Fill - Free fillable Drug Prior Authorization Form Kalydeco (ivacaftor), Orkambi (ivacaftor/lumacaftor), (Great-West Life Insurance for Personal, Group & Benefits in Canada) PDF form

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(Continued on next page)

Plan Member’s signature: Date:

This document contains both information and form fields. To read information, use the Down Arrow from a form field.

M6453(CF)-4/20

Any modification of this document without the express written consent of Canada Life is strictly prohibited.

Drug Prior Authorization Form

Kalydeco (ivacaftor), Orkambi (ivacaftor/lumacaftor),

Symdeko (ivacaftor/tezacaftor and ivacaftor)

The purpose of this form is to obtain information required to assess your drug claim.

IMPORTANT: Please answer all questions. Your claim assessment will be delayed if this form is incomplete or contains errors.

Any costs incurred for the completion of this form are the responsibility of the plan member/patient.

Canada Life recognizes and respects the importance of privacy. Personal information collected is used for the purposes of

assessing eligibility for this drug and for administering the group benets plan. For a copy of our Privacy Guidelines, or if you have

questions about Canada Life’s personal information policies and practices (including with respect to service providers), refer to

www.canadalife.com or write to Canada Life’s Chief Compliance Ofcer.

I authorize Canada Life, any healthcare provider, my plan administrator, any insurance or reinsurance company, administrators of

government benets or patient assistance programs or other benets programs, other organizations, or service providers working with

Canada Life or any of the above, located inside or outside Canada, to exchange personal information when relevant and necessary for

these purposes. I understand that personal information may be subject to disclosure to those authorized under applicable law within

or outside Canada.

I acknowledge that the personal information is needed to assess eligibility for this drug and to administer the group benets plan.

I acknowledge that providing consent will help Canada Life to assess my claim and that refusing to consent may result in delay or

denial of my claim. Canada Life reserves the right to audit the information provided on this form at any time and this consent extends

to any audit of my claim. This consent may be revoked by me at any time by sending written instruction to that effect.

I also consent to the use of my personal information for Canada Life and its afliates’ internal data management and analytics purposes.

If the patient is a person other than myself, I conrm that the patient has given their consent to provide their personal information and

for Canada Life to use and disclose it as set out above.

I certify that the information given below is true, correct, and complete to the best of my knowledge. Failure to provide true, correct

and complete information on this form could result in revocation of any approval decision, a requirement to repay paid claims or other

appropriate action.

Form Completion Instructions:

1. Complete “Patient Information” sections.

2. Have the prescribing physician complete the “Physician Information” sections.

3. Send all pages of the completed form to us by mail, fax or email as noted below.

Note: As email is not a secure medium, any person with concerns about their prior authorization form/medical information being

intercepted by an unauthorized party is encouraged to submit their form by other means.

Mail to: The Canada Life Assurance Company

Drug Claims Management

PO Box 6000

Winnipeg MB R3C 3A5

Fax to: The Canada Life Assurance Company

Fax 1-204-946-7664

Attention: Drug Claims Management

Email to: cldrug.services@canadalife.com

Attention: Drug Claims Management

For additional information regarding Prior Authorization and Health Case Management, please visit our Canada Life website at

www.canadalife.com or contact Group Customer Contact Services at 1-800-957-9777. Deaf or hard of hearing and require access to

a telecommunications relay service? Please contact us at 711 for TTY to Voice or 1-800-855-0511 for Voice to TTY.

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M6453(CF)-4/20

Plan Member:

Plan Name:

Patient Date of Birth (DD/MM/YYYY):

n n If yes, please provide email address:

Please indicate preferred contact number and if there are any times when telephone contact with you about your claim would be most convenient.

