18 October 2012
1
Follow-up to Previous Reviews
 Ciprofloxacin
 Synagis
 Growth Hormone
2
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
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
Ciprofloxacin DUR
 Retrospective DUR was done on patients less than 16
years of age with at least one paid claim between 2-1-12
and 4-30-12.
 N=77, mean age 10.3, std deviation 4.0 years.
5
Ciprofloxacin DUR
Oral Antibiotic Utilization 2-1-2012 through 4-30-2012 < 16 years of age
Product
Distinct
Recipients
Total Claims
Total Reimbursement
to Pharmacy
Average cost per claim
8
9
$827.62
$91.96
79
86
$2,772.86
$32.24
Amoxicillin
14,159
15,380
$194,848.07
$12.67
Augmentin
3,326
3,620
$119,378.31
$32.98
Azithromycin
6,620
7,157
$140,062.90
$19.57
Bactrim
1,883
2,240
$26,755.37
$11.94
Levofloxacin
Ciprofloxacin*
* Report ran after original run to identify 77 recipients so 2 new recipients showed up on this report
6
Ciprofloxacin DUR
Summary
Diagnosis
Total # 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 Patients
4
Oncology Patients
2
Asthma/Respiratory Distress
11
Pneumonia/URI/bronchitis
6
Other
16
No Diagnosis Listed
13
7
Ciprofloxacin DUR
Other
1 each - foot wound
infection, s/p liver
transplant, s/p kidney
transplant, peritoneal
abscess, skin infection,
appendicitis
1
cellulitis/skin
infection
2
abdominal pain
3
otitis media
# of recipients
4
pharyngitis
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)
0
8
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
Ciprofloxacin DUR
 World Health Organization: What is the evidence of
safety of quinolones use in children? International Child
Health Review Collaboration. September 2, 2008.
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
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
Synagis DUR
 Medical claims for 2011-2012 season: $274,881.27
 Pharmacy claims for 2011-2012 season: $1,362,626.70
 Grand Total for 2011-2012 season: $1,637,507.97
12
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)
 40 patients identified – ALL had prior authorization
approvals.
 PA Request Marked as:
 Billing using CPT Code:
 Pharmacy billing for drug:
 Nothing specific marked on form:
11
7
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
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 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
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 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
($1155.42).
15
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 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 ($1155.42).
16
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 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
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 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 $1155.42 for 4mg more, dose would have been
14.6mg/kg rather than 15mg/kg).
18
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)
 As of 10-11-2012, 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
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.
2.
Infant attends child care, defined as home or facility where
care is provided for any number of infants or young toddlers.
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
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
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
Growth Hormone DUR
Drug Utilization HIC3 = P1A (Growth Hormones) 7/1/2012 – 9/30/2012
Product
Unique Recipients
Total claims
Genotropin
12
30
Humatrope
3
7
Norditropin Flexpro*
24
54
Nutropin AQ*
3
5
Nutropin AQ Nuspin*
10
22
Saizen
1
1
Summary of All
53
119
* Currently preferred agents
23
Growth Hormone DUR
 Comments/Suggestions ???
24
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
P&T Committee Narcotic Analgesic
Studies
26
27
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
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
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
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
Other State Dispensing Restrictions:
Limits on Number of Prescriptions
State
Limit
New York
Total of 4 opioid prescriptions every 30 days
Florida
Four controlled substance prescriptions per month
Georgia
6 prescriptions/month (will go down to 5)
Oklahoma
13 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
Other State Dispensing Restrictions:
Therapeutic Duplication
State
Long-Acting
Short-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.
Alaska
1 long acting within a 19 day
look back period
1 short acting plus 1 combo
within 19 day look back
period
Oklahoma
1 long acting
Hard 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
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
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
Practitioners Included
 Physicians
 Physician Assistants
 Osteopathic Physicians
 Osteopathic Physician Assistants
 Advanced Registered Nurse Practitioners
 Dentists
 Podiatric Physicians
36
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
Example of Adopted Rules –
Department of Health-Medical Quality Assurance
Commission
Patient evaluation – lists what should be in the initial
evaluation
2. Treatment Plan
1.
