Recovering from IMS Failures IMS Queues - IMS UG May 2014 San Ramon
This information is confidential and proprietary and may ... · EvaluatePharma. World Preview...
Transcript of This information is confidential and proprietary and may ... · EvaluatePharma. World Preview...
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
1
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Specialty pharmacy:The topic that won’t stop growing.
2
Grant Knowles, PharmD, CSP
VP, Business Development
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Specialty pharmacy
An undeniable and growing proportion of healthcare spend.
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Defining
4
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
What are specialty medications?
AMCPAcademy of Managed Care Pharmacy
“Medications generally prescribed for people with complex or ongoing medical conditions such as multiple sclerosis, hemophilia, hepatitis, and rheumatoid arthritis. These medications also typically have one or more of the following characteristics: injected or infused, but some may be taken by mouth; unique storage or shipment requirements; additional education and support required from a health care professional; usually not stocked at retail pharmacies.”
NASP
National Association of Specialty Pharmacies
Specialty drugs are more complex than most prescription medications, and are used to treat patients with serious and often life-threatening conditions, including cancer, hepatitis C, rheumatoid arthritis, HIV/AIDS, multiple sclerosis, cystic fibrosis, organ transplantation, human growth hormone deficiencies, and hemophilia and other bleeding disorders. These medications may be taken orally, but must often be injected or infused, and may have special administration, storage, and delivery requirements.
There is no “industry standard”
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Specialty medications
High cost
$1,000-$40,000 per
Rx
Complex admin
Injection, infusion, complex
oral regimen
Unique monitoring
efficacy
concerns,
side-effect,REMS*
Specific climate needs
Specific storage or shipment protocol
Require additional
patient education
“high-touch” disease states,
adherence
Require 24/7
clinical support
High side-effects,
adherence assistance
Drugs not available in retail settings
LDD±
1. *REMS – Risk Evaluation and Mitigation Strategies
2. ± LDD – Limited Distribution Drugs
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
How payers define specialty
43%
66%
67%
73%
71%
81%
85%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
Requires patient admin training
Indicated for disease already classified as specialty
Limited distribution
Requires specialty handling
Treats orphan disease
Requiring special monitoring
High cost
1. From 91 payers with over 124 million lives
2. EMD Serono Injectable Digest (10th Edition).
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Traits of specialty medications
1. EvaluatePharma. World Preview 2015-2020.
2. IMS - Medicines Use and Spending Shifts – April, 2015
3. Milliman: Commercial Specialty Medication Research: 2016 Benchmark Projections
7 out of the top 10 medications
in 2014
9 out of the top 10 prescription
in 2020
$7,000 -$400,000
treatment year
28 times more costly than
non-specialty
Increase in price by 6%-20% annually
Patients have a 10X PMPM
99%
1%
UTILIZATION
Traditional Drugs Specialty Drugs
67%
33%
SPEND
Traditional Drugs Specialty Drugs
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
How payers define high cost
14%
40%
29%
17%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
<$600 $600-$800 $1000-1200 >$1,200
1. From 91 payers with over 124 million lives
2. EMD Serono Injectable Digest (10th Edition).
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Past & Future
10
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Healthcare spending(past and future)
11
1. CMS. National Health Expenditure Projections 2014-2024. Accessed April, 2016
0%
2%
4%
6%
8%
10%
12%
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
Bill
ion
s
National Health Expenditures (NHE) % NHE Growth
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Healthcare & Prescription spending(past and future)
12
0.00%
1.00%
2.00%
3.00%
4.00%
5.00%
6.00%
7.00%
8.00%
9.00%
10.00%
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
Bill
ion
s
National Health Expenditures (NHE) Prescription Drug Expenditures (PDE) % PDE of NHE
1. CMS. National Health Expenditure Projections 2014-2024. Accessed April, 2016
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Prescription spending(past and future)
