Mental Health Policy - Psychotropic Drugs

Mental Health Policy II
Mental Health Policy and Psychotropic
Drugs
10/28/2015 1Mental Health Policy II Jane Addams College of Social Work

10/28/2015 Mental Health Policy II Jane Addams College of Social Work 2

Recent Trends in the Use of Psychotropic Drugs
Mental Health Policy and Psychotropic Drugs

Recent General Trends in the Use of Psychotropic Drugs
• Psychiatric medications are among the most widely prescribed and biggest-
selling class of drugs in the U.S. In 2010, Americans spent $16.1 billion on
antipsychotics to treat depression, bipolar disorder and schizophrenia, $11.6
billion on antidepressants and $7.2 billion on treatment for ADHD.
• Overall use of psychiatric medications among adults grew 22% from 2001 to
2010.
• HHS projects US prescription drug spending to increase from $234.1 billion
in 2008 to $457.8 billion in 2019, almost doubling over the 11-year period.
• From 1995 to 2002, pharmaceutical manufacturers were the nation’s most
profitable industry (profits as a percent of revenues). They ranked 3rd in
profitability in 2003 and 2004, 5th in 2005, 2nd in 2006, and 3rd in 2007 and
2008, with profits of 19.3% in 2008.

Drug-Specific Trends and the Use of Psychotropic Drugs
• Use of antipsychotics such as J&J's Risperdal and Bristol-Myers
Squibb Co.'s Abilify grew substantially in the past decade in both kids
and adults (only a minority of patients on these medicines is getting
their blood sugar checked annually).
• (If you have such clients on your caseload and can advise on
medical issues, you need to check if they are having regular blood
tests for blood sugars, triglycerides, etc.).
• There was a pronounced increase in medications to treat ADHD
among young and middle-aged adults, particularly in women. Use of
ADHD drugs such as Concerta and Vyvanse tripled among those
aged 20 to 44 between 2001 and 2010, and it doubled over that time
among women in the 45-to-65 group. Use in the over-65 population
also increased about 30% for men and women between 2001 and
2010.10/28/2015 Mental Health Policy II Jane Addams College of Social Work 8

Drug-Specific Trends and the Use of Psychotropic Drugs
• Reasons for the rise (in ADHD treatment) could include people who
were diagnosed and treated as children who continue to suffer from
symptoms, adults who were never treated previously but suspect
they have symptoms, and increased awareness from marketing
pushes by companies approved to market these drugs to adults.
• While the use of most psychiatric drugs grew strongly, there were
declines in antidepressant use in children and anti-anxiety drug use
in the elderly, likely in part because of concern over potential side
effects.

Decline in Antidepressant Use among Children
• In 2004 the Food and Drug Administration required a "black box"
warning—its most serious—about the possible increase in suicidal
thoughts in children and teens taking antidepressants, and in 2005 it
warned about the increased risk of death with certain antipsychotics
in elderly patients with dementia.
• The evidence suggests that such warnings have impact:
Antidepressant use in children peaked in 2004 and dropped last year
to 2001 levels, around 2.5% for girls and just over 2% for boys.

Decline in Antianxiety (Anxiolytic) Use among the Elderly
• There has been a 44% decrease in use of anti-anxiety drugs in the
elderly representing a major shift in usage patterns in the last
decade.
• The trend is likely in part related to the fact that these drugs were not
originally covered by Medicare part D, which offers the drug
coverage for seniors and came into effect in 2006. However, this ban
was lifted in 2008 meaning that more recent data might show an
increase in use.

We spend much more on drugs than on “talk therapy”.
• Prescription drugs are “free” inputs to the specialty mental health
delivery system, and carve-out vendors have a strong economic
incentive to substitute drug treatments for other mental health
services when possible.
• They (MBHC) do this by making it easier for patients to obtain
referrals for medication management and psychopharmacology
than referrals for psychotherapy.
• Private insurance plans frequently only 50 percent per
psychotherapy visit compared with requiring only $10 or $20
copayments for drugs.

• Medicare continues to require 50 percent coinsurance for
psychotherapy and other outpatient mental health services that do
not involve medication management, in contrast to most private
insurance plans, which impose the same cost sharing for outpatient
mental health services as for other medical services.
We spend much more on drugs than on “talk therapy”.

