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Build or buy? Considerations for market access

As healthcare systems and regulatory landscapes evolve, pharmaceutical companies are facing greater challenges in getting their products to market. Market access professionals continue to play a critical role in navigating these complexities by ensuring timely regulatory approvals, cost-effectiveness evaluations, and securing favourable reimbursement and access agreements with healthcare providers and payers. As such, an increasing number of market access professionals are looking for digital solutions that bring efficiencies and allow them to make data-driven decisions.

However, as the demand for innovative digital strategies rises, a pivotal decision awaits these companies: Should they build an in-house digital application or buy pre-existing solutions from external vendors?

In this article, we delve into the complexities of this decision-making process and explore the key considerations that will empower market access teams to navigate the route towards the most optimal and cutting-edge digital solutions.  Read on to discover the pros and cons of both options and why we believe buying reigns supreme, nearly every time.

When should you BUILD?

Developing custom internal systems can prove advantageous when you want to retain full control over your unique processes and workflows. It is especially advantageous for systems that give a competitive edge or involve sensitive intellectual property. Bespoke home-grown solutions are also a better choice if off-the-shelf solutions seem too generic in comparison, and do not meet your specific needs.

Key considerations for BUILD

Building bespoke internal applications is not straightforward and can be complicated even for well-resourced teams.

1. Are you clear on your requirements?

When it comes to creating a custom application, having well-defined and documented requirements is crucial. Often, IT teams lack expertise in the subject matter and rely on their colleagues from the business side to explain what’s necessary. This means that if the main users (for market access, which includes both global and country teams) don’t actively contribute to shaping the requirements, the final solution may not be optimal. This challenge can be even greater for pharmaceutical companies due to their intricate organisational structure, the involvement of affiliates, and complex reporting hierarchies.

2. Are all your key stakeholders and users ready to commit time?

Consequently, the primary responsibility lies with the core market access team leading the custom application development. They must invest time in defining the requirements, providing clarifications to the IT team during the development phase, and conducting thorough end-user testing before release. Given the typically demanding schedules of market access professionals, this becomes a crucial factor to consider.

3. Have you considered the total cost of ownership?

Building software in-house carries higher development costs, longer timeframes and a risk of errors and defects — which can delay the roll-out. It is never a one-time effort and a one-off cost. There will be a need to commit to an ongoing budget and resources to provide support and take care of enhancements.

4. Have you considered the time it will take before you can start using the application?

Any bespoke application development follows a certain cadence.

It has to start with a detailed requirements elaboration phase so that the high-level requirements are well understood and documented. Starting with designing the user experience which requires intense end-user workshops, development of the application and testing, coupled with tight project management means that the entire process may take 6-12 months to complete. Many times, key personnel involved in the project change, the requirements evolve, and the end application doesn’t get the uptake that was expected.

Plug and Play: Explore the Perks of Purchasing SaaS

Although building software in-house can be a fantastic solution when done correctly — the reality is that for most companies, it’s simply not a practical option as they don’t have the necessary time or resources.

Market access teams in many pharma companies are accelerating their digital transformation by purchasing third-party software, that is then integrated into their existing operations and processes. This is particularly true when purchasing solutions from companies that specialise in market access and have built tailor-made solutions that cater to their needs.

Some unique advantages that SaaS solutions offer include:

  1. Lower total cost of ownership: Purchasing a SaaS solution does not have an upfront cost, and it is much easier to end the contract if businesses decide they no longer need the application. They can also benefit from new features and upgrades, without having to pay for all of them.
  2. Faster roll-out:  You start getting the value from day 1, as there is minimal set-up time involved in a SaaS solution.
  3. Customisation opportunities: Good SaaS platforms allow for many customisation opportunities to tailor to specific internal taxonomy and processes.
  4. Integrate to avoid duplication: Many SaaS platforms allow for integration with other internal and third-party applications. This eliminates duplication of efforts and increases adoption.
  5. Drive standardisation: Rolling out a SaaS solution already used by other leading pharma companies helps businesses stand a better chance of getting buy-in from the users. With an out-of-the-box system, pharmaceutical organisations are able to push through process standardisation and benchmark against some of the best in the industry.
  6. Try before you buy: Questions can be easily answered by gaining trial access, and simultaneously allay any concerns that the users may have.
  7. Long-term value and rate of adoption: Unlike a home-grown system that has been used by a handful of people, a SaaS solution benefits from years of evolution and feedback from clients — so a new client coming on board automatically benefits from having a robust, time-tested solution that already has the seal of approval by other businesses in the industry.

Building bespoke own solutions comes with risks, and adding to the complexity is the dearth of purpose-built SaaS solutions that cater to the digitisation needs of market access. So, it’s better for companies to avoid adopting generic or suboptimal applications. We have seen several market access teams try to build their own solutions and fail. This is particularly true for global launch activity tracking solutions that rely on affiliate teams to input lots of data into a system that isn’t easy to use. As a result, hardly anyone uses these applications, and it costs businesses a lot of money.

Discover our solutions

At Access Infinity, we have years of experience building solutions for market access and pride ourselves on delivering purpose-built platforms for Business Development, Pipeline, Early Assets and Launch teams.

Want to know more? Get in touch with our team, or browse our solutions, here.

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What is Analogue Analysis?

