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Idaho Medicaid Drug Utilization Review Program . 18 April 2013. ADURS (American Drug Utilization Review Society). February 21-23, 2013 Scottsdale, Arizona Representatives present from 40 state Medicaid programs 109 total participants. ADURS. - PowerPoint PPT Presentation
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Idaho Medicaid Drug Utilization Review Program
18 April 2013
1
ADURS (American Drug Utilization Review Society)
February 21-23, 2013Scottsdale, Arizona
Representatives present from 40 state Medicaid programs109 total participants
2
ADURSRound Table presentations from state
Medicaid representatives
Recurrent IssuesOpioid therapy for non-malignant painPsychotropic medications in childrenSuboxone therapy
3
ADURSOpening Session
Health Care Reform: How States are Responding
Speaker was from the National Conference of State Legislatures
4
ADURSContinuing Education Topics
Collaborative Care – How to increase safe use of psychotropic medications in children and adolescents.
Hemophilia 101
Medicaid Fraud and Abuse
Managed Care Medicaid5
ADURSContinuing Education Topics
Carving the Prescription Benefit Back In to Medicaid
340(b) Programs
New Drugs 2013
6
Follow-up to Previous ReviewsAtopic DermatitisP&T Committee Narcotic Analgesic
Studies
7
Atopic DermatitisThe 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
9
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.
Atopic Dermatitis
10
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)?
Atopic DermatitisEducational Document included in the Packet
11
Atopic Dermatitis
12
More than 6 claims for Elidel or Protopic in one yearPatient Number
Patient Age (years) Drug
# Claims for Elidel/Protopic
# Claims for Topical Steroid Prescriber
Diagnosis in Electronic Profile
64 15 Elidel 11 24 Dermatologist atopic dermatitis
269 14 Elidel 11 11 P.A.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. eczema
196 9 Protopic 9 9 Dermatologistatopic 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 eczema
156 10 Protopic 8 8 Allergistatopic dermatitis, eczema
75 41 Protopic 8 1 Family Medicineatopic dermatitis, eczema
203 10 Elidel 7 11 Dermatologist eczema
399 4 Elidel 7 0 Pediatricsatopic dermatitis, eczema
Atopic Dermatitis#201
9 year old male11 Elidel claims in one year; only 3 topical
steroid claims in the same time periodStill filling Elidel monthly.Family Medicine prescriber; no derm diagnosis
in electronic profile.Send letter.
13
Atopic Dermatitis#5
39 yr male10 Protopic claims in one year/ no topical
steroid claims in the same time period.Family Medicine prescriber; only derm
diagnosis is ICD-9 757.39 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 female9 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 male9 Elidel claims in one year; no topical steroids.
Last paid claim for topical steroid was in 2006. Elidel last filled 1-17-13.
Pediatric prescriber; no derm diagnosis in electronic profile.
Send letter.
16
Atopic Dermatitis#75
41yr female8 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 DermatitisComments/Questions?
19
P&T Committee Narcotic Analgesic Studies
20
Narcotic Analgesic UpdateParticipants 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
23
Lowest = 10 mgHighest = 2421 mg
0-99100 - 199200-299300-399400-499500-599600-699700-799800-899900-999
1000-10991100-11991200-12991300-1399
2000 or More
0 5 10 15 20 25 30 35 40 45
Daily Morphine Equivalents
Number of participants
Daily Morphine Equivalents (mg)
Average = 256 mg equivalents
Participants Receiving Over 500 Morphine Equivalents in 2011 StudyOriginal 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 ParticipantsCharacteristic Number of PatientsOriginal participants still meeting threshold (> 500 mg MS equivalents)
