REVIEW REQUEST FOR
Antihemophilic Factor and Clotting Factors
Provider Data Collection Tool Based on Medical Policy DRUG.00066
Policy Last Review Date:
11/05/2015
Policy Effective Date:
11/09/2015
Request Date:
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Initial Authorization Request
Buy and bill
Provider Tool Effective Date:
Subsequent Request
Individual’s Name:
Date of Birth:
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Individual’s Phone Number:
Insurance Identification Number:
Primary Diagnosis:
11/09/2015
Diagnosis Code(s) (if known):
Ordering Provider Name & Specialty:
Individual’s Weight
(lbs) (kg)
Individual’s Height
(in) (cm)
Provider ID Number:
Office Address:
Contact Name and Office Phone Number:
Office Fax Number:
Servicing Provider Name & Specialty (If different than Ordering Provider):
Provider ID Number:
Office Address:
Contact Name and Office Phone Number:
Place of Service:
Home
Office
Dialysis Center
Ambulatory Infusion
Ambulatory Infusion Center
Drug Name/HCPCS Code (if known)
Advate
J7192
Kogenate-FS
J7192
Alphanate
J7186
Monoclate-P
J7190
AlphaNine SD
J7193
Mononine
J7193
Alprolix
J7201
Novoeight
J7182
Bebulin VH
J7194
NovoSeven RT
J7189
Benefix
J7195
Nuwiq
J7192
Coagadex
J7199 (eff 1/1/16) Profilnine SD
J7194
Corifact
J7180
J7181 Recombinate
J7192
Eloctate
J7205 (eff 1/1/16)
RiaSTAP
J7178
Eloctate
Q9975 (delt 12/31/15) Rixubis
J7200
FEIBA NF
J7198
Tretten
J7180
J7181
Helixate-FS
J7192
Wilate
J7183
Hemofil M
J7190
Xyntha
J7185
Humate-P
J7187
Ixinity
J7195
Koate DVI
J7190
Obizur
J7191 (delt 12/31/15)
J7188 (eff 1/1/16)
Other:
When did the individual first start this drug?
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Duration:
(Weeks)
Office Fax Number:
Outpatient Hospital
Other:
Dose to be administered:
(I.U./kg)
(Other)
Frequency (Days, Wks, Months)
Start Date For This Request:
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This provider tool addresses requests for select hemophilia and clotting factor replacement treatments created from
blood products (human plasma-derived) and others that are manufactured (recombinant). The provider tool does not
address requests for fibrin products, fibrin sealants and blood products provided by blood banks. Replacement
therapy may be given on a routine, preventive basis which is also called prophylactic therapy. The infusion of
factor replacements given to stop a bleeding episode is called demand therapy.
Please identify and complete the appropriate section for this individual. Check all that apply.
A. Anti-inhibitor Coagulant Complex (FEIBA NF)
Anti-inhibitor coagulant complex (FEIBA NF) is requested to treat individual diagnosed with hemophilia A or B with
inhibitors to Factor VIII or Factor IX
FEIBA NF will be given to treat bleeding episodes. (If checked, mark the following when it applies)
The individual’s bleeding episodes are NOT a result of coagulation factor deficiencies in the absence of
inhibitors to coagulation Factor VIII or coagulation Factor IX.
FEIBA NF will be given as peri-procedural management for surgical, invasive or interventional radiology
procedures
FEIBA NF will be given as routine prophylaxis to prevent or reduce the frequency of bleeding episodes
B.
Factor VIIa Recombinant (NovoSeven RT)
Recombinant coagulation Factor VIIa (NovoSeven RT) is requested for treatment of bleeding episodes
(If checked answer the following)
Individual has hemophilia A or B with inhibitors to Factor VIII or Factor IX
Individual has acquired hemophilia
Individual has congenital Factor VII deficiency.