It’s no secret that the landscape for market access and pricing professionals is ever-changing. Today the role of the function has evolved to be a critical link between R&D, medical and commercial functions. It’s providing the foundation for clarity in evidence expectations, willingness to pay and market needs, all while communicating and connecting pharma’s other functions.

Within this challenging environment, data-driven decision making is fundamental to overall business success. Enter, analogue analysis – the process of looking at past products’ performance to guide strategy and planning for current and future brands

An “analogue” is essentially a brand in a similar situation to your own. No brand is entirely the same as another, but it can have many of the same characteristics. Analysing these analogue brands can provide critical insight for our own brands, as they have already navigated through similar waters.

Why is analogue analysis beneficial?

When we predict the price and health technology assessment (HTA) outcomes of pharmaceutical brands, we base many of our assumptions on previously approved drugs – otherwise known as analogues. This competitor analysis in the pharmaceutical industry is essential for benchmarking price and informing product launch strategies.

In market access, we have time pressures to answer a range of complex questions. We need to know how to produce more accurate analyses and provide evidence to support a product launch strategy. From TPP profile definition through to price estimation, we need to speed up analysis to present the best business cases for early asset investment decision committees.

Important considerations for analogue analysis

When searching for analogues, we might look at defining characteristics such as:

  • Product and disease characteristics
  • Considerations for the launch environment
  • Broad or specific product launches.

We also need to ask ourselves some key questions. For example, what pricing opportunities are there in a highly genericised landscape? Does our product have an orphan indication? What does differentiation look like in a crowded marketplace? How can we support a trial design acceptable to payers if our comparator is off label?

TPP versus aspiration-led approaches

Analogues are selected using one of two approaches. One involves starting with what you have and using your existing TPP to identify analogues.  Another is more aspirational, defining outcomes you wish to achieve and identifying analogues that achieved those outcomes.

The TPP-led approach

In this approach, analogues are selected based on how well they match to the target product profile (TPP) for the brand. 

This approach works well when the TPP is available, however, it can be long and iterative, as many different TPP variations are introduced.  It is also difficult for market access teams to influence clinical programmes and medical strategies to shape the TPPs. 

Aspirational pricing and market access approach

This approach is based on a target price, and HTA outcomes that are expected to achieve the price. We need evidence to reach the desired HTA outcomes, which we can achieve by reverse engineering the TPP.

This makes it possible to guide research and development teams on trial designs and optimal products, but it may be far from reality. Whatever the findings, adequate risk analysis in the pharmaceutical industry is paramount, so whatever is identified must be robust.

Best practices for analogue analysis

Many teams face challenges, whichever approach is followed.  Analogue identification is frequently restricted by limitations on yours and your team’s knowledge.  Up to eight in ten analogues are selected based on team members’ personal knowledge, rather than being identified in a systematic manner.

At Access Infinity, we have developed Nuro to help you identify analogues, and get the best out of your analogue assessments. We generally advise this approach to get the best results:

Step 1: Define product or disease characteristics

This may include therapy areas, clinical benefits, molecule types, acute or chronic treatments, orphan drug indication, route of administration, and adult or child use.

Step 2: Define the launch environment

This may include size of target population, number of indicated products, availability of price benchmarks, competitor activity and off-label/on-label comparators.

Step 3: Apply criteria comprehensively and systematically

Bearing in mind that the above factors are not exhaustive, we need to take a comprehensive approach. This means starting with all EMA or FDA approved products. We need to be systematic when applying matchability of criteria. This will ensure repeatability, making for better business cases.

Step 4: Create the funnel

With these steps, we can then create our own funnels, for example, filtering out other therapy areas and focusing on auto-immune disorders. But we also need to be aware of the limitations, and draw on our own experience in addition to existing data. Generally, nine in ten analogues start with the disease, but we cannot simply create a funnel in any order.

The future

As pharmaceuticals become more expensive and competitive, we need faster, more reliable methods to benchmark pricing and assist product launches. Technology such as Nuro helps us to see all the essential data in one dashboard, which we can augment with our own experience.

No single method is the ‘correct’ one for getting a product to market effectively, as there are so many variables. What we can do is refine our strategies by looking at historical data and grouping by key characteristics. In future, this will help us satisfy HTA outcomes faster and create competitive price benchmarks.

Find out more about Nuro for analogue analysis here.

You can also hear our Founding Director Shri Rao Mukku talk more about analogue analysis in this webinar recording: https://accessinfinity.com/webinar/analogue-analysis-dos-and-donts/

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5 reasons to track market access performance

As the role of the market access function continues to evolve, tracking its performance is becoming more important. Today, market access is the bridge between clinical and commercial functions and plays a pivotal role in launch (and overall business) success.

With market access performance becoming increasingly on the agenda at board and leadership level, understanding why it matters becomes paramount. That’s why we are rounding up our top 5 reasons to track market access performance to help market access teams work smarter, faster, and more efficiently.

1. Understand if we are making improvements:

One of the primary benefits of tracking market access performance is the ability to gauge whether improvements are being made. By using benchmarks such as competitor data or our own historical data, companies can set targets or adjust them in line with changing market conditions and evaluate their progress over time. This enables them to identify areas of success and areas that require further attention. Regular assessment of market access performance ensures that strategies are continuously refined and optimised to achieve better outcomes.

