Monday, July 22, 2013

Why the Fervor Over Drug Adherence?

sr-img-ftr-drugadherence
Drug adherence is one of the hottest topics in pharmacy today. What is driving this and what does it mean for community pharmacies?
Everywhere you turn — in industry publications, academic research, conferences, and even the mainstream press — there is mention of “drug adherence.” (A Google search of this term generates over 10 million hits.) It seems that increasingly drug adherence is a priority for the government, Medicare Advantage plans, private payers, pharmaceutical companies, PBMs, ACOs — and pharmacies.
But why is drug adherence getting so much attention lately? And why should community pharmacies care about it?

Why Adherence? Because Non-Adherence Remains a Huge Problem

Medication adherence is not a new issue, but remains an enormous problem. Half of the 4 billion prescriptions written annually are not filled in their entirety.[i] And, recent studies confirm that the failure to take medications as prescribed has a costly impact on the U.S. healthcare system, with estimates that the current cost could be as much as $290 billion annually — or 13% of total healthcare expenditures.[ii]
Even though the problem of non-adherence to prescribed drugs has been known and researched extensively, the rates of non-adherence have not changed much in three decades.[iii]
A few salient facts that illustrate the continuing adherence problem[iv]:

  • Nearly two-thirds of Americans who take medications do not take them properly.
  • 64% percent of Americans who take medications don’t always take their medications as prescribed; only 33% say they never miss taking their prescription medications.
  • Those who must manage multiple medications are most likely to not adhere; 70% of individuals who take 3 or more medications do not take them properly.
“Drugs don’t work in patients who don’t take them.”
— C. Everett Koop, former U.S. Surgeon General

Why Adherence? Because It Has Been Proven to Work

There is better and better evidence showing the adherence-focused interventions can work. A recent Health Affairs blog posting on adherence[v] highlighted three 2011 studies that showed associations between medication adherence and cost savings; the savings was attributable to lower medical utilization. When people were more adherent to their medications, their overall medical costs declined. These studies included patients with CHF (congestive heart failure), hypertension, diabetes and dyslipidemia. Even though spending on medications increased, there were corresponding decreases in hospitalizations and emergency department visits yielding benefit-cost ratios ranging from 3 to 1 (for dyslipidemia) to even 10 to 1 (for hypertension).
 Further, according to a recent Congressional Budget Office (CBO) report, a 1% increase in the number of prescriptions filled by Medicare beneficiaries would cause Medicare spending on medical services to fall by roughly 0.2% ($1.7B).[vi]
“CBO reviewed dozens of newer studies and determined a body of research now demonstrates a link between changes in prescription drug use and changes in the use of and spending for medical services.”
— CBO Report, November 29, 2012
The evidence base increasingly shows that better drug adherence leads to a reduction in healthcare costs, and has a positive return on investment.

