Donna Mize, Brenda Smith, Evelio Prieto, and Lavonya Chapman contributed to this post.
Back in January of 2006, the Centers for Medicare and Medicaid Services (CMS) mandated the inclusion of prescription medications in Workers’ Compensation Medicare Set Aside (WCMSA) arrangements. For several years after that, the Workers’ Compensation Review Contractor (WCRC) did not review medications and what was submitted was basically accepted “as is” on good faith. On 4/3/2009, CMS issued a memorandum stating that they would start to independently review/price Medicare-covered medications in WCMSAs, starting on June 1, 2009.
CMS subsequently published a document titled “CMS Prescription Drug Set-Aside Guidance for Submitters” which confirmed that the WCRC would be using RED BOOK® pricing, effective June 1, 2009, in their review of medications in WCMSAs. Additionally, it was stated that “Off-label use of medications in the United States is both legal and common. Once a drug has been approved for sale by the Food and Drug Administration (FDA) for one purpose, physicians are free to prescribe it for any other purpose that in their professional judgment is both safe and effective. Physicians are not limited to prescribing a drug only for official, FDA-approved indications.”
Fast forward to May 14, 2010, when CMS issued another memorandum further clarifying the definition of covered Part D drugs effective June 1, 2010.
A “covered Part D drug” is “a drug that may be dispensed only upon a prescription and that is described in subparagraph (A)(i), (A)(ii), or (A)(iii) . . .” of 42 U.S.C. section 1396r-8(k)(2). 42 U.S.C. Section 1395w-102(e)(1)(A). For a Part D drug to be covered by Medicare, and thus included properly in a WCMSA, the drug should be prescribed for an outpatient use that is approved under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. § 301 et seq.], or supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(I) of 42 U.S.C. Section 1396r-8”.
WCRC Includes Lyrica In Off-Label Lumbar Radicular Pain
Gabapentinoids like gabapentin (Neurontin) and pregabalin (Lyrica), utilized as “off-label” in workers’ compensation claims for lumbar radicular pain, had not initially been made part of an approved WCMSA. Since early 2011, the WCRC was including gabapentin in a WCMSA allocation for radicular pain, but Lyrica continued to be excluded, making it clear that Lyrica was considered off-label for lumbar radiculopathy without spinal cord injury―at least until September 2018, when the WCRC began to add Lyrica to MSA allocations despite being used to treat an “off-label” neuropathic pain.
Lyrica is approved by the FDA to treat diabetic peripheral neuropathy, fibromyalgia, partial seizures, postherpetic neuralgia, and radiculopathy/neuropathy in spinal cord injuries only (central cord syndrome). Lyrica, although similar to gabapentin (Neurontin), is still not FDA approved to treat radiculopathy without injury to the spinal cord. There are no peer-reviewed studies to support the effectiveness of Lyrica in treating lumbar radicular pain or evidence to support an increase in functional ability as a result of neuropathic pain relief from the use of Lyrica. However, there is plenty of evidence to support dizziness and cognitive loss with Lyrica use.
For the last several years the usual practice of the WCRC was to exclude Lyrica as off-label when used for radiculopathy without injury to the spinal cord which was consistent with national and state mandated practice guidelines that are supported by evidence based medicine as being effective for the FDA approved indications of Lyrica. However, as of September, 2018, the following is the WCRC rationale for now including Lyrica for chronic lumbar pain or neuropathic pain associated with lumbar radiculopathy as a result of a disc protrusion:
FDA APPROVED DRUGS USED FOR INDICATIONS OTHER THAN WHAT IS INDICATED ON THE OFFICIAL LABEL MAY BE COVERED UNDER MEDICARE IF THE CARRIER DETERMINES THE USE TO BE MEDICALLY ACCEPTED, TAKING INTO CONSIDERATION THE MAJOR DRUG COMPENDIA, AUTHORITATIVE MEDICAL LITERATURE AND/OR ACCEPTED STANDARDS OF MEDICAL PRACTICE. IN THE CASE OF DRUGS USED IN AN ANTI-CANCER CHEMOTHERAPEUTIC REGIMEN, UNLABELED USES ARE COVERED FOR A MEDICALLY ACCEPTED INDICATION AS DEFINED IN 50.5.’ THERE ARE MANY OFF-LABEL INDICATIONS THAT ARE LISTED IN RECOGNIZED COMPENDIA AND PEER-REVIEWED SOURCES; THUS, THEY WOULD BE COVERED UNDER THE PART D BENEFIT, AND SHOULD ALSO BE INCLUDED IN A WCMSA. FOR EXAMPLE, TRAZODONE IS APPROVED BY THE FDA FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER, BUT IS COMMONLY GIVEN OFF-LABEL TO TREAT INSOMNIA. SO THE WCRC WOULD INCLUDE TRAZODONE IN A WCMSA IF USED TO TREAT INSOMNIA, IF IT IS RELATED TO THE WORKERS’ COMPENSATION INJURY. ABSENT ADDITIONAL EVIDENCE THAT LYRICA IS NOT BEING UTILIZED FOR THE WORKER COMPENSATION INJURY, NO CHANGES WILL BE MADE.
