dur 7 18 2019 final v2 · rizatriptan: teratogenicity/effects in pregnancy u.s. food and drug...

July 18, 2019

Federal Fiscal Year 2018(10/1/2017 through 9/30/2018)

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.

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

Contents: Attachments

Pharmacy Oral Counseling Compliance ReportRetroDUR Educational Outreach SummarySummary of DUR Board ActivitiesGeneric Drug Substitution PoliciesCost Savings/Cost Avoidance Innovative PracticesE‐PrescribingExecutive Summary

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

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

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

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

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 %

Generic Drugs Generic Utilization Percentage 82.4%

Generic Expenditure Percentage 19%

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

Fraud, Waste and Abuse DetectionDo you have a documented process in place that identifies potential fraud or abuse of controlled drugs by beneficiaries?

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

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

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

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

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

DUR Board Activities ‐2 Hepatitis C

Nifedipine IR/Methyldopa

Long‐Term Use of Proton Pump Inhibitors/Deprescribing

Niacin

Typical Antipsychotics

Spinraza

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

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

Follow‐up to Previous Reviews

Butalbital DUR

July 18, 2019

Butalbital DUR

Question asked at April 2019 DUR Meeting:

What medications can be safely used to treat migraines during pregnancy?

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

Butalbital DUR

Rizatriptan: Breastfeeding

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

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.

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.

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.

Butalbital DUR

Diclofenac: Breastfeeding

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.

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.

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.

Butalbital DUR

Questions/Comments ???

Ongoing Reviews

Idaho Opioid Equivalent Dosing Project

Idaho Opioid Equivalent Dosing Project Update

DUR Presentation

July 18, 2019

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

• Prior Authorization

• First Rx

• First Trax

• First IQ

• Reporting

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

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

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

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.

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

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

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%

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

MORPHINE SULF ER 30 MG TABLET 30 4096 223

MORPHINE SULFATE IR 15 MG TAB 15 4091 154

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

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

ReportingTABLE 7: Top 20 Members with Highest Daily MME

Member ID Cardholder ID Total MME

Reporting

31% decrease in Members on Opioids from 1Q2017 through 1Q2019

37% decrease in Opioid Members on > 90 MED from 1Q2017 through 1Q2019

Current Interventions/Outcomes Studies

Injectable Testosterone DUR

Alprazolam utilization – looking for patients without any other anti‐anxiety medications

Tramadol utilization

Opioid Use Disorder

July 18, 2019

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.

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)

Testosterone cypionate

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

Testosterone undecanoate

Dose: 750mg IM, repeat in 4 weeks, and then every 10 weeks

Micromedex (evidence favors efficacy):Female to male transsexual – gender dysphoria

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.

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

N/A N/A YESJ3145

$915/750mg

PAD – physician administered drugN/A – not applicable

Testosterone cypionate Testosterone enanthate Testosterone undecanoate

Paid claims: 4/1/18 – 3/31/19number of claims

Rx PAD

$2.60 $0.30

Testosterone cypionate Testosterone enanthate

Paid claims: 4/1/18 – 3/31/19average cost paid per claim

Rx PAD

$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

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.

July 18, 2019

Alprazolam DUR

Background: Evaluate patients on alprazolam, presumably for treatment of anxiety, who are not concurrently on any SSRI, SNRI, hydroxyzine, or buspirone.

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

> 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

Alprazolam DUR

Reviewed profiles of 63 patients (half of the 125 patients identified)

# Tablets per Day

1 2 3 4 6

Alprazolam DUR

0 5 10 15 20

0.25‐0.5mg

0.75‐1mg

1.5‐2mg

Dose: mg/day

# Patients

Alprazolam DUR

0 5 10 15 20 25

< 2 years

2‐5 years

6‐10 years

> 10 years

Duration of alprazolam therapy

# Patients

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.

Alprazolam DUR

Prescriber

MD NP PA

Alprazolam DUR

MD ‐ Specialty

MD ‐ Family Medicine MD ‐ Psych MD ‐ ER MD ‐ Nephrology

Alprazolam DUR

Number of Patients per Prescriber

Alprazolam DUR

0123456789

f patients

Other psychiatric diagnoses in electronic profile

Alprazolam DUR

f patients

Other psychiatric diagnoses in electronic profile

# Patients

OtherDrugs

Alprazolam DUR

Yes, 31, 49%No, 32, 51%

ALSO ON OPIOIDS ?

Alprazolam DUR

Yes, 29, 46%

No, 34, 54%

PAYING CASH FOR ADDITIONAL CONTROLLED SUBSTANCES ?

Alprazolam DUR

Next Steps ?

July 18, 2019

P&T Committee Question

Does tramadol pose significant risk of addiction and/or overdose compared to other short‐acting

opioids?

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

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

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

Zeng et al. JAMA 2019; 321(10): 969‐82.95

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

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

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

Tramadol Utilization Reviewed claims for tramadol agents from 2nd Qtr 2019

Tramadol IR

Tramadol/APAP

Tramadol ER

Obtained client demographics and Tramadol utilization.

Tramadol Utilization

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.

Tramadol Utilization

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

Tramadol Utilization Question/Comments?

July 18, 2019

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.

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

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

Opioid Use Disorder Questions/Comments?

Study Proposals for Upcoming Quarters: ?

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

Prospective DUR Report

DUR Board Meeting July 18, 2019

Next Meeting October 17, 2019

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