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The PA Process

Mohanish Shrestha PharmD candidate Campbell University. The PA Process. ___________________________________________________________________. Raison d'etre : During state fiscal year 2012, the NC Medicaid program spent $563

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The PA Process

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  1. MohanishShrestha PharmD candidate Campbell University The PA Process ___________________________________________________________________ • Raison d'etre: • During state fiscal year 2012, the NC Medicaid program spent $563 • million on outpatient prescription drugs for 1.58 million recipients.1 • The PA program exists to control spiraling healthcare costs and ensure • that public funds are spent responsibly. • Most drugs included in the PA program are high dollar items or drugs • that have the potential for abuse and over-utilization. NC Medicaid and Health Choice Enhanced pharmacy program. http://ncmedicaidpbm.com. Accessed July 06, 2013.

  2. Brand Name Drugs ___________________________________________________________________ • For any brand name multisource drug that has an FDA (A-rated) • generic equivalent. Prescriber must state DAW1. • Criteria: • Prescriber must go to www.documentforsafety.org and complete the • FDA Medwatch form detailing the adverse event that the beneficiary has • experienced with the generic. • Non-preferred agents require PA and in most cases trial and failure of 2 • preferred agents are REQUIRED. • Brand name drugs Exempt from PA: • Medications used for the treatment of seizures • Medications designated as NTI drugs by the NC Board of Pharmacy (e.g., Coumadin, Synthroid) • Brand medications that are designated as Preferred on the NC Medicaid Preferred Drug List while • the equivalent generic medication is Non-Preferred (e.g., Kadian ER, Lovenox, Accolate, Aricept) • Brand name over the counter/non-prescription medications (e.g., Prilosec OTC, Nicorette)

  3. Anticonvulsants ___________________________________________________________________ • PA is not required for seizure medications for documented diagnosis • Of seizure disorder. • Procedure – Pharmacist may override at POS with PA code “1” if • prescriber writes “meets PA criteria” on the face of the prescription.

  4. Anticonvulsants contd… ___________________________________________________________________ • Special Criteria: • Lamictal– documented diagnosis of Bipolar Disorder I or II, Depressive • Or Maintenance phase. • Lyrica– documented diagnosis of: • Neuropathic pain1/Fibromyalgia2/Anxiety disorderSSRIANDdocumented • failure with a 60 day trial of # agents in the past 12 months • ORdocumented AE/CI. • Topamax – documented diagnosis of Migraine headacheAND • Documented failure with a 60 day trial of 2 agents in the past • 12 months ORdocumented AE/CI.

  5. Aranesp/Procrit/Epogen ___________________________________________________________________ • Criteria:6 months • Anemia associated with renal failure OR • Anemia associated with HIV Infection OR • Anemia associated with chemotherapy OR • Anemia associated with myelodysplastic syndromes OR • Drug induced anemia such as with ribavarin or zidovudine Initial Therapy - Beneficiary shall meet all requirements: 1. Hemoglobin less than or equal to 11 for initial therapy AND 2. Lab data within 3 months of PA

  6. Botox ___________________________________________________________________ • Botox or onabotulinum toxin A • Criteria: • Blepharospasm • Disorders of eye movement (strabismus) • Spasmodic Torticollis, secondary to cervical dystonia • Upper limb spasticity in adults • Severe axillaryhyperhidrosis • Urinary Incontinence • Chronic Migraine (age 18 and older)6 months • 15 or more days each month with HA lasting 4 or more hours • AND Trial and failure of Px medications from 3 drug classes • OR documented CI/intolerated side effect/allergy

  7. Narcotic Analgesics ___________________________________________________________________ • PA requests for Narcotic Analgesics should not be taken over the phone • Criteria: • Short Acting Non-Preferred Narcotic Analgesics:12 months • Document failure in the past year of 30 day trial of a preferred narcotic • analgesic at a dose equivalent to the brand being prescribed OR • Documented CI/Allergy to Preferred product AND • Prescriber has agreed to NCMB statement on the use of controlled • Substances in the treatment of pain and is adhering to treatment • guidelines • Long Acting Narcotic Analgesics:12 months • Documented diagnosis of chronic pain syndrome of at least 4 weeks • duration AND • Prescriber has agreed to NCMB statement… Dose Limit: equivalent dose of 750 mg of morphine/day; 4 g of APAP/ASA per day

