MEDICATION PRIOR AUTHORIZATION CRITERIA

Transcription

1 UNITY HEALTH PLAN MEDICATION PRI AUTHIZATION CRITERIA These medication prior authorization criteria do not apply to Unity State and Local Government members or Unity BadgerCare Plus members. State and Local Government members should call Navitus at (866) or visit for information about your prescription drug benefits. Unity BadgerCare Plus members must call the Wisconsin Department of Health and Family Services at (800) or visit for information about your prescription drug benefits. Underwritten by Unity Health Insurance Corporation

2 11/01/2018

3 Generic Name Brand Name HICL GCN Exception/Other ABEMACICLIB VERZENIO Abemaciclib (Verzenio) Two tablets per day dosing (#60) Drug must be prescribed and monitored by an Oncologist, Hematologist, or other specialist in the treatment of malignancy The requested drug is FDA-labeled for the treatment of the specific condition the person presents with* The requested drug has a class 1 or 2 recommendation for use from the National Comprehensive Cancer Network (NCCN) in the specific condition of the person* *includes any relevant genetic testing, mutations, etc. CRITERIA F QUANTITY EXCEPTION: Prescriber provides an evidence-based rationale for using a dose outside of the quantity limit. CONTINUATION OF COVERAGE CRITERIA: Persons new to coverage who are established on therapy will have coverage under their drug benefit for the remainder of the current treatment course. Restrictions to specific network pharmacies and participation in medication management programs may apply. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. Page 2

4 Generic Brand HICL GCN Exception/Other ABIRATERONE ZYTIGA ACETATE ABIRATERONE SUBMICRONIZED YONSA Abiraterone (Zytiga, Yonsa) (Zytiga Only): Medication is included in the Specialty Medication Outcomes Management program. Drug must be obtained from one of the Specialty Pharmacies. Please refer to the Pharmacy Benefits section of the website Drug must be prescribed and monitored by an Oncologist, Hematologist, or other specialist in the treatment of malignancy The requested drug is FDA-labeled for the treatment of the specific condition the person presents with* The requested drug has a class 1 or 2 recommendation for use from the National Comprehensive Cancer Network (NCCN) in the specific condition of the person* *includes any relevant genetic testing, mutations, etc. CONTINUATION OF COVERAGE CRITERIA: Persons new to coverage who are established on therapy will have coverage under their drug benefit for the remainder of the current treatment course. Restrictions to specific network pharmacies and participation in medication management programs may apply. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. Page 3

5 Generic Name Brand Name HICL GCN Exception/Other ACALABRUTINIB CALQUENCE Acalabrutinib (Calquence) Two capsules per day dosing (#60) Covered for the treatment of adults with mantle cell lymphoma (MCL) who have relapsed or progressed after at least one prior therapy Other FDA labeled indications not listed above CRITERIA F QUANTITY EXCEPTIONS: The prescriber provides an evidence-based clinical rationale for use of a dose outside of the quantity limit CONTINUATION OF COVERAGE CRITERIA: Persons new to coverage who are established on therapy will have coverage under their drug benefit for the remainder of the current treatment course. Restrictions to specific network pharmacies and participation in medication management programs may apply. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. Page 4

6 Generic Name Brand Name GCN HICL Exception/Other ACETAMINOPHEN- CAFFEINE- DIHYDROCODEINE ACETAMINOPHEN- CAFFEINE- DIHYDROCODEINE Acetaminophen-Caffeine-Dihydrocodeine Indefinite Therapeutic failure or intolerance of at least 2 preferred acetaminophen/narcotic analgesic combinations. Page 5

7 Generic Name Brand Name GCN HICL Exception/Other ACYCLOVIR SITAVIG Acyclovir Buccal (Sitavig) Diagnosis of herpes labialis Failure or intolerance to two preferred antiviral alternatives (such as acyclovir tablets or valacyclovir) Page 6

8 Generic Name Brand Name GCN HICL Exception/Other ACYCLOVIR/ XERESE HYDROCTISONE Acyclovir/Hydrocortisone Topical (Xerese) Contraindication to use of acyclovir 5% topical and hydrocortisone 1% topical as separate products Prescriber provides an evidence-based rationale for why the combination product would not be contraindicated Page 7

9 Generic Brand HICL GCN Exception/Other AFATINIB GILOTRIF Afatinib (Gilotrif) Initial therapy 3 months of partial fill (max 15 days) Maintenance therapy (after first 3 months) 1 month One tablet per day dosing Drug must be prescribed and monitored by an Oncologist, Hematologist, or other specialist in the treatment of malignancy The requested drug is FDA-labeled for the treatment of the specific condition the person presents with* The requested drug has a class 1 or 2 recommendation for use from the National Comprehensive Cancer Network (NCCN) in the specific condition of the person* *includes any relevant genetic testing, mutations, etc. Included in the Oral Oncology Program which requires: Prescription filled at a participating specialty pharmacy (call or ) Partial dispensing of 15 days supply for initial 3 three months of this therapy Participation in medication therapy program coordinated by oncology pharmacist from the specialty pharmacy CONTINUATION OF COVERAGE CRITERIA: Persons new to coverage who are established on therapy will have coverage under their drug benefit for the remainder of the current treatment course. Restrictions to specific network pharmacies and participation in medication management programs may apply. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. Page 8

10 Generic Brand HICL GCN Exception/Other ALECTINIB ALECENSA HYDROCHLIDE Alectinib (Alecensa) Initial therapy - 3 months of partial fill (max 15 days) Maintenance therapy (after first 3 months) - 1 month Eight capsules per day (#240) Covered for persons with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on, or are intolerant to, crizotinib. FDA labeled indications Included in the Oral Oncology Program which requires: Prescription filled at a participating specialty pharmacy (call or ) Partial dispensing of 15-day supply for initial 3 months of therapy Participation in medication therapy program coordinated by oncology pharmacist from the specialty pharmacy CONTINUATION OF COVERAGE CRITERIA: Persons new to the plan who are established on therapy will have coverage under their drug benefit for the remainder of the current treatment course. Restrictions to specific network pharmacies and participation in medication management programs may apply. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. CRITERIA F QUANTITY EXCEPTIONS: Clinical rationale for prescribed dosing regimen provided & regimen not possible within the quantity limits Page 9

