Julie Slezak, MS

In the first quarter of 2011, we continued to confront a marketplace with weary consumers. Although the jobless rate fell slightly (0.8%) from November 2010 to April 2011, the unemployment rate remained high at 9.0%, representing 13.7 million Americans who are still out of work.

 In addition, the price of gasoline reached nearly $4 a gallon on average in early May.

 Numerous studies and surveys have shown that those hit hard in difficult economic times are more likely to cut back on their use of medical services and prescription drugs.

A Commonwealth Fund survey conducted between July and November 2010 found that an estimated 9 million working-age adults lost their health insurance in the last 2 years. The survey also found that 52 million adults went without coverage at some point in 2010, up from 38 million in 2001. In addition, 75 million adults did not get needed healthcare last year, skipping prescriptions, doctor visits, and recommended tests and treatments because of costs that were 60% higher than a decade ago.

 Other anecdotal evidence also suggests that many Americans continue to postpone or forgo medical care as the result of a lingering recessionary mind-set. UnitedHealth Group told analysts that so far this year, insured hospital stays actually decreased in some instances. Cigna has also talked about the “low level” of medical use. Even with a halting economic recovery, doctors and others say many people are still extremely budget conscious, signaling the possibility of a fundamental change in Americans’ appetite for healthcare.

The CVS Caremark overall gross trend in the first quarter of 2011, excluding Medicare Part D, was 2.0% and the days of supply per member per month (PMPM) utilization trend was 1.7%. The slower-than-expected utilization trend is impacted by an intersection of circumstances, including the continued economic uncertainty, severe weather,5 the launch of over-the-counter (OTC) Allegra6 in March 2011, and an ongoing change in the underlying demographics of commercial members. Although more Americans are delaying retirement due to the economy,

 an estimated 10,000 Baby Boomers—the largest generational segment of our population&mdash;come eligible for retirement each day (which will be true for years to come).

 Many of these retirees move straight into a Medicare program and out of the employer groups to which they previously belonged, resulting in a shift of demographics of utilizing members.

The major drivers for prescription utilization trend include changes to the demographics (including the number of members utilizing a drug), change in members’ underlying health, and shift in age. In addition, a change in the days of supply or number of prescriptions utilized may be due to the availability of new therapies, an aging population, change in prescribing guidelines, reported adverse reactions, changes in drug benefit, and shift of prescription drugs to OTC status.

The shift in the underlying employer demographics may be driven by employers who reduce or eliminate healthcare coverage for retirees, which would certainly reduce average utilization in the employer segment of society. Most private-sector workers will never become eligible for health insurance in retirement through a former employer. Fewer employers are offering health benefits to future retirees; when those benefits are offered, eligibility criteria are becoming harder to meet; and employer subsidies are disappearing. In 2008, 26% of people aged 65 to 69 years had retiree health benefits, down from 32% in 1994, and the numbers were lower for older retirees. It is possible that the decline in coverage would have been even larger had it not been for changes in the work status of individuals eligible for Medicare. In 1995, 59% of individuals aged 65 to 69 years considered themselves retired, a percentage which fell to 53.6% in 2008, while those saying they were working increased from 28% in 1995 to 35% in 2008. The annual (2010-2011) Prescription Drug Benefit Cost and Plan Design Report published by the Pharmacy Benefit Management Institute found that the number of employers providing retiree drug coverage dropped to 31.5% in 2010 from 45.9% in 2007.

Another reason for a change in employer demographics is the extended age for dependents covered by an employee’s benefit. The coverage of persons aged 21 to 26 years due to the recent enactment of healthcare reform legislation would cause an increase in acute drug utilization and a decline in use of chronic medications since younger persons are less likely to be high utilizers.

Change in utilization may also be due to implementation of compliance and/or adherence programs. More attention has been focused on adherence in the benefit arena. Our data show that on average 40% of individuals are not being treated in accordance with current recommended therapeutic guidelines. To support physicians and individuals where evidencebased guidelines are clear, pharmacy benefit managers (PBMs) and health plans are implementing unique approaches to closing these gaps in therapy. One example is CVS Caremark’s adherence approach, which is delivered on behalf of PBM clients over the phone or on a face-to-face basis in CVS pharmacies to support individuals by reminding them to take their medication; CVS Caremark also works with patients’ physicians as necessary to close any gaps in therapy that may exist. Adherence outreach, when effective, has the ability to impact utilization and health.

Therapeutic class changes in utilization are due to prescription drugs moving to OTC status, Food and Drug Administration (FDA) safety warnings, or adverse studies reported in the lay press. There have been several year-to-date (YTD) studies in 2011 (

). In the last few years, several major blockbuster drugs have seen a significant decline in utilization due to an adverse safety profile (eg, Avandia).

Sales of the class and of Avandia in particular have suffered since a May 2007 meta-analysis of Avandia (rosiglitazone) studies published in the 

 showed a statistically significant increase in the risk of myocardial infarction and an increased risk of death from cardiovascular causes with borderline significance.

 CVS Caremark Industry Analytics subsequently undertook to examine and understand the impact of the published results in the company’s Book of Business (BOB) on the Avandia franchise (Avandia, Avandaryl, and Avandamet). Results of this analysis showed that of the base group of Avandia franchise users, 37.4% failed to renew theirprescriptions as of June 30, 2007. Of Avandia users, 40.3% failed to renew their prescriptions for the drug.

According to the results of a retrospective study published in June 2010, an estimated 48,000 elderly patients experienced serious cardiovascular harm or death as a result of using Avandia instead of Actos between 1999 and 2009. The study, which examined the records of 227,000 patients 65 years and older who received either drug between 2006 and 2009, found that use of Avandia was associated with a 27% greater chance of suffering a stroke and a 25% increased risk of suffering heart failure compared with Actos. Data also showed that patients who took Avandia had a 13% greater chance of dying. In addition, Avandia increased the overall risk of experiencing heart attack, stroke, heart failure, or death by 17%, the study found.

In compliance with a 2010 FDA directive, GlaxoSmith-Kline finalized new labeling for Avandia in February 2011, restricting the drug’s use to patients already taking it or to those who have failed other antiglycemic drugs. According to the new label, Avandia may be started only in patients who “are unable to achieve adequate glycemic control on other diabetes medications, and, in consultation with their healthcare provider, have decided not to take Actos for medical reasons.” In addition, a previous boxed warning has been amended to highlight the increased cardiovascular risks associated with Avandia—citing data from a meta-analysis of 52 earlier studies as well as 3 stand-alone trials that found higher rates of myocardial infarction in patients taking Avandia versus placebo or another comparator drug. The warning also notes that Avandia has not been compared with Actos in a head-to-head study of cardiovascular risks; however, a placebo-controlled trial of the latter drug did not indicate an increase in myocardial infarctions or deaths. The new label also expands previous language related to heart failure and associated conditions, such as edema and fluid retention. Patients with New York Heart Association class III or IV heart failure should not receive Avandia, and the drug may increase other cardiovascular risks in patients with milder forms of heart failure.

