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Lyrica and Savella Step Therapy with Quantity Limit Program Summary

Policy Number: PH-1055

 

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

 

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

7/1/2023

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Lyrica®*
(pregabalin)

Capsule
Oral solution

Neuropathic pain associated with diabetic peripheral neuropathy (DPN)

Postherpetic neuralgia (PHN)

Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older

Fibromyalgia (FM)

Neuropathic pain associated with spinal cord injury (SCI)

* – generic equivalent available

1

Lyrica® CR
(pregabalin ER)

Tablet

The management of:

  • neuropathic pain associated with diabetic peripheral neuropathy (DPN)
  • postherpetic neuralgia

9

Savella® 
(milnacipran)

Tablet
Titration pack

Management of fibromyalgia

Limitation of use: Savella is not approved for use in pediatric patients

2

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Fibromyalgia

Fibromyalgia is a chronic condition with unknown etiology. It is characterized by generalized body pain, fatigue, sleep disturbance, impaired cognition, and anxiety.  Diagnosis is often made by exclusion of other conditions such as neurological syndromes and depression.  There is no clear specific pathophysiological therapeutic target.  Various guidelines for treatment exist and they are not in agreement.  There has been an increase in non-pharmacologic therapies discussed in the guidelines.  Pharmacologic therapy varies, including classical analgesics, antidepressants, and anticonvulsants.  Commonly used agents include tricyclic antidepressants (TCAs), pregabalin, gabapentin, serotonin and norepinephrine reuptake inhibitors (SNRI), selective serotonin reuptake inhibitors (SSRI), tramadol, and cyclobenzaprine.(3)

Neuropathic Pain

Diabetic Peripheral Neuropathy
Diabetic peripheral neuropathy (DPN) develops as a late manifestation of uncontrolled or long-standing diabetes.  DPN patients may develop distal symmetric polyneuropathy (DSPN), which 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.(8) 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.(4)

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.  For patients with diabetic neuropathy, foot care is important to prevent ulceration, infection, and amputation.(4)

There are several pharmacological options for DPN. The American Diabetes Association (ADA) and American Academy of Family Physicians (AAFP) recommend use of pregabalin and duloxetine as first line therapy for painful diabetic neuropathy.  The ADA recommends gabapentin as the first-line alternative, though AAFP considers it a first-line therapy.(4,5) Other treatment options include antidepressants (e.g., amitriptyline, nortriptyline, desipramine, imipramine, venlafaxine), anticonvulsants (e.g. lamotrigine, topiramate, valproate), and topical agents (e.g., capsaicin cream, lidocaine 5% patch). (4,5) 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.(4)

Postherpetic Neuralgia
Postherpetic neuralgia (PHN), the most common complication of herpes zoster, is defined as pain in a dermatomal distribution that is sustained for at least 90 days after the rash. It occurs in approximately 10-20% of patients with herpes zoster, and 80% of cases occur in patients 50 years or older.  PHN is caused by nerve damage secondary to an inflammatory response induced by viral replication within a nerve.(6) Gabapentin, pregabalin, and the TCAs are considered first-line therapies, along with the topical therapies of lidocaine patch and capsaicin cream.  Tramadol is considered a third-line option.(6) The European consensus guideline on the management of Herpes Zoster recommends tricyclic antidepressants, gabapentin, or pregabalin for pain relief.(10)

Neuropathic Pain due to Spinal Cord Injury
Spinal cord injury (SCI) is an injury to the spinal cord that leads to varying degrees of motor and/or sensory deficits and paralysis. Chronic neuropathic pain is common and contributes to reduced quality of life. First-line drugs commonly used are amitriptyline, gabapentin, and pregabalin. Alternative agents are tramadol and duloxetine.(7)

Seizure Disorders

The occurrence of a single seizure does not always require initiation of antiepileptic drugs (AEDs).  In the absence of risk factors, physicians should consider delaying used of AEDs until a second seizure occurs.  Treatment should begin with monotherapy.(8) Pregabalin has FDA approval for adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.(1)

Safety

Savella carries a black box warning for suicidality and antidepressant drugs.

