The prevalence of the often disabling psychiatric diseases schizophrenia and major depressive disorder (MDD) is growing in Brazil and Mexico. Antipsychotics (older typical or newer atypical antipsychotics) are the standard of care for schizophrenia and an increasingly popular option for  patients with treatment-resistant depression (TRD). In an over-genericized market of well-established key agents, the uptake of new antipsychotics is hampered by stringent budgets and market access obstacles. However, high unmet need remains for therapies with demonstrated efficacy for both conditions. In this Access & Reimbursement analysis, we discuss the current access landscape for antipsychotics in Brazil and Mexico, with a focus on atypical antipsychotics’ use in schizophrenia and TRD. Based on primary research with psychiatrists and payers in these two countries, we also analyze the future uptake of emerging therapies (e.g., Lundbeck/Otsuka’s brexpiprazole) and pinpoint the levers of and roadblocks to their success.

Scope:

Decision Resources Group’s Access & Reimbursement module for schizophrenia and MDD in Brazil and Mexico explores the prescribing patterns for current antipsychotics for these indications; the potential impact of the anticipated arrival of novel therapies; and key national, regional, and institutional market access factors that will shape the use of antipsychotics over the next two to three years. This module draws on insights from 101 surveyed psychiatrists and interviews with 6 payers in Brazil and Mexico, all of whom have influence at the institutional, regional, or national level.

Markets covered: Brazil and Mexico.

Primary research:

  • 101 psychiatrists
  • 6 payers:
    • Brazil:
      • Member of the Pharmacology Commission in São Paulo’s State Health Department.
      • Medical audit department manager at national HMO.
      • Psychiatrist KOL.
    • Mexico:
      • Head of acquisition and distribution of medicines at ISSSTE.
      • Psychiatrist KOL.
      • Chief of the psychiatry department at an IMSS’s hospital; P&T committee member.

Questions Answered in This Report:

  • How does coverage of antipsychotics for schizophrenia and MDD vary between the profiled countries and public/private settings?
  • How do cost- and coverage-related constraints drive psychiatrists’ prescribing patterns for schizophrenia and MDD?
  • Which are the most prescribed and most preferred antipsychotics for the treatment of schizophrenia and MDD? What are the key drivers for the prescribing of one antipsychotic over another?
  • To what extent does generic availability affect the P&R of branded antipsychotics?
  • What are payers’ expectations for emerging therapies? How will market access barriers evolve, and what challenges will emerging therapies for schizophrenia and MDD be most likely to face in the future?
  • What role will head-to-head trials and pharmacoeconomic outcomes play in the coverage of novel agents versus current standards of care?
  • How do psychiatrists expect to prescribe emerging antipsychotics, and what is their likely impact on current brands in the next three years?

