18 April 2013
1
February 21-23, 2013
Scottsdale, Arizona
Representatives present from 40 state Medicaid programs
109 total participants
2
ADURS
 Round Table presentations from state Medicaid
representatives
 Recurrent Issues
 Opioid therapy for non-malignant pain
 Psychotropic medications in children
 Suboxone therapy
3
ADURS
 Opening Session
 Health Care Reform: How States are Responding
 Speaker was from the National Conference of State
Legislatures
4
ADURS
 Continuing Education Topics
 Collaborative Care – How to increase safe use of
psychotropic medications in children and adolescents.
 Hemophilia 101
 Medicaid Fraud and Abuse
 Managed Care Medicaid
5
ADURS
 Continuing Education Topics
 Carving the Prescription Benefit Back In to Medicaid
 340(b) Programs
 New Drugs 2013
6
Follow-up to Previous Reviews
 Atopic Dermatitis
 P&T Committee Narcotic Analgesic Studies
7
Atopic Dermatitis
 The P&T Committee requested a DUR on this drug class to
include patterns of use, presence or absence of step up therapy
from steroids, specialty of prescribers and geographic region
differences of prescribing patterns. The DUR should include an
educational piece on risks of these agents compared to risks from
steroids since many practitioners seem to be using these agents
to spare patients from steroid exposure.
 DUR completed April 2012 and it was felt that the medications
were being used appropriately based on the data presented and
these findings were presented to the P&T Committee.
8
Atopic Dermatitis
 The P&T Committee asked at their October 2012
meeting for the DUR Board to look at how frequently
these medications were being filled.
 A review of paid claims between 10/01/2011 and
10/01/2012 was done.
9
Atopic Dermatitis
 Conclusions:
 Overall only 13 of the 436 patients (3%) filled their
Elidel/Protopic more than once every other month.
 Of those 13 patients, 7/13 were filling prescriptions for
topical steroids at least as often as prescriptions for
Elidel/Protopic.
 For the 6 patients with no or infrequent topical steroid
fills over the same time period, should any action be
taken (e.g. send a DUR letter asking for chart notes)?
10
Atopic Dermatitis
 Educational Document included in the Packet
11
Atopic Dermatitis
More than 6 claims for Elidel or Protopic in one year
Patient Number
Patient Age
(years)
Drug
# Claims for
Elidel/Protopic
# Claims for
Topical Steroid Prescriber
Diagnosis in
Electronic Profile
64
15
Elidel
11
24
Dermatologist
269
14
Elidel
11
11
P.A.
atopic dermatitis
atopic dermatitis,
eczema
201
9
Elidel
11
3
Family Medicine
No derm diagnosis
5
38
Protopic
10
0
Family Medicine
No derm diagnosis
2
65
Elidel
9
15
N.P.
196
9
Protopic
9
9
Dermatologist
eczema
atopic dermatitis,
eczema
8
61
Protopic
9
0
Family Medicine
eczema, psoriasis
127
12
Elidel
9
0
Pediatrics
No derm diagnosis
73
13
Elidel
8
8
Family Medicine
156
10
Protopic
8
8
Allergist
75
41
Protopic
8
1
Family Medicine
eczema
atopic dermatitis,
eczema
atopic dermatitis,
eczema
203
10
Elidel
7
11
Dermatologist
399
4
Elidel
7
0
Pediatrics
eczema
atopic dermatitis,
eczema
12
Atopic Dermatitis
 #201
 9 year old male
 11 Elidel claims in one year; only 3 topical steroid claims
in the same time period
 Still filling Elidel monthly.
 Family Medicine prescriber; no derm diagnosis in
electronic profile.
 Send letter.
13
Atopic Dermatitis
 #5
 39 yr male
 10 Protopic claims in one year/ no topical steroid claims
in the same time period.
 Family Medicine prescriber; only derm diagnosis is ICD9 757.39 specified skin anomalies.
 Protopic last filled 12-20-12 so do NOT send letter as not
currently receiving it.
14
Atopic Dermatitis
 #8
 60 year old female
 9 Protopic claims in one year; no steroid claims.
 Family Medicine prescriber; diagnosis – eczema.
 Patient died in 2012 (pulmonary hypertension) so do not
send letter.
15
Atopic Dermatitis
 #127
 13 yr male
 9 Elidel claims in one year; no topical steroids. Last paid
claim for topical steroid was in 2006. Elidel last filled 117-13.
 Pediatric prescriber; no derm diagnosis in electronic
profile.
 Send letter.
16
Atopic Dermatitis
 #75
 41yr female
 8 Protopic claims; 1 steroid claim.
 Family Medicine; atopic dermatitis/eczema.
 Protopic was last filled 11-29-12 so do not send letter.
17
Atopic Dermatitis
 #399
 7 Elidel claims in one year; zero steroid claims.
 Pediatrics; atopic dermatitis/eczema.
 Elidel last filled 9-19-12 so do not send letter.
18
Atopic Dermatitis
 Comments/Questions?
19
P&T Committee Narcotic Analgesic
Studies
20
Participants Receiving Over 500 mg Morphine
Equivalents per Day
21
Original 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
 All profiles were hand reviewed by Idaho Medicaid
Pharmacists
22
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
23
Participants Receiving Over 500
Morphine Equivalents in 2011 Study
 Original study 5/1/2011 – 12/31/2011
 30 participants > 500 morphine mg equivalents
 Follow-up study of these 30 participants 6/1/2012-
11/30/2012
24
Data on 30 Original Participants
Characteristic
Number of Patients
Original participants
still meeting threshold
(> 500 mg MS
equivalents)
6
Ineligible or Inactive for
Idaho Medicaid
2
Deceased
5
Incarcerated
1
Current dose < 500 mg
MS equivalents
16
25
Follow-up Request
 Letter (see packet) sent 2/13/2013
 Included patient medication profile and Board of
Pharmacy controlled substance report
 Requested Chart Notes and Documentation for most
recent 6 months
 Evaluation and monitoring of pain relief
 Evaluation for improvement in daily function
 Potential misuse/abuse
 Current treatment plan
 Pain contract
 Random urine screen results
26
Participant Review
 5 of 6 participants’ prescribers returned
documentation
 Case Presentations
 Top User no longer receiving: Chris Johnson
 Most complex user: Jane Gennrich
 Remaining 4 users: Tami Eide
27
Current Interventions/Outcomes
Studies
 Zolpidem High Dose
 Migraine Prevention
 Prophylaxis Utilization in Chronic Triptan Utilizers
 Botulinumtoxin Products
 Testosterone enanthate/cypionate (injectable)
 Psychotropic Medications in Foster Children
 Two (2) or more concomitant stimulant medications

