The BTS MDR-TB Clinical Advice Service
New MDR-TB Clinical Advice Service Available from January 2018
BTS has redeveloped and improved its MDR-TB Clinical Advice Service, by which advice and support is given to clinicians who encounter MDR-TB and wish to receive advice about treatment. Support from Public Health England and NHS England is gratefully acknowledged.
The new UK-wide online service is now available. If you are a clinician who would like to make use of this service for expert advice from a multi-disciplinary panel of formally appointed expert Clinical Service Advisers, please register using the link below.
The BTS MDR-TB Clinical Advice Service has received Ethics Committee approval (26th October 2017. Ref: 17/LO/1539).
WHO Rapid Communication - August 2018
WHO has recently published a Rapid Communication on key changes to treatment of multi-drug and rifampicin-resistant TB (MDR/RR-TB) as a prelude to the formal guidance – the document is available here: http://www.who.int/tb/publications/2018/rapid_communications_MDR/en/ and the final guideline will not be issued until later this year. As such, the communications does not notify you of decisions that have been taken or immediate changes in practice that are to be implemented, but of advice which health systems now need to use to plan for future changes in implementation.
The document includes a new priority ranking of the available medicines for MDR-TB treatment, which has several major changes compared to the 2016 WHO MDR-TB guidance.
- Kanamycin and capreomycin are no longer in the regimen to treat MDR/RR-TB;
- Bedaquiline and linezolid (together with levofloxacin or moxifloxacin) have been upgraded and prioritized in the regimen to treat MDR/RR-TB;
- A new, all-oral, regimen for MDR/RR-TB treatment
- In the shorter regimen for MDR/RR-TB, kanamycin and capreomycin should be replaced with amikacin (or bedaquiline under operational research conditions).
Bedaquiline for 6 months in intensive phase has been categorised as a first line drug (along with a fluoroquinolone and linezolid) in this new proposed ranking. Currently, in the UK context, this is not the case and the current NHS England Clinical Commissioning Policy on prescribing bedaquiline and delamanid (NHS England F04/P/a) was published in July 2015. Hence bedaquiline is still subject to the conditions and criteria outlined in that policy document, which still conform to the 2016 WHO MDR-TB guidance. Applications for funding of bedaquiline or delamanid require support from the BTS MDR-TB Clinical Advice Service panel of Clinical Service Advisers (CSAs). NHS England operates a prior approval system to ensure prescribing in line with the policy criteria and the forms are being updated to ensure only those providers who were selected and commissioned to provide the drugs are reimbursed to do so.
From a clinical perspective the changes in terms of the new WHO recommendation not to use capreomycin or kanamycin, and also the changes in the group A and B drugs, can be incorporated by clinicians and the BTS MDR-TB CAS without any significant change to the current commissioning guidance. However, under the current specialist commissioning arrangements, any second line injectable and/or fluoroquinolone resistance or intolerance are a criteria for specialist commissioning of bedaquiline and delamanid and will only continue to be funded on that basis until the UK has completed the planning and commission work to revise commissioning policy. You will be aware of the potential ototoxicity, especially associated with the prolonged use of amikacin, and it is important to continue to be vigilant about detecting symptoms or early audiological evidence of toxicity and to then apply for one of the specialist commissioned drugs immediately should this occur. Any BTS MDR-TB CAS advice will continue to work on this basis should central funding be sought, although IFRs can be utilised outside these current criteria should clinicians wish to pursue this. We understand that NHSE are unlikely to fund these IFRs until there is a commissioning policy change as use based on the WHO Rapid Communication would inevitably represent a cohort.
In the long term, a full policy revision for specialised commissioning is anticipated to take into account the full new WHO guidance and will likely also take stock of the appropriate commissioning arrangements for MDR TB across CCGs and specialised commissioning. There is already an urgent policy application underway to allow for extension or concurrent use of bedaquiline and delamanid for specific cases.
The process for asking our panel to support applications for bedaquiline (and also for delamanid) continues as follows:
• Post your case to the BTS MDR-TB Clinical Advice Service site (https://mdrtb.brit-thoracic.org.uk).
• After you have completed the dataset, please post your query and request support for your application in the ‘Clinical Advice’ section of the site.
• During our monthly MDTs our panel will discuss cases and will post their consensus opinion to your case online – this will include details of whether the panel support your application and, if so, the duration of treatment they support the application for.
• For discussions outside an MDT (where CSAs respond individually to your query) a minimum of three CSAs must post their agreement for you to use bedaquiline/delamanid before your application may be considered to have the support of the BTS MDR-TB CAS.
BTS Clinical Statement: the Management of Multidrug-Resistant Tuberculosis
Advice on the 2016 WHO guidance for the management of MDRTB in the context of the UK is now available in the November 2016 BTS Clinical Statement.
11th September 2018