  • Increased risk of suicidal ideation, thinking, and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders.
  • Savella is not approved for use in pediatric patients.(2) 

REFERENCES                                                                                                                                                                           

Number

Reference

1

Lyrica prescribing information. Pfizer/Parke-Davis. June 2020.

2

Savella prescribing information. Forest Pharmaceuticals, Inc. February 2022.

3

Kia S, Choy E. Update on Treatment Guideline in Fibromyalgia Syndrome with Focus on Pharmacology. Biomedicines 2017;5(2):1-24. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489806/ 

4

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/40/1/136. 

5

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.html.

6

Saguil A, Kane S, Mercado M, Lauters R. Herpes Zoster and Postherpetic Neuralgia: Prevention and Management. Am Fam Physician 2017;96(10):656-663. Available at: https://www.aafp.org/afp/2017/1115/p656.html. 

7

Hagen EM, Rekand T. Management of Neuropathic Pain Associated with Spinal Cord Injury. Pain Ther 2015;4(1):51-65. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4470971/#__ffn_sectitle. 

8

Liu G, Slater N, Perkins A.  Epilepsy: Treatment Options.  American Family Physician 2017; 95(2):87-96.  Available at: https://www.aafp.org/afp/2017/0715/p87.html  

9

Lyrica CR prescribing information.  Pfizer/Parke-Davis.  June 2020.

10

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

 

POLICY AGENT SUMMARY STEP THERAPY

Agent Names

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

LYRICA*pregabalin cap  ; LYRICA*pregabalin soln  ; PREGABALIN*pregabalin cap  ; PREGABALIN*pregabalin soln

100 MG ; 150 MG ; 20 MG/ML ; 200 MG ; 225 MG ; 25 MG ; 300 MG ; 50 MG ; 75 MG

M ; N ; O

N ; O ; Y

LYRICA*pregabalin tab er  ; PREGABALIN*pregabalin tab er

165 MG ; 330 MG ; 82.5 MG

M ; N ; O ; Y

O ; Y

SAVELLA*milnacipran hcl tab

100 MG ; 12.5 & 25 & 50 MG ; 12.5 MG ; 25 MG ; 50 MG

M ; N ; O

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Lyrica

Pregabalin Cap 100 MG

100 MG

90

Capsules

30

DAYS

Lyrica

Pregabalin Cap 150 MG

150 MG

90

Capsules

30

DAYS

Lyrica

Pregabalin Cap 200 MG

200 MG

90

Capsules

30

DAYS

Lyrica

Pregabalin Cap 225 MG

225 MG

60

Capsules

30

DAYS

Lyrica

Pregabalin Cap 25 MG

25 MG

90

Capsules

30

DAYS

Lyrica

Pregabalin Cap 300 MG

300 MG

60

Capsules

30

DAYS

Lyrica

Pregabalin Cap 50 MG

50 MG

90

Capsules

30

DAYS

Lyrica

Pregabalin Cap 75 MG

75 MG

90

Capsules

30

DAYS

Lyrica

Pregabalin Soln 20 MG/ML

20 MG/ML

900

mLs

30

DAYS

Lyrica cr

Pregabalin Tab ER 24HR 165 MG

165 MG

30

Tablets

30

DAYS

Lyrica cr

Pregabalin Tab ER 24HR 330 MG

330 MG

60

Tablets

30

DAYS

Lyrica cr

Pregabalin Tab ER 24HR 82.5 MG

82.5 MG

30

Tablets

30

DAYS

Savella

milnacipran hcl tab

100 MG ; 12.5 MG ; 25 MG ; 50 MG

60

Tablets

30

DAYS

Savella titration pack

Milnacipran HCl Tab 12.5 MG (5) & 25 MG (8) & 50 MG (42) Pak

12.5 & 25 & 50 MG

1

Pack

180

DAYS

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Lyrica

pregabalin cap  ; pregabalin soln

100 MG ; 150 MG ; 20 MG/ML ; 200 MG ; 225 MG ; 25 MG ; 300 MG ; 50 MG ; 75 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica cr

