SOUTH COUNTRY PRIOR AUTHORIZATION CRITERIA MEDICAID

Transcription

1 SOUTH COUNTRY PRIOR AUTHORIZATION CRITERIA MEDICAID 2

2 South Country Prior Authorization Criteria H.P. Acthar (corticotropin) vials PA Criteria for Approval for Infantile Spasms (West Syndrome): Patient is <2 years of age The medication is being prescribed by a neurologist Documentation of the patient s current weight (in kg) and height/length (in cm) or body surface area (BSA) is provided If all of the above conditions are met, the request will be approved for up to a 1-month duration; if all of the above criteria are not met, then the request is referred to a Medical Director/Clinical Reviewer for medical necessity review. PA Criteria for Approval for Multiple Sclerosis: Documentation was submitted that patient is having acute attack with neurologic symptoms and increased disability or impairments in vision, strength, or cerebellar function, and has failed therapy with IV methylprednisolone. The medication is being prescribed by a neurologist If all of the above conditions are met, the request will be approved for up to a 1-month duration; if all of the above criteria are not met, then the request is referred to a Medical Director/Clinical Reviewer for medical necessity review. PA Criteria for all other FDA-approved conditions and indications: Documented trial and failure of IV methylprednisolone AND oral prednisone, or documented medical reason for why the patient cannot use these therapies for treatment Documentation was provided that ALL other standard therapies have been used to treat the member s condition as described in the medical compendium (Micromedex, AHFS, DrugPoints, and package insert) as defined in the Social Security Act and/or per recognized standard of care guidelines OR there is a documented medical reason (i.e. medical intolerance, treatment failure, etc.) as to why all other standard therapies could not be used to treat the member s condition. Prescriber is a specialist in the condition they are treating If all of the above conditions are met, the request will be approved for up to a 1-month duration; if all of the above criteria are not met, then the request is referred to a Medical Director/Clinical Reviewer for medical necessity review. NOTE: Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. Revision/Review Date: 6/2017 3

3 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Agents for Atopic Dermatitis Field Description Eucrisa (crisaborole), Protopic (tacrolimus), Elidel (pimecrolimus) Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See other criteria Provider must be a pediatrician or dermatologist If the criteria are met, the request will be approved with up to a 6 month duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review. Initial Authorization For Elidel : Diagnosis of mild to moderate atopic dermatitis in non immunocompromised patient in whom the use of alternative, conventional therapy is deemed inadvisable because of potential risks, or who are not adequately responsive to or intolerant of alternative conventional therapies. For Protopic : Diagnosis of moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or are intolerant of alternative, conventional therapies Revision/Review Date 03/2017 For Eucrisa : Diagnosis of mild to moderate atopic dermatitis AND Trial and failure of a formulary corticosteroid AND Trial and failure of Protopic or Elidel Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary. 6

4 Field Name Prior Authorization Group Description AMPYRA Field Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Dalfampridine (Ampyra) *Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), or the Drug Package Insert (PPI). History of seizures. Moderate or severe renal impairment (creatinine clearance 50mL/minute). See Other Criteria Patient must be 18 years of age or older Prescriber must be a neurologist If all of the criteria are met, the request will be approved for 6 months; if all of the above criteria are not met, the request is referred to a Medical Director/Clinical reviewer for medical necessity review. Initial Authorization: Baseline creatinine clearance (within 60 days of request) Patient has diagnosis of multiple sclerosis (MS), patient is ambulatory (baseline 25 foot walk was submitted with request), AND patient has walking impairment Documentation was submitted (consistent with pharmacy claims data, OR for new members to the health plan, consistent with chart notes) that patient is currently being treated for MS (e.g. immunomodulator, interferon, immunosuppressive), or documentation of a medical reason (intolerance, hypersensitivity) as to why patient is unable to use one of these agents to treat their medical condition Drug is being requested at an FDA approved dose Re-authorization: Documentation of improvement of 20% in 25 foot walk was submitted with request Documentation was submitted patient is on MS treatment (e.g. immunomodulator, interferon, immunosuppressive), or documentation of a medical reason (intolerance, hypersensitivity) as to why patient is unable to use one of these agents to treat their medical condition Drug is being requested at an FDA approved dose Review Date 6/2017 If all of the criteria are not met, the request is referred to a Medical Director or clinical reviewer for medical necessity review.

