Earlier this year, the Centers for Disease Control and Prevention (CDC), Division of Tuberculosis Elimination (DTBE) released provisional 2014 surveillance data on reported TB cases in the United States. The DTBE is pleased to announce that the full report, entitled Reported Tuberculosis in the United States, 2014, is now available for viewing online.
Launched on September 14, 2015, the Mayo Clinic Center for Tuberculosis Knowledge Base is an online resource designed for health care practitioners working in the field of tuberculosis to quickly find topic-specific information about TB. Users may enter search criteria on a variety of TB topics and the search engine will then display records with information pertaining to their topic. Along with topic information, links are provided to outside sources and other internal resources.
From the Minnesota Department of Health:
Our program was recently notified by our contracted pharmacy of a shortage of rifapentine, used for the latent TB infection (LTBI) isoniazid/rifapentine (INH-RPT) regimen. The drug is currently on back-order with a tentative supply relief date of early October 2015. Until a reliable supply is available, our program will not be filling any new requests for this regimen. We will post updates on our TB Medication Program website page. http://www.health.state.mn.us/divs/idepc/diseases/tb/meds/index.html
As an alternative, we are recommending the following:
1) If using an alternate drug source, please confirm they have a full course supply before beginning the patient. 2) Consider prescribing an alternative single drug (INH or Rifampin) LTBI treatment regimens. See that attached sheet Recommended Regimens for Treatment of Latent Tuberculosis Infection (LTBI).
Additional questions may be directed to our Tuberculosis Medications Coordinator, Lenette Bauer at 651.201.5506 or firstname.lastname@example.org.
Recommended Regimens for Treatment of LTBI
From the CDC DTBE:
CDC DTBE has been made aware of a large price increase of a critical tuberculosis (TB) drug, cycloserine. On 8/19/2015, Rodelis Therapeutics acquired sole-source manufacturing rights for cycloserine from The Chao Center for Industrial Pharmacy & Contract Manufacturing (Chao Center). The manufacturer’s price of the drug has subsequently increased from just under ~$500 to ~$10,800 for a package of 30 tablets (250 mg).
CDC DTBE understands and has communicated to the manufacturer the impact that this price increase would have on the continued management of TB patients, specifically MDR TB patients. DTBE is currently working with national partners including NTCA and the Food and Drug Administration (FDA) to address concerns regarding this price increase.
Rodelis Therapeutics has agreed to work with TB providers to ensure access to this medication. The company is planning to put into place a patient assistance program in the near future. More details on how to access this program will be forthcoming. Additionally, the company has set up a 30-day compassionate use program to mitigate the immediate impact on patient care and 340B pricing is currently unchanged. Rodelis Therapeutics has encouraged TB providers to email them directly at email@example.com for assistance with obtaining cycloserine through one of these programs or to discuss other alternatives.
If you have any further questions, please contact the DTBE Drug Shortage Workgroup point of contact, Neha Shah at (510) 620-3056 or at firstname.lastname@example.org. DTBE will continue to keep you informed when we obtain more information regarding access to this important TB drug.
Cycloserine Capsule Price Increase
In an August 19, 2015 product update regarding Cycloserine Capsules, Rodelis Therapeutics announced an increase in the price for a carton of 30 blister packs of Cycloserine Capsules to $10,800.
The Division of Tuberculosis Elimination is contacting Rodelis Therapeutics to clarify the pricing situation, the rationale for the recent price hike and explaining the constraints that this price increase will do for MDR patients whose treatment is primarily covered by limited State’s public health budgets.
In the short-term, the Mayo Clinic Center for Tuberculosis, in consultation with the CDC, advises no changes to current treatment for MDR patients unless prescriptions for Cycloserine have lapsed and there is a need to purchase more at this time.
STD Clinical Consultation Network
The National Network of STD Clinical Prevention Training Centers (NNPTC) has launched the STD Clinical Consultation Network (STDCCN), the first online STD consultation system for providers. STDCCN provides free STD clinical consultation services to health care providers in 1-5 business days, depending on urgency. The expert faculty at our eight regional PTCs will respond to STD consultation requests within their region. Operating nationally five days a week, during business hours, the STDCCN is convenient, simple, and free. For more information, please go online at: www.stdccn.org or www.nnptc.org.
The CDC Division of Tuberculosis Elimination (DTBE) is pleased to announce the implementation of phenotypic drug susceptibility testing of SIRTURO (Bedaquiline) as part of CDC’s Reference Laboratory services in the DTBE Laboratory Branch. Instructions regarding submission of isolates and additional contact information are provided here.
If you have questions regarding this expanded service, please contact Dr. Beverly Metchock, Reference Laboratory Team Lead (email@example.com, 404-639-1285). If your laboratory has archived isolates for BDQ Testing, please contact Dr. Metchock prior to shipping.
If you have questions regarding the BDQ Patient-Exposure Registry, please contact Dr. Sundari Mase, Medical Team Lead for the DTBE Field Services and Evaluation Branch (FSEB) at firstname.lastname@example.org or 404-639-5336.
June 4, 2015 [MMWR] The spread of airborne diseases such as tuberculosis can be a major risk in congregant settings like dormitories and schools. This article demonstrates that techniques regularly employed for mass response to emergencies can also be used for mass testing for infectious diseases like tuberculosis. In 2013, a local health department was able to test 1,800 individuals in 24 hours for tuberculosis (TB) at a local high school, based on concerns TB may have been actively spreading. Using the Incident Command System (ICS), the same system used nationally for emergency response, the department rapidly responded with sufficient personnel and equipment to evaluate students and staff and refer those who tested positive to treatment. It provides a framework for other public health agencies when presented with an urgent public health situation, and, specifically for tuberculosis, more evidence about when to initiate such a response. This article demonstrates that techniques regularly employed for mass emergency response can also be used for mass testing for infectious diseases like tuberculosis. Full Article.
January 16, 2015 - The CDC Division of Tuberculosis Elimination announced today that the California Microbial Diseases Laboratory (MDL) will serve as a Drug Susceptibility Testing Reference Center for Mycobacterium tuberculosis. MDL will serve as an extension of the CDC DTBE Laboratory Branch Reference Laboratory, providing services complementary to those at CDC for low volume public health laboratories with low volumes of drug susceptibility testing. Services are expected to begin in March, 2015. Read the January 16 announcement letter here.