Pharmacy Benefit Determination Policy
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1 Plicy Subject: Osteprsis Agents Plicy Number: SHS PBD17 Categry: Rheumatlgy Plicy Type: Medical Pharmacy Department: Pharmacy Prduct (check all that apply): Grup HMO/POS Individual HMO/POS PPO ASO Dates: Effective Date: July 26, 2006 Revisin Date January 2, 2018 Apprval Date: February 28, 2018 Next Review Date: Octber 2018 Clinical Apprval By: Medical Directrs PHP: Peter Graham, MD; SPHN: Harman Nagler, MD Pharmacy and Therapeutics Cmmittee PHP: Peter Graham, MD; Sparrw ASO: Harman Nagler, MD Plicy Statement: Physicians Health Plan and PHP Insurance & Service Cmpany will cver Osteprsis Agents thrugh the Medical & Pharmacy Benefit based n apprval by the Clinical Pharmacist r Medical Directr using the fllwing determinatin guidelines Drugs and Applicable Cding: J-cde: Bniva IV - J1740; Prlia - J0897 Frte - J3110, Tymls - pending Clinical Determinatin Guidelines: Dcument the fllwing with chart ntes A. Diagnsis & severity (Appendix I) 1. Treatment (Tx) & preventin f pstmenpausal steprsis (PMO) in wmen 2. Tx t bne mass in men w steprsis 3. Tx f gluccrticid-induced steprsis (GIO) in wmen & men 4. Tx f PMO in wmen w high risk f fractures (hx f/r multiple risk factrs fr fracture) B. Oral bisphsphnate agents 1. Other therapies: a. Failed generic bisphsphnates (must meet all) Statistically significant BMD lss n generic bisphsphnate(s) Cnsistent medicatin fill histry ver a 1 yr. perid b. Significant adverse effects experienced w generic bisphsphnate(s) 3. Apprval a. Initial: 1 yr. b. Re-apprval: 1 yr. ( r stable BMD) Page 1 f 6
2 C. Parenteral agents: Bniva IV, Prlia SC, Frte SC, Tyms SC 1. Cntraindicatins: a. Oral bisphsphnate (1 f the fllwing): Hypcalcemia, esphagus anmalies (eg. stricture, achalasia) delaying esphageal emptying, inability t stand/sit upright fr 30 mins. b. Zledrnic acid: Hypcalcemia, Cr Cl < 35ml/min. 2. Other therapies a. Failed generic ral bisphsphnates & zledrnic acid: >5% BMD n bisphsphnate(s): Mst fracture reductin efficacy f bisphsphnates nt captured by dual-energy x-ray absrptimetry (DXA) Verified adequate intake f calcium and vit. D Cnsistent medicatin fill histry ver a 1 yr perid b. Significant adverse effects experienced w generic ral bisphsphnate(s) & zledrnic acid 3. Frte, Tymls: a. Secnd line therapy b. T scre: < -3.5 even in absence f fracture, r < -2.5 w fragility fracture (See Appendix III) c. Tx duratin: 2 yrs. 4. Apprval a. Initial: 1 yr. b. Re-apprval: 1 yr. ( r stable BMD) D. Other 1. Lng term bisphsphnate tx. in pstmenpausal steprsis a. Adverse effects: N unexpected adverse effects were identified in lng term studies & tlerability prfiles remain favrable b. Residual fracture benefits: 3-5yrs after D/Ced tx. c. Tx. cntinuatin after 3-5 yrs. Cntinue: High risk f fracture w BMD t-scre < -2.5 &/r incidental vertebral fractures. Discntinue: Lw risk f fracture w BMD t-scres > Cmbinatin tx in Osteprsis: Bisphsphnate + PTH analgues a. BMD: Hip: significant BMD at 1 yr. Spine/femral neck: n significant change Lw level f evidence (level dwngraded due t high hetergeneity & lw quality amng studies) b. Risk f nn/vertebral fracture: N significant change Mderate level f evidence c. Cnclusin: N evidence fr the superirity f cmbinatin therapy Page 2 f 6
