Pf Magazine July 2018

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JULY 2018 PHARMAFIELD.CO.UK

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INTRODUCTION

I NTE LLI G E N CE .

I N FO R MATI O N .

TH E I N S I D E VI E W.

ACTING EDITOR

Amy Schofield amy@pharmafield.co.uk C R E AT I V E D I R E C T O R

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The market access challenge

T

oday, effective market access is more challenging than ever. As the healthcare environment constantly shifts and the squeeze of downward pressure on healthcare budgets is felt, the core objective – of making sure that the right patients get the right medicine at the right time – becomes harder to pin down. How do you successfully navigate this shifting landscape?

This, the first of our Pf Magazine Special Editions, addresses the key questions around how to succeed in developing sustainable market access strategies that demonstrate meaningful value while minimising risk.

In the pages of this guide, our industry leaders share their expertise in market access, including why the definition is so hard to agree on; the role of the industry/patient dialogue; the changing landscape, and the range of options open to industry.

While pulling this publication together in consultation with our pharma industry experts, one thing has become clear – there is no single definition of market access, and therefore no single way of ‘doing it right’.

The expert advice and analysis you’ll find in this publication will help you to address your own market access challenges, providing you with additional tools to make sense of the myriad organisations and processes involved in achieving success.

Let us know about your experiences of market access by getting in touch at hello@pharmafield.co.uk. The Pf Team

The information contained in this magazine and/or any accompanying brochure is intended for sales and marketing professionals within the healthcare industry, and not the medical profession or the general public.

Pf Magazine is published monthly. For a free U.K. subscription visit pharmafield.co.uk/subscribe.

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M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 1

CONTRIBUTORS DOUG NIVEN

CRAIG BRADLEY

MONIQUE MARTIN

Craig is currently Brand Manager within Internal Medicine at Shire Pharmaceuticals. Craig has worked for Shire since July 2006 within a variety of sales, marketing and market access roles. Craig has over 15 years’ experience within the pharmaceutical industry and has been the PM Society Market Access Interest Group Lead since May 2016 and PM Society Chair since February 2017 – making him the society’s first chair from a pharmaceutical firm.

Monique is Managing Director, Syneos Health Consulting UK. She has over 15 years’ consulting experience in pricing market access and HEOR and over 20 years’ experience working in the pharma industry. She holds Masters Degrees in pharmacology, epidemiology, health economics and business administration. She is based in Syneos Health’s London office.

H A S S A N C H AU D H U RY

Hassan is a founding director and Chief Commercial Officer at Health iQ. He is an expert in developing real world data solutions, having spent many years at the forefront of informatics, public health and commissioning support for the NHS. He is a member of the Pharmaceutical Health Information Group at the ABPI and a Committee Member of the PM Society.

2 | PH A R M A FI EL D.CO. U K

Doug is Senior Engagement Manager, Pricing and Market Access, Syneos Health Consulting UK, specialising in pricing, market access and asset strategy. Prior to this, Doug worked within PwC’s Healthcare Strategy practice.

Doug holds a PhD in physics from the University of Birmingham and a BSc in economics and finance from the University of London.

F U N M I O LU WA HUW NICHOLAS

With a background in healthcare sales, Huw has spent the last 30 years recruiting for the UK pharmaceutical industry.

Working with the majority of companies in the industry has given him valuable insight into how resourcing of Market Access Specialists has evolved.

He currently works as Executive Solutions Lead at CHASE, recruiting for Marketing/Senior Sales Management roles.

Funmi is Market Access Director UK/Ireland at LEO Pharma.

Funmi previously worked as a biochemistry scientist in the NHS and also held various roles in the pharmaceutical industry including Regional Business Manager and Senior Product Manager. She attained her BSC in Chemistry at Lagos State University, an MSC in Biochemistry from Brunel University, and also has a Business MBA from City University London.

NEIL OSMOND

Neil is a technologist and founder of digital solutions agency earthware, with 20 years’ experience in the healthcare industry. He has a passion for finding solutions to ‘real world’ healthcare problems and loves helping clients dream about ‘the art of the possible’ using technology.

K AT E PY M

Kate Pym is Managing Director of Pym’s Consultancy, developing new and innovative partnerships and working relationships across commercial and third sector enterprises, working closely with commissioners in health and social care. She possesses a thorough knowledge of the health and social care environment including all contributors to patient care, including NHS, carers, third sector, and pharmacists.

TIM RICHARDSON

Tim is Managing Director, Pharma Access to Health. He has extensive experience in Public Health Intelligence and Patient Access Schemes. Tim developed unique skills during his time at the Patient Access Scheme Liaison Unit, hosted by NICE, and offers the most up-to-date knowledge to drive market access needs forward when proposing Patient Access Schemes to gain positive NICE Technology Appraisal Guidance.

MAGA ZINE SPECIAL EDITION

Market Access CONTENTS I N T RODUCT ION

01

Why market access? | Amy Schofield

E N V I RON M E N T

04 Where are we now? PM Society survey findings | Ram Patel 08 What does modern market really access mean? | Hassan Chaudhury 10

Patient access to new medicines: the changing landscape | Tim Richardson

13

Engaging with the wider economy | Kate Pym

14

The ‘biosimilars battle’ | Adelphi Research UK

I N T E L L IGE NCE

16

Greater Manchester devolution – lessons learned so far | Amy Schofield

18

Making the patient the hero of their journey | Neil Osmond

20 Creating a good industry/patient dialogue | Craig Bradley PH A R M ATA L E N T

24 How to create a positive access environment | Funmi Oluwa 26 Are there barriers to market access careers? | Huw Nicholas

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 3

WHO TOOK PART? SURVEY CONDUCTED BY

Ram Patel at Brainsell on behalf of the MAIG

104 IN TOTAL, PROFESSIONALS COMPLETED

the questionnaire

OVERALL,

50% of the participants

ARE CURRENTLY WORKING FOR PHARMACEUTICAL COMPANIES

WHERE ARE WE NOW?

42% of participants

ARE CURRENTLY WORKING IN

MARKET ACCESS OF THESE, 52% ARE WORKING IN

PHARMACEUTICAL

COMPANIES and 48% in agencies

PARTICIPANTS HAVE BEEN WORKING IN MARKET ACCESS

for an average of

The PM Society Market Access interest group (MAIG) recently conducted a needs analysis survey to provide a view of the current market access landscape from an industry perspective and establish their current needs.

The objectives of the survey included determining how well market access is understood (personally and by employer organisation), to assess the variance in perceptions of the definition of market access and determine the main challenges and emerging trends in market access.

4 | PH A R M A FI EL D.CO.U K

10.7 YEARS

11%

of PARTICIPANTS ARE NOT CURRENTLY WORKING IN MARKET ACCESS,

but would like to.

ENVIRONMENT

SURVEY PARTICIPANTS

OTHER

5%

42% YE S

No, but I would like to work in Market Access

PH A R M A CO M PA NY

41% 50% AG EN CY

47% NO

11%

C U R R E NTLY WO R K I N G I N M A R K E T ACC E S S?  Yes  No  No, but I would like to work in Market Access

E M P LOY E R /S E C TO R  Agency  Pharmaceutical company  Other  Medical device company  CRO

HOW WELL IS MARKET ACCESS UNDERSTOOD?

