Drug Therapy Guidelines Orencia (abatacept) Applicable Medical Benefit x Effective: 2/21/18 Pharmacy- Frmulary 1 x Next Review: 12/18 Pharmacy- Frmulary 2 x Date f Origin: 11/28/06 Pharmacy- Frmulary 3/Exclusive x Review Dates: 11/28/06, 7/2/07, 11/5/07, 12/15/08, 12/09, 1/11, Pharmacy- Frmulary 4/AON x 9/11, 12/11, 12/12, 12/13, 12/14, 12/15, 12/16, 12/17 I. Medicatin Descriptin Abatacept, a selective c-stimulatin mdulatr, inhibits T-cell (T-lymphcyte) activatin by binding t CD80 and CD86, thereby blcking interactin with CD28. This interactin prvides a c-stimulatry signal necessary fr full activatin f T-lymphcytes. Activated T-lymphcytes are implicated in the pathgenesis f Rheumatid Arthritis (RA) and are fund in the synvium f patients with RA. T-cell prliferatin leads t increased prductin f the cytkines TNF-alpha, interfern-gamma, and interleukin which increases inflammatin and jint destructin. Abatacept s inhibitry actin n these cytkines suppresses inflammatin, decreases anticllagen antibdy prductin, and reduces antigen-specific prductin f interfern-gamma. II. Psitin Statement Cverage is determined thrugh a prir authrizatin prcess with supprting clinical dcumentatin fr every request. When administered subcutaneusly, Orencia is cnsidered a pharmacy benefit. When administered intravenusly, Orencia is cnsidered a medical benefit. III. Plicy Medical Benefit: See Sectin A and C Frmulary 1: See Sectin B and C Frmulary 2: See Sectin B and C Frmulary 3/Exclusive: See Sectin B and C Frmulary 4/AON: See Sectin B and C A. Cverage f intravenus Orencia under the medical benefit is prvided fr the fllwing cnditins when the listed criteria are met: Juvenile idipathic arthritis: Prescribed by a rheumatlgist AND Member has tried therapy with at least ne nn-bilgic DMARD with either treatment failure after 12 weeks r intlerable side effects (unless DMARDs are cntraindicated) AND Member has received at least a 3 mnth trial and failed n at least 1 plan-preferred selfinjectable TNF-α inhibitr (Enbrel r Humira) Psriatic arthritis (active disease): Prescribed by a rheumatlgist r dermatlgist AND One f the fllwing: Page 1 f 5
Member has tried therapy with at least ne nn-bilgic DMARD with either treatment failure after 12 weeks r intlerable side effects (unless DMARDs are cntraindicated) OR If predminantly axial disease is dcumented, the member has experienced treatment failure with at least tw ral NSAIDs (unless NSAIDs are cntraindicated) AND Member has first attempted therapy with a plan-preferred medicatin (Remicade r Simpni Aria) Rheumatid arthritis (mderate t severe disease): Prescribed by a rheumatlgist AND Member has tried therapy with at least ne nn-bilgic DMARD with either treatment failure after 12 weeks r intlerable side effects (unless DMARDs are cntraindicated) AND Member has first attempted therapy with a plan-preferred medicatin (Remicade r Simpni Aria) B. Cverage f subcutaneus Orencia under the pharmacy benefit is prvided fr the fllwing cnditins when the listed criteria are met: Juvenile idipathic arthritis: Prescribed by a rheumatlgist AND Member has tried therapy with at least ne nn-bilgic DMARD with either treatment failure after 12 weeks r intlerable side effects (unless DMARDs are cntraindicated) AND Member has received at least a 3 mnth trial and failed n at least 1 plan-preferred selfinjectable TNF-α inhibitr (Enbrel r Humira) Psriatic arthritis (active disease): Prescribed by a rheumatlgist r dermatlgist AND One f the fllwing: Member has tried therapy with at least ne nn-bilgic DMARD with either treatment failure after 12 weeks r intlerable side effects (unless DMARDs are cntraindicated) OR