Drug List Limitations, Exclusions and Preauthorization Criteria

Blue Cross and Blue Shield of New Mexico (BCBSNM) provides coverage of many drugs for our members. Effective communication about specific drug limitations is important for consistent benefit administration and customer satisfaction. The following information includes the drug exclusions and preauthorization criteria for the Blue Cross Community Centennial prescription drug plan. We do our best to update this document on a regular basis, but not all drugs that require preauthorization may be listed. Because indications and dosing recommendations are subject to change, please consult the product package insert for the most current prescribing information. Coverage for any drug may require review to assess proper utilization, quality, therapy, medical appropriateness, and costs per NMAC regulations. Reasons for coverage denials may include, but are not limited to, over-utilization, under-utilization, therapeutic duplication, drug-to-disease and drug-to-drug interactions, incorrect drug dosage or duration of treatment, and clinical abuse or misuse. Last revised December 2015 Table of Contents Select a category below to access information. Medication Therapy Index: Alphabetic list of brand-name drugs and their generic equivalents Drug Limitations: Specialty Pharmacy Program and Step Therapy Drug Exclusions: Medications for Weight Loss, Erectile Dysfunction, Infertility, Hair Loss, Cosmetic, Investigational Drugs, Drugs for International Travel, Compounded Medications Drug Preauthorization: Medications primarily acquired at retail pharmacies that require preauthorization 12/15 Page 1 of 41 rx_pa_criteria_medicaid_nm.doc

Medication Therapy Index All Listed Medications Require Clinical Review Search Tip: For fast look up, use Control F to find drugs within this document. Brand Name ABILIFY MAINTENA ABSTRAL ACTIQ ADCIRCA AFINITOR AMITIZA AMPYRA ANDRODERM, ANDROGEL, AXIRON ATRALIN AUBAGIO AVITA AVONEX BETASERON BYETTA Buprenorphine-Opioid Combinations Generic Name aripiprazole fentanyl citrate fentanyl citrate tadalafil everolimus lubiprostone dalfampridine testosterone tretinoin teriflunomide tretinoin interferon Beta-1a interferon Beta-1b exenatide CAYSTON aztreonam CIMZIA certolizumab pegol COPAXONE glatiramer COPEGUS ribavirin DAKLINZA daclatasvir Doxycycline and Minocycline BRANDED products (ADOXA, ALODOX, AVIDOXY, DORYX, MONODOX, ORACEA, ORAXYL, PERIOSTAT, VIBRAMYCIN, VIBRA-TABS, CLEERAVUE-M, DYNACIN, MINOCIN, MINOCIN PAC, SOLODYN) ENBREL etanercept Enteral Feeding products Enteral feeding products may be covered if prior authorization criteria is met and are limited to a 30-day supply during any 30-day period. A copay will apply IF the member has a copay. (SCHIP, WDI). EXALGO hydromorphone extended release EXJADE EXTAVIA FENTORA FORTEO FORTESTA GENOTROPIN degerasirox interferon beta-1b fentanyl citrate teriparatide testosterone somatropin 12/15 Page 2 of 41 rx_pa_criteria_medicaid_nm.doc

Brand Name GILENYA GLEEVEC Growth Hormones: ACCRETROPIN, GENOTROPIN, HUMATROPE, NORDITROPIN, NUTROPIN (AQ), NUTROPIN, OMNITROPE, SAIZEN, SEROSTIM, TEV-TROPIN, ZORBTIVE HARVONI HEPATITIS C Therapies, Provider Checklist HUMATROPE HUMIRA Injectable Hypercholesterolemia Drugs (PCSK Inhibitors): PRALUENT, REPATHA Injectable Long-Acting Antipsychotics: ABILIFY MAINTENA, INVEGA SUSTENNA, INVEGA TRINZA, RISPERDAL CONSTA, ZYPREXA RELPREVV INTRON-A INVEGA SUSTENNA INVEGA TRINZA KINERET KUVAN LAMISIL LAZANDA LETAIRIS LINZESS LOTRONEX MORPHINE EQUIVALENT DOSE NEXAVAR NORDITROPIN NUTROPIN, NUTROPIN (AQ) OLYSIO OMNITROPE ONSOLIS Oral Disease Modifying Multiple Sclerosis Therapies: GILENYA, AUBAGIO, TECFIDERA PEGASYS Generic Name fingolimod imatinib mesylate somatropin ledipasvir + sofosbuvir somatropin adalimumab alirocumab, evolocumab aripiprazole, paliperidone palmitate, risperidone, olanzapine interferon alfa 2b paliperidone palmitate paliperidone palmitate anakinra sapropterin dihydrochloride terbinafine fentanyl nasal spray ambrisentan linaclotide alosetron hcl various opioids sorafenib somatropin somatropin simeprevir somatropin fentanyl buccal soluble film fingolimod, teriflunomide, dimethyl fumarate peginterferon alfa-2a and alfa 2b 12/15 Page 3 of 41 rx_pa_criteria_medicaid_nm.doc

Brand Name PEG-INTRON PLEGRIDY PRADAXA PRALUENT PROMACTA PULMOZYME REBETOL REBIF REPATHA RETIN-A REVATIO REVLIMID RIBASPHERE RIBATAB RISPERDAL CONSTA SAIZEN SANDOSTATIN SEROSTIM SIMPONI SOVALDI SPRYCEL STRATTERA STRIANT SUTENT TARCEVA TASIGNA TAZORAC TECFIDERA TECHNIVIE TEMODAR TESTIM Testosterone: ANDRODERM, ANDROGEL, AXIRON, FORTESTA, STRIANT, TESTIM TEV-TROPIN THALOMID Generic Name peginterferon alfa-2a and alfa 2b peginterferon beta-1a dabigatran alirocumab eltrombopag dornase alfa ribavirin interferon beta 1a evolocumab tretinoin sildenafil citrate lenalidomide ribavirin ribavirin risperidone somatropin octreotide somatropin golimumab sofosbuvir dasatinib atomoxetine testosterone sunitinib erlotinib nilotinib tazarotene topical gel dimethyl fumarate ombitasvir/paritaprevir/ritonavir temozolomide testosterone testosterone somatropin thalidomide 12/15 Page 4 of 41 rx_pa_criteria_medicaid_nm.doc

Brand Name TRACLEER TRETIN-X TYKERB TYVASO VENTAVIS VFEND VIEKIRA PAK VIVITROL XELODA XENAZINE XIFAXAN XYREM ZORBTIVE ZORTRESS ZYPREXA RELPREVV ZYVOX Generic Name bosentan tretinoin lapatinib treprostinil iloprost voriconazole ombitasvir, paritaprevir, ritonavir, dasabuvir naltrexone capecitabine tetrabenazine rifaximin sodium oxybate somatropin everolimus olanzapine linezolid 12/15 Page 5 of 41 rx_pa_criteria_medicaid_nm.doc

Drug List Limitations The following limitations apply to the prescription benefit: Specialty Pharmacy Program Specialty medications are used to treat serious or chronic conditions such as cancer, multiple sclerosis, pulmonary hypertension, hepatitis, and rheumatoid arthritis. Specialty medications are available in both injectable and oral forms; these are intended to be administered by a patient or family member. Specialty medications are dispensed by a specialty pharmacy provider and limited to a 30-day supply. All Specialty Pharmacy drugs require preauthorization. Please check the Drug List. Step Therapy Requires the use of a generic drug within the same drug class be tried and failed before a branded product may be used. Examples of Step Therapies include: 4 The use of generic cholesterol lowering drugs (simvastatin, lovastatin, pravastatin, atorvastatin) before the branded drug product (CRESTOR) 4 The use of generic omeprazole, pantoprazole, lansoprazole, rabeprazole for gastroesophageal reflux disease (GERD) before the branded drug products NEXIUM, DEXILANT) 4 The use of a preferred blood glucose test strip (ACCU-CHEK, CONTOUR, OR BREEZE) before other brands of test strips For a complete list of Step Therapy medications, see the Drug List. Quantity Limits Specific drug quantity limits are identified in the preface of the Drug List. Requests for larger quantities are to be referred to the Blue Cross Community Centennial Pharmacy Department for review and must be supported by clinical documentation. Generics First Blue Cross Community Centennial is a generics first program. When possible, members must use at least two generic products available on the preferred drug list before a brand-name product will be covered. In some cases, members may be required to use all generic therapeutic alternatives before a brand-name product will be covered. 12/15 Page 6 of 41 rx_pa_criteria_medicaid_nm.doc