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
$0
$100
$200
$300
$400
$500
$600
Bill
ion
s
Prescription Drug Expenditures (PDE) % PDE Growth
13
1. CMS. National Health Expenditure Projections 2014-2024. Accessed April, 2016
Branded
Blockbusters
Patent Cliff
Specialty
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Limited generic relief
14
2010-2013
0-2%
2014-15
9-15%
2016+
6-8%Trend line
Rx spend
Generic & Biosimilar saving
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Towering trends
1. Drug Trend Report 2014 & 2015 – Express Script
2. IMS: Medicines Use and Spending in the U.S.
-0.5% -0.1%
22.6%
17.7%
9.0%
6.4%
-5.0%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
2015 Estimate 2015 Actual
Traditional Specialty Overall
Purchase
cost
Includes after
purchase
discounts
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Towering trends
1. Drug Trend Report 2014 & 2015 – Express Script
2. IMS: Medicines Use and Spending in the U.S.: April 2016
-0.5% -0.1%
22.6%
17.7%
9.0%
6.4%
-5.0%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
2015 Estimate 2015 Actual
Traditional Specialty Overall
MSRP
IMS 2015 Trend
Gross - 12.2%
Net - 8.5%
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Estimated specialty spend
$55 $151
$400
$1,700
$ in Billion
2005 2015 2020 2030
1. IMS - Medicines Use and Spending Shifts – April, 2016
2. PCMA - Pharmaceutical Care Management Association
3. UnitedHealth Center: The growth of specialty pharmacy
4. Milliman: Commercial Specialty Medication Research: 2016 Benchmark Projections
Farther reaching estimations diminish in accuracy
NASH (Nonalcoholic
Steatohepatitis)
Alzheimer’s disease
Muscular dystrophy
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Estimated spend distribution
1. IMS - Medicines Use and Spending Shifts – April, 2015
2. Drug Trend Report 2014 & 2015 – Express Script
81.0%
67.3% 62.3%50.0%
19.0%
32.7% 37.7%50.0%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2004 2014 2015 2018-2020
Traditional Drugs Specialty Drugs
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
81.0%
67.3% 62.3%50.0%
19.0%
32.7% 37.7%50.0%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2004 2014 2015 2018-2020
Traditional Drugs Specialty Drugs
Estimated spend distribution
1. IMS - Medicines Use and Spending Shifts – April, 2015
2. Drug Trend Report 2014 & 2015 – Express Script
3. Milliman: Commercial Specialty Medication Research: 2016 Benchmark Projections
2016 Estimates:
• Specialty will be 58% of medical drugs spend
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Cost of Hepatitis C. therapy
21
1. Forbes: For Hepatitis C Drugs, U.S. Prices Are Cheaper Than In Europe. Accessed 4/12/16
2. WSJ: What the ‘Shocking’ Gilead Discounts on its Hepatitis C Drugs Will Mean. Accessed 4/12/16
$53,760
$53,312
$60,480
$55,000
$54,541.67
$67,000
$84,000
$83,300
$94,500
Sovaldi
Viekira Pak
Harvoni
US - Purchase UK/Germany US - after purchase discount estimate
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Why so special?
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Why so special?
• Treatment & cures for conditions that may have had none
• Serious benefits and serious potential for side effects
• Shifting therapies to patient administered
• More home, less hospital
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Improved efficacy
+90%, 5-year survival
for CML
1. Cancer.Net: Leukemia – Chronic Myeloid – CML: Statistics
2. CML = chronic myeloid leukemia
Prior
Therapy
for CML
Gleevec
30%, 5-year survival
for CML
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Acute become chronic
1. Adapted from the Cancer Treatment & Survivorship. Facts & Figures: 2014-2015
26%
35%
41%
26% 27%
23%21%
35%
32%
37%
27%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
Cancer survivor increase by 2024
$4.4M more survivors
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Hepatitis C therapies
26
48
24
12
28%
66%
90%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0
10
20
30
40
50
60
2002 2011 2014-2015
Weeks on Therapy Cure Rate (SVR for Genotype 1)
1. HCSP Fact Sheet: A Brief History of Hepatitis
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Where’s the
generics? Trick question, there aren’t any…
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Biosimilars
Must demonstrate safety, purity, and potency with:
Types
• Biosimilars, 2 approved.
• Interchangeables, 0 approved
28
1. FDA.gov: Information on Biosimilars
Analytical testing
BioassaysAnimal studies
Human clinical studies
Per FDA, “Biosimilars are highly similar to the reference product they were compared to, but have allowable differences because they are made from living organisms. Biosimilars also have no clinically meaningful differences in terms of safety, purity, and potency from the reference product.”
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Size & Complexity – Small molecule drugs & biologics
1. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220037.htm
Siz
eC
om
ple
xity
Aspirin21 atoms
Small Molecule Drug Large Molecule Drug
Bike~21 lbs..
hGh~3000 atoms
Car~3000 lbs.
