Introduction

Alzheimer’s disease is a chronic disease than affects several million Brazilian and Mexican patients. Physicians have a small number of molecules available for the treatment of cognitive/functional deficits associated with the disease, and in both markets there are generics for most drugs available. Drug coverage is different in these countries; while Brazilian patients have access to most drugs through the public sector, the Mexican market has a very important OOP component, and drug coverage varies across the different healthcare programs. New agents will find two markets eager to adopt new technologies, especially those that demonstrate they can change the progression of the disease. However, adoption of new health technologies by each country is made with focus on budget balance, and manufacturers will have to adjust their expectations to each country’s price and reimbursement characteristics. This Access & Reimbursement analysis provides key insights for navigating the AD market in Brazil and Mexico while adapting your brand’s value message to payers and physician needs and expectations in each country.

Scope:

Decision Resources Group’s Access and Reimbursement module for Alzheimer’s disease in Brazil and Mexico explores the prescribing patterns for current AD therapies; 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 AD therapies over the next two to three years. This report draws on insights from 103 surveyed physicians and from 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:

  • 103 physicians:
    • 44 neurologists.
    • 26 psychiatrists.
    • 32 geriatricians.
    • 1 internal medicine/primary care physician.
  • 6 payers:
    • Brazil:
      • Member of the Pharmacology Commission in São Paulo’s State Health Department
      • Medical audit department manager at National HMO
      • Neurologist KOL
    • Mexico:
      • Head of acquisition and distribution of medicines at ISSSTE
      • Chief of Geriatrics Department at INNSZ
      • Neurologist and neurophysiologist KOL

Questions Answered in This Report:

  • Which agents are available for the treatment of AD, and which of them are covered at a national and institutional level in Brazil and Mexico.
  • The barriers AD patients encounter for diagnosis and treatment, and how they vary across the two countries and impact the disease progression.
  • What the current drivers of physician prescribing of AD therapies are, and how prescribing is impacted by payer policies.
  • The impact of reimbursement/coverage constraints on prescribing, and how patients access medicines when access is limited/non-existent.
  • The impact of health authorities’ policies in the prescription of generics.
  • The perceptions and expectations payers have for emerging therapies, and which challenges new therapies will need to overcome.
  • How new therapies meet physicians’ needs, and how they expect to prescribe them.
  • Which differentiating characteristics new therapies will need to show to be successful with coverage requests.