3 Appendix I Osteprsis Diagnsis Categries Categry T Scre Nrmal > -1 Ostepenia < -1 but > -2.5 Osteprsis < -2.5 Severe Osteprsis < -2.5 with histry f < -1 fracture Appendix II: Risk Factrs fr Osteprsis and related fractures Type Medical Risk Demgraphics Lifestyle Endcrine disrders Factr Fracture: Previus Hip fracture after age 50 yrs. BMD: Lw BMD Frame: Small bdy frame Gender: female Family Histry Ethnicity: white, Asian, Hispanic, Physical: inadequate physical activity, falling, immbilizatin Dietary: Lw Calcium intake, vitamin D insufficiency, high caffeine intake Substance use: alchl (> 3 drinks/day), smking (active r passive) Hypthyridism Estrgen Deficiency Appendix III: Strength f Evidence fr the Reductin f Risk f Fracture Types with Pharmactherapy in wmen with Pstmenpausal Osteprsis Agent Fracture Skeletal Site Vertebral Nn-veterbral Hip Wrist Alendrnate Ibandrnate Risedrnate Zledrnic Acid Densumab Teriparatide Ralxifene Strength f evidence legend: =insufficient strength evidence; = lw strength f evidence = mderate Strength f evidence; = high strength f evidence Page 3 f 6
4 Appendix IV: Osteprsis Agents Agent Osteprtic Indicatin Available dsage frms/dsing Bisphphnates Alendrnate (Fsamax) Ibandrnate (Bniva) Risedrnate (Actnel), Risedrnate ER (Atelvia) Zledrnic Acid (Reclast) Parathyrid Hrmne Analg Teriparatide (Frte) Abalparatide (Tymls) Bne-mdifying Agent Densumab (Prlia) Pstmenpausal steprsis (PMO): Treatment (Tx) & preventin in wmen Gluccrticid-induced steprsis (GIO):Tx in men & wmen PMO: Tx & preventin in wmen PMO: Tx & preventin in wmen* GIO: Tx in men & wmen PMO: Tx & preventin in wmen GIO: Tx in men & wmen GIO: Tx in men & wmen PMO: Tx. in wmen at high risk fr fracture PMO: Tx in wmen at high risk fr fracture PMO: Treat wmen at high risk fr fracture Breast cancer bne lss: Treat t bne mass in wmen at high risk f fracture & using armatase inhibitrs Prstate cancer bne lss: Treat t bne mass in amen at high risk f fracture & using andrgen therapy *Atelvia nly indicated fr treatment f PMO PMO: Preventin 35mg/wkly r 5mg/daily p; treatment - 10mg/day r 70mg/wk p Oste in men: 70mg/wk r 10mg/day p GIO: 5-10mg/day p PO - 150mg/mn. IV - 3mg/3 mn. IV PMO: IR - 75mg x 2 days/mn r 150mg/mn p, 35mg/wk r 5mg/day; ER - 35mg/wk p Oste in men: 35mg/wk p GIO: 5mg/day p All Indicatins: 5mg/yr IV 20mcg/day SC 80mcg/day SC 60mg/6 mn SC Page 4 f 6
