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PM Society debates Health Technology Assessments

The PM Society debated the topic of Health Technology Assessments (HTAs) and their impact on the pharmaceutical industry and healthcare in the UK

On 24 April in the heart of the City of London, the PM Society held a debate to discuss the topic of Health Technology Assessments (HTAs) and their impact on the pharmaceutical industry and healthcare in the UK.

The debate entitled "HTAs: opportunity or threat", was held at the IOD hub in New Broad Street, London and was attended by members and invitees from a range of pharmaceutical companies, advertising and marketing agencies.

HTAs cover a wide range of methods of intervening to promote health, including the prevention, diagnosing or treatment of disease, the rehabilitation or long-term care of patients, as well as drugs, devices, clinical procedures and healthcare settings.

The International Network of Agencies of HTA (INAHTA) describes HTA as "a multi-disciplinary field of policy analysis, which studies the medical, social, ethical and economic implications of development, diffusion and use of health technology."

The aim of an HTA is to provide a bridge between scientific evidence, the judgement of health professionals, the views of patients and the general public, and the needs of policymakers.

In a nutshell, HTAs ask four key questions:

ï           Does this treatment work?

ï           For which patients does it work?

ï           How much does this treatment cost?

ï           How does it compare with alternative treatments?

And seeks to answer one:                   

ï           Should it be funded or not?

Although the terms assessment and appraisal are often used interchangeably, assessment is the gathering, collating and evaluating the evidence and presenting it for appraisal. NICE, for example, uses a Technology Assessment Review (TAR) group (there are seven in the UK) to collect the information.

HTA is becoming an internationally recognised process, with recent research in Canada, Australia and the European Union (EU) defining it as a process to aid healthcare policy-making, which can be used throughout the life-cycle of a health technology (through development and field trials) even to the point where the technology is classed as obsolete.

The EU has recognised the importance of co-ordinating HTA work across member states and a process is currently under consideration by 23 of the EUís 25 countries, including the UK.

The panel was chaired by joint CEO of Westaway Gillis Consulting, Claire Gillis. Member of the panel were Lee Tomkins of Porter Novelli who is also a trustee of the Migraine Action Association (MAA), Clive Jackson of the National Prescribing Centre (NPC); and Richard Barker of the Association of the British Pharmaceutical Industry.

HTAs ñ a communications strategy
Tomkins, who began the debate, stressed that an integrated team approach was vital to presenting the right data in the right format to the right people. She added that company members must be aligned and have agreed timelines for the project plan and that accountability should lie with just one person.

Tomkins said that HTAs were a form of communications strategy. To achieve market access, coordination of internal key opinion leaders and external key opinion leaders was necessary. She added that a useful tool to understanding the process was to set up a ëshadowí NICE panel and cited the example of macular degeneration product, Visudyne (verteporfin). Novartis, which makes the drug, created a shadow NICE panel and was able to help the NHS to optimise the product from scope to implementation, thus insuring uptake.

Tomkins pointed out that HTA provides an opportunity for clarity in a guidance system, where different decisions are reached by the different groups involved. She cited the example of Rocheís cancer drug, Mabthera (rituximab), which was accepted by the Scottish Medicines Consortium (SMC) but not by the National Institute of Clinical Excellence (NICE).

The role of patient groups was then discussed by Tomkins, who cited a study which showed that patient groups misunderstood HTAs, thinking it was something to do with devices. Only a small number of patient groups, which tended to be large and well organised, knew about HTAs.

Tomkins had collected quotes from a number of patient groups regarding HTAs:

ï           "HTAs donít take us into consideration"

ï           "Our expert knowledge seemed to be ignored"

ï           "Pharmaceutical companies initially approached us, but didnít keep up the dialogue"

Tomkins added that Patient Groups were "hungry for information regarding HTAs", not only about drugs, but also about infrastructure: "Finding the right balance between innovation, patient awareness and implementation was paramount. Many patient groups have said the HTA process is ënot patient friendly.'"

HTAs are here to stay...
The next speaker, Clive Jackson of the NPC, started his presentation by saying: "HTAs are an integral part of the way the NHS will work, especially now there is an increasing 'arms-length' between the Department of Health and the NHS."

Jackson added: "HTAs are a multi-step process and the view they are either an opportunity or a threat very much depends on a companyís attitude to the final approval. To concentrate on this aspect of the process is wrong."

Jackson revealed: "The UK HTA system is influencing pricing in other countries, with the EU and the US looking closely at the system."

The impact of HTA on uptake depended on the following factors:

ï           Timing (NHS planning runs on a yearly basis)

ï           Clarity and quality of evidence based clinical testing (providing clear, targeted data)

ï           Linkage to existing priorities (national and public health needs assessments)

ï           Expertise of interpreting and implementing NICE guidance (ministerial and industrial strategy report)

ï           Professional interaction between doctor and patient (NICE "concordance" getting patients on-side, using patient knowledge, talking with health professionals)

ï           Feedback and monitoring groups

Jackson split HTA into two areas: Formal guidance from the Scottish Medicines Consortium (SMC) and NICE and informal guidance from Area Prescribing Committees (APCs).

For formal guidance, pharmaceutical companies must concentrate on PCTs, who must make money available to implement NICE guidance. He added that the efficiency of PCTs across the country varied considerably, especially with regards to the timings implementation of NICE guidance and effective advanced warning to PCTs.

