Getting a grip

You do not become a pharmaceutical marketer to enjoy a quiet life. The National Health Service (NHS) is always in flux; the Department of Health (DoH) is continually announcing reforms and implementing managerial changes. Over time, it becomes easy to accept this frantic rate of evolution as normal, to regard change as the only constant. However, it holds dangers for the unwary. In particular, it is easy to underestimate or not notice potentially important changes. Medicines management offers a case in point.

Over the past couple of years, medicines management has emerged to present opportunities and challenges that every pharmaceutical marketer needs to consider. Five critical examples clearly illustrate this.

But first, it is worth considering what medicines management actually is. According to the DoH, medicines management involves `the clinical, cost-effective and safe use of medicines to ensure that patients get the maximum benefit from the medicines they need, while at the same time minimising potential harm'. This raises the potential for conflict between the needs of the individual and the organisation.

A 2004 DoH document considering the implications of medicines management for three National Service Frameworks (NSFs) - diabetes, renal services and long-term conditions - cited evidence that up to two-thirds of people with Type II diabetes do not take their oral hypoglycaemics as prescribed and most patients are unaware of their medication's side effects.

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In renal disease, medication reviews revealed cases of considerable confusion between patients, nephrologists, GPs and community pharmacists about the medicine, formulation and dose. Moreover, adverse drug reactions seem to cause around 6.5 per cent of hospital admissions. Improved medicines management could have prevented almost 80 per cent of these admissions.

Against this background, the DoH intends that the Medicines Management Framework, launched in 2003, will promote 'greater working links across local health economies' to improve the quality of prescribing. The DoH charged Strategic Health Authorities with managing performance across the Framework's two key components:

• The Controls Assurance Standard: minimum, mandatory standards to ensure the safe and secure handling of medicines

• Developmental standards for clinical and cost-effectiveness.

The government signalled its commitment by investing heavily in the national Medicines Management Services (MMS) Collaborative. This approach brings together Primary Care Trusts (PCTs), GPs, nurses, community pharmacists and other healthcare professionals to optimise prescribing. The programme can now cite numerous examples where more rigorous medicines management has improved services. Another part of the collaboration focuses on issues relating to medicines management in hospitals.

In 2005, the Healthcare Commission (HC) undertook five major audits of medicines management across all English acute hospital trusts. Some 21 indictors were used to describe each Trust's level of control of medicines management. The results were used as part of the assessment exercise for the annual health check, which is the HC's new system of assessment for all NHS Trusts in England. It is designed to provide a fuller picture of the performance of a Trust against certain core and developmental standards.

In principle, medicines management seems to be sensible best practice. Medicines management should be about prescribing the most clinically efficacious, safest and most cost-effective drug, rather than the cheapest. This suggests that compelling clinical and health economic evidence should be able to tip the medicines management equation in pharma's favour.

Furthermore, reducing wastage - for example, by improving adherence - should improve outcomes revealed by audit. Audit initiatives can help build relationships with doctors and provide invaluable data. Nevertheless, the clinical and cost-effectiveness developmental standards potentially pose challenges, as well as opportunities, for pharma companies.

1. New stakeholders
It is now almost a truism that the essential ingredient of successful sales and marketing strategies is the ability to understand and address the needs of a growing and increasingly diverse customer base. However, this truism hides one of the most dramatic shifts in the pharmaceutical market since the foundation of the NHS: doctors have given up their sole right to prescribe prescription only medicines. A new generation of supplementary and independent prescribers now decide on patients' treatment within clinical management plans, and can prescribe any licensed medicine for any medical condition within their competence.

The implications for pharma are profound. Obviously, marketers need to ensure their brands form part of the clinical management plans. Furthermore, supplementary and independent prescribers need information and education, although their needs may differ from doctors and may vary between professional groups. Pharmacists may have different educational needs and interests from nurses, for example. Pharma companies will need to collect more complex and diverse data sets to target these new prescribers effectively and to assess the return on their promotional investment. It is early days and the new structure is still evolving, but this is an area that every marketer needs to watch carefully.

