Rare/Orphan Disease, Specialty Drug, Specialty Pharmacy

Specialty Pharmacy Limited Distribution Drug Agreements at Year-End 2022

Posted on by John Santilli
13
Jan

The leading specialty pharmacies were busy signing limited distribution drug agreements at the end of 2022. Here’s a round-up of the activities:

 

Biologics by McKesson

Selected by Mirati Therapeutics as one of two specialty pharmacies in a limited distribution network for KRAZATI® (adagrasib), which is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation as determined by an FDA-approved test, and who have received at least one prior systemic therapy.

Selected by Rigel Pharmaceuticals as one of two specialty pharmacies in a limited distribution network for REZLIDHIATM (olutasidenib), which is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

Selected by ImmunoGen, Inc., a leader in the expanding field of antibody-drug conjugates (ADCs), as the sole specialty pharmacy provider for ELAHERE™ (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Selected by Aadi Bioscience as a specialty pharmacy provider for FYARROTM (sirolimus protein-bound particles for injectable suspension) (albumin-bound). FYARRO was approved by the U.S. Food and Drug Administration (FDA) on November 22,2021. This therapy is a mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

 

Onco360

Selected by Mirati Therapeutics to be a specialty pharmacy partner for KRAZATI® (adagrasib), which is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.

 

Amber Specialty Pharmacy

Will begin dispensing TZIELD™ (teplizumab), an anti-CD3 monoclonal antibody, to delay Stage 3 Type 1 Diabetes (T1D) in patients ages 8 years and older with Stage 2 T1D. Indication for individuals ages 8 years and older with Stage 2 T1D is categorized by the presence of two or more T1D-related autoantibodies and abnormal blood sugars. TZIELD™ is manufactured by Provention Bio, Inc., a New Jersey-based biopharma company.

 

Orsini Specialty Pharmacy

Selected by Provention Bio as a specialty pharmacy for TZIELD® (teplizumab). TZIELD is the first and only treatment indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D approved by the FDA.

 

Optime Care

Announced a contractual partnership with Rigel Pharmaceuticals bringing its full suite patient support/HUB service capabilities to support Rezlidhia™(olutasidenib), a recent FDA-approved treatment for adult patients with relapse or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

 

Takeaway: AMI’s Specialty Pharmacy Database has a comprehensive list of Limited and Exclusive Distribution Drugs