Decision #61/20 - Type: Workers Compensation
The worker is appealing the decision made by the Workers Compensation Board ("WCB") that responsibility should not be accepted for the medication Nabilone. A file review was held on April 9, 2020 to consider the worker's appeal.
Whether or not responsibility should be accepted for the medication Nabilone.
Responsibility should not be accepted for the medication Nabilone.
On March 15, 2018, the worker filed a Worker Incident Report with the WCB claiming a psychological injury that occurred on March 2, 2018. She reported attending approximately five incidents over the previous 6-9 months that had affected her “…emotionally, causing sleep deprivation, occasional elevated heart rate and anxiety.”
The worker’s family physician provided a report dated March 3, 2018 in support of the worker’s claim noting that a review of her health history indicated the worker had symptoms since July 27, 2017 and the symptoms had been ongoing. The treating physician diagnosed the worker with post-traumatic stress disorder (PTSD) and anxiety.
The WCB discussed the claim with the worker on March 20, 2018. The worker detailed incidents that occurred in 2017 and noted that in January 2018 she noted an increase in physical symptoms such as chest pains and headaches, but no specific event caused the increase. The worker saw a psychologist on April 20, 2018 who concluded the worker met all of the criteria for a diagnosis of PTSD and was not able to return to work without further treatment.
The WCB gathered further information from the worker and the employer. A WCB psychological advisor reviewed the worker’s file on June 14, 2018 and accepted the report of the worker’s treating psychologist that the diagnosis of PTSD was related to the workplace incident of March 2, 2018. The WCB accepted the worker’s claim on June 26, 2018.
The worker continued to receive medical treatment from her family physician and psychologist. Due to an increase in PTSD symptoms that required the worker to attend at an emergency department, her family physician requested an urgent referral to a psychiatrist on August 7, 2018. The worker attended for her first assessment with the psychiatrist on August 13, 2018, and on the same date, the WCB received a medication request from a pharmacy for Nabilone, in addition to other medications prescribed by the psychiatrist. On August 28, 2018, the WCB requested information from the worker’s treating psychiatrist on the medications prescribed.
On September 7, 2018, the WCB advised the worker that some medications prescribed by her family physician and psychologist were not accepted for coverage and her request for coverage of Nabilone would be reviewed by a WCB medical advisor.
A WCB pain management consultant reviewed the worker’s file on September 13, 2018 and stated that Nabilone was approved for the treatment of nausea and vomiting secondary to chemotherapy and as such, the use of Nabilone for the worker’s condition would be considered “off label”. Further, applying a risk/benefit analysis, the WCB pain management consultant determined the potential risk of use of Nabilone by the worker exceeded the potential benefit and coverage should not be accepted.
The worker’s treating psychiatrist provided a letter dated October 11, 2018 in support of the worker’s use of Nabilone in treating her sleep issues.
On October 22, 2018, the WCB advised the worker that coverage for Nabilone would not be accepted.
On November 30, 2018, the worker requested reconsideration of the WCB’s decision to Review Office. In her submission, the worker noted her treating healthcare providers recommended the use of the medication to help reduce her PTSD symptoms. The worker also provided a copy of her treating psychiatrist’s October 10, 2018 letter in support of her request.
Review Office determined on January 15, 2019 that coverage for the medication Nabilone was not authorized. Review Office accepted and relied on the September 13, 2018 opinion of the WCB pain management consultant that the use of Nabilone in the worker’s case was considered “off label” and the risk/benefit analysis was not favourable. Further, Review Office found that the evidence showed the worker continued to use Nabilone with no clear indication that its use had benefitted the worker or improved her symptoms.
The worker’s representative filed an appeal with the Appeal Commission on December 13, 2019. A file review was arranged.
Applicable Legislation and Policy
The Appeal Commission and its panels are bound by The Workers Compensation Act (the "Act"), regulations under the Act and the policies established by the WCB's Board of Directors.
Section 27(1) of the Act authorizes the WCB to make payments for expenses where it determines that the medical aid is necessary to cure and provide relief from an injury resulting from an accident. Medical aid provided by the WCB is subject to the supervision and control of the WCB pursuant to s 27(10).
WCB Policy 44.120.10, Medical Aid, (the "Policy") sets out a comprehensive and coordinated approach to delivery of medical aid services to injured workers. The Policy states that medical aid is provided to minimize the impact of the worker's injury and to enhance an injured worker's recovery to the greatest extent possible. The WCB pays for prescription medications under this policy. The Policy requires the WCB to consider, in determining appropriateness and necessity of medical aid, recommendations from recognized healthcare providers, current scientific evidence about the effectiveness and safety of prescribed products and standards developed by the WCB Healthcare Department. The WCB will, under the Policy, refuse or limit funding of any medical aid it considers excessive, ineffective, inappropriate or harmful.
The worker was represented on her appeal by a worker advisor who submitted documents for consideration by the panel in advance of the file review.