long-acting plus short-acting ok
28
Zolpidem High Dose
 On January 10, 2013 the United States Food and Drug
Administration (FDA) notified the public of new
information regarding the safety of certain drugs that
contain zolpidem. (See packet for copy of Drug Safety
Announcement)
 The NEW immediate release zolpidem dose for women is
being lowered from 10 mg to 5 mg.
 The NEW extended release zolpidem dose for women is being
lowered from 12.5 mg to 6.25 mg.
 For men, the new labeling recommends that the same lower
doses be considered (zolpidem immediate release 5 mg or
zolpidem ER 6.25 mg).
29
Zolpidem High Dose
 A report was run looking at paid claims between October 1,
2012, and December 31, 2012, to identify the number of
Idaho Medicaid recipients who had received zolpidem:
Zolpidem Paid Claims 10/01/2012 – 12/31/2012
Ambien
5mg
Ambien
10mg
Ambien CR
6.25mg
Ambien CR
12.5mg
Male
≥2 per day
Female
63
10
223
≥2 per day Prescribers
33
209
457
1514
879
0
0
0
19
47
44
30
Zolpidem High Dose
 Patients were selected if they had doses above the NEW
recommended doses.
 Letters were sent to 877 prescribers about 1,984 patients on
1/18/2013.
 As of 4/16/2013, 246 responses have been received (28% response
rate.)
 See packet for copy of the letter.
31
Zolpidem High Dose
 Criteria Paragraph
 On January 10, 2013, the Food and Drug Administration (FDA) published a safety
announcement regarding the popular insomnia medication zolpidem (trade names
Ambien, Ambien CR, Edluar, Zolpimist). The announcement included two
important messages:


First, the FDA provided new, lower bedtime dosing recommendations on zolpidem immediate and
extended release products.
Next, the FDA reminded the public about safety concerns around driving or performing other
activities requiring alertness the morning after use.
 The risk of next-morning impairment is highest for women, who may eliminate the
medication more slowly. Impairment is also greater in those taking the extended
release formulation (Ambien CR/zolpidem ER). Manufacturers will be revising the
product labeling to reflect the following:
1.
2.
3.
The NEW immediate release zolpidem dose in women is being lowered from 10 mg to 5 mg.
The NEW extended release zolpidem dose in women is being lowered from 12.5 mg to 6.25 mg.
For men, the new labeling will recommend the same lower doses be considered (zolpidem 5 mg or
zolpidem ER 6.25 mg).
32
Zolpidem High Dose:
 Note that providers may choose more than one selection
per response.
 Reviewed and have or will modify the treatment
 Will use this information in care of future patients
 Information clinically useful: plan to monitor
 Reviewed and do not believe adjustment is needed
 Attempted to modify therapy unsuccessfully
 Not my patient, never has been
126
120
113
72
15
5
33
Zolpidem High Dose: Comments of
Interest
 “Patient is stable” (numerous similar responses)
 “will discuss with patient”
 “chronic sleep disorder. Pt. with chronic sleep problem nightly and
does not sleep without zolpidem”
 “dose was initially changed, had worsening of symptoms and strongly
favored higher dose”
 “attempts made to lower dosage or taper off without success. The pt
listed are long term complicated pts and to effectively recess her has
been reviewed previously. Thanks”
 “lower doses do not help. I still treat patients not studies.”
34
Zolpidem High Dose: Comments of
Interest
 “He has multiple sclerosis. Ambien was discontinued. Where is the







