Market Access + Policy

review coverage and access responsibilities

1. coverage: formulary inclusion, benefit design

2. access: prior auth, step therapy, cost sharing

review pharmaceutical policy questions

What 3 things create the foundation for access success?

policy, evidence, pricing

as time passes, do cost containments increase/decrease? Why is this important?

increases; healthcare budgets are tightening → marketing access and value demonstration is very critical

review different types of values: manufacturers, private payers, govt/regulators, pt/caregiver, employer, physicians/health systems

Some countries have a more decentralized evaluation involving cash pay. What is cash pay and which countries participate?

1. pts pay majority of drug costs out of pocket or through private insurance, and are the primary decision makers

2. Brazil, India, China, Russia

Some countries have a more decentralized evaluation involving health plans/HMOs. What are health plans/HMOs and which countries participate?

1. typically private payers/insurers (employer sponsored insurance); each payer may determine formulary and coverage for drugs and negotiate individual contracts

2. US, Argentina

Some countries have a more centralized evaluation involving regional/subnational decisions. What are regional/subnational decisions and which countries participate?

1. P&MA decision making is devolved to regional/subnational payers; level of region autonomy varies where some payers bound by national guidelines and others are primary decision makers

2. Spain, Italy, Mexico, Saudi Arabia

Some countries have a more centralized evaluation involving national decisions. What are national decisions and which countries participate?

1. typically single payer systems; national agencies evaluate new products; level of reimbursement and access is determined centrally and applies across the country

2. China, France, Germany, UK

What is the primary goal of the comparative clinical effectiveness archetype? give country examples.

1. comparing clinical evidence of a new product to an existing comparator

2. France, Germany, Italy, Japan

What is the primary goal of the cost effectiveness archetype? give country examples.

1. understanding value for money of new treatment vs an existing treatment

2. UK, Canada, Sweden, Austrailia, USA (ICER), South Korea

What is the primary goal of the budget optimization archetype? give country examples.

1. efficiently allocating the limited budget/resources

2. Brazil, China, Italy, Spain

What is the primary goal of the comparative free market archetype? give country examples.

1. commercial viability — attractive plan design that generates business and profit

2. USA, Canada

Why do we need to document evidence across drug lifecycle and include real world evidence post launch?

healthcare is shifting from volume based to value based payment so the planning begins a lot earlier

SEQ Pricing, Reimbursement, and Access Strategy Development

1. Early Development: map out development and commercialization; ID gaps and opportunities

2. Phase I: understand early product value proposition; set early payer and access assumptions

3. Phase II: early stakeholder engagement to validate value proposition

4. Phase III: generate evidence to support proposition, develop price and access strat, refine payer requirements and access through evidence

5. Filing: final payer value proposition and value dossier, execute market access strat

6. Launch

7. Post Launch: post launch data and real world evidence generation

What are the key Payer Questions related to Trial Design, and what corresponding Evidence Planning strategies address them?

• Payer Questions:

  • Is there additional benefit versus the SoC (Standard of Care)?

  • Is there evidence of additional benefit across some/all relevant sub-populations?

  • Does trial population reflect 'label' population?

• Evidence Planning:

  • Randomized controlled trials rather than single arm

  • Choice of comparator / head-to-head

  • Powering for sub-group analysis

  • Study cohort which reflects real-world patients

What are the key Payer Questions regarding Outcomes & Endpoints, and what Evidence Planning actions should be taken?

• Payer Questions:

  • Does the primary endpoint impact patient mortality, morbidity or quality of life?

  • What is the healthcare resource-use benefit?

  • How long does benefit last?

• Evidence Planning:

  • Consider outcomes used in other HTA evaluations

  • Measure PROs (Patient-Reported Outcomes) / quality of life

  • Capture resource use/workflow data

  • Conduct longer-term studies

What Health Economics questions do payers ask, and what Evidence Planning is required to answer them?

• Payer Questions:

  • Do we need it? What are the alternatives?

  • What is the budget impact? Can we afford it?

  • Is the product cost effective overall?

• Evidence Planning:

  • Target population / costs per patient

  • Health economic data to demonstrate cost per QALY gained

What is the core formula for Value ($V$) in terms of Competitive Alternative ($R$) and Incremental Value ($D$)?

V = R ± D

What is the Competitive Benchmark ($R$)?

The price of the gold standard for a specific line of therapy, including its positive and negative features.

How is Incremental Value ($D$) determined and defined

• Based on the relative importance of Value Drivers to customers.

• Quantified evidence of clinical, humanistic, economic, and societal benefits relative to the gold standard.

What are the four key Stakeholder Considerations when evaluating value?

• Perceptions of value

• Ability and willingness to pay

• Disease and economic priorities

• Cost-minimization

What are the key trade off in determining the optimum pricing and access strategy?

Market Access in industry…

1. ensures that appropriate payer strategies are developed and executed

2. is shifting from a function P&R role to a shared, organization-wide objective

3. has become of the agenda of multiple functions

market access summary