5 Field Name Field Description Prior Authorization Group ANDROGENIC AGENTS (*EXCLUDES GENDER DYSPHORIA, PLEASE REFER TO GENDER DYSPHORIA CRITERIA DOCUMENT) Drug(s) Androgel (testosterone) 1.62% Androderm (testosterone) Testim (testosterone) Axiron (testosterone) Android (methyltestosterone) Aveed (testosterone) Depo-testosterone (testosterone cypionate) Fortesta (testosterone) Methitest (methyltestosterone) Striant buccal (testosterone) Testopel implant (testosterone) Testred (methyltestosterone) testosterone enanthate testosterone cypionate Vogelxo (testosterone) Or any newly marketed testosterone agent Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI) and the Drug Package Insert). Patients that are female Prescriber must document medical reason for low testosterone, such as hypogonadism, and a copy of laboratory result demonstrating low testosterone is required. None None If all of the conditions are met, the initial request will be approved for a 3-month duration. Reauthorization duration: 12 months For Initial Authorization: Male patient Diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired) Documented low testosterone level(s) (copy of laboratory result required) For Re-Authorization: Documentation indicating the member has experienced a clinical benefit as a result of therapy Repeat testosterone level (copy of laboratory result required) Revision/Review Date: 6/2017 If the above conditions are not met, the request will be referred to a Medical Director for medical necessity review. NOTE: Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.

6 SOUTH COUNTRY PRIOR AUTHORIZATION CRITERIA Antipsychotic Medications Medications Used to Treat Emotional Disturbance or Mental Illness FORMULARY STATUS: Non-Formulary Risperdal Consta (risperidone): 12.5 mg/2ml, 25 mg/2ml, 37.5 mg/2ml, 50 mg/2ml syringes Invega Sustenna (paliperidone palmitate): 38 mg, 78 mg, 117 mg, 156 mg, 234 mg syringes Zyprexa Relprevv (olanzapine): 210mg, 300mg, 405mg vials Abilify Maintena (aripiprazole): 300mg, 400mg vials and syringes Geodon (ziprasidone): 20mg vial Abilify Discmelt (aripiprazole): 10mg, 15mg dipsersible tablet Abilify Intramuscular Solution (aripiprazole): 9.75mg/1.3ml vial FazaClo (clozapine): 12.5mg, 25mg, 100mg, 150mg, 200mg dispersible tablet Versacloz (clozapine): 50mg/ml oral suspension Fanapt (iloperidone): 1mg, 2mg, 4mg, 6mg, 8mg, 10mg, 12mg Zyprexa Zydis (olanzapine): 5mg, 10mg, 15mg, 20mg dispersible tablet Zyprexa (olanzapine): 10mg intramuscular solution Symbyax (olanzapine-fluoxetine): 3mg-25mg, 6mg-25mg, 12mg-25mg, 6mg-50mg, 12mg-50mg tablet Invega (paliperidone): 1.5mg, 3mg, 6mg, 9mg tablet InvegaTrinza (paliperidone palmitate): 273mg, 410mg, 546mg, 819mg syringes Seroquel XR (Quetiapine): 50mg, 150mg, 200mg, 300mg, 400mg Tablet extended release Risperdal M-Tab (risperidone): 0.5mg, 1mg, 2mg, 3mg, 4mg disintegrating tablet Chlorpromazine: 25mg ampule Fluphenazine: 5mg/ml oral concentrate Fluphenazine:2.5mg/5ml oral elixir Thioridizine: 10mg, 25mg, 50mg, 100mg tablet PA CRITERIA FOR APPROVAL: 1. Requested medication must be used to treat emotional disturbance # or mental illness ## a. Medication does not need to be FDA approved for the requested diagnosis AND 2. Prescriber indicates orally or in writing that the drug must be dispensed as communicated.(ex. Brand Necessary/DAW 1 requests ) AND 3. Prescriber Certifies in writing (PA request) that all equivalent drugs on the formulary were considered AND it was determined that the drug prescribed will best treat the patient's condition. 4. *******PLEASE NOTE, THE ABOVE CRITERIA DO NOT OVERRIDE MAX DOSING, SAFETY EDITS******* If the above criteria #1, #2 AND #3 are met, the request must be approved for 12 months. If the above criteria #1, #2 AND #3 are met for an injectable antipsychotic medication, the request will be approved for 16 weeks. If the prescribed drug has been removed from the SCHA s formulary due to safety reasons, SCHA does not have to provide coverage for the drug. PA CRITERIA FOR REAUTHORIZATION- Continuing of Care (Members on Existing therapy) INCLUDING MEMBERS NEW TO THE PLAN 1. Documentation the patient has been treated with the drug for at least 90 days prior to a change in SCHA s drug formulary or prior to becoming a SCHA member a. Medication does not need to be FDA approved for the requested diagnosis OR

