WORKSHOP B Monitor MSL and Field Force Compliance Jeremy Lutsky Sr. Legal & Compliance Counsel Theravance Biopharma US, Inc. Alison Benincasa Associate Director, Specialty Markets Compliance Christine Fiore Director, Specialty Markets Compliance Boehringer Ingelheim Pharmaceuticals, Inc. Disclaimer: The views contained in this presentation are our own and not that of our employers.
Workshop Objective & Agenda Access Module Pre-Survey Market Dynamics Case Study Sales Module Pre-Survey Market Dynamics Case Study MSL Module Pre-Survey Market Dynamics Case Study
Access Pre-Survey Has there been any changes in your compliance program as a result of the Affordable Care Act? Yes No I don t know what the Act is
Access Pre-Survey Does your Company sell or distribute products through specialty pharmacy? Yes No
Access Pre-Survey Does your Company contract for HUB services? Yes No I don t know what A HUB is
Pre-Survey What HUB services or Specialty Pharmacy programs does your Company have in place? Nursing hotline Patient starter kits Prior authorizations Reimbursement support Financial assistance Patient support services offered through home visits Patient education classes Dose exchange Support offered only for on label use Support for on label and off label use Other
Market Dynamics Drive Towards Care Quality and Patient Satisfaction Changes in Government Regulations Changing Financial Incentives and Emerging Care Models Implementation and Role of Health Information Technology (HIT)
Customer Focus Post ACA STAR Ratings Pipeline presentations Pre-approval discussions Economic benefits Items of value Partnerships Fee for service arrangements Data exchange Innovative contracting EMR integration
Access Case Study Scenario A Marketing Manager is in the process of preparing for the launch of a new specialty drug. The launch is expected at the end of the year or early next year. You were invited to a kick off meeting and hear the following information on the next slide. One of your team members is preparing to monitor this area, what advice or areas of risk would you provide/share with them?
Access Case Study Facts A HUB will be set up with the following value adds Nursing services to minimize side effects Reimbursement assistance for all prescriptions Administrative support to assist the office in filing Pas Copay cards for all patients Patient Assistance Programs Patient starter kits containing goodies for patients Key action items Presenting at formulary committee meetings Sales reps discussing disease state this month Marketing leveraging existing sales force as exhibit booths Nurse educators hired to help with chart reviews and conduct patient education Need marketing material to assist in quality metrics
Sales Pre-Survey Does your company conduct ride-a-longs? Yes, we do it proactively Yes, we are required to do it No
Sales Pre-Survey Do you personally conduct ride-a-longs? Yes No, another function in my Compliance organization does
Sales Pre-Survey Do you utilize findings data to identify trends? Yes No
Sales Pre-Survey In your organization, do acts of sales rep noncompliance impact compensation? Yes No
Market Dynamics Anti -Kickback Statue False Claims Act HIPAA/HITECH Sunshine Act FDA Regulation State Laws PhRMA Code
System vs. product sell Sales Role Changing Conversations with C-Suite Outcomes vs. product features Business and economic conversations Pathways vs Rx Strategic Account Management Leverage resources throughout organization to bring value New skill sets required
Sales Case Study You are a field monitor and have selected specialty sales consultant, James, for a ridealong. You provide ample notice to the sales consultant and his manager outlining your role and objectives On the day of the ride-a-long you meet James in the lobby of the hotel. James makes 2 calls
Sales Case Study Call 1: James takes you to one of his specialists offices. You observe the following during the interactions: Dr. informs James of an adverse event involving the specialty product Dr. asks James for information outside of the approved label. James answers the Drs question with information and data he had printed from a recent journal article Prior to ending the interaction James reviews fair balance, safety and efficacy. He also provides the Dr. with a PI.
Sales Case Study Call 2: You visit a specialist at the hospital: The MA explained to James that Bruce, a patient, was having difficulty getting his script filled through the specialty pharmacy. James asked for additional information and called the specialty pharmacy on behalf of the Drs office to help expedite the process. James conducted an in-office lunch, he did have a sign-in sheet but failed to obtain all attendee signatures While he was there, James posted an invitation for a local speaker program on the bulletin board
Post Ride-a-Long Activities Ride-a-long is over, now what? Systems Review Documentation of Findings CAPA Metrics & Trends
Changing Role of MSLs Commercial vs Medical
MSL Pre-Survey In what areas does your MSL team function? Medical Science Liaisons (MSLs) providing medical/clinical information Medical Information providing medical/clinical information Investigator Initiated Studies or Trials/Research grants Continuing Medical Education (CME) grants Advisory Boards to obtain important scientific input or data Publications Investor Communications
MSL Role Changing Is there a role in payer/formulary discussions? Should they be a part of the account team? Strategic and or tactical interactions? Leverage MSL knowledge to address clinical questions? Activity seen as promotional? New skill sets required
Role of MSLs Sales representatives role is to appropriately drive sales and utilization of company products by HCPs and HCOs MSLs role is to engage in medical and scientific exchange with KMEs relative to products and associated data as well as respond to unsolicited requests for information MSLs are field medical/scientific resources for internal and external customers MSLs support research for company-driven and Investigator-Initiatied Research (IIR) In limited situations, ability for MSLs to engage in off-label discussions in order to further scientific exchange of information for benefit of patients and providers MSLs are never to drive sales - therefore sales data and HCP prescribing patterns are not relevant to their role and should not be discussed
