mental health policy - psychotropic drugs

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Mental Health Policy II

Mental Health Policy and Psychotropic Drugs

05/01/2023 Mental Health Policy II Jane Addams College of Social Work

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Recent Trends in the Use of Psychotropic Drugs

Mental Health Policy IIMental Health Policy and Psychotropic Drugs


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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.


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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.


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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.


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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.


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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.


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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.



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• 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”.


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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.



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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.



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• 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


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


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• 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


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• 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?


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• 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


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• 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



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• 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)



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• 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



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Medicare Part D and Antidepressant prescriptions



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Medicare Part D and Antipsychotic prescriptions



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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.


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• 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?



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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



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• 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


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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…



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“CATIE Study”



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“CATIE Study”



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“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).



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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?



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“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.



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• 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.



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• 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.



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• 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.



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• 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 IIMental Health Policy and Psychotropic Drugs


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• 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.



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• 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.



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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.



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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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