dur 7 18 2019 final v2 · rizatriptan: teratogenicity/effects in pregnancy u.s. food and drug...
TRANSCRIPT
July 18, 2019
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Federal Fiscal Year 2018(10/1/2017 through 9/30/2018)
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BackgroundSection 1927(g)(3)(D) of the Social Security Act (the Act) requires each State to submit an annual report on the operation of its Medicaid Drug Utilization Review (DUR) program. Such reports are to include descriptions of :Nature and scope of the prospective and retrospective DUR programs
Retrospective DUR intervention summaryDUR Board Activities Program Assessment Impact on quality of care Cost savings generated by the program.
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Contents: Sections
Demographic InformationProspective DUR (ProDUR)Retrospective DUR (RetroDUR)DUR Board ActivityPhysician Administered DrugsGeneric Policy and Utilization DataProgram Evaluation/Cost Savings/Cost AvoidanceFraud, Waste, and Abuse Detection Innovative PracticesE‐PrescribingManaged Care Organizations
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Contents: Attachments
Pharmacy Oral Counseling Compliance ReportRetroDUR Educational Outreach SummarySummary of DUR Board ActivitiesGeneric Drug Substitution PoliciesCost Savings/Cost Avoidance Innovative PracticesE‐PrescribingExecutive Summary
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ProDUR Questions for Further Action
Do you receive and review follow‐up periodic reports providing individual pharmacy provider DUR alert override activity in summary and/or in detail?
If you receive reports, do you follow up with those providers who routinely override with interventions ? Contact Pharmacy ? Refer to Program Integrity for Review
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Top 10 PA Requests by Drug NameRank 2018 2017
1 duloxetine duloxetine
2 Lyrica Strattera
3 oxycodone Lyrica
4 Advair Advair
5 Symbicort Invega Sustenna
6 Invega Sustenna Symbicort
7 Norditropin Flexpro dextroamphetamine‐amphetamine
8 dextroamphetamine‐amphetamine Norditropin Flexpro
9 paroxetine Adderall XR
10 Adderall XR lamotrigine
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Top 10 PA Requests by Drug ClassRank 2018 2017
1 Serotonin‐Norepinephrine Receptor Antagonists Anticonvulsants
2 Beta Agonists and Glucocorticoid Combo Inhalers Serotonin‐Norepinephrine Receptor Antagonists
3 Anticonvulsants Beta Agonists and Glucocorticoid Combo Inhalers
4 Opioid Analgesics Adrenergics, aromatic, non‐catecholamine
5 Adrenergics, aromatic, non‐catecholamine Antipsychotic, Atypical, Dopamine, serotonin Antagonist
6 Antipsychotic, Atypical, Dopamine, serotonin Antagonist
TX for ADHD NRI Type
7 Growth Hormones Sedative‐hypnotics, non‐barbiturate
8 TX for ADHD/Narcolepsy Growth Hormones
9 Selective Serotonin Reuptake Inhibitors Narcotic Analgesics
10 TX for ADHD NRI Type TX for ADHD/Narcolepsy
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Top 5 Claim Denial ReasonsRank 2018 2017
1 Drug‐Disease Intervention Drug‐Disease Intervention
2 Prior Authorization Required Therapeutic Duplication
3 Therapeutic Duplication Prior Authorization Required
4 Plan limitations exceeded Plan limitations exceeded
5 Overuse Precaution Overuse Precaution
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Top 10 Drug Names by Amount Paid/Percent of Total Spend
Rank 2018 Drug 2017 Drug 2017 Percent of Total Spend
1 Norditropin Flexpro 3.81 % Latuda 3.3 %
2 Invega Sustenna 3.32 % Invega Sustenna 3.16 %
3 Latuda 3.01 % Norditropin Flexpro 2.94 %
4 Mavyret 2.46 % Abilify Maintena 2.73 %
5 Novoseven RT 2.27 % Invega 2.08 %
6 Sabril 1.98 % Strattera 1.83 %
7 Humira Pen 1.75 % Harvoni 1.75 %
8 Abilify Maintena 1.69 % Methylphenidate ER 1.59 %
9 Lyrica 1.67 % Lyrica 1.58 %
10 Methylphenidate ER 1.35 % Novoseven RT 1.55 %
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Generic Drugs Generic Utilization Percentage 82.4%
Generic Expenditure Percentage 19%
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Cost Savings/Cost Avoidance ProDUR Estimated Avoided Costs $ 15,178,970
Reversed claims not resubmitted RetroDUR Estimated Avoided Costs $ 1,544,479
Grand Total Estimated Avoided Costs $ 16,723,450
Savings = 7.8 % of Total Drug Expenditures
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Fraud, Waste and Abuse DetectionDo you have a documented process in place that identifies potential fraud or abuse of controlled drugs by beneficiaries?
