Blood-based biomarkers may predict cognitive impairment associated with Alzheimer’s disease
Early-stage Alzheimer’s disease, or AD, increasingly is the target of drug development efforts, but there are very few tools that measure the cognitive function of patients with the condition before the onset of dementia. Experts have concluded that it is best to treat patients prior to changes in cognition, before the symptoms of neurodegeneration appear. As a result, scientists have turned to biomarkers to provide some indication of whether AD is likely to develop.
Although cognitive capacity may not be measured easily before AD has caused significant neuronal damage, there now is a simple blood test that may predict whether a healthy person is likely to develop mild cognitive impairment or AD within a two- to three-year time frame with more than 90% accuracy.
The researchers behind the test — led by Howard Federoff, M.D., EVP health sciences at Georgetown University Medical Center — enrolled 525 healthy participants ages 70 years or older into a five-year observational study. Federoff and colleagues determined there were 74 participants who displayed signs of preclinical AD after testing participants for memory performance. Then the researchers compared the blood plasma biomarker levels of 53 of those 74 participants showing signs of cognitive impairment with those of 53 participants who were cognitively healthy.
The researchers determined that a set of 10 phospholipids predicted “phenoconversion” to the cognitive functional impairment that is the hallmark of AD. “This biomarker panel, reflecting cell membrane integrity, may be sensitive to early neurodegeneration of preclinical Alzheimer’s disease,” Mark Mapstone, M.D., wrote in a letter published in Nature Medicine.
The lower level of 10 lipids in the blood in the study subjects who went on to develop functional impairment might reflect the breakdown of neural cell membranes, the researchers hypothesized.
There are already tests in existence that measure cognitive function, but these rely on the examination of cerebrospinal fluid or brain imaging scans, and involve testing methods that are considered both expensive and complicated. A test that uses blood samples may be much cheaper and more practical in terms of widespread use, although the study researchers admit that the results need to be validated on a much larger scale for any definitive conclusions to be made.
This begs the question: How will patients change their behavior if they are found to have signs of the biomarkers associated with AD? There are currently no suitable disease-modifying therapies to treat AD, so having the knowledge of a predisposition for the condition may not be quite so helpful. However, knowledge of this risk could allow patients to enroll in experimental clinical trials, and could help scientists better understand the etiology of AD.
Although beta amyloid has been thought to be a promising therapeutic target for AD, many of the drugs that have been developed with the belief that reducing the amount of amyloid in the brain halts disease progression have failed in clinical trials.
Measles cases rise rapidly across U.S.
Recent measles outbreaks in New York City and California have many healthcare professionals concerned for their patients. According to the Center for Disease Control, measles was declared eliminated from the United States in 2000, with only an average of 60 cases of measles reported each year. But in 2013, that number increased to 189 cases. Many of the instances are occurring in areas with populations of unvaccinated children, which are the suspected result of anti-vaccination beliefs.
The New York City outbreak has 19 confirmed cases to date, 10 adults and nine children. Four of the affected children were too young to be vaccinated, three who had been vaccinated were 13 months to 15 months old and two others had not been vaccinated by parental choice, according to the New York Health Department. The California outbreak has 32 cases confirmed statewide, according to the California Department of Public Health, 10 of which have been imported by patients who visited countries with large measles outbreaks.
Pharmacists and clinicians play an important role in limiting the spread of measles. Make sure that patients know the facts: Measles is a highly contagious viral infection that causes fever, runny nose, cough and a rash all over the body. The virus is spread though the air by breathing, coughing or sneezing. Complications may include ear infections, pneumonia, miscarriage, encephalitis or death, and can occur in as many as 1-in-3 patients with measles. However, patients and parents need to understand that this highly infectious viral disease can be prevented.
The first measles vaccine was licensed in 1963, and the first combination measles-mumps-rubella, or MMR, vaccine first became available in 1971. Since then, the incidence of measles has dropped 99%. Prior to widespread vaccination, measles caused an estimated 2.6 million deaths per year. Globally, approximately 122,000 people died from measles in 2012, most of whom were children younger than 5 years.
Since maintaining high MMR vaccination coverage is essential to preventing measles outbreaks and sustaining measles elimination in the United States, pharmacists and clinicians need to emphasize the importance of immunizing patients in accordance with the CDC vaccine schedule. Although pharmacists are allowed to immunize in every state, most states do not allow them to immunize pediatric patients at the age when the MMR vaccine is recommended. Children should receive their first dose of MMR between 12 months and 15 months and a second dose between the ages of 4 years and 6 years. Two doses of the vaccine are recommended to ensure immunity and prevent outbreaks, as about 15% of vaccinated children fail to develop immunity from the first dose. The immunization schedule was developed to protect infants and children as early as possible by providing immunity before they are exposed to potentially life-threatening disease. There is no evidence that supports delaying a child’s immunizations, and parents who choose to follow an alternative schedule put their children at risk of developing disease while the vaccines are delayed. Make sure that all patients know that the MMR vaccine has never contained thimerosal, a mercury derivative, because it is manufactured as a single-dose vial and no preservatives are needed. Finally, studies continue to show that vaccines are not associated with autism spectrum disorders. By working to educate patients, the United States can return to an eradicated state for measles and many other diseases.