form for why my patient was abruptly stopped on Advair which had
been effective and helpful for the pt, why was my input not important
then.”
“I will change my prescribing habits. Have only given 1 dose.”
“I’m the physician. Waste of my time.”
“I already know.”
“Will change dose to Ambien 5mg”
“Patient has not responded to a lower dose”
“I did not prescriber this medicine to my knowledge”
“Both patients were (are) pregnant”
35
Zolpidem High Dose: Comments of
Interest
 “tolerates well, has taken since April 2009”
 “The benefits outweigh the risks”
 “I will attempt to modify therapy with pts as recommended”
 “But the patient is a male, not female”
 “He tolerates the current dose without side effects”
 “address at their next visit. Had already heard about the FDA
announcement”
 “I am not an Idaho Provider. This is not my patient.”
36
Zolpidem High Dose
Zolpidem Paid Claims
Month/Year
Ambien 5mg
Ambien
10mg
Ambien CR
6.25mg
Ambien CR
12.5mg
Male
>1 per day
Female
>1 per day
Prescribers
12/12 3/13
12/12 3/13
12/12 3/13
12/12 3/13
12/12 3/13
MAX
QTY
38
55
3
4
118
271
15
19
102
150
Q02
305
301
7
10
1010
823
51
30
639
558
Q02
0
0
0
8
0
8
Q01
17
11
38
34
35
33
Q01
Payment Amount to Pharmacy: 12/12 - $25,787; 3/13 - $24,555
37
Zolpidem High Dose
 Thoughts/Comments?
38
Migraine Prevention
 Idaho Medicaid paid over $770,000 worth of pharmacy
claims for the Triptan class of medication in 2012.
 There were more than 7,200 claims paid for in 2012.
 The question the Idaho DUR Board is beginning to
investigate is “Are these medications being used
appropriately and are recipients getting the
appropriate treatment for the prevention of
migraines?”
39
Migraine Prevention
 Epidemiology
 Migraines affect approximately 11% of the adult
populations in Western Countries.
 In the United States, more than 30 million people have
at least 1 migraine per year.
 Gender



Before puberty more common in boys than girls.
In people over 12 years of age, the prevalence increases in both
males and females peaking at age 30-40 years.
The ratio of female-to-male increases from 2.5:1 at puberty to
3.5:1 at age 40.
40
Migraine Prevention: recipients with paid
triptan claim between 1/1/2012 and 12/31/2012
 Gender (Idaho Medicaid Population)
 Overall Average Age: 35 (range 4 – 78)
 Average Age Females: 35 (range 6 – 68)
 Average Age Males: 31 (range 4 – 78)
41
Migraine Prevention: recipients with paid
triptan claim between 1/1/2012 and 12/31/2012
Unique Recipients (Idaho Medicaid Population)
Male
418
18%
Female
1949
82%
42
Migraine Prevention: recipients with paid
triptan claim between 1/1/2012 and 12/31/2012
Claims (Idaho Medicaid Population)
Male
1108
15%
Female
6143
85%
43
Migraine Prevention: recipients with paid
triptan claim between 1/1/2012 and 12/31/2012
Amount Paid at POS (Idaho Medicaid Population)
Male
$105,894.00
14%
Female
$667,532.00
86%
44
Migraine Prevention
 Epidemiology
 Race

