Download HIV Insight Report

Drug Class
Insight
HIV
Background, new developments, key strategies
INTRODUCTION
Human Immunodeficiency Virus (HIV) is the virus that can lead to Acquired
Immunodeficiency Syndrome, or AIDS. No safe and effective cure for HIV
currently exists, but with proper medical care, it can be controlled.1
Estimated lifetime cost of care
for one HIV/AIDS patient
1.2 million people in the United States
•
were living with HIV at the end of 2011
(most recent data).2
14% do not know they are infected.2
• New infections have remained at about
50,000 per year for over a decade.3
• 13,712 people diagnosed with AIDS
Up to
$402,000
•
died in 2012 in the US.
2
Truven Health Analytics. Impact of Pharmaceutical
Innovation in HIV/AIDS Treatment. December 2014.
HIV WORKS BY DESTROYING THE BODY’S DEFENSES
A human CD4 T-cell infected by numerous HIV particles
The HIV virus inserts itself into healthy immune system cells and then uses the cell to manufacturer new HIV virus that can infect
other immune cells. This process ends up by destroying most of the body’s functioning immune cells. Eventually, the body can’t
fight off infections and the HIV infection leads to AIDS plus other, opportunistic infections.1
Human blood with red blood cells,
T-cells (orange) and platelets (green)*
Based on image source: NIAID via amfAR: Boosting Killer T cells
to Eliminate HIV Reservoirs. Feb. 12, 2015.
T-cell
HIV particles in yellow*
Adapted from National Institutes of Health.
Life: Magnified. April 02, 2015.
* Colors enhanced for clarity.
Optum
www.optum.com
Page 1
HIV Insight Report
TREATMENT
Today, treatment for HIV involves antiretroviral therapy or ART. HIV mutates quickly;
attacking with 1 drug allows it to evade destruction and build resistance. Therefore, bestpractice calls for ART drugs taken in combination to suppress the growth of the virus.4
Cell infected with HIV (blue)
Mutated fragments survive
1-drug treatment
Reinfection with
mutated HIV
3-combined ART drugs
destroy new fragments
Virus suppressed to
undetectable levels
ART therapy
with 1 drug
Cell infected with HIV (blue)
ART therapy
with 3 or
more drugs
Based on AIDS InfoNet. Fact Sheet 403: What Is Antiretroviral Therapy (ART)? Revised July 23, 2014.
EFFECTIVE TREATMENTS MEAN FEWER DEATHS AND GREATER
PREVALENCE OF THE DISEASE
-72%
Decrease in deaths per year after 1995
Increase in persons living with HIV after 1995
+60%
National Institute on Drug Abuse. July 2012 at: http://www.drugabuse.gov/longdesc/estimated-personsliving-hiv-infection-diagnosed-undiagnosed-estimated-aids-deaths-among-adults-ado on 06.02.2015
ACCESS AND ENGAGEMENT IN CARE
HIV Care Continuum
Testing and care engagement lacking
PERCENT OF ALL PEOPLE LIVING WITH HIV
82%
Diagnosed
Optum
www.optum.com
40%
33%
25%
Engaged in care
Prescribed ART
Virally suppressed
CDC. Vital Signs: HIV
Diagnosis, Care, and
Treatment Among Persons
Living with HIV – United
States, 2011. MMWR. 2014,
63(47): 1113-1117
Page 2
HIV Insight Report
UNDERSTANDING TREATMENT COSTS
The average monthly cost for the top 5 HIV drugs is $1,400 per month, compared to
$3,000 per month for all specialty drugs.5,6 So, while not the most expensive specialty
drugs, medications used to treat HIV/AIDS can still be costly, since HIV treatments are
required for life.
