Insight Type: Case Studies

Background

Our previous work with a long-standing client highlighted a need for gathering intelligence on competitor messaging to hospital pharmacists so that the client could adopt the best tactics to differentiate from competitors and maintain market share.

The client was also interested in obtaining information on how decisions to acquire new products are being made at the local level and what drives the decision-making to ensure that value messaging aligns with stakeholder needs.

Valid Insight Approach

We commissioned a competitive landscape assessment including a review of publications, conference reports, news articles, press releases, earnings calls, company websites, and clinical trial records.

To enhance this, we conducted primary research in key markets, speaking to local hospital-level pharmacists to validate competitor positioning and messaging and understand the decision-making process for a formulary listing of the product class.

We then developed a comprehensive report, with key recommendations for the product messaging to maintain and extend market share.

Results

The client gained insight into the key differentiators being used by competitors in their discussions with hospital pharmacists.

We provided clear recommendations on how to improve the differentiation of the client’s molecule and what additional tactics could be considered to defend and even extend market share and positioning.

Background

Our client had an asset in early development for a neurology indication but wanted to understand which other indications in the neuroscience space would be most suitable, have the biggest unmet need, and produce the largest commercial success.

Valid Insight were asked to assess the commercial opportunity of ten potential indications. The results of this assessment would be utilised internally across the early asset pipeline and the neuroscience environment to support research & development. Importantly, the client wanted clear recommendations on where their asset could be best utilised​ to support cross-functional internal decision-making.

Approach

We utilised a three-way approach to determine the indications of value:​

1. Secondary research, which identified several factors including epidemiology, patient segmentation, clinical and economic burden​ for each of the indications.
2. Primary research with payers, KOLs and patient advocacy groups, which tested the target product profile, assumptions on cost-effectiveness, unmet need, current and future landscape, evaluation of the price, and the reimbursement landscape​.
3. Net Present Value and Monte Carlo modelling to support the commercial understanding of opportunity across the product lifecycle.

Results

The client had a clear understanding and ranking of the recommended indications for launch, including details of the commercial potential for the asset in each indication​.

This allowed for internal alignment on the asset and launch indications, and allowed the client to make informed, critical internal decisions, planning clinical development programs to support launch in selected indications​.

Background

As part of an optimised tender strategy, our client wanted to hold a tender summit for their global team and affiliates to address key challenges they have identified within their tender management.

Payers used increased competition as an opportunity to drive prices down, which became the default action to maintain position in the treatment pathway and market share.

Therefore, it was important for the client to consider all strategies and tactics, focusing on value, differentiation, stakeholder management, and the implications of any offer before submitting any bid.

Valid Insight Approach

We defined the final summit content to make sure it integrated and complemented the rest of the tender strategy assets that our client was planning to deploy.

Working collaboratively with our client, we developed training and mock business cases that reflected the company’s current situation and would be used during the tender summit.

We then developed and delivered a two-day face-to-face training for around 40 participants that allowed them to share best practices and tactics with other markets.

Results

Through interactive sessions, real-life mock business cases, and group work sessions, affiliates refreshed their knowledge on how price competition works and what local teams can do to minimize price erosion, support differentiated value, prepare for a tender, and develop winning offers.

Background

Our client was developing a targeted monoclonal antibody for the treatment of gastric and gastroesophageal cancer.

As the clinical results from Phase III trials become available, challenges were identified that would likely impact pricing and lead to reimbursement restrictions.

Valid Insight supported the client by developing an objection handler, enabling affiliate market access teams as they prepare for HTA and reimbursement submissions, and interactions with local/ regional payers at the time of launch.

Valid Insight Approach

We first conducted an insight generation phase, which included an online survey for key internal stakeholders, to understand anticipated access challenges and likely payer concerns at the global level and in individual markets.

The objections were drafted, and a four-hour face-to-face workshop was conducted to prioritise and refine them and discuss a potential approach.

Based on these discussions, a concise, interactive, user-friendly objection handler was developed, with anticipated payer objections and evidence-based responses.

Results

The objection handler highlighted the likely payer concerns and how to address these with evidence-based, company-approved responses.

At the time of launch, the affiliate teams were able to use the tool to support HTA and reimbursement submissions and to optimise their interactions and pricing and reimbursement negotiations with local/ regional payers.

