Transcript Idaho Medicaid Drug Utilization Review Program

23 August 2012
Follow-up to Previous Reviews
 Citalopram High Dose DUR
2
Citalopram High Dose DUR
 FDA Drug Safety Communication: Abnormal heart
rhythms associated with high doses of Celexa
(citalopram hydrobromide)
 On August 24, 2011, the Food and Drug Administration
(FDA) released a Safety Announcement addressing the
high dose of citalopram and potential adverse effects it
can have on the heart. The maximum daily dose is now
recommended to be 40 mg per day when it was
previously 60 mg per day.
3
Citalopram High Dose DUR
 On March 28, 2012 the FDA sent out a revised Drug Safety
Communication with updated recommendations:
 Recognition that although citalopram use should be avoided, if possible, in patients
with certain conditions because of the risk of QT prolongation, ECG monitoring
and/or electrolyte monitoring is recommended if citalopram must be used in such
patients.
 Patients with congenital long QT syndrome are at particular risk of Torsade de
Pointes, ventricular tachycardia, and sudden death when given drugs that prolong
the QT interval. Nevertheless, the labeling recommendation for patients with
congenital long QT syndrome has been changed from “contraindicated” to “not
recommended,” because it is recognized that there may be some patients with this
condition who could benefit from a low dose of citalopram and who lack viable
alternatives.
 The maximum recommended dose of citalopram is 20 mg per day for patients over
the age of 60.
 Citalopram is recommended to be discontinued in patients who are found to have
persistent QTc measurements greater than 500 ms.
4
Citalopram High Dose DUR
 It was decided at the last DUR Board Meeting that we
would look at the numbers again once a little time had
past after the FDA Safety Announcement.
5
Citalopram High Dose DUR
40mg citalopram use in recipients 60 years and older
77
80
51
60
40
10
20
0
Distinct recipients with a paid claim 1/1/2012-3/31/2012
Same recipients with a paid claim in June 2012
Recipients with a new claim in June 2012
6
Citalopram High Dose DUR
 Next steps ???
7
Current Interventions/Outcomes
Studies
 P&T Committee Narcotic Analgesic Studies
 Aliskiren DUR
 Lupron DUR
 Ciprofloxacin DUR
 Synagis DUR – Medical Claims Data
 Growth Hormone DUR
 Psychotropic Medications in Foster Children
 Update
 Five (5) or more psychotropic medications prescribed concomitantly
8
Complete Report
9
Profile Review
 Generated profiles for the top 150 recipients by total
narcotic claim count from the recipients who had at
least one narcotic claim in each of the 24 months of
the period ending December 2011
 Time Period: May 1, 2011 through December 31, 2011
 Evaluated 144 Cancer Diagnosis found in 6
 All profiles were hand reviewed by Idaho Medicaid
Pharmacists
10
Review Focus