Drug List Exclusions Certain classes of medications are excluded from the prescription drug benefit and, therefore, are not covered. Examples of common exclusions are drugs for: Drug Class Representative Drugs in Class Benefit Coverage Drugs used for weight loss: Drugs used to treat erectile dysfunction: Drugs to treat infertility: Phentermine, IONAMIN, ADIPEX-P, or PRO- FAST (SA, HS, SR) Benzphetamine, DIDREX Phendimetrazine, BONTRIL (PDM, SR), MELFIAT-105, PRELU-2 Diethylpropion XENICAL, ALLI (OTC) (orlistat) VIAGRA Alprostadil, MUSE, EDEX, CAVERJECT LEVITRA CIALIS STAXYN STENDRA Ganirelix FACTRL (gonadorelin) Chorionic Gonadotropin, PROFASI, CHORON 10, GONIC, NAVAREL, PREGNYL FOLLISTIM AQ (follitropin beta) GONAL-F (follitropin alfa) BRAVELLE (urofollitropin) MENOPUR, REPRONEX (menotropins) Clomiphene, CLOMID, SEROPHENE, MILOPHENE Excluded Excluded Excluded Drugs to treat hair loss: Drugs considered cosmetic: PROPECIA (Finasteride) ROGAINE (monoxadil) Tretinoin, RENOVA, RETIN-A, ALTINAC VANIQA (eflornithine) Hydroquinone (various) EGRIFTA (tesamorelin) Excluded Excluded 12/15 Page 7 of 41 rx_pa_criteria_medicaid_nm.doc

Drug Class Representative Drugs in Class Benefit Coverage Drugs for international travel: Non-formulary drugs: Compounded medications: Drugs considered experimental and investigational: Drugs Excluded by Federal Regulation Commerciallyavailable Food Alternatives LARIAM/mefloquine MALARONE (no generic) VIVOTIF BERNA (no generic) Various Various Various Drugs not approved as effective by the FDA (i.e., DESI drugs) Various Excluded Preauthorization required BCBSNM covers prescriptions written for traditional compounded drugs (medications with at least one ingredient that is a prescription drug) for Medicaid members. BCBSNM does NOT cover compounds that contain drugs or combinations of drugs that have not been approved by the FDA. Bulk powders used in compounding are not FDA approved and are not covered. Excluded Excluded Excluded Coverage does not include low- or sodium-free foods, lowor fat-free foods, low- or sugarfree foods, low- or high-calorie foods for weight loss or weight gain, or alternative foods due to food allergies or intolerance. 12/15 Page 8 of 41 rx_pa_criteria_medicaid_nm.doc

Drug Preauthorization Requests for drug preauthorization are to be directed to the Blue Cross Community Centennial Pharmacy Department. Changes to the list are published in the Blue Review provider newsletter and on the BCBSNM website (www.bcbsnm.com). Current BCBSNM Medical Policy regarding off-label use of FDA approved drugs as prescribed by a physician to treat chronic, disabling, or life-threatening illnesses may be considered medically necessary when supported by robust clinical research that appears in peer-reviewed literature and is recognized by standard reference compendia specific for the indication in question. New medications often will not have criteria developed. Available literature is frequently limited; therefore, coverage will be restricted to approved FDA indications only. All requests for offlabel use must be forwarded to the Blue Cross Community Centennial Pharmacy Department for review. BCBSNM allows for certain off-label uses of drugs when the off-label use has reputable medical literature supporting its safe and effective use. Use the following criteria in evaluating use of medication off label : Drug must have been approved by the FDA for at least one indication Must be prescribed by a participating licensed health care provider within his/her scope of practice Drugs in clinical phase I or II trials are considered investigational/experimental and, therefore, not a covered benefit Note: Not all medications requiring preauthorization may appear on the list. Please Note: For all medications on the preauthorization list: Hypersensitivity to any of the medications is a contraindication for use. Inclusion in the list by itself does not imply that the drug will be approved. Uses other than those defined in the criteria must meet the BCBSNM criteria for approval of new technologies and off-label use. Authorization duration may be different than stated in the criteria if warranted by individual circumstances in the reviewer's professional judgment. New members may be eligible for a 30-day transition fill for medications requiring preauthorization Satisfaction of stated criteria does not guarantee approval as other program requirements or individual circumstances may, in the exercise of the reviewer's professional judgment, warrant the application and evaluation of additional criteria. 12/15 Page 9 of 41 rx_pa_criteria_medicaid_nm.doc

Medications Requiring Preauthorization Primarily Acquired at Retail Pharmacies ACTIQ transmucosal (fentanyl citrate), FENTORA buccal tablet (fentanyl citrate), ONSOLIS (fentanyl buccal soluble film), ABSTRAL sublingual tablet (fentanyl citrate), or LAZANDA (fentanyl nasal spray) Treatment of: Breakthrough pain control for oncology patients ONLY Tolerant of opioid therapy Prescribed by either oncologist or pain management specialist Maximum Daily Dose: 4 doses per day Duration: 6 months (quantity limited to 120 units per month) Abuse potential, fatal overdose due to respiratory depression, fatal pediatric poisoning ADCIRCA (tadalafil) Documented Pulmonary Arterial Hypertension (PAH) Concurrent therapy limited to any two agents at a time (LETAIRIS, FLOLAN, REVATIO/VIAGRA/ADCIRCA, TRACLEER, VENTAVIS) Usual Dose: 40mg (two 20mg tablets) once daily. Dividing the dose over the course of the day is NOT recommended. 12/15 Page 10 of 41 rx_pa_criteria_medicaid_nm.doc

AFINITOR (everolimus) Advanced, hormone receptor positive, HER-2 negative breast cancer in postmenopausal women: In combination with exemestane after failure of treatment with letrozole or anastrozole PNET (Progressive neuroendocrine tumors of pancreatic origin): For unresectable, locally advanced, or metastatic tumors Advanced renal cell carcinoma: For the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib (SUTENT) or sorafenib (NEXAVAR) Renal angiomyolipoma and tuberous sclerosis complex: For patients not requiring immediate surgery Subependymal giant cell astrocytoma (SEGA) in pediatric and adult patients with tuberous sclerosis complex: For patients that require therapeutic intervention, but cannot be curatively resected Usual dose: 10mg once daily (for advanced PNET, advanced-hormone-receptor positive breast cancer, advanced renal cell carcinoma, and renal angiomyolipoma with tuberous sclerosis complex); initial dosing for SEGA is based upon body surface area (4.5mg/m 2) and subsequent dosage adjustments are based upon therapeutic drug monitoring. Note: For advanced SEGA only (AFINITOR): 3 months initial, then evaluate changes in SEGA volume. May be approved for 6 months thereafter. AMITIZA (lubiprostone) Chronic Idiopathic Constipation (CIC) Opioid-induced Constipation in Adults with chronic non-cancer pain (OIC) Treatment of Irritable Bowel Syndrome with constipation in women 18 years of age an older (IBS-C) AND Provider has supplied documentation that at least 2 OTC laxatives AND lactulose have been tried for 3 months without relief Usual Dose: CIC and OIC: 24 mcg twice daily IBS-C: 8 mcg twice daily Duration: 3 months initial, then evaluate response 12/15 Page 11 of 41 rx_pa_criteria_medicaid_nm.doc

