OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Syfovre (pegcetacoplan )BENEF IT TYPE Medical ST AT US Prior Authorization Required Syf ovre , approved by the FDA in 2023, is a complement (C3) inhibitor indicated f or the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It was the f irst drug approved f or this indication. There are 2 types of AMD : d ry or wet (neovascular). Syf ovre is approved for dry AMD which is mo r e c o mmo n but progresses more slowly to vision loss than wet AMD . GA can occur in the intermediate and advanced stages of dry AMD and is caused by the breakdown of cells in the macula , resulting in irreversible lesions that can impair vision or lead to blindness . Approval of Syf ovre was based on combined analysis of the Phase 3 DERBY and OAKS trials. It was also studied in the Phase 2 FILLY trial. Although it slows the growth r at e of GA lesions, Syfovre does not preserve visual f unction. It may also accelerate the development of new-onset wet AMD.Syfovre (pegcetacoplan) will be considered for coverage when the following criteria are met:Geographic Atrophy (GA)For initial authorization: 1. Member is at le as t 50 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a documented diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) ; AND 4. Diagnosis has been conf irmed by f undus autof luorescence (FAF) imaging with both of the f ollowing: a) Total GA area must be 2.5 and 17.5 mm2 (1 and 7 disk areas [DA] respectively) and b) If GA is multif ocal, at least one f ocal lesion must be 1.25 mm2 (0.5 DA); AND 5. Documentation of best corrected visual acuity (BCVA) of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/320 Snellen equivalent); AND 6. Member does NOT have any of the f ollowing: a) GA secondary to any condition other than AMD b) History or current evidence of wet AMD. 7. Dosage allowed/Quantity limit: 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each af f ected eye once every 25 to 60 days. (QL: 4 vials per 60 days) If all the above requirements are met , the medication will be approved for 12 months . For reauthorization : 1. GA lesion growth rate has slowed or stabilized. If all the above requirements are met , the medication will be approved for an additional 12 months .
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Susvimo (ranibizumab)BENEF IT TYPE Medical ST AT US Prior Authorization Required Susvimo , approved by the FDA in 2021, is a v as c u lar endothelial growth factor (VEGF) inhibitor intravitreal ocular implant, indicated f or the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor , and f or diabetic mac u lar edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor . VEGF inhibitors suppress endothelial cell prolif eration, neovascularization, and vascular permeability . Susvimo was previously ref erred to as Lucentis Port Delivery System (PDS) since it is essentially a longer lasting version of Lucentis, releasing ranibizumab over a 6-month period rather than needing to be administered monthly . Af ter 6 months, the port can be re-f illed. Lucentis is approved f or additional indications . Susvimo has a black box warning f or endophthalmitis, an inf ection inside the eye which is a medical emergency.Susvimo (ranibizumab) will be considered for coverage when the following criteria are met:Retinal DiseaseFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a conf irmed diagnosis of one of the f ollowing: a) Neovascular (wet) Age-related Macular Degeneration (AMD) , or b) Diabetic Mac u lar Edema (DME) ; AND 4. Member has previously responded to at least 2 intravitreal injections of a VEGF inhibitor; AND 5. Documentation of medical necessity rationale why a pref erred intravitreal injectable VEFG inhibitor cannot be used; AND 6. Documentation of best-corrected visual acuity (BCVA); AND 7. Member does NOT have any ocular or periocular inf ections or active intraocular inf lammation. 8. Dosage allowed/Quantity limit: 2 mg via surgical administration every 6 months. (1 single dose vial per eye per 6 months) If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes must include documentation of improved or stabilized visual acuity. If all the above requirements are met , the medication will be approved for an additional 12 months .
