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Specifying a service for people who need biologic drugs for the treatment of inflammatory disease in rheumatology, dermatology and gastroenterology

Service components

The key factors in commissioning biologic drugs for the treatment of inflammatory disease are:

Ensuring all eligible patients have access to timely and cost-effective treatment

Commissioners should work with clinicians and hospital trust managers to ensure that systems are in place that do not introduce unnecessary delays and that enable eligible patients to start biologic therapy in a timely fashion. This is crucial for achieving positive outcomes and limiting the progression of the disease[1][2].

People who are eligible for treatment with a biologic drug for inflammatory disease will usually be receiving care from specialist physicians or teams in secondary care, who are experienced in the diagnosis and management of disease in rheumatology, dermatology, gastroenterology or paediatric rheumatology. To ensure good coordination of care, particularly for people with comorbidities, commissioners should work with clinicians across these specialities so that the appropriate pathways are in place.

To ensure clinical effectiveness and cost-effectiveness, the local eligibility criteria for access to treatment with biologic drugs for inflammatory disease should be in line with NICE recommendations. Clinicians and commissioners should consider how they can ensure that the eligibility criteria is correctly applied, adhered to and monitored. See an example of an authorisation process from NHS East Lancashire and NHS Blackburn with Darwen Care Trust Plus (Figure 2).

Figure 2: Prior approval for biologic drugs in NHS East Lancashire and NHS Blackburn with Darwen Care Trust Plus

NHS East Lancashire and NHS Blackburn with Darwen requires local clinicians who are prescribing biologic drugs to complete a ‘prior approval' ‘tick box' form that is submitted and checked by the hospital pharmacy before treatment is authorised. Additional ‘continuation' forms which are completed following routine review, and also ‘discontinuation' forms which instruct that treatment with a particular drug should be stopped, complete the process.

The ‘tick box' form is used to demonstrate that patients are receiving appropriate treatment in line with NICE recommendations. It shows:

  • which drug and treatment schedule has been prescribed
  • whether patients meet eligibility criteria for the treatment of the condition, using a series of ‘yes' or ‘no' answers
  • whether patients have been offered evidence-based information about their treatment.

If a patient is not eligible for treatment, their case may be considered using the PCT's Individual Funding Request processes, which are used when there are exceptional clinical circumstances. The PCT's aim is to move from a paper based system to an electronic transfer of information and authorisation over time.

For further information on these prescription approval forms please see this example on the NICE shared learning database.

This example is offered to share practice and NICE makes no judgment on the compliance of this service with its guidance.

Commissioners should be aware that people starting biologic drugs for the treatment of inflammatory disease will typically:

  • Have a condition for which conventional treatments and/or pharmacotherapy has failed, or they have contraindications to conventional treatments and/or pharmacotherapy. Commissioners may wish to ensure that clinicians have tried alternative treatments and/or methods of drug administration in these cases.
  • Meet the disease severity assessment criteria, in line with NICE guidance. Commissioners may wish to ensure that the specialist team are consistent in measuring patient disease severity.

The topic-specific advisory group asks commissioners to note that they may occasionally receive a request to fund treatment for an exceptional patient - that is, a person who may benefit from treatment with a biologic drug but who does not meet the NICE selection criteria. When developing local policies and procedures for prescribing biologic drugs for exceptional patients, such as individual funding requests, commissioners and clinicians should take into account the impact of the drug on the patient's quality of life, the person's preferences and the perceived cost-effectiveness of the treatment.

