GILENYA (fingolimod) and First Dose Observation PHYSICIAN FAQs

Transcription

1 GILENYA (fingolimod) and First Dose Observation PHYSICIAN FAQs Q. What type of physician will be reading ECGs done as part of the baseline assessments and First Dose Observation? A. GILENYA Network physicians (Concentra and Contract GILENYA Access Network providers) are family practice, internal medicine or emergency physicians. Q. Are baseline labs/blood work drawn on site? A. Yes, baseline blood work is drawn on site. Samples are then sent to a central GILENYA Assessment Network lab for processing. Lab findings are faxed to your physician within two days of your visit Q. Can a patient refuse to go through the baseline assessments? A. Talk with your doctor about the assessments and the reason that your doctor ordered them. This will be noted in the baseline assessments results report that is faxed to the prescribing physician. Q. Will Novartis cover the cost for 3 EKGs at a GILENYA Access Network Site? A. (1) Two to three weeks prior to First Dose Observation to make sure patient is a good candidate for GILENYA (2) Immediately prior to First Dose Observation (3) Immediately following First Dose Observation. Novartis will cover the cost for all ECGs completed as part of the baseline assessments and all First Dose Observations for all patients eligible for the medical copay program. Q. How do GILENYA Access Network sites evaluate the patient for discharge at the end of the 6 hour observation period? A. The clinical protocol for the FDO has been developed independently by Concentra s Medical Leadership team. Evidence considered in the development of this protocol included the new label for Gilenya as well as publically available data and Concentra s clinical judgment. Q. How frequently have patients had to extend their monitoring beyond 6 hours? A. GILENYA Access Network sites have completed more than several thousand First Dose Observations to date and the number of patients who have required extension of time past the initial 6 hours is very infrequent Q. How long can a GILENYA Access Network site monitor a patient? A. GILENYA Access Network sites are set up to monitor patients for 6 hours with the flexibility of extending monitoring for approximately two additional hours. If, at the end of this extended observation, the patient does not meet discharge criteria, the GILENYA Access Network site will notify the neurologist and make arrangements to transfer the patient to the hospital.

2 Q. How will GILENYA Access Network sites manage a patient that requires observation beyond the 6 hour period? A. GILENYA Access Network will notify the neurologist and the patient and continue observation until they meet discharge criteria. If discharge criteria are not met, the site will notify the physician and make arrangements to transfer the patient to the hospital. Q. How will GILENYA Access Network sites manage the patient if they do not meet the discharge criteria? A. If discharge criteria are not met, the site will continue monitoring for up to 2 additional hours and/or until the patient meets discharge criteria. If, at the end of this extended observation, the patient does not meet discharge criteria, the GILENYA Access Network site will notify the neurologist for further consultation. Q. If, based on assessment, a patient needs continuous monitoring, who schedules The GILENYA Access Network site or the prescribing physician? A. If it is determined during the pre dose evaluation of the patient on the day of FDO that it is not appropriate to start the FDO, the GAN MD will notify the neurologist and advise the patient that they will need to work with their physician to re assess if and where they want to conduct the FDO. If during the FDO the patient develops symptomatic bradycardia, the GAN MD will notify the neurologist and make arrangements to transfer the patient to a hospital for further management. Q. If, after reviewing the patient s available medical information and history, the GILENYA Access Network doctor determines that the patient may not be a candidate for FDO at this time, how will communication with the HCP and patient occur? A. If the findings indicate an abnormality or medical history complication with label parameters that indicate the patient should not be put on drug, GILENYA Access Network will attempt to advise the neurologist and the patient of this and will not proceed with the First Dose Observation at this time In the event that the GAN MD is not able to reach the neurologist this information will also be provided in the post FDO report.