Recombinant coagulation Factor VIIa is requested as prevention of bleeding in surgical interventions or
invasive procedures
(If checked answer the following)
Individual has hemophilia A or B with inhibitors to Factor VIII or Factor IX
Individual has acquired hemophilia
Individual has congenital Factor VII deficiency
Recombinant coagulation Factor VIIa is requested for treatment of bleeding episodes and peri-operative management
in individuals with Glanzmann’s thrombasthenia and a documented refractoriness to platelet transfusions with
or without antibodies to Platelets
Other ______________________
C. Antihemophilic factor (factor VIII) Human plasma-derived (Hemofil M, Koate-DVI, Monoclate-P)
Human plasma-derived antihemophilic Factor VIII (Hemofil M, Koate-DVI, Monoclate-P) is requested for
treatment of bleeding episodes in an individual with hemophilia A and factor VIII deficiency
Human plasma-derived antihemophilic Factor VIII (Koate-DVI, Monoclate-P) is requested for
peri-procedural management for surgical, invasive or interventional radiology procedures in an
individual with hemophilia A and factor VIII deficiency
Human plasma-derived antihemophilic Factor VIII (Hemofil, Koate-DVI, Monoclate-P) is requested for routine
prophylaxis to prevent or reduce the frequency of bleeding episodes (If checked, answer the following)
Individual has severe hemophilia A (defined as less than or equal to 1 International Unit per deciliter [IU/dL]
or 1% endogenous Factor VIII)
Individual has mild to moderate hemophilia A (defined as endogenous Factor VIII less than
or equal to 40 IU/dL [less than or equal to 40%], but greater than 1 IU)
(IF checked, answer the following that apply)
Individual has a history of :
1 or more episodes of spontaneous bleeding into joint
1 or more episodes of spontaneous bleeding into the central nervous system
4 or more episodes of soft tissue bleeding in an 8 week period
Human plasma-derived antihemophilic Factor VIII will NOT be given to treat an individual with
von Willebrand disease (VWD)
Other ______________________
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D. Antihemophilic factor (factor VIII) Recombinant (Advate, Helixate FS, Kogenate FS,
Novoeight, Nuwiq. Recombinate, Xyntha)
Request is for Antihemophilic Factor VIII Recombinant (Advate, Helixate FS, Kogenate FS, Novoeight, Nuwiq,
Recombinate, Xyntha) treatment (If checked, answer the following uses that apply to the individual)
Treatment of bleeding episodes resulting from hemophilia A and factor VIII deficiency.
Peri-procedural management for surgical, invasive or interventional radiology procedures in an
individual with hemophilia A and factor VIII deficiency
Antihemophilic Factor VIII Recombinant (Advate, Helixate FS, Novoeight, Nuwiq) is requested as routine
prophylaxis to prevent or reduce the frequency of bleeding episodes (If checked, answer the following)
Individual has severe hemophilia A (defined as less than or equal to 1 International Unit per deciliter [IU/dL] or
1% endogenous Factor VIII)
Individual has mild to moderate hemophilia A (defined as endogenous Factor VIII less than or equal to 40 IU/dL
[less than or equal to 40%], but greater than 1 IU) (If checked, mark the following as they apply)
The individual has a documented history of:
1 or more episodes of spontaneous bleeding into joint
1 or more episodes of spontaneous bleeding into the central nervous system
4 or more episodes of soft tissue bleeding in an 8 week period
Antihemophilic Factor VIII Recombinant (Helixate FS, Kogenate FS) is requested as routine prophylaxis for a
child (age 0-16 years) with hemophilia A and factor VIII deficiency to reduce the risk of joint damage in those without
pre-existing joint damage
Antihemophilic Factor VIII Recombinant (Recombinate) is requested as treatment of an individual with acquired
Factor VIII inhibitors not exceeding 10 Bethesda Unit (BU) per milliliter (mL).
