Forecasting and Data Analytics Round Table Discussions – EphMRA 2019

Following the positive feedback from the inaugural Forecasting Roundtable Discussion from 2018, Erik Holzinger/groupH facilitated another 1-hour discussion together with Pascal Olier/Pierre Fabre on the topic of Forecasting and Data Analytics. There was a large group of attendees consisting of some very experienced individuals from both the pharma company and agency side, with regard to forecasting, as well as those who were hoping to increase their knowledge of this important business function.

The discussion focused on four key areas, supported by a separate handout to the audience with supporting analysis and case studies.

Key Take-Aways:

  1. US Long Term Outlook on Rx Spending. Cooling of Rx net price growth to low single digits or even decline across the board whereby list price growth will continue to outpace GDP growth. Roundtable participants from the US in particular agreed that politically there is consensus between parties that drug prices have to decrease for consumers. Forecasters are advised to focus on net prices and to allow for future US net price decrease scenarios.
  2. US Gross – Net Price Discounting to PBMs and other stakeholders creates complexity that makes the interpretation of audit or manufacturer reported revenue increasingly difficult. While manufacturers report these discounts on aggregate, they are unknown at product level. While this affects pricing, manufacturer initiated patient programmes can introduce another distortion to reported revenue through audit data because they are distributed outside of audited channels. This can lead to revenue under-reporting of up to 50%, according to one experienced senior participant of the forum. Forecasters should anticipate even higher gross to net discounts in future, particularly in contested indications, driven by marketing battles becoming fiercer and focusing on market access and contracting.
  3. The EphMRA META Analysis Project on Forecasting Accuracy / Patient Share Adjustments was discussed. The value of potential outcomes was confirmed, provided that after gathering suitable historic projects the scope of the analysis can remain manageable and meaningful. Roundtable participants suggested various ways of simplifying the analysis and structuring the projects, such as focus on patient share rather than revenue and the need to look at forecasts by type e.g. patient-based vs. market-based forecasting projects. The META analysis project will be further refined during 2019 and its next iteration presented on 11th October at EphMRA’s face-to-face forecasting forum in Ingelheim am Rhein.
  4. The Forecasting Clinic covered the topic of Predicting Time to Peak Share in Long Term Forecasting. Responses from the audience included the correct use of analogues matching as many of the product, indication and market characteristics as possible and the use of expert judgement ‘gut feel’.

For a more detailed summary with quotes please contact erik.holzinger@grouph.com.

Read the handout which set the scene for these four topics here

The Forecasting Forum continues to meet and discuss topics of interest on a monthly basis during 2019 and 2020. Participation is open to EphMRA members. Please contact Bernadette Rogers, generalmanager@ephmra.org for details. We want to hear from you!

Forecasting and Data Analytics Round Table Discussion – EphMRA 2018

The forecasting role and forecasting tools as part of a corporate business function, or as part of a commercial consulting project in Pharma, Biotech and Medical Device organisations, continue to evolve. Erik Holzinger (groupH) together with Ben Collins (Boehringer Ingelheim) hosted a round-table discussion during this year’s annual EphMRA 2018 Conference in Basel, during June 26 – 28, to open up a number of key topics to a wider audience, share views and come to a consensus on current best practice.

The group consisted of some very experienced individuals from a broad range of pharma companies and business functions, as well as several people from the agency side, providing for diverse backgrounds and insights into what one individual named “…a very big subject”.

The discussion focussed on four key areas:

  • Organising the forecasting process across the Pharma organisation – assumption, communication, and consensus
  • How to communicate strategic forecasts and illustrate uncertainties to senior management – does Monte Carlo simulation have a role here?
  • Required granularity and scope in forecasting strategic pipeline and in-licensing assets: US + RoW?
  • Insights into the application of Behavioural Economics to the forecasting process

View a summary of the discussion with key quotes here

Read the handout which set the scene for these four topics here

EphMRA is planning a Forecasting Roundtable No. 2 at our 2019 meeting in Warsaw. Please send any comments you might have on this year’s roundtable and potential ideas for topics to be discussed at future round tables to erik.holzinger@grouph.com. We want to hear from you!

