Author Archives: Evelio Prieto, PharmD., RPh., CPh.

U.S. Food and Drug Administration approves Aimovig™

On May 17, 2018, the U.S. Food and Drug Administration (FDA) approved Aimovig™ (erenumab-aooe) for the preventive treatment of migraines in adults. Aimovig (erenumab-aooe) is the first FDA approved drug in a new class of drugs that are classified as calcitonin gene-related peptide receptor blockers. The calcitonin gene related peptide receptor (CGRP-R) is associated with migraine headache. This new agent aids in reducing the number of headache days a month.

Aimovig was approved for the preventative treatment of migraines in adults based on evidence of three placebo controlled clinical trials. More than 3,000 patients participated in the efficacy and safety tests. Between the three studies, patients experienced one to two and one-half fewer migraines per month as compared to placebo. The most common side effects reported in clinical trials were injection site reactions and constipation. The discontinuation rate is listed at two percent. Ongoing open label extension studies will continue for up to five years.

Aimovig, developed in partnership by Novartis Pharmaceuticals and Amgen, Inc., is expected on the market in a week. Aimovig is administered once monthly by self-injection in either a 70 mg or a 140 mg dose. The U.S. list price according to Novartis is $575.00 for a once monthly 70 mg or 140 mg self-administered injection ($6,900 annually). The Redbook average wholesale price (AWP) pricing is not yet published. The pricing of Aimovig is comparable to the cost of botulinum toxin (Botox) 200 units every three months with an annual cost of $5,768. This cost does not include the in-office Botox administration provider fee. Botox is FDA approved for chronic migraine prophylaxis.

With the commonality of migraine headaches in workers’ compensation and liability claims, adjusters are likely to see the use of this medication in the near future. We expect that, similar to the criteria of botulinum toxin for prevention of chronic migraine, Aimovig users will have failed more conservative first line therapy (amitriptyline, beta-blockers, topiramate and valproic acid derivatives). At this time, there is no evidence for the use of botulinum toxin and Aimovig for chronic migraine prevention.

Optum will provide updates as new medications enter the marketplace as well as details on their impact on settlements.

View highlights of prescribing information here.

Additional sources:

  1. FDA approves new drug for preventive treatment of migraine in adults- Drug Information Update Available at: Aimovig Accessed May 18, 2018.
  2. Novartis and Amgen announce FDA approval of Aimovig™ (erenumab-aooe), a novel treatment developed specifically for migraine prevention. Available at: https://www.prnewswire.com/news-releases/novartis-and-amgen-announce-fda-approval-of-aimovig-erenumab-aooe-a-novel-treatment-developed-specifically-for-migraine-prevention-300650779.html. Accessed May 18, 2018.
  3. The Workloss Data Institute. The Official Disability Guidelines (ODG). http://www.disabilitydurations.com/. Accessed May 2018.

Prescription Medication Updates That May Affect Your Medicare Set-Aside

We continually monitor pricing of the most common medications seen in Workers’ Compensation Medicare Set-Aides (WCMSAs) in order to identify pricing changes affecting MSAs positively. The month of December brought a price drop for gabapentin 800mg tablets commonly used to treat neuropathic pain.

Below is the product confirmed to have a reduced AWP and confirmed in the Centers for Medicare and Medicaid Services (CMS) WCMSA portal.

Product name NDC Code Dosage form Strength AWP unit price reduction
Gabapentin 00904-6586-61 TAB 800 mg $2.16

Please note RED BOOK® AWP (Average wholesale price) is subject to change and this pricing is subject to an increase or decrease in the future.  

CMS will utilize the lowest AWP published by RED BOOK when reviewing a WCMSA, therefore the lower pricing of these medications will immediately impact the prescription costs for WCMSAs (both present as well as prior WCMSAs that have not settled and there is no CMS determination issued) where these drugs are prescribed.

It is our recommendation carriers, TPAs and claim handlers review cases where the above noted medication is prescribed to determine the benefit from decreased cost. We will proactively reach out to our clients in reference to previously completed WCMSA’s where this medication was prescribed and  continue to monitor future portal changes and generic equivalents introduced to the market in order to keep the industry informed.