Exceptional patients include but are not limited to:

  • Children: NICE makes recommendations on biologic drugs for juvenile idiopathic arthritis (JIA) and Crohn's disease. Commissioners should be aware that there may be children with other active inflammatory diseases, such as psoriasis, who may benefit from treatment with a biologic drug[d].
  • Young adults: NICE makes recommendations for the treatment of juvenile idiopathic arthritis in children and young people. However, commissioners should be aware that some young adults over the age of 17 may have active juvenile idiopathic arthritis.
  • People with co-morbidities: commissioners should ensure that there is good coordination of care across all specialist areas including dermatology, rheumatology and gastroenterology because a person's inflammatory condition may increase their susceptibility to co-morbidities. The presence of co-morbid conditions may affect an individual person's response to biologic drugs. See figure 8 and figure 9 for examples of care coordination.
  • People for whom a first biologic drug fails: NICE makes recommendations for people who have an adverse affect to biologic drugs within the first 3-6 months for all conditions. NICE also makes recommendations for treatment with a subsequent biologic drug for people with rheumatoid arthritis and psoriasis. Commissioners and clinicians should refer to the relevant NICE guidance for details. In all other circumstances local commissioning decisions may be needed.

Commissioners should ensure that clinicians provide people with information that enables them to make an informed decision about starting treatment with, or rejecting, a biologic drug, based on their assessment of the risks and benefits of treatment and cessation. It is good practice to ensure that the patient's consent for treatment is recorded.

Commissioners should work with clinicians to assess and favour, where appropriate and without jeopardising patient outcomes or efficacy, the prescription of the most cost-effective drug recommended by NICE for each condition. An assessment of the most cost-effective drug will include consideration of:

  • Differences in clinical outcomes for each of the drugs and conditions. Commissioners and clinicians should refer to the relevant NICE guidance and the ‘useful sources of information section' within this guide
  • Drug dose
  • Costs associated with administering biologic drugs to patients and monitoring the patient's safety and response
  • Opportunities for people to self-administer biologic drugs at home. When delivered to a person's home by a home-care company, biologic drugs are exempt from VAT.
  • Savings from patient access schemes. Patient access schemes are provided by pharmaceutical companies to enable people to gain access to selected high costs drugs. NICE recommends some biologic drugs for the treatment of inflammatory disease if there is a patient access scheme in place. Where patient access schemes provide cost savings in the first year of treatment, commissioners should be mindful that they will need to budget for the full cost of treatment in subsequent years.

Developing high-quality cost-effective services for the safe administration and monitoring of biologic drugs

When developing contracts and service specifications, commissioners should work alongside clinicians and hospital managers to develop robust and transparent quality and clinical governance arrangements for prescribing and delivering biologic drugs across different clinical specialities. Quality and clinical governance arrangements, along with clear selection criteria, could prevent the need for biologic drug prescriptions to be authorised on a case-by-case basis, thereby avoiding delays in initiating therapy and excessive administrative procedures. See the example from South Staffordshire PCT (Figure 3).

Figure 3: Developing a biologic drugs commissioning policy in South Staffordshire PCT

Faced with a 22% annual growth in the demand for, and expenditure on, biologic drugs, South Staffordshire PCT is developing a commissioning policy for biologic drugs for inflammatory disease.

The policy will be underpinned by NICE guidance and informed by clinicians and the latest available clinical evidence. The policy will:

  • Ensure that, before starting treatment with biologic drugs, patients have tried alternative conventional therapies that have failed to control symptoms, and that alternative administration methods have been attempted (for example trying subcutaneous methotrexate for patients who are intolerant to oral methotrexate).
  • Agree the local process for initiating biologic therapy. Clinicians prescribe the drug: this prescription is then checked by pharmacists to ensure it aligns with NICE recommendations, the local commissioning policy and available budget.
  • Detail a process for considering exceptional patients.
  • Outline procedures for monitoring patient response in accordance with NICE recommendations.
  • Detail procedures to be followed after the failure of treatment with a biologic drug.
  • Specify rules for continuing and stopping biologic therapies after treatment failure.

Audit will be used to ensure that clinicians are complying with the policy and to address any issues that emerge.

This example is offered to share practice and NICE makes no judgement on the compliance of this service with its guidance.

Commissioners may wish to work with clinicians to develop comprehensive rules for the continuation or maintenance of a person's treatment with a biologic drug. These rules should comply with NICE recommendations, and may include guidance for:

  • monitoring patient response
  • treatment after the failure of a first biologic drug
  • criteria for the discontinuation of therapy and palliative care options.