Changes in prescribing guidelines usually increase prescription utilization. However, in some cases when a single new therapy or combination is better than multiple separate existing therapies, utilization decreases. In January 2011, The American Geriatrics Society updated its 10-year-old guidelines on preventing falls in older persons. Recommendations for interventions that are new since the 2001 guidelines include medication reduction or withdrawal, particularly for sedatives, antidepressants, and other drugs affecting the central nervous system, regardless of the number of medications prescribed. This is a change from the 2001 guidelines, which recommended reducing medications only if patients were taking 4 or more. The new guidelines also specify that all older adults at risk for falls, and those with known or suspected vitamin D deficiency, should receive a daily vitamin D supplement.

 The updated guidelines could have an inhibitory effect on prescribing to the elderly in specific classes such as atypical antipsychotics and other central nervous system drugs, while driving increased utilization of prescription vitamin D.

More Lenient Guidelines for Atrial Fibrillation Include Pradaxa

Pradaxa (dabigatran) twice-daily capsules were approved by the FDA in October 2010 for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, or abnormal heart rhythm. It is the first anticoagulant to enter the market since warfarin (Coumadin and generics) was approved in the 1950s. Pradaxa is exponentially more expensive than generic warfarin, which has been available since 1997. Pradaxa’s competitive advantage relates to its superior efficacy; in a pivotal study used to support approval, Pradaxa patients had 34% fewer strokes and systemic embolisms than warfarin patients.

The shift from generic warfarin to branded Pradaxa will impact both generic dispensing rate and cost.

More lenient management of atrial fibrillation is safe for many patients, according to an update of existing guidelines from the American College of Cardiology and the American Heart Association, published online December 20, 2010. Under the new recommendations, treatment will aim to keep a patient’s heart rate at rest to fewer than 110 beats per minute in those with stable function of the ventricles, the heart’s lower chambers. Prior guidelines stated that strict treatment was necessary to keep a patient’s heart rate at fewer than 80 beats per minute at rest and fewer than 110 beats per minute during a 6-minute walk. The new thinking could lead to patients taking fewer daily medications, more convenient treatment, and perhaps the elimination of significant side effects from some of the drugs. Other treatment changes in the updated guidelines include prescribing a combination of aspirin and Plavix (clopidogrel) for patients who are poor candidates for warfarin; and prescribing Multaq (dronedarone), a newer antiarrhythmic, in place of amiodarone (Cordarone and generics), an older antiarrhythmic, to reduce side effects and hospitalizations.

While the approval of Pradaxa in October came too late for inclusion in the new guidelines published in December,

 an additional update was published by the groups in February 2011 that said that Pradaxa can be used as an alternative to warfarin to prevent blood clots and stroke in patients who have either recurrent episodes of atrial fibrillation that stop after 7 days (called “paroxysmal”) or ongoing (“permanent”) atrial fibrillation, and who have risk factors for blood clotting and stroke, provided that they don’t have a prosthetic heart valve, significant heart valve disease, severe kidney failure, or advanced liver disease.

The Centers for Disease Control and Prevention (CDC) laid out interim recommendations in January 2011 for use of Gilead Sciences’ Truvada (emtricitabine/tenofovir) as the US Public Health Service compiles the final guidelines for the drug, which is currently approved for treatment, not prevention, of HIV. Truvada, which was approved in 2004, combines 2 Gilead drugs, Viread and Emtriva, in a single pill. After a study last year found it can avert 44% of infections, haphazard use of the drug may give men a false sense of security and increase their chance of developing resistance to treatment if they contract the disease, the CDC said in its weekly report.

 It is essential for men to take the drug every day. Prevention rates soared to 73% for those who took the medicine regularly, and plunged to 21% among those who missed even 1 in 10 tablets. Truvada, if used properly, may help reduce the estimated 56,000 infections that occur each year, the agency said. The recommendations and the medication are intended only for men who engage in high-risk sexual practices, including unprotected sex and multiple partners. Additional studies will show in the next 2 years whether the drug provides similar protection against HIV during heterosexual intercourse or from intravenous drug use.

 Even an interim guidance validating use of Truvada as an HIV preventive measure is likely to be a utilization driver for the drug.

A major impact on utilization on the level of therapeutic class is a prescription-to-OTC switch. The most significant prescription blockbusters to have lost utilization to OTC products are the nonsedating antihistamines and proton pump inhibitors. The patent for prescription Prevacid expired on November 10, 2009. That was followed by the immediate launch of 2 competing generic versions as well as an OTC product, Prevacid 24HR (lansoprazole 15 mg). The OTC launch by Novartis was accompanied by a $200 million integrated marketing campaign. The campaign’s message focuses on offering a better quality of life and more choices to heartburn sufferers, and affordability and convenience to patients who had been taking the prescription version of the drug.

In January, sanofi-aventis announced that the FDA granted OTC status to all prescription versions of Allegra, and that the agency also approved behind-the-counter sale of Allegra-D. The company launched its branded line of OTC Allegra in the first week of March, with an April entry of a private-label line marketed by Perrigo.

 The second-generation antihistamine is a latecomer to the crowded nonprescription antihistamine category, and will immediately face competition from previously switched Claritin (loratadine) and Zyrtec (cetirizine) and their private-label counterparts.

Another major impact on prescription utilization is the continued drag on the economy and lack of consumer confidence. Increases in gasoline prices to ~$4 a gallon are forcing consumers to choose between gasoline purchases to get to work and other variable expenditures. It is an old story; a prescription copayment is too high, so the member decides to either go without the prescription entirely or selectively chooses to fill his or her prescriptions on a monthly basis.

A baseline client cohort was established to track changing marketplace and drug trends. The 2011 client cohort (excluding Medicare Part D) had more than 1200 clients and represented an average of 28 million members. Among the members, 62% were in the employer segment, 27% belonged to health plans, and the remainder were in the Medicaid segment. Only clients with stable membership (limited to a ±20% change in eligibility over 24 months) who had prescription claims in the entire study period were included. The CVS Caremark computerized deidentified database was used to study the utilization by days of supply and gross cost per member per year. The time frame was January 1, 2010, through March 31, 2011. Utilization was based on the change in the number of unique utilizers, average days of supply, and total prescriptions compared year-overyear (YOY). All metrics increased, including the number of utilizers, total number of scripts, and volume based on total days of supply YTD March 2010 compared with YTD March 2011.

The CVS Caremark overall gross trend in the first quarter of 2011, excluding Medicare Part D, was 2.0% and the days of supply PMPM utilization trend was 1.7%.