AMPYRA (dalfampridine) Multiple Sclerosis with documentation that patient is ambulatory AND œ Prescriber is a neurologist or has consulted a neurologist AND œ Patient is 18 years of age or older AND œ The patient is receiving concurrent therapy with a disease modifying product, if indicated AND œ There is documentation of significant limitations to activities of daily living related to slow ambulation AND œ Baseline walking speed must be provided (using the 25-foot walk test, with a timed speed between 8 and 45 seconds). Re-authorizations (after at least 2 months of therapy) will require documentation that walking speed (using the 25-foot walk test) has improved at least 20% from baseline. œ Contraindicated in patients with a history of seizure or moderate-severe renal impairment (CrCl less than 50mL/min) Usual Dose: 10mg twice daily. No additional benefit was demonstrated at doses greater than 10mg twice daily and adverse reactions and discontinuations because of adverse events were more frequent at higher doses. Duration: Initial request: 3 months; Renewal: 12 months only with documented 20% improvement in walking speed AVONEX (interferon beta-1a), BETASERON (interferon beta-1b),copaxone (glatiramer), EXTAVIA (interferon beta-1b), PLEGRIDY (peginterferon beta-1a), REBIF (interferon beta-1a) Relapsing, Remitting Multiple Sclerosis (RRMS only) Usual Dose: AVONEX: 30mcg IM once weekly (pkg of 4 pre-filled syringes) BETASERON: 0.25mg SQ every other day; titrated from 0.0625mg QOD to 0.25mg QOD over a 6-week period COPAXONE: 20mg SQ once daily (pkg of 30 pre-filled syringes) EXTAVIA: 0.25mg SQ every other day; titrated from 0.0625mg QOD to 0.25mg QOD over a 6-week period (pkg of 15 blister units, each containing a single use lyophilized powder vial, pre-filled diluent syringe, alcohol prep pads, vial adapter with needle) PLEGRIDY: 64mcg SQ on day 1, 94 mcg SQ on day 15, maintenance of 125 mcg SQ every 14 days beginning on day 29. REBIF: 22mcg or 44mcg SQ 3 times weekly (pkg of 12 pre-filled syringes) 12/15 Page 12 of 41 rx_pa_criteria_medicaid_nm.doc

Buprenorphine-Opioid Combinations Acute Pain, such as that related to surgery œ Ideally, buprenorphine should be discontinued 1-2 days prior to surgery œ Authorization for a short-acting opioid will be limited to a quantity sufficient to cover the acute pain episode (7-10 days of therapy) Usual Dose: Varies Duration: One-time fill Note: Alternatively, patients who are receiving buprenorphine for opioid replacement therapy AND who experience acute pain episodes can be treated with an increased dose of buprenorphine for a short period of time (7-10 days of therapy). BYETTA (exenatide) Note: VICTOZA is the preferred product in this class (requires step therapy through an oral antidiabetic agent) Type 2 Diabetes AND œ Monotherapy or adjunct therapy with a thiazolidinedione (TZD), metformin, sulfonylureas, and/or Lantus/Levemir but have not achieved adequate glycemic control (A1C>7) œ Metformin is recommended as first-line therapy Usual Dose: Initiate at 5mcg twice daily; increase to 10mcg twice daily after 1 month based on response Note: Exenatide is not a substitute for insulin. Exenatide should not be used in patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of exenatide with short-acting (prandial) insulin has not been studied and cannot be recommended. 12/15 Page 13 of 41 rx_pa_criteria_medicaid_nm.doc

CAYSTON (aztreonam) Cystic Fibrosis in patients with documented evidence of colonization with Pseudomonas Aeruginosa AND œ Indicated for use in patients 7 years of age and older with FEV-1 of 25% to 75% predicted œ Must be administered ONLY with the Altera Nebulizer System œ Treatment must be preceded by use of an inhaled beta-agonist œ NOT for use in combination with TOBI; If alternating with TOBI, send to apharmacist for review Usual Dose: One inhaled dose (1 single-use vial and 1 ampule of diluent) 3 times daily for 28 days (followed by 28 days off Cayston therapy) Duration: 6 months CIMZIA (certolizumab pegol) Note: HUMIRA is the preferred product in this class. Crohn s Disease AND prior failure/intolerance/contraindication to conventional therapy (oral aminosalicylates, topical mesalamine, oral corticosteroids, or immunomodulators, such as azathioprine or cyclosporine) Usual Dose for Crohn s Disease: 400mg (two 200mg SQ doses) at weeks 0, 2, 4, followed by 400mg every 4 weeks Rheumatoid or Psoriatic Arthritis AND prior failure/intolerance/contraindication with at least 1 DMARD (such as methotrexate) Usual Dose for Rheumatoid and Psoriatic Arthritis: 400mg (two 200mg SQ doses) at weeks 0, 2, 4, followed by 200mg every other week (400mg every 4 weeks can be considered for maintenance dosing) Ankylosing Spondylitis AND prior treatment with at least 2 NSAIDS after 3 months use of each Usual Dose for Ankylosing Spondylitis: 400mg (two 200mg SQ doses) at weeks 0, 2, 4, followed by 200mg every other week (400mg every 4 weeks can be considered for maintenance dosing) Note: Initial dose may be billed through the Medical benefit, but subsequent doses should be routed through the Pharmacy benefit Risk of serious infection, risk of malignancies in children and adolescents 12/15 Page 14 of 41 rx_pa_criteria_medicaid_nm.doc

Doxycycline and Minocycline BRANDED products (ADOXA, ALODOX, AVIDOXY, DORYX, MONODOX, ORACEA, ORAXYL, PERIOSTAT, VIBRAMYCIN, VIBRA-TABS, CLEERAVUE-M, DYNACIN, MINOCIN, MINOCIN PAC, SOLODYN) Moderate to severe Acne Vulgaris, Acne Rosacea (for ORACEA), adjunctive therapy to scaling and root planning in adults with periodontitis (for PERIOSTAT) AND Therapeutic failure of oral generic formulary alternatives (regular-release minocycline, tetracycline, doxycycline, demeclocycline) Usual Dose: Varies by product Duration: 3 months ONLY (except for ORACEA, which can be approved for up to 4 months AND PERIOSTAT, which can be approved for up to 9 months) ENBREL (etanercept) Note: HUMIRA is the preferred product in this class. Moderate to severe Rheumatoid Arthritis (RA), Polyarticular Juvenile Idiopathic Arthritis in patients 2 years of age and older, Psoriatic Arthritis Ankylosing Spondylitis: trial/failure of 2 NSAIDs after 3 months use of each Moderate to severe chronic Plaque Psoriasis by rheumatologist and history of topical steroids and methotrexate, cyclosporine, oral retinoids, OR UVB/PUVA and affected BSA>10% AND therapeutic failure of adequate trial of at least one of the following: PLAQUENIL (hydroxychloroquine) SOLGANAL or RIDAURA (gold) Methotrexate IMURAN (azathioprine) CUPRIMINE (penicillimine) AZULFIDINE(sulfasalazine) ARAVA (leflunomide) Usual Dose: Rheumatoid and Psoriatic Arthritis: 50mg once weekly (with or without methotrexate) Polyarticular Juvenile Idiopathic Arthritis: 0.8mg/kg weekly to a maximum of 50mg per week Psoriasis: 50mg twice weekly for 3 months, then 50mg once weekly Ankylosing Spondylitis: 50mg once weekly Risk of serious infections; risk of malignancies in children and adolescents 12/15 Page 15 of 41 rx_pa_criteria_medicaid_nm.doc

