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C. Bernie Good MD MPH
Department of Veterans Affairs
University of Pittsburgh
CADTH 2016
April 12, 2016
Chair Medical Advisory Panel for Pharmacy Benefits Management, U.S. Department of Veterans Affairs
Co-Director VA Center for Medication Safety
FDA Drug Safety Oversight Board Member
No COI with industry
Comprehensive health care system ◦ Direct provider of care
◦ Physicians are employees
◦ Prescription drug benefit is integrated
2014 Statistics ◦ 6.3 M veterans treated, 4.8M pharmacy users ◦ 271 million outpatient Rxes (30-day Eqv)
EMR ◦ Clinical data
◦ Pharmacy data
◦ Adverse drug events
VA Center for Medication Safety ◦ Dedicated group of pharmacists, data analysts, programmers,
and statisticians to support VA PBM
Routinely do data monitoring, rapid cycle analyses, and full studies as indicated
Work closely with FDA and other U.S. Federal Agencies
Drug/Drug Class
Issue Potential Impact
Real World VA Data
Outcome or Action
TZDs Rosiglitazone CV Safety?
166,000 pts on TZD (2006)
VA Data: Rosi > Pio for MI
Rosi removed as preferred
Zoster Vaccine Inc SAE’s in Clinical Trial
~ half VA patients >65 yo
No inc in SAEs in VA patients
Relaxed criteria
Varenicline Inc Neuropsych ADE, suicide comp NRT
24% VA smoke (17% U.S. > 18 yrs)
No sig signal Relaxed criteria
DOACs Safety, effectiveness v. warfarin in VA
307,000 VA pts with AF
Safety, effectiveness ~ clinical trials
3 DOACs on VA formulary
Hepatitis C Comp. Eff; safety of meds
170,000 VA pts with HCV
Real world < Clin Trials
Use info for contracting
Empagliflozin Comp Eff; Safety
> 1M VA pts on DM Rx
To Be Determined
Reassess Recs
Hep C Registry: Every VA patient with HCV ◦ Genotype, viral load, prior treatment, advanced liver disease
(ALD)
◦ Treatment response, adverse events, discontinuation, etc
Weekly reports for new starts, by drug ◦ National, Regional, and site facility level
◦ Track new starts also by presence/absence of ALD
◦ Feedback to facilities for ALD starts, drug choice, with benchmarking
Hep C data is used for contracting, CER among agents, and feedback to facilities to manage appropriateness
> 50,000 VA Pts treated with DAA
$599 FY 1999
$752
$697 $794
FY 2005
41% increase 3 Yrs
2013-2015
13% increase 14 Yrs
1999-2013
$672
$680
$752
$959
$-
$200
$400
$600
$800
$1,000
$1,200
FY1999 FY2000 FY2001 FY2002 FY2003 FY2004 FY2005 FY2006 FY2007 FY2008 FY2009 FY2010 FY2011 FY2012 FY2013 FY2014 FY2015
Annual Cost per Pharmacy Unique Patient in VA/ with and without Hep C
Post-marketing surveillance ◦ FDA warnings for neuropsychiatric adverse events, and suicide
VA had reports of Varenicline related suicide
As a result, VA developed criteria for use that restricted use of Varenicline as a third line treatment, with many safety measures
Use of Varenicline dropped dramatically in VA
Risk <<<< Benefit??
0
10000
20000
30000
40000
50000
60000
70000
80000
FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 FY 2013 FY 2014 FY
Varenicline Peak 2008 > 74,000 patients/ year Currently < 20,000 patients/ year
Propensity-matched study in the era *prior to FDA warnings*
NRT vs. Varenicline ◦ Primary Outcome: Psychiatric adverse events
Subgroups: Patients with and without psychiatric diagnoses
◦ Inpatient admissions, outpatient visits ◦ Suicide
Results (pending publication) ◦ No significant increased adverse outcomes with Varenicline
VA has changed criteria for use- significantly relaxed ◦ Education efforts to increase use in appropriate patients
DOACs- Clinical Trials: Better outcomes
outcomes strongly associated with INR control in the warfarin comparison patients- for both safety and efficacy
Greater patient convenience
Far more expensive than warfarin
VA Utilizes Pharmacy-based Anticoagulation Clinics
TTR’s in VA excellent
3 DOACs on VA Formulary- does comparative effectiveness warrant significantly greater cost?
New user cohort, propensity matched cohort for non-valvular AF
VA has done similar study, for dabigatran, rivaroxaban, and apixaban. Results show benefit >> warfarin
* Graham et al, Circulation 2014
Outcome HR (95% CI)
Ischemic Stroke 0.80 (0.67-0.96)
Intracranial Hemorrhage 0.34 (0.26-0.46)
Gastrointestinal Bleed 1.28 (1.14-1.44)
Acute Myocardial Infarction 0.92 (0.78-1.08)
Death 0.86 (0.77-0.96)
Real world data can inform clinical decisions ◦ Provide justification for increased expenditures based on
improved clinically relevant outcomes
◦ Provide information that suggests utilization in VA should increase, based on safety and or effectiveness
◦ Provide information that drugs should be de-emphasized or removed from formulary status based on safety concerns
Clinical guidance
Drug Monographs
Criteria for use
Clinical documents
> 1 million pts with DM get medications from VA
Have emphasized metformin, de-emphasized other newer oral agents without proven benefit
Recent empagliflozin study indicates clinical benefit ◦ VA has added drug to our formulary with criteria for use
◦ Concerns regarding whether safety and effectiveness will be similar to clinical trial data
◦ Will monitor use of drug carefully, and track ADE, and later assess benefits
0
200,000
400,000
600,000
800,000
1,000,000
1,200,000
All other diabetic agents
DPP-4's
GLP1 agonists
Total Unique Diabetic Patients
Insulin analogs only
Insulins- (No analogs)
Metformin
SGLT-2 inhibitors
Sulfonylurea
TZD's