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

 

The FDA approves new drugs and biologics using various pathways. Recent studies on the effectiveness of drugs and biologics going through different FDA pathways illustrate the importance of clinicians’ awareness 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. Follow this link to 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. Follow this link to learn more about the fast track process.
  • Priority review —A priority review designation means FDA’s goal is to take action on an application within six months. Follow this link to learn more about the priority review process.
  • Breakthrough therapy — This process is designed to expedite the development and review of drugs/biologics which may demonstrate substantial improvement over available therapy. Follow this link to learn more about the breakthrough therapy review process.
  • Orphan review — This refers to the review of drugs that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. Follow this link to learn more about the orphan drug review process.
  • Accelerated approval — These regulations allowed drugs/biologics for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. To learn more about the accelerated approval process, follow this link.

 

New molecular entities approvals: January 2020 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.

 

Note: This information has no impact on our standard prior authorization/pre-certification process.

 

Generic name

Trade name

Standard
review

Fast track

Priority

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



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January 2021 Anthem Provider News - Wisconsin