If predminantly axial disease is dcumented, the member has experienced treatment failure with at least tw ral NSAIDs (unless NSAIDs are cntraindicated) AND Member has first attempted therapy with TWO plan-preferred medicatins (Csentyx, Enbrel, Humira, r Stelara) Rheumatid arthritis (mderate t severe disease): Prescribed by a rheumatlgist AND Member has tried therapy with at least ne nn-bilgic DMARD with either treatment failure after 12 weeks r intlerable side effects (unless DMARDs are cntraindicated) AND The member has tried at least TWO f the fllwing plan-preferred medicatins (Actemra, Humira, Enbrel, r Xeljanz/Xeljanz XR) C. Step therapy criteria utlined in A and B apply unless the fllwing criteria are met: When requesting cverage f a brand medicatin fr which an A/B rated generic is available, there is sufficient evidence that the use f the A/B rated generic equivalent has resulted in inadequate results AND At least ne f the fllwing is met: The plan-preferred medicatins are cntraindicated r will likely cause an adverse reactin by r physical r mental harm t the member. Page 2 f 5
The plan-preferred medicatins are expected t be ineffective based n the knwn clinical histry and cnditins f the member and the member s prescriptin drug regimen. The member has tried the plan-preferred medicatins r anther prescriptin drug in the same pharmaclgic class r with the same mechanism f actin and such prescriptin drug was discntinued due t lack f efficacy r effectiveness, diminished effect, r an adverse event. The member is stable n the medicatin selected by their healthcare prfessinal fr the medical cnditin under cnsideratin (where stable is defined as receiving the medicatin fr an adequate perid f time, have achieved ptimal respnse, and cntinued favrable utcmes are expected UNLESS the medicatin was initially selected due t the availability f a drug sample r a cupn card). The plan-preferred medicatin is nt in the best interest f the member because it will likely cause a significant barrier t the member s adherence r t cmpliance with the member s plan f care, will likely wrsen a cmrbid cnditin f the member, r will likely decrease the member s ability t achieve r maintain reasnable functinal ability in perfrming daily activities. IV. Quantity Limits Cverage fr intravenus dsing is available as fllws: Fr the treatment f juvenile idipathic arthritis: Members 6 years and lder weighing mre than 100 kg: 3000 mg in the first 28 days f therapy, then starting at week 8, 1000mg every 28 days thereafter Members 6 years and lder weighing 75 kg t 100 kg: 2250 mg in the first 28 days f therapy, then starting at week 8, 750 mg every 28 days thereafter Members 6 years and lder weighing less than 75 kg: three 10 mg/kg dses in the first 28 days f therapy, then starting at week 8, 10 mg/kg every 28 days thereafter Fr the treatment f psriatic and rheumatid arthritis: Members 18 years and lder weighing mre than 100 kg: 3000 mg in the first 28 days f therapy, then starting at week 8, 1000mg every 28 days thereafter Members 18 years and lder and weighing 60 kg t 100 kg: 2250 mg in the first 28 days f therapy, then starting at week 8, 750 mg every 28 days thereafter Members 18 years f age and lder weighing less than 60 kg: 1500 mg in the first 28 days f therapy, then starting at week 8, 500 mg every 28 days thereafter Cverage fr subcutaneus dsing is available as fllws: Fr the treatment f juvenile idipathic arthritis: Members 2 years and lder weighing 50 kg r mre: fur 125 mg syringes r autinjectrs per each 28 days Members 2 years and lder weighing 25 kg t less than 50 kg: fur 87.5 mg syringes per each 28 days Members 2 years and lder weighing 10 kg t less than 25 kg: fur 50 mg syringes per each 28 days Page 3 f 5
