Clinical Policy Title: Diabetic neuropathy selected treatments

Transcription

1 Clinical Policy Title: Diabetic neuropathy selected treatments Clinical Policy Number: CCP.1324 Effective Date: August 1, 2017 Initial Review Date: July 20, 2017 Most Recent Review Date: July 3, 2018 Next Review Date: July 2019 Policy contains: Diabetic neuropathy. Related policies: CCP.1129 CCP.1016 CCP.1200 CCP.1065 Outpatient diabetes self-management training Continuous Interstitial glucose monitoring Debridement of diabetic foot ulcers Insulin infusion therapy (insulin pumps) ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina s clinical policies are not guarantees of payment. Coverage policy Select Health of South Carolina considers the oral or topical treatment of diabetic neuropathy to be clinically proven and, therefore, medically necessary when the following condition(s) have been met (Qaseem, 2017; van Nooten, 2017; Wiffen, 2017; American Academy of Family Physicians, 2016; Çakici, 2016; Bril, 2011; Wolff, 2010): Baseline glycemic control by suitable pharmacologic agents and behavioral modifications has been maximized. See Appendix A for prior authorization criteria for pregabalin capsule and extended-release tablets pregabalin and the lidocaine 5% patch. Limitations: 1

2 Select Health of South Carolina considers the following treatments for diabetic neuropathy to be investigational and therefore not medically necessary, including, but not limited to (Chan, 2017; Dimitrova, 2017; Panthi, 2017; Robinson, 2017; Tu, 2017; Yorek, 2017; Zhou, 2017; Çakici, 2016): Acupuncture. Articular and peri-articular injection of lidocaine and/or corticosteroids. Holistic remedies (e.g., fish oil, micronutrients, foot massage, photon stimulation therapy). Immunotherapy. Monochromatic infrared phototherapy. Oxcarbazepine. Surgical decompression of the peripheral nerves. Yang-warming Chinese medicines. Alternative covered services: Routine patient evaluation and management by a network healthcare provider. Background Peripheral neuropathy (pain, numbness, paresthesia) affects about 50 percent of persons with diabetes (Çakici, 2016). The manifestations range from sensory dysthesias to frank ulceration of the skin of the extremities. The disorder is the major cause of non-traumatic amputations among patients with diabetes. Currently there is no proven cure for diabetic neuropathy. With the prevalence of obesity and type 2 diabetes with its associated complications reaching epidemic levels, there is a critical need for finding effective and safe treatments to preserve nerve function in the diabetic population. Searches Select Health of South Carolina searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services. We conducted searches on May 10, Search terms were: Diabetic Neuropathies/diet therapy (MeSH), Diabetic Neuropathies/drug therapy (MeSH), Diabetic Neuropathies/therapy (MeSH), and free text terms diabetes mellitus, diabetic neuropathy, and peripheral diabetic neuropathy. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes 2

3 and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings An essential component of treatment for diabetic neuropathy is improved baseline glycemic control irrespective of the dietary modification or pharmaceutical agent prescribed (sulfonylureas, metformin, or insulin). These first-line therapies are considered essential fundaments of care for the disease as adequate control of blood sugar decreases the incidence of microvascular complications from retinopathy, neuropathy, or nephropathy. Evidence-based guidelines from multiple professional associations address the oral pharmaceutical treatment of painful diabetic neuropathy (Qaseem, 2017; Bril, 2011). The American College of Physicians guidelines make recommendations for the overall and specific care of persons with diabetes mellitus type 2 (Qaseem, 2017). These recommendations are also endorsed by the American Academy of Family Physicians (2016). Bothersome diabetic neuropathy also may respond to topical treatment (van Nooten, 2017; Baron, 2016). Notably, only a small fraction of drug administered topically reaches the systemic circulation, thereby reducing the risk of adverse systemic effects, drug-drug interactions, and overdose. There are limited data supporting acupuncture, articular and peri-articular injection, surgical decompression of the peripheral nerves, and holistic remedies as treatment of diabetic neuropathy (Dimitrova, 2017; Tu, 2017; Yorek, 2017; Çakici, 2016). Policy updates: In 2018, we added five systematic reviews of various treatments for diabetic neuropathy: immunotherapy (Chan, 2017); yang-warming Chinese medicines (Panthi, 2017); monochromatic infrared phototherapy (Robinson, 2017); gabapentin (Wiffen, 2017); oxcarbazepine (Zhou, 2017); and 5% lidocaine medicated plaster (Wolff, 2010). We added updated Perform Rx prior authorization criteria for pregabalin and the lidocaine 5% patch in Appendix A. The new findings are consistent with the current policy. The other treatment options are not medically necessary and were added to the list in the Limitations section. Summary of clinical evidence: 3