Years of opioid use
Number of different opioids used
Daily morphine equivalents
Number of different prescribers
Other concurrent potentially addictive drugs
Diagnosis or indication for chronic opioid use
Average days between refills
History of abuse diagnosis
Currently in lock-in program?
Additional opioid use outside of Medicaid
Length of Time for Continuous
Opioid Use
Number of Years on Opioids -Through 2011
26
24
22
Average = 8.2 years
20
18
16
Number of 14
Participants 12
10
8
6
4
2
0
1
Records only back to 1998
2
3
4
5
6
7
8
9
10
11
12
13
14
Number of Years
12
Number of Different Opioids
 Includes different drugs or dosage forms
 May or may not be concurrent, but over course of therapy
Number of Different Opioids
50
45
40
Average = 2.9
35
30
Number of
25
Participants
20
15
10
5
0
1
2
3
4
5
6
7
Number of Opioids
8
9
10
13
Daily Morphine Equivalents
Lowest = 10 mg
Highest = 2421 mg
Daily Morphine Equivalents
2000 or More
1300-1399
1200-1299
1100-1199
1000-1099
900-999
800-899
Daily Morphine
700-799
Equivalents (mg)
600-699
500-599
400-499
300-399
200-299
100 - 199
0-99
Average = 256 mg equivalents
0
5
10
15
20
25
30
35
40
45
Number of participants
14
Number of Prescribers for Opioids
Number of Prescribers for Opioids
70
65
60
Average number of prescribers per participant is 2
55
50
45
Number of
Participants
40
35
30
25
20
15
10
5
0
1
2
3
4
5
6
7
8
9
10
11
12
Number of Prescribers
15
Percent of Other Concurrent Potentially Addictive
Drugs
None
Benzodiazepines Only (up to 3)
3%
Muscle relaxants only
1%
1%
9%
Sedative Hypnotics Only
19%
12%
Benzodiazepines plus muscle relaxants
Benzodiazepines plus sedative hypnotics
13%
27%
Sedative Hypnotics plus muscle relaxants
5%
10%
Benzodiazepines plus a stimulant
Benzodiazapines plus a stimulant plus a
sedative hypnotic
For this count temazepam was classified as a sedative hypnotic and
diazepam as a benzodiazepine
Benzodiazepines plus muscle relaxants
plus sedative hypnotics
16
Diagnosis/Indications
Most patients had multiples diagnoses
Diagnosis
lumbago: unspecified disorder of back; back pain
Number of Participants
(incidence)
114
chronic pain; chronic pain syndrome; other chronic pain
90
intervertebral disc disorder; lumbar disc degeneration; cervical disc degeneration; cervicalgia; sciatica; disc
degeneration; spondylosis
84
knee injury; shoulder injury; pain in limb; lower leg pain; neck injury; hip and thigh injury; wrist injury
38
hand joint pain; osteoarthritis; rheumatoid arthritis; pain in joint of ankle and foot; ankylosing spondylitis;
other disorders of synovium tendon and bursa
headache; migraine
42
14
disorders of muscle ligament and fascia; other disease of bone and cartilage; myalgia
6
abdominal pain, generalized pain
7
multiple sclerosis
4
peripheral neuropathy; diabetic peripheral neuropathy
4
Unknown
2
17
Average Days Prior to Refill
80
70
60
Average = 27 days
50
Number of
Participants
40
30
20
10
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37
Average Days
18
Other Information Gathered
 Number on Medicaid Pharmacy Lock-In
 4 currently on lock-in
 1 previously on lock-in, released 1/2011
 Non-Medicaid Opioid Fills
 From Board of Pharmacy Reports
 43 of the 144 patients ( 30%) had fills not paid for by
Medicaid
 Extra number of doses ranged from 2 to 4275
 Concurrent Drug Abuse Diagnosis 56 (39%)
19
Comparison of Intermittent and
Complete Review
Intermittent (90 pts)
Total (150 pts)
Number with Cancer DX
3
6
Average # of Years on
Opioids
9.8 (Range 3-14)
8.2 (Range 3-14)
Average # of Different
Opioids
2.6 (Range 1-9)
2.9 ( Range 1-10)
Average Daily Morphine
Equivalents
202 (Range 10 mg-1080 mg)
256 (Range 10 mg -2421mg)
Average # of
Prescribers/Participant
2 (Range 1-12)
2 ( Range 1-12)
Average Days Prior to Refill
30
27
Lock-in Patients
3
4
Patients with Prescriptions
Paid Outside of Medicaid
34%
30%
20
Narcotic Analgesics
 DUR Board Recommendations April 2012
 Complete Review for the rest of top 150 patients
 Research other state restrictions and initiatives
 P&T Recommendations May 2012
 Long- Acting Narcotic Analgesics


Tighten up definition of “failure of a preferred agent” beyond
just a prior fill of preferred agent
Removal of history of preferred oral agent for fentanyl
transdermal
21
22
PROP – Physicians for Responsible
Opioid Prescribing
 www.responsibleopioidprescribing.org
 Mission Statement
Our mission is to reduce morbidity and mortality resulting from prescribing
of opioids and to promote cautious, safe and responsible opioid prescribing
practices.
 Disclosure Statement
PROP does not accept financial support from pharmaceutical companies,
medical device companies, urine toxicology laboratories or any other entities
that could be perceived as a potential conflict of interest.
 Cautious Evidence Based Opioid Prescribing
 Four page handout included in your packet.
 Video: Effectiveness for Chronic Pain:
http://www.supportprop.org/educational/index.html
23
FDA Recommendations July 9, 2012
 FDA introduced new safety measures for extended
release and long acting opioid medications as part of a
federal initiative to address the prescription drug
abuse, misuse, and overdose epidemic.
 Key components to REMS (risk evaluation and
mitigation strategies):
 Training for prescribers
 Updated Medication Guide and patient counseling
document
 Assessment/Auditing
24
Training for Prescribers
 Training for prescribers is OPTIONAL at this time.
 The Obama Administration is pursuing legislative changes to link
mandatory training on responsible opioid prescribing to DEA
registration.
 Companies will be required to make education programs available to
prescribers based on an FDA blueprint at no or a nominal cost.
 Companies will be required to perform periodic assessments of the
implementation of the REMS and the success of the program in
meeting its goals.
 FDA will review these assessments and may require additional
elements to achieve the goals of the program.
25
Updated Medication Guide
 Consumer friendly information on the safe use,
storage, and disposal of long acting opioids
 Signs of potential overdose
 Specific advice on safe storage to prevent accidental
exposure to family members and household visitors.
26
Assessment/Auditing
 Companies will be expected to achieve certain FDA-
established goals for the percentage of prescribers of
ER/LA opioids who complete the training (25% at the
end of the first year, 50% after two years, 60% after
four years).
 Assess prescriber’s understanding of important risk
information.
 Assess whether the REMS is adversely affecting
patient access to necessary pain medications.
27
PROP Response to FDA
Letter sent by PROP to the Food and Drug
Administration on July 25, 2012
 Recommendations
 Strike the term “moderate” from the indication for non-
cancer pain.
 Add a maximum daily dose, equivalent to 100mg of
morphine, for non-cancer pain.
 Add a maximum duration of 90 days for continuous
(daily) use for non-cancer pain.
28
PROP Future Activities
 National Summit on Opioid Safety
 October 31 – November 1, 2012
 Seattle, WA
 Keynote Speakers


