Stephen Whitehead: pharma has transformed

pharmafile | February 2, 2015 | Feature | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing |  ABPI, CDF, NHS, NICE, PPRS, Stephen Whitehead, lgbt, pharma 

According to The Association of the British Pharmaceutical Industry (ABPI) the dominant issue in 2015 will be the affordability and price of drugs, but one challenge still facing the UK is the need to address the low levels of patient access to innovative medicines.

We spoke to the ABPI’s chief executive Stephen Whitehead, who has been at the helm of the London-based industry group since June 2011. During this time he has played an important role in implementing pricing negotiations with the Department of Health.

Formed in 1891, the organisation was originally known as the ‘Drug Club’. Now well over 100 years later its members’ supply around 80% of the medicines prescribed through the NHS today.

At the ABPI’s R&D conference in November last year, Whitehead said that one of the things the ABPI tried to demonstrate was the changing nature of the R&D profile. He also set out to explain the varying landscape of R&D dynamics and the very significant ‘improvements of the pipeline’.

“The nature of discovery and development has changed, the industry has changed, but we’re still operating within a model that was probably designed in the 1980 and 1990s,” he said. “The nature of science has also changed but we are operating in a regulatory and healthcare technology assessment model and an NHS model that is living in the past.”

Speaking about the conference, which focussed on the opportunities and benefits of stratified medicine, Whitehead says: “The dynamic that we were trying to paint is what we call the ‘gap’, the gap of perception but also the gap of potential utilisation of those medicines when they come through.”

Government policies

On the eve of our interview, George Freeman, the UK’s new minister for life sciences, declared his government’s plans to cut the time it takes for life-saving drugs to become available through the NHS.

“It’s really a question of how do you marry the science with the system, the system being NHS and the regulator the MHRA, and also NICE,” says Whitehead in response.

“That’s really the challenge that we’re all confronting, that’s why what George [Freeman] announced is actually very refreshing because it really is saying ‘look, science is offering huge opportunities, how do we meet these opportunities and challenges in a way that is most productive for the patient?’”

The aim, according to Freeman, is to integrate the health service with the pharmaceutical industry and life sciences research to bring innovations to patients quicker. “We’d also really like a more vibrant NHS on the uptake and access of new medicines,” continues Whitehead.

Speaking about what the ABPI wants to see from the next government, he says: “We want a continuing commitment to political leadership in terms of the importance of this sector; Freeman’s appointment is absolutely unique to have a life sciences minister, a fabulous appointment, but whoever wins we want to see continuity and we want to see NICE becoming more pro-innovative to champion innovation.”

Earlier diagnosis of cancer

Much of this innovation centres around cancer drugs. Research published in 2009 by the National Awareness and Early Diagnosis Initiative reported that up to 10,000 people in England could be dying every year because their cancer was diagnosed late.

With almost one in four people developing cancer during their lifetime, recent guidelines from NICE tackling earlier diagnosis for cancer patients is a step towards addressing this.

The final document is expected to be published in May this year and will set out which symptoms could be linked to what cancers, and provide clear recommendations to GPs with suitable tests and referrals to specialist services.

When quizzed on the status of NICE and on the ongoing discussion around its reform, Whitehead tells us: “We think NICE is an important part of the NHS, an important part of sending signals to the NHS about value – what should and shouldn’t be done. “We do believe that NICE has significant authority that – with further reform – could be able to achieve these objectives.

“NICE has a strong international reputation. We do believe in value assessment, we think it’s important that the values of medicines are assessed and that signals are sent to the NHS.”

Any potential reform of NICE was put on hold in 2014 amid concerns over market access in the UK. The watchdog believes more deviations must be fashioned to deal with these concerns.

“I think that the way that the reform should be understood is in the context of what’s happening in the nature of medicines and changes, particularly stratification and targeted medicines,” continues Whitehead.

“There are enormous possibilities and NICE represents the new life science review. The position of NICE should be evaluated very clearly in that context.”

The proposed guidelines expected in the middle of 2015 may clear a path for such a reform, but time will tell. The UK body has also come under fire in recent years over its rejection of new medicines, sparking the creation of the Cancer Drugs Fund (CDF).

“Our view is very clear; those medicines need to go to NICE and NICE need to have greater flexibility on end of life criteria to access those medicines to get them into baseline commissioning,” says Whitehead. “We need to make sure that NICE works in cancer and that NICE sends the value signals to the NHS for usage.”

Since March 2011, the CDF has injected an extra £200 million a year into the NHS to pay for new oncology products not recommended by NICE.

In January the government announced the budget for the CDF would increase to an expected £340 million when the fund ends in April 2016.

As a result of the extra money being added into the fund NHS England says it will need to assess the price of fund medicines – and NICE has already said it should use its processes to do this.

Whitehead adds: “We believe that the correct approach is not for the NHS to set its own evaluation methodologies because NICE can do that. But NICE should be able to do that with greater flexibility – that’s the solution.”

PPRS: creating headroom for innovation

Another arrangement causing much debate is the 2014 PPRS pricing scheme, which terminates at the end of 2018. The pharma industry’s reaction to the plan has been mixed, with some suggesting that it is a missed opportunity for patients and also creates financial problems for smaller companies.

The amount of payment due from pharma via the PPRS scheme for 2015 was confirmed by the DH and the ABPI in December 2014. They calculated that a payment percentage of 10.36% will be due in order to underwrite the growth of the medicines bill.

Whitehead says: “Although the increased spend demonstrates a trend towards growth in the use of medicines, we know that this growth is not in new, innovative medicines but in older medicines and specialised commissioning.

“The Department of Health’s growth estimates for 2016-18 are one possible scenario for the future, however the PPRS scheme is designed to calculate payments based on actual growth.”

