FDA Approved 46 Novel Drugs in 2017

MedCost pharmacist

By Zafeira Sarrimanolis, PharmD, MedCost Clinical Consultant

In 2016 we saw 22 brand-new novel drugs hit the market. This year the FDA has approved 46 novel drugs.

A novel drug is an innovative product with a chemical structure that has never been FDA approved before and usually meets a previously unmet medical need.

In 2017, these novel drug approvals were accompanied by an influx of specialty and brand-name drugs to the market – many treating common chronic conditions like diabetes, asthma and RA.

It is a very exciting time in the healthcare world as these new drugs significantly advance patient care. However, these treatments come at a cost… literally.

This is not a comprehensive list of new-to-market drugs, and does not include all 46 novel drugs, but is a snapshot of key 2017 FDA approvals.

It is hard to predict what the FDA and drug manufacturers will do in 2018. However, we should expect even more high-cost drugs to be approved and available for members.

Hopefully these will be accompanied by the influx of generics and biosimilars to the market – which may help off-set rising drug costs.

One thing we know for sure is that managing drug costs will continue to be key. We employ cost-management strategies such as:

  • Formulary management
  • Prior authorizations
  • Step-therapy programs
  • Regulation of copay cards

All of these strategies will be foundational in conserving costs.MedCost

Drug
Approval Date
Approved Use(s)
Estimated Annual Cost
Notes
Hemlibra

(emicizumab)

11/16/17 Hemophilia A with FVIII inhibitors $450,000
Mepsevii

(vestronidase alfa-vjbk)

11/15/17 Mucopolysaccharidosis VII (MPS VII, Sly syndrome) $375,000
Fasenra

(benralizumab)

11/14/17 Severe asthma (add-on treatment) $30,000
Yescarta

(axicabtagene ciloleucel)

10/18/17 B-cell lymphoma $370,000
Verzenio

(abemaciclib)

9/28/17 Breast cancer $130,000
Aliqopa

(copanlisib)

9/14/17 Relapsed follicular lymphoma $160,000
Kymriah

(tisagenlecleucel)

8/30/17 Acute lymphocytic leukemia $475,000 per treatment First gene therapy ever approved in the US
Bespona

(inotuzumab ozogamicin)

8/17/17 Relapsed or refractory acute lymphoblastic leukemia $170,000

 

Idhifa

(enasidenib)

8/1/17 Relapsed or refractory acute myeloid leukemia $280,000

 

Vosevi

(sofosbuvir, velpatasvir, voxilaprevir)

7/18/17 Hepatitis C $75,000 for 3-month treatment
Nerlynx

(neratinib maleate)

7/17/17 Reduce risk of breast cancer returning $125,000
Tremfya

(guselkumab)

7/13/17 Moderate-to-severe plaque psoriasis

 

$58,000
Endari

(L-gultamine)

7/7/17 Sickle cell disease $11,000 – $18,000 Second drug approved for Sickle Cell in the US
Haegarda

(C1 esterase inhibitor)

6/22/17 Hereditary angioedema $400,000
Fibryna

(fibrinogen)

6/7/17 Congenital fibrinogen deficiency n/a Pending launch date
Rebinyn

(coagulation factor IX)

5/31/17 Hemophilia B n/a Expected launch early 2018
Kevzara

(sarilumab)

5/22/17 Rheumatoid arthritis $39,000 Second-line agent
Radicava

(edaravone)

5/5/17 ALS $145,000 Second drug ever approved for ALS
Ryadapt

(midostaurin)

4/28/17 Acute myeloid leukemia $180,000
Brineura

(cerliponase alfa)

4/27/17 Batten disease

 

$700,000 Very rare, inherited condition
Ingrezza

(valbenazine)

4/11/17 Tardive dyskinesia $64,000 – $128,000 depending on dose
Ocrevus

(ocrelizumab)

3/28/17 Multiple sclerosis $65,000 (~20% less than current treatments)
Dupixent

(dupilumab)

3/28/17 Moderate-to-severe eczema $37,000
Zejula

(niraparid)

3/27/17 Epithelial ovarian, fallopian tube or primary peritoneal cancers $160,000
Bavencio

(avelumab)

3/23/17 Merkel cell carcinoma $150,000
Kisqali

(ribociclib)

3/13/17 Breast cancer $130,000

 

 


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Facing Life’s Biggest Challenges

Margaret Nunez image

Three and a half years ago, Margaret Nunez first experienced MedCost’s Complex Case Management program when she was diagnosed with Multiple Myeloma, a type of cancer that causes abnormal plasma cells to accumulate in bone marrow and interfere with the production of normal blood cells. The disease is considered incurable but treatable.

Margaret received radiation and chemotherapy and responded well to the treatment. She also underwent a successful auto stem cell transplant. Several months later, with her condition stable, Margaret’s case management file was closed.

When later tests indicated an increase in Myeloma markers, her case management file was re-opened. While participating in the program this second time, Margaret was diagnosed with breast cancer and underwent surgery, followed by radiation. During breast cancer treatment, her Myeloma maintenance therapy was discontinued. Once the breast cancer treatments were over, she restarted maintenance therapy. Since her condition was stable, her case management file was closed once again.

Several months later, Margaret re-joined the program after a brief hospital admission for neutropenic fever. Neutropenia is an abnormally low count of white blood cells and makes an individual vulnerable to infection. Margaret’s next bone marrow biopsy showed persistent Myeloma.

“Having the same person follow my case from before my stem cell transplant and then periodically since then has been so important. I’ve been through so many changes and my case manager is always there for me.”*

The goal of our Complex Case Management is to ensure the best use of available health plan resources, while enhancing quality of life. For more information, visit our Case Management page or contact Jason at MedCost.

*Margaret Nunez gave MedCost permission to share her story to help others realize the benefits of the Complex Care Management program.