Table of contents

  • Schizophrenia - Access & Reimbursement - Detailed, Expanded Analysis Schizophrenia And Major Depressive Disorder (Brazil And Mexico)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for New Antipsychotics in Brazil and Mexico
    • Successes and Stumbles
      • Successes Among Atypical Antipsychotics for Schizophrenia and Major Depressive Disorder in Brazil and Mexico
      • Stumbles Among Atypical Antipsychotics for Schizophrenia and Major Depressive Disorder in Brazil and Mexico
      • Brazil: Coverage Successes and Stumbles
        • Mexico: Coverage Successes and Stumbles
        • Key Stakeholders in the Road to Market Access
          • Brazil
          • Mexico
        • Key Market Access Roadblocks
          • Key Market Access Roadblocks for Antipsychotics in Brazil and Mexico
          • Brazil: Key Market Access Roadblocks
          • Mexico: Key Market Access Roadblocks
        • Reimbursement Dynamics
          • Brazil: Reimbursement Dynamics for Antipsychotics
            • Brazil: HTA Process
            • Brazil: Drivers of Formulary Coverage for Schizophrenia and Major Depressive Disorder
            • Brazil: Key Background Details of the Healthcare System
            • Brazil: RENAME Components
            • Brazil: CEAF Drugs
          • Mexico: Reimbursement Dynamics for Antipsychotics
            • Mexico: HTA Process
            • Mexico: Drivers of Formulary Coverage for Antipsychotics
            • Mexico: Coverage Details for Atypical Antipsychotics for Schizophrenia and MDD
            • Mexico: Key Background Details of the Healthcare System
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Prescriber Preferences for Schizophrenia
            • Most Effective Antipsychotics for the Positive Symptoms of Schizophrenia
            • Preferred Antipsychotics for Schizophrenia by Symptom Domain in a Scenario of 100% Coverage
          • Prescriber Preferences for Major Depressive Disorder
            • Most Used Drug Classes Among Public Patients for Treatment-Resistant Depression
            • Preferred Antipsychotics for Major Depressive Disorder in a Scenario of 100% Coverage
          • Impact of Payer Policy on Prescribing for Schizophenia and Major Depressive Disorder
            • Percentage of Public Patients Who Are Eligible for Treatment of Schizophrenia and Major Depressive Disorder with Antipsychotics But Do Not Receive It Due to Cost, Budgetary, or Reimbursement Reasons
            • Impact of Payer Policy on Prescribing of Depot Formulations for Schizophrenia
          • Top Prescribing Drivers: Schizophrenia
            • Top Prescribing Drivers: Schizophrenia Public Patients
          • Top Prescribing Drivers: Major Depressive Disorder
            • Top Prescribing Drivers: Major Depressive Disorder Public Patients
          • Payer Policy Uptake Constraints
            • Impact of Out-of-Pocket Costs on Prescribing of Atypical Antipsychotics
          • Key Levers for and Constraints on Current Therapies
            • Key Levers for and Constraints on Current Antipsychotics
        • Market Access Landscape for Emerging Therapies
          • Likely Impact of Emerging Antipsychotics
            • Preferred Treatment for the Positive Symptoms of Schizophrenia Assuming 100% Coverage by 2019
            • Preferred Treatment for MDD Assuming 100% Coverage by 2019
          • Market Access Challenges for Emerging Antipsychotics for Schizophrenia and Major Depressive Disorder
            • Reasonable Price for Emerging Brexpiprazole, Cariprazine, and Pimavanserin Versus Abilify
            • Reasonable Price for Emerging Aripiprazole Lauroxil and Paliperidone Palmitate (three-month depot) Versus Risperdal Consta
          • Payer Opinion on Emerging Antipsychotics for Schizophrenia and Major Depressive Disorder
            • Brazil: Payer Opinion on Emerging Antipsychotics for Schizophrenia
            • Brazil: Payer Opinion on Emerging Antipsychotics for Major Depressive Disorder
            • Mexico: Payer Opinion on Emerging Antipsychotics for Schizophrenia
            • Mexico: Payer Opinion on Emerging Antipsychotics for Major Depressive Disorder
        • Methodology
          • Abbreviations
          • Primary Research Design
          • Background of Payers and Payer-Advising KOLs
          • Physician Demographics and Practice Setting
            • In what country is your practice located?
            • What is your specialty?
            • How many years have you practiced post-residency?
            • How would you best describe the setting(s) in which you practice?
            • How many adult patients (aged 18 or older) with the following indications do you treat or monitor per month, per type of setting?
            • What percentages of your private patients with schizophrenia and major depressive disorder, including those with suffering from treatment-resistant depression do you currently treat with atypical antipsychotics (e.g., risperidone, olanzapine, paliperidone, aripiprazole)?
            • What percentages of your public patients with schizophrenia and major depressive disorder, including those with suffering from treatment-resistant depression do you currently treat with atypical antipsychotics (e.g., risperidone, olanzapine, paliperidone, aripiprazole)?
