Medication Prior Authorization Form

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1 Policy Number: 1041 FEIBA NF Novoeight Mononine NovoSeven RT RECOMBINATE BEBULIN HEMOFIL M Xyntha Profilnine SD Koate-DVI Obizur BeneFix Monoclate-P Alphanate RIXUBIS ADVATE HUMATE-P Corifact Helixate FS Wilate TRETTEN Kogenate FS AlphaNine SD RiaSTAP Policy History Approve Date: 12/11/2015 Effective Date: 12/11/2015 Preauthorization All Plans Benefit plans vary in coverage and some plans may not provide coverage for certain service(s) listed in this policy. Decisions for authorization are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations as well as applicable state and/or federal laws. Please review the benefit plan descriptions for details. We utilize a combination of MCG and internally developed evidence-based clinical guidelines to support our prior authorization work. All internally developed prior authorization guidelines follow a rigorous process including, but not limited to, review by clinical pharmacist, clinical nurse manager, Chief Medical Officer, independent 3 rd party physician review agency and WEA Trust s Medical Advisory Committee. Prior authorization guidelines are reviewed at least annually, or when there are significant labeling changes made by FDA or peer-reviewed clinical outcomes (via Cochrane or Hayes). INSTRUCTIONS: Please review section I and complete sections II, III, and IV (type or print clearly). Prescribers are asked to submit this form along with supporting clinical documentation to the WEA Trust for review. Submission of form does not guarantee approval. Submit preauthorization (PA) by fax to the WEA Trust at (608) or by mail to WEA Trust, Pharmacy Services Prior Authorization, PO Box 21538, Eagan MN

2 Page 2 Section I Approval Criteria I. Anti-inhibitor Coagulant Complex (FEIBA NF) A. Anti-inhibitor coagulant complex agents (FEIBA NF) are medically necessary to treat individuals with hemophilia A or B with inhibitors when the following criteria are met: i. Treatment of bleeding episodes OR ii. Peri-procedural operative management for surgical, invasive or interventional radiology procedures OR iii. Routine prophylaxis to prevent or reduce the frequency of bleeding episodes B. Anti-inhibitor coagulant complex is not medically necessary when the above criteria are not met and for all other indications including, but not limited to treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation Factor VIII or coagulation Factor IX C. FEIBA NF (anti-inhibitor coagulant complex) has a black box warning for thrombotic and thromboembolic events, which have been reported during post marketing surveillance following infusion, particularly following the administration of high doses and/or in individuals with thrombotic risk factors II. Factor VIIa Recombinant (NovoSeven RT) A. Factor VIIa recombinant coagulation agents (NovoSeven RT) are medically necessary for the following: i. Treatment of bleeding episodes when the following criteria are met: 1. Individual has hemophilia A or B with inhibitors to Factor VIII or Factor IX OR 2. Individual has acquired hemophilia OR 3. Individual has congenital Factor VII deficiency OR ii. In the prevention of bleeding in surgical interventions or invasive procedures for the following: 1. Individual has hemophilia A or B with inhibitors to Factor VIII or Factor IX OR 2. Individual has acquired hemophilia OR 3. Individual has congenital Factor VII deficiency OR iii. To treat individuals with Glanzmann s thrombasthenia and a documented refractoriness to platelet transfusions with or without antibodies to platelets B. Recombinant coagulation Factor VIIa (NovoSeven RT) are not medically necessary when the above criteria are not met and for all other indications C. NovoSeven, NovoSeven RT [coagulation Factor VIIa (recombinant)] has a black box warning for serious arterial and venous thrombotic events following administration. Individuals should be monitored for signs and symptoms of activation of the coagulation system and for thrombosis III. factor (factor VIII) Human plasma-derived (HEMOFIL M, Koate-DVI, Monoclate-P) A. factor (Factor VIII) human plasma-derived agents (HEMOFIL M, Koate-DVI, Monoclate-P) is medically necessary for the following: i. Treatment of bleeding episodes in an individual with hemophilia A and factor VIII deficiency B. factor (Factor VIII) human plasma-derived agents (Koate-DVI, Monoclate-P) are medically necessary for the following: i. As peri-procedural management for surgical, invasive or interventional radiology procedures in an individual with hemophilia A and factor VIII deficiency C. factor (Factor VIII) human plasma-derived agents (HEMOFIL M, Koate-DVI, Monoclate-P) are not medically necessary when the above criteria are not met including, but not limited to treatment of individuals with von Willebrand disease (VWD) IV. factor (factor VIII) Recombinant (ADVATE, Helixate FS, Kogenate FS, Novoeight, RECOMBINATE, Xyntha) A. factor (Factor VIII) recombinant agents (ADVATE, Helixate FS, Kogenate FS, Novoeight, RECOMBINATE, Xyntha) are medically necessary for the following: i. For the treatment of bleeding episodes in an individual with hemophilia A and factor VIII deficiency OR ii. As peri-procedural management for surgical, invasive or interventional radiology procedures for an