Roger Chou MD, MPH
 Oregon Health & Science University
Jane Ballantyne, MD, MPH
 University of Washington
29
Current Activities
 Revision of long-acting opioid criteria
 Manual Review (automatic POS denial) for all new
patients with prescriptions for the following



Oxycodone ER
Fentanyl transdermal
Butrans
 Review of Other State Programs
 Alaska therapeutic duplication edit
 Washington second opinion by pain specialist
 Montana case management
 Oregon back pain management program
30
Possible Intervention
 Education on patients receiving > 500 morphine
equivalents per day
 From review n = 17
 Content ?
31
Aliskiren DUR
 The U.S. Food and Drug Administration (FDA) came
out with a safety announcement on April 20, 2012
warning of the possible risks when using aliskiren
containing products with ACEIs or ARBs in patients
with diabetes or kidney impairment. (see packet for
safety announcement)
 A report was run to identify patients who had received
an aliskiren containing product within the past 90
days.
32
Aliskiren DUR
 Letters were sent to 17 prescribers about 13 patients on
4/30/2012.
 As of 8/10/2012, 4 responses have been received (24%
response rate.)
 See packet for a copy of the letters.
33
Aliskiren DUR response detail as of
8/10/2012
 Note that providers may choose more than one selection
per response.
 Reviewed and have or will modify the treatment
 I will use this information in the care of future pts
 My patient, but I did not prescribe this
 Not useful to my practice
 Info regarding this pt appears to be correct
1
1
2
1
1
34
Aliskiren DUR response detail as of
8/10/2012
 “I am recipient’s PCP. Dr Rahim from Idaho Kidney Institute manages her BP
medications because of her nephrotic syndrome. There are frequent changes
made and he was the one who started her on aliskiren. He did decrease her
lisinopril to 20mg. She is being monitored closely with frequent lab and f/u
with the specialist. Thank you for the information.”
 “She is no longer on aliskiren.”
 “no longer on this combo. Also original rx was by the patient’s nephrologist Dr
Davidson.”
 “before sending information please do appropriate research. Pt has stage 5
CKD and is no longer approved for ACE or ARB therapy.”
 Please refer to packet for recipient’s profile
35
Aliskiren DUR
 Utilization Data
Product
January 2012 Claims
July 2012 Claims
Tekturna
12
7
Tekturna HCT
1
1
Valturna
2
0


Letters were sent to the prescriber of the Tekturna HCT and
two of the Tekturna July 2012 claims and one of the claims for
Tekturna elicited the first response on the previous slide.
5 other recipients have started Tekturna since January 2012
36
Aliskiren DUR
 Comments/Suggestions ???
37
Lupron DUR
 Reason for DUR Project – Received prior authorization request for
Lupron for a 14 year old genetically male patient who is in the process
of becoming a girl. Currently lives in another state – “he” and his
mother are planning on moving to Idaho so this prior authorization
request was submitted as “he” is now eligible for Idaho Medicaid.
 Nothing specific in Idaho Medicaid’s rules about paying or not paying
for transgender procedures. Would fall under “medical necessity”
review. Chart note was submitted with prior authorization request –
nothing written in endocrinologist’s chart note about chromosomal
mosaicism or genetic abnormality. Request was denied as not
medically necessary.
38
Lupron DUR
 Previously Lupron claims would pay at pharmacy with prior
authorization not needed. Have since instituted prior
authorization requirements.
 FDA approved indications
Precocious Puberty