Enteral Feeding Products (Nutritional Supplements) Nonprescription enteral nutritional products and special medical foods only when: Delivered by a medically necessary enteral access tube that has been surgically placed (e.g., gastrostomy, jejunostomy) OR Meeting the definition of special medical foods used to treat and to compensate for the metabolic abnormality of persons with genetic inborn errors of metabolism in order to maintain their adequate nutritional status OR When medically necessary to correct or ameliorate physical illnesses or conditions in an eligible member under the age of 21 Supply considerations: Benefits are limited to a 30-day supply during any 30-day period Duration: 12 months EXALGO (hydromorphone extended release) Diagnosis of : Moderate to severe pain in opioid-tolerant patients requiring continuous analgesia for an extended period of time AND Have failed or are intolerant of previous preferred long-acting narcotic analgesics (such as morphine sulfate ER, methadone, or fentanyl patch) Usual Dose: 8 64mg once daily Abuse Potential, life-threatening respiratory depression, accidental exposure 12/15 Page 16 of 41 rx_pa_criteria_medicaid_nm.doc

EXJADE (deferasirox) Chronic iron overload due to blood transfusions in patients 2 years of age and older Chronic iron overload due to non-transfusion-dependent thalassemia (NTDT) in patients 10 years of age and older and with a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin of greater than 300 mcg/l Usual Dose blood transfusion patients: Weight-based; 20 mg/kg once daily. Dose may be increased to 30 mg/kg when administered with potent UGT inducers (rifampicin, phenytoin, phenobarbital, or ritonavir) or with cholestyramine. Maximum recommended dose is 40mg/kg for this indication. Usual Dose NTDT patients: Weight-based, 10mg/kg once daily. May titrate up to 20mg/kg daily max dose. Hepatic or renal failure; gastrointestinal hemorrhage FORTEO (teriparatide) Osteoporosis in postmenopausal women who are at high risk for fracture (defined as a T-score of -2.5 or lower). This includes women with a history of osteoporotic fracture, or who have multiple risk factors for fracture. Primary or Hypogonadal Osteoporosis in men who are at high risk for fracture; treatment to increase bone mass. This includes men with a history of osteoporotic fracture, or who have multiple risk factors for fracture. Glucocorticoid-induced Osteoporosis in men and women at high risk for fracture AND Have failed or are intolerant of previous osteoporosis therapy (FOSAMAX, ACTONEL, BONIVA, SKELID, EVISTA, MIACALCIN) Usual Dose: 20mcg SQ once daily Duration: 12 months; maximum therapy of 24 months Potential risk of osteosarcoma 12/15 Page 17 of 41 rx_pa_criteria_medicaid_nm.doc

GLEEVEC (imatinib mesylate) Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML) Philadelphia Chromosome positive Acute Lymphoblastic Leukemia (ALL) in adult and pediatric patients Myelodysplastic/Myeloproliferative Disease associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangementskit-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST); adjuvant treatment of adult patients following resection of KIT-positive GIST Adult Aggressive Systemic Mastocytosis (ASM) without the D816V C-KIT mutation or with C-KIT mutational status unknown Dermatofibrosarcoma Protuberans (DFSP) Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL) Myelodysplastic/Myeloproliferative diseases Usual Dose: Varies according to diagnosis, but generally 100-800mg daily Growth Hormones HUMATROPE, GENOTROPIN, NORDITROPIN, NUTROPIN (AQ), NUTROPIN, OMNITROPE, SAIZEN, SEROSTIM, TEV-TROPIN, ZORBTIVE Note: OMNITROPE is the preferred product in this class In Children Panhypopituitarism Turner s Syndrome Prader-Willi Syndrome Growth failure associated with Noonan Syndrome Children with Chronic Renal Insufficiency Short Stature Homeobox (SHOX) containing gene deficiency; for the treatment of short stature or growth failure in children with SHOX deficiency whose epiphyses are not closed Growth hormone deficiency in children: œ Fail two provocative growth hormone stimulation tests (L-dopa, clonidine, glucagon, propranolol, arginine, or insulin Peak<10ng/ml) (24-hour monitoring of IGF or IGFBP are considered experimental) OR œ Documentation of growth hormone deficiency resulting from a destructive lesion of the pituitary, a medical treatment (such as ablative pituitary radiation or surgery) or trauma AND œ Height at least 2 standard deviations below the mean over one year or more OR more than 1.5 standard deviations sustained over two years œ Growth velocity of <5.0cm/yr AND œ Bone age (determined by standard x-ray techniques) of 2 standard deviations below chronological age Continued on page 19 12/15 Page 18 of 41 rx_pa_criteria_medicaid_nm.doc

Growth Hormones, Continued In Adults Growth hormone deficiency in adults: œ Have no contraindications to therapy; active malignancy, benign intracranial hypertension, proliferative or pre-proliferative diabetic retinopathy AND œ Fail 2 provocative growth hormone stimulation tests (insulin is the preferred test in most adults), each with a peak value < 5ng/ml OR œ Documentation of growth hormone deficiency resulting from a destructive lesion of the pituitary, a medical treatment (such as ablative pituitary radiation or surgery) or trauma OR œ Growth hormone deficiency during childhood with growth hormone deficiency syndrome confirmed as an adult before replacement therapy with somatropin is started. Panhypopituitarism AIDS wasting or Cachexia Full-thickness skin loss associated with third degree burn NOS Short Bowel Syndrome Usual Dose: Weight-based, according to diagnosis Duration: 6 months Growth hormone approved through Specialty Pharmacy Program providers only. For continuation of therapy every six months: Must be compliant with therapy For children with growth hormone deficiency: Usually discontinued when growth velocity is less that 2cm/yr, when epiphyseal fusion occurs, or when height reaches 5th percentile of expected adult height. 12/15 Page 19 of 41 rx_pa_criteria_medicaid_nm.doc

HEPATITIS C Therapies DAKLINZA (daclatasvir), HARVONI (ledipasvir + sofosbuvir), OLYSIO (simeprevir), SOVALDI (sofosbuvir), TECHNIVIE (ombitasvir/paritaprevir/ritonavir), VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) Note: HARVONI is the preferred product in this class Chronic Hepatitis C and genotype indicated for requested therapy in accordance with current AASLD/IDSA Guidelines(laboratory confirmation required) AND all of the following: œ Patient is at least 17 years of age œ An appropriate treatment regimen and duration of therapy is requested as per current Guidelines œ A pre-treatment HCV-RNA lab is provided œ The patient does not have any contraindications or drug interactions as listed on the package insert for the requested therapy or therapies. AND one of the following: APRI 0.7 FIB-4 1.45 Liver biopsy confirming METAVIR score of F2 Fibroscan Score 7.1 kpa Fibrosure Score of 0.49 Diagnosis of Cirrhosis obtained though imaging studies (MRI, CT, Ultrasound or other) Extra-hepatic manifestation of HCV to include leukocytoplastic vasculitis, type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations or kidney disease (proteinuria, nephrotic syndrome or mebranoproliferative glomerulonephritis) Decompensated Cirrhosis (ascites, variceal hemorrhage, encephalopathy, jaundice) with life expectancy of at least 12 months HIV- co-infection Hepatocellular Carcinoma (HCC) with life expectancy of at least 12 months Pre- or Post-liver transplant or other solid organ transplant Type 2 Diabetes Mellitus (insulin resistant) Debilitating fatigue impacting quality of life (e.g., secondary to extra-hepatic manifestations and/or liver disease) as documented in chart notes over prior 6 months Porphyria cutanea tarda Usual Dose/Duration: In accordance with current AASLD/IDSA Guidelines NOTE: Treatment with Harvoni for 8 weeks can be considered for treatment naïve patients without cirrhosis IF the pretreatment HCV-RNA is < 6 million IU/ml. Treatment experienced patients are those who have failed treatment with either peginterferon alfa + ribavirin OR HCV Protease Inhibitor + peginterferon alfa + ribavirin. Non-adherence to therapy will result in the preauthorization being discontinued. No additional treatments will be approved. Non-adherence is defined as failure to obtain refills in a timely manner, leading to an interruption in therapy. Upon receipt of request, BCBSNM will refer all patients to care coordination for disease management. Resistance-associated variants (RAVs) testing may be required based on AASLD guidance. Request will be denied if the patient s life expectancy is less than 12 months 12/15 Page 20 of 41 rx_pa_criteria_medicaid_nm.doc