Background

Our client’s flagship product, with multiple existing and planned future indications within the respiratory/allergy space, was to face new competition from four new competitors entering its primary indication within a 12-month period.

Two of the new competitors already had significantly lower price anchors in existing indications, creating the potential for aggressive pricing strategies. The client needed to support its global affiliates in preparing for these significant competitive forces, minimising the risk of price erosion and loss of market share during COVID-19 travel, and meeting restrictions.

The Valid Insight Approach

Valid Insight utilised its integrated dynamic negotiation training model, placed into a virtual workshop environment for 14 global affiliates.

40+ combined and country-specific facilitated interactive workshops:

• Embedding the product value story.
• Competitor ‘war-gaming’ sessions.
• Developing countermeasures to support position and price in the ‘new’ environment (local strategic and tactical plans).
• Comprehensive training in collaborative negotiations.
• Role-play negotiations with local payer experts in the local language.

Results

Affiliate teams were able to refine and pressure-test their local access strategy and tactical plans to support more challenging negotiations.

Cross-pollination of ideas, strategies, and tactics between affiliates contributed to a more motivated and better-prepared team.

Background

Our client needed to consider how to optimise pivotal study design concepts to ensure appropriate evidence is generated for maximum possible differentiation and optimal access with respect to the evolving treatment landscape and future standard of care.

The cross-functional team wanted to understand how key external stakeholders would perceive the proposed evidence-generation plan, specifically around the type and approach to patient-centred endpoints and how best to utilise such data to support optimal access.

Valid Insight Approach

Valid Insight developed a multi-stakeholder advisory board, including:

• Key global opinion leaders to share the complex clinical background of the disease and the lack of optimal therapeutic options, and to share such insights with payers.
• Patient advocacy representatives (patients themselves) to provide deep insight into the clinical, physiological, and emotional burden of the disease and implications of existing therapies.
• ‘Payers’ to use these insights to align on what optimal evidence would be needed to support the desired positioning, pricing and reimbursement position based on various clinical design scenarios.

Results

The company was able to determine the most effective evidence-generation scenario that would yield optimal position, price, and reimbursement.

The company could also determine the education needs of payers to help them interpret patient-centric evidence correctly and assign true product value to the product.

Background

Our client had an asset in a rare disease, which would be launched to replace the current standard of care, but would need to defend against potential newer entrants and generics. In this indication, we previously identified critical issues for payers, including the use of surrogate endpoints and how clinically meaningful these endpoints are when considering the value of the asset.

The client wanted to understand how best to ensure payers recognised the true value of the surrogate endpoints used in clinical trials, to achieve optimal access and price.

The Valid Insight Approach

We utilised robust secondary research to explore the key concepts and issues that payers may consider from previous HTA appraisals, coupled with detailed analogue assessments of similar product launches.

We then designed and conducted pragmatic payer research, which explored the perceived value of the product based on the expected evidence package across the EU5 and Canada.

The data was analysed and delivered to the client with key findings and clear recommendations to support the development and refinement of the pricing and access strategy.

Results

The client was able to utilise clear, reliable, payer-derived data to develop and support their access and pricing goals.

There was a clear understanding from payers of the potential challenges for the use of surrogate endpoints, with a clear knowledge of how to communicate endpoint value.

Background

ATC classifications are used extensively by payers for the definition of comparators. In addition, some countries are planning the pricing and reimbursement reviews of product groups based on their ATC codes. Thus, achieving an appropriate alternative ATC classification could have a significant impact on market access and reimbursement.

Our client wanted to understand the impact of each possible ATC code to assess the possible risks and benefits. The client had developed a novel formulation of a product to be the first treatment for treating rare parasitic infections and needed to understand the optimal ATC classification to ensure optimal patient access.

Valid Insight Approach

We conducted an initial assessment to identify all possible ATC classes, requirements for such classifications, and the probability of successful application for each classification. Collaborative workshops were held to present the proposed submission strategy, rationale and implications for market access and pricing​. Following the workshops, Valid Insight developed the main application letter and collected all documentation required to support our client with their WHO submission​.

Results

We provided our client with clear recommendations and identified the most appropriate ATC class for a novel formulation of the product with the highest benefit potential from a market access and commercial perspective. Furthermore, a clear mitigation strategy ensured we could minimize the risks of classification in an undesired class.