The new policy means clinicians in England will be able to access and prescribe bedaquiline more easily, via a registry, in order to monitor its use as well as patient outcomes.
The announcement follows a needs assessment, which highlighted that cases of TB in the UK are high compared to most other Western European countries. Out of a total 7,892 cases of TB in the UK in 2013, London accounted for the highest proportion (2,985 cases, 41%) followed by the West Midlands (981 cases, 13.4%). The assessment also cited an increase in cases of MDR-TB in the UK, rising from 28 cases in 2000 to 89 cases in 2012.
It also predicted a further rise in cases of MDR-TB due to migration patterns. The World Health Organization (WHO) estimates that up to half a million new cases of MDR-TB occur each year globally, and that more than two million people will be infected with MDR-TB between 2011 and 2015.
Bedaquiline is the first new medicine for MDR-TB with a novel mechanism of action to be introduced for almost 50 years. Phase 2 studies have shown that bedaquiline, as part of an appropriate combination regimen, can shorten time to culture conversion (an indicative measure assessing when the patient is responding to therapy) in adult patients with pulmonary MDR-TB.
After 24 weeks of treatment, the median time to culture conversion was significantly shorter for the bedaquiline group (83 days) compared to the placebo group (125 days). Additionally, treatment with bedaquiline continued to result in a significantly improved culture conversion rate at week 120 compared to the placebo-treated group.
Also, when final data are translated to the WHO-recommended treatment outcome definitions, the proportion of patients defined as cured at 120 weeks was 57.6% in the bedaquiline arm vs. 31.8% in the placebo arm. The most common adverse events observed during treatment were nausea (35.3% in the bedaquiline group vs 25.7% in the placebo group), arthralgia (29.4% vs 20.0%), headache (23.5% vs 11.4%), vomiting (20.6% vs 22.9%) and dizziness (12.7% vs 11.4%).
Professor Onn Min Kon, Respiratory Physician said: “The provision of a commissioning policy for these promising new drugs in the treatment of multi-drug resistant tuberculosis is welcomed by clinicians. This now allows clear criteria and funding for specialist clinicians to prescribe these new agents in a group of patients with the most complex and serious form of tuberculosis. Such access is critical for situations when standard recommended therapies for drug resistance are not suitable because of resistance patterns to the most effective drugs or because of side effects that may be seen in some patients. The addition of these to a suboptimal regime will potentially contribute to a reduction in periods of infectiousness and improve outcomes for the patient.”
In March 2014, the European Medicines Agency’s (EMA), Committee for Medicinal Products for Human Use (CHMP), granted approval for the use of bedaquiline in the European Union (including the UK) as part of an appropriate combination regimen for pulmonary MDR-TB in adults when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.