Antihemophilic Factor VIII Recombinant (Advate, Helixate FS, Kogenate FS, Novoeight, Nuwiq, Recombinate,
Xyntha) will NOT be given to treat an individual with von Willebrand disease (VWD)
Other ______________________
E. Recombinant Antihemophilic Factor, Fc Fusion Protein (Eloctate)
Recombinant antihemophilic factor, Fc fusion protein ([rFVIIIFc]) (Eloctate) is requested for an individual with
severe hemophilia A (congenital Factor VIII deficiency) (If checked, answer the following)
Individual has less than or equal to 1 International Unit per deciliter (IU/dL) (less than or equal to 1%)
endogenous factor VIII
Eloctate is planned for control and prevention of acute bleeding episodes
Eloctate is planned for peri-procedural management for surgical, invasive or interventional radiology procedures
Eloctate is planned for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Eloctate is requested for an individual with mild to moderate hemophilia A (congenital Factor VIII deficiency)
(If checked, answer the following)
Individual has endogenous factor VIII level less than 40 IU/dl (less than or equal to 40%) but greater than 1 IU/dl
Eloctate is planned for control and prevention of acute bleeding episodes
Eloctate is planned for peri-procedural management for surgical, invasive or interventional radiology procedures
Eloctate is planned for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
(If checked, answer the following)
The individual has a documented history of:
1 or more episodes of spontaneous bleeding into joint
1 or more episodes of spontaneous bleeding into the central nervous system
4 or more episodes of soft tissue bleeding in an 8 week period
Eloctate will NOT be given to treat an individual with von Willebrand disease (VWD)
Other ______________________
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F. Antihemophilic Factor (Recombinant), Porcine Sequence (Obizur)
Antihemophilic Factor (Recombinant), Porcine Sequence is requested for treatment of bleeding episodes in an adult
with acquired hemophilia A.
Antihemophilic Factor (Recombinant), Porcine Sequence is requested for: (check the following that apply )
Treatment an individual with congenital hemophilia A with Factor VIII deficiency
Treatment an individual with von Willebrand disease
Treatment of an individual with acquired hemophilia A AND baseline anti-porcine Factor VIII inhibitor titer
greater than 20 BU/mL
Other ______________________
G.
Antihemophilic Factor VIII/von Willebrand Factor Complex (Alphanate, Humate-P, Wilate)
Antihemophilic Factor VIII/von Willebrand Factor Complex (Alphanate, Humate-P, Wilate) is being requested as a
treatment for an individual with von Willebrand disease (VWD) (Type 1, 2 or unknown).
(If checked, answer the following)
VWD is severe
VWD is mild to moderate AND use of desmopressin is known or suspected to be inadequate
Individual is being treated for spontaneous or trauma-induced bleeding episodes
Individual’s treatment is for peri-procedural management for surgical, invasive or interventional
radiology procedures.
Antihemophilic Factor VIII/von Willebrand Factor Complex (Alphanate, Humate-P) is requested for
treatment of bleeding episodes in an individual with hemophilia A and Factor VIII deficiency
Antihemophilic Factor VIII/von Willebrand Factor Complex (Alphanate) is being requested for
treatment of bleeding episodes in an individual with acquired Factor VIII deficiency.
Antihemophilic Factor/von Willebrand Factor Complex (Alphanate, Humate-P, Wilate) is NOT being used for
prophylaxis therapy for an individual with VWD.
Antihemophilic Factor/von Willebrand Factor Complex (Alphanate) is NOT being used for an individual with severe
VWD (Type 3) undergoing major surgery.
Antihemophilic Factor/von Willebrand Factor Complex (Wilate) is NOT being used for an individual
with hemophilia A.
Other ______________________
H.
Coagulation Factor IX, Human plasma-derived (Alphanine SD, Mononine)
The request is for Human plasma-derived coagulation Factor IX (Alphanine SD, Mononine) to treat an individual
with hemophilia B and Factor IX deficiency
The request is for Human plasma-derived coagulation Factor IX (Alphanine SD, Mononine) as routine prophylaxis
to prevent or reduce the frequency of bleeding episodes (If checked, answer the following that apply to the individual)
Individual has severe hemophilia B (defined as less than or equal to 1 IU/dL or 1% endogenous Factor IX);
Individual has mild to moderate hemophilia B (defined as endogenous Factor IX less than or equal
to 40 IU/dL [less than 40% ], but greater than 1 IU/dL) (If checked, answer the following that apply)
The individual has a documented history of:
1 or more episodes of spontaneous bleeding into joint
1 or more episodes of spontaneous bleeding into the central nervous system
4 or more episodes of soft tissue bleeding in an 8 week period
Human plasma-derived coagulation Factor IX (Alphanine SD, Mononine) will NOT be used to treat or
reverse coumarin-induced anticoagulation
Human plasma-derived coagulation Factor IX (Alphanine SD, Mononine) will NOT be used to treat an individual
in a hemorrhagic state or with coagulopathy associated with liver dysfunction
Human plasma-derived coagulation Factor IX (Alphanine SD, Mononine) will NOT be used to treat an individual
with hemophilia A with inhibitors to factor VIII
Human plasma-derived coagulation Factor IX (Alphanine SD, Mononine) will NOT be used as replacement therapy
for other clotting factors which include factors II, VII and X
Other ______________________
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I.