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Signifor, Signifor LAR (pasireotide)BENEF IT TYPE Medical : Signif or LAR Ph ar mac y : Signif or ST AT US Prior Authorization Required Signif or is a second-generation somatostatin analog indicated f or the treatment of adult patients with Cushings disease f or whom pituitary surgery is not an option or has not been curative. Signif or LAR has the same indication f or Cushings disease, and it is also indicated f or patients with acromegaly who have had an inadequate response to surgery and/ or f or whom surgery is not an option.Signifor, Signifor LAR (pasireotide) will be considered for coverage when the following criteria are met:Cushings DiseaseFor initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescribed by or in consultation with an endocrinologist; AND 3. Member has a documented diagnosis of Cushings disease, with an elevated urinary f ree cortisol (UFC) level; AND 4. Documentation that pituitary surgery was not curative or surgery is not an option; AND 5. Member has tried and f ailed a pref erred adrenal steroidogenesis inhibitor or cabergoline f or at least 2 months at the maximum tolerated dose. 6. Dosage allowed/Quantity limit: Signif or: 0.3 mg to 0.9 mg subcutaneously twice daily . Quantity limit: 60 ampules per 30 days . Signif or LAR: 10 mg to 40 mg intramuscularly every 28 days . Quantity limit: 1 vial per 28 days . If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes must demonstrate reduced UFC level f rom baseline. If all the above requirements are met , the medication will be approved for an additional 12 months . Acromegaly (S ignifor LAR only )For initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescribed by or in consultation with an endocrinologist; AND 3. Member has documented diagnosis of uncontrolled acromegaly conf irmed by insulin-lik e g r o wt h f actor (IGF-1) elevation above normal ; AND 4. Documentation of an inadequate response to surgery or surgery is not an opti on; AND 5. Member h as persistent IGF-1 elevation af ter optimized treatment with octreotide or lanreotide .
OH-MED-P-366685 PHARMACYPOLICY STATEMENTOhio MedicaidDRUG NAME Rystiggo (rozanolixizumab-noli) BENEFIT TYPE Medical STATUS Prior Authorization Required Rystiggo is a neonatal Fc receptor blocker indicated for the treatment of generalized myastheniagravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive. Approval was based on the Phase 3 MycarinG study. It is the second FcRn antagonist to be approved; the first was Vyvgart, however, Vyvgart is not approved for the MuSK population. Myasthenia gravis is an autoimmune disorder affecting the neuromuscular junction, characterized by muscle weakness and fatigue. The cause is an antibody-mediated immunologic attack directed at proteins in the postsynaptic membrane of the neuromuscular junction, most commonly the acetylcholine receptor (90%). Autoantibodies attack the AChR, blocking or destroying the receptors and damaging the neuromuscular junction, which impairs neuromuscular transmission and prevents muscles from contracting, as acetylcholine is unable to activate its receptor. Ocular motility, swallowing, speech, mobility, and respiratory function can all be affected. Pyridostigmine, an acetylcholinesterase inhibitor, is the initial drug of choice prescribed for MG. It eases symptoms by slowing the breakdown of acetylcholine. If control is inadequate, immunosuppressive treatment is added, such as prednisone and/or azathioprine. Other drugs are used in cases of severe or refractory MG or myasthenic crisis, which is an emergency.Rystiggo (rozanolixizumab-noli) will be considered for coverage when the following criteria are met:Myasthenia GravisFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a documented diagnosis of MGFA class II-IV myasthenia gravis (see appendix); AND 4. Lab result in chart notes shows the member is seropositive for AChR or MuSK antibodies; AND 5. Member has tried and failed at least 1 conventional therapy: A. pyridostigmine B. corticosteroid for at least 4 weeks C. non-steroid immunosuppressant (e.g., azathioprine) for at least 6 months. 6. Dosage allowed/Quantity limit: Subcutaneous infusion once weekly for 6 weeks as 1 cycle of treatment; subsequent treatment cycles are based on clinical evaluation and must be at least 63 days apart. QL: 18 vials per 42 daysIf all the above requirements are met, the medication will be approved for 6 months.