6
Ineligible or Inactive for Idaho Medicaid
2
Deceased 5Incarcerated 1Current dose < 500 mg MS equivalents
16
25
Follow-up RequestLetter (see packet) sent 2/13/2013Included patient medication profile and Board of
Pharmacy controlled substance reportRequested Chart Notes and Documentation for
most recent 6 monthsEvaluation and monitoring of pain reliefEvaluation for improvement in daily functionPotential misuse/abuseCurrent treatment planPain contract Random urine screen results
26
Participant Review5 of 6 participants’ prescribers returned
documentationCase Presentations
Top User no longer receiving: Chris JohnsonMost complex user: Jane GennrichRemaining 4 users: Tami Eide
27
Current Interventions/Outcomes StudiesZolpidem High DoseMigraine Prevention
Prophylaxis Utilization in Chronic Triptan UtilizersBotulinumtoxin ProductsTestosterone enanthate/cypionate (injectable)Psychotropic Medications in Foster Children
Two (2) or more concomitant stimulant medications long-acting plus short-acting ok
28
Zolpidem High DoseOn 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 DoseA 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:
30
Zolpidem Paid Claims 10/01/2012 – 12/31/2012
Male ≥2 per day Female ≥2 per day Prescribers
Ambien 5mg 63 10 223 33 209
Ambien 10mg 457 1514 879
Ambien CR 6.25mg 0 0 0
Ambien CR 12.5mg 19 47 44
Zolpidem High DosePatients 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 DoseCriteria 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. The NEW immediate release zolpidem dose in women is being lowered from 10 mg
to 5 mg.2. The NEW extended release zolpidem dose in women is being lowered from 12.5 mg
to 6.25 mg.3. 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 treatment126
Will use this information in care of future patients120
Information clinically useful: plan to monitor113
Reviewed and do not believe adjustment is needed72
Attempted to modify therapy unsuccessfully15
Not my patient, never has been5
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
37
Zolpidem Paid Claims
Male >1 per day Female >1 per day Prescribers MAXQTY
Month/Year 12/12 3/13 12/12 3/13 12/12 3/13 12/12 3/13 12/12 3/13
Ambien 5mg 38 55 3 4 118 271 15 19 102 150 Q02Ambien
10mg 305 301 7 10 1010 823 51 30 639 558 Q02Ambien CR
6.25mg 0 0 0 8 0 8 Q01Ambien CR
12.5mg 17 11 38 34 35 33 Q01
Payment Amount to Pharmacy: 12/12 - $25,787; 3/13 - $24,555
Zolpidem High DoseThoughts/Comments?
38
Migraine PreventionIdaho 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 PreventionEpidemiology
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
Female194982%
Male41818%
Unique Recipients (Idaho Medicaid Popu-lation)
42
Migraine Prevention: recipients with paid triptan claim between 1/1/2012 and 12/31/2012
Female614385%
Male110815%
Claims (Idaho Medicaid Population)
43
Migraine Prevention: recipients with paid triptan claim between 1/1/2012 and 12/31/2012
44
Female 667532
86%
Male 105894 14%
Amount Paid at POS (Idaho Medicaid Population)
Migraine PreventionEpidemiology
Race Caucasians > African Americans > Asians
Geography Americas > Europe/Middle East > Asia > Africa
Economic ImpactEstimated 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 PreventionMedical Diagnosis (based on direct
questionnaires)1989 – 38% of sufferers1999 – 48% of sufferers
PrognosisChronic condition with severity and frequency
diminishing with advancing age.Treatment
AbortivePreventative
46
Migraine PreventionPreventative 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 PreventionIdaho 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 claimOf these 1,258 recipients, 281 (22%) had a
claim for one of the Level A Medications as described in the Evidence-based guideline update.
48
Migraine PreventionNext Steps???
