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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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.

 

Summary

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


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