Author Archives: Kay Whittemore

New Abuse-Deterrent Opioid Formulations Released

The Food and Drug Administration (FDA) released a notice in 2013, surrounding the long-time available acetaminophen (the active ingredient in brands like Tylenol®). This notice addressed two issues that would help to make acetaminophen-containing products safer for the ultimate consumer by limiting their exposure and drawing a connection to their risks. The first was a call to limit the amount of acetaminophen in prescription combination products to 325mg per tablet, capsule or other unit of dose. The second required updated labeling to include liver toxicity warning. This bulletin gave the manufacturers until January 14, 2014, to comply by removing medications containing more than 325mg of acetaminophen from the market.

Prescription combination products containing acetaminophen are frequently prescribed for workers’ compensation injuries, most commonly those with opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet®) and hydrocodone (Vicodin™, Norco®). As a result of the FDA restriction on acetaminophen, manufacturers reformulated their combination acetaminophen products (i.e. Vicodin 5/500mg (hydrocodone/acetaminophen immediate release) tablet to Vicodin 5/300mg). Other manufacturers began releasing new opioid products containing no acetaminophen (i.e. Zohydro® ER, Hysingla® ER, both hydrocodone extended release formulations).

With these new releases came concerns. Critics of the new single opioid formulations feared they would lead to more abuse, misuse, and deaths due to the removal of the acetaminophen. In other words, excessive use of acetaminophen would no longer be a deterrent for patients tempted to take the medications at higher doses than prescribed and it remained to be seen what steps would be taken by manufacturers to guard against abuse and misuse of these products. As part of the FDA’s strategy to address the opioid abuse epidemic, they encouraged manufacturers to produce abuse-deterrent formulations.

Recently there have been several new single opioid formulation products, containing no acetaminophen, approved by the FDA and released to the market. All have some form of abuse-deterrent property.

Arymo™ ER (morphine sulfate extended release) abuse-deterrent tablet: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 15mg, $5.18/tab*, 30mg, $10.38/tab*, and 60mg, $20.76/tab* strengths.

Vantrela™ ER (hydrocodone bitartrate extended-release) abuse-deterrent tablet: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 15mg, 30mg, 45mg, 60mg, and 90m strengths.

Xtampza® ER (oxycodone hydrochloride extended-release) abuse-deterrent capsule: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 9mg, $4.42/capsule*, 13.5mg, $6.51/capsule*, 18mg, $8.26/capsule*, 27mg, $11.49/capsule, and 36mg, $14.15/capsule*strengths.

Troxyca® ER (oxycodone hydrochloride/naltrexone hydrochloride extended-release) abuse-deterrent tablet: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 10mg/1.2mg, 20mg/2.4mg, 30mg/3.6mg, 40mg/4.8mg, 60mg/7.2mg and 80mg/9.6mg strengths.

Roxybond™ (oxycodone hydrochloride immediate-release) abuse-deterrent tablet: FDA approved for the treatment of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Available in 5mg, 15mg, and 30mg tablets.

*Centers for Medicare and Medicare Services (CMS) pricing utilized if available. Pricing at time of this article was not available in Redbook or CMS portal for all other medications.

Even though these abuse-deterrent formulations will not prevent consumption of large doses of opioids, the most common method of abuse, they do have one or more properties that make their non- therapeutic use less rewarding and more difficult. All, except Troxyca, utilize a physical and chemical barrier to deter abuse by cutting, crushing, grinding, or breaking for intravenous or intranasal use, while Troxyca utilizes the addition of an opiate antagonist to block the patient from experiencing the opiate effects of the medication.

Opioids have a long history of being utilized to treat pain in workers’ compensation injuries and while they are considered safe and effective when properly utilized they also have a high potential to lead to abuse, misuse, and addiction. This can lead to health risks for the injured worker and increased medical expenses over the life of the claim for the carrier. Therefore, it is imperative that carriers and Third Party Administrators (TPAs) take proactive measures to quickly get control of cases where they suspect fraud, misuse, and abuse in the early stages of the patient’s treatment. However, even at the final stage of the claim when the patient is rendered to be at MMI (Maximum Medical Improvement) and settlement is being discussed, there is still an opportunity to take advantage of clinical programs available to address inappropriate narcotic prescribing or abuse and misuse at the time. Optum Settlement Solutions offers a variety of clinical products and has a vast staff of pharmacists and nurses to assist clients with a plan to render the most cost effective treatment for the injured worker while allowing for the best therapeutic outcome.

Recently Released and Soon to be Released Generics Expected to Reduce Claims Costs

Over the past several years, prescription drug costs related to workers’ compensation claims have risen dramatically, making it increasingly important for claims professionals to carefully evaluate this exposure and mitigate costs when possible. Optum Settlement Solutions understands that keeping up to date on new generic formulations is part of an overall strategic approach to reduce the cost of claims and ultimately the prescription allocation of a Medicare Set-Aside (MSA).

Every brand medication has a patent life that will ultimately expire. Once the patent expires, generic formulations become available on the market, typically at a lower cost. Although there is no set brand-versus-generic price differential upon generic entry, clinical analysis shows, on average, the generic has a 10% lower price at time of launch over its brand counterpart.