4 Citation Chan (2017) Cochrane review Immunotherapy for diabetic amyotrophy Dimitrova (2017) Acupuncture for the treatment of peripheral neuropathy: a systematic review and metaanalysis Panthi (2017) Yang-warming method in the treatment of diabetic peripheral neuropathy Qaseem (2017) Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians (ACP) Robinson (2017) Content, Methods, Recommendations Systematic review included only one randomized controlled trial (RCT) of 75 patients published through September 2016 using intravenous methylprednisolone in diabetic amyotrophy, but full results were not available for analysis and risk of bias was unclear. Insufficient evidence. A systematic review of 13 original RCTs, a long-term follow-up, and a re-analysis of a prior RCT that assessed acupuncture for neuropathy of various etiologies, including diabetes. Acupuncture regimens, control conditions, and outcome measures differed among studies, and various methodological issues were identified. Insufficient evidence. Meta-analysis of 25 RCTs published through April Overall quality: low. Compared to western medicine alone, yang-warming Chinese medicine procedures used alone or in combination with western medicine improved the nerve conduction velocity (p<0.001) and clinical symptoms (p<0.001). Adverse events were not clearly reported. Insufficient evidence. The comparative effectiveness of oral medications for type 2 diabetes was studied for metformin, thiazolidinediones, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors. Evaluated outcomes included intermediate outcomes of hemoglobin A1c, weight, systolic blood pressure, and heart rate; all-cause mortality; cardiovascular and cerebrovascular morbidity and mortality; retinopathy, nephropathy, and neuropathy; and adverse events. The ACP and the American Academy of Family Physicians recommend: - Metformin to patients with type 2 diabetes when pharmacologic therapy is needed to improve glycemic control (strong recommendation; moderate-quality evidence). - A sulfonylurea, a thiazolidinedione, an SGLT-2 inhibitor, or a DPP-4 inhibitor added to metformin to improve glycemic control when a second oral therapy is considered (weak recommendation; moderatequality evidence). Effects of monochromatic infrared phototherapy in patients with diabetic peripheral neuropathy Systematic review and meta-analysis of six RCTs (304 patients, 594 total feet). Overall quality: low. Limited evidence suggests significant short-term (up to two weeks) improvement 4

5 Citation Tu (2017) Surgical decompression in the treatment of diabetic peripheral neuropathy: a systematic review and meta-analysis van Nooten (2017) Capsaicin 8% patch versus oral neuropathic pain medications for the treatment of painful diabetic peripheral neuropathy: a systematic literature review and network meta-analysis Wiffen (2017) Content, Methods, Recommendations in plantar sensitivity (standard mean difference [SMD] =0.41, 95% CI 0.18 to 0.64) that was not sustained over time (SMD=0.22, 95%CI to 0.51), and no significant effect on neuropathic pain (mean difference=0.49, 95% CI 0.30 to 0.68). Insufficient evidence. A systematic review (1,825 total patients) of surgical decompression procedures used in the treatment of diabetic peripheral neuropathy. Symptom severity and functional status of upper extremities, and distal motor latency and sensory conduction velocity of median nerve of patients were significantly improved after carpal tunnel release. Few high-quality RCTs or well-designed prospective studies exist; more data are needed to elucidate the role of surgical treatment of peripheral diabetic neuropathy. A systematic review of the efficacy and tolerability of a capsaicin 8% patch compared with oral, centrally acting agents (i.e., pregabalin, gabapentin, duloxetine, amitriptyline) in patients with painful diabetic peripheral neuropathy. For 30% pain reduction, the capsaicin 8% patch was significantly more effective than placebo (OR 2.28, 95% confidence interval [CI] 1.19 to 4.03]), exhibited a numerical advantage compared with pregabalin (OR 1.83, 95% CI 0.91 to 3.34) and gabapentin (OR 1.66, 95% CI 0.74 to 3.23), and similar to duloxetine (OR 0.99, 95% CI 0.5 to 1.79). Insufficient evidence to assess the relative efficacy of amitriptyline. Oral, centrally acting agents had a significantly elevated risk compared with placebo for somnolence (pregabalin, gabapentin, duloxetine, and amitriptyline), dizziness (pregabalin, gabapentin, duloxetine, and amitriptyline), nausea (duloxetine), diarrhea (duloxetine), fatigue (duloxetine), and discontinuation because of adverse events (pregabalin, gabapentin, and duloxetine). Compared with pregabalin and gabapentin, duloxetine had a significantly lower risk of dizziness but a significantly higher risk of nausea. Cochrane review Gabapentin for chronic neuropathic pain in adults (only data for painful diabetic neuropathy are presented) Systematic review and meta-analysis of 37 double-blind RCTs (5,914 total participants) of at least two weeks' duration, comparing gabapentin (any route of administration) with placebo or another active treatment. Overall quality: moderate to high. Risk of bias mainly due to small size (especially in cross-over studies) and handling of data after study withdrawal. Primary outcomes were participants with: substantial pain relief ( 50% pain relief over baseline or very much improved on Patient Global Impression of Change scale [PGIC]); moderate pain relief ( 30% pain relief over baseline or much or very much improved on PGIC); and adverse events. Compared to placebo, gabapentin 1200 mg daily was associated with significantly greater pain relief but more adverse events: 5