Why Adherence? Because Multiple Stakeholders Are Now Focused on It

A key reason adherence is now getting so much attention is because multiple stakeholders are increasingly interested in it for varying reasons. Here is who and why they are interested:
    • Government. Health expenditures in the U.S. now represent 17.9% of GDP, total $2.7 trillion, and are continuing to rise. The federal government and state governments pay for much of Medicare and Medicaid, and they view the level of healthcare spending and the continued growth in spending as unsustainable. As a result, efforts are under way to change the payment system and to find ways to control costs. Data showing that improvements in drug adherence can improve outcomes and reduce costs are getting governmental attention as officials look for ways to reduce spending.
    • Health plans. Like the government, health plans are continuing to see costs rise and are aware that improved drug adherence can translate into improved outcomes and decreased costs.
    • Medicare Advantage plans. Per Health Affairs,[vii] health plans provide pharmacy benefits to about 12 million Medicare beneficiaries in Medicare Advantage (MA) programs. MA plans receive a “Star Rating” of 1 to 5, and are focused on receiving 4- or 5-Star Ratings because these plans receive additional payments, which can be significant, as well as marketing advantages.
Of the 53 measures of quality used to calculate Star Ratings, 3 deal with drug adherence. For the 2013 Plan Ratings, CMS assigned the highest weight[viii] to outcomes and intermediate outcomes due to their clinical relevance. Therefore, medication measures used by Medicare receive a “triple rating,” accounting for 45% of total Star Ratings within Part D Stand-Alone PDPs, and 20% for the Medicare Advantage programs.
The Star Ratings program is spurring new attention and investments in medication adherence programs among Medicare Advantage plans.
  • PBMs. Increasingly, PBMs are forming “preferred networks” of pharmacies. Previously, the main criterion to be part of a PBM’s preferred network was cost/pricing. But this is changing. Today and in the future, PBMs are expected to be increasingly basing network decisions on “performance,” which looks at outcomes and factors such as drug adherence.
  • Pharmaceutical manufacturers. Non-adherence costs pharmaceutical manufacturers tens of billions of dollars each year, giving pharma companies a significant incentive to improve adherence.[ix]
StakeholderWhy they care about drug adherence
Payers (government and commercial)To reduce total medical costs
Medicare Advantage plansFor good Star Ratings and bonus payments
PBMsNew definition of “performance”
Pharmaceutical manufacturersTo increase revenue

Why Adherence? Because There Are Significant Short- and Long-Term Benefits for Pharmacies

In addition to the many stakeholders interested in improving drug adherence, there are also distinct advantages for pharmacies. These include:
  • Benefits to patients. Certain studies have shown medical costs have declined and outcomes improved from better patient adherence.
  • Filling more prescriptions. Improvements in adherence will mean more patients are having more prescriptions filled, which will generate more fills and refills at the store level and help drive additional revenue, traffic and profit for store owners.
  • Advancing professionally. It is the pharmacist’s basic role to ensure that patients understand their medications and take them as prescribed. This is the right thing to do professionally. Importantly, pharmacists are well positioned in the healthcare system to play a key role in driving adherence, which is just one more way that pharmacy continues to evolve in serving as a valuable community health resource.

