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WHAT is market access and WHY does it matter to your brand?
WHO are market access stakeholders?
HOW do these stakeholders control access
and influence prescriber and patient behavior?
HOW do manufacturers work to optimize market access?
Today is all about answering these fundamental questions
WHAT IS MARKET ACCESS
4
The ability for all appropriate patients
to access a given product
quickly, conveniently, and affordably.
In the world of pharma, market access refers to:
5
The ability for all appropriate patients
to access a given product
quickly, conveniently, and affordably.
In the world of pharma, market access refers to:
6
The ability for all appropriate patients
to access a given product
quickly, conveniently, and affordably.
In the world of pharma, market access refers to:
7
The ability for all appropriate patients
to access a given product
quickly, conveniently, and affordably.
In the world of pharma, market access refers to:
8
The ability for all appropriate patients
to access a given product
quickly, conveniently, and affordably.
In the world of pharma, market access refers to:
Market access stakeholders hold the keys
to product access for prescribers and patients
MARKET ACCESS
STAKEHOLDERS
MARKET ACCESS
STAKEHOLDERS
If prescribers and patients can’t get access to the product, then the most
innovative and creative professional, scientific, and consumer marketing campaigns
won’t achieve their full commercial potential.
The 3 Ps: Payers, Population health managers,
and Pharmacy managers/suppliers
Organization type A.K.A. A-list members Why they do what they do
Payers
Commercial Health
Insurance Companies
Aetna
Cigna
UnitedHealthcare
Contain costs (payments for covered
products and services)
Ensure appropriate utilization of covered
products and services
Self-Insured Employers
IBM
Microsoft
Government-Sponsored
Health Plans
Medicare
Medicaid
Veterans Affairs
Tricare
The 3 Ps: Payers, Population health managers,
and Pharmacy managers/suppliers
Organization type A.K.A. A-list members Why they do what they do
Population
Health
Managers
Health Systems Kaiser Permanente
UC Health
New York-Presbyterian
Cleveland Clinic
Health System
Deliver high-quality care that improves
patient outcomes
Contain costs (personnel, drugs and other
supplies, technology, etc) and maximize
reimbursement
Integrated Delivery
Networks (IDNs)
The 3 Ps: Payers, Population health managers,
and Pharmacy managers/suppliers
Organization type A.K.A. A-list members Why they do what they do
Pharmacy
Managers/
Suppliers
Pharmacy Benefits
Managers (PBMs)
Express Scripts
CVS Health
AllianceRx
Walgreens Prime
McKesson
US Bioservices
Contain drug costs and ensure
appropriate utilization of formulary
and nonformulary products
Specialty Pharmacies
(SPs)
Efficiently deliver products with complex
requirements or for rare diseases, and
provide services to optimize therapy
outcomes
Group Purchasing
Organizations (GPOs)
Vizient
Premier
HealthTrust
Intalere
Help health systems, IDNs, and providers
contain drug costs and run more
efficiently
There is considerable overlap among categories—for instance, some IDNs include payer
and pharmacy components, and several of the big payers also operate their own PBMs.
14
The top players at the 3 Ps
Responsible for cost and
quality of healthcare
Weighs medical savings
vs. pharmaceutical costs
Reports to Medical Director
Managed pharmacy benefit/budget
Liaison to P&T Committee
Manages PBM relationship
Responsible for population-
based quality
NCQA accreditation/HEDIS
Disease management
Responsible for employer- and
member-level sales and retention
Wants high quality and low rates
15
P&T committees: the formulary decision makers
Health plans, health
systems, hospitals,
Veterans Affairs, and
the military all have
Pharmacy and
Therapeutics (P&T)
Committees
Promote safe,
efficacious, and cost-
effective drug therapy
by developing policies
on drug evaluation,
selection, and
utilization
Manage the
development
and continuing
maintenance of
the formulary
Members mainly include
medical director, pharmacy
director, physicians (including
specialists), and pharmacists;
other members may include
be nurses, nutritionists,
administrators, and
quality directors
Health plan formularies:
the first line of defense for controlling drug costs
Tier 1
Tier 2
Tier 3
Tier 4/5
Generics
“Preferred” Brands
“Non-Preferred” Brands
Specialty Brands
But, in this venue the “cheap” seats are costly.
Client Goal: To get their
brand on formulary at
Tier 2 or “Preferred”
Tiered co-pay plans: drive generics, formulary compliance,
and maximize manufacturer rebates
Multi-tier
co-pay design
Possible
therapeutic
category Generic co-pay
Preferred brand
co-pay
Non-preferred
brand co-pay
Lowest (Level 1) Diabetes $7.50 $15 $35
Medium (Level 2) Statins $15 $40 $60
Higher (Level 3) PPIs $15 $60 $120
Highest (Level 4) Specialty 25% (Max $50) 25% (Max $200) 40% (Max $400)
PPIs = proton-pump-inhibitors.