Cost of Direct Medical Care
for HIV/AIDS
Therapy Line 1
$35
$30
$billions
People switch from one "line" or combination
of drugs to another because they develop a
resistance, or they are unable to tolerate
a particular drug or combination of drugs.7
HIV Ranks 3rd in Specialty Spending
$25
$33b
Oncology
$20
$22b
Autoimmune
$15
$15b
HIV Antivirals
$10
1
2
$5
RX: 45.9 / med: 46
0
46% 45.9% = $33,674
Rx
Medical
Source: IMS Health, National Sales Perspectives, Dec. 2014
RX: 45.9 / med: 46
3
RX: 45.9 / med: 46
ART Price Growth: Steady & Strong
Therapy Line 1
3
4
RX: 38.8 / med: 54
54% 38.8% = $39,191
Rx
Medical
RX: 38.8 / med: 54
5
RX: 35.5 / med: 58
Therapy Line 1
RX: 35.5 / med: 58
1
2
35.5 / med: 58
58% 35.5% =RX:$39,882
Medical
Rx
3
PLOS ONE. Cost of Treatment in a US
Commercially Insured, HIV-1 – Infected Population.
May 2014. Volume 9, Issue 5, e98152
Optum
www.optum.com
HIV antiviral spen ding in U.S. Non-discounted $billions
$15
RX: 38.8 / med: 54
$14
$13
$12.5
$12
$11.4
$11
$10
$14.3
+52%
increase
$10.4
$9.4
$9
$2
$1
0
2010
2011
2012
2013
2014
IMS Health, Medicines Use and Spending Shifts. April, 2015.
Page 3
HIV Insight Report
TREATMENT COSTS, BUT ALSO PAYS
Despite their high cost, studies have shown early use of combination treatments
to be cost-effective.7
Actual vs Projected death rates for HIV/AIDS in the United States
9%
8%
7%
ANNUAL
MORTALITY
RATE
Highly active
antiretroviral therapy
introduced
862,000
PREMATURE
DEATHS
AVOIDED
6%
DEATHS
AVERTED
5%
4%
3%
2%
1%
ACTUAL
MORTALITY
Truven Health Analytics.
Impact of Pharmaceutical
Innovation in HIV/AIDS
Treatment. Dec. 2014.
0%
YEAR 1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
ART therapies are helping people live longer, more productive lives:
HIV Medicines Increase Life Expectancy
0%10% 20%30% 40%50%60%70% 80%90%100%
79 years
A person
without HIV
A person with HIV
diagnosed at age 20
taking current
HIV medicines
A person with HIV
diagnosed at age 20
not taking current
HIV medicines
71 years
32 years
National Vital Statistics Reports, 2012; PLoS One, 2013; and Journal of the American Medical Association, 1993.
STILL NEEDED: A CURE OR VACCINE
Some experts worry about the growing cost of ART given the length of
treatment. The total year-over-year cost of therapy will continue to rise –
perhaps to unsustainable levels.8
Optum
www.optum.com
Page 4
HIV Insight Report
THE END OF HIV?
No major viral epidemic has ever been brought under control without a vaccine.9
Many argue that finding an HIV vaccine represents the world's best long-term hope for
breaking the chain of HIV infection and ending AIDS.10
HIV is an extremely difficult target for a vaccine. The virus comes in many varieties and can escape the immune system by
mutating rapidly. While vaccination studies began in 1987, to date, none has proven effective against HIV. Still, creating safe
and effective vaccines is rarely a quick or simple process:
Time to develop a vaccine
Duration between discovery of microbiologic cause of selected infectious diseases and development of a vaccine
Typhoid
1884
Polio
1908
HPV
1984
Measles
1953
HIV
1983
105 years
47 years
22 years
10 years
1989
1955
2006
1963
AVAC AIDS Vaccine Handbook
A breakthrough?
In 2009 a human trial in Thailand called RV144 demonstrated for the first time that a vaccine could reduce infection rates.11
Today there are many vaccines under development, including some that build directly on the RV144 results. Some are
in human trials now; others will be soon.
Decades of Failure – then sudden progress
0
1987-2008: Number of vaccines tested
that showed ANY protection from HIV
31%
RV 144 study results (2009): Percent
protection from HIV
New England Journal of Medicine. The Quest for an HIV-1 Vaccine — Moving Forward. 2013; 369:2073-2076 November 28, 2013 DOI:
10.1056/NEJMp1312711.
The number of aids vaccine trials underway (2015)
Vaccine strategies in clinical trial (2015)*
Phase II
6
Phase I
29
*Select vaccine strategies in ongoing clinical trials. Some strategies studied in more than one ongoing trial.
