Clinical Commissioning Policy: Chemotherapy Algorithms for Adults and Children. January 2013 Reference: NHS England XXX/X/X.

Transcription

1 Clinical Commissioning Policy: Chemotherapy Algorithms for Adults and Children January 2013 Reference: NHS England XXX/X/X England 1

2 NHS England Clinical Commissioning Policy: Chemotherapy Algorithms for Adults and Children First published: Month Year Prepared by NHS England Clinical Reference Group for Chemotherapy First published Month Year Published by NHS England, in electronic format only. 2

3 Contents Policy Statement... 4 Equality Statement... 4 Plain Language Summary Introduction Definitions Aim and objectives Epidemiology and needs assessment Evidence base Rationale behind the policy statement Criteria for commissioning Patient pathway Governance arrangements Mechanism for funding Audit requirements Documents which have informed this policy Links to other policies Date of review References Version Control Sheet

4 Policy Statement NHS England will commission chemotherapy in accordance with the criteria outlined in this document. In creating this policy NHS England has reviewed this clinical condition and the options for its treatment. It has considered the place of these treatments in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population in England. Equality Statement Throughout the production of this document, due regard has been given to eliminate discrimination, harassment and victimisation, to advance equality of opportunity, and to foster good relations between people who share a relevant protected characteristic (as cited in under the Equality Act 2010) and those who do not share it. Plain Language Summary Add summary information here 4

5 1. Introduction NHS England will commission systemic chemotherapy for use in adults and children in accordance with nationally approved chemotherapy algorithms and regimen protocols (herewith referred to in this document as algorithms). These NHS England approved chemotherapy algorithms and regimen protocols represent NHS England policy on chemotherapy commissioning. NHS England algorithms describe the acceptable ranges of regimen options for named steps on the patient pathway. Algorithms will be cancer site-specific. The algorithms will be developed and updated by NHS England s Chemotherapy and Paediatric Cancer Clinical Reference Groups. As they become formally agreed by NHS England they will be appended to this overarching policy. NHS England recognizes that the algorithm for a given cancer site cannot cover every possible circumstance that best meets the treatment needs of every individual patient. Therefore, this policy describes the process by which any given deviation from the algorithm should be formally agreed and reported. The algorithms will include drugs that are routinely commissioned by NHS England and drugs funded via the Cancer Drugs Fund. The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE's technology appraisals. NHS England will review the algorithms regularly to ensure they remain clinically relevant but also take account of NICE technology appraisals and changes to the National Cancer Drugs Fund List. Where possible patients should be offered entry into a clinical trial, as standard practice. If a trial is not open at the site, but is elsewhere within the Local Cancer Research Network, consideration should be given to referring patients appropriately. 2. Definitions The term 'chemotherapy' refers to the use of those cytotoxic agents commonly understood and accepted as being covered by this term. The inclusion of certain other agents which may or may not be understood to fall clearly into this group is permissible -such as, biological therapy and small molecule tyrosine kinase inhibitors. 'Systemic chemotherapy' is a term which covers monoclonal antibodies/targeted therapies and intravenous, oral, subcutaneous and intramuscular chemotherapy. Topical and intracavitary chemotherapy is not included. A chemotherapy regimen is defined by the therapeutic chemotherapy drugs used, often expressed as an acronym e.g. 'FEC'. A change of one or more of these drugs themselves would normally be necessary for it to be classed as a change of regimen. In some cases major changes in the dose or route of administration of one 5