We calculated utilization trend as the change in days of supply PMPM. Utilization can be affected by many factors, including new drug approvals and/or new approved indications, reformulations, off-label drug use, changing demographics (eg, our aging population), benefit designs, pharmaceutical promotional spending, new treatment guidelines, and the economy. The slower utilization growth during first quarter of 2011 might be tied to the decline in consumer confidence in the economy and rising gasoline prices. 

 shows the potential correlation between the average monthly price of gasoline in the United States and the change in prescription utilization.

With gas prices hovering at $4 a gallon, many Americans are making tough choices. An Associated Press—GfK poll showed that more than 40% of respondents expected the price of gas to cause serious financial hardship, while 71% said the rising prices would cause some hardship for them. Some seniors are reportedly choosing a tank of gas over their prescriptions.

A full list of new drug approvals can be found in 

, including all new molecular entities, therapeutic biologics, and other novel biologic products (eg, vaccines, immunoglobulins). The most significant of these identified by Industry Analytics as having a strong potential impact on utilization, cost, and overall trend include 2 new biologics (Benlysta for lupus and Yervoy for melanoma) and a protease inhibitor (Victrelis for hepatitis C).

On March 9, 2011, the FDA approved Human Genome Sciences’ Benlysta (belimumab), the first new drug for lupus in more than 50 years.

 The company said Benlysta would cost (at launch) $443 for a 120-mg vial and $1477 for a 400-mg vial. The FDA estimates the systemic lupus population to be at least 300,000.

On March 25, 2011, the FDA approved Bristol-Myers Squibb’s injectable drug Yervoy (ipilimumab) for latestage or metastatic melanoma, the first drug shown to prolong the lives of patients with advanced skin cancer. It will be priced at $30,000 per injection, for a total price of $120,000. Melanoma is the deadliest type of skin cancer, but the FDA has approved only 2 other drugs for advanced melanoma. The newer of those drugs was cleared more than 13 years ago. Neither drug has been shown to significantly extend patient lives.

On May 13, 2011, the FDA approved Merck’s Victrelis (boceprevir) for hepatitis C, which the company announced would be available to pharmacies within a week. The wholesale acquisition cost for Victrelis will be $1100 per week, Merck said.

 As new drugs become available, prescribing guidelines are updated and may impact utilization trend.

Flu cases started to peak in mid-December, and the peak ended in early February, according to the CDC. Statistics point to this flu season as a relatively mild one. The number of cases stayed low between October and mid-December before the winter peak. This year’s flu season also seems to be milder than last year’s because of the extent to which people developed antibodies to the H1N1 strain during last year’s flu season (see

In January 2011, the CDC’s Advisory Committee on Immunization Practices issued updated guidelines regarding the use of antiviral agents for the treatment and chemoprophylaxis of influenza. The new recommendations update those issued by the committee in 2008, principal changes or updates to which include the following:

• Antiviral treatment should be started as soon as possible in patients with confirmed or suspected influenza that is severe, complicated, or progressive, or that necessitates hospitalization.

• Antiviral treatment should be started in outpatients with confirmed or suspected influenza who are at greater risk for complications of influenza based on age (<5 years and especially <2 years, or ≥65 years) or underlying medical conditions.

• Tamiflu (oseltamivir) and Relenza (zanamivir) are the recommended antiviral medications because recent viral surveillance and resistance data show that more than 99% of currently circulating influenza virus strains are sensitive to these drugs. The recommended duration of treatment is 5 days, but longer treatment regimens may be needed in severely ill, hospitalized patients or in immunosuppressed persons.

• Either Tamiflu or Relenza can be used to treat persons with influenza caused by 2009 H1N1 virus, influenza A (H3N2) virus, or influenza B virus, or when the influenza virus type or influenza A virus subtype is unknown.

The new guidelines advocating early use in at-risk populations may bolster utilization of Tamiflu in particular.

In 2011 slower utilization may continue due to wavering of consumer confidence in the economy. Another impact from the economy is continued unemployment. If the consequences of individual budget pressure due to the recession include pill splitting or deferring refills, adherence will dwindle and there could be adverse outcomes. Estimates of the cost of nonadherence to pharmacy therapy nationally have been reported to be over $290 billion.

 A recent study from CVS Caremark showed that the healthcare costs of adherent individuals were actually lower than those of nonadherent individuals. Healthcare costs for patients who stayed on their diabetes medications came in $3756 a year lower than costs for patients who did not take the medicine. Costs for those who stuck with the medicine for congestive heart failure were $7823 a year less. For high blood pressure, the difference was $3908; for high cholesterol, it was $1258.

 Recent studies have shown that interventions face-to-face in the pharmacy are most impactful.

 However, getting the scale to deliver these types of outcomes face-to-face as well as via technology is time consuming and costly. The true public health advantage will come from being able to deliver impactful interventions across large populations.

Continued unemployment has the Medicaid segment growing. Another impact from the economy is that states are modifying coverage in the Medicaid programs.

 In fact, the Medicaid clients included in the cohort experienced the greatest enrollment change, a 5.5% increase in membership. With the continued high rate of unemployment, the Medicaid membership will continue to grow.

A demographic shift would be expected to have the greatest impact on the cholesterol-reducing statins and antiulcer proton pump inhibitors, as a previous analysis found that these 2 classes held either a top place or a second-ranked position in the oldest 3 generational segments in the CVS Caremark BOB: GI, Silent, and Baby Boomer.

 The aging population does increase utilization; however, with the shift away from employer-provided retiree coverage and the increasing number of Medicare Part D recipients (partly due to the wave of retiring Baby Boomers), this trend will continue.

The continued drug pipeline shift to specialty drugs and new therapies will also increase utilization. Three newly approved potential blockbusters in the first quarter of 2011 (Benlysta for lupus, Yervoy for melanoma, Victrelis for hepatitis C) will impact long-term trend.

Utilization potentially will increase because of the aging population and use of cholesterol-reducing agents such as statin drugs. According to a report published by the CDC in February, far more patients are taking statin drugs today than were taking them 20 years ago. Among Americans 45 years and older, 25% were on lipid-lowering therapy in the period from 2005 to 2008, up from just 2% in 1988-1994, according to the National Center for Healthcare Statistics. The report shows that the percentage of adults with high cholesterol has fallen, from 20% in 1988-1994 to 15% in 2005-2008. While heart disease deaths have declined across age groups, heart disease prevalence has remained stable over the last 10 years.

Another potential driver of utilization and cost is emerging oral therapies for multiple sclerosis patients that will improve patient compliance and persistency in therapy. Unfortunately, the agents are very expensive. The first of these agents to hit the market was Novartis’s Gilenya, approved in September 2010 and priced at ~$48,000, which may raise the bar for the cost of therapy in this class. In April 2011, Teva and Biogen Idec both announced that their investigational oral multiple sclerosis therapies had met their individual goals in pivotal Phase III studies. A New Drug Application submission for Teva’s laquinimod is expected by the end of 2011.

