PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Bunavail (buprenorphine and naloxone) buccal film BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENT SPrior Authorization Required (Non-Preferred Product) Alternative preferred product s include generic buprenorphine/naloxone sublingual tablets QUANTITY LIMIT 30-day supply at a time only Strength Quantity Limit 2.1 mg 0.3 mg 4.2 mg 0.7 mg 6.3 mg 1 mg 1 film per day 2 films per day 2 films per day LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Bunavail (buprenorphine and naloxone) is a non-pre ferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. OPIOID DEPENDENCE For initial authorization: 1. All of the following: a) The individual has failed an adequate trial of the preferred generic buprenorphine/naloxone sublingual tablets within the previous 120 days ( Note: Adequate trial is defined as at least 28 days of treatment); AND b) One of the following: i) The member experienced therapeutic failure with the preferred generic buprenorphine/naloxone sublingual tablets ( Note: Brand and non-preferred buprenorphine agents will not be approved for member s who report lesser efficacy as compared to the preferred generic buprenorphine sublingual tablets unless it would be clinically inappropriate to addres s efficacy with dose adjustment ); OR ii) Generic sublingual tablets caused adverse outcome; AND c) The prescri ber has provided a copy and confirmation of a MedWatch form submission to the FDA documenting the therapeutic failure or adverse outcome experienced by the member ( Note : Th e MedWatch form is available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) OR 2. Both of the following: a) The individual has a hypersensitivity reaction to an inactive ingredient in the preferred generic buprenorphine sublingual tablets ; AND b) The hypersensitivity reaction(s) is clearly documented in the member's medical record.3. Dosage allowed: The maintenance dose of Bunavail buccal film is generally in the range of 2.1/0.3 mg buprenorphine/naloxone to 12.6/2.1 mg buprenorphine/naloxone per day. Dosages higher than this have not been demonstrated to provide any clinical advantage. Addit ion a l Not e s: GI upset or irritation is not generally considered an allergy or failed treatment. Members should be referred to their physician or pharmacist for advice on dose adjustment, and/or other options to reduce GI upset/irritation. Common doc umented side effects attributed to the drug (i.e. , headache, nausea, blurred vision, fatigue, muscle aches) are not considered an allergy and would be expected to occur at the same level in both the generic and brand agent. Drug hypersensitivity symptoms may include skin rash, hives, itching, fever, swelling, shortness of breath, wheezing, runny nose, itchy and/or watery eyes, and in severe cases, anaphylaxis. If member meets all the requirements listed above, the medication will be approved for lifetime. Care Source conside rs Bunav ail (bupre norphine and nalox one) not m e dically ne ce ssary for the tre atment of the dise ases that are not liste d in this document. DATE ACTION/DESCRIPTION 03/04/2019 New policy for Bunavail created. Referenc es : 1. MedWatc h: The FDA Safety Information and Adverse Event Reporting Program. Available at http://www.fda.gov/s afety /medwatch/default.htm. 2. Bunav ail [pac kage ins ert]. Raleigh, NC : BioDelivery Sciences International, Inc . ; 2002. Effec tive date: TBD Rev is ed date: 03/04/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Nutropin AQ (somatropin) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include Omnitrope (somatropin) vials 5.8 mg QUANTITY LIMIT per diagnosis, see Dosage allowed LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Nutropin AQ (somatropin) is a non-preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. Adult GROWTH HORMONE DEFICIENCY (GHD) – Adult or Childhood Onset For initial authorization: 1. Member must have a documented 30-day trial and failure of Omnitrope 5.8 mg vial; AND 2. Member is 18 years of age or older; AND 3. Medication must be prescribed by an endocrinologist; AND 4. Member must have a diagnosis of GHD confirmed by one of the following: a) Chart notes documentation of acquired structural abnormality ( see Appendix ) of the hypothalamus or pituitary and 3 documented pituitary hormone deficiencies ( see Appendix ) with included lab results and reference ranges ; b) Documented childhood-onset of GHD with a documented congenital abnormality (see Appendix ) of the hypothalamus or pituitary; c) Two pre-treatment peak serum growth hormone (GH) concentration 35 years. Non-weight based dosing: starting dose 0.2 mg/day (0.15-0.30 mg/day) and increased every 1-2 months in increments of 0.1-0.2 mg/day, doses vary considerably. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member must be in compliance with all of the initial criteria; AND 2. Members current IGF-1 level not elevated for age/gender (does not apply to members w/ structural abnormality of hypothalamus/pituitary and at least pituitary hormone deficiencies or childhood onset GHD and congenital abnormality of hypothalamus/pituitary). If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. Pediatric GROWTH FAILURE due to CHRONIC KIDNEY DISEASE For initial authorization: 1. Member is age 17 years or younger ; AND 2. Member must have a diagnosis of growth failure due to chronic kidney disease (i.e., irreversible renal insufficiency with CrCl 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 5. If member is age 12 or older, the members epiphyses are open, confirmed by radiograph of the wrist and hand ( x-ray result s must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 6. Dosage allowed: 0.35 mg/kg/week. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member must be in compliance with all of the initial criteria; AND 2. If member is age 12 or older, the members epiphyses are open, confirmed by radiograph of the wrist and hand ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 Standard Deviations (SD) below the mean ( must include chart notes and documentation to confirm diagnosis and lab results with reference ranges ); AND 5. Member must have a pretreatment height ( must include growth charts) of > 2 SD below the mean for age and gender; AND6. If member is age 12 or older, radiographic evidence the members epiphyses are open (x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Dosage allowed: Pediatric: up to 0.3 mg/kg/week; p ubertal patient: up to 0.7 mg/kg/week. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member must be in compliance with all of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment 2 SD below the mean and 1 year height velocity is > 1 SD below the mean for age ( must include growth charts and documentation ); AND 6. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age. 7. Dosage allowed: Up to 0.375 mg/kg/week. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member must be in compliance with all of the initial criteria; AND 2. If member is age 12 or older, radiographic evidence the members epiphyses are open ( x-ray results must be included). Comparison of bone age to chronological age should be documented as abnormal by > 2 SD below the mean for chronological age; AND 3. Member has a growth rate > 2.5 cm/year unless there is a documented reason for lack of efficacy (on treatment