Girls less than 8 years old; boys less than 9 years old
Monthly dose 7.5mg – 15mg; Can switch to every 3 month depot
formulation
Uterine leiomyomata associated with anemia, in conjunction with
iron supplementation


3.75mg monthly x 3 months or 11.25mg depot single injection
39
Lupron DUR
 FDA approved indications continued
Endometriosis


3.75mg monthly x 3 months or 11.25mg depot single injection
Premenstrual syndrome


3.75mg monthly x 3 months
Prostate cancer, advanced (palliative treatment)


7.5mg monthly (indefinitely) or 22.5mg depot every 3 months or 30mg
depot every 4 months or 45mg depot every 6 months
In vitro fertilization


Not a diagnosis covered by Idaho Medicaid (do not cover fertility
treatment)
40
Lupron DUR
 Profiles reviewed for patients with paid Lupron claims
between 9/01/2011 and 3/31/2012 (n=25)
Patients
10
15
Children with
sexual
precocity
(ICD-9 259.1)
Women with
endometriosis
41
Lupron DUR
 15 children with precocious puberty – age as of 3/31/2012
 Minimum age: 3 years, 4 months
 Maximum age: 14 years, 8 months
 Mean age: 9 years, 4 months
 10 women with endometriosis – age as of 3/31/2012
 Minimum age: 17 years
 Maximum age: 35 years
 Mean age: 23 years
 Entered prior authorization approvals for all current patients who are still
receiving Lupron therapy (grandfathering).
42
Lupron DUR
 Cost of Lupron therapy (all strengths) from 4/1/2011 –
3/31/2012 through outpatient prescription drug program:
$289,971.77 (49 patients total)
 Cost of Lupron therapy (all strengths) from 4/1/2011 –
3/31/2012 through J-code billing on medical side:
$12,179.79 (24 patients total)
 Cost of Lupron therapy for requested patient (7.5mg
monthly): ~$880 per month - $10,560 per year
43
Lupron DUR
 Will be instituting auto-PA rule so that claims for children
with precocious puberty and women with endometriosis
would still pay at Point of Sale with no prior authorization
paperwork required IF the applicable diagnosis is in the
patient’s electronic profile at the time that the pharmacy
claim is run.
44
Lupron DUR
 Approve within age and dosage limits for the following FDA
approved diagnoses:







ICD-9
ICD-9
ICD-9
ICD-9
ICD-9
ICD-9
ICD-9
259.1
617.x
174.x
175.x
183.x
185.x
218.x
Sexual precocity
Endometriosis
Malignant neoplasm of female breast
Malignant neoplasm of male breast
Malignant neoplasm of ovary
Malignant neoplasm of prostate
Uterine leiomyoma
 Parameters in Rx POS System
 Age set at 0-999
 Quantity set at 0.04 (1 syringe/30 days = 0.033)
 Both (male and female)
45
Lupron DUR
 References
 Abbott Laboratories. Lupron Depot-PED prescribing
information.
 Cigna Medical Coverage Policy – Effective date 1/15/2011.
 Texas Medicaid Policy.
46
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.
47
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.
48
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.
49
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
50
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
51
Ciprofloxacin DUR
UTI or cystitis or pyelonephritis with at least one antibiotic tried before ciprofloxacin
amox+Augmentin
1
cefdinir
2
Augmentin
3
azith
4
amox
5
cephalexin
6
nitrofurantoin
Bactrim
n=18, mean age (standard deviation) 10.5 yrs (3.8), min=3, max=15
13/18 filled ciprofloxacin once; three (2 fills), one (3 fills), one (4 fills)
0
52
Ciprofloxacin DUR
Prescriber taxonomy for patients treated for
UTI/cystitis/pyelonephritis with previous antibiotic usage
6
5
5
4
4
3
2
2
2
1
2
1
1
Midwife (pt. is
14 years old)
Urology
1
0
Emergency
Medicine
NP
Family
Practice
PA
Peds
Unknown
53
Ciprofloxacin DUR
UTI or cystitis or pyelonephritis with no other antibiotic tried before ciprofloxacin
n=7, mean age (standard deviation) 11.7 yrs (3.7), min=6, max=15
All had only single fill of ciprofloxacin
8
# of recipients
7
7
6
5
4
3
2
1
0
54
Ciprofloxacin DUR
Prescriber taxonomy for patients treated for
UTI/cystitis/pyelonephritis without previous antibiotic usage
3
2
2
2
1
1
1
1
Family Practice
Peds
0
Emergency Medicine
General Practice
NP
55
Ciprofloxacin DUR
CF Patients
n=4, mean age (standard deviation) 9 yrs (4.6), min=4, max=14
13
12
15
8
7
10
5
5 3
Patient 4
Patient 3
2
1
0
Patient 2
Patient 1
prior
antibiotics
Ciprofloxacin
fills
56
Ciprofloxacin DUR
 Oncology Patients
 Both were 6 years old
 Kidney cancer with cellulitis of leg
 Bone cancer with infection of amputation stump
 Both had single fills of ciprofloxacin
57
Ciprofloxacin DUR
Asthma/Respiratory Distress
n=11, mean age (standard deviation) 9.6 yrs (5.0), min=1, max=15
4 had no prior antibiotics, 7 had prior antibiotics ranging from 1-15
5 patients had 1 fill only of ciprofloxacin, 3 fills (2 patients), 8 fills (1 patient), 11 fills (1 patient), 12 fills (1 patient)
8
7
# of recipients
7
6
5
4
4
3
2
1
0
no prior antibiotics
prior antibiotics
58
Ciprofloxacin DUR
Pneumonia/URI/bronchitis
n=6, mean age (standard deviation) 8.8 yrs (5.1), min=2, max=14
All had single fills of ciprofloxacin
6
# of recipients
5
5
4
3
2
1
1
0
no prior antibiotics
Augmentin/azithromycin
previously
59
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
60
Ciprofloxacin DUR
No Diagnosis Listed
n=13, mean age (standard deviation) 11.8 yrs (2.6), min=7, max=15
11 had one fill of ciprofloxacin; one had two fills and one had 3 fills
# of recipients
12
10
10
8
6
4
2
1
1
1
0
61
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.
62
Ciprofloxacin DUR
 Study 1 – Prospective safety study performed at the request
of the FDA by Bayer for ciprofloxacin.
 Studied rate of arthropathy 6 weeks after treatment with
ciprofloxacin (n=335) or comparator antibiotic (n=349) in eight
countries including the US.
 A difference was only detected in the US with a rate of arthropathy
21.0% (n=62) with ciprofloxacin vs. 11.3% (n=71) with comparator
antibiotic.
 Mexico had a zero incidence of arthropathy in both ciprofloxacin
and comparator antibiotic.
 The study used a non inferiority design to assess musculoskeletal
complaints across all countries, and as analyzed, the groups were
sufficiently different to suggest potential musculoskeletal toxicity
with ciprofloxacin (9.3%) vs. comparator (6.0%).
63
Ciprofloxacin DUR
 Study 2 - Prospective and randomized but not blinded
study performed by Johnson & Johnson for levofloxacin as
part of their FDA-coordinated program of pediatric drug
development.
 N=2523 from 3 large multicenter efficacy trials including a
community-acquired pneumonia trial in children aged 6 months to
16 years and acute otitis media in children 6 months to 5 years.
 An analysis of weight-bearing joint disorders had a statistically
greater rate between the levofloxacin and comparator treated
groups at 2 months (1.9% vs. 0.7%, p=0.025) and at 12 months (2.9%
vs. 1.6%, p=0.047).
 A history of joint pain accounted for 85% of all events, but there
were no findings of joint abnormality when assessed by physical
examination (all patients) or CT scan/MRI (selected patients).
64
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.
65
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?
66
Synagis DUR
 Medical claims for 2011-2012 season: $274,881.27
 Pharmacy claims for 2011-2012 season: $1,362,626.70
67
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?
68
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)
 Four patients identified with claims that should NOT
have paid:
 Patient 1

SEVEN doses paid for: 3 as medical claims and 4 as pharmacy
claims. Also kept switching between 50mg and 100mg vial
sizes.







12/5/11 – 50mg (pharmacy claim)
1/9/12 – 100mg (pharmacy claim)
1/13/12 – 50mg (medical claim)
2/6/12 – 100mg (pharmacy claim)
2/16/12 – 50mg (medical claim)
3/5/12 – 100mg (pharmacy claim)
4/26/12 – 50mg (medical claim)
69
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)
 Patient 2

A total of 5 doses paid but two paid in same month (one as
pharmacy claim and one as medical claim) plus four claims
paid as 100mg but third paid as 50mg.