Further information about the maintenance and discontinuation of treatment may be found in the NHS clinical knowledge summary for biologic drugs.

Because biologic drugs are a relatively new treatment, their long-term efficacy and side-effects are not fully known. It is important that records are kept of all patients who are eligible for and receiving biologic drugs for the treatment of inflammatory disease. Records should include dates of consultations and drug administrations, and demonstrate that patients fulfil NICE eligibility and continuation criteria. A current and accurate record can contribute to budget management, clinical governance, and audit and monitoring systems. See the example from Royal Derby NHS Trust (Figure 4). Commissioners should also encourage clinicians to use the national biologic drugs databases operated by the British Society for Rheumatology, British Association of Dermatology and British Society for Paediatric and Adolescent Rheumatology (currently there is no register specific to gastroenterology).

Figure 4: Royal Derby NHS Trust rheumatology biologics database

Nurse specialists use locally agreed algorithms to collect data on all patients before starting treatment with biologic drugs. Measurements include the patient's disease activity scores, previous disease-modifying anti-rheumatic drug (DMARD) treatment, contraindications to treatment and smoking status. Once the patient starts therapy, data on patient response are collected at 3 months and then at 6-monthly check-ups.

These data are fed into a database, which holds data on all patients who are currently taking, or have previously taken, biologic drugs. The database is maintained by a database clerk whose salary is paid for by the local PCTs.

The database prevents the need for case-by-case approval of biologic drugs. It is used to:

  • keep up-to-date records on patients who are prescribed and receiving biologic drugs
  • monitor compliance with NICE eligibility and criteria
  • provide regular reports to the host PCTs: this contributes to their audit and budget management processes
  • allow more detailed audits to be performed at the request of the PCTs
  • manage pharmacovigilance, risk and safety
  • contribute to understanding the short- and long-term effectiveness of biologic drugs
  • allow research projects to take place in the department.

This example is offered to share practice and NICE makes no judgement on the compliance of this service with its guidance.

There is a large and potentially increasing demand for biologic drugs, therefore it is important that commissioners manage their budget proactively to ensure that all eligible patients have access to the drugs in accordance with NICE guidance. Commissioners may wish to forecast the likely demand for biologic drugs for inflammatory disease in their area, and to set aside the funding to meet this need. The NICE forward planner, costing tools and commissioning and benchmarking tool may assist with forecasting. See the example from Bristol Health Community (Figure 5).

Figure 5: Meeting the demand for biologic drugs in the Bristol Health Community

To ensure that funding is available for all eligible patients to access biologic drugs for inflammatory disease, the Technology Appraisals Implementation Team for three acute trusts and three primary care trusts in the Bristol area operate a proactive four stage system:

  • The team use the NICE forward planner to identify upcoming NICE technology appraisals (TAs) and allocate a provisional budget to each prospective and published TA for the financial year.
  • An implementation plan is prepared at the final appraisal determination (FAD) stage and finalised on publication of the final guidance. This estimates the number of eligible patients, immediate and long-term cost impact, and actions needed for implementation. It also anticipates the impact on waiting lists, referral patterns and human resources. The group reviews the funding set aside to meet the estimated cost and compares this against the NICE costing tools.
  • After implementation, monthly monitoring of actual uptake and expenditure is fed back to the PCT; figures are readjusted where they differ significantly from initial estimates.
  • Periodic audit of practice is used to identify and resolve any issues.

This example is offered to share practice and NICE makes no judgement on the compliance of this service with its guidance.

