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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2 Obstacles to Managing Drug Costs (Video)

To Manage Employer Prescription Costs, Get the Right Drug for the Right Condition

Employer Prescription Costs

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Zafeira Sarrimanolis, MedCost Pharmacist and Clinical Consultant,knows the value of reviewing pharmacy usage patterns for clients, to identify opportunities to contain costs.

“From a more clinical perspective, the key to managing drug costs is making sure that the right people are using the right drug for the right medical condition,” she said.

Obstacle #1: Not Adhering to the Formulary

“What is a formulary?” asked Michael Cornwell, Director of Sales and Underwriting. “A formulary is a guide that the Pharmacy Benefit Manager puts out that says these brand drugs are the preferred versus the non-preferred versus generics.

“For example, the average cost of a generic today is about $28-$29. The average cost of a brand drug is probably in the $167 range.

employer prescription costs“Members do not always know what drugs are on the formulary,” said Ms. Sarrimanolis. “Certainly their providers don’t always know what drugs are on the formulary, so that’s where some of the confusion and disruption comes from.

“We try to fill a lot of these gaps through member education. Pharmacy Benefit Managers do a great job of outreaching to members through the mail, emails and on their websites. Unfortunately, members might not always understand that information.

“What we need to do is to encourage members to become smarter consumers and to make the best, most cost-effective choice for their own medication.”

The Pharmacy Benefit Manager’s Role

employer prescription costs

“A Pharmacy Benefit Manager, or PBM, serves multiple purposes,” Mr. Cornwell said. “One purpose is to process all the pharmacy claims. By doing that, benefits administrators like MedCost are able to collect the data and analyze it.

“Zafeira, as our pharmacist on staff, and our Care Management teams know what usage patterns are. We know what kinds of drugs people are taking.

“The PBMs certainly are negotiating discounts at the drugstore and contract rates for us to get the best prices that we can for the drugs that we take. PBMs can also provide data on clinical reasons to manage those drugs and make sure that they’re the most appropriate and cost-effective.

Obstacle #2: Not Educating Members

“One of the largest reasons that people are readmitted to the hospital is because they don’t adhere to directions to take their medication.

“Programs like step therapies ask: ‘Have you tried this drug before you try that one?’

“Prior authorizations ask: ‘Why do you need this drug?’ For example, you must have the proper genotype to be able to take certain treatments for Hepatitis C.

employer prescription costsPrior authorizations cause a lot of disruption to the member. You go to the doctor for a prescription.  You go to the drugstore and they say why do you need to take this drug? And you go back to your physician but they’re busy. It takes time, so it’s all disruptive at a time when you want your medication. It’s hard to understand.

Member education is extremely important. It would be nice if we could fill that gap to where physicians knew exactly what your formulary was at the point that physicians are prescribing that medication. Right now that doesn’t exist.

“Every 1% increase in generic utilization results in about 1.5% savings,” said Michael Cornwell.

“In drug costs, it becomes pretty significant. As Zafeira said, as the drug manufacturers continue to make more drugs (which is a good thing), it puts more challenges on us to make sure that the drugs are appropriate and cost-effective.

Using PBM Websites to Shop Employer Prescription Costs

employer prescription costs“We’re going to go through more disruption as a result of that. We’re going to have to get used to it. But there are a lot of new tools coming on the marketplace to try to help people shop for drugs,” Mr. Cornwell observed.

“The PBMs have websites where you can log in under your personal account with your PBM that is administering your drugs. You can put in the name of the drug and the details; and it will show you the best places the most price-competitive places, to buy that drug. It will also match up what your formulary is and if there are alternatives that are cheaper than the drug you have.

“The bigger issue is helping people to understand to be shoppers.”MedCost

(This post is a transcript from the video, “2 Obstacles to Managing Drug Costs.”)

employer prescription costs

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How Employer Plans Cover Prescription Drugs (Infographic)

An estimated 150 million Americans have employer-sponsored health insurance.[i] What is the complex system under which employer health plans cover the rocketing costs of prescription drugs?

employer prescription drugs

Members

Individuals covered by employer’s health plan. May pay premiums or copays for drug coverage.

