After FDA Authorization, Lots of Pressure to Rescind Zohydro ER Approval

Nahla RizkallahIn October 2013, the U.S. Food and Drug Administration (FDA) went against the recommendation of its own advisory committee and approved Zohydro® ER. The FDA’s Anesthetic and Analgesic Drug Advisory Committee of independent experts voted 11 to 2 to recommend against approval of Zohydro® ER due to concern of the potential for abuse because the product does not include acetaminophen.

What is Zohydro® ER? It is a Schedule II controlled substance under the Controlled Substances Act. It is the first FDA-approved single-entity extended-release hydrocodone without acetaminophen. Zohydro® ER is FDA indicated for the management of pain severe enough to require around-the-clock opioid, long-term treatment and for which alternative options are inadequate. Zohydro® ER has black box warnings all of which can cause fatal overdose: addiction potential, life-threatening respiratory depression, accidental exposure, neonatal opioid withdrawal syndrome, and interaction with alcohol.

Since the FDA approval of Zohydro® ER, several members of congress protested by sending an open letter to Health and Human Services Secretary, Kathleen Sebelius. In addition, in November, attorneys general of 29 states and territories have sent a letter to the FDA asking that the agency consider reversal of Zohydro® ER. Most recently, a petition from more than 40 consumer organizations, health care agencies, addiction treatment providers, and community-based drug and alcohol prevention programs called upon the FDA to revoke its approval of Zohydro® ER. However, despite all the sharp criticism that the FDA has received, Zohydro® ER was launched on March 3rd, 2014.

So, why all the hype? Why so much attention and objection? This decision was surprising to many because as the country is in the midst of a prescription drug abuse crisis, the FDA failed to apply its current standard and goal of requiring abuse-deterrent technology for all opioids. Zohydro® ER does not have abuse-resistant technology. It can be dissolved or injected, and the opioid will get into a person’s system all at once.

Because of this and the greater risks with a new extended release opioid, Zohydro ER® is not recommended as a first line drug in the Official Disability Guidelines (ODG). It is classified as an ‘N’ by ODG which means it requires pre-authorization. It is likely that Zohydro ER® will be paid for by Medicare through a prior authorization process where documentation is provided to support that the patient has tried and failed several other alternative narcotics. Post-marketing studies on Zohydro® ER are being required by the FDA to evaluate the risk of misuse, abuse, addiction, overdose and death.

The average wholesale price (AWP) per capsule is as follows: 10mg is $6.59, 15mg is $7.03, 20mg is $7.24, 30mg is $7.46, 40mg is $7.67, and 50mg is $8.00. The FDA approved frequency for Zohydro® ER is every twelve hours.

Generally, Zohydro® ER is expected to drive up the cost of MSAs. However, as with all other forms of treatment and prescriptions, Gould & Lamb uses varied clinical tools, such as drug management reviews, to assist with mitigation of such costs.

Future Considerations for Controlled-Release Oxycodone

Oxycodone CR is a slow release opioid narcotic currently indicated for use in moderate and moderate-to-severe pain. When initially released to the market, the indicated use was for pain management in cancer patients and for control of postoperative pain. As the use of controlled-release Oxycodone expanded, problems with addiction and abuse escalated.

In an effort to bring the use of Oxycodone CR under more effective control, H.R. 1366 cited as the “Stop Oxy Abuse Act of 2013” was introduced March 21, 2013 “to direct the Commissioner of Food and Drugs to modify the approval of any drug containing controlled-release (CR) oxycodone hydrochloride, to limit such approval to use for the relief of severe-only instead of moderate-to-severe pain, and for other purposes”. The introduction of the bill followed a petition filed by Physicians for Responsible Opioid Prescribing (PROP) calling for the FDA to modify opioid labeling such that future approval would exclude the term “moderate” from an indicated use for non-cancer pain. As such, approval for use would be limited to severe pain only within this population. However, the bill does not restrict the drug’s use to non-cancer pain but, rather, seeks to limit approval for use to “severe-only pain” for any patient population.

If H.R. 1366 passes, it will operate to remove use of the controlled-release oxycodone drugs for management of any form of moderate pain type diagnoses as an approved indication by the FDA. The prescribing of Oxycodone CR for “moderate” or “moderate-severe” pain would then be considered an “Off Label” use. Within the world of Medicare Set-Aside, provision of controlled-released Oxycodone for such diagnoses would be excluded from the plan of care. Any continued use of Oxycodone CR would require medical documentation and diagnosis of “severe” pain.