Fr the treatment f psriatic and rheumatid arthritis: Members 18 years and lder: fur 125mg syringes r autinjectrs per each 28 days V. Cverage Duratin Cverage is prvided fr 12 mnths and may be renewed. VI. Cverage Renewal Criteria Cverage can be renewed based upn the fllwing criteria: Clinical respnse r remissin f disease is maintained with cntinued use AND Absence f unacceptable txicity frm the drug VII. Billing/Cding Infrmatin J0129 1 billable unit is 10mg Available as: Orencia 250 mg lyphilized pwder in a single use vial fr recnstitutin prir t intravenus infusin Orencia single dse prefilled syringes fr subcutaneus use (prvided in a packs f 4 syringes): 50 mg/0.4 ml 87.5 mg/0.7 ml 125 mg/ml Orencia (single dse prefilled ClickJect autinjectr)- 125 mg/ml syringe fr subcutaneus use, prvided in a pack f 4 autinjectrs Pertinent diagnses: Juvenile rheumatid arthritis: M08.00, M08.3, M08.40 Psriatic Arthritis: L40.50- L40.53, L40.59 Rheumatid arthritis: M05.00, M05.30, M05.60, M06.1, M06.9 VIII. Summary f Plicy Changes 1/2011: Clarificatin f prir DMARD use requirements Clarificatin f plan-preferred medicatins: Humira and Enbrel 6/15/12: Additin f Orencia SC criteria fr cverage; Additin f Orencia SQ / prefilled syringe dsing and prduct infrmatin t guideline Cverage duratin extended t 12 mnths 3/15/13: n changes 7/1/13: Medical, Cmmercial Rx, and Medicaid/FHP Rx criteria differentiated 3/15/13: clarified need fr latent Tb testing Page 4 f 5
8/1/14: Cverage fr the treatment f RA under the medical benefit requires the use f either Remicade r Simpni Aria first 3/15/14: n plicy changes 7/1/15: frmulary distinctins made 3/15/16: n plicy changes 1/1/17: step therapy rules updated n the pharmacy benefit 5/1/17: step therapy criteria added 10/20/17: cverage f Orencia fr the treatment f psriatic arthritis added; available prducts and quantity limits updated 1/1/18: n plicy changes IX. References 1. Up-t-date Online, retrieved Nvember 2010 2. Clinical Pharmaclgy Online, retrieved Nvember 2017 (www.clinicalpharmaclgy.cm). 3. Facts and Cmparisns Online, retrieved Nvember 2010 4. Prduct Infrmatin: Orencia (Abatacept). Bristl-Myers Squibb. Revised 6/2017. 5. Genvese MC, Cvarrubias A, et al. Subcutaneus Abatacept Versus Intravenus Abatacept: A phase IIIb nn-inferirity study in patients with an inadequate respnse t methtrexate. Arthritis Rheum 2011 Oct;63(10):2854-64. di: 10.1002/art.30463. 6. Genvese MC, Schiff M, et al. Efficacy and safety f the selective c-stimulatin mdulatr Abatacept fllwing 2 years f treatment in patients with rheumatid arthritis and an inadequate respnse t antitumur necrsis factr therapy. Ann Rheum Dis 2008;67:547-554. 7. Remy A, Avuac J, et al. Clinical relevance f switching t a secnd tumur necrsis factr-alpha inhibitr in rheumatid arthritis: A systematic literature review and meta-analysis. Clin Exp Rheumatl 2011; 29:96-103. The Plan fully expects that nly apprpriate and medically necessary services will be rendered. The Plan reserves the right t cnduct pre-payment and pst-payment reviews t assess the medical apprpriateness f the abve-referenced therapies. The preceding plicy applies nly t members fr whm the abve named pharmacy benefit medicatins are included n their cvered frmulary. Members with clsed frmulary benefits are subject t trying all apprpriate frmulary alternatives befre a cverage exceptin fr a nn-frmulary medicatin will be cnsidered. The preceding plicy is a guideline t allw fr cverage f the pertinent medicatin/prduct, and is nt meant t serve as a clinical practice guideline. Page 5 f 5