Partners in Care: Gilenya First Dose Observation (FDO)

Concentra and Novartis have partnered to provide a network of clinics that administer the First Dose Observation (FDO) services that are required as patients start therapy on Gilenya (fingolimod). With more than 300 sites across the country, Gilenya Assessment Network (GAN) offers a comprehensive network of medical clinics that can provide the clinical services and support you need as you start your patient on Gilenya.

 

Commitment to continuous improvement

It’s our goal to work as partners-in-care with you, the prescribing neurologist, to ensure the best care for patients with MS as they start this new journey. To date, more than 15,000 FDOs have been administered at Concentra and our network sites. We strive for continuous improvement in the care and service we provide by you and your patient.

Smiling Woman Doctor

Support for the Prescribing Neurologist

  • More than 300 GAN sites across the country
  • More than 5000 FDOs provided since inception
  • Experienced physicians and staff attending to your patient
  • Physician consultation pre/post FDO administration and pre-discharge
  • Complete reporting of Baseline Assessment and FDO metrics
    Concentra Office Lobby

    Support for the MS Patient

    • Medical facility, with private room and accommodations to ensure patient comfort
    • Reclining chair, television, refrigerator, TV with DVD player
    • No out-of-pocket costs for eligible patients

      Scheduling and FDO process:

      To request GAN services, submit the Service Request Form (SRF) to the Gilenya Go patient services hub. The SRF serves as both the prescription for Gilenya and request for GAN services. A Navigator within the Gilenya Go hub will then work closely with the patient to schedule the services you requested at the time and location that best meet your patient’s needs.

      All scheduling is done via the Gilenya Go Program (GGP). The typical scheduling of appointments may be as follows:

      1. Scheduling baseline assessments

      These are scheduled at least a week before scheduling the FDO. This allows time for results to get back to the neurologist for review, and gives you the flexibility of cancelling the FDO if any of the lab values are concerning.

      Baseline assessments include the following options:

      • CBC with differential
      • Liver function panel
      • EKG
      • *Varicella (VZV) Serology

      *Rarely, the VZV serology will indicate that a patient requires vaccination. Most GAN sites will perform this vaccination at your request. The form required to request this will be distributed to you along with the results of the serology. You may also print a copy of the form from this link.

      2. Scheduling the FDO

      A minimum of 5 business days’ advance notice is required for scheduling at a GAN site. This allows time to ship paperwork and starter drug to the site and for schedule adjustments as needed. Documentation that the GAN site will receive prior to the FDO includes:

      • Service Request Form that you have submitted
      • General patient information
      • FDO forms that will be completed by the GAN site
      • Starter drug to administer the FDO

      3. Summary of a typical FDO

      • Check in and review patient’s current medications and medical history
      • Capture baseline heart rate, blood pressure and perform a pre-dose EKG
      • Contact the prescribing neurologist if to answer any key questions prior to dosing the patient
      • Administer the first dose of Gilenya
      • Monitor the patient’s heart rate and blood pressure every 30 minutes for a minimum of 6 hours
      • Post-dose EKG
      • Complete required forms

      4. Follow-up reporting

      The GAN staff completes all paperwork and faxes it to the Concentra Center Support Team (CST). The CST will double check the paperwork to ensure all forms are complete and then fax the completed set to the prescribing neurologist within 2-3 business days.

      Cost Of GAN Woman At Counter Signing Paper

      Costs of GAN Services

      There are no out-of-pocket costs for patients with commercial health insurance or patients who pay for health services with cash. In many of our locations, patients with Medicare and TriCare insurance may receive GAN services for only the copay required by their plans. Patients covered by Medicaid are typically not covered by GAN, but a few exceptions do exist.

      In Massachusetts, Michigan, and Rhode Island, state laws prevent manufacturers from sponsoring these services. Please view our GAN Network Locations to see the sites available in your market and specific information on which patients each covers.

      Training And Clinical Protocols Spilled Pills

      Training and Clinical Protocols

      Every GAN site operates according to thorough clinical protocols that outline the specific steps to be taken before, during, and after the administration of Gilenya. Prior to a site joining the GAN, the attending providers must complete comprehensive training in administering and responding to issues associated with Gilenya FDO. This includes credentialed certification in training and the overview and completion of FDO protocol.

      Concentra’s clinical protocol includes baseline and post-dose heart rate monitoring (EKG) on the day of the FDO. Throughout the observation, GAN staff monitors the patient’s heart rate and blood pressure and make detailed notation of progress and any sudden changes in measurements. Following the FDO, the GAN site will provide the prescribing neurologist with comprehensive documentation of all measurements and notes on the observation of the patient’s condition.