Why Adherence Matters

So, non-adherence to prescribed drugs remains a significant, costly problem. But when patients fill their prescriptions and adhere to them, the results include improved outcomes and lower costs. Many stakeholders see the value in drug adherence and are motivated to improve adherence. For community pharmacies, it is important to understand the factors driving the increased emphasis on adherence, the benefits to the pharmacy (more prescriptions filled), improved patient outcomes, and the role of a community pharmacy in improving drug adherence.
BY   |     |  TOPIC: PATIENT CARE & COUNSELINGPHARMACY OPERATIONS
[I] DAVID M. CUTLER, PHD, AND WENDY EVERETT, SCD, “THINKING OUTSIDE THE PILLBOX—MEDICATION ADHERENCE AS A PRIORITY FOR HEALTH CARE REFORM,” NEW ENGLAND JOURNAL OF MEDICINE 362: 1553-155, APRIL 29, 2010, HTTP://WWW.NEJM.ORG/DOI/FULL/10.1056/NEJMP1002305
[II] NEW ENGLAND HEALTHCARE INSTITUTE, “THINKING OUTSIDE THE PILLBOX: A SYSTEM-WIDE APPROACH TO IMPROVING PATIENT MEDICATION ADHERENCE FOR CHRONIC DISEASE,” AUGUST 12, 2009, WEBSITE
[III] ASHISH ATREJA, MD, MPH, NARESH BELLAM, MD, MPH, AND SUSAN R. LEVY, PHD, “STRATEGIES TO ENHANCE PATIENT ADHERENCE: MAKING IT SIMPLE,” MEDSCAPE GENERAL MEDICINE, 7(1), 4, MARCH 15, 2005, HTTP://WWW.NCBI.NLM.NIH.GOV/PMC/ARTICLES/PMC1681370/
[IV] GREENBERG QUINLAN ROSNER RESEARCH PUBLIC OPINION STRATEGIES, LACK OF MEDICATION ADHERENCE HARMS AMERICANS’ HEALTH: RESULTS FROM A U.S. NATIONAL SURVEY OF ADULTS, MAY 2, 2013, HTTP://POS.ORG/DOCUMENTS/CAHC_2013_PUBLIC_POLL_MEMO.PDF
[V]AARON MCKETHAN, JOSH BENNER, AND ALAN BROOKHART, “SEIZING THE OPPORTUNITY TO IMPROVE MEDICATION ADHERENCE,” HEALTHAFFAIRS BLOG, AUGUST 28, 2012, HTTP://HEALTHAFFAIRS.ORG/BLOG/2012/08/28/SEIZING-THE-OPPORTUNITY-TO-IMPROVE-MEDICATION-ADHERENCE/
[VI] CONGRESSIONAL BUDGET OFFICE, OFFSETTING EFFECTS OF PRESCRIPTION DRUG USE ON MEDICARE’S SPENDING FOR MEDICAL SERVICES, NOVEMBER 29, 2012, HTTP://WWW.CBO.GOV/PUBLICATION/43741
[VII]AARON MCKETHAN, JOSH BENNER, AND ALAN BROOKHART, “SEIZING THE OPPORTUNITY TO IMPROVE MEDICATION ADHERENCE,” HEALTHAFFAIRS BLOG, AUGUST 28, 2012, HTTP://HEALTHAFFAIRS.ORG/BLOG/2012/08/28/SEIZING-THE-OPPORTUNITY-TO-IMPROVE-MEDICATION-ADHERENCE/
[VIII] 4 CMS. MEDICARE HEALTH & DRUG PLAN QUALITY AND PERFORMANCE RATINGS 2013 PART C & PART D TECHNICAL NOTES. 8/9/2012
[IX] LIZ TIERNEY, “PATIENT NON-ADHERENCE COSTS UNDERESTIMATED,” PACKAGING WORLD, MARCH 22, 2013, HTTP://WWW.PACKWORLD.COM/PRINT/54751

Monday, July 15, 2013

Diabetes Drugs will Lead Specialty Category



Diabetes Drugs Will Lead Specialty Category
Diabetes drugs will lead the way in a dramatic rise in spending over the next two years on specialty drugs, according to a study by Express Scripts, a St. Louis-based prescription benefits management company.
The study estimates that U.S. spending on such drugs will reach nearly $115 billion in 2014. Specialty drugs are defined as drugs used to treat very serious ailments, such as cancer and autoimmune diseases like diabetes. The drugs require special handling and administration.
Their costs are high due to several factors, including the expense of developing them, and the fact that physicians are delaying treatment of some patients until drugs now under development come to market.
Heading the list of expensive specialty drug therapies will be diabetes drugs, where spending on them is expected to increase by 24 percent between now and 2015. (Other disease categories where Express Scripts expects to see higher spending on drugs are cancer, multiple sclerosis, and inflammatory conditions such as rheumatoid arthritis.)
According to Express Scripts, diabetes became the costliest prescription drug therapy class in 2011. The increasing incidence of the disease in the general population, plus an abundance of new diabetes drugs in the pipeline will add to the overall cost of drugs in that class.
Jun 14, 2013

Wednesday, July 10, 2013

Evolving Definition: What is a Specialty Pharmacy?

There has been a lot of buzz in the healthcare world lately about “specialty pharmacy” as an opportunity for rapid growth, financial opportunity, and expansive change, however there is some debate as to what exactly constitutes a specialty pharmacy.  

