Category Archives: News Bulletins

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.

Frank Fairchok Rejoins Optum Settlement Solutions

Optum is pleased to announce that Frank Fairchok has recently rejoined the settlement solutions team as vice president of Medicare compliance reporting and development. Frank will be responsible for MedicareConnect, our industry-leading platform for MMSEA Section 111 — Medicare Secondary Payer Mandatory Reporting — for non-group health plans. He will also help drive new product and technology growth for the division.

Frank originally joined Optum in 2010 and was instrumental in launching MedicareConnect. He managed the platform from the start of live reporting with CMS in January of 2011 and quickly brought it to the forefront of the industry with its capability and accuracy.

Frank has 30 years of business experience in the financial, telecom and workers’ compensation industries and holds a Bachelor’s Degree in Technology Management.

CMS Releases Update to WCMSA Reference Guide

The Centers for Medicare and Medicaid Services (CMS) released an update to their Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide (version 2.7) with two changes. To view the reference guide, click here.

  1. Section 14.0 (page 51), Appendix 1 and Appendix 5: This update provides the new Workers’ Compensation Contractor (WCRC) phone number: 833-295-3773 and hours of business, 9 a.m.–5 p.m. EST, Monday–Friday.
  2. The Confidentiality Statement now states the Medicare beneficiary must provide a written request or explicit written consent/authorization for a party to obtain information from CMS regarding the Medicare beneficiary.

As indicated by CMS in their March 7, 2018 teleconference, Capitol Bridge is the new WCRC. No material changes were made to the reference guide related to the WCMSA review process.  Please continue to watch this site for additional updates, news or trends from CMS.

Prescription drug updates may positively affect Medicare Set Aside

As part of our best business practices, we continually monitor RED BOOK®Average Wholesale Price (AWP) of the most common medications present in Workers’ Compensation Medicare Set-Aside (WCMSA) arrangements. This practice assists in identifying price changes positively affecting WCMSAs.

The month of February brought price drops of the following medications:

  • buprenorphine/naloxone (Suboxone®) commonly prescribed for opioid dependence
  • diclofenac (Voltaren®) in multiple strengths used to treat pain
  • methadone (Dolophine®) commonly prescribed for detoxification or pain management
  • bupropion (Wellbutrin®) in multiple strengths prescribed for depression
  • clonazepam (Klonopin®) used for anxiety or panic disorders
  • quetiapine (Seroquel®) commonly used to treat bipolar disorder, depression or schizophrenia
  • tramadol (Ultram®) used to treat pain

The products in the following table have a reduced AWP, confirmed in the Centers for Medicare and Medicaid Services (CMS) WCMSA portal.

Product Name

NDC Code

Dosage Form

Strength

AWP Unit Price Reduction

Bupropion Hydrochloride

00781-5528-31

TER

150 mg

$3.92

Bupropion Hydrochloride

00781-5529-31

TER

300 mg

$2.24

Diclofenac Sodium

61145-0102-12

ECT

75 mg

$0.51

Buprenorphine Hydrochloride/Naloxone Hydrochloride

00406-8020-03

SL TAB

8/2 mg

$0.34

Clonazepam

00781-8018-05

TAB

0.5 mg

$0.11

Diclofenac Sodium

61145-0101-18

ECT

50 mg

$0.10

Quetiapine Fumarate

00904-6639-61

TAB

50 mg

$0.09

Tramadol Hydrochloride

68094-0017-61

TAB

50 mg

$0.06

Methadone Hydrochloride

66689-0898-40

TBS

40 mg

$0.04

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

CMS uses the lowest AWP when reviewing a WCMSA. The lower price of these medications will immediately affect the prescription costs for WCMSAs (both present as well as prior WCMSA’s that have not settled and there is no CMS determination issued). We will contact our clients in reference to previously completed WCMSA’s where these medications have been prescribed. It is our recommendation that carriers, TPAs and claim handlers review cases to determine the benefit from decreased cost of these medications.

Optum will continue to keep the industry informed of changes in AWP pricing, in addition to when generic equivalents enter the market.