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18 October 2012 1. Follow-up to Previous Reviews Ciprofloxacin Synagis Growth Hormone 2.

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Presentation on theme: "18 October 2012 1. Follow-up to Previous Reviews Ciprofloxacin Synagis Growth Hormone 2."— Presentation transcript:

1 18 October

2 Follow-up to Previous Reviews Ciprofloxacin Synagis Growth Hormone 2

3 Ciprofloxacin DUR Rationale for study: Idaho Medicaid was requested to look at why ciprofloxacin was prescribed for pediatric patients less than 16 years old. Currently ciprofloxacin will pay at the pharmacy with no age limitations while levofloxacin currently requires an age override prior authorization for pediatric patients less than 16 years old. 3

4 Ciprofloxacin DUR Ciprofloxacin Package Insert: FDA approved for pediatric patients 1-17 years of age with complicated urinary tract infections and pyelonephritis due to E coli and for pediatric patients (age not specified) with inhalational anthrax. Levaquin Package Insert: FDA approved for pediatric patients (6 months of age and older) only for the prevention of inhalational anthrax (post-exposure) and for plague. 4

5 Ciprofloxacin DUR Retrospective DUR was done on patients less than 16 years of age with at least one paid claim between and N=77, mean age 10.3, std deviation 4.0 years. 5

6 Ciprofloxacin DUR Oral Antibiotic Utilization through < 16 years of age ProductDistinct Recipients Total ClaimsTotal Reimbursement to Pharmacy Average cost per claim Levofloxacin89$827.62$91.96 Ciprofloxacin*7986$2,772.86$32.24 Amoxicillin14,15915,380$194,848.07$12.67 Augmentin3,3263,620$119,378.31$32.98 Azithromycin6,6207,157$140,062.90$19.57 Bactrim1,8832,240$26,755.37$11.94 * Report ran after original run to identify 77 recipients so 2 new recipients showed up on this report 6

7 Ciprofloxacin DUR Summary DiagnosisTotal # of recipients UTI or cystitis or pyelonephritis with at least one antibiotic tried before ciprofloxacin 18 UTI or cystitis or pyelonephritis with no other antibiotic tried before ciprofloxacin 7 CF Patients4 Oncology Patients2 Asthma/Respiratory Distress11 Pneumonia/URI/bronchitis6 Other16 No Diagnosis Listed13 7

8 Ciprofloxacin DUR Other n=16, mean age (standard deviation) 9.9 yrs (4.0), min=3, max=15 9 had prior antibiotics (Bactrim x 3, amox x 2, Augmentin x 1, cephalexin x 1, minocycline x 1, Bactrim/Augmentin x 1) 13 had one fill of ciprofloxacin only; two had two fills and one had 5 fills (s/p liver transplant) 8

9 Ciprofloxacin DUR American Academy of Pediatrics: The Use of Systemic and Topical Fluoroquinolones. John S. Bradley, Mary Anne Jackson and the Committee on Infectious Diseases. Pediatrics 2011;128;e1034-e1045. Quotes from the article: Use of fluoroquinolones in children should continue to be limited to treatment of infections for which no safe and effective alternative exists. Animal toxicology data available with the first quinolones compounds documented their propensity to create inflammation and subsequent destruction of weight-bearing joints in juvenile animals. No published reports exist of physician-diagnosed cartilage damage in children in the United States, either from controlled clinical trials of fluoroquinolones or from unsolicited reporting to the FDA or drug manufacturers. No reports of tendon rupture in pediatric patients exposed to any quinolone. 9

10 Ciprofloxacin DUR World Health Organization: What is the evidence of safety of quinolones use in children? International Child Health Review Collaboration. September 2, Summary Statement: Fluoroquinolones are efficacious antimicrobial agents with an important role in the treatment of a variety of pediatric infections. Ciprofloxacin is a particularly useful fluoroquinolone for dysentery and typhoid. There is grade A evidence to support both the overall safety of ciprofloxacin use in children and lack of joint toxicity. 10

11 Ciprofloxacin DUR Recommendations for prior authorization for age override for pediatric patients receiving ciprofloxacin and levofloxacin? Add age criteria to cipro and/or remove age criteria from levofloxacin? 11

12 Synagis DUR Medical claims for season: $274, Pharmacy claims for season: $1,362, Grand Total for season: $1,637,

13 Synagis DUR – Medical Claims Data from through (RSV Season) 40 patients identified – ALL had prior authorization approvals. PA Request Marked as: Billing using CPT Code:11 Pharmacy billing for drug:7 Nothing specific marked on form:22 Future Question: Should we inform Idaho medical unit of all prior authorizations for Synagis as the doctors’ offices are not doing a good job of informing Medicaid if claim will be paid as a medical claim or as a pharmacy claim? 13

14 Synagis DUR – Medical Claims Data from through (RSV Season) Potential billing errors and dosing inconsistencies were discussed at the August 2012 DUR meeting. The DUR Board recommended asking for administration records to verify what had actually been given. 14

