The value of medicine: opportunities, not threats

Dr Bruce Charlesworth

Mapi Values

We’ve all heard similar phrases, but “activities to overcome market access hurdles” sounds very reactive. It’s as though an unpredictable threat needs addressing. “Improving patients’ lives by informing healthcare decisions” is something we speak of regularly at Mapi Values, and to me sounds more up-beat.

If a new healthcare product really improves lives, and does so at a reasonable cost (perhaps even saving the cost of other resources or therapies) it’s likely to be a no-brainer for decision makers and a great success for many. The trouble is that value demonstration has traditionally been the afterthought of many a healthcare business. It’s not been something carefully considered from the outset, nor studied in the same way as traditional efficacy or tolerability. The value proposition still doesn’t drive the selection and development of pharmaceuticals in the way that it perhaps should.

"…value demonstration has traditionally been the afterthought of many a healthcare business."

So is there a mind-set to address, and are there things to learn from other industries where competition, differentiation based pricing, niche consumers and slim margins have long been the norm? Where the pharmaceutical industry thinks “hurdles and barriers to entry”, the fast moving consumer goods sector (FMCG) sees “consumer and customer needs”. Where healthcare businesses talk of “target populations and indications”, FMCGs seek “brand champions and occasions”. The introduction of a new soap powder, beer or chocolate product into a crowded market is not underpinned by a contrived sounding “market access and payer strategy”, rather it’s supported from the outset by a genuine understanding of consumer (read patient) behaviour and needs, local retailers (read prescribers), supermarkets (read payers) and appropriate legislation (read regulators). Each and every need is carefully addressed using deep insight, generating appropriate information (read evidence), communicating through the right channels, and by working in partnership with every stakeholder. The ideal result is a product with a clear position, and value to all. If you think about it that way, the expectation for healthcare products to prove their worth may be quite reasonable, and in fact long overdue.

Value demonstration

Clearly healthcare products and consumer goods are different beasts, but given the current environment they have never been so similar as regards the requirement to demonstrate value. Given global economic pressures, the rising cost of healthcare provision, and the focus on a much-criticised industry, the approach is no longer “I have a product for the market that is efficacious and well-tolerated”, rather it’s time for a question - “Is there a willing market for my product?” The answer to this requires careful analysis and a dose of realism rather than a decent p-value and minimal side effects from some clinical studies. If the choice of chocolate bars is overwhelming, just another chocolate bar (or even one which is a mirror image of itself) is unlikely to be met with a great reception – especially at twice the cost of its stable mate.

"…just another chocolate bar (or even one which is a mirror image of itself) is unlikely to be met with a great reception…"

Unprecedented changes in the healthcare product market place have resulted in a pharmaceutical world that is fast appreciating the need to proactively and willingly address the needs of multiple stakeholders in bringing healthcare brands to the right consumers (read patients). Doing so requires a change of mind-set, different skills, and (given the technical nature of the evidence required) an ability to bridge the scientific-commercial gap. The demonstration of value to individual patients, public health and, increasingly, the public purse is no longer a nice to have, it’s essential. The value proposition needs to drive regulatory, commercial and development decisions like never before. Investigating, demonstrating and communicating value requires an unusual blend of scientific excellence and commercial acumen and a strategic approach to Insight, Evidence, Tools and Communication.

Insight

Just as competitors, retailers and consumers are key considerations in a new food product launch, patients, prescribers, carers, payers and the existing therapies all need to be understood when it comes to healthcare innovation. It goes without saying that it is essential to understand the market into which the product is likely to launch, but this now goes beyond traditional market research and should ideally be done before the clinical trials are designed. Fitting four seats to a car after building a two-seater chassis is not easy to implement. Value landscaping is a multi-faceted process looking at the competition now and in the future, pre-existing reimbursement decisions, regulatory outcomes, practice guidelines, patient needs and treatment pathways. The process requires a commercially astute but scientific approach, providing a detailed and realistic view of the potential opportunity, the unmet need (or lack of it) and the likely evidence requirements.

"Value landscaping is a multi-faceted process looking at the competition now and in the future…"

Thinking in terms of a Target Value Profile and overlaying the product profile builds a list of Target Value Claims for the product. Strategic literature reviews, structured patient and stakeholder interviews, advisory discussions and decision mapping are all useful techniques to uncover insight early in development and so inform future activities. A realistic Target Value Profile analysis will highlight any potential evidence gaps, inform next steps, and ensure the developing evidence base is ultimately complete and appropriately built. Perhaps even a no-go decision at this stage can be considered if the value landscape is deemed unfavourable. Many a chocolate bar has ended this way.