2. Quantify market access success:

Tracking market access performance allows professionals to quantify the value they bring to the business from a price and access perspective. Measurable figures allow market access professionals the chance to showcase their value to wider commercial teams. These figures help tell the story of the business, showcasing the impact of pricing and access strategies on the company’s overall success. This quantitative evidence strengthens their position and highlights the value they bring to the organisation.

3. Make better predictions:

Market dynamics are constantly evolving, making it crucial for businesses to anticipate and plan for the future. By tracking market access performance, companies can build on information from the public domain and their previous pricing or access strategies. This enables them to make more accurate predictions and informed decisions regarding future product launches. Looking both backward and forward allows organisations to learn from past experiences and adapt their strategies to align with changing market conditions.

4. Build institutional knowledge:

Tracking market access performance generates a wealth of data that can be consolidated into an accessible dashboard. This centralised platform ensures that all stakeholders can stay informed and build their institutional knowledge. By leveraging this knowledge, businesses can make informed decisions and seize opportunities while mitigating potential pitfalls.

5. Navigate changing market conditions:

With the volatility of drug pricing, understanding value-based pricing is critical. By continuously tracking market access performance, companies can identify trends and patterns over time. This insight allows them to adapt pricing and access strategies to align with evolving market dynamics. By staying ahead of the curve, businesses can navigate changing market conditions effectively and maintain a competitive edge.

Key takeaways

As we look ahead to the future, it is evident that the trends shaping market access performance will continue to gain momentum, especially with the rapid advancements in technology. By monitoring and evaluating market dynamics, companies can identify areas for improvement, quantify their value, make accurate predictions for the future, build institutional knowledge, and navigate changing market conditions. Through the continuous refinement of market access strategies, businesses can enhance their product launch strategies and ultimately benefit patients, who can get faster access to lifesaving healthcare.

The 5 reasons to track market access performance are also available as an infographic, download below. 

Download infographic
If you want to find out more about market access performance tracking then you can request access to our ultimate guide to tracking performance in market access by filling in the form below.
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Learn the true value of Market Access Performance Tracking in our new guide

Download 'The ultimate guide to tracking performance in market access'

The Access Infinity team has just launched a new guide. The ultimate guide to tracking performance in market access offers key insights into the value-led strategies for launching new pharmaceutical products.

Authored by Access Infinity Founder Ahmed Edathodu, the guide takes market access professionals through the KPIs that help them to achieve the best price and broadest access in the shortest possible time. It also draws on testimonials from real customers, including Astellas and Pfizer.

Hear from the faces behind Access Infinity 

Access Infinity’s game-changing learnings, taken from years of working with top-tier pharma companies and interviews with access leaders, paint a clearer picture of market access performance tracking today. We hear from Founder Ahmed Edathodu, as well as Product Owner Thomas Gilboy.

What the guide will cover

The guide will address some of the most pertinent topics in market access performance tracking, including:

  • The state of market access performance today
  • Why measure market access performance
  • Why become a market access performance champion
  • How to measure market access performance
  • Who’s championing market access performance in industry
  • What to do next.

Why measure market access performance

While measuring market access has been on the agenda to some degree, understanding performance is becoming a priority at board and leadership level. So how can market access teams do it better and communicate their success?

Historically, while teams have relied on legacy technology like Microsoft Excel, this does not provide a holistic overview. Our new guide showcases exactly why and how we should measure market access performance – benchmarking our performance against competitors, target dates, industry averages and more. From improving our institutional knowledge to bettering patient care, there has never been a more crucial time to measure market access performance.

Likewise, having a keen eye on both internal and external data gives us competitive advantage. This guide shows market access teams how to leverage information in the public domain, as well as internal figures for future strategic planning.

Download the guide today

The ultimate guide to tracking performance in market access is an essential for market access teams that want to demonstrate commercial success stories. It comes as just one of many free resources from Access Infinity, including an upcoming benchmark report and ‘Market Access Matters’ podcast. You can also find out more in our on-demand webinars.

Gain deeper insights and plan for a more profitable future. Read our free guide today. 

To get a copy of the full guide, complete the form below and we’ll be in touch by email.

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World EPA Congress 2023: Our Takeaways

It was another standout World Evidence, Pricing and Access (EPA) Congress this March. More than 1,200 delegates attended to visit 100 exhibitors and watch 300 presentations at the RAI Congress Centre in Amsterdam.

This year’s resounding themes were focusing on the patient perspective, putting them at the heart of market access. These themes extended to the true definition of patient outcomes, and the need to look beyond initial patient care.

Nothing stands still in market access, and we were encouraged to “never stop exploring”. 

Key messages on the growth of the market access function

Echoing the sentiment of never standing still, we turn to the panel discussions. On Day 1, speakers from A.M. Pharma, GSK and Janssen discussed Exploring the use of access operating models.

Christoph Glaetzer, Chief Global Value and Access Officer at The Janssen Pharmaceutical Companies of Johnson & Johnson said: “At its core, market access is not a function, it’s a strategy. And it’s because we need subject matter experts that it became a function.”

Within this, we are seeing an evolution of market access, with more light being shone on price function.