 Personal understanding  Company's understanding

Rating out of 10 (0 = Not at all, 10 = Extremely well/good)

10 9 8

7.35

7 6

6.26 6.28

7.00 5.77

5

6.04

6.71 6.49

5.74

6.04

4.18 4.40

4 3 2 1 0 All (N=104)

Working in Market Access (N=44)

Not working in Market Access, but would like to (N=11)

Not working in Market Access (N=49)

Pharma (N=56)

Agency (N=48)

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 5

ENVIRONMENT

The main challenges facing participants currently working in market access are:

The definitions of

MARKET

ACCESS are extremely varied,

WITH THE MAIN THEMES EMERGING AS:

Budget / pricing pressures

Access to key decision makers (e.g. heads on medicines management within CCGs)

PATIENT ACCESS to the right medications

RE-IMBURSEMENT AT NATIONAL AND/OR REGIONAL LEVELS

OPTIMISATION of

OPPORTUNITIES Constantly changing NHS structures and responsibilities

Inertia within NHS and reluctance to engage

Removal of policy barriers

COMPANY SUPPORT LEVELS FOR MARKET ACCESS ACTIVITIES 10

Rating out of 10 (0 = Not at all, 10 = Extremely well

9 8 7 6 5

6.51

7.27

6.11

6.93

4

3.45

3 2 1 0 All (N=55)

6 | PH A R M A FI EL D.CO.U K

Working in Market Access (N=44)

Not working in Market Access, but would like to (N=11)

Pharma (N=28)

Agency (N=27)

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What does modern market access really mean?

WORDS BY

Hassan Chaudhury

8 | PH A R M A FI EL D.CO.U K

I

come at the topic of market access as a relative outsider because I began my career working in health and social care and eventually as an analyst in NHS Informatics, Commissioning and Public Health.

I have never worked for a pharmaceutical company. I’ve never ‘carried the bag’ or launched a drug. So when I first heard the phrase, I was stumped.

I’ve had the opportunity to reverse engineer what market access means to various people from discussing their challenges; I soon discovered that it meant different things to different people.

S H I F TI N G D E F I N ITI O N S Years ago, some thought market access primarily meant securing Health Technology Assessment (HTA) approval from NICE or similar. For others it was more about the many tactical local battles to win key opinion leaders (KOLs), get a drug onto formularies and getting ‘pullthrough’. The more experienced were clear market access wasn’t just a part of their commercial strategy but actually was their commercial strategy. They believed they had to encompass every relevant factor that could act as a barrier from helping the system to adapt to a particular form of drug delivery to finding incentives that meant everyone could win, to writing template business cases. I came to the conclusion that none of them was wrong, but each answer was incomplete without the other.

It was like the Sufi parable of the elephant and the blind men. If they encountered an elephant for the very first time and each attempted to learn about it by touch alone then each would come to a different conclusion. The experience of one touching the tusk would differ from one holding the trunk, the ear, the leg or the tail.

Market access is similar in that different perspectives are inevitable based on each person’s role. The experiences of head office teams will differ from field-based teams, and so on.

ENVIRONMENT

THERE IS NO ONE DEFINITION FOR MODERN MARKET ACCESS – WHAT DOES IT MEAN TO YOU?

DIVERSE EXPERIENCES This is even more true in the UK because of the fragmented and ever-changing nature of our healthcare system. The agenda to devolve power has led to Devo Manc in Greater Manchester. We already have Regional Medicines Optimisation Committees (RMOCs), and successful Sustainability and Transformation Plan (STP) footprints are morphing into Integrated Care Systems (ICSs). This is leading to pharma increasingly focussing on regional marketing.

I recently met some visiting American market access experts who could not get their heads around the fact that there was so much regional divergence in a single payer system. They left the UK wondering if the only national thing about the NHS is the name.

It’s not just the organisations. The processes too are incredibly diverse. What route should one take for reimbursement? Via NICE? Specialised commissioning or via Clinical Commissioning Groups (CCGs)? What about Patient Access Schemes (PAS), the Cancer Drugs Fund (CDF) or the Early Access to Medicine Scheme (EAMS)? With such a disjointed system and so many possibilities, there’s no wonder people have diverse experiences and therefore understandings of what modern market access entails.

N O O N E S I Z E F IT S A L L The PM Society has long acted as an impartial forum for marketing professionals to meet and network. It relaunched its own Market Access Interest Group (MAIG) because the only way to grasp the concept is to have a multi-functional and multidisciplinary group form around the topic.

The MAIG is filled with a range of people interested in market access with experts in head office and field-based market access, brand teams, agency suppliers and consultants. I was fortunate to be involved when the MAIG surveyed market access professionals about their views (see pages 4 and 5). I asked if respondents could provide their own definition of what market access means. The results were surprising. There was no consensus on the definition at all.

None of the 93 responses matched each other. We found that we could generate a new definition taken from the 93 replies that matched the average response length of 23 words if we ignored all the common words, for example the, and, or, and so on. We came up with the following: ‘Ensuring patients receive appropriate treatment at the right time and right price, working with the local/regional NHS and their processes based on value.’

It was interesting to compare it to the existing PM Society definition: ‘Principally market access involves preparing a positive environment which supports uptake of your product and demonstrating the ‘value’ of your product to the range of customers who influence uptake. Strategically, market access is about packaging data in the right way, for the right customer at the right time.’

We found that the new definition was similar but there were fewer mentions of a positive environment in our survey and much more around processes. While there is still no single ‘one size fits all’ definition, the emphasis on processes hints at how market access professionals are having to be less creative and stick to formal processes as they adjust to the numerous and weighty changes to the NHS landscape.

It could well be that this shifts back again so the MAIG will rerun the survey to help track the changes. All we can say for sure is that it isn’t an easy area to define and it will shift subtly in emphasis as the system shifts. We at the MAIG look forward to seeing how it will change.

Hassan Chaudhury is Chief Commercial Officer & Co-Founder, Health iQ. Go to healthiq.co.uk

“ Different perspectives are inevitable based on each person’s role”

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 9

Perpetual motion In a constantly changing market access landscape, industry has a greater range of options. But do these complicate the route to market further?

THE LINGO Centre for Health Technology Evaluation (CHTE): Develops guidance on use of new and existing treatments within the NHS, including medicines and medical technologies.

Commercial Access Agreements (CAAs): The standard way for pharma companies to make cancer drugs cost effective for the NHS. Managed Access Arrangements (MAAs): Consist of two components – a data collection arrangement, and a commercial access agreement.

Multiple Technology Appraisals (MTAs): Usually covers more than one technology, or one technology for more than one indication.

Patient Access Scheme (PAS): Pricing agreements proposed by pharma companies to enable patients to gain access to high cost drugs.

Patient Access Scheme Liaison Unit (PASLU): Set up by NICE to work with companies considering a patient access scheme for their drug or treatment, to assess if it’s one that would work in the NHS. Single Technology Appraisals (STAs): This process assesses a single drug or treatment; usually new pharmaceutical products or license extensions for existing products.

WORDS BY

Tim Richardson

10 | PH A R M A FI EL D.CO.U K

T

he market access landscape has changed substantially since the introduction of NICE in 1999 and the Pharmaceutical Price Regulation Scheme (PPRS, 2009, updated 2014). Increasingly formalised pricing mechanisms were introduced in the PPRS in 2009 to allow a range of options to industry, including patient access schemes.