GA-MED-P -366579 DCH Approved Template o n: 12/23/2020PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Retisert (fluocinolone acetonide)BENEF IT TYPE Medical ST AT US Prior Authorization Required Retisert is a 0.59 mg f luocinolone acetonide intravitreal implant indicated f or the treatment of chronic non-inf ectious uveitis affecting the posterior segment of the eye. It is released over a period of 30 months and has been shown to reduce the rate of recurrence and improve visual acuity. Uveitis is an inf lammation of the uvea (middle layer of the eye). It can be inf ectious or non-infectious. Non-inf ectious uveitis (NIU) is of ten associated with inf lammatory conditions such as rheumatoid arthritis. If the anterior segment of the uvea is af f ected, it can be treated with topical glucocorticoids. If resistant or af fecting the intermediate or posterior segments, more invasive or systemic treatment is needed. Retisert (fluocinolone acetonide) will be considered for coverage when the following criteria are met:Uveitis For initial authorization: 1. Member is at least 12 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a diagnosis of chronic (1 year or more) non-inf ectious uveitis af f ecting the posterior segment of the eye; AND 4. Member has tried and f ailed at least one of the f ollowing f or at least 3 months: a) Systemic corticosteroid (e.g., prednisone) b) Non-biologic immunosuppressive (e.g., mycophenolate mof etil, methotrexate, cyclosporine, tacrolimus); AND 5. Member has had a f ailed trial of Ozurdex, Yutiq , or Iluvien; AND 6. Member does not have any active inf ections of the eye. 7. Dosage allowed/Quantity limit: One implant (0.59 mg) per eye Limit: 2 implants (1 per eye) per 30 months If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must show improved or stabilized visual acuity f ollowing treatment and/or an improved vitreous haze score; AND 2. At least 3 0 months have elapsed since the prior treatment (of the same eye) ; AND 3. Member has recurrent symptoms . If all the above requirements are met , the medication will be approved for an additional 3 months .
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Ozurdex (dexamethasone)BENEF IT TYPE Medical ST AT US Prior Authorization Required Ozurdex is an intravitreal implant containing dexamethasone 0.7 mg. It is indicated f or the treatment of r e t in al vein occlusion (RVO), posterior segment uveitis, and diabetic macular edema (DME). RVO occurs when there is a partial or complete obstruction of a retinal vein. Macular edema is a complication of RVO and can lead to vision loss. First-line treatment is with an t i-vascular endothelial growth f actor ( an t i-VEGF) drugs. DME is a common consequence of diabetic retinopathy. It is caused by leakage f rom retinal capillaries and leads to f luid build-up in the macula part of the retina. This can result in loss of central vision. The importance of maintaining glucose control cannot be understated. Uveitis is an inf lammation of the uvea (middle layer of the eye). It can be inf ectious or non-infectious. Non-inf ectious uveitis (NIU) is of ten associated with inf lammatory conditions such as rheumatoid arthritis. If the anterior segment of the uvea is af f ected, it can be treated with topical glucocorticoids. If resistant or af fecting the intermediate or posterior segments, more invasive or systemic treatment is needed. Ozurdex (dexamethasone) will be considered for coverage when the following criteria are met:Retinal Vein Occlusion (RVO) For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a documented diagnosis of macular edema f ollowing branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO ); AND 4. Trial and f ailure of or contraindication to an an t i-VEGF drug; AND 5. Member does NOT have any of the f ollowing: a) A ctive or suspected ocular or periocular inf ections b) Glaucoma with a cup to disc ratio of greater than 0.8 c) Torn or ruptured posterior lens capsule 6. Dosage allowed/Quantity limit: One implant (0.7 mg) per eye Limit: 2 implants (1 per eye) per 4 months If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must include documentation of improved or stabilized visual acuity; AND 2. At least 4 months have elapsed since the prior treatment (of the same eye) . If all the above requirements are met , the medication will be approved for an additional 12 months. OH-MED-P-366685UveitisFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a documented diagnosis of non-infectious uveitis af f ecting the posterior segment of the eye ; AND 4. Member has tried and f ailed at least one of the f ollowing f or at least 3 months: a) Systemic corticosteroid (e.g., prednisone) b) Non-biologic immunosuppressive (e.g., mycophenolate mof etil, methotrexate, cyclosporine, tacrolimus); AND 5. Member does NOT have any of the f ollowing: a) A ctive or suspected ocular or periocular inf ections b) Glaucoma with a cup to disc ratio of greater than 0.8 c) Torn or ruptured posterior lens capsule. 