HEPATITIS C Therapies, Continued Uniform New Mexico HCV Checklist for Centennial Care 1. DIAGNOSIS: Chronic Hepatitis C Infection a. Genotype Subtype (if applicable) (attach results) b. HCV RNA Level within the past 3 months: Level: Date: / / (attach results) c. Yes No Does the patient have HIV-1 coinfection or one of the following extra-hepatic manifestation of HCV Infection (if yes, circle and include documentation): Lymphoma, Vasculitis, or Renal Disease, insulin resistant DM, debilitating fatigue (documented in chart notes x 6 months), porphyria cutanea tarda. 2. ADDITIONAL REQUIRED LABS (within 3 months of request- please attach results) AST, ALT, Bilirubin, Albumin, INR, Platelet count, ANC, Hemoglobin, Creatinine 3. Yes No Patient has had or is patient being considered for LIVER TRANSPLANT? If yes, do not complete the rest of this form; just fax this form and relevant labs/records to member s Health Plan. 4. LIVER ASSESSMENT a. Yes No Does the patient have (circle all that apply) APRI >= 0.7 (F2), OR Fib-4 >= 1.45, OR METAVIR Score >= F2, OR Transient Elastography Score >= 7.1 kp (F2), OR FibroSure >= 0.49 (F2), OR radiographic imaging or physical examination findings consistent with cirrhosis (attach relevant results and notes) 5. Yes No Is patient TREATMENT EXPERIENCED? (If Yes, answer a, b & c. If No, go to 6) a. List regimen(s) patient has received in past including year and duration of therapy: b. Yes No Unknown Did patient complete treatment regimen(s)? If not, reason for discontinuation: c. What was patient s response to therapy? Unknown Relapse (post treatment SVR, then elevated HCV RNA level some time later). Non-response (HCV RNA remained detectable after complete treatment course) 6. REQUESTED MEDICATION(S) Drug: Dose: Duration: weeks Drug: Dose: Duration: weeks Drug: Dose: Duration: weeks I am agreeable to approval and use of alternative and equivalent formulary drug(s) with equal or greater SVR; please substitute and notify me. I am agreeable to approval and use of alternative drug(s), dose(s) and/or duration(s) based on current AASLD/IDSA guidance. Comments: Important Additional Recommendations: 1. If patient has alcohol or illicit drug abuse history, please refer patient to addiction specialist for counseling and treatment 2. HIV and Hepatitis A and B screening including HAV Ab, HBsAg, anti-hbs, anti-hbc, should be performed 3. Hepatitis A and Hepatitis B vaccination series should be initiated if not already completed (and patient non-immune) 4. If patient has decompensated liver disease (Child-Pugh B or C) it is recommended that treatment be co-managed with a gastroenterologist, infectious disease specialist or hepatologist, and that referral for transplant be strongly considered 5. Patients being considered for retreatment after failure of initial treatment with all-oral therapy should be considered for presentation to Project ECHO (attach notes) 12/15 Page 21 of 41 rx_pa_criteria_medicaid_nm.doc

HUMIRA (adalimumab) Note: HUMIRA is the preferred product in this class. Diagnosis by rheumatologist of moderate to severe: Rheumatoid Arthritis Juvenile Idiopathic Arthritis Psoriatic Arthritis AND therapeutic failure of adequate trial of at least one of the following: PLAQUENIL (hydroxychloroquine) SOLGANAL or RIDAURA (gold) Methotrexate IMURAN (azathioprine) CUPRIMINE (penicillimine) AZULFIDINE (sulfasalazine) ARAVA (leflunomide) Moderate to severe chronic Plaque Psoriasis (affected BSA > 10%), confirmed by a rheumatologist, and history of use of topical steroids AND methotrexate, cyclosporine, oral retinoids, or UVB/PUVA OR Moderate to severe Crohn s Disease or Ulcerative Colitis (confirmed by a gastroenterologist) and prior failure/intolerance/contraindication to conventional therapy (oral aminosalicylates, topical mesalamine, oral corticosteroids, or immunomodulators, such as azathioprine or cyclosporine) OR Ankylosing Spondylitis and trial/failure of 2 NSAIDS after 3 months use of each Hydradenitis Supurativa evaluated by a specialist Usual Dose: Varies according to diagnosis, but limited to 2 doses per month (every other week). Requests for weekly dosing should be referred to a pharmacist for review. Serious infections (e.g., Tuberculosis, invasive fungal infections, other opportunistic infections), Malignancy in children and adolescents 12/15 Page 22 of 41 rx_pa_criteria_medicaid_nm.doc

INJECTABLE LONG-ACTING ANTIPSYCHOTICS: ABILIFY MAINTENA (aripiprazole), INVEGA SUSTENNA, and INVEGA TRINZA (paliperidone palmitate), RISPERDAL CONSTA (risperidone), ZYPREXA RELPREVV (olanzapine) Schizophrenia Bipolar I Disorder (for Risperdal ONLY for use alone or in combination with lithium or valproate for maintenance therapy) AND Previous trial of oral therapy to ensure tolerance AND Documented non-compliance with oral therapy for at least 3 months or hospitalization due to noncompliance Usual Dose: ABILIFY: 400mg IM monthly, some patients may do well on lower doses INVEGA SUSTENNA: Initial doses of 254mg IM, then 156mg 2 weeks later. Recommended maintenance is 117mg monthly, but can range anywhere from 39mg-254mg INVEGA TRINZA: ONLY after successful treatment with SUSTENNA for a minimum of 4 months. INVEGA TRINZA is given once every 3 months Last Dose of SUSTENNA INITIAL DOSE OF TRINZA 78 mg 273 mg 117 mg 410 mg 156 mg 546 mg 234 mg 819 mg RISPERDAL: 25mg 50mg IM every 2 weeks ZYPREXA: 150mg 300mg IM every 2 weeks or 300mg 405mg every 4 weeks œ Zyprexa Relprevv is only available through a restricted distribution program called Zyprexa Reprevv Patient Care Program. Administration requires prescriber, health care facility, patient, and pharmacy enrollment and a minimum 3-hour patient observation period after each injection. Duration: 9 Months initial, then 12 months after assessment of compliance and lack of psych-related hospitalizations Increased mortality in elderly patients with dementia-related psychosis 12/15 Page 23 of 41 rx_pa_criteria_medicaid_nm.doc

INJECTABLE HYPERCHOLESTEROLEMIA DRUGS (PCSK9 Inhibitors): PRALUENT(alirocumab), REPATHA (evolocumab) Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia, or Atherosclerotic Cardiovascular Disease AND Patient is on a high-intensity statin, with at least a 6-month history of adherence OR Has documented history of intolerance to at least 2 different statins or documented contraindication to use of statins AND Patient is also taking ezetimibe, with at least a 6-month history of adherence Usual Dose: PRALUENT: 75mg administered subcutaneously once every 2 weeks; may be increased to a maximum of 150mg every 2 weeks REPATHA: 140mg administered subcutaneously once every weeks OR 420 mg every once monthly Duration: 6 months, unless there is a change in dosing INTRON-A (interferon alfa 2b) Hairy Cell Leukemia AIDS-related Kaposi s Sarcoma Chronic Hepatitis B, serum HBe Ag positive (1 year of age or older for this diagnosis only) Condylomata Acuminata involving external surfaces of the genital or perianal area Non-Hodgkin s Lymphoma (clinically aggressive follicular NHL) Malignant Melanoma Note: Must be 18 years of age and older. Usual Dose: Varies according to diagnosis ; maximum therapy 2 years for Hepatitis C Fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders 12/15 Page 24 of 41 rx_pa_criteria_medicaid_nm.doc