The core focus of NICE at the start of its existence, in particular the Centre for Health Technology Evaluation (CHTE), was on Single and Multiple Technology Appraisals (STAs and MTAs). These still form the backbone of the CHTE work-streams, albeit mostly STAs. The current position for the NHS is that no Patient Access Scheme (PAS) should be required and if so, then it should be a simple discount, except in exceptional circumstances.

Historically these schemes evolved from less structured and robust offerings, to the current situation with simple discount (confidential upon request) and complex schemes being available. However, the introduction of NHS England also brought Commercial Access Agreements (CAAs) and Managed Access Arrangements (MAAs) around 2016, and the range of options in the future look to be even more innovative, albeit with simplicity at their core, relative to complex PAS. The patient access scheme liaison unit (PASLU) was introduced in 2009, to provide the Department of Health (DH) with an independent and robust PAS review mechanism.

PASLU provided the DH with advice, upon which the DH was able to recommend, or not, a PAS for ministerial approval. This arrangement changed on 1st January 2018, with NHS England becoming the new customer for PASLU, and instead of ministerial sign-off, senior NHS England staff now undertake this task.

26 FEB 19 9 9

JA N 2009

OCT 2009

NICE established

PPRS formally introduced, including PASs

PASLU established

2011

Cancer Drugs Fund established

ENVIRONMENT

NUMBER CRUNCHING

“ A necdotally, there is a greater preference for simple discount schemes to be proposed than previously”

CAA

S I M P L E D I S CO U NT S The number of appraisals with an operational PAS has increased over time and the PAS-type moving between Simple Discount, to Complex, and back again, with the majority being implemented in the oncology disease area (see chart).

There are many reasons for this, including industry concerns of confidentiality, commercial viability of offering a simple discount, as well as the stronger stance by DH, PASLU and NHS England, that simple discounts in themselves should only be offered in exceptional circumstances.

Anecdotally, there is a greater preference for simple discount schemes to be proposed than previously. However, as long as the complex scheme option is available through the PPRS (2014), due for review this year, industry still has the option to propose complex scheme submissions when these are more appropriate to address the NICE cost-effectiveness hurdle. This is important, because complex schemes are more appropriate to address uncertainty in the clinical data when modelled to a specific time horizon, than simple discounts (cost focused).

The change of customer from DH to NHS England raises a number of questions, in particular the change in focus that may be placed upon PASLU. To clarify, NHS England take an equally firm position as the DH, however they are known to negotiate and be more directive in approach.

5% Complex

13%

81% Simple discount

CO U NT O F T Y P E  Simple discount  Complex  Commercial access agreement (CAA)

121 20 8

Data relates to the period October 2009 to the most recent published on the NICE website, approx. April 2018.

6% Respiratory

54% Oncology

Optometry

7%

Arthritis

15%

DISEASE AREA  Oncology  Arthritis  Optometry  Respiratory  Dermatology  MS  Liver and Kidney  Highly Specialised  Bowel  Haematology  HST  Other  Other Auto-Immune  Hormonal

80 23 11 9 6 4 4 3 3 2 1 1 1 1

Disease area relates to the product indication to which either a CAA or PAS would apply.

APR 2 0 13

JA N 2014

2016

NHS England established

Updated PPRS published

CAAs and MAAs introduced

2 9 J U LY 2016

1 JA N 2018

New CDF established (NICE)

Charts, timeline and ‘The lingo’ descriptions adapted from information available at nice.org.uk

PASLU customer changed from DH to NHS England

2018

PPRS (2014) review due for PPRS (2019)

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 1 1

ENVIRONMENT

Market Access Arrangements

MAAs

Commercial Access Agreements

Patient Access Scheme

CAAs

PASs

?

THE COMPLICATED ROUTE TO MARKET

U

p to this point, the options to improve the cost effectiveness of a product being reviewed by the NICE TA process were relatively simple; PAS or no PAS. The introduction of Commercial Access Agreements (CAAs) and Market Access Agreements (MAAs,) around 2016, provided additional options for industry to propose more innovative mechanisms by which to gain positive NICE TA Guidance.

These are agreements that are submitted, reviewed and approved through NHS England, which like PASs, can be taken into consideration by the NICE Technology Appraisal committees.

When industry proposes CAAs, like simple discount PASs, it is possible for them to request that the details of the CAA remain confidential. Although details of

1 2 | PH A R M A FI EL D.CO.U K

CAAs, MAAs and all PAS-types remain confidential during the review period, this is not the case when they are included in NICE TA guidance. Only CAAs and Simple Discount scheme details can remain confidential in the NICE guidance, when it is published on the NICE website.

The introduction of the Early Access to Medicines Scheme, the Accelerated Access Review, the Budget Impact Test, Highly Specialised Technologies programme at NICE, and numerous other options, create opportunities and challenges to the uptake of new medicines. These new options to industry have assisted with speedier uptake through the NICE review, however it has provided a greater range of options to industry and complicates the route to market further; which option does industry choose?

FU T U R E G A Z I N G A key driver for more innovative approaches comes from ground-breaking regenerative therapies, such as CAR T-cell therapy, when treatment is administered once. If a patient remains in remission for more than five years, they are considered cured.

The co-authored report ‘Exploring the assessment and appraisal of regenerative medicines and cell therapy products’ (University of York and NICE, 2016) explored a hypothetical scenario in which the new regenerative treatment of CAR T-cell therapy could be reviewed satisfactorily through the current NICE TA processes and potential new innovative pricing mechanisms, outside of the current options. One option that was considered to have promise was a leasing model.

“ More innovative approaches may be required for routinely commissioned treatments” While a conventional leasing model would spread the cost of obtaining a product, it encounters a range of barriers, namely the standing operating protocol and standing financial flows within the NHS. This is because the flow of money through the system has to follow that of the products (the treatment). However, with CAR T-cell treatment, a leasing arrangement would mean that there would be a one-off treatment, but future flows of money through the system against which no ‘new’ product is being purchased and allocated against that money.

While CAR T-cell therapy is likely to be provided only by a small number of specialist centres, this would not be the case for less specialised treatments, and more innovative approaches may be required for routinely commissioned treatments that are expensive upfront and approved through the NICE Technology Appraisal process. This raises the key questions about how innovative industry can be allowed to be, compared with the potential complexity of that innovation and whether or not they can be implemented by the wider NHS. In addition, the current ability for the NHS to collect and maintain a data recording system for such an approach would place substantial additional and disproportionate administrative burden on the NHS treatment centres. Tim Richardson is Director, Pharma Access to Health Ltd. Go to pa2h.co.uk

ENVIRONMENT

WORDS BY

Kate Pym

A broader perspective Pharma really has to start to engage beyond traditional organisations; some companies are ahead of the curve on this but if those who are behind the curve don’t catch up, they will be left behind.

M

arket access does not begin and end within the NHS and private healthcare providers; the principle of market access is to take a broader, more lateral perspective.

Following the process from sales to market access, the focus changes as companies seek to engage with key stakeholders moving further and further up the decisionmaking process. From working with doctors, healthcare professionals and business unit managers, the focus expands to include NHS Commissioners, Health and Wellbeing Boards, and Social Care Commissioners – to name a few.