11 Generic Brand HICL GCN Exception/Other ALGLUCOSIDASE MYOZYME, ALFA LUMIZYME Alglucosidase-Myozyme/Lumizyme Medical Benefit Covered for persons with a diagnosis of Pompe disease F BADGERCARE COVERAGE: Please see Forward Health for criteria or diagnosis restrictions Page 10

12 Generic Brand HICL GCN Exception/Other ALOSETRON HCL LOTRONEX Alosetron 0.5mg- #90/30 days, 1mg- #60/30 days Person with diarrhea- predominant irritable bowel syndrome (IBS) Prescribed by physician certified in the alosetron REMS Program Failed one month trial of conventional therapy (such as loperamide or diphenoxylate/atropine) CRITERIA F COVERAGE OF QUANTITY EXCEPTIONS: Therapeutic failure or intolerance to twice daily dosing for available strengths Clinical rationale for prescribed dosing regimen provided & regimen not possible within the quantity limits CONTIUATION OF COVERAGE CRITERIA: Persons new to coverage who are established on therapy will have coverage under their drug benefit for the remainder of the current treatment course. Restrictions to specific network pharmacies and participation in medication management programs may apply. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. Page 11

13 Generic Brand HICL GCN Exception/Other ALPHA-1- PROTEINASE INHIBIT ARALAST NP GLASSIA PROLASTIN C ZEMAIRA Alpha-1 Proteinase Inhibitors Medical Benefit Alpha-1 proteinase deficient (< 11 mmol/l) Person is no longer smoking Evidence of COPD (FEV 1 25% to 80% predicted) attributable to emphysema Maximized COPD therapy based on GOLD guidelines Page 12

14 Generic Name Brand Name GCN HICL Exception/Other AMANTADINE HCL GOCOVRI 43787, AMANTADINE HCL OSMOLEX ER 44471, 44472, Amantadine ER (Gocovri, Osmolex ER) One per day (#30) Prescribed by a Neurologist or other expert in the treatment of Parkinson s disease Person with dyskinesia despite maximized dosing of carbidopa/levodopa (documentation of adjustments required) Drug-induced extrapyramidal symptoms that persist despite dose reduction or discontinuation of the causative drug or the drug cannot be stopped due to uncontrolled symptoms Use of maximized amantadine immediate-release did not control symptoms or caused side effects CRITERIA F COVERAGE OF QUANTITY EXCEPTIONS: Therapeutic failure or intolerance to one dose unit per day and the prescriber provides an evidencebased clinical rationale for use of a dose outside of the quantity limit Page 13

15 Generic Name Brand Name GCN HICL Exception/Other AMOXICILLIN MOXATAG Amoxicillin ER (Moxatag) Covered for persons with therapy-limiting side effects that limit use of a preferred amoxicillin product at equivalent doses The prescriber provides an evidence-based clinical rationale as to why a different result would be expected with use of amoxicillin ER Page 14

16 Generic Brand HICL GCN Exception/Other ANAKINRA KINERET Anakinra (Kineret) #30 injections per month Prescribed by a Rheumatologist Medication must be self-administered A diagnosis of moderate to severely active rheumatoid arthritis (RA), reactive arthritis, juvenile idiopathic arthritis (JIA) and failure of two other biologic DMARD therapies such as etanercept, adalimumab, certolizumab, golimumab or infliximab. A diagnosis of cryopyrin associated periodic syndromes (CAPS) including Muckle Wells, neonatalonset multisystemic inflammatory disorder, familial cold autoinflammatory syndrome CRITERIA F COVERAGE OF QUANTITY EXCEPTIONS: Therapeutic failure or intolerance to one dose unit per day for available strengths Clinical rationale for prescribed dosing regimen provided & regimen not possible within the quantity limits CRITERIA F CONTINUATION OF THERAPY: Prescriber provides clinical documentation from the previous 12 months that describes the person s response as stable disease or improvement seen on therapy. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. IMPTANT INFMATION: Although anakinra is FDA-labeled for use in moderate to severely active RA, it is not the preferred choice for this diagnosis as other therapies are better tolerated and have greater efficacy for this indication. Page 15

17 Generic name Brand name HICL GCN Exception/Other ASENAPINE SAPHRIS MALEATE BREXPIPRAZOLE REXULTI CARIPRAZINE VRAYLAR HCL ILOPERIDONE FANAPT LURASIDONE HCL LATUDA Restricted Antipsychotics DRUG NAME FMULARY STATUS QUANTITY LIMITS Asenapine (Saphris) Brexpiprazole (Rexulti) 1 tablet/day (#30) Cariprazine (Vraylar) 1 capsule/day (#30) Iloperidone (Fanapt) Lurasidone (Latuda) 1 tablet/day (#30) CRITERIA F COVERAGE (asenapine, cariprazine, iloperidone, lurasidone): Therapeutic failure after an adequate trial (dose and duration) with, or development of a clinically significant intolerance to, at least one preferred second generation antipsychotic (aripiprazole, olanzapine, risperidone, quetiapine, or ziprasidone). CRITERIA F COVERAGE (brexpiprazole): Therapeutic failure after an adequate trial (dose and duration) of, or development of a clinically significant intolerance to, aripiprazole. CONTINUATION OF COVERAGE CRITERIA: Persons new to the plan who are being treated for depression or other mood disorders and are established on therapy will have coverage under their drug benefit with documentation of symptom improvement or disease stability. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. CRITERIA F QUANTITY EXCEPTIONS: Therapeutic failure or intolerance of one tablet per day dosing or prescriber presents rationale, clinical reason for utilizing a dosing regimen that is not possible within the quantity limits. Page 16