7 2. The prescriber indicates orally or in writing that the drug must be dispensed as communicated (ex. Brand Necessary/DAW 1 requests). AND 3. Prescriber certified in writing the drug prescribed will be best to treat patient s condition If the above criteria are met (#1 or #2 AND#3), the request must be approved for 12 months If the above criteria are met (#1 or #2 AND#3) for an injectable medication, the request must be approved for 12 months NOTE: If the prescribed drug has been removed from the SCHA s formulary due to safety reasons, SCHA does not have to provide coverage for the drug. # - Emotional disturbance: means an organic disorder of the brain or a clinically significant disorder of thought, mood, perception, orientation, memory, or behavior. ## Mental Illness: means an organic disorder of the brain or a clinically significant disorder of thought, mood, perception, orientation, memory, or behavior that seriously limits a person s capacity to function in primary aspects of daily living such as personal relations, living arrangements, work, and recreation. Revision/Review Date: 6/2017 Associated Policy: Prior Authorization of Medications MN Statutes 62Q.527; MN Statutes, section 62M.02; MN Statutes, section , subd. 15; MN Statues, section subd. 20, paragraph (a); State Health Care Program Requirements; Article 6 DHS Contrac

8 Field Name Field Description Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Avinza Avinza (morphine sulfate) extended-release capsules Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See other criteria Coverage Duration If the criteria are met, the request will be approved with up to a 6 month duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review. Other Criteria Initial Authorization: Diagnosis of moderate to severe pain requiring opioid analgesic for extended period of time. AND Documented trial and failure or intolerance to generic morphine sulfate extended release tablets. AND Documented trial and failure or intolerance to Kadian. Revision/Review Date 06/2017 Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

9 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Bactroban Field Description Bactroban (mupirocin calcium ointment) Nasal Ointment Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See other criteria If the criteria are met, the request will be approved with a 5 day duration; if the conditions are not met, the request will be referred to a Medical Director for medical necessity review. Use is consistent with pre-operative prophylaxis of S. aureus Revision/Review Date 03/2017 Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

10 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Banzel Field Description Banzel (rufinamide) tablet and oral suspension Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See other criteria Patient is 1 year of age or older Prescriber Restrictions Coverage Duration If the conditions are met, the request will be approved with a 12 month duration; if the conditions are not met, the request will be referred to a Medical Director for medical necessity review. Other Criteria Diagnosis of Lennox-Gastaut syndrome AND Revision/Review Date 03/2017 Patient is currently receiving another anticonvulsant medication at a therapeutic dosage. AND Patient does not have Familial Short QT syndrome Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

11 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Revision/Review Date 6/2017 Botulinum Toxins A&B Field Description OnabotulinumtoxinA (Botox ), IncobotulinumtoxinA (Xeomin ), AbobotulinumtoxinA (Dysport ), RimabotulinumtoxinB (Myobloc ), or any newly marketed agent Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. None If all of the conditions are met, the request will be approved for 3 month duration. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review. **The use of these medications for cosmetic purposes is NOT a covered benefit under the Medical Assistance program.** For Approval: If the diagnosis is lower limb spasticity for pediatric patients (2-17 years old), cervical dystonia (spasmodic torticollis) or upper limb spasticity in adult patients Dysport is the preferred agent. The request is for a FDA approved indication and dose or is supported by compendia or standard of care guidelines. Documentation was submitted, that the patient had an adequate trial (consistent with pharmacy claims) standard first line therapy for their disease state and/or has a documented medical reason (intolerance, hypersensitivity, contraindication, etc) for not taking first line therapy to treat their medical condition. If the diagnosis is Chronic Migraines ( 15 days per month with headache lasting 4 hours a day or longer), the patient has a documented adequate trial (consistent with pharmacy claims data) of beta blockers (e.g. propranolol), tricyclic antidepressants (e.g. amitriptyline), Depakote, and topiramate, or a medical reason was submitted (intolerance, hypersensitivity, contraindication, etc) why patient is not able to utilize these therapies. If the diagnosis is Overactive Bladder, the patient has a documented adequate trial (consistent with pharmacy claims data) of at least 2 formulary medications (e.g. oxybutynin) Physician/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

