New Strategies in Pharmaceutical Market Access Albert Wertheimer, PhD., MBA Temple University Philadelphia, Pennsylvania 19140, USA HealthEcon and Policy Association Ankara, Turkey 5 December 2014

Market Access Definition Process pharma companies undertake to ensure that their medicines are made available as widely as possible; are reimbursed and listed on formularies

M.A. History Important last 5-10 years due to high-tech and costly products reaching the market, while great pressure by payers to cut costs

Tradition health economic KOL Reimbursement and payer KOL Market to clinical knowledgeable Opinion Leader (KOL) but recently to: health economic KOL Reimbursement and payer KOL

Market Access Customers Commissioners Aescribing Advisors Heads of Med. Depts. Dir. Of Publ. Health NICE leads Chief Pharmacists Hosp. Business Mgrs. Service Managers

Early 2000s Movement to Cost: Benefit and Comparative Effectiveness Research

Comparative Clinical and Econ Value (CCEV) Payers want to know: What outcomes will be achieved for their pt population What outcomes have already been achieved What is the rationale for product’s price point What product attributes justify a premium price

The Old Days Company reputation Field force personal relationships Low prices

The Transition Period Deals with Multiple Products and Reference Pricing Schemes

Today: Several Approaches Value based, risk sharing Cost per QALY CER

Today and Tomorrow Pay for Value Focus on Most Benefitted Groups Promote for those failing generics & combos

Expensive Drugs Cap Total Expenditures Refund above agreed-upon sales level Promote to specific segments Offer post-marketing studies

Decline of Surrogates & Models Actual QoL data on morbidity and mortality Actual Outcomes for specific populations

Actual Outcomes Availability of Electronic Health Records

Differentiate Markets Local clinical trials Local KOLs Individual pricing Germany wants pt. data Make negotiated deals—France

Solvani Example UK pays $9 billion for this hepatitis C drug, because they see “value”

Market Access Strategy Demonstrate Value to Various Stakeholders Set the product apart Understand that market’s characteristics

Some Final Thoughts Price reduction for Longer contracts Share R&D Expense with Payer Share Education Expense

Thank you albertw@temple.edu