6 Citation Yorek (2017) Is fish oil a potential treatment for diabetic peripheral neuropathy? Zhou (2017) Cochrane review Oxcarbazepine for neuropathic pain Baron (2016) The 5% lidocaine-medicated plaster: its inclusion in international treatment guidelines for treating localized neuropathic pain, and clinical evidence supporting its use Çakici (2016) Systematic review of treatments for diabetic peripheral neuropathy Bril (2011) Content, Methods, Recommendations Notably, more than half treated with gabapentin will not have worthwhile pain relief but may experience adverse events. A narrative review offered perspectives on the effect of fish oil on diabetes complications including neuropathy. Pre-clinical studies suggest a potential role for fish oil in slowing progression and reversing diabetic neuropathy. Its anti-inflammatory, antithrombotic, neuroprotective, and neurostimulative properties may have beneficial effects in diabetic neuropathy, but further research is needed. Systematic review included three multicenter, double-blind RCTs (634 total patients) reporting a treatment duration of at least six weeks, regardless of administration route and dose. Two trials found little or no benefit but provided incomplete data for meta-analysis. Overall quality: low with significant risk for publication bias, selective reporting of outcome data, and potential unblinded designs. Outcomes were the proportion of participants who reported 50% or 30% reduction of pain scores after 16 weeks of treatment, and adverse effects. Compared to placebo, oxcarbazepine was associated with significantly improved pain relief but more serious adverse effects: Insufficient evidence. A narrative review noted that 5% lidocaine-medicated plaster has been used for several years to treat painful diabetic neuropathy particularly in frail and/or elderly patients and those receiving multiple medications. Apparent benefits that emerge from clinical studies on the use of this agent are: - Excellent tolerability and safety of the plaster. - Increased patient compliance with treatment. - Sustainable efficacy over long-term administration. - Significant reduction in size of the painful area. A systematic review of 27 trials on pharmacological, non-pharmacological, and alternative treatments for neuropathic pain and sensory symptoms resulting from diabetic peripheral neuropathy of the feet. In the meta-analysis of trials of α-lipoic acid versus placebo, total symptom score was reduced by (95% CI -4.52; ) with 600 mg i.v. α-lipoic acid (three trials), and was reduced by (95% CI -2.89; -1.01) with 600 mg oral α-lipoic acid (two trials). Significant improvements in diabetic peripheral neuropathy symptoms were found with opioids, botulinum toxin A, mexidol, reflexology and Thai foot massage, but not with micronutrients, neurotrophic peptide, and photon stimulation therapy. 6

7 Citation Evidence-based guideline: treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation Wolff (2010) 5% lidocaine medicated plaster in painful diabetic peripheral neuropathy Content, Methods, Recommendations Pregabalin is established as effective and should be offered for relief of painful diabetic neuropathy (Level A, strong recommendation). Venlafaxine, duloxetine, amitriptyline, gabapentin, valproate, opioids (morphine sulfate, tramadol, and oxycodone controlled-release), and capsaicin are probably effective and should be considered for treatment of diabetic peripheral neuropathy (Level B, favorable recommendation). Other treatments have less robust evidence or the evidence is negative. Effective treatments for painful diabetic neuropathy are available, but many have side effects that limit their usefulness, and few studies have sufficient information on treatment effects on function and quality of life. Systematic review and meta-analysis of 23 RCTs (38 publications) comparing 5% lidocaine to another treatment or placebo; six trials reported the change in pain from baseline and were included in the limited network meta-analysis as direct comparative studies were not available. Findings suggested that 5% lidocaine medicated plasters provided comparable pain reduction to amitriptyline, capsaicin, pregabalin and gabapentin in patients with painful diabetic peripheral neuropathy and may be associated with fewer adverse events. 5% lidocaine medicated plaster could be considered a first-line treatment for diabetic peripheral neuropathy, but the low number and size of included trials limits firm conclusions. References Professional society guidelines/other: Bril V, England J, Franklin GM, et al; American Academy of Neurology; American Association of Neuromuscular and Electrodiagnostic Medicine; American Academy of Physical Medicine and Rehabilitation. Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2011; 76(20): DOI: /WNL.0b013e ebe. Clinical Practice Guidelines. Diabetes. Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus. (Endorsed, December 2016). American Academy of Family Physicians website. Accessed May 10, Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus: A Clinical Practice Guideline Update From the American College of Physicians. Ann Intern Med. 2017; 166(4): DOI: 7