AVAC Prevention Research & Development Database, 2015
While prevention and treatment with ART drugs have helped, we are still far from stopping
the spread of HIV. Ultimately, the only guarantee of an end to the AIDS pandemic is the
combination of prevention methods and a safe and effective HIV vaccine.12
Optum
www.optum.com
Page 5
HIV Insight Report
SPECIALTY MANAGEMENT PROGRAM
Integrated management allows for consistent management and holistic care coordination.
A Holistic Care Management Approach
Personal Care Team
Physician Coordination
Personally dedicated clinician
coordinates with nurses, doctors
other services
Physician outreach, interaction
and involvement
• Dedicated to specific conditions
• Missed refill notifications
• Behavior health support
• Care plan summaries
• Side effect management
Adherence Support
Helping to ensure members have
what they need to take their drugs
on time, as directed
• Pharmacist counseling
• Refill reminders
• Educational materials
• Empathy training
Managing the Total Cost of Complex Conditions
Appropriate Use
Benefit Management
Drug Cost and Choice
Limiting waste of expensive
specialty drugs
Making an impact with Specialty
Pharmacy Management Programs:
Driving lower cost options:
• Quantity management
• Adherence
• Step therapy
• Prior authorization
• Increased medical savings
• Price protection
• Tier 2 options – all conditions
• Genetic testing
Optum
www.optum.com
Page 6
HIV Insight Report
MEET BRENDA
What does it mean to
manage the total cost
of Brenda's condition?
Brenda was diagnosed with HIV 5 years
ago. She is working hard to stay compliant
with her ART medication regimen. Brenda
transitioned into our Specialty Pharmacy
Program shortly after her employer
switched to OptumRx. She has the
advantage of our advanced customer
service model that continuously monitors
her condition.
Synchronize member touch
points and data into ONE system.
Opportunities
Traditional
PBM
1
Adherence Programs
NOT OPTIMIZED
2
Clinical Management
Program
NOT OPTIMIZED
3
Healthy lifestyle
programs to encourage
condition-appropriate
exercises and diet
MISSED

4
Manage co-morbid
depression with
synchronized
behavioral referrals
MISSED

OPTIMIZED*


OptumRx Connected Care
A traditional PBM looking only at pharmacy
claims or pharmacy solutions can miss
opportunities. Our ONE team approach
manages multiple consumer touch points
to promote real behavior change, like lower
cost alternatives, medication adherence or
engagement in clinical management programs.
* The synchronized care management model described here depends on a minimum specific set of OptumHealth care
management services, plus OptumRx pharmacy services. Please speak to your OptumRx or UnitedHealthcare representative
for more information about how synchronization can work for you.
Connected Engagement:
Every interaction is
Online
an opportunity to
reduce health risk
and lower costs
Pharmacy
Health Care
Advisor
Mobile
Nurse
Advisor
Customer
Service
Synchronized Touch Points
Self Service
Optum
www.optum.com
+
Outreach
Inbound
Page 7
HIV Insight Report
MANAGING COSTS WITH CONNECTED CARE
Traditional PBM's do an adequate job of negotiating discounts, paying claims, managing formularies and so on. But OptumRx is
more than an traditional PBM: We are a complete pharmacy care services company.
We focus on managing total condition spending by connecting pharmacy’s impact across all benefits.
Connected Data
and Expertise
Incremental
3-6% savings*
compared to total
pharmacy spend
Connected Value
• Care Management,
Wellness, Behavioral
Program Connections
• Advanced Nurse Advisor
• Pharmacist Consults
• 360˚ Alert System
• Connected Medical,
Pharmacy, Specialty
Connected
Engagement
Core PBM Value
Like other PBMs, OptumRx
delivers savings through core
PBM programs
• PDL Management
Connected
Care
• Clinical Programs
• Utilization Management
• Exclusions
• Specialty Pharmacy
• Home Delivery
• Adherence programs
• Drug cost management
• Claims processing
• Network
*Estimated additional savings over traditional core PBM services based on
total pharmacy spend. Illustrative only; results may vary.