W H Y LO O K F U R TH E R A F I E L D? With Brexit looming, the associated uncertainties for the UK economy, and the call for change that the Brexit vote demonstrated, the Government has been working on post-Brexit policy and producing key documents, specifically The Industrial Strategy and the Life Sciences Sector Deal.

The Green Paper, Building our Industrial Strategy, identified 10 pillars, including: • The first: Investing in science, research and innovation – we must become a more innovative economy and do more to commercialise our world leading science base to drive growth across the UK • Supporting businesses to start and grow • Improving procurement • Cultivating world-leading sectors • Creating the right institutions to bring together sectors and places.

All the pillars show the potential for a positive impact on accessing markets for new products and services, and growing life sciences businesses.

The White Paper went further: identifying the importance of life sciences to the UK, not just economically, but in the opportunities it offers for employment, equality, life expectancy and quality of life, naming multiple pharmaceutical companies within the document as key drivers for UK growth. The Government saw this sector as so important that the first Sector Deal was for Life Sciences.

“So what?” you might ask; why does this change anything for pharmaceutical market access? Industrial Strategy documents also highlighted other potential collaborations and interfaces where company growth can be improved.

ACC E S S TH R O U G H U N I V E R S ITI E S We have world-leading universities in the UK, that have excellent resources for R&D and a history of great innovative ideas. However, we are not capitalising on this resource to its full potential, restricting the flow of innovations coming to market. Businesses are not regularly and systematically engaged to partner with universities, sharing knowledge and networks in a way which would build revenue growth for both sides.

Universities are evaluated on their impact – with a strong focus on regional economies and populations. For example, the recent funding call ‘UK Research and Innovation strength in places fund’ – took a place-based approach to research and innovation funding, to support significant regional economic growth and offering up to £50 million per application.

Universities want to talk to companies local to them, especially life sciences – but may be struggling to find out how. Now is the time to reach out to their business engagement and technology transfer teams. They can provide access to networks of clinicians and academics often inaccessible to general company representation.

CO NTI N U E D G R OW TH Academic Health Science Networks, Local Enterprise Partnerships (responsible for writing and delivering Regional Industrial Strategies), and the Department for International Trade all see pharmaceutical companies as key to meeting their targets and objectives.

They each have a remit of expanding access to markets for innovation and building internal and external investment, and so are being paid to help UK-based businesses grow.

Kate Pym is Managing Director at pymsconsultancy.co.uk

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 13

B I OS I M I L ARS VS O R I G I NATO RS

The Biosimilars Battle In 2017, Adelphi published research around biosimilars to assess the overall impact on patients, payers and physicians, along with the commercial implications for pharma. Although things are constantly moving on, some interesting insights emerged.

While traditional market access has been about new product entities and new indications, as the biosimilar market develops the market access landscape is also changing much faster than ever before.

Why is this dynamic changing and how and where are biosimilars already impacting on our UK market?

PE RS PEC TIVE S TO CO N S I D E R

THE PRICE

ADVANTAGE

PAYER S

PATI ENTS

BIOSIMILARS

of a biosimilar over originator IS TYPICALLY AROUND

30% 89% of UK PAYERS now positively

PH A R M A

PHYS I CI A N S

ENDORSE use of biosimilars

ACROSS A RANGE OF THERAPY AREAS

1 4 | PH A R M A FI EL D.CO.U K

ENVIRONMENT

THE IMPACT ON PHARMA

1.

Originator brands are cutting prices and making significant cuts to Beyond the Pill services to enable discounted prices.

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Companies are rigorously defending their own branded biologic patents while also developing biosimilar versions of competitors to take to market.

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Many major pharma companies are investing themselves in the development of biosimilars.

AR E A S WH E R E B I OS I M I L ARS HAVE B E E N AC TIVE LY E N D O RS E D

USAG E O F B I OS I M I L ARS

37%

SW ITC H PATI ENTS

ASK YOURSELF Is your value story right?

What evidence are payers looking for?

How can you differentiate your offering?

44% N E W PATI ENTS

19% B OTH

With thanks to Adelphi Research UK for use of material. Adelphi Research is a healthcare insight consultancy specialising in UK market access research.

For more information please email aruk@adelphigroup.com Go to adelphiresearchuk.co.uk

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 15

WORDS BY

Amy Schofield

CLOSING THE GAP DEVOLUTION INVOLVED

10 BOROUGHS

12 CCGs AND 15 NHS TRUSTS – WITH A BUDGET OF AROUND

£6BN

Dynamic devolution What has Greater Manchester’s devolution achieved in terms of benefits to pharma’s market access activities?

I

t’s two years since Greater Manchester (GM) took control of its £6bn health and social care budget, following the deal struck in February 2015 to become the first English region to gain control of its health spending.

This immense devolution project involved 10 boroughs, 12 CCGs, and 15 NHS Trusts – with a budget of around £6bn. The aim of devolution was to better respond to local people’s needs, by using their experience to influence spending plans. According to the Greater Manchester Combined Authority, the result would be to ‘close the gap between those with the best health, and those with the worst’. But what did this mean for pharma?

Speaking at a webinar last year, Peter Rowe, Deputy Chairman of East Lancashire NHS Trust, said that the new environment had great potential benefits for industry: “Potentially GM could really be the test bed for things that you’ve wanted to do for years, which is to improve the value of your medicines, and prove the case that innovative use of medicines can make a difference to health outputs in the real world.”

The Greater Manchester devo team engaged with pharma companies by joining forces with the ABPI, EMIG and various other bodies in the pharma industry to sign a ‘Memorandum of Understanding’ (MOU), which would answer the many questions that industry had.

What is now happening on the ground in Greater Manchester, and how is it affecting pharma’s customer relationships and market access at a local level?

16 | PH A R M A FI EL D.CO.U K

HEALTH POORER IN GREATER MANCHESTER IS

than the UK average MORE THAN TWO THIRDS OF

EARLY DEATHS IN THE REGION ARE CAUSED BY

SMOKING ALCOHOL DEPENDENCY, POOR DIET AND AIR POLLUTION

BY 2021

1300 DEVOLUTION AIMS TO ACHIEVE:

fewer people dying from cancer 600 FEWER PEOPLE DYING FROM

HEART DISEASE

580 fewer people dying from

LUNG DISEASE Source: Greater Manchester Health and Social Care Partnership. Go to gmhsc.org.uk

INTELLIGENCE

W H AT H A S B E E N AC H I E V E D? James Roach, Managing Director, Conclusio Limited, is a firm believer in the need to open up a new and more impactful dialogue between the NHS and industry. He led the development of the business case and service strategies on Greater Manchester for integrated COPD and Hepatitis C elimination. He worked closely with industry partners and was able to see first hand the positive impact that the ABPI and wider industry MOU had.

He noted that, in general terms, devolution has so far achieved: • integrated delivery partnerships across pathways of care • an ambitious focus on the wider determinants of health such as housing, education and commitment • a political commitment to prevention and eradication • improved health outcomes for the population • more sustainable financially efficient service provision.

“ A ll pharma, whatever their size, scale and specialty, have a real opportunity now” “ W hat we are effectively seeing is a commitment to transition the perception of pharma from supplier to partner” A S E AT AT TH E TA B L E Devolution positively affected pharma’s customer relationships at a local level, says James: “The main impact is positive and what we are effectively seeing is a commitment to transition the perception of pharma from supplier to partner,” he explains. “There is a real recognition that beyond the product itself, pharma has speciality experience and expertise that can be a much-needed catalyst for change.”