  8. Celebrex ___________________________________________________________________ • Criteria6 months: • Management of Acute/Chronic pain for one of following: • Hx of GI bleed/Gastric ulcer/Duodenal ulcer • Previous intolerance to at least 2 non-COX2 NSAids • Concurrent use of corticosteriods • Concurrent use of warfarin or heparin • Hx of platelet dysfunction or coagulopathy • Use in reducing adenomatus colorectal polyps in FAP • Age > 60 are exempt from PA

  9. Cialis ___________________________________________________________________ • Criteria: • Beneficiary is 18 or older male AND • Confirmed Dx of BPH AND • No concurrent therapy with alpha blockers or nitrates AND • Tried and failed all preferred products AND • May not be prescribed to treat ED

  10. Emend ___________________________________________________________________ • Criteria: • Must be undergoing surgery and requires prevention post-operative N/V • OR • Receiving highly/moderately emetogenic chemotherapy agent • AND • Concurrent use of Dexamethasone • Must have tried and failed or intolerant to ondansetron/Zofran/Kytril • /Anzemet • Dosage limits apply to each cycle: • 125 mg for 1 day • 80 mg daily for 2 days

  11. Growth Hormones ___________________________________________________________________ • Children with growth hormone deficiency • Criteria: (separate criteria for Adults) • Coverage is provided in the presence of ALL the following: • GH dysfunction or lack of adequate endogenous GH documented by • any of two provocative tests of less than 10mg/ml • Beneficiary’s height must be below the third percentile for their age and • gender related height • Epiphysis confirmed as open in beneficiaries greater than 9 years of age P&T recommends that a pharmacist handle all prior authorization requests for this therapeutic class

  12. Kalydeco ___________________________________________________________________ • Criteria: • Recipient has been diagnosed with Cystic Fibrosis • AND • Recipient is age 6 or greater • AND • Recipient has a documented G551D mutation in the CFTR gene • AND • Dosing is 150mg taken every 12 hours (300mg/day total) or less • AND • A baseline ALT and AST assessed prior to beginning therapy $30,723 for a month supply

  13. Leukotrienes ___________________________________________________________________ • Criteria: • Covered with diagnosis of Asthma if: • Beneficiary has documented CI/AE to inhaled corticosteroids • OR • Beneficiary has growth suppression due to inhaled corticosteroids • OR • Beneficiary is on medium dose inhaled corticosteroid and needs addition • of Leukotriene Receptor Antagonist or 5-Lipooxygenase Inhibitor to • achieve control (Stepwise Approach for Managing Asthma Long Term) • Exercise Induced Broncho-constriction (singulair): • Documented 30 day T&F of SA bronchodilator OR documented AE/CI • Allergic Rhinitis (singulair): • Documented 30 day T&F of steriod nasal spray/NS antihistamine • OR documented AE/CI

  14. Lidoderm ___________________________________________________________________ • Criteria: • Patient diagnosed with Post-Herpetic Neuralgia. • OR • Neuropathic pain with a previous documented T&F of at least • two of the following drug categories: TCAs, SSRI’s, SNRI’s, • anticonvulsants, NSAID’s or COXII’s • OR • Chronic musculo-skeletal pain (greater than 6 month in duration) with • a previous documented T&F of at least two of the following drug • categories: TCAs, SSRI’s, SNRI’s, anticonvulsants, NSAID’s or COXII’s • AND • Prescribed dose within the FDA recommended maximum amount • of 3 patches per day and no more than 90 patches per month. New prescriptions will be limited to coverage of 1 box (30 patches) upon the first fill. Subsequent refills will be for up to a 34 day supply.

