Support Access To A New Therapy

Overview

Following marketing approval, your group may continue to play a role in ensuring the new therapy is accessible and available to your disease community. Enabling broad access to a newly approved therapy often requires working with public and private insurance providers about these new changes in patient care to inform appropriate decisions on coverage. 

Currently there is a lot of debate concerning the cost of accessing cutting edge treatments, but no clear solutions. Thus, there are limited resources providing tips or strategies available on this topic. As patient groups and other key stakeholders work together to find ways to ensure accessibility, more information and relevant resources will be added to this section. 

You are encouraged to share any helpful resources, tips, or strategies that your group used to successfully address access barriers to a new treatment in your disease community for possible addition to NCATS Toolkit through the Contact Page. You may also wish to share current challenges and even strategies that have not been successful.

Working with Insurance Providers

Public and private insurance providers make decisions on the value of a newly marketed therapy and determine how the new treatment will be covered. The following resources provide insight into the complexities of insurance provider reimbursement and help you navigate ways to identify the barriers and promote coverage.

  • FasterCures Value and Coverage Program is working to create a shared strategy to ensure that newly marketed therapies are not only developed but accessible to patients. 
    • At the core is bringing together the key stakeholders:
      • Patient and patient communities
      • Medical professionals working with the patients
      • Public and private medical insurance providers
      • Pharmaceutical manufacturers
      • Investors.
    • Partnering with Patients on Value, Coverage, and Reimbursement (2015) is a brief, but powerful written summary of a FasterCures workshop that included patients, insurance providers, and industry. The workshop sought to allow for a better understanding of challenges to insurance provider coverage and reimbursement. 
      • Key takeaway points include:
        • Early engagement with insurance providers can improve alignment between the evidence needed for the Food and Drug Administration (FDA) marketing review process and postmarket insurance provider reimbursement.
        • Both patient groups and insurance providers need to broaden their understanding of each other’s role.
        • Insurance providers need to build systematic processes for soliciting and using input from patient groups and communities.
        • Patient groups can provide data on unmet medical needs, burden of disease, patient and caregiver experience, and the value of therapies to support insurance provider reimbursement.
        • The disease community should maintain as united a front as possible, and collaborate when possible with other groups who are also working towards getting a newly marketed therapy approved for reimbursement.
      • Other helpful insights include the importance of:
        • Being aware that patient registries, along with clinical trials, can provide data supporting insurance provider reimbursement approval. 
        • Understanding what motivates different types of insurance providers to pay out claims to tailor messaging more effectively. For example:
          • Self-insured companies may strongly consider reimbursement of a new treatment if a part of the cost will be offset by the employee missing fewer days of work. This consideration usually applies to time taken off to care for a partner or child, if the employee is not the person who will receive the treatment. 
          • Managed care and pharmacy organizations might be more motivated by factors that will give them a competitive edge in the market, such as customer satisfaction.
        • Knowing the interactions and key players within a primary provider that may factor into the approval of a newly marketed therapy. For example: 
          • Pharmacy benefit managers may be focused on decreasing the cost of pharmaceuticals.
          • Managed care organizations may be focused on decreasing the cost of overall care.
          • Risk-bearing provider entities may also be involved in the decision making process. 
        • Conveying an understanding of trade-offs, both about the benefits and risks of treatment and the costs and outcomes of access, in order for requests for insurance provider reimbursements to be credible from the viewpoint of the insurance provider.
    • Links to more resources are available on FasterCures Value & Coverage Reports and Briefs webpage.
    • Consider contacting FasterCures to learn about this Program’s latest efforts: fastercures@milkeninstitute.org.
  • Working with Regulators: A Focus on CMS (2014) is an online, text-based toolkit that provides information for patient groups about the FDA marketing review process and the changing patient engagement landscape. The toolkit was developed by the Cancer Policy Institute of the Cancer Support Network.
    • The focus of the toolkit is on the Center for Medicare and Medicaid Services (CMS) from the perspective of cancer patient groups but the messages apply to patient groups in general.
    • The toolkit provides:
      • Information to help you develop a working knowledge of the mechanics of the regulatory process and the role that CMS plays.
      • Tips to help you:
        • Monitor CMS activity to be aware of proposed new rules.
        • Learn about the engagement opportunities available to patient advocates in the national coverage process.
        • Identify the types of evidence and data that influence the decision-making process.
        • Understand the benefits, and potential risks of proactively requesting a coverage decision.
        • Develop strategies to optimize engagement with CMS and its key staff.
  • The Patient Voice in Value: The National Health Council Patient-Centered Value Model Rubric (2016) can be used to evaluate whether existing value models are patient-centered and to guide patient engagement in the development of future value models.
    • Value models are used to help assess the value of new treatments.
    • The rubric was developed by the National Health Council