KINERET (anakinra) Moderate to severe Rheumatoid Arthritis (RA), confirmed by a rheumatologist AND the following: Not currently on ENBREL or REMICADE AND Therapeutic failure of adequate trial of at least one of the following: œ PLAGUENIL (hydroxychloroquine) œ SOLGANAL or RIDAURA (gold) œ Methotrexate œ IMURAN (azathioprine) œ CUPRIMINE (penicillimine) œ AZULFIDINE (sulfasalazine) œ ARAVA (leflunomide Note: Cryopyrin-Associated Periodic Syndromes (CAPS) Refer all requests to a pharmacist for review Usual Dose: 100mg/day SQ Duration: 6 months initial treatment, for a quantity of thirty 100mg injections per month; 12 months thereafter KUVAN (sapropterin dihydrochloride) Note: Refer all requests for KUVAN to a pharmacist for review LAMISIL (terbinafine) Fingernail Onychomycosis Duration: 6-week course of therapy; one course per lifetime as documented by BCBSNM Toenail Onychomycosis Duration: 12-week course of therapy; one course per lifetime as documented by BCBSNM Tinea Capitis (only oral granules indicated for this diagnosis) Duration: 6-week course of therapy for the treatment of Tinea Capitis in patients 4 years of age and older Usual Dose: 250mg once daily (tablets); dosage for Lamisil granules is weight-based Note: For treatment of onychomycosis, LAMISIL will not be approved if there is documentation of prior use of either itraconazole or fluconazole. 12/15 Page 25 of 41 rx_pa_criteria_medicaid_nm.doc

LETAIRIS (ambrisentan) Pulmonary Arterial Hypertension AND Concurrent therapy limited to any two agents at a time (LETAIRIS, FLOLAN, REVATIO/VIAGRA/ADCIRCA, TRACLEER, TYVASO, VENTAVIS), recommended in combination with ADCIRCA (tadalafil) 20mg once daily Usual Dose: Initiate at 5mg once daily; may be increased to 10mg once daily if tolerated. Doses higher than 10mg once daily have not been studied in patients with Pulmonary Arterial Hypertension. Serious risk of birth defects contraindicated in pregnancy LINZESS (linaclotide) Irritable Bowel Syndrome with Constipation (IBS-C) Chronic Idiopathic Constipation (CIC) AND Provider has supplied documentation that at least 2 OTC laxatives AND lactulose have been tried for 3 months without relief Usual Dose: IBS-c: 290 mcg once daily CIC: 145 mcg once daily Duration: 3 months initial, then evaluate response Pediatric Risk-Safety and efficacy not established in pediatric patient under the age of 18 12/15 Page 26 of 41 rx_pa_criteria_medicaid_nm.doc

LOTRONEX (alosetron hcl) Severe diarrhea-predominant Irritable Bowel Syndrome (IBS) ONLY IN WOMEN who have chronic IBS symptoms (generally lasting 6 months or longer) and who have not responded adequately to conventional therapy Usual Dose: Initiate at 0.5mg twice daily; may be increased to 1mg twice daily after 4 weeks if tolerated Note: Discontinue Lotronex in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1mg twice daily. Gastrointestinal, serious complications of constipation and ischemic colitis MORPHINE EQUIVALENT DOSE ( MED various opioids) Usual Dose: Morphine equivalent dose is, generally, limited to 240mg morphine equivalents per day. Doses greater than 240 mg MED will be approved when the following criteria are met: The patient has a diagnosis of cancer, is enrolled in hospice, or meets hospice criteria for life expectancy less than 6 months OR The patient is undergoing treatment of chronic (non-cancer) pain and ALL of the following are met œ Prescriber provides documentation of formal evaluation of the primary pain state, including diagnosis and a complete medical history that details prior pharmacologic and nonpharmacologic interventions œ The prescriber has a narcotic contract with the patient, and the patient has complied with the rules of the contract œ The New Mexico Prescription Monitoring Program ( PMP ) report for the patient is appropriate and indicates that the member is using only one provider for their controlled substance medications within the past 90 days œ The prescriber has confirmed that there is no suspicion of abuse/diversion and/or urine drug screens have been appropriate for the past 90 days, showing the presence of all prescribed substances as tested œ The prescriber has submitted clinically-sound documentation/rationale to support a higher dose œ The patient is being managed by a pain management specialist and/or in consultation with a pain management specialist œ The patient is being routinely monitored for changes in severity of pain, ability to function, and adverse effects Duration: At the discretion of the approving clinician 12/15 Page 27 of 41 rx_pa_criteria_medicaid_nm.doc

NEXAVAR (sorafenib) Advanced Renal Cell Carcinoma Unresectable Hepatocellular Carcinoma Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment Usual Dose: 400mg (2 tablets) twice daily Oral Disease Modifying Multiple Sclerosis Therapies: GILENYA (fingolimod), AUBAGIO (teriflunomide), TECFIDERA (dimethyl fumarate) Relapsing Multiple Sclerosis and prior use of a biological product (AVONEX, REBIF, BETASERON, or EXTAVIA) or COPAXONE Usual Dose: GILENYA: 0.5mg orally once daily AUBAGIO: 7 or 14mg by mouth once daily TECFIDERA: 120mg by mouth twice daily initially, titrated to 240mg twice daily maintenance dose Duration: 6 months initial; then 12 months thereafter if no change in dosing AUBAGIO: Hepatotoxicity and teratogenicity 12/15 Page 28 of 41 rx_pa_criteria_medicaid_nm.doc

PEGASYS (peginterferon alfa-2a) and PEGINTRON (peginterferon alfa-2b) Preferred Product: PEGASYS Chronic Hepatitis C Diagnosis by gastroenterologist of Chronic Hepatitis C in patients who meet the following criteria: œ Must be used in accordance with current AASLD/IDSA guidelines Usual Dose: Pegasys: 180mcg once weekly PegIntron: 1.5mcg/kg/week (Adult); 60mcg/m 2 /week (Pediatric); 1 mcg/kg/week for monotherapy (Adult only) Duration: Will vary dependent upon individual diagnosis and treatment combination being used. Fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders; pregnancy warning with combination ribavirin use PRADAXA (dabigatran) Note: XARELTO is the preferred product in this class (where clinically appropriate) Reduction of risk of Stroke and Systemic Embolism in patients with Non-Valvular Atrial Fibrillation (a-fib) Treatment of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) Reduction in risk of recurrence of DVT and PE Prophylaxis of DVT and PE following hip replacement surgery Usual Dose: between 75-220 once or twice daily depending on diagnosis Duration: 6 months initial, then 12 months thereafter is no change in dosing Note: Refer requests for off-label indications to a pharmacist for review Discontinuing Pradaxa without adequate continuous anticoagulation increases risk of stroke 12/15 Page 29 of 41 rx_pa_criteria_medicaid_nm.doc