8 /m Peer-reviewed references: Baron R, Allegri M, Correa-Illanes G, et al. The 5% Lidocaine-Medicated Plaster: Its Inclusion in International Treatment Guidelines for Treating Localized Neuropathic Pain, and Clinical Evidence Supporting its Use. Pain Ther. 2016; 5(2): DOI: /s Çakici N, Fakkel TM, van Neck JW, Verhagen AP, Coert JH. Systematic review of treatments for diabetic peripheral neuropathy. Diabet Med. 2016; 33(11): DOI: /dme Chan YC, Lo YL, Chan ES. Immunotherapy for diabetic amyotrophy. Cochrane Database Syst Rev. 2017; 7: Cd DOI: / CD pub4. Dimitrova A, Murchison C, Oken B. Acupuncture for the Treatment of Peripheral Neuropathy: A Systematic Review and Meta-Analysis. J Altern Complement Med. 2017; 23(3): DOI: /acm Henriksen M, Christensen R, Klokker L, et al. Evaluation of the benefit of corticosteroid injection before exercise therapy in patients with osteoarthritis of the knee: a randomized clinical trial. JAMA Intern Med. 2015; 175(6): DOI: /jamainternmed Panthi S, Jing X, Gao C, Gao T. Yang-warming method in the treatment of diabetic peripheral neuropathy: an updated systematic review and meta-analysis. BMC Complement Altern Med. 2017; 17(1): 424. DOI: /s Robinson CC, Klahr PDS, Stein C, et al. Effects of monochromatic infrared phototherapy in patients with diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials. Braz J Phys Ther. 2017; 21(4): DOI: /j.bjpt Tu Y, Lineaweaver WC, Chen Z, Hu J, Mullins F, Zhang F. Surgical Decompression in the Treatment of Diabetic Peripheral Neuropathy: A Systematic Review and Meta-analysis. J Reconstr Microsurg. 2017; 33(3): DOI: /s van Nooten F, Treur M, Pantiri K, Stoker M, Charokopou M. Capsaicin 8% Patch Versus Oral Neuropathic Pain Medications for the Treatment of Painful Diabetic Peripheral Neuropathy: A Systematic Literature Review and Network Meta-analysis. Clin Ther. 2017; 39(4): e18. DOI: /j.clinthera Wiffen PJ, Derry S, Bell RF, et al. Gabapentin for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017; 6: Cd DOI: / CD pub4. 8

9 Wolff RF, Bala MM, Westwood M, Kessels AG, Kleijnen J. 5% lidocaine medicated plaster in painful diabetic peripheral neuropathy (DPN): a systematic review. Swiss Med Wkly. 2010; 140(21-22): DOI: smw Yorek MA. Is Fish Oil a Potential Treatment for Diabetic Peripheral Neuropathy? Curr Diabetes Rev DOI: / Zhou M, Chen N, He L, et al. Oxcarbazepine for neuropathic pain. Cochrane Database Syst Rev. 2017; 12: Cd DOI: / CD pub3. CMS National Coverage Determinations (NCDs): Diagnosis and Treatment of Diabetic Sensory Neuropathy with Loss of Protective Sensation (aka Diabetic Peripheral Neuropathy). Accessed May 11, Local Coverage Determinations (LCDs): L37642 Nerve Blocks and Electrostimulation for Peripheral Neuropathy. Accessed May 11, L35456 Nerve Blockade for Treatment of Chronic Pain and Neuropathy. Accessed May 11, L35457 Nerve Blockade for Treatment of Chronic Pain and Neuropathy. Accessed May 11, L35249 Nerve Blocks for Peripheral Neuropathy. Accessed May 11, Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments N/A Not Applicable ICD-10 Code Description Comments E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified E08.41 Diabetes mellitus due to underlying condition with diabetic mononeuropathy E08.42 Diabetes mellitus due to underlying condition with diabetic polyneuropathy E09.40 Drug or chemical induced diabetes mellitus with neurological complications with diabetic neuropathy unspecified E09.42 Drug or chemical induced diabetes mellitus with neurological complications with 9