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Tysabri (natalizumab) BILLING CODE J2323 (1 unit = 1 mg) BENEF IT TYPE Medical SIT EOF SERVICE ALLOWED Outpatient/Office COVERAGE REQUIREMENT SPrior Authorization Required (Non-Preferred Product) Alternative preferred product for Crohns Disease includes Cimzia QUANTITY LIMIT 300 units/mg per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Tysabri (natalizumab) is a non-pre ferred product and will only be considered for coverage under the m e dical benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. CROHNS DISEASE (CD) For initial authorization: 1. Medication is prescribed by a gastroenterologist; AND 2. Member must be at least 18 years or older moderate to severe CD; AND 3. Member has documentation in chart notes that member was tested for John Cunningham virus (JCV) with ELISA prior to initiating treatment; AND 4. Medication is not being used in combination with immunosuppressants or TNF-alpha inhibitors; AND 5. Member has documented inadequate response or contraindication to trial of at least two different therapies such as: a) Corticosteroids (e.g. , budesonide (Entocort), prednisone)); b) Methotrexate (e.g. , Rheumatrex); c) Immunosuppressants (e.g. , 6-mercaptopurine (Purinethol), Azathioprine (Im uran) or cyclosporine (Neoral, Sandimmune, Gengraf)). 6. Dosage allowed: 300 mg intravenous infusion over one hour every 4 weeks. If member meets all the requirements listed above, the medication will be approved for 12 months . For r e a ut ho riza tion: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months . RELAPSING-REMITTING MULTIPLE SCLEROSIS (RRMS), SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS (SPMS) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Medication must be prescribed by, or in consultation with, or under the guidance of a neurologist; AND 3. Member has documentation in chart notes that member was tested for John Cunningham virus (JCV) with ELISA prior to initiating treatment; AND 4. Member has documented trial and failure or contraindication to at least two pref erred multiple sclerosis agents (two injectable drugs OR two oral drugs OR one injectable and one oral drug). Treatment failure requires at l east 30 days of therapy without an adequate response. 5. Dosage allowed: 300 mg intravenous infusion over one hour every 4 weeks. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app rov e d f or a n a ddit ion a l 12 months. Care Source conside rs Ty sabri (natalizumab) not m e dically ne ce ssary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Clinically Isolated Syndrome (CIS) in Multiple Sclerosis Primary Progressive Multiple Sclerosis DATE ACTION/DESCRIPTION 05/10/2017 New policy for Tysabri created. Policy SRx-0041 archived. For diagnosis of CD: trial of Humira required. For RRMS and SPMS diagnose s trial of two formulary agents required. List of diagnoses considered not medically necessary was added. 12/06/2017 Age coverage expanded. 02/26/2019 Humira trial removed from criteria for CD. Referenc es : 1. Ty s abri [pac kage ins ert]. Cambridge, MA; Biogen, Inc.: Dec ember, 2016. 2. Americ an Gas troenterological As sociation. Identification, ass essment and initial medical treatment in Crohns dis eas e. AGA ins titute. 2014. http://www.gas tro.org/IBDcarepathway . Acc essed April 20, 2017. 3. Terdiman JP, Grus s CB, Heidelbaugh JJ, et al. Americ an Gas troenterologic al Ass ociation Institute Guideline on the Us e of Thiopurines , Methotrexate, and Anti TNF-a Biologic Drugs for the Induction and Maintenance of Remis s ion in Inflammatory Crohns Diseas e. Gastroenterology 2013; 145:1459-1463. 4. Goodin DS, Frohman EM, Garmany GP Jr, et al. Dis ease modifying therapies in multiple s clerosis: report of the Therapeutic s and Tec hnology As sessment Subcommittee of the Americ an Ac ademy of Neurology and the MS Counc il for Clinic al Prac tice Guidelines . Neurology . 2002 Jan;58(2):169-78. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Tremfya (guselkumab) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include Cimzia, Cosentyx, Enbrel, Otezla and Siliq QUANTITY LIMIT see Dosage allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Tremfya (guselkumab) is a non-pre ferred product and will only be con sidered for coverage under the pharm acy benefit when the following criteria are met:Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member has PsO for 6 months or longer; AND 5. Member has PsO involves 10% or more of the members body surface area; AND 6. Members Psoriasis Area and Severity Index (PASI) score is greater than or equal to 12; AND 7. Member has tried and failed to respond to treatment with at least one of the following: a) At least 30 days of photochemotherapy (i.e. , psoralen plus ultraviolet A therapy); b) At least 30 days of phototherapy (i.e. , UVB light therapy, Excimer laser treatments) (tanning beds emit mostly UVA light and therefore would not meet this criteria). c) At least a 30-day tr ial with topical antipsoriatic agents (i.e. , anthralin, calcipotriene, coal tar, corticosteroids, tazarotene); AND 8. Member has tried and failed to respond to treatment with traditional first-line oral/systemic therapies (i.e. , cyclosporine, methotrexate, ac itreti n) for at least 30 days ; AND 9. Member has tried and failed treatment with at least two of the following: Cimzia, Cosentyx, Enbrel, Otezla and Siliq. Treatment failure requires at least for 30 days of therapy with each drug. 10. Dosage allowed: 100 mg administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter . If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 1 2 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease (e.g., documented members PASI score improvement, etc.). If member meets all the reauthorization requirements above, the medication will be app r ov e d f or an additional 12 months. Care Source conside rs Tre mfya (guse lkumab) not m e dically ne ce ssary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Active infections Ankylosing spondylitis Asthma Cellulitis Crohns Disease Dissecting scalp cellulitis For use in combination with other TNF-inhibitors (i.e. , Humira, Kineret, Enbrel, Remicade) Giant-cell arteritis Infectious uveitis Juvenile idiopathic arthritis Lupus perino Osteoarthritis Psoriatic Arthritis Recurrent pregnancy loss Relapsing polychondritis Rheumatoid arthritis Sarcoidosis Sciatica Spondyloarthritis (other than ankylosing spondylitis) Takayasus arteritis Ulcerative Colitis Vogt-Koyanagi DATE ACTION/DESCRIPTION 10/19/2017 New policy for Tremfya created. 02/26/2019 Humira was removed from criteria; Cimzia, Cosentyx, Otezla and Siliq added to trial agents list. Initial authorization length increased to 12 months. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. Reauthorization criteria on documented members PASI score improvement incorporated into general chart noted documentation requirements. Referenc es : 1. Tremf y a [pac kage insert]. East Hanover, NJ:Novartis Pharmaceutic als Corporation; 2015. Ac cessed on May 1, 2017. 2. Menter A, Korman NJ , Elmets CA, et al. Guidelines of care for the management of psoriasis and ps oriatic arthritis. Sec tion 6. Guidelines of c are for the treatment of ps orias is and ps oriatic arthr itis: Case-based pres entations and ev idenc e-bas ed c onclusions. Journal of the American Academy of Dermatology, Volume 65, Issue 1, 137 174. 