 Separately, pending success in another ongoing Phase III study, Biogen plans to submit a New Drug Application to the FDA for BG-12 in the first half of 2012.

Severe weather in winter and spring 2011 may prevent or delay many members from getting prescriptions filled, so rebound utilization may occur in the remainder of 2011. The significant factors that will impact 2011 prescription utilization include the prolonged economic recession, change in employment rate, new generic and brand launches, and the changes in retirement plans of Baby Boomers. 

Articles

Significant factors for 2011 prescription utilization include the recession, change in employment rate, new generic and brand launches, and changes in Baby Boomers' retirement plans.

A Look Into 2011 Drug Utilization Trend and Beyond

In Part 1 of “Generational Impact on Prescription Drug Trend,” we identified overall generational trends in prescription drug use along with top therapeutic classes common across multiple age bands, and sought to understand what impact the economy has had on trend at a generational level. In Part 2 we continue to explore how member age demographics affect prescription drug trends, provide top therapeutic classes by generation, and take a more in-depth look at the specific behaviors associated with each of the 6 generations of Americans (see 

This was a retrospective study of 558.9 million prescription claims in a computerized database. The study population was 25.9 million members across a multitude of funded benefit prescription plans administered by CVS Caremark. The plan sponsors included Medicaid, national and local employers, health plans, managed care organizations, insurance companies, unions, and government agencies located throughout the United States with prescription claims for all months between January 1, 2007, and December 31, 2008. The generational trend was categorized by age bands: 83 and older, 63 to 82 years, 44 to 62 years, 30 to 43 years, 18 to 29 years, and 17 years and younger. The utilization trend was based on average days supply and gross cost (which includes both plan sponsor and member contributions) and is reported on a per member per month (PMPM) basis. Medicare Part D plans were excluded. Note that the trend includes member contribution (gross trend) and specialty drugs. The plan sponsors had average eligibility changes limited to within ±15% period over period.

The GI Generation, born between 1900 and 1925, is the generation of Americans that fought and won World War II, later to become the “Establishment” and the parents who had a generation gap with their Baby Boomer children. From youth to old age, the GI Generation commanded the admiration and respect of older and younger generations. They became America’s first Boy Scouts and Girl Scouts, and half a century later, America’s first senior citizens.

During this time, the US Food and Drug Administration (FDA) was created; major pharmaceutical breakthroughs include the introduction of aspirin and insulin.

As we discussed in Part 1 of this Drug Trends article, proton pump inhibitors and lipid-lowering agents (statins) are common in multiple generations (GI, Silent, and Baby Boomer).

Antidementia agents ranked third with the GI Generation (see 

). According to the Alzheimer’s Association, as many as 5.2 million Americans are living with disease, and 10 million Baby Boomers will be diagnosed with it in their lifetime. Every 71 seconds, someone is diagnosed with Alzheimer’s disease, which the Centers for Disease Control and Prevention (CDC) reported in June 2008 has surpassed diabetes as the sixth leading cause of death in this country.

Most Americans fear cancer the most and Alzheimer’s disease second, but this order is reversed for those age 55 years and older. Alzheimer’s is the disease they most fear, according to a survey by Harris Interactive.

The Silent Generation, who were born between 1926 and 1945, consist of the “traditionalists.” They personify the American values of hard work, personal sacrifice, law and order, conformity, and delayed gratification. Technologically, they are characterized by their lack of exposure to computers.

 The name Silent Generation was coined in the November 5, 1951, cover story of 

magazine to refer to the generation coming of age at the time, born during the Great Depression or World War II.

In 1938, the Food, Drug, and Cosmetic Act broadened the FDA’s authority and instituted important safety regulations.

 Synthetic cortisone was made available in 1944. Drug therapy was otherwise still limited both in the number and scope of the conditions that could be treated. 

The HMG-CoA reductase inhibitor (statin) class was ranked 1st for the Silent Generation (see 

), 2nd for the Baby Boomers and the GI Generation, and 10th for Generation X. The class continues to experience growth as the population ages and studies advocate proactive utilization. A recent study found that continuous treatment with statin drugs reduced the risk of death in patients with high cholesterol by 45% over 4 to 5 years. An article about the study notes, “People who hadn’t yet been diagnosed with heart disease and those who had already been diagnosed both showed the reduction in death if they took the drugs 90% of the time, when compared with patients who took the drugs less than 10% of the time.”

 The authors concluded that the benefits of statins were greater than clinical trials had previously suggested. 

This class ranked 3rd among the Silent Generation and 4th among the GI Generation.

Baby Boomers were born between 1946 and 1964, and are more optimistic economically, largely because they did not experience the Great Depression. They are better educated. Women of this generation worked outside the home in greater numbers. Baby Boomers are more comfortable with technology, growing up within the age of computers. They are an individualistic generation, with a focus on self and a tendency to reject authority. Hectic lifestyles are common for baby boomers, with their leisure time infringed upon by the various demands of life.

Tetracycline became available in 1955, and the first oral contraceptive, Enovid, was launched in 1960.

 Much of the direct-to-consumer (DTC) advertising is targeted toward the 44+ consumer and plays on the Boomers’ characteristics of proactive wellness and preventive prescription drug use.

Consider the size of the Baby Boomer population segment—78 million&mdash;and their exceptional buying power. Today, however, rather than entering a period of economic certainty, job security, and peak earning years, many Baby Boomers are facing layoffs as corporations downsize. Retirement funds, when saved, have been significantly impacted by the market’s instability. The Boomers’ financial status is even more uncertain because they are a spending generation, who liberally use credit to finance purchases.

Baby Boomers will research all options and most likely provide their healthcare providers with articles or references relating to their treatment options. As people mature, they spend more in drugstores, usually for prescription medicine. Drugstores should benefit from aging Baby Boomers, not only for prescriptions, but also for health and beauty aids. This generation has a strong desire to counter the aging process and retain its youth. This group kept fit in their early years and will continue to maintain a healthy lifestyle. Boomers’ aging also will support increased medical services, particularly specialties such as optometrists and plastic surgeons.

For decades pharmaceutical manufacturers have focused their research and marketing programs on drugs that target the Boomers. Specific examples include Viagra for impotence and Lipitor for high cholesterol, both billion-dollar blockbusters. Entire classes have arisen around hair-growth remedies, osteoporosis treatments, and arthritis pain therapies.

The use of proton pump inhibitor ulcer drugs and lipid-lowering statins among Baby Boomers has reached a level of pervasiveness that will likely continue for the rest of their lives, if the patterns established by the older Silent and GI generations are any indication of what to expect. 

The Baby Boomers’ 2008 gross trend was 3.1% and the utilization trend was nearly flat at 0.2% (see 

). Insulin utilization trends increased 8.3%, and the miscellaneous anticonvulsant (eg, gabapentin [Neurontin] and Lyrica) utilization trend increased 11.1%. 