The worker’s position was outlined in materials submitted in support of her request to the Review Office for reconsideration. In an undated letter from the worker, received by the WCB on December 14, 2018 with the Request for Reconsideration, the worker stated as follows:
“Nabilone was prescribed to me after I was diagnosed with PTSD as I was having severe nightmares. The nightmares were all related to my work…. Some of the nightmares included things such as death, dying, murder and suicide. I would wake up in a panic with severe chest pain and increased heart rates. The Nabilone has almost completely eliminated the nightmares that I was having. That has brought my heart rate down and I have now been able to go off [another medication] as the Nabilone has reduced the nightmares….
I ask you to re consider the medications as they are making a significant difference in my life.”
The worker also relied, in her request for reconsideration, on a letter from her treating psychiatrist dated October 10, 2018. The psychiatrist outlined that daily use of Nabilone over the previous several weeks was helping the worker with PTSD-related sleep disturbance, especially nightmares. The psychiatrist noted, referring to Nabilone and another medication the worker was trialing, “Although their use is off-label, both [other medication] and Nabilone have RCT [random control trial] studies that support their use in the treatment of PTSD-related sleep disturbance.” The psychiatrist went on to state that the worker “…has had only mild improvement in her PTSD symptoms. Specifically, her sleep has improved with the addition of Nabilone…”
In sum, the worker’s position is that use of Nabilone improved her sleep by reducing her PTSD-related nightmares. The WCB should therefore accept responsibility for Nabilone because it provides a benefit to the worker in terms of reduction of her PTSD symptoms and because her treating psychiatrist prescribed it.
The employer did not participate in the appeal.
The issue for determination is whether or not the WCB should accept responsibility for the medication Nabilone. In order to find that the WCB should accept responsibility for Nabilone, the panel would have to determine that the worker requires the medication in order to cure and provide relief from the compensable injury. The panel was not able to make such a finding for the reasons that follow.
The panel carefully reviewed the medical opinions and reports on file with respect to the worker’s prescription of Nabilone, noting the following in particular:
• In a letter dated August 13, 2018, the treating psychiatrist explained that he recommended to the worker taking Nabilone to help with her nightmares, as it could help with PTSD-related sleep disturbances.
• In chart notes dated August 27, 2018, the treating psychiatrist stated the worker reported she “…has not improved much in the past two weeks, if at all…She initiated the trial of Nabilone and said that she took 1 mg, then 2 mg, and has now taken 3 mg per night for the past three nights. She thinks that the content of her nightmares is less gruesome, but she had found Nabilone to be sedating during the daytime and she finds it harder to tell if she is awake at night or still dreaming.” The treating psychiatrist recommended the worker continue with the Nabilone as prescribed.
• In a report to the worker’s treating physician dated September 4, 2018, the treating psychiatrist noted the worker continued to report some improvement in her sleep, in that she was sleeping longer and her nightmares were less gruesome. He stated that this is “…probably related to Nabilone….”
• In a report to the worker’s treating physician dated September 10, 2018, the treating psychiatrist again noted that the combination of Nabilone and another medication “seems to be helpful” in regard to the worker’s sleep.
• The WCB pain management consultant stated in a file memo dated September 13, 2018 that Nabilone is approved by Health Canada for use in treatment of nausea and vomiting secondary to chemotherapy and that the use proposed here, to reduce the worker’s sleep disturbance, would be considered to be off-label usage. The WCB pain management consultant stated that:
“Review of the medical literature does not reveal the presence of such quality evidence arising out of robustly designed studies wherein the test subjects would form a cohort of the claimant and yield results that would give rise to high grade recommendations for the use of Nabilone in this case. Therefore the use of Nabilone in this case would not be evidence informed and as such the risk/benefit ratio for the use of Nabilone in this case is considered to be not favourable.”
• In a report to the worker’s treating physician dated September 25, 2018, the treating psychiatrist noted the worker reported she was sleeping through the night, but was still having some nightmares, though less gruesome and vivid and more difficult to recall. The worker attributed the improved sleep to “...increasing the dose of Nabilone to 4 mg a few weeks ago.” The treating psychiatrist recommended the worker continue Nabilone at that dosage.
• In a chart note dated October 9, 2018, the treating psychiatrist noted the worker reported “…her sleep over the last several nights has been worse, and she has started to have nightmares again and wake up earlier. Poor memory is an ongoing issue.” The psychiatrist noted in the treatment plan “I decided to increase her dose of Nabilone to 5 mg…to see if that would provide additional benefit, despite the fact that it may also cause more sedation and memory issues.”
• The worker’s treating psychiatrist explained in his letter dated October 10, 2018 that the use of Nabilone was supported by randomized control studies (not specified) for PTSD-related sleep disturbance, but acknowledged that this was “off-label” usage. The psychiatrist further noted that after a few weeks of daily use, the worker had benefited in terms of improved sleep.
• Chart notes from the worker’s visit to the local hospital emergency department on November 8, 2018 indicated that the worker reported PTSD symptoms were worse lately and interfering with her sleep.