Plan Number:

Address (number, street, city, province, postal code):

Plan Member ID Number:

Patient Name:

– (please print)

n n

If Yes, a) indicate start date (DD/MM/YYYY):

b) coverage provided by:

(if coverage is not provided by Canada Life please provide pharmacy print-out showing purchase of this drug)

n n

If Yes, name of other Insurance Company:

If other plan is with Canada Life, tell us the plan and ID number:

Name of plan member:

Relationship to patient:

Provide details and attach documentation of acceptance or decline:

n n

If Yes, name of program or other source:

Provide details and attach documentation of acceptance or decline:

n n

1. Patient assistance program patient ID Number:

Contact Name: Phone Number:

(Continued on next page)

Kalydeco (ivacaftor), Orkambi (ivacaftor/lumacaftor),

Symdeko (ivacaftor/tezacaftor and ivacaftor)

Patient Information

Plan Member Information Complete all sections of this page

May we contact you by email? (Note that some correspondence may still need to be sent by regular mail).

Yes No

Tell us if you have been on this drug before

Is the patient currently on, or previously been on this drug? Yes No

Tell us if you have coverage with any other beneﬁts plan

Does the patient have drug coverage under any other group benets plan? Yes No

Tell us about any Provincial or other coverage you may have

Does the patient have coverage under a provincial program or from any other source? Yes No

Is the patient currently receiving disability benets for the condition for which this drug has been prescribed? Yes No

Tell us about any Patient Assistance Program you might be enrolled in

Has the patient enrolled in the patient assistance program for this drug? Yes No

If Yes, please provide the following information:

2. Patient assistance program contact person name and phone number:

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M6453(CF)-4/20

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Kalydeco (ivacaftor), Orkambi (ivacaftor/lumacaftor),

Symdeko (ivacaftor/tezacaftor and ivacaftor)

(Continued on next page)

Name of prescribing physician:

Specialty:

Address (number, street, city, province, postal code):

Telephone Number (including area code): Fax Number (including area code):

(please print)

(include date of initial diagnosis) (MM/YYYY):

Physician Information

Note to Physician: In order to assess a patient’s claim for this drug, we require detailed information on the patient’s

prescription drug history as requested below.

Attach extra information if necessary. GENETIC TEST RESULTS ARE NOT REQUIRED

Physician’s Information

1. Prescribed Medication:

Kalydeco (ivacaftor)

Orkambi (ivacaftor/lumacaftor)

Symdeko (tezacaftor/ivacaftor and ivacaftor)

2. Health Canada indication

Approved Health Canada Indications and Clinical Use for Kalydeco:

KALYDECO (ivacaftor) tablets (150 mg) are indicated for the treatment of patients with cystic brosis (CF) aged 6 years and older and weighing

25 kg or more who have one of the following mutations in the cystic brosis transmembrane conductance regulator (CFTR) gene: G551D,

G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

KALYDECO tablets (150 mg) are also indicated for the treatment of cystic brosis (CF) in patients age 18 years and older with an R117H

mutation in the CFTR gene.

KALYDECO granules (50 mg and 75 mg) are indicated for the treatment of children with cystic brosis (CF) aged 12 months and older and

weighing 7 kg to less than 25 kg who have one of the following mutations in the cystic brosis transmembrane conductance regulator (CFTR)

gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

Approved Health Canada Indications and Clinical Use for Orkambi:

ORKAMBI (lumacaftor/ivacaftor) is indicated for the treatment of cystic brosis (CF) in patients 2 years of age and older who are homozygous

for the F508del mutation in the cystic brosis transmembrane conductance regulator (CFTR) gene.

Approved Health Canada Indications and Clinical Use for Symdeko:

SYMDEKO (tezacaftor/ivacaftor and ivacaftor) is indicated for the treatment of patients with cystic brosis (CF) aged 12 years and older who

are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the

cystic brosis transmembrane conductance regulator (CFTR) gene: P67L, D110H, R117C, L206W, R352Q, A455E, D579G, 711+3AG, S945L,

S977F, R1070W, D1152H, 2789+5GA, 3272-26AG, and 3849+10kbCT.

Other (approved by Health Canada):

Complete questions 1 - 7 and Other condition (Health Canada approved)

Is this drug being prescribed in accordance with approved Health Canada indications ?