Caucasians > African Americans > Asians
 Geography

Americas > Europe/Middle East > Asia > Africa
 Economic Impact
 Estimated at more than $2.5 billion per year in cost of
medical care (Direct costs)
 Estimated at more than $13 billion per year in loss of
productive time (Indirect costs).
45
Migraine Prevention
 Medical Diagnosis (based on direct questionnaires)
 1989 – 38% of sufferers
 1999 – 48% of sufferers
 Prognosis
 Chronic condition with severity and frequency
diminishing with advancing age.
 Treatment
 Abortive
 Preventative
46
Migraine Prevention
 Preventative Therapy
 Taken in absence of headache with the goal of reducing
the frequency and severity of the migraine, make acute
attacks respond better to abortive therapy, and
ultimately improve the patient’s quality of life.
 3 primary classes of medications that are effective:
antiepileptics, antidepressants, and antihypertensives.
 Botulinum toxin A will be discussed in greater detail in
slides to follow.
 Please refer to handout in packet regarding the
evidenced based guideline update .
47
Migraine Prevention
 Idaho Medicaid Numbers
 In 2012 there were 5,022 unique recipients with a
Migraine Diagnosis in their electronic medical record.
 Of these 5,022 recipients, 1,258 had a triptan claim in
their profile.

Side note: In 2012 there were 2,367 unique recipients with a
triptan claim
 Of these 1,258 recipients, 281 (22%) had a claim for one
of the Level A Medications as described in the Evidencebased guideline update.
48
Migraine Prevention
 Next Steps???
49
Migraine Prevention
 References
50
Botulinumtoxin Products
 Botulinumtoxin products are excluded from coverage by
the outpatient pharmacy prescription drug program –
these medications are only administered by health care
professionals and are not safe for patients to pick up and
“brown bag” to the doctor’s office.
 Botulinumtoxin products are currently payable on the
medical side using the J codes listed on a future slide.
 There are four commercially available products at this time;
they are not therapeutically equivalent and they have
different dosages and different FDA approved indications.
51
Botulinumtoxin Products
 While Idaho Medicaid does not cover medications for
cosmetic uses (e.g. wrinkles), at this time there is no
diagnosis verification or medical review for J0585, J0586, or
J0587 to assure that the botulinumtoxin is being prescribed
for a medical diagnosis rather than for a cosmetic
indication.
 Therefore, the Pharmacy Unit at Idaho Medicaid has done
a DUR (Drug Utilization Review) project evaluating
diagnoses of patients who have paid claims for
botulinumtoxin in the past 3 months.
52
Botulinumtoxin Products
Procedure
Code
Trade
Name
Generic Name and
Billing Units
Prior
Authorization
Required?
# Claims
12/01/2011 –
11/30/2012
$ for claims
12/01/2011 –
11/30/2012
J0585
Botox
onabotulinumtoxin A,
1 unit
NO
478
$405,615
J0586
Dysport
abobotulinumtoxin A,
5 units
NO
21
$14,286
J0587
Myobloc rimabotulinumtoxin B,
100 units
NO
23
$11,133
J0588
Xeomin
3 (prior to
August 2012)
$647
525
$431,681
TOTALS
incobotulinumtoxin A,
1 unit
YES (as of
August 2012)
53
Botulinumtoxin Products
Trade
Name
Botox
Generic Name and Billing
Units
onabotulinumtoxin A, 1 unit
FDA approved
indications
Urinary incontinence
Migraines
Spasticity
Cervical dystonia
Hyperhidrosis
Blepharospasm
Strabismus
Overactive bladder (new –
January 2013)
Cosmetic (not covered by
Idaho Medicaid)
54
Botulinumtoxin Products
Trade
Name
Generic Name and Billing
Units
Dysport
abobotulinumtoxin A, 5 units
Myobloc
rimabotulinumtoxin B, 100 units
Xeomin
incobotulinumtoxin A, 1 unit
FDA approved
indications
Cervical dystonia
Cosmetic (not covered by
Idaho Medicaid)
Cervical dystonia
Cervical dystonia
Blepharospasm
55
Botulinumtoxin Products
 Patients with paid claims for botulinumtoxin between
10/01/2012-12/31/2012: 98
 Diagnoses
 Cerebral Palsy: 49

42 children, 7 adults
 Cervical dystonia, torsion dystonia, or upper limb
spasticity: 28
 Traumatic brain injury/intracranial hemorrhage with
muscle spasms: 12
 Migraines: 5
 Misc: 4 (details on next slide)
56
Botulinumtoxin Products
 Diagnoses
 Misc: 4




Patient #7 – dysphagia
Patient #20 – spina bifida
Patient #91 – closed fracture of vertebral column, muscle
spasm
Patient #77 - blepharospasm
57
Botulinumtoxin Products
 MIGRAINES
 References