Making medicines available to patients

The event also highlighted some key statistics around medicine availability. Notable conclusions were the relatively high speed of access in Germany, compared to the concerningly slow pace in Romania.

There continue to be discrepancies across Europe. In Germany, only 8% of medicines are unavailable, whereas Spain suffers from 47% unavailability, and Lithuania 83%. We may see additional challenges as the UK turns to a US-like model for regulatory decisions.

In general, many low-middle-income countries have been overlooked when it comes to country registrations and P&R strategies. Our hope is that the new trends in access planning will improve access for all.

Feedback from the Access Infinity stand

Away from the panels, the whole Access Infinity team loved connecting with delegates on our stand. In particular, visitors showed a keen interest in:

  • The digitalisation of market access
  • Overall digital transformation in market access planning
  • How to use modern tech to streamline processes and make teams more efficient.
On the first day of the event, we were delighted to announce the availability of our NURO solution on the Microsoft Azure Marketplace, making it even easier for organisations to subscribe to our platform through their existing Microsoft Enterprise Agreement. Read the full story here.
 
Our teams also had some keen insights to share from the patient perspective. In particular, it’s essential to monitor the patient not only during their treatment, but afterwards. Patient-reported outcomes are ideal for measuring this, looking at real-world evidence as well as general outcomes.

Thought-provoking talks from our team

In addition to our stand, we took to the stage. Digital Solutions Product Owner Thomas Gilboy  on Day 1 and Founding Director Shri Mukku on Day 2. We delivered game-changing insights on the state of market access right now, plus actionable tips for analogue analysis.

The talks underscored the influence of market access and pricing functions on clinical and commercial operations. They also addressed the common mistakes made and how to avoid them – as guided by more than 10 years’ experience in the industry.

The future of access planning: key opportunities

Looking to the future, the conference wound down with an overview of emerging trends. These started with better access planning, focusing on affordability and inclusive business models. Proponents of this strategy include:

  • Sanofi’s non-profit impact brand
  • Pfizer’s accord for a healthier world.

With these influential brands at the helm, we should see these trends start to increase. Another brand setting a new trend is Novartis. The Novartis Access Model aims to increase access to on- and off-patent medicines for noncommunicable diseases in Africa, Latin America and Asia.

Best practices from world-leading brands

The Novartis name came up again as a leading example of tailored pricing strategies. Joining them were GSK and Pfizer, who have implemented strong access strategies among different income classifications.

These have given rise to new opportunities in product delivery and access planning. On top of equitable pricing strategies, we’ll also see more registrations and the use of non-exclusive voluntary licensing. In the future, this may lead to further scaling in access.

On the access planning front, there is now more focus on comprehensive plans for late-stage R&D products. The quality of these plans will be improved, no doubt bolstered by technology like Access Infinity.

Looking ahead to 2024

It’s hard to believe that after three days, 300 talks and 100 exhibitors, the World EPA Congress is over for another year. We’re excited to see these trends develop, taking a patient-first approach and making medicines accessible to all.

The World EPA Congress returns to Amsterdam between March 12 and 13, 2024.

We’re also heading out to ISPOR US and Europe events later this year, we look forward to seeing many of you soon! 

Missed the event and want to connect with us? Get in touch here. 

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Excel tools for Global Pricing and Market Access teams

Authored by 
Shrinivas Rao Mukku, Ph. D, M. Phil (Cantab), Founding Director, Access Infinity. 
Vanit Patel, Senior Consultant, Access Infinity. 

Introduction

Excel is a powerful tool that is widely used for developing models in various sectors, including our own, the pharmaceutical industry. Within pharma, forecasting teams use it to forecast sales, commercial teams to analyse revenue scenarios and clinical teams to interpret data, on a daily basis. For the pricing and market access function, some excel tools are essential and constantly used to support decision making at different stages of the product life cycle. Several companies, including Access Infinity offer these tools as products and services to the Global Pricing and Market Access function.

Excel tools do their job

Excel has limitations when it comes to user interface and UX design however it does have several advantages such as ease and speed of build, scalability and editing flexibility. It also enables users to see and amend calculations.

During our time as a Market Access and Pricing (MAP) consultancy business, we’ve seen time and time again how clients use Excel to great effect. In this article, we’ve pulled together our top 10 tools that specifically serve the global MAP function.

1. International Price Referencing (IRP) Tool

Excel IRP tools are commonly used by pricing teams to determine the impact of IRP on different countries and the subsequent influence on global price corridors. By analysing and quantifying the negative impact of IRP, these Excel tools can help generate a revenue-optimising country launch sequence. They are also used to mitigate and reduce IRP-driven price erosion as part of a product’s post launch lifecycle management. 

2. Country launch sequencing

Launch sequencing of a product in different countries is one of the key strategic responsibilities of global pricing and market access function. Launch sequencing in many instances is an extension of IRP modelling. In addition to this, the time taken to conduct the HTA review, and the subsequent price negotiation are also incorporated as inputs while developing the optimal launch sequence. This varies by country and could be between 0 – 400 days. Mitigating the risk of IRP impact through optimal launch sequence is achieved by closely monitoring the outcomes of price negotiations factoring what price is visible and the time it is published in the national journal for other countries to access. Launch sequence is closely monitored and global price approval teams need to flexible to make quick tactical decisions. 