PROMACTA (eltrombopag) Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP) œ Patients who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy œ Should not be used in an attempt to normalize platelet counts (maintain count above 50,000) Maximum Daily Dose: 75mg Risk of hepatotoxicity requires lab monitoring of liver function tests prior to and during therapy PULMOZYME, rhdnase (dornase alfa) Cystic Fibrosis œ Five years of age or older AND œ Baseline forced vital capacity (FVC) > 40% of predicted Usual Dose: 2.5mg once daily dosing (some patients may benefit from twice daily dosing) Duration: 12 months REBETOL, RIBASPHERE, RIBATAB, COPEGUS (ribavirin) Chronic Hepatitis C in patients with compensated liver disease and meets the following criteria: œ Must be used in accordance with current AASLD/IDSA guidelines Usual Dose: Weight-based Duration: Will vary dependent upon individual diagnosis and treatment combination being used. Note: Diagnosis must be confirmed by gastroenterologist. Will not be approved in patients with decompensated cirrhosis. Refer to BCBSNM medical director for use during pregnancy. Ribavirin monotherapy not effective for treatment of chronic Hepatitis C, Hemolytic Anemia and worsening cardiac disease, significant teratogenic and/or embryocidal effects 12/15 Page 30 of 41 rx_pa_criteria_medicaid_nm.doc

RETIN-A, AVITA, ATRALIN, TRETIN-X (tretinoin) (RENOVA is not a covered benefit) Acne Vulgaris in patients age > 40 years Actinic Keratosis in patients age > 40 years Usual Dose: Apply once daily at bedtime Duration: 12 months Please Note: RENOVA is not a covered benefit since it is only indicated for cosmetic purposes. REVATIO (sildenafil citrate) Pulmonary Arterial Hypertension (PAH) in adults Note: Concurrent therapy limited to any two agents at a time (LETAIRIS, FLOLAN, REVATIO/VIAGRA/ADCIRCA, TRACLEER, TYVASO, or VENTAVIS) Usual and Maximum Daily Dose: 20mg TID Note: NOT recommended for use in pediatric patients (increased mortality with increasing doses) Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity REVLIMID (lenalidomide) MDS Myelodysplastic Syndrome Multiple Myeloma (combination with dexamethasone, after at least one prior therapy thalidomide) Mantle Cell Lymphoma (MCL) that has relapsed or progressed after prior treatment with bortezomib (VELCADE) and one other prior therapy. Usual Dose MDS: 10mg once daily Usual Dose Multiple Myeloma and MCL: 25mg once daily on days 1-21 of repeated 28-day cycles Note: Not recommended for the treatment of patients with CLL Duration: 6 months, acquired through FDA approved restricted distribution program REVASSIST Teratogenic effects, hematologic toxicity (neutropenia and thrombocytopenia), DVT&PE 12/15 Page 31 of 41 rx_pa_criteria_medicaid_nm.doc

SANDOSTATIN (octreotide)/sandostatin LAR Acromegaly Metastatic Carcinoid Tumor with severe diarrhea/flushing episodes Vasoactive Intestinal Peptide Tumors (VIPomas) with profuse watery diarrhea Usual Dose: Varies according to diagnosis Duration: 3 months initial, then 6 months thereafter Note: Sandostatin LAR will only be approved in those patients have previously received Sandostatin and have responded to and tolerated treatment. Note: Refer requests for off-label indications to a pharmacist for review SIMPONI (golimumab) Note: HUMIRA is the preferred product in this class. Ankylosing Spondylitis (AS) Psoriatic Arthritis (PsA) alone or in combination with methotrexate Ulcerative Colitis (UC) - moderate to severe with inadequate response or intolerance to prior treatment or requiring continuous steroid therapy Rheumatoid Arthritis (RA) moderate to severe in combination with methotrexate with therapeutic failure or adequate trial of at least one of the following: œ PLAQUENIL (hydroxychloroquine) œ SOLGANAL or RIDAURA (gold) œ Methotrexate œ IMURAN (azathioprine) œ CUPRIMINE (penicillimine) œ AZULFIDINE (sulfasalazine) œ ARAVA (leflunomide) Usual Dose: AS, PsA and RA: 50mg subcutaneously once monthly, UC: 200mg initial, 100mg at week 2, then 100mg every 4 weeks Note: SIMPONI is intended for use under the guidance and supervision of a health care provider. After proper training, a patient may self-inject if a health care provider determines that it is appropriate. Serious infections (e.g., Tuberculosis, invasive fungal infections, and other opportunistic infections); malignancy in children and adolescents 12/15 Page 32 of 41 rx_pa_criteria_medicaid_nm.doc

SPRYCEL (dasatinib) Chronic Myeloid Leukemia (CML) Acute Lymphoblastic Leukemia (ALL) Usual Dose Chronic phase: 100mg once daily Usual Dose Accelerated phase or myeloid/lymphoid blast phase: 140mg once daily Usual Dose Acute Lymphoblastic Leukemia: 140mg once daily Duration: 6 months STRATTERA (atomoxetine) Attention Deficit Hyperactivity Disorder AND at least one of the following: Trial and failure of at least 2 formulary therapeutic alternatives for ADHD Any medical history of cardiovascular disease Any history of drug abuse or addiction to stimulants Usual Dose: 40mg daily, target dose of 80mg daily, MAX 100mg daily Duration: 3 months initial, 12 months continuation if no change in dosing SUTENT (sunitinib) GI Stromal Tumor (GIST) Advanced Renal Cell Carcinoma (RCC) Progressive, well-differentiated Pancreatic Neuroendocrine Tumors (PNET) in patients with unresectable locally advanced or metastatic disease Usual Dose GIST/RCC: 50mg once daily (4 weeks of treatment followed by 2 weeks off) Usual Dose PNET: 37.5mg once daily continuously (without a schedule off-treatment period) Hepatotoxicity 12/15 Page 33 of 41 rx_pa_criteria_medicaid_nm.doc

TARCEVA (erlotinib) Non-Small Cell Lung Cancer (NSCLC) Pancreatic Cancer (for use in combination with gemcitabine) Usual Dose: NSCLC: 150mg once daily Pancreatic Cancer: 100mg once daily Note: Not recommended for use with platinum-based chemotherapies. TASIGNA (nilotinib) Resistant or tolerant Chronic Myelogenous Leukemia (CML) Newly diagnosed Philadelphia chromosome positive CML Usual Dose Resistant or intolerant CML: 400mg twice daily Usual Dose Newly diagnosed CML: 300mg twice daily QT prolongation and sudden deaths TAZORAC (tazarotene topical gel and cream) Plaque Psoriasis in patients age > 40 years Acne Vulgaris in patients age > 40 years Actinic Keratosis in patients age > 40 years Note: Efficacy of Tazorac gel has not been established in acne previously treated with other retinoids or resistant to oral antibiotics. Usual Dose: Apply once daily Duration: 12 months 12/15 Page 34 of 41 rx_pa_criteria_medicaid_nm.doc

TEMODAR (temozolomide) Anaplastic Astrocytoma which has failed treatment with a regimen containing nitrosourea and procarbazine Glioblastoma Multiforme Usual Dose: Based on Body Surface Area. Contact pharmacist for dosing considerations or questions. Testosterone: ANDROGEL, ANDRODERM, AXIRON, FORTESTA,TESTIM, STRIANT, testosterone cypionate Note: Testosterone cypionate, testosterone gel 1%, and ANDRODERM are preferred products in this class Low serum testosterone in males ONLY œ Documented lab results of serum levels below 300ng/dL total testosterone OR below the lower limit of the normal range for the specific test used œ Restricted to males OR œ Hormonal support for female-to-male transgender individuals Usual Dose: Varies according to product, diagnosis, and patient response Duration: 12 months Secondary exposure risk (Testosterone Gel and Solution ONLY) 12/15 Page 35 of 41 rx_pa_criteria_medicaid_nm.doc

