Chapter VIII Table of Contents  

Access and Utilization of New Antidepressant and Antipsychotic Medications

Appendix A   |   Appendix B   |   Appendix C   |   References

Appendix A. Interview Protocol

The following document displays a generic form of the interview protocol used in this study. Please note that this template was tailored specifically for the type of respondent being interviewed.

  1. General Background
    1. Services Provided
    2. Number of covered lives
    3. Geographic area(s) covered _______________________
    4. Full time clinical staffing
    5. Medical directors
    6. Number ______________________________
      1. Specialty (ies) _________________________
    7. Pharmacists
      1. Number ___________________
    8. Psychiatrists
      1. Number ___________________
    9. Psychologists
      1. Number ___________________

  2. Benefit Design
    1. Which of the following coverages do you offer?
      • Inpatient Mental Health
      • Outpatient Mental Health
      • Employee Assistance Programs (EAP)
      • Other:
    2. Are pharmaceutical benefits provided for:
      • Inpatient
      • Outpatient
      • EAP
      • Other:
    3. What types of patients do you manage?
    4. What persons or patients otherwise denied coverage (e.g., drug coverage for non-Medicaid populations) are eligible for your programs?
    5. Once patients have exceeded their limit on services provided under your plans, where do they typically receive their care?
    6. In what settings does your system provide mental health services?
      • State hospital
      • Community-based Centers
      • Individual Providers
    7. Who is responsible for managing the plan's pharmacy benefit?
    8. (If carved out to PBM) Can you describe the extent to which benefits are coordinated between your plans and the PBMs?
    9. Are you at risk for the pharmacy benefit?
    10. How are pharmaceutical benefits financed?
    11. What mechanisms are in place to coordinate inpatient and outpatient pharmaceutical benefits, with particular regard to the use of different medications?
    12. Are there any pharmaceuticals that require a specialist to prescribe in order to approve coverage (i.e., are there drugs that a Primary Care Physician (PCP) is not allowed to prescribe)?
    13. Please describe any differences between what is covered for inpatient versus outpatient services.
      1. Antipsychotics
      2. Antidepressants
    14. Do your plans have differences in the pharmaceutical benefits for behavioral health relative to other classes of pharmaceuticals?
    15. Do psychotropic drugs available to your covered persons vary according to:
      • Inpatient/outpatient?
      • Prescriber specialty?
      • EAP or other programs?
    16. Are pharmaceutical benefits for psychotropics reimbursed under the pharmacy benefit or under the behavioral health benefit?

  3. Formulary Issues
    1. Do your plans use a formulary?
    2. Which of the following products are included on your formulary?
Antipsychotics SSRIs Others
Risperidone
(Risperdal)		 Citalopram
(Celexa)		 Buproprion
(Wellbutrin)
Olanzapine
(Zyprexa)		 Fluoxetine
(Prozac)		 Nefazadone
(Serzone)
Quetiapine
(Seroquel)		 Fluxvoxamine
(Luvox)		 Venlafaxine
(Effexor)
Clozapine
(Clozaril) 		Paroxetine
(Paxil) 		TCAs
(Elavil, Pamelor, etc.)
Haloperidol
(Haldol)		 Sertraline
(Zoloft)		 MAOIs
(Nardil, etc.)
Chlorpromazine
(Thorazine)		   Mirtazapine
(Remeron)
Others
(fluphenazine, etc.)		    
    1. Are there any State laws mandating coverage for a particular psychotropic drug?
    2. Do you actively enforce compliance with the formulary? What methods do you use?
    3. Do you engage in switching practices?
      • Active switching
      • Outbound calling
      • Others (specify)
    4. Is switching more or less frequent for psychotropics than for physical health medications?
    5. Do you use or require generic or therapeutic substitution? For which drugs?
    6. What is the composition of your P & T committee? How often do they meet to consider new products?
    7. Do you include any behavioral health specialists on your P&T committee?
    8. (If a PBM is in place) Please describe your working relationship with the PBM's P&T committee.
    9. Please describe how decisions are made to include/exclude particular drugs from approved formulary lists.
    10. What are the most important pieces of information necessary to make formulary decisions? Please rank these from most to least important.
      • Safety
      • Effectiveness
      • Cost effectiveness
      • Cost
      • Therapeutic duplication
      • Consumer/provider choice
    11. Do these practices differ for psychotropics compared to other pharmaceutical classes? (If yes, rerank question 4)
    12. Are external benefit consultants used in the decision-making process to set drug benefit coverage policies?
    13. Do you run any real world effectiveness trials, registries, or formal reviews of specific drug classes to assess their suitability for formulary inclusion?
    14. Do you collect any pharmacoeconomic/cost-effectiveness data on recipients of psychotropic medications?
    15. How does consumer demand for a particular drug influence your decision to include it on your formulary or otherwise make it available to your patients?
    16. Is the mean time from FDA approval to formulary acceptance longer for psychotropics than other class of drugs?
    17. What can manufacturers do to speed formulary acceptance (e.g., present cost-effectiveness data from a prospective clinical trial, modify trial design to demonstrate superiority over current agents, etc.)?
    18. What are you doing to speed formulary review of new products?
    19. What is currently in place as far as contracts and rebates with pharmaceutical companies? Are these different for psychotropics versus other therapeutic classes?

