Emerging Pharmaceutical Industry Strategies: Transparency, Privacy and COI Concerns

1. Emerging Pharmaceutical Industry Strategies: Transparency, Privacy and COI Concerns Jennifer L. Reck, Policy Analyst, Prescription Policy Choices NLARx Meeting Washington, DC December 8, 2008

2. Prescription Policy Choices • Nonprofit, nonpartisan 501(c)(3) educational and public policy organization focused on prescription drug policy • Evaluate policies and programs that effectively reduce prescription drug prices, increase access to medications, minimize conflicts of interest & promote evidence-based prescribing

3. Opposition Research Sources: • Pharmaceutical industry trade magazines • Pharmaceutical Executive (PE) • Pharmaceutical Representative (PR) • Webinars • Quarterly opposition reports starting Q3 2008

4. Pharmaceutical Representative

5. An industry under pressure • Dry pipelines • Major brands going off patent • Increased scrutiny of industry / medical profession relationships, new regulations • Decreased physician willingness to meet with sales representatives – the “no-see trend”

6. Time to shape shift

7. New service roles for pharma • Disease management • Enabling patient / physician communication • Promoting patient compliance Worthy endeavors – but appropriate roles for pharma? • Conflict of interest, transparency and patient privacy concerns

8. New roles for pharma: Disease management services for MCOs • “Many companies are transitioning from merely selling a pharmaceutical product to providing a variety of integrated resources in addition to drugs that solve therapeutics challenges in specific disease areas (PR, Sept 08).” • The sales rep becomes: • “a service provider to the healthcare system,” and a “disease management specialist, providing the uniform, agreed-upon protocols set by the health plan to physicians, pharmacists, etc.” • Services provided: • Disease-oriented symposia, educational materials, in-service trainings for practitioners, CME, drug utilization review

9. What’s in it for pharma? • “Partnerships with healthcare organizations in disease management programs… offer benefits to the pharmaceutical company, including access to medical and pharmacy data and access to patient populations that could potentially use the company’s product.” • Some companies have partnered with PBMs (“an excellent source of patient and prescription data”) • Some have own disease management subsidiaries

10. Enabling physician/patient communication – for a large ROI • Shire gave parents of children taking their ADHD drug a starter kit and invited them to join a feedback program (three surveys taken in early stage of product use) • Shire shares the information with the doc • 8:1 ROI – docs who received feedback reports prescribed more of the sponsor’s product

11. Patient compliance • Pharma estimates that it loses about $177 billion of potential revenue each year (out of $700 billion in annual global revenues) due to patients not complying properly with their prescriptions • With drying product pipelines, maximizing sales of existing products takes on greater importance

12. Patient Compliance • The value of patient compliance depends upon the appropriateness of the prescription. • Compliance programs involve data on individual’s prescription drug use and raise important privacy concerns, especially given convergence with e-prescribing. • What data are they getting access to? How are they accessing it? Using it?

13. Compliance programs aimed at minors • Makers of Gardasil have used text-messaging to remind girls they need all three doses of the vaccine to make it effective • Serano’s website for its growth hormone offered kids free MP3 downloads for answering a quiz correctly (www.coollearnings.com)

14. Compliance online • RealAge.com “has compliance built into its basic business strategy” – of 20 mil. users, 9 mil. have opted to receive information for drug companies on their health issues • AZ “Measure of Success” program – log in or phone daily to report on use of asthma drugs and get rewards such as books on asthma • Getting data directly from patients

15. Patients increase in importance • DTC is now 40% of all promotional spending in the US • “Brand managers are beginning to view patients as an audience of equal value to prescribers.” • Implications for our current policy focus on the relationship between the industry and physicians? How can we also monitor & address their relationships with patients?

16. Perfect Storm? • New focus on disease management and patient compliance at the same time there are.. • New technologies for direct patient outreach (You Tube, text messaging, online compliance tracking, etc.), data collection (EHRs) and data mining Will pharma blur the line between marketing and clinical care the way it has blurred the line between marketing and medical research? And between marketing and education?

17. Policy Approaches • Establishing standards for third party contracts (industry / MCO contracts, industry / PBM contracts, etc.) • Tightening HIPPA protections relating to disclosure of patient data for marketing • Anti-trust regulation related to industry ownership of disease management subsidiaries?

18. Contact: jreck@policychoices.org