Drug Therapy Guidelines

Transcription

1 Applicable Medical Benefit x Effective: 1/1/18 Pharmacy- Frmulary 1 x Next Review: 12/18 Pharmacy- Frmulary 2 x Date f Origin: 5/28/06 Pulmnary Arterial Hypertensin : Revati (sildenafil), Ventavis (ilprst), Tracleer (bsentan), Letairis (ambrisentan), Adcirca (tadalafil), Tyvas (treprstinil), Remdulin (treprstinil), Fllan /Veletri (epprstenl), Adempas (riciguat), Opsumit (macitentan), Orenitram (treprstinil), Uptravi (selexipag) Pharmacy- Frmulary 3/Exclusive x Review Dates: 5/28/06, 3/6/07, 11/5/07, 3/25/08, 12/15/08, Pharmacy- Frmulary 4/AON x 12/09, 12/10, 9/11, 9/12, 9/13, 9/14, 12/15, 12/16, 12/17 I. Medicatin Descriptin Pulmnary Arterial Hypertensin (PAH) is a cnditin characterized by unusually high and persistent pulmnary artery pressure. Cmmn symptms patients initially experience are shrtness f breath, fatigue, and fainting. As the disease prgresses, symptms becme mre acute and patients may develp cyansis, edema, and angina. The disease is prgressive and can lead t right-sided heart failure and death. Several bilgical drug targets have been identified as mechanisms invlved in PAH. Phsphdiesterase-5 inhibitrs inhibit a specific phsphdiesterase enzyme fund in the smth muscle f the pulmnary vasculature, thus resulting in a relaxatin f pulmnary smth muscles and ultimately, a decrease in resistance. Prstacyclin analgs decrease pulmnary vascular resistance by taking advantage f the vasdilatry effects f this prstaglandin. Endthelialreceptr antagnists blck endthelin s ability t bind t receptrs n lung bld vessels, thus preventing cnstrictin f these vessels. Sluble guanylate cyclase stimulatrs decrease vascular tne independent f nitric xide. II. Psitin Statement Cverage is determined thrugh a prir authrizatin prcess with supprting clinical dcumentatin fr every request. All medicatins in this plicy may be cvered under the pharmacy benefit if they are self-administered. Fllan, Veletri, Remdulin, Ventavis may als be cvered under the medical benefit if they are administered by a healthcare prfessinal. III. Plicy Cverage f the pulmnary arterial hypertensin agents in this plicy is prvided in accrd with the fllwing: Fr Pulmnary Arterial Hypertensin (all agents in this plicy): Patient is fllwed by a cardilgist r pulmnlgist AND Patient has been evaluated with a right heart catheterizatin AND Patient is diagnsed with pulmnary arterial hypertensin (WHO Grup 1) based n the fllwing: Page 1 f 6

2 Pulmnary Arterial Hypertensin Mean pulmnary arterial pressure (mpap) greater than r equal t 25mm Hg AND Pulmnary capillary wedge pressure (PCWP) r pulmnary artery cclusin pressure (PAOP) less than r equal t 15mm Hg AND Pulmnary vascular resistance (PVR) greater than 3 Wd units AND Fr Chrnic Thrmbemblic Pulmnary Hypertensin (Adempas nly): Patient is fllwed by a cardilgist r pulmnlgist AND Patient has been evaluated with a ventilatin-perfusin (VQ) scan AND After surgical treatment r inperable AND Patient is diagnsed with chrnic thrmbemblic pulmnary hypertensin with the fllwing signs/symptms: Chest discmfrt/angina, fatigue, lightheadedness, r syncpe AND Pulmnary flw murmur r bruit OR Histry f recurrent pulmnary embli IV. Quantity Limitatins Revati: 90 tablets per 30 days Revati Oral Suspensin: 224 ml (2 bttles) per 30 days Adcirca: 60 tablets per 30 days Fllan: Individualized per patient. Veletri: Individualized per patient. Remdulin: Individualized per patient. Tyvas : 1 bx f 28 ampules per 28 days. Ventavis: 270 ampules per 30 days. Letairis: 30 tablets per 30 days. Tracleer: 62.5mg: 60 tablets per 30 days 125mg: 60 tablets per 30 days 32 mg tablets fr ral suspensin: 120 tablets per 30 days Adempas: 90 tablets per 30 days Opsumit: 30 tablets per 30 days Orenitram: Individualized per patient. Uptravi Titratin (first tw mnths): up t 140 x 200mcg tabs per mnth and ne titratin pack Maintenance: (each individual strength): 60 tablets per 30 days V. Cverage Duratin Cverage will be granted indefinitely thrugh the life f this plicy nce the initial criteria are met. VI. Cverage Renewal Criteria n/a Page 2 f 6