  1. Mail Service

    1. Are psychotropics available through mail service programs?
    2. Are the available discounts to the consumer/payer through mail order the same as those available for physical health medications?

  2. Treatment Guidelines, Disease Management and Other Related Programs

    1. Please describe your approach to inpatient and outpatient case management for schizophrenia, depression, obsessive compulsive disorder, and manic depressive-bipolar disorder.
    2. Where do pharmaceuticals fit within the sum of treatment for schizophrenia, depression, OCD, and MD/Bipolar disorder? Please cite specific practices or drugs.
    3. Have you designed any treatment or diagnosis algorithms for schizophrenia, depression, MD-bipolar disorder, or OCD?
    4. Describe your approach to designing these programs/algorithms.
    5. How do these protocols differ between the State hospital, Community-based Centers, and Medicaid (if applicable)?
    6. What are your first-line choices for (indicate class or brand name, and rationale)?
      1. Antipsychotics
      2. Antidepressants
    7. Are step-care protocols administered by your pharmacy claims processor?
    8. If a new psychotropic is added to the formulary and treatment protocols and practice guidelines are updated or altered, how are these disseminated to the providers?

  3. Provider and Patient Compliance

    1. Do you monitor providers for compliance with guidelines? Please describe how you do so.
    2. How effective have these programs been in assuring quality (e.g., appropriate choice of medication and/or dosing).
    3. Do you use any formal programs to assist patients with medication compliance? Please describe.
      1. Can you estimate the number of covered lives?
      2. What is the program status?
      3. How effective have these programs been?
      4. What measures of effectiveness do you use?
    4. Do you monitor providers' prescribing practices to insure they dose patients correctly (e.g., prescribe at least a minimal therapeutic does, etc.)? If so, how do you monitor this?
    5. Do you have any special programs for treating high cost (e.g., treatment refractory) cases?
      1. High-cost episodes of care
      2. High-cost lifetime of care
    6. Do you offer any discounts, incentives, or other programs to increase access/compliance/utilization for use in high cost cases?
    7. Have you designed (do you use) any special programs to target historically under-served populations (e.g., African Americans, Hispanics)? Please describe.

  4. Prior Authorization

    1. What psychotropic drugs are commonly placed on your prior authorization list?
    2. What is your justification for requiring PA?
    3. Who initiates a PA request?
    4. Who reviews a PA request?
    5. How long does a PA request take for a decision?
    6. How is the requestor notified of PA decision?
    7. Do you have an automated PA processing system (e.g., computer, telephone, etc.)?