The antihypertensive combinations are ranked 3rd for Baby Boomers, 4th for the Silent Generation, 10th for the GI Generation, and 20th for Generation X. The overwhelming majority of hypertensive patients are receiving multiple layers of therapy for their hypertension.

 Use of combination therapy has been identified as a trend and a growth driver in the treatment of hypertension because it helps to build patient compliance by reducing the pill burden and the level of side effects.

 Key drugs in this class include the generic drug lisinopril-hydrochlorothiazide, Diovan HCT, generic Lotrel (amlodipine and benazepril), and Benicar HCT. 

Serotonin-Norepinephrine Reuptake Inhibitors.

 All the generations have at least 1 antidepressant class in the top 20 therapeutic classes. The more recent serotoninnorepinephrine reuptake inhibitor class of antidepressants are more popular among the Baby Boomers (ranked 5th), Generation X (ranked 6th), Generation Y (ranked 8th), and the Silent Generation (ranked 19th in 2008, up from 27th in 2007).

Cymbalta currently is approved for depression, generalized anxiety disorder, diabetic nerve pain, and fibromyalgia. It was the third most heavily DTC-promoted drug in 2008, with more than $156 million having been spent.

Opioid agonists ranked 6th among Baby Boomers and 8th among Generation X. Recently published results of a survey conducted by researchers from the Boston University School of Medicine found that 2.2% of respondents in 2006 said they took opioids at least 5 days a week for the past month, part of a rising trend since the 1.6% reported in 1998. Half of these regular users had been taking the drugs that often for 2 years or more and one-fifth said they had been taking them for at least 5 years. An additional 2.9% of respondents said they had used opioids fewer than 5 days a week over the past month. The survey’s overall percentages translate into 10 million individuals taking opioids and 4.3 million taking them regularly. Researchers also said those who took opioid pain drugs were likely taking other medications, including additional painkillers and antidepressants.

 Key drugs in this class include OxyContin and the generics fentanyl and tramadol.

The market for prescription pain drugs was approximately $4.1 billion in 2007. Continued growth in the demand for prescription pain management products is projected because of the aging population, the increasing incidence of chronic pain conditions, increasing physician recognition of the benefits of pain management, and a steady stream of new pain products expected to enter the market.

Insulins ranked 10th among Baby Boomers and the Silent Generation; the class continues to be a contributor to gross trend. A 2007 study by the American Diabetes Association estimated that approximately 17.5 million Americans have been diagnosed with diabetes and that the number of people diagnosed with diabetes is growing by roughly 1 million per year. This study estimated that $27 billion is spent on care directly to treat diabetes.

Results from a recent study conducted by epidemiologists from the National Institutes of Health and the CDC showed that nearly 13% of adults age 20 years or older have diabetes but that 40% of them have not been diagnosed. Researchers noted that diabetes is especially common in the elderly; nearly one-third of those age 65 and older have the disease. An additional 30% of adults have prediabetes, a condition marked by elevated blood sugar that is not yet in the diabetes range. Prediabetes, which causes no symptoms, substantially raises the risk of a heart attack or stroke and of developing type 2 diabetes. Type 2 diabetes accounts for up to 95% of all diabetes cases and virtually all cases of undiagnosed diabetes. The study also found that diabetes is rare in young people age 12 to 19 years, but about 16% of these have prediabetes.

Born between 1965 and 1978, Generation Xers grew up during the end of and after the Cold War. A Wikipedia article notes that “this generation saw the inception of the home computer, the rise of video games, and the Internet as a tool for social and commercial purposes.”

 Members of Generation X value self-reliance, informality, and techno literacy; they are more skeptical; and are not intimidated by authority, rules, and the chain of command.

A major new class of agents to treat gastrointestinal disorders, the H2 blockers, was created with the launch of Tagamet in 1976; it was the first drug developed to treat a condition that normally would have required a substantial lifestyle change (in the form of a very bland diet) or surgical intervention.

The Generation X gross trend in 2008 was 3.3%; their utilization trend was −0.4% (see 

Multiple Sclerosis. Multiple sclerosis agents ranked 5th with Generation X and 8th with Baby Boomers. SG Cowen Consultants say that there is a growing trend toward earlier treatment of multiple sclerosis with these disease-modifying agents, but compliance rates can be highly variable and discontinuations common.

 Key drugs in this class include Copaxone, Avonex, and Rebif. 

Merck KGaA became the leading contender in the race to release the first oral medicine for multiple sclerosis, after the company announced promising results from a late-stage clinical trial. Merck KGaA said its cladribine pill met the primary goal of a company-run study on 1326 patients with relapsing-remitting multiple sclerosis. The drug currently is used in injectable form to treat leukemia.

 The approval of oral cladribine would likely have an impact on the drug trend for Generation X and Baby Boomers.

Members of Generation Y (also referred to as the Millennials), born between 1979 and 1990, are younger than age 30 years and tend to be a relatively affluent, highly educated, and practical-minded group. After all, they have been raised in a technologically advanced society.

 Nearly half (approximately 40%) of the millennial generation grew up in or lives in a single-parent household, where surveys show them to be deeply involved in family purchases at every level. Members of Generation Y are said to demonstrate positive social habits, valuing diversity and teamwork—an outgrowth, perhaps, of the fact that roughly one-third of this population segment is other than Caucasian.

In 1987, Prozac was the first selective serotonin reuptake inhibitor brought to market for the treatment of depression and other mental illnesses. In 1997, the ban on DTC advertising was lifted in the United States.

Generation Y’s top class for 2008 was combination oral contraceptives (see 

). According to IMS Health, oral contraceptives were the 12th most commonly dispensed class of drugs overall in 2008, with approximately 81.6 million prescriptions filled during the year.

 In a January 2009 survey of Canadian Generation Y members, 77% of respondents said that birth control pills are not just about contraception and that they want an oral contraceptive that reduces the symptoms they experience around the time of their period.

 Reducing menstrual cramps (66%), having more control over their monthly cycle (61%), and improving the condition of their skin (52%) are at the top of Generation Y wish lists when it comes to their oral contraceptive. This is just another example of how Generation Y wants more control over their lives.

 Key drugs in this class include Yaz, Ocella, and Ortho Tri-Cyclen Lo.

Not surprisingly, acne products appear as a leading class among both Generation Y and Generation Z members, at 3rd and 5th, respectively. The Department of Health and Human Services estimates that 45 million people in the United States have acne vulgaris, with a prevalence of approximately 85% in the population 15 to 24 years of age. The disease is more common and more severe in males than in females.