Optum
www.optum.com
Page 8
HIV Insight Report
References
1. C
enters for Disease Control and Prevention: Division of
HIV/AIDS Prevention, National Center for HIV/AIDS, Viral
Hepatitis, Sexual Transmitted Diseases and Tuberculosis
Prevention. About HIV/AIDS. Jan 16, 2015. Accessed
at: http://www.cdc.gov/hiv/basics/whatishiv.html on
06.02.2015.
2. T ruven Health Analytics. Impact of Pharmaceutical
Innovation in HIV/AIDS Treatment During the Highly Active
Antiretroviral Therapy (HAART) Era in the U.S., 1987–2010.
December 2014. Accessed at: http://truvenhealth.com/
Portals/0/Assets/Life-Sciences/White-Papers/pharmainnovation-hiv-aids-treatment.pdf on 06.10.2015.
3. K
aiser Family Foundation Fact Sheet: The HIV/AIDS
Epidemic in the United States. April 7, 2014. Accessed
at: http://kff.org/hivaids/fact-sheet/the-hivaids-epidemicin-the-united-states/ on 06.09.2015.
4. A
IDS InfoNet. Fact Sheet 403: What Is Antiretroviral
Therapy (ART)? Revised July 23, 2014. Accessed at:
http://www.aidsinfonet.org/fact_sheets/view/403 on
06.04.2015.
5. H
ealth Affairs, 33, no.10 (2014): 1736-1744. Specialty
Medications: Traditional and Novel Tools can address
Rising Spending on these Costly Drugs. Accessed at:
http://content.healthaffairs.org/content/33/10/1736.
abstract on 07.08.2015.
6. Clinical Guidelines Portal. Guidelines for the Use of
Antiretroviral Agents in HIV-1-Infected Adults and
Adolescents. Limitations to Treatment Safety and Efficacy.
Cost Considerations and Antiretroviral Therapy. April 8,
2015. Accessed at: https://aidsinfo.nih.gov/guidelines/
html/1/adult-and-adolescent-treatment-guidelines/0 on
06.23.2015.
7. P LOS ONE. Cost of Treatment in a US Commercially
Insured, HIV-1 – Infected Population. May 2014. Volume
9, Issue 5, e98152. Accessed at: http://journals.plos.org/
plosone/article?id=10.1371/journal.pone.0098152 on
06.02.2015.
8. MedPage Today. Increasing Optimism Over HIV Cure.
April 17, 2015. Accessed at: http://www.medpagetoday.
com/HIVAIDS/HIVAIDS/51049 on 06.01.2015.
9. a mfAR. Progress in the Quest for an HIV Vaccine? May 19,
2005. Accessed at: http://www.amfar.org/Articles/
In-The-Lab/Older/Progress-in-the-Quest-for-an-HIVVaccine--%28May-2005%29/ on 06.26.2015.
10. National Institutes of Health, National Institute of Allergy
and Infectious Diseases (NIAID). HIV Vaccine Research.
Last Updated June 08, 2015. Accessed at: http://www.
niaid.nih.gov/topics/hivaids/research/vaccines/Pages/default.aspx on 06.23.2015.
11. National Institutes of Health, National Institute of Allergy
and Infectious Diseases (NIAID). History of HIV Vaccine
Research. May 21, 2013. Accessed at: http://www.niaid.
nih.gov/topics/hivaids/research/vaccines/Pages/history.
aspx on 06.25.2015.
12. T he New England Journal of Medicine. Ending AIDS —
Is an HIV Vaccine Necessary? Anthony S. Fauci, M.D., and
Hilary D. Marston, M.D., M.P.H. Feb. 6, 2014. Accessed
at: http://demystifyingmedicine.od.nih.gov/DM14/201402-11/NEJM-y2014v370p495.pdf on 07.07.2015.
For more information about how you can manage the cost of HIV,
please contact your OptumRx representative.
www.optum.com
11000 Optum Circle, Eden Prairie, MN 55344
Optum and the Optum logo are registered trademarks of Optum. All other brand or product names are
trademarks or registered marks of their respective owner. Because we are continuously improving our
products and services, Optum reserves the right to change specifications without prior notice. Optum is
an equal opportunity employer.
M33018-P 10/15 © 2015 Optum. All Rights Reserved.
Page 9