Cigna Drug and Biologic Coverage Policy
|
|
- Mervin McCoy
- 5 years ago
- Views:
Transcription
1 Cigna Drug and Biologic Coverage Policy Subject Transmucosal Fentanyl Effective Date... 4/15/2018 Next Review Date... 4/15/2019 Coverage Policy Number Table of Contents Coverage Policy... 1 General Background... 7 Coding/Billing Information... 9 References... 9 Related Coverage Resources Controlled Substance Analgesic and Narcotic Antagonist Quantity Limitations - (1706) INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Coverage Policy Cigna covers generic transmucosal fentanyl lozenge as medically necessary for the treatment of breakthrough cancer pain in an individual 16 years of age and older who is currently receiving and tolerant to opioid therapy. Cigna covers transmucosal fentanyl (Actiq ) as medically necessary for the treatment of breakthrough cancer pain in an individual 16 years of age and older who is currently receiving and tolerant to opioid therapy AND ONE of the following: For Employer Group Benefit Plans, ONE of the following: o For Standard and Performance Prescription Drug Lists: documented prior use of generic transmucosal fentanyl lozenge AND documented inadequate response, intolerance, inability to use, or individual is not a candidate for the preferred brand transmucosal fentanyl product, Subsys. o For Value and Advantage Prescription Drug Lists: documented prior use of generic transmucosal fentanyl lozenge For Individual and Family Plans: documented prior use of generic transmucosal fentanyl lozenge Page 1 of 11
2 Cigna covers transmucosal fentanyl (Subsys ) as medically necessary when ONE of the following is met: For Employer Group Benefit Plans, ONE of the following: o Standard and Performance Prescription Drug Lists: Treatment of breakthrough cancer pain in an individual 18 years of age and older who is currently receiving and tolerant to o opioid therapy Value and Advantage Prescription Drug Lists: Treatment of breakthrough cancer pain in an individual 18 years of age and older who is currently receiving and tolerant to opioid therapy AND documented inadequate response, intolerance, inability to use or individual is not a candidate for the generic formulation of transmucosal fentanyl lozenge For Individual and Family Plans: Treatment of breakthrough cancer pain in an individual 18 years of age and older who is currently receiving and tolerant to opioid therapy AND documented inadequate response, intolerance, inability to use or individual is not a candidate for the generic formulation of transmucosal fentanyl lozenge Cigna covers transmucosal fentanyl (Abstral, Fentora, Lazanda ) as medically necessary for the treatment of breakthrough cancer pain in an individual 18 years of age and older who is currently receiving and tolerant to opioid therapy AND: For Employer Group Benefit Plans, ONE of the following: o For Standard and Performance Prescription Drug Lists: Documented inadequate response, intolerance, inability to use or individual is not a candidate for the generic formulation of transmucosal fentanyl lozenge AND the preferred brand transmucosal o fentanyl product, Subsys. For Value and Advantage Prescription Drug Lists: Documented inadequate response, intolerance, inability to use or individual is not a candidate for the generic formulation of transmucosal fentanyl lozenge For Individual and Family Plans: Documented inadequate response, intolerance, inability to use or individual is not a candidate for the generic formulation of transmucosal fentanyl lozenge Cigna does not cover the use of transmucosal fentanyl for any other indication including the following because it is considered experimental, investigational or unproven (this list may not be all-inclusive): Management of acute pain in children (intranasal fentanyl) Outpatient treatment of acute refractory migraine headache pain in patients with history of opioid use refractory to conventional treatment Pain relief during childbirth Pediatric dental sedation Relief of episodic breathlessness in patients with advanced cancer When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to transmucosal fentanyl therapy. Note: Receipt of sample product does not satisfy any criteria requirements for coverage FDA Approved Indications Product Abstral Indication Abstral is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to aroundthe-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, aroundthe-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids while taking Abstral. Page 2 of 11
3 Actiq Fentora Lazanda Limitations of Use: Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency department. As a part of the TIRF REMS Access program, Abstral may be dispensed only to outpatients enrolled in the program. For inpatient administration of Abstral (For example; hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required. Actiq is an opioid agonist indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, aroundthe-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids while taking Actiq. Limitations of Use: Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine or dental pain. As a part of the TIRF REMS Access program, Actiq may be dispensed only to outpatients enrolled in the program. For inpatient administration of Actiq (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required. Fentanyl buccal tablets are an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, aroundthe-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablets. Limitations of Use: Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine, or dental pain. As a part of the TIRF REMS Access program, fentanyl buccal tablets may be dispensed only to patients enrolled in the TIRF REMS Access program. For inpatient administration of fentanyl buccal tablets (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required. Lazanda is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to aroundthe-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, aroundthe-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids while taking Lazanda. Limitations of use: Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room. As a part of the TIRF REMS Access program, Lazanda may be dispensed only to outpatients enrolled in the program. For inpatient administration of Lazanda (e.g., hospitals, Page 3 of 11