YES
What actions does this process initiate? Denies claims and requires prior authorization Refer to lock‐in program
Do you have a “ lock‐in” program for beneficiaries who misuse or abuse controlled substances? Yes What criteria does your state use to identify candidates for lock‐in
Number of controlled substances Different prescribers of CS Multiple pharmacies Multiple ER visits PDMP Data Other: Provider and Board of Pharmacy Referrals
Beneficiary restricted to both prescriber and pharmacy Lock‐ in Time Period ‐ 12 months
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Provider and Beneficiary Fraud and Abuse
Do your have a documented process in place that identifies potential fraud or abuse of controlled drugs by prescribers? No
Do your have a documented process in place that identifies potential fraud or abuse of controlled drugs by pharmacy providers? No
Do you have a documented process in place that identifies potential fraud or abuse of non‐controlled drugs by beneficiaries? No
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PDMP Agency able to query ? Yes
Require prescribers access to PDMP before prescribing? No
Access to border states PDMP data? Yes
Do you also have PDMP data (i.e. outside of MMIS, such as a controlled substance that was paid for by using cash) integrated into your POS edits? No
Identified barriers : Lag time between dispensing and PDMP reporting from other states Lack of aggregate reports (cash, > threshold from any source) Not able to see methadone clinics
Improvements Addition of VA and military information
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Retrospective Educational Outreach Summary
Top 150 Utilizers of Opioids CDC Guidelines individualized based on treatment duration, high dosage, multiple prescribers, cash paying for additional opioids and benzodiazepines concomitant with opioids
Methadone Case management to taper to < 40 mg/day or switch opioids
Buprenorphine Prescriber contact for cash paying for opioids or concurrent benzodiazepines
Two or More Benzodiazepines Lettered on patients with at least 60 days of 2 or more overlapping during a 6 month period
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DUR Board Activities Narcotic Prescribing Improvement Project
Top 150 Utilizers Idaho Opioid Equivalent Dosing Project Methadone
Buprenorphine and Benzodiazepine Concomitant Use
Buprenorphine vs. buprenorphine/naloxone for treatment of substance use disorder
Buprenorphine and Presence or Absence of Adjunct Therapy
Naloxone
Benzodiazepines
Temazepam
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DUR Board Activities ‐2 Hepatitis C
Nifedipine IR/Methyldopa
Long‐Term Use of Proton Pump Inhibitors/Deprescribing
Niacin
Typical Antipsychotics
Spinraza
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Innovative Practices Buprenorphine direct to the prescriber intervention
Pharmacist Case Management – Methadone and Hemophilia
Narcotic Prescribing Improvement Project 90 MME limit Since January of 2017 decrease in number of members on opioids by 28% and number of members on > 90 MME by 32%
Physician Administered Drugs Added PA of genetic tests specific to drug indication, dosing and metabolism
High Cost Drug Prediction Model Able to extend Hepatis C coverage to F0 and above – doubled the number of patients treated in previous years at 1/3 of cost
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Executive Summary Highlights Idaho Medicaid and Magellan Partnership
Internal PA Call Center
DUR Outcome Studies on PDL Impact
Lack of Legislative Restriction
Physician Administered Drugs
18 RetroDUR Studies
Narcotic Analgesics Emphasis
Generic Utilization – not best measure $ 1.5 million cost avoidance per quarter with brand
> 80 Drug Classes on Preferred Drug List
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Follow‐up to Previous Reviews
Butalbital DUR
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July 18, 2019
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Butalbital DUR
Question asked at April 2019 DUR Meeting:
What medications can be safely used to treat migraines during pregnancy?
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Butalbital DUR
The A, B, C, D and X pregnancy risk categories, in use since 1979, are now replaced with narrative sections on pregnancy, lactation, and fertility.
PREVIOUSLY Category A
Adequate and well‐controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well‐controlled studies in pregnant women.
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Butalbital DUR
The A, B, C, D and X risk categories, in use since 1979, are now replaced with narrative sections on pregnancy, lactation, and fertility.
PREVIOUSLY Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well‐controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category D There is positive evidence of human fetal risk based on adverse reaction data from investigational
or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category X Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive
evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
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Butalbital DUR
The A, B, C, D and X risk categories, in use since 1979, have been replaced with narrative sections and subsections to include:
Pregnancy (includes Labor and Delivery): Pregnancy Exposure Registry Risk Summary Clinical Considerations Data
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Butalbital DUR
The A, B, C, D and X risk categories, in use since 1979, are now replaced with narrative sections and subsections to include:
Lactation (includes Nursing Mothers) Risk Summary Clinical Considerations Data
Females and Males of Reproductive Potential Pregnancy Testing Contraception Infertility
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Butalbital DUR
Butalbital: Teratogenicity/Effects in Pregnancy
U.S. Food and Drug Administration's Pregnancy Category: Category C (All Trimesters)
Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
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Butalbital DUR
Butalbital: Teratogenicity/Literature Reports
a) Exposure to medications containing butalbital in infants during the periconceptional period resulted in a statistically significant increase in the odds of developing congenital heart defects, including tetralogy of Fallot, pulmonary valve stenosis, or secundum‐type atrial septal defects.
b) In a large study, butalbital use during the first trimester of 112 pregnancies was not associated with any fetal malformations.
c) Barbiturate withdrawal syndrome with symptoms of overactivity, irritability, vasomotor instability, and tremulousness was seen in a male infant 2 days after birth. His mother had taken butalbital 150 mg daily throughout the last 2 months of pregnancy.
