Takeda’s Patient Assistance Program

Statement of Medication Necessity Application

CONTACT Email:[email protected]
PHYSICIAN NAME*
Jose D. Sollano (E-mail, Phone)* Cellphone: 09353654165/09228138454

CLINIC/HOSPITAL Gastrohep Endoscopy Unit, Malvar Hospital

PATIENT INFORMATION

Name* Mohamad T. Pungutan

Address Block 5 Lot 5 Lumina homes eastridge, brgy bilibiran Binagonan Rizal
Telephone* Mobile No: 09273925861 Home:
Date of Birth* Age > 18 years Yes
(DD/MM/YY) 06/10/85 (at time of completetion) No
Email Address* [email protected]
DIAGNOSIS
Moderately to severely active ulcerative colitis who have had an inadequate response with, lost
response to, or were intolerant to either conventional therapy or tumour necrosis factor-α
(TNFα) antagonist in adult patients
Patient Diagnosis*
Moderately to severely active Crohn's disease who have had an inadequate response with, lost
response to, or were intolerant to either conventional therapy or tumour necrosis factor-α
(TNFα) antagonist in adult patients

Medication* Vedolizumab (Entyvio®)

Y1
Treatment* >Y1

By signing below, I certify that: (a) The above therapy is medically necessary for the patient and the patient medically qualifies for the therapy as per the locally approved
indications; (b) I am authorized to release the above-referenced information and other protected health information for the purpose of seeking assistance in initiating or
continuing medication therapy and/or the evaluation of the patient’s eligibility to the Takeda Patient Assistance Program (“Program”); (c) Any medication units received through
the Program will be used solely for the patient who the medication units are assigned to and will not be redistributed or sold. If for some reason the medication units received
through the Program can no longer be administered to the patient, the unused medication units will be returned to the pharmacy unit; (d) I agree to report any Adverse Event1
that may occur to any patients enrolled in the Program and to provide related clinical patients’ data if requested; (e) I agree to comply with the Program guidelines and
understand and have informed the patient that Takeda Healthcare Philippines, Inc. (“Takeda”), at its sole and absolute discretion, reserves the right to modify or discontinue the
Program at any time; (f) I agree that Axios International Consultants Limited (“Axios”) may verify the accuracy of the submitted information, audit supplied goods inventory and
share any findings with Takeda; (g) I have provided the patient with full information about the treatment, its benefits and its known risks; (h) I have no financial interest in this
Program and have not been offered to offer, promise, authorize or accept any payment or give anything of value, either directly or indirectly to any public official, regulatory
authority or other stakeholder for the purpose of influencing, inducing or rewarding any act, omission or decision in order to secure an improper advantage, or obtain or retain
business through the Program; (i) I hereby authorize Axios to collect, store, use, transfer, disclose or otherwise process (“Process” and/or “Processing”) my personal data, such
as full name, occupation, telephone number(s), email, place of employment, which is voluntarily disclosed as mentioned above and/or collected through the Program for the
purposes of the Program (“Purposes”). I understand that my personal data will be kept as long as necessary for the fulfilment of the Purposes, as further discussed below, and
in order to comply with all applicable legal, regulatory, scientific, or other requirements. I understand that Axios maintains appropriate physical, administrative and technical
safeguards to protect my personal data from loss, misuse, unauthorized access, disclosure, alteration and/or destruction; (j) I furthermore agree that Axios may transfer my
personal data for the same Purposes to Takeda, or affiliates of Axios; (k) I agree that Axios may engage service providers, agents, contractors or other third parties (“Third Parties”)
to perform services for or on its behalf, including, but not limited to, the Processing of personal data about me for the Purposes, and, as a result, Axios may share personal data
about me with such Third Parties. Axios has executed appropriate contracts with such Third Parties that prohibit them from using or sharing personal data except as necessary
to perform the contracted services with Axios, or to comply with applicable legal requirements. I agree that the transfer of personal data by Axios to its affiliates, to Takeda or
to any Third Parties may necessarily take place outside Philippines and the Asia and Pacific Region, to countries which may not always provide the same level of protection but
for which Axios and/or its affiliates have taken appropriate steps to ensure that any personal data is adequately protected; (l) I understand that I may at any time ask to be
provided with information as to my personal data stored by Axios and/or its affiliates and require correction, deletion or blocking of any incorrect data. In such case, or if I have
any enquiries or would like to submit any complaint about privacy practices of Axios, I should submit a written request, including my name and contact information (e.g.
telephone, email address, mailing address) to Axios at: [email protected] and Axios will respond to such requests within thirty (30) business days; (m) I understand that I also
have the right to file a complaint directly with the National Privacy Commission (www.privacy.gov.ph); (n) I understand that I am free to amend or limit my consent, upon written
consent sent to Axios, to the email address stated.

I understand that signing this consent form is voluntary and I confirm having read and understood its content in full before signing below.