pregabalin tab er

165 MG ; 330 MG ; 82.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Savella ; Savella titration pack

milnacipran hcl tab

100 MG ; 12.5 & 25 & 50 MG ; 12.5 MG ; 25 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Lyrica

Pregabalin Cap 100 MG

100 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica

Pregabalin Cap 150 MG

150 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica

Pregabalin Cap 200 MG

200 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica

Pregabalin Cap 225 MG

225 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica

Pregabalin Cap 25 MG

25 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica

Pregabalin Cap 300 MG

300 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica

Pregabalin Cap 50 MG

50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica

Pregabalin Cap 75 MG

75 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica

Pregabalin Soln 20 MG/ML

20 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica cr

Pregabalin Tab ER 24HR 165 MG

165 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica cr

Pregabalin Tab ER 24HR 330 MG

330 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Lyrica cr

Pregabalin Tab ER 24HR 82.5 MG

82.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Savella

milnacipran hcl tab

100 MG ; 12.5 MG ; 25 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Savella titration pack

Milnacipran HCl Tab 12.5 MG (5) & 25 MG (8) & 50 MG (42) Pak

12.5 & 25 & 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Lyrica

Evaluation

Lyrica will be approved when ONE of the following is met:

  1. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy
    1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
    2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
  2. The patient has a diagnosis of a seizure disorder OR
  3. The patient’s medication history includes use of another anticonvulsant within the past 90 days OR
  4. The patient’s medication history includes use of generic duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, cyclobenzaprine, venlafaxine, gabapentin, pregabalin or tramadol within the past 90 days OR
  5. The patient has an intolerance or hypersensitivity to ONE of the following: generic duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, cyclobenzaprine, venlafaxine, gabapentin, pregabalin, or tramadol OR
  6. The patient has an FDA labeled contraindication to ALL of the following: generic duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, cyclobenzaprine, venlafaxine, gabapentin, pregabalin, and tramadol

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Lyrica CR

Evaluation

Target Agent(s) will be approved when ONE of the following is met:

  1. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy
    1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
    2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
  2. BOTH of the following:
    1. ONE of the following:
      1. The patient's medication history includes use of generic duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, venlafaxine, or gabapentin within the past 180 days OR
      2. The patient has an intolerance or hypersensitivity to ONE of the following: generic duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, venlafaxine, or gabapentin OR
      3. The patient has an FDA labeled contraindication to ALL of the following: generic duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, venlafaxine, and gabapentin AND
    2. ONE of the following:
      1. The patient's medication history includes use of pregabalin immediate release within the past 180 days OR
      2. The patient has an intolerance or hypersensitivity to pregabalin immediate release OR
      3. The patient has an FDA labeled contraindication to pregabalin immediate release

Length of Approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

 

Savella

Evaluation

Savella will be approved when ONE of the following is met:

  1. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy
    1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
    2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
  2. The patient’s medication history includes use of generic duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, cyclobenzaprine, venlafaxine, gabapentin, pregabalin, or tramadol within the past 90 days OR
  3. The patient has an intolerance or hypersensitivity to ONE of the following: generic duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, cyclobenzaprine, venlafaxine, gabapentin, pregabalin, or tramadol OR
  4. The patient has an FDA labeled contraindication to ALL of the following: generic duloxetine, amitriptyline, nortriptyline, imipramine, desipramine, cyclobenzaprine, venlafaxine, gabapentin, pregabalin, and tramadol

Length of Approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) is greater than the program quantity limit AND ONE of the following:
    1. BOTH of the following:
      1. The requested agent does not have a maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support therapy with a higher dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
    3. BOTH of the following:
      1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

 

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 Blue Cross and Blue Shield of Alabama’s 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.

Commercial _ PS _ Lyrica and Savella Step Therapy with Quantity Limit _ProgSum_ 7/1/2023