15 Synagis DUR – Medical Claims Data from through (RSV Season) Patient #30 – Billing Error Four doses were paid as pharmacy claims with an additional dose in January 2012 paid as a medical claim. The medical office was contacted via letter and documentation was sent that the patient received four doses with the drug being supplied by a pharmacy. The January dose was billed incorrectly by the doctor’s office for both an administration fee as well as the drug fee when the drug had been provided by a pharmacy and not purchased by the doctor’s office. The doctor’s office has been asked to reverse the drug fee ($ ). 15

16 Synagis DUR – Medical Claims Data from through (RSV Season) Patient #38 – Billing Error Approved for up to 2 doses between 3/30/12 and 4/30/12. Doses were billed on 4/5/12 (which is fine) but also on 6/1/12 which is after the approval date as well as after the RSV season had ended. After being contacted by the Pharmacy Unit, the medical facility has stated that Synagis was not administered on 6/1/2012. The medical facility has been asked to reverse the 6/1/12 claim ($ ). 16

17 Synagis DUR – Medical Claims Data from through (RSV Season) Patient #12 – Dose Inconsistency Paid for 150mg dose on 1/3/12 but for a lower 100mg dose on 1/30/12. Received administration records – using current weight at time of dosing, 1/3/12 dose was 109mg and 1/30/12 dose was 116mg so Idaho Medicaid was actually undercharged for the 1/30/12 dose. Patient has other primary insurance so Idaho Medicaid is secondary payor and is paying only part of the cost of the drug. 17

18 Synagis DUR – Medical Claims Data from through (RSV Season) Patient #10 – Dose Inconsistency Paid for 150mg for doses #1,2,3,5 but 200mg for dose #4 Based on current weight, doses were calculated correctly to be: 1– 145mg, 2– 145mg, 3– 150mg, 4– 154mg, 5 – 150mg Baby lost a little weight between dose 4 and 5 (but could have rounded dose #4 down to 150mg to avoid paying an extra $ for 4mg more, dose would have been 14.6mg/kg rather than 15mg/kg). 18

19 Synagis DUR – Medical Claims Data from through (RSV Season) As of , still waiting to hear back on four additional letters requesting administration records. Prescribers have been contacted by telephone, reminding them of request for additional information. 19

20 Synagis - July 2012 AAP Red Book Updates for Synagis Prophylaxis Gestational Age 32 weeks, 0 days through 34 weeks, 6 days AND chronological age less than 90 days Synagis prophylaxis (maximum of 3 monthly doses) may be considered for infants who have at least 1 of 2 risk factors: 1. Infant attends child care, defined as home or facility where care is provided for any number of infants or young toddlers. 2. One or more older siblings younger than 5 years of age or other children younger than 5 years of age lives permanently in the same household. Multiple births younger than 1 year of age do not qualify as fulfilling this risk factor. 20

21 Synagis - July 2012 AAP Red Book Updates for Synagis Prophylaxis Infants with congenital abnormalities of the airway or neuromuscular disease Immunoprophylaxis may be considered for infants who have either congenital abnormalities of the airway or a neuromuscular condition that compromises handling of respiratory secretions. Infants and young children in this category should receive a maximum of 5 doses of palivizumab during the first year of life. 21

22 Growth Hormone DUR Idaho Medicaid’s Pharmacy & Therapeutics (P&T) Committee requested that the DUR Board look at the utilization numbers of the Growth Hormone class. The potential exists to save the State money should patients be switched from a non-preferred to a preferred agent. Previously patients have been grandfathered to allow them to remain on their current therapy. 22

23 Growth Hormone DUR Drug Utilization HIC3 = P1A (Growth Hormones) 7/1/2012 – 9/30/2012 ProductUnique RecipientsTotal claims Genotropin1230 Humatrope37 Norditropin Flexpro*2454 Nutropin AQ*35 Nutropin AQ Nuspin*1022 Saizen11 Summary of All53119 * Currently preferred agents 23

24 Growth Hormone DUR Comments/Suggestions ??? 24

25 Current Interventions/Outcomes Studies P&T Committee Narcotic Analgesic Studies Psychotropic Medications in Foster Children Update (Washington DC Conference) Two (2) or more concomitant antidepressants Zometa Leukotrienes vs. inhaled corticosteroids in children with asthma Migraine Prevention Topiramate PA, Medical Claim Mismatch Immune Globulin (IV and SC) 25

26 P&T Committee Narcotic Analgesic Studies 26

27 27

28 Idaho Current Management -1 Daily and monthly quantity limits Use of preferred agents Long-acting Documented failure of at least a 30 day trial of a preferred agent within previous 6 months Fentanyl transdermal Inability to swallow capsules or pills Allergy to morphine and/or methadone Failure of a preferred agent 28