Drugs are not risk free
• A 2009 study found that the cost of drug-related morbidity, including
poor adherence (not taking medication as prescribed by doctors)
and suboptimal prescribing, drug administration, and diagnosis, is
estimated to be as much as $289 billion annually, about 13% of
total health care expenditures.
• The barriers to medication adherence are many: cost, side effects,
the difficulty of managing multiple prescriptions, patients’
understanding of their disease, forgetfulness, cultural and belief
systems, imperfect drug regimens, patients’ ability to navigate the
health care system, cognitive impairments, and a reduced sense of
urgency due to asymptomatic conditions.

Selected PPACA Changes
Affecting the Pharmaceutical Industry
• Imposes an annual fee on certain manufacturers and importers of
brand name drugs (including biological products but excluding
orphan drugs) whose branded sales exceed $5 million: an annual
fee of $2.5 billion beginning in 2011, rising to $4.1 billion in 2018
and dropping to $2.8 billion in 2019 and thereafter, allocated across
the industry according to the proportion of sales for government
programs.
• Changes certain drug labeling requirements and requires the HHS
Secretary to determine whether adding certain information to a
prescription drug’s labeling and advertising would improve health
care decision-making.

• Both prescription use and shifts to higher-priced drugs are influenced
by advertising, which is usually conducted for brand name rather than
generic drugs. Manufacturer spending on advertising was over 1.5
times as much in 2009 ($10.9 billion) as in 1999 ($6.6 billion).
• The share directed toward consumers in 2009 (through advertising on
television, radio, magazines, newspapers, and outdoor advertising),
was over twice the amount spent in 1999 ($4.3 billion compared to
$1.8 billion).
• The share directed toward physicians (through the sales activities of
pharmaceutical representatives and through professional journals) in
2009 ($6.6 billion) was almost 1.5 times the amount in 1999 ($4.8
billion).
The Role of Advertising

https://www.youtube.com/watch?v=YQZ2UeOTO3I

• These forces have translated into a greater willingness by
physicians to make psychotherapeutic drugs a central feature of
treating mental illness.
• In 1977, about 63 percent of visits for the care of mental disorders
in the United States included the use of psychotropic drugs. By 1996
psychotropic drugs were prescribed in about 77 percent of such
visits.
• A significant portion of these visits were made to primary care
physicians, who may be more likely to use these medications
because of the ease of dosing and the greater safety of the new
psychotropic drugs, particularly the SSRIs.
Direct to Consumer Advertising

• Reflecting how we pay for health care generally, paying for
prescription drugs is a mix of:
• Employer-sponsored insurance
• Self-pay
• Medicaid
• Medicare (Part-D)
How do Americans Pay for Prescription Drugs?

• The Medicaid Drug Rebate Program is a partnership between CMS,
State Medicaid Agencies, and participating drug manufacturers that
helps to offset the Federal and State costs of most outpatient
prescription drugs dispensed to Medicaid patients.
• All fifty States and the District of Columbia cover prescription drugs
under the Medicaid Drug Rebate Program.
• The program requires a drug manufacturer to enter into a national
rebate agreement with the Department of Health and Human Services
in exchange for State Medicaid coverage of most of the manufacturer’s
drugs. Manufacturers are responsible for paying a rebate on those
drugs each time that they are dispensed to Medicaid patients.
• Rebates are paid by drug manufacturers on a quarterly basis and are
shared between the States and the Federal government to offset the
overall cost of prescription drugs under the Medicaid Program.
Medicaid Drug Rebate Program

• Prior to January 1, 2006, the traditional Medicare program (the
federal health program for the elderly and disabled) did not provide
coverage for outpatient prescription drugs.
• As a result, about one-quarter (27%) of seniors age 65 and older,
and one-third of poor (34%) and near-poor (33%) seniors, had no
drug coverage in 2003.
• The Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 established a voluntary Medicare outpatient prescription
drug benefit (known as Part D), effective January 1, 2006, under
which the 47 million eligible Medicare beneficiaries can enroll in
private drug plans. These plans vary in benefit design, covered
drugs, and utilization management strategies.
Medicare

• Reliance on stand-alone drug plans in the context of the Part D
benefit creates strong incentives for prescription drug plans (PDPs)
to compete in order to avoid expensive enrollees (adverse
selection; e.g., It is possible in theory to offer a plan with a
formulary that does not cover the drugs most frequently used in the
modern treatment of depression.)
• However, for certain therapeutic categories—antidepressants,
antipsychotics, anticonvulsants, anticancer drugs, immuno-
suppressants, and HIV/AIDS drugs—plans are required to list "all or
substantially all" of the drugs in the category.
• Medicare is prohibited by law from directly negotiating drug prices or
rebates with manufacturers to control costs. In the 110th Congress,
the 2008 presidential campaign, and the 111th Congress, proposals
to allow or require Medicare to negotiate drug prices with drug
makers have been considered but not enacted.
Medicare Modernization Act (MMA)