49
Migraine PreventionReferences
http://www.neurology.org/content/78/17/1337.full.html http://www.neurology.org/content/78/17/1346.full.html http://www.neurology.org/content/63/12/2215.full.html http://emedicine.medscape.com/article/114256-overview http://www.medscape.com/viewarticle/429665_print
50
Botulinumtoxin ProductsBotulinumtoxin 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 ProductsWhile 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 ProductsProcedure Code
Trade Name
Generic Name and Billing Units
Prior Authorizati
on 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
incobotulinumtoxin A, 1 unit
YES (as of August 2012)
3 (prior to August 2012)
$647
TOTALS 525 $431,681
53
Botulinumtoxin ProductsTrade Name
Generic Name and Billing Units
FDA approved indications
Botox onabotulinumtoxin A, 1 unit
Urinary incontinenceMigrainesSpasticityCervical dystoniaHyperhidrosisBlepharospasmStrabismusOveractive bladder (new – January 2013)Cosmetic (not covered by Idaho Medicaid)
54
Botulinumtoxin ProductsTrade Name
Generic Name and Billing Units
FDA approved indications
Dysport abobotulinumtoxin A, 5 units
Cervical dystoniaCosmetic (not covered by Idaho Medicaid)
Myobloc rimabotulinumtoxin B, 100 units
Cervical dystonia
Xeomin incobotulinumtoxin A, 1 unit
Cervical dystoniaBlepharospasm
55
Botulinumtoxin ProductsPatients with paid claims for botulinumtoxin
between 10/01/2012-12/31/2012: 98Diagnoses
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: 5Misc: 4 (details on next slide)
56
Botulinumtoxin ProductsDiagnoses
Misc: 4 Patient #7 – dysphagia Patient #20 – spina bifida Patient #91 – closed fracture of vertebral column,
muscle spasm Patient #77 - blepharospasm
57
Botulinumtoxin ProductsMIGRAINES
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 ProductsMIGRAINES
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 ProductsMIGRAINES
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 ProductsMIGRAINES
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 ProductsMigraine patient #6
58 year old femaleLong history (many years) of migraines2010: 20 ER visits/office visits specifically for migrainesJan 1- Sep 30, 2011: 11 ER visits/office visits specifically
for migrainesBotox started: 9/30/2011Receiving Botox approximately every 3 months: 1/20/12,
4/13/12, 7/5/12, 11/02/12No ER visits/office visits for migraines Oct 1 – Dec 31,
20118 ER visits/office visits for migraines in 2012Has been on verapamil and nadolol 2010 – presentOne paid claim for triptan 7/19/2010 62
Botulinumtoxin ProductsMigraine patient #18
51 year old female2010: 9 ER/office visits specifically for migrainesJan 1 – Sep 30, 2011: 7 ER/office visits specifically for
migrainesBotox started: 9/30/2011Receiving Botox approximately every 3 months since
then2 more ER/office visits for migraines Oct 1 – Dec 31,
20119 ER/office visits specifically for migraines in 2012Has been on propranolol 2010 – present
63
Botulinumtoxin ProductsMigraine 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 ProductsMigraine patient #12
24 year old femaleHistory of viral meningitis as well as physical abuse with
injury to neck/upper backProphylactic medications tried – divalproex and
amitriptylineRescue 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 ProductsMigraine patient #40
48 year old maleBotox given 7-05-12 and 12-07-124 office visits specifically for migraines in 2010; 1 office
visit and 1 ER visit in 2011 for migraines3 office visits for migraines in 2012 prior to Botox; none
afterwardsTriptan was approved for patient back in 2007 but only
filled once.Other medical history – has pacemaker.
66
Botulinumtoxin ProductsMigraine Patient #87
36 year old female.Botox given 10-11-2012 (only once).Also has diagnosis of cervicalgia with frequent physical
therapy appointmentsOn topiramate and sumatriptan regularly.No ER visits for migraines.
67
Botulinumtoxin ProductsMIGRAINES
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 ProductsRecommendations for Botox used for chronic
headaches/migrainesRequire 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 ProductsRecommendations for Botox used for chronic
headaches/migrainesTherapeutic 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 ProductsRecommendations for Botox used for chronic
headaches/migrainesTherapeutic 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 ProductsCEREBRAL 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 ProductsDYSTONIAS
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 ProductsTREATMENT OF OVERACTIVE BLADDER OR
URINARY INCONTINENCEBotox 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 ProductsTREATMENT OF MUSCLE SPASMS s/p
MAJOR HEAD TRAUMANo 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 ProductsBotulinumtoxin – Recommendations for
other indications besides chronic headaches/migrainesOveractive bladderUrinary incontinenceUpper limb spasticityCervical dystoniaSevere axillary hyperhidrosisBlepharospasmStrabismus
77
Botulinumtoxin Products1. 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
Testosterone Injection DUR
79
Injectable Testosterone DURTopical formulation of testosterone requires a prior authorizationDiagnosis of Testicular hypo function
(hypogonadism)Idaho Medicaid does not authorize payment
of medications for sexual dysfunctionInitial requests are approved for 3 months
with follow-up lab results.
80
Injectable Testosterone DURInjectable testosterone does not require a prior authorizationAppropriate use per diagnosis not evaluated
Multiple medical non-FDA indicated usesControlled substance with potential for abuse
Performance enhancer
81
Injectable Testosterone DURQuestions:
Are testosterone injections being prescribed appropriately?
