Dominion Diagnostics Medication Monitoring

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Dominion DiagnosticsMedication Monitoring

• Presented to
• National Council of Self-Insurers
• May 18, 2009

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Frank A. Fornari, Ph.D Chief Executive
Officer [phone] ffornari_at_dominiondiagnosti
cs.com
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About Dominion

• National medical laboratory accredited by the
  College of American Pathologists (CAP), the
  Clinical Laboratory Amendments Act (CLIA) and
  other appropriate state specific governing bodies
• Provides clinical pharmacological/ toxicological
  and molecular diagnostic services
• Invents, develops, validates and performs
  state-of-the-art quantitative medication
  monitoring
• Provides pharmacokinetic and pharmacogenomic data
  regarding drug usage, drug-drug Interactions,
  elimination, and prescription adherence

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Mission and Goals

• Create a personalized diagnostic-based model for
  pharmacotherapy (every patient is an individual
  clinical trial)
• Improve patient care and clinical efficiency
• Objective patient outcomes analyses through
  quantitative drug testing integrated with
  traditional clinical metrics
• Establish diagnostic guidelines and a financial
  model for the development, management and
  monitoring of pharmacotherapeutic agents

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Targeted Market Segments

• Drug Treatment and Mental Health Clinics
• State and Private Workers Compensation Systems
• Pain Management Practices
• Primary Care Physicians
• Hospital Systems and Self-Insured Corporations
• Pharmaceutical Companies
• Pharmacy Benefits Management Companies
• Commercial Healthcare Insurance Payers

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Testing Rationale

• Clinical Pharmacotherapeutic and Pharmacokinetic
  Issues
• Substance Abuse, Misuse, Diversion and Addiction
  Issues
• Medico-Legal Concerns

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Laboratory Medicine

• Laboratory medicine accounts for less than 5 of
  the national healthcare expenditure, while
  greater than 85 of all medical decisions involve
  laboratory results
• The healthcare system must have a sufficient
  understanding of, and have access to the
  laboratory and its processes
• The laboratory is held accountable for issues
  involving medical necessity, ordering procedures
  and reimbursement
• There must be an efficient, fair, and functioning
  reimbursement system that can create new and
  upgraded CPT codes as technology develops and the
  cost of analyses increases

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Healthcare Concerns

• Medicare is experiencing financial difficulty
• Over 35 of Americans have limited access to
  medical care
• Pharmacy and related costs are nearly 50 of the
  overall healthcare expenditure and are spiraling
  out of control
• 50 of all medications do not demonstrate
  efficacy, are toxic or fatal (ADR is the 6th
  leading cause of death 137,000 reported deaths
  last year)
• Healthcare professionals are leaving the field
  and are not being replaced
• Decision makers are require more training to
  understand the systems problems
• It is becoming a political rather than a
  scientific issue

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Business Model and Opportunity

• Hundreds of millions of prescriptions filled for
  pain medications each year. 50 Million pain
  patients per year and growing.
• Life truly is Pain. Particularly when paying
  for these medications
• Very little basic understanding of the
  biochemical and neurogenetic mechanisms of pain.
  If the pain is controlled recovery is expedited.
• We possess a highly evolved endogenous pain
  relief system.
• We have not been able to uncouple addiction and
  nociception nor create a series of truly
  efficacious non opioid medications.
• The industry is currently focused upon new drug
  delivery devices and non traditional compounds
  (i.e., Cannabinoids etc.)
• Polymorphic activity at CYP2D6 plays a
  significant role and is now measurable

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The Top 10 Drugs Processed by Cost 2007

• Lidoderm 5 patch (anesthetic)
• OxyContin (pain)
• Celebrex (anti-inflammatory pain)
• Oxycodone (pain)
• Skelaxin (muscle relaxant)
• Gabapentin (anticonvulsant/pain)
• ACTIQ (pain)
• Ambien (insomnia)
• Lyrica (anticonvulsant/pain)
• Duragesic patches (pain)

Source 1 Cypress Care Data 2007
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Therapeutic Drug Classification 2007 YTD

• Narcotic Analgesics continue to make up a
  majority (36) of all prescriptions processed.
• Non-steroidal anti-inflammatory drugs, such as
  Celebrex and Ibuprofen represent 12 of all
  prescription activity.
• Generally speaking, pain medications continue
  to make up almost 50 of all processed
  medications.

Source 1 Cypress Care Data 2007
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Current Workers Comp Environment

• Medical expense is almost 60 total claims cost
• Total medical expenses in 2006 were over 35
  billion
• Pharmacy accounts for more than 14 of the total
  medical expense
• Pharmacy expenses in 2006 were over 5 billion

Source NCCI Workers Compensation Market
Outlook 2007 Figure derived by Health Strategy
Associates (HSA) from a combination of NCCI
statistics trended forward by 10 from 2005, and
estimate of medical inflation in workers
compensation, and HAS client data by HSA.
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Opioid Utilization

• The use of opioids for workers compensation
  claimants with chronic pain became popular after
  effectiveness in treating acute pain and cancer
  pain was demonstrated.
• Chronic pain is not the same as acute or cancer
  pain.
• Using drugs developed for those purposes can lead
  to addictions that are not often recognized or
  acknowledged by providers.
• Studies of opioid use for chronic back pain
  showed no pain-relieving advantage of opioids
  over placebo or non-opioid control groups.
• Studies indicated only insignificant drops in
  pain from the break-through pain baseline with
  opioid use.