6 or more of the drugs effectively changes the regimen but these cases are generally known and recognised nationally. A treatment protocol is defined as constituting all the parameters specified in the bullet points: cancer type; name of regimen and the therapeutic drugs used; therapeutic intent-palliative/adjuvant/neoadjuvant/radical, as applicable; doses of therapeutic drugs; routes of administration; number of cycles or whether this is indeterminate; length of cycle and number and timing of administrations within a cycle; tests required before starting a course and prior to an individual cycle; supportive drugs with each cycle; therapeutic drug dose modifications and their indications. A chemotherapy treatment algorithm may be described as a guideline which specifies the acceptable ranges of regimen options for named steps on the patient pathway. Treatment algorithms are cancer site-specific. They are not specific to individual patients, i.e. they are not individual treatment plans. Thus, a treatment algorithm for breast cancer would include a statement of the range of regimens agreed as acceptable for adjuvant chemotherapy and for first, second and third line palliative chemotherapy etc. Targeted Medicines These are drugs that are able to be targeted at smaller groups of patients with a particular genetic characteristic, enabling improved efficacy, more accurate dosing and sparing patients who will not benefit from possible side effects. Suitable patients are identified through a variety of tests. Examples include the HER2 test which predicts whether a breast cancer patient will respond to trastuzumab or lapatinib. Similarly the K-RAS test can help predict how well a bowel cancer patient will respond to cetuximab. Many more examples of targeted treatment are expected to become available in the near future. 3. Aim and objectives This policy aims to ensure that patients in England have equitable access to the most effective chemotherapy drugs and that the prescribing of chemotherapy is informed by national algorithms. The objectives are to: - ensure anticancer medicines are prescribed according to the appropriate cancer site-specific algorithm approved by NHS England. 6

7 - detail the arrangements for using, monitoring and reporting use of chemotherapy algorithm deviations, which may include one-off chemotherapy regimens that 4. Epidemiology and needs assessment An audit undertaken across four cancer centres serving a combined population of around 3 million showed that the total number of programmes of chemotherapy (a planned period of repeated cycles of treatment) increased by around 60% over a four year period (2002/3 to 2006/7). Scaling up the figures from that audit to the population of England as a whole would indicate an increase from around 40,000 to around 65,000 programmes of chemotherapy per annum. This level of increase is commensurate with the overall increase in expenditure on systemic therapies for cancer (approximately 60%) between 2002 and 2006 reported in the Cancer Reform Strategy (2007). This increase is fully expected to have continued in following years and particularly with the introduction of the Caner Drugs Fund in Between April 2012 and March out of 152 NHS Trusts providing chemotherapy were regularly submitting the minimum required 8 mandatory fields of the Systemic Anti-cancer Therapy (SACT) database. - Treatment data for 101,284 individual patients was received. - Data for 184,969 new regimens and 439,799 new cycles was received. - It should be noted that there are recognised data quality issues where some data is being duplicated or is missing. - This emerging data from SACT also shows significant variation across providers in the use of chemotherapy regimens by cancer tumour site, It is important to note that the patient, regimen and cycle data above are likely to be significant underestimates due to not all Trusts submitting data and even in those who did data not being submitted on all patients. 5. Evidence base The national chemotherapy algorithms for each tumour site will include, where relevant, drugs and regimens approved by the National Institute for Health and Care Excellence (NICE) and those approved by the Cancer Drugs Fund (CDF). These will already have been assessed for clinical effectiveness, health benefits, comparison to standard therapy, cost effectiveness and safety. However, in addition, the algorithms will include drugs and regimens that have not been reviewed by NICE or the CDF but are in, and have been for some time, standard use across NHS England. The evidence base for new additions to the algorithms will be reviewed in future via the processes outlined in section 7 below. 7