6. Dosage allowed/Quantity limit: One implant (0.7 mg) per eye Limit: 2 implants (1 per eye) per 6 months If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must show improved or stabilized visual acuity f ollowing treatment and/or an improved vitreous haze score; AND 2. At least 6 months have elapsed since the prior treatment (of the same eye) ; AND 3. Member has recurrent symptoms . If all the above requirements are met , the medication will be approved for an additional 12 months . Diabetic Macular Edema (DME) For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a documented diagnosis of diabetic macular edema; AND 4. Member does NOT have any of the f ollowing: a) A ctive or suspected ocular or periocular inf ections b) Glaucoma with a cup to disc ratio of greater than 0.8 c) Torn or ruptured posterior lens capsule. 5. Dosage allowed/Quantity limit: One implant (0.7 mg) per eye Limit: 2 implants (1 per eye) per 3 months If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must show improved or stabilized visual acuity f ollowing treatment; AND 2. At least 3 months have elapsed since the prior treatment (of the same eye). If all the above requirements are met , the medication will be approved for an additional 12 months. CareSource considers Ozurdex (dexamethasone) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Onpattro (patisiran)BENEF IT TYPE Medical ST AT US Prior Authorization Required Onpattro , approved by the FDA in 2018, contains a transthyretin-directed small interf ering RNA (siRNA) and is indicated f or the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. It is an RNA interf erence (RNAi) drug that causes degradation of mutant and wild-type TTR mRNA, which results in a reduction of serum TTR protein and TTR protein deposits in tissues by targeting the liver where TTR protein is synthesized. In the APOLLO clinical trial, changes f rom baseline to Month 18 on both the mNI S+7 (primary endpoint) and the Norf olk QoL-DN signif icantly f avored Onpattro, as well as changes in modif ied body mass index (mBMI) and gait speed (10-meter walk test). Changes were evident at 9 months. hATTR is a rare and progressive inherited disorder where misf olded TTR accumulates as amyloid f ibrils in the body. In polyneuropathy of hATTR (hATTR-PN), these fibrils deposit in the peripheral nerves which leads to pain, muscle weakness, and autonomic dys f unction.Onpattro (patisiran) will be considered for coverage when the following criteria are met:Hereditary Transthyretin Amyloidosis (hAT TR Amyloidosis): PolyneuropathyFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a diagnosis of hATTR amyloidosis with documentation of a transthyretin (TTR) mutation conf irmed by genetic testing; AND 4. Member has signs/symptoms of polyneuropathy; AND 5. Member has a polyneuropathy disability (PND) score of IIIb or less (i.e., member is not wheelchair-bound or bedridden); AND 6. Onpattro will NOT be used in combination with another TTR silencer or a TTR stabilizer . 7. Dosage allowed/Quantity limit: For intravenous (IV) administration by a healthcare provider. Weight less than 100 kg: 0.3 mg/kg every 3 weeks . Weight 100 kg or more: 30 mg every 3 weeks . (QL: 3 vials per 21 days) If all the above requirements are met , the medication will be approved for 9 months . For reauthorization : 1. Chart notes must include documentation of positive clinical response to therapy such as improvement or stabilization of neuropathy impairment, gait speed, nutritional status, disability, or quality of lif e compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months.
Admin istrative Policy StatementOHIO MEDICAID Policy Name Policy Number Date Effective Multi-ingredient Compound Policy PAD-0005-OH-MCD 10/01/2025 Policy Type Medical ADMINISTRATIVE Ph ar mac y Reimbursement A d min istra tive Po licy Statement s prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. A d min istra tive Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the serv ice (s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract ( i.e ., Evidence of Coverage), then the plan contract ( i.e ., Evidence of Coverage) will be the controlling document used to make the determination . Table of Contents Administrative Policy Statement ………………………………………………………………………………….. 1 A. Subject …………………………………………………………………………………………………………….. 2 B. Background ………………………………………………………………………………………………………. 