  15. Incivek ___________________________________________________________________ • Criteria:12 weeks • Beneficiary is 18 or older • AND • Beneficiary has confirmed diagnosis of HCV with genotype 1 • AND • Beneficiary has concurrent therapy with ribavirin and peginterferon • AND • Beneficiary has no previous HCV NS3/4A protease inhibitor treatment • for Hepatitis • Approved for up to 12 weeks • One course of treatment per lifetime $22,110 for a bottle of 168

  16. Oral Inhaled steroids ___________________________________________________________________ • Criteria: • QVAR (beclomethasonedipropionate) does not require PA. • Patients must have a documented 30-day T&F of QVAR to receive • other brand name oral inhaled steroids. • OR • Patients must have a documented 30-day T&F of any oral inhaled steroid • product to receive long acting inhaled beta-agonist/steroid combination • products. • Exemptions: • AE/CI to QVAR • COPD patients • Children up to 5 years old may use Flovent without PA

  17. Provigil/Nuvigil ___________________________________________________________________ • Criteria: • Approval will be considered as treatment to improve wakefulness if • Have a diagnosis of narcolepsy • OR • Have excessive sleepiness associated with shift work sleep disorder • OR • Require adjunct treatment for a diagnosis of obstructive • sleep apnea/hypopnea syndrome (OSAHS) with concurrent use of CPAP • OR • Have excessive fatigue associated with multiple sclerosis • or myotonic dystrophy The maximum daily dose for modafinil is 400 mg The maximum daily dose for armodafinil is 250 mg

  18. Qualaquin ___________________________________________________________________ • Criteria: • Treatment for uncomplicated Malaria • May be approved for 1 month

  19. Sedative hypnotics ___________________________________________________________________ • PA requests for Sedative hypnotics should not be taken over the phone • Criteria:6 months • Must have a diagnosis of chronic primary insomnia lasting • one month or longer • OR • Being discontinued from a sedative hypnotic and tapering • is required to prevent symptoms of withdrawal3 months • OR • Being actively assessed for a diagnosis of chronic primary • or secondary/co-morbid insomnia.

  20. Subutex/Suboxone ___________________________________________________________________ • Criteria (suboxone): • Prescription must be written by a physician who has an “X”DEA number • AND • Beneficiary must have a diagnosis of opioid dependence. • AND • Physician must have reviewed the Controlled Substances Reporting • System Database • For Subutex/Buprenorphine: • Must be unable to take suboxone due to pregnancy/CI/AE • Maximum daily dose of 24 mg/day • Length of therapy may be approved for up to 12 months • Request for renewal will require a treatment plan

  21. Synagis ___________________________________________________________________ • Each Synagis dose is individually authorized • After the initial approval, providers must submit a “next dose request” • Maximum of five doses during the RSV season can be authorized for • Chronic lung disease (CLD) and hemodynamically significant congenital • heart disease (HSCHD) for infants and children less than 24 months of • age $2807 for 1 ml IM injection

  22. Topical anti-inflammatories ___________________________________________________________________ • Criteria (for Elidel and Protopic 0.03%): • For areas other than groin or face, failed 2 generic topical • corticosteroids in highest potency class and patient is greater • than 2 years of age. • For groin and face failed 2 topical generic corticosteroids from • preferred list in any potency class and patient is greater than • 2 years of age. • OR • Patient has a documented AE/CI that precludes trial of 2 generic • topical corticosteroids from preferred list.

  23. Triptans ___________________________________________________________________ • Criteria (> 12 units/doses): • Documentation of Dx of migraine headache/cluster headache with • > 6 mod/sev headaches per month • AND • Beneficiary must have T&F NSAIDS within the last year or currently • being using NSAIDS, unless CIed • AND • Beneficiary must concurrently be using migraine preventative medication(s) • (i.e. Beta-Blockers, TCAs, Anticonvulsants) unless CIed • AND • Beneficiary must not have history, symptoms, or signs of • CVD, angina, MI, strokes, uncontrolled hypertension etc. • AND • Prescribing clinician has reviewed evidence based recommendations