• The worker’s treating psychiatrist wrote to the WCB on November 21, 2018 in support of the worker’s request for coverage of Nabilone. He referenced numerous studies that indicate the benefit of Nabilone for treatment of PTSD nightmares without significant adverse outcomes, although “…admittedly off-label for treating PTSD symptoms (as per Health Canada)….[N]abilone is an evidence-based, expert-recommended medication that is used when other options have not been successful. Clinically, [the worker] has found [N]abilone to be the most effective medication for her PTSD symptoms thus far.”
• On November 21, 2018, the treating psychiatrist wrote to another psychiatrist seeking consultation and indicated in that letter that “Nabilone has been effective but only at higher than usual doses….”
• The consulting psychiatrist reported in a letter to the treating psychiatrist dated December 19, 2018 that at the time of her assessment appointment, the worker reported recurring nightmares and identified “anxiety, nightmares, and avoidance as her most troubling and interfering symptoms.” The consulting psychiatrist recommended another trial of a different medication to suppress the worker’s nightmares, as well as recommending psychotherapeutic intervention to address her persistent nightmares.
• A WCB psychiatric consultant assessed the worker on May 7, 2019 and reviewed her claim file. In terms of medications, the WCB psychiatric consultant stated that use of Nabilone did “…not represent best evidence based practice in regards to treatment of the workplace-related injury” and concluded “…this review is not able to support ongoing use of the aforementioned medications.”
• In a letter to the WCB received July 24, 2019, the consulting psychiatrist noted that he wasn’t certain that the worker’s intrusion symptoms, including nightmares, had improved much in the past year. He went on to note “[a]ddition of the medication Nabilone completely suppressed nightmares, but likely contributed to the problems with sedation, cognition, and balance. Since discontinuing, nightmares have been more problematic again.”
The Policy outlines the WCB’s objectives in terms of medical aid as including promotion of a safe and early recovery and elimination or minimization of the impacts of a worker’s injuries. The WCB will refuse or limit funding of medical aid that it considers excessive, ineffective, inappropriate or harmful. To determine whether treatment is appropriate and necessary, the WCB considers recommendations from recognized healthcare providers, current scientific evidence about the effectiveness and safety of the prescribed product and WCB Healthcare standards.
The worker’s submission sets out that the Nabilone “almost completely eliminated the nightmares” she was having. This is reflected by much of the reporting of the treating professionals, although the panel notes that as early as October 2018 the file also contains reports to the contrary.
The panel noted that the worker does not reference any side effects from the use of Nabilone; however, side effects of memory issues and sedation are noted in the medical reports beginning in late August, a few weeks after she began taking the medication. As well, the consulting psychiatrist in his July 24, 2019 report also noted the worker was experiencing side effects from the use of Nabilone including issues with cognition, balance and sedation.
The panel accepts that the use of Nabilone as a treatment for nightmares arising from PTSD is off-label, consistent with the information provided by both the WCB pain management consultant and the worker’s treating psychiatrist. Nonetheless, here the worker’s treating psychiatrist repeatedly recommends the use of Nabilone by the worker.
The consulting psychiatrist also noted that Nabilone is an evidence-based treatment for PTSD nightmares, although he recommended treatment of the worker’s nightmares by psychotherapeutic intervention and proposes another medication be trialed to address the nightmares.
The WCB pain management consultant’s opinion of September 13, 2018 sets out that there is not quality research evidence to support “high grade recommendations” for the use of Nabilone as prescribed to the worker. Therefore, the WCB pain management consultant concluded the “…use of Nabilone in this case would not be evidence informed and as such the risk/benefit ratio for the use of Nabilone in this case is considered to be not favourable.”
The reported benefits to the worker from taking Nabilone are some reduction in her recollection of nightmares and reduction in the gruesomeness and vividness of those nightmares. The panel notes, from the medical reporting, that these benefits appear to fluctuate and are not consistently reported. Furthermore, there are also side effects reported and noted in the medical reports as early as late August 2018.
The panel noted as well that by the time the worker saw the consulting psychiatrist in July 2019, the worker was no longer prescribed Nabilone.
The panel acknowledges the recommendations and opinions of the worker’s treating professionals that off-label use of Nabilone to treat the worker’s sleep disturbances is appropriate and may be supported by some research; however, we prefer the opinion of the WCB pain management consultant in this regard and find that opinion to be aligned with the provisions of the Medical Aid Policy as outlined above.
The panel accepts the opinion of the WCB pain management consultant that usage of Nabilone in this case is not informed by “…quality evidence arising out of robustly designed studies wherein the test subjects would form a cohort of the claimant and yield[ing] results that would give rise to high grade recommendations for the use of Nabilone…” Furthermore, the evidence does not support that the benefits of off-label use of Nabilone to manage the worker’s PTSD-related sleep disturbances outweigh the potential risks associated.
The panel therefore finds on a balance of probabilities that responsibility should not be accepted for the medication Nabilone.
The appeal is dismissed.
K. Dyck, Presiding Officer
P. Challoner, Commissioner
M. Kernaghan, Commissioner
Recording Secretary, J. Lee
K. Dyck - Presiding Officer
(on behalf of the panel)
Signed at Winnipeg this 3rd day of June, 2020