2 C. Def initions ………………………………………………………………………………………………………… 2 D. Policy ………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………. 2 F. Related Policies/Rules ………………………………………………………………………………………… 3 G. Review/Revision History ……………………………………………………………………………………… 3 H. Ref erences ……………………………………………………………………………………………………….. 4 Ph armac y Mul ti-ingredient Compound Policy Ohio Med i c ai d PAD-0005-OH-MCD Effec ti v e Date: 10/01/20252A. Subjec t Pharm acy Mul ti-ingredient Compound Policy . B. Bac k ground Pharmac y c ompounding is d efined as the c ombining, mixing or altering of ingredients to c reate a c us to mized medication for a s pec ific patient. Co mp o und ed med ic atio ns are mad e b as ed o n a p rac titioners pres cription in whic h individual ingredients are mixed together in the ex ac t s treng th and dosa g e f o rm req uired b y the p atient . C. Def initions x Mul ti-ingredient Compound a p ro duc t c ontaining two or more ingredients that is no t FD A ap p ro v ed and is p rep ared up o n the o rd er o f a p hy s ic ian f o r a p atient. D. Polic y All m ul ti-ingredient compounds (ex cept topical p ain c ompounds) will b e c o ns id ered med ic ally nec es s ary when ALL o f the f o llo wing c riteria are met: I. The p rimary ac tive ingredients in the c ompound are ap prov ed b y the FDA f o r the ind ic atio n, ag e o r ro ute o f ad minis tratio n; OR II. If any ac tiv e ingredient in the c ompound is no t FDA ap p ro v ed f o r the req ues ted ind ic atio n, ag e, o r ro ute of administration, mus t hav e evidence from TWO p ublished s tudies f ro m majo r s c ientific or medical peer-rev iewed journals to s upport the us e of the c ompound as s af e and ef f ec tiv e AND III. The ac tiv e ing red ients are p res c rib ed in therap eutic amo unts b as ed o n FD A ap p ro v ed ind ic atio ns AND IV . The c o mp ound c ontains o nly one ac tive ingredient per any spec ific therapeutic c lass of d rugs as d ef ined b y Firs t Data Bank AND V. If a c o mpound is similar to a c ommercially av ailable prod uc t b ut d if f ers in d o s ag e, d o s ag e f o rm, o r inert ingredient (s uch as f lav o ring , d y e, o r p res erv ativ e), c hart no tes are req uired f ro m the pres criber s up p o rting the need f o r the c o mp o und (i.e. d o c ument ed d if f iculty o r inab ility to swallow oral d osage fo rms , d o c umented allerg ies to inac tiv e ing red ients ) AND VI. If any ing red ient in the c ompound, ac tive o r inactive, o therwis e req uires p rio r autho rizatio n, the memb er mus t meet criteria es tab lis hed f o r med ic al nec es s ity f o r that ing red ient AND VII. The memb er has tried and failed a trial at least 3 p referred medications (if av ailable) that c an b e us ed to treat the members c ondition. Trial d ates must b e included with prior authorizatio n req ues t AND VIII. Compound will no t b e c o v ered und er the f o llo wing c irc ums tanc es : 1. The c o mp ound is being us ed for an ex c luded b enefit (e.g., c osmetic, obesity , s ex ual dysf unction, inf ertility, etc.) 2. The c o mp ound c ontains ing redients that were withd rawn or removed from the market f o r s af ety reas o ns 3. The c o mp o und is f o r a p ro d uc t that is c o mmerc ially av ailab le 4. The c o mp o und is f o r p urp o s es o f c o nv enienc e o nly . Topical pain compounds will be c ons id ered med ic ally nec es s ary when ALL of the following c riteria are met: I. Memb er mus t hav e a d iag no s is o f c hro nic mo d erate to s ev ere p ain as s o c iated with neuro p athic p ain o r no c ic ep tiv e p ain AND Ph armac y Mul ti-ingredient Compound Policy Ohio Med i c ai d PAD-0005-OH-MCD Effec ti v e Date: 10/01/20253II. Memb er mus t hav e tried at least 3 of the following drugs from different groups for at leas t 30 d ay s eac h: a. No n-opioid oral medications or a documented contraindication b. Dic lo f enac s o d ium g el 1% o r o v er-the-c o unter (OTC) Vo ltaren g el c. To p ic al lid o c aine (e.g ., lid o c aine c ream 3% , 4% , lid o c aine p atc h 4% ) d. To p ic al c ap s aic in AND III. The c o mp ound c ontains no more than 1 ac tive ingredient p er any spec if ic d rug c las s as d ef ined b y Firs t Data Bank AND IV . The c o mp o und c o ntains no mo re than 3 d rug c las s es f o r ac tiv e ing red ients AND V. The c o mp o und d o es NOT c o ntain any c o ntro lled s ub s tanc es AND VI. The ac tiv e ing redients must be FDA approved o r c omp end ia s up p o rted f o r to p ic al us e and f o r the p ain ind ic atio n. Reauthorization: Pain c o mp o und : x Memb er mus t hav e doc umented improvement of pain s upported b y c hart no tes (d ef ined as imp