  24. Victrelis ___________________________________________________________________ • Criteria:36 weeks • Beneficiary is 18 or older • AND • Beneficiary has confirmed diagnosis of HCV with genotype 1 • AND • Beneficiary has at least 4 weeks of prior therapy with ribavirin and • peginterferon • AND • Beneficiary has concurrent therapy with ribavirin and peginterferon • AND • Beneficiary has no previous HCV NS3/4A protease inhibitor treatment • for Hepatitis C

  25. Vusion ___________________________________________________________________ • Criteria:60days • Requires a trial of at least two different prescription products from • the following list within the previous 60 days: • nystatin cream, nystatin ointment, nystatin/triamcinolone cream, • nystatin/triamcinolone ointment, or clotrimazole cream. • AND • Beneficiary must be at least 4 weeks of age • AND • A quantity limit of 50 gm per 60 days prescription is in place.

  26. Xolair ___________________________________________________________________ • Criteria for initial therapy: • Must be 6 years of age and older • AND • Must have a diagnosis of asthma • AND • Must have inadequately controlled asthma • AND • A percutaneous skin test or RAST allergy test in the past twelve months • indicating reactivity to at least one perennial aeroallergen • AND • IgE level above 30 IU/mL • For continuation of therapy reductions in asthma exacerbation should be • Evidenced by current asthma status/response to Xolair/smoking status $862 for a SC injection

  27. Diabetic Supplies ___________________________________________________________________ • Roche is NC Medicaid’s preferred Diabetic supplier • Meters: Accu-Chek Aviva/Compact/Nano • Test Strips: Accu-Chek Aviva/Smart/Compact • Lancets: Accu-ChekMulticlix/Softclix/Fastclix • Lancing Devices: Accu-ChekMulticlix/Softclix/Fastclix • Diabetic supplies are covered under the Outpatient pharmacy program and can be submitted under the pharmacy POS system • With a valid Rx. They can also be submitted under DME • using the NDC and HCPCS code.

  28. Quantity limitations ___________________________________________________________________ Cetirizine-D/Loratadine-D OTC limited to 102 days supply for 12 months Solodyn ER is limited to 12 weeks supply Chantix - 6 month supply per 12 months Triptansare limited to 12 units (doses). This includes oral tablets, Nasal sprays and injections. Additional quantity requires PA.

  29. Exemptions from PA ___________________________________________________________________ PPIs for patients < 12 years old are exempt Renvela powder pack for patients < 12 years old are exempt QVAR does not require PA Children up to 5 years old may use Flovent without PA TCN antibiotics – Non-preferred TCNs required failure of Doxy and Mino. Solodyn ER is limited to 12 weeks supply. Oral Doxy liquid is exempt for patients < 12 Accuneb/generic Accunebfor patients < 2 years old are exempt Patients < 4 years old are exempt from PA for steroids (nasal sprays) Serostim used for AIDS wasting syndrome is exempt Clarinex syrup in patients < 2 years old are exempt

  30. Exemptions from PA contd… ___________________________________________________________________ Lovaza is exempt if triglycerides are > 500 mg/dL (must be Documented) All Anticonvulsants(1st and 2nd gen. anticonvulsants) are exempt if documented diagnosis of seizures Pantoprazole is exempt if used concomitantly with Plavix Celebrex is exempt for recipient age > 60 Oral Doxy liquid is exempt for patients < 12 Narcotic Analgesics for patients with diagnosis of pain secondary to cancer is exempt

  31. Useful facts contd… ___________________________________________________________________ Pro-Air HFA is now the preferred SABA inhaler (previously was Ventolin HFA) ARB/combn requires trial and failure of ACEiOR CI/AE when using preferred product DRI/combnrequires trial and failure of ACEiOR CI/AE when using preferred product Amylin analogs, GLP-1 receptor agonists, DPP-IV inhibitors require trial and failure of metformin containing products OR CI/AE when using preferred product Daliresp – requires failure of only one preferred agent ICD-9 diagnosis codes are not required by Medicaid. They should either be removed entirely or put in without decimals. 25000 NOT250.00

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