 Written
 Objectives to determine treatment success
 Other treatment modalities or rehabilitation program
3. Prescription must include ICD-9 indication
38
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
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
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
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
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
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 evidencebased and evidence-informed interventions
 Facilitate development and implementation of each
State’s oversight plan
44
10/18/2012
45
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
Implementation of Red Flags
Retroactive
Evaluation
Identify
outliers
Profile
Review
DUR Board
Intervention
Reevaluation
Point of
service edits
• Targeted
education
• individuals
• overall
• Informational
(soft) –
pharmacist
override
• Hard Stop
Further
Action
47
October 2012
48
40%
35%
Percent of Foster and Non-Foster Children Psychotropics by
36%
Drug Class
Calendar Year 2011
Total foster =2785
Total Non-Foster = 106,024
30%
25%
23%
21%
% Foster Children
20%
% Non-foster Children
15%
13%
10%
9%
6%
5%
4%
0%
0%
ADHD Drugs
Anti-depressants
Mood Stabilizers
Atypical Antipsychotics
49
Antidepressants in Foster Children
8%
Foster Children Receiving Antidepressants
Percent by Age and Gender
7%
6%
5%
Foster
4%
Non-Foster
3%
2%
1%
0%
0-6 F
0-6 M
7-12 F
7-12 M
13-17 F
13-17 M
50
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
Number of Participants by Age and
Sex Meeting Threshold
Number of Participants by Age and Sex
8
7
6
5
4
3
2
1
0
4M 4F 5M
5F 6M 6F 7M
7F 8M 8F 9M 9F 10M 10F 11M 11F 12M 12F 13M 13F 14M 14F 15M 15F 16M 16F 17M 17F
52
53
Antidepressants in Foster Children
Using Two or More Concurrently
Two or More Concurrent Antidepressants in Foster
Children
one week overlap only
1
same drug, different strengths only
2
trazodone plus TCA plus SSRI
3
trazodone plus two SSRI
1
trazodone plus bupropion plus SSRI
2
TCA plus SNRI
1
TCA plus SSRI
1
mirtazapine plus SSRI
1
bupropion plus SSRI
6
trazodone plus mirtazapine
5
trazodone plus bupropion
3
trazodone plus SSRI
49
0
10
20
30
40
50
60
54
Zometa DUR
 Zometa (zoledronic acid) injection is a
bisphosphonate that is FDA approved for:
Hypercalcemia of malignancy
2. Patients with multiple myeloma and patients with
documented bone metastases from solid tumors in
conjunction with standard antineoplastic therapy.
1.
 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
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: $803.60
 Total annual expenditure: $107,266
56
Zometa DUR
 Zometa is anticipated to go generic in March 2013.
 Eight pharmaceutical companies are planning on
making generic zoledronic acid.
 Price is expected to drop significantly.
57
Zometa DUR
Diagnosis
Multiple
myeloma, 3
Breast cancer, 8
Secondary
malignant
neoplasm of
bone, 39
58
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
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
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
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
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
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
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
Asthma DUR
 References
 http://www.acaai.com. Retrieved October 3, 2012.
 http://www.nhlbi.nih.gov/guidelines/asthma/.
Retrieved October 3, 2012.
67
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 – 9/30/2011
3,232
1/1/2012 – 3/31/2012
3,000
7/1/2012 – 9/30/2012
3,253
68
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 – 9/30/2011
1,875
1/1/2012 – 3/31/2012
2,143
7/1/2012 – 9/30/2012
2,012
69
Leukotrienes vs. inhaled corticosteroids in
children with asthma
# of distinct recipients
3500
3000
3000
2500
2000
3253
3232
2143
1875
2012
LTRA
1500
ICS
1000
500
0
7/1/2011-9/30/2011
1/1/2012 - 3/31/2012
7/1/2012 - 9/30/2012
70
Leukotrienes vs. inhaled corticosteroids in
children with asthma
 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
71
Leukotrienes vs. inhaled corticosteroids in
children with asthma
7/1/2012 – 9/30/2012
# of distinct recipients
3500
3253
3000
LTRA Total
2561
2500
2000
1500
1000
2014
LTRA w/Asthma, Allergic
Rhinitis, or Both dx
1305
LTRA w/Asthma dx
LTRA w/Allergic Rhinitis dx
500
0
72
Leukotrienes vs. inhaled corticosteroids in
children with asthma
7/1/2012 – 9/30/2012
# of distinct recipients
2500
2000
1500
2014
LTRA w/Asthma dx
1318
LTRA w/Asthma dx no
ICS
1000
500
504
LTRA w/Asthma dx no
ICS with albuterol
MDI Rx
0
73
Leukotrienes vs. inhaled corticosteroids in
children with asthma
7/1/2012 – 9/30/2012
# of distinct recipients
2500
2000
2012
ICS Total
1718
1659
ICS w/Asthma, Allergic
Rhinitis, or Both dx
1500
ICS w/Asthma dx
1000
500
527
ICS w/Allergic Rhinitis
dx
0
74
Leukotrienes vs. inhaled corticosteroids in
children with asthma
7/1/2012 – 9/30/2012
2500
# of distinct recipients
ICS Total
2000
2012
1659
1500
ICS w/Asthma dx
1000
500
38
ICS w/Asthma dx on both
HIC3=B6M & J5G (individual
and combo product filled during
time period)
0
75
Leukotrienes vs. inhaled corticosteroids in
children with asthma
 Next Steps ???
