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Constipation Agents Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1036
This program applies to Blue Partner, Commercial, GenPlus, 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# |
Amitiza®* (lubiprostone) Capsule |
Treatment of chronic idiopathic constipation (CIC) in adults Treatment of opioid-induced constipation (OIC) in adults with chronic, non-cancer pain including patients with chronic pain related to prior cancer of its treatment who do not require frequent (e.g., weekly) opioid dosage escalation Limitation of Use: Effectiveness of Amitiza in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established Treatment of irritable bowel syndrome with constipation (IBS-C) in women greater than or equal to 18 years old |
*generic available |
1 |
Ibsrela® (tenapanor) Tablet |
Treatment of irritable bowel syndrome with constipation (IBS-C) in adults |
|
18 |
Linzess® (linaclotide) Capsule |
Treatment of functional constipation (FC) in pediatric patients 6 to 17 years of age Treatment of irritable bowel syndrome with constipation (IBS-C) in adults Treatment of chronic idiopathic constipation (CIC) in adults |
|
3 |
Motegrity® (prucalopride) Tablet |
Treatment of chronic idiopathic constipation (CIC) in adults
|
|
11 |
Movantik® (naloxegol) Tablet |
Treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation
|
|
14 |
Relistor® (methylnaltrexone) Subcutaneous injection (SC) Tablet |
Injection/Tablet: Treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation Injection: Treatment of OIC in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care |
|
13 |
Symproic® (naldemedine) Tablet |
Treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation
|
|
15 |
Trulance® (plecanatide) Tablet |
Treatment of chronic idiopathic constipation (CIC) in adults. Treatment of irritable bowel syndrome with constipation (IBS-C) in adults |
|
9 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Irritable Bowel Syndrome with Constipation (IBS-C) |
Irritable Bowel Syndrome (IBS) is a chronic functional disorder of the gastrointestinal system. Patients experience abdominal pain and altered bowel habit, with either predominantly diarrhea (IBS-D), constipation (IBS-C), or both (IBS-M). There is no definitive investigation as no biomarker has been found, so IBS is diagnosed clinically. The Rome criteria were developed by a panel of international experts in the field of functional gastrointestinal disorders. Although initially developed to guide researchers, these criteria have undergone several revisions with the intent of making them clinically useful whereas the criteria can be applied to diagnose IBS.(17) Rome IV defines IBS as recurrent abdominal pain, on average, at least one day per week in the last three months associated with two or more of the following:(2,17)
The goal of treatment of IBS-C is to improve symptoms such as abdominal bloating, discomfort, and constipation. The American College of Gastroenterology (ACG) updated (2021) guidelines suggest that soluble (e.g., psyllium, oat bran, barley, and beans), but not insoluble (e.g., wheat bran, whole grains, and some vegetables), fiber be used to treat IBS especially when the predominant symptom is constipation. Updated guidelines recommend against the use of polyethylene glycol (PEG), probiotics and antispasmodics. However, the authors do recognize that clinicians may use PEG as a first-line treatment for constipation in IBS, given its low cost and availability.(2) Tricyclic antidepressants (TCAs) are also recommended for use with global symptoms of IBS, such as patients who report abnormal bowel habits of constipation, diarrhea, or both. TCAs are believed to improve visceral pain and central pain by acting on norepinephrine, and dopaminergic receptors, thus making them attractive candidates for the treatment of IBS-related abdominal pain. A recent systematic review and meta-analysis evaluated 7 RCTs that evaluated the effect of antidepressant therapy on abdominal pain. Antidepressants were more likely to improve symptoms of abdominal pain than placebo; however, the beneficial effects were due to TCA therapy, not serotonin reuptake inhibitors (SSRIs).(2,5,8) The 2021 American Gastroenterological Association guidelines recommend lubiprostone with a strong recommendation, and with moderate quality of evidence; in addition to guanylate cyclase activators (linaclotide and plecanatide) with a strong recommendation, high quality of evidence to treat global IBS- C symptoms. Lubiprostone exhibits an appropriate safety profile and efficacy with the most common adverse events being gastrointestinal (i.e., nausea) in nature. Although there may be a delay in initial response, improvement in global symptoms is maintained or increases over time. Guanylate cyclase-C (GC-C) agonists, linaclotide 290 mcg and plecanatide 3 mg, target GC-C receptors residing in the apical membranes of intestinal epithelial cells. Recent comparative analyses suggest that both are comparably effective, safe, and well-tolerated. Responses develop quickly and are maintained over time. Diarrhea is the most common adverse event experienced, but discontinuation rates due to diarrhea are low and both are well-tolerated.(2,5,8) |