3 Page 3 individual with hemophilia A and Factor VIII deficiency B. Factor VIII Recombinant (ADVATE, Helixate FS, Novoeight) is medically necessary as routine prophylaxis to prevent or reduce the frequency of bleeding episodes when the following criteria are met (i alone OR ii and iii): i. Individual has severe hemophilia A (defined as less than or equal to 1 International Unit per deciliter [IU/dL] or 1% endogenous Factor VIII) OR ii. 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) AND iii. When the individual has documented history of one of the following: 1. One or more episodes of spontaneous bleeding into joint OR 2. One or more episodes of spontaneous bleeding into the central nervous system OR 3. Four or more episodes of soft tissue bleeding in an eight week period C. Factor VIII Recombinant (Helixate FS, Kogenate FS) is medically necessary for the following: i. As routine prophylaxis for children (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 D. Factor VIII Recombinant (Recombinate) is medically necessary for the following: i. As treatment of individuals with acquired Factor VIII inhibitors not exceeding 10 Bethesda Unit (BU) per milliliter (ml) E. Factor VIII Recombinate (ADAVATE, Helixate FS, Kogenate, Novoeight, Recombinate, Xyntha) are not medically necessary when the above criteria are not met and for all other indications including, but not limited to treatment of individuals with VWD V. Factor VIII (Recombinant), Porcine Sequence (Obizur) A. Factor (Recombinant), Porcine Sequence are medically necessary for the following: i. For treatment of bleeding episodes in adults with acquired hemophilia A B. Factor (Recombinant), Porcine Sequence (Obizur) are not medically necessary when the above criteria are not met and for all other indications including, but not limited to: i. Treatment of individuals with congenital hemophilia A with Factor VIII deficiency ii. Treatment of individuals with von Willebrand disease iii. Treatment of individuals with acquired hemophilia A and baseline anti-porcine Factor VIII inhibitor titer greater than 20 BU/ml VI. Factor VIII/von Willebrand Factor Complex (Alphanate, Humate-P, Wilate) A. Factor VIII/von Willebrand Factor Complex (Alphanate, Humate-P, Wilate) are medically necessary as treatment for individuals with von Willebrand disease (Type 1, 2 or unknown) when the following criteria are met (i alone OR ii & iii): i. VWD is severe OR ii. VWD is mild to moderate and use of desmopressin is known or suspected to be inadequate AND iii. Individual is being treated for either: 1. Spontaneous and trauma-induced bleeding episodes OR 2. Peri-procedural management for surgical, invasive or interventional radiology procedures B. Factor VIII/von Willebrand Factor Complex (Alphanate, Humate-P) is medically necessary for the following: i. For treatment of bleeding episodes in an individual with hemophilia A and Factor VIII deficiency C. Factor VIII/von Willebrand Factor Complex (Alphanate) is medically necessary for the following: i. For treatment of bleeding episodes in an individual with acquired Factor VIII deficiency D. Factor/von Willebrand Factor Complex (Alphanate, Humate-P, Wilate) is not medically necessary when the above criteria are not met and for any of the following: i. All other indications including, but not limited to prophylaxis therapy in individuals with VWD ii. Alphanate for individuals with severe VWD (Type 3) undergoing major surgery iii. Wilate for individuals with hemophilia A