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Butalbital DUR
Butalbital: Teratogenicity/Clinical Management
Although there are few reports concerning butalbital specifically, teratogenic effects have been associated with use of barbiturates in general. Because use of butalbital does not represent a medical necessity, use of butalbital during pregnancy is not recommended. If pregnancy occurs during treatment with butalbital, the patient should be advised of possible consequences to the fetus.
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Butalbital DUR
Butalbital: Breastfeeding
Micromedex Lactation Rating: Infant risk cannot be ruled out.
Available evidence and/or expert consensus is inconclusive or is inadequate for determining infant risk when used during breastfeeding. Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during breastfeeding.
No reports describing the use of butalbital specifically in lactation are available. Since small amounts of barbiturates are eliminated in breast milk and there is the potential for serious adverse reactions in the infant, the decision should be made to discontinue nursing or to discontinue the drug based upon the importance of the drug to the mother.
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Butalbital DUR
Rizatriptan: Teratogenicity/Effects in Pregnancy
U.S. Food and Drug Administration's Pregnancy Category: Category C (All Trimesters)
Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
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Butalbital DURRizatriptan: Teratogenicity/Literature Reports
a) Data collected by Merck's pregnancy registry which monitors the outcomes of pregnant women exposed to rizatriptan indicates that there have been 2 congenital abnormalities (3.1%, 95% confidence interval (CI), 0.4% to 11.1%) out of 65 prospective live birth reports.
b) There are no adequate and well‐controlled studies of rizatriptan use during pregnancy. Reproductive studies conducted in rats, administered 10 and 100 mg/kg/day rizatriptan (approximately 15 and 225 times, respectively, the human exposure at a maximum recommended daily dose (MRDD) of 30 mg) demonstrated no maternal toxicity. However, reduced birth weights and pre‐ and post‐weaning weight gain were observed in the offspring.
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Butalbital DURRizatriptan: Teratogenicity/Clinical Management
Although there have been a small number of successful outcomes of pregnancy after exposure to rizatriptan, there are no adequate and well‐controlled studies of rizatriptan use during pregnancy. Until additional data are available, rizatriptan should be used in pregnant women only if the potential benefit outweighs the potential risk to the fetus. Merck & Co., Inc. maintains a registry to monitor the pregnancy outcomes of women exposed to Maxalt(R) while pregnant. Healthcare providers are encouraged to report any prenatal exposure to Maxalt(R) by calling the Pregnancy Registry at (800) 986‐8999.
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Butalbital DUR
Rizatriptan: Breastfeeding
Micromedex Lactation Rating: Infant risk cannot be ruled out.
Clinical ManagementIt is not known whether rizatriptan is excreted into human breast milk and the potential for adverse effects in the nursing infant from exposure to the drug are unknown. Rizatriptan is excreted in the milk of lactating rats at levels of 5 times and greater than in maternal plasma levels. Therefore, caution is advised when rizatriptan is administered to nursing mothers
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Butalbital DUR
Diclofenac: Teratogenicity/Effects in Pregnancy
Micromedex Pregnancy Rating: Fetal risk cannot be ruled out.
Crosses Placenta: Yes
Available evidence is inconclusive or is inadequate for determining fetal risk when used in pregnant women or women of childbearing potential. Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during pregnancy.
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Butalbital DUR
Diclofenac: Teratogenicity/Literature Reports
There are no adequate and well‐controlled studies of diclofenac during pregnancy. However, premature closure of the ductus arteriosus is a known effect of NSAIDs, including diclofenac, when used starting at 30 weeks gestation. In animal studies, maternal toxicity and embryotoxicity, including dystocia, prolonged gestations, reduced fetal weights and growths, and reduced fetal survival were noted in rats administered diclofenac sodium doses up to approximately 0.7 times the maximum recommended human dose (MRHD). No evidence of teratogenicity was observed, but maternal toxicity was noted in rats and rabbits administered doses 0.7 and 1.3 times, respectively the MRHD, as well as in mice with doses of up to approximately 0.7 times the MRHD. Diclofenac crosses the placental barrier in mice, rats, and humans.
A prospective cohort study examining NSAID use during pregnancy found no major congenital malformations; however, there were low birthweight and asthma with ibuprofen use, and low birthweight and maternal vaginal bleeding with diclofenac use. This study involved 90,147 pregnant women, with 6,511 exposed and 83,906 unexposed to the following 4 NSAIDs: diclofenac, ibuprofen, naproxen, or piroxicam. There was no significant difference in infant survival, congenital malformations, or structural heart defects in women taking these NSAIDs during the first‐trimester. However, diclofenac was associated with a significant 3.1‐fold increase in risk of low birthweight when used in the second trimester, as well as a significant 1.8‐fold increased risk of maternal vaginal bleeding when used in the third trimester.
