Dramatic increase in drug use for opioid-induced constipation


A call for the more appropriate use of a new class of drugs for the treatment of opioids constipation (OIC) has been published by researchers who found that the number of Medicare beneficiaries using these drugs, as well as the associated costs, skyrocketed over a 4-year period (2014-2018).

This class of drugs, known as µ-opioid receptor peripheral antagonists (PAMORA), include methylnaltrexone (Relistor), which was approved by the FDA in 2008; naloxegol (Movantik), approved in 2014; i naldemedina (Symproic), approved in 2017.

During this four-year period, the number of Medicare beneficiaries taking these drugs increased nearly 20-fold, from 4,221 to 72,592 patients.

The team also found that the prescription for these medications was not limited to palliative care and pain specialists. Among the 6989 physicians who prescribed any of the three PAMORAs currently available during the study period, 20.2% were family physicians, 18% were internal medicine specialists, and 15.4% were nurses.

“Our findings, a significant and growing expenditure on PAMORA, and use between specialties, serve as a call to first define and then implement the appropriate use of PAMORA,” the researchers say.

The study was published online April 19 at Journal of Palliative Medicine.

Lead author Arjun Gupta, MD, senior member in hematology / oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, suspects that clinical guidelines on their use are not being followed medicines. These guidelines recommend that PAMORAs be used only after traditional ones laxatives are tested.

He also suspects that aggressive marketing has played an important role.

In a tweetorial about his study, Gupta notes that in the middle of the study period (2014-2018), the 2016 Super Bowl television coverage featured a featured ad for OIC that included a link to a website for the naloxegol.

The study documents a sharp increase in the prescription of these drugs after 2016 and shows that naloxegol was the most widely used drug of the three drugs available in 2018.

The researchers note that their study “does not explain the suitability of PAMORA therapy, which we have not been able to assess using this database.” They point out that PAMORAs are indicated for laxative-refractory OICs.

“Considering multiple oncology guidelines or gastrointestinal societies, the use of PAMORA is only recommended in very select situations, which is just the OIC treatment that is already established,” Gupta said. Medscape Medical News.

For example, the 2019 guidelines of the American Gastroenterological Association (AGA) recommend that PAMORA be used only after a “proper trial” of traditional laxatives has not resolved symptoms.

The AGA defines an appropriate trial as testing two or more laxatives on a scheduled basis rather than doing as needed.

“This means that a PAMORA should only be used in patients who have been following an appropriate regimen of preventive medication against constipation, that is, traditional laxatives, which are usually available without a prescription and are economical,” he said. underlined Gupta.

Instead, a 10-day supply of PAMORA costs $ 700, he points out.

“OIC is perhaps the most common and distressing complication of opioid use, so I don’t want the message to be that PAMORAs are useless: we’ve used them successfully in patients who really need them. and patients have really benefited. ”Gupta said.

He also noted that almost all patients taking opioids have a very high risk of developing OIC and that, once the OIC is established, it is very difficult to treat, Gupta stressed.

“There is a memorable opinion:“ The hand that writes the opioid prescription will write the intestinal regimen at the same time, otherwise the same hand will be responsible for the disaffection, ”Gupta noted.

Commenting on the findings, Timothy Brown, MD, a fellow in hematology / oncology, University of Pennsylvania, Philadelphia, Pennsylvania, noted that in his own studio, almost 90% of lung cancer patients for whom opioids had been initiated received inadequate or inadequate OIC prophylaxis. However, he commented: “Much of the data we collected was prior to the widespread publication of the current guidelines in 2019, so it is possible that not much attention was paid to the OIC at that time.”

Brown said Medscape Medical News that according to his experience, “most patients are able to tolerate a prophylactic regimen.”

Brown agrees with Gupta, noting that because people taking opioids have a high risk of developing OIC, “they should be prescribed a prescription for a prophylactic regimen at the same time as the opioid is prescribed and should of being a cathartic laxative, such as Senna, or an osmotic laxative, such as MiraLAX. “

Results of the Medicare dataset

For their study, the team used a Medicare data set that contains outpatient drug costs for approximately 75% of all Medicare beneficiaries.

“For each PAMORA, we extracted the annual expense, the number of beneficiaries who received a PAMORA prescription, the number of claims for the PAMORA, and the expense per beneficiary and claim,” Gupta and colleagues explain. Expenditure was adjusted for inflation and is presented in 2018 US dollars.

“After FDA approval in 2014, naloxegol surpassed methylnaltrexone in number of users in 2015 and in spending in 2016 and continued to be the most consumed drug in 2018,” the researchers note.

Unit spending was even higher for methylnaltrexone, which reached $ 178 in 2016, after which it declined after the introduction of naloxegol and the oral formulation of methylnaltrexone.

Among clinicians who prescribed a PAMORA, 8.5% issued a prescription to more than 10 beneficiaries. In this particular subgroup, the most common prescribers were practicing nurses, with 19.6%, followed by anesthesiologists, with 13.2%, and medical assistants, with 12.2%. Gupta commented that it is unclear whether the practicing nurses acted alone in prescribing a PANOMA or whether they were part of an oncology practice and did so under the supervision of a physician.

“We just wanted to point out that it’s not just highly specialized professionals like palliative care professionals who treat patients with very high doses of opioids and who treat OICs all the time,” he stressed.

In fact, a previous study who analyzed IQVIA data from 2016 to 2017 showed that the prescription of PAMORA by hospice and palliative medicine clinicians and oncologists was low.

Gupta and Brown have not revealed any relevant financial relationship.

J Palliat Med. Published online April 19, 2021. Summary

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