Managed Entry: creating a dialogue ahead of your launch
pharmafile | November 17, 2008 | Feature | Sales and Marketing | NHS, healthcare, managed entry, marketing, product launch
Pharmaceutical companies are increasingly looking to 'managed entry' programmes to build strong relationships with NHS customers and ensure new products reach as many patients as possible.
In the age of NICE and tight controls on NHS prescribing, it is difficult for new products to establish themselves on the market without first creating a dialogue with key health service decision-makers.
One of the key elements of managed entry is that it aims to be beneficial to all – pharma company, the NHS and the patient. This is achieved by working with key decision-makers to help them prepare for the arrival of a product or a licence extension to an existing product.
Managed entry is advisable not just for newly licensed products, but also any new indication or the launch of a new formulation.
Key decision-makers need to know about new drugs, new formulations and extended indications for established drugs, as these can have an impact on the organisation of care and prescribing budgets. In the past, these people have obtained information from a variety of sources, some from Quangos, some from clinicians or pharmacists, some from the industry. But this information is often of variable quality and depth, ad hoc and not timely.
The ABPI Code
Pharmaceutical companies have traditionally been wary about communicating in this way ahead of launch. One barrier to early dialogue with the NHS is the fear of falling foul of the ABPI Code rules on the promotion of unapproved medicines. But this doesn't mean pharma companies and agencies can't talk about new products with purchasers and healthcare professionals prior to licensing.
The ABPI Code makes it clear that pre-launch communication with budget holders is allowable. The Code recognises that health authorities, trust hospitals and primary care trusts need advance notification of new launches in order to plan for their potential impact on budgets.
Communication must be non-promotional and via routes that communicate directly with those responsible for making policy decisions on budgets rather than 'ordinary' prescribers. Information can relate to specific products and can be discussed in relation to other products, however, it needs to be factual and kept in context to allow an easy understanding of the product's properties and the likely implications on budgets.
Information written by senior clinicians who know the disease area and are familiar with a new drug can provide a valuable 'real world' insight into its potential place in therapy and impact on management.
Following licence approval it is important to capitalise on the 'window of opportunity' often afforded before the sales force(s) launch the product or make meaningful in-roads into target coverage. A fundamental aim is to ensure peer reviewed, reader friendly, communication reaches all potential prescribers and influencers. It needs to include those who will be difficult or impossible to access through normal sales force channels, and should create a platform which the sales representatives can build on with follow up and one to one discussions.
Educational initiatives that are non-product specific provide an additional parallel approach to communication to budget holders. It is important that these initiatives fulfil a real need and are not a pseudo promotional exercise. These initiatives should be measured quantitatively where possible, while qualitative assessment provides an indication of whether or not the programme is providing meaningful benefits.
On the basic level, communicating effectively with all the different budget holders and stakeholders is an act of simple courtesy. But for the industry its potential is greater, since providing the right information at the right time to the right stakeholders is good for business.
By informing budget holders and creating a collaborative relationship, a well-executed managed entry strategy can provide the basis for rapid uptake of a new product or indication.
Mike Weetman is head of business development at Wiley-Blackwell publishing group, which provides managed entry communications and support through Future Prescriber and associated journals.
For further information contact Mike via e-mail at mweetman@wiley.com or telephone 01243 770319.
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