Botulinum Toxin A Treatment for Chronic Headache and
Chronic Migraine. Center for Evidence-based Policy:
Medicaid Evidence-based Decisions Project. Oregon Health
& Science University. February 2012.
Botox Prescribing Information. Allergan, Inc. Revised
01/2013.
58
Botulinumtoxin Products
 MIGRAINES
 General Conclusions from Medicaid Evidence-based
Decisions Project
 Overall, the evidence for the effectiveness of BTX-A on chronic
migraine is inconsistent, with the studies that do show a benefit
finding the improvement small and potentially clinically
insignificant.
59
Botulinumtoxin Products
 MIGRAINES
 General Conclusions from Medicaid Evidence-based
Decisions Project
 Key Question 1: Does BTX-A reduce the frequency, severity,
or duration of chronic headaches of migraines?
 The largest available study (N=1384) evaluated onaBTX-A and
found a small but statistically significant decrease in the mean
number of headache days per month (-8.4 versus -6.6) and in
the mean number of migraine days/month (-8.2 versus -6.2).
Although statistically significant, the small size of the
treatment effect relative to placebo suggests that this may not
be clinically significant.
60
Botulinumtoxin Products
 MIGRAINES
 General Conclusions from Medicaid Evidence-based
Decisions Project
 Key Question 2: Does BTX-A improve qualify of life in
patients who have chronic headaches or migraines?

Only three trials assessed any aspect of QOL (quality of life) in the
treatment of chronic tension type headache. The smallest found
significant improvement in QOL in the treatment group compared to
placebo at both 30 and 90 days. A second trial found some reductions
on affective distress outcomes compared to placebo at four weeks, but
these were not sustained at eight weeks. The third found no significant
difference between treatment and placebo groups in sleep duration.
61
Botulinumtoxin Products
 Migraine patient #6
 58 year old female
 Long history (many years) of migraines
 2010: 20 ER visits/office visits specifically for migraines
 Jan 1- Sep 30, 2011: 11 ER visits/office visits specifically for migraines
 Botox started: 9/30/2011
 Receiving Botox approximately every 3 months: 1/20/12, 4/13/12,




7/5/12, 11/02/12
No ER visits/office visits for migraines Oct 1 – Dec 31, 2011
8 ER visits/office visits for migraines in 2012
Has been on verapamil and nadolol 2010 – present
One paid claim for triptan 7/19/2010
62
Botulinumtoxin Products
 Migraine patient #18
 51 year old female
 2010: 9 ER/office visits specifically for migraines
 Jan 1 – Sep 30, 2011: 7 ER/office visits specifically for migraines
 Botox started: 9/30/2011
 Receiving Botox approximately every 3 months since then
 2 more ER/office visits for migraines Oct 1 – Dec 31, 2011
 9 ER/office visits specifically for migraines in 2012
 Has been on propranolol 2010 – present
63
Botulinumtoxin Products
 Migraine patient #18, con’t
 Received prior authorization request for Botox in February 2013 –
prescriber states “she has had an excellent response to Botox” but
ER visits have not changed between 2010 and 2012.
 Also received prior authorization request for Maxalt in August 2012
(which was approved) but was only filled once. Request stated
“Patient has been using Maxalt since 2008 with good results” but
even though patient has been on Medicaid since 2008, she has only
one paid claim for Maxalt in 2012.
64
Botulinumtoxin Products
 Migraine patient #12
 24 year old female
 History of viral meningitis as well as physical abuse with injury to




neck/upper back
Prophylactic medications tried – divalproex and amitriptyline
Rescue medications used – tramadol described as being effective,
also filling hydrocodone/acetaminophen (no triptans)
Botox given 10/08/2012 and 12/20/2012.
No ER visits for migraines either before or after Botox therapy.
65
Botulinumtoxin Products
 Migraine patient #40
 48 year old male
 Botox given 7-05-12 and 12-07-12
 4 office visits specifically for migraines in 2010; 1 office visit and 1 ER
visit in 2011 for migraines
 3 office visits for migraines in 2012 prior to Botox; none afterwards
 Triptan was approved for patient back in 2007 but only filled once.
 Other medical history – has pacemaker.
66
Botulinumtoxin Products
 Migraine Patient #87
 36 year old female.
 Botox given 10-11-2012 (only once).
 Also has diagnosis of cervicalgia with frequent physical therapy
appointments
 On topiramate and sumatriptan regularly.
 No ER visits for migraines.
67
Botulinumtoxin Products
 MIGRAINES
 Have been receiving prior authorization requests for Botox for
migraines as it has been assumed by some physicians that
prior authorization is required.
 In general, insufficient documentation is being sent especially
quantifying the number of migraines per month and the
duration of headache/migraine per day.
 Inadequate description of success/failure of both prophylactic
and abortive medications to treat migraines.
68
Botulinumtoxin Products
 Recommendations for Botox used for chronic
headaches/migraines
 Require prior authorization for botulinumtoxin for treatment of
chronic headaches and migraines. Prior authorization form has
been created (see copy in your packet). Implementation date would
be July 1, 2013.
 Therapeutic criteria:
1.
Quantification of headaches/migraines prior to
botulinumtoxin therapy. Botox is FDA approved for the
treatment of 15 or more chronic headaches per month with
each headache lasting at least 4 hours. Per package insert:
Safety and efficacy has not been established for prophylaxis of
episodic migraine (14 headache days or fewer per month).
69
Botulinumtoxin Products
 Recommendations for Botox used for chronic
headaches/migraines
 Therapeutic criteria:
2.
What has been tried prior to botulinumtoxin – including
prophylactic therapy and treatment of migraines.
a)
Should prophylactic trials of at least one or two agents be
required ?
b)
Documentation of fills of abortive medications at least
monthly for the previous three months ?
70
Botulinumtoxin Products
 Recommendations for Botox used for chronic
headaches/migraines
 Therapeutic criteria:

