TYPICAL PROJECT ISSUES

Generic impact. How will the generic of a strong brand impact the remaining brands?

Managed environment. What is the optimal strategy in a generic first and prior authorization environment?

HECON vs history. How do we leverage our unique position with reduced hospitalization data to secure exclusivity, when the older brand contracts “just enough” to stay on Tier 2?

Supplemental rebates. How critical are supplemental rebates for formulary access in carve-in and carve-out Medicaid state environments?

New mechanism and premium price. What is the recommended WAC and rebate for a new mechanism with incrementally better efficacy and a mixed safety/side effect profile?

Later entrant. What is the pricing and contracting strategy for a later entrant with a stronger safety profile?

Future generic. What contracting approach should be taken by a small molecule oncologic facing generic competition in the class?

Tier 3 Formulary Bias. If Tier 2 is effectively ruled out for the class, what contract offer will secure a preferred Tier 3 position and what clinical message is needed?

Adverse event risk. Where is the tipping point between acceptable and unacceptable AE risk?

Implications of risk reduction. At what point does absolute and relative risk reduction become clinically meaningful?

Differentiation vs class effect. How will class effect assumptions impact a new indication? Is differentiation possible?

Comparative effectiveness research. How is CER different from what P&T committees do now? How will CER affect the real-world willingness of health plans to adopt stricter management practices?

Launch indication. Which of two indications should a brand launch with?

Second indication. Which should drive the second indication: clear but limited market opportunity, or potential for bigger market opportunity but where the FDA “may” be more critical?

Modified formulation. How should a modified formulation with superior delivery be positioned against the original, soon to be generic agent?

Hospital-driven new starts. Can an oral brand build payer leverage around the fact that new RXs are primarily hospital-based?

Biosimilar competition. What is the likelihood a biosimilar will displace an existing brand in hospital formularies?

Challenging an established brand. What are the pricing and positioning requirements for an acute care agent to have equal access in tightly managed hospital formularies?

Pricing complicated by waste. Will the projected launch price of a topical agent having modest clinical advantages need to be lowered because of waste associated with unused medication remaining in the tube?

Oral battle in infusion setting. What does a new Tier 3, twice-a-day oral need to do to displace a monthly 30-minute IV from which the hospital OPD realizes a steady stream of revenue?

Best Practices. What best practices operate within adherence programs and which offer the best yield?

Program Assessment. What manufacturer programs do customers value the most and how did their success contribute to both the customer and the brand?

Program planning. What new areas should a manufacturer invest in for future program development that will best serve account managers with customers?

Discharge planning. Is there a viable commercial opportunity to develop patient education programs that can be coordinated with hospital discharge planning?

Traction of older, gold standard. To what degree will a new mechanism cannibalize an experienced gold standard?

Generic first to brand. What will it take for physicians who have to prescribe a generic first, to follow up more routinely so they can determine if patients need the more potent brand?

Leveraging prescriber behavior. Can physician unwillingness to prescribe a generic at the highest dose create a messaging opportunity with payers?

ACO and patient-centered medical home. What medical practice issues and priorities should Managed Markets and Field Sales focus on to provide maximum support around ACO and patient-centered medical home developments?

REMS and Specialty Pharmacy. How will the pros and cons of open vs closed distribution in specialty pharmacy affect a new product’s REMS implementation? (Risk Evaluation and Mitigation Strategies)

Restrictions and Specialty Pharmacy. How will emerging health plan management practices in specialty pharmacy affect a future product’s launch environment?

Closed distribution and value chain. What is the most effective way for a brand to utilize a closed distribution system to increase new RXs and maximize patient support?

Competition with SP vendors. Is there a win-win opportunity to create competition with SP vendors around patient adherence and other key quality measures?