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PBMs Overriding FDA Guidelines for GLP-1 Medications: What Can We Do?

Updated: Jun 14

In a troubling trend, Pharmacy Benefit Managers (PBMs) are implementing their own stringent requirements for covering GLP-1 medications, such as Saxenda, Wegovy, and Zepbound, used for the treatment of obesity. These requirements go beyond the established FDA guidelines, potentially disqualifying many patients who would otherwise be eligible.

FDA Guidelines for GLP-1 Medications

The FDA has clear criteria for prescribing GLP-1 medications for chronic weight management: a BMI of 30 or higher, or a BMI of 27 with at least one weight-related comorbidity. These guidelines ensure that individuals who need these medications the most have access to them, addressing both obesity and related health conditions such as type 2 diabetes, hypertension, and dyslipidemia.

New PBM Requirements

Recent letters from PBMs illustrate how they are setting their own coverage criteria, which are often more restrictive than those set by the FDA. For instance, Express Scripts and Blue Cross Blue Shield of Michigan have introduced new guidelines that include:

  1. Higher BMI Thresholds and Multiple Comorbidities: Express Scripts now requires a BMI of 32 or higher, or a BMI of 27 with documentation of two comorbid conditions. This deviates significantly from the FDA's guidelines and can block access for patients who meet the FDA's criteria but not the PBM's.

  2. Mandatory Program Enrollment: Patients are required to enroll in specific health programs, such as Omada or Teladoc Health Program for Weight Management, and adhere to stringent participation rules. These programs often require regular use of apps, participation in coaching sessions, and monthly weigh-ins, adding a layer of complexity and burden for patients.

  3. Prior Authorization Requirements: Blue Cross Blue Shield of Michigan has changed its prior authorization criteria, requiring members to have an established relationship with their healthcare provider and participate actively in a lifestyle modification program for at least six months. Additionally, prior authorizations for these medications will end on specific dates, necessitating new requests and potential disruptions in treatment.

The Impact on Patients

These new PBM rules pose significant risks to patient health and well-being:

  • Access Barriers: By setting higher BMI thresholds and demanding multiple comorbidities, PBMs are effectively denying access to patients who fall within the FDA's approved criteria but not the PBM's more restrictive guidelines. This can delay or prevent treatment for individuals who could benefit significantly from these medications.

  • Increased Burden: Mandatory enrollment in health programs and regular check-ins create additional hurdles for patients. These requirements may be challenging for those with busy schedules, limited access to technology, or other barriers to regular participation.

  • Potential Health Risks: Interruptions in medication due to stringent prior authorization processes can lead to lapses in treatment, potentially exacerbating obesity-related health issues. Consistent access to GLP-1 medications is crucial for managing chronic conditions and improving long-term health outcomes.

  • Restrictions on Telehealth Prescriptions: Moves to restrict the prescribing of branded GLP-1 medications through telehealth services add another layer of difficulty. Many patients rely on the convenience and accessibility of telehealth to receive their prescriptions, and these restrictions could limit their access to necessary treatments, particularly for those in remote or underserved areas.

Potential Spread of PBM Guidelines

There is a significant concern that these restrictive PBM guidelines could spread to other PBMs, further limiting access to essential medications for patients across the country. As one PBM adopts these stringent criteria, others may follow suit, creating a ripple effect that could make it increasingly difficult for patients to receive the treatments they need.

Advocacy and Action Steps

To combat these restrictive PBM practices, it is crucial for patients and advocates to take action:

  1. Contact Legislators: Reach out to local, state, and federal representatives to express concerns about PBM practices and advocate for legislation that protects patient access to medications. Recent legislation in Oklahoma seeks to put some restrictions on PBMs, setting a precedent for other states to follow.

  1. Engage in Advocacy Groups: Join or support advocacy organizations that work to protect patient rights and access to medications. These groups can amplify individual voices and push for policy changes at a larger scale.

  1. Advocate Directly with PBMs: Patients can also advocate directly with their PBMs by requesting exceptions or appealing formulary exclusions. Documenting medical necessity and providing detailed support from healthcare providers can sometimes help in gaining approval for needed medications.

  2. Stay Informed and Share Information: Educate yourself and others about PBM practices and changes in coverage guidelines. Sharing information through social media, blogs, and community groups can raise awareness and encourage collective action. Sharing content from on your personal pages can help get the advocacy message outside the GLP-1 community and engage a broader audience.

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