James says that behind the rhetoric of the MOU, the partnership has true value.

“This is not just warm words; all of this positive engagement and commitment by the industry MOU that was agreed with the ABPI gives the partnership status, provides industry with a seat at the table and binds the partnership in real terms.”

E N G AG E M E NT W ITH P H A R M A The GM devolution team has engaged with pharma companies in a number of ways says James, including: • mapping service provision and patient journey to understand constraints and delays in pathways of care, helping both commissioners and providers to maximise efficiency from funded services. This has been undertaken successfully in the Hep C Elimination programme in Greater Manchester • focused education and training, in particular, upskilling clinical professionals and supporting them to optimise the benefits of therapy • aligned project management resource • provision of technology • providing the real world evidence to support the longitudinal case for change • pump priming IT innovation.

A D D E D VA LU E The GM devo project can also improve the value of a company’s medicines, as Peter Rowe predicted. “Education about the medicine and its impact can then lead to standardisation of good practice and improved outcomes for patients and the wider health and social care system,” explains James. “One example, in relation to COPD, has been the development of the Greater Manchester Medicines Management Group guidelines for COPD which will standardise the use of approved medications, supporting patients to manage their condition in community settings, improving their health outcomes and potentially saving commissioners circa £5 million per annum.”

This approach has an enormous benefit to market access activities, he adds: “This has the potential the change the dynamics of the relationship and give pharma the opportunity to demonstrate its value ‘beyond the pill’, and its commitment to helping health and social care systems achieve their objectives. All pharma, whatever their size, scale and specialty, have a real opportunity now.”

Conclusio Ltd’s area of focus is developing integrated care systems and approaches across the NHS, working closely with industry on a number of levels.

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 17

The hero’s

JOURNEY How can market access enable every patient be the hero of their own journey? Popular films and ancient mythology may hold the answer.

WORDS BY

Neil Osmond

18 | PH A R M A FI EL D.CO.U K

C

ould market access be comparable to the Force in Star Wars, or any Disney, sci-fi, or Harry Potter film? When thinking about The Force, for example, the question in your head may be: “How can you compare the ethereal, imaginary, fictional bonds between all nature to the detailed, scientific, serious work of market access?” Suspend your disbelief for a few minutes and I will take you on a journey of discovery.

The comparison can apply to any film with a hero’s journey at the heart. In his book ‘The Hero with a Thousand Faces’, published in 1949, Joseph Campbell suggests that important myths from around the world conform to a monomyth he describes as: ‘A hero ventures forth from the world of common day into a region of supernatural wonder: fabulous forces are there encountered and a decisive victory is won: the hero comes back from this mysterious adventure with the power to bestow boons on his fellow man.’

Campbell outlines the stages in a hero’s journey (Departure, Initiation and Return), and the common character types (from Mentors to Villains) and characteristics (for example obtaining a gift, or elixir). While Campbell was examining myths and fairy tales – from Prometheus and the Odyssey up to 1949 – many have observed that more modern books such as Watership Down; films including The Lion King, The Matrix, Harry Potter, 2001: A Space Odyssey and Star Wars; TV series such as Lost; and even computer games like Journey, follow the fundamental structures outlined by Campbell.

There are many ways that Campbell’s work has been represented, using different terminology, character archetypes and so on over the years.

TH E B I G G E R P I C T U R E But what has this got to do with market access? My view is that in the delivery of market access tasks and the creation of market access functions over the last 20 years, since NICE was launched in 1999, we may have at times lost sight of the bigger picture. Or, as Mel Walker, Regional Vice President, Innovation, Business Development and Market Access for Otsuka Europe puts it: “The whole premise of a market access function (is) to remove any barrier that prevents the right medicine being available to the right patient at the right time. When you strip away all the models, data and formularies, we need to help every patient to successfully navigate their own personal journey through the healthcare system to a successful outcome.”

What if we took a moment to see market access not as a siloed set of capabilities such as HTA, Government and Public Affairs, Health Economics, Pricing and so on, that seem designed around the needs of the payors and healthcare professionals?

What if we saw the role of market access as one to enable the patients to become the heroes of their own healthcare journey?

It may appear a subtle distinction but what if market access functions were less concerned about what they do and how they do it, and more about WHY they do it?

Or as Simon Sinek puts in in his book ‘Start with the Why’: ‘It’s not just WHAT or HOW you do things that matters; what matters more is that the WHAT and HOW you do things is consistent with your WHY.’

INTELLIGENCE

“ Maybe the role of market access is less about ‘making heroes’ and more about preventing ‘nearly heroes”

W H AT I S YO U R ‘ W H Y ’ ?

When searching for ‘the purpose of market access’ in Google, the first result I clicked on said: ‘To understand the needs of all stakeholders involved in the adoption, positioning and funding of your product and to develop messages that improve its chances of success.’

Does this sound right for your organisation? While functionally accurate, and no doubt well founded, I am not sure I would class this as terribly inspiring. What would a market access group look and behave like if they were all aligned behind a ‘WHY’ such as: ‘To fight for the right for every patient to be the hero of their own personal health story.’ Perhaps the journey would look something like this:

THE HERO’S JOURNEY IN MARKET ACCESS

C H A R AC TE R S

NORMAL LIFE

Unaware of health issue, fear or resistance until visit to HCP

RETURNS A HERO

Protagonist: Mentor: Ally: Patient HCP Carers Shapeshifter: Villain: Friends/family Funders

Operation or completion of treatment, mastery of condition

Commitment to diagnosis and treatment

Operation or completion of treatment

Elixir: Medicine

TRIGGER

D

New world

W

IN

TH

New life

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AT

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ORDEAL

Adherence challenge

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TA S K S

Life changes to accommodate treatment

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Normal life

R

E

SH

TR I A L S

Side effects HERO DISABLERS 

H

Evidence  Environmental  Funding  Equipment  Clarity  People

ave you noticed that no one writes stories, or releases films, about the people who fall along the journey – the ‘nearly heroes’.

Yet for so many patients, through limited access, information, funding and awareness combined with adherence and circumstantial challenges, they fall by the wayside.

Maybe the role of market access is less about ‘making heroes’ and more about preventing ‘nearly heroes’.

As a digital specialist, it is becoming

HERO ENABLERS

Health economics  Real world data  Pricing  Digital specialists  Key accounts  Government affairs



increasingly clear that market access will become increasingly digitised over the coming years as artificial intelligence changes diagnostics, chatbots change access to information, and real world data enables personalised risk stratification. I believe those companies that embrace the challenges of personal, dynamic patient journeys and see these as an opportunity for market access to do its best work will rise above those that cling onto market access being a function.

In these new, evolving, digitally enabled experiences will market access be the Mentor, the Ally, the Villain or potentially, the Enabler – or the Force – behind the changes in the health journeys for patients?

Neil Osmond is a Technologist and Founder of earthware, a digital healthcare agency. Go to earthware.co.uk Joseph Campbell. The Hero with a Thousand Faces.

Princeton: Princeton University Press, 1968, p. 30 / Novato, California: New World Library, 2008, p. 23.

