Drug Therapy Guidelines

Transcription

1 Applicable* Medical Benefit x Effective: 2/15/19 Pharmacy- Frmulary 1 Next Review: 12/19 Pharmacy- Frmulary 2 Date f Origin: 4/1/05 Pharmacy- Frmulary 3/Exclusive Review Dates: 4/1/05, 2/1/06, 10/15/06, 11/5/07, 12/15/08, Pharmacy- Frmulary 4/AON 12/09, 6/10, 1/11, 12/11, 12/12, 12/13, 12/14, 12/15, 12/16, 6/17, 12/17, 12/18 I. Medicatin Descriptin Remicade (infliximab) is a chimeric mnclnal antibdy that neutralizes the bilgical activity f tumr necrsis factr-α (TNF-α) by binding with high affinity t the sluble and transmembrane frms f TNF-α, which subsequently inhibits binding f TNF-α with its receptrs. Bilgical activities attributed t TNF-α include the fllwing: inductin f prinflammatry cytkines such as interleukins 1 and 6; enhancement f leukcyte migratin by increasing endthelial layer permeability and expressin f adhesin mlecules by endthelial cells and leukcytes; activatin f neutrphil and esinphil functinal activity; and inductin f acute phase reactants and ther liver prteins, as well as tissue-degrading enzymes prduced by synvicytes and/r chndrcytes. The clinical result f inhibiting TNF-α activity includes reductin in inflammatry prcesses assciated with specific autimmune disrders. Inflectra (infliximab-dyyb) and Renflexis are bisimiliar t infliximab. Bisimilar medicatins are apprved and treated as therapeutically equivalent t the reference bilgic medicine, including having identical cntraindicatins, precautins, adverse reactins, drug interactins, and administratin instructins. II. Psitin Statement Cverage is determined thrugh a prir authrizatin prcess with supprting clinical dcumentatin fr every request. III. Plicy Cverage is prvided fr the fllwing cnditins when the listed criteria are met: Ankylsing spndylitis (active disease): Prescribed by a rheumatlgist AND The member has had inadequate results with at least tw NSAIDs (unless NSAIDs are cntraindicated) Crhn s disease (mderate t severe): Prescribed by a gastrenterlgist AND At least ONE f the fllwing criteria is met: The member has had an inadequate respnse t r nt tlerated immune mdulatrs (ex. azathiprine, 6-MP, methtrexate) OR The member has nt respnded t sterids r is sterid refractry OR The member has fistulizing disease Plaque psriasis (mderate t severe disease): Prescribed by a rheumatlgist r dermatlgist AND Page 1 f 5

2 AND At least 10% f BSA affected r less than 10% BSA affected but with palmar, plantar, head/neck, r genitalia invlvement AND Member has had an inadequate respnse t PUVA r UVB therapy unless cntraindicated AND Member has had an inadequate respnse t nn-bilgic systemic therapy (i.e. methtrexate, cyclsprine, acitretin) unless cntraindicated 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) Rheumatid arthritis (mderate t severe disease): Prescribed by a rheumatlgist AND Medicatin is used in cmbinatin with methtrexate (unless cntraindicated) 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) Ulcerative clitis (mderate t severe disease): Prescribed by a gastrenterlgist AND Member has had an inadequate respnse r intlerance t any TWO f the fllwing: Sulfasalazine r 5-Aminsalicylic acid (5-ASA) Immune mdulatrs (ex. azathiprine, 6-MP) Oral r intravenus (IV) sterids (sterid refractry) Cverage f the nn-preferred medicatins (Inflectra and Renflexis) can be cnsidered if the member has first attempted therapy with ne diagnsis-apprpriate plan-preferred medicatin (Remicade r Simpni Aria) OR if the fllwing criteria have been 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. 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 Page 2 f 5

3 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 and the member des nt therwise meet the definitin f stable ). 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 Fr Rheumatid Arthritis Mnth 1 (inductin dsing): n mre than 100 billable units (1,000mg) Mnth 2 (inductin dsing): n mre than 60 billable units (600mg) Mnth 3 and after (maintenance dsing): n mre than 100 billable units every 4 weeks Fr Crhn s Disease Mnth 1 (inductin dsing): n mre than 100 billable units (1,000mg) Mnth 2 (inductin dsing): n mre than 60 billable units (600mg) Mnth 3 and after (maintenance dsing): n mre than 100 billable units every 8 weeks Fr Ankylsing Spndylitis Mnth 1 (inductin dsing): n mre than 100 billable units (1,000mg) Mnth 2 (inductin dsing): n mre than 60 billable units (600mg) Mnth 3 and after (maintenance dsing): n mre than 60 billable units every 6 weeks Fr all ther indicatins: Mnth 1 (inductin dsing): n mre than 100 billable units (1,000mg) Mnth 2 (inductin dsing): n mre than 60 billable units (600mg) Mnth 3 and after (maintenance dsing): n mre than 60 billable units every 8 weeks V. Cverage Duratin Cverage is available fr 1 year 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 Remicade (infliximab) J billable unit is 10mg Page 3 f 5

