diabetic neuropathy—selected treatments...diabetes. currently there is no proven cure for diabetic...

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

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.

2

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:

3

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.

4

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.


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.


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).

5


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).


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.

6


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:


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.

7


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

https://www.aafp.org/patient-care/clinical-recommendations/all/type2-diabetes.html

8

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.

9

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

10

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.

11

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

12

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.

diabetic neuropathy—selected treatments...diabetes. currently there is no proven cure for diabetic...

Documents