12 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions CHELATING AGENTS Field Description Non-Formulary (PA required) Exjade (Deferasirox) Jadenu (Deferasirox) Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See other criteria Prescriber Restrictions Coverage Duration If the conditions are met, the request will be approved for a 6 month duration. If the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

13 Other Criteria Chronic iron overload due to blood transfusions: Revision/Review Date: 08/2017 Pediatric Population (2-20 years of age): Patient must be > 2 years old and Diagnosis of chronic iron overload due to blood transfusions and Patient receiving blood transfusions on a regular basis/participating in blood transfusion program and Serum ferritin concentration is consistently > 1000 mcg/l. If the serum ferritin levels fall consistently below 500 mcg/l, Exjade or Jadenu must be discontinued and The medication requested is being prescribed at an FDAapproved dose Adult Population (>21 years of age): Diagnosis of chronic iron overload due to blood transfusions and Patient receiving blood transfusions on a regular basis/participating in blood transfusion program and Serum ferritin concentration is consistently > 1000 mcg/l. If the serum ferritin levels fall consistently below 500 mcg/l, Exjade or Jadenu must be discontinued and Documentation that patient is unable to use deferoxamine (Desferal) parenterally and The medication requested is being prescribed at an FDAapproved dose Chronic iron overload in non-transfusion-dependent thalassemia syndromes: Patient must be 10 years old and Diagnosis of thalassemia syndrome and Liver iron content (LIC) by liver biopsy of 5 mg Fe/g dry weight and Serum ferritin level > 300mcg/L on 2 measurements one month apart and The medication requested is being prescribed at an FDAapproved dose Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.

14 Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Cholbam Cholbam (cholic acid) Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See other criteria MD is a gastroenterologist OR hepatologist If all of the conditions are met, the request will be approved for a 3 month duration for the first year of therapy, and then for a 6 month duration after one year of treatment. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review. Initial authorization: Patient has a confirmed diagnosis of: Bile acid synthesis disorder due to single enzyme defect (SEDs) OR peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients that exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption Current labs (within 30 days of request) have been submitted for the following: ALT/AST GGT (serum gamma glutamyltransferase) ALP (Alkaline phosphatase) Bilirubin INR Re-authorization: Documentation has been submitted indicating clinical benefit/ liver function has improved since beginning treatment* * Treatment should be discontinued if liver function does not improve within 3 months of starting treatment, if complete biliary obstruction develops or if cholestasis occurs Current labs (within 30 days of request) have been

15 Revision/Review Date: 12/2017 submitted for the following: ALT/AST GGT (serum gamma glutamyltransferase) ALP (Alkaline phosphatase) Bilirubin INR Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

16 SOUTH COUNTRY PRIOR AUTHORIZATION CRITERIA CIPRODEX (0.3% ciprofloxacin, 0.1% dexamethasone) otic suspension FORMULARY STATUS: Non-Formulary PA CRITERIA FOR APPROVAL Documented trial and failure, contraindication, or intolerance to ofloxacin otic AND Cortisporin otic drops. OR Prescribing provider is an ear, eye, nose and throat (EENT) physician If the above conditions are met, the request will be approved for a 3 month duration. If the above conditions are not met, the request will be referred to a Medical Director for medical necessity review. Revision/Review Date: 12/2017 NOTE: Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary

17 SOUTH COUNTRY PRIOR AUTHORIZATION CRITERIA COLCRYS (colchicine) FORMULARY STATUS: Non- formulary PA CRITERIA FOR APPROVAL: Acute gout attack: Member is 17 years of age or older Has a documented history of therapeutic failure, intolerance, or contraindication to the following at appropriate doses and frequencies for the treatment of gout: NSAIDs, COX-2 inhibitors, systemic corticosteroids, or intra-articular glucocorticoids If the above conditions are met, the request will be approved for up to three 0.6 mg tablets (total of 1.8 mg) for up to a 2 week duration. If the above conditions are not met, the request will be referred to a Medical Director for medical necessity review. Chronic gout: Member is 17 years of age or older Colchicine is being prescribed in combination with a uric acid lowering medication for the prophylaxis of gout attacks (such as allopurinol, probenecid, or febuxostat) If the above conditions are met, the request will be approved for a 6 month duration. If the above conditions are not met, the request will be to a Medical Director for medical necessity review. Familial Mediterranean Fever (FMF): o Member is 4 years of age or older If the above condition is met, the request will be approved for a 12 month duration. If the above conditions are not met, the request will be referred to a Medical Director for medical necessity review. NOTE: Ph ysician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary Revision/Review Date: 08/2017 Associated Policy: Prior Authorization of Medications

