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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, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
07-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
LYRICA®* Capsule |
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 Neuropathic pain associated with spinal cord injury |
* generic available |
1 |
LYRICA® CR |
The management of:
|
*generic available |
9 |
Savella® (milnacipran) |
Management of fibromyalgia 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 increased focus on non-pharmacologic therapies discussed in the guidelines, however, pharmacology remains the mainstay of therapy. 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.(5) 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 alternative first-line agent, 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 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 and capsaicin. 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) LYRICA has FDA approval for adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.(1) |
Safety |
LYRICA and LYRICA CR are contraindicated in patients with a known hypersensitivity to pregabalin or any of its components.(1,9) Savella has the following contraindications:(2)
Savella carries a boxed warning for suicidality and antidepressant drugs.(2)
|
REFERENCES
Number |
Reference |
1 |
LYRICA prescribing information. Parke-Davis Div of Pfizer. June 2020. |
2 |
Savella prescribing information. Allergan, Inc. September 2023. |
3 |
Kia S, Choy E. Update on Treatment Guideline in Fibromyalgia Syndrome with Focus on Pharmacology. Biomedicines. 2017;5(2):20. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489806/ |
4 |
Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154. https://care.diabetesjournals.org/content/40/1/136. |
5 |
Snyder MJ, Gibbs LM, Lindsay TJ. Treating Painful Diabetic Peripheral Neuropathy: An Update. Am Fam Physician. 2016;94(3):227-234. 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. 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. https://www.aafp.org/afp/2017/0715/p87.html |
9 |
LYRICA CR prescribing information. Parke-Davis Div of Pfizer. 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. 2017,31, 20-29. doi: 10.1111/jdv.13957 |
POLICY AGENT SUMMARY STEP THERAPY
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Lyrica |
pregabalin cap ; pregabalin soln |
100 MG ; 150 MG ; 20 MG/ML ; 200 MG ; 225 MG ; 25 MG ; 300 MG ; 50 MG ; 75 MG |
M ; N ; O |
O ; Y |
|
|
Lyrica cr |
pregabalin tab er |
165 MG ; 330 MG ; 82.5 MG |
M ; N ; O ; Y |
O ; Y |
|
|
Savella ; Savella titration pack |
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 |
LYRICA will be approved when ONE of the following is met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
||
Lyrica CR |
Target Agent(s) LYRICA CR (pregabalin ER)^ ^ - generic available; targeted in the step therapy program Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
|
||
Savella |
Savella will be approved when ONE of the following is met:
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:
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_STQL _ProgSum_ 07-01-2024