Ensuring  your
product a successful
access to the market

 

Pricing & Market Access

In a landscape that is ever changing, we are present with local expertise on three continents. Backed by evidence, deep knowledge, experience and industry insight, our competent staff are amongst the best at analyzing the pricing and market access landscape and prepare for future challenges.

From planning to execution, we can assist you with the strategic and the technical work needed to optimize the price and market access for your product:

  • Evaluate market access drivers, barriers and price potential for products in development and develop recommendation for strategy and actions to undertake
  • Define pricing and reimbursement strategy for launch based on analysis of environment, competitors, external and internal price referencing
  • Perform pricing research including conjoint analysis
  • Develop positioning and value proposition
  • Test and validate value proposition and pricing strategy through payer interviews or payer advisory boards
  • Develop core value dossiers, Health Technology Assessment (HTA) submissions and other value communication tools
  • Develop negotiation guides and trainings

We are flexible and perform tailor-made projects to meet clients specific needs in all areas related to pricing, reimbursement and market access. Some examples of type of projects we have performed:

  • HTA monitoring to identify trends and future requirements
  • Screening of opportunities for new indications
  • Development of pricing/market scenarios and business cases
  • Global forecasts development
  • Evaluation and strategic recommendation for early access programs
  • Recommendations on clinical trial designs that meet expectation of both payers and regulatory bodies

Contact us to find out how our pricing and market access services can help your business clear the market access hurdle.

Recent projects

Creativ-Ceutical engages in a number of projects should they be for pharmaceutical companies, biotechs or public institutions such as the EU Commission:

Core Value Dossier

As co-leader in the field of combination vaccines, our client wanted to develop new market access strategies to increase the rational use of pertussis booster vaccinations. The company asked Creativ-Ceutical to develop a Core Value Dossier to provide company affiliates with the rationales and arguments to demonstrate the public health need for health authorities to implement a new adolescent or adult booster strategy for pertussis vaccination, in accordance with the vaccination schedule of each country.
We conducted a limited literature search to complete the client’s own research, and then developed a fully-referenced dossier that presented the most compelling evidence for expanded use of pertussis booster vaccinations. Each section was carefully linked to the medical and health economic evidence in favour of such strategies, and specific recommendations were made to enable Affiliates to adapt and use the material in a consistent way that was still appropriate to their local market conditions.
As a complement to the dossier, we also developed a strategic market access guide for the Affiliates, so that they could identify and evaluate the appropriate expansion strategy based on clear criteria. This then served as a basis for the national dossier and negotiations with local authorities.

Payer Appreciation of a Novel Adherence-improving Technology in Multiple Sclerosis, in USA and Europe

Our client wanted to investigate payer reactions to a possible “value enhancing” adherence technology that could be combined with a new drug. Adherence is an issue in the management of chronic diseases and for the disease in question (a chronic, degenerative autoimmune disorder), adherence was an issue due to the side effects of therapy and the long durations where patients might be asymptomatic. The company had identified a novel, non-invasive monitoring technology from a third-party supplier which they felt could complement their product. We were asked to evaluate payer willingness-to-pay and reactions to the new technology in the USA and Europe (top-5 countries). To do so, we developed a questionnaire that presented different adherence options, asked payers to value the benefits of each, and asked payers to comment on the way each would evaluate the incremental benefit. These interviews were complemented by secondary research into previous decisions to finance similar technologies. As a result of our investigations, we advised our client not to invest in the technology, as payer scepticism was high, perceptions of the benefit were low, and methods of evaluation of benefit were both immature and variable among the countries. Given this, it was unlikely that the company would achieve a price premium via the technology. Furthermore, we identified other disease areas where the technology might be more valuable, and provided guidance on the evidence requirements for the evaluation of an adherence benefit. Consequently, the company chose not to license the technology.

Real World Data

One of the top 5 worldwide pharmaceutical industries hired Creativ-Ceutical to investigate on Real World Data (RWD) utilization and their impact on Market Access and Pricing. In the last 5 years there has been a strong trend to link coverage and reimbursement of medical products to the collection of additional evidence and/or to measures of health outcomes in the “Real World”—that is, outside the context of highly controlled clinical trials.
The increased demand for RWD is equally coming from the wide variety of Health Authorities. Regulatory agencies, reimbursement & pricing agencies and HTA agencies are all integrating RWD in their decision-making processes at different levels and with different mechanisms.
Creativ-Ceutical implemented a systematic literature review on the subject (Pubmed/Embase) also analyzing material from the major pharmaeconomic societies and principal Health Authorities. We complemented the analysis by interviewing experts in the field of RWD in order to value, from their direct experience, the factual utilization of such data by health authorities and its impact.
We delivered a detailed report which addressed both current and future utilization of RWD in the main EU countries plus U.S.A., considering both the payer and the company perspective. Objectives of this research were also to establish the best practice in modelling and construction of observational studies and describe the impact with different practical case studies. Using the data coming from this study, complemented with Creativ-Ceutical strategic advice, the client has implemented a specialized RWD Task Force in order to be proactive and tackle this fundamental aspect of the Market Access.