Source Experts Warn of Wounded Syndrome. Dr.
Susan Novak. July 2007. Presented to Southern
Association of Workers Compensation
Administrators (SAWCA) Annals of Internal
Medicine 2007 Report
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Patient Prescription Adherence

• Unpublished data analyses in our laboratory
  demonstrate a significant lack of patient
  adherence in chronic WC cases (approximately
  50), and that the prescribing physician was able
  to predict overall patient adherence in a little
  more than 50 of patients but was only correct in
  approximately 10 of the nonadherent group.
• A recently published study involving pain
  management patients revealed that 45 had
  abnormal urine drug test results
• Michna, E., et al. Urine Toxicology Screening
  Among Chronic Pain Patients on Opioid Therapy
  Frequency and Predictability of Abnormal
  Findings. Clin J Pain, Volume 23, Number 2,
  February 2007.
• Workers Compensation report, Emerging Trends,
  Vol. 19, No 2 page 39, 12/18/07

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Study Objectives

• Objectifying Pharmacotherapy Integrating
  Pharmacy Benefits Management and Clinical
  Medication Monitoring
• Overall objective To examine prescription
  adherence in a group of chronic workers
  compensation patients using state-of-the-art
  clinical drug monitoring and identify and
  stratify these patients based upon
  pharmacological, clinical, and biopsychosocial
  parameters.

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THREE-MONTH SUMMARY, OCT-DEC Percentage of
Patient Adherence to Prescription Regimens ()
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Patient Issues

• Extended treatment times and excess office visits
• Physical Therapy Issues
• ER visits, additional physicians and consults
• Additional diagnostics (MRI, X-ray etc)
• Lost wages, slow or no return to work
• Ancillary issues (depression,anxiety, etc)

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SAMMScientifically Accurate Medication
Monitoring

• A New Level of Interpretation
• The SAMM test results report offers a new level
  of interpretation and clinical support that has
  not been available to the Pain Medicine field to
  date. SAMM, included as part of the Laboratory
  Detail Report that clients currently receive,
  provides quantitative information on commonly
  prescribed pain medications and illicit
  substances as well as information on potential
  sources of drugs detected but not prescribed.
• Scientifically Validated References
• Dominion is the only laboratory of its kind that
  provides scientifically validated and published
  references to support clinical interpretation and
  enhance individual patient pharmacotherapy.
• Patient Prescription Correlation
• The SAMM report correlates an individual
  patients prescribed medications with detected
  drug analytes. The results are displayed in an
  easy-to-read format, and are referenced with
  published pharmaceutical literature. The SAMM
  test results report is generated for each
  laboratory sample for each Pain Management
  patient. The report is self-explanatory, and is
  backed by Dominions clinical team of
  Pharmacologists, Physicians, Pharmacists, and
  PharmDs.

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Case Study

• 48 year old male
• Unsuccessful procedural intervention
• 18 months post injury
• Referred to expert in chronic cases
• Pharmacotherapy for pain and anxiety
• Taking hydromorphone prior to first visit

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Injury
Diagnostics
Diagnosis
Treatment (ProceduresPharmacotherapy etc.)
IMMAP, Baseline UDM
(PBM) Identifies highest users of prescription
medications
Group Plan identifies other expenditures, i.e.,
Med Checks, Office Visits, ER Visits PT Excess
diagnostics etc.
Acute/Chronic Injury and treatment
Pharmacotherapy
IMMAP Survey (Clinical observations and metrics)
Stratify (Toxicity, Efficacy, Genetic,
Psychosocial)
Establish testing (change in dose, drug SAMM
results)/ IMMAP, Patient feedback) frequency per
group
Iterations and case management utilization review
and evaluation
Integrate SAMM, IMMAP (Complete case Mgt.
Utilization and Financial reports)
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Medication Costs
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Without Urine Drug Monitoring
Prescription Cost
Event Cost
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With Urine Drug Monitoring
Prescription Cost
Event Cost
UDM Cost
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Pharmacogenomics

• Individualize Medicine Based on Genetic Profiles
  
• Detect, Monitor and Treat the Molecular Cause(s)
  of Disease
• Identify Genetic Variations Affecting Drug
  Response, Drug Metabolism, Adverse Effects,
  and/or Disease Progression
• Advance Genomic and Proteomic Technologies,
  Rational Drug Design, and Laboratory Diagnostics
• Develop and perform Emerging Technologies
  Utilizing Pharmacogenomic Concepts
• Address Ethical and Regulatory Issues Arising
  from Genomic Research and Technology

Anne Bardsley-Elliot, Editor, May 2001
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• Successful prescription drugs work only part
  (40-60) of the time
• e.g., Try this and call me in the morning
• But of the 4060 of patients who respond to a
  drug, that drug is very (100) effective
• Select the right drug, in the right dose, at
  the right time, the first time.

Weber, SOFT 2003
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Bradford LD. CYP2D6 allele frequency in European
Caucasians, Asians, Africans and their
descendants. Pharmacogenomics. 2002
Mar3(2)229-43. Review
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Evans and McLeod
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Conclusions

• Prescribing drugs to patients who need them and
  demonstrating pharmacovigilance need not be
  divergent issues.
• Sound monitoring, patient documentation, and
  adherence with state and federal legal guidelines
  are essential.
• The integration of every aspect of the healthcare
  system is necessary to ensure patient safety,
  clinical efficacy, fiscal responsibility,
  expediency, accuracy, and ethicality.
• Making new technologies including UPLC/MS/MS the
  standard of care is a rational way to move
  healthcare forward

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Thank You!

• 211 Circuit Drive
• North Kingstown, RI 02852
• Toll Free [phone]
• www.dominiondiagnostics.com