Tips for Success

  • Talk to other patient groups at conferences and other events to share strategies that have been successful and those that have not been. 
  • Watch for conferences focused on achieving reimbursement through public and private insurance providers for newly marketed therapies.
  • If your newly marketed therapy uses a cutting edge technology, such as gene transfer, consider collaborating with other patient groups who also have a newly marketed therapy using the same technology. 
  • Request members of your disease community share with you their own successes with specific insurance providers. 
    • You may be able to leverage one person’s success into a more global acceptance by the specific insurance provider. 
    • You can share the strategy used to gain approval with other members of your community who have the same medical insurance provider.
    • Determine whether there are any common strategies that might be applicable to other insurance providers.
    • Develop a toolkit of possible strategies that individual patients/families may use to gain reimbursement approval.
  • Involve members of your Scientific/Medical Advisory Board as well as the specialists who treat your disease communities to advocate for insurance provider reimbursement.
    • Many professional societies have advocacy committees. You, members of your Scientific/Medical Advisory Board, or specialists in your clinical care network may consider reaching out to these committees to determine if a collaboration can be formed.

Following marketing approval, your group may continue to play a role in ensuring the new therapy is accessible and available to your disease community. Enabling broad access to a newly approved therapy often requires working with public and private insurance providers about these new changes in patient care to inform appropriate decisions on coverage. 

Currently there is a lot of debate concerning the cost of accessing cutting edge treatments, but no clear solutions. Thus, there are limited resources providing tips or strategies available on this topic. As patient groups and other key stakeholders work together to find ways to ensure accessibility, more information and relevant resources will be added to this section. 

You are encouraged to share any helpful resources, tips, or strategies that your group used to successfully address access barriers to a new treatment in your disease community for possible addition to NCATS Toolkit through the Contact Page. You may also wish to share current challenges and even strategies that have not been successful.

Public and private insurance providers make decisions on the value of a newly marketed therapy and determine how the new treatment will be covered. The following resources provide insight into the complexities of insurance provider reimbursement and help you navigate ways to identify the barriers and promote coverage.

