PF Magazine February 2020

IN SHORT

SUPPLY “ A perfect storm of manufacturing issues and growing global demand led to a nationwide drug shortage” Page 10

FEBRUARY 2020

Medicines access and uptake Future of innovative medicine ABPI and congresses PHARMAFIELD.CO.UK

CO M I N G U P I N TH E N E X T

PF MAG A Z I N E S PECIAL E D ITI O N:

DIGITAL HEALTH How is digital health innovation transforming healthcare?

The digitally enabled representative • Artificial intelligence & Virtual reality Putting the patient in control • E-prescribing • Wearable technology • And more...

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Our Pf Magazine Special Editions cover the issues at the heart of the pharmaceutical sales and marketing environment, including expert intelligence, comment and analysis from industry insiders.

Our next issue will be the Pf Special Edition on Digital Health.

Look out for your copy in March.

Other Pf Special Editions scheduled for 2020 include recruitment and careers and the NHS.

If you would like to contribute an article, supply expert comment, or promote to our readers, contact amy@pharmafield.co.uk or call 01462 226130.

HEAD OF CONTENT

B

Hello.

y the looks of this issue of Pf Magazine, 2020 appears to be driven by the developments of 2019, whether that’s drug shortages or policy implementation across health, pharma and pharmacy.

Drug shortages were an escalating situation in 2019 as global rising demand and manufacturing issues took their toll on supply. Many were keen to blame Brexit, which is something that the Department of Health and Social Care has been quick to dismiss. Whatever the cause, it has left patients anxious and put pressure on pharmacists and clinicians. Our cover story looks at the situation and whether it is likely to continue this year.

We also look at a raft of policies, published and on the horizon, that are likely to impact on medicines access and uptake in 2020. Whether they lead to ‘business as usual’ only time will tell, but there is hope that we are moving on from 2019’s uncertainty.

In politics, we explore the future for innovative medicines in the NHS and whether the new Conservative-majority Government in post-Brexit Britain could affect that.

In the NHS, we look at how digital transformation is likely to help busy clinicians to work smarter whilst the Government works to address recruitment challenges.

In more general content, our ABPI column looks into how the Code of Practice applies to congresses and combines PMCPA case examples with ways to reduce the risk of a Code breach. We also explore cardiovascular disease in our therapy focus and have an interesting conversation about Lyme disease.

Finally, as the beginning of the year is traditionally a time for people to look for a new job, we look at ways to stem the brain drain, and what to consider if you’re asked to undertake psychometric testing in your next job application process.

I hope you enjoy this issue and if you’d like to be involved in a future Pf Magazine, or have a comment to make, email me at hello@pharmafield.co.uk.

Emma Morriss emma.morriss@pharmafield.co.uk SPECIAL EDITIONS EDITOR

Amy Schofield amy@pharmafield.co.uk CREATIVE DIRECTOR

Emma Warfield emma@pharmafield.co.uk GRAPHIC DESIGNER

Olivia Cummins olivia@pharmafield.co.uk COMMERCIAL DIRECTOR

Hazel Lodge hazel@pharmafield.co.uk SALES & MARKETING EXECUTIVE

Emma Hedges emma.hedges@pharmafield.co.uk NEWS DESK

Hannah Alderton newsdesk@pharmafield.co.uk FINANCIAL CONTROLLER

Fiona Beard finance@e4h.co.uk Pf AWARDS

Melanie Hamer melanie@e4h.co.uk PUBLISHER

Karl Hamer karl@e4h.co.uk HEAD OFFICE

3 Waterloo Farm Courtyard, Stotfold Road Arlesey, Bedfordshire SG15 6XP United Kingdom www.pharmafield.co.uk www.e4h.co.uk ADVERTISING

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M AG A ZI N E | FEB R UA RY 2020 | 1

February HAVE YOUR SAY: If you’d like to share an idea for a feature or collaborate with us on a captivating advertorial, please get in touch.

GET IN TOUCH: hello@pharmafield.co.uk

Contributors

@pharmafield

@pharmajobsuk

OLI HUDSON

DEBORAH EVANS

Oli is Content Director for Wilmington Healthcare. He oversees material for training and education, consultancy services, network meetings, thought leadership, events and webinars. In previous roles at the company, he has worked with the NHS and industry on a wide range of training, access, collaboration and partnership projects. Going digital, page 13.

Deborah is Managing Director of Pharmacy Complete, a training and consultancy company working with pharmacy and the industry.

Points mean more than prizes, page 24.

ANGELA MCFARLANE

CLAUDIA FORSYTH

Claudia is a consultant at Decideum and is an experienced market access and healthcare policy professional.

Innovative, effective and reasonably-priced, page 14.

Pf Magazine

Angela is Market Development Director for IQVIA. She works with Government, the NHS, the life science industry and patient organisations on pioneering collaborations that will improve NHS patient access to medicines.

Hope on the horizon, page 20.

PAUL MIDGLEY

NICK WILLIAMS 

Paul is Director of NHS Insight for Wilmington Healthcare’s Consulting Team. His interest is in NHS and joint industry projects around service integration, particularly in mental health, neurological and other long-term conditions.

He co-chairs Regional Mental Health, Diabetes, Rheumatology,Dermatology and GI Networks across England.

Going digital, page 13.

Nick is Co-Director of Triducive with 20 years’ experience in pharma commercial leadership.

Triducive focuses on designing practical solutions that help shape and support better decisions in healthcare.

Sell the problem you solve, not (just) the solution, page 29.

In this issue ALAN WHITE 

Alan is Chief Executive Officer of Arriello, a specialist global provider of innovative,high-impact market access, regulatory affairs and pharmacovigilance solutions and services for pharma and biotech firms primarily in Europe and North America.Stemming the pharma brain drain, page 32.

DR RINA NEWTON 

Rina is Managing Director of CompliMed, experts on the ABPI Code. CompliMed supports any activity that results in better engagement with the ABPI Code, transparency and consistency in PMCPA case rulings and improvements in self-regulation.

Content to conduct, page 16

AMANDA BARRELL 

Amanda is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.

Falling short, page 10.

04 NEWS

PF AWARDS

25

Bringing you the essential headlines

Mark Pringle on why he’s a Pf Awards Judge

COVER STORY

10

THERAPY AREA

Is the end in sight for drug shortages?

Look after your heart to prevent cardiovascular disease

INSIDE NHS

13

ADVERTORIAL

Technology holds the key to NHS transformation

Practical support to shape new market opportunities

POLITICS

14

IN CONVERSATION

What does the future hold for innovative medicines in the NHS?

Working to find a treatment for Lyme disease

16 ABPI

PF TALENT

How does the ABPI Code apply to congresses?

Stemming the pharma brain drain

20 FEATURE

MOVERS & SHAKERS

Policy, medicines access and uptake

Who’s moving where in the industry?

PHARMACY

24

36

The opportunities of the Pharmacy Quality Scheme

Psychometric testing in pharma

26 29

30 32

34 CAREERS

QUICK DOSES M S D ’ S new HIV-1 treatment, doravirine, has been recommended for use on the NHS in England.

• The N ATI O N A L I N S TIT U TE FO R H E A LTH A N D C A R E E XC E L LE N C E ( N I C E ) approved P F I Z E R ’ S Ibrance with fulvestrant on the Cancer Drugs Fund for some people with advanced breast cancer.

• The M E D I C I N E S A N D H E A LTH C A R E P R O D U C T S R E G U L ATO RY AG E N CY ( M H R A ) granted a licence update for Dysport® in some paediatric cerebral palsy patients.

• The European Commission has approved R O C H E ’ S Kadcyla® (trastuzumab emtansine) for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy.

• N I C E recommended V I FO R P H A R M A’ S Veltassa® for adults with hyperkalaemia in England.

• P F I Z E R ’ S VYNDAQEL® (tafamidis) received a positive CHMP opinion for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.

• N I C E expanded its recommendation for A S TR A Z E N E C A and M S D ’ S Lynparza™ (olaparib) tablets for women with relapsed, BRCAmutated, advanced ovarian cancer.

The S COT TI S H M E D I C I N E S CO N S O RTI U M also accepted Lynparza™ for advanced BRCA1/2mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer following chemotherapy.

• The E U R O P E A N M E D I C I N E ’ S AG E N CY approved two new regimens of M S D ’ S KEYTRUDA (pembrolizumab) as first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma.

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

MEDICINES COSTS

Significant differences

M

edbelle has revealed the differences in medicines costs across the globe. The comparative index across 50 countries shows the differences in cost of some of the most widely recognised and indispensable medications. The medications chosen for comparison span a variety of common conditions; from heart disease and asthma, to anxiety disorders and erectile dysfunction. The average prices of both the brand compound and their generic versions were included in order to have a complete profile of each medication.

The top 10 countries for the most expensive medications are USA (1st), Germany, UAE, Italy, Denmark, Qatar, Spain, Netherlands, Israel and Iceland.

The 10 countries where medication is the least expensive are Thailand (50th), Kenya, Malaysia, Indonesia, India, South Africa, Russia, Turkey, Egypt and South Korea. The UK ranks 21st out of 50.

Pf View: The differences in medicines pricing is staggering. The percentage deviation from the median can be found on the Pf Website and ranges from +306.82% in the US to -93.93% in Thailand.

Pf IN NUMBERS

7.4 PEOPLE

MILLION

P f N E W S : B R I N G I N G YO U T H I S M O N T H ' S E S S EN T I A L H E A D L I N E S

ARTIFICIAL INTELLIGENCE

Effective AI Artificial intelligence (AI) has been shown to be as effective as human radiologists in spotting breast cancer from x-ray images.

The international team behind the study, which includes researchers from Google Health, DeepMind, Imperial College London, the NHS and Northwestern University, designed and trained an AI model on mammography images from almost 29,000 women.

The findings, which were published in Nature, show that the AI was able to correctly identify cancers from the images with a similar degree of accuracy to expert radiologists, and holds the potential to assist clinical staff in practice.

When tested on a large UK dataset as part of the OPTIMAM project, funded by Cancer Research UK and a smaller US dataset from Northwestern University, the AI also reduced the proportion of screening errors – where cancer was either incorrectly identified or where it may have been missed.

The researchers say the work demonstrates how AI could potentially be applied in clinical settings around the world.

IN THE UK ARE LIVING WITH CARDIOVASCULAR DISEASE. Look after your heart, p26

C

IN THE BLOOD CANCER.

ancer Research UK scientists have found a breast cancer blood test that can help to identify rare mutations in advanced breast cancer. It may enable patients to access effective treatments more quickly in the future.

As part of the plasmaMATCH clinical trial, funded by Stand Up To Cancer, a joint fundraising campaign from Cancer Research UK and Channel 4, the researchers were able to detect mutations in the DNA from the tumours, which had been shed into the bloodstream.

They found specific weaknesses in the breast cancer DNA that could be targeted with drugs, suggesting that this blood test could be a better way of guiding treatment than standard tissue biopsies, which can be painful and take longer to analyse.

The team at the Institute of Cancer Research, London, and the Royal Marsden NHS Foundation Trust, analysed the blood from around 1000 women with breast cancer that had returned after treatment, or had spread to another part of the body. They wanted to explore if taking a liquid biopsy, where traces of tumour DNA circulating in the blood can be detected, was a quicker and easier alternative to traditional tumour testing.

MEN’S HEALTH

Super survival Some men with advanced prostate cancer who have exhausted all other treatment options could live for two years or more on immunotherapy, a major clinical trial has shown.

