SCWEA Meeting
Charleston, SC
Feb 28, 2011
Proactive Prescription Management
Matthew Foster, PharmD
Clinical Pharmacy Manger, PMSI
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Outline
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Common Medications in Workers Compensation
Off Label Medication Use
Managing the high risk injured worker
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Common Medications
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Top 5 Therapeutic Categories by # of
Prescriptions 2009
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Top 10 Medications by # of Prescriptions 2010
Generic name
HydrocodoneAcetaminophen
Oxycodone W/
Acetaminophen
Oxycodone
Cyclobenzaprine
Tramadol
Gabapentin
Pregabalin
Ibuprofen
Zolpidem
Celecoxib
Common Brand names
% of Total
Prescriptions
Vicodin, Lortab
14.1%
Percocet, Tylox
Oxycontin, Oxyfast
Flexeril, Amrix
Ultram, Ultram ER
Neurontin
Lyrica
Motrin
Ambien, Ambien CR
Celebrex
5.0%
4.1%
3.6%
3.5%
3.2%
2.9%
2.6%
2.5%
2.4%
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Top 10 Drugs by Spend 2010
Generic name
Oxycodone
Lidocaine
Oxycodone W/
Acetaminophen
HydrocodoneAcetaminophen
Pregabalin
Gabapentin
Fentanyl
Celecoxib
Fentanyl Citrate
Duloxetine
% of Total
Common Brand names
Spend
Oxycontin, Oxyfast
10.2%
Lidoderm
5.4%
Percocet, Tylox
4.2%
Vicodin, Lortab
Lyrica
Neurontin
Duragesic
Celebrex
Fentora, Actiq
Cymbalta
4.1%
4.2%
3.5%
3.1%
3.4%
2.4%
3.2%
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Short-acting opioid analgesics
Short Acting Narcotics
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Are useful to relieve acute and chronic pain
Useful for moderate to severe pain
Are useful in the management of breakthrough pain
May be used and are appropriate with long-acting opioid
analgesics
Common Medications
Hydrocodone-acetaminophen
Oxycodone-acetaminophen
Morphine
MSIR
Fentanyl
Actiq, Fentora
Meperidine
Demerol
Tramadol
Ultram
Vicodin, Lortab, Norco
Percocet
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Long-acting opioid analgesics
Long Acting Narcotics
 Indicated for the management of persistent, moderate to severe
pain
 Patients that require continuous, around the clock opioid
administration for an extended period of time
 For pain that can not be managed by non-steroidal antiinflammatory analgesics, opioid combination medications, or
immediate-release opioids
 Patients should be opioid-tolerant before initiating therapy
 Should not be used for intermittent pain or for the management of
mild pain
Common Medications
Oxycodone
Oxymorphone
Morphine
Fentanyl
Methadone
Hydromorphone
Tramadol
Oxycontin
Opana
MS Contin, Avinza, Kadian
Duragesic
Methadose
Exalgo
Ultram ER
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Long-acting Opioids
Morphine - Naltrexone
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Brand name: Embeda®
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FDA approved for moderate to severe pain
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Abuse deterrent formulation of morphine
- tampering will release opioid antagonist naltrexone
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Dosage:
– With appropriate dosage titration, there is no maximum
dose of morphine
– Most common adverse effects
- Drowsiness, dizziness, constipation
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total spend is greater than generic morphine
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Non-steroidal Anti-Inflammatory
NSAIDs
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Beneficial for inflammatory and pain component
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Potential for decrease opioid utilization
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Gastrointestinal and cardiovascular adverse effects
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Recommend lowest effective dose for shortest possible duration
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Topical NSAIDs may decrease systemic exposure
Common Medications
Celecoxib
Celebrex
Ibuprofen
Motrin
Naproxen
Naprosyn
Meloxicam
Mobic
Diclofenac
Voltaren, Flector Patches, Pennsaid
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NSAID Risk
■ Exacerbation of hypertension and congestive heart failure
■ May cause fluid retention and edema
■ History of ulcer adverse effects
■ Consider a gastro-protective agent when appropriate
■ American Geriatric Society recommends low dose opioids in geriatric
population
■ Liver impairment
■ May compromise kidney function
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PRE0010-0910-Therapeutic Drug Info. Anticonvulsants
Skeletal Muscle Relaxant Overview
Skeletal Muscle Relaxants
■May be effective in reducing pain and muscle tension
■Lack of evidence of efficacy with long-term use
■Efficacy appears to diminish over time
■Prolong use may lead to dependence with certain agents
Common Medications
Cyclobenzaprine
Flexeril, Amrix
Carisoprodol
Soma
Metaxalone
Skelaxin
Tizanidine
Zanaflex
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PRE0010-0910-Therapeutic Drug Info. Anticonvulsants