  • FasterCures Value and Coverage Program is working to create a shared strategy to ensure that newly marketed therapies are not only developed but accessible to patients. 
    • At the core is bringing together the key stakeholders:
      • Patient and patient communities
      • Medical professionals working with the patients
      • Public and private medical insurance providers
      • Pharmaceutical manufacturers
      • Investors.
    • Partnering with Patients on Value, Coverage, and Reimbursement (2015) is a brief, but powerful written summary of a FasterCures workshop that included patients, insurance providers, and industry. The workshop sought to allow for a better understanding of challenges to insurance provider coverage and reimbursement. 
      • Key takeaway points include:
        • Early engagement with insurance providers can improve alignment between the evidence needed for the Food and Drug Administration (FDA) marketing review process and postmarket insurance provider reimbursement.
        • Both patient groups and insurance providers need to broaden their understanding of each other’s role.
        • Insurance providers need to build systematic processes for soliciting and using input from patient groups and communities.
        • Patient groups can provide data on unmet medical needs, burden of disease, patient and caregiver experience, and the value of therapies to support insurance provider reimbursement.
        • The disease community should maintain as united a front as possible, and collaborate when possible with other groups who are also working towards getting a newly marketed therapy approved for reimbursement.
      • Other helpful insights include the importance of:
        • Being aware that patient registries, along with clinical trials, can provide data supporting insurance provider reimbursement approval. 
        • Understanding what motivates different types of insurance providers to pay out claims to tailor messaging more effectively. For example:
          • Self-insured companies may strongly consider reimbursement of a new treatment if a part of the cost will be offset by the employee missing fewer days of work. This consideration usually applies to time taken off to care for a partner or child, if the employee is not the person who will receive the treatment. 
          • Managed care and pharmacy organizations might be more motivated by factors that will give them a competitive edge in the market, such as customer satisfaction.
        • Knowing the interactions and key players within a primary provider that may factor into the approval of a newly marketed therapy. For example: 
          • Pharmacy benefit managers may be focused on decreasing the cost of pharmaceuticals.
          • Managed care organizations may be focused on decreasing the cost of overall care.
          • Risk-bearing provider entities may also be involved in the decision making process. 
        • Conveying an understanding of trade-offs, both about the benefits and risks of treatment and the costs and outcomes of access, in order for requests for insurance provider reimbursements to be credible from the viewpoint of the insurance provider.
    • Links to more resources are available on FasterCures Value & Coverage Reports and Briefs webpage.
    • Consider contacting FasterCures to learn about this Program’s latest efforts: fastercures@milkeninstitute.org.
  • Working with Regulators: A Focus on CMS (2014) is an online, text-based toolkit that provides information for patient groups about the FDA marketing review process and the changing patient engagement landscape. The toolkit was developed by the Cancer Policy Institute of the Cancer Support Network.
    • The focus of the toolkit is on the Center for Medicare and Medicaid Services (CMS) from the perspective of cancer patient groups but the messages apply to patient groups in general.
    • The toolkit provides:
      • Information to help you develop a working knowledge of the mechanics of the regulatory process and the role that CMS plays.
      • Tips to help you:
        • Monitor CMS activity to be aware of proposed new rules.
        • Learn about the engagement opportunities available to patient advocates in the national coverage process.
        • Identify the types of evidence and data that influence the decision-making process.
        • Understand the benefits, and potential risks of proactively requesting a coverage decision.
        • Develop strategies to optimize engagement with CMS and its key staff.
  • The Patient Voice in Value: The National Health Council Patient-Centered Value Model Rubric (2016) can be used to evaluate whether existing value models are patient-centered and to guide patient engagement in the development of future value models.
    • Value models are used to help assess the value of new treatments.
    • The rubric was developed by the National Health Council
  • Talk to other patient groups at conferences and other events to share strategies that have been successful and those that have not been. 
  • Watch for conferences focused on achieving reimbursement through public and private insurance providers for newly marketed therapies.
  • If your newly marketed therapy uses a cutting edge technology, such as gene transfer, consider collaborating with other patient groups who also have a newly marketed therapy using the same technology. 
  • Request members of your disease community share with you their own successes with specific insurance providers. 
    • You may be able to leverage one person’s success into a more global acceptance by the specific insurance provider. 
    • You can share the strategy used to gain approval with other members of your community who have the same medical insurance provider.
    • Determine whether there are any common strategies that might be applicable to other insurance providers.
    • Develop a toolkit of possible strategies that individual patients/families may use to gain reimbursement approval.
  • Involve members of your Scientific/Medical Advisory Board as well as the specialists who treat your disease communities to advocate for insurance provider reimbursement.
    • Many professional societies have advocacy committees. You, members of your Scientific/Medical Advisory Board, or specialists in your clinical care network may consider reaching out to these committees to determine if a collaboration can be formed.