In the above case, Lyrica 150 mg, 90 pills per month, was included over an 18-year life expectancy, increasing the WCMSA by $173,210.40. The increased cost of adding Lyrica to WCMSAs will be significant, and could stall or make a settlement unattainable.
Should Lyrica Be Included In Your Next WCMSA?
Whether Lyrica is reimbursable by Medicare and should be included in the WCMSA allocation has recently become an issue and a surprise to many. According to § 9.4.4 of the WCMSA Reference Guide, v 2.7, March 19, 2018, when reviewing medications prescribed, the WCRC will include medications that are approved by the “Food and Drug Administration (FDA) approved or supported for inclusion in the approved compendia.” The two approved compendia listed in § 188.8.131.52 are the American Hospital Formulary Service Drug Information database and the Micromedex’s DrugDex database. If either or both of the compendia establish a medically accepted off-label use or non-FDA approved use of the drug, the medication is considered to be covered and reimbursable by Medicare.
In addition, according to the Medicare Benefit Policy Manual, 100-02, Ch. 15, § 50.4.2, it states in pertinent part that the Medicare Part D plan may determine that an unlabeled use of a drug is covered by Medicare if the use is medically accepted in the medical community, which is evident from “the major drug compendia, authoritative medical literature and/or accepted standards of medical practice.”
In 2012, the FDA approved Lyrica for the management of neuropathic pain associated with spinal cord injury. Traumatic instances of a spinal cord injury typically begin with a sudden, traumatic blow to the spine that fractures or dislocates vertebrae. The damage begins at the moment of injury when displaced bone fragments, disc material, or ligaments bruise or tear into spinal cord tissue.
This analysis is also consistent with the WCRC’s prior approvals that excluded Lyrica from WCMSAs for chronic low back pain with radiculopathy. In light of the recent CMS approvals that have included Lyrica as being covered by Medicare for neuropathic pain secondary to lumbar radiculopathy, it is plausible that the new WCRC has modified their interpretation of a spinal cord injury to include a Lyrica indication that is not medically sound or reasonably interpreted. However, because so many authorized treating physicians in the workers’ compensation context prescribe Lyrica, there may be enough evidence as interpreted by the WCRC to conclude the Lyrica must be medically indicated, an accepted practice, or effective in this context.
According to Drs. Christopher Goodman and Allen Brett in the August 3, 2017 edition of the New England Journal of Medicine, “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain. According to Drs. Goodman and Brett, clinicians shouldn’t assume that gabapentinoids are an effective approach for most pain syndromes.” In addition, “We believe that gabapentinoids are being prescribed excessively, partly in response to the opioid epidemic.”
Regardless, the WCRC’s actions in including Lyrica for off-label and non-compendia-approved indications are inconsistent with the guidance outlined in the most recent applicable WCMSA Reference Guide. Payment for a medication not otherwise reimbursable by Medicare does not make it appropriate for inclusion in an MSA. Attempts to deviate from the Reference Guide, FDA indications, and compendia consensus should be challenged if Lyrica is included in your WCMSA for neuropathic pain not associated with central cord injury.
How Can Optum Help?
As is our norm, Optum Settlement Solutions will proactively contact clients when we have previously completed a WCMSA, but which has not yet been approved, where Lyrica was prescribed. It is our recommendation that carriers, self-insureds, TPAs and claim handlers review cases to determine if inclusion of Lyrica will adversely impact settlement options. Our team of industry experts can assist our clients with resubmission of WCMSAs on cases with counter high allocations due to the inclusion of Lyrica
Additionally, Optum has clinical intervention products available, which may help mitigate costs and improve patient outcomes through more suitable clinical and cost effective therapeutic equivalents. Radicular/neuropathic pain is commonly treated with various adjuvant medications. Anti-convulsants (gabapentin, Lyrica (pregabalin), topiramate, and lamotrigine) are common first line agents used in combination with other agents to alleviate neuropathic pain. Other agents commonly prescribed include anti-depressants classified based on their chemical structure and action at receptors on the nerves. Tri-cyclic antidepressants (TCAs) include amitriptyline and nortriptyline. Selective serotonin norepinephrine reuptake inhibitors (SSNRIs) include duloxetine and venlafaxine. These anti-depressants are commonly prescribed to aid patients with neuropathic pain. Topical agents such as lidocaine and capsaicin in the form of creams, lotions and patches are another option for patients with neuropathic pain. Often times a combination of these agents is needed for optimal relief of neuropathic pain.
Optum’s team of clinical pharmacists are well-versed in the use of these medications and use their knowledge and clinical guidelines to provide case-specific recommendations for potential cost mitigation while providing the same level or potentially increased therapeutic outcomes. Our goal is optimal treatment for the patient while exploring the most cost effective options. If Lyrica is part of your WCMSA, consider Optum’s clinical mitigation products for a case-specific evaluation and action plan.