myAgios Patient Support Services enrollment

Fill out the myAgios Enrollment Form to connect your TIBSOVO® (ivosidenib tablets) patient to a variety of services. Please complete required fields to select the services your patient may need. Once completed, fax the form to either myAgios Patient Support Services at 1-844-409-1143 or to one of our network specialty pharmacies, depending on your needs. Please note that the form should not be sent to both myAgios and a network specialty pharmacy.

 

APPLY FOR THE COMMERCIAL $25 CO-PAY PROGRAM

Help eligible patients with commercial insurance apply for the Commercial $25 Co-Pay Program at myAgios-copay.com. The myAgios Enrollment Form is not required for co-pay assistance.


GET STARTED WITH ENROLLMENT


ENROLL ONLINE
Use the form below to enroll online. You will need to send in the form separately via fax or your e-prescribing system.
OR
DOWNLOAD AND COMPLETE

The fillable PDF version of the enrollment form can be downloaded, saved, and faxed to myAgios.

Please see the myAgios Annotated Enrollment Form for step-by-step guidance on the prescription and enrollment process.

DOWNLOAD AND COMPLETE

The fillable PDF version of the enrollment form can be downloaded, saved, and faxed to myAgios.

Please see the myAgios Annotated Enrollment Form for step-by-step guidance on the prescription and enrollment process.

OR
ENROLL ONLINE
Use the form below to enroll online. You will need to send in the form separately via fax or your e-prescribing system.
CONNECT YOUR PATIENTS TAKING TIBSOVO TO A VARIETY OF SERVICES
Please select from the paths below, depending on your patient's needs. Choose all that apply.
My patient:

Requires prescription fulfillment through network specialty pharmacy

Note: Do not use this form if you are fulfilling the TIBSOVO prescription at your associated office- or hospital-based pharmacy. Please contact a specialty distributor directly.
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Complete sections 1, 2, 3, 4, and 5. In section 5, please choose “no” if your patient requires SP prescription fulfillment.

Section 6 is optional in the event of insurance delays or interruption. Note: QuickStart OR Coverage Interruption requests will not be initiated unless patient faces a delay in access or disrupted coverage.


Fax to a network specialty pharmacy:

Biologics
Fax: 1-800-823-4506
Ph: 1-800-850-4306

Diplomat
Fax: 1-800-550-6272
Ph: 1-877-977-9118

Requires benefits investigation assistance (from myAgios only)

+

Complete sections 1, 2, 3, 5, and 7.
Note: In section 5, please choose "no" if your patient requires SP prescription fullfilment.


Fax to myAgios at 1-844-409-1143

Has an insurance delay or interruption (QuickStart or Coverage Interruption program)

+

Complete sections 1, 2, 3, 5, 6, and 7.
Note: In section 5, select “yes” if you would like to keep the TIBSOVO prescription fulfillment at your associated office- or hospital-based pharmacy after the program is over; otherwise select "no." In section 6, select either 30-day QuickStart OR 30-day Coverage Interruption.


Fax to myAgios: 1-844-409-1143

Is uninsured/underinsured (Patient Assistance Program)

+

Complete sections 1, 2, 3, 5, 6, 7, 8, and 9.

Note: In section 5, select "yes" if you would like to keep the TIBSOVO prescription fulfillment at your associated office- or hospital-based pharmacy after the program is over; otherwise, select "no."


Fax to myAgios: 1-844-409-1143

Contact myAgios for assistance at any stage in the prescription or access process.

Section One
Patient &
insurance information

1

PATIENT INFORMATION

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(to be used for verifying identity and eligibility for some programs)



2

INSURANCE INFORMATION

Please copy both sides of patient's insurance card(s).

Patient insurance (check all that apply):

Primary health insurance
/ /
Policy holder (if other than patient)
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Prescription drug insurance
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Secondary insurance
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3

PATIENT DIAGNOSIS

Section Two
Prescription &
prescriber information

4

TIBSOVO PRESCRIPTION (ONLY required if fulfilling through a specialty pharmacy)

Please be sure to fill out the below information in its entirety, including number of refills.