Large Biologic
IgG Antibody~25,000 atoms
Business Jet~30,000 lbs. (without fuel)
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Size & Complexity – Small molecule drugs & biologics
1. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220037.htm
Siz
eC
om
ple
xity
Aspirin21 atoms
Small Molecule Drug Large Molecule Drug
Bike~21 lbs..
hGh~3000 atoms
Car~3000 lbs.
Large Biologic
IgG Antibody~25,000 atoms
Business Jet~30,000 lbs. (without fuel)
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Market impact - biosimilars
Potential $44.2 billion reduction in spending from 2014 to 2024
New competition
• Reference product (brand) will not go away
• Interchangeable >5 years away
• 10-35% savings
Slow market entry
• Generic approvals take 30-48 months
• Two biosimilars have been approved in the last 2 years.
Biosimilar approved
• Zarxio to compete with Neupogen
• Inflectra to compete with Remicade
311. The Cost Savings Potential of Biosimilar Drugs in the United States. RAND Corporation
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Focus
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Focused industry
1. IMS: Medicines Use and Spending in the U.S.
Other
19%
HIV
11%
MS
12%
Hepatitis
12%
Autoimmune
20%
Oncology
26%
80% of spend
from five
categories
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Specialty pipeline
1. Pharmaceutical Research and Manufacturers of America.
2. FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. Accessed April 2016
3. EvaluatePharma. World Preview 2015-2020..
4. IMS - Medicines Use and Spending Shifts – April, 2016
2012-2015: over 50% of FDA approvals
were specialty
Oncology, autoimmune, & viral
hepatitis are expected to lead
Manufacturer R&D is estimated at $493B
2015: FDA approved 19 oncology drugs at
+$8K a prescription
630 products in phase II or higher, 37% are
for specialty
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
FDA new drug approvals
35
22 2218
23 24
1217
21
9
24 27
6 78
810
14
18
22
19
2727
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Traditional Specialty
1. Adaption from PWC Behind the number, 2016. Slide 5
2. FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. Accessed April 2016
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Fueling the growth
TrendNovel mechanisms
Improved efficacy
Larger patient
populations
Expanding drug
indications
Large pipeline of new drugs
Price increases
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Fueling the growth
TrendNovel mechanisms
Improved efficacy
Larger patient
populations
Expanding drug
indications
Large pipeline of new drugs
Price increases
Price
increase
expected to
account for
10-12% of trends
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Specialty
Pharmacies
38
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Specialty, Pharmacy?
US population
~320 million
~0.9/RX /patient/month
Specialty RX’s are ~1%
# of US pharmacies
~67,000
Typical retail
pharmacy dispenses:
~1,075 RX/week
~11 specialty Rx/week
Specialty pharmacy dispense:
~500-5000 specialty RX/week
Specialization
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
The 1%
40
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
The 1% is our 100% focus
41
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Expertise
• Appropriate to start?
• Appropriate to continue?
• Drug interactions?
Right medication
• Initiation of therapy?
• Continuation of therapy?
Right dose
• Is it being taken?
• What is the frequency?
Right time
Specialty medication can make up 80% or more of a patient’s health care spend.
Multiple Sclerosis therapies can reduce other healthcare spending (ER, hospital, etc.) by 18%.
1. Milliman. Multiple Sclerosis: New Perspective on the Patient Journey
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
High-touch advantages
43
Eligibility verification
Benefit issue resolution
Coordination of benefits
PA assistancePA
recertification (30 days)
<1 business day Rx transfer
<1 business day new patient
contact
Financial assistance enrollment
Support program
connection
Website injection
training videos
Health history check
Drug utilization review
Medication reconciliation
Comprehensive business
continuity
Transition override
coordination
Effectiveness review
Clinical programs
24/7/365 pharmacist call
line
Therapy education
Preemptive refill coordination
Multiple patient outreach & MD coordination
Adherence management
Side effect management
Provider & RX coordination
Same-day delivery options
Next-day delivery
Email package tracking
Ancillary supplies for free
Overuse reviewMedication
replacement coordination
E-prescribingPerson-to-
person contact
Experienced specialty
pharmacists
Same-day delivery
opportunities
Bilingual customer service
Translation capabilities for
>200 languages
36-hour validated coolers
Saturday delivery options
Shipment monitoring &
extraction
Summer packing
Winter packingState-of-the-art
call center
Dedicated to the positive impact of every patient with every interaction
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Improving outcomes
44
Experienced specialty
pharmacists
Patient
ManufacturerPrescriber
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Improving outcomes
45
Experienced specialty
pharmacists
Patient
ManufacturerPrescriber
Side effects
Adherence
Administration
Stability
Drug interactions
Side effects
Adherence
Drug interactions
Dose confirmation
Length of therapy
Effectiveness
Side effects
Malfunctions
Stability
Drug replacement
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Improving access
46
87% of fills were connected
with assistance
Median
patient paid:
$5.00
Average obtained:
$138.45
Average patient paid: $22.47
2015 financial assistance
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Adherence
47
• Medication Possession Ratio (MPR), standard measurement
• 80% considered adherent− 2 out of every 10 days of therapy is skipped
1. Visaria J, Frazee SG. Role of pharmacy channel in adherence to hepatitis C regimens. American Journal of Pharmacy Benefits. 2013;5(1):17-24.