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Butalbital DUR
Diclofenac: Teratogenicity/Clinical Management
Avoid use in pregnant women starting at 30 weeks of gestation due to the risk of premature closure of the fetal ductus arteriosus. Diclofenac may be used during pregnancy prior to 30 weeks gestation only if the potential benefit to the mother outweighs the potential risk to the fetus. Consider discontinuing use in women who have difficulties conceiving or who are undergoing investigation of infertility, as the drug is associated with reversible infertility.
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Butalbital DUR
Diclofenac: Breastfeeding
Micromedex Lactation Rating: Infant risk cannot be ruled out.
Available evidence and/or expert consensus is inconclusive or is inadequate for determining infant risk when used during breastfeeding. Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during breastfeeding.
Based on current data, diclofenac is present in small amounts in human milk. Currently, there are no data on the effects on the breastfed infant or the effect on milk production.
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Butalbital DUR
American Migraine Foundation
Migraine and Pregnancy: What Moms‐to‐Be Need to Know
First, the good news: Between 50 and 80% of pregnant migraine patients actually experience a reduction in migraine attacks during their pregnancy.
Recommendations – Start with non‐drug options1. Identify and avoid triggers (e.g. chocolate, processed foods).2. Make sleep a priority.3. Stay hydrated – including electrolyte fluids.
For drug therapy recommendations, they refer to the FDA website for risk in pregnancy and breastfeeding.
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Butalbital DUR
Association of Migraine Disorders
Beginning with the simplest and safest medication options, acetaminophen (or Tylenol, pregnancy category B) is considered the first line of therapy to control pain in a pregnant female. If you are lucky enough to have Tylenol on your list of effective migraine strategies, leave it on the list.
NSAIDs (such as ibuprofen, pregnancy category B during the first two trimesters, category D in the third) have some risks that are dependent on trimester.
Studies on triptan (pregnancy category C) use during pregnancy has been fairly reassuring. For pregnancies where triptan use is needed, sumatriptan (Imitrex) is usually the first triptan to be prescribed. Sumatriptan has been available longest and has the most safety data. Other triptans have not been shown to be harmful, but they have rarely been studied. It has been hypothesized that the vasoconstricting action of triptans could cause harm to an unborn fetus. However, studies have investigated outcomes including miscarriage, congenital malformations (physical defects present at birth), prematurity, and low birth weight and found no conclusive evidence of adverse effects.
Opioids are not considered an effective treatment for migraine and are rarely prescribed as a rescue treatment in this setting.
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Butalbital DUR
Questions/Comments ???
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Ongoing Reviews
Idaho Opioid Equivalent Dosing Project
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Idaho Opioid Equivalent Dosing Project Update
DUR Presentation
July 18, 2019
Idaho Opioid Equivalent Dosing Project
Today IDHW’s Pharmacy Unit is managing Opioid utilization in various ways, such as • Quantity Limits on all drugs• PA on specific State Drug Classes • Profile review and educational outreach
MME (Morphine Milligram Equivalence) of 90 is now the recommended goal, a point to understand is that there is not just one MME Calculator:
• CMS MME Calculator (calculator we are going to utilize)• Other MME Calculators• Customized MME Calculator
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Idaho Opioid Equivalent Dosing Project
• Prior Authorization
• First Rx
• First Trax
• First IQ
• Reporting
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Prior Authorization
Goal: require a prior authorization if a patient exceeds the > 90 Morphine Milligram Equivalence (MME) per day combined Short and Long acting narcotic agents*• According to the CDC, clinicians should avoid increasing dosage to ≥ 90 MME or carefully
justify a decision to go above that threshold.
*A report was run to determine those recipients who had an MME of > 90 in the previous 90 days and Prior Authorizations were entered for those recipients for 1 year.
A total of 3,669 members had PA’s entered into the First Rx system.
Criteria to approve override of quantity limit > 90 MME
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First RX
First Rx ‐ capable of supporting standard and custom MME cumulative dosing limits, conversion factors, and drug lists
• Recommend using the CMS standard conversion factor and drug list
‒ Allows for a one time entry and QC
‒ Conversion factor layout (First Rx team) is already defined and approved
‒ Maintenance of the standard drug list
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First Trax – MME display and calculator
1. FirstTrax enhancement to allow IDHW Clinical Pharmacists to view:• MME of the incoming claim that exceeded the MME Quantity Limit• MME of each claim that contributed to the incoming claim to exceed the limit • Total Combined MME of all claims that contributed to the incoming claim to
exceed the limit
2. Calculator:• First Trax has a Calculator functionality installed
‒ Pulls information from relevant opioid claims only‒ Auto‐populates calculator with necessary claims data‒ Enables the Clinical Pharmacist to change the value of some fields
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First Trax – MME display and calculator, continued
Calculator (continued):• Calculator functionality
‒ Targeted opioids‒ Conversion factors‒ MME limit
Status:• First Trax development is complete• Training and rollout for IDHW Staff occurred in July, prior to edit going into
place.