8 Since April 2012, the Chemotherapy Intelligence Unit (CIU) has mapped over 18,000 regimens submitted via the SACT database to around 1,200 regimens for analytical purposes. This suggests significant variation in practice and the danger that some patients are not receiving treatment considered best practice. National chemotherapy algorithms will aim to ensure greater equity of provision, improved access to best-practice, evidence based chemotherapy and a greater control over the rate of increase in expenditure on chemotherapy. This should enable improvements in patient outcomes and an increase in the overall value derived from NHS Englands investment in chemotherapy. The algorithms will include targeted medicines (where targeted medicines for the specific cancer site are available) and reference the appropriate genetic/molecular test that should inform the prescribing decision of the targeted medicine. 6. Rationale behind the policy statement This policy statement is framed such as to allow a current position to be agreed (i.e the algorithms and protocols) and then the implementation of a national system to ensure any new regimen/protocols are both recognised as such consistently in NHS England and are subject to a review of their evidence base before their addition to the algorithms. 7. Criteria for commissioning NHS England will commission systemic chemotherapy in accordance with the nationally approved chemotherapy algorithms. These NHS England algorithms describe the acceptable ranges of regimen options for named steps on the patient pathway. Algorithms will be cancer site-specific. The algorithms will be developed and updated by NHS England s Chemotherapy Clinical Reference Group. As they become formally agreed by NHS England they will be appended to this overarching policy and available on the NHS England website. NHS England recognizes that the algorithm for a given cancer site cannot cover every possible circumstance that best meets the treatment needs of every individual patient. Therefore, this policy describes the process by which any given deviation from the algorithm should be formally agreed and reported Process for handling protocol deviations On occasion when a deviation from a recognised and routinely commissioned regimen protocol or the algorithms is required there are four options: A. If the deviation substantively affects the chemotherapy regimen such that it is not recognised as being routinely commissioned for that particular indication, or if a new regimen is required that is not on the approved algorithm for that indication, and the patient is representative of a prospectively definable 8

9 cohort then an application for a policy development may be made to the NHS Cancer Drugs Fund B. If the deviation substantively affects the chemotherapy regimen such that it is not recognised as being routinely commissioned for that particular indication, or if a new regimen is required that is not on the approved algorithm for that indication, and the patient is NOT representative of a prospectively definable cohort. then an application may be made to the local CDF Individual Funding Request (IFR) panel. C. If the regimen protocol deviation consists of a simple variation to a single drug within a routinely commissioned regimen, and there is no impact with respect to the overall drug cost of the regimen, and the variation is recognised as having an improved safety profile; then the trust can process such protocol deviations in accordance with its own governance procedures. D. Additionally if a new regimen that is not on the approved algorithm directly replaces an existing regimen and there is no impact with respect to the overall cost of regimen then the trust can process such protocol deviations in accordance with its own governance procedures. For example in points C and D, this would require formal approval from a named senior clinician (as outlined in the Trust s policy) or via a drugs & therapeutics committee or similar group. Trusts are required to document any such decisions and report to the network Chemotherapy Group (point 5). This would include a drug substitution to reduce the potential toxicity of a regimen for an individual patient, for example substituting etoposide instead of doxorubicin in R-CHOP. Where option 1. C above has been implemented, trusts should record the request on a locally agreed form detailing the recognised regimen protocol and highlighting the change to that protocol so that all healthcare professionals involved in the patient s care have the appropriate information to safely deliver treatment. Any such form should include as a minimum: Patient details & diagnosis Reason for request (why the recognised regimen could not be used) Regimen details; dose(s), likely duration, cost, clinical references & evidence Prescriber name, signature & date Second clinical opinion or multi-disciplinary team signatory & date (to ensure peer approval) Governance / financial authorisation signature(s) (May be same as 2 nd opinion) Oncology/haematology pharmacist signature (note: essential to ensure availability of drug) The form must be reviewed by the Oncology/Haematology Pharmacist for the Trust BEFORE the patient is booked into clinic for treatment. 9