            • Brazil: In what city is your practice located?
            • Mexico: In what city is your practice located?
            • What is your hospital type?
            • Mexico: What is your public hospital affiliation?
        • Appendix
          • Commercial Context
            • Schizophrenia Diagnosed Lifetime Prevalence
            • Major Depressive Disorder 12-Month Prevalent Cases
            • Guidelines for Schizophrenia in Brazil
            • Guidelines for Schizophrenia in Mexico
            • Treatment Guidelines for Major Depressive Disorder in Mexico
            • Guidelines for Depressive Disorder in Mexico
            • Profiles of Key Atypical Antipsychotics for Schizophrenia and Major Depressive Disorder in Brazil and Mexico
            • Advantages and Disadvantages of Key Atypical Antipsychotics for Schizophrenia and Major Depressive Disorder
            • Daily Cost of Select Atypical Antipsychotics for Schizophrenia
            • Timeline of Approvals of Key Current and Emerging Therapies
            • Emerging Therapy Profile: Brexpiprazole
            • Lundbeck’s Brexpiprazole
            • Emerging Therapy Profile: Cariprazine
            • Allergan’s Cariprazine
            • Emerging Therapy Profile: Pimavanserin
            • Acadia Pharmaceuticals’ Pimavanserin
            • Emerging Therapy Profile: Aripiprazole Lauroxil
            • Alkermes’s Aripiprazole Lauroxil
            • Emerging Therapy Profile: Paliperidone Palmitate (three-month depot)
            • Janssen Pharmaceutical’s Paliperidone Palmitate (Three-Month Depot)
          • Physician Survey Data
            • Patient Eligibility for Treatment With Atypical Antipsychotics: Schizophrenia
            • Patient Eligibility for Treatment With Atypical Antipsychotics: Major Depressive Disorder
            • Brazil: Formulary Inclusion of Atypical Antipsychotics for Schizophrenia
            • Open End Responses: Formulary Inclusion of Atypical Antipsychotics for Schizophrenia
            • Brazil: Formulary Inclusion of Atypical Antipsychotics for Major Depressive Disorder
            • Open End Responses: Formulary Inclusion of Atypical Antipsychotics for Major Depressive Disorder
            • Mexico: Formulary Inclusion of Atypical Antipsychotics for Schizophrenia
            • Open End Responses: Formulary Inclusion of Atypical Antipsychotics for Schizophrenia
            • Mexico: Formulary Inclusion of Atypical Antipsychotics for Major Depressive Disorder
            • Open End Responses: Formulary Inclusion of Atypical Antipsychotics for Major Depressive Disorder
            • Private Formulary Inclusion of Antipsychotics for Schizophrenia
            • Private Formulary Inclusion of Antipsychotics for Major Depressive Disorder
            • Patients Not Treated with Antipsychotics for Budgetary/Reimbursement Reasons
            • Coverage/Reimbursement and Cost Restrictions Limiting Prescribing for Antipsychotics of Eligible Patients with Schizophrenia
            • Coverage/Reimbursement and Cost Restrictions Limiting Prescribing for Antipsychotics of Eligible Patients with Major Depressive Disorder
            • Common Access Routes to Antipsychotics When Unavailable or Uncovered
            • Open End Responses: Common Access Routes to Antipsychotics When Available or Uncovered
            • Percentages of Patients Diagnosed with Schizophrenia and Major Depressive Disorder
            • Drug-Treatment Rates
            • Prescribing of Atypical Antipsychotics for the Treatment of Schizophrenia and Major Depressive Disorder
            • Percentages of Patients with Schizophrenia Treated with Typical Antipsychotics
            • Percentages of Patients with Schizophrenia Receiving Haloperidol Versus Other Typical Antipsychotics
            • Open End Responses: Percentages of Patients With Schizophrenia Receiving Haloperidol Versus Other Typical Antipsychotics
            • Patient Shares for Atypical Antipsychotics: Schizophrenia
            • Open End Responses: Patient Shares for Atypical Antipsychoitcs: Schizophrenia
            • Prescribing Drivers of Olanzapine for Public Patients with Schizophrenia
            • Prescribing Drivers of Risperidone for Public Patients with Schizophrenia
            • Prescribing Drivers of Olanzapine for Private Patients with Schizophrenia
            • Prescribing Drivers of Risperidone for Private Patients with Schizophrenia
            • Percentages of Public Patients with Schizophrenia Receiving an Oral Formulation Versus a Depot Formulation
            • Percentages of Private Patients with Schizophrenia Receiving an Oral Formulation Versus a Depot Formulation
            • Budgetary/Reimbursement Impact on the Prescribing of Depot Formulations for Schizophrenia
            • Reasons for Delaying or Forgoing Treatment With Antipsychotics
            • Open End Responses: Reasons for Delaying or Foregoing Treatment With Antipsychotics
            • Most-Preferred Antipsychotics for the Positive Symptoms of Schizophrenia
            • Drug Classes Used for the Treatment of Negative and Cognitive Symptoms of Schizophrenia
            • Most Used Antipsychotics for the Cognitive Symptoms of Schizophrenia
            • Most Used Antipsychotics for the Negative Symptoms of Schizophrenia
