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Excel tools for Global Pricing and Market Access teams

Post author By [email protected]
Post date February 23, 2023

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 [email protected].

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.

Blog

The 8 Market Access Performance Metrics You Should Be Tracking

Post author By admin
Post date August 24, 2022

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

Post author By admin
Post date August 9, 2022

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

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

Book a demo today and experience the breadth of our apps.

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THE UPS AND DOWNS OF CIPM PRICE REVISIONS

Post author By admin
Post date March 9, 2022
No Comments on 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

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

Post author By admin
Post date March 9, 2022
No Comments on 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?

0 +

years industry experience

0 K

hours pharma experience

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people helped on their market access learning journey

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.

BALANCING A FASTER TIME TO LAUNCH VS OPTIMAL ACCESS: CONDITIONAL MARKETING AUTHORISATION AND HTA BODIES

Post author By admin
Post date March 7, 2022

Generating comprehensive data in rare diseases or chronic progressive conditions, can be challenging often requiring lengthy study durations and very high investment. The European Medicines Agency (EMA) therefore considers granting early market authorisation of a product for seriously debilitating, life-threatening, or rare diseases. Given the current global climate from challenges posed by COVID-19, even more interest has been directed towards fast-tracking regulatory approval. Conditional Marketing Authorisation (CMA) is a regulatory pathway for such diseases that enables timely access to therapies.

Our question is: what are the HTA implications of launching with a CMA?

1. Among the many attributes of these products, our initial exploration was to look at the HTA outcomes for drugs with orphan or for oncology indications.

2. We wanted to take a closer look at those 40 drugs. We categorised them by their orphan designation and clinical evidence packages to see if categorisations commonly sought a CMA.

Of 40 products launched with CMA:

Among non-orphan drugs, majority of the products were for oncology indications
0% have since converted to CMA to SMA, with the average conversion being 4 years
The remaining 70% are still approved for use under CMA

+ 1 Holoclar – a highly specialised stem cell therapy that only had observational clinical studies submitted

3. We did a deep-dive into the HTA outcomes of the 40 drugs that launched via a CMA. The purpose of our analysis was to explore HTA outcomes of CMA products in indicative HTA markets.

Among the many attributes of these products, our initial exploration was to look at the HTA outcomes for drugs with orphan or for oncology indications.

HTA Outcomes achieved by oncology and non-oncology indications that launched with a CMA in FR, DE, and UK

Majority of the products not assessed by respective HTA body are very recent entrants and likely to be assessed in the near future.

In Germany, a clear majority of drugs that were assessed were given ‘not quantifiable’ or ‘added benefit not proven’ as outcomes. The majority of the outcomes are not quantifiable, which may be due to the additional clinical benefit rating in certain circumstances for orphan drugs under AMNOG.

In the UK, more favourable HTA outcomes were observed from the 40 drugs that launched via a CMA in comparison to both France and Germany. Like France and Germany, orphan drugs also achieved more favourable HTA outcomes in the UK as opposed to non-orphan drugs.

Interestingly, the most common HTA outcome in the UK was recommended via CDF, which shows that oncology drugs may be the main driver for CMA products obtaining a favourable HTA outcome. Moreover, the future prospect of an Innovative Medicines Fund for the UK may act in a similar way to the CDF for oncology drugs, opening the opportunity for non-oncology products to pursue a conditional reimbursement route.

HTA Outcomes achieved by Oncology and Non-Oncology indications that launched with a CMA in FR, DE, and UK

Building on our previous analysis of orphan drugs, we decided to take a closer look at non-oncology vs. oncology drugs. The country that exhibited a noticeable difference in non-oncology vs. oncology HTA outcomes is the UK with most drugs recommended via CDF. This proves that oncology drugs launching via a CMA achieve favourable HTA outcomes because of the special considerations of the CDF.

4. We collated the obvious key observations, and we are now prepared to ask the bigger questions.

Our information database allowed us to quickly obtain all the data we needed to complete our analysis exploring links between CMAs on the type of evidence submitted and HTA outcome.

We made five key observations.

All products with CMA were subject to the same degree of evaluation by HTA bodies as SMA. Thus, pharma companies will not be granted a less rigorous process had they already launched via a CMA.
Almost half (44%) of drugs that attained CMA status were drugs that submitted PII clinical trial data. This was expected given that CMAs are used for extraordinary situations that necessitate a drug in the market as soon as possible.
In France and Germany, new product evaluation process do not seem to disadvantage CMA drugs.
In the UK, most drugs were recommended via CDF, noting that oncology drugs launching via a CMA achieve favourable HTA outcomes. The possibility of an Innovative Drugs Fund may have implications for other non-oncological indications. The relatively large proportion of oncology treatments in this sample may be the reason why the UK seemed to grant more favourable HTA outcomes.
If the link between CMA status and HTA outcome is also supported by commercially attractive price decision, this route could be considered as an attractive strategic option alongside access pathways such as the UK’s Early Access to Medicines Scheme (EAMS) or France’s Autorisation Temporaire d’Utilisation (ATU).

Now that we have established our observations, we are now in the position to ask deeper questions. Through our observations, we are able to pinpoint criticalities that will reshape our understanding of the CMA pathway and its implications on HTA and price.

If you are considering launching your drug via a CMA or if you have an orphan drug, reach out and find out more about what we can do for you.