3 Q. What is the GILENY ccess Network s protocol going to be if they have a patient that needs to be admitted, and they are unable to reach the prescribing physician? A. GILENYA Access Network will leave a message with the office or paging service to notify the neurologist of the patient's condition and logistics. The GAN will contact EMS and transfer the patient to the ER with full explanation of the patient s conditions, provide full documentation including a copy of the full prescribing information for Gilenya as reference for the ER physician. The emergency services/hospital charges will be the responsibility of the patient s insurance and the patient. In the event the patient does not have sufficient coverage the GILENYA Go Program will review for Q. What is the interval for monitoring Heart Rate (HR) and Blood Pressure (BP)? A. HR and BP are documented prior to dosing the patient along with the ECG and survey of medical history; the over seeing physician will evaluate all of these metrics to ensure they feel the patient is appropriate to initiate drug. If the patient is approved to initiate drug, HR and BP will be monitored every 30 minutes throughout the course of the 6 hour observation period. Q. Will GILENYA Access Network do an ECG prior to dosing on every patient? A. Yes; ECGs will be done prior to dosing all patients on the day of First Dose Observation to ensure no patient is administered drug who may have some ECG abnormality that would disqualify them for treatment with GILENYA Q. Will GILENYA Access Network handle overnight monitoring for high risk patients? If not, where will these patients be sent to (i.e. at end of the First Dose Observation if there issues)? A. GILENYA Access Network sites are not equipped to monitor patients over night. If it is determined during the course of the First Dose Observation that the patient requires such, GILENYA Access Network will notify the physician and make arrangements to transfer the patient to the hospital. Q. Do GILENYA Access Network sites provide interpretation for the ECGs done as part of the baseline assessments? A. Baseline Assessment ECG: the GAN MD will review the ECG strip and automated interpretation and acknowledge if they agree or disagree with the findings. If they disagree, they will make not of their interpretation and provide to the neurologist via the Baseline Assessment report. In this report, the neurologist will receive the findings but the GAN MD will not provide recommendations for whether or not the patient is an appropriate candidate for Gilenya or the setting of their FDO (e.g. GAN site, Hospital) Pre dose ECG on day of FDO: The GAN MD will evaluate the ECG and note agreement/disagreement as done in the BA. If they are concerned about what the ECG reveals, they may seek consult from the Concentra Medical Director. If they determine the patient is not a candidate to initiate the FDO, they will attempt to contact the neurologist to advise them. If they can t reach the neurologists, they will

4 advise the patient of the situation and that they need to follow up with their neurologist to determine next steps. All notes in such a situation will be sent to the neurologist in the Post FDO assessment forms. Post dose ECG During FDO: Same as prior from an interpretation and reporting perspective. If it is determined that the patient should be sent to the hospital, the GAN MD will attempt to notify the neurologist to advise them of the situation and provide the EMS/Hospital with full notes on the patient s condition and the product label as reference for their clinical management of the patient. The emergency services/hospital charges will be the responsibility of the patient s insurance and the patient. In the event the patient does not have sufficient coverage the GILENYA Go Program will review for Q. Why is the first dose observation so expensive? A. We understand this may be a significant cost. However, the rate reflects the need to have a wellequipped site and trained medical staff on hand for the entire 6 hour process Q. Can payments be made in installments for the first dose observation, instead of paying all at once? A. No, full payment is needed on the date of the patient s first dose observation. First Dose Observation (General) Q. Can patients in MN, MA, RI and MI submit a claim with their Commercial insurance for the [$200] cost of the first dose observation? A. Commercial patients residing in an ineligible state (MN, MA, RI, MI) may be able to submit a claim directly to their insurer for reimbursement. Check with your insurance carrier to see if they will accept claims directly from a patient and for the coverage options. Q. Will Medicare pay for the labs and ECG? A. Medicare will be billed for lab tests and ECG. Additional co pay cost may apply for the ECG only. Q. Are patients with Medicare and Medicaid (dual eligible) covered by insurance for their first dose observation? A. The GILENYA Assessment Network does accept dual eligible patients as long as the patient has Medicare as their primary payer. Not all GAN sites will accept Medicare patients so it will be important to understand this. Q. Why can t Novartis provide free assessments and First Dose Observation in MA, MI, MN, and RI and to patients with government insurance? A. The government views providing these services as an inducement to prescribe. Q. Why do baseline assessments and the first dose observation need to be completed in two appointments? A. The first appointment will be for the baseline assessments and the second appointment will be scheduled at least 5 business days later for the first dose observation. The physician will be faxed the

5 results of the baseline assessments within 48 hours of the completed tests. This will help to ensure that the physician has the opportunity to review the results prior to the scheduled first dose observation. If, based on the results, the physician would like to postpone the scheduled first dose observation appointment; they can call the GILENYA Go Program at GILENYA ( ) within 24 hours of the scheduled appointment (if one was scheduled previously). If we do not hear from them, the patient will proceed with the first dose observation as scheduled. Q. Why does the patient have to pay for the first dose observation if he/she resides in Massachusetts, Michigan, Minnesota, or Rhode Island or if he/she has Medicare insurance? A. Because this patient resides in MN/MI/MA/RI/has Medicare insurance they will be charged [$200] on the day of their first dose observation appointment due to state and federal rules. This patient will need to pay the full amount at the time of his/her appointment. Acceptable forms of payment include cash or credit card, no checks. This patient s insurance will be billed for all required baseline assessments however they are responsible for any additional co pay costs. Q. What if the physician specifies that both the exams and the first dose observation should occur on the same day? A. GILENYA Assessment Network protocol will override this request. This protocol is set to help ensure patient safety. Q. What if I don t want the first dose observation appointment set until after I have received and acknowledged the results of the baseline ECG/lab? A. This is at your discretion. This information should be shared with the GILENYA Go Program. Q. Can I halt the first dose observation if I have already requested it? A. Yes. The GILENYA Go Program will send a confirmation fax to the prescribing physician after the firstdose observation appointment has been confirmed with the patient. The fax to the physician will include the date of the first dose observation, the GILENYA Go Program number ( ) and instructions on how to halt the process, if necessary. Q. How will I know when my patient'] appointments are scheduled and completed? A. The GILENYA Go Program will send you a fax confirming the patient s schedule of appointments after the GILENYA Go Program has scheduled them with the patient. When the First Dose Observation site faxes the physician the baseline assessment findings, this fax will also include the date of the first dose observation appointment, the GILENYA Go Program phone number, and instructions on how to halt the process, if necessary. Q. There is no First Dose Observation location near my patient. When will my Nurse Educator be able to locate one? A. A Nurse Educator will be in contact with us on a regular basis as we work to identify a new site. Q. Why don't I have the ability to do the First Dose Observation? A. The First Dose Observation process requires a well equipped site and trained medical staff on hand for the entire 6 hour process. This process is typically performed at off site observation locations. First Dose Observation (Restart)