3 Pulmnary Arterial Hypertensin VII. Billing/Cding Infrmatin Pertinent indicatins: I27.0, I27.2 Revati: J mg/ 12.5 ml slutin fr injectin 20 mg tablets 10 mg/ml ral suspensin Medical benefit when administered by a healthcare prfessinal Fllan: J1325 (each billable unit = 0.5 mg) 0.5mg, 1.5mg pwder fr injectin Medical benefit when administered by a healthcare prfessinal when self-administered Veletri: J1325 (each billable unit = 0.5mg) 0.5mg, 1.5mg pwder fr injectin Medical benefit when administered by a healthcare prfessinal Pharmacy benefit when self-administered Remdulin: J3285 (each billable unit = 1 mg) 1mg/ml, 2.5mg/ml, 5mg/ml, and 10mg/ml vials fr cntinuus SC infusin Medical benefit when administered by a healthcare prfessinal when self-administered Ventavis: Q4074 (each billable unit = up t 20mcg) 10mcg/ml r 20mcg/ml ampules (1 ml each) Medical benefit when administered by a healthcare prfessinal when self-administered Tyvas: 0.6mg/ml and 1.74 mg/ 2.9 ml ampules fr inhalatin Tracleer: 62.5mg, 125mg ral tablets 32 mg tablets fr ral suspensin Letairis: 5mg, 10mg ral tablets Adcirca: Page 3 f 6

4 Pulmnary Arterial Hypertensin 20mg ral tablets Pharmacy benefit Adempas: 0.5mg, 1mg, 1.5mg, 2mg, 2.5mg ral tablets Opsumit : 10mg ral tablets Orenitram 0.125mg, 0.25mg, 1mg, 2.5mg, 5mg ral tablets Uptravi 200mcg, 400mcg, 600mcg, 800mcg, 1000mcg, 1200mcg, 1400mcg, and 1600mcg ral tablets; Titratin pack VIII. Summary f Plicy Changes 1/1/12: Additin f Veletri t plicy Remval f Black Bx Warning frm Letairis Implement PA reviews f Ventavis, Fllan, and Veletri 9/15/12: Lnger apprval duratin applies 12/15/12: Requirement f hemdynamic diagnstic testing results and right heart catheterizatin added fr initial cverage Warnings edited (reference t full prescribing infrmatin made) Cverage f Revati limited t patients wh are at least 18 years f age 12/15/13: Fllan/Veletri pharmacy cverage prvided Adempas and Opsumit added t plicy 3/31/14: restrictin f Revati t patients aged 18 and lder remved 6/15/14: Orenitram added t plicy 1/1/15: Veletri 0.5mg added t plicy 7/1/15: frmulary distinctins made 3/15/16: addressed Tracleer 125mg quantity limits f 60/mnth; Uptravi added t plicy text 11/15/16: updated quantity limits fr Orenitram t allw fr apprpriate titratin dsing 1/1/17: n plicy changes 8/25/17: clarificatin n Uptravi titratin cverage added 1/1/18: updated cverage criteria fr Adempas, updated available prducts IX. References Page 4 f 6

