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.

Generic Cymbalta® is available

On December 11th, 2013, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Cymbalta® (duloxetine).  Progressive Medical 2013 Drug Trends reported that Cymbalta® accounted for 4.2% of total spend in 2012, which places it in the number five of the top medications by total spend.

Cymbalta® is an antidepressant in the therapeutic class of selective norepinephrine reuptake inhibitor which is FDA approved for the following conditions: chronic musculoskeletal pain, diabetic peripheral neuropathic pain, fibromyalgia, generalized anxiety disorder, and major depressive disorder.  It is often used off-label to treat neuropathic pain.  The usual dosage is 60mg once daily, swallowed whole.  There is no evidence that dosages greater than 60mg per day confer any additional benefits.

The generic drug manufacturers include: Aurobindo Pharma, Actavis Pharmaceuticals, Citron Pharmaceuticals, Dr Reddy’s Laboratories, Lupin Pharmaceuticals, Caraco Pharmaceuticals/Sun Pharma USA, Teva Pharmaceuticals and Torrent Pharmaceuticals.

The AWP per Redbook Online as of 1.6.2014 for Cymbalta® 20mg is $7.77 per capsule; whereas duloxetine 20mg ranges from $6.22 to $6.99 per capsule.  Cymbalta® 30mg is $8.72 per capsule; duloxetine 30mg ranges from $6.97 to $7.85 per capsule.  Cymbalta® 60mg is $8.72 per capsule; duloxetine 60mg ranges from $6.97 to $7.85 per capsule.

Savings will accrue for the Workers’ Compensation payers once claimants are switched from the brand name product to the generic agent.

Generic interchange regulations vary from state to state.  Gould and Lamb’s ‘Stop the Pain’SM (STP) is an interventional and actionable product which can assist in switching from the brand name medications to the more cost-effective generic agent.  STP can produce significant savings, assess appropriateness of current therapy, optimize drug therapy, assist clients in lower claims costs, and lower Medicare Set-Aside allocations.

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.

Pharmacists’ Role in Workers Compensation Medicare Set Aside Allocation

In-house Team of Pharmacists Is Essential for Proper Projection of Part-D Costs in WCMSA

Gould & Lamb Medicare Drug Management ServicesTwo recent CMS policy memoranda have had a significant impact on the way Part-D costs are calculated in a Workers’ Compensation Medicare Set Aside (WCMSA) . The April 3, 2009, Centers for Medicare Medicaid Services  (CMS) policy memo dealing with the independent review of prescription medications in conjunction with the May 14, 2010 CMS procedure memorandum  concerning the exclusion of those identified as “off-label,” pharmacists are playing a bigger role in the WCMSA process and their importance to any MSA vendor is invaluable.

Pharmacy costs will continue to represent a large portion of a total MSA. Due to their high skill set and command of pharmacotherapy, pharmacists can identify therapeutic duplications, potential drug-drug interactions and contraindications that may result in other costs or expenses if continued without intervention.

Pharmacists Key in Identifying Off-label or Excluded Medications in WCMSA Allocation

Furthermore, some studies have shown that 85% of all prescription drugs may be written off-label and most come with some sort of risk when taken for long-term. Pharmacists are best able and most knowledgeable to identify medications that are appropriate for a claimants’ care and those that may be off-label and therefore excluded from a WCMSA allocation. Pharmacists have command of both drug language and literature retrieval, thereby ensuring that the most up-to-date information concerning prescription medications is reported and properly excluded from the WCMSA.

Pharmacists are highly trained and skilled healthcare professionals well versed in pharmacotherapy, drug information, and appropriateness of prescription medications through many years of didactic coursework and specialized training. Today, the profession of pharmacy is more than a “count, pour, lick, stick” operation of years past. Pharmacists are now an integral part of a healthcare team along with both doctors and nurses as the scope of clinical pharmacy has evolved. Pharmacist-Physician collaboration in a WCMSA to determine an appropriate long-term plan may be one way to contain costs ensuring a practical and beneficial medication regimen is established.

Pharmacists are the true “drug experts” and should work harmoniously and in concert with other members of your organization when preparing and possibly defending a WCMSA.

Pharmaceutical Team Essential in Workers’ Compensation Medicare Set Aside Allocation

If there is anything we can take away from the recent CMS policy memoranda is that having an in-house team of pharmacists are essential to the proper projection of Part-D costs. As prescription drug use will only continue in Worker Compensation Medicare Set Aside Allocation, utilizing a pharmacist may be one way to help contain costs while ensuring appropriate medical care for long-term is achieved.

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