3. Hs u S, Papp KA, Lebwohl MG, et al. Cons ensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Taltz (ixekizumab) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include Cimzia, Cosentyx, Otezla, Siliq and Xeljanz QUANTITY LIMIT see Dosage allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Taltz (ixekizumab) is a non-pre ferred product and will only be considered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member has PsO for 6 months or longer; AND 5. Member has PsO involves 10% or more of the members body surface area; AND 6. Members Psoriasis Area and Severity Index (PASI) sc ore is greater than or equal to 12; AND 7. Member has tried and failed to respond to treatment with at least one of the following: a) At least 30 days of photochemotherapy (i.e. , psoralen plus ultraviolet A therapy); b) At least 30 days of phototherapy (i.e. , UVB light therapy, Excimer laser treatments) (tanning beds emit mostly UVA light and therefore would not meet this criteria). c) At least a 30-day tr ial with topical antipsoriatic agents (i.e. , anthralin, calcipotriene, coal tar, corticosteroids, tazarotene); AND 8. Member has tried and f ailed to respond to treatment with traditional first-line oral/systemic therapies (i.e. , cyclosporine, methotrexate, aci tretin) for at least 30 days ; AND 9. Member has tried and failed treatment with at least two of the following: Cimzia, Cosentyx, Enbrel, Otezla and Siliq. Treatment failure requires at least for 30 days of therapy with each drug. 10. Dosage allowed: Recommended dose is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks . If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease (e.g., documented members PASI score improvement, etc.). If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months. PSORIATIC ARTHRITIS (PsA) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member has tried and failed treatment with at least two of the following: Enbrel, Cimzia, Cosentyx , Otezla and Xeljanz . Treatment failure requires at least for 30 days of therapy with each drug; AND 5. Member has predominately non-axial disease ( e.g., peripheral synovitis or dactylitis or nail involvement ) and has tried and failed to respond to treatment with at least 30-da y trial of methotrexate and NSAID taken at the maximum recommended dosages (if unable to tolerate or has contrai ndication to methotrexate than 30-d ay trial of sulfasalazine or azathioprine or cyclosporine) . 6. Dosage allowed: Recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks . If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. Care Source conside rs Taltz (ix e kizumab) not m e dically necessary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Active infections A sthma Cellulitis Crohns Disease Dissecting scalp cellulitis For use in combination with other TNF-inhibitors (i.e. , Humira, Kineret, Enbrel, Remicade) Giant-cell arteritis Infectious uveitis Lupus perino Osteoarthritis Recurrent pregnancy loss Relapsing polychondritis Sarcoidosis Sciatica Spondyloarthritis (other than ankylosing spondylitis) Takayasus arteritis Ulcerative colitis Vogt-Koyanagi DATE ACTION/DESCRIPTION 10/19/2017 New policy for Taltz created. 02/05/2018 New indication for Psoriatic Arthritis added. 02/26/2019 Humira was removed from criteria; Cimzia, Cosentyx, Otezla, Siliq and Xeljanz added to trial agents list. Initial authorization length increased to 12 months for PsO. TB test allowed to be done wit hin 12 months prior to initiation of therapy; chest x-ray option removed. Requirements on axial disease type removed from PsA. Reauthorization criteria on documented members PASI score improvement incorporated into general chart noted documentation requir em e nt s . Other drugs options allowed for PsA if there is an intolerance or contraindication to methotrexate. Referenc es : 1. Taltz [pac kage ins ert]. Indianapolis, IN ; Eli Lilly and Company: Marc h, 2016. 2. Menter A, Korman NJ , Elmets CA, et al. Guidelines of care for the management of psoriasis and ps oriatic arthritis. Sec tion 6. Guidelines of c are for the treatment of ps orias is and ps oriatic arthritis: Cas e-based pres entations and ev idenc e-bas ed c onclusions. Journal of the American A cademy of Dermatology, Volume 65, Issue 1, 137 174. 3. Hs u S, Papp KA, Lebwohl MG, et al. Cons ensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Simponi (golimumab) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternat ive preferred products include Actemra, Enbrel, Cimzia, Cosentyx, Kevzara, Olumiant , Otezla and Xeljanz QUANTITY LIMIT 1 per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Simponi (golimumab) is a non-pre ferred product and will only be considered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. ANKY LOSING SPONDYLITIS (AS) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member has had back pain for 3 months or more that began before the age of 50; AND 5. Current imaging results show an inflammation of one or both of the sacroiliac joints; AND 6. Member shows at least one of the following signs or symptoms of Spondyloarthritis: a) Arthritis; b) Elevated serum C-reactive protein; c) Inflammation at the tendon, ligament or joint capsule insertions; d) Positive HLA-B27 test; e) Limited chest expansion; f) Morning stiffness for 1 hour or more; AND 7. Member meets at least o ne of the following scenarios: a) Member has Axial (spinal) disease; b) Member has peripheral arthritis without axial involvement and has tried and failed treatment with methotrexate or sulfasalazine. Treatment failure requires at least 30 days of therapy without an adequate response; AND 8. Member has tried and failed to respond to treatment with at least two prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 30 days of therapy w ithout an adequate response; AND 9. Member must have tried and failed treatment with at least two of the following: Enbrel, Cimzia and Cosentyx. Treatment failure requires at least for 30 days of therapy with each drug. 10. Dosage allowed: 50 mg subcutaneously once a month. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of dise ase. If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months. PSORIATIC ARTHRITIS (PsA) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member must have tried and failed treatment with at least two of the following: Enbrel, Cimzia, Cosentyx , Otezla and Xeljanz. Treatment failure requires at least for 30 days of therapy with each drug; AND 5. Member meets at least o ne of the following scenarios: a. Member has predominantly axial disease (i.e. , sacroiliitis or spondylitis) as indicated by radiographic evidence; b. Member has shown symptoms of predominantly axial disease (i.e. , sacroiliitis or spondylitis) for more than 3 mont hs (i.e., limited spinal range of motion, spinal morning stiffness for more than 30 minutes) AND has tried and failed to respond to treatment with at least 2 prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 30 days of therapy without an adequate response; c. Member has predominately non-axial disease (e.g., peripheral synovitis or dactylitis or nail involvement) and has tried and failed to respond to treatment with at least 30-da y trial of methotrexate and NSAID taken at the maximum recommended dosages (if unable to tolerate or has contraindication to methotrexate than 30-d ay trial of sulfasalazine or azathioprine or cyclosporine) . 6. Dosage allowed: 50 mg subcutaneously once a month. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app r ov e d f or a n a ddit ion a l 12 months. RHEUMATOID ARTHRITIS (RA) For initial authorization: 1. Member must be 18 years of age or older with moderate to severe active RA; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Medication is being given in combination with methotrexate or with another immunosuppressive agent if the member cannot tolerate methotrexate; AND 5. Member must hav e tried and failed treatment with at least two non-biologic DMARDS (i.e. , methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine and leflunomide) or must have documented contraindication to all non-biologic DMARDS. Treatment trial duration with each non-biologic DMARD agent must have been at least 30 days ; AND 6. Member has tried and failed treatment with at least two of the following: Actemra, Cimzia, Enbrel, Kevzara, Olumiant and Xeljanz. Treatment failure requires at least for 30 days o f therapy with each drug. 7. Dosage allowed: 50 mg subcutaneously once a month. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app r ov e d f or a n a ddit ion a l 12 months. ULCERATIVE COLITIS (UC) For initial authorization: 1. Member is 18 years of age or older with moderate to severe active UC; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a gastroenterologist; AND 4. Member must meet at least one of the following: a) Member was hospitalized with ful minant ulcerative colitis (i.e. , severe ulcerative colitis with more than 10 stools per day, continuous bleeding, abdominal pain, and distension, and acute, severe toxic symptoms including fever and anoxia); b) Member was hospitalized and after three days of intravenous steroids still has a CRP greater than 45 or more than 8 bloody bowel movements; c) Member is r efractory to or requires continuous immunosuppres sion with corticosteroids (e.g., methylprednisolone, prednisone at a dose of 40 to 60 mg/day (or equivalent), cortisone, etc.) AND i s refractory to or has a contraindication to 5-aminosalicylic acid agents (e.g., balsalazide, mesalamine, sulfasalazine) and immunosuppressants (azathioprine and 6-mercaptopurine); AND 5. Dosage allowed: 200 mg subcutaneously at week 0, then 100 mg at week 3, followed by 100 mg every 4 weeks thereafter. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app r ov e d f or a n a ddit ion a l 12 months. Care Source conside rs Sim poni (golim umab) not m e dically ne ce ssary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Active infections Asthma Cellulitis Crohns disease Disse cting scalp cellulitis For use in combination with TNF-inhibitors ( i. e., Enbrel, Humi ra, Remicade, Kineret) Giant-cell arteritis Infectious uveitis Lupus perino Osteoarthritis Relapsing polychondritis Sarcoidosis Sciatica Spondyloarthritis Takayasus arteritis Vogt-Koyanagi DATE ACTION/DESCRIPTION 05/15/2017 New policy for Simponi created. Policies SRx-0041 and SRx-0042 archived. For diagnoses of AS and RA: trial of Humira and Enbrel was added. For UC: trial of Humira required. List of diagnoses considered not medically necessary was added. 02/26/2019 Humira was removed from criteria; Actemra, Cimzia, Cosentyx, Kevzara, Olumiant, Otezla and Xeljanz added to trial agents list. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. References added. Symptoms of back pain for AS extended till before age of 50. Other drugs options allowed for PsA if there is an intolerance or contraindication to methotrexate. Referenc es : 1. Simponi [pres c ribing information]. Hors ham, PA; Jans sen Biotech, Inc .: January, 2014. 2. Menter A, Korman NJ , Elmets CA, et al. Guidelines of care for the management of psoriasis and ps oriatic arthritis Sec tion 6. Guidelines of c are for the treatment of ps orias is and ps oriatic arthritis: Cas e-based pres entations and ev idenc e-bas ed c onclusions. JAm Ac ad Dermatol. 2011 Feb 7. 3. Singh, J ., et.al.,(2012). 2012 Update of the 2008 American College of Rheumatology Rec ommendations for the Us e of Dis eas e-Modify ing Anti-rheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. A rt hrit is Care & Res earc h, 64(5), 625-639, May 2012. 4. Terdiman JP, Grus s CB, Heidelbaugh JJ, Sultan S, Falck-Ytter YT; AGA Ins titute Clinic al Prac tice and Quality Management Committee. Americ an Gastroenterologic al As sociation Institute guideline on the us e of thiopurines, methotrex ate, and anti-TNF-biologic drugs for the induction and maintenanc e of remiss ion in inflammatory Crohn's dis eas e. Gas troenterology. 2013 Dec ;145(6):1459-63. 5. Higgins J , Green S, editors. Coc hrane handbook for s ystematic rev iews of interventions , Version 5.1.0 [updated Marc h 2011]. The Coc hrane Collaboration. Available from: URL:www.cochrane-handbook.org. 6. FDA Approv es New Drug for Rheumatoid Arthritis; Pharmacis t's Letter; March 2010; Vol: 26 Rheumatoid arthritis: the role of DMARDs . Pharmacist's Letter/Pres criber's Letter July 2012;25(2):250210. 7. Li Z, et al. Efficacy and s afety res ults from a Phase 3, randomiz ed, placebo-c ontrolled trial of s ubcutaneous golimum ab in Chines e patients with active rheumatoid arthritis des pite methotrexate therapy . Int JRheum Dis. 2016 Nov ;19(11):1143-1156. 8. Smolen JS. Insights into the efficac y of golimumab plus methotrex ate in patients with ac tive rheumatoid arthritis who dis c ont inued prior anti-tumour necros is factor therapy : pos t-hoc analyses from the GO-AFTER study. Ann Rheum Dis . 2014 Oc t;73(10):1811-8. 9. Mic helon MA, et al. Role of golimumab, a TNF-alpha inhibitor, in the treatment of the ps oriatic arthritis . Clin Cos met Inv es tig Dermatol. 2010;3:79-84. 10. Kav anaugh A, et al. Golimumab in ps oriatic arthritis: one-year c linic al efficacy, radiographic, and s afety results from a phas e III, randomized, placebo-controlled trial. Arthritis Rheum. 2012 Aug;64(8):2504-17. 11. Sieper J , et al . A randomiz ed, double-blind, placebo-c ontrolled, s ixteen-week study of s ubc utaneous golimumab in patients with ac tive nonradiographic ax ial s pondyloarthritis . Arthritis Rheumatol. 2015 Oc t;67(10):2702-12. 12. Inman RD, et al. Efficacy and s afety of golimumab in patients with ank ylosing s pondy litis : res ults of a randomiz ed, double-blind, plac ebo-c ontrolled, phase III trial. Arthritis Rheum. 2008 Nov ;58(11):3402-12. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Simponi Aria (golimumab) BILLING CODE J1602 (1 unit = 1 mg) BENEF IT TYPE Medical SIT EOF SERVICE ALLOWED Outpatient/Office COVERAGE REQUIREMENT SPrior Authorization Required (Non-Preferred Product) Alternative preferred products include Actemra, Enbrel, Cimzia, Cosentyx, Kevzara, Olumiant , Otezla and Xeljanz QUANTITY LIMIT 120 units every 56 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Simponi Aria (golimumab) is a non-pre ferred product and will only be considered for coverage under the m e dical benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. ANKY LOSING SPONDYLITIS (AS) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member must have tried and failed treatment with at least two of the following: Enbrel, Cimzia and Cosentyx. Treatment failure requires at least for 30 days of therapy with each drug; AND 5. Member has had back pain for 3 months or more that began before the age of 50; AND 6. Current imaging results show an inflammation of one or both of the sacroiliac joints; AND 7. Member shows at least one of the following signs or symptoms of Spondyloarthritis: a) Arthritis; b) Elevated serum C-reactive protein; c) Inflammation at the tendon, ligament or joint capsule insertions; d) Positive HLA-B27 test; e) Limited chest expansion; f) Morning stiffness for 1 hour or more; AND 8. Member meets at least o ne of the following scenarios: a) Member has Axial (spinal) disease; b) Member has peripheral arthritis without axial involvement and has tried and failed treatment with methotrexate or sulfasalazine. Treatment failure requires at least 30 days of therapy without an adequate response; AND 9. Member has tried and failed to respond to treatment with at least two prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 30 days of therapy with each NSAID without an adequate response. 10. Dosage allowed: 2 mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved f or an additional 12 months. PSORIATIC ARTHRITIS (PsA) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member must have tried and failed treatment with at least two of the following: Enbrel, Cimzia, Cosentyx , Otezla and Xeljanz . Treatment failure requires at least for 30 days of therapy with each drug; AND 5. Member meets at least o ne of the following scenarios: a) Member has predominantly axial disease (i.e. , sacroiliitis or spondylitis) as indicated by radiographic evidence; b) Member has shown symptoms of predominantly axial disease (i.e. , sacroiliitis or spondylitis) for more than 3 months (i.e. , limited spinal range of motion, spinal morning stiffness for more than 30 minutes) AND has tried and failed to respond to treatment with at least 2 prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 30 days of therapy with each NSAID without an adequate response; c) Member has predominately non-axial disease (e.g., peripheral synovitis or dactyliti s or nail involvement) and has tried and failed to respond to treatment with at least 30-da y trial of methotrexate and NSAID taken at the maximum recommended dosages (if unable to tolerate or has contraindication to methotrexate than 30-d ay trial of sulfasalazine or azathioprine or cyclosporine) . 