  5. Appeal Programs

    1. Please describe the appeal mechanisms for
    2. Not medically necessary PA determinations (if PA exists)
    3. Off formulary coverage
    4. Do you assist patients/providers in making appeals for denied coverage?
    5. What information is required to make an appeal?
    6. What percent of appeals are overturned?
    7. Generally speaking, why are appeals overturned?
    8. Who adjudicates appeals?
    9. Do consumers/providers have the right to appeal to an outside, independent adjudicator?
    10. During the appeal process are there usually provisions to make emergency approvals for dispensing of the contested drug?

  6. DUR and Related Programs

    1. Please describe your DUR program.
    2. Is the program:
      1. In-House
      2. Contracted
    3. Who monitors the DUR program?
    4. What is the major goal of the DUR program?
    5. What steps do you usually take to enforce formulary compliance, attempt to reduce drugs costs?
    6. What types of DUR criteria apply to psychtropics?

Appendix B. Interview Strategy

This study focused on identifying and interviewing individuals from a variety of organizations or programs represented by the following perspectives:

In order to determine which entities or groups should be interviewed under each perspective, a qualitative approach was utilized. Moreover, the project officers and The Lewin Group team identified specific criteria that were used to select each interview target. From this criteria, a possible pool of candidates for each type of respondent was generated based on expert recommendations, data collected from the literature and other trade press articles, and personal contacts at the respective entity. Many of the final interview respondents were self-selected, as interviews with some companies or organizations proved particularly challenging and the project team resorted to alternate candidates.

The information that follows lists the specific criteria for each respondent type and consequently, the final list of candidates. No delineation is made as to whether the interview respondent was a first, second, or third choice.

A. Pharmaceutical Companies

Pharmaceutical manufacturers were selected based on the following criteria: 1) medium to large size company; and 2) company has current products and products in development in the area of newer atypical antidepressants and/or antipsychotics. As a result, Janssen, AstraZeneca, Eli Lilly, and GlaxoWellcome (GW) were selected.(1) GW and Eli Lilly are both large companies with current pharmaceuticals directed toward treating depression. Eli Lilly also has an atypical antipsychotic on the market to treat schizophrenia. Medium-sized firms include AstraZeneca and Janssen, both of which offer atypical antipsychotics to treat schizophrenia. Specialized neuropharmaceutical companies (e.g., Neurogen) do not have products in development beyond Phase I, and were excluded for this reason. 1

1 One pharmaceutical company is not listed for confidentiality reasons.

Originator Name Current Indications Phase III Mechanism of Action
Large Pharmaceutical Companies
Glaxo Wellcome Wellbutrin®
  • Depression
  • Smoking Cessation
   Unknown
Eli Lilly and Company Prozac®
  • Depression
  • OCD
  • Panic Disorder
Selective serotonin reuptake inhibitor (SSRI)
Zyprexa® (olanzapine)
  • Schizophrenia
  • Bipolar depression
  • Mood stabilization
  • Alzheimer's psychoses
  • Parkinson's disease
Multiple
Medium Sized Pharmaceutical Companies
AstraZeneca Seroquel®
  • Schizophrenia
   Unknown
Janssen Risperdal®
  • Schizophrenia
   Unknown

B. Managed Behavioral Health Care Organizations

The criteria used to select three managed behavioral health care organizations (MBHCOs) for this study included:

  1. Number of covered lives;
  2. Geographic proximity (in order to fulfill the required two site visits);
  3. Client make-up; and
  4. Involvement in other social service sectors.

As a result, Magellan and Value/Options were selected as they represent the two largest MBHCOs and are located in the Washington, DC metropolitan area which is in close proximity to The Lewin Group offices. Additionally, Magellan and Value/Options are involved in other sectors, such as the prison system, welfare, and state Medicaid programs. The third MBHCO, United Behavioral Health, was selected for its client make-up, which favors the private sector (off-setting the large public sector client make-up of Magellan and Value/Options) and because The Lewin Group has an excellent relationship with UBH.