THALOMID (thalidomide) Multiple Myeloma: œ In combination with dexamethasone, for the treatment of newly diagnosed patients Erythema Nodosum Leprosum: œ Acute treatment: Acute treatment of the cutaneous manifestations of moderate to severe Erythema Nodosum Leprosum. Not indicated as monotherapy for such Erythema Nodosum Leprosum treatment in the presence of moderate to severe neuritis. œ Maintenance therapy: For prevention and suppression of the cutaneous manifestations of Erythema Nodosum Leprosum recurrence. Orphan Status: Clinical manifestations of mycobacterial infection caused by Mycobacterium Tuberculosis and Non- Tuberculous Mycobacteria; Crohn s Disease; HIV-associated Wasting Syndrome; Kaposi Sarcoma; Multiple Myeloma; Myelodysplastic Syndrome; primary brain malignancies; treatment and maintenance of Reactional Lepromatous Leprosy; treatment and prevention of GVHD; treatment and recurrent Aphthous Stomatitis; treatment and prevention of recurrent Aphthous Ulcer in severely, terminally immunocompromised patients. Usual Dose: Varies according to diagnosis and patient response Duration: 6 months through STEPS, then 12 months thereafter if no change in dosing Note: Thalidomide is approved for marketing only under a special restricted distribution program approved by the FDA called System for Thalidomide Education and Prescribing Safety (STEPS). Only program registered pharmacists and prescribers are allowed to possess and use the product. Teratogenic effects, DVT&PE TRACLEER (bosentan) Pulmonary Arterial Hypertension (PAH) Note: Concurrent therapy limited to any two agents at a time (LETAIRIS, FLOLAN, REVATIO/VIAGRA/ADCIRCA, TRACLEER, TYVASO, VENTAVIS) Usual Dose: Initiate at 62.5mg twice daily; increase to a maximum of 125mg twice daily Hepatotoxicity, teratogenic effects 12/15 Page 36 of 41 rx_pa_criteria_medicaid_nm.doc

TYKERB (lapatinib) Hormone-positive and HER-2 positive advanced or metastatic Breast Cancer AND the following: Combination therapy with capecitabine AND Prior therapy including an anthracycline, taxane, or trastuzumab OR Combination therapy with letrozole when hormonal therapy is indicated Usual Dose: Varies according to diagnosis and patient response Hepatotoxicity TYVASO (treprostinil) inhalation solution Documented Pulmonary Arterial Hypertension (PAH) with NYHA (New York Heart Association) Class III symptoms (marked limitation of physical activity; comfortable at rest) Note: Concurrent therapy limited to any two agents at a time (LETAIRIS, FLOLAN, REVATIO/VIAGRA/ADCIRCA, TRACLEER, TYVASO, VENTAVIS) Usual Dose: 4 separate treatment sessions daily, approximately 4 hours apart, during waking hours (6mcg/breath) Initial: 3 breaths (18 mcg) per treatment session Titration: Increase by an additional 3 breaths at approximately 1-2 week intervals (if tolerated) Maintenance: Target is 9 breaths (54 mcg) per treatment session (as tolerated) 4 times daily VENTAVIS (Iloprost) Pulmonary Arterial Hypertension (PAH) Note: Concurrent therapy limited to any two agents at a time (LETAIRIS, FLOLAN, REVATIO/VIAGRA/ADCIRCA, TRACLEER, TYVASO, or VENTAVIS) Maximum Dose: 5mcg 9 times daily 12/15 Page 37 of 41 rx_pa_criteria_medicaid_nm.doc

VFEND (voriconazole) Candidemia in non-neutropenic patients with disseminated infections in the skin, abdomen, kidney, bladder wall, and wounds Esophageal Candidiasis after treatment failure to fluconazole Invasive Aspergillosis Serious infections caused by fusarium species or S. apiospermum in patients intolerant of or refractory to other therapy Usual Dose: Varies according to diagnosis, but generally 100 300mg every 12 hours Duration: 1 month VIVITROL (naltrexone for extended-release injectable suspension) Treatment of: Alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL Prevention of: Relapse to opioid dependence, following opioid detoxification AND all the following: Patient should have voluntarily abstained from alcohol for at least 4 days and/or have been opioidfree for at least 7 days prior to beginning therapy with Vivitrol AND Patient should be participating in a program that provides psychosocial support AND Patient should have documented evidence of previous failure/intolerance to oral therapy (disulfiram, acamprosate, or naltrexone) AND Documented decrease in use of abused substance with oral therapy AND Documented non-adherence to oral naltrexone AND Patient does not have acute hepatitis or liver failure AND Patient does not have a documented hypersensitivity to naltrexone and/or the diluent Usual Dose: 380mg IM every 4 weeks (once monthly). Should be administered by a health care professional as an IM gluteal injection. Duration: 6 months initially, may be extended by an additional 6 months. Note: All VIVITROL requests are to be routed through BCBSNM s Specialty Pharmacy vendor. 12/15 Page 38 of 41 rx_pa_criteria_medicaid_nm.doc

XELODA (capecitabine) Metastatic Colorectal Cancer Colon Cancer (as adjuvant) Metastatic Breast Cancer Esophageal Cancer Usual Dose: Varies according to diagnosis; based upon body surface area (BSA) Capecitabine-warfarin drug interaction XENAZINE (tetrabenazine) Chorea associated with Huntington s Disease Dosing considerations: Titration required For CYP2D6 poor metabolizers: 25mg/dose, 50mg per day For CYP2D6 intermediate to extensive metabolizers: 37.5mg/dose, 100mg per day Dosing greater than 25mg per day should be divided into three equal doses Maximum dose (adult): 37.5mg/dose, 100mg per day Depression, suicidality 12/15 Page 39 of 41 rx_pa_criteria_medicaid_nm.doc

XIFAXAN (rifaximin) Hepatic Encephalopathy: For reduction in risk of overt Hepatic Encephalopathy recurrence in patients 18 years of age and older. Traveler's Diarrhea: For the treatment of patients 12 years of age and older with Traveler's Diarrhea caused by noninvasive strains of Escherichia coli. Do not use rifaximin tablets in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than E. coli. Irritable Bowel Syndrome with Diarrhea (IBS-D) Note: Off-label indications ( such as clostridium difficile diarrhea should be referred to a pharmacist for clinical review. Usual Dose: Varies according to diagnosis; FDA-approved uses: Hepatic Encephalopathy: 550mg 2 times a day Traveler's Diarrhea: 200mg 3 times a day for 3 days ONLY IBS-D: 550mg 2 times daily x 14 days for up to two regimens Duration: Hepatic Encephalopathy: 6 months initial, then 12 months thereafter if no change in dosing XYREM (sodium oxybate) Narcolepsy with symptoms of excessive daytime sleepiness or cataplexy in patients 16 years of age and older Usual Dose: Initial: 4.5gm/night, divided into 2 equal doses of 2.25gm Maximum: 9gm/night Note: Xyrem is available through the Xyrem Success Program, using a centralized pharmacy Duration: 3 months Central Nervous System Depressant with Abuse Potential 12/15 Page 40 of 41 rx_pa_criteria_medicaid_nm.doc

ZORTRESS Renal transplantation: For the prophylaxis of organ rejection in adult patients at low to moderate immunologic risk receiving a kidney transplant. For use in combination with basiliximab (SIMULECT), reduced-dose cyclosporine and corticosteroids. Liver transplantation: For the prophylaxis or organ rejection 30 days post-transplant in combination with reduced-dose tacrolimus and corticosteroids. Dosing considerations: Usual dose: Initial dose: 0.75mg twice daily; Maintenance dose: titrate to serum target Immunosuppression, renal function, mortality in heart transplantation, and kidney graft thrombosis: Increased susceptibility to infection and the possible development of malignancies, such as lymphoma and skin cancer, may result from immunosuppression. ZYVOX (linezolid) Vancomycin-resistant Enterococcus Faecium or Enterococcus Faecalis Duration: 28 days Methicillin-resistant Staphylococcus Aureus Methicillin-resistant Streptococcus Pyogenes or Streptococcus Agalactiae Duration: 14 days Usual Dose: Varies according to diagnosis, but generally 400 600mg every 12 hours Note: Culture and sensitivities required. 12/15 Page 41 of 41 rx_pa_criteria_medicaid_nm.doc