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 19

“Patient centricity has moved from a buzzword to a concept embedded in many organisations”

TWO WAY

STREET

WHAT IS THE ROLE OF THE INDUSTRY/PATIENT DIALOGUE IN MARKET ACCESS?

WORDS BY

Craig Bradley

2 0 | PH A R M A FI EL D.CO.U K

he UK market access landscape is constantly evolving with environmental developments, pricing and reimbursement challenges, regulatory changes, customer financial pressures, and innovations through new technology.

However at the heart of the pharmaceutical industry remains the need to develop and communicate a medicine’s value proposition to all relevant stakeholders from macro to micro level in order to ensure that our true customer, the patient, receives the greatest benefit.

The last few years have seen a genuine move toward patient centricity as the industry has realised the benefit of the informed, educated and motivated patient. However is there still more that can be done to understand the pharma/life sciences industries-patient dialogue and its role in market access, becoming truly patient centric?

INTELLIGENCE

PATI E NT E N G AG E M E NT A PM Society patient engagement survey 1 in October 2017 found that 100% of the respondents felt that there was more that pharma could be doing to engage with patients, whilst 89% believed a patient-centric approach was extremely important. As a follow up, a recent PM Society report 2 highlighted that there is also a real need to engage patients not only in commercial and patient support programmes, but also in research and development, clinical trial design and market access communications.

Patient centricity refers to the process of developing improved healthcare outcomes through direct engagement with patients – in the UK within the frameworks set out by the ABPI/PMCPA3 and MHRA 4 . Patient centricity should be focused on: • understanding the patient’s experience of their condition • the treatment journey that the patient has to take • their pathway of touchpoints with healthcare providers and healthcare professionals along the way • most importantly, what the individual patient’s values and needs are.

Historically the product-based pharmaceutical culture has not necessarily been aligned with the more agile and responsive patient centric culture. However, patient centricity has moved from a buzzword to a concept embedded in many organisations, resulting in them engaging differently with patient and carer groups and representatives. There are numerous ways the pharma/life sciences industries can hold dialogue with patient and carer groups and patients for mutual benefit.

C R ITI C A L I N P U T From an access perspective, patients are now more involved than ever, with patient groups and patient responses involved in UK health technology assessments, in particular in the rare disease sphere, whilst payors are increasingly accepting evidence in the form of patient-reported outcomes and quality of life/carer burden measures.

There is increasing recognition from regulatory bodies that patient input is critical to informing clinical decision-making processes and the management and treatment of patients to help, while also aiding in the evaluation of novel medical interventions. With regard to health technology assessment and patient centricity in Scotland, the Scottish Medicines Consortium has the Patient and Clinician Engagement5 (PACE) process for either end of life treatment or very rare conditions.

The main part of PACE is a meeting which brings together patient representatives with healthcare professional experts which allows a discussion on the benefits of a medicine, including how it can impact the quality of a patient’s life – potentially capturing feedback and information which may not always be fully captured within the conventional assessment process.

For the rest of the UK, patient carer organisations can register with NICE as consultees for technology appraisals or an independent motivated patient can feedback on appraisals via the NICE website during public consultations6. Decisions regarding treatment reimbursement are becoming increasingly dependent on the demonstrated value of medicines not just to healthcare providers but also to patients.

P O S ITI V E PA RTN E R S H I P S Obviously when patient engagement is considered it is vital to ensure compliance frameworks are adhered to. This includes ensuring that campaigns include a clear declaration of sponsorship, that sponsorship of patient organisations is listed on the pharmaceutical company website, and all third parties are informed of their compliance responsibilities. To overcome historic misconceptions around patient group engagement by the pharmaceutical industry, any related activities must have clear rules for engagement and mechanisms in place to ensure transparency. When executed well and with the intention of improving outcomes and value for patients, working in partnership with patients and patient organisations can ensure a positive result for all involved.

J O I N TH E CO N V E R SATI O N At the PM Society, the Patient Engagement Interest Group is focussed solely on the pharma/life sciences industries-patient dialogue and seeks to explore and support initiatives to improve the way in which we involve patients in the decisions, strategies and policies that shape their healthcare.

With patient centricity being a major focus for the industry this group is invaluable for anyone wishing to be involved in sharing best practice initiatives and success stories relating to patient engagement. Check out the PM Society website to get involved and join the conversation!

Craig Bradley is Brand Manager Shire, PM Society Chair & PM Society Market Access Interest Group Lead.

R EFER EN C ES : 1. PM Society. 2017. PM Society Patient Engagement Interest Group. [ONLINE] Available at: https://pmsociety.org.uk/article/patient-engagement-survey-results. [Accessed 8 June 2018].

2. PM Society. 2018. PM Society Patient Engagement Interest Group. [ONLINE] Available at: https://pmsociety.org.uk/uploads/files/Empowered%20patients%20improve%20outcomes%20 March%202018.pdf. [Accessed 8 June 2018].

3. The Prescription Medicines Code of Practice Authority (PMCPA). 2016. Welcome to the Interactive ABPI Code of Practice for the Pharmaceutical Industry 2016. [ONLINE] Available at: http://www.pmcpa.org.uk/ thecode/InteractiveCode2016/Pages/default.aspx. [Accessed 8 June 2018].

4. Medicines and Healthcare products Regulatory Agency (MHRA). 2014. The Blue Guide advertising and promotion of medicines in the UK. [ONLINE] Available at: https://assets.publishing.service.gov.uk/ government/uploads/system/uploads/attachment_data/file/376398/Blue_Guide.pdf. [Accessed 8 June 2018].

5. Scottish Medicines Consortium (SMC). 2017. PACE – Patient and Clinician Engagement. [ONLINE] Available at: https://www.scottishmedicines.org.uk/files/PACE/PACE_factsheet_0417.pdf. [Accessed 8 June 2018].

6. National Institute for Health and Care Excellence (NICE). 2018. Patient and public involvement policy.

[ONLINE] Available at: https://www.nice.org.uk/about/nice-communities/public-involvement/patient-andpublic-involvement-policy. [Accessed 8 June 2018].

7. PM Society. 2017. The PM Society Market Access Survey 2017 Results. [ONLINE] Available at: https:// pmsociety.org.uk/article/the-pm-society-market-access-survey-2017-results. [Accessed 8 June 2018].

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 2 1

ADVERTORIAL

WORDS BY

Monique Martin & Doug Niven

COUNTING THE COST: High-cost orphan drugs in Europe – a ray of hope or a bottomless pit?

“Over the years we have seen a gradual but sustained increase in prices of new orphan drugs”

A

landmark European regulation was introduced in 2000 to stimulate the development of treatments for orphan diseases (regulation 141/2000) which before this regulation were neglected due to a lack of commercial success. This regulation introduced several commercial incentives such as 10-year exclusivity, reduced or waived regulatory fees and protocol assistance.

To benefit from these incentives, the product needs to obtain an orphan drug designation (ODD) from the European Medicines Agency (EMA), which defines an orphan disease as having a prevalence of < 5 per 10,000 in Europe. In the US there

is a similar process with similar incentives, but a rare disease is defined as a disease affecting fewer than 200,000 people, or a prevalence of ~ 6 per 10,000 individuals. It should be noted that the EMA is stricter in its application of the ODD than the FDA, in that it does not extend ODDs to sub-indications.

This regulation has been very successful.