Organization
(Covered Lives)		 Reason For Inclusion
Magellan (65 million)
  • Largest BHMCO in terms of covered lives
  • Involvement in States, Welfare, etc.
Value/Options (22 million)
  • #2 in terms of covered lives
  • Involvement with Prison System
United Behavioral Health (UBH) (16 million)
  • #3 in terms of covered lives
  • Higher proportion of private sector clients than others

C. Large Integrated HMOs

In order to examine a more typical arrangement, The Lewin Group decided to focus on integrated health maintenance organizations (HMOs) for this study. Consequently, The Lewin Group identified participants based on the following criteria:

Additionally, the pool of HMOs interviewed were required to represent a variety of financing mechanisms and risk-sharing arrangements (i.e., fee-for-service, capitation) as well as pharmacy management models (i.e., in-house, carve-out). The final HMOs selected included: FirstOption, Harvard Pilgrim, HealthPartners, Group Health, and Kaiser Permanente.

HMO Reason For Inclusion
First Option (New Jersey) (250,000, consolidated w/Physicians Health Services as of 1/2000)
  • Reputation for providing comprehensive coverage and quality care.
  • Good reputation for substance abuse coverage
  • Contacts at The Lewin Group
  • Well-liked in behavioral health community
  • Reputation for good benefits
  • Group model and PPO
  • Carve-out pharmacy benefit
Harvard Pilgrim (1.6 million)
  • New England
  • Group model and PPO
  • Provide continuum of behavioral health care
  • Depression screening program for enrollees and non-enrollees
  • Internally manage pharmacy benefit
HealthPartners (Minnesota) (800,000)
  • Midwest
  • Staff and network models
  • Provide continuum of behavioral health care
  • Established collaborative program between behavioral health specialists and primary care physicians
  • Internally manage pharmacy benefit
Group Health Cooperative of Puget Sound (Washington) (600,000)
  • Pacific Northwest
  • Staff and network models
  • Internally manage pharmacy benefit
Kaiser Permanente Mid-Atlantic (540,000)
  • Mid-Atlantic
  • Staff model
  • Carve-out 10% of pharmacy benefit; remainder is managed internally

D. Pharmaceutical Benefits Managers

The following criteria were used to select the pharmacy benefit managers (PBMs) interviewed:

As a result, five PBMs were identified and interviewed: Value Rx/Express Scripts, PCS Health System, Rx Innovations, Prescription Solutions, and Advance Paradigm.

Company (Covered Lives) Reason for Inclusion
Value Rx/Express Scripts (38.5 million)
  • National
  • Independent
PCS Health System (>50 million)
  • National
Rx Innovations (~5,000)
  • Regional
  • Carve-out of Value/Options
Prescription Solutions (>3 million)
  • Regional
  • Carve-out of PacifiCare
Advance Paradigm (27 million)
  • National
  • Independent

E. Employers

In order to gain an industry-wide perspective on the approach to behavioral health and pharmacy benefits, The Lewin Group interviewed the William Mercer Corporation. As a result, the following criteria were identified as necessary characteristics of the employers selected for this study:

From this established criteria, two employers were named: Motorola and Delta Airlines. Motorola and Delta were identified as large Fortune 500 employers who self-insure, and with whom The Lewin Group has established contacts. Motorola presents an interesting perspective as it customized a behavioral health specialist provider network based on employee preferences and past claims data in order to ensure that its employees requiring mental health or substance abuse treatment receive the highest possible quality of care. On the other hand, Delta Airlines, as a member of the airline industry, faces a variety of challenges specific to pilots. Namely, federal regulations ground pilots taking psychoactive medications, including standard antidepressants, and often make pilots fearful of seeking any behavioral health treatment. Delta recognized the special needs of this unique population and has attempted to structure its benefits plan accordingly.

