ph-991055
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Lyrica CR® (pregabalin CR) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-991055

This program applies to Blue Partner, Commercial, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

Lyrica CR Prior Authorization with Quantity Limit

TARGET AGENT(S)

Lyrica® CR (pregabalin ER)

Brand (generic)

GPI

Multisource Code

Quantity Limit (per day or as listed)

Lyrica CR (pregabalin ER)

82.5 mg tableta

62540060007520

M, N, O, or Y

1 tablet

165 mg tableta

62540060007530

M, N, O, or Y

1 tablet

330 mg tableta

62540060007540

M, N, O, or Y

2 tablets

  1. Generic equivalent available

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has ONE of the following diagnoses:
    1. Neuropathic pain associated with diabetic peripheral neuropathy (DPN)

OR

    1. Postherpetic neuralgia (PHN)

OR

    1. The patient has another FDA approved indication for the requested agent

OR

    1. The patient has another indication that is supported in compendia [AHFS, or DrugDex 1 or 2a level of evidence] for the requested agent

AND

  1. ONE of the following:
    1. The patient has tried and had an inadequate response to ONE of the following prerequisite generic agents:  duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, venlafaxine, or gabapentin

OR

    1. The patient has an intolerance or hypersensitivity to ONE prerequisite generic agent: duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, venlafaxine, or gabapentin

OR

    1. The patient has an FDA labeled contraindication to ALL prerequisite generic agents: duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, venlafaxine, and gabapentin

AND

  1. ONE of the following:
    1. The patient has tried and had an inadequate response to pregabalin immediate release

OR

    1. The patient has an intolerance or hypersensitivity to pregabalin immediate release that is not expected to occur with the requested agent

OR

    1. The patient has an FDA labeled contraindication to pregabalin immediate release

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) is greater than the maximum FDA labeled dose

AND

      1. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval:  12 months

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process

AND

  1. The patient has had clinical benefit with the requested agent

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
  1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

  1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose

AND

  1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

  1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) is greater than the maximum FDA labeled dose

AND

  1. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval:  12 months

FDA APPROVED INDICATIONS AND DOSAGE1

Agent(s)

Indication(s)

Dosage

Lyrica CR®

(pregabalin ER)

Tabletsa

Management of:

  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
  • Postherpetic neuralgia (PHN)

Efficacy of Lyrica CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures

DPN pain: Initially 165 mg/day as a single dose.  Titrate to 330 mg/day as a single dose within 1 week.

PHN: Initially 165 mg/day as a single dose.  Titrate to 330 mg/day as a single dose within 1 week.  Maximum dose of 660 mg/day once daily.

  1. Generic equivalent available

CLINICAL RATIONALE

Diabetic peripheral neuropathy (DPN)

Diabetic peripheral neuropathy develops as a late manifestation of uncontrolled or long-standing diabetes. Distal symmetric polyneuropathy (DSPN) is characterized by burning pain, paresthesias, and numbness that follows a stocking-glove pattern and progresses proximally. Poorly controlled blood glucose levels, especially greater variation in glucose levels, contribute to the occurrence and severity of painful DPN.2 DSPN is the most important cause of foot ulceration and a prerequisite to the development of Charcot neuroarthropathy (CN), which are both recognized as late complications of DSPN. The late complications also drive amputation risk and economic costs of diabetic neuropathy and are also predictors of mortality. DSPN is also a major contributor to falls and fractures.3

Due to lack of treatments that target the underlying nerve damage, prevention is the key component of diabetes care. Prevention of diabetic neuropathies focuses on glucose control and lifestyle modifications, which includes dietary modifications and exercise.  Enhanced glucose control in people with type 1 diabetes dramatically reduces the incidence of DSPN.  Enhanced glucose control in those with type 2 diabetes confers modest risk reduction of DSPN.   Intensive glucose control has been shown to prevent the development of peripheral neuropathy3.

There are several pharmacological options for DPN. The American Diabetes Association (ADA) recommend use of pregabalin and duloxetine as the initial therapy for symptomatic treatment for neuropathic pain.3 The American Academy of Family Physicians recommends gabapentin as the first-line alternative.2 Other treatment options include antidepressants (e.g., amitriptyline, nortriptyline, desipramine, imipramine, venlafaxine), and capsaicin cream.2 Tramadol has been shown to be effective in the treatment of DPN. Although tramadol has a lower potential for abuse compared with other opioids, given the safety concern, it is not recommended as first or second line treatment.3

Postherpetic neuralgia (PHN)

Scrutiny of the existing evidence base for pharmacologically based analgesic therapies in established postherpetic neuralgia (PHN; defined as persistent pain for ≥3 months after the resolution of cutaneous lesions) reveals that currently available therapies are generally of modest efficacy and have a narrow therapeutic index.  Studies are positive for oral tricyclic antidepressants, oral gabapentin, oral pregabalin, and oral opioids.4 The European consensus guideline on the management of Herpes Zoster recommends tricyclic antidepressants, gabapentin, or pregabalin for pain relief.5

 

REFERENCES

  1. Lyrica CR prescribing information. Pfizer, Inc. June 2020.
  2. Snyder, Matthew J, DO, et al. Treating Painful Diabetic Peripheral Neuropathy: An Update. American Family Physicians. 2016; 94 (3):227-234.  Available at: https://www.aafp.org/afp/2016/0801/p227.pdf  Accessed 12/28/2020
  3. Pop-Busui, Rodica, et al. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017; 40: 136-154.  Available at: https://care.diabetesjournals.org/content/diacare/40/1/136.full.pdf  Accessed 12/28/2020
  4. Finnerup NB, Attal N, Haroutounian S, et. al.  “Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis.”  The Lancet, Neurology, 14, 162-173.  https://s3.amazonaws.com/rdcms-iasp/files/production/public/AM/Images/GYAP/Neuropathic/lancet_pharmacotherapy_neuropathic_pain.pdf  Accessed 12/28/2020.
  5. Werner RN, Nikkels AF, Marinovic B, et. al.  “European consensus-based (S2k) Guideline on the Management of Herpes Zoster – guided by the European Dermatology Forum (EDF) in cooperation with the European Academy of Dermatology and Venereology (EADV), Part 2: Treatment.  Journal of the European Academy of Dermatology and Venereology.  31, 20-29, 2017.  https://www.edf.one/dam/jcr:52309899-e825-43b9-aea5-0f7d2f42f513/Werner_et_al-2017-Journal_of_the_European_Academy_of_Dermatology_and_Venereology%20(1).pdf  Accessed 12/28/2020

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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