J.
Factor IX Complex, Human plasma-derived (Bebulin, Profilnine SD)
The request is for Human plasma-derived Factor IX complex (Bebulin, Profilnine SD) to treat bleeding episodes in an
individual diagnosed with hemophilia B (congenital factor IX deficiency or Christmas disease).
The request is for Human plasma-derived Factor IX (Bebulin, Profilnine SD) as routine prophylaxis
to prevent or reduce the frequency of bleeding episodes (If checked, answer the following)
Individual has severe hemophilia B (defined as less than or equal to 1 IU/dL or 1% endogenous Factor IX);
Individual has mild to moderate hemophilia B (defined as endogenous Factor IX less than or equal
to 40 IU/dL [less than 40% ], but greater than 1 IU/dL) (If checked, answer the following that apply)
The individual has a documented history of:
1 or more episodes of spontaneous bleeding into joint
1 or more episodes of spontaneous bleeding into the central nervous system
4 or more episodes of soft tissue bleeding in an 8 week period
Human plasma-derived Factor IX (Bebulin, Profilnine SD) will NOT be used to treat an individual diagnosed with
Factor VII deficiency
Other ______________________
Factor IX Recombinant (Benefix, Ixinity, Rixubis)
Request is for Recombinant coagulation Factor IX (Benefix, Rixubis) to treat an individual with hemophilia B
(congenital factor IX deficiency or Christmas disease). (If checked, answer the following)
The agent is to treat bleeding episodes
The agent is for peri-procedural management for surgical, invasive or interventional radiology procedures
The request is for Recombinant coagulation Factor IX (Benefix, Rixubis) for routine prophylaxis to prevent or
reduce the frequency of bleeding episodes. (If checked, answer the following)
Individual has severe hemophilia B (defined as less than or equal to 1 IU/dL or 1% endogenous Factor IX)
Individual has mild to moderate hemophilia B (defined as endogenous Factor IX less than or equal to 40 IU/dL
[less than 40% ], but greater than 1 IU/dL) (If checked, answer the following that apply)
The individual has a documented history of:
1 or more episodes of spontaneous bleeding into joint
1 or more episodes of spontaneous bleeding into the central nervous system
4 or more episodes of soft tissue bleeding in an 8 week period
Request is for recombinant coagulation Factor IX (Ixinity) to treat an individual age 12 years or older with
hemophilia B (congenital factor IX deficiency or Christmas disease)
(If checked, answer the following)
Ixinity will be used to treat bleeding episodes
Ixinity will be used for peri-procedural management for surgical, invasive or interventional radiology procedures
Ixinity will be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
(If checked, answer the following)
Individual has severe hemophilia B (defined as less than or equal to 1 IU/dL or 1% endogenous Factor IX);
Individual has mild to moderate hemophilia B (defined as endogenous Factor IX less than or equal
to 40 IU/dL [less than 40% ], but greater than 1 IU/dL) (If checked, answer the following that apply)
The individual has a documented history of:
1 or more episodes of spontaneous bleeding into joint
1 or more episodes of spontaneous bleeding into the central nervous system
4 or more episodes of soft tissue bleeding in an 8 week period
Recombinant coagulation Factor IX (Benefix, Ixinity, Rixubis ) will NOT be used to treat an individual with
other factor deficiencies (for example, factors II, VII, VIII and X)
Recombinant coagulation Factor IX (Benefix, Ixinity, Rixubis ) will NOT be used to treat an individual
with hemophilia A with inhibitors to factor VIII
Recombinant coagulation Factor IX (Benefix, Ixinity, Rixubis ) will NOT be used to reverse coumarin-induced
anticoagulation
Recombinant coagulation Factor IX (Benefix, Ixinity, Rixubis ) will NOT be used to treat bleeding due to
low levels of liver-dependent coagulation factors
Recombinant coagulation Factor IX (Benefix, Ixinity, Rixubis) will NOT be used to induce immune tolerance in
an individual with hemophilia B.