Class- and drug-level restrictions and limitations:
controlling the who, when, and where
Prior authorizations
(PAs)
Product A will not
be covered and
reimbursed unless
the HCP sends the
health plan a form
specifying certain
key criteria (eg,
diagnosis)
Step edits/Step
therapy (SEs)
Members must first
try Product A before
trying Products B
and C
Quantity limits
(QLs)
Product A will only
be covered for 30 pills
for a 30-day period;
another example
is 6 months of
therapy
Provider-specific
restrictions
Health Plan A will
cover only prescriptions
for Product B written
by a specific type of
specialist (eg, urologist
or enocrinologist)
The spectrum of payer management strategies
Restrictive
Prescribing Strict
PA
Step
TherapyMild PA
Quantity
Limits
Plan
Spending
Caps
Tiered/
Co-pay
Drug
Utilization
Review
Basic Formulary Controls (less to more restrictive)
$
$
$$ $
$
Financial
Control
Clinical
Control
Tighter restrictions don’t necessarily mean
control of product choice; goal may be:
• Appropriate use of treatment
• Implementation of treatment algorithm
• Proper diagnosis
• Monitor patient/disease management
What’s so special about specialty drugs?
•Specialty drugs include
–Biotechnology products
–Orphan drugs to treat rare diseases
–High-cost drugs (>$300 per Rx)
–Injectables and drugs that must be administered by HCPs
–Drugs requiring high-touch patient services (education,
follow-up calls, adherence support)
•These drugs are typically Tier 4 (or even 5) and require
patients to pay coinsurance (a percentage of the cost)
What’s so special about specialty drugs?
They are on the rise!
20 years ago
there were very few
on the market, most were
covered by medical benefits,
and they accounted for only
7% to 10% of per member/
per year payer costs.
Today, more orphan
drugs are approved each
year, payers are shifting
coverage to pharmacy
benefits (where patients
share more costs), and they
now account for about
40% of payers’ pharmacy
budgets.
The bottom line: specialty products are complex and are an area of focus.
MARKET ACCESS?
Contracting: edging out the competition
•Under some circumstances, such as a crowded market, education
may not be enough to gain favorable access
•In these cases, drug manufacturers often negotiate contracts with
payers, PBMs, GPOs, and even some IDNs to gain market share
•As part of the contract,
–The health plan or PBM places a branded product on
Tier 2, making it a preferred brand
–The manufacturer returns a (predetermined) percentage
of the money the organization spent for the product if
the designated market share is met
In addition to volume-based contracting, the drive toward greater value
in healthcare is giving rise to value- or outcomes-based contracting,
in which reimbursement is tied directly to patient outcomes.
Educating and detailing to market access stakeholders:
making the case for value
Informed market access stakeholders who understand
the value of the product are more likely to make favorable
decisions and policies
•Key topics for market access tactics
–Disease state education
–Product information
•Clinical trial data, MoA, dosing, ordering, storage, price
–Health economics and outcomes research (HEOR) data
–Real-world data
The core tactic for the Market Access audience is the Value Proposition—usually a presentation,
sometimes with a leave-behind component—that covers most or all of the topics above.
Access & reimbursement support programs:
building a safety net
•“Hub” services—insurance, financial
–Investigate the patient’s insurance benefits
–Support for prior authorizations, appeals
–Co-pay assistance programs
–Referrals to other sources of financial assistance
for patients who don’t qualify for co-pay assistance
In many therapeutic areas, Hub and patient support programs
are becoming the norm. Manufacturers have to work harder
to distinguish their programs.
•Patient support—education, adherence
–Telephone hotline to speak with a nurse/pharmacist
–Outbound calls to check in with patient
–Adherence tools/support
Pull-through pays it off
•Between education/detailing, contracting, and access support
programs, manufacturers are investing significant funds and
resources to ensure favorable access to their products
•But low awareness of coverage and support programs can result
in perceived barriers that keep HCPs from prescribing and/or
keep patients from filling prescriptions
•The pressure is on the sales force and brand teams to ensure that
HCPs and patients get the message about the access that exists
–Communicate access wins with major health plans
–Generate awareness of available support services
–Identify access problems as they occur at the regional or
institutional level, and engage the appropriate mechanisms
to address these problems
28

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Market Access 101: Connecting Access Challenges to Brand Opportunities

  • 1.
