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
Estimated Annual Cost
|11/16/17||Hemophilia A with FVIII inhibitors||$450,000|
|11/15/17||Mucopolysaccharidosis VII (MPS VII, Sly syndrome)||$375,000|
|11/14/17||Severe asthma (add-on treatment)||$30,000|
|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|
|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|
|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)
|6/7/17||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|
|$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)|
|3/27/17||Epithelial ovarian, fallopian tube or primary peritoneal cancers||$160,000|
|3/23/17||Merkel cell carcinoma||$150,000|
- OptumRx® RxNews
- FDA: “Novel Drug Approvals for 2017”. Accessed: https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm537040.htm
- FDA: “Drugs@FDA: FDA Approved Drug Products”. Accessed: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
- Pharmacy Times (http://www.pharmacytimes.com/)
- Specialty Pharmacy Times (https://www.specialtypharmacytimes.com/)
(To print, click on the title and scroll to “PRINT THIS PAGE” at the bottom)
To Manage Employer Prescription Costs, Get the Right Drug for the Right Condition
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.
“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
“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.
“Prior 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
“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.
(This post is a transcript from the video, “2 Obstacles to Managing Drug Costs.”)