diabetic neuropathy—selected treatments...diabetes. currently there is no proven cure for diabetic...
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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
Related policies:
CCP.1129 Outpatient diabetes self-management training
CCP.1016 Continuous Interstitial glucose monitoring
CCP.1200 Debridement of diabetic foot ulcers
CCP.1065 Insulin infusion therapy (insulin pumps)
ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ 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 peer-reviewed 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 AmeriHealth Caritas 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. AmeriHealth Caritas’ 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. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.
Coverage policy
AmeriHealth Caritas 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:
Policy contains:
Diabetic neuropathy.
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AmeriHealth Caritas 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
AmeriHealth Caritas 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, 2018. 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:
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Systematic reviews, which pool results from multiple studies to achieve larger sample sizes
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.
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Summary of clinical evidence:
Citation Content, Methods, Recommendations
Chan (2017)
Cochrane review
Immunotherapy for diabetic
amyotrophy
Key points:
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.
Dimitrova (2017)
Acupuncture for the treatment of
peripheral neuropathy: a
systematic review and meta-
analysis
Key points:
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.
Panthi (2017)
Yang-warming method in the
treatment of diabetic peripheral
neuropathy
Key points:
Meta-analysis of 25 RCTs published through April 2016.
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.
Qaseem (2017)
Oral pharmacologic treatment of
type 2 diabetes mellitus: a clinical
practice guideline update from the
American College of Physicians
(ACP)
Key points:
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; moderate-
quality evidence).
Robinson (2017)
Effects of monochromatic infrared
Key points:
Systematic review and meta-analysis of six RCTs (304 patients, 594 total feet).
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Citation Content, Methods, Recommendations
phototherapy in patients with
diabetic peripheral neuropathy
Overall quality: low.
Limited evidence suggests significant short-term (up to two weeks) improvement
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 -0.07 to 0.51), and no
significant effect on neuropathic pain (mean difference=0.49, 95% CI 0.30 to
0.68).
Insufficient evidence.
Tu (2017)
Surgical decompression in the
treatment of diabetic peripheral
neuropathy: a systematic review
and meta-analysis
Key points:
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.
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
Key points:
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.
Wiffen (2017)
Cochrane review
Gabapentin for chronic
neuropathic pain in adults
(only data for painful diabetic
neuropathy are presented)
Key points:
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.
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Citation Content, Methods, Recommendations
Compared to placebo, gabapentin ≥1200 mg daily was associated with
significantly greater pain relief but more adverse events:
Notably, more than half treated with gabapentin will not have worthwhile pain
relief but may experience adverse events.
Yorek (2017)
Is fish oil a potential treatment for
diabetic peripheral neuropathy?
Key points:
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. Zhou (2017)
Cochrane review
Oxcarbazepine for neuropathic
pain
Key points:
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.
Baron (2016)
The 5% lidocaine-medicated
plaster: its inclusion in
international treatment guidelines
for treating localized neuropathic
pain, and clinical evidence
supporting its use
Key points:
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.
Çakici (2016)
Systematic review of treatments
for diabetic peripheral neuropathy
Key points:
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 -2.45 (95% CI -4.52; -
0.39) with 600 mg i.v. α-lipoic acid (three trials), and was reduced by -1.95 (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.
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Citation Content, Methods, Recommendations
Bril (2011)
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
Key points:
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.
Wolff (2010)
5% lidocaine medicated plaster in
painful diabetic peripheral
neuropathy
Key points:
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):
1758 - 1765. DOI: 10.1212/WNL.0b013e3182166ebe.
Clinical Practice Guidelines. Diabetes. Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus.
(Endorsed, December 2016). American Academy of Family Physicians website.
https://www.aafp.org/patient-care/clinical-recommendations/all/type2-diabetes.html. Accessed May
10, 2018.
Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College
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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): 279 - 290. DOI:
10.7326/m16-1860.
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): 149-169. DOI: 10.1007/s40122-016-0060-3.