/ /
 
 

The recommended dose for TIBSOVO is 500 mg (two 250 mg tablets) orally once daily until disease progression or unacceptable toxicity.

 

Physician signature:
Please be sure to print and sign before faxing completed form.
/ /
5

PRESCRIBER INFORMATION AND DECLARATION

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/ /
 

Mandatory: My practice wants to dispense TIBSOVO from an associated office- or hospital-based pharmacy:


/ /
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I certify that the patient and physician information contained in this enrollment form is complete and accurate to the best of my knowledge. I have prescribed TIBSOVO based on my judgment of medical necessity and I will be supervising the patient’s treatment. I authorize the forwarding of this prescription to an authorized specialty pharmacy on behalf of myself and the patient. I understand that neither I nor the patient may seek reimbursement from any government program or third-party insurer for any free product received under the program.

I certify that I have obtained the patient’s authorization to release the above information and such other information as may be required by Agios or its agents to assist the patient in obtaining coverage for TIBSOVO, to assist the patient in initiating or continuing TIBSOVO therapy and to provide financial assistance to the patient.

If requesting QuickStart, I certify that this prescription is for a new patient with a positive test for an IDH1 mutation who either a) has newly diagnosed AML and is aged ≥75 years or has comorbidities that preclude the use of intensive induction chemotherapy, or b) has been diagnosed with relapsed/refractory AML.

 

Physician signature:   
Please be sure to print and sign before faxing completed form.
/ /

Can myAgios™ Patient Support Services follow up with you regarding your experience by phone or email?

Section Three
Insurance delay or
interruption

6

COVERAGE DELAY OR INTERRUPTION PROGRAMS

(if needed, select only 1 of the 2 programs below or call myAgios with questions)
30-day Coverage Interruption prescription for an existing privately insured patient
Note: May require documentation of a temporary loss of coverage

Quantity: 30-day supply (250 mg tablets).
30-day QuickStart prescription in the event of coverage delay of 5 or more days (available only for a new patient with a positive test for an IDH1 mutation who either a) has newly diagnosed AML and is aged ≥75 years or has comorbidities that preclude the use of intensive induction chemotherapy, or b) has been diagnosed with replapsed/refractory AML).

It is mandatory that you indicate the date the completed prior authorization form was submitted to the insurer.

Please insert date here:
/ /

Quantity: 30-day supply (250 mg tablets)


FREE PRODUCT PRESCRIPTION. Please be sure to fill out the below information in its entirety, including number of refills.


/ /

[TIBSOVO (ivosidenib tablets 250 mg)]


The recommended dose for TIBSOVO is 500 mg (two 250 mg tablets) orally once daily until disease progression or unacceptable toxicity.



Physician signature:   
(Dispense as written). Signature stamps not acceptable.
/ /
Physician signature:   
(Substitution permitted). Signature stamps not acceptable.
/ /
Please be sure to print and sign before faxing completed form.

Section Four
Patient authorization

7

PATIENT AUTHORIZATION TO USE/DISCLOSE HEALTH INFORMATION

I understand that myAgiosTM Patient Support Services is a service offered by Agios Pharmaceuticals, Inc. to help eligible patients who have been prescribed TIBSOVO obtain insurance coverage and financial assistance for TIBSOVO, including through its co-pay assistance, Quick Start, Coverage Interruption and Patient Assistance Program (the “Programs”).

I give permission for my physician and their staff to disclose my health and other personal information, including, but not limited to the information on this form, to Agios Pharmaceuticals, Inc. and its agents and representatives (collectively “Agios”) so that Agios may use and further disclose my information to healthcare providers, pharmacies, insurance companies, prescription drug plans and other third-party payers and patient assistance groups (collectively, “Third Parties”) in order to: (1) enroll me in the Programs; (2) facilitate the filling of my prescription for and the delivery and administration of TIBSOVO; (3) assist me in obtaining insurance coverage for TIBSOVO; (4) contact me about TIBSOVO and the Programs (this may include supplemental educational materials, information, offers and services related to my therapy or my medical condition, or opportunities to participate in focus groups, surveys, or interviews); and (5) manage the Programs.