Amphetamines (eg, Vyvanse and Adderall XR) ranked 5th among Generation Y and 6th among Generation Z; the drugs are used to treat attention-deficit/hyperactivity disorder (ADHD). The adult ADHD market is growing much faster than the pediatric market. In 2008, adult prescriptions, which represented more than 30% of the overall ADHD market, rose 17% compared with an increase of 4% in pediatrics. The growth, in part, reflects an ongoing promotional push to raise awareness of adult ADHD, especially among women who juggle jobs and families.

Generation Z, also known as Generation 9/11, was born between 1991 and present. As expected, they have a very different drug mix than the older generations. They are exposed to cell phones and iPods, and are well versed in computers and the Internet. In multigenerational households, they may be assisting grandparents in navigating through the Medicare Part D Web site to enroll. 

This retrospective study of 558.9 million prescription claims explores how member age demographics affect prescription drug trends and provides top therapeutic classes by generation.

Generational Impact on Prescription Drug Trend: Part 2

Growth trends in retail prescription drugs slowed to historically low levels in 2008. We have seen an increase in generic alternatives, changes in utilization patterns, a significantly higher number of black box warnings, and a reduction in the number of significant new drug approvals of new molecular entities (NMEs) over the past 2 years that have set the stage for the single-digit overall growth trends reported by pharmacy benefit managers (PBMs). In the discussion that follows, we will focus on the drivers of pharmacy.

The major PBMs reported 2007 drug trend growth in the single digits—a dramatic shift from the double-digit growth rates recorded in this sector just a few years ago. CVS Caremark, a pharmacy healthcare company, forecasts continued single-digit growth in prescription drug spending in the near-term future (

In addition to CVS Caremark reporting a decrease in drug spending, on October 29, 2008, IMS Health published a revised forecast for slower (1%-2%) growth in both 2008 and 2009. Earlier in 2008, IMS had expected growth of 2% to 3%, and they attributed the lower-than-expected growth projections to less-than-expected demand for recently introduced products, continuing patent expirations, fewer new product launches, and a tighter economy. IMS now expects sales of $287 billion to $297 billion in 2008 and $292 billion to $302 billion in 2009.

This is a retrospective study of 377.3 million prescription claims in a computerized database. The study population includes 27.7 million members who are representative of funded and unfunded benefit prescription plans administered by CVS Caremark. The plan sponsors include Medicaid, national and local employers, health plans, managed care organizations, insurance companies, unions, and government agencies located throughout the United States between January 1, 2007, and June 30, 2008. The plan sponsors have average eligibility changes limited to within ±15% period over period.

Drug trend has 3 major components—drug mix, utilization, and cost. Product (drug) mix includes the impact of new drugs and the relative proportion of biotechnologic, brand, and generic drugs in the overall product mix. New drugs are defined as NMEs approved by the US Food and Drug Administration (FDA). Cost is measured by average wholesale price (AWP)&mdash;changes between products available in both time periods and ingredient drug cost per day’s supply. Utilization is calculated as the day’s supply per eligible member per year.

In the trend cohort group, drug mix is a major component of trend. This is mainly due to the relative increase in generic drug availability compared with brand-name products. In recent years, an increase in generic utilization has positively impacted trend for PBM clients. Our analysis of several commonly used generics shows that client drug spending has been reduced by as much as 52.3% through generic substitution. 

 compares the average gross cost per day of several leading brand-name drugs with that of their generic equivalents. The savings can be substantial.

Significantly, the increase in generic substitution has to do partly with the effectiveness of the CVS Caremark utilization management programs and the increased availability of generic equivalents to major blockbuster brand-name drugs that have expired patents. It also is a byproduct of reduced pipeline productivity in the pharmaceutical industry, as evidenced by the declining number of NMEs approved by the FDA in recent years (

Eleven NMEs were approved by June 2008; 16 NMEs were approved in all of 2007. In addition to fewer NMEs,

 the number of blockbuster drugs (ie, those with sales in excess of $1 billion annually) is decreasing. In 1997, 6 drugs were considered blockbusters compared with 52 drugs in 2006. In 2007, for the first time, the number of blockbusters fell to 48 drugs. As more blockbusters go off patent and fewer new ones are developed, the share of sales attributable to blockbuster molecules will likely decline even further.

Utilization is usually the primary driver of trend as new drugs become available, the population grows older, and new treatment guidelines call for more aggressive management of conditions such as high cholesterol and diabetes. The top therapeutic classes have contributed more than 1% to the overall utilization trend (

). These classes include lipid-lowering agents 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, blood pressure—lowering agents (antihypertensive combinations), gastrointestinal agents (proton pump inhibitors), and thyroid hormone replacement therapy.

The top therapeutic classes that contributed to the lowering of utilization trend did so in response to movement from prescription to nonprescription status (eg, Zyrtec’s impact on the cough/cold and nonsedating antihistamine classes) and negative drug studies (eg, Avandia’s impact on insulin-sensitizing agents, Zetia/Vytorin’s impact on antihyperlipidemic combinations and intestinal cholesterol absorption inhibitors).

Utilization growth continues to be tempered by safety concerns, as seen with the impact of Avandia on the insulin-sensitizing class, which had a 24.3% decrease in utilization. The impact of this class on the overall utilization trend was −0.22% (Table 2).

Class and product decline may be directly tied to safety concerns and can be seen in the dramatic and immediate impact that negative study results have had on the insulin-sensitizing agents. Comprised of just 2 drugs, Actos and Avandia, this class enjoyed an eighth-place ranking in our year-to-date April 2007 Book of Business, at 2.0% of total gross cost. Actos (10.4%) and Avandia (8.9%) combined to hold a 19.3% share of the oral antidiabetic drug market in April.

On May 21, 2007, a meta-analysis of Avandia studies was published in the 

 showing a statistically significant increase in the risk of myocardial infarction and an increased risk of death from cardiovascular causes with borderline significance.

 The FDA subsequently required that Avandia franchise (Avandia, Avandamet, and Avandaryl) labeling include a black box warning emphasizing the increased risk of heart failure.

 In addition, there was a separate expansion later to the Avandia label that mentioned only an increased risk of other cardiac events.