Proper Communication between Sales Reps and MSLs Sales Reps and MSLs may communicate for the purpose of discussions related to their respective roles, geography-related general issues (on-label) and information regarding KME/HCPs Sales Reps may receive information from MSLs about HCPs with questions on particular topics they can address (not off-label) e.g. meeting dates and general topics covered, provided that details of the discussion with the HCPs are not shared MSLs may not seek or obtain sales and promotional information from a Sales Rep Information re: an HCP s prescribing patterns or usage of a particular product (whether for an approved use or an off-label use) is generally not relevant for MSLs to impart medical information about such product Joint targeting of KMEs/HCPs or customer prescribing patterns is not permitted Sales Reps and MSLs may generally discuss that they have visited or had discussions with a particular HCP MSL and Sales Reps can communicate that meetings occurred, generally recap discussion(s), but MSLs may not provide any off-label recap Sales Reps should use MIRF process to forward off-label questions
Proper IAM/MSL Interactions (continued) Sales Reps and MSLs are expected/encouraged to have appropriate ongoing communications Verbal communications are preferred Face-to-face meetings are encouraged when possible Email is recommended for scheduling and logistics rather than exchange of substantive content as emails can be misinterpreted or taken out of context Both Sales Reps and MSLs may meet with members of formulary committees Typically this should not be a joint meeting IAMs discuss coverage, reimbursement MSLs provide scientific/medical education (can include off-label discussion, so preference is for Sales Rep not to be present) Consult with Legal/Compliance in advance of any potential joint meeting to help assess whether joint meeting may be acceptable in limited specific circumstances
MSL Interactions: Do s and Dont s DO: Exchange limited general information re: interactions with HCPs (e.g. meeting dates and general on-label topics covered, provided that details of HCP discussions with the HCPs are not shared) Discuss HCPs in your territory and coordinate efforts so you are informed as to each other s relationships and activities (generally) with HCPs/HCOs Reasonable for this type of coordination as HCP/HCOs view IAMs/MSLs as collectively representing company OK to Introduce your counterpart to HCPs if you have prior relationship DON T S: Participate in joint HCP discussions (other than for purposes of brief introductions) Establish joint priorities or jointly target KMEs or HCPs Share specific lists of customer prescribing or purchasing patterns Proactively offer a KME or HCP MSL visit or represent that MSLs are now available to discuss off-label topics (unless HCP asks about MSLs or requests a visit) MSLs can not be used as end-around limits on off-label discussions
MSL Case Study (based on 2013 Settlement) $491M federal settlement (plus additional state settlements) PharmaCo marketed its product for approved and unapproved uses, including use in non-renal transplant patients even after a boxed warning was added to the label MSLs and sales representatives were jointly trained on offlabel uses of the product at joint product meeting Sales Representatives were compensated for all product sales, including off-label uses Sales reps and MSLs coordinated at sales meetings, went on joint sales calls and use of sales reps used MSLs to provide off-label presentations to HCPs that sales reps could not give themselves
Hypothetical Proper Interactions between MSLs and Commercial Team A Sales Rep just received updated territory sales data and is eager to collaborate with his new MSL to create a joint approach to targeting certain HCPs. He requests to meet weekly and offers to download on all his accounts, commercial strategies and areas in which his MSL can assist from a medical standpoint. Is this appropriate why or why not?
Hypothetical (Answer) Commercial Reps and MSLs may Appropriately Collaborate IAMs may share limited information with MSLs such as general trends, coordinating schedules, discussion on-label topics and issues seen in the field, and on-label gaps where MSLs and Med Affairs may both provide information However, IAMs and MSLs should NOT collaborate on commercial sales tactics jointly strategize how to drive utilization or purchasing for specific accounts target specific HCPs as part of a joint goal to maximize sales share sales data or any information related to prescribing or purchasing patterns
MSL Case Study Manufacturer sponsors a Phase III study to explore a new indication for a product currently on the market HCPs are already using the product off-label in the indication being explored, as well as several other off-label indications Manufacturer has funded an IIR to study the efficacy of its product in another indication with frequent off-label prescribing. Check-in discussions between the MSL and Investigator indicate that the research is yielding preliminary favorable results. Manufacturer has also recently collaborated with HCPs to conduct research on safety data related to its approved indications. Findings from this research were published by the authors in a leading journal. Sales representative and MSL who share Territory X meet weekly to discuss activity in their territory. As part of these discussions, Sales Rep shares the offlabel questions he/she received in the field with the MSL. He/she suggests that the MSL visit these HCPs and encourage the HCP in engage in off-label discussions since the Sales Rep in unable to engage in this dialogue.
MSL Case Study (cont ) Sales Rep shares sales data with MSL about certain shared accounts and they discuss how to grow these accounts Sales Rep mentions that he/she has a Speaker Presentation coming up and suggests that the MSL attend the Speaker Program. At the Speaker Program, the Speaker gets an off-label question and states that although he can t answer this, there is an MSL in the room. The MSL responds to the group with scientific information in response to the off-label question. Finally, the Marketing Team has created an Off-Label Reprint of a separate journal article discussing the use of one its products in combination with another product. Although the study indicated positive findings around these products together, the FDA has not approved this combination therapy and the data is off-label. While the Sales Team in limited in ability to distribute this Off-Label Reprint, the MSL team carry copies with them for all HCPs visits and make it a point to discuss the article and leave behind a copy at all visits. WHAT IS WRONG WITH THE MSL ACTIVITIES IN THE ABOVE FACT PATTERN. DISCUSS AND IDENTIFY ALL ISSUES. WHAT IS CORRECT BEHAVIOR?
Questions