I further authorize the Third Parties to disclose health and other personal information about me in their possession to Agios in order to assist Agios in accomplishing the purposes described above.

I understand that once my information is disclosed pursuant to this authorization, it may no longer be protected by federal privacy laws (the Health Insurance Portability and Accountability Act) or state privacy laws and may be further disclosed to others. However, I understand that Agios will not release my information to any party, except as provided in this authorization or as permitted by applicable law, without first obtaining my (or my authorized representative’s) separate written consent.

I understand that I may refuse to sign this authorization and such refusal will not affect my ability to receive TIBSOVO that is paid for by my insurer, my treatment, payment for treatment, eligibility for or enrollment in health benefits, but it will limit my ability to receive support services for TIBSOVO, including participation in free medication programs.

I understand that this authorization will remain in effect for 3 years, or a shorter period as may be required by state law, from the date of my signature, unless I revoke it earlier by contacting Agios in writing at AllCare c/o Agios Patient Support Services, 50 Bearfoot Rd, Northborough, MA, 01532. If I revoke this authorization, Agios and any Third Parties who are notified of my revocation will stop using and disclosing my information as soon as possible, but the revocation will not affect prior use or disclosure of my information in reliance on this authorization.

I understand that the services described in this authorization may be reduced at any time, without prior notification. However, if any services are added, Agios will obtain my authorization to receive any such additional services.

I understand that certain Third Parties may receive compensation in exchange for their disclosure of my information to Agios. I also understand that I have the right to receive a copy of this authorization.

I verify the information provided is true and correct. If I am the caregiver/representative for the patient, I confirm I am authorized to sign on behalf of the patient.



Patient name (print):   
Representative name (print, if applicable):   
Patient/Representative signature:   

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Please be sure to have patient/representative print and sign before faxing completed form.

Section Five
Uninsured or underinsured

8

INTEREST IN PATIENT ASSISTANCE PROGRAM (PAP) FOR
UNINSURED/UNDERINSURED PATIENTS


(people who contribute to or are dependent on the household income)
Note: dollar amount should be consistent with your 1040 tax form or W2

Yes, I understand that in order to qualify for the Patient Assistance Program I must meet program requirements. I certify that the information I have provided about my household income and size is accurate. I know that myAgiosTM Patient Support Services may ask me for a copy of my recent tax returns or other proof of income for the purpose of an audit and I agree to provide such documentation in a timely manner, if requested. I certify that the information provided above is truthful and accurate to the best of my knowledge and that any other information I provide at the Agios' request will be truthful and accurate.

I understand that my eligibility for the program is based on requirements determined by Agios in its discretion (that AgiosTM Patient Support Services may change at any time) and that, if approved, I must reapply and continue to meet eligibility requirements on an ongoing basis. I certify that I will notify the Patient Assistance Program at 1-844-409-1141 if my income or health insurance status changes. I agree not to seek reimbursement from any government program or third-party insurer for any free product received under the program.

I verify the information provided is true and correct. If I am the caregiver/representative for the patient, I confirm I am authorized to sign on behalf of the patient.


Patient name (print)   
Representative name (print if applicable)   
Patient/Representative signature:   
Please be sure to have patient/representative print and sign before faxing completed form.
/ /
9

PATIENT ASSISTANCE PROGRAM

30-day Patient Assistance Program (PAP) prescription for a new/existing uninsured or underinsured patient
Note: Requires documentation of denial of coverage and completion of income eligibility, see section 8.

Quantity: 30-day supply (250 mg tablets)

PAP PRESCRIPTION

Please be sure to fill out the below information in its entirety, including number of refills.


/ /

[TIBSOVO (ivosidenib tablets 250 mg)]

The recommended dose for TIBSOVO is 500 mg (two 250 mg tablets) orally once daily until disease progression or unacceptable toxicity.