Another example of the impact negative study results or efficacy questions can have on utilization is the study data released in mid-January 2008 suggesting that the Merck/Schering-Plough joint-venture drug Vytorin (ezetimibe/simvastatin) was no more effective on plaque buildup in the carotid artery than its statin constituent, Zocor (simvastatin), which is available as a less expensive generic on its own. IMS recently reported that total monthly prescriptions for the Vytorin/Zetia (ezetimibe) franchise had fallen by 39% from January to November. In the CVS Caremark Book of Business, we saw Vytorin’s share of the market for lipid-lowering drugs fall from 10.9% in January 2006 to 8.6% in June 2008 (

In addition, the utilization trend for the cold/cough/allergy combination class decreased nearly 21% because of the delayed flu season and the collapse in prescription sales of nonsedating antihistamines, precipitated by the conversion to nonprescription status of Pfizer’s Zyrtec in January 2008. The nonsedating antihistamines were the 16th-ranked class of drugs in our October 2007 Book of Business, representing 1.5% of total gross cost. By March 2008, the class had fallen entirely from our top 25 drugs. Nonprescription Zyrtec had a negative impact of nearly −1.0% on overall utilization in our Book of Business for the year (Table 2). By June 2008, the nonsedating antihistamine class utilization trend decreased 36.4% (

The number of black box warnings issued by the FDA—the strongest warning the agency can require&mdash;has grown substantially every year since 2003 (

A key driver to utilization continues to be the impact of influenza. The influenza season in 2006-2007 was similar to that in 2007-2008; however, the peak in the latter season was significantly later (February 2008) than the peak in the previous season (

The delay in the 2007-2008 flu season and lower utilization of flu-related drugs in early 2008 contributed to the lower trend in 2008.

The major impact on trend was the price component. The major driver of price is the increase in AWP inflation for brand drugs. In 2008, AWP inflation was 5.7%, led by brand products at 8.7% and a decrease of −0.5% for generics

Year over year, the cost of pharmaceutical drugs increases because of inflation. However, this can be moderated by product competition and increasing generic availability. Changes in distribution channels between mail and retail also can impact the pricing component of trend.

Our internal data sources allow us to estimate the number of people with diabetes in the United States. Combining CVS Caremark data with information from the Centers for Disease Control and Prevention National Health Survey (15% not medicated) and the American Diabetes Association (30% estimated undiagnosed), we can get a complete picture of the state of the diabetes population using the PBM population as a backdrop. We define antidiabetic therapies in this analysis as insulins and oral hypoglycemics, and medications like statins and angiotensin-converting enzyme inhibitors for the prevention of complications (

It is surprising that only 17% of people with diabetes receive appropriate therapies and have at least 80% adherence to these medications. The potential risk of adverse events for the remaining 83% of the diabetes population should concern the healthcare industry.

The current single-digit growth rate is more than likely to continue given the significant slowdown in the economy and the increased number of underinsured people looking for low-cost alternative generics. In addition, the decrease in new innovative drugs to treat chronic conditions also contributes to the decrease in cost and utilization. However, the aging population, the increase in obesity and diabetes, and the decline in patients’ and employers’ investment in proactive health improvement may reverse the single-digit trend.

Our finding of reduced growth in prescription drug spending is confirmed in the secondary literature; a newly published Centers for Medicare & Medicaid Services report found that retail prescription drug spending grew by 4.9% in 2007, down from 8.6% in 2006. The slowing growth is seen as being the result of several factors, including continued growth in the generic dispensing rate, slower growth in prescription drug prices, and rising consumer anxiety about drug safety issues.

Possible drivers of spending growth include broader treatment guidelines, which are likely to underlie higher utilization of specific therapeutic classes (eg, agents for cholesterol and hypertension). Expanding indications also could result in increased utilization; this trend could be particularly expensive when it involves higher-priced specialty drugs.

The increase in generic medications, changes in utilization patterns, and the significant decrease in the approval of new molecular entities have slowed 2008 pharmacy trends to historically low levels.

Factors Affecting Pharmacy Trends in 2008

The year 2009 has been one of economic uncertainty, rising unemployment, declining consumer confidence, and a looming fear of a flu pandemic. Each factor contributes to abnormal stress and subsequently to increased levels of short-term anxiety—potentially increasing the use of antianxiety medication. Although some populations may have an advantage in preparedness or conditioning, having previously experienced a recession or the ability to sustain financial stability, the depth and breadth of the current downturn appear to be collectively taking its toll on the American population. However, certain demographic groups appear to be more heavily affected.

Approximately 40 million American adults age 18 years and older, or about 18.1% of people in this age group in a given year, have an anxiety disorder, which is more likely to be present in women.

 Two therapeutic classes are commonly used to treat anxiety: benzodiazepines and selective serotonin reuptake inhibitors (SSRIs). The SSRIs are utilized for longer-term treatment of anxiety combined with various levels of depression. Compared with benzodiazepines, SSRIs have a lower generic dispensing rate, and a higher average gross cost per day. This article will focus on the utilization of the older class of antianxiety agents: the benzodiazepines.

Benzodiazepines (4-digit Generic Product Identifier 5710) are primarily prescribed for the short-term treatment of anxiety, insomnia, and panic disorders.

 Demonstrating efficacy for more than 40 years, many drugs in this class are used intermittently and as a first-line treatment. The article is intended to provide an overview of benzodiazepine utilization and gross trend, including demographic details on users of benzodiazepines.

The analysis is a retrospective study and was conducted using 571.3 million prescription claims from CVS Caremark’s computerized database. The population identified for the study consisted of 29.4 million members across funded benefit prescription plans administered by CVS Caremark. The plan sponsors included Medicaid, national and local employers, health plans, managed care organizations, insurance companies, unions, and government agencies located throughout the United States with prescription claims for all months between July 1, 2007, and June 30, 2009. The members were categorized by generation with the following age bands: GI generation (age ≥83 years), Silent generation (age 63-82 years), Baby Boomers (age 44-62 years), Generation X (age 30-43 years), Generation Y (age 18-29 years), and Generation Z (age ≤17 years).

 In addition to categorizing utilizers by age band, we also separated metrics by sex. The utilization trend was based on average days supply and gross cost (which included both plan sponsor and member contributions), reported on a per member per month (PMPM) basis. Medicare Part D plans were excluded. The plan sponsors had average eligibility changes limited to within a ±15% period over period. Note that Klonopin (clonazepam), although classified as a benzodiazepine, was not included in this study as it is primarily indicated as an anticonvulsant (4-digit Generic Product Identifier 7210).

Benzodiazepines often are used to treat short-term anxiety for a variety of conditions and are commonly used in conjunction with talk therapy.

 Antianxiety medications work to alter GABA (γ-aminobutyric acid, an amino acid that induces relaxation and sleep) neurotransmitters in the brain. However, the exact method of action is unknown. Benzodiazepines are not recommended as monotherapy for social anxiety patients with major depression or a history of substance abuse.

 shows the approved US Food and Drug Administration indications for benzodiazepines. Note that all of these drugs are available as generics.

Despite the introduction of newer drugs such as SSRIs, benzodiazepines are widely used for short-term and intermittent use and have a rapid onset of action. They are contraindicated for long-term use because of an apparent loss of efficacy over time, the possibility of addiction, and the risk of potentially severe withdrawal symptoms. Benzodiazepines are also regulated as Schedule IV controlled substances. In contrast, SSRIs are indicated for longer-term utilization, and have a much slower onset of action (commonly 6 to 8 weeks to reach full potential), limiting effectiveness for short-term anxiety. Additionally, SSRIs have greater variability in response than benzodiazepines and are not associated with the same risk of drug dependence.