ro v ement o f at leas t 3 p o ints o n a 0 to 10 p o int p ain s c ale) All other compounds: x Ev id ence of effectiveness and s afety for c ompound must b e d o c umented in c hart no tes f o r c o ntinuatio n o f ap p ro v al. Additional notes: x Reimb urs ement will not be p rovided for additives such as flavorings, dyes , o r p res erv ativ es . x Req ues ts res ulting f ro m a d rug s ho rtag e will b e c o ns id ered o n a c as e-by-case basis. E. Conditions of Cov erage HCP CS CP TA UTHORI ZATI ON PE RI OD Initial approval: 3 mo nths o r pres cribers reques ted length of therapy (if s ho rter than 3 mo nths ) Reauthorization: 12 mo nths F. Related Polic ies/Rules Medical Necessity f or Non-Fo rmulary Med ic atio ns Po lic y Medical Necessity-Of f Lab el, Ap p ro v ed Orp han and Co mp as s io nate Us e Drug s Ev id enc e o f Co v erag e ("Pres c rip tio n Drug s " and "What is No t Co v ered ") G. Rev iew/Rev ision History DATE S ACTIONDate Issued 07/01/2016 Initial Releas e to P&P Co mmitteeDate Revised 08/01/2016 2016 Annual Rev iew with No Chang es 06/01/2017 2017 Annual Rev iew with No Chang es
Administrative Policy StatementOHIO MEDICAID Policy Name Policy Number Date Effective Medical Necessity Off Label PAD-00 05-OH-MCD 10/01/2025 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Administrative Policy Statement s prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. Table of Contents Administrative Policy Statement ……………………………………………………………………………………… 1 A. Subject ………………………………………………………………………………………………………………….. 2 B. Background ……………………………………………………………………………………………………………. 2 C. Definitions ……………………………………………………………………………………………………………… 2 D. Policy ……………………………………………………………………………………………………………………. 2 E. Conditions of Coverage …………………………………………………………………………………………… 3 F. Related Policies/Rules …………………………………………………………………………………………….. 3 G. Review/Revision History ………………………………………………………………………………………….. 3 H. References ……………………………………………………………………………………………………………. 4 Medical Necessity Off Label Ohio MedicaidPAD-0005-OH-MCD Effective Date : 10/01/2025 2 A. Subject Medical Necessity Off Label B. Background The U.S. Food and Drug Administration (FDA) approves drugs for specific indications included in the drugs product information label. Off-label or unlabeled drug use is the utilization of an FDA approved drug for uses other than those listed in the FDA approved labeling or in treatment regimens or populations that are not included in approved labeling. Many off-label uses are effective, well documented in the peer-reviewed literature, and widely used even though the manufacturer has not pursued the additional indications. The FDA advises physicians use of off-label or unlabeled drugs must be done in a well-informed manner in conjunction with firm scientific rationale and medical evidence. CareSource will employ, at its discretion, drug utilization management programs (i.e., prior authorization) to ensure appropriate and safe use of medications. Npol mdoc gi c C. Definitions 0078 FDA Approved medication: Is the official description of a drug product which includes indication; who should take it; adverse events; instructions for uses in pregnancy; children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging. 0078 Off-label or unlabeled drug use: Is the use of a drug approved by the U.S. Food and Drug Administration (FDA) for other uses that are not included in approved labeling. The FDA approves drugs for specific indications that are included in the drugs labeling. When a drug is used for an indication other than those specifically included in the labeling, it is referred to as an off-label use. Many off-label uses are effective, well documented in the literature, and widely used. D. Policy CareSource will review prior authorization requests for coverage based on medical necessity . This policy will not supersede drug-specific criteria developed and approved by the CareSource Pharmacy and therapeutics Committee (P&T). Requests for off-label uses of a drug will be considered for approval according to the following criteria: I. Documentation must be submitted showing the member has tried and failed the existing FDA approved and/or clinical guideline recommended therapies unless contraindicated or not tolerated; AND II. The prescribed use must be supported by one or more of the following: a. Narrative information from American Hospital Formulary Service Drug Information (AHFS) or Clinical Pharmacology Medical Necessity Off Label Ohio MedicaidPAD-0005-OH-MCD Effective Date : 10/01/2025 3 b. Lexicomp: Evidence level A c. Micromedex: Recommendation class I, IIa, or IIb d. Evidence from at least two published studies from major scientific or