18 Generic Name Brand Name HICL GCN Exception/Other APALUTAMIDE ERLEADA Apalutamide (Erleada) Four tablets per day dosing (#120) Drug must be prescribed and monitored by an Oncologist, Hematologist, or other specialist in the treatment of malignancy The requested drug is FDA-labeled for the treatment of the specific condition the person presents with* The requested drug has a class 1 or 2 recommendation for use from the National Comprehensive Cancer Network (NCCN) in the specific condition of the person* *includes any relevant genetic testing, mutations, etc. CRITERIA F QUANTITY EXCEPTIONS: The prescriber provides an evidence-based clinical rationale for use of a dose outside of the quantity limit CONTINUATION OF COVERAGE CRITERIA: Persons new to coverage who are established on therapy will have coverage under their drug benefit for the remainder of the current treatment course. Restrictions to specific network pharmacies and participation in medication management programs may apply. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. Page 17

19 Generic Brand HICL GCN Exception/Other ARIPIPRAZOLE ABILIFY 26445, DISCMELT Aripiprazole Rapid Tabs Aripiprazole rapid tabs (Abilify Discmelt) - One tablet per day dosing (#30) Person is established on aripiprazole with objective clinical documentation of benefit. Person has breakthrough symptoms due to documented poor adherence (a medication possession ratio (MPR 60% based on the previous 6 months of claims) despite interventions from a pharmacist and other health care providers. CONTINUATION OF COVERAGE CRITERIA: Therapeutic failure or intolerance of one tablet per day dosing or prescriber presents rationale, clinical reason for utilizing a dosing regimen that is not possible within the quantity limits. Page 18

20 Generic Name Brand Name HICL GCN Exceptions/Other ASFOTASE ALFA STRENSIQ Asfotase alfa (Strensiq) 12 months Initiated by an Endocrinologist Covered for persons with a diagnosis of perinatal, infantile, or juvenile-onset hypophosphatasia (HPP) with symptom onset by age 6 months documented hypophosphatasia-related skeletal disease Other FDA labeled indications CONTINUATION OF COVERAGE CRITERA: The doctor provides clinical documentation from the previous 12 months demonstrating improvements in skeletal quality from baseline Page 19

21 Generic Brand HICL GCN Exception/Other ASPIRIN DURLAZA Aspirin ER (Durlaza) One tablet per day (#30) Covered for persons with a history of: o Myocardial infarction (MI) o Unstable angina o Transient ischemic attack (TIA) o Ischemic stroke Initiated by, or in consultation with, a Cardiologist or Neurologist The person has experienced a side effect, or has a contraindication to, over the counter aspirin use The prescribing provider documents a clinical rationale why this reaction would not occur with the extended-release product CRITERIA F QUANTITY EXCEPTIONS: Therapeutic failure or intolerance to once daily dosing for available strengths Clinical rationale for prescribed dosing regimen provided & regimen not possible within the quantity limits IMPTANT INFMATION: Use of extended-release aspirin when a rapid onset of action is required (such as acute treatment of myocardial infarction) is not recommended. Page 20

22 Generic Name Brand Name HICL GCN Exception/Other METHYLPHENIDATE APTENSIO XR 40/ , 97235, 97236, 97237, 97238, 97239, METHYLPHENIDATE QUILLICHEW ER 24HR 40292, 40293, METHYLPHENIDATE QUILLIVANT SUSPENSION ER AMPHETAMINE EVEKEO 19821, AMPHETAMINE ADZENYS XR ODT, ADZENYS ER SUSP, DYANAVEL XR SUSP METHYLPHENIDATE COTEMPLA XR ODT DEXTROAMPHETAMINE/ AMPHETAMINE MYDAYIS Attention Deficit Disorder Medications Aptensio XR 40/60 Quillichew ER 24 Quillivant suspension ER Evekeo Adzenys XR ODT, ER suspension Dyanavel XR suspension Cotempla XR ODT Mydayis Indefinite Failure of an adequate trial of 2 preferred long acting ADHD stimulant medications or intolerable side effects from 2 preferred long-acting ADHD stimulant medications. Page 21

23 Generic Brand HICL GCN Exception/Other AVATROMBOPAG DOPTELET LUSUTROMBOPAQ MULPLETA Thrombopoietin Receptor Agonists For Liver Failure Avatrombopaq - Lusutrombopaq - Avatrombopaq - Lusutrombopaq - 5 days (1 fill) 7 days (1 fill) Avatrombopaq - Three tablets per day (#15) Lusutrombopaq - One tablet per day (#7) Prescribed by Hematology Platelet count < 50,000/mL due to liver cirrhosis Scheduled procedure with moderate to high bleeding risk scheduled in the next 14 days CRITERIA F COVERAGE OF QUANTITY EXCEPTIONS: The prescriber provides an evidence-based rationale for using a dose outside of the quantity limit. CRITERIA F DURATION EXCEPTIONS: The prescriber provides published evidence to support a duration of treatment greater than 14 days. Page 22

24 Generic Brand HICL GCN Exception/Other AXITINIB INLYTA Axitinib (Inlyta) Initial therapy- 3 months of partial fill (max 15 days) Maintenance therapy (after first 3 months) - One month Covered for persons with advanced renal cell carcinoma after failure of one prior systemic therapy FDA labeled indications Included in the Oral Oncology Program which requires: Prescription filled at a participating specialty pharmacy (call ) Partial dispensing of 15 days supply for initial 3 three months of this therapy Participation in medication therapy program coordinated by oncology pharmacist from the specialty pharmacy CONTINUATION OF COVERAGE CRITERIA: Persons new to coverage who are established on therapy will have coverage under their drug benefit for the remainder of the current treatment course. Restrictions to specific network pharmacies and participation in medication management programs may apply. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. Page 23