29 Idaho Current Management -2 Short Acting Non-preferred only after documented failure of 3 preferred agents with at least a 7 day trial of each in the past 180 days (stated, but not operational) Fentanyl buccal/sublingual/transmucosal Breakthrough cancer pain in patients already receiving, and tolerant to opioid therapy 29

30 Idaho In Process Changes-1 Fentanyl transdermal – additional requirements Manual review Dose equivalent to preferred agent tried or documentation for increase or decrease Good documentation for use over oral therapy Oxycodone – additional requirements Dose equivalent or less than preferred agent tried or documentation for increase or decrease Good documentation for use over other available narcotic analgesics 30

31 Idaho In Process Changes- 2 Butrans Manual review No history of opioid abuse or addiction ICD-9 diagnosis of moderate or severe chronic pain History of long-acting opioid within last 60 days at a dose less than 30 morphine equivalents Inability to take oral medications 31

32 Other State Dispensing Restrictions: Limits on Number of Prescriptions StateLimit New YorkTotal of 4 opioid prescriptions every 30 days FloridaFour controlled substance prescriptions per month Georgia6 prescriptions/month (will go down to 5) Oklahoma13 prescriptions of hydrocodone per 12 months. To override need a PA and Pain Contract (in general OK has a 6 total, 2 brand per month limit on all drugs) 32

33 Other State Dispensing Restrictions: Therapeutic Duplication StateLong-ActingShort-Acting Arkansas (allows 1 long acting and 1 short acting from same provider) Reject if > 25% remains.Reject if > 25% remains. Includes injectables and nasal. Alaska1 long acting within a 19 day look back period 1 short acting plus 1 combo within 19 day look back period Oklahoma1 long actingHard stop if received a prior prescription for a different strength of hydrocodone and new claim is within previous claim’s active period Most programs exclude cancer, hospice and long-term care from these restrictions 33

34 Other State Management Strategies Montana: Case management program Oregon : Commissioned evidence-based review on treatment of low back pain Alaska: Implementing a second opinion reviewer for high dose/duplicate opioid therapy requests 34

35 Washington State Legislation “too many patients getting drugs at dosages that were too high for too long” Engrossed Substitute House Bill 2876 In effect July 1, 2011 for all except physicians and physician assistants – January 2, 2012 Directs 5 boards and commissions to adopt rules concerning management of chronic non-cancer pain 35

36 Practitioners Included Physicians Physician Assistants Osteopathic Physicians Osteopathic Physician Assistants Advanced Registered Nurse Practitioners Dentists Podiatric Physicians 36

37 Key Points Elements for a patient evaluation A Dosing Threshold trigger for consultation with a pain specialist Criteria to be considered a pain specialist Periodic review of a patient’s course of treatment Guidance for episodic care practitioners Consultation exemptions for special circumstances and for the practitioner Continuing education requirements 37

38 Example of Adopted Rules – Department of Health-Medical Quality Assurance Commission 1. Patient evaluation – lists what should be in the initial evaluation 2. Treatment Plan Written Objectives to determine treatment success Other treatment modalities or rehabilitation program 3. Prescription must include ICD-9 indication 38

39 Example of Adopted Rules – Department of Health-Medical Quality Assurance Commission 4. Informed Consent Written agreement for treatment Patient agrees to allow biological testing Protocol for lost prescriptions and early refills Spells out what constitutes violation of agreement One physician and one pharmacy (recommended) Agreement for release of agreement to local emergency departments, urgent care facilities and pharmacies 39

40 Example of Adopted Rules – Department of Health-Medical Quality Assurance Commission 5. Periodic Review At least every 6 months Annually if non-escalating daily dose of < 40 morphine equivalents Taper or discontinue No improvement in function or pain Evidence of significant adverse effects Evidence of misuse, addiction, or diversion 40

41 Example of Adopted Rules – Department of Health-Medical Quality Assurance Commission 6. Methadone prescribing requires four hours of continuing education 7. Episodic Care (urgent/emergency care) review of tracking information (PMP) minimum amount to control pain until can see primary 41

42 Example of Adopted Rules – Department of Health-Medical Quality Assurance Commission 8. Mandatory Consultation with Pain Specialist Threshold of 120 morphine equivalent dose per day Allows for consultation between primary and specialist Both primary and specialist must document consult Pain Specialist qualifications are spelled out in rule 42

43 Because Minds Matter: Collaborating to Strengthen Management of Psychotropic Medications for Children and Youth in Foster Care Washington DC August 27-28, 2012 Six team members from each state Medicaid (Dave Simnitt, Tami Eide) Child Welfare (Kathy Morris, Miren Unsworth) Mental Health (Kelly Palmer, Ken Kraft) Sponsored by Administration for Children and Families Substance abuse and Mental Health Services Administration Centers for Medicare and Medicaid Services 43

44 Purpose of Meeting Enhance cross-system efforts Showcase collaborative projects and initiatives Offer state-of-the art information Encourage strategies for addressing mental health and trauma-related needs of foster children with evidence- based and evidence-informed interventions Facilitate development and implementation of each State’s oversight plan 44

