Life in the balance

by IainBate 24. January 2013 12:32

As the incidence of diabetes in the UK soars, the austerity NHS is increasingly unable to meet the needs of patients with this complex and lethal disease. How can the pharmaceutical industry help the situation?

122044024 Blindness. Foot and leg amputation. Kidney failure. These are among the complications of diabetes, a complex metabolic disorder that is now the leading health challenge facing western society.
In diabetes the absorption of glucose (sugar) from the blood fails, causing it to accumulate in the circulatory system. This occurs either because the pancreas stops producing the hormone insulin (type 1 diabetes) or because insulin production is inadequate or the body’s response to it is poor (type 2 diabetes).
Both types of diabetes have genetic risk factors, but type 2 or ‘mature onset’ diabetes has other risk factors such as age, obesity and lack of exercise. Type 1 or ‘juvenile onset’ diabetes is fatal unless the missing insulin is replaced by injection. In type 2 diabetes, a range of medications such as metformin can be used to improve glucose uptake.

The number of people diagnosed with diabetes in the UK has increased from 1.4 million in 1996 to 2.9 million in 2012, and continues to rise, with type 1 diabetes now accounting for only 10% of the total. The prevalence of type 2 diabetes has risen sharply, due to the ageing population and the trend towards obesity.

There is no cure for diabetes. A range of medications exist to treat it, but establishing the correct dosage levels is not easy: only an estimated 6% of diabetes patients get the balance right. Since no medication can make diabetes go away, the condition demands constant monitoring and medication adjustment, as well as checks for complications.

And at a time of deepening austerity in NHS funding, that level of attention to patient needs is getting harder to afford. All the signs are that people with diabetes (especially the more high-maintenance type 1) in the UK are at increasing risk of disabling or fatal complications. Sugar is killing more of us all the time.

High and dry
In November 2012, the Public Accounts Committee observed that diabetes care in England was “depressingly poor”, with 24,000 preventable deaths from the disease happening each year. The report pointed to a lack of clinical leadership and a ‘postcode lottery’ in diabetes care.

Barabara Young, Chief Executive of charity Diabetes UK, commented: “Given all the increasingly strong evidence of inadequate care, we simply cannot understand why the NHS has sleepwalked into this situation.”

During 2012, Diabetes UK drew attention to the need for better access to diagnostics, more referrals to specialist care, and wider awareness of the role of healthy lifestyle in preventing and controlling diabetes.
In April 2012, Young noted that 80% of NHS spending on diabetes care went on treating preventable complications. In May 2012, Diabetes UK stated that diabetes care in England was in a “state of crisis” with fewer than half of patients receiving adequate care.

Yet the medicines and diagnostics exist to reduce the incidence of diabetes, manage the condition and avoid complications. It’s not rocket science. What has gone wrong – and what is the solution?

A preventable crisis
Tracy Kelly, Head of Care at Diabetes UK, spoke to Pf about the problems of diabetes care. For the patient, she said, “Optimal diabetes control requires dedication and motivation from the individual to test, inject or take medication, adjust their dietary intake, potentially make lifestyle changes, monitor their condition and ensure they are receiving their health checks.”

This puts the patient under intense pressure, especially if they have other chronic conditions. How can the pharmaceutical industry help? In three ways, Kelly said: “Better provision of information and education for people with diabetes and for the healthcare professionals; commitment to research into new and improved treatments and monitoring approaches; and bridging the gap in healthcare services by supporting specialist nurses and dieticians in hospitals, for example with pump training and starting on insulin.”
Importantly, Kelly noted, the agendas of drug treatment and lifestyle change are not opposed: “There should always be a dual approach.” In treating both types of diabetes, clinicians need to look for the optimum blend of medication and lifestyle factors for each patient. The NHS needs to deliver programmes of risk assessment and early diagnosis; offer effective education in self-care for all patients; and ensure that they receive the nine regular checks recommended by NICE.

Working together
Successful diabetes care depends on integrating primary and specialist care, Kelly emphasised. “Effective diabetes care can only be achieved through integration. There must be clear referral plans in place and transparency about who does what and where specialist diabetes care is required. Specialist teams also have a key role to play in educating and supporting primary care.”