If approved, initial approval would be for two injections (given 3
months apart). This duration was used in the clinical studies that
the FDA reviewed to approve Botox for chronic headaches. Idaho
Medicaid would then require additional documentation including
quantification of migraines after botulinumtoxin therapy as well
as utilization of migraine treatment medications (e.g. triptans),
ER utilization, office visits for migraines, and any adverse
reactions to Botox.

Sample Prior Authorization form for Botox for Migraines/Chronic
Headaches included in packet.
71
Botulinumtoxin Products
 CEREBRAL PALSY
 Botox is injected into spastic or stiff muscles where it blocks
transmission between the nerves and the affected muscles which
relaxes the muscle and reduces stiffness. Once the muscles are
relaxed, therapists are able to stretch the muscles. Children under
the age of six respond best to this treatment as it is especially
effective in children who have not developed fixed joint
contractures. Benefits of therapy include improvement in range of
motion, tolerance to wearing braces, and developmental
improvements in crawling, standing, and gait. Duration of effect is
typically four months. Side effects include flu-like symptoms and
weakness of the legs.
72
Botulinumtoxin Products
 DYSTONIAS
 Dystonias are involuntary muscle contractions that cause repetitive
movements or distorted postures.
 Cervical dystonia – contractions cause the head to twist and turn to
one side or pull forward or backward
 Blepharospasm – involuntary spasms causing eyelids to close
73
Botulinumtoxin Products
 TREATMENT OF OVERACTIVE BLADDER OR
URINARY INCONTINENCE
 Botox is approved for treatment in adults who have an inadequate
response to or are intolerant to anticholinergic medications.
 There were no patients receiving Botox for this indication during
the three months of this DUR.
74
Botulinumtoxin Products
 TREATMENT OF MUSCLE SPASMS s/p MAJOR HEAD
TRAUMA
 No specific FDA indication for this situation.
 Treatment of cervical dystonia or upper limb spasticity does not
specify etiology of dystonia or spasticity.
75
Botulinumtoxin Products
76
Botulinumtoxin Products
 Botulinumtoxin – Recommendations for other
indications besides chronic headaches/migraines
 Overactive bladder
 Urinary incontinence
 Upper limb spasticity
 Cervical dystonia
 Severe axillary hyperhidrosis
 Blepharospasm
 Strabismus
77
Botulinumtoxin Products
1.
Require prior authorization for all botulinumtoxin
products ?
2. Grandfather current patients vs. request chart notes to
document effectiveness and safety of current therapy ?
Same decision for all indications ?
3. Proposed implementation date: July 1, 2013
78
79
Injectable Testosterone DUR
Topical formulation of testosterone requires a prior
authorization
 Diagnosis of Testicular hypo function (hypogonadism)
 Idaho Medicaid does not authorize payment of
medications for sexual dysfunction
 Initial requests are approved for 3 months with followup lab results.
80
Injectable Testosterone DUR
Injectable testosterone does not require a prior
authorization
 Appropriate use per diagnosis not evaluated
 Multiple medical non-FDA indicated uses
 Controlled substance with potential for abuse
 Performance enhancer
81
Injectable Testosterone DUR
Questions:
Are testosterone injections being prescribed
appropriately?
Are there duplicative treatments between outpatient
pharmacy benefit and medical benefit (J-codes)?
82
Testosterone DUR
 Evaluated injectable testosterone use in 2012
 Testosterone cypionate
 Testosterone Enanthate
 Compared prescriptions and medical procedure codes
with common diagnosis for use


