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Commissioning biologic drugs for the treatment of inflammatory disease in rheumatology, dermatology and gastroenterology

In the past ten years, biologic drugs[b] have emerged as an important advance in the treatment of inflammatory disease such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease and ulcerative colitis. These are chronic conditions which can cause pain, debilitation, loss of independence and premature mortality[4][5][6]. These conditions may have a detrimental impact on a person's quality of life and place a significant financial burden on society - for example, one-third of people with rheumatoid arthritis stop working within 2 years of diagnosis[5].

NICE guidance makes recommendations about the use of biologic drugs based on clinical and cost-effectiveness. Biologic drugs are typically recommended for the treatment of people with an active, and moderate or severe form of their inflammatory condition, and who have contraindications to or whose condition is not responding to conventional treatments and/or pharmacotherapy (please refer to the recommendations in the original guidance). Conventional treatments vary depending on the condition, but commonly include corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs) or disease-modifying immunosuppressant drugs, often used in combination.

Where conventional treatments become ineffective for the treatment of rheumatoid arthritis, biologic drugs may slow the destruction of joints, reduce inflammation, slow disease progression or induce full remission[5][7][8]. In dermatology and gastroenterology biologic drugs may suppress disease activity, improve the person's condition and provide sustained clinical disease remission[9][10][11].

On average biologic drugs cost around £9500 per patient per year, compared with around £450 per year for conventional therapy[c]. Because of their high cost and specialised nature they are excluded from Payment by Results.

In 2007-8, expenditure on biologic drugs for the treatment of rheumatoid arthritis alone ranged between £0.8 and £3.5 million per acute trust. Expenditure on biologic drugs accounts for the highest pharmaceutical spend within some trusts[5]. The unrestricted and inappropriate use of biologic drugs could place a large financial burden on the NHS.

The National Audit Office asserts that 14% of acute trusts are not able to provide biologic drugs for the treatment of rheumatoid arthritis to everyone who qualifies for them in accordance with NICE criteria[5]. Funding is known to be an obstacle to prescribing biologic drugs for eligible patients, and 30% of professionals feel restrained by primary care trusts (PCTs) ‘capping' expenditure on biologic drugs[12]. Other constraints in rheumatology services include a lack of nurse specialist resource and staff or day-case facilities[5]. Similarly 40% of UK psoriasis services cite funding as a significant obstacle to prescribing biologic drugs[4].

Effective commissioning and clinical governance of biologic drugs has the potential to contribute to efficiency savings within the care pathway. For example, earlier initiation and better long-term care of patients may help to prevent or reduce costly exacerbations of the disease, hospital admissions and surgical interventions[5][11].

Benefits

The potential benefits of robustly commissioning biologic drugs for the treatment of inflammatory disease include:

  • improving clinical outcomes and the quality of life for people with inflammatory disease
  • ensuring that the drugs are prescribed and delivered in a safe environment by trained and competent staff
  • improving integrated systems for prescribing and administering biologic drugs to patients across several pathways including rheumatology, dermatology and gastroenterology
  • reducing local and regional inequalities and improving timely access to treatment with biologic drugs
  • preventing unnecessary costs through effective commissioning and delivery of biologic drugs, improving patient outcomes and reducing the need for hospital visits and surgical interventions[5][11]
  • increasing patient choice and improving clinical pathways, resulting in more efficient care pathways for patients and care closer to home
  • increasing clinical and cost effectiveness. By making commissioning decisions based on NICE guidance and accredited information from NHS Evidence, commissioners can ensure that they are using their resources more effectively.