Whitehead continues: “It’s gradually being digested by all parties who are asking: ‘have you really done that? Have you really assumed the risk of growth in the medicines bill?’ And the answer is yes we have, in very difficult and trying circumstances with very few alternatives available.”

In its first year the PPRS payments were fixed at 3.74% of companies’ net sales; the allowed year-on-year growth is set to rise from zero in 2014/15 to 1.9% by its final year in 2018.

“It will be a difficult scheme to manage but definitely preferable to a significant price cut, and one that has a lot of opportunities to address the uptake issues of new medicines to make sure they can be utilised.”

Last year the UK government received a £79 million refund from the pharma industry after having spent too much on patented medicines under the PPRS. The total paid in 2014 was £229 million; when the overall sum was actually expected to be around £300 million.

The industry will continue to make payments to the DH if NHS spending on branded medicines exceeds the allowed growth rate. “Getting that rebate back to the decision-makers, getting that hard cash is critical,” says Whitehead.

“We want that money to be used to create headroom for new medicines coming through or current medicines that are not being utilised, so the whole concept here is to create the headroom for innovation. This extra money will allow more medicines to be prescribed to address the deficit in terms of prescriptions of medicines in the UK.”

Manifesto for change

Commenting on the future of the ABPI, Whitehead told us: “The dominant issue for 2015 will probably be affordability and price of medicines.” The industry group’s main activity for 2015 he says “honours transforming relationships, the commercial environment and tomorrow’s medicine, today”.

The reputation of pharma itself is of course always a topic of discussion, and according to Whitehead the ABPI is doing what it can to give the industry more credibility.

“Sometimes the industry has struggled with reputation issues. We are seeking to drive a further understanding of the role of medicines, the value of medicines to the patient and the healthcare system.”

According to Whitehead the greatest challenge facing UK pharma is not reputation, but rather addressing low levels of patient access to innovative medicines. In a nutshell, the body hopes for continued public investment in science and innovation to help the UK reach Organisation for Economic Co-operation and Development (OECD) targets during the next Parliament.

“We know we are confronting difficult times, we know the pressures the NHS is under. The way to resolve those is through partnership, discussion and collaboration to make sure medicines are utilised properly.”

Diversity and equality

Funding and access to medicines aside, a somewhat different manifesto for change facing industries all over the world is reflecting the general differences within society itself and creating diversity.

Since the introduction of the Equality Act in 2010, all institutes within the NHS have been required to promote equality for their gay, lesbian, bisexual or transgender (LGBT) staff.

A subject not too often discussed in the pharma sector and also among wider healthcare environments are LGBT social issues. We addressed this topic with Whitehead, who last year was named one of the 25 most influential LGBT people within healthcare, and is working to promote inclusion and lead by example.

“I’ve never been shy about my sexuality, and to me it’s never been an issue. It says something quite significant about the pharma industry that they want to have an openly gay man representing them with all sorts of stakeholders. So that’s just one of the things that the industry should be credited for.”

Whitehead explains: “My role is a very high profile political role, representing a very important industry often considered quite traditional and conservative. So I think it says something quite significant about the pharma industry.”

The first ever Health Service Journal’s ‘LGBT Role Models’ list was supported by the NHS Leadership Academy and was voted for by HSJ readers and a judging panel.

The judges responsible for assembling the list included representatives from the NHS Leadership Academy and the Royal Free London Foundation Trust.

“One of the reasons I was really pleased about it was because I was there with a lot of people from the NHS which I thought was great. To be included in that context represented to me a significant barrier had been broken about what the NHS thinks of the industry.”

A member on the HSJ judging panel concluded: “To see Stephen take his partner along to meetings or events with the other chief executives or chairs of the board of the biggest pharmaceutical companies in the UK is extremely impressive.

“Stephen takes no prisoners, and what he does – and to do it as an openly gay man – deserves recognition.”

One thing the judging panel picked up on was the fact that the NHS appears to be working hard to make itself a more welcoming, understanding, tolerant and positive environment for LGBT employees and patients.

Readers taking part in an accompanying survey were asked whether the NHS is as inclusive, accessible and welcoming to the LGBT community as it could be.

Generally, the study suggested that workplaces are performing well in terms of their attitudes and support towards the LGBT public. However, many felt there was room for improvement in how the service deals with homophobic behaviour from colleagues or service users when complaints do occur.

The survey asked around 800 healthcare employees whether or not the sector had become friendlier towards the LGBT community in the past five years – over half said yes.

Such diversity and acceptance of general differences is good for the healthcare industry and also for pharma. A fresh outlook is sincerely welcome within a sector bogged down by bad reputation.

The ABPI 2015 manifesto

Employing over 73,000 people in the UK, the biopharma industry invests more in R&D than any other business sector.

To reflect this, the MHRA has to put pressure on the government to encourage and maintain investment in the UK biopharma industry, to meet challenges in an increasingly competitive global environment.

Ahead of this year’s general election in May, the ABPI manifesto says it will call on the government to:

• Conduct a review of how NICE can better align to help meet the UK’s priorities, including reviewing the suitability of the QALY

• Make the medicines that are not referred to NICE available to patients as early as possible by ensuring they are adopted and funded by NHS organisations

• Embed accountability for delivering the right of patients to access new medicines, on the advice of their doctors, in NHS England’s performance monitoring system

• Run a public awareness campaign on the NHS constitution and give clearer guidance for patients on their rights

• Hold a multi-stakeholder strategic review of stratified medicines and their use in the NHS to identify key challenges.

Has the ABPI got the right priorities in its manifesto? Tweet us your comments and join the conversation on Twitter.

Tom Robinson