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Insurance Considerations for Initiating Parenteral or Inhaled Prostacyclins in the Hospital for Pulmonary Arterial Hypertension

Teshia Sorensen, PharmD, BCPS

John J. Ryan, MD, FACC, FAHA

Erin Michaelis, APRN
University of Utah Hospital
Salt Lake City, UT, USA

Current pulmonary arterial hypertension (PAH) guidelines recommend parenteral prostacyclins (e.g., epoprostenol, treprostinil) and inhaled prostacyclins (e.g., iloprost, treprostinil) for patients with WHO Group 1 PAH and Functional Class III or IV symptoms. Initiating prostacyclins in an acutely decompensated patient in the hospital requires a substantial amount of effort and coordination from the Pulmonary Hypertension team and pharmacy team to ensure therapy can be continued at home following hospital discharge. Developing an institutional process for initiating prostacyclins can help ensure that a safe and timely discharge is not delayed due to issues with insurance approval for continued outpatient use. Potential obstacles include obtaining insurance approval through prior authorization processes, applying for patient assistance programs for individuals with limited resources, and scheduling comprehensive education and delivery of outpatient medication, equipment, and supplies prior to discharge through the specialty pharmacy. This article will describe some experience with these challenges as well as methods that can be developed to reduce the burden on the Pulmonary Hypertension team, and ultimately, the patient.

Prior Authorization:

Before initiating the prior authorization, the treatment options should be discussed with the patient and their family in a shared decision manner. The medicines available in PAH are complex and expensive, especially the parenteral and inhalation therapies. The regimens can be burdensome, and in some cases, overwhelming from a psychological and practical perspective. A significant limitation is the dexterity and sterility that is required for the parenteral therapies. As infusion therapies and inhaled therapies are presented to patients, it is important to ensure that they will be able to manage the regimen at home. It is also important to discuss a time frame with the patient and their family for obtaining insurance approval for these treatments, as well as an expected time frame for discharge from the hospital.

If prostacyclins are being prescribed for long-term use, the patient's insurance carrier should be contacted early during the hospitalization so that the prior authorization process can be initiated and the appropriate documentation can be prepared and submitted. Common requirements include submitting the results of an echocardiogram, the results of the right heart catheterization documenting the hemodynamics, most specifically the pulmonary arterial pressures, pulmonary capillary wedge pressure, pulmonary vascular resistance, and the results of a vasodilator challenge. Oftentimes, the 6-minute walk distance (6MWD) results are submitted. The history and physical and progress notes are required and should detail the onset of symptoms, WHO Functional Class, the speed of disease progression, the presence of poor prognostic factors including right heart failure, and treatment history, including current and discontinued medications for pulmonary hypertension. It is important to document that the diagnosis reflects Group 1 PAH. If the patient has risk factors for Group 2 or 3 pulmonary hypertension, detailed documentation is required to explain whether these risks factors are adequately treated and if the patient's pulmonary vascular disease is independent of these risk factors. Once all the requested documentation is submitted, the insurance will review and respond with either an approval or denial. If denied, additional documentation may be submitted through a formal appeal process.

Patient Assistance:

Once insurance approval is obtained, it is important to assess the patient's out-of-pocket costs, which can be a significant financial burden on some patients. Patient assistance programs can provide financial grants for co-payments and insurance premiums for qualifying patients. Oftentimes, patients are asked to submit proof of household income in order to qualify for assistance programs. This documentation can be difficult to obtain when the patient is hospitalized.

Specialty Pharmacy:

Specialty pharmacies provide the PAH therapy and supplies to the patient at home, and can provide significant assistance to the Pulmonary Hypertension team, patient, and family during the hospitalization. Prior to the patient discharging from the hospital, the specialty pharmacy needs to complete sufficient patient and family education regarding preparation and administration of the prostacyclin and troubleshooting the delivery device (i.e., intravenous pump, subcutaneous pump, inhalation device). The education process can be delayed until the insurance approves the prior authorization. Contacting the specialty pharmacy early in the prior authorization process can expedite the training process. Typically, educational sessions for infusion and inhaled therapies can be held over 2-3 days in order to ensure that the patient and their family are comfortable with their medications and the effort required to adhere to the regimen. The specialty pharmacy can also assist in transitioning the patient from hospital pump to home pump on the day of discharge.

Additional Considerations:

With parenteral therapies, patients may need to be changed from intravenous to subcutaneous prostacyclins. This can occur in the setting of a line infection, or it may be a patient preference. Patients may also need to be transitioned from subcutaneous to intravenous prostacyclins in the setting of intolerable infusion site pain. It is important to recognize that transitions between different routes of the same medication requires going through the prior authorization process again to justify the change to the insurance company.

Infusion therapy in the hospital poses additional challenges. The high cost of patient-specific inhalation devices and drug may not be feasible from a formulary standpoint. If inhalation therapy is the preferred treatment, one option is to complete the prior authorization and education while the patient is hospitalized, and initiate therapy within 24 hours of discharge with the specialty pharmacy's assistance.

Ultimately, these medications and regimens, although arduous, can have a positive impact on people's lives. And although the approval process and introduction of prostacyclins can be time consuming for both patients and providers, having an institutional process in place can help alleviate the burden of getting these therapies initiated.

Table 1. Institutional Process for Initiating Prostyacyclin Therapy

  • Verify patient has insurance coverage
  • Discuss treatment options with patient and family
  • Evaluate patient and family's ability to manage therapy at home
  • Submit documentation for insurance approval of selected therapy
    • History and physical
    • Progress notes
    • Echocardiogram
    • Right heart catheterization
    • Vasodilator challenge
    • 6-minute walk distance
    • Additional documentation if component of Group 2 or 3 PH
  • Confirm insurance approval and patient's out-of-pocket costs
    • Apply for patient assistance if needed
  • Contact specialty pharmacy
    • Schedule patient and family education sessions
    • Schedule transition to home equipment on day of discharge

Disclosure Statement: The authors have no conflicts of interest to disclose.

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