25 Generic Name Brand Name GCN HICL Exception/Other AZATHIOPRINE AZASAN 19173, Azathioprine (Azasan) Person is nonadherent to use of azathioprine 50 mg tablets (medication possession ration (MPR < 70%) despite active interventions by a pharmacist and other health care providers* *requires prescription records for validation of nonadherence Page 24

26 Generic Brand HICL GCN Exception/Other AZELAIC ACID 20% AZELEX AZELAIC ACID 15% FINACEA 19198, Azelaic acid (Azelex, Finacea) Azelaic acid 20% (Azelex): Azelaic acid 15% (Finacea): 1. For azelaic acid 15% (Finacea) Diagnosis of rosacea Diagnosis of acne failure/intolerance of tretinoin and adapalene 2. For azelaic acid 20% (Azelex) Diagnosis of acne Failure/intolerance of tretinoin and adapalene Page 25

27 Generic Brand HICL GCN Exception/Other AZELASTINE/FLUTICASONE DYMISTA Azelastine hydrochloride and fluticasone propionate (Dymista ) Diagnosis of seasonal allergic rhinitis Person has had a therapeutic failure to concurrent use of at least one PREFERRED agent in BOTH of the following drug classes: o Intranasal antihistamine (ex. azelastine) o Intranasal corticosteroid (ex. fluticasone propionate, budesonide (PA required)) Page 26

28 Generic Name Brand Name HICL GCN Exception/Other AZTREONAM CAYSTON LYSINE Aztreonam Inhalation Solution (Cayston ) Preferred-Restricted Indefinite #84 (28 day supply, three times daily dosing) Person with a diagnosis of cystic fibrosis History of recurrent Pseudomonas aeruginosa lung infections For inhalation only Recurrence despite prior use of tobramycin inhalation solution or documented tobramycin resistance CRITERIA F COVERAGE OF QUANTITY EXCEPTIONS: Therapeutic failure or intolerance to three times daily dosing Clinical rationale for prescribed dosing regimen provided & regimen not possible within the quantity limits IMPTANT INFMATION: For chronic suppressive therapy, dosing regimen is 28 days on, 28 days off repeating. Page 27

29 Generic Name Brand Name GCN HICL Exception/Other BALSALAZIDE GIAZO DISODIUM Balsalazide (Giazo) Person is age 18 or older and male Use of maximized balsalazide 750 mg capsules (Colazal equivalent) did not control symptoms or caused side effects Page 28

30 Generic Brand HICL GCN Exception/Other BELIMUMAB BENLYSTA Belimumab (Benlysta) (Subcutaneous Injection) Medical Benefit-Restricted (Infusion) 12 months One injection per week (#4 per fill) Prescribed by a Rheumatologist or other expert in the treatment of systemic lupus erythematosus (SLE) Diagnosis of auto-antibody positive moderate to severe SLE but not severe active lupus nephritis or severe active central nervous system lupus Symptoms persist despite treatment with hydroxychloroquine, nonsteroidal anti-inflammatories (NSAIDS such as ibuprofen, naproxen, etc.), a steroid-sparing immunosuppressive such as azathioprine or methotrexate, and a short course of oral steroids. Prescription benefit medications are included in the Specialty Pharmaceuticals Program. Medications except where noted must be obtained from one of the participating pharmacies. Contact or for more details. Prescription benefit medications must be self-administered CRITERIA F COVERAGE (For infusion): Inability to self-administer weekly injection despite adequate teaching and interventions from a pharmacist and other health care providers CRITERIA F COVERAGE OF QUANTITY EXCEPTIONS: Symptoms persist despite treatment with one injection per week and the prescriber provides an evidence-based clinical rationale for use of a dose outside of the quantity limit CRITERIA F CONTINUATION OF COVERAGE: Clinical documentation from the previous 12 months demonstrating benefits from therapy Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers IMPTANT INFMATION: Should not be used in combination with other biologics or IV cyclophosphamide Page 29

31 Bezlotoxumab (Zinplava ) Medical benefit-restricted One dose Person is 18 years or older Prescribed by, or in consultation with, an Infectious Disease specialist Has a confirmed diagnosis of current C diff infection and a positive stool test for toxigenic C difficile from a recent stool sample Has recurrent/refractory C diff infection Must be currently on standard of care antibiotics for C diff (metronidazole, vancomycin, fidaxomicin) Person has had a therapeutic failure, intolerance, or contraindication to fecal microbiota transplantation (FMT) Important information: Use of bezlotoxumab has only been evaluated as a one-time infusion; coverage for additional infusions is considered experimental and will not be covered. Page 30

32 Generic Brand HICL GCN Exception/Other BINIMETINIB MEKTOVI Binimetinib (Mektovi) Six tablets per day (#180) Drug must be prescribed and monitored by an Oncologist, Hematologist, or other specialist in the treatment of malignancy The requested drug is FDA-labeled for the treatment of the specific condition the person presents with* The requested drug has a class 1 or 2 recommendation for use from the National Comprehensive Cancer Network (NCCN) in the specific condition of the person* *includes any relevant genetic testing, mutations, etc. CONTINUATION OF COVERAGE CRITERIA: Persons new to the plan who are established on therapy will have coverage under their drug benefit for the remainder of the current treatment course. Restrictions to specific network pharmacies and participation in medication management programs may apply. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. Page 31