5 Appendix V: Mnitring & Patient Safety Drug Adverse Reactins Mnitring REMS Actnel Risendrnate CV: HTN (11%) CNS: HA (3-18%) Derm: Skin rash (8-12%) GI: perfratins/ulcers/bleeding (51%); diarrhea (5-20%), nausea (4-13%), ab pain (2-12%) GU: UTI (11%) Neu/MSK: Arthralgia/back pain (6-33%) chrnic back pain Labs: 25(OH)D, Ca Nne needed Bniva ibandrnate Fsamax alendrnate Reclast zledrnic acid Densumab (Prlia) Teriparatide (Frte) Abalparatide (Tymls) Misc.: Infectin (31%) GI: Dyspepsia (4-12%) Neur/MSK: Back pain (4-14%) Resp: URI (2-34%) End/meta.: hypcalcemia (18%) Pregnancy categry C CV: L ext. edema (39%), CNS: Fatigue (39%), HA (5-19%), dizzy (18%), insmnia (16%), anxiety/depressin (11-14%), agitatin (13%), cnfusin (7-13%), hypesthesia (12%), rigrs (11%) Derm: Alpecia (12%), dermatitis (11%) End/meta: hydrat. (5-14%), PO/K/Mg (11-13%) GI: N/V (14-46%), CNST (27-31%), diarrhea (17-24%), anrexia (9-22%), ab pain (14-6%), wgt (16%), appetite (13%) GU: UTI (12-14%) Hem/Onc: anemia (22-33%), neutrpenia (12%) Neur/MSK: Ostealgia (55%), weak (5-24%), myalgia (23%), arthralgia (5-21%), paresthenia (15%), limb/skeletal/back pain (12-15%), Renal: renal fx (8-17%); abnrmal Cr.(40%) Resp: Dyspnea (22-7%), cugh (12-22%) Misc: fever (32-44%), candidiasis (12%) CV: HTN (11%) Derm: Dermatitis (4-11%), eczema (4-11%), Neur/SKM: Arthralgias (7-14%), limb pain (10-12%), back pain (8-12 %) Other: Preg. categry X, influenza (11%) End/meta: Ca (6-11%) Pregnancy categry C End/meta: Uric acid (25%) GU: Hypercalciuria (11-20%) Immume: Antibdies49-68% Other: injectin site, Preg cat. C chrnic back pain Labs: Serum Cr (pre each dse), 25(OH)D, Ca, PO3, Mg Fluid status: adequately hydrate pre & pst dse chrnic back pain Labs: 25(OH)D, Ca, PO3, Mg, urinary Ca Infectins Derm: allergic Rx. SKM: pre ral exam Chrnic back pain Labs: 25(OH) D, urinary Ca (w prb.) Orth hyptensin Warn re. infectin, derm rxs, bne turn ver ; Med guide dispensed Warn re stesarcma; Med guide dispensed Page 5 f 6
6 References and Resurces: 1. An Integrated Apprach: Bisphsphnate Management fr the treatment f Osteprsis. Amer J f Manag Care 2007;13:S290-S308) 2. An Update n steprsis. Amer J f therap. 2009;16(5): Lexicmp Online, Lexi-Drugs, Hudsn, Ohi: Lexi-Cmp, Inc.; Frte, Tymls accessed Jan Lexicmp Online, Lexi-Drugs, Hudsn, Ohi: Lexi-Cmp, Inc.; Reclast, accessed Jan Lexicmp Online, Lexi-Drugs, Hudsn, Ohi: Lexi-Cmp, Inc.; Prlia, accessed Dec. Jan Lexicmp Online, Lexi-Drugs, Hudsn, Ohi: Lexi-Cmp, Inc.; Bisphsphnates, accessed S Jan Summary f AHRQ s Cmparative Effectiveness Review f Treatment t Prevent Fractures in Men and Wmen with Lw Bne Density r Osteprsis: Update f the 2007 Reprt. JMCP 2012;18(4-b):S1-S15 8. Update n lng-term treatment with bisphsphnates fr pstmenpausal steprsis: A systematic review. Bne 2014;58; The Efficacy f Parathyrid Hrmne Analgues in Cmbinatin with Bisphsphnates fr the Treatment f Osteprsis. Medicine 2015;90(94): Overview f the management f steprsis in pstmenpausal wmen. accessed frm UpT Date Dec 2016 Apprved By: Peter Graham, MD PHP Executive Medical Directr Date: 2/28/18 Harman Nagler, MD SPHN Executive Medical Directr Date: 2/28/18 Human Resurces Date: 2/28/18 Page 6 f 6
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