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Calcitonin Gene-Related Peptide (CGRP) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1033
This program applies to Blue Partner, Commercial, GenPlus, NetResults A, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Aimovig® (erenumab-aooe) Subcutaneous autoinjector Subcutaneous prefilled syringe |
Preventive treatment of migraine in adults |
|
1 |
AJOVY® (fremanezumab-vfrm) Subcutaneous autoinjector Subcutaneous prefilled syringe |
Preventive treatment of migraine in adults |
|
2 |
Emgality® (galcanezumab-gnlm) Subcutaneous prefilled pen Subcutaneous prefilled syringe |
Preventive treatment of migraine in adults Treatment of episodic cluster headache in adults |
|
3 |
Nurtec ODT® (rimegepant sulfate) Orally disintegrating tablet |
Acute treatment of migraine with or without aura in adults Preventive treatment of episodic migraine in adults |
|
19 |
QULIPTA® (atogepant) Tablet |
Preventive treatment of migraine in adults |
|
21 |
UBRELVY® (ubrogepant) Tablet |
Acute treatment of migraine with or without aura in adults Limitations of Use: UBRELVY is not indicated for the preventive treatment of migraine. |
|
20 |
Zavzpret™ (zavegepant) Nasal spray |
Acute treatment of migraine with or without aura in adults Limitations of Use: Zavzpret is not indicated for the preventive treatment of migraine. |
|
23 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Migraine and Cluster Headache Management |
Migraine is a common disabling primary headache disorder with high prevalence, ranking second globally in terms of years lost to disability.(7) Typical characteristics of the headache are unilateral location, pulsating quality, moderate or severe intensity, aggravation by routine physical activity, and association with nausea and/or photophobia and phonophobia. Migraines can present with or without aura, unilateral fully reversible visual, sensory, or other central nervous system symptoms that usually develop gradually and are most-often followed by headache and associated migraine symptoms.(5) The International Classification of Headache Disorders 3rd Edition (ICHD-3) Diagnostic Criteria:(5)
The IHS notes that cluster periods usually last between 2 weeks and 3 months.(5) The 2024 American Headache Society (AHS) position statement update states that for those with episodic migraine (4-14 monthly migraine days) based on ICHD-3 with at least moderate disability (Migraine Disability Assessment [MIDAS] score greater than or equal to 11 or Headache Impact Test [HIT-6] score greater than 50), and those with chronic migraine (greater than or equal to 15 headache days/month) based on ICDH-3, CGRP-targeting agents are a first line migraine prevention treatment options and initiation of CGRP-targeting agents should not require the trial and failure of other migraine preventative medications.(6) The 2021 American Headache Society Consensus Statement recommends the following indications for initiating treatment acute treatment with gepants and ditans agents:(22)
Lasmiditan is a selective serotonin 5HT-1F receptor agonist that lacks vasoconstrictor activity. Lasmiditan is structurally different than triptans and therefore constitutes a new class of drugs called “ditans”.(22) Ditans are selective for the 5HT-1F receptor and its mechanism of action is neuronal without evidence of vasoactive effects.(27) Triptans non-specifically bind to the 5HT-1B and 5HT-1D receptors and with varying affinity bind the 5HT-1F receptors, causing direct vascular vasoconstriction. The safety, tolerability, and efficacy of co-administering lasmiditan with a triptan or a gepant has not been assessed.(22) Patients who do not respond to initial therapy with a triptan, may benefit from a second triptan or different therapy such as use of a gepant (ubrogepant or rimegepant) or a ditan (lasmiditan).(7) The Medical Letter Treatment Guidelines (2023) and Institute for Clinical Systems Improvement Guideline Diagnosis and Treatment of Migraine Headache - Drugs for Migraine states that a triptan is the drug of choice for moderate to severe migraine. The short-acting oral serotonin (5-HT1B/1D) receptor agonists (triptans) sumatriptan (IMITREX, and others), almotriptan (Axert, and generics), eletriptan (RELPAX), rizatriptan (Maxalt, and generics), and zolmitriptan (Zomig, and generics) are similar in efficacy.