10 In addition: 1. Trusts should ensure they have arrangements to consider the funding and cost implications of any protocol deviations. Trusts will approve such deviations as previously described at their own financial risk. Trusts may wish to consult the appropriate commissioners at the relevant NHS England Area Team. 2. Trusts are required to report all protocol deviations, as described, to NHS England via the relevant NHS England Area Team Cancer Pharmacist. 3. The Chemotherapy CRG will regularly review deviations and new regimens and will consider these for addition to the algorithms. 4. Patients have a right to request funding from commissioners in exceptional circumstances but to do so the support of their consultant is required. Patients also have an option to purchase medicines using private funds. 5. Patients who enter clinical trials will be considered to have left the pathway outlined in the algorithm and should rejoin the pathway at the same point in the algorithm, unless there is a biologically plausible reason why rejoining at that point would be wrong (i.e. patient received a drug in trial with the same or similar mechanism of action as the drug(s) to be received when rejoining the pathway). 8. Patient pathway Each national chemotherapy algorithm will represent a guideline which specifies the acceptable ranges of regimen options for named steps on the patient pathway for a particular tumour site. There is currently no agreed national baseline position for such pathways / regimens in relation to chemotherapy prescribing, However the NHS England Algorithms have been informed by existing algorithms used at a local level (i.e. those developed by the previous 28 Cancer Networks which informed the commissioning of chemotherapy prior to the advent of NHS England. 9. Governance arrangements The service outlined in this policy is for adults and children with cancer requiring specialised chemotherapy treatment, whether curative or palliative, as part of their planned cancer treatment and support, outlined within the Adult Chemotherapy and Paediatric Cancer Specifications. The contracting framework for adult and paediatric systemic cancer therapy services describes systemic cancer therapy as encompassing all types of treatments for patients who require chemotherapy or immunotherapy delivered by the parenteral (including intrathecal, subcutaneous) or oral route. This specification covers both 10

11 solid tumour oncology and haemato-oncology services. NHS England s Chemotherapy CRG will review each algorithm as necessary and, at least, annually. NHS England s Chemotherapy CRG will update the algorithms immediately to reflect any new NICE Technology Appraisal Guidance or changes to the National Cancer Drugs Fund Cohort Drugs List. The current version of each Algorithm will be made available on the NHS England website. 10. Mechanism for funding All chemotherapy is commissioned by NHS England. Delivery tariffs are mandatory since April Procurement tariff is yet to be made mandatory and will not be made mandatory in 2014/15. Current chemotherapy funding mechanisms are historical, complex and including: variable Block contract Local/National Tariff Cost-per-case Pass-through payments The Algorithms will define the treatment regimens / protocols that NHS England normally fund. 11. Audit requirements In September 2011, the NHS Information Standards Board granted Full Stage approval to the Systemic Anti-Cancer Therapy (SACT) Information Standard. The standard covers all patients receiving cancer chemotherapy in or funded by the NHS in England. The data standard relates to all cancer patients, both adult and paediatric, in acute inpatient, day case, outpatient settings and delivery in the community. It covers chemotherapy treatment for all solid tumour and haematological malignancies, including those in clinical trials. NHS Trusts providing cancer chemotherapy services in England are required to collect and submit chemotherapy data. Full compliance under this agreement is expected with the mandated SACT dataset and reported with the required format and timelines. All trusts with e-prescribing systems should currently be submitting monthly chemotherapy data to the Chemotherapy Intelligence Unit (CIU) via the upload portal on the website. Those without e-prescribing systems should be uploading at least the mandatory fields (September 2012) and have an action plan and timetable agreed with the CIU for uploading the entire dataset which will be due by April

12 12. Documents which have informed this policy NHS England (2013) Service Specification for Adult Chemotherapy B15/S/a Department of Health (2013) National Cancer Peer Review, Chemotherapy Measures, Manual for Cancer Services 13. Links to other policies This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR). 14. Date of review This policy will be reviewed in April 2016 unless information is received which indicates that the proposed review date should be brought forward or delayed. References NHS England (2013) Service Specification for Adult Chemotherapy B15/S/a Department of Health (2013) National Cancer Peer Review, Chemotherapy Measures, Manual for Cancer Services Department of Health (2013) Improving Outcomes A Strategy for Cancer. Version Control Sheet Version Section/Para/Appendix Version/Description of Amendments Date Author/Amended by

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