Company (Covered Lives) Reason for Inclusion
Motorola (58,800 employees)
  • Large employer
  • Staff at Lewin have worked with Randy Johnson, benefits manager
  • Reputation for comprehensive and innovative programs
  • Built its own network for mental health services based on employee input
  • Pharmacy benefit managed by PBM
  • Self insure
Delta Airlines (200,000)
  • Large employer
  • Network model HMO and FFS
  • Tailors benefits to specific needs of employees
  • Pharmacy benefit managed by HMO

F. Federal and State Programs (HCFA(now known as CMS), IHS, CHAMPUS, VA, Medicaid)

The Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS)) (HCFA(now known as CMS)) and the Indian Health Service (IHS) were automatically selected without the use of specific criteria in order to provide a necessary background behind federally-operated and state- or tribally-administered public insurance programs. More specifically, HCFA(now known as CMS) handles the administration of the publicly funded programs, Medicaid and Medicare. The IHS is responsible for the Native American population which has a documented prevalence of behavioral health disorders in its communities.

The Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) and the Veteran's Administration (VA) were selected as additional federal interviews, but ones that provide more narrow perspectives, largely dictated by the specific populations served under each program. Under CHAMPUS, active duty individuals and their dependents along with retirees are covered, while the VA covers those individuals who were in active duty but retired due to a service-related disability or are a dependent of a veteran. These two perspectives present unique snapshots as Federal programs instituted on an individual basis through treatment facilities (CHAMPUS) or networks (VA). Additionally, the CHAMPUS viewpoint provides and interesting perspective into the social and cultural issues associated with serving in the military with a diagnosed mental illness.

On the state level, four Medicaid programs were selected based on the following criteria:

As such, California, Georgia, Texas, and Wisconsin were selected. Each state handles the administration of its behavioral health and pharmacy benefit in a slightly different manner and each state has different restrictions attached to its formulary and/or prescription coverage.

Program
(Covered Lives)		 Reason for Inclusion
Federal
HCFA(now known as CMS)
  • Essential
Indian Health Service, Navajo Region (201,583)
  • Covers a special needs population
  • Pharmacist involvement is progressive
  • Navajo nation is large
Department of Defense (8 million)
  • Offers variety of managed care products
  • National formulary as well as individual military treatment facility formularies
Veteran's Administration (10-11 million)
  • National formulary as well as individual formularies
State
California (4.9 million)
  • Largest state program
  • Reputation for restrictive formularies
  • Combination of FFS and MC for behavioral health
Texas (2.5 million)
  • Moving Houston and Dallas behavioral health into MC
  • Has a reputation for poor coverage for behavioral health (BH)
  • State-approved treatment algorithms for mental illness (TMAP) have drawn attention for being progressive
Georgia (1.2 million)
  • Mental health still in fee-for-service
  • Restrictions of number of prescriptions allowed per patient per month (5)
  • Legislature considering bill to mandate coverage for all FDA-approved drugs by all insurance providers
Wisconsin (390,000)
  • Uses an integrated Medicaid MC program
  • Five BH carve-outs for special needs programs
  • Considered a leader in innovative, comprehensive programs

G. State Mental Health Systems

The following criteria were used to identify four public sector mental health systems to be interviewed:

As a result, Arizona, Maryland, Massachusetts, and Ohio were selected to be interviewed. More specifically, Arizona, Ohio, and Maryland operate separate public sector mental health systems from their state Medicaid programs. However, Arizona uses the same infrastructure as its Medicaid program and Maryland consistently collaborates with its Medicaid program. Massachusetts integrates its Medicaid and state mental health systems under a managed care framework.

State (Covered Lives, Reported by Respondent) Reason for Inclusion
Ohio (250,000)
  • Marked separation between Medicaid and state mental health system
Massachusetts (24,500)
  • Integrated Medicaid and State Mental Health System: all managed care
Arizona (102,000)
  • Marked separation between Medicaid and state mental health system in theory, but they use the same infrastructure
Maryland (Not Reported)
  • Separate state mental health system and Medicaid (managed care, but FFS), that cooperate extensively.
  • Disparity between behavioral health carve-out and physical health Medicaid managed care pharmacy coverage

H. Corrections System

The corrections system was selected as an interview type because of the documented mental illness of the population it serves. More specifically, New York's correctional system was identified through expert recommendations as an appropriate interview target because it is well-known for instituting a progressive and innovative prison system statewide.