Researchers found that a small proportion of men were ‘super responders’ and were alive and well even after the trial had ended despite having had a very poor prognosis before treatment.

The study found that one in 20 men with end-stage prostate cancer responded to the immunotherapy, pembrolizumab – but although the number who benefitted was small, these patients sometimes gained years of extra life.

The most dramatic responses came in patients whose tumours had mutations in genes involved in repairing DNA, and the researchers are investigating whether this group might especially benefit from immunotherapy.

The study was published in the Journal of Clinical Oncology and funded by MSD.

GENETICS

DNA ERRORS A major international study of the genetics of breast cancer has identified more than 350 DNA ‘errors’ that increase an individual’s risk of developing the disease. The scientists involved say these errors may influence as many as 190 genes.

The results, published in the journal Nature Genetics, provide the most comprehensive map of breast cancer risk variants to date. The researchers involved, from over 450 departments and institutions worldwide, say the findings will help provide the most detailed picture yet of how differences in our DNA put some women at greater risk than others of developing the disease.

M AG A ZI N E | FEB R UA RY 2020 | 5

WOMEN’S HEALTH

Preventing miscarriage A study led by the University of Warwick has found that an existing drug designed to treat diabetes can also be used to improve the womb for pregnancy.

The study found that sitagliptin could be repurposed as the first treatment to prevent miscarriage by targeting the lining of the womb itself, according to a clinical trial led by the university.

Sitagliptin is the first drug of its kind shown to increase stem cells in the lining of the womb, improving the conditions to support pregnancy.

Previous research by the University of Warwick team revealed that a lack of stem cells in the womb lining is causing thousands of women to suffer from recurrent miscarriages.

The research team also demonstrated that stem cells protect specialised cells (decidual cells) from excessive stress and inflammation.

Decidual cells surround the implanting embryo and excessive stress can cause breakdown of the womb lining in pregnancy.

A new class of diabetes drugs called gliptins targets an enzyme involved in the recruitment of circulating stem cells to the womb.

The researchers investigated whether inhibiting this enzyme, called DPP4, using sitagliptin, would improve conditions in the womb for pregnancy.

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

CANCER.

WORLD FIRST

C

ancer Research UK and Vaccitech Oncology Limited have announced a new partnership for a firstin-human trial for a new lung cancer immunotherapy in order to bring a novel immunotherapeutic vaccine strategy to patients with the condition.

The vaccine treatment is designed to stimulate the body’s immune system to attack cancer cells. It will deliver cancer-associated antigens to antigenpresenting cells called dendritic cells, causing the immune system to produce cytotoxic T cells, which target and kill cancerous cells expressing the antigens.

This is the first time a viral vaccine programme using this platform will be tested in the treatment of non-small cell lung cancer, the most common type of lung cancer. Separate clinical trials are ongoing to test similar recombinant virus vaccines to treat people with late-stage prostate cancer.

SAFETY

Biologic batches Research carried out by the UK’s Drug Safety Research Unit and Lygature, has found that health professionals need to improve how they record brand and batch numbers for biologic medicines to ensure patients stay safe.

The research published in the journal Drug Safety, shows hospital pharmacists, doctors and nurses only recorded batch numbers for biologic medicines between 38% and 58% of the time during routine hospital practice.

The analysis of UK data showed brand names were recorded more frequently – between 79% and 91% of the time.

Analysis of spontaneous adverse drug reaction reports showed brand names were only included 38% of the time, while batch number traceability was only 15%.

P f N E W S : B R I N G I N G YO U T H I S M O N T H ' S E S S EN T I A L H E A D L I N E S

N

MEDICINES DISCOVERY

All ears

Action on Hearing Loss and Medicines Discovery Catapult have launched the Hearing Medicines Discovery Syndicate, a unique collaboration to accelerate the much-needed development of treatments for hearing loss and tinnitus.

Hearing loss affects almost half a billion people globally, with almost 12 million people in the UK impacted. Despite the vast number of people affected, there are no registered pharmaceutical treatments for hearing loss or tinnitus. Recent scientific developments in the understanding of the biology underlying hearing loss are beginning to address this issue.

The opportunity to advance treatments for patients is now accelerating as never before.

The Hearing Medicines Discovery Syndicate will connect researchers and companies to the vital expertise and infrastructure needed to fast track the development of hearing therapeutics. For companies new to the field, or academic groups with limited experience of drug discovery and clinical development, the Syndicate brings together the relevant expertise to allow them to rapidly connect with the specific support they need to drive the development of new hearing therapeutics.

COMMERCIAL FRAMEWORK.

OPEN AND CLOSED

HS England has published the NHS Commercial Framework for Medicines. The Commercial Framework outlines the purpose and principles on which NHS commercial medicines activity will be based; defines the roles and responsibilities of those involved in commercial medicines activity and details how pharmaceutical companies can engage with the NHS; clarifies the routes to routine commissioning in the NHS, and where commercial activity can occur in those routes; and outlines commercial flexibilities, and circumstances where they could be considered.

It was open for consultation but closed in January. The final framework will be released in due course.

PF IN NUMBERS

Spend on medicines has decreased by around

0.4%

YEAR ON YEAR OVER THE PAST FIVE YEARS

Innovative, effective and reasonably-priced, p14

50,000

MORE NURSES

6000 MORE GPs

50,000,000 MORE GP SURGERY APPOINTMENTS promised in the Conservative General Election manifesto Going digital, p13

M AG A ZI N E | FEB R UA RY 2020 | 7

S

NHS

Trust in tech NHS staff are uncomfortable with multinational ‘big tech’ companies analysing anonymised NHS patient data, according to a survey.

A YouGov poll of 1027 healthcare professionals, commissioned

by Sensyne Health, found that 81% support the analysis of anonymised NHS patient data to enable quicker diagnosis and more effective treatments, while 71% believe this analysis can help solve some of the greatest healthcare challenges in the UK, such as cardiovascular disease.

But just 12% of NHS staff and private healthcare workers said they would be comfortable with a multinational ‘big tech’ company which pays little tax in the UK carrying out the analysis. Only 17% said they would trust multinational ‘big tech’ companies to handle NHS patient data in a confidential manner. In comparison, 80% believe the UK should have a domestic capability in artificial intelligence and health data analysis so it doesn’t need to be outsourced to other countries or multinational companies.

More than 8 in 10 (85%) say the NHS should receive a fair share of any financial gains made from subsequent medical discoveries, with 87% explicitly calling on the Government to step in and ensure that both the NHS and UK taxpayers benefit from discoveries and gains resulting from any analysis.

Pf View: With just 12% of healthcare professionals trusting big tech with NHS patient data, there’s a lot to be done to marry up the need for data analysis for the future of healthcare and the level of trust in the current data processors.

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

DRUG DELIVERY.

SMALLER THAN AVERAGE

cientists have been investigating how to make better use of nanoparticles in drug delivery for several decades.

Now a new study demonstrates how a new technique in chemistry could pave the way for producing uniform nanoparticles for use in drug discovery systems.

Significantly smaller than an average cell, nanoparticles are more similar in size to proteins.

This makes them good at interacting with biomolecules and transporting drug molecules attached to their surface across cell membranes.

To date, however, only a handful of nanoparticle-based drugs have succeeded in reaching the clinic. This is due to the challenges in controlling the size and shape of nanoparticles – and understanding fully how these variables affect the way the particles behave in the body.

In the study, published in Nature Communications, researchers from the University of Birmingham and the University of Bath demonstrated a technique that will allow chemists to more closely control the size and shape of nanoparticles.

PF IN NUMBERS

3000

NEW LAB-CONFIRMED CASES OF LYME DISEASE A YEAR IN THE UK Tick, tick, tick, p30

MERGER

All clear The Competition and Markets Authority (CMA) has cleared Roche and Spark Therapeutics’ merger, paving the way for Roche’s anticipated purchase of gene therapy company Spark Therapeutics.

Both companies develop treatments that aim to prevent bleeding in patients with Haemophilia A, a genetic blood disorder.

The CMA has been examining whether the deal could negatively affect the future treatment choices available to the NHS, doctors and patients.

Roche supplies Hemlibra, a relatively recent market entrant that has already become recognised as an important and innovative medicine for patients in the UK. Spark is in the process of developing a gene therapy treatment for Haemophilia A that is expected to compete with Hemlibra.

ACQUISITION

BMS COMPLETES

Bristol-Myers Squibb Company has completed its acquisition of Celgene following the receipt of regulatory approval from all government authorities required by the merger agreement and approval by Bristol-Myers Squibb and Celgene stockholders.

P f N E W S : B R I N G I N G YO U T H I S M O N T H ' S E S S EN T I A L H E A D L I N E S

ACQUISITIONS.

CASH OFFER

R

ecipharm AB and Consort Medical have reached an agreement on the terms of a recommended cash offer

by Recipharm Holdings Limited for Consort.

Recipharm’s aim is to become a leading global contract development and manufacturing organisation.

Pf IN NUMBERS

ICYMI

Pf View: This is one of many recent mergers and acquisitions. Are we experiencing a period of consolidation, or are companies making strategic acquisitions to bolster their position in the market?

IN CASE YOU MISSED IT

THE UK EXPORTS

47m

PACKS OF MEDICINES

Simon Grime of Wilmington Healthcare, explains how data and intelligence tools help pharma deliver tailored engagement programmes to diverse stakeholders.

OVERCOMING THE CHALLENGES TO MAKING DATA FAIR IN PHARMA

Data have long been the strong foundation on which scientific discovery has been built, giving the means for validating discoveries, supporting peer review and predicting the unknown. As we see an increase in the uptake of technologies like artificial intelligence and machine learning across the sciences, data will remain just as critical. Ted Slater shares his thoughts on how to overcome the challenges of making data Findable, Accessible, Interoperable and Reusable.

AND IMPORTS

35m

EVERY MONTH Hope on the horizon, p20

MAPPING THE INTRICATE ONCOLOGY LANDSCAPE

TOP 10 REGULATORY ISSUES AFFECTING PHARMACY

MORE THAN JUST PRINT. We publish daily news and exclusive articles on www.pharmafield.co.uk.

Here’s a look at some of the exclusive content you may have missed.

Susan Hunneyball offers her top 10 regulatory issues affecting the pharmacy sector including the Community Pharmacy Contractual Framework, Falsified Medicines Directive, homeopathy, medicinal cannabis and more.

VIDEO LINK GP APPOINTMENTS

Phil Galt shares his experience of video link GP appointments using state-of-the-art diagnostic technology in community pharmacy.

 Want the full stories? Find these and the latest news at www.pharmafield.co.uk M AG A ZI N E | FEB R UA RY 2020 | 9

Falling short

Is there an end in sight for 2019’s headline-hitting drug shortages?

At the moment, pharmacists are working incredibly hard to get the medicines that patients need. They spend hours tracking down stock and working together to help patients

WORDS BY Amanda Barrell

TOP 5 TAKEAWAYS 10 | P H A R M A FI EL D.CO.U K

C OV ER S TO RY

A

perfect storm of manufacturing issues and growing global demand led to a nationwide drug shortage that took its toll on clinicians and communication channels alike in 2019.

Adrenaline, fluticasone and rivaroxaban are among the medicines which can no longer be parallel exported out of the UK, as part of a sector-wide bid to prevent further shortages.