4 Page 4 iv. Wilate for individuals with VWD when used as prevention of excessive bleeding during and after surgery VII. Coagulation Factor IX, Human plasma-derived (Alphanine SD, Mononine) A. Human plasma-derived coagulation Factor IX (Alphanine SD, Mononine) is medically necessary for the following: i. For treatment of bleeding episodes in an individual with hemophilia B and Factor IX deficiency B. Human plasma-derived coagulation Factor IX (Alphanine SD, Mononine) is not medically necessary when the above criteria are not met, including but not limited to the following: i. Treatment or reversal of coumarin-induced anticoagulation ii. Hemorrhagic state or coagulopathy associated with liver dysfunction iii. Treatment of individuals with hemophilia A with inhibitors to factor VIII iv. Replacement therapy of other clotting factors which include factors II, VII and X VIII. Factor IX Complex, Human plasma-derived (Bebulin, Profilnine SD) A. Human plasma-derived Factor IX complex (Bebulin, Profilnine SD) is medically necessary for the following: i. For treatment of bleeding episodes in an individual with hemophilia B (congenital factor IX deficiency or Christmas disease) B. Human plasma-derived Factor IX complex (Bebulin, Profilnine SD) is not medically necessary when the above criteria are not met and for all other indications including, but not limited to use for treatment of individuals with Factor VII deficiency IX. Factor IX Recombinant (Benefix, RIXUBIS) A. Recombinant coagulation Factor IX (Benefix, RIXUBUS) is medically necessary to treat individuals with hemophilia B (congenital factor IX deficiency or Christmas disease) when the following criteria are met: i. To treat bleeding episodes OR ii. For peri-procedural management for surgical, invasive or interventional radiology procedures B. Recombinant coagulation Factor IX (RIXUBIS) is medically necessary as routine prophylaxis to prevent or reduce the frequency of bleeding episodes when the following criteria are met (i alone OR ii & iii): i. Individual has severe hemophilia B (defined as less than or equal to 1 IU/dL or 1% endogenous Factor IX) OR ii. 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) AND iii. When the member has documented history of one of the following: 1. One or more episodes of spontaneous bleeding into joint OR 2. One or more episodes of spontaneous bleeding into the central nervous system OR 3. Four or more episodes of soft tissue bleeding in an eight week period C. Recombinant coagulation Factor IX (Benefix, RIXUBIS) is not medically necessary when the above criteria are not met and for all other indications including, but not limited to the following: i. Treatment of other factor deficiencies (for example factors II, VII, VIII and X) ii. Treatment of individuals with hemophilia A with inhibitors to factor VIII iii. To reverse coumarin-induced anticoagulation iv. Treatment of bleeding due to low levels of liver-dependent coagulation factors v. Benefix for routine prophylaxis to prevent or reduce the frequency of bleeding episodes vi. RIXUBIS for the induction of immune tolerance in individuals with hemophilia B X. Factor XIII (Corifact, TRETTEN) A. Human plasma-derived concentrate Factor XIII (Corifact) is medically necessary for individuals with Factor XIII deficiency for the following indications: i. As routine prophylactic treatment OR ii. Peri-procedural management for surgical, invasive or interventional radiology procedures for

5 Page 5 individuals with congenital Factor XIII deficiency B. Recombinant coagulation Factor XIII A-Subunit (TRETTEN) is medically necessary for the following: i. As routine prophylaxis for bleeding in individuals with congenital Factor XIII A-subunit deficiency C. Coagulation Factor XIII (Corifact, TRETTEN) is not medically necessary when the above criteria are not met and for all other indications including, but not limited to treatment of individuals with congenital Factor XIII B-subunit deficiency XI. Fibrinogen Concentrare, Human plasma-derived (RiaSTAP) A. Human plasma-derived fibrinogen concentrate (RiaSTAP) is medically necessary for the following: i. For the treatment of acute bleeding episodes in individuals with congenital fibrinogen deficiency (that is, afibrinogenemia or hypofibrinogenemia) B. Human plasma-derived fibrinogen concentrate (RiaSTAP) is not medically necessary when the above criteria are not met and for all other indications including, but not limited to treatment of individuals with dysfibrinogenemia. Renewal Criteria I. All renewals will be for six months if therapy determined to be effective and without significant adverse events References 1. Hoots W. Keith and Shapiro, Amy D, UpToDate July , Factor VIII and Factor IX Inhibitors in Patients with Hemophilia 2. Keating GM, Dhillon S. Octocog alfa (Advate ): a guide to its use in hemophilia A. BioDrugs Aug 1; 26(4): doi: / Manco-Johnson MJ, Abshire TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, Ingram JD, Manco-Johnson ML, Funk S, Jacobson L, Valentino LA, Hoots WK, Buchanan GR, DiMichele D, Recht M, Brown D, Leissinger C, Bleak S, Cohen A, Mathew P, Matsunaga A, Medeiros D, Nugent D, Thomas GA, Thompson AA, McRedmond K, Soucie JM, Austin H, Evatt BL Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007; 357(6): Gringeri A, Lundin B, von Mackensen S, Mantovani L, Mannucci PM, ESPRIT Study Group A randomized clinical trial of prophylaxis in children with hemophilia A (the ESPRIT Study). J Thromb Haemost. 2011; 9(4): National Hemophilia Foundation MASAC Recommendation Concerning Prophylaxis (Regular Administration of Clotting Factor Concentrate to Prevent Bleeding) November 3, 2007, and adopted by the NHF Board of Directors on November 4, Richards M, Williams M, Chalmers E, Liesner R, Collins P, Vidler V, Hanley J, Paediatric Working Party of the United Kingdom Haemophilia Doctors' Organisation A United Kingdom Haemophilia Centre Doctors' Organization guideline approved by the British Committee for Standards in Haematology: guideline on the use of prophylactic factor VIII concentrate in children and adults with severe haemophilia A. Br J Haematol. 2010; 149(4): Hermans C, De Moerloose P, Fischer K, Holstein K, Klamroth R, Lambert T, Lavigne-Lissalde G, Perez R, Richards M, Dolan G; European Haemophilia Therapy Standardisation Board. Management of acute haemarthrosis in haemophilia A without inhibitors: literature review, European survey and recommendations. Haemophilia 2011 May; 17(3): doi: /j x. Epub 2011 Feb Tuohy E, Litt E, Alikhan R. Treatment of patients with von Willebrand disease. J Blood Med. 2011;2: doi: /JBM.S9890. Epub 2011 Apr 20. Erratum in: J Blood Med May 20; 4: MASAC Recommendations Regarding the Treatment of Von Willebrand Disease Approved by the Medical and

