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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Controlling Specialty Drug Costs (Video)

Specialty Drug Costs Can Be Managed with These Strategies
specialty drug costs

WATCH VIDEO NOW

“It’s interesting that a lot of these specialty drugs are designed for a very small percentage of the population that have a certain disease state,” said Michael Cornwell, MedCost Director of Sales and Underwriting.

“There may be less than 200,000-300,000 people in the country that need that particular drug. That’s one of the reasons specialty drugs are so expensive.”

MedCost Pharmacist Zafeira Sarrimanolis agrees. “It’s an exciting time in the drug manufacturing world, because all of these new medications have been coming out over the past ten years or so for medical conditions that really weren’t treatable before.

“For example, hepatitis C medications previously were not very effective and really hard for patients to tolerate. Now we have new medications on the market that are practically a 100% cure rate for patients.

specialty drug costsThese drugs are also a lot easier for them to take and tolerate. Part of the problem with that is the price tag on some of those new medications.”

“One of the largest reasons people are readmitted to the hospital is because they don’t adhere to the medication,” said Michael Cornwell. “Programs like step therapy ask you to try a clinically appropriate drug before you try a similar but more expensive one.

Prior authorizations probe a physician’s reasoning behind prescription choices. A lot of these specialty drugs are really for a pretty small percentage of the population. So when you look at a population as a whole, the people taking those drugs are usually between 1%-1½% of your population. That’s the good news.

“The bad news is they’re very expensive. Probably the biggest growth area in the specialty arenas are the cancer drugs. There’s a whole pipeline of new cancer treatments hitting the marketplace. But in that pipeline, member education and aid in helping and consulting is a good thing too. It allows us to have some personal outreach try to help these people manage their disease state.MedCost

(This post is a transcript from the video, CONTROLLING SPECIALTY DRUG COSTS.”)