3. Parallel trade impact analysis

Parallel trade is one of the key challenges pharmaceutical companies face. It is therefore important to identify the countries that are impacted and assess the implications to revenue. This would help in not only managing the risk through different tactical decisions but also considering other elements of price referencing as well as parallel trade laws. Based on the understanding of which countries are impacted and the magnitude of loss, strategies could be developed to curtail this, e.g. packaging, language on the pack etc.


4. Revenue optimisation

Revenue-optimisation excel tools can cater to many use cases such as the optimisation of revenues based on the line of usage (patient volumes x price potential) or analysing the impact of different pricing scenarios. As the name suggests, these Excel models can include multiple variables to assess short- and long-term revenues to inform strategic decisions.  Revenue optimisation tools are typically used at every stage of the product lifecycle.

5. Indication sequencing

Indication sequencing tools are important for analysing the overall revenue for a product launching in multiple indications. This is extremely common in oncology and immunology where products are often tested in various distinct indications and lines of treatments. Price potential and volumes can vary by indication and are driven by the price and LOE (loss of exclusivity) status of competitor products, along with the incidence and prevalence of the diseases.

Modelling indication sequencing can help guide the cross-indication launch strategy and is critical not only for the P&MA function but also to influence R&D and commercial planning.

6. Risk sharing agreements

Many payer institutions are looking at managed entry agreements to make novel, expensive products, more accessible. Managed entry agreements exist in multiple options such as pure-play discounting, free goods, cumulative tiered pricing, pay for performance and others. The revenue analysis based on these options can also evaluate launching in multiple indications and multiple countries.  

An excel tool that is able to intuitively compare the revenues of all the options for both the pharmaceutical account managers as well as payers to make access decisions, is a win-win for both parties. Our experience indicates that simple calculators for account managers can help in quick decision making as one is able to present which agreement serves the purpose of the payer, both at the regional and/or hospital level. 


7. Price calculator

The margins applied on the ex-factory price to arrive at the price paid by the consumer (list price) and other stakeholders vary by market. Margins are applied at the wholesaler level and pharmacy level and the percentages in any country depends on several factors such as the point of care, distribution channel (hospital vs retail) and cost of the medicine. For instance, for more expensive products, the percentage commission is lower for both wholesalers and pharmacies.

Another variable is the addition of government tax e.g. VAT (value added tax), GST (goods and services tax) and others. This also varies if the product is funded through the retail route or hospital. The most complex price to estimate is the net price which is based on the discounts applied at ex-factory, wholesaler or pharmacy levels.

Price calculators are simple Excel tools that can help derive prices at all levels for a given product in each country. Users are able to select a country, input one of the known prices (list, ex-factory, pharmacy or wholesaler price)  and the tool is able to determine automatically prices at all other levels for that country.

8. Due Diligence framework

Due diligence of potential acquisitions is conducted on a frequent basis and is a time drain for many P&MA executives. To ensure that a systematic approach is used for due diligence exercises, a simple model can help to assess product value at the time of its launch.  

This framework helps in defining the product environment through scoring of disease severity, unmet need, current and future competition, patient numbers and prices of current treatments. Once the environment is defined, users can overlay the product characteristics being tested, including the efficacy and safety of the product over its current and future competition and the quality of data supporting it. Through a simple logic of value differentiation, one can derive the potential HTA outcome and price of the product. Although the hypotheses is based on performance of past launches and future competition, it is a great starting point to conduct a quick BD assessment. 

9. Price forecasting tool

Pricing teams play a key role in product investment decisions – they need to generate defendable price forecasts to assess if assets are worth investing in. 

An Excel model can help to forecast the price in several countries and/or regions. Country-specific baseline assumptions can be used to estimate price evolution over time. Example assumptions include: time to reimbursement, gross-to-net discount, LOE and price changes due to specific country events such as mandatory price cuts, currency conversion policy and others. This provides a quick and validated starting point for users to tailor their forecast.

10. Payer decision driver matrix

As payer expectations, reimbursement drivers and WTP vary across markets, tools that map where an asset is meeting expectations can be of great use. In order to effectively plan evidence-generation activities, teams must be able to identify, categorize and track payer expectations and the associated data gaps.

An Excel tool provides the ability to collate this information as a single source of truth that enables teams to:

  • Understand country-specific payer decision drivers
  • Track and make informed decisions on the evidence generation activities to pursue
  • Easily share and distribute information with internal teams

Let us know your top Excel tools

In this article we’ve shared our top 10 Excel tools for Market Access and Pricing teams, based on our experiences in industry and client feedback. 

How many of these tools are you using in your own team? Are there any others that you think should make our list? 

We’d love to hear your thoughts, drop us a line on hello@access-infinity.com.

About the authors

Dr. Shrinivas Rao Mukku (Shri)

Shri is the founding director of Access Infinity and has 16+ years of consulting and industry experience. Shri worked at Merck as Global Director, MAP (Market Access and Pricing) responsible for Erbitux and other oncology products and at Lundbeck as ‘Pricing Specialist’ in the Global Pricing team. Work in many regions and countries including UK, the current location, France, Germany, Denmark and Southeast Asia in biotech, pharma, research and management consulting has led to a very good understanding of drivers of access globally. In addition, this has led to personally managed of strong network of payers and key opinion leaders.