18 Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Crinone Crinone (micronized progesterone) Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See other criteria If the criterion is met for prevention of spontaneous preterm delivery, the request will be approved for 30 single use applicators per 30 days until the end of pregnancy. If the criterion is met for secondary amenorrhea, the request will be approved for 6 doses of 4% gel. Six doses of 8% gel may be approved following failure of 4% gel. If the criterion is not met, the request will be referred to a clinician for medical necessity review. Initial Authorization: Documented ultrasound of transvaginal cervical length (TVCL) less than 20 mm between 16 and 24 weeks of gestation OR history of spontaneous preterm singleton birth regardless of cervical length OR diagnosis of secondary amenorrhea AND Crinone is not being used for infertility. Revision/Review Date 08/2017 Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

19 Prior Authorization Group Description Drug(s) Covered Uses Exclusion Criteria Required Medical Information Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Cystic Fibrosis Agents Aztreonam lysine (Cayston ), dornase alfa (Pulmozyme ), tobramycin (Tobi, Tobi Podhaler ), ivacaftor (Kalydeco, Kalydeco Granules ), Lumacaftor/Ivacaftor (Orkambi ) Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), and/or per standard of care guidelines. See Other Criteria See Other Criteria See Other Criteria See Other Criteria Prescriber must be a pulmonologist If all of the conditions are met, for Kalydeco and Orkambi the initial request will be 6 months, all other meds will be approved with a 12-month duration. Reauthorization for Kalydeco and Orkambi will be 12 months. If all of the criteria are not met, the request is referred to a Medical director/clinical reviewer for medical necessity review. CRITERIA FOR THE USE OF KALYDECO (IVACAFTOR) IN THE TREATMENT OF CYSTIC FIBROSIS: The medication is for the treatment of a CF patient who has an FDA approved indication for treatment of the patient s genotype (there is a FDA cleared CF mutation test that can be used to determine genotype if unknown). Copy of the FDA-cleared CF mutation test has been provided with request, or documentation from the National Cystic Fibrosis Registry (screen shot from registry would be acceptable) has been provided that documents the patients genetic mutations The patient is 2 years or older. For patients age 2-6, documentation of the patient s weight The patient is not a homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Baseline FEV1 has been submitted with request (within 90 days of request) Documentation of current ALT/AST levels (within 90 days of request). The medication is being prescribed at a dose that is within FDA approved guidelines. CONTINUATION OF THERAPY for KALYDECO (IVACAFTOR): Documentation has been submitted that patient has obtained clinical benefit from medication (i.e. improvement in FEV1, BMI, decrease in number or frequency of pulmonary exacerbations, or improvement in quality of life) Repeat ALT/AST (within 90 days of request) The medication is being used for an FDA approved indication at an FDA approved dose CRITERIA FOR THE USE OF TOBI (TOBRAMYCIN) PRODUCTS IN THE TREATMENT OF CYSTIC FIBROSIS: The medication is being prescribed for the treatment of a cystic fibrosis