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2. NICE's expanding role
The National Institute for Health and Clinical Excellence (NICE) has a significant role in shaping the market. If it rejects a treatment, prescribing it on the NHS will be very difficult, if not impossible. NICE guidance also underpins much of the medicines management agenda. Nevertheless, its influence is set to grow even further.

Even if NICE accepts that a treatment is both clinically- and cost-effective, ensuring PCTs follow the advice can still prove to be problematic, usually because of limited funds. Just because NICE decides that a drug is cost-effective, it does not necessarily follow that local health economies can afford it.

If some PCTs pay for NICE-recommended treatment, purchasers may need to take money out of other areas. On the other hand, the DoH rhetoric emphasises that healthcare provision and funding should meet local needs. This means that marketing needs to ensure that the issue remains high on the local agenda, supported with local data.

It is a firmly held belief that there are sufficient funds for innovative drugs - if only better medicines management could cut expenditure on ineffective treatments. Recently, NICE announced new initiatives to reduce spending on ineffective treatments. As with so much of medicines management, this is a classic double-edged sword. On the one hand, you could face serious problems if your brand is one of the treatments it targets. On the other, the guidelines could help you answer the perennial question, `where is the money coming from?'

Firstly, NICE intends to use guidelines and appraisals to highlight where current practice is no longer appropriate or effective. For example, NICE has suggested developing a clinical guideline about the management of sore throats in children, most of which tend to be viral. This would help to reduce inappropriate use of antibiotics, which could release resources to be deployed elsewhere.

Secondly, NICE plans to issue reminders of recommendations from existing guidance that advises the NHS to stop using ineffective or poor value interventions. As an example, NICE will issue a reminder that suitable patients with end-stage renal failure should be able to choose between home dialysis and haemodialysis in a hospital or satellite unit. NICE notes that home dialysis is the less expensive option, but at least as effective. Increasing the number of patients receiving home dialysis to 15 per cent would save £9.7m.

Finally, the institute will develop guides offering practical advice about commissioning routine services in line with NICE recommendations.

3. Generic substitution
Generic substitution is the backbone of cost-effective prescribing and a core component of medicine management. With almost 70 per cent of drugs thought to be prescribed generically, pharma companies are recognising increasingly that they cannot market a branded drug as the first-line treatment versus a generic; the generic's position is unassailable. Instead, marketing strategies target the lower volume, but higher per 'scrip value, as the second- or third-line treatment.

Despite this, some health authorities advocate greater generic prescribing, even beyond the point whereby patient outcomes may start to suffer.

The underlying principle to generic prescribing is that substitution is acceptable provided that there is no detrimental effect on patient care. In line with this, the British National Formulary advocates prescribing certain medications, such as some anti-epileptic treatments, controlled release formulation or CFC-free asthma inhalers, by brand. However, in the quest for cheaper prescribing, some health authorities have introduced didactic policies that could go against the second half of this principle. In one recent example, a health authority demanded an 80 per cent target for generic simvastatin, even though statins are not pharmacological synonyms. Current estimates suggest some GP practices are achieving over 70 per cent. In most cases, the only danger is confusion among patients and the associated risk of undermining compliance. Furthermore, cardiologists continually highlight the high proportion of patients who do not meet recommended blood cholesterol levels. So if a patient attains the recommended lipid levels on, for example, atorvastatin, it seems poor practice to switch to generic simvastatin.

Pharma has learnt to live with generic prescribing. The biotech sector needs to learn the same lesson. Over the next few years, generic prescribing is likely to move up the agenda, as several blockbuster biotechnology products move off patent.

In response, several firms are producing or planning biosimilars. These are essentially generic versions of protein-based drugs, such as erythropoietin. However, biosimilar substitution is a far more complex proposition than that for small molecules. Proteins tend to be between 100 and 1,000 times larger than the traditional small molecule drugs and are much more difficult to produce. Living cells manufacture the proteins, a process that is sensitive to culture conditions. Even in a stringently controlled environment, variations can emerge in the way that the protein is folded or in the sugar and other groups that are attached to the amino acid backbone.

These subtle differences can affect both the efficacy and tolerability. Current analytical methods are often inadequate to detect these differences, which means that guaranteeing a biosimilar as equivalent to the originator biotech product is difficult.

