European Pharmaceutical Market Access, Pricing & Reimbursement

10th October to 11th October 2016,
London, United Kingdom

SMi Group’s 22nd annual European Pharmaceutical Market Access, Pricing and Reimbursement conference returns to London from 10-11 October 2016. The conference is one of the most established in the world, focusing on the changes in pricing and reimbursement and market access.

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Exploring High and Low Pharma Staffing Levels for Medical Affairs

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Senior Research Analyst

Global medical affairs teams come in all shapes and sizes — some comprise a large percentage of pharma staffing, and others a small percentage.  In many cases, the size of a medical affairs team will reflect not only the company’s resources but also its product portfolio.  For instance, companies with mostly early-stage investigational products may not need a large medical affairs force.  Conversely, companies with constant product launches will benefit from a robust team.

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Early Brand Commercialization Strategy: New Product Planning Paves the Way for Other Teams’ Involvement

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Increasingly competitive markets—combined with the uptake in evaluative measures like comparative effectiveness—require companies to initiate new product planning activities as soon as possible.  Often, dedicated new product planning teams are among the earliest-involved in commercial strategy-building.  At the preclinical development stage, 80% of surveyed life science teams include new product planning in their brand commercialization committees (Figure 1).  By Phase 3, a smaller percentage of companies—63%—report the same (Figure 2).

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Moving Forward with Physician Payment Disclosure Requirements in Scotland

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Already, many countries have established physician payment disclosureregulations that require companies to publish any exchanges of value that take place between healthcare practitioners (HCPs) and themselves. In some cases—as with the Loi Bertrand in France—these regulations may also extend to other members of the healthcare community. Beyond HCPs, the Loi Bertrand also covers audiences such as pharmacists, nurses and professional medical associations.

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Ameliorate the Regulatory Inspection Process with eTMFs

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Successful trial master file management involves preparing for regulatry audits. Anticipating and preparing for upcoming regulatory inspections can be a difficult undertaking for life science organizations. In some circumstances, companies expect regulatory agencies’ visits. For example, life science teams that have recently launched a new product may undergo an inspection within two years of product launch.

In other situations, a regulatory inspection may occur without warning. A senior vice president at one biotech company explained that business development deals often prompt a surprise visit from regulators. In her experience, regulatory authorities may conduct an inspection between three and six months after acquisition or merger deals are finalized. These visits help regulators assess how well companies have integrated their respective standard operating procedures (SOPs).

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Be On the Lookout for New Innovations in Late Stage Studies

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Senior Research Analyst

Teams have a variety of options when conducting a post-marketing study, and these options only increase as researchers continue to innovate new trial designs beyond the standard randomized controlled trial (RCT). For instance, teams may decide to collect real-world data with observational cohort studies. Others may want to directly compare two competing treatments with crossover studies. Alternatively, study teams may try to collect near real-world data with pragmatic RCTs.

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Building Assumptions Documents that Work for You and for CMS Sunshine Act Reporting

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Data Products Team Leader

As the Sunshine Act becomes part of standard regulatory procedures, pharmaceutical companies are looking to further develop their compliance efforts. Many of our clients are looking to streamline their reporting processes and proactively identify potential compliance pitfalls. One key way to maintain consistency and accuracy in reporting processes is through a comprehensive assumptions document.

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Fair Market Value Annual Rate Caps: A Look at How Individual Events Contribute to Life Science Teams’ Maximum Compensation Hours

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Fair market value (FMV) activities help life science teams develop consistent, defensible remuneration rates for the healthcare practitioners (HCPs) with whom they work. As part of their FMV configuration processes, companies may consider each HCP’s scope of influence and his or her specialty type. For example, life science teams may develop compensation rates based on three tiers:

• Tier 1 reflects HCPs or other industry influencers with global-level reach.
• Tier 2 indicates HCPs or other industry influencers with regional influence, and
• Tier 3 denotes HCPs or other industry influencers with a strong local-level following.

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The Pharmaceutical Perspective: How #Brexit and the Falling Sterling Impacts HCP FMV Rates and Policies in the UK

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Data Products Team Leader

On June 23, 2016 the United Kingdom voted in a referendum to leave the European Union, to the surprise of most political observers. It must be noted the referendum does not have an immediate impact on the UK’s legal status as a member of the EU and negotiations under Article 50 for the formal withdrawal are expected to take up the maximum two years. However, the impact on the British economy has been immediate in terms of the pound sterling and the stock markets. Additionally, the political reaction sheds light on how the regulatory environment could change in the short and long term. Continue reading