4 Inflectra (infliximab-dyyb) Q billable unit is 10 mg Renflexis (infliximab-abda) Q billable unit is 10 mg Pertinent Indicatins: Rheumatid Arthritis M06.9, M05.00, M05.30, M05.60, M06.1, M06.4, M08.00, M12.00 Ankylsing Spndylitis M45.9 Crhn s Disease K50.00, K50.10, K50.80, K50.90 Plaque psriasis L40.0-L40.4, L40.8 Psriatic arthritis L40.54, L40.59 Ulcerative Clitis K51.00, K51.20, K51.30, K51.50, K51.80, K51.90 VIII. Summary f Plicy Changes 4/1/11: Clarificatin f prir DMARD use requirements 6/15/12: Additin f pediatric Crhn s diagnsis Revisin f DMARD and sterid requirements fr Crhn s and Ulcerative Clitis Additin f pprtunistic infectins t Black Bx (Listeria, Leginella) Revisin f systemic r phttherapy requirements fr Plaque Psriasis 3/15/13: n plicy changes 3/15/14: n plicy changes 3/15/15: n plicy changes 7/1/15: frmulary distinctins made, remval f need fr Tb testing n members nt at high risk 3/15/16: updated quantity limits t including inductin dsing 1/1/17: additin f Inflectra (infliximab-dyyb) t the plicy as a nn-preferred medicatin 5/1/17: step therapy criteria added 7/1/17: additin f Renflexis (infliximab-abda) t the plicy as a nn-preferred medicatin 1/1/18: updated billing/cding infrmatin; clarified criteria fr use in RA; updated step criteria 4/1/18: updated billing/cding infrmatin 2/15/19: added sterid trials t CD and UC cverage criteria IX. References 1. Up-t-date Online, retrieved Nvember Clinical Pharmaclgy nline, Elsevier/Gld Standard. Accessed 11/ Facts and Cmparisns Online, retrieved Nvember Prduct Infrmatin: Remicade (infliximab). Janssen Bitech. Revised 6/ Rutgeerts P; Sandbrn WJ; Feagan BG; Reinisch W; Olsn A; Jhanns J; Travers S; Rachmilewitz D; Hanauer SB; Lichtenstein GR; de Villiers WJ; Present D; Sands BE; Clmbel JF. Infliximab fr inductin and maintenance therapy fr ulcerative clitis. N Engl J Med Dec 8; 353(23): Page 4 f 5

5 6. Singh JA, et al update f the 2008 American Cllege f Rheumatlgy recmmendatins fr the use f disease-mdifying antirheumatic drugs and bilgic agents in the treatment f rheumatid arthritis. Arthritis Care Res (Hbken) May;64(5): Prduct Infrmatin: Inflectra (infliximab-dyyb). Celltrin, Inc. Revised 7/ Ward MM, Dedhar A, Akl EA, et al. American Cllege f Rheumatlgy/Spndylitis Assciatin f America/Spndylarthritis Research and Treatment Netwrk 2015 Recmmendatins fr the Treatment f Ankylsing Spndylitis and Nnradigraphic Axial Spndylarthritis. American Cllege f Rheumatlgy DOI Prduct Infrmatin: Renflexis (infliximab-abda). Merck & C., Inc. Revised 11/ Centers fr Medicare and Medicaid Services. Medicare Benefit Plicy Manual: Chapter 15. (CMS Publicatin N ). Retrieved frm Lichtenstein G, Lftus E, Isaacs K et al. ACG Clinical Guideline: Management f Crhn s Disease in Adults. Am J Gastrenterl 2018; 113: Krnbluth A, Sachar DB. Ulcerative clitis practice guidelines in adults: American cllege f gastrenterlgy, practice parameters cmmittee. Am J Gastrenterl 2010; *These guidelines are nt applicable t benefits cvered under Medicare Advantage. Medicare Advantage benefit cverage requests are reviewed in accrdance with the guidance set frth in Chapter 15 Sectin 50 f the Centers fr Medicare & Medicaid Services Medicare Benefit Plicy Manual. 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 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