12/12/11 – 100mg (pharmacy claim)
1/9/12 – 100mg (pharmacy claim)
1/20/12 – 50mg (medical claim)
2/6/12 – 100mg (pharmacy claim)
3/5/12 – 100mg (pharmacy claim)
70
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)
 Patient 3

PA was approved through 4/30/12 but second dose paid on
6/1/12 and second dose paid for 50mg when first dose was for
100mg.


4/5/12 – 100mg (medical claim)
6/1/12 – 50mg (medical claim)
 Patient 4

Only approved for four doses as one dose was already given in
hospital. Five doses were paid for as pharmacy claims and an
additional claim was submitted on the medical side that was
not paid.
71
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)
 Other Dosing Issues per each individual patient
 Claims paid on pharmacy side not medical side
 First dose paid for 150mg but second through fifth doses paid for 100mg
 Claims paid on medical side
 Doses 1, 2, 3, 5 – 150mg but Dose 4 - 200mg
 Claims paid on medical side
 Doses 1, 3, 4, 5 – 150mg but Dose 2 - 100mg
 Claims paid on pharmacy side
 Dose 1 – 150mg but Dose 2 100mg
 Claims paid on medical side
 Doses 1, 2, 4, 5 – 150mg but Dose 3 100mg
72
Synagis DUR – Medical Claims Data from
10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)
 Comments/suggestions ???
73
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.
74
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.
75
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.
76
Growth Hormone DUR
Drug Utilization HIC3 = P1A (Growth Hormones) 1/1/2012 – 6/24/2012
Product
Unique Recipients
Total claims
Genotropin
16
65
Humatrope
4
15
Norditropin Flexpro*
29
112
Norditropin Nordiflex*
1
2
Nutropin*
2
5
Nutropin AQ*
2
10
Nutropin AQ Nuspin*
10
41
Saizen
1
4
Serostim
1
2
Summary of All
66
256
* Currently preferred agents
77
Growth Hormone DUR
 Comments/Suggestions ???
78
Preliminary Idaho Medicaid Data
8/2012
79
Use of Psychotropic Medications in Foster
Children
Comparison of Idaho Medicaid to Five States in GAO Study
Percentage of children
(0-17 years old)
prescribed
psychotropic
Medications in named
State and year
Foster Children
Nonfoster children
Ratio of foster to
nonfoster children
Florida 2008
22.0%
8.2%
2.7
Massachusetts 2008
39.1%
10.2%
3.8
Michigan 2008
21.0%
7.9%
2.7
Oregon 2008
19.7%
4.8%
4.1
Texas 2008
32.2%
7.1%
4.5
Idaho 2008
38.8%
14.8%
2.6
Idaho 2011
42.9%
14.8%
2.9
80
Foster Children and Non-Foster
Children Population Basis
Year
Total # of Foster children
Total # of Non-Foster children
2007
2,384
85,894
2008
2,516
86,419
2009
2,658
96,979
2010
2,718
103,199
2011
2,785
106,024
81
Percentage of Children Receiving Psychotropic
Medications Over Time
50%
45%
Percentage of Children
40%
35%
30%
25%
20%
15%
10%
5%
0%
2007
2008
2009
2010
2011
Foster
34%
39%
39%
41%
43%
NonFoster
14%
15%
14%
14%
15%
82
Focus on Calendar Year 2011
83
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
84
ADHD Drugs in Foster Children
14.0%
Foster Children Receiving ADHD Drugs
Percent by Age and Gender
12.0%
10.0%
8.0%
Foster
Non-Foster
6.0%
4.0%
2.0%
0.0%
0-6 F
0-6 M
7-12 F
7-12 M
13-17 F
13-17 M
85
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
86
Atypical Antipsychotics in Foster
Children
7.0%
Foster Children Receiving Atypical Antipsychotics
Percent by Age and Gender
6.0%
5.0%
4.0%
Foster
Non-Foster
3.0%
2.0%
1.0%
0.0%
0-6 F
0-6 M
7-12 F
7-12 M
13-17 F
13-17 M
87
Who is Prescribing These Drugs?
Prescriber Type by Claims Volume Statewide
Other
0%
Physican
Assistant
6%
Child/Adolescent
Psychiatrist
18%
Nurse Practitioner
15%
Internal Medicine
1%
Family Medicine/General
Practice
17%
Pediatrician
15%
Psychiatrist
19%
Behavioral/Development
al Pediatrician
Neurologist
7%
2%
88
Regional Prescriber Variation
Prescriber Type by Region
By Percentage of Psychotropic Prescriptions for Foster
Children
100%
90%
80%
70%
Region 1
Region 2
60%
Region 3
50%
Region 4
Region 5
40%
Region 6
30%
Region 7
20%
10%
0%
Specialist
Generalist - MD
Midlevel
89
Age Distribution
Percent of Prescription Volume by Age
50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
0-6
7-12
13-17
90
8/21/2012
91
Red Flags
 Five (5) or more psychotropic medications prescribed