6. Dosage allowed: 2 mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. RHEUMATOID ARTHRITIS (RA) For initial authorization: 1. Member must be 18 years of age or older with moderate to severe active RA; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Medication is being given in combination with methotrexate or with another immunosuppressive agent if the member cannot tolerate methotrexate; AND 5. Member must hav e tried and failed treatment with at least two non-biologic DMARDS (i.e. , methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine and leflunomide) or must have documented contraindication to all non-biologic DMARDS. Treatment trial duration with each non-biologic DMARD agent must have been at least 30 days ; AND 6. Member has tried and failed treatment with at least two of the following: Actemra, Cimzia, Enbrel, Kevzara, Olumiant and Xeljanz . Treatment failure requires at least for 30 days of therapy with each drug. 7. Dosage allowed: 2 mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months. Care Source conside rs Sim poni Aria (golim umab) not m e dically ne cessary for the tre atment of the following disease state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Active infections Asthma Cellulitis Crohns disease Dissecting scalp cellulitis For use in combination with TNF-inhibitors (Enbrel, Humi ra, Rem icade, Kineret) Giant-cell arteritis Infectious uveitis Lupus perino Osteoarthritis Relapsing polychondritis Sarcoidosis Sciatica Spondyloarthritis Takayasus arteritis Ulcerative colitis Vogt-Koyanagi DATE ACTION/DESCRIPTION 05/10/2017 New policy for Simponi Aria created. Policy SRx-0042 archived. List of diagnoses considered not medically necessary was added. 11/13/2017 New indications of AS and PsA added. 02/26/2019 Dosing information corrected. Humira was removed from criteria; Actemra, Cimzia, Cosentyx, Kevzara, Olumiant , Otezla and Xeljanz added to trial agents list. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. References added. Symptoms of back pain for AS extended till before age of 50. Other drugs options allowed for PsA if there is an intolerance or contraindication to methotrexate. Referenc es : 1. Simponi Aria [pres cribing information]. Hors ham, PA; Janss en Biotec h, Inc.: Oc tober, 2017. 2. Menter A, Korman NJ , Elmets CA, et al. Guidelines of care for the management of psoriasis and ps oriatic arthritis Sec tion 6. Guidelines of c are for the treatment of ps orias is and ps oriatic arthritis: Cas e-based pres entations and ev idenc e-bas ed c onclusions. JAm Ac ad Dermatol. 2011 Feb 7. 3. Singh, J., et al . 2012 Update of the 2008 American College of Rheumatology Rec ommendations for the Us e of Dis eas e-Modifying Anti-rheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. Arthritis Care & Res earc h, 64(5), 625-639, May 2012. 4. Terdiman JP, Grus s CB, Heidelbaugh JJ, Sultan S, Falck-Ytter YT; AGA Ins titute Clinic al Prac tice and Quality Management Committee. Americ an Gastroenterologic al As sociation Institute guideline on the us e of thiopurines, methotrex ate, and anti-TNF-biologic drugs for the induction and maintenanc e of remiss ion in inflammatory Crohn's dis eas e. Gas troenterology. 2013 Dec ;145(6):1459-63. 5. Higgins J , Green S, editors. Coc hrane handbook for s ystematic rev iews of interventions , Version 5.1.0 [updated Marc h 2011]. The Coc hrane Collaboration. Available from: URL:www.cochrane-handbook.org. 6. FDA Approv es New Drug for Rheumatoid Arthritis; Pharmacist's Letter; March 2010; Vol: 26 Rheumatoid arthritis: the role of DMARDs . Pharmacist's Letter/Pres criber's Letter July 2012;25(2):250210. 7. Smolen JS. Insights into the efficac y of golimumab plus methotrex ate in patients with ac tive rheumatoid arthritis who dis c ontinued prior anti-tumour necros is factor therapy : pos t-hoc analyses from the GO-AFTER study. Ann Rheum Dis . 2014 Oc t;73(10):1811-8. 8. Li Z, et al. Effic acy and s afety res ults from a Phase 3, randomized, placebo-controlled trial of subc utaneous golimumab in Chines e patients with active rheumatoid arthritis des pite methotrexate therapy . Int JRheum Dis. 2016 Nov ;19(11):1143-1156. 9. Inman RD, et al. Efficacy and s afety of golimumab in patients with ank ylosing s pondy litis : res ults of a randomiz ed, double-blind, plac ebo-c ontrolled, phase III trial. Arthritis Rheum. 2008 Nov ;58(11):3402-12. 10. Sieper J , et al. A randomiz ed, double-blind, placebo-c ontrolled, s ixteen-week study of s ubc utaneous golimumab in patients with ac tive nonradiographic ax ial s pondyloarthritis . Arthritis Rheumatol. 2015 Oc t;67(10):2702-12. 11. Kav anaugh A, et al. Golimumab in ps oriatic arthritis: one-year c linic al efficacy, radiographic, and s afety results from a phas e III, randomized, placebo-controlled trial. Arthritis Rheum. 2012 Aug;64(8):2504-17. 12. Mic helon MA, et al. Role of golimumab, a TNF-alpha inhibitor, in the treatment of the ps oriatic arthritis . Clin Cos m et Inv estig Dermatol. 2010;3:79-84. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Siliq (brodalumab) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT 420 mg or 3 mL per 28 days (after loading dose) LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Siliq (brodalumab) is a pre ferred product and will only be considered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Member m ust have a documented negative TB test (i .e ., tuberculosis skin test (PPD), an interferon-release assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a dermatologist or rheumatologist; AND 4. Member has PsO for 6 months or longer; AND 5. Member is not going to receive systemic therapy or phototherapy while on Siliq ; AND 6. Members PsO involving 10% or more of the body surface area (BSA) or 5% or more of BSA if psoriasis involves sensitive areas (hands, feet, face, or genitals); AND 7. Members Psoriasis Area and Severity Index (PASI) score 12; AND 8. Member must not have a diagnosis of Crohns Disease ( Siliq is contraindicated in patients with Crohns disease) ; AND 9. Documented consultation on risks of suicidal ideation or behavior while on Siliq is submitted with members chart notes ; AND 10. Member has tried and failed to respond to treatm ent with at least one of the following: a) At least 30 days of photochemotherapy (i.e. , psoralen plus ultraviolet A therapy); b) At least 30 days of phototherapy ( i.e., UVB light the rapy, Excimer laser treatments (tanning beds emit mostly UVA light and therefore would not meet this criteria)) ; c) At least a 30-day trial with topical antipsoriatic agents (i.e. , anthralin, calcipotriene, coal tar, corticosteroids, tazarotene); AND 11. Member has tried and failed to respond to treatment with traditional first-line oral/systemic therapies (i.e. , cyclospori ne, methotrexate, aci tretin) for at least 30 days . 12. Dosage allowed: 210 mg subcutaneously once weekly at weeks 0, 1, and 2 followed by 210 mg every 2 weeks. If member meets all the requirements listed above, the medication will be approved for 12 months.For r e a ut ho riza tion: 1. Member must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease (e.g., d ocumented members PASI score improvement, etc.) . If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months. Care Source conside rs Siliq (brodalum ab) not m e dically ne ce ssary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Active infections Ankylosing spondylitis Asthma Cellulitis Crohns Disease Dissecting scalp cellulitis For use in combination with other TNF-inhibitors (i.e. , Humira, Kineret, Enbrel, Remicade) Giant-cell arteritis Infectious uveitis Juvenile idiopathic arthritis Lupus perino Osteoarthritis Psoriatic Arthritis Recurrent pregnancy loss Relapsing polychondritis Rheumatoid arthritis Sarcoidosis Sciatica Spondyloarthritis (other than ankylosing spondylitis) Takayasus arteritis Ulcerative Colitis Vogt-Koyanagi DATE ACTION/DESCRIPTION 05/15/2017 New policy for Siliq created. 