6 Page 6 Scientific Advisory Council (MASAC) on April 18, 2010, and adopted by the NHF Board of Directors on June 26, Gill JC, Shapiro A, Valentino LA, Bernstein J, Friedman C, Nichols WL, Manco-Johnson M. von Willebrand factor/factor VIII concentrate (Humate-P) for management of elective surgery in adults and children with von Willebrand disease. Haemophilia Nov; 17(6): Windyga J, Lissitchkov T, Stasyshyn O, Mamonov V, Rusen L, Lamas JL, Oh MS, Chapman M, Fritsch S, Pavlova BG, Wong WY, Abbuehl BE Pharmacokinetics, efficacy and safety of BAX326, a novel recombinant Factor IX: a prospective, controlled, multicentre phase I/III study in previously treated patients with severe (FIX level<1%) or moderately severe (FIX level?2%) haemophilia B. Haemophilia. 2014; 20(1): National Hemophilia Foundation, MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Other Bleeding Disorders, Revised October 2013 Available at Antunes SV, Tangada S, Stasyshyn O, Mamonov V, Phillips J, Guzman-Becerra N, Grigorian A, Ewenstein B, Wong WY. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors. Haemophilia Jan; 20(1): Stasyshyn O, Antunes S, Mamonov V, Ye X, Epstein J, Xiong Y, Tangada S. Prophylaxis with antiinhibitor coagulant complex improves health-related quality of life in haemophilia patients with inhibitors: results from FEIBA NF Prophylaxis Study. Haemophilia Mar 3. doi: /hae [Epub ahead of print] 15. Inbal A, Oldenburg J, Carcao M, Rosholm A, Tehranchi R, Nugent D Recombinant factor XIII: a safe and novel treatment for congenital factor XIII deficiency. Blood. 2012; 119(22): Manco-Johnson MJ, Dimichele D, Castaman G, Fremann S, Knaub S, Kalina U, Peyvandi F, Piseddu G, Mannucci P, Fibrinogen Concentrate Study Group. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost. 2009; 7(12): 2064

7 Page 7 Section II Member Information Name (Last, First, Middle Initial) Date of Birth WEA Trust Subscriber Number Diagnosis 1. MEDICATION 2. STRENGTH 3. DIRECTIONS 4. QUANTITY FEIBA NF NovoSeven RT HEMOFIL M Koate-DVI Monoclate-P ADVATE Helixate FS Kogenate FS Novoeight RECOMBINATE Xyntha Obizur Alphanate HUMATE-P Wilate AlphaNine SD Mononine BEBULIN Profilnine SD BeneFix RIXUBIS Corifact TRETTEN RiaSTAP Specify: 5. DIAGNOSIS:

8 Page 8 6. APPROVAL CRITERIA: CHECK ALL BOXES THAT APPLY NOTE: Any areas not filled out are considered not applicable to your patient and MAY AFFECT THE OUTCOME of this request. FEIBA NF: Yes No Patient is using FEIBA NF to treat bleeding episodes and the patient has Hemophilia A or B Yes No Patient is using FEIBA NF as peri-procedural operative management for surgical, invasive or interventional radiology procedures and the patient has Hemophilia A or B Yes No Patient is using FEIBA NF as routine prophylaxis to prevent or reduce the frequency of bleeding episodes and the patient has Hemophilia A or B NovoSeven RT: Yes No Patient is using NovoSeven RT for treatment of bleeding episodes Yes No Patient is using NovoSeven RT for prevention of bleeding in surgical interventions or invasive procedures Yes No Patient is using NovoSeven RT to treat Glanzmann s thrombasthenia and a documented refractoriness to platelet transfusions with or without antibodies to platelets Yes No Does the patient have hemophilia A or B with inhibitors to Factor VIII or Factor IX; OR has the patient acquired hemophilia Yes No Does the patient have congenital Factor VII deficiency HEMOFIL M: Yes No Patient has hemophilia A and factor VIII deficiency and is using HEMOFIL M to treat bleeding episodes Koate-DVI OR Monoclate-P: Yes No Patient has hemophilia A and factor VIII deficiency and is using the request drug to treat bleeding episodes Yes No Patient has hemophilia A and factor VIII deficiency and is using the request drug as peri-procedural management for surgical, invasive or interventional radiology procedures ADVATE OR Novoeight: Yes No Patient has hemophilia A and factor VIII deficiency and is using the request drug to treat bleeding episodes Yes No Patient has hemophilia A and factor VIII deficiency and is using the request drug as peri-procedural management for surgical, invasive or interventional radiology procedures Yes No Patient is using request drug as routine prophylaxis to prevent or reduce the frequency of bleeding Episodes If Yes: Yes No Patient has severe hemophilia A (defined as less than or equal to 1 International Unit per deciliter [IU/dL] or 1% endogenous Factor VIII) Yes No Patient 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 Yes: Patient has a documented history of one of the following (please indicate): Yes Yes Yes No One or more episodes of spontaneous bleeding into joint No One or more episodes of spontaneous bleeding into the central nervous system No Four or more episodes of soft tissue bleeding in an eight week period

9 Page 9 Helixate FS: Yes No Patient has hemophilia A and factor VIII deficiency and is using Helixate FS to treat bleeding episodes Yes No Patient has hemophilia A and factor VIII deficiency and is using Helixate FS as peri-procedural management for surgical, invasive or interventional radiology procedures Yes No Helixate FS is being used 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 Yes No Patient is using Helixate FS as routine prophylaxis to prevent or reduce the frequency of bleeding episodes If Yes: Yes No Patient has severe hemophilia A (defined as less than or equal to 1 International Unit per deciliter [IU/dL] or 1% endogenous Factor VIII) Yes No Patient 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 Yes: Patient has a documented history of one of the following (please indicate): Yes Yes Yes No One or more episodes of spontaneous bleeding into joint No One or more episodes of spontaneous bleeding into the central nervous system No Four or more episodes of soft tissue bleeding in an eight week period Kogenate FS: Yes No Patient has hemophilia A and factor VIII deficiency and is using Kogenate FS to treat bleeding episodes Yes No Patient has hemophilia A and Factor VIII deficiency and is using Kogenate FS for peri-procedural management for surgical, invasive or interventional radiology procedures Yes No Kogenate FS is being used for 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 RECOMBINATE: Yes No Patient has hemophilia A and factor VIII deficiency and is using RECOMBINATE to treat bleeding episodes Yes No Patient has hemophilia A and Factor VIII deficiency and is using RECOMBINATE for peri-procedural management for surgical, invasive or interventional radiology procedures Yes No Patient is using RECOMBINATE as treatment of acquired Factor VIII inhibitors not exceeding 10 Bethesda Unit (BU) per milliliter (ml) Xyntha: Yes No Patient has hemophilia A and factor VIII deficiency and is using Xyntha to treat bleeding episodes Yes No Patient has hemophilia A and Factor VIII deficiency and is using Xyntha for peri-procedural management for surgical, invasive or interventional radiology procedures Obizur: Yes No Patient is using Obizur for treatment of bleeding episodes in adults with acquired hemophilia A