20 patient colonized with Pseudomonas aeruginosa. The medication is being prescribed at a dose that is within FDA approved guidelines. CRITERIA FOR THE USE OF PULMOZYME (DORNASE ALFA) IN THE TREATMENT OF CYSTIC FIBROSIS: The medication is not being used as monotherapy. The patient is 5 years or older. The medication is being prescribed at a dose that is within FDA approved guidelines. CRITERIA FOR THE USE OF CAYSTON (AZTREONAM LYSINE) IN THE TREATMENT OF CYSTIC FIBROSIS: The medication is being prescribed for the treatment of a cystic fibrosis patient colonized with Pseudomonas aeruginosa. The medication is being prescribed at a dose that is within FDA approved guidelines. CRITERIA FOR THE USE OF ORKAMBI (LUMACAFTOR/IVACAFTOR) IN THE TREATMENT OF CYSTIC FIBROSIS: The patient is > 6 years of age. The patient IS homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Copy of the FDA-cleared CF mutation test has been provided with request, or documentation from the National Cystic Fibrosis Registry (screen shot from registry would be acceptable) has been provided that documents the patients genetic mutations Baseline FEV1 has been submitted with request (within 90 days of request) Documentation of current ALT/AST and bilirubin levels (within -90 days of request) The medication is being prescribed at a dose that is within FDA approved guidelines. Review/Revision Date: 3/2017 CONTINUATION OF THERAPY for ORKAMBI (LUMACAFTOR/IVACAFTOR): Documentation has been submitted that patient has obtained clinical benefit from medication (i.e. improvement in FEV1, BMI, decrease in number or frequency of pulmonary exacerbations, or improvement in quality of life) Repeat ALT/AST (within 90 days of request) The medication is being used for an FDA approved indication at an FDA approved dose.

21 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Danocrine (danazol) Field Description Danocrine (danazol) capsules Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Pregnancy-see other criteria See other criteria See other criteria If the criteria are met, the request will be approved with a 6 month duration for generic medication; if the criteria are not met, the request will be referred to a Medical Director for medical necessity review. ENDOMETRIOSIS Diagnosis of endometriosis AND Documented trial and failure, intolerance or documented medical reason for not using first line therapy of oral contraceptive therapy. AND Prescribing physician is a gynecologist. AND Negative Pregnancy Test FIBROCYSTIC BREAST PAIN DISEASE Diagnosis of fibrocystic breast disease. AND Documented trial and failure, intolerance or documented medical reason for not using first line therapy of analgesics including acetaminophen and NSAIDs. AND Prescribing physician is a gynecologist. AND Negative Pregnancy Test HEREDITARY ANGIOEDEMA: Diagnosis of hereditary angioedema. AND Negative Pregnancy Test Revision/Review Date 03/2017 Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

22 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Revision/Review Date 12/2017 Daraprim Daraprim (pyrimethamine) Field Description Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Patients with documented megaloblastic anemia due to folate deficiency. If diagnosis is toxoplasmosis, and request is for PRIMARY PROPHYLAXIS, a medical reason was provided as to why patient is not able to use trimethoprim-sulfamethoxazole. If diagnosis is toxoplasmosis, request is for TREATMENT and will be used in combination with a sulfonamide. If member is allergic to sulfa, desensitization should be attempted or another preferred regimen should be used. If request is for CHRONIC MAINTENANCE treatment of toxoplasmosis, and patient was NOT TREATED with a pyrimethamine regimen, a medical reason is provided why patient is not able to continue with alternative regimen for maintenance. If diagnosis is isosporiasis in an HIV patient, a medical reason was provided as to why patient is not able to use trimethoprim-sulfamethoxazole or ciprofloxacin to manage their condition If diagnosis is pneumocystis pneumonia in an HIV patient, documentation was submitted with a medical reason for not utilizing trimethoprim-sulfamethoxazole or dapsone If diagnosis is prophylaxis of malaria, documentation was submitted with a medical reason as to why patient is not able to use all other first line malaria agents (resistance to Prescriber must be an appropriate specialist or documentation has been provided that prescriber has consulted with an appropriate specialist (i.e. infectious disease, OB/GYN). If all of the conditions are met, PRIMARY PROPHYLAXIS requests will be approved for 3 months, TREATMENT requests will be approved for 6 weeks, and CHRONIC MAINTANENCE requests will be approved for 3 months at a time. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

23 Field Name Prior Authorization Group Description Drugs Covered Uses DDAVP Field Description DDAVP (desmopressin) Tablets & Nasal Spray/Nasal Solution (Rhinal Tube) Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See other criteria Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration If the conditions are met, the request will be approved with a 12 month duration. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review. Other Criteria Tablets Diagnosis of central cranial (neurogenic) diabetes insipidus. NOTE: Tablet formulation will process at the point-of-sale for members 6 years old. Nasal Spray and Rhinal Tube (nasal solution): Diagnosis of central cranial (neurogenic) diabetes insipidus. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary. Revision/Review Date 03/2017