Chronic Idiopathic Constipation (CIC) |
Chronic idiopathic constipation (CIC) is a common functional bowel disorder characterized by difficult, infrequent, and/or incomplete defecation. Functional constipation Rome IV diagnostic criteria requires the presence of the following for at least 3 months:(12)
According to 2021 American College of Gastroenterology (ACG) guidelines, polyethylene glycol (PEG) is a relatively inexpensive, widely available, nonprescription osmotic laxative that is US FDA-approved for occasional constipation based on several RCT studies. Four trials in chronic idiopathic have yielded improvement in stool frequency and stool consistency. American Gastroenterology Association recommends a gradual increase in fiber intake, as both foods included in the diet and as supplements and/or an inexpensive osmotic agent (e.g., milk of magnesia or polyethylene glycol (PEG)). Depending on stool consistency, the next step may be to supplement the osmotic agent with a stimulant laxative (e.g., bisacodyl or glycerol suppositories), preferably administered 30 minutes after a meal to synergize the pharmacologic agent with the gastrocolonic response. A newer agent (e.g., linaclotide, lubiprostone) should be considered when symptoms do not respond to other laxatives.10 Although linaclotide and lubiprostone are effective in CIC and are well tolerated, there have been no comparative studies. As both were evaluated in comparison with placebo rather than “standard therapy,” a recommendation regarding their precise position in a CIC treatment algorithm (i.e., for those who have failed fiber, osmotic, or stimulant laxatives, or as primary therapy) cannot be made at this time.(5) |
Pediatric Functional Constipation |
Rome IV defines functional constipation separately for infants and children greater than 4 years of age. For children greater than 4 years, must include 2 or more of the following occurring at least once per week for a minimum of 1 month with insufficient criteria for a diagnosis of irritable bowel syndrome:(19)
Polyethylene glycol (PEG 3350) has become the first line treatment of functional constipation due to its efficacy, safety profile, and because it is well tolerated. There are variations in the amount of PEG 3350 recommended for the cleanout phase of the treatment regime, but a reasonable dose would be 1 to 1.5 grams per kilogram PEG 3350 mixed with 6 to 8 oz. water or juice. Significantly higher doses have been used, especially in the hospital setting. Patients should be encouraged to drink this over 3 hours, if possible. If there has not been a significant response to this treatment, the patient can repeat the dose the next day. If there is no response after two days of treatment or significant abdominal discomfort, persistent vomiting, or any other concerns, the family should present for follow-up and reevaluation.(19) In the second phase of treatment, maintenance therapy, the goal is to keep the stool very soft, preventing reaccumulation of hard stool while the colon returns to normal size and function.(19) Drugs in this phase are oral medications:(19)
Normal fiber and fluid intake are recommended for children with constipation, along with an average amount of physical activity. There is no evidence to support the routine use of intensive behavioral protocolized therapy programs or biofeedback in addition to conventional treatment. There is no evidence to suggest the use of prebiotics or probiotics in the treatment of constipation. Among patients referred to pediatric gastroenterologists, 50 percent will recover as defined by 3 or more bowel movements per week without fecal incontinence and be without laxatives after 6 to 12 months. Approximately an additional 10 percent are well while taking laxatives, and 40 percent will still be symptomatic despite laxatives.(19) |
Opioid-Induced Constipation (OIC) |