            • Open End Responses: Most Used Antipsychotics for the Negative Symptoms of Schizophrenia
            • Drivers for Prescribing an Oral Antipsychotic for the Treatment of Negative and Cognitive Symptoms of Schizophrenia
            • Prescibing of Antipsychotics for the Treatment of Negative and Cognitive Symptoms of Schizophrenia
            • Physicians' Choice of Treatment for Schizophrenia Without Access Barriers
            • Open End Responses: Physicians' Choice of Treatment for Schizophrenia Without Access Barriers
            • Physicians' Definition of Treatment-Resistant Depression
            • Percentages of Patients Diagnosed with Treatment-Resistant Depression
            • Most Used Drug Classes for Treatment-Resistant Depression
            • Patient Shares for Atypical Antipsychotics for Treatment-Resistant Depression
            • Open End Responses: Patient Shares for Atypical Antipsychoitcs for Treatment-Resistant Depression
            • Prescribing Drivers of Olanzapine for Public Patients with Major Depressive Disorder
            • Prescribing Drivers of Risperidone for Public Patients with Major Depressive Disorder
            • Prescribing Drivers of Olanzapine for Private Patients with Major Depressive Disorder
            • Prescribing Drivers of Quetiapine IR for Private Patients with Major Depressive Disorder
            • Limitations on the Off-Label Use of Antipsychotics for Major Depressive Disorder
            • Physicians' Choice of Antipsychotic Treatment for Major Depressive Disorder Without Access Barriers
            • Current Patient Shares of Branded Antipsychotics Versus Generic Antipsychotics: Schizophrenia
            • Current Patient Shares of Branded Antipsychotics Versus Generic Antipsychotics: Treatment-Resistant Depression
            • Drivers for Choosing a Novel Antipsychotic for the Treatment of Positive, Negative, and Cognitive Symptoms of Schizophrenia
            • Drivers for Choosing a Novel Antipsychotic for Treatment-Resistant Depression
            • Anticipated Use of Brexpiprazole and Cariprazine for Schizophrenia by 2019
            • Reasons for Prescribing Brexpiprazole and/or Cariprazine for Schizophrenia by 2019
            • Reasons for Not Expecting to Prescribe Brexpiprazole and/or Cariprazine for Schizophrenia by 2019
            • Anticipated Use of Brexpiprazole and Cariprazine for Treatment-Resistant Depression by 2019
            • Reasons for Prescribing Brexpiprazole and/or Cariprazine for Treatment-Resistant Depression by 2019
            • Reasons for Not Expecting to Prescribe Brexpiprazole and/or Cariprazine for Treatment-Resistant Depression by 2019
            • Preferred Treatment of MDD Assuming 100% Coverage in the Future
            • Anticipated Patient Shares for Antipsychotics for Treatment-Resistant Depression Public Patients
            • Anticipated Patient Shares for Antipsychotics for Treatment-Resistant Depression Private Patients
            • Anticipated Use of Depot Formulations by 2019
            • Reasons for Not Expecting to Increase Prescribing of Depot Formulations by 2019
            • Anticipated Use of Pimavanserin for Schizophrenia
            • Reasons for Not Expecting to Prescribe Pimavanserin for Schizophrenia by 2019
            • Preferred Treatment of Schizophrenia Assuming 100% Coverage in the Future
            • Anticipated Patient Shares for Antipsychotics for Schizophrenia Public Patients
            • Anticipated Patient Shares for Antipsychotics for Schizophrenia Private Patients
            • Anticipated Use of Oral Formulations Versus Depot Formulations by 2019 Among Public Patients
            • Brazil: Anticipated Use of Oral Paliperidone Versus Depot Paliperidone by 2019 Among Public Patients
            • Anticipated Use of Oral Formulations Versus Depot Formulations by 2019 Among Private Patients
            • Brazil: Anticipated Use of Oral Paliperidone Versus Depot Paliperidone by 2019 Among Private Patients
            • Acceptable Launch Prices for Brexpiprazole, Cariprazine, and Pimavanserin
            • Acceptable Launch Prices for Aripiprazole Lauroxil and Paliperidone Palmitate (three-month depot)

      Author(s): Susana Ribeiro Da Silba; Andreia S. Ribeiro, PhD

      Andreia Ribeiro, Ph.D., is a Director in DRG’s Market Access Insights team. In this role, she manages the Emerging and European Markets Access & Reimbursement portfolios, the industry’s only primary market research solution that includes insights from both physicians and payers to get a true sense of how both parties determine access to key pharmaceutical markets. She joined DRG over 4 years ago as a Latin American analyst where she has pioneered extensive primary and secondary research in the Brazil, Mexico, and Argentina payer systems exploring how the different reimbursement contexts impact prescribing.

      Dr. Ribeiro has a Ph.D. in chemical and biochemical engineering from the University of Maryland Baltimore County focused on translational biomaterials research. She holds a B.S./M.S. degree from the University of Porto and two professional certifications in biochemical regulatory engineering and biotechnology management. A native of Portugal, Dr. Ribeiro is fluent in Portuguese and Spanish.


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