33 Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA APREMILAST OTEZLA BRODALUMAB SILIQ CERTOLIZUMAB CIMZIA ETANERCEPT ENBREL IXEKIZUMAB TALTZ SECUKINUMAB COSENTYX USTEKINUMAB STELARA TILDRAKIZUMAB ILUMYA GUSELKUMAB TREMFYA Biologic Therapy for Dermatology Drug Name Benefit Formulary Status Quantity Limit (maintenance/28 days) First Line Agents: Adalimumab (Humira) RX Preferred Restricted #2 #4 for HS indication Etanercept (Enbrel) RX Preferred Restricted 25 mg - #8 50 mg - #4 Second Line Agents: Apremilast (Otezla) RX Nonpreferred Restricted #60 Certolizumab (Cimzia) RX Nonpreferred Restricted #1kit Infliximab (Remicade, Medical Restricted N/A Inflectra, Renflexis) Ixekizumab (Taltz) RX Nonpreferred Restricted #1 Secukinumab (Cosentyx) RX Nonpreferred Restricted #2 (150 mg) Third Line Agents: Brodalumab (Siliq) RX Nonpreferred Restricted #2 Guselkumab (Tremfya) RX Nonpreferred Restricted #1 Tildrakizumab (Ilumya) RX #1 every 12 weeks Ustekinumab (Stelara) RX Nonpreferred Restricted #1 every 12 weeks Ustekinumab (Stelara) Medical Restricted N/A Quantity Limits: Induction therapy: adalimumab #4 injections 40mg for first month brodalumab #3 injections 210mg for the first month certolizumab #6 injections for first month etanercept #8 injections 50mg for first 3 months ixekizumab #8 injections 80mg for first month, #4 for month 2 and 3 secukinumab #8 (150mg) injections for first month ustekinumab #1 injection/month for first 2 months guselkumab #2 injections for the first month trildrakizumab #2 injections for the first month Maintenance therapy: Approval Limits: See table above Page 32

34 PSIASIS GENERAL 1. Prescribed by a Dermatologist 2. Diagnosis of moderate to severe plaque psoriasis with significant functional disability: a. BSA involvement (>10%) b. debilitating palmar/plantar psoriasis or other vulnerable areas that are difficult to treat such as nails, hairy/scalp areas, genitals or intertriginous areas 3. Clinical failure of prior therapy or contraindication to: Details including medication, dose, potency, duration must be provided for each therapy a. Topical: (e.g. topical corticosteroids, calcipotriene, retinoids) b. Oral Therapy: (e.g. methotrexate, mycophenolate) c. Phototherapy: (e.g. broad band UVB, narrow band UVB, PUVA, excimer) i. If clinic-based phototherapy- record of phototherapy episodes provided. Adherence defined as 3 times per week for one month or if necessary, modified regimen based on required adjustments for tolerability ii. If home-based phototherapy- provision of data log recording use and dose adjustments as need for tolerability Failure is defined as the inability to achieve a clinically significant reduction in plaque thickness and/or erythema and/or scaling and/or itching and lack of clinically significant reduction in the BSA despite adherence to prescribed regimen for a minimum of 12 weeks (topical, systemic) and 4 weeks at maintenance phototherapy. Inability to attend phototherapy sessions will not constitute failure. 4. Prescription benefit medications must be self-administered and are included in the Specialty Pharmaceuticals Program. Medications must be obtained from one of the Specialty Pharmacies. Contact or for more details. 5. Specialty Pharmaceuticals Program excludes brodalumab, guselkumab, and adalimumab 10 and 20 mg dose forms at this time. Note: For psoriatic arthritis, refer to the Rheumatology Biologic Therapy criteria DRUG SPECIFIC CRITERIA F TREATMENT OF MODERATE to SEVERE PLAQUE PSIASIS: For adalimumab General criteria met For etanercept General criteria met For apremilast General criteria met Failure/ intolerance to one preferred first-line biologic DMARDs documented contraindication to anti-tnf therapy Therapy is not being used in combination with other biologics (i.e. anti-tnf therapy, etc) For certolizumab General criteria met Failure/ intolerance to two preferred first-line biologic DMARD For infliximab General criteria met Page 33

35 Failure/ intolerance to two preferred first-line biologic DMARDs For ixekizumab General criteria met Failure/ intolerance to two preferred first-line biologic DMARDs For secukinumab General criteria met Failure/ intolerance to two preferred first-line biologic DMARDs For ustekinumab and tildrakizumab General criteria met Failure/ intolerance to two preferred first-line biologic DMARDs Failure/ intolerance to two second line biologic DMARDs For brodalumab and guselkumab General criteria met Failure/ intolerance to two preferred first-line biologic DMARDs Failure/ intolerance to two second line biologic DMARDs HIDRADENITIS SUPPURATIVA (HS) 1. Prescribed by a Dermatologist 2. Severe and/or refractory disease (Hurley II/Hurley III stage) with lesions despite previous treatment with topical antibiotics, systemic antibiotics, intralesional glucocorticoids, and/or surgical debridement Therapy options: Adalimumab or infliximab CRITERIA F QUANTITY EXCEPTIONS (Adalimumab/Etanercept): Requires concomitant methotrexate (unless contraindicated) Failure of an adherent 3-month trial of standard maintenance dosing with concomitant methotrexate (unless contraindicated) CRITERIA F CONTINUATION OF THERAPY: For members new to the plan, the prescriber must provide clinical documentation from the previous 12 months of the person s response to therapy (e.g. improvement in PASI, PGA, TBSA affected, etc.) Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. Page 34

