Access and Utilization of New Antidepressant and Antipsychotic Medications. Appendixes

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
      
      2. Number ___________________
   9. Psychologists
      
      2. 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?

4. 3. Are there any State laws mandating coverage for a particular psychotropic drug?
   4. Do you actively enforce compliance with the formulary? What methods do you use?
   5. Do you engage in switching practices?
      • Active switching
      • Outbound calling
      • Others (specify)
   6. Is switching more or less frequent for psychotropics than for physical health medications?
   7. Do you use or require generic or therapeutic substitution? For which drugs?
   8. What is the composition of your P & T committee? How often do they meet to consider new products?
   9. Do you include any behavioral health specialists on your P&T committee?
   10. (If a PBM is in place) Please describe your working relationship with the PBM's P&T committee.
   11. Please describe how decisions are made to include/exclude particular drugs from approved formulary lists.
   12. 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
   13. Do these practices differ for psychotropics compared to other pharmaceutical classes? (If yes, rerank question 4)
   14. Are external benefit consultants used in the decision-making process to set drug benefit coverage policies?
   15. Do you run any real world effectiveness trials, registries, or formal reviews of specific drug classes to assess their suitability for formulary inclusion?
   16. Do you collect any pharmacoeconomic/cost-effectiveness data on recipients of psychotropic medications?
   17. 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?
   18. Is the mean time from FDA approval to formulary acceptance longer for psychotropics than other class of drugs?
   19. 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.)?
   20. What are you doing to speed formulary review of new products?
   21. What is currently in place as far as contracts and rebates with pharmaceutical companies? Are these different for psychotropics versus other therapeutic classes?
5. 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?
6. 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?
7. 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.
8. 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.)?
9. 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?
10. 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?

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

• Pharmaceutical companies;
• Managed behavioral health care companies;
• Health maintenance organizations;
• Pharmacy benefit managers;
• Employer-provided insurance plans;
• Publicly-funded insurance (Medicaid, Veteran's Administration, CHAMPUS);
• State Mental Health systems;
• Corrections system;
• Provider associations; and
• Consumer and advocacy groups.

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.

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.