Shri’s consulting experience includes launch pricing strategy, country and indication sequencing, qualitative payer and KOL research on impact of clinical evidence generation on product value assessment, post LoE (loss of exclusivity) pricing strategy and assessment of new products for BD opportunities (in- and out-licensing). He has also established and/or led pricing and market access departments of different consulting companies such as Access Partnership and Double Helix Consulting. With is strong interest in excel tools, he has developed several on-demand tools for pharma clients. Shri has a Ph.D in Bioprocess Engineering from Asian Institute of Technology, Bangkok and an M.Phil from the University of Cambridge, UK in Bioscience Enterprise as a fellow of Melinda and Gates foundation.

Vanit Patel

Vanit is a senior consultant at Access Infinity and has 6+ years consulting in the healthcare industry. In this time, he has created 20+ bespoke Excel models for top-20 pharmaceutical companies. Vanit has also conducted and managed over 60 projects focusing on global pricing and market access strategy, evidence generation, value assessment, value message creation and testing, international reference pricing, forecasting, due diligence exercises and leading internal client workshops.

Vanit is a UK qualified pharmacist, graduating from University College London (UCL). He previously worked at the Royal Free London NHS foundation trust and also completed academic research at Monash University in Australia, where he studied PfPDE inhibition and produced published data on PI3K inhibition.

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The 8 Market Access Performance Metrics You Should Be Tracking

Here Are 8 Essential KPIs Your Market Access Teams Should Be Looking At

The route to market for any given drug is rarely a straight line. There are many obstacles to overcome and expectations are high. You need to achieve the best price and broadest possible access in the shortest possible time across the greatest number of markets, all the while communicating value to payers.

There is much to do leading up to dossier submission, including getting your evidence strategy right, developing CE/BI models, payer value story, P&R strategy, and much more – work that starts years before launch.  

So it’s no surprise that some areas of market access don’t get the attention they deserve. In fact, the whole area of market access performance isn’t on the radar for 90% of market access teams. By ‘market access performance’, we mean tracking a number of key metrics to achieve the following:

  • Deliver critical insights to help track as well as shape your launch strategy.
  • Demonstrate performance of the access function in numbers.
  • Learn from past mistakes and be better prepared for future launches.
  • Make the access function more successful and improve the chances of achieving your P&R goals.

Where Market Access KPIs Fit In

You’re a global market access director and are responsible for the P&R strategy for your drug. You’re launching next year and you’ve done everything you can to dot the i’s and cross the t’s. You’re feeling nervous, but confident in the strategy you’ve put in place. Now the regulatory approvals come in thick and fast and the race is on to get your product through submission, contract negotiation and into reimbursement lists at a price that’s in line with your strategy.

But how do you know if you’ve done a good job? How well did you actually perform on your objectives? This is where KPIs (Key Performance Indicators) come in.

By not implementing KPIs you’re missing out on valuable insights that could help you understand how well you’re performing on key access metrics. You’re also losing an opportunity to further refine your strategy throughout the launch phase.

Thankfully, it is easier to track performance than you might think. In fact, you don’t need to put in any extra time or effort to track KPIs. There are tools out there to help.

But first, you need to know what to track. You might be monitoring some of them already. But it’s unlikely you’re tracking all of them.

The 8 KPIs You Should Track
 

These 8 KPIs aren’t something we dreamt up one afternoon. They are the result of a long journey, following many years of helping top brands track performance and conducting hundreds of interviews across global and country teams.

Including these KPIs for your own products will give you a more complete picture of how well your launch is going and enable you to make improvements for the future.

We split the 8 KPIs into three groups addressing the most common P&R objectives. They are: Speed-of-access, Breadth-of-access and Price Performance. The diagram below provides a visual summary:

To access the full guide, fill the form below and you will receive it by email.

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GETTING MORE OUT OF YOUR ANALOGUE ASSESSMENTS WITH NURO

GETTING MORE OUT OF YOUR ANALOGUE ASSESSMENTS WITH NURO

‘What pricing opportunities do I have when launching in a highly genericised landscape?’

‘What does differentiation look like in a crowded market place?’

‘If my clinical comparator is off label, how do I support a trial design that is acceptable to payers?’

These can be difficult questions to tackle. Often, the first place to look for answers are analogues, i.e. what other products faced a similar situation and what can we learn from them? Finding good analogues (or even no analogues!) can go a long way in better informing your market access strategy and in developing stronger business cases internally.

Below, I’ve put together some considerations and best practices we apply ourselves while conducting analogue assessments.

Create a robust set of matching criteria

Before embarking on any assessment the first step is to make a thorough list of criteria that characterise your situation. Defining criteria by ‘product/disease characteristics’ and ‘launch environment’ can often be a good place to start.

Define product/disease characteristics

  • Therapy area(s)
  • Incremental clinical benefit demonstrated (efficacy, safety, QoL)
  • Molecule type (small molecule, biologic, ATMP)
  • Acute or chronic treatment
  • Orphan designation
  • Route of administration
  • Adult/paediatric use

Define the launch environment

  • Size of target population
  • Number of other indicated products
  • Availability of generic price benchmarks
  • Launch indication or follow-on indication
  • Parallel or sequential launch of indication
  • Competitors using active comparator or placebo in clinical trials
  • Off-label/on-label comparators

The list above is not comprehensive

You may choose to apply a very broad matching criteria (e.g. products with orphan designation regardless of therapy area) or be very specific (e.g. products that are small molecule, oncology, oral-only, launched in at least two indications simultaneously, having used active comparators in pivotal trials)

Either way, this sets up the basis of your analogue search. The next step is to apply this criteria to a reference data set. To make the best business case for your assessment, use either the EMA or FDA drug databases (or both) as your starting point.