Here we will examine that questions and look at some of the definitions that have been recently emerging by focusing on three key questions:

what is a specialty pharmacy
What is a Specialty Drug?
Specialty Pharmacies are most often focused on the dispensation of specialty drugs.  While there is no standardized definition of what constitutes a specialty drug, most often the meet the following criteria:
  • the drug is a specialized, high cost product (typically more than $500 per dose or $6000 or more per year)
  • the drug is utilized as a complex therapy for a complex disease
  • the drug requires special handling or administering, shipping, or storage (such as an injectable)
  • the drug may have a Food and Drug Administration (FDA) Risk Evalaution and Mitigation Strategy (REMS) in place specifying that there is required training, certifications, or other requirements that must be met in order for the drug to be administered.
  • The drug has the potential for significant waste due to high cost
Specialty drugs are used to treat a variety of complex and chronic conditions including but not limited to: anemia, cancer, infertility, multiple sclerosis, HIV and hepatitis.  Some categorize specialty drugs as meeting all of the three H’s: High Cost, High Complexity, High Touch.
Because of the specialized way in which these drugs need to be administered, specialty pharmacies come into play with a specific focus on this group of drugs and the required comprehensive and coordinated delivery and support required to effectively deliver these drugs to patients.  Leading us to the question “What is a Specialty Pharmacy?”

What is a Specialty Pharmacy?

Now that we have identified what a specialty drug is, we can begin to touch on what constitutes a specialty pharmacy.  In broad terms, a specialty pharmacy is a specific type of pharmaceutical delivery system which coordinates delivery and offers comprehensive support in the distribution of drugs which are high cost or complex and utilized to treat complex conditions.
The Academy of Managed Care Pharmacy (AMCP) in a recent publication entitled Format for Formulary Submission, version 3.1 defined specialty pharmacy as the following:
“Specialty pharmacies are distinct from traditional pharmacies in coordinating many aspects of patient care and disease management.  They are designed to efficiently deliver medications with specialized handling, storage, and distribution requirements with standardized processes that permit economies of scale.  Specialty pharmacies are also designed to improve clinical and economic outcomes for patients with complex, often chronic and rare conditions, with close contact and management by clinicians.  health care professionals employed by specialty pharmacies provide patient education, help ensure appropriate medication use, promote adherence, and attempt to avoid unnecessary costs.  Other support systems coordinate sharing of information among clinicians treating patients and help patients locate resources to provide financial assistance with out of pocket expenditures.”
 
What we are essentially seeing is a distinct new entity emerging in the form of Specialty Pharmacy that collaborates and  coordinate for patients on a much more meaningful level than expected by traditional pharmacies.  
Not only do specialty pharmacies specialize in the administration of specific medications, they also work to educate patients, conduct coordination regarding care, and manage inefficiencies related to cost providing a service in which the pharmacist and patient are much more collaborative and closely connected.  
In addition to this being a newly emerging care model, statistics have shown that the emergence of specialty pharmacies has gained incredible momentum in recent years, which brings us to our third question:

Why is This Area Poised For Growth?

The specialty pharmacy care model is being supported by several initiatives and is another way in which healthcare providers are looking to improve patient care while effectively managing costs in one coordinated system.  This means that the specialty pharmacy model is in the right place at the right time from a care provision perspective.  Add to this the explosion in specialty drugs.  
  • “Within 4 years, specialty drugs will account for 40% to 45% of pharmaceutical manufacturer sales” Specialty Pharmacy Today
  • “7 of the top 10 bestselling drugs (by revenue) are projected to be specialty drugs in 2016 compared with 3 in 2010″ EvaluatePharma
  • Furthermore, according to Jon Haas, VP, Managed Markets, Palio “in 1990 there were 10 specialty drugs on the market, while in 2010 there were 250 specialty drugs”
Growth for this segment of the healthcare industry is undeniable, and specialty pharmacies will begin to see much more competition in the coming years and should begin positioning themselves for success early to capitalize on the expected gains in their market over the next decade.  
One of the ways that specialty pharmacies can accomplish this is through pharmacy accreditation. Later this week will will focus on the two accrediting bodies for specialty pharmacy accreditation, and how accreditation can give specialty pharmacies a strategic advantage in the marketplace.
Authored by:
Linda Ringquist, MBA is a Healthcare Marketing Consultant with BHM Healthcare Solutions – www.bhmpc.com a firm recognized as one of the “top healthcare organizations to watch in 2013”. Her primary areas of expertise are content management, social media (especially Linkedin), healthcare blogging, project management, strategic coordination, and marketing analytics.