  • 2. 2 WHAT is market access and WHY does it matter to your brand? WHO are market access stakeholders? HOW do these stakeholders control access and influence prescriber and patient behavior? HOW do manufacturers work to optimize market access? Today is all about answering these fundamental questions
  • 3. WHAT IS MARKET ACCESS
  • 4. 4 The ability for all appropriate patients to access a given product quickly, conveniently, and affordably. In the world of pharma, market access refers to:
  • 5. 5 The ability for all appropriate patients to access a given product quickly, conveniently, and affordably. In the world of pharma, market access refers to:
  • 6. 6 The ability for all appropriate patients to access a given product quickly, conveniently, and affordably. In the world of pharma, market access refers to:
  • 7. 7 The ability for all appropriate patients to access a given product quickly, conveniently, and affordably. In the world of pharma, market access refers to:
  • 8. 8 The ability for all appropriate patients to access a given product quickly, conveniently, and affordably. In the world of pharma, market access refers to:
  • 9. Market access stakeholders hold the keys to product access for prescribers and patients MARKET ACCESS STAKEHOLDERS MARKET ACCESS STAKEHOLDERS If prescribers and patients can’t get access to the product, then the most innovative and creative professional, scientific, and consumer marketing campaigns won’t achieve their full commercial potential.
  • 10.
  • 11. The 3 Ps: Payers, Population health managers, and Pharmacy managers/suppliers Organization type A.K.A. A-list members Why they do what they do Payers Commercial Health Insurance Companies Aetna Cigna UnitedHealthcare Contain costs (payments for covered products and services) Ensure appropriate utilization of covered products and services Self-Insured Employers IBM Microsoft Government-Sponsored Health Plans Medicare Medicaid Veterans Affairs Tricare
  • 12. The 3 Ps: Payers, Population health managers, and Pharmacy managers/suppliers Organization type A.K.A. A-list members Why they do what they do Population Health Managers Health Systems Kaiser Permanente UC Health New York-Presbyterian Cleveland Clinic Health System Deliver high-quality care that improves patient outcomes Contain costs (personnel, drugs and other supplies, technology, etc) and maximize reimbursement Integrated Delivery Networks (IDNs)
  • 13. The 3 Ps: Payers, Population health managers, and Pharmacy managers/suppliers Organization type A.K.A. A-list members Why they do what they do Pharmacy Managers/ Suppliers Pharmacy Benefits Managers (PBMs) Express Scripts CVS Health AllianceRx Walgreens Prime McKesson US Bioservices Contain drug costs and ensure appropriate utilization of formulary and nonformulary products Specialty Pharmacies (SPs) Efficiently deliver products with complex requirements or for rare diseases, and provide services to optimize therapy outcomes Group Purchasing Organizations (GPOs) Vizient Premier HealthTrust Intalere Help health systems, IDNs, and providers contain drug costs and run more efficiently There is considerable overlap among categories—for instance, some IDNs include payer and pharmacy components, and several of the big payers also operate their own PBMs.
  • 14. 14 The top players at the 3 Ps Responsible for cost and quality of healthcare Weighs medical savings vs. pharmaceutical costs Reports to Medical Director Managed pharmacy benefit/budget Liaison to P&T Committee Manages PBM relationship Responsible for population- based quality NCQA accreditation/HEDIS Disease management Responsible for employer- and member-level sales and retention Wants high quality and low rates
  • 15. 15 P&T committees: the formulary decision makers Health plans, health systems, hospitals, Veterans Affairs, and the military all have Pharmacy and Therapeutics (P&T) Committees Promote safe, efficacious, and cost- effective drug therapy by developing policies on drug evaluation, selection, and utilization Manage the development and continuing maintenance of the formulary Members mainly include medical director, pharmacy director, physicians (including specialists), and pharmacists; other members may include be nurses, nutritionists, administrators, and quality directors
  • 16.
  • 17. Health plan formularies: the first line of defense for controlling drug costs Tier 1 Tier 2 Tier 3 Tier 4/5 Generics “Preferred” Brands “Non-Preferred” Brands Specialty Brands But, in this venue the “cheap” seats are costly. Client Goal: To get their brand on formulary at Tier 2 or “Preferred”
  • 18. Tiered co-pay plans: drive generics, formulary compliance, and maximize manufacturer rebates Multi-tier co-pay design Possible therapeutic category Generic co-pay Preferred brand co-pay Non-preferred brand co-pay Lowest (Level 1) Diabetes $7.50 $15 $35 Medium (Level 2) Statins $15 $40 $60 Higher (Level 3) PPIs $15 $60 $120 Highest (Level 4) Specialty 25% (Max $50) 25% (Max $200) 40% (Max $400) PPIs = proton-pump-inhibitors.