Be comprehensive and systematic in applying the criteria

It’s important to take a comprehensive approach (e.g. start with all EMA or FDA approved products) to avoid cherry-picking only those analogues you are already aware of. It’s equally important to be systematic in applying the matching criteria to ensure repeatability of the exercise and build defendable business cases.

In taking this approach, what you normally get is a ‘funnel’ that starts with a very large dataset and ends with a manageable shortlist of analogues for you to deep-dive into. For instance, let’s imagine you’re looking for examples of non-orphan biologic products in selected therapy areas that achieved an ASMR III or higher having submitted only placebo controlled pivotal studies. Your analogue selection funnel might look something like this:

Be aware of the limitations: think directional insights

It’s tempting to look to analogues to answer all your questions. More often than not they’re there to shine light on some, often critical, aspects and to reduce that cloud of uncertainty surrounding your business objectives. After all, you’re bringing a new product to market with characteristics that are unique to it. But despite their limitations, analogues can be a source of great insights that support a better understanding of your product’s price and access opportunities. The exercise also gives you valuable arguments in situations such as when leadership expects a price you know will be difficult to achieve or perhaps in convincing the clinical team about the importance of ‘hard endpoints’ in payer negotiations.

Having done several projects where finding analogues have generated critical insights, we recently launched a digital solution called Nuro that helps identify analogues for your products rapidly. The hypothetical funnel I created above, for instance, can be built and relevant analogues identified in a matter of minutes using Nuro.

About the author

Ahmed Edathodu
Founding Director at Access Infinity

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THE UPS AND DOWNS OF CIPM PRICE REVISIONS

THE UPS AND DOWNS OF CIPM PRICE REVISIONS

The Spanish healthcare system is notorious for being cost-conscious. With COVID-19 acting as a major setback in terms of budget allocation and public debt (1), this could have consequential knock-on effects on Spain’s willingness to pay for drugs. One mechanism that allows them to exercise their predisposition to implement budget control is drug pricing.

How are drugs in Spain priced?

The Comisión Interministerial de Precios de Medicamentos y Productos Sanitarios (CIPM) is the pricing committee under the Ministry of Health (MoH) responsible for pricing drugs in Spain. Following a drug’s positive assessment for reimbursement by the MoH, the CIPM sets maximum ex-factory prices based on value assessments, then publishes these prices. Moreover, the CIPM employs reference pricing – a system that allows them to annually exert downward pressure on groupings of drugs based on their active ingredient or their INN. Through this, all drug prices in a reference grouping are recalculated downwards. These measures also apply to generics that contain the same active ingredient.

Whilst they have a set criteria for funding medicinal products, their pricing reports are not public leading to accusations for a lack of transparency with the existence of seemingly arbitrary price reviews and price reductions.

Ultimately, these pricing controls have led the CIPM to be viewed as a harsh institution. However, our review of the CIPM pricing revisions demonstrates that pricing increases do happen (2), which led us to explore further.

What happens in the CIPM’s price revisions?​

To investigate these concepts further, we accomplished an analysis of CIPM pricing revisions from 30th May 2019 to 7th April 2021 (2).

The CIPM executed price revisions through stock keeping units (SKUs), which refer to the specific price increase or decrease of every unit. Thus, single drug would have several SKUs if manufactured and reimbursed for a variety of dosages. During this time frame, the CIPM published 71 SKU price increases and 54 SKU decreases. This fact alone is surprising, considering that increases in SKU price were not expected of the CIPM.

Upon closer analysis, we ordered all the drugs according to their ex-factory SKU price to establish whether there was a relationship between baseline price level and the likelihood of a price increase of decrease. All drugs under the lower quartile had experienced a price increase, while the third quartile exhibited the most price decreases.

Number of price increases and decreases per quartile baseline SKU price from May 2019-April 2021

Why are there so many price decreases in the €22.40-33.00 range?

It is imperative to comprehend what led to the bulk of price decreases in the third quartile, and what could have motivated the sudden fall of multiple products.

Number of price increases and decreases per CIPM price revision

The decreases in SKU prices in the third quartile are accredited to the pricing report published in February 2020 (3), with 45 drug decreases for asthma and pulmonary disease.

What was the justification given for the price decreases?

The Minister of Health Salvador Illa in the Health Commission held in February of last year specifically stated drugs for asthma and COPD as an example of how the ”new pharmaceutical policy strategy” and the latest framework agreement has saved approximately €30 million (4). ​

On the report, the specific reason provided for every SKU decreases in price was the same across the board – Article 96.2 (3). Under this article, price is modified by ”changes in economic, technical, health circumstances, or in assessment of its therapeutic utility”. Whilst this reasoning appears vague, we are aware of the larger economic incentive in place.​

What does this mean for future price revisions?