The edit went into production on July 19, 2017.
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First IQ ‐ RDUR
FIQ can be used for• Member identification only, or • FIQ can used to generate letters for to:
‒ members, prescribers and/or pharmacies
FIQ is highly flexible • Drug groups for criterion are defined within the application • Criterion and output can be customized
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Reporting
OPIOID OVERUTILIZATIONHealth Plan Group: Idaho
Line: Medicaid
Date Generated: 7/9/2019
Evaluation Period: 4/1/19 ‐ 6/30/19
Data Sources: PDW
TABLE 1: # of Members Filling Opioids, by Quarters
4/1/20196/30/2019
Members on Opioids 9,996
TABLE 2: Opioid Members by MED/Day (mg) > 90 mg MEDDuration of MED > 90 MED 4/1/2019
6/30/2019>= 0 Days 2339
< 90 Days 1080
> = 90 Days 1259
Total 2,339
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ReportingTABLE 3: All Opioid Members by # of Prescribers and Pharmacies
n of n of pharmacies
4/1/2019 % of Total Opioid
Membersprescribers 6/30/2019
≥ 4 ≥ 4 9 0%
≥ 4 3 17 0%
≥ 4 < 3 86 1%
3 ≥ 3 35 0%
3 < 3 277 3%
< 3 ≥ 3 46 0%
< 3 < 3 9526 95%
Totals 9,996 100.00%
TABLE 4: Opioid Members with >= 90 mg MED, by # of Prescribers and Pharmacies
n of prescribers n of pharmacies4/1/2019
% of ≥ 90 consecutive
days > 90 MED Members
% of Total Opioid
Members 6/30/2019
≥ 4 ≥ 4 3 0.24% 0.03%
≥ 4 3 6 0.48% 0.06%
≥ 4 < 3 17 1.35% 0.17%
3 ≥ 3 10 0.79% 0.10%
3 < 3 68 5.40% 0.68%
< 3 ≥ 3 19 1.51% 0.19%
< 3 < 3 1136 90.23% 11.36%
Totals 1,259 100.00% 12.60%
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ReportingTABLE 5: Top 20 Prescribed Opioids
Label Name Strength GSN Total Drugs
HYDROCODONE‐ACETAMIN 5‐325 MG 5 47430 5,021
HYDROCODONE‐ACETAMIN 10‐325 MG 10 30623 4,371
TRAMADOL HCL 50 MG TABLET 50 23139 3,324
OXYCODONE‐ACETAMINOPHEN 10‐325 10 48977 1,516
HYDROCODONE‐ACETAMIN 7.5‐325 8 47431 1,506
OXYCODONE‐ACETAMINOPHEN 5‐325 5 4222 1,152
HYDROCODONE‐ACETAMN 7.5‐325/15 1 53582 811
MORPHINE SULF ER 15 MG TABLET 15 11887 382
OXYCODONE HCL 10 MG TABLET 10 13467 371
OXYCODON‐ACETAMINOPHEN 7.5‐325 8 48976 371
OXYCODONE HCL 5 MG TABLET 5 4225 228
MORPHINE SULF ER 30 MG TABLET 30 4096 223
MORPHINE SULFATE IR 15 MG TAB 15 4091 154
OXYCODONE HCL 15 MG TABLET 15 46474 138
ACETAMINOPHEN‐COD #3 TABLET 30 4165 94
FENTANYL 25 MCG/HR PATCH 25 15880 90
METHADONE HCL 10 MG TABLET 10 4240 88
HYDROMORPHONE 2 MG TABLET 2 4110 87
HYDROMORPHONE 4 MG TABLET 4 4112 84
OXYCONTIN ER 10 MG TABLET 10 72862 70
Totals 20,081
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ReportingTABLE 6: Top 20 Pharmacies Dispensing Opioids
Pharmacy Name Pharmacy NPI Total
WALGREENS 10603 1811030950 435
WALGREENS 05648 1417962531 411
WALGREENS 06863 1962417089 397
WALGREENS 04942 1881609907 396
DICK'S PHARMACY 1295832574 369
WALGREENS 06380 1144235268 333
WALGREENS 07276 1871508994 328
SHAVER HOLDINGS INC 1083720494 274
ALBERTSONS, LLC 1295781110 262
FRED MEYER STORES INC 1740225275 227
WALGREENS 11622 1023281656 215
WALGREENS 11541 1902087794 197
WALMART PHARMACY 10‐2780 1174540421 187
WALMART PHARMACY 10‐5494 1255358503 184
WALGREENS 15973 1093996399 180
WALGREENS 05839 1326053448 180
WALGREENS 07949 1598770612 179
SMITHS FOOD & DRUG CENTERS INC 1699790212 179
RIDLEY'S PHARMACY 7152 1114053444 177
WALGREENS 09157 1316952435 177
Totals 5,287
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ReportingTABLE 7: Top 20 Members with Highest Daily MME
Member ID Cardholder ID Total MME
2,764
2,430
2,287
2,130
2,040
1,780
1,779
1,767
1,575
1,560
1,485
1,260
1,208
1,200
1,170
1,095
1,089
1,080
1,080
1,060
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Reporting
31% decrease in Members on Opioids from 1Q2017 through 1Q2019
37% decrease in Opioid Members on > 90 MED from 1Q2017 through 1Q2019
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Idaho Opioid Equivalent Dosing Project
Questions/Comments ???
