Generic Brand HICL GCN Exceptin/Other NALTREXONE CONTRAVE ER 41389 /BUPROPION LORCASERIN BELVIQ 34733 PHENTERMINE PHENTERMINE 20691 20692 20693 20713 PHENTERMINE LOMAIRA 20715 PHENTERMINE/TO PIRAMATE GUIDELINES FOR USE QSYMIA 32515, 32744, 32746, 32745 INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Are weight lss prducts (anti-besity medicatins) a cvered benefit? If yes, cntinue t #2. If n, guideline des nt apply. 2. Is the request fr phentermine r Lmaira fr weight lss/weight management and the patient meets ALL the fllwing criteria? Patient 17 years f age r lder The patient has ONE f the fllwing: Bdy mass index (BMI) f 30kg/m(2) r greater OR BMI f 27kg/m(2) r greater AND at least ne weight-related cmrbidity (e.g., hypertensin, type 2 diabetes mellitus, r hyperlipidemia) Evidence f active enrllment in an exercise and calric reductin prgram r a weight lss/behaviral mdificatin prgram If yes, apprve fr 3 mnths by GPID with a quantity limit f #1 tablet per day. If n, cntinue t #3. Page 1
INITIAL CRITERIA (CONTINUED) SUMMACARE COMMERCIAL 3. Is the request fr Cntrave, Qsymia, r Belviq fr weight lss/weight management and des the patient meet ALL the fllwing criteria? Patient 18 years f age r lder The patient has ONE f the fllwing: Bdy mass index (BMI) f 30kg/m(2) r greater OR BMI f 27kg/m(2) r greater AND at least ne weight-related cmrbidity (e.g., hypertensin, type 2 diabetes mellitus, r hyperlipidemia) Evidence f active enrllment in an exercise and calric reductin prgram r a weight lss/behaviral mdificatin prgram If yes, apprve as fllws: CONTRAVE: Please enter tw authrizatins by HICL as fllws: CONTRAVE 8/90mg: #70 tablets fr 1 mnth. CONTRAVE 8/90mg: #4 tablets per day fr 3 mnths with a start date ne day after the end date f the first authrizatin. QSYMIA: Please enter tw authrizatins by GPID as fllws: QSYMIA 3.75/23mg: #1 capsule per day fr 2 weeks. QSYMIA 7.5/46mg: #1 capsule per day fr 3 mnths with a start date ne day after the end date f the first authrizatin. BELVIQ: Apprve fr 3 mnths by GPID with a quantity limit f #2 tablets per day. If n, d nt apprve. DENIAL TEXT: Our guideline fr requires an indicatin f weight lss/weight lss management. Additinal guideline requirement apply. Fr phentermine and Lmaira requests, apprval requires all f the fllwing criteria: Patient 17 years f age r lder The patient has ONE f the fllwing: Bdy mass index (BMI) f 30kg/m(2) r greater OR BMI f 27kg/m(2) r greater AND at least ne weight-related cmrbidity (e.g., hypertensin, type 2 diabetes mellitus, r hyperlipidemia) Evidence f active enrllment in an exercise and calric reductin prgram r a weight lss/behaviral mdificatin prgram Fr Belviq, Cntrave, r Qsymia, apprval requires all f the fllwing criteria: Patient 18 years f age r lder The patient has ONE f the fllwing: Bdy mass index (BMI) f 30kg/m(2) r greater OR BMI f 27kg/m(2) r greater AND at least ne weight-related cmrbidity (e.g., hypertensin, type 2 diabetes mellitus, r hyperlipidemia) Evidence f active enrllment in an exercise and calric reductin prgram r a weight lss/behaviral mdificatin prgram Page 2
GUIDELINES FOR USE (CONTINUED) RENEWAL CRITERIA SUMMACARE COMMERCIAL 1. Is the request fr Phentermine r Lmaira? If yes, d nt apprve. DENIAL TEXT: See the renewal denial text at the end f the guideline. If n, cntinue t #2. 2. Is the request fr Belviq and des the patient meets the fllwing criteria? The patient lst at least 5% f baseline bdy weight after 3 mnths f treatment If yes, apprve fr 12 mnths by GPID with a quantity limit f #2 tablets per day. If n, cntinue t #3. 