medical peer reviewed journals demonstrates safety and efficacy for the specified condition in a comparable population (i.e., age group, level of disease severity, etc.) Im. III. Requests for members less than 21 years old are reviewed for coverage for Early and Periodic Screening, Diagnosis, and Treatment (ESPDT) on a case-by-case basis in addition to the criteria above. NOTE: For off-label use of oncology drugs, please refer to the policy titled Oncology Regimens accessible from the CareSource website. For Reauthorization: I. Documentation has been provided showing the member has had a positive response to therapy; AND II. Documentation has been provided showing the member is compliant with therapy . E. Conditions of Coverage AUTHORIZATION PERIOD Approved authorizations are designated an appropriate authorization period. Continued treatment may be considered when the member has shown tolerability and a positive clinical response. F. Related Policies/RulesOncology Regimens G. Review/Revision History DATES ACTIONDate Issued 06/06/2013Date Revised 10/30/2014 Added definition to excluded indications 05/05/2015 Removed indications in reference of plan specificmember handbooks, EOC, etc. Removed specialty and subspecialty associations and combined with no determinations policy12/15/ 20 15 Revised class/category and defined evidence criteria for article submissions01/11/ 20 18 Updated format02/12/2021 Updated format, copied to new template. General editsfor clarity. Added note about clinical trials in progress. Removed content related to orphan drugs and compassionate use. Removed cancer drug section and refer to separate policy. Added component that member must try and fail available FDA approved on label drugs first. Amended list of acceptable compendia to include Lexicomp. Updated reference section.11/02/2022 Updated the title of the oncology policy that is referenced. No other changes.2/24/2023 Added note on EPSDT. 5/21/2024 Annual review, no updates.
Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. Administrative Policy StatementOhio MedicaidPolicy Name Policy Number Date Effective Medical Benefit Medications PAD-0005-OH-MCD 10/01/2025 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Table of ContentsA. SUBJECT ………………………………………………………………………………………………………….. 2B. BACKGROUND ………………………………………………………………………………………………….. 2 C. DEFINITIONS …………………………………………………………………………………………………….. 2 D. POLICY …………………………………………………………………………………………………………….. 3 E. CONDITIONS OF COVERAGE …………………………………………………………………………….. 4 F. RELATED POLICIES/RULES ……………………………………………………………………………….. 4 G. REVIEW/REVISION HISTORY …………………………………………………………………………….. 4 2 A. SUBJECT Medical Benefit Medications Ohio Medicaid PAD-0005-OH MCD Effective date: 10/01/2025CareSource uses Pharmacy Policy Statements to determine coverage for medications that are covered under the medical benefit, as determined by the CareSource Pharmacy and Therapeutics (P&T) Committee. Pharmacy Policy Statements contain criteria designed to ensure that CareSource members safely receive effective medication. Some medical benefit medications may not be addressed by a specific Pharmacy Policy Statement. In that case, the reviewing pharmacists will make a clinical determination based on the information outlined here.B. BACKGROUND The intent of CareSource Policy Statements is to encourage appropriate selection of drug therapy for members according to product labeling, clinical guidelines, and/or clinical studies as well as to encourage use of Marketplace preferred drugs. The CareSource Policy Statement is a guideline for determining health care coverage for our members with benefit plans covering prescription drugs. Pharmacy Policy Statements are written on selected prescription drugs requiring prior authorization or step therapy. The Pharmacy Policy Statement is used as a tool to be interpreted in conjunction with the members specific benefit plan. Note: The Introduction section is for your general knowledge and is not to be construed as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals and is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider can also be a place where medical care is given, like a hospital, clinic, or lab. This policy informs providers about when a product or service may be covered. C. DEFINITIONS Administrative Review/Approval/Denial: a decision for coverage or non-coverage of a drug which is made regarding the organization and delivery of the drugs according to a members benefits, policies & procedures, and/or legislature & regulation which do not require clinical expertise or subject knowledge. Clinical Judgement: decisions made within the scope and expertise of a pharmacist