The Quality Imperative
Message to federal health plan payers from community pharmacy: We have the systems in place and the professional expertise to help millions of patients to better their health outcomes at a lower cost. Message to pharmacy from the U.S. Department of Health and Human Services and its Centers for Medicare and Medicaid Services: Prove it.
That’s the basic impetus behind the drive to measure and improve patient adherence, safe medication management and other performance benchmarks by both the private health plans that serve Medicare patients and the pharmacies they and their patients depend on. It’s become a bedrock principle for CMS through its Star ratings system for Medicare Advantage, or MAPD, and Part D prescription drug plans.
CMS’ Star ratings system was created by law in 2003 with establishment of the Part D drug benefit program. That system assigns ratings of one to five stars — five being the highest — to a variety of performance measures for every Part D or MAPD plan that serves Medicare beneficiaries.
“CMS has been evaluating health plans on Star measures for years,” said A.J. Caffentzis, SVP sales and marketing for AmerisourceBergen. “The shift in the healthcare industry to performance-based care has made a plan’s Star rating a critical factor for the community pharmacy, especially since five of the performance measures, 48% of the total Part D Star rating, are related to medication management.”
Three of those measures are related to patient adherence, and in particular, how successful a plan’s participating pharmacies are at keeping their patients on track with the medication therapy as measured by “proportion of days covered” for a prescription drug, or PDC. The other two pharmacy-driven performance benchmarks are related to patient safety and the reduction of risk, particularly for elderly patients.
Indeed, the Star rating system puts a lot of weight on the careful management of high-risk medications, or HRMs, by elderly patients. According to CMS’ rating system, the fewer high-risk meds dispensed to older Americans, the better — particularly when lower-risk alternatives are available.
“A plan’s effectiveness in proactively managing the use of HRMs is weighted heavily in the plan’s CMS Star ratings,” Express Scripts noted in a report. “Plan sponsors can achieve healthier outcomes — and a higher CMS Star rating — by strategically using advanced clinical pharmacy benefit management solutions to more effectively monitor and control the high-risk medications that members receive.”
Particularly with the advent of the National Quality Strategy, a framework from HHS for overhauling the nation’s health system to make it more cost-effective and outcomes-driven, the quality and performance measurement efforts embodied in the Star ratings system are key to pharmacy’s future. The reason: retail pharmacy’s ability to participate in the new healthcare system that is emerging from the chaotic soup of health reform, pay-for-performance reimbursement trends and evidence-based medicine will depend on its ability to benchmark and measure pharmacists’ success in providing safe and effective medication therapy to millions of patients and improving adherence rates — and demonstrating improved patient outcomes as a result of those efforts. That benchmarking effort also depends on communicating those quality and safety performance metrics to health plans and payers.
“With the shift to value-based purchasing, the U.S. healthcare system faces significant transformation,” said Robert McMahan, president of United Drugs, a major member-owned pharmacy services administration organization with roughly 1,300 independent pharmacies as members. “Payers are navigating the complexities of a new reimbursement environment, and independent pharmacists must be able to show value by driving quality metrics and positive outcomes.”
Laura Cranston, executive director of the Pharmacy Quality Alliance, agreed. “We are moving to a value-based [healthcare] model, and this model relies on performance measures,” she said. “Performance measures and adoption of measures is about driving value and making value part of the healthcare equation — being able to measure it, and also being able to hold people accountable. So measures are being created to hold entities accountable.”
It’s essential, Cranston told DSN Collaborative Care, that chain and independent pharmacies adopt a system of tracking and communicating performance and quality metrics, and align those metrics with those of the health plans and PBMs they do business with. And that’s particularly true given the increasing reliance by CMS on its Star rating system as a basis for performance-based payments to MAPD and Part D health plans. Also lending urgency to the adoption of performance metrics: the move toward pay-for-performance incentive payments that go directly to pharmacies.
“Pharmacists … want to be recognized [by law] as a healthcare provider. If they are, they are able to bill directly to … payers in government and elsewhere,” Cranston said. However, she added, “you are not going to be recognized as a healthcare provider unless you’re willing to accept accountability, because every healthcare provider recognized by CMS as a distinct healthcare provider has performance measures of accountability. And performance measures are going to be part and parcel of every federal- or state-funded program.”