A spokesperson for the Pharmaceutical Services Negotiating Committee (PSNC) said there was no clear-cut reason for the issues, which have left pharmacies unable to access a growing list of drugs.

“There are many reasons why pharmacies are not always able to get certain medicines,” she said. “For example, manufacturers can have problems with making the medicine, transporting them or with ingredients for medicines.

“Sometimes when lots of people are suddenly prescribed a medicine this can use up all the supply, or there may be pricing concerns about medicines.”

But the complex, multi-factorial causes of the problem have very clear consequences – increased workloads for physicians and pharmacists, and mounting anxiety for patients.

VIEW FROM THE FRONT LINE

One area which has borne the brunt of these nationwide shortages is women’s health, where clinicians have faced an ever-changing landscape of hormone replacement therapy (HRT) availability.

Two leading HRT brands, Mylan’s Elleste, and Evorel, which Theramex has recently

1

There is no single reason for drug shortages.

2

acquired from Johnson & Johnson, have been in short supply in recent months. Mylan has attributed shortages to its manufacturing partners’ supply chain issues, while Evorel has been impacted by increases in demand.

This has placed enormous pressure on GPs and pharmacists, who have been locked in a game of cat and mouse as they attempt to track down appropriate products for their patients.

“There is a lot of confusion about what is and what is not available,” explained Bradford-based Dr Anne Connolly, a GP with a special interest in gynaecology.

“I sit in clinic, write a prescription and give it to the patient. They go off to the pharmacy, and then the pharmacy says they don’t have it.”

This has been happening with “increasing frequency” over the last several months, she added, explaining that the picture was changing all the time.

“It is not quite as cut and dry as product X isn’t available and product Y is. Usually some pharmacies will have some products in stock and others won’t. Then it will be down to the women to go hunting for it, or for us, the doctors, to be ringing around to find it.

“It does make life much more complex and has a massive impact on our workload.”

The Royal Pharmaceutical Society (RPS) said medicines shortages were an “increasing problem”, driven by manufacturing issues, soaring demand and fluctuations in the exchange rate.

“At the moment, pharmacists are working incredibly hard to get the medicines that patients need. They spend hours tracking down stock and working together to help patients,” said an RPS spokesperson.

The PSNC added that pharmacy teams were doing all they could to ensure patients

HRT has been particularly affected.

3

GPs are struggling to know what’s out of stock.

had access to the medicines they needed.

“Pharmacists do all kinds of things to assist patients, such as ‘staged’ dispensing, liaising with GPs to find alternative medicines that may be suitable, and making many phone calls to suppliers,” said the body.

LINES OF COMMUNICATION

The problem has been compounded, said Executive Director of the Primary Care Women’s Health Forum, Dr Sarah Gray, by a lack of communication.

“The situation on the ground has been difficult for in excess of a year, and the biggest problem has been the lack of information. There have been major manufacturing issues, but this has not been adequately communicated,” said Dr Gray, a GP with a special interest in women’s health.

“There was a period where a whole raft of products was unavailable, but we didn’t know that until the patients tried to fill their prescriptions.”

The doctors believe that clearer lines of communication would have allowed them to better navigate the shortages, as well as help them put patients’ minds at rest.

Explained Dr Gray: “I have got women who are in tears, they are distraught because they can’t get what they need to function. Women who have finally been stabilised on treatment and have got their lives back want to stay that way.”

Dr Connolly added that she understood the difficulties of keeping clinicians up to date. “It’s hard because it is a moving feast. What’s available one week might not be available the next,” she explained, signposting fellow prescribers to the British Menopause Society’s website for updates and resources on HRT.

4

Pharmacists are working hard to find solutions.

5

DHSC says Brexit is not to blame.

M AG A ZI N E | FEB R UA RY 2020 | 11

C OV ER S TO RY

PROTOCOLS AND RESPONSIBILITIES

Explaining that companies were required to notify the Department of Health and Social Care (DHSC) of shortages, an Association of the British Pharmaceutical Industry (ABPI) spokesperson said manufacturers did everything they could to prevent supply problems.

“The DHSC has guidance which outlines the obligations on companies to inform the Department of any medicine discontinuations or anticipated supply shortages. Companies take their responsibilities very seriously and are accountable to UK regulators should supplies of their products become unavailable,” he said.

The DHSC, which was quick to dismiss Brexit as a reason for shortages, confirmed that it received regular reports from the pharmaceutical industry.

“The Department has well-established procedures to deal with medicine shortages and works with NHS England and NHS Improvement (NHSE/I) to disseminate information about shortages and management plans to NHS staff, including GPs,” said a spokesperson.

Emphasising that the NHSE/I took the lead in disseminating information, she said methods included regularly sharing potential supply issues and management plans with primary and secondary care networks, and liaising with relevant patient groups.

“The DHSC Medicine Supply Team uses various routes to communicate supply issues to GPs. This includes issuing Supply Disruption Alerts via the MHRA Central Alerting System and utilising email cascade via the NHSE Primary Care Commissioning route.

“The team also engages with stakeholders in primary care including PSNC, the Royal College of GPs and others to cascade messages about supply issues to relevant healthcare professionals in primary care,” she said.

THE ROAD AHEAD

From the DHSC to the ABPI, bodies across the sector are keen to highlight the work going on to address drug shortages in the UK, and pharmaceutical companies say they are addressing their manufacturing roadblocks.

The manufacture of Elleste, for example, is currently being transferred to a Mylanowned and operated facility, and production is expected to re-commence in the second half of this year.

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

Since acquiring Evorel, Theramex, has said it is “working with…suppliers to shorten the manufacturing timelines, accelerate supply, and bring the product back to market”.

“We estimate, with the new timelines in place, the Evorel, Conti and Sequi ranges will be back in stock in the UK from February 2020 onwards.

“Please rest assured that this is a priority for us, and we are committed to bringing this product back to patients as quickly as we can,” said the company in a press release.

From the Government perspective, new measures, such as restrictions on the parallel export of medicines in short supply and the introduction of Serious Shortage Protocols, which are published on the NHS Business Service Authority’s website, have been implemented. And in November, the English Local Medicines Committees conference passed a motion to explore changes that would enable pharmacists to offer alternative medicationsin times of shortages.

Taken together, the sector hopes these measures will go at least some way to hastening the end of the current drug shortages, easing the pressure on clinicians, pharmacists and patients alike in 2020.

To see the Government’s full list of medicines that cannot be parallel exported from the UK, go to www.gov.uk/government/publications/ medicines-that-cannot-be-parallel-exportedfrom-the-uk

NHS

Going digital How technology holds the key to NHS transformation helping hard-pressed clinicians work smarter as the Government grapples with staff recruitment challenges.

WORDS BY Paul Midgley and Oli Hudson

I

n their General Election manifesto, the Tories pledged to provide 50,000 more nurses, 6000 more GPs and 50 million more GP surgery appointments each year as part of ‘the biggest cash boost for the NHS for a generation’.

The number of nurses promised may have changed since then, but the recruitment challenge remains the same. Increasing the workforce will take time. Also, given that many new staff are expected to come from overseas, Brexit is a major hurdle; notwithstanding the Tories’ General Election manifesto promise of a new ‘NHS visa’ to make it easier for doctors and nurses from around the world to work in the UK. To mitigate the problem, the NHS needs to improve patient pathways so they can be better managed by its existing workforce. The use of digital technology – which forms a central plank of the NHS Long Term Plan – will be accelerated to make this happen.

NHSX, the NHS’s joint organisation for digital, data and technology, will be a key enabler. For example, it has been tasked with supporting the uptake of digital initiatives, such as Local Health and Care Records, which help healthcare professionals (HCPs) to access joined-up patient information quickly and efficiently.

LONG TERM PLAN COMMITMENTS

The NHS Long Term Plan has pledged that ‘digitally-enabled’ primary and outpatient care will become mainstream across the NHS over the next five years.

As part of this, all patients in England will have access to online consultations by 2022-23 and the ‘right’ to switch to ‘digital first’ GP practices. Babylon’s GP at Hand,

which launched in London, was the first of these kinds of services and it has since expanded into Birmingham.

The NHS Long Term Plan envisages a similar expansion of online consultations in secondary care in a bid to avoid a third of all hospital outpatient appointments within five years. Screening and diagnostic services will be increasingly provided in the community and some hospitals have already demonstrated how they can successfully engage with patients online and monitor their progress at home.

For example, Imperial College Healthcare NHS Trust has extended its use of video consultations to a range of specialties; while Oxford University Hospitals NHS Foundation Trust remotely monitors gestational diabetes to track glucose levels.

Engaging with patients online and monitoring conditions remotely can enable HCPs to take more proactive and preventative measures. It also helps patients better manage their condition and take more control of their health.

Overall, this can help to reduce the need for face-to-face contact with GPs and practice nurses and cut outpatient appointments and hospital admissions.

As HCPs grow accustomed to engaging with patients via a variety of digital platforms, pharma must ensure that its own communications strategy meets its customers’ evolving needs. Engaging with HCPs via different online channels and in a variety of formats will be essential, particularly as technology paves the way for more HCPs to work remotely, making face-to-face meetings harder to secure.

Paul Midgley is Director of NHS Insight and Oli Hudson is Content Director at Wilmington Healthcare.

Go to www.wilmingtonhealthcare.com M AG A ZI N E | FEB R UA RY 2020 | 13

INNOVATIVE, EFFECTIVE AND REASONABLY-PRICED What does the future hold for innovative medicines in the NHS?

D

ecember 2019 saw the Conservative Party deliver its largest majority since Margaret Thatcher’s historic win of 1987, and while the Opposition insists that this was a ‘Brexit election’, the NHS also played a central role in both main parties’ election campaigns.1 This is unsurprising given suggestions in early December that the NHS was heading into the winter in ‘unusually bad shape’.2 With Boris Johnson’s unexpectedly comfortable win, the Government will have freedom to implement much of the health policy it set out in its manifesto.

This includes writing into law the first multi-year funding settlement for the NHS, abolishing hospital car parking charges and introducing a £500m funding pot for innovative medicines.3 CRITICISM

During the run up to the election, the Conservative Party was taken to task on a number of its health policy pledges, with most of the criticism batted away relatively easily. However, one accusation that Johnson has failed to shake was the suggestion that the price the NHS pays for drugs could increase under the terms of a trade agreement with the US. 4 Labour claimed that the NHS would ‘be forced to pay £500m a week to US corporates for drugs’ under a Tory Government, which would easily eat up the funding ring-fenced in the Conservative manifesto for innovative medicines.5 This has been shown to be a highly unrealistic and extreme scenario. Indeed, it would be naïve to think that there would be no push back from the National Institute for Health and Care Excellence (NICE) or NHS England at the prospect

14 | P H A R M A FI EL D.CO.U K

of a hike in drug prices.6 It is highly probable that both independent organisations would mount a robust challenge to Government in such a situation. Nevertheless, leaked documents show an intent from the US to discuss the prices paid for medicines in the NHS with the UK Government, with a view to negotiating greater pricing freedom.

DICHOTOMY

This raises an interesting issue – a dichotomy lies at the heart of British attitudes to healthcare: there is a belief that NHS patients should be able to access the most innovative, clinically-effective therapies free at the point of use, but also that the NHS should resist paying higher prices for these treatments.

In the meantime, the cost to companies hoping to launch medicines in the UK has increased in the past year, with the introduction of charges for NICE appraisals (regardless of whether the medicine is recommended) and the voluntary and statutory rebate schemes, which see companies returning a growing percentage of revenue to the Treasury each quarter.