  • 19. Class- and drug-level restrictions and limitations: controlling the who, when, and where Prior authorizations (PAs) Product A will not be covered and reimbursed unless the HCP sends the health plan a form specifying certain key criteria (eg, diagnosis) Step edits/Step therapy (SEs) Members must first try Product A before trying Products B and C Quantity limits (QLs) Product A will only be covered for 30 pills for a 30-day period; another example is 6 months of therapy Provider-specific restrictions Health Plan A will cover only prescriptions for Product B written by a specific type of specialist (eg, urologist or enocrinologist)
  • 20. The spectrum of payer management strategies Restrictive Prescribing Strict PA Step TherapyMild PA Quantity Limits Plan Spending Caps Tiered/ Co-pay Drug Utilization Review Basic Formulary Controls (less to more restrictive) $ $ $$ $ $ Financial Control Clinical Control Tighter restrictions don’t necessarily mean control of product choice; goal may be: • Appropriate use of treatment • Implementation of treatment algorithm • Proper diagnosis • Monitor patient/disease management
  • 21. What’s so special about specialty drugs? •Specialty drugs include –Biotechnology products –Orphan drugs to treat rare diseases –High-cost drugs (>$300 per Rx) –Injectables and drugs that must be administered by HCPs –Drugs requiring high-touch patient services (education, follow-up calls, adherence support) •These drugs are typically Tier 4 (or even 5) and require patients to pay coinsurance (a percentage of the cost)
  • 22. What’s so special about specialty drugs? They are on the rise! 20 years ago there were very few on the market, most were covered by medical benefits, and they accounted for only 7% to 10% of per member/ per year payer costs. Today, more orphan drugs are approved each year, payers are shifting coverage to pharmacy benefits (where patients share more costs), and they now account for about 40% of payers’ pharmacy budgets. The bottom line: specialty products are complex and are an area of focus.
  • 24. Contracting: edging out the competition •Under some circumstances, such as a crowded market, education may not be enough to gain favorable access •In these cases, drug manufacturers often negotiate contracts with payers, PBMs, GPOs, and even some IDNs to gain market share •As part of the contract, –The health plan or PBM places a branded product on Tier 2, making it a preferred brand –The manufacturer returns a (predetermined) percentage of the money the organization spent for the product if the designated market share is met In addition to volume-based contracting, the drive toward greater value in healthcare is giving rise to value- or outcomes-based contracting, in which reimbursement is tied directly to patient outcomes.
  • 25. Educating and detailing to market access stakeholders: making the case for value Informed market access stakeholders who understand the value of the product are more likely to make favorable decisions and policies •Key topics for market access tactics –Disease state education –Product information •Clinical trial data, MoA, dosing, ordering, storage, price –Health economics and outcomes research (HEOR) data –Real-world data The core tactic for the Market Access audience is the Value Proposition—usually a presentation, sometimes with a leave-behind component—that covers most or all of the topics above.
  • 26. Access & reimbursement support programs: building a safety net •“Hub” services—insurance, financial –Investigate the patient’s insurance benefits –Support for prior authorizations, appeals –Co-pay assistance programs –Referrals to other sources of financial assistance for patients who don’t qualify for co-pay assistance In many therapeutic areas, Hub and patient support programs are becoming the norm. Manufacturers have to work harder to distinguish their programs. •Patient support—education, adherence –Telephone hotline to speak with a nurse/pharmacist –Outbound calls to check in with patient –Adherence tools/support
  • 27. Pull-through pays it off •Between education/detailing, contracting, and access support programs, manufacturers are investing significant funds and resources to ensure favorable access to their products •But low awareness of coverage and support programs can result in perceived barriers that keep HCPs from prescribing and/or keep patients from filling prescriptions •The pressure is on the sales force and brand teams to ensure that HCPs and patients get the message about the access that exists –Communicate access wins with major health plans –Generate awareness of available support services –Identify access problems as they occur at the regional or institutional level, and engage the appropriate mechanisms to address these problems
  • 28. 28

Editor's Notes

  1. Less restrictive measures typically used for: Rare disease Diseases with low prevalence Diseases where patients react differently to treatment, such as diabetes or rheumatoid arthritis (RA) Drug categories with no generics Acute disease categories More restrictive measures typically used for: Extremely high-cost treatments, such as biologics for cancer or immunologic disorders Highly genericized drug categories Drug categories with multiple, branded, options with similar outcomes Drugs with high potential for off-label use or abuse
  2. Approximately 90% of all drugs written today are generic Remaining 10% capture dollars depending on how much value they can deliver to the plan based on Cost savings and offsets Outcomes and RWE Physician demand Durable efficacy, safety, adherence Market size and demand Unmet need Medical loss ratio Co-pay programs are under scrutiny (CA and MA banned use) because they conflict with drug formularies MCO/PBM mergers put pressure on manufacturers to erode GTN