New cancer medicines: Joint working between the NHS and the pharmaceutical industry

Steve Williamson, Conference Chair and Consultant Pharmacist for Cancer Services

Introduction

A bright and crisp November morning in Newcastle saw the first national conference to be held by the North of England Cancer Drugs Approval Group (NECDAG). The theme of the conference was joint working between the National Health Service (NHS) and the pharmaceutical industry and how the two might work together to optimise access to cancer medicines for NHS patients.

Delegates included representatives from both camps, each understanding that there was a lot to learn from the other. How can we work effectively together, for example, until the NHS understands fully how the pharmaceutical industry tackles oncology drug pricing and marketing in the UK and, in turn, the pharmaceutical industry has an in-depth understanding of the constraints under which the NHS commissions cancer drugs?

In developing the agenda for the meeting, my aim was to encourage debate and provide an opportunity to explore controversial issues, hopefully highlighting opportunities for improved joint working, which I have no doubt will ultimately benefit the patient.

As I said on the day, we are all NHS patients whether we work for the industry or the NHS, and at some point cancer will touch the lives of ourselves or those in our family, so it is an important issue to tackle. Here, I provide a brief overview of the meeting, with links to the slides presented on the day for those who want to explore further.

Please click here to view Mr Steve Williamson’s slides

Please click on the following session headings:

NECDAG: A brief overview

NHS perspective on individual funding requests (IFRs)

Industry perspective: UK oncology market

Drug pricing in the UK: Are risk-share schemes here to stay?

Future challenges for access to new cancer medicines

De-mystifying QALYs

Communication with patients

Breakout sessions

Final remarks

NECDAG: A brief overview

The meeting was opened by Ken Bremner, Chief Executive Officer, Sunderland Hospitals, and Chair of NECDAG.

Mr Bremner outlined the history of NECDAG, explaining how media pressure, patient campaigns against postcode prescribing and lack of access to drugs (including, for example, pemetrexed and trastuzumab) had forced its formation.

In response to the public, the Northeast NHS Chief Executives had worked together to encourage the individual cancer networks to form a regional drugs approval body that could make decisions about non-National Institute for Health and Clinical Excellence (NICE) approved drugs for the whole local population of 3.2 million, thereby ensuring consistency of access to medicines across the northeast.

While NECDAG has achieved a great deal since its inception, including approving drugs like temozolomide, erlotinib and sunitinib all at least 12 months before they received a positive NICE approval, the group has also faced numerous challenges, such as those raised by the introduction of patient access schemes (PASs) and the NICE end-of-life ruling. Ultimately, while groups like NECDAG have an important role to play at the moment, it is hoped that NICE will soon be in a position to assess drugs in a more timely manner. At that point, the need for a group like NECDAG would cease to exist.

NHS perspective on individual funding requests (IFRs)

Dr Mike Guy (Medical Director, NHS North of Tyne) talked about the impact of decision making at primary care trust (PCT) level and what happens when there are drugs that either NICE or a group like NECDAG are not able to approve—particularly when patients come to the PCT via their clinician with IFRs or requests for treatment under the umbrella of ‘exceptional circumstances’.

Dr Guy discussed patients’ rights to treatment under the new NHS Constitution and how that meant that the PCT had to have policies in place to deal with requests and, in turn, how a group like NECDAG might support the PCT. Concern was expressed about the number of IFRs that were coming through under the banner of ‘exceptional circumstance’ when the reality was that, for the majority, no exceptional circumstance existed.

Dr Guy discussed the very personal nature of these requests from the point of view of both the clinician and the patient, and how emotional and difficult decisions related to them could be. He concluded that PCTs are facing increasing financial challenges and that while these funding requests only account for a very small proportion of the PCT budget, they take up huge amounts of time and emotional energy.

Industry perspective: UK oncology market

Amanda Cunnington (Head of Healthcare Development, Roche Products Ltd) gave an industry perspective on the UK health market, covering such topics as drug access, marketing and the challenges faced in preparing submissions to NICE and other regulatory bodies.

Drug pricing in the UK: Are risk-share schemes here to stay?

During this session the floor was shared by Allan Karr and Eric Bokmans.

Mr Karr (Pharmacy Business Services Manager, University College London Hospital) has worked in pharmaceutical procurement for many years and is part of the national group that looks at contracting drugs for the NHS. He talked the delegates through how drug prices are set in the UK, looking at the Pharmaceutical Price Regulation Scheme (PPRS) and how this impacts on drug prices and what that means for access to medicines for cancer patients.

Dr Karr then talked about PASs and how they have been growing, particularly in the area of oncology medicines, rendering drugs that might not otherwise be cost effective accessible on the NHS. He talked through some of the many challenges that these schemes have posed, mentioning, for example, administrative burden and poor reimbursement strategies.

Drug pricing in the UK: Are risk-share schemes here to stay? contd.

Erik Bokmans (Director of Sales and Marketing, Celgene Ltd) then provided the industry perspective.

Celgene are the manufacturers of lenalidomide, a drug approved by NICE at the beginning of 2009. Its approval was dependent on a PAS, without which the drug was not considered cost effective by NICE.