Evidence

Value demonstration must be evidence-based. With appropriate insight, appropriately compelling evidence can be collected or generated with a well-designed clinical development programme and evidence synthesis strategy. In parallel, and to complement the collection of traditional clinical data, health economics and health outcomes must come into play as early as possible.

These days an array of new techniques such as network meta-analysis facilitates the indirect comparison of clinical trial data, and can be used to generate robust, previously absent evidence, or augment expensive studies. Systematic reviews of the ever-increasing published data can be a valuable source of evidence with the right approach and methods.

In designing and collecting evidence, its acceptability and usability must be considered carefully - for cost-effectiveness and budget impact modelling or HTA submissions, for example. Evidence that traditionally had a purely regulatory audience now needs to address a number of other questions and serve a variety of purposes. It may well even need a real-world slant.

Expertise in the interpretation and presentation of value evidence is critical to ensuring a set of value messages that truly answer payer, prescriber and other customer needs. Such expertise will also ensure that messages are supported by the most comprehensive, robust and compelling scientific evidence available.

"…the days of incorporating a few ‘soft’ endpoints into studies are long gone..."

From a patient (consumer) perspective, the days of incorporating a few ‘soft’ endpoints into studies are long gone, and the science of patient-reported outcomes is now a reality. If the evidence plans include patient-reported outcomes (as they likely should), appropriate instrument selection is critical, and in some circumstances new end-points or a new instrument may need to be properly developed and / or validated according to the latest standards. The rising importance of valid patient-reported data in bringing new products to the market cannot be overstated.

Tools and Communication

Data without a story or framework are just data. Whilst still a useful means of dissemination, the traditional routes of publication and presentation may not reach the correct audience nor represent a strong, holistic product value story. Both during collection and after interpretation the evidence needs to be made digestible, readily available internally and adapted for effective onward use. Compilation into a well-structured and comprehensive value pack and / or dossier provides the basic platform, however it is also important that those further afield are able to access specific evidence that satisfies their stakeholders’ perception of value, in their market, at the right time.

The digital era and new technologies have vastly improved our ability to hold, interrogate and present data. Applications and interactive interfaces with user-adaptable variables can present visually compelling stories of product value, and can be put to use with numerous decision-makers or made publically available. Such tools are replacing the detail-aids of time gone by.

"Data without a story or framework are just data."

The need to trawl through a weighty tome can now also be avoided by making value messages and supporting evidence available through an interactive online platform. This allows the end-user to navigate evidence easily, and to compile reports tailored to support specific value claims. Tools to highlight evidence gaps and to enable the interactive building of ideal product portfolios based on current and future landscapes are fast emerging.

Provided the work up to this stage has been sufficiently insight and evidence driven, the data presentation can evolve in line with reimbursement conversations – supporting and informing specific interactions such as HTA submissions, formulary discussions and more with the same science.

Summary

A lot has changed in the healthcare innovation space over the past few years, particularly in regard to value demonstration. With the patient perspective, health economics, robust clinical evidence and real-world outcomes ever increasing in importance, the need to understand, investigate and demonstrate value has never been higher.

Success is dependent upon an early, critical look at the value landscape, and a change in mind-set. The days of opening a bottle on the granting of regulatory approval should perhaps make way for access-based celebration. Perhaps then development programmes will start to focus on real customer and consumer needs like with the making of our fictional chocolate bar.

With deep enough insight, appropriate evidence, intuitive tools and creative communication the ‘challenge’ of market access can be viewed as an opportunity to shine. That opportunity is to improve patients’ lives with not just innovative products, but with innovative products that have relevant, understandable, universally appreciable, and scientifically proven value.

About the author:

Dr Bruce Charlesworth is Managing Director of Mapi Values UK and the Global Lead for the company’s Value Insight &amp, Communication discipline. He is a medical doctor with 11 years of experience in the pharmaceutical and FMCG sectors across clinical development, general management and marketing.

Mapi Values is a global healthcare consultancy business with offices in the USA, UK, France, Netherlands and Japan. Their passionate people investigate and develop scientific evidence to understand the benefit of healthcare products and services to patients, clarifying and communicating the value to decision-makers.

Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK | Tel: +44 (0) 1625 578870

www.mapivalues.com.

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