Are there duplicative treatments between outpatient pharmacy benefit and medical benefit (J-codes)?
82
Testosterone DUREvaluated injectable testosterone use in 2012
Testosterone cypionateTestosterone Enanthate
Compared prescriptions and medical procedure codes with common diagnosis for use
257.2 Testicular Hypo function 257.9 Testicular Dysfunction Unspecified
83
Testosterone DUR2012 ResultsAge: 0- 75 years Average of 41 yearsAverage days supply: 28 days ( range: 14-34 daysAverage dispensed quantity: 4 mls (range: 1-10 mls)The most prescribed: Testosterone cypionate 200mg vial
Pharmacy Data:Total 152 clients with 532 claims4 femaleMedical Data:Total 104 clients with 533 claims6 femaleDuplicative Data:Total of 15 clients with both Pharmacy and Medical claims
5 clients had pharmacy/medical claims on the same dates84
257.2
Testi
cular
hypo
functi
on
No Diag
nosis
253.2
Panh
ypop
ituita
rism
758.7
Klin
efelte
r syn
drom
e
604.0
Orch
itis, O
ther M
ale G
enita
l diso
rder
s NOS
259.0
Dela
yed s
exua
l dev
elopm
ent
302.8
5 Gen
der I
denti
ty dis
orde
r
607.8
4 Impo
tence
of or
ganic
origi
n
611.1
Hyp
ertro
phy o
f bre
asts
302.7
2 Psy
chos
exua
l dys
functi
on w
ith in
hibite
d sex
ual e
xcite
ment
255.2
Adre
noge
nital
disor
der
752.6
4 Micr
open
is
256.2
Post
ablat
ive ov
arian
failu
re
627.2
Sympto
matic f
emale
clim
acter
ic sta
te0
10
20
30
40
50
60
70
80
90
100
110
120 113
18
5 5 2 1 1 1 1 1 1 1 1 1
Testosterone Injection by Diagnosis N= 152 (Rx)C
lient
s
85
0
10
20
30
40
50
60
70
80
90
10091
4 2 1 1 1 1 1 1 1
Testosterone Injection by Diagnosis N=104 (Medical)C
lient
s
86
Total Rx clients on patches Patches only History of Both0
20
40
60
80
100
120113
93
20
Topical Testosterone C
lient
87
Testosterone DURConclusions
Pharmacy15.7% of clients without a documented diagnosis or unapproved
diagnosis
Medical7.6% of clients without a documented diagnosis or unapproved
diagnosis33% 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
Foster Children Psychotropic Drugs Red Flags
4/18/2013
89
Red FlagsFive (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 okThree (3) or more concomitant mood stabilizer
medicationsPsychotropic polypharmacy (2 or more agents) for a
given mental disorder prescribed before utilizing psychotropic monotherapy 90
91
Implementation of Red Flags
Retroacti
ve Evaluatio
n
Identify outliers
Profile
Review
DUR Board Intervention• Targ
eted education
Re-evaluation• indi
viduals
• overall
Further
Action
Point of service edits• Informa
tional (soft) – pharmacist override
• Hard Stop
ADHD Drugs Anti-depressants Mood Stabilizers Atypical Antipsychotics0%
5%
10%
15%
20%
25%
30%
35%
40%
36%
23%
13%
21%
9%
6%
0%
4%
Percent of Foster and Non-Foster Children Psychotropics by Drug Class
Calendar Year 2011
% Foster Children% Non-foster Children
Total foster =2785Total Non-Foster = 106,024
92
Foster Children ADHD Drug Therapy Focus
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 Adderall XR (amphetamine salt
combo extended release) dexmethylphenidate Focalin XR
(dexmethylphenidate extended release)
dextroamphetamine IR/ER Procentra (dextroamphetamine) Vyvanse (lisdexamfetamine) Metadate CD (methylphenidate) Methylin Chew tabs
(methylphenidate) methylphenidate ER (Concerta
generic) Methylin solution
(methylphenidate) methylphenidate IR methylphenidate ER (Ritalin SR
generic) methylphenidate ER (Ritalin LA
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 therapyException: 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
*12 children’s therapy counted in 2-4 different entities included an IR/ER combination of one of the entities, not counted here
One Drug with One Dose
IR and ER Dosage Forms (same drug class)*
Same Chemical Entitiy with More than One Strength
