mitigated, and recent studies released since ESI’s annual drug trend report have offered some clues as to how.


Another CVS Caremark study in May, titled “Targeting Cardiovascular Medication Adherence Interventions” and published in the May/June issue of the Journal of the American Pharmacists Association, found that more than one-third of adherence interventions targeted to nonadherent patients resulted in improved medication adherence, compared with 18% of broad interventions.


The researchers reviewed nearly 60 peer-reviewed articles about randomized controlled trials for three types of interventions to improve medication adherence for cardiovascular disease or diabetes. These interventions included broad interventions targeting all patients, focused interventions targeting nonadherent patients and dynamic interventions initially administered to all patients but then targeted to nonadherent patients based on real-time adherence information. Results found that dynamic interventions and focused interventions were more likely to show impact on adherence as compared with broad interventions.


“While medication nonadherence is widely recognized as a major public health issue that impacts patient health and contributes to rising healthcare costs, there has not been a clear consensus about how best to influence patient behavior and support appropriate medication use,” said Sarah Cutrona, a former research associate at Brigham and Women’s Hospital. “These results suggest that broad interventions, which aim to prevent nonadherence by educating and motivating all patients, were the least effective. Without the benefit of identifying patients and their specific barriers to adherence, these types of interventions may be too general to motivate individual patients to change their medication taking behavior.”


A study released by Walgreens found that patients starting cholesterol medication for the first time who participated in enhanced face-to-face counseling sessions with a community pharmacist demonstrated better medication adherence than those who did not participate in the sessions.


Nonadherence is an especially important issue for patients with high cholesterol, as the condition places them at a greater risk of complications from heart disease. The study, titled “The impact of pharmacist face-to-face counseling to improve medication adherence among patients initiating statin therapy,” was published in April in the online journal Patient Preference and Adherence.


“This study demonstrates the power of face-to-face pharmacist interactions,” said Jeff Kang, Walgreens SVP health and wellness services and solutions. “Just two sessions focused on barriers to adherence for patients taking a new medicine for high cholesterol helped them establish a routine for adhering to their treatment. As a result, these patients potentially improved their long-term health outcomes. At Walgreens, our goal is to help our patients stay well while reducing overall healthcare costs, and programs that address the significant issue of prescription medication nonadherence are a crucial element of this.”


The study followed a group of more than 2,000 patients new to statin therapy for 12 months. After inclusion and exclusion criteria were applied, the intervention group consisted of 586 patients, and the comparison group comprised 516 patients. Pharmacists trained in brief motivational interviewing conducted counseling sessions that addressed barriers to adherence for statin patients, such as perceptions of the value of the therapy, fear of side effects and simple forgetfulness or establishing a routine to take medication.


Whatever it takes to combat the problem of medication nonadherence, one thing is certain: Pharmacists are one of the most important components. The National Association for Chain Drug Stores emphasized last month in a statement sent to the U.S. Senate Health, Education, Labor and Pensions Committee the value of community pharmacies in improving patient health and lowering health costs through medication therapy management. 


“Community retail pharmacies are at the front line in the healthcare system, interacting with patients on a daily basis,” NACDS wrote. “Community pharmacists are uniquely qualified through their comprehensive education and training to significantly reduce the problem of poor medication adherence. We are convinced that [medication therapy management] is a key way to vastly improve health outcomes and reduce costs by ensuring that individuals receive the maximum health benefit from their prescription medicine.”

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