Anticonvulsant Overview
Anticonvulsants
■Anticonvulsants used for pain since the 1960s
■Carbamazepine originally approved for neuralgia
■Beneficial for neuropathic pain, seizures, and migraine prevention
Common Medications
Gabapentin
Neurontin
Pregabalin
Lyrica
Tiagabine
Gabitril
Carbamazepine
Topirimate
Tegretol
Topamax
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PRE0010-0910-Therapeutic Drug Info. Anticonvulsants
Antidepressant Overview
Antidepressants
■Versatile class of agents in worker’s compensation
■Selective agents are beneficial for depression, anxiety, insomnia,
musculoskeletal and neuropathic pain
■Tricyclic and SNRIs most studied and used for neuropathic pain
■Use allows for simplification of drug regimen
■May reduce requirement of opioids
Common Medications
Duloxetine
Cymbalta
Venlafaxine
Effexor XR
Amitriptyline
Elavil
Escitalopram
Lexapro
Sertraline
Zoloft
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PRE0010-0910-Therapeutic Drug Info. Anticonvulsants
Dermatologics
Lidoderm 5% Patch
Topical lidocaine patch formulation acts as a local anesthetic
Approved for the treatment of neuropathic pain
Recommended dose: up to 3 patches to intact skin over the painful
area for up to 12 hours in a 24 period
Patches may be cut into smaller sizes with scissors prior to removal of
release liner
Lidoderm is one of the top 10 medications by number of prescriptions
used in the workers compensation population
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Sedative-Hypnotic Overview
Sedative/Hypnotics
Insomnia associated with chronic pain
 Insomnia
associated
with chronic
pain body part
Sleep
disturbance
from contact
with injured
Recommended fro short-term use
Encourage
proper sleep hygiene
 Sleep disturbance from contact with injured body part
Manage underlying psychiatric disorders
Recommended fro short-term use
Common Medications
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Zolpidem
Encourage
Ambien,
Ambien
CR
proper
sleep
hygiene
Eszopiclone Lunesta
Ramelteon
Manage underlying
psychiatric disorders
Rozerem
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Off label Prescribing
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Overview of off-label prescribing
FDA focuses on market entry for prescription drugs
– Does not specifically regulate prescribing practices
– Prescribers can write for any medication aside from the FDA
approval (therefore, off-label)
 Non-approved indications may not receive same degree of
scrutiny as those submitted to FDA
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Overview of off-label prescribing
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What defines “off-label” specifically?
Age? Antidepressants in children
Pregnancy? Zofran for nausea
Comorbid conditions? Cancer/non-cancer
Dose ranges?
Duration?
Studies are often VERY narrow populations
i.e. Actiq/Fentora: Cancer pain!
i.e. Cymbalta/Lyrica: Diabetic neuropathic pain
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Overview of off-label prescribing
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Overall 21% of medication use is off-label (Arch Intern Med. 2006;
166:1021-1026)
– Neurontin (83%), Elavil (81%)
 Study finds 90% of Actiq prescriptions are off-label (Prime
Therapeutics Jan 16, 2007)
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In 2002, 94% of Neurontin sales for off-label use (USA Today 8-162004)
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Common off-label medications in workers’
compensation
Medication
FDA indication
Neurontin
Anticonvulsant; Shingles pain
Neuropathic pain
Lidoderm
Shingles pain
Neuropathic pain
Acute cancer pain
Acute pain (noncancer)
Actiq/Fentora
Ambien
Short-term use sedative
Off-label use
Long-term use
sedative
Lyrica
Anticonvulsant; diabetic
neuropathic pain; fibromyalgia
Neuropathic pain
Cymbalta
Antidepressant; diabetic
neuropathic pain, chronic pain
Neuropathic pain
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Off-label prescribing versus off-label promotion
Where the pharma industry has gone wild
– Neurontin, Actiq, and Oxycontin
 Generally, sales reps can speak on package insert approved
information; everything else has to be requested specifically through
their clinical affairs departments
– Not well defined criteria; education versus promotion; company
policies
– How the information is solicited
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Education vs. Promotion
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FDA Office of Criminal Investigations
$430 million fine to Warner Lambert (Pfizer) due to off-label
promotion of Neurontin
 Paid physicians to detail other physicians
 Long-list of off-label treatments promoted
$700 million fine to Purdue (Oxycontin)
 Promotion that it was less addictive, less prone to withdrawal
$600 million fine to Allergan (Botox)
 Caused false claims to be processed to Medicare
$425 million fine to Cephalon (Actiq)
 Off-label promotion of Actiq
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Cymbalta ads and website
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Why risk off-label promotion?
