3rd Quarter 2007

Questions to Ponder as you Develop Your 2008 Tactical Plan and Budget

By Lynn Carlsen and John McDermott

For most of Covance's clients, it's that time of year again: time to identify strategic imperatives and market support needs for the coming year, develop a plan of action, and secure the budget dollars needed to get it all done. Below are some questions we commonly ask our clients to help them think through the key issues.

1. Are you expecting approval for a new product or a new indication in 2008, and do you know how the market will treat your product once it is commercially available?
2. Are you prepared to present your product's value in the best light to managed care plans through an Academy of Managed Care Pharmacy (AMCP) dossier?
3. Do you and your customers understand how the proposed revamping of the Medicare Hospital Inpatient Prospective Payment System diagnosis-related groups (DRGs) will affect your product?
4. Are generics or other category entrants affecting formulary tier placement and pricing for your brand?
5. Could your product's value proposition be enhanced through additional phase IV studies, registries, outcomes research or modeling of the economic impact of its clinical benefits?
6. Are there commercially valuable efficacy or safety claims that could be addressed through additional clinical studies or registries performed in a real-world setting?
7. Do you anticipate needing to transition patients from free clinical-trial product to commercially paid product next year?
8. Is there a key phase IV study you could perform to better position your product and address market changes since your approval?
9. Do you have comprehensive Web-based reimbursement resources, and are they up to date?
10. Is your sales force up to date on recent relevant reimbursement changes, and are they equipped to respond helpfully to customer inquiries?
11. Does your product have any post marketing commitments that will be addressed this coming year?
12. Have you undertaken a quantitative analysis to assess the value of your customer support program?
13. When was the last time you surveyed your customers about their level of satisfaction with your support services?
14. Are you interested in consolidating your branded reimbursement support programs to improve consistency, standardize reporting, and achieve greater efficiencies?
15. Are you considering a donation to a 501(c)(3) copayment assistance foundation to address patient coinsurance challenges?
16. Have you used quantitative modeling techniques to inform your design of patient support programs (by modeling your financial exposure under different patient assistance assumptions, or by modeling patient out-of-pocket costs and the impact of a foundation gift on market share, for example)?
17. Are there any key safety concerns about your product or its therapeutic class that have emerged that would warrant developing a risk management plan or performing a proactive safety study?