Service Insight: Keeping up with changes in the NHS

pharmafile | June 23, 2011 | Feature | Sales and Marketing |  Service Insight 

SERVICE INSIGHT

Following the election of the coalition government, the NHS has been targeted for a significant ‘overhaul’. In an effort to make the NHS run more efficiently, the major changes will see clinicians at the forefront of healthcare with GP commissioners, holding budgets and making decisions on access to tests and drugs which are important to their patient populations.

These changes will have an effect on the healthcare market in the UK into which pharma and biotech are both significant players, and an understanding of this changing market is essential if new drugs and diagnostic tests are to be successfully introduced and ultimately used as part of the treatment regimes.

Historically, under the Labour government, budgets were held by local health managers working in primary care trusts (PCTs), and they had responsibility to buy services from local clinics and hospitals. Under the coalition, responsibility for this will pass to GPs working in consortia across the UK. PCTs and regional bodies such as strategic health authorities (SHAs) which had been key entities with the power to make decisions on tests/services, are to be phased out by 2013.

Central to these changes is the National Institute for Health and Excellence (NICE), which has a role in quality standards and cost/benefit analysis. NICE ultimately decide if a treatment or test will be re-imbursed by the NHS, and thus inform the commissioning of NHS care including decisions on the adoption of new drug treatments.

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Keeping up with these changes in the NHS can be extremely time consuming and difficult, especially for smaller pharma and biotech companies who do not have the resource, time or expertise for such a commitment.

Big pharma have dedicated departments with staff who have many years experience, dealing with the NHS and whose main objective is to ‘facilitate’ relationships and meetings with key opinion leaders, regulatory bodies and health authority teams with responsibility for adopting new tests and treatments. 

So what should pharma biotech without this experience look for in a potential partner to help support their drug or diagnostic launches to the NHS?

One option available to these smaller entities is to outsource to companies who have the experience required, ideally those already selling into the NHS and private healthcare markets, with dedicated sales teams who have well developed relationships with key opinion leaders in many different therapeutic areas, and who are used to presenting information to NHS bodies and key decision makers.

In such situations, it is very important to be succinct in what it is you are promoting and to put across the important information needed to hook the decision makers and adopters.

Such information will include details of the new drug, diagnostic; information on how the test/treatment was validated and most importantly, how it could benefit the NHS.

Case studies or examples of calculations on cost savings compared to current treatment/test options can be invaluable, especially with regards to follow up care which can add significant costs to treatment regimes. All data presented must be validated and ideally some at least should have been generated in the UK. It is no longer enough to show a product is effective it must also have clinical utility. A company which can organise utility trials in the UK to help gather support for a product is a useful partner, and it is important to use well established partners preferably with experience in supporting new drug/test launches in the UK.

A well known example of this would be the successful launch and roll out of Herceptin in the UK, a new treatment made available several years ago for breast cancer, and more recently, granted as a new indication for gastric cancer.

Herceptin is a tyrosine kinase inhibitor which binds to HER2 /neu receptor which is over-expressed in approximately 20-30% of breast cancer patients. When launched, it was important that the drug be used only in patients with over-expression of the targeted protein, and to determine this, immunohistochemistry (IHC) and fluorescent in situ hybridisation techniques (FISH) had to be carried out on all patient samples before the drug was given. An analysis of the UK and NHS markets was made and it was determined that 3 key reference labs be used to support the HER2 IHC and FISH testing.

For a certain time period, funds to test patients was provided to support the launch and then evaluate the value of the drug in the light of these tests.

With this all in place, it became a much easier prospect for the NHS to send patient samples for evaluation to these reference labs. It was clear that the value of drug to patient overall survival was significant, and the ease of testing to determine which patients would benefit from receiving this targeted therapy could also be seen. Another significant factor was the cost of the tests for IHC and FISH which were cost-effective.

This should be an important consideration for pharma biotech hoping to launch their drug/test into the UK where the NHS is a significant part of the healthcare market, since exorbitant pricing can be prohibitive to gaining NICE approval.

In summary, the NHS is changing and it is important to keep up with these changes in order to be able to deal successfully in the UK marketplace. Any company without the experience or expertise in the NHS or private sectors should ideally seek a partner who can provide them with this support.

Roger Coombes is head of healthcare at Source BioScience. For more information visit: www.sourcebioscience.com

For more information on Service Insight features contact InPharm’s sales team on +44 (0)1243 772 010 or email pharmafilesales@wiley.com

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