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Build a patient base faster than
waiting for FDA approvals that are
“inevitable”
Weighing the potential fines versus
the actual reveue
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Strategies to ensure appropriate use of off-label
medications
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Treatment plans
 Defined goals in therapy
 Doesn’t just apply to FDA approved indications
Provide evidence for use
 “can” prescribe versus “should” prescribe
Informed consent
 Educating patients on their treatments
Early referral to specialists
 Washington State guidelines on opioid therapy
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Managing the patient
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Medication Use as Claim Ages without Clinical Oversight
Increased Risk Without Intervention
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As claim progresses, number of medications and cost of
each prescription escalates
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As claim progresses, likely hood of using generic products
decreases
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PBM Strategies to Reduce Utilization
■ Prior authorization
programs
■ Point-of-sale Drug
Utilization Reviews
■ Clinical Escalation
Alerts
■ Targeted Medication
Review and Intervention
Programs
– In-network and
out-of-network
transactions
■ Formulary Management
– Risk assessment
– Specific to workers’
compensation
– Prescriber Alerts
– Pharmacy and
Therapeutics
Committee oversight
■ Comprehensive
Medication Reviews –
Care Management
■ Screening for fraud
and abuse
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MedAssess™ Levels of Care
Utilization Control
Care Management
Targeted Intervention
Acute and Chronic
Chronic and Complex
Chronic
Services that address point-ofcare access to medications,
products and services for both
acute and chronically injured
individuals
Services that address
concerns regarding high risk
or high cost therapy in
chronically injured individuals
Services that address
longitudinal concerns regarding
course of therapy for chronic or
complex cases
Approach
 Targeted evaluation
Approach
 Expanded evaluation
Approach
 Comprehensive evaluation
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One-time intervention
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Limited intervention
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Customized intervention
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Limited outreach
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Expanded outreach
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Ongoing outreach
Benefit
 Detect and prevent
inappropriate utilization
Benefit
 Identify high-risk patients
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Early intervention for
appropriate, cost-effective
care
Benefit
 Intervene and monitor to
provide therapeutically
appropriate, cost effective care
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Improve long-term outcomes
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Focus on Pain Management
Formulary Management
■ Blocks potential inappropriate narcotic
use according to medication and time
after initial injury
High-Risk Profiling Service
■ Identifies high-risk narcotic and other
medication use to prescriber and case
management
Multiple Prescriber Service
■ Reduces inappropriate use of more
than one prescriber to obtain narcotics
Medication Review (with or without
Peer-to-Peer)
■ Reviews medication use and develops
an action plan, with emphasis on pain
management
Drug Testing and Monitoring
■ Identifies injured workers requiring
urine drug testing to assess
compliance and appropriate use of
narcotic therapy
High-Risk Profiling Service
■ Success Rate: 64%
■ Average annualized savings per successful
intervention: $1,200 - 1,400
Multiple Prescriber Service
All Meds
Narcotics
Decrease in Prescription Count
41%
50%
Decrease in Prescription Spend
19%
21%
Business Impact
Program Success Rate = 90% reduction
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Medication Review with Peer Outreach Outcomes
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Client type
– TPA with existing case management capability
– Average age of claims - 8 years
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Outcomes
– Analysis of first nine claimants receiving Medication Review for
which Peer Outreach made direct contact with the prescriber
– Outcomes measured at five months post intervention
– Recommendations included discontinuing drug or continuing drug,
increasing or decreasing dose of medication
– 57 of 71 recommendations were accepted by prescriber yielding
80% success rate
– 25 interventions resulted in cost savings
– Average monthly savings per successful intervention: $148.01/Rx
– Total savings related to 25 interventions: $3,700/month
– Annualized pharmacy savings ($3700 x 12): $44,404
– Client ROI : 3.8
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Medication Review with Peer Outreach Outcomes
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Client type
 Insurer of run-off claims, minimal clinical oversight
 Average age of claims - 12+ years
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Outcomes
 Analysis of first 40 claimants receiving Medication Review regardless
of whether Peer Outreach made direct contact with the prescriber
 Outcomes measured at 6 months post intervention
 Only counted recommendations related to discontinuing drug or
changing dose of medication
 114 of 291 recommendations were accepted by prescriber yielding
39% success rate
 All successful interventions resulted in cost savings
 Average monthly savings per successful intervention: $313.73/Rx
 Total Savings related to 114 interventions: $35,766/month
– Annualized pharmacy savings ($35,766 x 12): $429,192
– Client ROI: 7.4
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Comprehensive Pharmacy Program – Clinical Oversight
Typical Medication Related Issues
Seen across the injury lifecycle
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In Summary…
Understand drivers of pharmacy spend
■ Know which factors are most influential in driving changes in your
pharmacy spend…
– Is it price, utilization or a combination?
■ Understand which factors can be controlled and partner with your
PBM to take action
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In Summary…
Determine appropriate strategies to control spend
■ Decrease average cost per prescription by working with your
PBM to:
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Increase network penetration, generic use and mail order
pharmacy enrollment
■ Decrease inappropriate medication utilization by working with your
PBM to:
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Identify high-risk, high-cost claimants
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Utilize clinical pharmacy programs to drive rationale, costeffective drug therapy
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In Summary…
Determine appropriate strategies to control spend
■ PBM-based Pain Management Programs should:
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Identify high-risk injured workers early
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Enhance the impact of internal case management efforts
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Monitor and manage pain medication use throughout the
injury lifecycle via
■ Prospective utilization controls
■ Retrospective targeted interventions
■ Ongoing care management activities
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