Name: Emcitate (tiratricol) in MCT8 deficiency: Access and distribution
Published: 2026-09-14T15:39:06-04:00

U.S. commercial availability

“The Company expects EMCITATE to be commercially available in the United States in eight to ten weeks post approval.” (opens the source at this quote in a new tab)

Specialty pharmacy: PANTHERx Rare

“As part of its U.S. commercialization strategy, Egetis has partnered with PANTHERx® Rare to support medication access, education, care coordination and ongoing treatment services.” (opens the source at this quote in a new tab)

“I authorize the forwarding of this start form (and the information included herein) to PANTHERx Rare Pharmacy.” (opens the source at this quote in a new tab)

Patient support program: Egetis RareLink

“Egetis launches Egetis RareLink™, the EMCITATE patient support program, in partnership with PANTHERx® Rare” (opens the source at this quote in a new tab)

“Such services include: disease state and product education (including starter kit), medication and adherence communications, insurance coverage and financial assistance support, product administration training support, free drug (if eligible), coordination of medication delivery” (opens the source at this quote in a new tab)

QuickStart, Bridge, patient assistance, and copay programs

“FOR INSURED PATIENTS ONLY: An optional program available to eligible patients at no cost if coverage approval is delayed.” (opens the source at this quote in a new tab)
“I authorize Egetis RareLink to forward this prescription to the pharmacy dispensing the QuickStart, Bridge, and PAP product to the patient named herein, if eligible.” (opens the source at this quote in a new tab)
“I also understand any products distributed under the patient support program are provided free of charge, and may not be submitted for reimbursement to any payer, including a federal healthcare program, and may not be sold, traded, distributed for sale or returned for credit; nor may I bill for administration of such product.” (opens the source at this quote in a new tab)
“I understand that copay card details (such as card identification number and processing information) will be sent to my specialty pharmacy so the copay benefit can be applied when my prescription is filled, and any assistance with my cost-sharing or co-payment for EMCITATE will be made in accordance with the Egetis RareLink Copay Card Program’s Terms and Conditions.” (opens the source at this quote in a new tab)

Prior authorization support

“I authorize PANTHERx and Egetis RareLink™ to prepare and submit prior authorization requests, appeal requests, and other administrative tasks on my behalf and to receive notices in connection with requests which may include faxes, phone calls, mail, email, or any other form of communication.” (opens the source at this quote in a new tab)

Prescription requirements

Form item	Form text
Prescriber attestation	“Prescriber Attestation: I confirm that the patient has been diagnosed with MCT8 deficiency.”
Genetic confirmation	“Genetic test result for a mutation in SLC16A2”
Copy of genetic test	“Copy of genetic test result included”
Baseline thyroid function	“Baseline serum T3 (include units of measurement and date of result)”
Prior thyromimetic therapy	“Has the patient ever received DITPA (3,5-diiodothyropropionic acid)?”
Prior tiratricol exposure	“Did the patient take EMCITATE® as part of the EAP or clinical trial?”
Body weight	“Weight (kg)”

Distribution and expanded access: U.S. distribution

“During the period we have contracted a specialty pharmacy and a distributor to assist us in providing Emcitate to patients with MCT8 deficiency after approval.” (opens the source at this quote in a new tab)

Distribution and expanded access: U.S. Expanded Access Program

“At FDA’s request, Egetis has implemented an Expanded Access Program (EAP) in the U.S. Currently, 17 hospitals are included and approximately 60 patients are receiving tiratricol in the EAP. The EAP allows physicians to access tiratricol for patients not eligible for clinical trials prior to marketing approval, as well as for continued treatment of patients who completed the ReTRIACt and Triac Trial II studies.” (opens the source at this quote in a new tab)

Distribution and expanded access: managed access policy

“In exceptional circumstances and where permitted by local laws and regulations, Egetis may consider providing access to investigational medicines through Managed Access programs.” (opens the source at this quote in a new tab)
“Managed Access programs are governed by local laws, regulations and company policies. Availability may differ between countries and programs.” (opens the source at this quote in a new tab)