In anticipation of potential OIC development with long-term opioid use, treatment guidelines recommend initiation of a prophylactic bowel regimen that may involve increased fluid and fiber intake, stool softeners, and/or laxatives. When a diagnosis of OIC is suspected despite prophylactic treatment, clinicians should confirm that initiation of opioid therapy has led to a change from baseline in the patient’s typical bowel habits, before consideration of further or alternative interventions. First line approaches to intervention also include dietary changes, OTC treatments, and exercise.(6) National Comprehensive Cancer Network (NCCN) guidelines on adult cancer pain include the following recommendations on OIC. Preventative measures include prophylactic medications such as a stimulant laxative (e.g., senna and polyethylene glycol) in addition to maintaining adequate fluid intake, maintaining adequate dietary fiber, and exercise if feasible. Supplemental medicinal fiber (e.g., psyllium) is unlikely to control OIC and may worsen constipation. Docusate does not provide benefit. If constipation develops, pharmacological recommendations include titrating stool softeners/laxatives as needed to achieve one non-forced bowel movement every 1-2 days. Consider adjuvant analgesics to allow reduction of opioid dose. If constipation persists, pharmacological recommendations include the consideration of adding another agent (magnesium hydroxide, bisacodyl, rectal suppository, lactulose, sorbitol, magnesium citrate, or polyethylene glycol). When response to laxative therapy has not been sufficient for OIC in patients with advanced illness, then consider peripherally acting mu opioid receptor antagonists such as methylnaltrexone or naloxegol; other second line agents include lubiprostone and linaclotide.(4) The American Gastroenterological Association Institute 2019 guideline for OIC recommends that patients with OIC, first line agents are traditional laxatives which include osmotic, stimulant, detergent/surfactant stool softener, and lubricant agents. In patients with laxative refractory OIC, naldemedine, naloxegol, and methylnaltrexone are recommended over no therapy. No recommendations are made on lubiprostone or prucalopride. Fiber or bulk-forming agents have limited role in OIC. Enemas may occasionally be prescribed as rescue therapy, but are not used regularly due to inconvenience, patient preference, and safety concerns.(16) |
Safety |
Amitiza carries the following contraindication:(1)
Ibsrela carries the following contraindications:(18)
Linzess carries the following contraindications:(3)
Movantik carries the following contraindications:(14)
Motegrity carries the following contraindications:(11)
Relistor carries the following contraindication:(13)
Symproic carries the following contraindications:(15)
Trulance carries the following contraindications:(9)
|
REFERENCES
Number |
Reference |
1 |
Amitiza Prescribing Information. Sucampo Pharmaceuticals, Inc. November 2020. |
2 |
Lacy, B, Chey WD, et al. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Am J Gastroenterol 2021;116:17–44. https://doi.org/10.14309/ajg.0000000000001036. |
3 |
Linzess Prescribing Information. Forest Pharmaceuticals, Inc. June 2023. |
4 |
National Comprehensive Cancer Network (NCCN) Clinical Practice guidelines in oncology. Adult Cancer Pain. Version 1.2023. |
5 |
Weinberg DS, Smalley W, et al. American Gastroenterological Association Institute Guideline on the Pharmacological Management of Irritable Bowel Syndrome. Gastroenterology. 2021;116:17-44. |
6 |
Argoff C, Brennan M, Camilleri M, et al. Review Article: Consensus recommendations on initiating prescription therapies for opioid-induced constipation. Pain Med. 2015;16(12):2324-2337. DOI: 10.1111/pme.12937. |
7 |
Chang, Lin, et al. American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation. Gastroenterology, vol. 164, no. 7, 1 June 2023, pp. 1086–1106. https://doi.org/10.1053/j.gastro.2023.03.214. |
8 |
World Gastroenterology Organization Global Guidelines. IBS: a Global Perspective Update September 2015. Available at: https://www.worldgastroenterology.org/guidelines/irritable-bowel-syndrome-ibs/irritable-bowel-syndrome-ibs-english |
9 |
Trulance prescribing information. Synergy Pharms, Inc. April 2021. |
10 |
American Gastroenterological Association Medical Position Statement on Constipation. Gastroenterology. 2013;144:211–217. https://www.gastrojournal.org/article/s0016-5085(12)01545-4/fulltext. |
11 |
Motegrity prescribing information. Shire US, Inc. November 2020. |
12 |
Crockett SD, Greer KB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation. Gastroenterology 2019;156:218-226. |
13 |
Relistor prescribing information. Salix Pharmaceuticals. April 2020. |
14 |
Movantik prescribing information. Astra Zeneca Pharmaceutical LP. March 2023. |
15 |
Symproic prescribing information. Purdue Pharma LP. March 2020. |
16 |
American College of Gastroenterology monograph on management of irritable bowel syndrome. American Journal of Gastroenterology. 2018; 113:1–18. https://journals.lww.com/ajg/fulltext/2018/06002/american_college_of_gastroenterology_monograph_on.1.aspx |
17 |
Lacy BE, Patel NK. Rome Criteria and a Diagnostic Approach to Irritable Bowel Syndrome. Journal of Clinical Medicine. 2017; 6(11):99. https://doi.org/10.3390/jcm6110099. |
18 |
Ibsrela prescribing information. Ardelyx, Inc. April 2022. |
19 |
Allen P, Setya A, Lawrence VN. Pediatric Functional Constipation. Updated 2022 Aug 19. In: StatPearls. StatPearls Publishing; 2023 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK537037/. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