45 10/18/

46 Red Flags Five (5) or more psychotropic medications prescribed concomitantly (reviewed August 2012) Two (2) or more concomitant antidepressants (current) Two (2) or more concomitant antipsychotic medications Two(2) or more concomitant stimulant medications long-acting plus short-acting ok Three (3) or more concomitant mood stabilizer medications Psychotropic polypharmacy (2 or more agents) for a given mental disorder prescribed before utilizing psychotropic monotherapy 46

47 Implementation of Red Flags Retroactive Evaluation Identify outliers Profile Review DUR Board Intervention Targeted education Re- evaluation individuals overall Further Action Point of service edits Informational (soft) – pharmacist override Hard Stop 47

48 October

49 49

50 Antidepressants in Foster Children 50

51 Study Parameters and Results Children in Foster Care ages 0-17 Time Period 3/1/2012 through 8/31/2012 Two or more antidepressants 75 children met criteria 66 had two concurrent 6 had three concurrent 2 had same drug with different strengths only 1 had two with only a one week overlap Trazodone was the second drug in 63 children 51

52 Number of Participants by Age and Sex Meeting Threshold 52

53 53

54 Antidepressants in Foster Children Using Two or More Concurrently 54

55 Zometa DUR Zometa (zoledronic acid) injection is a bisphosphonate that is FDA approved for: 1. Hypercalcemia of malignancy 2. Patients with multiple myeloma and patients with documented bone metastases from solid tumors in conjunction with standard antineoplastic therapy. Dosage is 4mg as an intravenous infusion over no less than 15 minutes. May repeat after a minimum of 7 days for hypercalcemia of malignancy or every 3-4 weeks for patients with multiple myeloma or bone metastases from solid tumors. 55

56 Zometa DUR Medical claims (J3487) were reviewed from 8/01/2011 through 7/31/2012 to determine if the Pharmacy Unit should prior authorize this medication requiring therapeutic criteria to be met. Number of claims:169 Number of patients:50 Cost per dose when Medicaid is the sole payer: $ Total annual expenditure: $107,266 56

57 Zometa DUR Zometa is anticipated to go generic in March Eight pharmaceutical companies are planning on making generic zoledronic acid. Price is expected to drop significantly. 57

58 Zometa DUR 58

59 Zometa DUR Summary All patients had an FDA approved diagnosis for Zometa in their electronic profile. All patients with repeat doses had appropriate intervals between doses. All charges were for a 4mg dose. Recommendation: Prior authorization with therapeutic criteria is NOT needed at this time. 59

60 Asthma DUR More than 25.7 million Americans are affected by the disease; 7 million under the age of 18 Economic impact: $20.7 billion annually Mortality: almost 4,000 deaths per year 456,000 hospitalizations, 1.75 million ER visits annually 10.5 million missed school days each year 60

61 61

62 Asthma DUR Diagnosis and Management of Asthma Accurate Diagnosis Medical History Physical Exam – spirometry in all ≥ 5 years of age Rule out all other causes Goal is Control Reduce Impairment Maintain close to normal lung function and activity levels Reduce Risk Prevent exacerbations 62

63 Asthma DUR Four Components of Asthma Care 1. Assessment and Monitoring 2. Education for a Partnership in Care 3. Control Environmental Factors and Other Conditions 4. Medications 63

64 Asthma DUR Medications Stepwise Approach (both up and down) Consideration must be given to both impairment and risks General Principles for All Ages Use of all four components of asthma care for each step Initiate therapy based on severity Monitor and adjust treatment based on asthma control (step up if needed and down if possible when asthma controlled for 3 months) 64

65 Asthma DUR 2007 Asthma Treatment Guidelines Achieving and maintaining control When stepping up treatment, combination therapy is often recommended Intermittent Asthma (Step 1) Short Acting Beta Agonists (SABAs) Persistent Asthma (Steps 2-6) Inhaled Corticosteroids are the preferred treatment across all age groups 65

66 Asthma DUR Leukotriene modifiers (LTRAs) Alternative, but not preferred, therapy for patients who require Step 2 (mild, persistent asthma) care. Can be used as adjunctive therapy with ICSs, but for patients > 12 years not preferred adjunctive therapy as compared to addition of LABAs. LTRAs can attenuate Exercise Induced Bronchospasm (EIB) 66

67 Asthma DUR References Retrieved October 3, Retrieved October 3,

68 Leukotrienes vs. inhaled corticosteroids in children with asthma Number of recipients < 18 years of age with paid claim for leukotriene (HIC3=Z4B): Z4B = Leukotriene Receptor Antagonists Date# of recipients 7/1/2011 – 9/30/20113,232 1/1/2012 – 3/31/20123,000 7/1/2012 – 9/30/20123,253 68