Why Can’t Workers’ Compensation Use OTC Products?

William F. BellTwo strategies are routinely sought after in healthcare: positive clinical outcomes for the patient and controlling the costs.  The proper use of generic medications is one way to manage costs. Another way costs can be controlled, while simultaneously achieving positive clinical outcomes, is through the use of Over-the-Counter (OTC) medications.

Controlling Costs with OTC Medications

Because OTC medications do not require visiting a physician or a physician’s prescription, the cost of going to a doctor’s office is eliminated and there is greater and easier access to the medications. Over the last two decades, the notion of “self-care”, a program where the patient can treat conditions they normally would not due to perceived barriers, such as socio-economic factors or the inability to see a physician, has increased. The greater access to OTC medications to treat conditions prevents unnecessary ER or hospital visits, thereby allowing physicians to focus their time and energy on more serious conditions.

A recent study released by the Consumers Healthcare Products Association (CHPA) concluded that for every $1 spent on an OTC medication, a $7 in savings to the overall healthcare system is realized.

Potential Savings Recognized in Workers’ Compensation Cases

In the Workers’ Compensation insurance sector, use of OTC medications is an under utilized standard of care and makes good sense. Factors such as the lack of formulary management allow for the prescription version of OTC medications to continue to be prescribed with the payer ultimately absorbing the costs. As an example, the chart below illustrates the AWP for two common GI medications and the potential savings as measured against the OTC version. We see these medications commonly prescribed in the Workers’ Compensation industry secondary to NSAID usage (Meloxicam, Ibuprofen) or with opioids (Hydrocodone/APAP) to alleviate upset stomach or other GI effects.

Medication

Rx Cost (AWP/30day supply)*

OTC Cost (30 tablets)

Omeprazole (Prilosec)

$35

$15

Lansoprazole (Prevacid)

$110

$19


*AWP based on 30 day supply. BC/BS Michigan Pharmacy Sheet.

Although this may not seem significant or substantial, use of an OTC medication to take the place of a prescription can yield substantial savings to a Workers’ Compensation Medicare Set-Aside and could make the difference between settling the file or having to keep it open.  Keep in mind, both Omeprazole and Lansoprazole are not indicated to be utilized for chronic periods. Thus, it makes sense to utilize OTC versions of these products once or twice yearly as opposed to funding a Workers’ Compensation Medicare Set-Aside monthly for the prescription versions.

In today’s Workers’ Compensation claims handling setting, each and every dollar must be managed appropriately. OTC medication utilization is one way that Part-D allocations can be significantly reduced and properly funded in a Workers’ Compensation Medicare Set-Aside, providing both positive outcomes while being cost effective as well.


About the Author: William F. Bell, Jr. is the Senior Clinical Pharmacy Specialist for Gould & Lamb, LLC.  His primary responsibility is the review of a claimant’s pharmacotherapy regimen and the identification of off-label medications in a Medicare Set Aside Allocation.  He has given numerous presentations on the subject of medication management and how it relates to Workers’ Compensation and Medicare Set Aside Claims.  Bill has also authored two continuing education articles for the Pharmacist’s Letter, a nationally known education resource for practicing pharmacists.

Gould & Lamb is a global leader of MSA/MSP Compliance Services in the country, serving domestic and international insurance companies, third-party administrators and self-insured entities.

Carisoprodol to Receive Federal Controlled Status

William F. BellOf all the medications utilized in Workers’ Compensation claims, none has the abuse potential of Carisoprodol. Known by its brand names Soma or Soma Compound, Carisoprodol is a skeletal muscle relaxant FDA indicated for the relief of acute, painful musculoskeletal conditions in adults.[1]

On the market for close to 50 years, Carisoprodol is available in 250mg and 350mg tablets, along with a 200mg tablet in combination with aspirin and codeine phosphate. The abuse potential  exists because of the way Carisoprodol is metabolized in the body.  It may cause an individual to become addicted.

For this reason, on December 12, 2011, the Drug Enforcement Administration (DEA) issued a final ruling on the status of Carisoprodol making it a Schedule IV controlled substance effective January 12, 2012. Already classified as a controlled substance in 17 states, this ruling will make Carisoprodol a scheduled medication in all other states for which specific handling and dispensing rules must be followed.

When this ruling takes effect in January 2012, some of the changes which will occur include:

  • New and refill prescriptions of Carisoprodol must be treated as a controlled substance, impacting the number of refills which can be authorized at one time.
  • All facilities handling and dispensing Carisoprodol must include it on every controlled substance inventory.

