PHC Medi-Cal P & T: October 08, 2020 Approved New & Revised PA Criteria: Effective 01/01/2021 Brand/Trade names are shown for reference purposes only. Criteria apply to the generic product when a generic equivalent has been approved by the FDA. Additional criteria apply to brand name requests (when a generic is available), per PHC Policy #MPRP4033 . C-1 esterase inhibitor (human) inj, 10 units C-1 esterase inhibitor (human) inj, 10 units Ecallantide inj, 1 mg SC IV inj. (Berinert™) IV inj. (Cinryze™) (Kalbitor™) C-1 esterase inhibitor (recombinant) inj, 10 C-1 esterase inhibitor (human) inj, 10 units Icatibant inj, 1 mg SC units IV inj. (Ruconest™) SC (Haegarda™) (Firazyr™) Hyaluronic acid derivative, per dose intra- Hyaluronic acid derivative, per dose, intra- Hyaluronic acid derivative inj. 0.1 mg articular inj. (Euflexxa™) articular inj. (Gel-One™) intra-articular inj. (Gelsyn-3™) Hyaluronic acid derivative inj. 1 mg intra- Hyaluronic acid derivative inj, per dose intra- Hyaluronic acid derivative inj. per articular inj. (Genvisc 850™) articular inj. (Hyalgan™, Supartz FX™) dose intra-articular inj. (Visco-3™) Hyaluronic acid derivative inj, per dose Hyaluronic acid derivative inj, per dose Hyaluronic acid derivative inj. 1 mg intra-articular inj.(Monovisc™) intra-articular inj. (OrthoVisc™) intra-articular inj. (Trivisc™) Hyaluronic acid derivative Hyaluronic acid derivative inj. 1 mg intra- Hyaluronic acid derivative, 1 mg inj. 1 mg intra-articular inj. (Hymovis™) articular inj. (Synvisc- One™) intra-articular inj. (Durolane™) TNF Blocking Agent, Golimumab inj, 1 mg TNF Blocking Agent, Infliximab – axxq inj, Lanadelumab-flyo inj, 1 mg SC IV (Simponi Aria™) 10 mg IV (Avsola™) (Takhzyro™) Triamcinolone acetionide/PF, ER inj. 1 mg Interleukin-6 receptor antagonist, DMARD Mometasone Furoate Intra-articular inj. (Zilretta™) Tocilizumab inj. 1 mg IV (Actemra™) Sinus Implant (Sinuva™) Selective T-Cell Costimulation Blocker, TNF Blocking Agent, Golimumab inj, 1 mg Abatacept, 10 mg IV (Orencia™) sub-cutaneous pen & pre-filled syringes. Self-injectable (Simponi™) Eureka | Fairfield | Redding | Santa Rosa (707) 863-4100 | www.partnershiphp.org Requirements for Berinert (C1 Inhibitor Concentrate) Unless otherwise specified as having renewal requirements, criteria apply to new starts only. Include documentation of continuation of care if member is not new to treatment. PA Criteria Criteria Details Covered Uses Treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adults and pediatric patients. Short-term prophylaxis before high-risk dental, medical, or surgical procedure (e.g. any mechanical impact to the upper aerodigestive tract) in the setting of confirmed HAE diagnosis. Exclusion Criteria Combination with another FDA-approved product for treatment of acute HAE attacks (e.g. Ruconest, Firazyr, Kalbitor). Required Medical Clinical documentation to support the following must be provided: Information 1) Confirmation and classification of HAE subtype required by laboratory evidence (see Other Criteria below for additional subtype documentation) 2) Frequency, severity, and duration of cutaneous attacks without concomitant urticaria, abdominal attacks, or airway swelling attacks along with any treatment history for the attack(s). 3) Medications known to cause angioedema or exacerbate the frequency and/or severity of HAE attacks (e.g. Estrogens, ACE-Inhibitors, ARBs, NSAIDs, tamoxifen) have been evaluated and discontinued when appropriate. 4) Confirmation of antihistamine-refractory angioedema may be required (see Other Criteria, below). Age Restriction 5 years of age and older Prescriber Diagnosis of hereditary angioedema, which has been clinically established by an Restrictions allergist or immunologist. A minimum of an annual assessment by a specialist is required for renewals. Coverage Duration Pharmacy TARs: TBD Medical TARs: Self-administered drug; limited to one dose at a medical practice. Other Criteria Evidence to support diagnosis of one of the following subtypes: HAE with C1-INH deficiency (Type I) HAE with C1-INH dysfunction (Type II) HAE with normal C1-INH also known as FXII-HAE or U-HAE (Type III) Acquired Angioedema with C1-INH deficiency (C1INH-AAE) Supporting evidence must be provided as follows: 1) Required laboratory evidence for all HAE types – serum C4 level, C1-INH functional level, and C1-INH antigenic protein level. 