The field medical team’s primary external customer base of key opinion leaders (KOLs) is expanding to a broader group of healthcare decision makers, most notably payors, to meet the needs of the evolving value-based healthcare economic model.
For field-based medical to be a strategic, leading partner with external and internal partners, life science companies must invest in continuous professional development for MSLs to give them the skills and capabilities they need to be successful in their roles. DMH offers a variety of training programs specifically designed for field-based medical teams to engage in credible medical discussions and scientific exchange and to enhance their effectiveness with a broad group of customers and internal colleagues. Below is a list of our most popular workshops.
This workshop includes real-world learning scenarios. (These are subtle examples of how various customer interactions play out in the learner’s world – reflect everyday situations – and how to handle those situations in an effective and ethical manner.) The scenarios may be customized to take into account a learner’s job function, companies’ brand(s), SOPs and risk areas content, unique workshops, and thought-provoking activities are customized for your organization and are delivered in a language that your field medical team will understand. The training curriculum has a strong emphasis on what participants can and should do. As a result, learners are empowered to engage in effective and ethical customer presentations.
Given the firewall that exists between commercial and medical, firms need to ensure the ethical sharing of potential customer insights and the utilization of appropriate communication channels. This workshop explores how to:
- Ensure the independence and integrity of the field medical team, the access team and field-based sales functions
- Enable effective and compliant information sharing and communication across functions
- Address the challenges that may arise between MSLs, the access team and field sales, and develop strategies to overcome them
Conversely, DMH also takes into account situations where there is a hesitancy to share customer insights or to write call notes. DMH addresses the underlying fears and provides proven strategies to overcome them.
Organizations create numerous written documents every day. Many of these documents are hastily written, poorly worded and may not be consistent with the laws that govern promotion. As a result, these documents may pose a significant risk for your organization. During these interactive training sessions, participants will see firsthand how their communications may be taken out of context and will learn how to write effective and ethical documents. This section includes emails and free text call note examples between field-based medical, the access team and the commercial sales organization.
DMH understands the need to deliver effective and ethical clinical and economic value to customers. DMH BioPharm’s base curriculum is designed to help field-based medical leads expand their account planning and presentation skills to ensure the effective delivery of clinical data and Healthcare Economic Information (HCEI). The curriculum is customized to meet the needs of the customer and reflect current medical strategy priorities.
The workshop:
- Updates learners on the latest regulatory developments of FDAMA 114 and ensures that learners understand the rules of engagement in the utilization of clinical and healthcare economic information.
- Examines the value and applicability of clinical and economic information to determine customer relevance and population value.
- Teaches learners how to effectively and compliantly translate data to provide context and enhance customer comprehension, handle obstacles and objections, and utilize proper call-to-action techniques.
In 1997 section 114 of the Food, Drug and Cosmetic Act (FDAMA 114) sought to provide direction for the dissemination of Health Care Economic Information (HCEI) by drug manufacturers to formulary committees. Unfortunately, the direction was vague, and thus companies were hesitant to the extent that they could move forward without further clarification.
It took 18 years, but in May of 2015, the 21st Century Cures Act was approved, which contained a provision (Section 3037) which amended FDAMA 114 and expanded the permissible scope of drug manufacturer’s promotion of HCEI.
In the wake of the Cures Act, the FDA on January 18, 2017, released its long-await draft guidance on the proactive communication of HCEI to payors and formulary committees. The draft guidance is thorough in its scope and contains important changes that affect key stakeholders in medical affairs, HEOR, access teams, compliance and legal.
The timing of this comes at a critical point as payors are looking for real-world HCEI evidence and evidence-based value rationale from the field medical and account team. And as a result of new laws and state mandates, population health decision makers are under strict evaluation timelines evaluate their plan designs, formularies and rates 12-18 months before the beginning of the intended plan year.
Manufacturers who provide timely HCEI to Payors will have a competitive advantage.
DMH offers a variety of training programs specifically designed around the FDA’s new draft guidance. Below is a list of our most popular workshops.
This workshop is designed for the field medical and access teams. The workshop explains the FDA’s new draft guidance on the sharing of HCEI with payors and formulary committees in an easy to understand format that is customized to the field based medical and account manager role and level of responsibility. This workshop is a good precursor to the “Delivery of Effective and Compliant HCEI Presentations to Customers” workshop.
Compliance challenges may occur in the communication of Health Care Economic Information (HCEI) and Real World Evidence (RWE). The objectives of this workshop are to enhance:
- Knowledge of presentation risks in communication Health Care Economic Information (HCEI)
- The delivery of effective and compliant HCEI to payors
- The sharing of effective and compliant customer insights with internal colleagues
- MSL presentation skills