In 2017 a total of 1952 orphan designations have been approved by the EMA, covering 508 conditions. Oncology represented 34% of all orphan drugs. Applications for ODD increased year after year until 2014 when it decreased slightly but there is a clear upward trend. This has resulted in many patients benefitting from treatments where before there were none, representing a substantial benefit.

Shortening the distance from lab to life®.

10 Bloomsbury Way, London, WC1A 2SL +44 207 6321800 | www.syneoshealth.com 2 2 | PH A R M A FI EL D.CO.U K

CO S T V B E N E F I T However, these benefits have come at a high price. Over the years we have seen a gradual but sustained increase in prices of new orphan drugs. Overall the average cost of treatment per patient is 13x higher for orphan drugs than for non-orphan drugs. This combined with the continued flow of new orphan drug applications is concerning for payers. While the argument has been that the impact on the healthcare budget is negligible given the small population, when combining the cost of all orphan drugs, this represents about 8% of the healthcare budget. Of further concern for payers is that frequently the first orphan indication is extended to cover non-orphan indications, with a price that was set at the orphan drug level, increasing the financial impact on the healthcare system.

VA LU E P R O P O S I TI O N Regular drugs, after regulatory approval, will be reviewed in Europe by national reimbursement or health technology assessment (HTA) agencies. While all countries are trying, in their own way, to establish the value of new drugs, the process is different across European countries.

Orphan drugs are also reviewed for their value and there are marked differences in this process in Europe.

In some countries, such as the UK and Germany, there are separate processes which are tailored to the assessment of orphan drugs. In others, orphan drugs often have to follow the same reimbursement/ assessment path as regular drugs. This can be challenging as orphan drugs often present a less complete clinical package simply due to the lack of patients available for participation in clinical trials. Furthermore, due to the substantial unmet need for certain diseases, the development process may be fast-tracked.

This can result in some orphan drugs obtaining their regulatory approval based on Phase IIb trials, which often do not hold all information desired by payers.

“It is important to develop a strategy focused on achieving success with both payers and regulators”

WHAT DOES THE FUTURE HOLD? We know from the European statistics that there are about 7000 defined orphan diseases. Treatments have been developed for only 508 of these, so we can expect a continued stream of developments in the orphan space. Given the prices that we have recently seen for these drugs, this will make the current European model of provision of healthcare, mostly free at the point of care, hard to sustain.

Whether companies want to outlicense or commercialise themselves, it is important to develop a strategy focused on achieving success with both payers and regulators and understand their specific needs. Regulators are focused on efficacy, quality and safety.

Most companies set up their clinical trial programme to meet those needs. Payers, however, need to make reimbursement decisions, requiring them to compare the new drug to the current standard of care.

This can be a drug but also supportive care, which is often the case in orphan drugs. Alas, many orphan drugs submit for reimbursement based on single arm trials, making comparisons challenging.

Frequently trials are conducted over very short periods of time, not providing payers with the ‘hard’ endpoints they seek.

Early discussions with payers, which most agencies now offer, can provide insights relatively early on in the development process of payers’ needs and allow manufacturers to change trial protocols to collect additional data that will improve their chances of reimbursement.

Manufacturers of orphan drugs need to be mindful that payers will be increasingly sceptical of new orphan drugs and real benefit at a value-based price will need to be shown to obtain reimbursement.

It is expected that ‘easy’ access routes in certain countries will be closed to curb the effect on the healthcare budget. Therefore, for the future, adequate preparation for demonstration of value will be of paramount importance. Monique Martin is Managing Director, Syneos Health Consulting UK. Doug Niven is Senior Engagement Manager, Pricing and Market Access, Syneos Health Consulting UK. Go to syneoshealth.com

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 2 3

UNDER THE SKIN Funmi Oluwa, Market Access Director UK/Ireland, LEO Pharma, on how creating a positive market access environment enables successful product launches.

INTERVIEW BY

Amy Schofield

H

ow would you define market access? Market access involves preparing the appropriate healthcare environment so that patients have rapid and continued access to medicines at the right time. At LEO, a global organisation focused on improving the lives of people that live with dermatological conditions, market access spans the entire product journey starting in pre-launch; providing Advance Product Notification and generating evidence for Health Technology Assessments, through to securing price and reimbursement approvals at launch and post launch where we look for joint working opportunities, work on pathways and real-world evidence generation.

Why is market access so critical in a product launch? With the increase in payer pressure coupled with the challenging financial environment, for a launch to be commercially successful you need a positive access environment. The market access journey starts many years before

2 4 | PH A R M A FI EL D.CO.U K

product launch. Our aim is to ensure we get patients timely access to the medicines they need. The decision-making landscape in the healthcare system has become quite complex with regional and local decision makers playing an increasing role in developing treatment pathways to support local adoption of new treatment options.

Therefore, ensuring that your strategy can be translated by the local NHS is critical to the success of any product launch.

What elements are key to a good market access strategy? A strong market access strategy starts early in the drug development lifecycle, with a thorough needs analysis of your marketplace; who the key stakeholders and influencers are, their needs and how they work in your disease area. These insights can be built into clinical trial design and provide data that both the payers and regulators need to make decisions. The strategy needs to be built into the launch plans of all new products and needs to be done early.

What are the main barriers to market entry? One of the biggest challenges from an access perspective is gaining timely access and uptake of new innovative medicines.

Market access has become increasingly complex, involving sequential discussions with multiple stakeholders. Timelines and complexity of duplicative regional and local decision-making increases for non-NICE medicines. The NHS is changing and our approach to providing care must change with it. The ambition in the Life Sciences Industrial Strategy is to get to the upper quartile of comparator countries in medicines (for medicines which have been positively reviewed by NICE). This needs to be addressed if the UK is to ensure people get early access to new medicines, and to make the UK a more attractive place for industry investment. In addition for LEO, dermatology not being a national priority and outside the Quality and Outcomes Framework incentive system can make it difficult to gain interest in Joint Working initiatives at local level.

How do you ensure that all stakeholders are involved from the start? We develop a detailed market access plan where we identify and segment all market access stakeholders from pre-launch to launch and beyond. For each step in the patient access map, key stakeholders and their influencers are identified and their interactions mapped.

We validate these by seeking stakeholders’ advice on our plans/messages. We then tailor our proposition and messages in line with their needs at the various time points and agree an action plan on how we will communicate the messages.

How do you successfully navigate the changing healthcare market? By collaborating with relevant stakeholders and utilising key customer insights effectively.

A recent example of collaborating with stakeholders was LEO’s involvement with the former ABPI Dermatology Initiative (ABPI DI) who produced a report to examine the urgent issues in the care of people with long term skin conditions. The report highlights how dermatology is ideally placed to benefit from a ‘FYFV approach’. It outlines practical solutions that could positively impact patient experience and reduce burden on the NHS by enabling people to have greater control of their own care, allowing greater local flexibility and the integration of new models of care.

P H A R M ATA L E N T

FUNMI’S TOP 5 TIPS

for understanding your environment & your customers.

1.

Establish valued relationships with a network of stakeholders where you are seen as a partner.

2.

“ The market access journey starts many years before product launch”

Don’t spend all your time behind the desk – go out and meet people to understand their challenges and needs.

3.

Be part of industry groups where policy updates and wider environmental changes are discussed, and be part of shaping industry’s response to the changes.