Contrary to popular belief, the spend on medicines has actually decreased by about 0.4% year on year over the past five years, when adjusted for inflation. This is in contrast with the 3.3% increase in spending that the rest of the health service has enjoyed.7 One has to consider whether this constant squeezing of drug spend isn’t rather short-sighted, if the NHS is to continue to pioneer the best and most innovative healthcare in the world.

ACCUSATIONS

The UK has, in the past, managed to balance both the interests of the taxpayer and patients, by keeping spend on medicines low, whilst ensuring access for most patients.

This has prompted accusations, notably from the US, that this is at the expense of patients elsewhere in the developed world.8 When questioned by the Senate on why America spends 160% more per capita on prescriptions than the UK, the leaders of several large multi-national pharmaceutical companies posited that America was carrying the cost of research and development (R&D) for the rest of the world, as they are unable to recoup costs elsewhere.9 The Prime Minister may yet be cornered on this as Donald Trump bids for re-election on a platform including a promise to reduce drug prices for American patients.10 Trump’s rhetoric may firmly put pharmaceutical prices at the forefront of the public consciousness. Yet it remains the case that it is increasingly challenging to launch new medicines in the UK. This is ultimately to the detriment of patients and wider society.

RECOGNITION

As Johnson embarks on his first 100 days in office, setting the tone for the rest of the term, he will wish to put to bed the concerns about an increased medicines bill. Allowing unbridled spending on all medicines would not be a fair or popular use of Treasury funds. But if he is to deliver other aspects of his vision – investment in R&D, delivering a first class NHS and encouraging inward investment in life sciences – he will also need to ensure that the true value of medicines is recognised and that the UK is seen to be a life sciences friendly jurisdiction.

Only by doing this will the concerns of multinational companies be addressed to prevent de-prioritising the UK as a primary launch market. The £500m Innovative Medicines Fund may be a good start,

POLITICS

Leaked documents show an intent from the US to discuss the prices paid for medicines in the NHS with the UK Government, with a view to negotiating greater pricing freedom

WORDS BY

but there is more to do in order to ensure the patients get access to new medicines at prices reflective of the value delivered to the NHS and society.

Claudia Forsyth is a consultant at Decideum. Go to www.decideum.com References 1 https://www.bbc.co.uk/news/ election-2019-50766114 | 2 https://www. kingsfund.org.uk/blog/2019/12/fivereasons-why-nhs-winter-may-be-different | 3 https://assets-global.website-files. com/5da42e2cae7ebd3f8bde353c/5dda92490 5da587992a064ba_Conservative%20 2019%20Manifesto.pdf | 4 https://www. nuffieldtrust.org.uk/news-item/couldthe-nhs-be-the-price-of-a-us-tradedeal#they-pay-more | 5 https://twitter.com/ JonAshworth/status/1190223025997799424 | 6 https://fullfact.org/health/500-millionnhs-drug-prices/ | 7 https://www.abpi.org. uk/new-medicines/medicine-pricing-inthe-uk/what-was-the-pprs/ | 8 https://www. ft.com/content/e92dbf94-d9a2-11e9-8f9b77216ebe1f17 | 9 Ibid. | 10 https://apnews. com/49f06ed656b842539ee0b62797ba4de0

TOP 5 TAKEAWAYS

Claudia Forsyth

1

US INTENDS TO DISCUSS THE PRICE THE NHS PAYS FOR MEDICINES WITH THE GOVERNMENT.

2

COST OF LAUNCHING MEDICINES IN THE UK IS INCREASING.

3

SPENDING ON MEDICINES HAS DECREASED.

4

IS AMERICA CARRYING THE R&D COST FOR THE REST OF THE WORLD?

5

GOVERNMENT HAS WORK TO DO ON ACCESS, PRICING AND VALUE. M AG A ZI N E | FEB R UA RY 2020 | 15

ABPI

CONTENT TO CONDUCT How does the ABPI Code apply to congresses?

Mitigating the risks of breaching the Code.

WORDS BY Dr Rina Newton

T

he ABPI Code of Practice provides guidance for pharmaceutical industry meetings and third-party meetings that the industry supports, covering meeting content and arrangements. Congresses, by their very nature, tend to include a variety of different activities that fall under the scope of the Code and activities continue to bring about complaints to the PMCPA (eight complaints relating to this area were published in the past two years).

Given all planned meetings must be checked to ensure they comply with the Code, from the outset there must be a clear and unambiguous Meetings Standard Operating Procedure (SOP) covering the various ways in which congresses can be supported. These are highlighted below with typical examples of issues observed (in our dealings and noted in PMCPA case reports).

COMPANY EMPLOYEES

Occasionally, employees attend congresses as delegates in their own right. Both the type and number of employees attending must be considered: e.g. “If several medical science liaisons were attending a congress symposia about the company’s own medicine, were they there to solicit enquiries on that medicine?”

CONDUCT OF COMPANY EMPLOYEES

Given that staff are on professional duty 24/7 at congresses, risks associated with their conduct tend to occur during ‘downtime’.

These range from staff acting inappropriately (Case AUTH 2174/10/08 Anonymous v Merck Serono) and even getting thrown out of bars (Case AUTH 2509/6/12 Anonymous v Roche).

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

SPONSORING DELEGATES

Companies may provide subsistence, accommodation, registration fees and travel to delegates they sponsor to attend a congress. Delegates should be suitably qualified or in an appropriate role to gain benefit from the congress, and this leads to potential risk: e.g. “Were delegates chosen solely for promotional purposes?

Can attendees that are not part of the sponsored delegation be provided with any subsistence?”

HOSTING A NON-PROMOTIONAL EXHIBITION STAND

Whilst medical education, medical information, clinical research and corporate stands are acceptable, increasingly, the cumulative impression of all company activities at congresses can pose risks: e.g. “If the company symposium is about an unlicensed medicine, will their medical education stand be deemed to solicit questions on this medicine?” (Case AUTH 2868/8/16 JanssenCilag v Sanofi Genzyme)

COMPANY SYMPOSIA

As with all meetings, there must be clear educational content, in a venue that is not lavish, with reasonable subsistence, secondary to the nature of the meeting.

Although the programme, audience and hospitality pose risks, other risks can be associated with content and company-paid speakers: e.g. “Why was the speaker allowed to keep slides that mention product? Why did the speaker mention the product in a medical education presentation?” (Case AUTH 2598/4/13 Consultant rheumatologist v Roche)

SUPPORTING SCIENTIFIC SESSIONS

Pharmaceutical companies’ support of congress activities range from speaker payment, to room hire or providing lunch.

Declaration of involvement must be made clear on all meeting materials. e.g. “Will the company be held liable if the agenda contains an untrue declaration?” (Case AUTH 3133/12/18 Anonymous v Novo Nordisk).

PRESENTING ABSTRACTS/POSTERS

Research and development activities generally fall outside the scope of the Code.

HOSTING A PROMOTIONAL EXHIBITION STAND

KEY ACTIONS TO MITIGATE RISKS

These must be separate to non-promotion as all material, staff and discussions will be promotional. There are risks associated with applicable Codes at international congresses as well as social media: e.g. “Is the company liable if the stand production company posts a picture of a promotional stand panel on social media in the interests of business development?” (Case AUTH 3010/1/18 Bristol Myers Squibb and Pfizer v Daiichi Sankyo)

There are several key actions that can help mitigate risks of breaching the Code at congresses.

1. A ssemble a steering group with oversight of the whole congress to ensure all activities (stands, symposia, affiliate meetings, dinners etc.) are known in advance, documented and in line with business strategy. This allows for the overall cumulative impression to be considered.

2. Communicate well with affiliates to allow good planning of activities and materials in line with applicable Codes.

3. M obilise and engage stakeholders through clear and concise SOPs and checklists to aid efficient approval.

4. Centralised teams to efficiently assess all plans and materials to allow clear categorisation of each type of activity and determine the applicable Codes vs company involvement, e.g. Company symposia flyers in congress delegate bags vs open invites from stands.

5. O nce each activity is well understood, associated materials can be approved vs a compliance checklist.

TRIED AND TESTED TOP TIPS

• Sometimes the company strategy is poorly understood which can manifest as compliance issues. Diligence defines liability in situations where company support of third-party congresses is varied. This diligence must be welldocumented. E.g. If the only support a company has provided is a stand, they will not be held liable for other aspects (according to strict conditions).

(Case AUTH/2561/11/12 Anonymous group of NHS health professionals v Recordati).

If the company provides a stand and lunch, was the strategy still focused on promotional interactions at the stand?

Unfortunately, liability now depends on diligence (What was the lunch?

What was the cost per head? Did it comply with all applicable codes? Was it in proportion to the education on the agenda? Is education good quality and relevant to clinical or medical aspects?)

– and this is far more difficult to check and approve.

• Agencies used to support congresses (from stand production to social media and events management) must be kept well-informed about Code requirements and relevant PMCPA cases. This should ensure that risks due to company liability are reduced.

• Evening meal provision does not always require there to be associated education at that time. More companies are benefitting from providing evening subsistence to attendees that have attended the congress (and therefore received education) but have not been taken as delegates by that company.

• Medical symposia under the scope of the Code must be further categorised so their compliance can be checked.

It is not acceptable for such symposia to bypass relevant requirements because they are ‘medical’ or ‘scientific’ etc.

• If a medical area is needed on promotional stands solely to address questions, consider booking a separate room for medical staff to deal with enquiries so that conversations can’t be overheard, requests can be well-documented and the juxtaposition of the promotional vs medical stands cannot be accused of soliciting enquiries.

• Lastly, staff briefings about expected behaviour prior to congresses are key to ensuring no complaints (and therefore no breaches). These should ideally contain a list of dos and don’ts with examples and cross-reference to relevant case rulings.

Ashfield

See the world in a new light...

It is possible for all activities and materials at international and national congresses to be well-planned, approved in a timely manner and executed well in line with all applicable codes. However, this is not an easy task so should not be entered into lightly. Dr Rina Newton is Managing Director of CompliMed. Go to www.complimed.co.uk

Top 5 takeaways 1 Have a clear Meetings SOP supported by staff briefings.

2 Ensure good oversight of all congress activities.

3 Use checklists to aid comprehensive checks.

4 Diligence must be well-documented.

Ashfield is a vibrant and exciting recruitment agency Field, office and home based roles Pharma | Biotech | Medical Find your perfect role today www.ashfieldhealthcare.com

5 Agencies must be well-informed.

M AG A ZI N E | FEB R UA RY 2020 | 17

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HOPE ON THE HORIZON MEDICINES ACCESS AND UPTAKE Will a raft of policies designed to create a more positive prescribing environment make a difference in 2020?

WORDS BY Angela McFarlane

2

019 was epitomised by two words ‘Brexit’ and ‘Uncertainty’ whilst the NHS and pharma had to deliver on ‘business as usual’, as well as work truly collaboratively to mitigate risk of a No Deal Brexit and avoid a potential national crisis of medicines shortages.

Every month the UK exports 47m packs of medicines and imports 35m packs of medicines, 90% of which leave and enter the country from Dover and Calais1. The Department of Health and Social Care (DHSC), pharma, biotech, and medtech collaborated in an unprecedented way to keep medicines flowing, including: • building buffer stocks of prescription-only and pharmacy medicines in case of difficulties in shipping medicines using current transport routes2 • introducing arrangements for community pharmacists to dispense alternative equivalent medicine without redress to the patient’s GP in the event of an out of stock situation3 • procuring new cross channel ferry routes3,4 .

