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Pricing and Reimbursement Risk and Opportunities in Pharmaceutical Deal Making
PharmaDeals, July 2007, Pages: 88
“Understanding the world in which the customer operates and taking steps to bring your new product into that world with the customer’s workload in mind can enhance the adoption of new drugs.”
This report will focus on the critical application of the challenging political and market environment within the specific context of pricing and reimbursement (P&R) in the process of deal making.
The in-licensing of new drugs has increased dramatically over the past 30 years.
As deal making has intensified, the nature of deals has changed and issues such as market dynamics and the uncertainty around future pricing have increased in profile and can impact licensing deal valuation.
Where once a licensor would expect its new licensee partner to take responsibility for price setting and price expectations, now both parties need to increase their focus on the key price limitations that impact the deal value.
Valuation in deal making is not an exact science.
The message coming clearly from the pricing and reimbursement dynamics is that traditional models need frequent revision.
Health economic considerations that drive reimbursement decisions will play an increasing make-or-break role in new drug planning.
As deal making for unlicensed drugs grows in importance, so smarter deal making will become vital to the efficiency of the pharmaceutical business. P&R awareness is integral to that smarter deal making.
This report will teach you the key P&R drivers that shape tomorrow’s market.
You will learn what likely effects will surface from today’s political noise and be better prepared to anticipate product opportunity and maximise future success.
Overview of the report
Preparing for the ‘negotiation’
A New Profile for Pricing
Deal making in 2006
2006 deals by type
Why deals fail
Price and unpredictability
Deal making the strategic pipeline
New hurdles for new drugs
The shift in phase deals
Potential reasons for shifts
Changes in Deal Making Risks
Risks in the pipeline
More risk less value?
The cost-containment driver
Shared P&R responsibility
Unanticipated reimbursement issues
Reducing the risk with ‘future’ P&R focus
Current P&R Environment
Price and value
Cost-containment, generic opportunity
Healthcare efficiency and value
The value Opportunity for Innovative pharma
Pricing and reimbursement in the US
Control of price in a free market
List versus actual selling price
Medicare and Medicaid in the US
Medicare part D
Political sensitivity to drug prices
Part D drug price negotiation
Opposition to the federal role
Potential Impact on the US market
A US version of NICE?
Useful US ‘Federal’ Price definitions
Pricing and reimbursement in Europe
Europe’s reference countries
International price interrelationships
The Irish example
Pharmacoeconomics versus reference pricing
No ‘Single Market’ for drugs
The UK and the Pharmaceutical Pricing Regulation
The Office of Fair Trading review
The Institute for Quality and Economic Efficiency
Parallel Imports and the Treaty of Rome
Trends in European P&R
The Pharmaceutical Forum
One market one launch strategy?
The outlook for Europe
Pricing and reimbursement in Japan
Controlling Japan’s healthcare costs
Getting onto the NHI list
Changes to reward innovation
Generic Drug Pricing in Japan
US political pressure on Japan
Local help and advice
Future Effects on Biotech Drug Prices
Biosimilars – generic equivalents
The Sandoz-Momenta deal
A Limit to the available funds
A rosier future for monoclonal antibodies (mAbs)?
What price the cure for cancer?
Too expensive for NICE
Conclusions for biotech drug deals
Orphan Drugs, Risk and Opportunity
Orphan drugs in the US
What is an orphan drug?
Limiting Medicare orphan drug coverage
Orphan drugs in Europe
Is Europe’s orphan drug legislation working?
High cost of ERT
Orphan Drugs in Japan
Orphan drugs and Medicare part D implications
Political focus – Waxman concerns
Europe’s patent protection concerns
Paediatric Drugs and Patent Life
US and section 111
Who should pay?
Mylan and BMS
Pravachol patent extension
Industry not to blame
European paediatric drugs 2007
Pharmacoeconomics – Pricing Value
Breaking out of the silo
The Academy of Managed Care Pharmacy
Integration into on-going activity
Moving pharmacoeconomics further back in the
The UK and the role of The National Institute for
Clinical Excellence (NICE)
Rights of Appeal against NICE recommendations
Quality Adjusted Life Years (QALY)
Willingness to pay
Incremental Cost-Effectiveness Rate (ICER)
Living off the fat of the land?
Benchmarking Product Value
Estimated Net Present Value (ENPV)
Monte Carlo simulation
Solutions for Deal Makers
The role of politics in mathematical modelling
Pareto and DiMasi
Tweaking the model
What can impact your value?
International launch strategy
Converging prices from divergent systems
US versus EU prices
A Global Price Convergence Model
Which deal is the best deal?
Pricing and innovation
Drivers of premium price
Targeting protected me-too and followers
Ten years of change
Pricing and Reimbursement Risk and Opportunity in Pharmaceutical Deal Making covers those essential market changing initiatives which make tomorrow’s drug market different from that of today. Successful deal making has accurate valuation at its heart.
Anything that impacts a drugs ability to achieve in the future a fair and profitable market price impacts its value today. The current market is more challenging than ever before. Payer-driven price negotiation for reimbursement, and cost-containment programmes to control prescribing both challenge the traditional pricing model the industry has used to generate valuable R&D resource to further the search for innovation and better disease control.
The adoption of new ways in assessing value offers industry and payers opportunity to find common ground. Economic arguments will predominate in decision making and should be modelled early in a product’s life and be both visible and valuable to deal makers.
The report begins with a review of pricing elements, highlighting the role public policy takes in all aspects of pricing. An overview is given of the current deal making environment in Chapter 1, identifying significant trends in deals and the challenges these trends put on deal valuation. In Chapter 2, the risks associated with these changes are analysed. It examines the current growth in deal volume and value, and questions the traditional risk models used.
The current P&R market is outlined in Chapter 3 with in depth analysis of political initiatives to control drug pricing. The new Medicare part D programme in the US is detailed along with the controversy and implications of drug pricing proposals aimed at controlling public spending on this new and very politically sensitive initiative.
Chapter 4 looks at the impact biotech drugs have had on the market to date and the future pricing opportunities and limitations these high price agents have in store. High price biotechs also characterise the specific markets accessed by orphan drugs. Chapter 5 analyses the past and present causes of today’s orphan drug concerns and pressures and extrapolates these issues into a more cost-conscious future.
The benefits of extended patent protection for paediatric drugs are reviewed in Chapter 6 along with the implications for future pricing strategies. The field of pharmacoeconomics is covered in detail in Chapter 7. This ‘fourth hurdle’ represents a significant challenge to conventional pricing strategies yet holds the key to a successful deal and to a value-based viable revenue stream for many new drugs. Advice to dealmakers on benchmarking, what to look for and where to find help is covered in Chapter 8. Benchmarking can give real life objectivity to academic valuation exercises and can bring insight on potential partners as well as product therapy comparisons from unexpected sources. Finally, Chapter 9 gives detailed advice to deal makers on valuation components and future drivers of value.
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