In response, European regulators introduced strict regulations surrounding biosimilars, which probably means that the percentage difference in price may be less than with conventional generics. However, these are expensive agents and, as the NHS implements the cost-effectiveness agenda of medicine management over the next few years, marketers working in this area can expect competition from biosimilars to emerge as a key issue.

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4. Skewed primary care priorities
Primary care is firmly in the driving seat for medicines management, and for the NHS more widely. However, the managerial and political structures that form the framework supporting a primary care-led NHS can skew the market. This simplifies marketing if you are working in a priority area, but is much harder if you go against the grain.

For example, National Service Frameworks (NSFs) are now a well-established mechanism to establish clinical priorities. The DoH sees NSFs as being 'central to improving quality of services to patients, improving health, reducing health inequalities and building services around the needs of patients'.

In effect, NSFs set the clinical priorities for the NHS, which skews the NHS towards focusing on the conditions covered by them. Diseases that are not deemed as priorities may not receive the attention they deserve.

More recently, the Quality and Outcomes Framework (QOF), a component of the new General Medical Services contract for general practices, introduced from April 1, 2004, rewards practices for providing quality care.

The clinical QOF includes 76 indicators in 11 areas: coronary heart disease, left ventricular disease, stroke or transient ischaemic attack, hypertension, diabetes, chronic obstructive pulmonary disease, epilepsy, hypothyroidism, cancer, mental health, and asthma. Once again, the QOF potentially skews primary care priorities towards focusing on conditions GPs are incentivised to manage.

The QOF encourages GPs to follow many of the precepts of medicines management, in these areas at least. As such, you may gain a competitive advantage if you can demonstrate that your drug helps practices to accumulate QOF points. However, if your drug lies outside these 11 areas, it represents an additional hurdle. Unlike the NSF, QOF impacts directly on income, which may mean that the QOF skews the market to an even greater extent.

5. purchasing/commissioning
The shift to a primary care-led NHS means that GPs hold the purse strings and, increasingly, fund secondary care through `payment by results'. The DoH claims that payment by results provides `a transparent, rules-based system' that rewards efficiency while supporting `patient choice and diversity'.

The principles of medicines management could inform some elements in the contract, such as quality markers, and guidelines defining the relationship between primary and secondary care.

However, a number of high cost medicines are not included on the payment by results tariff and need to be negotiated through practice-based commissioning.

Marketers may need to be creative to overcome this hurdle. In some cases, a drug could help to attain tough contractual quality markers. The payment by results offsets the cost of the drug. In other cases, marketers may consider risk-sharing agreements by which the company refunds costs if certain criteria are not met.

As this suggests, primary care knows its fiscal strength and is becoming less afraid to use it. Indeed, there is a growing trend towards centralised purchasing, which allows primary care to flex its financial muscle. Some drugs have been purchased centrally for a while, such as factor VIII, which replaces a defective protein in some people with haemophilia. The anti-TNF biologicals may well follow.

Aside from national programmes, primary care commissioning has spawned several local or regional consortia. For example, the Healthcare Purchasing Consortium is the major provider of purchasing, supply chain and commercial services across the West Midlands and North Central London. The Consortium works on behalf of more than 60 NHS Trusts, spending £2.4bn a year on goods and services. The Consortium purchasing power allows it to deliver savings.

The final element is NICE's plans to address NHS spending on ineffective drugs by bolstering commissioning. The intsitute plans to issue guides offering practical advice about commissioning routine services that help local services implement its recommendations. The guides will set commissioning benchmarks and provide data allowing local health economies to compare outcomes with these standards. An interactive spreadsheet will help decision makers calculate costs and savings associated with service changes.

Medicines management encapsulates many of the principles and trends that characterised the NHS reforms over the past few years. The DoH's definition of medicines management may sound benign and laudable. Nevertheless, few would argue with its aim and this seemingly innocuous idea could have profound implications for pharmaceutical marketing. How well you meet these challenges will determine your success as a pharmaceutical marketer over the next few years.

The author
Brian Gunson is chairman, and Bryony Box is head of healthcare, at Munro & Forster Communications