Çakici N, Fakkel TM, van Neck JW, Verhagen AP, Coert JH. Systematic review of treatments for diabetic
peripheral neuropathy. Diabet Med. 2016; 33(11): 1466 - 1476. DOI: 10.1111/dme.13083.
Chan YC, Lo YL, Chan ES. Immunotherapy for diabetic amyotrophy. Cochrane Database Syst Rev. 2017; 7:
Cd006521. DOI: 10.1002/14651858.CD006521.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): 164 - 179. DOI:
10.1089/acm.2016.0155
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): 923 - 930. DOI: 10.1001/jamainternmed.2015.0461.
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: 10.1186/s12906-017-1927-5.
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): 233 - 243. DOI: 10.1016/j.bjpt.2017.05.008.
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): 151 - 157. DOI: 10.1055/s-0036-1594300.
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): 787 - 803.e18. DOI:
10.1016/j.clinthera.2017.02.010.
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Wiffen PJ, Derry S, Bell RF, et al. Gabapentin for chronic neuropathic pain in adults. Cochrane Database
Syst Rev. 2017; 6: Cd007938. DOI: 10.1002/14651858.CD007938.pub4.
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): 297 -
306. DOI: smw-12995.
Yorek MA. Is Fish Oil a Potential Treatment for Diabetic Peripheral Neuropathy? Curr Diabetes Rev. 2017.
DOI: 10.2174/1573399813666170522155327.
Zhou M, Chen N, He L, et al. Oxcarbazepine for neuropathic pain. Cochrane Database Syst Rev. 2017; 12:
Cd007963. DOI: 10.1002/14651858.CD007963.pub3.
CMS National Coverage Determinations (NCDs):
70.2.1 Diagnosis and Treatment of Diabetic Sensory Neuropathy with Loss of Protective Sensation (aka
Diabetic Peripheral Neuropathy). Accessed May 11, 2018.
Local Coverage Determinations (LCDs):
L37642 Nerve Blocks and Electrostimulation for Peripheral Neuropathy. Accessed May 11, 2018.
L35456 Nerve Blockade for Treatment of Chronic Pain and Neuropathy. Accessed May 11, 2018.
L35457 Nerve Blockade for Treatment of Chronic Pain and Neuropathy. Accessed May 11, 2018.
L35249 Nerve Blocks for Peripheral Neuropathy. Accessed May 11, 2018.
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
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ICD-10 Code Description Comments
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
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 Description Comments
J3490 Lyrica(Pregabalin)
Appendix A.
Prior Authorization
Group Description
KF/AHC/AHN/CHC, AHDC, and SHSC - Lyrica® & Lyrica® CR
Drugs Lyrica® (pregabalin) capsule & Lyrica® CR (pregabalin) extended-release tablets
Covered Uses 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.
Exclusion Criteria N/A
Required Medical
Information
See “other criteria”
Age Restrictions N/A
Prescriber Restrictions 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.
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Prior Authorization
Group Description
KF/AHC/AHN/CHC, AHDC, and SHSC - Lyrica® & Lyrica® CR
Revision/Review Date 4/2018
Documented trial and failure or intolerance to gabapentin. Postherpetic Neuralgia for Lyrica® and 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.
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
BCC - Lidocaine (Lidoderm®)
Drugs Lidocaine (Lidoderm®) 5% patch
Covered Uses Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
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Prior Authorization
Group Description
BCC - Lidocaine (Lidoderm®)
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.
Exclusion Criteria Pain that is not neuropathic in nature
Required Medical
Information
Diagnosis of post-herpetic neuralgia or other neuropathic pain.
Age Restrictions N/A
Prescriber Restrictions N/A
Coverage Duration 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).
Other Criteria
Revision/Review Date 4/2018
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.
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: AmeriHealth Caritas Enterprise* Pharmacy & Therapeutics Committee Meeting Minutes. April
30th, 2018. Accessed May 14, 2018.