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Current Interventions/Outcomes Studies
Injectable Testosterone DUR
Alprazolam utilization – looking for patients without any other anti‐anxiety medications
Tramadol utilization
Opioid Use Disorder
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July 18, 2019
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Injectable Testosterone DUR
Background: Discussion at April 2019 P&T Committee meeting that topical androgenic agents require prior authorization but that most injectable testosterone products do not require prior authorization.
Recommendation: Review utilization data at DUR.
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Injectable Testosterone DUR
Testosterone enanthate
FDA Approval: Primary hypogonadism, male
Dose: 40‐500mg IM every 2‐4 weeks based on patient response and presence of adverse effects.
Delayed puberty, male
Metastatic breast cancer, female
Micromedex (evidence favors efficacy):Female to male transsexual – gender dysphoriaWeight gain (adults)
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Injectable Testosterone DUR
Testosterone cypionate
FDA Approval: Primary hypogonadism, male
Dose: 40‐500mg IM every 2‐4 weeks based on patient response and presence of adverse effects.
Micromedex (evidence favors efficacy):Female to male transsexual – gender dysphoriaWeight gain (adults)Male contraception
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Injectable Testosterone DUR
Testosterone undecanoate
FDA Approval: Primary hypogonadism, male
Dose: 750mg IM, repeat in 4 weeks, and then every 10 weeks
Micromedex (evidence favors efficacy):Female to male transsexual – gender dysphoria
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Injectable Testosterone DUR
Testosterone undecanoate
Must be administered by a healthcare professional. Healthcare providers and healthcare settings must be certified through the REMS program and must have on‐site access to equipment and personnel trained to manage serious POME (pulmonary oil microembolism) and anaphylaxis.
5.1 Serious Pulmonary Oil Microembolism (POME) Reactions and AnaphylaxisSerious POME reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular testosterone undecanoate 1000 mg (4 mL). The majority of these events lasted a few minutes and resolved with supportive measures; however, some lasted up to several hours and some required emergency care and/or hospitalization. To minimize the risk of intravascular injection of Aveed, care should be taken to inject the preparation deeply into the gluteal muscle, being sure to follow the recommended procedure for intramuscular administration.
In addition to serious POME reactions, episodes of anaphylaxis, including life‐threatening reactions, have also been reported to occur following the injection of intramuscular testosterone undecanoate.
Both serious POME reactions and anaphylaxis can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
Following each injection of Aveed, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions and anaphylaxis.
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Injectable Testosterone DUR
Drug PA – RX Reimbursement for typical dose
PA – PAD Reimbursement for typical dose
Testosterone cypionate
NO $14.22/200mg NOJ0171
$4.00/200mg
Testosterone enanthate
NO $9.12/200mg NOJ3121
$6.00/200mg
Testosterone undecanoate
N/A N/A YESJ3145
$915/750mg
PAD – physician administered drugN/A – not applicable
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Injectable Testosterone DUR
1779
6 0
740
9 00
200
400
600
800
1000
1200
1400
1600
1800
2000
Testosterone cypionate Testosterone enanthate Testosterone undecanoate
Paid claims: 4/1/18 – 3/31/19number of claims
Rx PAD
67
Injectable Testosterone DUR
$45
$50
$2.60 $0.30
$0
$10
$20
$30
$40
$50
$60
Testosterone cypionate Testosterone enanthate
Paid claims: 4/1/18 – 3/31/19average cost paid per claim
Rx PAD
68
Injectable Testosterone DUR
$80,034
$300 $1,923 $2.67 $0
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
$70,000
$80,000
$90,000
Testosterone cypionate Testosterone enanthate
Paid claims: 4/1/18 – 3/31/19amount paid
Rx PAD
69
Injectable Testosterone DUR
Recommendation #1
Continue to NOT require prior authorization for testosterone cypionate or testosterone enanthate.
Rationale: High utilization (cypionate) and inexpensive.
Recommendation #2
Continue to require prior authorization for testosterone undecanoate.
Rationale: Higher risk and higher cost than therapeutically equivalent testosterone injectable products.
70
Injectable Testosterone DUR
Questions/Comments ???
71
July 18, 2019
72
Alprazolam DUR
Background: Evaluate patients on alprazolam, presumably for treatment of anxiety, who are not concurrently on any SSRI, SNRI, hydroxyzine, or buspirone.