Table of contents

  • Alzheimer's Disease - Access & Reimbursement - Detailed, Expanded Analysis (Brazil/Mexico)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for New AD Therapies in Brazil and Mexico
    • Successes and Stumbles
      • Successes Among Alzheimer's Disease Therapies in Brazil and Mexico
      • Stumbles Among Alzheimer's Disease Therapies in Brazil and Mexico
      • Brazil: Coverage Successes & Stumbles
        • Brazil Reimbursement/Coverage Successes and Stumbles
      • Mexico: Coverage Successes & Stumbles
        • Mexico Reimbursement/Coverage Successes and Stumbles
    • Key Stakeholders in the Road to Market Access
      • Brazil
      • Mexico
    • Key Market Access Roadblocks
      • Key Market Access Roadblocks for Alzheimer’s Disease Therapies in Brazil and Mexico
      • Brazil: Key Market Access Roadblocks for Alzheimer’s Disease
      • Mexico: Key Market Access Roadblocks for Alzheimer’s Disease
    • Reimbursement Dynamics
      • Brazil: Coverage Dynamics for Alzheimer’s Disease
        • Brazil: Health Technology Assessment Process
        • Brazil: Drivers of Formulary Coverage for Alzheimer’s Disease Therapies
        • Brazil: Drivers of Formulary Coverage for Alzheimer’s Disease Drugs
        • Brazil: Coverage and Health Technology Assessment Details for Key Alzheimer’s Disease Therapies
        • Brazil: Coverage and Health Technology Assessment Details for Key Alzheimer’s Disease Therapies
        • Brazil: Key Background Details of the Healthcare System
        • Brazil: RENAME Components
        • Brazil: RENAME Components
        • Brazil: CEAF Drugs
        • Brazil: CEAF Drugs
      • Mexico: Coverage Dynamics for Alzheimer’s Disease
        • Mexico: Health Technology Assessment Process
        • Mexico: Drivers of Formulary Coverage for Alzheimer’s Disease Therapies
        • Mexico: Drivers of Formulary Coverage for Alzheimer’s Disease Drugs
        • Mexico: Coverage Details for Key Alzheimer’s Disease Therapies
        • Mexico: Coverage Details for Key Alzheimer’s Disease Therapies
        • Mexico: Key Background Details of the Healthcare System
    • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
      • Prescriber Preferences for Alzheimer’s Disease
        • Patient Shares for Key Alzheimer’s Disease Drugs, by Disease Severity
        • Patient Shares for the Different Versions of Key Alzheimer’s Disease Treatments: Public Patients
        • Most-Prescribed AChEI/Memantine Combination Therapies
      • Impact of Payer Policy on Prescribing for Alzheimer’s Disease
        • Percentage of Patients Who Are Eligible for Treatment of Alzheimer’s Disease with AChEIs and/or Memantine But Do Not Receive It Due to Cost, Budgetary, or Reimbursement Reasons
        • Physician Choice of Alzheimer’s Disease Therapy in a Scenario of 100% Coverage
      • Top Prescribing Drivers: Alzheimer’s Disease
        • Top Prescribing Drivers: Mild Alzheimer’s Disease Public Patients
      • Payer Policy Uptake Constraints
        • Impact of Out-of-Pocket Costs on Prescribing of Alzheimer’s Disease Drugs
      • Key Levers and Constraints on Current Therapies
        • Key Levers and Constraints on Current Therapies for Alzheimer’s Disease
    • Market Access Landscape for Emerging Therapies
      • Likely Impact of Emerging Therapies on Alzheimer’s Disease
        • Prescription of Emerging Therapies upon Availability
        • Preferred Treatment of Mild Alzheimer’s Disease Patients Assuming 100% Coverage in the Future
        • Biggest Unmet Needs When Treating Alzheimer’s Disease Patients
      • Market Access Challenges for Emerging Therapies for Alzheimer’s Disease
        • Reasonable Price for Emerging Therapies Versus Memantine
        • Future Prescribing Taking into Consideration the Future Coverage and Access Environment in Brazil and Mexico
      • Payer Opinion on Emerging Therapies for Alzheimer’s Disease
        • Brazil: Payer Opinion on Emerging Therapies for Alzheimer’s Disease
        • Mexico: Payer Opinion on Emerging Therapies for Alzheimer’s Disease
    • Methodology
      • Abbreviations
      • Primary Research Design
      • Background of Payers and Payer-Advising KOLs
        • Physician Demographics and Practice Setting
          • In what country is your practice located?
          • Brazil: In what city is your practice located?
          • Mexico: In what city is your practice located?
          • What is your specialty?
          • How many years have you practiced post-residency?
          • How many adult patients (aged 18 or older) with the following indications do you see (i.e., treat or monitor) per month?