Commissioners may wish to consider collaborating with sub-regional or regional partners when commissioning biologic drugs - for example, at regional medicines management or commissioning groups. There are several advantages to sub-regional or regional collaboration when commissioning biologic drugs, including:

  • developing regional commissioning strategies to ensure all commissioners apply the same clinical thresholds and processes, to help reduce inequalities in patient access to drugs
  • sharing good practice and resources such as audit criteria, audit pharmacists, or contracts for the home delivery of biologic drugs
  • achieving economies of scale and improving quality and accountability by regional tendering or negotiating contracts for services, such as home delivery for biologic drugs
  • negotiating with pharmaceutical companies to achieve reductions in the cost of drugs
  • preventing duplication of resources in the development of policies, procurement strategies and contracts for biologic drugs.

Service models

Commissioners may wish to consider commissioning biologic drugs for the treatment of inflammatory disease in a number of different ways. These should be informed by the patient's needs and preferences, and provide opportunities for care closer to home. Mixed models of provision may be appropriate across a local health economy.

Commissioners should ensure that a patient's care pathway is led by a specialist multi-disciplinary team including specialist physicians and nurses. Typically the team will be based in a secondary care setting. However, commissioners may wish to consider the possibility of developing services provided by specialist teams in a community setting. See the example from Pennine Musculoskeletal Partnership Ltd (Figure 6). The team should always maintain a treatment plan, provide regular reviews of the patient's response in accordance with NICE guidance and maintain responsibility for prescribing biologic drugs, including any that are delivered by third-parties.

Figure 6: Community-based care for rheumatology patients in Oldham

Pennine Musculoskeletal Partnership Ltd provides community-based care for all people with inflammatory arthritis and osteoarthritis in Oldham. The service is conveniently located in the town centre, and is provided by a rheumatology integrated care and assessment team (ICAT) that includes consultant rheumatologists, GPs with specialist interest, a nurse consultant, nurse specialists, occupational therapists, physiotherapists and podiatrists.

Care pathways are led by nurse specialists. Patients who are identified and assessed as eligible for biologic drugs in accordance with NICE guidance are referred to a consultant rheumatologist for the prescription. Ongoing patient response is measured by nurse specialists, who also coordinate and monitor the services provided by home-care companies.

Other services for patients taking biologic drugs include a telephone helpline providing advice and follow-up care for patients and an infusion clinic.

This example is offered to share practice and NICE makes no judgement on the compliance of this service with its guidance.

With support and training most people can self-administer subcutaneous biologic drugs at home. Training may be provided by the specialist team or by a private home-care company. Patients should understand how to respond to unanticipated side-effects. See the example from the Aneurin Bevan Health Board (Figure 7). Commissioners should engage primary care colleagues to ensure that they identify, manage or refer people with issues related to biologic drugs. Commissioners may also consider commissioning a telecare or telehealth service to provide telephone or online support for people taking biologic drugs. This may help reduce the number of patients' appointments and their travel time, and free-up clinics for priority patients.

Figure 7: Care for patients with psoriasis in Aneurin Bevan Health Board

The safety net for patients taking biologic drugs is provided by both primary and secondary care, with primary care dealing with minor issues and secondary care with more urgent issues. Patients receive training from clinical nurse specialists to help them understand what they should do if they have an unexpected problem with their health; patients are encouraged to involve secondary care early, to prevent minor problems from becoming exacerbated.

This example is offered to share practice and NICE makes no judgement on the compliance of this service with its guidance.

Most people who self-administer biologic drugs, and some who receive infusions, will have their drugs delivered to their home by a private home-care service. When commissioning home-care services commissioners should:

  • ensure that the home-care service is well integrated into the care pathways provided by the specialist multidisciplinary teams
  • provide a quality assurance system to monitor the efficacy, safety and quality of the home-care service provided
  • ensure that the home-care service is meeting the needs of patients
  • negotiate with home-care services to ensure that they are receiving a cost-effective service
  • consider whether similar services could be delivered in a more cost-effective manner by other enterprises or by developing or using their own home-care services.