The reality of the General Election result is that the Government got the majority it needed to get its Withdrawal Agreement through.

By the time you read this, the UK will have ‘left’ the EU and be ‘in transition’, negotiating trade deals with the US, EU, Asia-PAC and implementing legislation to either UK-adopt or change the existing EU legislation it operates under.

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

MEDICINES POST-BREXIT

On medicines, clear statements have been made that the UK wishes to ‘align as closely as possible’ to EU Regulation. What does that mean in terms of keeping the UK as the third priority country in the world in which global pharma and biotech choose to launch medicines?

There is no doubt that Brexit was a catalyst for the Government to improve the environment for UK life sciences. The Life Sciences Sector Deal, with its commitment to increase the uptake of innovative medicines to the upper quartile of the Organisation for Economic Cooperation and Development (OECD) average by 2023, and its point to NHS England (NHSE) to improve its collaboration with industry, sent a strong message to DHSC and NHSE ahead of the renegotiation of the Pharmaceutical Pricing and Regulation Scheme – now the Voluntary Pricing Access Scheme (VPAS).

Government was genuinely concerned that a toxic combination of the historic low and slow uptake of medicines reputation and Brexit uncertainty would lead to global pharma reducing its investment in UK clinical research and delaying or not launching at all in the UK. The positives for industry from the VPAS included: • greater transparency of process for launch, culminating in the new NHSE Commercial Framework5 • a commitment that the National Institute for Health and Care Excellence (NICE) would review its methodologies to ensure they

F E AT U R E

Moving from a world of uncertainty bundled up under the banner of Brexit, there is hope as we go forward that we can return to business as ‘unusual’ within the UK pharma and biotech market

are more aligned to the needs of complex specialised medicines and Advanced Therapy Medicinal Products than the traditional primary care blockbusters it was set up to review in 1999 • maintaining the cost-effectiveness threshold despite strong pressure from certain vociferous health economists to reduce it to £15,000.

• the implementation of the NHSE Commercial Framework • Health Data Research Hubs • expansion of the Accelerated Access Collaborative • acceleration of the implementation of the NHS Long Term Plan • the new Medicines and Medical Devices Bill6.

MHRA

POSITIVE POLICIES

Now there is a Government with a majority, industry can be certain about the implementation of several proposed policy initiatives during 2020, that are broadly positive for medicines access and uptake. The policies that will create a more positive prescribing environment in 2020 include: • the Medicines and Healthcare products Regulatory Agency’s (MHRA) proposals to accelerate clinical trials and licensing approvals and be leaner and faster than the European Medicines Agency (EMA) and US Food and Drug Administration • the Review of NICE Methodologies

Following the EMA leaving London for the Netherlands two years ago, the MHRA has made clear commitments to be not only open for business from Brexit, but importantly approving licensing within 150 days – and unlike the EMA it’s already taking account of real world studies in its considerations for license.

This could propel the MHRA to become the regulatory and licensing ‘Kitemark’ and the first-choice regulatory authority for global pharma and biotech. This would move the UK from being a ‘participatory’ country, as in the EMA days, to become a landmark registration country, running clinical research studies and not a small element of them as is the case today.

M AG A ZI N E | FEB R UA RY 2020 | 21

NICE METHODS REVIEW

NICE has now started the process of reviewing its methodologies to optimise its evaluation methods7. It has faced new challenges over the last five years and this major overhaul is designed to address issues, including: • increasingly complex therapies being developed • growing pipeline of cell and gene therapies e.g.: CAR-T and a UK view that they are gaining EMA approval based on limited evidence • increasing levels of uncertainty, particularly regarding complex therapies and treatments for rare diseases, making it difficult for NICE to determine the true value of products, resulting in delayed access for patients.

Crucially, NICE is planning to increase its use of real world evidence in submissions, using broader sources of data including primary and secondary care databases, registries, surveys and national trend data.

NICE is pace-setting amongst global Health Technology Appraisals (HTAs) in this respect.

The 2019 IQVIA White Paper, Orphan Medicines Launch Excellence8 evidenced that having real world data in a NICE submission increased the chances of a positive outcome for rare disease medicines by 20%.

History has shown that where NICE leads, other countries’ HTA bodies follow. Having a real world strategy as part of a new medicines clinical research and HTA strategy is now a key launch differentiator.

NHS COMMERCIAL FRAMEWORK

As part of the 2019 VPAS, it was agreed that NHSE would develop a Commercial Framework for branded medicines. The NHSE Commercial Framework9 was released in November 2019, with a consultation that closed on 10 January 2020. Key messages include: • route maps in respect of how NHSE will implement additional commercial flexibility, and reiterate that simple patient access schemes (straight discount) remain the preferred option • a commitment to make Commercial Access Agreements (CAAs) (as exist in the Cancer Drugs Fund (CDF), the Highly Specialised Technology (HST) programme, and the NICE budget impact test (BIT) available more widely – though there is limited detail on the circumstances that would warrant it • at present, confidential complex CAAs are available within the context of the CDF and HST programmes, and products where spending exceeds NICE’s BIT. A key part of the Framework is a commitment to make these agreements available more widely where such flexibility is useful – again there is limited detail on what circumstances would warrant it • other mechanisms that might be part of a negotiation such as a cap on the total budget, price/volume agreements, cost-sharing, or outcomes-based agreements • quality-adjusted life years need to be closer to £20k than £30k • NHSE Commercial Directorate’s message that companies should work with NICE’s Office for Market Access and/or NHSE as early as possible (ie during Phase III) is key and provides very clear guidance on how to effectively engage.

2020 will see more new medicines and devices added to the first round of the Accelerated Access Collaborative as the vehicle to implement the recommendations of the Accelerated Access Review (AAR). The AAR is working on developing innovative commissioning routes to accelerate transformative medicine and technology uptake at pace and scale in the NHS. To date, the medicines in the AAR include Merck’s Mavenclad for multiple sclerosis and Amgen and Sanofi’s PSCK9s.10

22 | P H A R M A FI EL D.CO.U K

HEALTH DATA RESEARCH HUBS

A key differentiator for the UK on the competitively global clinical research stage is its uniquely rich health data ecosystem11 – the foundation for the UK to become a global leader in health data science. In 2020, the seven Health Data Research Hubs will be fully operational.12 They are: • DATA-CAN – the national health data research hub • Breathe – for respiratory health • GutReaction – for irritable bowel disease • DiscoverNOW – for real world research • NHS DigiTrial – for clinical trials • PIONEER – for acute care • Insight – for eye health.

The Hubs are centres of excellence with expertise, tools, knowledge and ways of working to maximise the insights and innovations developed from the UK’s health data. As an example of how they will support industry, patients and academia, the DATA-CAN partners (UCLP, Genomics England, IQVIA, Leeds Teaching Hospitals, Queens University Hospital, Belfast) have set out to enable and expand UK-wide cancer dataset access for research.

DATA-CAN will provide high-quality real world data to support health and care transformation and use real world data to support patient enrolment in clinical trials, improve clinical trial design and reduce delays in start-up times through the IQVIA Oncology Data Network platform (ODN).

Crucially, DATA-CAN will be able to determine the real world impact of NICE approved cancer treatments, through the ODN platform, that can then be used to support evidence for new indications and budget impact discussions of the future. All the Hubs are seeking industry engagement and support, now they are through their initial start-up phase.

NHS LONG TERM PLAN AT LOCAL LEVEL

Accelerating the implementation of the NHS Long Term Plan at local level will see Integrated Care Systems (ICSs) bringing together local organisations in a pragmatic and practical way to deliver the ‘triple integration’ of primary and specialist care, physical and mental health services, and health with social care.

ICSs will work with local authorities at ‘place’ level, and through ICSs, commissioners will make shared decisions with providers on population health, service redesign and NHS Long Term Plan implementation.

Every ICS will need streamlined commissioning arrangements to enable a single set of commissioning decisions at system level. This will typically involve a single clinical commissioning group (CCG) for each ICS area. CCGs will become leaner, more strategic organisations that support providers to partner with local government and other community organisations on population health, service redesign and NHS Long Term Plan implementation.

F E AT U R E

THE MEDICINES AND MEDICAL DEVICES BILL

The Medicines and Medical Devices Bill will ensure patients have ‘faster access to innovative medicines’ and support the growth of the UK life sciences sector. The Bill proposes cutting bureaucracy in clinical trials and licensing, making it simpler for NHS hospitals to manufacture and trial the most innovative new personalised and short life medicines, as their usage increases, and they are mainstreamed across the NHS. The Bill also proposes increasing the range of professions able to prescribe and supply certain medicines to make the most effective use of the NHS workforce where recommended by experts, as well as developing more innovative ways of dispensing medicines in local pharmacies.

HOPE ON THE HORIZON

Moving from a world of uncertainty bundled up under the banner of Brexit, there is hope as we go forward that we can return to business as ‘unusual’ within the UK pharma and biotech market. The collection and understanding of real world data sit at the heart of moving from a peri-Brexit fog with the promise of addressing some key pricing, funding and access issues that stand in the way of truly delivering medicines to patients that need them. Angela McFarlane is Senior Market Development Director at IQVIA www.iqvia.com References 1 https://phrmaccess.com/tag/efpia/ | 2.www.england.nhs. uk/eu-exit/medicines/medicines-faq/#q3 | 3 https://psnc.org. uk/contract-it/brexit-and-community-pharmacy/seriousshortage-protocols-ssps/ | 4 https://wwwmedia.supplychain. nhs.uk/media/191008-industry-letter-eu-exit-october-2019. pdf | 5 https://www.engage.england.nhs.uk/consultation/ nhs-commercial-framework-for-medicines/ | 6 https://assets. publishing.service.gov.uk/government/uploads/system/ uploads/attachment_data/file/853886/Queen_s_Speech_ December_2019_-_background_briefing_notes.pdf.| 7 https:// www.nice.org.uk/news/article/nice-announces-details-ofhealth-technology-evaluation-methods-review | 8 https:// www.iqvia.com/library/white-papers/orphan-medicineslaunch-excellence | 9 https://www.england.nhs.uk/blog/ commercial-framework-working-in-partnership-withthe-pharmaceutical-industry-for-the-benefit-of-patients | 10 https://www.nice.org.uk/Media/Default/acceleratedaccess-collaborative/aac-rapid-uptake-products-list.pdf | 11 https://www.worldhealthcarejournal.com/wp-content/ uploads/2019/11/Excellence-in-the-UK-Research-Ecosystem. pdf | 12 https://www.hdruk.ac.uk/infrastructure/the-hubs/

TOP 5 TAKEAWAYS 1

The UK wishes to ‘align as closely as possible’ to EU Regulation on medicines.

2

There are several policies that will create a more positive prescribing environment in 2020.

3

The MHRA could become the first choice regulatory authority for global pharma and biotech.

4

The NHS Commercial Framework commits to making Commercial Access Agreements more widely available.

5

The Medicines and Medical Devices Bill will ensure ‘faster access to innovative medicines’.