6 Q. Will Novartis pay for patients that need a second first dose observation or those who may need additional assessments or an electrocardiogram (ECG)? A. There are certain circumstances that Novartis is able to pay for the second First Dose Observation and assessments required for it. Agent Note Refer to SOP GL 305 for eligibility information. Q. Will my patient need to have his/her blood work redrawn if they have to stop GILENYA for more than one day? A. This will depend on physician s orders. Patients will need to follow up with their physician for information regarding the additional need for assessments. Q. Why do patients need to submit the attestation form for the second FDO? A. This form is required to attest that the patient not received a commercial shipment of GILENYA immediately prior to receiving assistance for the restart of GILENYA. Q. Does the Attestation form need to be notarized? A. No, the form does not need to be notarized. Q. Why does the patient have to pay another $125 for the medical copay program? A. The medical copay program eligibility expires when the first commercial shipment is delivered. To reenroll, the Medical Copay program requires the patient to fulfill all patient obligations, including the $125 upfront cost. GILENYA Go Program Services Q. What services can the GILENYA Go Program provide to patients that live in MA, MI, MN, and RI? A. The GILENYA Go Program can provide all services to these patients with the exception of medical copay support. Q. My patient lives in Massachusetts and now qualifies for the prescription copay assistance program. Why couldn't he/she before? A. Previously, Massachusetts state law prohibited residents from participating in the Novartis Prescription Copay Support Program. Due to recent changes in the state law we are now able to assist qualifying patients with prescription copayment effective September 10, Q. I understand this change was made in Massachusetts in July, why is this only eligible for assistance now? A. Patient eligibility for this program is based on the date that the GILENYA GO Program was able to implement these changes. This policy does not apply retroactively. Q. Can Novartis assist with my medical copayment as well? A. No, residents in Massachusetts do not qualify for medical copayment support based on current state laws.

7 Q. My patient just had my prescription filled yesterday the day before this went active. Can he/she be reimbursed for that since it was so recent? A. No, in order to assist as many qualifying patients as possible we are not able to apply this benefit retroactively. However, we can determine if you qualify for this assistance moving forward. Q. How quickly will my patient be rescheduled? A. This will depend on both the availability of the First Dose Observation site and the patient to attend the appointment. We will follow up via fax once we have the appointment date. Q. Why do I need a new Service Request Form for GGP to begin scheduling appointments for my patients? A. The Service Request Form is required if you would like GGP to complete additional scheduling services for your patient. This is required for referrals to the appropriate First Dose Observation/scheduling sites. Varicella Zoster Vaccine (VZV) Q. What is the Varicella Zoster vaccination? A. The chickenpox vaccine is a live attenuated vaccine. This means live, disease producing virus was modified, or weakened, in the laboratory to that can grow and produce immunity in the body without causing illness. (Refer to GYA _GILENYA Product FAQ for more information). Q. Why does a patient have to wait for the First Dose Observation if he/she needs the varicella vaccination? A. Verivax is a two dose series and the patient must wait 30 days after the second dose because this is a live vaccine. Q. Does Novartis offer VZV vaccination? A. Yes, Novartis does offer the Varicella Vaccine through GILENYA Access Network. To request this, the HCP must first request the VZV serology be completed during the baseline assessments. GILENYA Access Network will fax the results along with the Varicella Request Form to the physician. If the HCP feels it is necessary for the vaccination he/she will send it into GILENYA Go Program. GILENYA Go Program will cancel the first dose observation appointment (if already scheduled) and contact the patient to schedule the vaccination appointments. Q. When will the First Dose Observation be scheduled if the patient needs the Varicella Vaccine? A. GILENYA Go Program will request permission from the physician to schedule the first dose observation 4 weeks after the final vaccination. Q. How much will the varicella vaccination cost? A. Commercial patients will have VZV immunization paid through the Novartis Medical Copay Support Program. Most Medicare plans do not cover VZV vaccination so the patient will be responsible for the cost. GILENYA Access Network will submit the claim to the payer and bill the patient if the claim is rejected.