69 Leukotrienes vs. inhaled corticosteroids in children with asthma Number of recipients < 18 years of age with paid claim for inhaled corticosteroid (HIC3=B6M & J5G): B6M = orally inhaled glucocorticoids (individual) J5G = beta adrenergic and glucocorticoid combinations Date# of recipients 7/1/2011 – 9/30/20111,875 1/1/2012 – 3/31/20122,143 7/1/2012 – 9/30/20122,012 69

70 Leukotrienes vs. inhaled corticosteroids in children with asthma 70

71 Leukotrienes vs. inhaled corticosteroids in children with asthma 71 Total number of recipients less than 18 years of age that had a prescription of any medication filled between 7/1/2012 and 9/30/2012 that had an Asthma diagnosis on their profile: 8,582

72 Leukotrienes vs. inhaled corticosteroids in children with asthma 72

73 Leukotrienes vs. inhaled corticosteroids in children with asthma 73

74 Leukotrienes vs. inhaled corticosteroids in children with asthma 74

75 Leukotrienes vs. inhaled corticosteroids in children with asthma 75

76 Leukotrienes vs. inhaled corticosteroids in children with asthma Next Steps ??? 76

77 Migraine Prevention Topiramate use other than Seizure Disorder/Migraine Headache Evaluate the use of topiramate for non-FDA labeled indications. Off label use for weight loss Off label use as a mood stabilizer for Bipolar symptoms All patients on topiramate were evaluated from 1/1/2012 thru 6/30/ ,222 patients on topiramate 970 patients with approved criteria (ICD-9 code in Medical Profile) of Seizure Disorder/Migraine Headache 252 (20.62%) of patients without approved criteria 77

78 Migraine Prevention Topiramate use other than Seizure Disorder/Migraine Headache 78

79 Migraine Prevention 79

80 Migraine Prevention FDA approved indications for topiramate Monotherapy or adjunctive therapy for partial onset seizures Monotherapy or adjunctive therapy for primary generalized tonic-clonic seizures Adjunctive treatment of seizures associated with Lennox- Gastaut syndrome Prophylaxis of migraine headache 80

81 Migraine Prevention Off-label & Investigational uses for topiramate bipolar disorder ** weight loss and obesity ** alcohol dependence * binge eating disorder cocaine dependence bulimia nervosa cluster headaches chronic daily headache infantile spasms 81

82 Migraine Prevention Off-label & Investigational uses for topiramate smoking cessation post-traumatic stress disorder ** neuropathic pain sleep-related eating disorder (SRED) and nocturnal eating syndrome (NES) scar therapy migraine prevention in children pathologic gambling painful diabetic neuropathy 82

83 Immune Globulin (IV and SC) Currently prior authorization is not needed for either an outpatient prescription (as long as cost per claim is less than $7500) or for a claim on the medical side. Also checked for paid claims for Immune Globulin Intramuscular between 8/1/2011 – 7/31/2012 Only one paid claim on the medical side. No paid pharmacy claims. Therefore, did not include this route of administration in this DUR project. 83

84 Immune Globulin (IV and SC) FDA Approved Indications for Immune Globulin (intravenous and subcutaneous): Primary immunodeficiency disorders Kawasaki disease, for prevention of coronary aneurysms Immune-medicated thrombocytopenia, to increase platelet count Pediatric human immunodeficiency virus infection, for replacement therapy Secondary immunodeficiency in B-cell chronic lymphocytic leukemia Bone marrow transplantation Chronic inflammatory demyelinating polyneuropathy (CIDP) Multifocal motor neuropathy Note: not all IVIG/SCIG products are approved by the FDA for all indications 84

85 Immune Globulin (IV and SC) Medical Claims Medical Claims between 8/1/2011 – 7/31/2012 for IVIG and SCIG J1459Privigen J1557 Gammaplex J1559Hizentra J1561Gamunex J1566Immune Globulin Intravenous, not otherwise specified J1568Octagam, intravenous J1569Gammagard Liquid Bolded J-codes had paid claims during the study timeframe. 85

86 Immune Globulin (IV and SC) Medical Claims Claims paid on medical side between 8/01/2011 and 7/31/2012 $288, claims 24 patients Average cost per prescription: $

87 Immune Globulin (IV and SC) Medical Claims 24 letters sent out between August , 2012 to the medical facilities that had paid claims for IVIG or SCIG requesting administration records and progress notes. By 9/21/2012, 10 responses. On 9/25/2012, an Idaho Medicaid pharmacy technician called the medical facilities that had not responded yet. As of 10/11/2012, there were 3 additional responses for a total response rate of 54% (13/24). 87

88 Immune Globulin (IV and SC) Medical Claims 88

89 Immune Globulin (IV and SC) Medical Claims Patient A 33 year old male Diagnosis listed as hypogammaglobulinemia Baseline IgG level 557mg/dl IVIG ordered as 400mg/kg IV every six weeks One dose given on 1/23/12 with follow-up IgG level ordered. No further doses of IVIG have been paid for by Idaho Medicaid. Question – did patient really have hypogammaglobulinemia? Do not have follow-up IgG level. 89