Prescription medication updates that may affect your Medicare Set Aside

We continually monitor RED BOOK® Average Wholesale Price (AWP) of the most common medications seen in Workers’ Compensation Medicare Set-Aides (WCMSA) in order to identify pricing changes affecting MSAs positively. The month of September brought additional price drops for the medication quetiapine fumarate (Seroquel®), in 100mg and 300mg tablets, commonly prescribed to treat bi-polar disorder.

Below are the products we have identified with a reduced AWP and confirmed in the Centers for Medicare and Medicaid Services (CMS) WCMSA portal.

Product name

NDC Code

Dosage form

Strength

AWP unit price reduction

Quetiapine Fumarate

00904-6640-61

TAB

100 mg

$5.89

Quetiapine Fumarate

00904-6642-61

TAB

300 mg

$9.60

Please note that RED BOOK AWP is subject to change and this pricing is subject to an increase or decrease in the future.

CMS will utilize the lowest AWP when reviewing a WCMSA, therefore the lower pricing of these medications will immediately impact the prescription costs for WCMSAs (both present as well as prior WCMSA’s that have not settled and there is no CMS determination issued) where these drugs are prescribed.

It is our recommendation carriers, TPAs and claim handlers review cases where the above noted medications are prescribed to determine the benefit from decreased cost. We will proactively reach out to our clients in reference to previously completed WCMSA’s where these medications were prescribed and continue to monitor future AWP changes and generic equivalents introduced to the market in order to keep the industry informed.

Prescription Drug Updates that may affect your Medicare Set Aside

We continually monitor RED BOOK® Average Wholesale Price (AWP) of the most common drugs seen in Workers’ Compensation Medicare Set-Aides (WCMSA) in order to identify pricing changes affecting MSAs positively. The month of August brought price drops for the medications quetiapine (Seroquel®), in multiple strengths, commonly prescribed to treat bi-polar disorder and lansoprazole (Prevacid®) 30mg a Proton-Pump Inhibitor, used to treat stomach ulcers, gastro esophageal reflux disease (GERD) and high levels of stomach acid.

Below are the products Optum identified with a reduced AWP and confirmed in the Centers for Medicare and Medicaid Services (CMS) WCMSA portal.

Product Name NDC Code Dosage Form Strength AWP Unit Price Reduction
Quetiapine Fumarate 00904-6638-61 TAB 25 mg $0.04
Quetiapine Fumarate 00310-8280-60 TER 50 mg $8.01
Quetiapine Fumarate 00310-8281-60 TER 150 mg $14.98
Quetiapine Fumarate 00310-8282-60 TER 200 mg $16.46
Quetiapine Fumarate 00310-8283-60 TER 300 mg $21.75
Quetiapine Fumarate 00310-8284-60 TER 400 mg $25.63
Lansoprazole 70700-0263-05 ECC 30 mg $1.60

Please note that RED BOOK AWP is subject to change and this pricing is subject to an increase or decrease in the future.

CMS will utilize the lowest AWP when reviewing a WCMSA, therefore the lower pricing of these medications will immediately impact the prescription costs for WCMSAs (both present as well as prior WCMSA’s that have not settled and there is no CMS determination issued) where these drugs are prescribed.

It is our recommendation that carriers, TPAs and claim handlers review cases where the above noted medications are prescribed to determine the benefit from decreased cost. We will proactively reach out to our clients in reference to previously completed WCMSA’s where these medications were prescribed.

Another change occurring is the generic availability of Relpax® tablets (eletriptan hbr tablets) in 20mg and 40mg. This new generic offers an 11 percent decrease in AWP price. As more manufacturers bring generics for Relpax to market, we expect the price to decrease even more over the next year.

We previously identified pricing changes for several other drugs recently, such as carisoprodol, aripiprazole and esomeprale providing significant MSA savings for clients on cases not settled or approved by CMS. We will continue to monitor future AWP changes and generic equivalents introduced to the market and will keep the industry informed.