Mr Bokmans gave an excellent insight into the thought process behind designing a PAS and making it work, and also into the workload involved for the pharmaceutical company in managing the scheme. These schemes require time and personnel commitments from both stakeholders.

Future challenges for access to new cancer medicines

The afternoon was opened up by Professor John Burn (Lead Clinician, NHS North East) who gave an excellent presentation, elegantly and eloquently linking the latest developments in genetics and genetic testing with the issues surrounding drug development and then market access for new drugs.

He described some of the trial work that the Newcastle Genetics Lab has been doing and leading on, and gave an insight into new cancer medicines on the horizon that have been developed with genetic input.

De-mystifying QALYs

Paul Trueman (Economist, York Health Economic Consortium) gave an inspiring presentation, the aim of which was to try to demystify quality adjusted life years (QALYs), which are a key factor in assessing the cost effectiveness of new cancer medicines.

Mr Trueman explained how QALYs can be unnecessarily complicated and talked us through how a QALY is developed and how they can be used by drug groups, such as NECDAG and local groups, to aid in decision making. He reminded delegates that QALYs are just one part of the overall decision making process and that other factors, including patient factors, the overall cost impact and the potential benefits, need to be taken into account when considering the introduction of a new cancer drug.

Mr Trueman concluded that a QALY is a useful tool to support difficult resource allocation decisions, and essentially provides a common currency in a framework for evaluating value for money. However, he was keen to stress that QALYs are only one factor in the decision-making process and that they should be considered in context.

Communication with patients

Rachel Chapman (Director of Public Engagement and Communications, NHS North of Tyne) reminded delegates about the importance of choosing the right communication channel when announcing important decisions to the general public; engaging with the local media is crucial. She stressed that any decision that is made on a cancer medicine by groups such as NECDAG needs to be communicated to the public as if talking not to the general public, but to a person with cancer and their family.

Ms Chapman highlighted the power of the local press, going through some of the negative publicity that decisions not to fund cancer medicines have had and highlighting both the national and the local impact. She talked through a campaign that the Communications Team in the northeast has been running to counteract negative publicity.

The team engages with the local media, talks directly to the editors of newspapers, issues press statements and is generally proactive in keeping the local media informed about decisions and why they have been made. She noted that this action has had a positive impact on how access to cancer medicines is perceived in the area. Ms Chapman also talked about the importance of maximising any good news about access to cancer medicines.

By building these links with the media, she said she felt her team has facilitated less sensational and more honest reporting of decisions surrounding access to cancer medicines.

Break-out sessions

Delegates then split into four small groups for a series of ‘bite-size’ break out sessions, designed to stimulate discussion about important topics.

Chemotherapy tariff

Anne Hines (Network Pharmacist and Chair of the Cancer Network Pharmacists’ Group, Merseyside and Cheshire Cancer Network) talked about how cancer medicines are going to be funded in the future.

She explained how Payment by Results was going to be implemented for cancer medicines and how cancer medicines would have their own tariff system. Cancer medicines were likely to be banded into ten different health resource groups, which would affect the way that PCTs and trusts would charge each other for cancer medicines in the future.

Ms Hines highlighted the current challenges within the NHS of gathering reference cost information to allow for price setting and how this task has proven more problematic than originally thought. She indicated that it was likely to be 2011 before the new system was introduced.

Patient access schemes

Calum Polwart (Network Pharmacist, North of England Cancer Network) presented some research done by the Cancer Network Pharmacists’ Group into the actual impact of risk share schemes on the NHS.

The headlines from this session were that:

• The schemes were not being operated successfully
• The NHS needs to put resource into these schemes in order to make them work Schemes need to provide a range of options for refund (e.g. replacement stock, credit notes or cash back) because of the differences in how trusts and pharmacies process orders and price drugs F
• inancial flows need to be assessed; in many instances refunds associated with PASs are not reaching those who initially pay for the drugs

The NETAG experience

The next parallel session was lead by Will Horsley (Lead Pharmacist, North East Treatment Advisory Group, Newcastle-upon-Tyne), who talked delegates through the North East Treatment Advisory Group (NETAG) experience.

NETAG covers all high-cost non-cancer medicines in parallel to NECDAG; the group was developed following the success of NECDAG, to ensure the same level of consistency of approach applied to non-cancer as well as cancer drugs. He talked through how NETAG operates and some of the challenges the group has faced.

He also discussed how some of the lessons learned from the NECDAG experience have affected the set up of this second group.

Bridging the gap between the NHS and the pharmaceutical industry

The last session was led by Carolyn Staines (Account Director, Succinct Healthcare Communications and Consultancy) and explored the role of third-party consultancy communication agencies in bridging the gap between the NHS and the pharmaceutical industry.

Ms Staines talked through the role of these third-party consultancy agencies and how they acted as facilitators and go-betweens to successfully bring together industry and the NHS, optimising co-operative working and facilitating a greater understanding of the workings and needs of both parties.

Final remarks

The day appeared to have been a great success, with delegates leaving the northeast with hopefully a greater understanding of the opportunities, constraints, challenges and benefits allied with joint working between the NHS and industry.