concomitantly
Two (2) or more concomitant antidepressants
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
92
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
93
August 2012
94
Study Parameters
 Foster Children with 5 or more distinct behavioral
health drugs
 Service Dates between 11/1/2011 and 4/30/2012 (6
months)
N=5
95
Mental Health Drug List: Stimulants
Stimulants
amphetamine mixed salts
generic, Adderall, Adderall XR
dextroamphetamine
generic, Dexedrine, Dexedrine Spansule
lisdexamfetamine
Vyvanse
methylphenidate
generic, Ritalin, Metadate ER, Metadate
CD, Methylin, Methylin ER, Concerta,
Daytrana TD
dexmethlyphenidate
generic, Focalin, Focalin XR
96
Mental Health Drug List: Other
ADHD Treatments
Other ADHD Treatments
atomoxetine
Strattera
clonidine
generic, Catapres
guanfacine
generic, Tenex, Intuniv
bupropion
generic, Wellbutrin, Wellbutrin SR,
Wellbutrin XR
imipramine
generic, Tofranil, Tofranil-PM
nortriptyline
generic, Aventyl, Pamelor
97
Mental Health Drug List:
Antidepressants
SSRI
citalopram
generic, Celexa
escitalopram
generic, Lexapro
fluoxetine
generic, Prozac
paroxetine
generic, Paxil, Paxil CR
fluvoxamine
generic, Luvox, Luvox CR
sertraline
generic, Zoloft
SNRI
velafaxine
generic, Effexor, Effexor XR
duloxetine
Cymbalta
desevenlafaxine
Pritiq
98
Mental Health Drug List: Mood
Stabilizers
Mood Stabilizers
carbamazepine
generic, Carbatol, Tegretol, Tegretol XR
divalproex
generic, Depakote
lithium
generic, Eskalith, Eskalith CR, Lithobid
lamotrigine
generic, Lamictal
99
Mental Health Drug List: Second
Generation (atypical) Antipsychotics
Second Generation Antipsychotics
aripiprizole
Abilify
asenapine
Saphris
clozapine
generic, Clozaril
iloperidone
Fanapt
lurasidone
Latuda
olanzapine
generic, Zyprexa
paliperidone
Invega
quetiapine
generic, Seroquel, Seroquel XR
risperidone
generic, Risperdal
ziprasidone
generic, Geodon
100
Mental Health Drug List: First
Generation (Typical) Antipsychotics
First Generation Antipsychotics
chlorpromazine
generic, Thorazine
haloperidol
generic, Haldol
perphenazine
generic, Trilafon
pimozide
Orap
101
Patient 101
 15 year old female
 Mental Health Diagnoses
 Pervasive Developmental Disorder
 Encephalopathy, other
 Oppositional Defiant Disorder
 Attention Deficit with Hyperactivity
 Posttraumatic Stress Disorder
Drug
Duration
Vyvanse 70 mg #30
2 years 5 months
Amphetamine Salt Combo 10 mg #60
3 years 3 months
Clonidine 0.1 mg #30
10 months
Fluoxetine 10 mg #30
6 months
Geodon 80 mg #60
1 year 3 months
Geodon 60 mg #30
1 year 7 months
102
Patient 105
 16 year old female
 Mental Health Diagnoses
 Reactive Attachment Disorder
 Posttraumatic Stress Disorder
 Bipolar Disorder, Unspecified
Drug
Duration
Amphetamine Salt Combo 20 mg
#62
2 years
Sertraline 100 mg #30
1 year 5 months
Oxcarbazepine 600 mg #60
4 years
Lithium 300 mg #120
4 years
Risperidone 0.5 mg #60
1 year 11 months
Quetiapine 400 mg #30
6 years
103
Patient 113
 8 year old female
 Mental Health Diagnoses
 Bipolar I Disorder, Unspecified
 Bipolar I Disorder, Mixed Severe
 Attention Deficit Disorder with Hyperactivity
 Reactive Attachment Disorder
 Unspecified Delay in Development
104
Patient 113
Drug
Duration
Adderall XR 20 mg #30
3 years 8 months
Amphetamine Salt Combo 10 mg #30
1 year 7 months
Vyvanse 70 mg #30
1 year 8 months
Clonidine 0.1 mg #120
1 year 11 months
Geodon 40 mg
1 month
Abilify 30 mg #30
1 year 7 months
Quetiapine 100 mg #60
Quetiapine 200 mg #60
Quetiapine 300 mg #30
Quetiapine 400 mg #30
Quetiapine was
started 5/20/2011.
Dose during the
evaluated 6 month
period 700 mg daily.
105
Patient 117
 17 year old female
 Mental Health Diagnoses
 Moderate Intellectual Disability
 Unspecified Developmental Delay
 Bipolar Disorder, Unspecified
106
Patient 117
Drug
Duration
Guanfacine 1 mg #30
2 months
Citalopram 20 mg #30
1 month
Citalopram 40 mg #30
2 years 4 months
Quetiapine 200 mg #30
2 years 4 months
Quetiapine 400 mg #30
2 years 4 months
Risperidone 1 mg #60
4 years 3 months
107
Patient 120
 11 year old male
 Mental Health Diagnoses
 Attention Deficit Disorder with Hyperactivity
 Unspecified Episodic Mood Disorder
 Unspecified Emotional Disturbance of Childhood or
Adolescence
108
Patient 120
Drug
Duration
Concerta 54 mg #30
3 years 8 months
Strattera 60 mg # 30
10 months
Clonidine 0.1 mg #90
2 years 7 months
Abilify 5 mg #30
2 months
Quetiapine * 50 mg #90
1 month
Quetiapine * 200 mg #60
4 months
Quetiapine * 300 mg #60
2 years 8 months
Patient has been on varying doses of
quetiapine since 9/16/2008
109
Proposed Studies for Next Quarter:
 P&T Committee Narcotic Analgesic Studies – Next Steps
 Leukotrienes vs. inhaled corticosteroids in children with
asthma
 Use of Psychotropic Medications in Foster Children
 Two (2) or more concomitant antidepressants
 Migraine Prevention
 Prophylaxis Utilization in Chronic Triptan Utilizers
 Topiramate