(24,25) Onset of pain relief generally occurs 30-60 minutes after administration. The longer-acting oral triptans naratriptan (Amerge, and generics) and frovatriptan (Frova, and generics) have a slower onset of action and lower initial response rate than other triptans, but they are better tolerated. Patients with migraine who have nausea or vomiting may not be able to take an oral triptan. Intranasal triptan formulations have a more rapid onset of action than oral tablets, but their efficacy is partially dependent on GI absorption of the portion of the dose that is swallowed. Use of sumatriptan nasal powder (ONZETRA Xsail) results in a faster rise in sumatriptan plasma concentrations and higher peak concentrations than use of a similar dose of sumatriptan nasal spray, suggesting that a larger portion of the dose is absorbed intranasally with the powder. Subcutaneously administered sumatriptan relieves pain faster (in about 10 minutes) and more effectively than other triptan formulations, but it causes more adverse effects.(25) American Headache Society (AHS) (2015): Triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan [oral, nasal spray, injectable, transcutaneous patch], zolmitriptan [oral and nasal spray]) are effective (Level A) and considered by AHS guidelines (2015) to be the gold standard for acute treatment of moderate to severe migraine headaches.(8) Dihydroergotamine is recommended for use as a second- or third-line therapy for select patients or for those with refractory migraine. Intranasal dihydroergotamine has strong evidence of effectiveness but more adverse effects than triptans because of its decreased receptor specificity.(18) An assessment of new migraine treatments by the AHS (2018; updated 2021) reaffirms previous migraine guidelines. The update lists triptans, dihydroergotamine, the oral gepants (Nurtec ODT [rimegepant] and UBRELVY [ubrogepant]), and REYVOW (lasmiditan) as effective treatment of moderate or severe acute attacks and mild to moderate attacks that respond poorly to non-specific nonsteroidal anti-inflammatory drugs (NSAIDs), non-opioid analgesics, acetaminophen, or caffeinated combinations (e.g., aspirin/acetaminophen/caffeine). The recommendation remains that prescribers must consider medication efficacy and potential medication-related adverse effects, potential adverse events, patient-specific contraindications to use with a particular medication, and drug-drug interactions when prescribing acute medications for migraine.(7,8,22) The American Academy of Neurology (AAN) 2010 Guideline: Acute and preventive pharmacologic treatment of Cluster Headache (CH) state that sumatriptan subcutaneous injection and zolmitriptan nasal spray are first line-options for acute treatment of CH.(12,24) Since the publication of the 2010 AAN review, and re-reviewed in 2016, there is no new data from randomized, double-blind, controlled trials that contribute to determining the efficacy or safety for a number of acute treatments, including specifically sumatriptan and zolmitriptan. For acute treatment, sumatriptan subcutaneous, zolmitriptan nasal spray, and high flow oxygen remain the treatments with a Level A recommendation.(26) Guidelines suggest that prophylactic therapy should be started and continued for the duration of the CH period. Prophylactic pharmacological therapy includes verapamil, corticosteroids, lithium, topiramate, melatonin, gabapentin, valproic acid, ergotamine, and capsaicin. Verapamil is commonly considered the first option for prophylactic therapy in practice.(10,11,12) Corticosteroids can be used as transitional or bridging therapy until another prophylaxis agent is established.(10) Corticosteroids may be used by some practitioners for short periods of CH.(11,12) The American Academy Neurology lists the following agents as option that maybe considered or should be advised as preventative treatments:
The European Headache Federation and WHO consensus article (2019) states the following:(13)
The European Headache Federation guideline states the following on combining migraine prophylaxis therapy:(14)
The clinical trials referenced in FDA labeled package inserts for the preventative CGRP agents excluded patients that had received botulinum toxin within 4 months prior to receiving the CGRP agent.(15,16,17) However the 2021 American Headache Society consensus statement states that CGRP monoclonal antibody treatment (e.g., eptinezumab-jjmr, erenumab, fremanezumab, galcanezumab) may be added to greater than or equal to one established preventative treatment, based on clinical judgement, in adults who meet the ICHD-3 criteria for migraines.(5,22) |
||||||||||||
Medication overuse headache (MOH) |
The European Headache Federation and WHO consensus article (2019) states the following:(13)
|
||||||||||||
Safety |
Atogepant is contraindicated in patients with a history of hypersensitivity to atogepant or to any of the components of QULIPTA.(21) Erenumab-aooe is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients.(1) Fremanezumab-vfrm is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm to any of the excipients.(2) Galcanezumab-gnlm is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm to any of the excipients.(3) Rimegepant is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, Nurtec ODT, or to any of its components.(19) Ubrogepant is contraindicated in the following:(20)