10 ICD-10 Code Description Comments diabetic polyneuropathy E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified E10.41 Type 1 diabetes mellitus with diabetic mononeuropathy E10.42 Type 1 diabetes mellitus with diabetic polyneuropathy E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified E11.41 Type 2 diabetes mellitus with diabetic mononeuropathy E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified E13.41 Other specified diabetes mellitus with diabetic mononeuropathy E13.42 Other specified diabetes mellitus with diabetic polyneuropathy HCPCS Level II Code J3490 Description Lyrica(Pregabalin) Comments Appendix A. Prior Authorization Group Description Drugs Covered Uses Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions KF/AHC/AHN/CHC, AHDC, and SHSC - Lyrica & Lyrica CR Lyrica (pregabalin) capsule & Lyrica CR (pregabalin) extended-release tablets Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. N/A See other criteria N/A N/A Coverage Duration If the criteria are met, the request will be approved with up to a 12 month duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review. Other Criteria Initial Authorization: Partial-Onset Seizures for Lyrica : Documented diagnosis of partial-onset seizures. Patient currently receiving another anticonvulsant medication at a therapeutic dosage. Documented trial and failure or intolerance to gabapentin. Postherpetic Neuralgia for Lyrica and Lyrica CR: 10

11 Prior Authorization Group Description KF/AHC/AHN/CHC, AHDC, and SHSC - Lyrica & Lyrica CR Documented diagnosis of postherpetic neuralgia. Documented trial and failure of two formulary alternatives (gabapentin, amitriptyline, nortriptyline, desipramine). Neuropathic Pain Associated with Diabetic Peripheral Neuropathy for Lyrica and Lyrica CR: Documented diagnosis of peripheral neuropathy. Neuropathic Pain Associated with Spinal Cord Injury for Lyrica : Documented diagnosis of neuropathic pain associated with spinal cord injury. Trial and failure of one formulary alternative ( i.e. gabapentin, amitriptyline). Fibromyalgia for Lyrica : Documented diagnosis of fibromyalgia. Trial and failure of two formulary alternatives (i.e. gabapentin, duloxetine, amitriptyline, Savella ). Trigeminal Neuralgia Pain for Lyrica : Documented diagnosis of trigeminal neuralgia. Documented trial and failure or intolerance to at least three of the following: baclofen, carbamazepine, gabapentin, lamotrigine, oxcarbazepine, phenytoin. Revision/Review Date 4/2018 Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary. PerformRx recommends approving the Lyrica prior authorization criteria with the addition of the newly approved Lyrica CR and placement of this product with its FDA approved indication of use for KF/AHC/AHN/CHC, AHDC, and SHSC. Prior Authorization Group Description Drugs Covered Uses BCC - Lidocaine (Lidoderm ) Lidocaine (Lidoderm ) 5% patch Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. 11

12 Prior Authorization Group Description Exclusion Criteria Required Medical Information Age Restrictions Prescriber Restrictions Coverage Duration Other Criteria BCC - Lidocaine (Lidoderm ) Pain that is not neuropathic in nature Diagnosis of post-herpetic neuralgia or other neuropathic pain. N/A N/A If the criteria are met, the request may be approved for up to 6 months. A maximum quantity of 1 patch per day may be approved unless affected surface area justifies an additional patch (may be cut to cover areas of most severe pain). Trial and failure of at least 2 of the following: gabapentin, a tricyclic antidepressant, nerve block, trigger point injection, a SNRI (duloxetine, desvenlafaxine, levomilnacipran, milnacipran, venlafaxine), TENS unit, lidocaine 4% cream, or an NSAID for a duration of adequate length to see a response. AND Trial and failure of Aspercreme 4% patch. OR Documentation has been submitted justifying why these therapies are not appropriate for treating the patient. Revision/Review Date 4/2018 If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review. PerformRx recommends approving this newly developed criteria for BCC. Source: Select Health of South Carolina Enterprise* Pharmacy & Therapeutics Committee Meeting Minutes. April 30th, Accessed May 14,