PA, Medical Claim and Triptan Use Mismatch
 IVIG
110
Leukotrienes vs. inhaled corticosteroids in
children with asthma
 Number of recipients < 18 years of age with paid claim
for leukotriene:
Date
# of recipients
7/1/2011 – 9/30/2011
3,369
1/1/2012 – 3/31/2012
3,059
 Number of recipients < 18 years of age with paid claim
for inhaled corticosteroid:
Date
# of recipients
7/1/2011 – 9/30/2011
1,595
1/1/2012 – 3/31/2012
2,156
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 antidepressants
114
Migraine Prevention
 Prophylaxis Utilization in Chronic Triptan Utilizers
 See packet for summary handout
115
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.



1,223 patients on topiramate
949 patients with approved criteria (ICD-9 code in Medical Profile) of
Seizure Disorder/Migraine Headache
274 (22.4%) of patients without approved criteria
 Review patients to determine topiramate use other than FDA
approved indications
116
IVIG – Intravenous Immune Globulin
 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.
117
IVIG – Intravenous Immune Globulin
 Reviewing outpatient prescription claims between
8/01/2011 and 7/31/2012
 $279,527
 79 claims
 14 patients
 Average cost per prescription: $3538
 Claims paid on medical side between 1/01/2011 and
12/31/2011
 $106,414
 136 claims
 37 patients
 Average cost per prescription: $783
118
IVIG – Intravenous Immune Globulin
 In the process of sending out letters to gather medical
information:
 Diagnosis
 Dosing regimen
 Response to therapy
 Will review information at October 2012 DUR
meeting. Future question to answer: Should IVIG
require prior authorization?
119
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
120
Prospective DUR Report
Idaho Medicaid Program
ProDUR Message Report
July-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
1,810
14,750
67,726
4
189
68
63,676
239,425
290,817
100
11
4
83
224
29
14
114,360
33,293
21,690
Message
Amount
$436,467.09
$2,464,369.13
$11,376,540.02
$58.07
$42,290.26
$3,956.14
$8,404,657.29
$46,436,371.98
$50,899,774,.57
$1,065.85
$542.34
$109.25
$19,811.01
$22,883.60
$3,143.66
$259.81
$24,014,747.46
$5,183,695.34
$3,721,624.57
848,273
$153,032,367.44
Total Number of Claims with Messages 210,213
Average ProDUR Message Per Claim
4.04
121
DUR Summer Newsletter
 Copy of Spring Newsletter in packet
 Brainstorm for new topics
122
Medicaid Update
123