90 Immune Globulin (IV and SC) Medical Claims Patient B 52 year old male No diagnosis listed on administration records. In electronic profile, has diagnosis of optic neuritis listed from June Five doses IVIG paid for between 6/11/12 – 6/15/12 ($8638). Infusion Clinic has no record of these doses being administered. Two doses given 7/9/12 and 7/10/12. Administration records sent confirming that these two doses were given. 90

91 Immune Globulin (IV and SC) Medical Claims Patient C 14 year old male Single dose given 1/27/12. No diagnosis listed on administration record. In electronic profile – common variable immunodeficiency and selective IgA immunodeficiency. Question – only one dose IVIG needed ? 91

92 Immune Globulin (IV and SC) Medical Claims Patient D 10 year old male No diagnosis on administration records, but ITP listed in electronic profile. Received 60gm (given as two 30gm doses) – billed incorrectly as two 60gm doses. Patient E 15 year old male No diagnosis on administration records but hypogammaglobulemia listed in electronic profile. Receiving IVIG approximately monthly. No baseline or follow-up IgG levels were provided in medical records. Patient’s weight was not provided to calculate mg/kg dosage. 92

93 Immune Globulin (IV and SC) Medical Claims Patient F 28 year old female CIDP – chronic inflammatory demyelinating polyneuropathy Receiving IVIG 400mg/kg for three consecutive days every 3 weeks ($69,054 annually) Patient states that she “feels better” on IVIG. IVIG is considered first line therapy for this diagnosis. Unfortunately, no specific criteria for when to continue or discontinue therapy. 93

94 Immune Globulin (IV and SC) Medical Claims Patient G 35 year old male Single 554mg/kg dose given on 2/17/12. Hypogammaglobulemia listed in electronic profile. No documentation provided why this single dose was ordered. No IgG levels listed in medical records that were sent. 94

95 Immune Globulin (IV and SC) Medical Claims Patient H 54 year old male Diagnosis – immunodeficiency. Primary insurance is Medicare. Has been on IVIG therapy since 1995 per medical records. Therapy plan is to receive IVIG dose when IgG level falls <600mg/dl. However, dose given early (chart note stated “patient doesn’t really need it”) as patient spends the winter in Arizona and requested a dose prior to leaving Idaho. No doses paid for by Idaho Medicaid over the winter. 95

96 Immune Globulin (IV and SC) Medical Claims Patient I 52 year old female with CIDP Received 400mg/kg/day x 5 days in May 2012 ($14,611) with plan being to receive 1000mg/kg monthly after that time but patient has not received any more IVIG. Administration records sent but no follow-up notes describing how patient is doing. Patient J 7 year old female ITP with mucosal bleeding, received IVIG 1000mg/kg x single dose. Platelet count improved from 6000 to 16,000 and bleeding resolved. 96

97 Immune Globulin (IV and SC) Medical Claims Patient K 55 year old male CIDP Received two IVIG doses (9/22/11, 10/27/11) Administration records received but no progress notes on how patient responded to therapy and why therapy was not continued. 97

98 Immune Globulin (IV and SC) Medical Claims Patient L 42 year old male Agammaglobulinemia Received doses 1/5/12, 2/29/12, 5/12/12 Administration records sent but no progress notes describing therapy plan or IgG levels. 98

99 Immune Globulin (IV and SC) Medical Claims Patient M 24 year old female pregnant patient Neonatal alloimmune thrombocytopenia IVIG 2000mg/kg weekly ($154,784) from week 19 to Week 37 of pregnancy (10/06/11 – 2/08/12) 54% of total medical claim charges Third pregnancy – history of neonatal thrombocytopenia with second baby. Recurrence rate with subsequent pregnancies is over 80%. 99

100 Immune Globulin (IV and SC) Medical Claims Patient M, continued The thrombocytopenia in the baby is often mild and may be asymptomatic, but potential exists for serious complications including intracranial hemorrhage which leads to fetal death in 10% and neurologic sequelae in 20% of cases. Usual dosage is 1000mg/kg weekly. Per progress notes submitted, plan of therapy was to give 2000mg/kg every two weeks but what was given was 2000mg/kg every one week. No information provided on baby (due date February 2012). 100

101 Immune Globulin (IV and SC) Pharmacy Claims Reviewing outpatient prescription claims between 8/01/2011 and 7/31/2012 $279, claims 14 patients Average cost per prescription: $

102 Immune Globulin (IV and SC) Pharmacy Claims Sent letters to the prescribers of the seven patients still receiving IVIG/SCIG requesting chart notes and serum IgG levels. After four weeks, had received replies from three prescribers. An Idaho Medicaid pharmacy technician called the four remaining prescribers reminding them of the request for information. As of 10/11/12, one additional prescriber sent in the requested information. Total response rate: 57% (4/7) 102