76
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
6/30/2012.



1,222 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
Migraine Prevention
 Topiramate use other than Seizure Disorder/Migraine
Headache
Those w/o Approved Criteria
31
23
52
Obesity
Bipolar
146
Obesity & Bipolar (of
these 3 on phentermine)
no diagnosis of either
78
Migraine Prevention
Topiramate Total Claims
1,000
Total Claims
800
600
400
200
0
79
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 LennoxGastaut syndrome
 Prophylaxis of migraine headache
80
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
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
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
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
Immune Globulin (IV and SC) Medical Claims
 Medical Claims between 8/1/2011 – 7/31/2012 for IVIG
and SCIG
 J1459
 J1557
 J1559
 J1561
 J1566
 J1568
 J1569
Privigen
Gammaplex
Hizentra
Gamunex
Immune Globulin Intravenous, not otherwise specified
Octagam, intravenous
Gammagard Liquid
Bolded J-codes had paid claims during the study timeframe.
85
Immune Globulin (IV and SC) Medical Claims
 Claims paid on medical side between
8/01/2011 and 7/31/2012
 $288,410
 116 claims
 24 patients
 Average cost per prescription: $2486
86
Immune Globulin (IV and SC) Medical Claims
 24 letters sent out between August 13 - 22, 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
Immune Globulin (IV and SC) Medical Claims
Diagnoses
Administration records sent
but no diagnosis listed on
medical records
7
6
6
Hypogammaglobulinemia
5
4
Thrombocytopenia
3
3
2
1
0
CIDP
2
1
1
Neonatal alloimmune
thrombocytopenia
88
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
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 2012.
 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
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
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
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
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
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
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
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
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
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
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
Immune Globulin (IV and SC)Pharmacy Claims
 Reviewing outpatient prescription claims
between 8/01/2011 and 7/31/2012
 $279,527
 79 claims
 14 patients
 Average cost per prescription: $3538
101
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
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 2011. 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
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: $77,251
104
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: $67,779
105
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
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
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:
 14
108
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
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
P&T Committee Narcotic Analgesic
Studies – Next Steps
111
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 2008.
 It was determined that HHS Guidance Could Help
States Improve Oversight of Psychotropic
Prescriptions.
112
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
Use of Psychotropic Medications in
Foster Children: Next Steps
 Two (2) or more concomitant antipsychotic
medications
114
Migraine Prevention
 Prophylaxis Utilization in Chronic Triptan Utilizers
 See packet for summary handout
115
Multiple Strengths of Atypicals
116
Antipsychotic Indication EvaluationHold for Future
117
AAP and DVTs- Hold for future
118
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
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
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
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
Retrospective DUR
Total Savings
$5,283,320
$1,025,067
$6,308,387
122
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): $6120
123
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
$259,358
124
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): $4545
125
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
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
2011 Annual DUR Report
 See Packet for Annual Report Summary Handout
128
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
Prospective DUR Report
Idaho Medicaid Program
ProDUR Message Report
September-12
ProDUR
Message
Drug To Drug
Drug To Gender
Drug To Known Disease
Drug To Pregnancy
Duplicate Therapy
Min Max
Too Soon Clinical
ALL
ProDUR
Severity
1
2
3
9
1
2
1
2
3
1
2
A
B
C
D
X
0
0
0
Message
Count
1,982
13,721
64,858
1
142
66
60,144
231,138
278,367
78
15
11
90
215
30
71
109,074
29,581
20,666
Message
Amount
$508,240.31
$2,366,938.96
$10,803,435.09
$10.00
$25,871.47
$3,314.61
$7,566,928.90
$37,167,498.02
$45,042,030.49
$727.58
$617.84
$63.92
$12,830.64
$14,358.85
$3,238.68
$1,850.44
$22,436,109.73
$4,187,367.17
$3,380,392.35
810,250
$133,521,825.05
Total Number of Claims with Messages 201,368
Average ProDUR Message Per Claim
4.02
130
DUR Fall Newsletter
 Copy of Summer Newsletter in packet
 Brainstorm for new topics
131
Medicaid Update
132