73
Alprazolam DUR
Patient selection (5/7/18 – 5/6/19)
No paid claims for any SSRI, SNRI, buspirone, or hydroxyzine in the previous 365 days
AND
> 2 claims for alprazolam in 90 days: n=223> 3 claims for alprazolam in 90 days: n=159> 6 claims for alprazolam in 183 days: n=125
74
Alprazolam DUR
Reviewed profiles of 63 patients (half of the 125 patients identified)
19
19
20
4 1
# Tablets per Day
1 2 3 4 6
75
Alprazolam DUR
Reviewed profiles of 63 patients (half of the 125 patients identified)
0 5 10 15 20
0.25‐0.5mg
0.75‐1mg
1.5‐2mg
3mg
4mg
6mg
8mg
Dose: mg/day
# Patients
76
Alprazolam DUR
Reviewed profiles of 63 patients (half of the 125 patients identified)
0 5 10 15 20 25
< 2 years
2‐5 years
6‐10 years
> 10 years
Duration of alprazolam therapy
# Patients
77
Alprazolam DUR
Package Insert
Demonstrations of the effectiveness of XANAX by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
78
Alprazolam DUR
Reviewed profiles of 63 patients (half of the 125 patients identified)
3615
12
Prescriber
MD NP PA
79
Alprazolam DUR
Reviewed profiles of 63 patients (half of the 125 patients identified)
23
11
1 1
MD ‐ Specialty
MD ‐ Family Medicine MD ‐ Psych MD ‐ ER MD ‐ Nephrology
80
Alprazolam DUR
Reviewed profiles of 63 patients (half of the 125 patients identified)
53
2 3
Number of Patients per Prescriber
1 2 3
81
Alprazolam DUR
0123456789
Num
ber o
f patients
Other psychiatric diagnoses in electronic profile
82
Alprazolam DUR
0
5
10
15
20
25
Num
ber o
f patients
Other psychiatric diagnoses in electronic profile
# Patients
OtherDrugs
83
Alprazolam DUR
Yes, 31, 49%No, 32, 51%
ALSO ON OPIOIDS ?
84
Alprazolam DUR
85
Alprazolam DUR
Yes, 29, 46%
No, 34, 54%
PAYING CASH FOR ADDITIONAL CONTROLLED SUBSTANCES ?
86
Alprazolam DUR
Next Steps ?
Questions/Comments ???
87
July 18, 2019
88
P&T Committee Question
Does tramadol pose significant risk of addiction and/or overdose compared to other short‐acting
opioids?
89
90
Thiels et al. BMJ 2019; 365: l1849STUDY POPULATION STUDY DESIGN
• 357,884 Commercial & Medicare Advantage enrollees in large, private, US health plan 2009‐2018
• 51% M, 72% commercial, 26% Medicare >65, 2% Medicare‐disabled
• Recently had one of 20 common surgeries & filled initial opioid rx
• Retrospective cohort study using claims data
• Exposure: opioid at discharge• Outcome: prolonged opioid use at
discharge for tramadol rx vs other short‐acting opioids
DEFINITIONS OF PROLONGED OPIOID USE
• Additional: at least 1 opioid fill 90‐180 days after surgery• Persistent: any span starting w/in 180 days of surgery & lasting 90+ days• CONSORT*: any opioid use w/in 180 days of surgery, spans 90+ days, incl 10+ refills
OR 120+ day supply*CONsortium to Study Opioid Risks & Trends
91
Results
Thiels et al. BMJ 2019; 365: l1849.
Most commonly prescribed opioids post surgery: hydrocodone 53%, oxycodone 37.5%, tramadol 4%
Additional: 7.1%, Persistent 1%, CONSORT 0.46% (the bigger the initial rx, the higher the risk). Higher risk with tramadol than other opioids.
DEFINITIONS OF PROLONGED OPIOID USE
• Additional: at least 1 opioid fill 90‐180 days after surgery• Persistent: any span starting w/in 180 days of surgery & lasting 90+ days• CONSORT: any opioid use w/in 180 days of surgery, spans 90+ days, incl
10+ refills OR 120+ day supply
92
93
Zeng et al. JAMA 2019; 321(10): 969‐82. STUDY POPULATION STUDY DESIGN• 88,902 patients at general practice
in UK• >50yo (avg age 70), 61% F, w
osteoarthritis dx in Health Improvement Network database
• 2000‐2015, w/ f/u to 2016
• Sequential, propensity‐matched cohort study
• Exposure: initial rx for tramadol (vs naproxen, diclofenac, celecoxib, etoricoxib, codeine)
• Outcome: all‐cause mortality w/in 1yr of initial tramadol rx, compared w other meds
RESULTS• Higher mortality for tramadol vs NSAIDs at 1yr f/u
• Similar mortality to codeine• Mortality rates from CVD, GI, infectious, cancer, resp diseases all higher for
tramadol vs NSAIDs, BUT not statistically significant
94
Zeng et al. JAMA 2019; 321(10): 969‐82.95
96
Shah et al. MMWR 2017; 66(10): 265‐9. STUDY POPULATION STUDY DESIGN• 10% sample of patient records 2006‐2015 from IMS Lifelink+ database (US commercially insured population)
• Avg age 44, 54% F, 18% back pain, 30% joint pain
• At least 1 new opioid rx after 6mo without; no cancer, sud
• Retrospective cohort study• Exposure: duration/refill initial opioid prescription
• Outcome: incidence of continuous opioid use 1 year and 3 years after first opioid rx
RESULTS• Probability of long‐term opioid use increases sharply even after a few days of opioid
use. Opioid use at 1 year was 13.5% for those whose first episode of use was >= 8 days, 29.9% for >=31 days.