Physician signature:   
(Dispense as written). Signature stamps not acceptable.
/ /
Physician signature:   
(Substitution permitted). Signature stamps not acceptable.
/ /
Please be sure to print and sign before faxing completed form.

ISI


INDICATIONS

TIBSOVO is indicated for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in:

  • Adult patients with newly-diagnosed AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy
  • Adult patients with relapsed or refractory AML


IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME
Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.


WARNINGS AND PRECAUTIONS
Differentiation Syndrome: See BOXED WARNING: In the clinical trial, 25% (7/28) of patients with newly diagnosed AML and 19% (34/179) of patients with relapsed or refractory AML treated with TIBSOVO experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms of differentiation syndrome in patients treated with TIBSOVO included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumor lysis syndrome, and creatinine increased. Of the 7 patients with newly diagnosed AML who experienced differentiation syndrome, 6 (86%) patients recovered. Of the 34 patients with relapsed or refractory AML who experienced differentiation syndrome, 27 (79%) patients recovered after treatment or after dose interruption of TIBSOVO. Differentiation syndrome occurred as early as 1 day and up to 3 months after TIBSOVO initiation and has been observed with or without concomitant leukocytosis.

If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If concomitant noninfectious leukocytosis is observed, initiate treatment with hydroxyurea or leukapheresis, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt TIBSOVO until signs and symptoms are no longer severe.

QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. One patient developed ventricular fibrillation attributed to TIBSOVO. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (e.g., anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, or electrolyte abnormalities, or in those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary.

Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

Guillain-Barré Syndrome: Guillain-Barré syndrome occurred in <1% (2/258) of patients treated with TIBSOVO in the clinical study. Monitor patients taking TIBSOVO for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue TIBSOVO in patients who are diagnosed with Guillain-Barré syndrome.

ADVERSE REACTIONS

  • The most common adverse reactions including laboratory abnormalities (≥20%) were hemoglobin decreased (60%), fatigue (43%), arthralgia (39%), calcium decreased (39%), sodium decreased (39%), leukocytosis (38%), diarrhea (37%), magnesium decreased (36%), edema (34%), nausea (33%), dyspnea (32%), uric acid increased (32%), potassium decreased (32%), alkaline phosphatase increased (30%), mucositis (28%), aspartate aminotransferase increased (27%), phosphatase decreased (25%), electrocardiogram QT prolonged (24%), rash (24%), creatinine increased (24%), cough (23%), decreased appetite (22%), myalgia (21%), constipation (20%), and pyrexia (20%).
  • In patients with newly diagnosed AML, the most frequently reported Grade ≥3 adverse reactions (≥5%) were fatigue (14%), differentiation syndrome (11%), electrocardiogram QT prolonged (11%), diarrhea (7%), nausea (7%), and leukocytosis (7%). Serious adverse reactions (≥5%) were differentiation syndrome (18%), electrocardiogram QT prolonged (7%), and fatigue (7%). There was one case of posterior reversible encephalopathy syndrome (PRES).
  • In patients with relapsed or refractory AML, the most frequently reported Grade ≥3 adverse reactions (≥5%) were differentiation syndrome (13%), electrocardiogram QT prolonged (10%), dyspnea (9%), leukocytosis (8%), and tumor lysis syndrome (6%). Serious adverse reactions (≥5%) were differentiation syndrome (10%), leukocytosis (10%), and electrocardiogram QT prolonged (7%). There was one case of progressive multifocal leukoencephalopathy (PML).


DRUG INTERACTIONS
Strong or Moderate CYP3A4 Inhibitors: Reduce TIBSOVO dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation.
Strong CYP3A4 Inducers: Avoid concomitant use with TIBSOVO.
Sensitive CYP3A4 Substrates: Avoid concomitant use with TIBSOVO.
QTc Prolonging Drugs: Avoid concomitant use with TIBSOVO. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation.

LACTATION
Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children, advise women not to breastfeed during treatment with TIBSOVO and for at least 1 month after the last dose.


If you have questions, please call 1-844-409-1141,
Monday through Friday 8 AM to 6 PM ET