36 Generic Brand HICL GCN Exception/Other ABATACEPT ENCIA ADALIMUMAB HUMIRA APREMILAST OTEZLA CERTOLIZUMAB CIMZIA PEGOL ETANERCEPT ENBREL GOLIMUMAB SIMPONI SARILUMAB KEVZARA SECUKINUMAB COSENTYX TOCILIZUMAB ACTEMRA TOFACITINIB CITRATE XELJANZ (IR, XR) USTEKINUMAB STELARA IXEKIZUMAB TALTZ BARICITINIB OLUMIANT Biologic Therapy for Rheumatology Drug Name Benefit Formulary Status Quantity Limit (maintenance/28 days) First Line Agents: Adalimumab (Humira) RX Preferred Restricted #2 Etanercept (Enbrel) RX Preferred Restricted 25 mg - #8 50 mg - #4 Second Line Agents: Abatacept (Orencia) RX Nonpreferred Restricted #4 Abatacept infusion (Orencia) Medical Restricted N/A Apremilast (Otezla) RX Nonpreferred Restricted #60 Certolizumab (Cimzia) RX Nonpreferred Restricted #1 Infliximab infusion (Remicade, Medical Restricted N/A Inflectra, Renflexis) Secukinumab (Cosentyx) RX Nonpreferred Restricted #1 Tocilizumab infusion Medical Restricted N/A (Actemra) Tocilizumab (Actemra) RX Nonpreferred Restricted #2 Tofacitinib (Xeljanz) RX Nonpreferred Restricted #60 Tofacitinib ER (Xeljanz XR) RX Nonpreferred Restricted #30 Third Line Agents: Baricitinib (Oluminat) RX Nonpreferred Restricted #30 Golimumab (Simponi) RX Nonpreferred Restricted #1 Golimumab infusion Medical Restricted N/A (Simponi Aria) Sarilumab (Kevzara) RX Nonpreferred Restricted #2 Ustekinumab (Stelara) RX Nonpreferred Restricted #1 every 12 weeks Ustekinumab (Stelara) Medical Restricted N/A Ixekizumab (Taltz) RX Nonpreferred Restricted #1 Page 35

37 Quantity Limits: Induction therapy: adalimumab #6 injections 40mg for first month certolizumab #3 injection kits for first month golimumab #3 injections 100mg for first month secukinumab #4 injections for the first month ixekizumab #2 injections 80 mg for the first month (If also treating active psoriasis: #8 injections 80 mg for first month, #4 for month 2 and 3 Maintenance therapy: as listed in the table Approval Limits: RHEUMATOLOGY INDICATION GENERAL Prescribed by a Rheumatologist Prescription benefit medications are included in the Specialty Pharmaceuticals Program. Medications except where noted must be obtained from one of the participating pharmacies. Contact or for more details. Specialty Pharmaceuticals Program excludes adalimumab 10 and 20 mg and sarilumab dose forms at this time. Prescription benefit medications must be self-administered 1. For diagnosis of moderate to severely active established (disease duration of greater than 6 months) rheumatoid arthritis (RA), reactive arthritis, or juvenile idiopathic arthritis (JIA) Documented failure with a 3 month trial of methotrexate at therapeutic doses unless contraindicated Persons intolerant to, or with a contraindication to MTX therapy should fail an adequate trial (3 months) with another disease modifying anti-rheumatic drugs such as hydroxychloroquine, sulfasalazine, leflunomide or minocycline 2. For diagnosis of early RA (less than 6 months disease duration) with feature of poor prognosis (at least one item) 1. Functional limitations (based on HAQ or similar tool) 2. Extraarticular disease (e.g. presence of rheumatoid nodules, RA vasculitis or Felty s syndrome (rheumatoid arthritis with splenomegaly and neutropenia) 3. positive rheumatoid factor or anti-cyclic citrullinated peptide antibodies (anti-ccp antibodies) 4. bony erosions on X-ray. 3. For diagnosis of ankylosing spondylitis (AS) not controlled by a 2 month trial of scheduled prescription doses of two different NSAIDs (such as naproxen, nabumetone, diclofenac, etc.) 4. For diagnosis of moderate to severely active psoriatic arthritis (PsA) and documented failure/intolerance to adequate trial (minimum 3 months) of methotrexate therapy (unless contraindication). DRUG-SPECIFIC For adalimumab General criteria met For etanercept General criteria met Page 36

38 For certolizumab General criteria met Failure/intolerance of two preferred first line biologic DMARD For golimumab General criteria met Failure/intolerance of two first line biologic DMARD and one second line biologic DMARD for a diagnosis of AS Failure/intolerance of two first line biologic DMARD and two second line biologic DMARD with a diagnosis of RA, reactive arthritis, JIA, other auto-inflammatory arthropathies, or PsA used in combination with methotrexate unless contraindicated For infliximab General criteria met Failure/intolerance of two first line biologic DMARD For abatacept General criteria met Failure/intolerance of two first line biologic DMARD Contraindication to anti-tnf therapy For tocilizumab General criteria met Diagnosis of moderate to severely active established RA, JIA or reactive arthritis Failure/intolerance to two first line biologic DMARD Contraindication to anti-tnf therapy General criteria met Diagnosis of systemic juvenile idiopathic arthritis or adult-onset Still s disease Failure of an adequate trial (3 months) of corticosteroids and methotrexate General criteria met Diagnosis of giant cell arteritis which has relapsed despite use of corticosteroids or methotrexate Inability to taper corticosteroids (Intravenous only) Approval of therapy for chimeric antigen receptor (CAR) T cell to treat T-cell induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age or older For tofacitinib/tofacitinib ER General criteria met Diagnosis of moderate to severely active RA or PsA Failure/intolerance to two first line biologic DMARD Contraindications to anti-tnf therapy not used in combination with other biologic DMARD therapies For ustekinumab: General criteria met Diagnosis of PsA Failure/intolerance to two first line biologic DMARD Contraindications to anti-tnf therapy Failure/intolerance to two second line biologic DMARDs Page 37