5 Pulmnary Arterial Hypertensin 1. Up-t-date Online, retrieved Octber Clinical Pharmaclgy Online, retrieved 10/ Facts and Cmparisns Online, retrieved Octber Barst RJ; Rubin LJ; Lng WA; McGn MD; Rich S; Badesch DB; Grves BM; Tapsn VF; Burge RC; Brundage BH; et al. A cmparisn f cntinuus intravenus epprstenl (prstacyclin) with cnventinal therapy fr primary pulmnary hypertensin. The Primary Pulmnary Hypertensin Study Grup. N Engl J Med 1996 Feb 1;334(5): Simnneau G; Barst RJ; Galie N; Naeije R; Rich S; Burge RC; Kegh A; Oudiz R; Frst A; Blackburn SD; Crw JW; Rubin LJ. Cntinuus subcutaneus infusin f treprstinil, a prstacyclin analgue, in patients with pulmnary arterial hypertensin: a duble-blind, randmized, placeb-cntrlled trial. Am J Respir Crit Care Med 2002 Mar 15;165(6): Olschewski H; Simnneau G; Galie N; Higenbttam T; Naeije R; Rubin LJ; Nikkh S; Speich R; Heper MM; Behr J; Winkler J; Sitbn O; Ppv W; Ghfrani HA; Manes A; Kiely DG; Ewert R; Meyer A; Crris PA; Delcrix M; Gmez-Sanchez M; Siedentp H; Seeger W. Inhaled ilprst fr severe pulmnary hypertensin. N Engl J Med 2002 Aug 1;347(5): Galie N; Rubin Lj; Heper M; Jansa P; Al-Hiti H; Meyer G; Chissi E; Kusic-Pajic A; Simnneau G. Treatment f patients with mildly symptmatic pulmnary arterial hypertensin with bsentan (EARLY study): a dubleblind, randmised cntrlled trial. Lancet Jun 21;371(9630): Michelakis E, et al. Oral sildenafil is an effective and specific pulmnary vasdilatr in patients with pulmnary arterial hypertensin: cmparisn with inhaled nitric xide. Circulatin 2002;105: Rubenfire M, McLaughlin VV, Allen RP, et al. Transitin frm IV epprstenl t subcutaneus treprstinil in pulmnary arterial hypertensin: a cntrlled trial. Chest Sep;132(3): Badesch DB, Abman SH, Ahearn GS, Barst RJ, McCrry DC, Simnneau G, McLaughlin VV. Medical therapy fr pulmnary arterial hypertensin: ACCP evidence-based clinical practice guidelines. Chest 2004 Jul;126(1 Suppl):35S-62S. 11. Badesch DB, Abman SH, Simnneau G, Rubin LJ, McLaughlin VV. Medical therapy fr pulmnary arterial hypertensin: updated ACCP evidence-based clinical practice guidelines. Chest 2007 Jun;131(6): McLaughlin, McGn. Pulmnary Arterial Hypertensin. Circulatin. 2006;114: Revati package insert, revised 7/ Adcirca package insert, revised 8/ Fllan package insert, revised 6/ Remdulin package insert, revised 12/ Tyvas package insert, revised 6/ Ventavis package insert, revised 10/ Tracleer package insert, revised 9/ Letairis package insert, revised 10/ Veletri package insert, revised 7/ Revati (sildenafil): Drug Safety Cmmunicatin Recmmendatin Against Use in Children. Drug Safety Cmmunicatin Fd and Drug Administratin (psted 8/30/12). Available at htm 23. Adempas package insert, revised 2/2017 Page 5 f 6

6 Pulmnary Arterial Hypertensin 24. Opsumit package insert, revised 3/ FDA clarifies Warning abut Pediatric Use f Revati (sildenafil) fr Pulmnary Arterial Hypertensin. Accessed 3/31/14 at Orenitram package insert, revised 1/ Uptravi package insert, revised 7/ Barst RJ, Gibbs JS, Ghfrani HA, Heper MM, McLaughlin VV, Rubin LJ, Sitbn O, Tapsn VF, Galiè N. Updated evidence-based treatment algrithm in pulmnary arterial hypertensin. J Am Cll Cardil Jun 30;54(1 Suppl):S 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 6 f 6