02/26/2019 Humira and Enbrel trials removed from criteria. Reauthorization criteria on documented members PASI score improvement incorporated into general chart noted documentation requirements. Static Physicians Global Assessment (sPGA ) score removed. Ulcerative Colitis added to not covered diagnosis. Immunosuppressant therapies changed to treatment of traditional first-line oral/systemic therapies. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. References added. Referenc es : 1. Siliq [pres c ribing information]. Bridgewater, NJ; Valeant Pharmaceutic als North America LLC. Rev is ed February 2017. 2. Hs u S, Papp KA, Lebwohl MG, et al. Cons ensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. 3. Sbidian E, et al. Sy stemic pharmacological treatments for c hronic plaque psoriasis: a network metaanaly sis. Coc hrane Databas e Sy st Rev . 2017;12: CD011535. Epub 2017 Dec 22. 4. Nas t A, et al. European S3-Guideline on the s ystemic treatment of ps oriasis v ulgaris-Update Apremilast and Sec uk inumab-EDF in c ooperation with EADV and IPC. JEur Acad Dermatol Venereol. 2017;31(12):1951. 5. Smith CH, et al. British Association of Dermatologists guidelines for biologic therapy for psorias is 2017. Br JDermatol. 2017 Sep;177(3):628-636. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Remicade (infliximab) BILLING CODE J1745 (1 unit = 10 mg or 1 x 100 mg vial = 10 units) BENEF IT TYPE Medical SIT EOF SERVICE ALLOWED Office/Outpatient COVERAGE REQUIREMENT SPrior Authorization Required (Non-Preferred Product) Alternative preferred products include Actemra, Cimzia, Cosentyx, Enbrel, Kevzara, Olumiant, Otezla, Siliq and Xeljanz QUANTITY LIMIT1200 mg (120 units per dose) LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Remicade (infliximab) is a non-pre ferred product and will only be considered for coverage under the m e dical benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. ANKY LOSING SPONDYLITIS (AS) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member has had back pain for 3 months or more that began before the age of 50; AND 5. Current imaging results show an inflammation of one or both of the sacroiliac joints; AND 6. Member shows at least one of the following signs or sy mptoms of Spondyloarthritis: a) Arthritis; b) Elevated serum C-reactive protein; c) Inflammation at the tendon, ligament or joint capsule insertions; d) Positive HLA-B27 test; e) Limited chest expansion; f) Morning stiffness for 1 hour or more; AND 7. Member meets at least o ne of the following scenarios: a) Member has Axial (spinal) disease; b) Member has peripheral arthritis without axial involvement and has tried and failed treatment with methotrexate or sulfasalazine. Treatment failure requires at least 30 days of therapy without an adequate response; c) Member has tried and failed to respond to treatment with at least two prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 30 days of therapy with each NSAID without an adequate response; AND 8. Member must have tried and failed treatment with at least two of the following: Enbrel, Cimzia and Cosentyx. Treatment failure requires at least for 30 days of therapy with each drug. 9. Dosage allowed: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Prior to any dosages or dosing frequencies greater than listed, medical necessity documentation must be supplied to justify c o v e rage. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months . CROHNS DISEASE (CD) For initial authorization: 1. Member is 6-17 years of age with moderately to severely active CD as defined by Pediatric Crohns Disease Activity Index (PCDAI) greater than 30 OR member is 18 years of age or older with moderately to severely active non-fistulizing CD as defined by Crohns Disease Activity Index (CDAI) greater than 220 and less than 400; AND 2. Member has had a trial and inadequate response to at least 30 days of one of the following: a) 6-mercaptopurine; b) Azathioprine; c) Methotrexate; d) Corticosteroid(s); OR 3. Member is 18 years of age or older with fistulizing CD; AND 4. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA) ) within 12 months prior to starting therapy; AND 5. Medication must be prescri bed by a gastroenterologist. 6. Dosage allowed: 5 mg/kg at 0, 2, and 6 weeks, followed by 5 mg/kg every 8 weeks thereafter. If no response by week 14, consider discontinuing therapy. If member meets all the requirements listed above, the medi c a t ion will b e a ppr ov e d f or 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease; AND 4. Documented members PCDAI or CDAI score improvement. If member meets all the reauthorization requirements above, the medication will be app r ov ed f or a n a ddit ion a l 12 months . PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a dermatologist or rheumatologist; AND 4. Member has PsO for 6 months or longer; AND 5. Member is not going to receive systemic therapy or phototherapy while on Remicade; AND 6. Members plaque psoriasis involving 10% or more of the body surface area (BSA) or 5% or more of BSA if psoriasis involves sensitive areas (hands, feet, face, or genitals); AND 7. Members Psoriasis Area and Severity Index (PASI) greater than or equal to 12; AND 8. Member has tried and failed to respond to treatment with at least one of the following: a) At least 30 days of photochemotherapy (i.e. , psoralen plus ultraviolet A therapy); b) At least 30 days of phototherapy (i.e. , UVB light therapy, Excimer laser treatments (tanning beds emit mostly UVA light and therefore would not meet this criteria)). c) At least a 30-day trial with topical antipsoriatic agents (i.e. , anthralin, calcipotriene, coal tar, corticosteroids, tazarotene); AND 9. Member has tried and failed to respond to treatment with traditional first-line oral/systemic therapies (i.e. , cyclosporine, methotrexate, ac itreti n) for at least 30 days ; AND 10. Member has tried and failed treatment with at least two of the following: Cimzia , Cosentyx, Enbrel, Otezla and Siliq. Treatment failure requires at least for 30 days of therapy with each dr ug. 11. Dosage allowed: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Prior to any dosages or dosing frequencies greater than listed, medical necessity documentation must be supplied to justify coverage . If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease (e.g., documented members PASI score improvement, etc.). If memb er me ets all the reauthorization requirements above, the medication will be app r ov e d f or a n a ddit ion a l 12 months. PSORIATIC ARTHRITIS (PsA) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member meets at least o ne of the following scenarios: a) Member has predominantly axial disease (i.e. , sacroiliitis or spondylitis) as indicated by radiographic evidence; b) Member has shown symptoms of predominantly axial disease (i.e. , sacroiliitis or spondylitis) for more than 3 months (i.e. , limited spinal range of motion, spinal morning stiffness for more than 30 minutes) and has tried and failed to respond to treatment with at least 2 prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 30 days of therapy with each NSAID without an adequate response; c) Member has predominately non-axial disease (e.g., peripheral synovitis or dactylitis or nail involvement) and has tried and failed to respond to treatment with at least 30-da y trial of methotrexate and NSAID taken at the maximum recommended dosages (if unable to tolerate or has contraindication to methotrexate than 30-d ay trial of sulfasalazine or azathioprine or cyclosporine) ; AND 5. Member must have tried and failed treatment with at least two of the following: Enbrel, Cimzia, Cosentyx, Otezla and Xeljanz. Treatment failure requires at least for 30 days of therapy with each drug. 6. Dosage allowed: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Prior to any dosages or dosing frequencies greater than listed, medi cal necessity documentation must be supplied to justify coverage. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the m edication will be appr ov e d f or a n a ddit ion a l 12 months. RHEUMATOID ARTHRITIS (RA) For initial authorization: 1. Member must be 18 years of age or older with moderate to severe active RA; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Medication must be used in combination with methotrexate, or if intolerant to methotrexate, another immunosuppressant (i.e. , azathioprine, hydroxychloroquine, cyclosporine, etc.); AND 5. Member must have tried and failed treatment with at least two non-biologic DMARDS OR must have a contraindication to all non-biologic DMARDS. Treatment trial duration with each non-biologic DMARD agent m ust have been at least 30 days (non-biologic DMARDs include: methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine and leflunomide); AND 6. Member has tried and failed treatment with at least two of the following: Actemra, Cimzia, Enbrel, Kevzara, Olumiant and Xeljanz. Treatment failure requires at least for 30 days of therapy with each drug. 7. Dosage allowed: 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Prior to any dosages or dosing frequencies greater than listed, medical necessity documentation must be supplied to justify coverage. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app r ov e d f or a n a ddit ion a l 12 months. ULCERATIVE COLITIS (UC) For initial authorization: 1. Member is 6-17 years of age with moderate to severe active UC as defined by Pediatric Ulcerative Colitis Activity Index (PUCAI) of 35 or greater OR member is 18 years of age or older with moderately to severely active UC as defined by Mayo score of 6 or greater with an endoscopy subscore of 2 or 3; AND 2. Medication must be prescribed by a gastroenterologist; AND 3. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 4. Member must have tried and failed with at least 3 0-day treatment with o ne or more of the following: a) 6-mercaptopurine; b) Azathioprine; c) Methotrexate; d) Oral corticosteroids; e) Salicylates. 5. Dosage allowed: 5 mg/kg at 0, 2, and 6 weeks, followed by 5 mg/kg every 8 weeks thereafter. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. Care Source conside rs Re m icade (inflix imab) not m e dically ne cessary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Amyloid angiopathy Asthma Behcet's disease Bi rdshot retinochoroidopathy Bronchiolitis obliterans Central nervous system amyloidosis Chemotherapy induced enterocolitis (not due to Yervoy or Opdivo) Chronic immune-mediated myelitis Chronic obstructive pulmonary disease Cogan's syndrome Corneal ulcer Cr anial nerve palsy Cystoid macular degeneration Disc herniation-induced sciatica Discoid lupus erythematosus Eczema Eosinophilic fasciitis Graft-versus-host-disease Granuloma annulare Granulomatous angiitis Granulomatous mastitis Hepatitis Cgenotype 1 IgG4-related disease Infectious uveitis Iritis Juvenile idiopathic arthritis Kawasaki syndrome Localized scleroderma/morphea Membranous glomerulopathy Microscopic colitis Multifocal osteomyelitis (e.g., (chronic recurrent multifocal osteomyelitis (CRMO)) Neurosarcoidosis Nodular scleritis Panniculitis Polyarteritis nodosa Polymyositis Prevention of post-operative recurrence of Crohn's disease Rejection following small bowel transplantation Relapsing polychondritis Scleroderma Sjogren's syndrome Still's disease Systemic lupus erythematosus Takayasu arteritis Tolosa-Hunt syndrome Tubulo-interstitial nephritis with uveitis (TINU) syndrome Wegener's granulomatosis/Wegener's peripheral neuropathy. Referenc es : 1. Remic ade [pres c ribing information]. Horsham, PA; Janssen Biotech, Inc .: January , 2015. 2. Remic ade. Lex i-Drugs . Lex icomp. Wolters Kluwer Health, Inc. Riverwoods , IL. Av ailable at: http://online.lexi.c om. Acc essed February 28, 2017. 3. Lofberg R. Treatment of fis tulas in Crohn's dis ease with infliximab. Gut. 1999;45(5):642-643. 4. Lic htens tein GR, Hanauer SB, Sandborn WJ , Practice Parameters Committee of American College of Gas troenterology . Management of Crohn's disease in adults. American Journal of Gastroenterology 2009;104(2):465-83; quiz 464, 484. DOI: 10.1038/ajg.2008.168. 5. Terdiman JP, Grus s CB, Heidelbaugh JJ, Sultan S, Falck-Ytter YT; AGA Ins titute Clinic al Prac tice and Quality Management Committee. Americ an Gastroenterologic al As sociation Institute guideline on the us e of thiopurines, methotrex ate, and anti-TNF-alpha biologic drugs for the induction and maintenance of remission in inflammatory Crohn's dis eas e. Gas troenterology. 2013 Dec ;145(6):1459-63. 6. Sandborn, W., Binion, D., Persley, K., Atreja, A., & Kos ins ki, L. (2014). AGA Institute Guidelines for the Identific ation, As sessment and Initial Medical Treatment in Crohn's Dis ease: Clinic al Dec ision Support Tool. AGA Ins titute. Retrieved August 14, 2015, from www.gastro.org/IBDc arepathway . 7. Foundation for Sarc oidos is Researc h. http://www.stopsarcoidosis.org/wp-c ontent/uploads /2013/03/FSR-Physicians-Protocol1.pdf . 8. How Is Sarc oidos is Treated? National Heart, Lung, and Blood Institute. Updated: June 14, 2013. Available at: https ://www.nhlbi.nih.gov/health/health-topics/topics/sarc/treatment. Acces sed February 28, 2017. 9. Ric art E, Sandborn WJ . Infliximab for the treatment of fistulas in patients with Crohn's dis ease. Gastroenterology. 1999;117(5):1247-1248. 10. Sands BE, Anderson FH, Berns tein CN et al. A randomiz ed controlled trial of infliximab maintenance therapy for fis tuliz ing Crohns diseas e (ACCENT II). NEngl JMed. 2004;350:876 885. 11. Americ an College of Rheumatology Ad Hoc Committee on Clinical Guidelines . Guidelines for the management of rheumatoid arthritis : Arthritis Rheum. 1996;39(5):713-723. 12. Hs u S, Papp KA, Lebwohl MG, et al. Cons ensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. 13. Americ an Gas troenterological As sociation. Identification, ass essment and initial medical treatment in Cohns dis eas e. AGA ins titute. 2014. http://www.gas tro.org/IBDcarepathway. Acc essed April 20, 2017. DATE ACTION/DESCRIPTION 05/16/2017 New policy for Remicade created. Polices SRx-0041, SRx-0042, and SRx-0043 archived. For diagnosis of AS: trial of Humira and Enbrel requirement was added. For CD: Pediatric Crohns Disease Activity Index (PCDAI) and Crohns Disease Activity Index (CDAI) we r e requirements added; trial of Humira was added. For diagnosis of PsO : immunosuppressive drug criterion was separated from phototherapies and topical agents trials; Psoriasis Area and Severity Index (PASI) score requirement was added; t rials of Humira and Enbrel we r e added. For PsA: tri als of Humira and Enbrel were added. For RA: non-biologic DMARDS were listed and criterion was added to use drug in combination with methotrexate, or if intolerant to methotrexate, us e another immunosuppressant; t ria ls of Humira and Enbrel were added. For UC: requirement for moderate to severe UC was revised, Pediatric Ulcerative Colitis Activity Index (PUCAI) was added. Tria l of Humira required for member 18 y.o. List of diagnoses considered not medically necessary was added. 02/26/2019 Humira removed from trial criteria. Actemra, Cimzia, Cosentyx, Enbrel, Kevzara, Olumiant, Otezla, Siliq and Xeljanz added to trial agents list. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. Symptoms of back pain for AS extended till before age of 50. Other drugs options allowed for PsA if there is an intolerance or contraindication to methotrexate.14. Terdiman JP, Grus s CB, Heidelbaugh JJ, et al. Americ an Gas troenterologic al Ass ociation Institute Guideline on the Us e of Thiopurines , Methotrexate, and Anti TNF-a Biologic Drugs for the Induction and Maintenance of Remis s ion in Inflammatory Crohns Disease. Gastroenterology 2013; 145:1459-1463. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Orencia (abatacept) BILLING CODE J0129 (1 unit = 10 mg)infused product Must have valid NDC for self-administered product BENEF IT TYPE Medical or Pharmacy SIT EOF SERVICE ALLOWED Outpatient/Office/ Ho me COVERAGE REQUIREMENT SPrior Authorization Required (Non-Preferred Product) Alternative preferred products include Actemra, Enbrel, Cimzia, Kevzara, Olumiant and Xeljanz QUANTITY LIMIT Infused product 100 units per 28 days Self-administered product 4 per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Orencia (abatacept) is a non-preferred product and will only be con sidered for coverage under the m e dical or pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. JUV ENILE IDIOPATHIC ARTHRITIS (JIA) For initial authorization: 1. Member must be 2 years of age or older with moderate to severe active JIA; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member must have least 6 months of active disease AND have five or more joints involved; AND 5. Member must have tried and failed treatment with at least two non-biologic DMARDS (i.e. , methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine and leflunomide) or must have documented contraindication to all non-biologic DMARDS. Treatment trial duration with each non-biologic DMARD agent must have been at least 30 days ; AND 6. Member must have tried and failed treatment w ith b ot h Enbrel and Act e m ra . Treatment failure requires at least for 30 days of therapy with each drug. 7. Dosage allowed: Body weight of patient dose (once weekly subcutaneous): 10 to less than 25 kg 50 mg; 25 to less than 50 kg 87.5 mg; 50 kg or more 125 mg. Weight less than 75 kg receive 10 mg/kg intravenously based on the patients body weight. Pediatric pat ients weighing 75 kg or more should be administered Orencia following the adult intravenous dosing regimen, not to exceed a maximum dose of 1000 mg. Intravenous dosing has not been studied in patients younger than 6 years of age. If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 1 2 mon t h s. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months. PSORIATIC ARTHRITIS (PsA) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member must have tried and failed treatment with at least two of the following: Enbrel, Cimzia , Cosentyx , Otezla and Xeljanz . Treatment failure requires at least for 30 days of therapy with each drug; AND 5. Member meets at least o ne of the following scenarios: a) Member has predominantly axial disease (i.e. , sacroiliitis or spondylitis) as indicated by radiographic evidence; b) Member has shown symptoms of predominantly axial disease (i.e. , sacroiliitis or spondylitis) for more than 3 months (i.e. , limited spinal range of motion, spinal morning stiffness for more than 30 minutes) AND has tried and failed to respond to treatment with at least 2 prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 4 weeks of therapy with each NSAID without an adequate response; c) Member has predominately non-axial (e.g., peripheral synovitis or dactylitis or nail involvement) and has tried and failed to respond to treatment with at least 30-d ay trial of methotrexate and NSAID taken at the maximum recommended dosages (if unable to tolerate or has contraindication to methotrexate than 30-da y trial of sulfasalazine or azathioprine or cyclosporine). 6. Dosage allowed: Body weight of patient (intravenous): less than 60 kg 500 mg; 60 to 100 kg 750 mg; more than 100 kg 1000 mg. Administer by subcutaneous injection once weekly with or without an intravenous loading dose. For patients initiating therapy with an intravenous loading dose, administer a single intravenous infusion (as per body weight categories above), followed by the first 125 mg subcutaneous injection given within a day of the intravenous infusion. Patients transitioning from Orencia intravenous therapy to subcutaneous administration should administer the first subcutaneous dose inst ead of the next scheduled intravenous dose. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be a ppr ov e d f or an additional 12 months. RHEUMATOID ARTHRITIS (RA) For initial authorization: 1. Member must be 18 years of age or older with moderate to severe active RA; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member must have tried and failed treatment with at least two non-biologic DMARDS (i.e ., methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine and leflunomide) or must have documented contraindication to all non-biologic DMARDS. Treatment trial duration with each non-biologic DMARD agent must have been at least 30 days ; AND 5. Member must have tried and failed treatment with at least two of the followi ng: Actemra, Enbrel, Cimzia, Kevzara, Olumiant and Xeljanz . Treatment failure requires at least for 30 days of therapy with each drug. 6. Dosage allowed: Body weight of patient (intravenous): less than 60 kg 500 mg; 60 to 100 kg 750 mg; more than 100 kg 1000 mg. Administer by subcutaneous injection once weekly with or without an intravenous loading dose. For patients initiating therapy with an intravenous loading dose, administer a single intravenous infusion (as per body weight categories above), followed by the first 125 mg subcutaneous injection given within a day of the intravenous infusion. Patients transitioning from Orencia intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If me mber meets all the reauthorization requirements above, the medication will be app r ov e d f or a n a ddit ion a l 12 months. Care Source conside rs Ore ncia (abatace pt) not m e dically ne ce ssary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Ankylosing spondylitis Crohns disease Hidradenitis suppurativa Plaque psoriasis Uveitis (children/adolescents) D ATE ACTION/DESCRIPTION 05/10/2017 New policy for Orencia created. Policy SRx-0042 archived. Age adjusted for JIA. List of diagnoses considered not medically necessary added. 08/02/2017 New diagnosis of PsA added. 02/26/2019 Humira trial removed from criteria; Actemra, Cimzia, Kevzara, Olumiant, Otezla and Xeljanz added to trial agents. Clarifications entered for PsA on NSAIDs trial length. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. References added. Referenc es : 1. Ore nc ia [pac k age insert]. Princeton, NJ: Bristol-Myers Squibb Company ; March, 2017. 2. Americ an College of Rheumatology . Guidelines for the management of rheumatoid arthritis: American College of Rheumatology Ad Hoc Committee on Clinical Guidelines . Arthritis Rheuma. 1996;39(5):713-723. 3. Ringold S, Weis s PF, Beukelman T, et al. 2013 Update of the 2011 Americ an College of Rheumatology Rec ommendations for the Treatment of Juvenile Idiopathic Arthritis . Rec ommendations for the Medic al Therapy of Children With Sy s temic Juvenile Idiopathic Arthritis and Tuberc ulosis Screeni ng Among Children Rec eiv ing Biologic Medic ations Vol. 65, No. 10, October 2013, pp 2499 2512. 4. Kremer JM, et al. Effects of Abatacept in Patients with Methotrexate-Res istant Active Rheumatoid Arthritis: A Randomiz ed Trial. Ann Intern Med. 2006 Jun 20;144 (12):865-76. 5. Meas e PJ , et al. Efficac y and s afety of abatacept, a T-c ell modulator, in a randomised, double-blind, plac eboc ontrolled, phas e IIIs tudy in ps oriatic arthritis. Ann Rheum Dis. 2017 Sep;76(9):1550-1558. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
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