Key clinical issues

Key clinical issues in providing biologic drugs for the treatment of inflammatory disease include:

  • providing the best possible outcomes for individual patients and their carers
  • ensuring that all eligible patients are identified promptly and prescribed biologic drugs in accordance with the relevant NICE technology appraisal(s)
  • providing transparent and equitable care to everyone needing biologic drugs
  • identifying exceptional patients and ensuring that systems are in place that allow them to be considered for treatment with biologic drugs
  • managing risk and ensuring the safe and effective delivery of biologic drugs to patients in the appropriate setting and in accordance with NICE guidance and local clinical governance arrangements
  • ensuring that the multidisciplinary team are skilled and competent to prescribe and deliver biologic drugs and monitor their effects on the patient across different specialities and settings
  • ensuring robust monitoring and recording procedures are in place
  • providing a quality assured service.

National drivers

National priorities and initiatives relevant to commissioning biologic drugs for the treatment of inflammatory disease include:

Although many or all of these priorities may be relevant to the services nationally, your local service redesign may address only one or two of them.

[b] The term ‘biologic' describes treatments developed and produced in live cell systems, which mimic the effects of substances made naturally by the body's immune system[1][2]. Biologic drugs contain monoclonal antibodies and soluble receptors that specifically modify the disease process, by blocking key protein messenger molecules (for example cytokines such as tumour necrosis factor alpha (TNF-α) or an interleukin, or cells (such as B- or T-lymphocytes))[3]. The drugs may also be referred to as biological drugs, biologic therapies, biologic interventions, or cytokine modulators. At a first glance these drugs are used for apparently unrelated conditions. However, research has shown that all of these inflammatory diseases have common cytokine disregulation factors[2].

[c] The average annual cost of conventional therapy is derived from the average annual cost per patient of methotrexate, sulfasalazine, hydroxychloroquine sulphate, leflunomide, azathioprine, gold and penicillamine listed in the British National Formulary 59 (March 2010). The average annual cost of a biologic therapy is calculated from the average costs of adalimumab, etanercept, abatacept and infliximab as detailed in the costing report for TA195 Rheumatoid arthritis - drugs for the treatment after the failure of a TNF inhibitor and TA198 - Rheumatoid arthritis - tocilizumab: costing template (where the cost per patient per year ranges from £8846 to £10,771).

References

1. Royal College of Nursing (2009) Assessing, managing and monitoring biologic therapies or inflammatory arthritis: Guidance for rheumatology practitioners

2. Palmer D, El Miedany Y (2010) Biological nurse specialist: goodwill to good practice. British Journal of Nursing 19: 477-80

3. Royal College of Physicians (2009) Rheumatoid arthritis: National clinical guideline for management and treatment in adults. London: Royal College of Physicians

4. Smith CH, Anstey AV, Barker JNWN et al. (2009) British Association of Dermatologists' guidelines for biologic interventions for psoriasis 2009. British Journal of Dermatology 161: 987-1019

5. National Audit Office (2009) Services for people with rheumatoid arthritis. London: The Stationery Office

6. The Psoriasis and Psoriatic Arthritis Alliance (2010) Psoriasis and psychological factors. Available from: www.iltdev.co.uk/papaawiki/tiki-read_article.php?articleId=91

7. Graudal N, Jurgens G (2010) Similar effects of disease modifying anti rheumatic drugs, glucocorticoids and biologics on radiographic progression in rheumatoid arthritis: meta-analysis of 70 randomised placebo or drug controlled studies including 112 comparisons. Arthritis and Rheumatism June 2010 (electronic version)

8. National Institute for Health and Care Excellence (2010) Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor. NICE technology appraisal guidance 195

9. Walsh S, Shear N (2004) Psoriasis and the new biologic agents: interrupting a T-AP dance. Canadian Medical Association Journal 170: 1933-41

10. The Psoriasis Association (2010) Biologic drugs for the treatment of psoriasis. Available from: www.psoriasis-association.org.uk/biologics.html

11. Cummings J, Keshav S, Travis S (2008) Medical management of Crohn's disease. BMJ 336:1062-6

12. The King's Fund for the Rheumatology Futures Group (2009) Perceptions of patients and professionals on rheumatoid arthritis care

This page was last updated: 19 October 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.