257.2 Testicular Hypo function
257.9 Testicular Dysfunction Unspecified
83
Testosterone DUR
2012 Results
Age: 0- 75 years Average of 41 years
Average days supply: 28 days ( range: 14-34 days
Average dispensed quantity: 4 mls (range: 1-10 mls)
The most prescribed: Testosterone cypionate 200mg vial
Pharmacy Data:
 Total 152 clients with 532 claims
 4 female
Medical Data:
 Total 104 clients with 533 claims
 6 female
Duplicative Data:
 Total of 15 clients with both Pharmacy and Medical claims
 5 clients had pharmacy/medical claims on the same dates
84
Testosterone Injection by Diagnosis N= 152 (Rx)
120
113
110
100
90
Clients
80
70
60
50
40
30
20
10
18
5
5
2
1
1
1
1
1
1
1
1
1
0
85
Testosterone Injection by Diagnosis N=104 (Medical)
100
91
90
80
70
Clients
60
50
40
30
20
10
4
2
1
1
1
1
1
1
1
0
86
Topical Testosterone
120
113
100
93
Client
80
60
40
20
20
0
Total Rx clients on patches
Patches only
History of Both
87
Testosterone DUR
Conclusions
Pharmacy
 15.7% of clients without a documented diagnosis or unapproved
diagnosis
Medical
 7.6% of clients without a documented diagnosis or unapproved
diagnosis
 33% of clients with duplicative claims noted between medical and
pharmacy claims for the same billing dates.
Prior Authorization of injectable testosterone for therapeutic diagnosis
may be required to evaluate appropriate use and maintain consistency
across the two programs
88
4/18/2013
89
Red Flags
 Five (5) or more psychotropic medications prescribed





concomitantly (reviewed August 2012)
Two (2) or more concomitant antidepressants (reviewed October
2013)
Two (2) or more concomitant antipsychotic medications
(current)
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
90
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
91
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
92
4/18/2013
93
Study Methodology
 Children in Foster Care ages 0-17
 Claims review of any foster child receiving an ADHD
Drug between 11/1/2012 and 1/31/2013
94
Stimulants Included
 amphetamine salt combo
 Methylin solution (methylphenidate)
 Adderall XR (amphetamine salt
combo extended release)
 methylphenidate IR
 dexmethylphenidate
 methylphenidate ER (Ritalin SR
generic)
 Focalin XR (dexmethylphenidate
 methylphenidate ER (Ritalin LA






extended release)
dextroamphetamine IR/ER
Procentra (dextroamphetamine)
Vyvanse (lisdexamfetamine)
Metadate CD (methylphenidate)
Methylin Chew tabs
(methylphenidate)
methylphenidate ER (Concerta
generic)
generic)
 Daytrana (methylphenidate)
 Quillivant XR (methylphenidate)
95
Non-Stimulants Included
 Strattera (atomoxetine)
 Clonidine
 Kapvay (clonidine extended release)
 Guanfacine
 Intuniv (guanfacine extended release)
96
Methodology Limitations
 “Snap-Shot” in time – did not include drug and
dose changes before or after except as noted below
 Excluded from analysis any child that did not have
2 continuous months of stable (same) drug
therapy
 Exception: if less than two months because of new start
between 12/24/2012 and 1/31/2013 then following month
was looked at in electronic record for evaluation of
continuation
 No medical history or profile review completed
97
Final Evaluation Numbers
 759 children in original data pull
 187 with less than 2 months of any drug
 572 evaluated
98
Treatment Patterns
Number of Children in Different Pharmacotherapy
Categories
Four Different Chemical Entities
Three Different Chemical Entities
1
19
109
Two Different Chemical Entities
Same Chemical Entitiy with More than One Strength
IR and ER Dosage Forms (same drug class)*
20
33
One Drug with One Dose
*12 children’s therapy counted in 2-4 different entities included an IR/ER
combination of one of the entities, not counted here
390
99
One Drug/One Dose Summary
 Stimulants (67% of patients)
 Most Used Stimulants


49 % methylphenidate ER
26% amphetamine salt combination ER
 11 % received only an IR formulation
 Non-Stimulants (33% of patients)
atomoxetine (Strattera)
clonidine IR
guanfacine IR
guanfacine ER (Intuniv)
22%
32%
30%
15%
100
Mixture of ER and IR Dosage Forms
 45 total patients (including 12 counted elsewhere)
 methylphenidate ER plus IR
47%
 dexmethylphenidate XR plus IR
18%
 amphetamine salt combo XR plus IR
11%
 Combo of different chemical entities
24%
101
Same Chemical Entity with More
than One Strength
 Total Patients = 22
 Stimulants = 20

Methylphenidate ER 16/20 (80%)
 Non-stimulants = 2
 Dosing
 36% exceeded daily dose guidelines