103 Immune Globulin (IV and SC) Pharmacy Claims Patient #1 Diagnosis: CVID (chronic variable immunodeficiency) Receiving SCIV 20 gm weekly (weight not listed in chart notes so cannot calculate mg/kg dose). Very adherent to therapy. Still having multiple infections per chart notes. Has been on IVIG/SCIG therapy since No comparison made between rate of infections before and after IVIG/SCIG therapy began. Trough IgG level (2/06/2012) = 1108mg/dl Annual cost of therapy: $129,794 (67% of pharmacy claims for this drug class) 103

104 Immune Globulin (IV and SC) Pharmacy Claims Patient #2 Diagnosis: hypogammaglobulinemia not otherwise specified IVIG 55gm every 4 weeks (469mg/kg) Documentation provided that the number of infections has decreased since on IVIG monthly. Trough IgG level (3/09/2012) 878mg/dl; next trough level scheduled to be drawn in October 2012 (follow-up prescriber visits with labs every 6 months). Annual cost of therapy: $77,

105 Immune Globulin (IV and SC) Pharmacy Claims Patient #4 Diagnosis: CIDP Chart note from 7/17/12 stated: “Pt has IVIG infusion scheduled for tomorrow but says she no longer feels this is beneficial and is considering taking a break from this Tx.” Subsequent phone call from pharmacy stating that patient decided to continue with the therapy. Has had multiple infusion reactions from IVIG and dose has been adjusted (both downward and upward) multiple times. Most recent dose is 60gm every 3 week Annual cost of therapy: $67,

106 Immune Globulin (IV and SC) Pharmacy Claims Patient #11 Diagnosis: CIDP Receiving 1000mg/kg IVIG monthly Problem: patient has very uncontrolled diabetes and has gained more than 100 pounds in the last year so dose keeps escalating higher. Chart notes state that he has had significant improvement of his neuropathy with IVIG monthly. Annual cost of therapy: $102,243 (21% of pharmacy claims for this drug class) 106

107 Immune Globulin (IV and SC) What weight to use? Actual body weight Ideal body weight Adjusted body weight Rounding Dosages In reviewing dosages, there is potential for cost savings by rounding dosages to match single vial sizes. For example, no clinical difference between giving 120gm rather than 125gm. Pharmacies tend to automatically round dosages up. 107

108 Immune Globulin (IV and SC) Total cost of therapy from 8/01/2011 – 7/31/2012: $567,937 Total number of patients: 37 (one patient had both medical and pharmacy claims) Number of patients receiving single dose of IVIG:

109 Immune Globulin (IV and SC) Recommendation Require prior authorization for this expensive therapy. It is reasonable to check for an FDA approved diagnosis and to verify clinical benefit as well as monitoring periodic IgG levels (if applicable to diagnosis, such as hypogammaglobulinemia). Initial approval would be for 3-6 months with additional documentation required after that time period to renew the authorization. 109

110 Proposed Studies for Next Quarter: P&T Committee Narcotic Analgesic Studies – Next Steps Use of Psychotropic Medications in Foster Children – Next Steps Migraine Prevention Prophylaxis Utilization in Chronic Triptan Utilizers Multiple Strengths of Atypicals Antipsychotic Indication Evaluation- Hold for Future AAP and DVTs- Hold for future 110

111 P&T Committee Narcotic Analgesic Studies – Next Steps 111

112 Use of Psychotropic Medications in Foster Children The U.S. Government Accountability Office released the results from a study that they performed examining the rates of psychotropic medications for foster and nonfoster children in It was determined that HHS Guidance Could Help States Improve Oversight of Psychotropic Prescriptions. 112

113 Use of Psychotropic Medications in Foster Children Medication Classes included in the report ADHD drugs Anti-anxiety Anticonvulsant Antidepressants Anti-enuretic (just desmopressin acetate) Antiparkinson Antipsychotics Combination anti-anxiety and antidepressant Hypnotic Mood stabilizer (just lithium) Sleep aid (just melatonin) 113

114 Use of Psychotropic Medications in Foster Children: Next Steps Two (2) or more concomitant antipsychotic medications 114

115 Migraine Prevention Prophylaxis Utilization in Chronic Triptan Utilizers See packet for summary handout 115

116 Multiple Strengths of Atypicals 116

117 Antipsychotic Indication Evaluation- Hold for Future 117

118 AAP and DVTs- Hold for future 118

119 2011 Annual DUR Report State name abbreviation: ID Medicaid Agency Information Tami Eide, Pharm.D., BCPS Magellan Medicaid Administration Prospective DUR Comes from First Data Bank DUR criteria approved by DUR Board Currently reviewing criteria How do pharmacists handle ProDur messages? Early Refills (Prior Authorizations) Non-controlled as well as Controlled 119