Two Different Chemical Entities
Three Different Chemical Entities
Four Different Chemical Entities
390
33
20
109
19
1
Number of Children in Different Pharmacotherapy Categories
99
One Drug/One Dose SummaryStimulants (67% of patients)
Most Used Stimulants 49 % methylphenidate ER 26% amphetamine salt combination ER
11 % received only an IR formulationNon-Stimulants (33% of patients)
atomoxetine (Strattera) 22%clonidine IR 32%guanfacine IR 30%guanfacine ER (Intuniv) 15%
100
Mixture of ER and IR Dosage Forms45 total patients (including 12 counted
elsewhere)
methylphenidate ER plus IR 47%
dexmethylphenidate XR plus IR 18%
amphetamine salt combo XR plus IR11%
Combo of different chemical entities24%
101
Same Chemical Entity with More than One StrengthTotal Patients = 22
Stimulants = 20 Methylphenidate ER 16/20 (80%)
Non-stimulants = 2Dosing
36% exceeded daily dose guidelines 7/16 methylphenidate ER patients 1 lisdexamfetamine (Vyvanse) patient
102
Summary of Two Different Chemical Entities109 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 Entities19 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 Entitiesdexmethylphenidate IR 5 mg dailydexmethylphenidate XR 15 mg dailyclonidine 0.2 mg dailyguanfacine 5 mg daily atomoxetine 40 mg daily
105
Duplicate TherapyTwo different long-acting stimulants = 5 patients
dexmethylphenidate ER + Daytrana (methylphenidate) = 1dexmethylphenidate ER + methylphenidate ER = 1Vyvanse (lisdexamfetamine) + methylphenidate ER = 2
Two different short-acting stimulants = 1 patientTwo different long-acting non-stimulants = 1 patientTwo different short-acting non-stimulants = 12 patients
clonidine + atomoxetine = 6guanfacine + atomoxetine = 5clonidine + guanfacine = 1
Three different non-stimulants = 1 patientclonidine + 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 StepsUse of Psychotropic Medications in Foster
Children – Next StepsThree (3) or more concomitant mood stabilizer
medicationsHepatitis C AgentsAntipsychotic Indication Evaluation- Hold
for FutureAAP 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
ADHD Drugs Anti-depressants Mood Stabilizers Atypical Antipsychotics0%
5%
10%
15%
20%
25%
30%
35%
40%
36%
23%
13%
21%
9%
6%
0%
4%
Percent of Foster and Non-Foster Children Psychotropics by Drug Class
Calendar Year 2011
% Foster Children% Non-foster Children
Total foster =2785Total Non-Foster = 106,024
111
Use of Psychotropic Medications in Foster Children: Next StepsThree (3) or more concomitant mood stabilizer
medications
112
Hepatitis C AgentsIncivek 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. non-responders to therapy based on viral counts) vs. non-compliance.
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 AgentsIncivek 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 Evaluation- Hold for Future
115
AAP and DVTs- Hold for future
116
Prospective DUR ReportHistory 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 ReportIdaho Medicaid ProgramProDUR Message Report
March-13
ProDUR ProDUR Message MessageMessage Severity Count Amount
Drug To Drug 1 1,696 $464,457.99 2 14,228 $2,471,750.95 3 73,113 $12,541,653.63Drug To Gender 1 220 $76,867.77 2 2,699 $319,980.77Drug To Known Disease 1 68,820 $10,040,216.19 2 242,531 $44,050,971.97 3 305,006 $52,254,965.87Drug To Pregnancy 1 100 $1,348.97 2 25 $840.03 A 8 $106.64 B 104 $11,723.20 C 204 $18,054.61 D 24 $2,068.05 X 50 $1,416.20Duplicate Therapy 0 119,918 $35,587,342.92Min Max 0 32,097 $6,412,192.38Too Soon Clinical 0 22,077 $4,131,301.25ALL 882,920 $168,387,259.39 Total Number of Claims with Messages 215,450 Average ProDUR Message Per Claim 4.10
118
DUR Spring NewsletterCopy of Winter Newsletter in packetBrainstorm for new topics
119
Medicaid Update
120