2. Understanding and Improving Adherence for Specialty Products: IMS. Accessed January 2016.
3. Tschida SJ, Aslam S, Lal LS, et al. Outcomes of a specialty pharmacy program for oral oncology medications. American Journal of Pharmacy Benefits. 2012;4(4):165-174.
MPR = Sum of days’ supply for all fills in period
Number of days in period
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Improving adherence
48
• Case studies show pharmacies achieve MPR of
− Retail: 75-82%
− Specialty: 85-90%
1. Visaria J, Frazee SG. Role of pharmacy channel in adherence to hepatitis C regimens. American Journal of Pharmacy Benefits. 2013;5(1):17-24.
2. Understanding and Improving Adherence for Specialty Products: IMS. Accessed January 2016.
3. Tschida SJ, Aslam S, Lal LS, et al. Outcomes of a specialty pharmacy program for oral oncology medications. American Journal of Pharmacy Benefits. 2012;4(4):165-174.
4. IMS: Avoidable Costs in U.S. Healthcare. June 2013
Ardon maintained a
92% MPR in 2015Non-adherence:
A $105B problem
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Improving adherence
49
• Case studies show pharmacies achieve MPR of
− Retail: 75-82%
− Specialty: 85-90%
1. Visaria J, Frazee SG. Role of pharmacy channel in adherence to hepatitis C regimens. American Journal of Pharmacy Benefits. 2013;5(1):17-24.
2. Understanding and Improving Adherence for Specialty Products: IMS. Accessed January 2016.
3. Tschida SJ, Aslam S, Lal LS, et al. Outcomes of a specialty pharmacy program for oral oncology medications. American Journal of Pharmacy Benefits. 2012;4(4):165-174.
4. Yermakov S, Davis M, Calnan M, et al. Impact of increasing adherence to disease-modifying therapies on healthcare resources utilization and direct medical and indirect work loss costs for
patient with multiple sclerosis. J Med Econ. 2015;18(9):711-720
Ardon maintained a
92% MPR in 2015
10% increase in adherence for MS:
Reduction in ER visits:
9-19%
Reduction in work loss
days:
3-8%
Reduction in direct/
indirect cost:
3-5%
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Managing
specialty
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
Benefit strategies
Prior Authorization (PA)
•Evidence-based uses
•FDA approved indications
•Off-label: national clinical guidelines & peer-reviewed articles
Rebates
•Increased brand competition
Step-therapy
•Conditions with multiple evidence-based treatment modalities
•Requires the use of preferred, cost-effective therapies
Value-based cost share
•Exclusive specialty tiering
•Primer for biosimilars
Waste mitigation
•30-day supply on all treatments options
•Consider lower supplies for therapies with high discontinuation rates (15 day)
Selecting specialty pharmacy partner
•10% on drug costs and substantial savings on non-drug medical costs compared to retail pharmacies
1. Mail-Service and Specialty Pharmacies Will Save More than $300 Billion for Consumers, Employers, and Other Payers Over the Next 10 Years. Visante. September 2014
2. Pharmacy Benefit Managers (PBMs): Generating Savings for Plan Sponsors and Consumers. Visante. January 2016
PCMA, estimates $654 billion savings from 2016-2025
This information is confidential and proprietary and may not be reproduced in whole or in part unless authorized in writing by an authorized representative of Ardon Health.
52