There were several brand name medications during 2016 and already in 2017, commonly prescribed in workers’ compensation claims, whose patents expired with their Food and Drug Administration (FDA) approved generic formulations released to the market.

Generics released in 2016 and first quarter of 2017:

Intermezzo (Zolpidem sublingual tablet): Sedative/hypnotic which is FDA approved for the treatment of insomnia. This is the only indication The Centers for Medicare and Medicaid Services (CMS) currently accepts for inclusion of Intermezzo (Zolpidem) in an MSA. Brand: $13.60/tab* Generic: $10.03/tab* (all strengths)

Frova (Frovatriptan 2.5mg): Central serotonin-receptor 1B and 1D agonist which is FDA approved for the treatment of acute migraine attacks with or without aura. This is the only indication CMS currently accepts for inclusion of Frova (Frovatriptan) in an MSA. Brand: $88.35/tab* Generic: $72.27/tab*

Nasonex (Mometasone Furoate 50mcg/actuation nasal spray): Medium –potency synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties which is FDA approved for the treatment of allergic rhinitis and allergic rhinitis prophylaxis. These are the only indications CMS currently accepts for inclusion of Nasonex (Mometasone Furoate) in an MSA. Brand: $16.74/gm* Generic: $15.07/gm*

Voltaren Gel 1% (Diclofenac Gel): Topical non-steroidal anti-inflammatory which is FDA approved for the treatment of osteoarthritis of the feet, ankles, knees, wrists, hands, and elbows. It is utilized most often in workers’ compensation claims for the treatment of inflammation and mild to moderate pain. While not FDA approved indications, CMS recognizes these as “medically accepted” indications for use on the body parts listed above and will include Voltaren Gel (Diclofenac Gel) in an MSA. It is considered to be utilized off-label when applied to other body parts such as the neck, shoulder or back and CMS will exclude this medication from the MSA. Brand: $0.49/gm* Generic: $0.54/gm* (Note: currently the generic formulation is more expensive, but as more manufacturers release their generic products the cost should become more competitive and decrease).

Nuvigil (Armodafinil): A psychostimulant which is FDA approved for the treatment of circadian rhythm disruption, narcolepsy, and sleep apnea. It is utilized most often in workers’ compensation claims off-label for daytime somnolence or fatigue due to the utilization of narcotic pain medications which is not recognized by CMS as an accepted indication (FDA or “medically accepted”); therefore, it would be excluded from the MSA for this diagnosis. Brand: 50mg, $8.86/tab, 150,200, & 250mg, $26.60/tab* Generic: 50mg, $7.26/tab, 150,200,250mg $21.86/tab*.

Seroquel XR (Quetiapine Fumarate Extended Release): Atypical antipsychotic which is FDA approved for the treatment of bipolar disorder, schizophrenia, and depression. These are the only indications CMS currently accepts for inclusion of Seroquel XR (Quetiapine Fumarate Extended Release) in an MSA. It is most often utilized in workers’ compensation claims for the treatment of depression. Brand: e.g., 200mg strength, $19.47/tab* Generic: 200mg, $15.52/tab* (Note: All strengths are available in generic formulation).

Pristiq (Desvenlafaxine Succinate): Serotonin-norepinephrine reuptake inhibitor which is FDA approved for the treatment of depression. This is the only indication CMS currently accepts for inclusion of Pristiq (Desvenlafaxine Succinate) in an MSA. Recently released in March 2017, no generic price available for comparison at this time.

*Current pricing based on lowest Redbook AWP

Generics to be released later in 2017:

Relpax (Eletriptan): Serotonin agonist which is FDA approved for the treatment of acute migraine attacks with or without aura. This is the only indication CMS currently accepts for inclusion of Relpax (Eletriptan) in an MSA.

Proair HFA (Albuterol Sulfate inhaler): Moderately selective short-acting beta -2 receptor agonist which is FDA approved for the treatment of acute bronchospasm and exercise-induced bronchospasm prophylaxis. These are the only indications CMS currently accepts for the inclusion of Proair HFA (Albuterol Sulfate) in an MSA.

Viagra (Sildenafil): Phosphodiesterase type 5 inhibitor which is FDA approved for the treatment of erectile dysfunction (ED) and pulmonary hypertension. CMS accepts the indication of pulmonary hypertension for inclusion of Viagra (Sildenafil) in an MSA; however, Viagra (Sildenafil) is Part D excluded for treatment of erectile dysfunction and would not be included by CMS in the MSA for this diagnosis.

Generics can help to lower the cost of the claim:

As healthcare expenditures continue to climb, the effect has been felt in the workers’ compensation industry. Generic medications play a key role in helping to lower costs. It is important, as an industry, we keep up to date on generic availability and intercede when necessary if generics are not being utilized by the treating physician. Optum, being a leader in the industry, has products and programs which can assist clients with managing and mitigating prescription drug costs. These include identification of claims where generic options are available (based on availability of data) and, when applicable, reaching out to the treating physician to discuss conversion to lower cost prescription drug alternatives.

For questions, please contact our Settlement Solutions Division at 888-672-7674 or contactus@helioscomp.com