• Department of Health and Human Services data show that as of
February 16, 2010, approximately 41.8 million (90%) of the 46.5
eligible Medicare beneficiaries had drug coverage.
• About 4.7 million Medicare beneficiaries (10%) had no drug
coverage.
Medicare

Medicare Part D and Antidepressant prescriptions

Medicare Part D and Antipsychotic prescriptions

Selected ACA Changes Affecting
Prescription Drug Coverage for Medicaid and Medicare
• ACA provides that prescription drugs is one of the “essential health
benefits” that must be included in health plans in the Exchanges and
in the benchmark benefit package or benchmark-equivalent for newly
eligible adults under Medicaid.
• Provided for a $250 rebate to Medicare Part D beneficiaries with out-
of-pocket spending in the Medicare Part D coverage gap in 2010, a
50% discount for brand name drugs for beneficiaries in the coverage
gap in 2011, a phasing-in of coverage in the gap for generic and brand
name drugs that will reduce the beneficiary coinsurance rate from
100% in 2010 to 25% in 2020, and a reduction between 2014 and
2019 in the threshold that qualifies enrollees for catastrophic
coverage.

• Lack of insurance coverage for prescription drugs can have adverse
effects. An April 2009 survey found that uninsured nonelderly adults
(ages 18-64) are more than twice as likely as insured nonelderly
adults to say that they or a family member did not fill a prescription
(45% vs. 22%) or cut pills or skipped doses of medicine (38%
vs.18%) in the past year because of the cost.
• Among nonelderly adults in 2008, 27% of the uninsured could not
afford a prescription drug in the past 12 months, compared to 13%
of those with Medicaid or other public coverage, and 5% of those
with employer or other private coverage.
• A September 2009 survey found that during the past 12 months,
26% of American adults did not fill a prescription, and 21% cut pills
in half or skipped doses of medicine, because of cost.
How does insurance coverage (or lack thereof) affect
prescription drug use?

Incentive PDLs cover about 67 percent of privately insured people.
PDLs (previously called formularies) are used to control rising
prescription drug costs. A popular form of an incentive PDL is the three-
tiered (or sometimes four-tiered) PDL, under which insured consumers
are offered three levels of copayment for prescription drugs.
• PBMs create competition among manufacturers within a therapeutic
class (such as the SSRIs) for the placement of their products in the
second rather than the third tier. This permits PBMs to bargain for
price concessions from manufacturers.
• Other PBM incentives and rules: prior authorization, appeals
process for non-included drugs (how onerous), and generic
substitution requirements.
Pharmacy Benefit Managers and Preferred Drug Lists

• In 2009, over three-quarters (78%) of workers with employer-
sponsored coverage were in plans with 3 or more 4 tiers of cost
sharing for prescription drugs, almost 3 times the proportion in 2000
(27%).
• Worker copayments have increased from 2000-2009: 25% for
generic drugs, 80% for preferred drugs, 59% for non-preferred
drugs, and 44% for fourth-tier drugs (data from 2004-2009)
• The average copayment amounts in 2009 were $10 for generics,
$27 for preferred drugs, $46 for non-preferred drugs, and $85 for
fourth-tier drugs.
• Twelve percent of covered workers had a separate annual drug
deductible which averaged $108.
Pharmacy Benefit Managers and Preferred Drug Lists

Clinical Antipsychotic Trials of Intervention Effectiveness
(“CATIE Study”)
• CATIE was designed to determine comparative effectiveness of
newer atypical antipsychotics vs an older conventional neuroleptic.
• One primary outcome measure was time to discontinuation of
treatment for any reason; another was the length of time the patient
and treating clinician continued assigned antipsychotic before
completion of trial or treatment discontinuation.
• Note: In approving a new drug, the FDA does not require that you
show it is more effective or even equivalent to an existing drug, just
that it is better than a placebo…

“CATIE Study”

“CATIE Study”
• Only a minority of patients in each group took their assigned drug
for the duration of phase 1 (rates of discontinuation ranged from 64
to 82 percent). This outcome indicates that antipsychotic drugs,
though effective, have substantial limitations in their effectiveness in
patients with chronic schizophrenia.
• Within this limited range of effectiveness, the olanzapine (Zyprexa)
group had the lowest rate of discontinuation, which might lead one
to consider olanzapine the most effective of the medications studied.
• However, olanzapine was associated with greater weight gain and
increases in glycosylated hemoglobin, cholesterol, and triglycerides
(metabolic syndrome).