39 For apremilast: General criteria met Diagnosis of PsA Failure/intolerance to one first line biologic DMARD Contraindications to anti-tnf therapy not used in combination with other biologic DMARD therapies For secukinumab: General criteria met Diagnosis of PsA or AS Failure/intolerance to two first line biologic DMARD Contraindication to anti-tnf therapy For sarilumab General criteria met Diagnosis of moderate to severely active established RA Failure/intolerance/contraindication to two first line biologic DMARD Failure/intolerance to adequate trial of tocilizumab For ixekizumab General criteria met Diagnosis of PsA Failure/intolerance to two first line biologic DMARDs contraindications to anti-tnf therapy Failure/intolerance to two second line biologic DMARDs For baricitinib General criteria met Diagnosis of RA Failure/intolerance to two first line biologic DMARDs contraindications to anti-tnf therapy Failure/intolerance to two second line biologic DMARDs CRITERIA F COVERAGE OF ADALIMUMAB F UVEITIS: Person with non-infectious uveitis verified by an ophthalmologist or other eye specialist Ongoing symptoms despite an adequate trial with BOTH topical glucocorticoids and at least one systemic immunomodulator (e.g. oral corticosteroids, methotrexate, azathioprine, mycophenolate, or cyclosporine) CRITERIA F COVERAGE OF QUANTITY EXCEPTIONS (listed drugs only): For adalimumab (#4 40mg injections/month) Failure of a three month trial of every other week therapy with concomitant methotrexate (unless contraindicated) For etanercept (50mg twice weekly) Failure of a three month trial of 50mg per week (either as 25mg twice weekly or 50mg once weekly) with concomitant methotrexate For tocilizumab (SQ) (#4 per month) Weight > 100 kg or failure of a three month trial of every other week therapy with concomitant methotrexate (unless contraindicated). For patients converting from IV 8mg/kg dose to SQ therapy. Page 38

40 For apremilast/tofacitinib: Therapeutic failure or intolerance of two tablets per day dosing or prescriber presents rationale or clinical reason for utilizing a dosing regimen that is not possible within the quantity limits. CRITERIA F CONTINUATION OF THERAPY: For persons new to the plan: prescriber provides clinical documentation from the previous 12 months that describes response as stable disease or improvement seen on therapy Examples of improvement include: laboratory assessment (i.e. C-reactive protein, ESR, anemia improvement), symptomatic improvements (i.e. fatigue, function, HAQ score if available, joint pain) Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. Page 39

41 Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA CERTOLIZUMAB CIMZIA PEGOL USTEKINUMAB STELARA GOLIMUMAB SIMPONI TOFACITINIB XELJANZ Biologic Therapy for Gastroenterology Drug Name Benefit Coverage Status Quantity per month: maintenance therapy First Line-Agents: Adalimumab (Humira) Rx Preferred Restricted #2-40mg injections Infliximab (Remicade, Medical Restricted na Inflectra, Renflexis) Second Line Agents: Certolizumab (Cimzia) RX Non-preferred Restricted #1-400mg syringe kit Golimumab (Simponi) RX Non-preferred Restricted #1-100 mg syringe Vedolizumab (Entyvio) Medical Restricted na Third Line Agents: Natalizumab (Tysabri) Medical Restricted na Tofacitinib (Xeljanz) RX Restricted # 2 Ustekinumab (Stelara) Medical Restricted single dose infusion Ustekinumab (Stelara) RX Non-preferred Restricted #1 per 8 weeks Quantity Limits: Induction therapy: adalimumab #6 injections 40mg for first month certolizumab #3 injection kits for first month golimumab #3 injections 100mg for first month ustekinumab weight-based infusion X1 Maintenance therapy: Approval Limits: As listed in the table Prescribed by a Gastroenterologist Prescription benefit medications are included in the Specialty Pharmaceuticals Program. Medications must be obtained from an authorized network specialty pharmacy. Contact or for more details. Specialty Pharmaceuticals Program excludes adalimumab 10 and 20 mg dose forms at this time. Diagnosis of inflammatory bowel disease as described below. Page 40

42 Diagnosis of moderate to severely active Crohn s disease In a low-risk individual: intolerance/contraindication to 2 conventional therapies inadequate disease control or inability to achieve remission after an adequate trial of 3 months with 2 conventional therapies demonstrated steroid dependence. Therapy options Adalimumab Infliximab Certolizumab if failure/intolerance to adalimumab and infliximab Ustekinumab in adults if failure/intolerance of 2 anti-tnf trial Vedolizumab in adults if failure/intolerance of 2 anti-tnf trial, contraindication to anti-tnf therapy In a high-risk individual with moderate to severely active Crohn s disease Therapy options Adalimumab Infliximab Certolizumab if prior failure/intolerance of adalimumab and infliximab Ustekinumab in adults if prior failure/intolerance of 2 anti-tnf trials Vedolizumab if failure or intolerance of 2 anti-tnf trials contraindication to anti-tnf therapy In a hospitalized patient with acute flare of severely active Crohn s disease with a lack of response to IV corticosteroids (dose equivalents of 60mg methylprednisolone) after 3-5 days in attempt to avoid surgical intervention with documentation of inflammatory component Therapy options Adalimumab Infliximab Vedolizumab if contraindication to anti-tnf therapy failure/intolerance to two anti-tnf in attempt to avoid surgical intervention Ustekinumab- in adults if failure/intolerance of 2 anti-tnf trials For natalizumab General criteria met for diagnosis of moderate to severely active Crohn s disease in adults Failure of two preferred anti-tnf therapies or a contraindication to anti-tnf therapy exists failure/intolerance to vedolizumab or ustekinumab Must be used as monotherapy (without immunomodulatory therapy) For use of Tysabri (natalizumab) for Crohn s disease, patients and prescriber must be enrolled in the manufacturer TOUCH Risk-Management Program. Refer to touchprogram.com for details Diagnosis of moderate to severely active ulcerative colitis In a high-risk individual Therapy options (after short course of corticosteroids plus azathioprine unless contraindicated) Adalimumab Infliximab Vedolizumab if adult patients with a failure of anti-tnf trial or contraindication to anti-tnf therapy Golimumab if remission not achieved on preferred anti-tnf therapy disease relapsed on preferred anti-tnf therapy Adverse reaction to preferred anti-tnf therapy Tofacitinib IF adult patients with a failure/intolerance of 2 anti-tnf trials Page 41