Zavegepant is contraindicated in patients with a history of hypersensitivity reaction to zavegepant or to any of the components of Zavzpret.(23) |
REFERENCES
Number |
Reference |
1 |
Aimovig prescribing information. Amgen Inc. May 2023. |
2 |
AJOVY prescribing information. Teva Pharmaceuticals USA, Inc. October 2022. |
3 |
Emgality prescribing information. Eli Lilly. March 2021. |
4 |
Reference no longer used. |
5 |
ICHD-3 Classification. International Headache Society. 2018. |
6 |
Charles A, Digre KB, Goadsby P, Robbins MS, Hershey AD. Calcitonin gene‐related peptide‐targeting therapies are a first‐line option for the prevention of migraine: An American Headache Society position statement update. Headache: The Journal of Head and Face Pain. March 2024. doi:10.1111/head.14692 |
7 |
The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. American Headache Society. 12/10/2018. Available at https://onlinelibrary.wiley.com/doi/10.1111/head.13456. |
8 |
Marmura M, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the American Headache Society evidence assessment of migraine pharmacotherapies. Headache. 2015;55:3–20. |
9 |
Reference no longer used. |
10 |
Weaver-Agostoni, J. Cluster headache. American Family Physician. 2013 Jul 15; 88(2): 122-128. |
11 |
Goadsby PJ. Information for Health Care Professionals: Treatments for Cluster Headache. American Headache Society. 2018 June. https://americanheadachesociety.org/wp-content/uploads/2018/06/Goadsby-Cluster-Headache.docx. |
12 |
Francis GJ, Becker WJ, Pringsheim TM. Acute and preventative pharmacologic treatment of cluster headache. August 03, 2010; 75 (5). |
13 |
Steiner TJ, Jensen R, Katsarava Z, et al. Aids to management of headache disorders in primary care (2nd edition). Journal of Headache and Pain. 2019; 20:57. https://doi.org/10.1186/s10194-018-0899-2. |
14 |
Sacco S, Bendtsen L, Ashina M, et al. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. The Journal of Headache and Pain. (2019) 20:6. |
15 |
Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S, Winner P, Leonardi D, Mikol D, Lenz R. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomized, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jun;16(6):425-434. doi: 10.1016/S1474-4422(17)30083-2. |
16 |
Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018 Dec 11;91(24):e2211-e2221. doi: 10.1212/WNL.0000000000006640. |
17 |
Lipton RB, Cohen JM, Gandhi SK, Yang R, Yeung PP, Buse DC. Effect of fremanezumab on quality of life and productivity in patients with chronic migraine. Neurology. 2020 Aug 18;95(7):e878-e888. doi: 10.1212/WNL.0000000000010000. |
18 |
Mayans L, Walling A. Acute Migraine Headache: Treatment Strategies. Am Fam Physician. 2018; 97(4): 243-251. |
19 |
Nurtec ODT prescribing information. Pfizer Laboratories Div Pfizer Inc. April 2023. |
20 |
UBRELVY prescribing information. Allergan, Inc. June 2023. |
21 |
QUILIPTA prescribing information. AbbVie Inc. June 2023. |
22 |
Ailani J, Burch RC, Robbins MS, on behalf of the Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021;61(7):1021-1039. |
23 |
Zavzpret prescribing information. Pfizer Laboratories Div Pfizer Inc. March 2023. |
24 |
Beithon J, Gallenberg M, Johnson K, Kildahl P, Krenik J, Liebow M, Linbo L, Myers C, Peterson S, Schmidt J, Swanson J. Institute for Clinical Systems Improvement. Diagnosis and Treatment of Headache. ICSI. Updated January 2013. https://www.icsi.org/wp-content/uploads/2019/01/Headache.pdf. |
25 |
Drugs for Migraine. Med Lett Drugs Ther. 2023 Jun 12; 65(1678):89-96. doi:10.58347/tml.2023.1678a. |
26 |
Robbins MS, Starling AJ, Pringsheim TM, Becker WJ, Schwedt TJ. Treatment of Cluster Headache: The American Headache Society Evidence-Based Guidelines. Headache. 2016; 56: 1093-106. doi:10.1111/head.12866. |
27 |
Oswald JC, Schuster NM. Lasmiditan for the treatment of acute migraine: a review and potential role in clinical practice. J Pain Res. 2018; 11: 2221-2227. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Qulipta |
atogepant tab |
10 MG ; 30 MG ; 60 MG |
M ; N ; O ; Y |
N |
|
|
Aimovig |
erenumab-aooe subcutaneous soln auto-injector |
140 MG/ML ; 70 MG/ML |
M ; N ; O ; Y |
N |
|
|
Ajovy |
fremanezumab-vfrm subcutaneous soln auto-inj |
225 MG/1.5ML |
M ; N ; O ; Y |
N |
|
|
Ajovy |
fremanezumab-vfrm subcutaneous soln pref syr |
225 MG/1.5ML |
M ; N ; O ; Y |
N |
|
|
Emgality |
galcanezumab-gnlm subcutaneous soln auto-injector |
120 MG/ML |
M ; N ; O ; Y |
N |
|
|
Emgality |
galcanezumab-gnlm subcutaneous soln prefilled syr |
100 MG/ML ; 120 MG/ML |
M ; N ; O ; Y |
N |
|
|
Nurtec |
rimegepant sulfate tab disint |