About the authors

Dr. Jesvin Samuel

Jesvin is an immunologist by training, and has 9 years of experience in translational research in haemato-oncology. He has successfully published in leading journals such as NEJM, Blood, and the British Journal of Haematology. Jesvin has transferred his expertise to Consulting with Access Infinity, and has managed numerous global market access strategy projects.

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 both digital solutions and Consulting projects such as a CNS opportunity assessment 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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HOW GARDASIL RESHAPED THE VACCINES MARKET

Post author By admin
Post date March 5, 2022

Generated through leveraging our vaccine expertise from multiple client projects

COVID-19 has enhanced interest in infectious diseases, such that vaccine rollout is seen as the light at the end of the pandemic tunnel. For decades, the vaccine segment of the pharmaceutical industry had been regarded as a market with limited revenue opportunities. However, these myths have been dispelled by novel, high-price products such as Prevnar and Gardasil, illustrating that vaccines have commercial potential with the right strategies in place.

Gardasil, an exceptionally successful example, achieved blockbuster status soon after its market debut. In 2019 alone, Gardasil generated $3.7 billion in revenue (1).

Developed by Merck, Gardasil was the first human papillomavirus (HPV) vaccine to be granted regulatory approval by EMA and the FDA in 2006 (2,3). This approval represented a significant breakthrough in women’s health considering the association with cervical cancer secondary to HPV infection. Gardasil is a quadrivalent recombinant vaccine that spurs production of antibodies against HPV subtypes 16 and 18, which cause approximately 70% of HPV-related cervical cancer cases, and subtypes 6 and 11, which cause about 90% of genital wart cases (4).

In 2015, Merck received regulatory approval for its 9-valent Gardasil vaccine, which includes 5 additional HPV strains (5). The vaccine is widely known as Gardasil 9.

The Gardasil case could potentially offer several lessons for future vaccine launches.

Merck primed the market prior to launch by establishing the link between HPV and cervical cancer through several campaigns such as “Tell Someone”, “One Less”, or “Make the Connection”. By creating awareness amongst healthcare professionals, governments, and the public and simultaneously steering clear of cultural taboos, Merck positioned Gardasil as a cancer vaccine rather than an STD vaccine. This strategy was effective in the early generation of disease burden data, clearly demonstrating the substantial burden of cervical cancer on women and healthcare systems. With such momentum built prior to its regulatory approval in Europe, it received a positive recommendation by all EU5 National Immunization Technical Advisory Groups (NITAGs) within one year of regulatory approval – a considerably shorter time compared with other vaccines launched within the last two decades. (Bexsero was recommended after 3 years, while Zostavax was recommended after 5 years)

Gardasil is one of the most expensive vaccines on the market. Its relatively high price was driven by the vaccine characteristics and value it offers, alongside a robust pricing strategy that encompassed capturing and anticipating health impacts and economic saving. Moreover, Gardasil has a remarkable efficacy of 100% for prevention of HPV vaccine type-related persistent infection. However, it was the protection against genital warts which represented a key differentiating factor against its competitor Cervarix, making Gardasil the preferred product to be reimbursed by payers, so much that in the US, Cervarix was discontinued from the market in 2016.

Merck collaborated with universities and research centres to publish cost-effectiveness analyses up to 3 years prior to regulatory approval in order to demonstrate the reduction of burden of disease and the estimation of the monetary savings. Complex modelling was required due to both the long and uncertain time to cancer development (20‒30 years) and the inability to quantify healthcare expenditure reductions in the near future.

Another reason for the enhancement of the cost-effectiveness of Gardasil was the inclusion of genital warts prevention. Since prior to Gardasil’s launch the economic impact of genital warts was scarce, Merck commissioned health economic consultancies to generate the required evidence.

Finally, Merck engaged with key stakeholders in order to secure public acceptance and widespread vaccine uptake. In the UK for example, the Department of Health commissioned work on knowledge and public attitudes about cervical cancer, HPV and vaccination. The study looked at the parental responses to the introduction of a vaccine against HPV. The work demonstrated that parents were generally very positive about a vaccine to prevent cervical cancer. A crucial factor of these attitudinal studies is that they were not company led, which helped build public confidence on the vaccine safety and efficacy.

Conclusively, by generating the appropriate evidence prior to NITAG evaluation and employing the right stakeholder engagement and pricing strategy, higher priced vaccines such as Gardasil have reshaped a market with historically low margins. The strategies employed by Merck could potentially be leveraged by other vaccines in the pipeline to spur another wave of double-digit growth in the future.

Related Links

https://www.spglobal.com/ratings/en/research/articles/200803-covid-19-may-accelerate-disruption-in-the-global-vaccine-market-11568238
https://www.ema.europa.eu/en/documents/product-information/gardasil-epar-product-information_en.pdf
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/gardasil-vaccine-safety#:~:text=FDA%20approved%20Gardasil%20on%20June,HPV%20types%206%20and%2011.
Braaten KP, Laufer MR. Human Papillomavirus (HPV), HPV-Related Disease, and the HPV Vaccine. Rev Obstet Gynecol. 2008;1(1):2-10.
https://www.ema.europa.eu/en/documents/variation-report/gardasil-9-h-c-3852-p46-0008-epar-assessment-report_en.pdf

About the author

Jona is a UK qualified pharmacist, registered with the General Pharmaceutical Council (GPhC). She holds an MPhil in Management from the University of Cambridge. Jona has extensive experience in the healthcare sector gained through several UK NHS Trusts and rotations within pharmaceutical companies. Jona has transferred her expertise to Consulting with Access Infinity.

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