24 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Diamox Sequel Field Description Diamox Sequel (acetazolamide sustained release) capsules Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See other criteria Prescriber Restrictions Coverage Duration If the conditions are met, the request will be approved with a 6 month duration; if the above conditions are not met, the request will be referred to a Medical Director/clinical reviewer for medical necessity review. Other Criteria Initial authorization: Diagnosis of chronic simple open angle glaucoma, or secondary glaucoma. AND Documented trial and failure with therapeutic doses or intolerance to acetazolamide immediate release tablets. Revision/Review Date 03/2017 Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

25 SOUTH COUNTRY PRIOR AUTHORIZATION CRITERIA Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Diclegis Field Description Diclegis (doxylamine/pyridoxine HCL) Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Member is male See other criteria Prescriber must be an obstetrician/gynecologist If the above conditions are met, the request will be approved for 6 (six) months. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review. Other Criteria Revision/Review Date 3/2017 Initial authorization: The indicated diagnosis of nausea and vomiting due to pregnancy. AND The member has had an adequate trial and failure with one (1) of the following agents: o ondansetron o pyridoxine (vitamin B6) o metoclopramide Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

26 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Dostinex Field Description Dostinex (cabergoline) tablets Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See other criteria If the conditions are met, the request will be approved for a12- month duration; if the above conditions are not met, the request will be referred to a Medical Director/clinical reviewer for medical necessity review. Initial authorization: Diagnosis of hyperprolactinemia. AND Documented trial and failure with therapeutic doses or intolerance to bromocriptine therapy. Revision/Review Date 03/2017 Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

27 SOUTH COUNTRY PRIOR AUTHORIZATION CRITERIA ELMIRON (pentosan polysulfate sodium) FORMULARY STATUS: Non-Formulary PA CRITERIA FOR APPROVAL: Diagnosis of interstitial cystitis If the above conditions are met, the request will be approved for a duration of 6 months. If the above conditions are not met, the request will be referred to a Medical Director for medical necessity review. Associated Policy: Prior Authorization of Medications NOTE: Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. Revision/Review Date: 12/2017

28 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Revision/Review Date: 6/2017 Emflaza Field Description Emflaza (deflazacort) Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. See Other Criteria Patient must be 5 years of age or older Prescriber must be a neurologist If all of the conditions are met, the approval will be for a 6 month duration. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review. For Approval: Confirmed diagnosis of Duchenne Muscular Dystrophy (documented mutation of dystrophin gene), and copies of testing were submitted with request Patient has onset of weakness before 5 years of age, and serum creatinine kinase activity of at least 10 times the upper limit of normal (ULN) at some stage in their illness Patient is ambulatory Patient has had a baseline eye examination Patient has had a baseline behavioral health evaluation Patient has had a baseline bone mineral density (BMD) screening completed (include date and results) Patient is or will be taking adequate calcium and vitamin D supplementation If patient has been previously established on deflazacort before available in the U.S., provider has submitted detailed chart notes including dates of therapy and response Patient has trial and failure with prednisone or prednisolone for at least 12 months Documented medical reason why prednisone or prednisolone are not able to be continued, and Emflaza would be medically necessary and not have the same side effect as the preferred agents The request is for an FDA approved dose Reauthorization: The patient is ambulatory Physician attests that the patient s muscle strength has stabilized or improved since starting treatment Patient s claim history shows consistent therapy (monthly fills) Physician attests patient has had repeat eye and BMD screenings as appropriate The request is for an FDA approved dose Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.

29 Field Name Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria Revision/Review Date 12/2017 Endari Field Description Endari (L-Glutamine) Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. see other criteria Prescriber must be a hematologist If all of the conditions are met, requests will be approved for 12 months. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review. Initial: Member has diagnosis of sickle cell anemia Documentation was provided that the patient has had 2 or more crises in the last 12 months Documentation was provided that the member has been taking hydroxyurea at the maximum tolerated dose and has been compliant within the last 6 months (or a medical reason was provided why patient is unable to use hydroxyurea) Request is for an FDA-approved dose Reauthorization: Prescriber attests member had a reduction in number of sickle cell crises while taking Endari Request is for an FDA-approved dose Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.