M AG A ZI N E | FEB R UA RY 2020 | 2 3

PHARMACY

POINTS MEAN MORE THAN PRIZES The Pharmacy Quality Scheme (PQS) offers community pharmacies the opportunity to receive financial incentives. WORDS BY Deborah Evans

N

HS England and NHS Improvement (NHSE/I) introduced the new PQS for 2019/20 as part of the new five-year agreement for community pharmacy (2019/20 to 2023/24) in England. This scheme, designed to incentivise change in the sector and align pharmacy more closely to General Practice, builds upon the success of the previous Community Pharmacy Quality Payments Scheme.

Incentives (as points) are available for clusters of activity with the aim of supporting community pharmacy to be a more integrated, clinical service-focused function within the wider NHS system, and provide even safer, accessible healthcare to patients. Activities included within PQS help support the NHS Long Term Plan.

Before being able to achieve the criteria, and therefore receive the financial incentives, pharmacies must meet the PQS Gateway Criteria which require them to: • be delivering the New Medicine Service and/or flu vaccinations • be connected by NHS mail • have updated content in their NHS website entry, and • have undertaken safeguarding level 2 training in last two years.

Once these Gateway Criteria have been achieved, pharmacies work on PQS clusters to earn points. One point has a minimum value of £64 with the potential to earn more from the scheme if some pharmacies do not achieve all their points. The declaration period for 2019/20 is February 2020.

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

The PQS clusters align closely with the new GP contract 3 and include activities on: • Risk management and safety – including a focus on reducing Look-Alike, SoundAlike (LASA) medicine errors, raising awareness of sepsis and creating a safety report.

• Medicines safety – undertaking audits in lithium, valporate, NSAIDs to complement the GP Quality Outcomes Framework Quality Improvement scheme.

• Disease and illness prevention – including Healthy Living Pharmacy (HLP) accreditation, all staff as dementia friends, creating a dementia-friendly environment, undertaking a diabetes foot and eye audit and reducing the sale of sugar sweetened beverages by 10%.

• Integration into Primary Care Networks (PCNs) – enabling a collaborative approach across all pharmacies in the PCN and having an appointed named pharmacy lead who must start engaging with the PCN clinical director.

• Asthma reviews – making sure appropriate action plans are in place and referrals are made for those using short-acting bronchodilators but not inhaled corticosteroids and identifying and referring children five to 15 without a spacer device and/or an asthma action plan.

• Digital enablers – updating the NHS website opening hours and demonstrating access to the Summary Care Record.

The PQS programme strongly indicates the intent of the NHS to use community pharmacy’s accessibility and capability to support the ambitions of the NHS Long Term Plan. Early indications are that community pharmacy is responding positively to the challenge to integrate into the local healthcare system, work closely with their GP colleagues and improve quality and safety for patients.

Community pharmacy is an increasingly important stakeholder for the industry, taking on an enhanced role in urgent care, prevention and medicines safety.

PHARMACY QUALITY SCHEME BUNDLES

30 points: Risk management and safety 25 points: Medicines safety audits 25 points: Prevention 12.5 points: Primary Care Networks (10 extra points for PCN lead) 5 points: Asthma 2.5 points: Digital 1 point is worth a minimum of £64.00 and a maximum of £128.00 A PCN lead pharmacy can expect to earn around £8500 if they meet all the requirements. Deborah Evans FFRPS FRPharmS FRSPH is Managing Director of Pharmacy Complete, a training and consultancy company working with pharmacy, the NHS and industry. Go to www.pharmacycomplete.org

Top 5 takeaways 1 NHSE/I introduced the new Pharmacy Quality Scheme for 2019/20.

2 It incentivises change and aligns pharmacy more closely to General Practice.

3 Incentives are available for clusters of activity.

4 Activities help support the NHS Long Term Plan.

5 PCN lead pharmacies can earn around £8500.

P F AWA R D S

T THE OLYMPICS OF THE PHARMA INDUSTRY Pf Awards Judge Mark Pringle, on why he’s involved in the prestigious event.

ELL ME A LITTLE ABOUT YOURSELF I’m an experienced

executive coach, business skills trainer and professional facilitator and have worked with international clients across Europe, Asia and America. In 1988 I started my career in direct pharmacy sales before moving into pharmaceutical sales.

I’ve worked in learning and development for a number of pharmaceutical companies and was EU Head of Training at Elan before I founded my first company, Business Edge Solutions and Training in 2001.

In 2008, Business Edge Solutions and Training became part of Ashfield Healthcare, and in 2018 I started my second company MORExcellent based around four key principles: • Maximise personal, team and organisation performance through…

• Optimising the strengths and talents of the people, allowing them to…

• Realise their genuine and authentic potential, leading to…

• Excellence in a truly genuine and authentic fashion.

My passion is enabling and empowering individuals, teams and organisations to become the very best versions of themselves, and I believe that my values and beliefs around best practice development is reflected in my involvement with the Pf Awards.

WHY ARE YOU INVOLVED IN THE PF AWARDS? I believe the Pf Awards

are the most robust and comprehensive benchmarking process in the industry.

They give the best of the industry’s talent an opportunity to ‘compete’ in a safe and secure way and truly test themselves.

I have been lucky enough to judge across many categories and am constantly impressed by the reliability and validity of the Pf Awards process. Year after year the organising team behind the Pf Awards look to how they can improve all aspects of the process and content, keeping them fresh and always relevant.

I BELIEVE THE PF AWARDS ARE THE MOST ROBUST AND COMPREHENSIVE BENCHMARKING PROCESS IN THE INDUSTRY

INTERVIEW BY

Emma Morriss

WHY DO YOU JUDGE? I’ve spent

my whole career developing and helping people learn how to be the best versions of themselves. I have been judging for the Pf Awards for over 10 years, and one of the many reasons I come back every year is the quality of the event and the superb logistics that make this the number one awards in the industry. The quality of the governance that underpins the process of judging ensures that the Pf Awards really do measure and recognise the best of the best.

WHAT DO PF AWARDS DO FOR INDUSTRY? Every year the industry that

we work in changes and adapts to massive shifts in the market. The Pf Awards are consistently reinventing and improving how they operate, meaning they really are at the forefront of the awards scene. The breadth and depth of the categories means that the Pf Awards offer the industry an unrivalled opportunity to recognise and reward the best of the talent they have developed. I’d have to say that, because they are the best, fairest and most reliable awards in the industry, in my view they are the Olympics of the UK pharma industry. Mark Pringle is Founding Director of MORExcellent.

R E A D Y F O R A L I F E - C H A N G I N G W I N ? V I S I T W W W. P F A W A R D S . C O . U K T O F I N D O U T M O R E M AG A ZI N E | FEB R UA RY 2020 | 2 5

LOOK AFTER YOUR HEART Responsible for more than a quarter of deaths in the UK, cardiovascular disease has been identified in the NHS Long Term Plan as the single biggest area where the NHS can save lives over the next 10 years.

W hat is cardiovascular disease?

Cardiovascular disease includes any conditions which affect either the heart itself or blood vessels and can include: • Coronary heart disease • Heart attack • Heart valve disease • Heart muscle conditions such as heart failure • Inherited heart conditions such as hypertrophic cardiomyopathy • Congenital heart disease • Atrial fibrillation • Stroke • Transient ischaemic attack or mini stroke • Peripheral arterial disease • Aortic disease • Vascular dementia.

It is responsible for more than a quarter of all deaths in the UK.

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

WORDS BY Emma Morriss

Coronary heart disease is the most common type of cardiovascular disease and is also the main cause of a heart attack. It is connected to vascular dementia – according to the BHF, those with a history of coronary heart disease are at least twice as likely to develop vascular dementia.

There is also a link between diabetes and cardiovascular disease as people with diabetes are at higher risk of developing coronary heart disease. Diabetes is associated with one third of heart attacks and one in four strokes in the UK. REDUCING THE RISK OF CARDIOVASCULAR DISEASES

Not all heart and circulatory diseases are preventable, but there are things you can do to reduce your risk. Prevention is better than cure when it comes to some forms of cardiovascular disease and the most effective way to reduce the risk of these is to implement long term lifestyle changes.

The National Institute for Health and Care Excellence recommends that people at high risk of, or living with, cardiovascular disease should: • Stop smoking • Keep alcohol consumption within the recommended weekly limit

• Eat a healthy, balanced diet with plenty of fruit and vegetables • Reduce their saturated fat intake • Replace saturated fats with unsaturated fat • Undertake at least 150 minutes of moderate intensity aerobic activity or 75 minutes of vigorous intensity aerobic activity or a mix of moderate and vigorous aerobic activity every week • Aim to achieve or maintain a healthy weight.

CARDIOVASCULAR DISEASE POLICY

Prevention is a significant part of NHS England’s and Public Health England’s work on the condition. The NHS Long Term Plan has a key priority to detect patients at risk of cardiovascular disease, prevent and treat the condition. It says that it’s the single biggest area where the NHS can save lives over the next decade and aims to prevent over 150,000 heart attacks, strokes and dementia cases during the period.

Working alongside the NHS Long Term Plan is the National Cardiovascular Disease Prevention System Leadership Forum which aims to improve the detection and management of atrial fibrillation, high blood pressure and high cholesterol, which can lead to cardiovascular disease, as well as reducing the health inequalities.

THERAPY AREA

KEY STATS

7.4 MILLION PEOPLE IN THE UK ARE LIVING WITH CARDIOVASCULAR DISEASE.

27%

of all UK deaths are caused by cardiovascular disease.

80% OF PEOPLE WITH HEART AND CIRCULATORY DISEASES HAVE AT LEAST ONE OTHER HEALTH CONDITION.

44,000

PEOPLE WILL DIE PREMATURELY (UNDER THE AGE OF 75) FROM CARDIOVASCULAR DISEASE EVERY YEAR.

THE ANNUAL HEALTHCARE COST OF CARDIOVASCULAR DISEASE IN THE UK IS

£9

BILLION. Source: British Heart Foundation (BHF)

Its 10-year ambitions for cardiovascular disease include: • 85% of the expected number of people with atrial fibrillation are detected • 90% of people with atrial fibrillation who are known to be at high risk of stroke to be adequately anticoagulated • 80% of the expected number of people with high blood pressure are diagnosed • 80% of people already diagnosed with high blood pressure are treated to target • 75% of people aged 40 to 74 to have received a cardiovascular disease risk assessment and cholesterol reading in the last five years by 2029 • 45% of people aged 40 to 74 identified as having a 20% or greater 10-year risk of developing cardiovascular disease are treated with statins.

CARDIOVASCULAR DISEASE TREATMENT

Statins are probably the most commonly known treatment associated with cardiovascular disease and the most commonly prescribed medication in the UK. They are used to lower ‘bad’ cholesterol or LDL (low-density lipoprotein) in the blood, reducing the risk of the build-up of fatty deposits in the arteries which can increase the risk of cardiovascular disease.

People who have had a heart attack or stroke are prescribed statins to reduce the risk of it happening again. People at high risk of cardiovascular disease are often prescribed them as they can lower the risk of a heart attack or stroke happening.

Other medications may include: • ACE inhibitors (angiotensinconverting enzyme inhibitors) • Angiotensin-II antagonists (ARBs) • ARNi (angiotensin-II receptorneprilysin inhibitor) • Antiarrhythmic medicines • Anticoagulant medicines • Antiplatelet medicines • Beta-blockers • Calcium channel blockers • Digoxin • Diuretics • Nitrates.

The British Heart Foundation has a lot of useful information on medication for heart conditions www. bhf.org.uk.