43 In a hospitalized patient with acute flare of severely active ulcerative colitis with lack of response to IV corticosteroids (dose equivalents of 60mg methylprednisolone) after 3-5 days in attempt to avoid surgical intervention with documentation of inflammatory component. Therapy options Adalimumab Infliximab Vedolizumab (failure of anti-tnf trial or contraindication to anti-tnf therapy) Golimumab (after failure/intolerance topreferred anti-tnf therapy) Tofacitinib IF adult patients with a failure/intolerance of 2 anti-tnf trials CRITERIA F COVERAGE OF QUANTITY EXCEPTIONS (listed drugs only): For weekly dosing of adalimumab Failure of a two month trial of every other week therapy after completion of induction dosing regimen Based on subtherapeutic drug concentrations and absence (or low levels) of drug antibodies. CRITERIA F CONTINUATION OF THERAPY: For persons new to the plan: must have a clinical assessment provided by the gastroenterologist (or other specialist if co-managed by Rheumatology) within previous 12 months and prescriber documents individual response to therapy, including individual improvement in functional status related to therapeutic response. Provision of recent labs, current symptoms and change in status should be provided to review for improvement and demonstrate effectiveness. Examples of documentation include laboratory assessment (i.e. CRP, hemoglobin, ESR, WBC, albumin, etc), symptom assessment (i.e. bleeding, stooling pattern, abdominal pain, extraintestinal complaints, fatigue, fever, etc) or recent endoscopy results. Continuation of therapy/coverage criteria will not be applied to persons who were not previously approved for coverage whose therapy was initiated using a manufacturer-sponsored free drug program, provider samples, and/or vouchers. IMPTANT INFMATION: While the anti-tnf agents are category B in pregnancy, certolizumab does not appear to cross the placenta and therefore, it may pose less risk to a fetus. For pregnant women established on anti- TNF therapy, therapy interruptions prior to delivery are recommended with infliximab (8-10 weeks prior) and adalimumab (4-5 weeks prior). For pregnant women established on anti-tnf therapy and requiring an adjustment to anti-tnf therapy, consideration will be given to use of certolizumab. For persons already established on biologic therapy, consider dose escalation, addition of immunomodulator or change in biologic therapy (different anti-tnf or different class) as appropriate based on drug concentrations and antibody levels as noted below o o If remission not achieved or disease relapsed on adalimumab/infliximab and subtherapeutic drug concentration with high antibody level then change to drug within the same class (i.e. Infliximab to adalimumab adalimumab to infliximab) If remission not achieved or disease relapsed on adalimumab/infliximab and subtherapeutic drug concentration with low or absent antibody level then Increase adalimumab/infliximab dose Decrease the dosing interval Add immunomodulator to anti-tnf therapy Page 42

44 o If remission not achieved or disease relapsed on adalimumab/infliximab therapy based on therapeutic drug concentrations and lack of anti-drug antibodies (primary non-response or secondary loss of response) inflammation still present, then change to different drug class Vedolizumab Ustekinumab DEFINITIONS OF TERMS: Inadequate Disease Control: Worsening of baseline symptoms (i.e. bowel frequency, presence of blood, abdominal pain or tenderness, fever, etc), extraintestinal manifestations (i.e. fatigue, joint pain, skin rash, and ocular symptoms), laboratory assessment (i.e. C-reactive protein (CRP), hemoglobin, ESR white blood count (WBC), albumin, platelets, fecal calprotectin, etc) and/or recent endoscopy results demonstrating ongoing inflammation High Risk in Ulcerative Colitis: -Patient with extensive colitis, deep ulcers, age<40 years, High CRP and ESR, steroid-requiring disease, history of hospitalization, C difficile infection, CMV infection -Low risk patient (with limited anatomic disease or mild endoscopic disease) inability to achieve remission on induction and maintenance therapy with conventional agents achieved remission on induction and maintenance therapy but has relapsed after steroid taper (primary non-response or secondary loss of response) High Risk in Crohn s Disease: -Age<30 at diagnosis, extensive anatomic involvement, perianal and/or severe rectal disease, deep ulcers, prior surgical resection, stricturing and/or penetrating behavior, fistulizing disease, extraintestinal manifestations of inflammation (i.e. uveitis, erythema nodosum, pyoderma gangrenosum, spondyloarthropathy, etc) Induction and Maintenance Therapy with Conventional Agents: -Conventional therapy with immunomodulator therapy such as azathioprine, balsalazide, corticosteroids, mesalamine, mercaptopurine, methotrexate, sulfasalazine Steroid Dependence: -Demonstrated steroid dependence (defined as equivalent to prednisone 10mg daily for >3 months) with the inability to taper or when tapering of dose leads to loss of symptom control Inflammatory status: Signs/Symptoms/Labs/Endoscopy for diagnosis -Bloody diarrhea, weight loss, tenesmus, urgency, abdominal pain, fever, joint swelling/redness, localized abdominal tenderness, anemia, cutaneous signs -CBC, CMP, CRP, ESR, stool cultures, C difficile assay, fecal calprotectin -endoscopy, colonoscopy, sigmoidoscopy Ulcerative Colitis Disease Severity: Based on the degree of presentation of the signs and symptoms and change in baseline inflammatory status Moderate disease - more than four stools per day with minimal signs of toxicity, anemia, abdominal pain, low grade fever Severe disease - more than six bloody stools per day, fever, tachycardia, anemia or elevated ESR or CRP Page 43