Benzodiazepines continue to experience growth in utilization and are currently ranked in the top 20 therapeutic classes by volume. However, these drugs are far less costly than drugs in other classes, because all drugs in this class are available as generics. Utilization trend increased 5.1% (July 2007-June 2008 compared with July 2008-June 2009), while the year-over-year gross trend declined 3.1%, driven by a 7.9% decrease in the trend for gross cost per day.

The generics, alprazolam, lorazepam, and diazepam, experienced both prescription claim and days supply increases per member per month, while the 2 major brandname drugs, Xanax and Valium, experienced declines (

). Further, while all 3 major generic drugs experienced increased utilization, associated gross cost per day figures declined. Alprazolam continued to dominate the class at 53.1% and continued to outpace all other drugs in year-over-year growth.

Xanax (alprazolam) is a short-acting benzodiazepine launched in the early 1980s that is approved for the treatment of generalized anxiety and panic disorders. The extended-release formulation of the drug (Xanax XR) was launched in 1996 and is indicated only for panic disorder. Generics of both products have been on the market for several years.

The increased utilization of alprazolam also is noted nationally. According to an August 2008 study by the Drug Testing Advisory Board (DTAB) of the federal Substance Abuse and Mental Health Services Administration (part of the Department of Health and Human Services), the total number of extended units dispensed for alprazolam through outpatient retail pharmacies increased by 83% from 1998 to 2007, representing 1.18 billion more units dispensed in 2007 than in 1998. The total number of prescriptions increased by 71% during that time, from 24.8 million to 42.4 million.

 In addition to the greatly increased volume of prescriptions, there may be a utilization shift by demographics.

The DTAB study also found that alprazolam was the most commonly dispensed benzodiazepine for both men and women at outpatient retail pharmacies. For both sexes, the majority of prescriptions were dispensed to individuals age 41 to 50 years (

Women were more likely to be diagnosed and treated for anxiety than men. However, results from our study indicate the number of men receiving benzodiazepines increased from 34.8% to 37.0% year-over-year. There was a decrease in the percentage of female utilizers from 65.2% in July 2007-June 2008 to 63.1% in July 2008-June 2009.

The cohort membership population grew 1.7% year-over-year while the number of unique benzodiazepine utilizers increased 6.5%, almost 4 times the rate of growth for the cohort population. The Baby Boomers experienced the largest increase in unique utilizers year-over-year, followed by the X and Y Generations. However, Generation Y experienced the largest percentage increase, followed by the GI and Z Generations. Interestingly, all 6 age bands experienced significant year-over-year growth in unique utilizers (

During the first period of the study, a ratio of approximately 108 benzodiazepine utilizers per 10,000 members was present. In the second year of the study, the ratio increased to 114 utilizers per 10,000 members, demonstrating noteworthy growth in benzodiazepine utilization.

The American Journal of Pharmacy Benefits

, the overall generational impact on prescription drug trend was reviewed in detail.

 The Baby Boomers (born between 1946 and 1964) and Generation X (born between 1965 and 1978) were the highest utilizers of the benzodiazepines in both time periods (

). But as Table 4 shows, there was a substantial increase in utilization for Generation Y (born between 1979 and 1990) in the July 2008-June 2009 time frame.

The benzodiazepine class experienced a 4.5% PMPM growth in claims and a 5.1% PMPM growth in days supply year-over-year. The CVS Caremark study found a 1.14% prevalence of benzodiazepine utilizers for the July 2008-June 2009 period, an increase of 0.06% year-over-year. The number of benzodiazepine utilizers was significantly lower than the number of persons diagnosed with anxiety in a given year, as suggested by several industry experts. This may be due to the popularity of SSRIs for treatment of anxiety. However, we are seeing an increase in benzodiazepine utilization, which may indicate that these agents are used for short-term situational anxiety. In addition, the theory that anxiety is underdiagnosed as well as undertreated may be changing as younger generations are more comfortable seeking assistance.

The increase in unique utilizers across all 6 age bands combined with overall growth in benzodiazepine utilization is likely attributable to the additional stresses surrounding the economic recession.

The substantial change in the percentage of Generation Y utilizers (higher than other age bands) may be due to several factors including increased prevalence, abuse, dependence, and/or a substantial shift in utilization from other generations. In 2006 and 2007, persons aged 18 to 25 years were more likely (17.9%) than any other group to experience serious psychological distress, of which 38.8% of all sufferers received prescription medication.

 Additionally, those aged 18 to 25 years have the highest prevalence of serious mental illness (7.4%) of all age groups.

 Although these figures do not show a direct relationship to benzodiazepine utilization, they do demonstrate that this age group is susceptible to stressrelated disorders.

A potential contributor to a recent increase in anxiety levels may be attributed to the economic downturn. Anecdotal evidence in the secondary literature suggests that Generation Y members have been most affected by a slumping economy that has shed millions of jobs since the recession was declared to have officially begun in December 2007.

 Consequently, greater job competition leaves job seekers with less experience at a significant disadvantage.

According to Labor Department figures, the unemployment rate jumped to more than 11% in December 2008 (compared with less than 9% the previous year) for workers under age 29 years.

 For those aged 20 to 24 years, the unemployment rate increased to 13%.

 A disadvantage in professional experience, a sense of entitlement, and the potential for stress-related disorders, combined with financial instability, may be influencing a higher rate of growth in benzodiazepine utilization for Generation Y.

Benzodiazepines provide a low-cost, rapid-onset option for the treatment of anxiety and other disorders. Increased awareness of their utility for general and more specific anxiety disorders may also play a significant role in utilization growth as not-for-profit organizations and several media outlets use print, the Internet, and broadcast television to assist the public in obtaining information on anxiety and anxiety-related conditions.

The potential for benzodiazepine abuse has been identified. However, metrics obtained in our study did not provide an indication that abuse played a significant role in utilization growth.

The 5.1% increase in benzodiazepine utilization by days supply, an overall increase in the number of utilizers, and the year-over-year prescription claim increases for SSRIs and other antidepressants demonstrate the growing demand for psychotherapeutic medications. Whether the economic recession acts as a primary driver or simply a catalyst, there appears to be a correlation between higher levels of psychotherapeutic drug utilization and the overall economic condition of the country. As the effects of the recession linger and the population ages, benzodiazepine utilization is projected to increase as more people will likely seek relief from symptoms of short-term anxiety.

Since benzodiazepines are primarily utilized for short-term treatment, combined with the class having lower-cost generic availability, overall cost trends will be less impacted by benzodiazepine utilization than by utilization of other therapeutic classes and medications that are only available as brand-name products. Consequently, although utilization of the benzodiazepine class is expected to continue to increase, overall class costs should continue to remain low.

Although utilization of benzodiazepines is expected to continue to increase, overall class costs should remain low because of the availability of generics.