WHY WE INVENT AT MSD, WE ARE INVENTING FOR LIFE. We are not inventing for invention’s sake – we are on a quest to cure – and to have an impact on countless people’s lives worldwide.

MSD is inventing because the world still needs cures for cancer, Alzheimer’s disease, HIV, and so many other causes of widespread suffering in people and animals.

We are taking on the world’s most challenging diseases to help people go on, unburdened, to experience, create and live their best lives.

MSD. Inventing for Life.

To explore our commitment to invention, visit www.msd-uk.com and connect with us @MSDintheUK on Twitter, Instagram, LinkedIn, YouTube and Facebook.

Copyright © 2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Kenilworth, NJ, USA. All rights reserved.

Merck Sharp & Dohme Limited. Registered Office: Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU. Registered in England No. 820771.

Date of preparation: January 2020

GB-NON-02113.

M AG A ZI N E | FEB R UA RY 2020 | 27

THERAPY AREA

SULAKHAN’S STORY

I

n 2000, Sulakhan Singh Dard had a heart attack that required two heart operations including bypass surgery. He discovered his arteries had become blocked due to high cholesterol.

He explained: “Having a heart attack was very frightening. My son used to ask me about what I was eating, which was high in fat, but I felt I was a healthy man and not likely to have a heart attack.

“When I had the heart attack, I was very surprised to learn that it was due to high cholesterol. I don’t smoke or drink alcohol and I’m a vegetarian, so I thought I was healthy.

“My GP explained to me what high cholesterol was, and that it put me at further risk of stroke or vascular dementia. I didn’t want to have either of those, so I looked for ways to bring the cholesterol down.

“I sat down and analysed what I was doing and what I needed to do if I wanted to live. I understood that I needed to make some positive lifestyle changes and change my eating habits in order to improve my health. My family have supported me all the way.

“I now have less saturated fat, salt and sugar in my diet, and I eat things in moderation. I exercise daily, without fail. I walk over a mile every day, and I have joined a gym.

Gardening also helps to keep me physically active. I grow vegetables and have fruit trees which help with my healthy diet.

“Through healthy eating, regular exercise and medication I have lowered my cholesterol and managed to keep it under control.

“I feel more energetic, happier and in a way, I feel freer. I have a very positive outlook and I use my experience to help others.

“I volunteer up to 20 hours a week bringing awareness to the South East Asian community about how to live a heart healthy lifestyle. I say to everybody that if they have high cholesterol, they should do everything they can to bring it down and stay healthy.”

Sources https://www.bhf.org.uk/what-we-do/our-research/heart-statistics | https://www.diabetes.org. uk/guide-to-diabetes/complications/cardiovascular_disease | https://www.gov.uk/government/ publications/health-matters-preventing-cardiovascular-disease/health-matters-preventingcardiovascular-disease#cvd-ambitions-and-secondary-prevention | https://www.gov.uk/ government/publications/health-matters-preventing-cardiovascular-disease/health-matterspreventing-cardiovascular-disease | https://pharmafield.co.uk/healthcare/nhs-focus-oncardiovascular-disease/ | https://www.england.nhs.uk/rightcare/products/pathways/cvd-pathway/ | https://www.england.nhs.uk/ourwork/clinical-policy/cvd/ | https:// publichealthmatters.blog.gov. uk/2019/02/14/health-matters-preventing-cardiovascular-disease/

I sat down and analysed what I was doing and what I needed to do if Iwanted to live

Top 5 Takeaways

1 Cardiovascular disease includes any conditions which affect either the heart or blood vessels.

2 27% of all UK deaths are caused by cardiovascular disease.

3 Coronary heart disease is the most common type of cardiovascular disease.

4 The NHS Long Term Plan has a key priority to detect patients at risk of the condition, prevent and treat it.

5 Statins are the most known treatment associated with cardiovascular disease.

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

A DV ERTO R I A L

SELL THE PROBLEM YOU SOLVE, NOT (JUST) YOUR SOLUTION

CREATE EVIDENCE-BASED RECOMMENDATIONS AND ASSETS

There is a challenge for new innovation to succeed. WORDS BY Nick Williams

• Manuscripts for publication in peer-reviewed journals • Slide decks and materials to drive advocacy • Clinician/payer education activities.

Triducive’s Market Shaping Programme results in Level 4 evidencebased recommendations to improve care in a way that supports the market needs that your brand particularly addresses.

Tangible assets include:

BUILD NEW MARKET OPPORTUNITIES

I

n an environment where healthcare system affordability is at best static; being clear about the incremental value of a product entering an established market is vital to meet growth expectation.

But taking on existing treatment approaches head-to-head and entering an established product’s domain can be challenging. In this environment, the rules have already been set by other brands and are often well understood by healthcare stakeholders.

In light of this, clinical and commissioning decision-makers often fail to value important aspects of new treatments, with decisions often naturally defaulting to price or comfort with the status quo.

FOCUS ON THE PROBLEM YOUR BRAND IS BEST PLACED TO SOLVE

Adjusting the proposition is one way to address value gaps (and should certainly be tested), but much of this will have already been defined based on the initial evidence base and pricing policy.

So how do marketing teams ‘win’ in an established field with accepted norms and treatment expectations? The short answer: change the rules.

The key is to articulate the problem that patients, clinicians and the health system face in a way that is not yet widely appreciated but, if it were, your brand would be the most relevant solution.

SHAPE THE NEEDS OF YOUR MARKET

Since 2009, Triducive have developed relationships with healthcare system stakeholders and expertise at successfully engaging with them. This positions us to develop and harness expert decisionmaker opinion to shape the needs of markets. Triducive’s Market Shaping Programme delivers this through a proven and proprietary approach in order to: 1. Identify the opportunity to change the status quo 2. Create focus with thought-leading experts around new market ‘norms’ 3. Amplify this perspective to add weight and credibility.

making your brand

At Triducive, we have worked with more than 100 healthcare brands across the UK, EU and US to create new, ownable opportunities for pharmaceutical brands EXAMPLES OF MARKETS SHAPED THROUGH TRIDUCIVE’S MARKETING SHAPING PROGRAMME MARKET FOCUS

OUTPUTS DELIVERED

IMPACT

Emergency contraception (UK)

4 Months

National guideline changed

Severe infection (EU)

6 Months

EU-wide prescribing policy updated

Autoimmune disease (UK)

4 Months

Recognition of specific patient cohort

Mental Health (UK)

6 Months

New commissioning priorities adopted

“There is now so much weight of opinion that payers don’t have any reason to say no” Brand Director, UK Pharma

Contact Triducive for initial advice if your team needs practical support to shape new market opportunity, then we’d love to talk to you. Please contact us using info@triducive.co.uk or visit us at www.triducive.co.uk

more relevant to healthcare systems

triducive.co.uk

M AG A ZI N E | FEB R UA RY 2020 | 2 9

I N C O N V E R S AT I O N

Tick, tick, tick

Rosie Milsom, Fundraising and Communications Manager at Caudwell LymeCo Charity is hoping to find a treatment that works for every patient, at every stage of Lyme disease.

WORDS BY Emma Morriss

W

hat is Caudwell LymeCo Charity?

We are a UK charity whose vision is for everyone who catches Lyme disease in the UK to be tested and fully cured on the NHS. Our mission is to find a truly reliable test and treatment for Lyme disease that’s able to diagnose and cure every patient.

What’s the charity’s history? We were founded in 2016 by businessman and philanthropist, John Caudwell, after he and 11 members of his family were diagnosed with Lyme disease. After going public with the struggles he and his family had faced in getting diagnosed, he was inundated with stories from other patients, many of whom had suffered for years without answers. It became clear to him that something needed to be done to improve care for patients in the NHS, so he started the charity in order to fund vital research.

In 2018, the charity was on the National Institute for Health and Clinical Excellence (NICE) Guideline committee

TOP 5

TAKEAWAYS

for Lyme disease, helping to form the latest recommendations and advice for medical professionals on approaches to diagnosis and treatment, and we also helped to form the NICE Quality Standard for Lyme disease, published in July 2019.

We’re excited about what 2020 will bring as we move closer towards a Lyme disease research project.

What are your objectives? We have three objectives. Our primary aim is to raise money to fund desperately needed research into a truly reliable test and treatment for Lyme disease.

Our secondary aim is to raise awareness – among the public and with health professionals – of how Lyme disease can be spotted, and even prevented, so that as many people as possible can avoid suffering from this debilitating illness.

We also provide an information and advice service to patients, based on the NICE Guideline.

What is Lyme disease? Anyone can catch Lyme disease. It’s an infection spread by tick bites that attacks the nerves, brain,

1

Anyone can catch Lyme disease from a tick bite.

3 0 | P H A R M A FI EL D.CO.U K

heart, joints, and eyes. It can also cause a characteristic skin rash. A common misconception is that Lyme disease can only be caught by those spending time in forests and countryside, but ticks can also be found in gardens and urban parks.

Initial symptoms are a bit like the flu – fever, headaches, swollen glands, or stiff neck. Some people may experience joint pain, cognitive issues and nerve pain, as well as severe fatigue. Many people end up being diagnosed with conditions such as Chronic Fatigue Syndrome, ME or fibromyalgia.

2

There’s no truly reliable test for Lyme disease.

3

Delayed diagnosis can lead to life-limiting symptoms.

Public Health England suggests there are around 3000 new lab-confirmed cases of Lyme disease a year in the UK. However, given the lack of a truly reliable diagnostic test and treatment, the true figure is thought to be much higher.

A study published by BMJ Open in July 2019 looked at UK GP medical records from 2001 to 2012. It found that cases of Lyme disease increased ten-fold within this time, and that if the increase had continued at the same rate, there will be around 8000 cases diagnosed and treated in primary care in 2019.

The treatment for Lyme disease is a three-week course of doxycycline at 200mg a day. If symptoms persist after this initial course, the NICE Guideline recommends a further three-week course of amoxicillin at 3g a day. When Lyme disease is treated early after infection, antibiotic treatment enables a full recovery in most people. However, if diagnosis is delayed, life-limiting symptoms can develop, from which some people sadly never recover.

Although peak tick season is from May to October, ticks are active all year round, so preventative measures should always be taken. We recommend sticking to wellmaintained pathways when out walking, tucking clothes in, wearing insect repellent on exposed skin, and checking yourselves and your pets carefully for ticks when you return home; removing them safely with a tick removal tool.

What research is being undertaken into Lyme disease? A small amount of research on improving diagnostics and tick ecology is being undertaken in the UK, but it’s not getting the breakthroughs that are required. We are currently in talks with the Department of Health and Social Care to co-fund a project into

4

Caudwell LymeCo Charity is funding research and raising awareness.

improving the current diagnostic tests, as their limitations mean that many patients are receiving incorrect results which are impacting their care. We hope these talks will be successful and that we’ll be able to begin this project in the next year or so.

There is a larger amount of Lyme disease research happening in the US, both on improving diagnostics and finding effective treatment for those with a long-term infection. We are watching it with interest. However, it’s important that research happens here in the UK, on UK patients with UK strains of the disease.

How is the pharma industry tackling Lyme disease? Is there more that it could do? As mentioned, the current treatments available on the NHS do not work for every Lyme disease patient.

We need the pharma industry to support research which helps to find a treatment that works for every patient, at every stage of the disease.

Educating themselves about Lyme disease would be of massive benefit to all involved in the industry. Although there seems to be a widened recognition of the disease in recent years, there is still a lot of work to be done in fully understanding the infection and the issues patients face – especially for those who work directly with members of the public (in pharmacies, for example), who may be the first point of contact for people experiencing symptoms.