Other ______________________
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K. Recombinant Coagulation Factor IX, Fc Fusion Protein (Alprolix™)
Request is for recombinant coagulation Factor IX, Fc Fusion [rFIXFc] (Alprolix™ ) to treat an individual
with severe hemophilia B (congenital Factor IX deficiency) (If checked answer the following)
Individual has less than or equal to 1 International Unit per deciliter (IU/dl) (less than or equal to 1%)
endogenous factor IX
Alprolix™ is planned for treatment of bleeding episodes
Alprolix™ is planned for peri-procedural management for surgical, invasive or interventional radiology procedures
Alprolix™ is planned for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Request is for recombinant coagulation Factor IX, Fc Fusion [rFIXFc] (Alprolix™ ) to treat an individual
with mild to moderate hemophilia B (congenital factor IX deficiency)
(If checked answer the following as they apply to the individual)
Individual has endogenous factor IX level less than 40 International Units per deciliter (IU/dl) (less than or
equal to 40%) but greater than 1 IU/dl
Alprolix™ is planned for treatment of bleeding disorders
Alprolix™ is planned for peri-procedural management for surgical, invasive or interventional radiology procedures
Alprolix™ is planned for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
The individual has a documented history of:
1 or more episodes of spontaneous bleeding into joint
1 or more episodes of spontaneous bleeding into the central nervous system
4 or more episodes of soft tissue bleeding in an 8 week period
Alprolix™ will NOT be used to induce immune tolerance in an individual with hemophilia B
Other ______________________
L.
Coagulation Factor X Human plasma- derived (Coagadex®)
Request is for human plasma derived coagulation Factor X (Coagadex) for individual is age 12 years or older
(If checked, mark all of the following that apply to the individual)
Individual has severe or moderate hereditary Factor X deficiency (defined as less than 5 International Unit per
deciliter (IU/dl) or 5% endogenous Factor X)
Coagadex® will be used for the treatment of bleeding episodes
Coagadex® will NOT be used for perioperative management of bleeding in major surgery
Individual has mild hereditary Factor X deficiency (defined as greater than or equal to 5 International Unit
per deciliter (IU/dl) or 5% endogenous Factor X)
Coagadex® will be used for peri-procedural management for surgical, invasive or interventional
radiology procedures.
Other: _____________________________________
M.
Factor XIII (Corifact, Tretten)
Human plasma-derived concentrate Factor XIII (Corifact) is to be given to an individual diagnosed with
Factor XIII deficiency (If checked, identify the purpose of the treatment)
As routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes
For peri-procedural management for surgical, invasive or interventional radiology procedures
Recombinant coagulation Factor XIII A-Subunit (Tretten) is to be given to an individual with congenital
Factor XIII A-subunit deficiency for routine prophylaxis of bleeding
Coagulation Factor XIII (Corifact, Tretten) will NOT be used to treat an an individual with congenital
Factor XIII B-subunit deficiency
Other ______________________
N.
Fibrinogen Concentrate, Human plasma-derived (RiaSTAP)
Human plasma-derived fibrinogen concentrate is requested for treatment of acute bleeding episodes as a result
of congenital fibrinogen deficiency (that is, afibrinogenemia or hypofibrinogenemia).
Human plasma-derived fibrinogen concentrate will NOT be given to treat an individual with dysfibrinogenemia
Other ______________________
O.
Other uses not specified above. Please specify:
(Please submit all supporting documents including labs, progress notes, imaging, etc., for review.)
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This request is being submitted:
Pre-Claim
Post–Claim. If checked, please attach the claim or indicate the claim number
I attest the information provided is true and accurate to the best of my knowledge. I understand that the health plan or its
designees may perform a routine audit and request the medical documentation to verify the accuracy of the information
reported on this form.
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/
Name & Title of Provider or Provider Representative Completing Form
Date
& attestation (Please Print)*
*The attestation fields must be completed by a provider or provider representative in order for the tool to be accepted
Anthem UM Services, Inc., a separate company, is the licensed utilization review agent that performs utilization
management services on behalf of your health benefit plan or the administrator of your health benefit plan.
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