7/16 methylphenidate ER patients
1 lisdexamfetamine (Vyvanse) patient
102
Summary of Two Different Chemical
Entities
 109 patients
 61% ER stimulant and IR non-stimulant

Most common


methylphenidate ER with clonidine
methylphenidate ER with guanfacine
 16% ER stimulant and ER non-stimulant
 Most common



Vyvanse (lisdexamfetamine) with Intuniv (guanfacine)
methylphenidate ER with Intuniv
Adderall XR (amphetamine salt combo) with Intuniv
 The dose was maximized for one or both of the agents in
18 patients ( 17%)
103
Summary of Three Different
Chemical Entities
 19 patients had three different chemical entities
 6 patients had an ER stimulant + ER non-stimulant + IR
non-stimulant

4 included a combination of clonidine plus Intuniv
(guanfacine ER)
 5 patients had an ER stimulant plus 2 IR non-stimulants

All of these included guanfacine + Strattera (atomoxetine)
 Dose was maximized in one or all agents in only 3
patients
104
Patient with Four Different
Chemical Entities
dexmethylphenidate IR 5 mg daily
dexmethylphenidate XR 15 mg daily
clonidine 0.2 mg daily
guanfacine 5 mg daily
atomoxetine 40 mg daily
105
Duplicate Therapy
 Two different long-acting stimulants = 5 patients
 dexmethylphenidate ER + Daytrana (methylphenidate) = 1
 dexmethylphenidate ER + methylphenidate ER = 1
 Vyvanse (lisdexamfetamine) + methylphenidate ER = 2
 Two different short-acting stimulants = 1 patient
 Two different long-acting non-stimulants = 1 patient
 Two different short-acting non-stimulants = 12 patients
 clonidine + atomoxetine = 6
 guanfacine + atomoxetine = 5
 clonidine + guanfacine = 1
 Three different non-stimulants = 1 patient
 clonidine + guanfacine + atomoxetine
 TOTAL = 20 patients
106
Next Steps
 ? Profile and medical history review of outliers
 ? Evaluation of number and specialty of prescribers
 ? Other
107
Proposed Studies for Next Quarter:
 P&T Committee Narcotic Analgesic Studies – Next
Steps
 Use of Psychotropic Medications in Foster
Children – Next Steps
 Three (3) or more concomitant mood stabilizer
medications
 Hepatitis C Agents
 Antipsychotic Indication Evaluation- Hold for
Future
 AAP and DVTs- Hold for future
108
P&T Committee Narcotic Analgesic
Studies – Next Steps
109
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.
110
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
111
Use of Psychotropic Medications in
Foster Children: Next Steps
 Three (3) or more concomitant mood stabilizer
medications
112
Hepatitis C Agents
 Incivek and Victrelis
 Review past 6 months of data for usage





Are patients that started on therapy continuing therapy?
Will be requesting chart notes to determine why patients
discontinued therapy (e.g. intolerable side effects vs. nonresponders to therapy based on viral counts) vs. noncompliance.
Will look for trends in patients that discontinued therapy (e.g.
does rate vary between practices or geographically)
Are patients on TRIPLE therapy with ribavirin and
interferon? Check for adherence to all three medications.
Audit for checking viral counts at appropriate time intervals
113
Hepatitis C Agents
 Incivek and Victrelis
 Look at quarterly trends in usage since Incivek/Victrelis
were approved by the FDA in May 2011 as patients were
not started on double therapy (ribavirin/interferon) as
the specialists were waiting for triple therapy to be
available.
 In the future an all oral regimen is going to be available
for treatment of Hepatitis C so there may be patient
“warehousing” again.
114
Antipsychotic Indication EvaluationHold for Future
115
AAP and DVTs- Hold for future
116
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
117
Prospective DUR Report
Idaho Medicaid Program
ProDUR Message Report
March-13
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
1
2
1
2
3
1
2
A
B
C
D
X
0
0
0
Message
Count
1,696
14,228
73,113
220
2,699
68,820
242,531
305,006
100
25
8
104
204
24
50
119,918
32,097
22,077
Message
Amount
$464,457.99
$2,471,750.95
$12,541,653.63
$76,867.77
$319,980.77
$10,040,216.19
$44,050,971.97
$52,254,965.87
$1,348.97
$840.03
$106.64
$11,723.20
$18,054.61
$2,068.05
$1,416.20
$35,587,342.92
$6,412,192.38
$4,131,301.25
882,920
$168,387,259.39
Total Number of Claims with Messages 215,450
Average ProDUR Message Per Claim
4.10
118
DUR Spring Newsletter
 Copy of Winter Newsletter in packet
 Brainstorm for new topics
119
Medicaid Update
120