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:


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Prescription Insurance: Why Are Costs Rising?

MedCost pharmacistBy Zafeira Sarrimanolis, PharmD, MedCost Clinical Consultant

Prescription insurance has become an increasingly major cost for employers. New drug approvals by the US Food and Drug Administration (FDA) are expected to escalate this year with multiple innovative drugs already being approved for cancer, multiple sclerosis and other conditions.

As researchers discover more treatments, costs will continue to climb. For this reason, smart management of pharmacy plans will be even more vital for employer health plans.

2017 Drug Pipeline

2016 saw a below average number of drug approvals. 2017 is expected to bounce back with 30+ new specialty drugs.

Specialty medications are high-cost prescription drugs used to treat complex conditions. The blue bar (below) shows specialty medication drug approvals. The green bar represents traditional brand and generic drugs. Technology, innovation and new scientific discoveries have caused specialty medication drug approvals to rapidly increase over the last few years.

prescription insurance

Growth of Novel Drugs in Prescription Insurance

In 2016, 22 novel drugs were approved, which was the lowest number since 2010. A novel drug is an innovative product with a unique chemical structure that has never been approved by the FDA before.  Typically novel drugs meet an unmet medical need.

prescription insurance As of May 5th, 20 novel drugs have already been approved this year. It’s an exciting time for healthcare as we treat more complex conditions and improve member health and quality of life.

But it comes at a cost – literally.



When 1% of prescriptions drive 40-45% of an employer’s pharmacy spend, avoiding wise management is no longer optional. Part of my role as a MedCost Pharmacist is to emphasize the importance of cost-management strategies to our employers and consultants.

prescription insurance

I also work closely with our clients to help employers understand the importance of educating their employees about these changes and why they are needed.

It’s all about making sure each employee gets the right drug for the right medical condition at the right time. That’s how we control pharmacy costs.MedCost