Cutting down on GP referrals is a growing NHS trend, praised by David Nicholson in his 2012 NHS review and promised in many CCG commissioning plans. Does this pose a threat to diabetes care? Kelly’s response was clear: “Cutting down referrals to specialist care may increase the risk of complications and could result in increasing costs to the health system. Diabetes is complex and any blanket rules to cut referrals could put lives at risk over the long term.”

For patients with type 1 diabetes, in particular, referral management is a recipe for trouble: “We know it is important for people with type 1 to have access to a team of specialists such as a dietician, podiatrist and counsellor. But often their access to this kind of support only comes once complications have developed.”
In short, drug manufacturers and healthcare providers can work together to support patients in avoiding complications – but clumsy cost-driven applications of QIPP are tending to disable care.

The hidden disease
As Louis MacNeice said, the North begins inside. Danish pharmaceutical company Novo Nordisk has specialised in diabetes care since its launch in 1923. Its insulin products (used by many type 2 as well as type 1 patients) are the standard of care in the UK. The company’s CEO, Lars Sorensen, recently observed: “What we are good at, all of a sudden becomes the biggest public health problem we have ever seen.”
Peter Meeus, Vice President, Novo Nordisk UK and Ireland, spoke to Pf about the company’s role in meeting the diabetes challenge. He noted that according to the National Diabetes Audit, only half of diagnosed patients in the UK are achieving treatment targets, while fewer than half of all people with diabetes receive all nine recommended healthcare checks.

Too often, Meeus noted, diabetes is only detected when secondary complications arise such as retinopathy and foot ulcers. Insulin can be the most effective treatment, but fear of injecting is sometimes a barrier to its adoption. As a result, “many patients start on insulin too late and are therefore at risk for developing serious late complications”. This is unfortunate, as the needles used today are much thinner and less painful.

Shot in the dark
According to Meeus, the pharmaceutical industry can help the NHS meet the challenge of diabetes by helping to identify the high proportion of diabetes patients who are poorly controlled, and to ensure these patients achieve control within the national guidelines.

He added: “Novo Nordisk is working with the DH and local health economies, together with physicians, to deliver agreed diabetes health outcomes at both national and local level, using appropriate innovative medicinal interventions as well as service design and support.” Specifically, the company provides Diabetes Education Nurse Facilitators to primary and secondary care organisations where needed, and its local Diabetes Outcomes Directors work to assist the redesign of diabetes services.

The company may owe its current growth in part to the growing incidence of diabetes, Meeus said, but its depth of experience in this therapy area has enabled it to take advantage of the opportunities: “Innovation and science have always been at the core of Novo Nordisk’s business, and as a result we today have the broadest portfolio of R&D diabetes projects. At a time when others in the pharmaceutical industry are cutting R&D budgets, we’re increasing our investment.”

“The challenge going forward,” he concluded, “is the fact that diabetes today is the biggest problem for healthcare systems, but at the same time the healthcare budgets are under increased pressure.” Diabetes UK and millions of patients would agree. But where there’s a will, there’s (sometimes) a way.

Lilly and Amylin end diabetes pact

by emma 10. November 2011 12:19

Pharma Industry News

Eli Lilly and Amylin Pharmaceuticals have mutually terminated their decade-long diabetes partnership for exenatide.

As part of the global agreement, Amylin will gain full responsibility for the drug and make an upfront payment of $250 million, plus 15% of future global net sales to Lilly, up to the combined total of $1.2 billion.

Enrique Conterno, President of Lilly Diabetes, said: “This marks an amicable end to a very productive 10-year collaboration that will continue to benefit many people worldwide. Lilly and Amylin are proud of the important accomplishments we achieved together.”

The partnership between Amylin and Lilly provided various innovations to the diabetes market, including Byetta and Bydureon.

Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA in April 2005. It is an injectable prescription that improves glucose control in adults with type 2 diabetes mellitus, when used in conjunction with a diet and exercise programme.

Investigational Bydureon received marketing authorisation in the EU in June 2011 for type 2 diabetes, and is currently under review in the US.

Daniel M. Bradbury, President and CEO of Amylin, said: “We anticipate working with one or more partners outside the US in order to maximise the global potential of this innovative molecule and achieve greater operational flexibility and efficiency.”

The mutual agreement confirms that Amylin will resume worldwide drug development and commercialisation, starting in the US and progressing to all markets by the end of 2013.

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