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

Approval Date
Approved Use(s)
Estimated Annual Cost


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

(vestronidase alfa-vjbk)

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


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

(axicabtagene ciloleucel)

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


9/28/17 Breast cancer $130,000


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


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

(inotuzumab ozogamicin)

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




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



(sofosbuvir, velpatasvir, voxilaprevir)

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

(neratinib maleate)

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


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




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

(C1 esterase inhibitor)

6/22/17 Hereditary angioedema $400,000


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

(coagulation factor IX)

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


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


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


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

(cerliponase alfa)

4/27/17 Batten disease


$700,000 Very rare, inherited condition


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


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


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


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


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


3/13/17 Breast cancer $130,000



Key sources:


(To print, click on the title and scroll to “PRINT THIS PAGE” at the bottom)


Childhood Diabetes Rates and Costs Climb

childhood diabetes employer health costsChildhood diabetes rates are on the rise, and a report released Monday pointed to the impact that the cost of their care could have on families — even those who have employer-sponsored health insurance.

The study, conducted by the Health Care Cost Institute (HCCI), found that children as old as 18 with diabetes who were insured through an employer-sponsored plan racked up $2,173 per capita in out-of-pocket health care costs in 2014. That spending level was nearly five times higher than that of kids without the illness.

The HCCI researchers analyzed data from claims submitted from 2012 to 2014 through group, individual and Medicare Advantage insurance policies to analyze health care spending and utilization trends among people younger than 65 who had diabetes and employer-sponsored coverage plans.

In terms of use of medical services, children with diabetes visited the emergency room 2.5 times more often than children without it. Acute inpatient services were used nearly five times more often. In all, a year’s worth of care cost $17,380 — the second only to adults aged 55 through 64 with diabetes.

Although more prescriptions and frequent doctor’s visits help explain the difference inchildhood diabetes rates cost the health care costs generated by children with and without this illness, researchers were still surprised by the magnitude of the disparity.

Families are “spending more out-of-pocket across the board on all types of services,” said Amanda Frost, a senior researcher at HCCI. “And it’s just higher use. So when you end up using all of these health care services, you end up with a very personal impact on your wallet, especially if you’re a parent with a child with diabetes.”

(Kaiser Health News, Heredia Rodriguez June 20, 2016)

Kaiser Health News

To print this article, click on the title and 
scroll to “PRINT THIS PAGE” at the bottom.