Monday, July 1, 2013

Expiring Prescription Drug Patents Benefit Consumers

Medicine is getting cheaper. That may come as a surprise amid hand-wringing about the spiraling cost of health care, but two new studies, one from research company IMS Health and one from pharmacy benefit manager Express Scripts, show that the amount of money Americans spend on prescription drugs went down in 2012 for the first time in decades.
The reason for this welcome development is an influx of generic medications. Recently, the patents on a slew of blockbuster drugs — like Lipitor, which fights cholesterol, and Plavix, which prevents blood clots — have expired, paving the way for less expensive versions. The research behind a new drug is protected for a fixed number of years, after which competing firms can begin manufacturing generic forms.
In 2012, 84 percent of all prescriptions were dispensed as generics, the highest rate in history. It’s a boon for consumers.

These new studies also found the prices of specialty medicines are rising. These new drugs involve cutting edge technologies and can, therefore, be expensive, priced as they are to help inventors recoup their investments. Fearful of what the newest medicines may cost patients and insurers, some politicians have proposed measures aimed at forcing these prices down.
We shouldn’t fear the price tag of these new medicines. Expensive medicine may be a bitter pill, but these advanced therapies offer hope to millions of patients, keeping them healthier for longer. Lawmakers must continue to promote smart policies that encourage the research investments critical to invention.
We’re living in a golden age of drug development. New treatments for everything from cancer to rare genetic diseases are entering the market all the time, many of which are cutting-edge biologic medicines derived from living cells.
Biologics offer amazing promise. Consider their potential impact on cancer. Conventional cancer treatments often generate significant collateral damage to the patient. In contrast, the biologic approach injects a genetically engineered protein designed to knock out a tumor’s ability to produce new blood vessels, thereby cutting off its capacity to grow. No innocent tissue is harmed in the process. Such a biologic has already been approved for treating colorectal cancer.
Or consider a vaccine that, when injected directly into a tumor, would not only destroy the malignant cells but also stimulate the body’s immune system to go after similar tumor cells. That therapy for treating melanoma is already in the development pipeline, along with 906 other biologics targeting over 100 diseases from autoimmune disorders to viruses. There are currently 176 biologics in development to treat infectious diseases alone.
But the most specialized and complex drugs can come at an astronomical price. According to an exclusive Forbes’ survey of the most expensive medications, four biopharmaceuticals approved in 2012 cost more than $200,000 per year, per patient.
That’s because it costs on average, $1.2 billion dollars to bring a new drug to market — from the time it is a twinkle in a scientist’s eye, through a decade or more of lab research, to clinical trials and finally FDA approval. To put this in perspective, the entire cost of one of the greatest physics experiments of all time, the search for the Higgs boson — including building a super collider — would produce no more than 10 drugs.
The beauty of our system is that it encourages companies to make the massive investments of time and money required to bring a new drug to market. The biopharmaceutical industry’s legacy of risk-taking research has led to a world in which eight of every 10 medicines dispensed is generic.
And study after study proves these investments are paying off. Innovative therapies, though costly, are far more effective. By treating patients faster and keeping them well, advanced pharmaceuticals lower health care costs elsewhere.
For example, researchers are working to develop a medicine to delay the onset of Alzheimer’s — the sixth leading cause of death in the United States. Such a breakthrough therapy could reduce the cost of care for Alzheimer’s patients in 2050 by $447 billion.
Our children and grandchildren will grow up to marvel at the biologic revolution, just as an earlier generation marveled at the space race. But that can only happen if we accept the reality that innovation comes at a high price.
Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.