Employer or Insurer

Employer or insurer pays PBM to develop preferred drug pricing & process prescription claims. PBM returns some or all rebates to employer or insurer.

Pharmacy Benefit Manager (PBM)

Negotiates discounts and rebates from manufacturer. Contracts with pharmacy.

Manufacturer

Negotiates rebates with PBM.
Sells discounted drugs to wholesaler from core price.

Wholesaler

Negotiates price with pharmacy.

Pharmacy

Pharmacy dispenses to members & collects copays.

For more resources, view: ”10 Pharmacy Terms Employers Need to Know” and “5 Factors in Employer Prescription Drug Costs” from Pharmacist Zafeira Sarrimanolis.MedCost

____________________________________________________________________________________

[i Robert Galvin and Troyen Brennan, “Can Employers Take a Bigger Role in Controlling Drug Costs?” Health Affairs blog, February 17, 2017, http://healthaffairs.org/blog/2017/02/17/can-employers-take-a-bigger-role-in-controlling-drug-costs/ (accessed April 6, 2017).

 

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.”)

 

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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10 Pharmacy Terms Employers Need to Know

MedCost pharmacistBy Zafeira Sarrimanolis, PharmD, MedCost Clinical Consultant

Pharmacy terms in health plans can be confusing. Employers must understand their pharmacy plans, especially in this era of rising drug costs.

As a pharmacist, I help MedCost clients navigate their Pharmacy Benefit Manager and identify opportunities for cost-saving in their company health plans. Here are some terms employers need to know when determining prescription drug benefits for their health plan.

1. Pharmacy Benefit Manager (PBM)

An organization that develops and maintains preferred drug lists, contracts with pharmacies, and negotiates discounts and rebates with drug manufacturers. PBMs also process and pay prescription drug claims in addition to implementing strategies that save pharmacy plan dollars, while improving member health.

2. Formulary 

A prescription drug list that is preferred by a health insurance plan. Identifies medications available to treat certain medical conditions and organizes into tiers.

3. Tiers

Different cost levels a member pays for a medication. A tier 1 medication is generally generic and lower-cost, while higher-cost brand name medications fall in Tier 2 or 3.

pharmacy terms4. Brand-name drug

Developed, patented and sold exclusively by a pharmaceutical manufacturer.

5. Generic drug

Manufactured and sold after the brand-name patent has expired. For example, Tylenol® is a brand-name medication and acetaminophen is its generic equivalent. Generics promote competition and drive down drug costs. Almost 80% of prescription drugs sold in the US are generics.

6. Specialty drug

A high-cost, prescription drug that treats complex conditions such as rheumatoid arthritis, cancer or multiple sclerosis. These drugs typically have special storage requirements, administration techniques and require specific monitoring. Specialty drugs may account for up to 45% of a plan’s total drug costs.

7. Exclusion

A drug or service not paid for by a health plan.

8. Rebates

Money paid by manufacturers after drug purchases, as part of negotiations with payers (insurance companies, PBMs, benefits administrators, Medicare). Rebates cut about $40 billion from drug sales annually (see examples).

pharmacy terms9. Prior authorization

Requires a doctor to provide additional clinical information to determine coverage of the prescription drug under the plan.

10. Step therapy

Trying a lower-cost, clinically-similar drug before a higher-cost drug for the same medical condition is allowed under the plan.

Summary

Step therapies and prior authorizations feel disruptive to employees. For that reason, employers are faced with the challenge of balancing employee satisfaction with cost containment.

Our clients are seeing significant results using preferred formularies and these cost-saving strategies. One group avoided expenses of over $250,000 in the first months after adopting a managed approach with one of our PBM vendors.

The goal is to ensure the right people get the right drug for the right medical condition at the right time.  With our PBM partners, we work to ensure that our members are utilizing safe, clinically-appropriate, cost-effective treatments. Employers can partner with their employees to become better healthcare consumers so everyone benefits in the use of prescription drugs.