10 Page 10 Alphanate: Yes No Patient has a diagnosis of von Willebrand disease (Type 1,2 or unknown) If Yes Yes No The patient has severe von Willebrand disease (VWD) Yes No The patient has mild to moderate von Willebrand disease (VWD) and use of desmopressin is known or suspected to be inadequate If Yes: The patient is being treated for (please indicate: Yes No Spontaneous and trauma-induced bleeding episodes Yes No Spontaneous Peri-procedural management for surgical, invasive or interventional radiology procedures Yes No The patient has hemophilia A and Factor VIII deficiency and is using Alphanate to treat bleeding episodes Yes No The patient has acquired Factor VIII deficiency and is using Alphanate to treat bleeding episodes HUMATE-P: Yes No Patient has a diagnosis of von Willebrand disease (Type 1, 2 or unknown) If Yes Yes No The patient has severe von Willebrand disease (VWD) Yes No The patient has mild to moderate von Willebrand disease (VWD) and use of desmopressin is known or suspected to be inadequate If Yes: The patient is being treated for (please indicate: Yes No Spontaneous and trauma-induced bleeding episodes Yes No Spontaneous Peri-procedural management for surgical, invasive or interventional radiology procedures Yes No The patient has hemophilia A and Factor VIII deficiency and is using HUMATE-P to treat bleeding episodes Wilate: Yes No Patient has a diagnosis of von Willebrand disease (Type 1, 2 or unknown) If Yes Yes No The patient has severe von Willebrand disease (VWD) Yes No The patient has mild to moderate von Willebrand disease (VWD) and use of desmopressin is known or suspected to be inadequate If Yes: The patient is being treated for (please indicate: Yes No Spontaneous and trauma-induced bleeding episodes Yes No Spontaneous Peri-procedural management for surgical, AlphaNine SD OR Mononine: invasive or interventional radiology procedures Yes No The patient has hemophilia B and Factor IX deficiency and is using requested drug to treat bleeding episodes BEBULIN OR Profilnine SD: Yes No The patient has hemophilia B (congenital factor IX deficiency or Christmas disease) and is using the requested drug to treat bleeding episodes BeneFix: Yes No The patient has hemophilia B (congenital factor IX deficiency or Christmas disease) and is using the requested drug to treat bleeding episodes Yes No The patient has hemophilia B (congenital factor IX deficiency or Christmas disease) and is using BeneFix as peri-procedural management for surgical, invasive or interventional radiology procedures

11 Page 11 RIXUBIS: Yes No The patient has hemophilia B (congenital factor IX deficiency or Christmas disease) and is using the requested drug to treat bleeding episodes Yes No The patient has hemophilia B (congenital factor IX deficiency or Christmas disease) and is using BeneFix as peri-procedural management for surgical, invasive or interventional radiology procedures Yes No Patient has severe hemophilia B (defined as less than or equal to 1 IU/dL or 1% endogenous Factor IX) and using RIXUBIS as routine prophylaxis to prevent or reduce the frequency of bleeding episodes Yes No Patient 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) and using RIXUBIS as routine prophylaxis to prevent or reduce the frequency of bleeding episodes If Yes: The patient has a documented history of one of the following (please indicate): Yes No One or more episodes of spontaneous bleeding into joint Yes No One or more episodes of spontaneous bleeding into the central nervous system Yes No Four or more episodes of soft tissue bleeding in an eight week period Corifact: Yes No Patient has Factor XIII deficiency and is using Corifact as routine prophylactic treatment Yes No Patient has congenital Factor XIII deficiency and is using Corifact as peri-procedural management for surgical, invasive or interventional radiology procedures TRETTEN: Yes No Patient has congenital Factor XIII A-subunit deficiency and is using TRETTEN for routine prophylaxis for bleeding RiaSTAP: Yes No Patient has congenital fibrinogen deficiency (that is, afibrinogenemia or hypofibrinogenemia) and is using RiaSTAP to treat acute bleeding episodes

12 Page 12 Section III Physician Information Physician Name National Provider Identification (NPI) Number Clinic Name Address (Street, City, State, Zip Code) Physician Telephone Number Physician Fax Number Physician Signature Date Section IV For WEA Trust Use Only Plan: Copay Tiers: Date of Receipt: Remarks: Approve Deny More information is needed Incomplete form Submission and review of this form does not guarantee approval of this request. Unless approved, payment of the brand-name medication will be limited to the amount the Trust would have paid for the generic equivalent. Insureds and providers will be informed of the decision in writing within approximately 30 days. Fax to: Pharmacy Services (608) Mail to: WEA Trust Pharmacy Services Prior Authorization PO Box Eagan, MN

Medication Prior Authorization Form

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