• Probability of long‐term opioid use also increases with refills
97
Shah A et al. MMWR 2017; 66(10): 266‐26998
TramadolSpecific Results
Shah A et al. MMWR 2017; 66(10): 266‐269
Highest probabilities of continued opioid use at 1 and 3 years: Long‐acting opioid (27.3% at 1yr, 20.5% at 3yrs) Tramadol (13.1% at 1yr, 6.8% at 3yrs)
Among patients who initiated tramadol, >64% who continued opioid use beyond 1yr were still on tramadol – perhaps intentionally rx’d for chronic pain management
99
Summary
Tramadol use, like other opioid use, increases the risk of chronic use (addiction?) and death
There may be a slightly higher risk of long‐term use with the use of tramadol compared to other short‐acting opioids after surgery
The data is limited and observational only
Likely not enough information to change how we manage tramadol, other than considering it as high risk like any other opioid
100
101
Tramadol Utilization Reviewed claims for tramadol agents from 2nd Qtr 2019
Tramadol IR
Tramadol/APAP
Tramadol ER
Obtained client demographics and Tramadol utilization.
102
Tramadol Utilization
103
Tramadol Utilization
104
Tramadol Utilization
105
Tramadol Utilization
106
Tramadol Utilization Reviewed all claims from January 1, 2019 to July 16,2019 for tramadol patients obtained from 2nd Qtr. 2019 data.
Therapeutic Class Description: H3A (Analgesic Narcotics and H3N (Analgesics, Narcotic Agonist, NSAID)
Reviewed #clients with other opioid agents prior and after 2nd Qtr. 2019 data.
107
Tramadol Utilization
108
Tramadol Utilization
109
110
111
Tramadol ConclusionsTramadol IR utilization appears to be decreasing. 77% of tramadol IR claims are for women.Minimal concomitant use of other opioids.Research limited and studies observational based on claims data, but do suggest that tramadol is at least as risky as other opioids
Given decreasing utilization and limited research, likely no need to change preferred status or add PA to tramadol at this point
112
Tramadol Utilization Question/Comments?
113
July 18, 2019
114
Opioid Use DisorderReview requested by Medicaid Pharmacy and Therapeutics Committee. How many Medicaid clients are on active Medication‐Assisted Treatment (MAT)?
How many Medicaid clients have a diagnosis of opioid use disorder?
Review of from Apr‐June 2019 calendar 2nd quarter Medicaid clients with active buprenorphine/naloxone (BUP/NAL) and buprenorphine (BUP) claims.
ICD‐10 diagnosis codes (F11.xx) for opioid related disorders.
115
ICD‐10 Code: F11.xx Opioid Related Disorders
F11.1 Opioid Abuse
F11.12 Opioid abuse with intoxication
F11.15 Opioid abuse with opioid‐induced psychotic disorder
F11.18 Opioid abuse with other opioid‐induced disorder
F11.2 Opioid dependence
F11.22 Opioid dependence with intoxication
F11.25 Opioid dependence with opioid‐induced psychotic disorder
F11.28 Opioid dependence with other opioid‐induced disorder
F11.9 Opioid use, unspecified
F11.92 Opioid use, unspecified with intoxication
F11.95 Opioid use, unspecified with opioid‐induced psychotic disorder
F11.98 Opioid use, unspecified with other specified opioid‐induced disorder
Opioid Use Disorder
116
Opioid Use Disorder
117
Opioid Use Disorder
118
Opioid Use Disorder
119
Opioid Use Disorder
120
121
122
ConclusionsApproximately 577 (10%) Medicaid clients are on MAT based upon ICD‐10 coding for Opioid Related Disorders.
Majority of ICD‐10 coding for Opioid Related Disorders are in Regions 1, 3, and 4. Limitations to data:
Billing codes may not be accurate. Potential for incorrect coding for chronic pain or cancer pain.
Methadone treatment for opioid use disorder is not available through outpatient pharmacy services.
Majority of MAT is for BUP/NAL (75%) vs BUP. Region 1 has the highest percentage of Medicaid clients on MAT.
Opioid Use Disorder
123
Opioid Use Disorder Questions/Comments?
124
Study Proposals for Upcoming Quarters: ?
125
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
126
Prospective DUR Report
127
DUR Board Meeting July 18, 2019
128
Next Meeting October 17, 2019
129