Formed in 2006, PQA is a public-private alliance that has taken a lead role in the development of medication-related quality measures for evaluating health plans, pharmacy benefit managers and pharmacies. Its goal: To “improve the quality of medication management and use across healthcare settings with the goal of improving patients’ health through a collaborative process to develop and implement performance measures,” the organization said. That vision also means recognizing “examples of exceptional pharmacy quality.”
The group’s new vision statement expands on its original mission, which also includes “reporting meaningful information to consumers, pharmacists, employers, payers and other healthcare decision-makers to help make informed choices, improve outcomes and stimulate the development of new payment models.”
PQA’s performance and quality metrics have been endorsed not only by CMS and its Star rating system for Medicare Advantage and Medicare Part D plans, but also by the National Quality Forum; the National Committee for Quality Assurance; the National Council for Prescription Drug Programs; the National Business Coalition on Health; and URAC, a major independent healthcare accrediting agency. Inland Empire Health Plan also adopted its quality and performance measurement standards for a major pay-for-performance demonstration project in California that involved pharmacies.
PQA’s membership comprises more than 130 organizations, including virtually every pharmacy advocacy group, including the American Pharmacists Association, the National Association of Chain Drug Stores and the National Community Pharmacists Association; retailers Walgreens, CVS Caremark, Rite Aid, Walmart, Target, Kroger and Safeway; and dozens of pharmaceutical manufacturers, pharmacy benefit management firms, colleges of pharmacy, health plans and government agencies.
“We’re moving to a value-based healthcare system where providers, hospitals and other organizations are going to be paid based on their ability to both generate positive outcomes and control costs,” said Anne Burns, VP professional affairs for APhA. “This is an opportunity for pharmacists to get on board with: How can I help a healthcare entity; how can I help a physician; how can I help an ACO meet their quality measures?”
What’s more, APhA noted, “pharmacies’ performance on Star measures may determine if they’re eligible for a bonus payment, and also may determine whether that plan includes the pharmacy in a preferred network.”
David Nau, president of Pharmacy Quality Solutions, added, “if you try to align the financial incentives for better quality, you ultimately get people to produce better quality because they have that financial incentive to do so.” Community pharmacy, he said, “is really one of the last entities to be folded into this value-driven model.”
PQS has developed a national platform for medication-related quality measurement, benchmarking and collaboration among health plans, PBMs and pharmacies that aggregates and disseminates data from all those sources to measure the quality of medication utilization, including adherence and patient safety processes through medication management. The system is called Electronic Quality Improvement Platform for Plans and Pharmacies, or EQuIPP.
The need to adopt performance and quality metrics will only increase, according to Nau’s company. “The healthcare system is trending toward a proliferation of value-based purchasing arrangements in which payment for services is tied not just to a set fee per service, but also to an incentive for providers who can demonstrate improvements in patient care,” PQS noted in a statement. “One of the strongest drivers for this change is the Centers for Medicare and Medicaid Services’ Star Ratings for Parts C/D and ‘quality bonus payments’ for Medicare Advantage plans. Medicare plans have millions of dollars at stake relative to their Star ratings.”
Given their position at the front lines of community-based accessible care — and at the nexus where the needs of patients intersect with the cost-saving demands and quality performance objectives of health plan payers and pharmacy benefit managers — pharmacists have a big role to play in the shift to performance-based payment systems, PQS asserted. They’re also essential to the success of the Medicare Part D plans that provide drug benefits to millions of seniors.
“Pharmacists have long been a care provider with the expertise and accessibility necessary to influence positive changes in patients’ medication use,” PQS said. “The traditional fee-for-service financial arrangements that drive most, if not all, payment for pharmacy services does not foster an environment where pharmacists can be optimally engaged in large-scale continuous quality improvement efforts outside of those that directly impact the accurate and timely dispensing of medications.”
Among other pharmacy providers, all three of the nation’s top drug wholesale companies — McKesson, AmerisourceBergen and Cardinal Health — have adopted the EQuIPP performance measurement platform from Pharmacy Quality Solutions and PQA, and have made it available to the thousands of independent and franchised pharmacy members they supply and service.
AmerisourceBergen, for instance, announced a major initiative in December 2013 to align its network of 3,200 Good Neighbor Pharmacy owner-operators with CMS’ Star measure improvement goals. The initiative includes an agreement with Pharmacy Quality Solutions to bring EQuIPP to GNP members, and to offer those members an educational series in dozens of locations around the United States on CMS’ Star measuring system, and on how pharmacies can improve their rating in partnership with the health plans whose patients they serve.