We are always happy to deliver free awareness talks to medical or general community groups. Should anyone like more information on this, or general information/leaflets on Lyme disease, they can contact the charity directly.

Go to www.caudwelllyme.com

Passionate about outstanding performance Passionate about improving the lives of patients

5

The pharma industry needs to support research into treatments.

Contact us on: UKinfo@tillotts.com Telephone: 01522 813500 NU-00200 Date of preparation: July 2018

M AG A ZI N E | FEB R UA RY 2020 | 31

Stemming the pharma brain drain What more can life sciences firms do to hang on to restless pharmacovigilance talent, as their most valued employees crave broader experience?

WORDS BY Alan White

32 | P H A R M A FI EL D.CO.U K

A 2018 survey by ABPI in the UK found that over 45% of respondents rated PV as a high or medium priority for talent attraction/retention

A

t a recent industry event – the FT Global Pharmaceutical and Biotechnology Conference in London – there was a lot of talk about the challenge of retaining talent in life sciences, not least in safety and regulatory fields. This is particularly the case as younger professionals’ ambitions for a broad base of experience conflict with companies’ needs to hang onto the expertise they have invested in.

The challenge is acute in safety/quality and regulatory areas, where companies’ ability to achieve and retain the optimum depth of skills and experience is continuously threatened by employees’ ambitions to build rounded CVs, and keep their work interesting – by trying out a range of roles.

The issue appears to be global, too. More modest-sized biotechnology companies find themselves particularly affected, unable to match the salaries and ‘on-paper’ benefits of the global pharmaceutical giants. Too often, these smaller firms are giving new graduates a good grounding in pharmacovigilance for instance, only for a larger brand to poach them and capitalise on all that experience.

While filling regulatory roles continues to be a challenge across the industry, recruitment for pharmacovigilance (PV) roles is a particularly acute issue. This is because PV is a moving target: new safety risks are emerging all the time, as are new means of locating and identifying them. PV positions also require applied experience: the ability to understand whether a safety signal is significant or not, amid all the real-world market feedback.

A 2018 survey by the Association of the British Pharmaceutical Industry (ABPI) found that over 45% of respondents rated PV as a high or medium priority for talent attraction/retention. People able to step up to a Qualified Person role are in particularly short supply, a trend which is replicated across Europe.

FULFILLING GROWING DEMAND FOR WORKPLACE FLEXIBILITY

Rather than continue to lament the problem, the life sciences industry needs to come up with new and creative ways to foster and hold on to rising talent. For instance, while younger employees may be ambitious for a range of different experiences, they are reputedly less influenced by salary than previous generations.

P F TA L E N T

Freedom to explore, create, innovate and experiment at work are often among their personal priorities, along with the ability to protect their work-life balance – which may mean being able to apply for extended periods off work to fulfil extra-curricular ambitions, work from home, or have more control over their working hours.

This shift in values plays to the strengths of biotechnology firms, which may not be able to match the eye-watering salaries offered by higher-profile brands – but are more agile and dynamic in structure and culture, and better able to offer more flexible terms, as well as the chance to shadow and try out different roles.

In our own company, we had to draw a line and acknowledge that trying to match 20% to 50% salary hikes that larger industry players are offering is unsustainable. Rather than try to meet unrealistic remuneration terms, we focus on fostering a culture that people want to be part of; and offering the chance to work from home – where a larger corporate culture might not allow this.

Balancing the age/maturity of a company’s talent is important, too – so, if Millennials are prone to getting itchy feet within one to two years, there are already experienced senior PV staff to cover any gaps. Balancing the demographics also gives younger professionals the chance to shadow mentors; not just in their own field, but in neighbouring disciplines – to broaden their experience and take advantage of a more holistic opportunity to grow. So if someone comes out of university with a pharmacy degree without being quite sure of the career route they want to take, they have an opportunity to feel their way into different areas before committing to specialisation.

INVITING INNOVATION

Something else that workplace newcomers tend to rate in employers is the ability to make a difference, be heard, and have access to the latest tools and techniques. Smaller firms–biotechnology, or service providers–can provide more of an entrepreneurial environment: one that fosters innovation, supported by structure. It isn’t just younger members of the team that appreciate this; those in their 40s, who might otherwise find themselves in a career rut, can relish the chance to broaden their horizons, push boundaries and try something new, so that they keep evolving and expanding their own skills and experience.

We have a pot of cash set aside for process improvements and technology-enabled transformation, triggered by ideas from front-line team members. This gives people a sense of inclusion and buy-in, via the ability to see their ideas through. From the automation of international medical literature screening, to speech-enabled case reporting, we have taken these proposals and run with them, which has been thrilling for those responsible and kept them motivated and engaged.

The skills crisis in our industry is unlikely to subside any time soon, but it’s through new thinking that modest-sized organisations will succeed in overcoming talent shortfalls. The other option, of course, is to talk to service partners about how they might help fill any glaring skills gaps, or provide additional opportunities for valued employees to round out their experience.

Alan White is Chief Executive Officer of Arriello. Go to www.arriello.com Source: Bridging the skills gap in the biopharmaceutical industry: Maintaining the UK’s leading position in life sciences, 2018 study by the Association of the British Pharmaceutical Industry (ABPI)

Top 5 takeaways 1 Retaining talent in life sciences is challenging.

2 In PV, it is a particularly acute issue.

3 Foster an attractive culture.

4 Offer employees flexible terms and chances to innovate.

5 Balance the age/maturity of talent.

M AG A ZI N E | FEB R UA RY 2020 | 3 3

Movers &Shakers WHO’S GOING WHERE AND WHY THEY’RE GOING THERE. WORDS BY

Hannah Alderton

PHARMA

PHARMA

Jo Bullen

Stuart Hughes

MSD has appointed Jo Bullen as the new Executive Director of External Affairs for the UK. Jo brings over 20 years of policy and communications expertise from life sciences and pharmaceutical organisations to MSD and has extensive experience from previous leadership roles.

Pathios Therapeutics has appointed Stuart Hughes as Chief Executive Officer and Director. Formerly Senior Director and Head of Pharmacology at Vertex, Stuart is seasoned in drug discovery and development, with a breadth of experience leading translational drug development programmes.

PHARMA

Stefan Fraenkel

HEALTHCARE

Timothy Irish The National Institute for Health and Care Excellence (NICE) has announced Timothy Irish as its new Interim Chair. Tim has worked in the life sciences industry for 30 years.

3 4 | P H A R M A FI EL D.CO.U K

Inceptua has appointed Stefan Fraenkel as Chief Executive Officer. Previously Stefan was the Executive Vice President, and a Member of the Executive Leadership Team.

Stefan said: “I’m both humbled and proud to get this opportunity as we are growing and transforming Inceptua to further strengthen our position.”

MOVERS & SHAKERS

AGENCY

David Thompson & Brian Hepburn The Envision Pharma Group has announced that David Thompson, (right) current Chief Commercial Officer, is to become the new Chief Executive Officer (CEO) to coincide with the appointment of its current CEO, Brian Hepburn, (left) to the position of Executive Co-Chair.

TIME TO TAKE A NEW

DIRECTION.

2

PHARMA

Lewis Cameron Lewis Cameron has been appointed Chief Operating Officer at Ergomed. Lewis is an experienced senior executive and was Head of Global Clinical Development at Covance.

He was also Executive Vice President of Oncology and General Manager for Central and Eastern Europe, and Asia-Pacific Regions at Chiltern International.

PHARMA

Dr Richard Torbett The Association of the British Pharmaceutical Industry (ABPI) has appointed Dr Richard Torbett as its new Chief Executive. Richard joined the ABPI in July 2015 and was Executive Director of Economic, Health and Commercial Policy where he was responsible for negotiating the 2019 Voluntary Scheme for Medicine Pricing and Access.

Please get in touch to discuss your new career path!

AGENCY

Greg Flynn Ashfield has promoted Greg Flynn to President of Ashfield Commercial and Patient Solutions. He has almost 25 years’ experience working within both the pharmaceutical service and manufacturer sector in Europe, the US and Asia.

chasepeople.com 0131 553 6644 connect@chasepeople.com

M AG A ZI N E | FEB R UA RY 2020 | 35

PHARMAJOBS

PSYCHOMETRIC TESTING IN PHARMA Psychometric testing in pharma has become increasingly popular.

Pf asked its recruiters for insight. WORDS BY Emma Morriss

APTITUDE AND ABILITY

SKILL AND ATTAINMENT

PERSONALITY TESTING

LAUREN WARD, RECRUITMENT CONSULTANT, EVOLVE

CLARE JONES, SENIOR CONSULTANT, CHASE

Psychometric tests are commonly used to provide an objective and impersonal view during a recruitment process, without unconscious bias. Certain tests are specifically designed to carry out in-depth measures of factors such as intelligence, working style, numerical and verbal reasoning and logical thinking. The type of test that is used by an organisation will vary depending on the job type and sector.

Applicants due to take psychometric tests can normally expect to answer a series of multiple-choice questions, where one answer is selected under time limited conditions.

Many of these tests are performed online.

The answer chosen will reflect the applicant’s own opinion of their capability, so it is important not to give answers that the applicant thinks the employer will want to see. Psychometric tests can usually detect when this happens.

Commonly, the results are assessed by an independent organisation who will provide a detailed insight as to how an applicant would potentially fair in a given role. Results can then be used during the interview process to ask probing questions to further assess an individual’s suitability for the vacancy.

Go to www.evolvecouk.com

There are three main types of psychometric tests: aptitude and ability tests, skill and attainment testing, and personality testing. They are designed to allow employers and recruiters the ability to check a potential employee’s mental abilities, personality traits, skill, motivations, intellect, and interests.

By applying psychometric assessments, the emphasis is to ensure that only the right people are hired.

Typically, a psychometric test should never be used in isolation, but as one part of a wider, integrated evaluation strategy. When used with other selection tools (interview/assessment centre), an employer can get a more rounded view of the candidate’s likelihood of success.

Rather than focusing retrospectively on experience and skills, psychometric tests can be useful in assessing a candidate’s future potential and possible development needs. Given the limitations of an interview situation, this is often otherwise difficult to ascertain. They can also be of advantage in helping candidates, who feel that they have underperformed in their interview or assessment centre, make up some lost ground. Go to www.chasepeople.com

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MARTIN ANDERSON, MANAGING DIRECTOR, CARROT PHARMA RECRUITMENT

Beyond traditional testing, Emotional Intelligence (EI) and Fluid Intelligence (FI) are frequently being used. EI is a person’s ability to be aware of their emotions and those of other people, understand how they and others may feel and behave as a result of these emotions and use this to form productive working relationships. It’s about empathy, understanding, being flexible and adapting to other working styles.

FI is ‘the capacity to think logically and solve problems in novel situations…the ability to identify patterns and relationships that underpin novel problems and to extrapolate these findings using logic.’1 When it comes to taking these tests, answer honestly and accurately. Numerical or verbal reasoning tests can be challenging but there are practice versions online.

I’d suggest that candidates make time for the tests, as some can be up to an hour. If doing them online, be in a quiet place with no distractions and be in good physical and mental health. They’ll perform better if they’re feeling fresh and positive.

When coupled with a strong interview performance, candidates can land that dream job. Go to www.carrotpharma.co.uk References: 1 Psychologytoday.com

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