          • Which of the following therapies do you currently prescribe?
          • What type of hospital(s) do you practice at?
          • How would you best describe the setting(s) in which you practice?
          • Among the AD patients you treat per month, what percentage are public vs. private patients?
          • What is your public hospital affiliation?
        • Pricing Methodology
      • Appendix
        • Commercial Context
          • Prevalent Cases
          • Treatment Guidelines for Alzheimer's Disease in Brazil
          • Guidelines for Alzheimer's Disease in Brazil
          • Treatment Guidelines for Alzheimer's Disease in Mexico
          • Guidelines for Alzheimer's Disease in Mexico
          • Profiles of Key Drugs for Alzheimer's Disease in Brazil and Mexico
          • Advantages and Disadvantages of Key Drugs for Alzheimer's Disease
          • Daily Cost of Select Alzheimer's Disease Drugs
          • Brazil: APAC Values for Alzheimer's Disease Drugs
          • Brazil: APAC values
          • Timeline of Approvals of Key Drugs for Alzheimer's Disease
          • Timeline of Approvals of Key Current and Emerging Therapies
          • Emerging Therapy Profile: Idalopirdine
          • Lundbeck's Idalopirdine
          • Emerging Therapy Profile: Solanezumab
          • Eli Lilly's Solanezumab
          • Emerging Therapy Profile: Gantenerumab
          • Roche's Gantenerumab
          • Mexico: Plan de Acción Alzheimer Y otras Demencias
          • WHO/PAHO Dementias Initiative
        • Physician Survey Data
          • Most Commonly Tests Used for the Diagnosis of AD
          • Most Commonly tests Used for the Diagnosis of AD in the Public Sector - Larger Cities versus Smaller Cities
          • AD-specific Biomarkers Used in Clinical Practice
          • Impact of Biomarker Positive Result on Diagnosis/Management
          • Impact of Availability of Resources in Ability to Establish an Accurate Diagnosis of AD
          • Association Between Confirmation of Diagnosis of AD and Treatment with AD Drugs
          • Differential Diagnosis Between AD and Other Dementias Prior to Initiation of Treatment
          • Average Period From Onset of Symptoms Until Diagnosis of AD
          • Reasons for Delays Superior to One Year in Diagnosis
          • Average Period from Diagnosis of AD until Initiation of Cognitive Treatment
          • Physicians' Opinion About the Length of the Period Between Diagnosis and Initiation of Treatment
          • Reasons for Delays Superior to One Year in Treatment Initiation
          • Most Frequent Physicians Diagnosing AD
          • Physicians Allowed to Prescribe Cognitive Treatments for AD
          • Physician's Level of Comfort with Primary Care Physicians Receiving Specific Training for the Early Identification of Alzheimer Symptoms
          • Percentage of Diagnosed AD Patients per Stage of Disease
          • Percentage of Diagnosed Public AD Patients Currently Receiving the Different Modalities of Treatment for the Cognitive Defects of AD
          • Percentage of Diagnosed Private AD Patients Currently Receiving the Different Modalities of Treatment for the Cognitive Defects of AD
          • Percentage of Diagnosed AD Patients Currently Receiving Treatment of Behavioral Symptoms
          • Brazil: Public Formulary Inclusion of Agents for AD
          • Brazil: Public Formulary Inclusion of Agents for AD
          • Mexico: Public Formulary Inclusion of Agents for AD
          • Mexico: Public Formulary Inclusion of Agents for AD
          • Public Patient Shares for AD Therapies
          • Private Patient Shares for AD Therapies
          • Public Patient Shares of Branded and Generic AD Therapies
          • Private Patient Shares of Branded and Generic AD Therapies
          • Brazil: AD Treatment Regimens
          • Mexico: AD Treatment Regimens
          • Most Prescribed Combination Regimen of AChEIs and Memantine
          • Drivers for Initiation of Treatment with Memantine
          • Brazil: Impact of Availability of Galantamine Generics on Prescribing
          • Reasons Ceasing/Switching Treatments with AChEIs
          • Brazil: Actions Taken when Treatment With One AChEI Fails
          • Mexico: Actions Taken when Treatment With One AChEI Fails
          • Brazil: Impact of Shortages of Medicines on Patients’ Access to AD Medicines
          • Mexico: Prescribing of Donepezil/Memantine FDC Pill Upon Availability
          • Mexico: Drivers for Prescribing Donepezil/Memantine FDC Pill
          • Mexico: Drivers for Not Prescribing Donepezil/Memantine FDC Pill
          • Prescribing Drivers for Current Therapies in Public Patients