30 Field Name Field Description Prior Authorization Group Description Entocort EC Drugs Entocort EC (budesonide) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria See other criteria If the criteria are met, the request will be approved for up to a 20 week duration. If the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review. Initial Authorization: Diagnosis of mild to moderately active or remissive Crohn s disease involving the ileum and/or the ascending colon. AND Prescription written by a gastroenterologist AND Documented trial and failure with at least 8 weeks each of therapy at therapeutic doses of at least two of the following: sulfasalazine, mesalamine and prednisone. Revision/Review Date 08/2017 Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

31 EPOGEN (epoetin alfa): 2,000 units/ml, 3,000 units/ml, 4,000 units/ml, 10,000 units/ml, 20,000 units/ml, 40,000 units/ml PA Criteria for Approval Administration of Epogen in ESRD Patients Treated at Dialysis Centers. Patient is being treated at a dialysis center. AND The necessary lab work (listed below) is documented on the PA form or submitted with request; -Hemoglobin last 3 months results (to determine rolling Hgb) -Hematocrit last 3 months results (to determine rolling Hct) -Serum ferritin within past 2 months -Transferrin saturation within past 2 months -Vitamin B12 and Folate levels within past 2 months -History of Epogen usage If all of the above criteria are not met then the request is referred to a Medical Director/clinical reviewer for medical necessity review. Initial request for treatment naïve patients: The patient has a hemoglobin <10g/dL and/or hematocrit <33% If the member is deficient in iron, B12 or folate the member is in the process of receiving supplementation The medication is being recommended and/or prescribed at an FDA appropriate dose. Reauthorization requests or currently on Epogen therapy: The patient has a hemoglobin <12g/dL and/or hematocrit <36% If the patient is iron deficient, the member is currently receiving oral or IV iron supplementation If request is for a change in dose one of the following apply: 1) The ordered dose is reduced by 25% of previous dose if the rate of Hgb increase was greater than 1g/dL over a two week period. 2) The ordered dose is increased from the previous dose if the patients Hgb improved less than 1g/dL after 4 week period and iron stores were adequate. 3) An increase in dose does not occur more than once per month. The medication is being recommended and/or prescribed at an FDA appropriate dose. If all of the above conditions are met, the request will be approved with a 3-month duration, if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. NOTE: Physician/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary. Revision/Review Date: 6/2017

32 South Country Health Alliance Prior Authorization Group: Erythropoiesis-Stimulating Agents Drug(s): Darbepoetin Alfa-Polysorbate 80 (Aranesp ), Epoetin Alfa (Procrit ) ***ARANESP is preferred agent for Chronic Kidney Disease and for patients receiving chemotherapy that are 18 years of age or older.*** ****Procrit requires documentation (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) of adequate trials and/or has a documented medical reason (e.g. intolerance or hypersensitivity) for not utilizing ARANESP when appropriate**** Covered Uses: Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), and/or national treatment/standard of care guidelines. For all cases if criteria is met, the request will be approved for up to 1 month if the patient is deficient in iron, B12 or folate, and up to 3 months for all other requests. If the criteria is not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. Criteria: All lab results must be submitted within 30 days of the request Hemoglobin, Hematocrit, Serum ferritin level (normal is greater than 100ng/ml), Transferrin saturation (TSAT) (normal is greater than 20%), Vitamin B12 level, Folate level, and Erythopoietin level (for HIV related anemia) 1. Initial approval for anemia of Pre-dialysis chronic kidney disease or anemia due to chemotherapy: Hemoglobin less than 10g/dl OR if the member is new to the health plan and was receiving therapy at the previous health plan the member has a documented (submitted lab result dated within 30 days of request) hemoglobin <12 g/dl. If the member has low B12 levels, folate levels or is iron deficient, the patient is either receiving appropriate supplementation or member is beginning therapy to correct deficiency. The medication is being recommended and/or prescribed at an FDA appropriate dose for indication. If the request is for Procrit, the provider submitted a documented medical reason (i.e. intolerance) why they are unable to use Aranesp for patients that are 18 or older. Reauthorization: If the member has been receiving therapy and their hemoglobin is less than 12 g/dl and one of the following apply (if applicable): a) The ordered dose is reduced by 25% of previous dose if the rate of Hgb increase was greater than 1g/dL over a two week period. b) The ordered dose is increased from the previous dose if the patients Hgb improved less than 1g/dL over a 4 to 6 week period and iron stores were adequate. c) An increase in dose does not occur more than once per month (by 25%). If the member is iron deficient, the member is in the process of receiving either oral or IV iron supplementationthe medication is being recommended and/or prescribed at an FDA appropriate dose for indication.