Download An Introduction to Dominion Diagnostics, LLC

Dominion Diagnostics
Medication Monitoring
Presented to:
National Council of Self-Insurers
May 18, 2009
Frank A. Fornari, Ph.D
Chief Executive Officer
(877) 734-9600
[email protected]
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
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
Targeted Market Segments
• Drug Treatment and Mental Health Clinics
• State and Private Worker’s Compensation Systems
• Pain Management Practices
• Primary Care Physicians
• Hospital Systems and Self-Insured Corporations
• Pharmaceutical Companies
• Pharmacy Benefits Management Companies
• Commercial Healthcare Insurance Payers
Testing Rationale
• Clinical Pharmacotherapeutic and Pharmacokinetic Issues
• Substance Abuse, Misuse, Diversion and Addiction Issues
• Medico-Legal Concerns
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
Healthcare Concerns
1.
2.
3.
4.
5.
6.
7.
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 system’s problems
It is becoming a political rather than a scientific issue
Business Model and Opportunity
1.
2.
3.
4.
5.
6.
7.
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
The Top 10 Drugs Processed by Cost 2007
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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
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
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.
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
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
Study Objectives
• Objectifying Pharmacotherapy: Integrating Pharmacy
Benefits Management and Clinical Medication Monitoring
• Overall objective: To examine prescription adherence in a
group of chronic worker’s compensation patients using stateof-the-art clinical drug monitoring and identify and stratify
these patients based upon pharmacological, clinical, and
biopsychosocial parameters.
THREE-MONTH SUMMARY, OCT-DEC: Percentage of Patient
Adherence to Prescription Regimens (%)
7%
47%
Adherence
Non-Adherence
46%
Further Testing
Required
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)
SAMM™
Scientifically 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 patient’s 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 Dominion’s clinical team of
Pharmacologists, Physicians, Pharmacists, and PharmDs.
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
Injury
Diagnostics
Diagnosis
IMMAP, Baseline UDM
Treatment (ProceduresPharmacotherapy etc.)
(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)
Medication Costs
Prescription
Xanax 0.25mg
Percocet 5/325mg
Soma 350mg
Opana ER - 40 mg
Dilaudid - 8mg
Prescription
Cost
49.00
320.00
737.00
2503.95
322.00
Monthly Quantity Brand Cost
30
49.00
90
320.00
120
737.00
80
2,503.95
120
322.00
Generic Cost
5.33
22.00
57.30
Not Available
139.95
Active Compound
Alprazolam
Oxycodone
Carisoprodol
Oxymorphone
Hydromorphone
Without Urine Drug Monitoring
Prescription Cost
Costs
Event Cost
3,609.95
UDM Cost
150.00
0.00
=
Monthly
Annual
$3,759.95 $45,119.40
Financial Impact
Adherence
Prescription Cost
Event Cost
Dec-07
Nov-07
Oct-07
Sep-07
No
0%
Yes
0%
Events
Unknown
100%
Alert
0%
Aug-07
Jul-07
Jun-07
May-07
Apr-07
Mar-07
Feb-07
Jan-07
3,500.00
3,550.00
3,600.00
3,650.00
Costs
3,700.00
3,750.00
3,800.00
With Urine Drug Monitoring
Prescription Cost
Cost
Event Cost
14,168.85
Adherence
Annual
$18,718.85
UDM Cost
1,800.00
2,750.00
=
Financial Impact
Dec-07
Oct-07
Sep-07
Events
No
17%
Nov-07
Alert
0%
Yes
83%
Aug-07
Jul-07
Jun-07
May-07
Apr-07
Prescription Cost
Event Cost
UDM Cost
Mar-07
Yes
No
Alert
Feb-07
Jan-07
0.00
500.00
1,000.00 1,500.00 2,000.00 2,500.00 3,000.00 3,500.00 4,000.00 4,500.00
Costs
$50,000.00
Financial Impact - Single Patient
$45,119.40
$40,000.00
$30,000.00
$18,718.85
$20,000.00
$10,000.00
$0.00
Without Urine Drug Monitoring
With Urine Drug Monitoring
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
Rationale for Pharmacogenetics
• Successful prescription drugs work only part (40-60%) of the time
e.g., “Try this and call me in the morning”
• But of the 40–60% 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
Bradford LD. CYP2D6 allele frequency in European Caucasians, Asians, Africans and their descendants.
Pharmacogenomics. 2002 Mar;3(2):229-43. Review
All patients with same diagnosis
1
Remove
non-responders
and toxic responders
2
Treat
Responders and Patients
Not Predisposed to Toxicity
Evans and McLeod
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
Thank You!
211 Circuit Drive
North Kingstown, RI 02852
Toll Free: (877) 734-9600
www.dominiondiagnostics.com