2) Additional requirement for HAE type III – documented evidence of either HAE- causing gene mutation (e.g. F12, angiopoietin-1, or plasminogen gene) OR failure to respond to chronic, high-dose antihistamine therapy in a patient with family history of HAE. 3) Additional requirement for C1INH-AAE type - C1q lab result, no documented family history of angioedema, and evaluation for an underlying hematologic or lymphoproliferative disorder must be completed. Quantity limit per month: 20 IU/kg of body weight per single dose, up to 2 doses administered in a 24-hour period. Up to 4 doses in a 28-day period (covering 2 attacks per month). Note: Consideration for routine prophylactic therapy may be required for patients requiring 2 or more on-demand (acute) treatments per month. Pharmacy Claims: AllianceRX/Walgreens Prime Specialty Pharmacy required. Medical Drug Billing: HCPCS J0597, Injection, C-1 Esterase Inhibitor (human), Berinert, 10 units. NOTE: Berinert is FDA approved as a self-administered injection, and as such, should be provided to the member by a pharmacy. Exceptions may be made for a one-time request for medical reimbursement when necessary for first dose administration training &/or to monitor the member’s response to the first dose. Subsequent doses must be provided by issuing a prescription for pharmacy dispensing to the member. Partnership HealthPlan of California Effective Jan 1, 2021 Eureka | Fairfield | Redding | Santa Rosa (707) 863-4100 | www.partnershiphp.org UnlessRequirements otherwise specified as having for renewal Cinryze requirements, criteria(C1 apply Inhibitor to new starts only. Concentrate) Include documentation of continuation of care if member is not new to treatment. Unless otherwise specified as having renewal requirements, criteria apply to new starts only. Include documentation of continuation of care if member is not new to treatment. PA Criteria Criteria Details Covered Uses Routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients greater than or equal to 6 years of age with hereditary angioedema (HAE). Exclusion Criteria Combination with another FDA-approved product for routine prophylaxis of HAE attacks (e.g. Haegarda, Takhzyro). Required Medical Clinical documentation to support the following must be provided: Information 1) Confirmation and classification of HAE subtype required by laboratory evidence (see Other Criteria below for additional subtype documentation). 2) Frequency, severity, and duration of cutaneous attacks without concomitant urticaria, abdominal attacks, or airway swelling attacks along with any treatment history for the attack(s). 3) Medications known to cause angioedema or exacerbate the frequency and/or severity of HAE attacks (e.g. estrogens, ACE-Inhibitors, ARBs, NSAIDs, tamoxifen) have been evaluated and discontinued when appropriate. 4) Confirmation of antihistamine-refractory angioedema and failure to preferred Lanadelumab (Takhzyro) may be required (see Other Criteria, below). Age Restrictions 6 years of age and older Prescriber Diagnosis of HAE, which has been clinically established by an allergist or Restrictions immunologist. A minimum of an annual assessment by a specialist is required for renewals. Coverage Duration Pharmacy TARs: Initial, up to 3 months. Renewals up to 6 months. Medical TARs: Self-administered drug; limited to one dose at a medical practice. Other Criteria Evidence to support a diagnosis of one of the following subtypes: HAE with C1-INH deficiency (Type I), HAE with C1-INH dysfunction (Type II), HAE with normal C1-INH also known as FXII-HAE or U-HAE (Type III), Acquired Angioedema with C1-INH deficiency (C1INH-AAE). Supporting evidence must be provided as follows: 1) Required laboratory evidence for all HAE types – serum C4 level, C1-INH functional level, and C1-INH antigenic protein level. 2) Additional requirement for HAE type III – documented evidence of either HAE-causing gene mutation (e.g. F12, angiopoietin-1, or plasminogen gene) OR failure to respond to chronic, high-dose antihistamine therapy in a patient with family history of HAE. 3) Additional requirement for C1INH-AAE type -- C1q lab result, no documented family history of angioedema, and evaluation for an underlying hematologic or lymphoproliferative disorder must be completed. Once diagnosis is confirmed and prophylactic therapy is established as medically necessary, adequate trial and failure, or contraindication, to preferred prophylactic therapy of lanadelumab (Takhzyro) must be provided (requirement waived for children less than 12 years of age). Renewals may be approved for up to 6 months when TAR is submitted with documentation of reduction in frequency, severity, and duration of HAE attacks since starting therapy and reduction of acute treatment medication fills as supported by pharmacy claim history. Medical Drug Billing: HCPCS J0598, Injection, C-1 Esterase Inhibitor (human), Cinryze, 10 units. NOTE: Cinryze is FDA approved as a self-administered maintenance drug, and as such, should be provided to the member by a pharmacy. Exceptions may be made for