I. Professional Associations

Two professional associations, the American Psychiatric Association (APA), which represents psychiatrists, and the American Academy of Family Physicians (AAFP), which represents family physicians, were identified to participate in this study. Since psychiatrists primarily prescribe antipsychotics and antidepressants and primary care physicians (often family practice physicians) can prescribe antidepressants and/or make referrals to a psychiatrist for such a prescription, these two professional associations were selected as the most appropriate to present the desired perspectives of physician prescribing practices around the use of newer atypical antipsychotics and antidepressants.

Association Reason for Inclusion
American Psychiatric Association
  • Leading association for prescribing providers (psychiatrists)
American Academy of Family Physicians
  • Provides relevant policy statements

J. Consumer Advocay Associations

Two consumer associations, the National Alliance for the Mentally Ill (NAMI) and the National Mental Health Association (NMHA), were selected because of their national presence in the mental health field. Additionally, NAMI specializes in advocating for consumers who suffer from schizophrenia and their families. These two organizations' perspectives were essential in understanding the consumers' point-of-view and gaining a more balanced picture of the access and utilization issues associated with newer atypical antidepressants and antipsychotics.

Association Reason for Inclusion
National Alliance for the Mentally Ill
  • Leading consumer advocacy organization
  • Special interest in schizophrenia
National Mental Health Association
  • Leading consumer advocacy organization

Appendix C. Interview Respondents

Stakeholder Group Interviews Completed Request for Interview Refused or Unable to Schedule
Federal Government Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS))
Indian Health Service
  • Navajo Region
Department of Defense (DoD)
Pharmaco-Economic Center
Mental Health Policy Division
Tri-Care Mental Health Benefits
  • Patient Advocacy and Medical Ethics
Pharmacy Division
Veterans Administration
Mental Health Division		  
State Mental Health Systems Arizona
Maryland
Massachusetts
Ohio		  
State Medicaid Programs California
Georgia
Texas
Wisconsin		  
State Correctional Systems New York State  
Pharmaceutical Companies AstraZeneca
  • Government Affairs
Janssen Pharmaceuticals
  • Multiple Divisions
Eli Lilly and Company
  • Multiple Divisions
Glaxo Wellcome
  • Care Management
One Additional Pharmaceutical Company
(Anonymous by Request)
  • Government Affairs
 AstraZeneca
  • Seroquel Marketing
Forest Labs
Pfizer
Solvay Pharmaceuticals
Health Maintenance Organizations (HMOs) Harvard Pilgrim
Health Partners (MN)
First Option (NJ)
Group Health (WA)
Kaiser Permanente Mid-Atlantic		 Aetna US Healthcare, Mid-Atlantic
Health Options HMO (BCBC, Florida)
Kaiser Permanente, Northern California
Kaiser Permanente, Pacific Northwest
Pharmacy Benefit Managers (PBMs) ValueRx/Express Scripts
PCS Health System
Prescription Solutions PBM Division of Pacificare (CA)
Rx Innovations Division of Value/Options
One Additional PBM (Anonymous by Request)		  
Behavioral Health Managed Care Organizations (BHMCOs) Magellan
Value Options		 United Behavioral Health
Employers Delta Airlines
Motorola
William Mercer and Company		 Washington Business Group on Health
Consumer and Advocacy Associations National Alliance for the Mentally Ill
National Mental Health Association		  
Provider Associations American Academy of Family Physicians
American Psychiatric Association		 American College of Physicians
Note: Due to geographic and other scheduling difficulties, it was often necessary to conduct more than one interview with each respondent. As a result, the number of interviews reported in Table I-3 is greater than the number of interviewees.

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