How groupH can assist in developing Market Access strategies

The importance of planning market access strategies at an early stage.

There is an ever-increasing influence of payers in treatment decision-making processes. The commercial success of new pharmaceutical agents will therefore be heavily dependent on their market access position.

In the past it was the norm to engage with regulators at an early stage of drug development, but leave payer discussion to much later on in the process. Now though, it is becoming critical to evaluate the market access position of early-stage candidates right from the outset – the objectives being to reduce the overall go-to-market risk, achieve significant savings, and increase speed and magnitude of return on development dollars. One should never forget that any product that is denied reimbursement or provided only limited coverage is a product that has been approved by regulatory authorities. This illustrates the different perception of value across various stakeholders.

However, few drug-developers or investors are as yet dealing with payer value uncertainty in their clinical development plans and commercial strategies from this early stage.

How to tackle payer value uncertainty.

The task at first sight seems difficult if not impossible. Especially when trying to predict future uncertainty across several geographies.  But actually, payer decisions on a new treatment are based on answers to four key questions:

  • Can the product increase survival?
  • Can it reduce symptoms?
  • Can it increase patient quality of life?
  • Can it reduce health resource utilization?

Nicolas Touchot, who heads up groupH’s newly formed Market Access practice, brings his insights from working with payers over many years to the task. With Nicolas’s expertise to enhance groupH’s offerings, we can help enable our customers to develop and refine their market access strategies and integrate these considerations into key product and therapeutic area decisions along the full pharma value chain: from allocation of R&D resources to product life cycle management.

For instance, we can help integrate market access considerations into Opportunity Assessments. Target product profiles, even at early stage, should include well-defined Payer Value Elements (PVEs). GroupH can aid in the identification of theoretical PVEs (clinical and/or economical), help express those PVEs compared to expected standard of care at launch, and identify approaches for demonstration of these PVEs.

We believe we achieve more from our payer work than other organisations, because only experienced and dedicated market access experts interact with carefully selected senior payers. Also, our payers can rely on comprehensive and detailed briefing materials prior to a discussion, which greatly enhances their ability to make meaningful comments in particular in orphan and other rarer indications. All this of course, is complemented by our proven track record in in-depth primary KOL and secondary research.

Introducing MAPPI

As an easy first step, Nicolas has developed a simple scoring system based on the four key questions above, answered by payers across many geographies with disparate health care systems. This provides a global view and allows characterization of the market access potential of early-stage assets. The algorithm, known as MAPPI (Market Access Potential and Pricing Index) has been validated by investors and research executives.

  • Step 1: scores the product’s ability to generate realistic benefits that are highly valued by payers
  • Step 2: assesses whether the payer value elements described in Step 1 can be demonstrated as part of the regulatory development process or require investment into additional trials
  • Step 3: evaluates the product’s ability to generate economic arguments supporting the clinical value,  and translates this clinical value into a pricing premium

Results are then combined through a series of scores and matrixes to define a market access environment score and to evaluate the impact on investment decisions and modelling assumptions.

Figure 1: Example MAPPI output

Get in touch for more information on how groupH can help.

Nicolas has addressed many other issues facing the industry with respect to market access in articles he has written recently (see below for details). He is also very happy to provide additional information and support, so please feel free to drop him a line!

Want to Dig Deeper?

Maximizing the Value of Early Engagement Between Manufacturers, Payers and Regulators in Europe – Key Lessons Learned From TCA’s Experience. TCA Viewpoints. November 2013.

Projecting Market Access Success For Early-Stage Pharma Assets: Getting Past The Hurdles. Nicolas Touchot, Lynn Nishida, Mathias Flume. In Vivo. February 2013.

Pharma strategies for development of payor evidence programs. Marie Cassese and Nicolas Touchot. In Vivo. February 2012.

The New Role of Payer Advisory Boards in Shaping Clinical Development Preparation, Structure, Outcomes and Key Success Factors. TCA Viewpoints. February 2012.

Integrating payor requirements into phase III clinical trials. Nicolas Touchot and Marie Cassese. In Vivo. June 2011.