Leading doctors, advocacy groups and medical organizations remain concerned on several fronts regarding access to delamanid.
The letter asks the company to commit publicly and formally to:
1) immediate availability of delamanid for patients meeting criteria for compassionate use, regardless of whether they are being treated by pilot compassionate use programs;
2) rapid registration of delamanid in trial site countries and other high TB burden countries;
3) widespread availability of delamanid in TB markets post-approval, without restricting access to phase IV trials or rich countries; and
4) fair and accessible pricing of delamanid that utilizes mechanisms such as voluntary licensing, rather than tiered pricing.
The letter welcomes the news that Otsuka has initiated its compassionate use program but finds it unacceptable that only one patient has benefitted so far. Of particular urgency is underlined another case of extensively drug-resistant TB in the US requiring compassionate use of delamanid.
“Patients and providers in the many settings where pilot compassionate use programs do not exist immediately need the option to access delamanid, and to have a clear point-of-contact at Otsuka to whom to address requests. We also remind Otsuka that the risk-benefit considerations for patients in need of compassionate use access (who are by definition in urgent need of possible rather than approved treatment options) differ from those of the general population with TB, and encourage Otsuka to make delamanid available to patients hoping to benefit from the use of as yet unapproved drug combinations when no viable alternatives exist.”
This letter is the third of a series of open letters to Otsuka regarding the delamanid compassionate use. The requests to the company to implement a pre-approval access program date back to 2011 (read here and here). The most recent Otsuka's response regarding this issue can be viewed here.