Some people may need to attend community or hospital facilities for the infusion of intravenous drugs. Commissioners may wish to consider whether they have sufficient day-case facilities to meet the demand for these patients, and that they can provide this care close to a person's home where possible. They may also wish to provide shared-infusion clinics across the range of inflammatory conditions where biologic drugs may be used; see the examples from the Royal Derby NHS Trust (Figure 8) and Leeds General Infirmary (Figure 9).

Figure 8: Combined joint and skin clinics for patients with psoriatic arthritis in Royal Derby NHS Trust

The monthly combined joint and skin clinic is provided by rheumatology and dermatology nurse specialists. The aim is to provide better coordinated care for patients with psoriatic arthritis.

The clinic provides:

  • individual patient response scores (PASI [psoriasis area severity index] and PsARC [psoriatic arthritis response criteria]) for dermatology and rheumatology)
  • annual skin cancer screening
  • the opportunity for patients to discuss both joint and skin problems.

The clinic enables the coordination of treatment across dermatology and rheumatology, including the use of an appropriate biologic drug for both conditions, resulting in better skin and joint outcomes for the patient.

The trust also operates a combined day case unit where infusions for rheumatology and dermatology are delivered.

This example is offered to share practice and NICE makes no judgement on the compliance of this service with its guidance.

Figure 9: Combined clinics for inflammatory diseases in Leeds General Infirmary

Some patients who have one immune-mediated inflammatory disease (IMID) may also have a second related IMID - for example, patients with Crohn's disease who also have ankylosing spondylitis or rheumatoid arthritis. To improve the quality and coordination of patient care for such patients, the gastroenterology and rheumatology departments run a bi-monthly joint clinic to help ensure that their choice of biologic therapy is appropriate for both conditions.

Leeds General Infirmary also operates a combined infusion clinic for IMIDs, operated by a specialist IMID nursing team. The team oversees biologic drug infusions and nurse specialists monitor patient response. Advantages to this model include specialist nurse review reducing out-patient follow up and drug vial sharing[f] between patients, which greatly reduces cost.

This example is offered to share practice and NICE makes no judgment on the compliance of this service with its guidance.

Service specification

Local stakeholders, including clinicians and service users, should be involved in determining what is needed when commissioning biologic drugs for the treatment of inflammatory disease in order to meet local needs. The service should be patient-centred and integrated with other elements of care for people with inflammatory disease.

The service specification needs to consider:

  • How quickly any changes in service provision are likely to take place
  • Staff competencies, including possible training requirements. See Skills for Health long term conditions case management competence framework
  • The number of people with each condition who are prescribed biologic drugs, including estimates of future demand and numbers of people who will cease therapy
  • Service accessibility, with opportunities to provide care closer to home. This should take into account the age profile of the population, time, distance and cost of travel to secondary or primary care facilities (this may differ between rural and urban areas) and the needs of vulnerable patients
  • Patient's views on preferred methods and locations for administering biologic drugs and monitoring their outcomes. This might include their views on cost and time impact of alternative methods and how this affects their quality of life
  • Rules for the identification of patients, initiation and continuation of therapy
  • The patient care pathway
  • Available resources, both financial and human
  • Planned service improvement, including redesign, quality, equitable access, and referral-to-treatment times
  • Address any safeguarding concerns and promote the welfare of children and vulnerable adults
  • Service monitoring criteria.

Useful sources of information may include:

[d] Further information on assessment, management and resource planning for children can be found in the Royal College of Nursing's guidance on assessing, managing and monitoring biologic therapies for inflammatory arthritis and from the British Society for Paediatric and Adolescent Rheumatology.

[f] NICE has not considered or made recommendations relating to vial sharing. Where clinicians undertake vial sharing, clinical governance processes should take full account of licensing, safety and good manufacturing practice. For further information please consult the NPSA safety alert Promoting Safer Use of Injectable Medicines. Standards for the preparation and manufacture of injectable medicines within hospital pharmacies are set out in EL(97) 52 Aseptic Dispensing in NHS Hospitals and the European Union Guide on Good Manufacturing Practice.

References

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

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

This page was last updated: 16 October 2012

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

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

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

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