3. Is the request fr Cntrave and des the patient meets the fllwing criteria? The patient lst at least 5% f baseline bdy weight after 3 mnths f treatment at the maintenance dse (tw 8/90mg tablets twice daily). If yes, apprve fr 12 mnths by HICL with a quantity limit f #4 tablets per day. If n, cntinue t #4. 4. Is the request fr Qsymia 7.5/46mg and des the patient meets the fllwing criteria? The patient lst at least 3% f baseline bdy weight n Qsymia after at least 3 mnths f treatment If yes, apprve Qsymia 7.5/46mg fr 12 mnths by GPID with a quantity limit f #1 capsule per day. If n, cntinue t #5. 5. Is the request fr dse escalatin t Qsymia 11.25/69mg fr 2 weeks fllwed by Qsymia 15/92mg? If yes, apprve and enter tw authrizatins by GPID as fllws: Qsymia 11.25/69mg: #1 capsule per day fr 2 weeks. Qsymia 15/92mg: #1 capsule per day fr 3 mnths with a start date ne day after the end date f the first authrizatin. If n, cntinue t #6. Page 3
RENEWAL CRITERIA (CONTINUED) SUMMACARE COMMERCIAL 6. Is the request fr cntinuatin f therapy after at least 12 weeks f Qsymia 15/92mg and des the patient meet the fllwing criteria? The patient lst at least 5% f baseline bdy weight after 3 mnths f treatment If yes, apprve QSYMIA 15/92mg fr 12 mnths by GPID fr #1 capsule per day. If n, d nt apprve. Please enter a partial apprval fr ne fill f Qsymia by HICL up t #4 capsules ttal t taper dse in rder t discntinue therapy. DENIAL TEXT: See the renewal denial text at the end f the guideline. RENEWAL DENIAL TEXT: PHENTERMINE AND LOMAIRA DENIAL TEXT: Our guideline fr ANTI-OBESITY AGENTS (PHENTERMINE r LOMAIRA) allws apprval fr phentermine fr a maximum duratin f 3 mnths. Phentermine and Lmaira are indicated as a shrt-term adjunct in a regimen f weight reductin. QSYMIA DENIAL TEXT: Our guideline fr (QSYMIA) renewal requires dcumentatin f weight lss. Qsymia dse shuld be discntinued if the patient has nt lst at least 5% f baseline bdy weight after 3 mnths f treatment. Fr Qsymia 7.5/46mg, the dse shuld be escalated r discntinued if patient has nt lst at least 3% f baseline bdy weight after 3 mnths f treatment. BELVIQ DENIAL TEXT: Our guideline fr (BELVIQ) renewal requires weight lss f at least 5% f baseline bdy weight after 3 mnths f treatment. CONTRAVE DENIAL TEXT: Our guideline fr (CONTRAVE) renewal requires weight lss f at least 5% f baseline bdy weight after 3 mnths f treatment at the maintenance dse (tw 8/90mg tablets twice daily). RATIONALE Limit use t FDA apprved indicatins and efficacy (weight lss) per manufacturer recmmended time pints in therapy as depicted in the prescribing insert. Page 4
FDA APPROVED INDICATIONS & DOSING CONTRAVE Cntrave is indicated as an adjunct t a reduced-calrie diet and increased physical activity fr chrnic weight management in adults with an initial bdy mass index (BMI) f: 30 kg/m2 r greater (bese), Or 27 kg/m 2 r greater (verweight) in the presence f at least ne weight related cmrbidity (e.g., hypertensin, type 2 diabetes mellitus, r dyslipidemia) Limitatins f Use: The effect f Cntrave n cardivascular mrbidity and mrtality has nt been established. The safety and effectiveness f Cntrave in cmbinatin with ther prducts intended fr weight lss, including prescriptin and ver-the-cunter drugs, and herbal preparatins, have nt been established. Cntrave dsing shuld be escalated accrding t the fllwing schedule: A ttal daily dsage f tw Cntrave 8 mg/90 mg tablets twice daily is reached at the start f Week 4 (ttal daily dse=32mg/360mg). Respnse t therapy shuld be evaluated after 12 weeks at the maintenance dsage. If a patient has nt lst at least 5% f baseline bdy weight, discntinue Cntrave, as it is unlikely that the patient will achieve and sustain clinically meaningful weight lss with cntinued treatment. Cntrave is