following the review of subjective and objective medical data for a member. A pharmacist can use Clinical Judgement for the benefit determination for an exceptions request for a Medical Benefit Drug. If the request is outside the scope of a pharmacists expertise, a benefit determination will be made in collaboration with a medical director. Drug: a medication or substance which induces a physiologic effect on the body of a member (i.e., medication, agent, drug therapy, treatment, product, biosimilar drug, etc.). Medical Benefit Drug: a drug that is usually administered by a healthcare provider or in a supervised healthcare setting and is billed to CareSource through the medical benefit and is subject to the appropriate member cost share based on the Schedule of Benefits (SOB) and/or Summary of Benefits and Coverage (SBC). 3 Medical Benefit Medications Ohio Medicaid PAD-0005-OH MCD Effective date: 10/01/2025 Non-Preferred Drug: a drug that has been determined by CareSource to be less clinically efficacious or cost-effective for an FDA-approved use than other available drugs by the CareSource P&T Committee. Preferred Drug: the drug of choice for CareSource for an FDA-approved use as indicated on a Pharmacy Policy Statement available on the CareSource website and based on clinical efficacy and cost as determined by the CareSource P&T Committee. Specialty Drug: a drug which treats highly complex diseases and/or requires special handling or distribution and is usually high cost. Many of these drugs require prior authorization and may be dispensed at limited locations. Please see CareSources Specialty Drug List on the CareSource website. D. POLICY I. Medical Benefit Drugs may require review and approval by a pharmacist and/or medical director before being approved for payment. This policy will not supersede drug-specific clinical criteria developed and approved by the CareSource P&T Committee. When CareSource approves coverage of a Medical Benefit Drug it will be considered Medically Necessary when ALL of the following criteria have been met: A. Prior Authorization requests should be submitted for each Medical Benefit Drug with chart notes and member-specific documentation AND B. The members indication, dose, and duration for the use of the requested Medical Benefit Drug is approved by the Food & Drug Administration (FDA) or an indication supported in the compendia or current peer-reviewed literature or evidence-based guidelines AND C. One of the following is true: 1. The Medical Benefit Drug is a Preferred Drug by CareSource OR 2. The member is unable to take the Preferred Drug(s) because: a. The member has a clinical condition for which there is no Marketplace Preferred Drug and/or needed dosage form suitable to treat the members diagnosis OR b. The Marketplace Preferred Drug(s) is/are not recommended based on published guidelines or clinical literature OR c. The Marketplace Preferred Drug(s) is/are expected to be ineffective or less effective for the member based on submitted documentation and medical history OR d. The Marketplace Preferred Drug(s) is/are expected to cause an adverse effect based on submitted documentation and medical history. II. For Reauthorization: A. Documentation has been provided showing the member has had a positive response to therapy; AND B. Documentation has been provided showing the member is compliant with therapy; AND C. The requested use and dosage remain consistent with FDA-approved prescribing information in the drug package insert. 4 E. CONDITIONS OF COVERAGE HCPCS CPT Medical Benefit Medications Ohio Medicaid PAD-0005-OH MCD Effective date: 10/01/2025 AUTHORIZATION PERIOD: as determined by the approving pharmacists Clinical JudgementF. RELATED POLICIES/RULES Non-Formulary Medications Policy Off Label Medication Requests Policy Drug-specific policies posted on the CareSource website may applyG. REVIEW/REVISION HISTORY DATES ACTION Date Issued 11/07/2019 Drafted policy language; updated references to SOB and SBC Date Revised 11/17/2021 Annual review, no changes. 12/19/2022 Annual review, no changes.6/6/2023 Removed Medical Necessity and updated related policies and rules to align with new policy titles. 5/21/24 Annual review, no changes5/22/2025 Added reauthorization criteria . ODM approved on07/23/25. Date Effective 10/01/2025 Date Archived H. REFERENCES 1. Definitions for Administrative Review or Clinical Judgement: Ombudsman Saskatchewan, Canada; Administrative versus Clinical Decisions January 2016. 2. 45 CFR Chapter A Subchapter B-156.122 Prescription drug benefits. 3. 2018 NCQA Standards and Guidelines for the Accreditation of Health Plans.
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