120 2011 Annual DUR Report Prospective DUR, continued Therapeutic Duplications (Prior Authorizations) Prospective criteria reviewed by the Board (Table 1) Prospective DUR Review Summary (Attachment 1) Prospective DUR Pharmacy Compliance Report (Attachment 2) Retrospective DUR Magellan Medicaid Administration Retrospective DUR Board Approved Criteria (Attachment 3) 120

121 2011 Annual DUR Report Physician Administered Drugs Deficit Reduction Act requires collection of NDC numbers for covered outpatient physician administered drugs. Has MMIS been designed to incorporate this data into DUR for both Prospective and Retrospective DUR? DUR Board Activity Summary Report of activities/meetings (Attachment 4) DUR Board Involvement Disease Management Program Medication Therapy Management 121

122 2011 Annual DUR Report Generic Policy and Authorization Data Generic Drug Substitution Policies (Attachment 5) Generic Utilization Percentage:74% Generic Expenditure Percentage:18% Program Evaluation/Cost Savings Cost Savings Estimate (Attachment 6) Prospective DUR$5,283,320 Retrospective DUR$1,025,067 Total Savings$6,308,

123 2011 Annual DUR Report Cost Savings from DUR Projects: $815,633 October 1, 2010 through September 30, 2011 October 2010: $216,834 Type 2 diabetes management – underutilizing metformin Cost savings if use metformin rather than more expensive hypoglycemic agent Estimate based on 50 patients using metformin rather than incretin enhancer Annual savings: $129,960 Suboxone/Subutex – requiring diagnosis of opioid abuse/dependency (not covering for pain) Cost avoidance (based on 6 less patients per year): $36,114 Suboxone/Subutex – not paying for concomitant opioid therapy while on Suboxone/Subutex Cost avoidance (based on 124 patients receiving concomitant opioids): $44,640 Multiple long acting opioids Cost avoidance (based on 17 patients receiving one less LAO monthly): $

124 2011 Annual DUR Report January 2011: $384,165 Overuse of short acting albuterol inhaler Annual cost avoidance (of two extra albuterol inhalers/year x 102 patients): $12,125 Inappropriate use of LABA/Steroid MDI Annual cost avoidance (of monthly inhalers for 15 patients): $86,810 Fentanyl patches – administered every 72 hours rather than every 48 hours Annual cost savings (10 patches rather than 15 patches monthly x 44 patients): $25,872 Ondansetron utilization review – compare utilization with other states that do not have therapeutic criteria Estimated increase in cost if double utilization (conservative estimate) 1085 average monthly claims x $19.92 average monthly claim x 12 months/year $259,

125 2011 Annual DUR Report April 2011: $115,663 Limit quetiapine doses < 50mg/day to initial dose titration (not cover for insomnia) Annual cost avoidance: $106,118 PPIs – hard edit for two concomitant PPIs Annual cost avoidance (of one PPI monthly for 22 patients): $5000 PPIs – education on using for as short of a time interval as possible Annual cost avoidance (of one PPI monthly for 20 patients): $

126 2011 Annual DUR Report July 2011: $98,971 Colcrys prior authorization criteria (did not have criteria for generic colchicine) Annual cost avoidance: $98,663 Ketorolac – quantity allowed decreased from 10 tablets daily to 4 tablets daily 9 patients in 6 months who had received too many tablets Annual cost avoidance: $308 (18 fewer prescriptions/year) Tramadol with SSRI/SNRI (possible serotonin syndrome) No real cost savings as potential for switching from tramadol to non-interacting analgesic agent instead (e.g. hydrocodone/acetaminophen) 126

127 2011 Annual DUR Report Fraud, Waste, and Abuse Detection Does the State have ways to identify fraud or abuse of controlled drugs by recipients, prescribers, and/or providers? Prescription Drug Monitoring Program (Attachment 7) Innovative Practices E-Prescribing Executive Summary 127

128 2011 Annual DUR Report See Packet for Annual Report Summary Handout 128

129 Prospective DUR Report History Errors: DD – drug-to-drug PG – drug to pregnancy TD – therapeutic duplication ER – early refill MC – drug-to-disease Non-History Errors: PA – drug-to-age HD – high dose LD – low dose SX – drug-to-gender 129

130 Prospective DUR Report Idaho Medicaid Program ProDUR Message Report September-12 ProDUR Message SeverityCountAmount Drug To Drug11,982$508, ,721$2,366, ,858$10,803, $10.00 Drug To Gender1142$25, $3, Drug To Known Disease160,144$7,566, ,138$37,167, ,367$45,042, Drug To Pregnancy178$ $ A11$63.92 B90$12, C215$14, D30$3, X71$1, Duplicate Therapy0109,074$22,436, Min Max029,581$4,187, Too Soon Clinical020,666$3,380, ALL 810,250$133,521, Total Number of Claims with Messages 201,368 Average ProDUR Message Per Claim

131 DUR Fall Newsletter Copy of Summer Newsletter in packet Brainstorm for new topics 131

132 Medicaid Update 132


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