Preferred method to receive patient updates and frequency E-mail Phone Major Events Monthly Never

Prescriber’s Signature:* Date*:

PH/VED/2020/00005 1
EMA Guideline on good pharmacovigilance practices, Annex 1 - Definitions. Adverse event (AE)
1 January 2022 Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal
product and which does not necessarily have a causal relationship with this treatment. An adverse
event can therefore be any unfavorable and unintended sign (e.g. an abnormal laboratory finding),
symptom, or disease temporally associated with the use of a medicinal product, whether or not
considered related to the medicinal product.
Takeda’s Patient Assistance Program
Statement of Medication Necessity Application

I, hereby, acknowledge by signing this form: (a) To allow my doctors to release the above-referenced information and other protected health information related to my treatment with
Entyvio®, if required, and information about my health insurance plan, if applicable; (b) To be contacted by the PAP Program Manager as part of the Takeda Patient Assistance Program
(“Program”); (c) To allow Axios International Consultants Limited (“Axios”) to anonymously report any Adverse Event1 to Takeda Healthcare Philippines, Inc. (“Takeda”) that may be
identified by Axios during our interactions within the Program; (d) To agree for Takeda to contact my treating physician to get more details about Adverse Event, if needed; (e) My personal
data and health information will be used to help apply to and qualify for the Program and as well as for tracking medications received within the Program; (f) This application and consent
form do not guarantee that I will be eligible for the Program; (g) If I receive free medication as a part of the Program, I will use it as my doctor has prescribed and will not sell or distribute
any free medications received within the Program. I understand that violation of this obligation will result in losing my access to the Program; (h) I agree to comply with the Program
guidelines and understand that Takeda, at its sole and absolute discretion, reserves the right to modify or discontinue the Program at any time; (i) All information that I have given to
Axios, and will give to Axios in the future as a part of the Program, is complete, true and accurate to the best of my knowledge; (j) All information provided by me as a part of the Program
may need to be verified through the request of documentation; (k) I am aware that if it becomes evident that I have provided false information, I may be excluded from the Program; (l)
This consent form remains in effect for 1 (one) year upon date of signature specified herein below; (m) I understand that my participation in the Program is voluntary and I may withdraw
it at any time; (n) I hereby authorize Axios to collect, store, use, transfer, disclose or otherwise process (“Process” and/or “Processing”) my personal data which is voluntarily disclosed as
mentioned above and/or collected through the Program for the purposes of the Program (“Purposes”). Personal data about me may include my name, home address, telephone
number(s) and email, accounts, investments or any other personal information provided during my financial assessment – along with information about my health – including medical
diagnosis, medical tests, medication and treatment, medical appointments as may be disclosed by me in this form and/or at a later stage by my physician or a next of kin authorized by
me for purposes of my proper assessment, potential enrolment and management in the Program; (o) I understand that my personal data will be kept by Axios as long as necessary for
the fulfilment of the Purposes, as further discussed below, and in order to comply with all applicable legal, regulatory, scientific, or other requirements. I understand that Axios maintains
appropriate physical, administrative and technical safeguards to protect my personal data from loss, misuse, unauthorized access, disclosure, alteration and/or destruction; (p) I further
agree that Axios may transfer my personal data for the same Purposes to health authorities, NGO partners, pharmacies, or distributors involved in the Program; (q) I agree that Axios may
transfer anonymized data related to me for the same Purposes to affiliates of Axios and transfer of such anonymized data may take place outside of the Philippines, to countries which
may not always provide the same level of protection but for which Axios and/or its affiliates have taken appropriate steps to ensure that any anonymized data is adequately protected;
(r) I understand that I may at any time ask to be provided with information as to my personal data stored by Axios and/or its affiliates and require correction, deletion or blocking of any
incorrect data or withdraw my consent. In such case, or if I have any enquiries or would like to submit any complaint about privacy practices of Axios, I should submit a written request,
including my name and contact information (e.g. telephone, email address, mailing address) to Axios at: [email protected] and Axios will respond to such requests within thirty (30)
business days; (s) I understand that I also have the right to file a complaint directly with the National Privacy Commission (www.privacy.gov.ph); (t) I further understand the result of the
means-based assessment and my payment plan provided within the Program will be kept confidential by Axios and may only be disclosed by Axios to my treating physician by Axios upon
my written consent; (u) I understand that I am free to withdraw my consent form to personal data processing at any time with future effect upon written consent sent to Axios, to the
email address : [email protected].

I understand that signing this consent form is voluntary and I confirm having read and understood its content in full before signing below.

Preferred method of communication Cellphone: 09273925861 Email: [email protected] E-mail Phone

April-25-2022
Patient’s Signature*: Date*:

PH/VED/2020/00005 1
EMA Guideline on good pharmacovigilance practices, Annex 1 - Definitions. Adverse event (AE)
1 January 2022 Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal
product and which does not necessarily have a causal relationship with this treatment. An adverse
event can therefore be any unfavorable and unintended sign (e.g. an abnormal laboratory finding),
symptom, or disease temporally associated with the use of a medicinal product, whether or not
considered related to the medicinal product.