4.

Keep up to date with latest trends, environmental changes and policies.

5.

Don’t be siloed: Seek insights from other areas of the business such as sales regarding what their customers tell them about the changing policy environment, and with marketing and medical teams to understand different perspectives.

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 2 5

ACCESS ALL AREAS? Huw Nicholas, Executive Solutions Lead at CHASE, explores the barriers facing both new and established talent looking to break into market access careers.

INTERVIEW BY

Amy Schofield

2 6 | PH A R M A FI EL D.CO.U K

W

hat barriers face those seeking careers in market access?

There certainly are considerable barriers to overcome. These are mainly based around two aspects. Firstly, there are few true market access roles available. Secondly, how does new talent prove themselves to have the competency/experience to take on a complex role with such a diverse customer group, when they haven’t had the opportunity to face those challenges before?

Companies that identify talent within their organisation and give them exposure to the broader payer/more challenging non-payer customer groups, will surely begin to break down these barriers. By backing existing talent and allowing them to work on specific projects with more senior colleagues, companies can make a career in market access attainable for those who want to make the step up. When recruiting externally, the same principles apply but we would encourage companies to seek new talent that is where the future of our industry lies.

Is the lack of a solid definition of market access deterring people from forging a career in the sector? If not actively putting talent off, it certainly is creating ambiguity. As with the definition of key account management, so much is down to the interpretation of the concept of market access. For example, in some companies a Market Access Specialist may be little more than Key Account Management with a couple of additional customer groups added on. While many companies feel that the true definition of market access should mean that there is no accountability for sales, others feel that the two are inexorably linked. If you can’t agree on what customer group you interact with and the remit to be covered, how can you define what profile of candidate you require?

But equally, is it naïve to suggest that you can simply define market access as ‘a process to ensure that [your] medicines are made available to patients who need them’ and not only expect everyone to agree, but also build generic job descriptions that capture the nuances that reflect an organisation’s structure, therapy areas, customer group and competitor landscape?

P H A R M ATA L E N T

Are there also barriers for experienced personnel who wish to move into the area? While they exist, the barriers are less severe. They’re typically based around the complexity/detail of the recruitment processes, the lack of clarity of ‘what good looks like’ when defining success in previous roles, and the lack of experience that candidates at a certain level have of going through a challenging recruitment process.

Is there enough support within companies? So much is down to the candidate. They need to drive themselves through self-development and push hard for the opportunities for project work within their company (even if outside the scope of their current role) to gain the experience needed to ‘step up’. However, companies could always invest more in nurturing talent and identifying a path for their progression into these roles.

What do your clients look for when recruiting market access personnel?

Proof of the ability to look beyond transactional interactions of a clinical nature, to broader discussions that involve complex working with a diverse customer group across their whole health economy.

Market access requires work across a wide stakeholder network including internal (marketing, medical, cross-functional team) and external functions (Meds Management, Prescribing Advisors, Chief Pharmacists etc).

How can potential candidates successfully approach market access to capitalise on the ever-changing healthcare environment? This is where the crystal ball becomes cloudy - there is only so much that you can anticipate! Our advice is for candidates to keep on top of Brexit, changes in NHS, changes in funding, competitor activity, future launches, patient/ advocacy groups and so on.

Successful candidates will be those who are aware of the wider landscape, adapting to the needs of their customers. The deeper their knowledge of their own therapy area the more success they will have. Understanding the challenges faced by customers and how they can support them whilst maintaining competitive and commercial advantage is key.

What is your advice to those wanting to move into market access? New talent: emphasise the relevance of your experience, and ensure you understand how to fully articulate your desire to enter the commercial world - yes, a market access role is commercial!

Established professionals: don’t underestimate the difficulty and complexity of the role. Build your portfolio of experience working with the payer group across as many customer types as possible. Stay ahead of the changes/challenges of our ever-evolving NHS! Huw Nicholas is Executive Solutions Lead at CHASE. Go to chasepeople.com

“ Successful candidates will be those who are aware of the wider landscape, adapting to the needs of their customers”

“ If you can’t agree on what customer group you interact with and the remit to be covered, how can you define what profile of candidate you require? ”

M AG A ZI N E S PECI A L ED IT I O N | J U LY 2018 | 2 7

MARKET ACCESS DIRECTORY ACCESSION

HAVAS M&C

accessionhealth.com innovate@accessionhealth.com 01491 577563

havasmandc.com caroline.roberts @havasmandc.com 07813 085 639

DRG ABACUS

decisionresourcesgroup.com Access@TeamDRG.com 01869 241281 EARTHWARE

Digital consultancy, websites and apps that solve real world problems. Experts in healthcare, we drive to the heart of every challenge by asking ‘Why?’. earthware.co.uk chris@earthware.co.uk 0845 642 9880

mosaic-mmagency.com DEVELOPED susan.sudovar BY THE INDUSTRY FOR THE INDUSTRY @mosaic-mmagency.com PriMe Training offers a range of courses designed for those working within the

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PHARMACEUTICAL MARKETING TRAINING MOSAIC GROUP

HEALTH IQ

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inicio.consulting info@inicio.consulting 07595 821 220

An independent consultancy service agencies. As an alternative to Essentials of pharmaceutical marketing - 3 DAY COURSE openaccessconsulting.com offering market access solutions sending one or two people on a group Managing a portfolio - 1 DAY COURSE course we also provide in-house cathywright@ for health and social care.

Strategy masterclass - 1 DAY COURSE training which makes sense if you openaccessconsulting.com through How to getFrom the bestinspiration, out of your creative agency - 1 DAY COURSE have 4 or more people to train.

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E4H

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GPI is an innovative price and access organisation providing intelligence, analytics and specialist consulting.

We offer solutions to industry-wide challenges improving performance for life sciences. globalpricing.com info@globalpricing.com 0203 874 3050

2 8 | PH A R M A FI EL D.CO.U K

LEO PHARMA

PM SOCIETY

LEO Pharma helps people achieve healthy skin by offering care solutions to patients in more than 100 countries globally. leo-pharma.co.uk comms@leo-pharma.com 01844 347 333

The PM Society was established over 40 years ago as a not for profit organisation to serve the needs of the pharmaceutical industry and its service agencies. pmsociety.org.uk info@pmsociety.org.uk 01403 264 898

MAP BIOPHARMA

mapbiopharma.com enquiries@mapbiopharma.com 01480 832 360

policy-matters.com info@policy-matters.com 020 7118 0763

VITACCESS

vitaccess.com info@vitaccess.com 01865 261 400

PRIORITIS MARKET ACCESS

prioritis.com contact@prioritis.com 07775 029 191

MKTXS

mktxs.com info@mktxs.com 01908 864 4090

We are a global market access consultancy and specialists in optimising pricing, market access and value communication strategy throughout the product lifecycle. validinsight.com discover@validinsight.com 020 3750 9833

POLICY MATTERS

MAWDSLEYS

mawdsleys.com info@mawdsleys.com 0844 736 9016

VALID INSIGHT

WG ACCESS

wg-access.com enquiries@wg-access.com 020 3037 3276

PRMA CONSULTING

prmaconsulting.com info@prmaconsulting.com 01252 786 284

WICKENSTONES

wickenstones.com wickenstones @wickenstones.com

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