          • Brazil: Prescribing Drivers of Specific Therapies for Mild AD Public Patients
          • Mexico: Prescribing Drivers of Specific Therapies for Mild AD Public Patients
          • Brazil: Prescribing Drivers of Specific Therapies for Moderate AD Public Patients
          • Mexico: Prescribing Drivers of Specific Therapies for Moderate AD Public Patients
          • Brazil: Prescribing Drivers of Specific Therapies for Severe AD Public Patients
          • Mexico: Prescribing Drivers of Specific Therapies for Severe AD Public Patients
          • Prescribing Drivers for Current Therapies in Private Patients
          • Brazil: Prescribing Drivers of Specific Therapies for Mild AD Private Patients
          • Mexico: Prescribing Drivers of Specific Therapies for Mild AD Private Patients
          • Brazil: Prescribing Drivers of Specific Therapies for Moderate AD Private Patients
          • Mexico: Prescribing Drivers of Specific Therapies for Moderate AD Private Patients
          • Brazil: Prescribing Drivers of Specific Therapies for Severe AD Private Patients
          • Mexico: Prescribing Drivers of Specific Therapies for Severe AD Private Patients
          • Prescription Drivers for Exelon Patch
          • Coverage/Reimbursement and Cost Restrictions Limiting Prescribing for Treatment of Eligible AD Patients
          • Analysis of Physicians Who do Not Indicate any FactorLimiting Their Prescribing to Eligible AD Patients
          • AD Patients Not Treated with AD Drugs for Budgetary/Reimbursement Reasons
          • Common Access Routes to AD Drugs When Unavailable or Uncovered
          • Physicians' Recommendation for Coverage of Rivastigmine Patch
          • Reasons to Agree on Coverage of Rivastigmine Patch
          • Reasons to Disagree on Coverage of Rivastigmine Patch
          • Impact of Coverage of Rivastigmine Patch on Current Prescribing
          • Patients receiving Rivastigmine Patch If Covered
          • Mexico: Physicians' Opinion on Coverage of AChEIs
          • Mexico: Factors Deterring Coverage of AChEIs by IMSS/SSA
          • Physicians' Recommendation for Coverage of Memantine
          • Reasons for Recommending Coverage of Memantine
          • Impact of Memantine Coverage on Prescribing
          • Physicians' Choices of Treatments for AD Patients Without Access Barriers
          • Healthcare Authorities’ Preferred Therapy for Treatment of AD Patients
          • Brazil: Health Authority Bodies Considered Barriers to Coverage/Reimbursement of AD Drugs
          • Mexico: Health Authority Bodies Considered Barriers to Coverage/Reimbursement of AD Drugs
          • Brazil: Perception of PDP Developed Galantamine's Quality
          • Impact of PDP Developed Galantamine on Prescribing Upon Availability
          • Mexico: Impact of Generic Oral Rivastigmine and Galantamine on Prescribing Upon Availability
          • Unmet Needs When Treating AD Patients
          • Physicians' Prescription of ETs Upon Availability
          • Drivers for Prescribing ETs
          • Drivers for Not Prescribing ETs
          • Physicians' Recommendation for Coverage of ETs
          • Physicians' Recommendations for Coverage of ETs─Current Agents Likely to Replace
          • Acceptable Launch Prices for Idalopirdine
          • Acceptable Launch Prices for Gantenerumab and Solanezumab
          • Impact of IV Delivery on Access
          • Impact of SC Delivery on Access
          • Impact of Requirement for the Use of AD-Specific Biomarkers on Access
          • Expected Access to Gantenerumab
          • Expected Access to Idalopirdine
          • Expected Access to Solanezumab
          • Expected Choices of Treatments for AD Patients
          • Physicians' Choices of Treatments for AD Patients Without Access Barriers

    Author(s): Nuno Tiago Giao Antunes, PhD

    Nuno T. Antunes, Ph.D., is senior business insights analyst on the Infectious, Niche, and Rare Diseases team at Decision Resources Group, specializing in antibacterial agents. Previously, he was a Latin America Market Access senior analyst in the Global Market Access Insights Team, where he developed expertise in market access, pricing and reimbursement, health technology assessment, and health policy.

    Nuno holds a Ph.D. in animal health from the Universidad de las Palmas de Gran Canaria, Spain, and a D.V.M. degree from the Universidade de Trás-os-Montes e Alto Douro, Portugal. Prior to joining DRG, he conducted research in antimicrobial resistance and antimicrobial development, and worked in the medical devices industry as a scientist.


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