Yes, complete questions 1 - 7 and Physician’s Information

No, prescribed use is not approved by Health Canada:

Complete questions 1 –7 and Off-label use

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M6453(CF)-4/20

Physician Information

Kalydeco (ivacaftor), Orkambi (ivacaftor/lumacaftor),

Symdeko (ivacaftor/tezacaftor and ivacaftor)

Body Mass Index (indicate date measured):

Baseline CFQ-R score:

Number of exacerbations and hospitalizations in the past year:

Provide dates of exacerbation/hospitalizations:

n n n

Clinical details:

n n n

Clinical details:

n n n

Clinical details:

Physician’s Information (continued) (please print)

3. Prescribed dosage and regimen:

Provide rationale:

4. What is the anticipated duration of treatment with this drug?

n n n n n

6. Please provide medical rationale why this drug has been prescribed instead of an alternate drug in the same therapeutic class:

Please provide any relevant information related to the disease and attach supporting documentation.

5. Where will treatment be administered? Home Physician’s Ofce Private clinic Hospital in-patient Hospital out-patient

7. Drug and Treatment History – must be completed for every request.

Drug(s) and Treatment(s)

past and present

Dosing Regimen Start Date

(DD/MM/YYYY)

End Date

(DD/MM/YYYY)

Clinical Results/Outcome

Failure Intolerance Other

Cystic Fibrosis – Genetic test results are not required

Required Documentation: Please ensure the following test results are included in the application.

Baseline Sweat Chloride Test Result

Pulmonary function tests (current within 6 months of this application)

Other Supporting Information:

Other condition (Health Canada approved) – Genetic test results are not required

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M6453(CF)-4/20

Physician Information

Kalydeco (ivacaftor), Orkambi (ivacaftor/lumacaftor),

Symdeko (ivacaftor/tezacaftor and ivacaftor)

Date of initial diagnosis (DD/MM/YYYY):

n n

Provide medical rationale why this drug has been prescribed off-label instead of an alternate drug with an approved indication for this condition.

Provide any pertinent medical history or information to support this off-label request.

If this is a renewal request, provide documentation showing treatment efcacy since previous request.

Body Mass Index (indicate date measured):

Current CFQ-R score:

Number of exacerbations and hospitalizations in the past year:

Provide dates of exacerbation/hospitalizations:

n n

Describe the patient’s response to treatment, particularly in relation to the signs and symptoms of their disease at initial presentation. Please provide

objective evidence of effectiveness. Attach copies of relevant test results, specialist consultations or clinical notes.

Renewal Request – Genetic test results are not required

Initial Renewal Only

Required Documentation: Please ensure the following test results are included in the application.

Pulmonary function tests (current within 6 months of this application)

Other supporting information:

For All Renewals

Is the patient still receiving a clinical benet from their cystic brosis drug therapy? Yes No

Off-label use – Genetic test results are not required

Questions 1 - 7 must be completed.

Is there clinical evidence supporting the off-label use of this drug? Yes No

Provide clinical literature/studies to support the request for off-label use, such as:

• At least two Phase II or two Phase III clinical trials showing consistent results of efcacy; and

• Published recommendations in evidence-based guidelines supporting its use.

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M6453(CF)-4/20

Physician Information

Kalydeco (ivacaftor), Orkambi (ivacaftor/lumacaftor),

Symdeko (ivacaftor/tezacaftor and ivacaftor)

Physician’s Signature: Date:

License Number:

Note for Physician: To be eligible for reimbursement, Canada Life may require your patient to purchase a drug requiring prior

authorization from a pharmacy designated by Canada Life. If applicable, a health case manager will contact you with further

information.

I certify that the information provided is true, correct, and complete.

It is important to provide the requested information in detail to help avoid delay in assessing claims for the above drug. This form may

be subject to audit. The completed form can be returned to Canada Life by mail, fax, or email.

Note: As email is not a secure medium, any person with concerns about their prior authorization form/medical information being

intercepted by an unauthorized party is encouraged to submit their form by other means.

Mail to: The Canada Life Assurance Company

Drug Claims Management

PO Box 6000

Winnipeg MB R3C 3A5

Fax to: The Canada Life Assurance Company

Fax 1-204-946-7664

Attention: Drug Claims Management

Email to: cldrug.services@canadalife.com

Attention: Drug Claims Management

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Drug Prior Authorization Form Kalydeco (ivacaftor), Orkambi (ivacaftorlumacaftor), (Great-West Life Insurance for Personal, Group & Benefits in Canada)

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