Testing early product concept, pricing and positioning studies & assess the P&MA landscape

Our client was completing a research plan to assess the potential of a new diabetes treatment and was conducting research among physicians, patients and payers on a global basis. This project aimed at assessing the price and reimbursement potential of the new product by testing payer receptivity to the product concept and by evaluating their willingness to pay for (and reimburse) the product. Using the results of a preliminary desk research (competition: therapy prices, reimbursement status, access conditions), new commercial agreements (e.g. risk-sharing, price-volume agreements or similar), latest news in the diabetes market), we established several possible scenarios for the future market at time of launch. We then select one scenario to be tested in the payer discussion.

Product positioning and Launch sequence analysis

The Client would like to develop its Market Access and pricing strategies for a new product in gastroenterology, in Germany, France, Spain, Italy, UK and Poland. The aim was to assess what could be the optimal pricing strategy (versus competitors) and what would be the optimal launch sequence in Europe. By putting in perspective the product profile with the competitive environment, market dynamic, practice, and guidelines, we positioned the product with preliminary scenarios and value propositions for pricing and market access. We then selected the most promising scenarios with the client and tested them through payer interviews. Thereafter, weestimated the appropriate launch sequence based on the fact that a reference pricing system is adopted in most of the countries in focus.

EU pharmaceutical expenditure forecast within selected EU countries.

Creativ-Ceutical was requested to provide a forecast model to assess the impact of new patented medicinal products versus medicinal products going off-patent until 2016 in 7 EU countries, including the impact of changes in national pharmaceutical policies.
Download the report here: http://ec.europa.eu/health/healthcare/key_documents/index_en.htm

Performance of an EU-wide overview of the market of blood, blood components and plasma derivatives

The objectives are to get an overview of the market and costs of blood components and plasma derivatives; of the blood supply management at EU level; of public and private actors involved in blood supply chain at EU-level; of interaction between the different actors; and of donor recruitment processes in each EU member state and voluntary non- remunerated donation systems. Project ongoing, further outcome will be published shortly.

External reference pricing of medicinal products: simulation-based considerations for cross-country

The objectives are to have an overview of the current ERP policies outcomes, and to identify and assess ERP cross-country coordination issues to be addressed in view of further development policies with regard to possible optimisation of this system. 27 EU Member States will be involved, plus Croatia and ROW. Project ongoing, further outcome will be published shortly.

Early Access Programme

A Northern European pharma company, developing a promising new therapy for an orphan indication, having received positive mid-term Phase III results, requested Creativ-Ceutical to provide a strategic advice on the possible benefits of the implementation of an Expanded Access Programme for its new compound.
Early access to drugs that are still in the pre-launch phase can offer essential alternatives or life-saving treatment options to patients, when very few or no other option exists. The possibility of implementing an Early Access Programme also provides the pharmaceutical company with the possibility to obtain early funding, which is - in most of the cases for small biotech companies - fundamental to conclude the development cycle of the molecule.
After having reviewed a vast spectrum of Expanded Access Programme opportunities worldwide, Creativ-Ceutical identified the different pricing and regulatory processes in each country, the timelines for Expanded Access Programme approval, the major stakeholders involved, the feasibility of the execution of an Expanded Access Programme, having previously recognized the potential barriers with the current study package of the new molecule, and determined the key factors that would have contributed mostly to a successful Expanded Access Programme launch.As final deliverable, Creativ-Ceutical also recommended the countries where the Expanded Access Programme will have greatest impact in terms of commercial success for the Scandinavian company, by assessing and forecasting the potential revenue in each country and determining the ideal launch sequence.

Recommendations on clinical trial designs that meet both payers and regulatory requirements

Increasingly, EU payers expect that phase III clinical trials directly address their needs in making P&R decisions. However, a balance is required between the regulatory and payer requirements as well as differential commercial impact of such trials in the EU versus in the US. In this context, we were commissioned by a small US pharmaceutical company to recommend the structure and design of the phase III program for their novel gastrointestinal drug.
First, we reviewed the market access landscape in the specific disease area in Europe. This included landscaping of current, future and discontinued therapies in the EU, their prices, reimbursement decisions, health technology appraisals and an analysis of payer unmet needs. In addition, we reviewed the designs of the ongoing or recently completed phase III clinical trials of the drug’s competitors. Based on these insights, we recommended an addition of a phase IIIb EU trial specifically designed for payer negotiations to the two other standard phase IIIa trials carried out for global regulatory purposes. Crucially, the proposed novel design will clearly position the drug in the treatment pattern where there are clear unmet needs and a possibility to achieve high price.

Pricing research including conjoint and discrete-choice analysis

For a client developing a first disease modifying treatment for patients with osteoarthritis, we conducted payer research to assess the payer’s appreciation on osteoarthritis medical needs in today’s environment and payer receptivity to the product attributes. By using a conjoint analysis, we determined and prioritised product attributes that are taken into account for reimbursement and identified subpopulations for which the reimbursement is more easily granted. We also assessed payers’ willingness to pay for the product and asked them how the upcoming clinical trials should be designed. This research was performed and interviews were conducted with payers in Europe, Australia and Brazil.Main results were that awareness of disease cost is low and that large countries as for example the UK, Germany and France which are sensitive to widespread drug consumption in the general population, have high focus on this disease.