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Opioid Receptor Antagonists for Treating Opioid Induced Constipation

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Opioid Receptor Antagonists for Treating Opioid Induced Constipation DORSET MEDICINES ADVISORY GROUP COMMISSIONING STATEMENT FOR PRESCRIBING PERIPHERALLY ACTING MU- OPIOID RECEPTOR ANTAGONISTS FOR TREATING OPIOID INDUCED CONSTIPATION SUMMARY The Dorset Clinical Commissioning Group commissions peripherally acting mu-opioid receptor antagonists (PAMORAs) naloxegol and naldemedine in accordance with NICE guidance (TA345 and TA651, respectively). This commissioning statement covers two peripherally acting mu-opioid receptor antagonists (PAMORAs) – naloxegol and naldemedine. Naldemedine (Rizmoic®) is an antagonist of opioid binding at the mu-, delta-, and kappa-opioid receptors. It functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids without reversing the central nervous system (CNS)-mediated opioid effects. It has a marketing authorisation in the UK for the treatment of opioid-induced constipation in adult patients who have previously been treated with a laxative. BACKGROUND Naloxegol (Moventig®) is a form of naloxol which has been pegylated (that is, attached to a molecule of polyethylene glycol, or PEG). In this form, it selectively antagonises peripheral opioid receptors to relieve constipation. It has a marketing authorisation for treating opioid-induced constipation in adults whose constipation has had an inadequate response to laxative(s). The marketing authorisation for naloxegol defines an inadequate response to laxative(s) as moderate, severe or very severe symptoms of opioid induced constipation in at least 1 of the 4 stool symptom domains (that is, incomplete bowel movement, hard stools, straining or false alarms) while taking at least 1 laxative class for at least 4 days during the prior 2 weeks. RELEVANT NICE NICE TA345: Naloxegol for treating opioid‑induced constipation (July 2015) GUIDANCE NICE TA651: Naldemedine for treating opioid-induced constipation (Sep 2020) FORMULARY STATUS Green PBR STATUS Included within PbR tariff NICE consider naloxegol would be an alternative to methylnaltrexone and COMMISSIONING would be similarly positioned in the treatment pathway after treatment with a IMPLICATIONS stimulant and osmotic laxative had failed. There is no formal treatment pathway for people with OIC. PAMORAs are PATIENT PATHWAY intended to be used after standard laxatives, either alone or in combination. IMPLICATIONS Both naldemedine and naloxegol are a similar cost at the time of writing. The most commonly reported adverse reactions to naloxegol and naldemedine are abdominal pain, diarrhoea, nausea and vomiting. The PRESCRIBING majority of gastrointestinal adverse reactions are graded as mild to moderate, INFORMATION occur early in treatment and resolve with continued treatment. For full details of adverse reactions and contraindications, see the summary of product characteristics for the individual medicine. Naldemedine is a black triangle drug (▼), it is important to report suspected adverse reactions using the Yellow Card Scheme. The treatment of opioid-induced constipation depends on whether the opioid is the only cause of the constipation (pure opioid-induced constipation) or if there are other contributing factors (mixed aetiology constipation). Treatment may include a peripherally acting mu-opioid receptor antagonist (PAMORA) alone. But, commonly a PAMORA and a conventional laxative are used together. NICE TA345 states that naloxegol is effective compared with placebo in treating opioid induced constipation that has not responded adequately to SUMMARY OF EVIDENCE laxatives. TO SUPPORT Clinical evidence also shows that naldemedine increases the frequency of FORMULARY STATUS bowel movements compared with no treatment and other PAMORAs. The cost-effectiveness evidence in NICE TA651 includes naldemedine in several clinical scenarios, for both pure opioid-induced constipation and mixed aetiology constipation. In all scenarios, the most likely cost-effectiveness results are within what NICE normally considers an acceptable use of NHS resources. Therefore, naldemedine is recommended for opioid-induced constipation in adults who have had laxative treatment. Combination standard laxatives are recommended for mixed aetiology constipation, when initial laxative therapy has been tried. The list price for naloxegol is £55.20 per 30-tablet pack of 12.5-mg or 25-mg film-coated tablets. The recommended dose is 25 mg taken orally once daily (or 12.5 mg for people with renal insufficiency). Costs may vary in different settings because of negotiated procurement discounts. The list price of a 28-tablet pack of naldemedine is £41.72 per 28-tablet pack ASSESSMENT OF COST of the 200microgram tablets (excluding VAT; BNF online, accessed March IMPLICATIONS 2020). The recommended dose is 200micrograms taken orally once daily. The cost of a course of treatment depends on the duration of opioid-induced constipation needing treatment. Costs may vary in different settings because of negotiated procurement discounts. Prices correct as at October 2020. Summary of product characteristics for naloxegol (accessed 15/10/2020) NICE TA345: Naloxegol for treating opioid‑induced constipation (July 2015) REFERENCES Summary of product characteristics for naldemedine (accessed 15/10/2020) NICE TA651: Naldemedine for treating opioid-induced constipation (Sep 2020) APPROVED BY DMAG November 2020 REVIEW DATE November 2022 or before, in light of new information CONTACT FOR THIS The Gastroenterology Working Group via POLICY [email protected] .
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