Rules of the game

Managed entry is one of those phrases isn't it? It has become a term used commonly by both the NHS and the pharmaceutical industry alike, but does anyone have a real understanding of it?

We all think we mean the same thing, but ask for a working interpretation from either the health sector, or the industry, and it's like asking for a definitive clarification of the offside rule.

It is misunderstood and leads to decisions made under pressure by a small group that have dire consequences for one side. The ultimate disappointment is felt by the fans, or in this case, the patients. Yet, despite this lack of clarity, both the industry and the NHS think they are doing it - to a greater or lesser degree.

So what is it? Is industry doing it as the NHS expects? Does the NHS know what it should look like and how did we get here in the first place?

Let's start with the evolution of managed entry. Until the mid-1990s, managed entry was something the industry did to the NHS. However, the tables were suddenly turned in 1994, in EL (94) 72, in which the Department of Health asked Health Authorities (HAs) to get a grip on new drugs. Under EL (94) 72 action required included:

• Strategies improving cost-effectiveness of prescribing across the primary/secondary care interface
• Developing HA-wide policy for managed entry of new drugs into the NHS.

Health authorities reacted by forming Area Prescribing Committees (APC) - 99 of the then 100 HAs went on to have an APC. Then came a new piece of NHS jargon for managed entry: the traffic light system. Red indicated hospital specialist use only; amber referred to shared care and green meant that the product is freely prescribable in the community by GPs.

As a result, a process that was intended to improve systems for managing new drugs spawned the political nightmare of postcode prescribing. Different HAs were putting the same drug under a different light, leading to well-publicised inequalities of access to treatments by patients.

Such inequalities would be enough to send people demented and prompted Labour to pledge - rather naively given its latest AcHEI consultation proposals - that the National Institute for Clinical Excellence (NICE) would bring an end to postcode prescribing.

While NICE was busy sorting out form and function, the newly formed PCOs still had to make decisions to fund, or not to fund, new drugs.

The cannier PCTs set up Prescribing Priorities Committees, local horizon scanning and medicines management groups, such as MTRAC, and the London New Drugs Group emerged, followed by the ultimate managed entry committee the Scottish Medicines Consortium (SMC).

Playing the game
The late 1990s saw some companies really feel the pain of launch failures. The pressure to succeed became greater, with fewer NCEs coming to market, greater shareholder expectation, and trends towards more specialist medicines, with service as well as cost issues.

Yet, many launch programmes still focus on the prescriber alone, employing traditional key opinion leader strategies, only to be smashed against a funding brick wall, with zero scripts and a P45 for the marketer associated with poor uptake.

Some NHS commentators have implied that the pharma industry deliberately hides essential information about a new treatment from planners and payers. In my experience, it is less a wilful act by the industry, than a lack of knowledge and understanding by pre-launch marketing teams of the precise rules of the English managed entry game.

The rules 
The rules of managed entry are largely unwritten, yet in our NHS stakeholder focus groups, the same requirements for successful managed entry emerge:

• Early dialogue pre-launch, to coincide with budget planning, helping NHS planners and payers assess the local budget impact of the drug and plan for service configuration issues
• Where does the treatment fit?
• What will it replace and what happens if we don't use it?
• How many patients and exactly what type of patients will it suit in a locality?
• How can the locality manage the phasing of its uptake - will it become a significant cost pressure?
• How will the locality audit its impact to ensure local return on investment?

My perception has been that the pharma industry is improving its communication with stakeholders prior to launch, and developing support for those in the NHS charged with arriving at funding decisions. However, this is based on experience of companies asking for help with managed entry and is, therefore, weakened as we are working with a self-selecting group.

The experience of those in the NHS at the receiving end of launches is less positive. The cardinal sins remain the same:

• KOL development that only involves secondary care
• Treatments initially launched in hospital, quickly followed by primary care activity with little or no notice, yet with large budgets attached to them
• Treatments that lend themselves to shared care arrangements launched in the community without reference to who is responsible for the prescription
• Cynical activities around patent expiry that result in a product being withdrawn, only to be replaced by a longer acting model
• Differential primary/secondary care pricing

When asked for positive experiences, I drew a complete blank for managed entry. Yet, should all the blame for perceived poor managed entry be laid at industry's door? Has the NHS failed to be transparent by not clearly stating its aims in managing the entry of new drugs? Has it asked the tough question about the value of managed entry of new products, or just assumed that controlling the entry of new drugs must be a good thing?

Perhaps the Association of the British Pharmaceutical Industry (ABPI) consultation on the Code of Practice is a golden opportunity for managed entry to be looked at? Clause 3 doesn't provide the flexibility needed to answer the NHS-critical questions.

Hopefully, the ABPI is engaged in meaningful dialogue about the goals of managed entry with the NHS, involving national/ local stakeholders, seeking to establish information needs and process for communication.

The industry needs to have its hands untied on managed entry communication. Then it can be judged on its willingness to meet stated information requirements and demonstrate the kind of maturity we see now with clinical trial disclosure.

The Author
Angela McFarlane is managing director of HealthGain Solutions