What this means is that Carisoprodol has been identified as a medication with an abuse potential. Classifying Carisoprodol as a Schedule IV controlled substance may allow for lower utilization, which in turn may result in alternative, non-addicting medications (Tizanidine/Baclofen) to be used appropriately and with better clinical outcomes.

About the Author: William F. Bell, Jr. is the Senior Clinical Pharmacy Specialist for Gould & Lamb, LLC. His primary responsibility is the review of a claimant’s pharmacotherapy regimen and the identification of off-label medications in a Medicare Set Aside Allocation.  He has given numerous presentations on the subject of medication management and how it relates to Workers’ Compensation and Medicare Set Aside Claims.  Bill has also authored two continuing education articles for the Pharmacist’s Letter, a nationally known education resource for practicing pharmacists.

Gould & Lamb is a global leader of MSA/MSP Compliance Services in the country, serving domestic and international insurance companies, third-party administrators and self-insured entities.


[1] Facts and Comparisons Online. Carisoprodol. Wolters Kluwer Health, Inc. 2008.

Workers’ Compensation Medicare Set-Aside (WCMSA) – Prescription Drugs Challenges

William F. BellCarriers face enormous challenges when attempting to settle cases with Workers’ Compensation Medicare Set-Aside (WCMSA) arrangements.  Currently, one of these challenges is the appropriate use of prescription medications and their proper allocation. The Center for Medicare and Medicaid Services’ (CMS) operating memo of April 2009 changed the entire landscape as we know it, especially with regard to the management and allocation of prescription medications.

CMS Decisions Regarding Prescriptions Drug Therapy

I travel across the country educating carriers, attorneys, physicians, Workers’ Compensation judges, and even a state senator about these changes and how to best handle the ever-rising prescription drug costs and utilization in a WCMSA in the hope of a favorable decision by CMS.

A recent audit by Gould & Lamb has found that in a six month period, CMS has agreed to an alteration of prescription drug therapy that resulted in approval for nearly 51% of the submitted files. Considering how the April 2009 memo changed everything with Part-D allocations, this is very encouraging. Could it be the realization by CMS of inappropriate drug therapy, contraindications, or other factors which account for these approvals? Or, could it once again show the value of Pharmacists as a member of the multi-disciplinary approach to WCMSA?

Value-Added with Pharmacists Involvement

Some may say that use of a Pharmacist in WCMSA reviews is both useless and senseless. As the Senior Clinical Pharmacist for Gould & Lamb, I differ with this notion.  Pharmacists bring a unique perspective and training that is a valuable asset to both carrier and organization alike. Who can best explain whether a medication can be identified as off-label, compensable, or contraindicated as part of a claimant’s long-term drug regimen? Who can best engage the prescribing physician in dialogue concerning the long-term impact of a claimant’s pharmacotherapy regimen?

For many Pharmacists, daily responsibilities center on both off-label review and Part-D allocations, while they spend hours reading medical journals, and presenting relevant pharmacy information to keep those involved with WCMSA educated and informed on the ever-changing Part-D rules.

As prescription utilization continues to escalate in the Workers’ Compensation industry, carriers will continue to rely on Pharmacists for guidance and recommendations on how to best handle rising costs and cost-containment strategies in order to settle claims.

Handling WCMSA Through Multi-Disciplinary Approach – Best Solution

As the favorable decisions from CMS continue, it is prudent for carriers to use a vendor with the proper professions on staff, including Pharmacists.  WCMSA are best handled through a multi-disciplinary approach that involves input and skill from many different professions, not just pharmacy. Although Part-D represents a huge slice of the total MSA allocation, other disciplines are needed as well to ensure both the appropriateness and accuracy of them.

Don’t listen to the nay-sayers!  Pharmacists will continue to play an important part in WCMSA reviews. As a licensed pharmacist for close to twenty years, I cannot give you legal advice, but I can give you pharmacy advice. You wouldn’t go to an accountant to fill a prescription, would you??


About the Author: William F. Bell, Jr. is the Senior Clinical Pharmacy Specialist for Gould & Lamb, LLC. His primary responsibility is the review of a claimant’s pharmacotherapy regimen and the identification of off-label medications in a Medicare Set Aside Allocation.  He has given numerous presentations on the subject of medication management and how it relates to Workers’ Compensation and Medicare Set Aside Claims.  Bill has also authored two continuing education articles for the Pharmacist’s Letter, a nationally known education resource for practicing pharmacists.