For informal guidance, Jackson said that pharmaceutical companies must work with APCs six months pre-launch and four to six weeks post-launch. Although this approach is not mandatory, early intervention can help earlier uptake of NICE guidance, especially with regards to clinical data issues, service configurations and delivery implementation and infrastructure.

With clinical trial data, Jackson said that pharmaceutical firms should work 12-15 months in advance with PCTs, improving clinical information and service configuration. Jackson then went on to suggest how pharmaceutical companies could improve HTA outcomes through one-to-one meetings in the form of horizon scanning for upcoming pipeline drugs, better quality and depth of information about these products, improved dissemination and support for clinical data, improving PCTs understanding of NICE guidance and better monitoring and feedback from PCTs.

Concordance versus compliance: patient perspectives are changing
A big issue attached to HTAs at the meeting was that of concordance versus compliance in patients.

Compliance

Concordance

Patients take their drugs as directed by their physician to maximise the effectiveness of drugs (passive mode)

Physicians share clinical information with their patients concerning the effectiveness of a given drug (active mode)

Jackson cited a Medicine Paths study, which found that a third of patients (tended to be older) were happy to be told what to do by their GP regarding their drug treatment. A third of all patients wanted more information to help them arrive at a decision about their treatment, while a third wanted to discuss clinical trial data and evidence to support the treatment claims.

Concordance was seen as a better way of empowering patients, as discussing the clinical effectiveness of a drug enabled patients to take an active involvement in their treatment and an understanding the mechanism of action. Jackson concluded that patients must know why they are taking a drug and that medical education programmes from the pharmaceutical industry were vital to patient concordance. He also qualified this statement by saying that cost saving in this arena had not been studied widely, but adopting a concordant approach may reduce reconsultation and concentrate doctorsí minds on de-novo consultations.

Jackson said patient groups were "avid" for information and that the HTA process must be simplified for patients, while the attitude toward patient letters was not good. He added that patient groups did understand the situation and wanted help with the role of patients in clinical trials.

Jackson concluded his presentation by saying that the partnership between government and industry must be improved. He suggested that the pharmaceutical industry would benefit more from the relationship by being more open about what kinds of clinical information it had, understanding what types of people sat on APCs and what information APCs have access to. He stated that pharmaco-economic models did help, but their effectiveness depended on the pharmaceutical company involved and its efficiency in the assessment of the information.

"The pharmaceutical industry," Jackson declared, "needs to move from a product-based to a service-based focus by thinking about how patients and doctors interact. Advanced planning is crucial to the successful implementation of a newly marketed drug and reduction in drug waste from compliance failure."

ABPI: "HTAs must not stymie innovationÖ"
The final speaker at the meeting was Richard Barker from the ABPI who said that HTAs were a potentially explosive issue for the pharmaceutical industry: "HTA is a fact of life and the pharmaceutical industry has to get used to it, as it is fundamental to achieving market access. How as an industry should we shape it? How do we avoid NICE blight? How do we evolve NICE to do a better job? Can industry be critical of NICE? How can we invest in best practice?"

Barker said that the pharmaceutical industry must add value to its products by practicing evidence-based medicine, but qualified this statement by adding that HTAs were not yet a precise science as it was based on imprecise calculations and may affect innovation adversely.

Barker added that the potential for approval delay was huge due to the lack of accuracy in current HTAs. He stated this would inevitably affect patient access to innovative drugs and that political decisions underscored many of the initial approvals or rejections of drugs, citing Avastin and Herceptin as examples of healthcare as a political issue.

PCTs which cite a lack of NICE guidance was not a good enough reason for restricting patient access to drugs, added Barker: "HTA should be factored into long-term leadership strategies and an earlier dialogue with NICE, as well as broader assessments of value and a revisit of the appeals process. HTA price setting activities must be fit for process. The pharmaceutical industry needs to re-examine what the marketing of a drug actually should be. Pharma should be allowed to sit on government panels right through to PCTs."

Barker agreed with audience representatives from pharmaceutical companies who said that the industry should be sorting out its own pricing as early in the process as possible, but qualified this by saying that it was difficult to see how ante-launch pricing could be done accurately.

Conclusions
For pharmaceutical companies, the impact of HTAs cannot be expressed strongly enough. Indeed, many of the attendees of the meeting said that the industry was changing on all levels of operations; from small biotechs to pharmaceutical giants.

Steve Bramham-Jones of Napp Pharmaceuticals said: "From concept to launch, youíve got to get clinical trials right; itís evidence-based medicine all the way down the line which is needed to drive successful HTA submisssions."

David Southern, senior brand manager for NHS Marketing at Napp Pharmaceuticals, added: "Not a single part of sales and marketing of a drug is unfocused on HTAs. Clinical data is no longer just a matter of safety and efficacy. Getting it wrong can severely damage the prospect of getting your drug to market."

HTAs have been around since 1982 in some form or another, so getting clinical trials wrong severely damages the prospect of getting a drug to market. The increased focus on clinical trials has shown that safety and efficacy is no longer enough to guarantee approval. The industry is facing structural change, with no single part of sales and medical unfocused.

At the moment, the pharmaceutical industry, HTA organisations (NHS, etc) and patients are all separated by ideological barriers. Savings must be made, but not at the price of curtailing innovation ñ the all-too-familiar argument which ricochets back and forth between pharma, patients and the NHS.

2nd September 2008

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