pregnancy categry X. BELVIQ Belviq is indicated as an adjunct t a reduced-calrie diet and increased physical activity fr chrnic weight management in adults with an initial bdy mass index (BMI) f 30kg/m 2 r abve (bese), r thse with a BMI f 27kg/m 2 (verweight) r abve with at least ne weight-related cmrbidity (e.g. hypertensin, type 2 diabetes mellitus, r dyslipidemia). Maximum dse is Belviq 10mg twice daily. The manufacturer recmmends discntinuatin f therapy if 5% f baseline bdy weight is nt lst after 12 weeks f therapy with Belviq 10mg twice daily. Belviq is pregnancy categry X. Page 5
FDA APPROVED INDICATIONS & DOSING (CONTINUED) PHENTERMINE Phentermine is a sympathmimetic amine anrectic indicated as a shrt-term adjunct (a few weeks) in a regimen f weight reductin based n exercise, behaviral mdificatin and calric restrictin in the management f exgenus besity fr patients with an initial bdy mass index greater than r equal t 30 kg/m 2, r greater than r equal t 27 kg/m 2 in the presence f ther risk factrs (e.g., cntrlled hypertensin, diabetes, hyperlipidemia). DOSAGE Dsage shuld be individualized t btain an adequate respnse with the lwest effective dse. The usual adult dse is ne tablet as prescribed by the physician, administered in the mrning, with r withut fd. Suprenza is nt recmmended fr use in pediatric patients less than r equal t 16 years f age. BMI is calculated by taking the patient's weight, in kilgrams (kg), divided by the patient's height, in meters (m), squared. Metric cnversins are as fllws: punds 2.2 = kg; inches x 0.0254 = meters. QSYMIA Qsymia is indicated as an adjunct t a reduced-calrie diet and increased physical activity fr chrnic weight management in adults with an initial bdy mass index (BMI) f 30kg/m 2 r abve (bese), r thse with a BMI f 27kg/m 2 (verweight) r abve with at least ne weight-related cmrbidity (e.g. hypertensin, type 2 diabetes mellitus, r dyslipidemia). Maximum dse is Qsymia 15/92mg nce daily. The maximum dse fr patients with mderate t severe renal impairment r mderate hepatic impairment is Qsymia 7.5/46mg nce daily. The manufacturer recmmends discntinuatin f therapy r dse escalatin if 3% f baseline bdy weight is nt lst after 12 weeks f therapy with Qsymia 7.5/46mg nce daily and discntinuatin f therapy if 5% f baseline bdy weight is nt lst after 12 weeks f therapy with Qsymia 15/92mg nce daily. QSYMIA REMS PROGRAM Qsymia is pregnancy categry X. Females taking Qsymia shuld utilize effective cntraceptin during Qsymia treatment. A negative pregnancy test shuld be btained prir t initiatin f Qsymia therapy and each mnth thereafter. Administratin f tpiramate, a cmpnent f Qsymia, during the first trimester f pregnancy has been assciated with an increased risk f ral cleft lip and cleft palate. If a patient becmes pregnant during Qsymia therapy, treatment shuld be immediately discntinued. Because f the fetal risk assciated with Qsymia use during pregnancy, a Qsymia risk evaluatin and mitigatin strategy (REMS) prgram is available, and Qsymia can be btained thrugh certified pharmacies nly. Page 6
REFERENCES Belviq [Prescribing Infrmatin]. Wdcliff, NJ Eisai, Inc.; December 2014. Cntrave [Prescribing Infrmatin]. La Jlla, CA: Orexigen Therapeutics, Inc.; September 2014. Qsymia [Prescribing Infrmatin]. Muntain View, CA: Vivus, Inc.; Octber 2014. Suprenza [Prescribing Infrmatin]. Cranfrd, NJ: Akrimax Pharmaceuticals; June 2013. The Practical Guide Identificatin, Evaluatin, and Treatment f Overweight and Obesity in Adults. NIH Publicatin N. 00-04084 Octber 2000. Cmmercial Excluded frm benefit Market Place X Created: 07/05/2016 Effective: 01/01/2017 Client Apprval: P&T Apprval: 11/03/2016 Page 7