75 MG |
M ; N ; O ; Y |
N |
|
|
Ubrelvy |
ubrogepant tab |
100 MG ; 50 MG |
M ; N ; O ; Y |
N |
|
|
Zavzpret |
zavegepant hcl nasal spray |
10 MG/ACT |
M ; N ; O ; Y |
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 |
|
|||||||||
Nurtec |
Rimegepant Sulfate Tab Disint 75 MG |
75 MG |
16 |
Tablets |
30 |
DAYS |
|
|
|
Qulipta |
Atogepant Tab |
10 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Qulipta |
Atogepant Tab |
30 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Qulipta |
Atogepant Tab |
60 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Ubrelvy |
Ubrogepant Tab 100 MG |
100 MG |
16 |
Tablets |
30 |
DAYS |
|
|
|
Ubrelvy |
Ubrogepant Tab 50 MG |
50 MG |
16 |
Tablets |
30 |
DAYS |
|
|
|
Zavzpret |
zavegepant hcl nasal spray |
10 MG/ACT |
8 |
Devices |
30 |
DAYS |
|
|
|
Aimovig |
Erenumab-aooe Subcutaneous Soln Auto-Injector 140 MG/ML |
140 MG/ML |
1 |
Injection Device |
28 |
DAYS |
|
|
|
Aimovig |
Erenumab-aooe Subcutaneous Soln Auto-Injector 70 MG/ML |
70 MG/ML |
1 |
Injection Device |
28 |
DAYS |
|
|
|
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Auto-Injector 120 MG/ML |
120 MG/ML |
1 |
Injection Device |
28 |
DAYS |
|
|
|
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 100 MG/ML |
100 MG/ML |
9 |
Syringes |
180 |
DAYS |
|
|
|
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 120 MG/ML |
120 MG/ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
Ajovy |
Fremanezumab-vfrm Subcutaneous Soln Auto-inj 225 MG/1.5ML |
225 MG/1.5ML |
3 |
Injection Devices |
84 |
DAYS |
|
|
|
Ajovy |
Fremanezumab-vfrm Subcutaneous Soln Pref Syr 225 MG/1.5ML |
225 MG/1.5ML |
3 |
Syringes |
84 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Aimovig |
erenumab-aooe subcutaneous soln auto-injector |
140 MG/ML ; 70 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ajovy |
fremanezumab-vfrm subcutaneous soln auto-inj |
225 MG/1.5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ajovy |
fremanezumab-vfrm subcutaneous soln pref syr |
225 MG/1.5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Emgality |
galcanezumab-gnlm subcutaneous soln auto-injector |
120 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Emgality |
galcanezumab-gnlm subcutaneous soln prefilled syr |
100 MG/ML ; 120 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Nurtec |
rimegepant sulfate tab disint |
75 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Qulipta |
atogepant tab |
10 MG ; 30 MG ; 60 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ubrelvy |
ubrogepant tab |
100 MG ; 50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zavzpret |
zavegepant hcl nasal spray |
10 MG/ACT |
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 |
Nurtec |
Rimegepant Sulfate Tab Disint 75 MG |
75 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Qulipta |
Atogepant Tab |
10 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Qulipta |
Atogepant Tab |
60 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Qulipta |
Atogepant Tab |
30 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ubrelvy |
Ubrogepant Tab 100 MG |
100 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ubrelvy |
Ubrogepant Tab 50 MG |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zavzpret |
zavegepant hcl nasal spray |
10 MG/ACT |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Aimovig |
Erenumab-aooe Subcutaneous Soln Auto-Injector 140 MG/ML |
140 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Aimovig |
Erenumab-aooe Subcutaneous Soln Auto-Injector 70 MG/ML |
70 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Auto-Injector 120 MG/ML |
120 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 100 MG/ML |
100 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 120 MG/ML |
120 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ajovy |
Fremanezumab-vfrm Subcutaneous Soln Auto-inj 225 MG/1.5ML |
225 MG/1.5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ajovy |
Fremanezumab-vfrm Subcutaneous Soln Pref Syr 225 MG/1.5ML |
225 MG/1.5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||||||||||||||||||
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence Length of Approval: Cluster headache treatment - 6 months; migraine prophylaxis - 6 months; all other indications - 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence 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 |
QL |
Quantity limit for Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months. NOTE: For agents that require a loading dose for a new start, approve the loading dose based on FDA labeling AND the maintenance dose for the remainder 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.
ALBP _ Commercial _ CSReg _ CGRP_PAQL _ProgSum_ 10-01-2024 _
© Copyright Prime Therapeutics LLC. August 2024 All Rights Reserved