Through Preferred |
||||||
Symproic |
naldemedine tosylate tab |
0.2 MG |
M ; N ; O ; Y |
N |
|
1. Preferred |
Movantik |
naloxegol oxalate tab |
12.5 MG ; 25 MG |
M ; N ; O ; Y |
N |
|
1. Preferred |
Trulance |
plecanatide tab |
3 MG |
M ; N ; O ; Y |
N |
|
1. Preferred |
Linzess |
linaclotide cap |
145 MCG ; 290 MCG ; 72 MCG |
M ; N ; O ; Y |
N |
|
2. Non-Preferred |
Amitiza |
lubiprostone cap |
24 MCG ; 8 MCG |
M ; N ; O ; Y |
O ; Y |
|
2. Non-Preferred |
Relistor |
methylnaltrexone bromide inj ; methylnaltrexone bromide tab |
12 MG/0.6ML ; 150 MG ; 8 MG/0.4ML |
M ; N ; O ; Y |
N |
|
2. Non-Preferred |
Motegrity |
prucalopride succinate tab |
1 MG ; 2 MG |
M ; N ; O ; Y |
N |
|
2. Non-Preferred |
Ibsrela |
tenapanor hcl tab |
50 MG |
M ; N ; O ; Y |
N |
|
2. Non-Preferred |
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 |
Through Preferred |
|||||||||
Amitiza |
Lubiprostone Cap 24 MCG |
24 MCG |
60 |
Capsules |
30 |
DAYS |
|
|
|
Amitiza |
Lubiprostone Cap 8 MCG |
8 MCG |
120 |
Capsules |
30 |
DAYS |
|
|
|
Ibsrela |
tenapanor hcl tab |
50 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Linzess |
linaclotide cap |
145 MCG ; 290 MCG ; 72 MCG |
30 |
Capsules |
30 |
DAYS |
|
|
|
Motegrity |
prucalopride succinate tab |
1 MG ; 2 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Movantik |
naloxegol oxalate tab |
12.5 MG ; 25 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Relistor |
methylnaltrexone bromide inj |
12 MG/0.6ML |
60 |
Vials |
30 |
DAYS |
Quantity Limit allows for dosing for individuals at least 90th percentile weight |
|
65649055102 |
Relistor |
methylnaltrexone bromide inj |
12 MG/0.6ML |
30 |
Syringes |
30 |
DAYS |
|
|
65649055103 ; 65649055107 |
Relistor |
Methylnaltrexone Bromide Inj 8 MG/0.4ML (20 MG/ML) |
8 MG/0.4ML |
30 |
Syringes |
30 |
DAYS |
|
|
|
Relistor |
methylnaltrexone bromide tab |
150 MG |
90 |
Tablets |
30 |
DAYS |
|
|
|
Symproic |
naldemedine tosylate tab |
0.2 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Trulance |
plecanatide tab |
3 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
ADDITIONAL QUANTITY LIMIT INFORMATION
Wildcard |
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Additional QL Information |
Targeted NDCs When Exclusions Exist |
Effective Date |
Term Date |
Through Preferred |
|||||||
52580050102020 |
Relistor |
methylnaltrexone bromide inj |
12 MG/0.6ML |
Quantity Limit allows for dosing for individuals at least 90th percentile weight |
65649055102 |
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Movantik |
naloxegol oxalate tab |
12.5 MG ; 25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Symproic |
naldemedine tosylate tab |
0.2 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Trulance |
plecanatide tab |
3 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Amitiza |
lubiprostone cap |
24 MCG ; 8 MCG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Ibsrela |
tenapanor hcl tab |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Linzess |
linaclotide cap |
145 MCG ; 290 MCG ; 72 MCG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Motegrity |
prucalopride succinate tab |
1 MG ; 2 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Relistor |
methylnaltrexone bromide inj ; methylnaltrexone bromide tab |
12 MG/0.6ML ; 150 MG ; 8 MG/0.4ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Amitiza |
Lubiprostone Cap 24 MCG |
24 MCG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Amitiza |
Lubiprostone Cap 8 MCG |
8 MCG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Ibsrela |
tenapanor hcl tab |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Linzess |
linaclotide cap |
145 MCG ; 290 MCG ; 72 MCG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Motegrity |
prucalopride succinate tab |
1 MG ; 2 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Movantik |
naloxegol oxalate tab |
12.5 MG ; 25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Relistor |
methylnaltrexone bromide inj |
12 MG/0.6ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Relistor |
methylnaltrexone bromide inj |
12 MG/0.6ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Relistor |
Methylnaltrexone Bromide Inj 8 MG/0.4ML (20 MG/ML) |
8 MG/0.4ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Relistor |
methylnaltrexone bromide tab |
150 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Symproic |
naldemedine tosylate tab |
0.2 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Trulance |
plecanatide tab |
3 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||
Through Preferred |
TARGET AGENT(S) Preferred Agent(s) Nonpreferred Agent(s) Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 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:
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.
ALBP _ Commercial _ CSReg _ Constipation_Agents_PAQL _ProgSum_ 10-01-2024 _
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