The case of asthma and COPD could be indicative of future price revisions by the CIPM, especially for chronic disease products that have the potential to yield a significant amount of savings and ultimately reduce budget impact.
 
The lack of transparency in CIPM price revisions ensues an intense level of unpredictability for pharmaceutical manufacturers in the Spanish market. Arbitrary reductions in price remain a cause of concern despite the observed modest increases in price. When coupled with the recent introduction of the pharmacoeconomic assessment in the reimbursement process (6) and the much expected COVID-19 budgetary pressures, the future of Spain’s pharmaceutical market remains full of uncertainty.
Sources
  1. https://www.funcas.es/wp-content/uploads/2020/10/Sanz-y-Romero_9-5.pdf​
  2. https://www.mscbs.gob.es/profesionales/farmacia/CIPMyPS.htm​
  3. https://www.mscbs.gob.es/profesionales/farmacia/pdf/ACUERDOS_DE_LA_CIPM_198_web.pdf ​
  4. https://www.diariofarma.com/2020/02/27/eficiencia-y-sostenibilidad-guiaran-la-politica-farmaceutica-de-illa ​
  5. https://www.consalud.es/pacientes/epoc-cuarta-causa-muerte-espana-olvidada-sanidad-desconocida-sociedad_88349_102.html ​
  6. https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/2021/IPT_32-2021-Talzenna.pdf?x60265
About the author

Marianna Reyes

Marianna graduated from the University College London with a BSc in Human Sciences, a multidisciplinary biosciences degree. At Access Infinity, Marianna works on Consulting projects such as a CNS opportunity assessment, extensive nephrology landscape researching, and global hepatology value message development and pricing. She also has deep knowledge of Spanish and Swedish price and reimbursement systems.
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MARKET ACCESS IS EASY, THERE ARE ONLY 5 STEPS

MARKET ACCESS IS EASY, THERE ARE ONLY 5 STEPS

As we welcome our 6th director to Access Infinity and take our collective market access experience to well over a century, we have been thinking about what sets us apart as a market access consultancy. Our digital solutions are an obvious answer with many thousands of expert hours going into their design and development (1), allowing us as consultants to work faster, smarter, and more rigorously than we have ever been able before. These are the distilled essence of our ongoing learning in market access. But one of our true differences is our passion for sharing what we have learned about market access with our colleagues and clients. For those setting out on the journey, there are some great foundational training courses, including the very popular CELforPharma foundation course (2), but if you want to build your career in this space, how would you do it?

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The 5 steps to market access mastery:

We work with many talented linguists, and like any new language it’s often useful to connect the words or concepts back to something we understand. Whether you have a background in biosciences or business, maths or marketing, there are some basic forms of the market access language which are familiar. At the most basic level, we bring our experience as consumers of healthcare in our home countries that gives us a solid starting point. Start with what you know and build out from there.

There is a wealth of information out there to learn about market access if you just know where to look. Learning where those facts are, how to quickly access them, and turn them into digestible analysis is invaluable. Knowing how to navigate a 300-page HTA document or the G-BA website in minutes is great, but it is just as important to learn what you would not be able to find there. Find someone to show you around and help you work out what’s important and what isn’t

Once you have looked at the market access landscapes of a few different health systems, HTA processes, assessments or even therapy areas, you will soon start to see patterns emerging. These trends will turn into your own unique set of heuristics to guide and give you an intuition on how to answer some of the trickier market access problems. Build on the patterns and similarities which appear to you and are shared by others.

Healthcare is complicated and the commercial business of healthcare even more so. Every health system has their own way of doing things and they are rarely simple. From the nuances of health economic analyses to the commercial attributes of country distribution channels, a true sign of the skill is not only collecting the similarities but then understanding which differences are important. Try to embrace the complexity, it might seen overwhelming but it is worth it.

Malcolm Gladwell (3) famously and controversially cited the 10,000 hours of practice (4) required for mastery of a skill. In market access consulting terms, this adds up to about 6 years of work in the world of payer insights, evidence generation and commercial planning. The often-under-recognised aspect of this 10,000-hour estimate is that the practice must be deliberate. Therefore, it is not enough to just spend the time, we must be dedicated, focussed, and intentional in our learning so we can apply what we know to the vast range of market access needs faced by the industry. Try to structure your continuing learning, sharing what you know with others is a great way to do that.

Related Links
  1. https://accessinfinity.com/thought_leadership/tools-articles/nuro/
  2. https://www.celforpharma.com/course/understanding-market-access-payers-europe
  3. https://en.wikipedia.org/wiki/Outliers_(book)
  4. https://psycnet.apa.org/record/1993-40718-001
About the author

Nick Proctor

Nick has spent the last 20 years helping pharmaceutical companies meet their development and commercial objectives and in that time he has been fortunate enough to learn from the finest mentors, advisors and coaches in the industry. During his time in price, reimbursement and market access consultancy he has realised that the key to delivering great client work is a great team and a common understanding of the challenges, so Nick is always looking for new ways to help colleagues and clients keep learning about payers and their world. Nick is a tutor, coach and lecturer in market access and has been a member of the expert faculty at CELforPharma for almost 7 years. Nick has a PhD in medicine and pharmacy from the University of Manchester and worked on his postdoctoral research at the University of Sheffield.

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