Criticisms of CATIE (Naber and Lambert)
• Treatment resistant population – might not be best to test
effectiveness of drugs.
• Improved subjective well-being of SGA’s not well assessed.
• Lower risk of tardive dyskinesia not well assessed.
• Did trial encourage patients to switch drugs prematurely?
• Correct dosages given/used?

“Sequenced Treatment Alternatives to Relieve Depression”
• The overall goal of the STAR*D trial was to assess the effectiveness
of depression treatments in patients diagnosed with major
depressive disorder, in both primary and specialty care settings. It
was the largest and longest study ever conducted to evaluate
depression treatment.
• Each of the four levels of the study tested a different medication or
medication combination. The primary goal of each level was to
determine if the treatment used during that level could adequately
treat participants’ major depressive disorder (MDD). Those who did
not become symptom-free could proceed to the next level of
treatment.

• The design of the STAR*D study reflects what is done in clinical
practice because it allowed study participants to choose certain
treatment strategies most acceptable to them and limited the
randomization of each participant only to his/her range of acceptable
treatment strategies. No prior studies have evaluated the different
treatment strategies in broadly defined participant groups treated in
diverse care settings.
• Over a seven-year period, the study enrolled 4,041 outpatients,
ages 18-75 years, from 41 clinical sites around the country, which
included both specialty care settings and primary medical care
settings. Participants represented a broad range of ethnic and
socioeconomic groups. All participants were diagnosed with MDD
and were already seeking care at one of these sites.

• Of the initial 4,041 participants, 1,165 were excluded because they
either did not meet the study requirements of having “at least
moderate” depression (based on a rating scale used in the study) or
they chose not to participate.
• 2,876 “evaluable” people were included in level 1 results.
• Level 2 results include 1,439 people who did not become
symptom-free in level 1 and chose to continue.
• Level 3 results include 377 people, and
• Level 4 results include 142 people.

• In level 1, about one-third of the participants reached remission and
about 10-15 percent more responded, but did not reach remission.
Still, these are considered good results because study participants
had high rates of chronic or recurrent depression and other
psychiatric medical problems.
• It took an average of six weeks of treatment for participants to
improve enough to reach a response and nearly seven weeks of
treatment for them to achieve a remission of depressive symptoms.
In addition, participants visited their care providers an average of
five to six times. Participants who achieved remission stayed on the
treatment for an average of 12 weeks before going on to a 12-month
follow-up period.

• In the level 2 switch group, about 25 percent of participants became
symptom-free. All three of the switch medications performed about
the same and were equally safe and well-tolerated. In the add-on
group, about one-third of participants became symptom-free.
• Patients who received cognitive psychotherapy (either alone or in
combination with citalopram) had similar response and remission
rates compared with those assigned to medication-only strategies.
• Mental Health Policy II

• In the level 3 switch group, 12 to 20 percent of participants became
symptom-free, and the two medications used fared about equally
well, suggesting no clear advantage for either medication in terms of
remission rates or side effects.
• In the add-on group, about 20 percent of participants became
symptom-free, with little difference between the two treatments.
However, the T3 treatment was associated with fewer troublesome
side effects than lithium.

• In level 4, seven to 10 percent of participants became symptom-free,
with no statistically significant differences between the medications
in terms of remission, response rates or side effect burden.

Conclusions:
• About half of participants in the STAR*D study became symptom-
free after two treatment levels.
• Over the course of all four treatment levels, almost 70 percent of
those who did not withdraw from the study became symptom-free.
• The rate at which participants withdrew from the trial was meaningful
and rose with each level—21 percent withdrew after level 1, 30
percent withdrew after level 2 and 42 percent withdrew after level 3.

Conclusions:
• Patients with difficult-to-treat depression can get well after trying
several treatment strategies, but the odds of beating the depression
diminish with every additional treatment strategy needed.
• Those who become symptom-free have a better chance of
remaining well than those who experience only symptom
improvement. And those who need to undergo several treatment
steps before they become symptom-free are more likely to relapse
during the follow-up period.
• Those who required more treatment levels tended to have more
severe depressive symptoms and more co-existing psychiatric and
general medical problems at the beginning of the study than those
who became well after just one treatment level.

Mental Health Policy - Psychotropic Drugs

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