Anthem Blue Cross and Blue Shield (Anthem) reviews the activities of the Food and Drug Administration’s (FDA) approval of drugs and biologics on a regular basis to understand the potential effects for both our providers and members.

 

The FDA approves new drugs/biologics using various pathways of approval. Recent studies on the effectiveness of drugs/biologics going through these different FDA pathways illustrates the importance of clinicians being aware of the clinical data behind a drug or biologic approval in making informed decisions.

 

Here is a list of the approval pathways the FDA uses for drugs/biologics:

 

  • Standard Review – The Standard review process follows well-established paths to make sure drugs/biologics are safe and effective when they reach the public. From concept to approval and beyond, FDA performs these steps: reviews research data and information about drugs and biologics before they become available to the public; watches for problems once drugs and biologics are available to the public; monitors drug/biologic information and advertising; and protects drug/biologic quality. Learn more about the Standard Review process.

 

  • Fast Track – Fast Track is a process designed to facilitate the development, and expedite the review of drugs/biologics to treat serious conditions and fill an unmet medical need. Learn more about the Fast Track process.

 

 

 

  • Orphan Review – Orphan Review is the evaluation and development of drugs/biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. Learn more about the Orphan Review process.

 


New Molecular Entities (NMEs) Approvals: January through August 2020

 

Certain drugs/biologics are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active ingredients that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients.

 

Anthem reviews the FDA-approved NMEs on a regular basis. To facilitate the decision-making process, we are providing a list of NMEs approved from January to August 2020 along with the FDA approval pathway utilized.

 

Generic Name

Trade Name

Standard
Review

Fast Track

Priority Review

Break-through Therapy

Orphan Review

Accelerated Approval

Approval Date

Indication

Abametapir

Xeglyze

X

 

 

 

 

 

7/24/2020

Head lice

Amisulpride

Barhemys

X

 

 

 

 

 

2/26/2020

Postoperative nausea and vomiting

Avapritinib

Ayvakit

 

X

X

X

X

 

1/9/2020

PDGFRa exon 18 mutant gastrointestinal stromal tumor

Belantamab mafodotin

Blenrep

 

 

 X

X

X

X

8/05/2020

Multiple myeloma

Bempedoic acid

Nexletol

X

 

 

 

 

 

2/21/2020

Dyslipidemia

Brexucabtagene autoleucel

Tecartus

 

 

X

X

X

X

7/24/2020

Mantle cell lymphoma

Capmatinib

Tabrecta

 

 

X

X

X

X

5/6/2020

Non-small cell lung cancer (NSCLC)

Decitabine/ cedazuridine

Inqovi

 

 

X

 

X

 

7/07/2020

Myelodysplastic syndromes

Eptinezumab-jjmr

Vyepti

X

 

 

 

 

 

2/21/2020

Migraine prevention

Fostemsavir

Rukobia

 

X

X

X

 

 

7/02/2020

Human immunodeficiency virus (HIV) treatment

Inebilizumab

Uplizna

X

 

 

X

X

 

6/11/2020

Neuromyelitis optica spectrum disorder

Isatuximab

Sarclisa

X

 

 

 

X

 

3/2/2020

Multiple myeloma

Lurbinectedin

Zepzelca

 

 

X

 

X

X

6/15/2020

NSCLC

Nifurtimox

Lampit

 

 

X

 

X

X

8/06/2020

Chagas disease

Oliceridine

Olinvyk

X

X

 

 

 

 

8/07/2020

Moderate to severe acute pain

Opicapone

Ongentys

X

 

 

 

 

 

4/24/2020

Parkinson’s disease

Osilodrostat

Isturisa

X

 

 

 

X

 

3/6/2020

Cushing’s disease

Ozanimod

Zeposia

X

 

 

 

 

 

3/25/2020

Multiple sclerosis

Peanut (Arachis hypogaea) allergen powder-dnfp

Palforzia

X

X

 

X

 

 

1/31/2020

Peanut allergy

Pemigatinib

Pemazyre

 

 

X

X

X

X

4/17/2020

Cholangiocarcinoma

Remimazolam

Byfavo

X

 

 

 

 

 

7/02/2020

Sedation for procedures

Rimegepant

Nurtec ODT

 

 

X

 

 

 

2/27/2020

Migraine treatment

Risdiplam

Evrysdi

 

X

X

X

X

 

8/07/2020

Spinal muscular atrophy

Ripretinib

Qinlock

 

X

X

X

X

 

5/15/2020

Gastrointestinal stromal tumor

Sacituzumab-hziy

Trodelvy

 

X

X

X

X

X

4/22/2020

Triple negative breast cancer

Selpercatinib

Retevmo

 

 

X

X

X

X

5/8/2020

NSCLC and thyroid cancers

Selumetinib

Koselugo

 

X

X

X

X

 

4/10/2020

Neurofibromatosis type 1

Tafasitamab

Monjuvi

X

X

 

X

X

X

7/31/2020

Large B-cell lymphoma

Tazemetostat

Tazverik

 

 

X

 

X

X

1/23/2020

Epithelioid sarcoma

Teprotumumab-trbw

Tepezza

 

X

X

X

X

 

1/21/2020

Thyroid eye disease

Triheptanoin

Dojolvi

X

X

 

 

X

 

6/30/2020

Long-chain fatty acid oxidation disorders

Tucatinib

Tukysa

 

X

X

X

X

 

4/17/2020

Breast cancer

Viltolarsen

Viltepso

 

X

X

 

X

X

8/12/2020

Duchenne muscular dystrophy

 

 

Source: www.fda.gov

 

650-1020-PN-VA



Featured In:
October 2020 Anthem Provider News - Virginia