4 Subsys hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required. Subsys is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to aroundthe-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, aroundthe-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking Subsys. Limitations of Use: Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room. As a part of the TIRF REMS Access program, Subsys may be dispensed only to outpatients enrolled in the program. For inpatient administration of Subsys (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required. FDA Recommended Dosing Product Abstral Dosing Individually titrate Abstral to a dose that provides adequate analgesia and minimizes side effects. Due to differences in the pharmacokinetic properties and individual variability, even patients switching from other fentanyl containing products to Abstral must start with the 100 mcg dose except patients switching from Actiq. Abstral is not equivalent on a mcg per mcg basis with all other fentanyl products, therefore, do not switch patients on a mcg per mcg basis from any other fentanyl product. Abstral is NOT a generic version of any other fentanyl product. Conversion of ABSTRAL from Actiq a. For patients being converted from Actiq, prescribers must use the Initial Dosing Recommendations for Patients on Actiq. See Table 1 for initial dosing recommendations. Patients must be instructed to stop the use of Actiq and dispose of any remaining units. Table 1: Initial Dosing Recommendations for Patients on Actiq Current Actiq Dose (mcg) Initial Abstral Dose (mcg) b. For patients converting from Actiq doses of 200 mcg and 400 mcg, initiate titration with 100 mcg and 200 mcg of Abstral, respectively and proceed using multiples of this strength. c. For patients converting from Actiq doses of 600 and 800 mcg, initiate titration with 200 mcg and 200mcg Abstral, respectively and proceed using multiples of this strength. d. For patients converting from Actiq doses of 1200 and 1600 mcg, initiate titration with 200 mcg and 400 mcg Abstral, respectively and proceed using multiples of this strength. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. When opioid therapy is no longer required, consider discontinuing the medication along with a gradual downward of other opioids to minimize possible withdrawal effects. Page 4 of 11
5 Actiq Fentora The appropriate dosing and safety of fentanyl citrate in opioid tolerant children with breakthrough cancer pain have not been established below the age of 16 years. The initial dose of oral transmucosal fentanyl citrate to treat episodes of breakthrough cancer pain is always 200 mcg. Patients should be prescribed an initial titration supply of six 200 mcg oral transmucosal fentanyl citrate units, thus limiting the number of units in the home during titration. Patients should use up all units before increasing to a higher dose. Because potent opioids can cause hypoventilation, fentanyl citrate should be titrated with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to hypoventilation. Per FDA approved label, once a successful dose has been found, patients should limit consumption to four or fewer units per day. Once titrated to an effective dose, patients should generally use ONLY ONE Actiq unit of the appropriate strength per breakthrough pain episode. On those occasions when the breakthrough pain episode is not relieved 15 minutes after completion of the Actiq unit, patient may take ONLY ONE additional dose using the same strength for that episode. Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with Actiq. Once a successful dose has been found (i.e., an average episode is treated with a single unit), patients should limit consumption to four or fewer units per day. If the patient experiences greater than four breakthrough pain episodes per day, the dose of the maintenance (around-the-clock) opioid used for persistent pain should be re-evaluated. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. When opioid therapy is no longer required, consider discontinuing the medication along with a gradual downward of other opioids to minimize possible withdrawal effects. Fentora is not bioequivalent with other fentanyl products. Do not convert patients on a mcg per mcg basis from other fentanyl products. There are no conversion directions available for patients on any other fentanyl products other than Actiq. All patients should be titrated from the 100 mcg dose. Patients on Actiq - The initial dose of Fentora is always 100 mcg with the only exception being patients already using Actiq. For patients being converted from Actiq, prescribers must use the Initial Dosing Recommendations for Patients on Actiq table below. The doses of Fentora in this table are starting doses and not intended to represent equianalgesic doses to Actiq. Patients must be instructed to stop the use of Actiq and dispose of any remaining units. Current Actiq Dose (mcg) Initial Fentora Dose (mcg) x x 200 For patients converting from Actiq doses equal to or greater than 600 mcg, titration should be initiated with the 200 mcg Fentora tablet and should proceed using multiples of this tablet strength. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. When opioid therapy is no longer required, consider discontinuing the medication along with a gradual downward of other opioids to minimize possible withdrawal effects. Maintenance Dosing a. Once titrated to an effective dose, patients should generally use only ONE Fentora tablet of the appropriate strength per breakthrough pain episode. b. On occasion when the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY ONE additional dose using the same strength for that episode. Page 5 of 11
6 Lazanda Subsys c. Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with Fentora. d. Dosage adjustment of Fentora may be required in some patients. Generally, the Fentora dose should be increased only when a single administration of the current dose fails to adequately treat the breakthrough pain episode for several consecutive episodes. e. If the patient experiences greater than four breakthrough pain episodes per day, the dose of the around-the-clock opioid used for persistent pain should be re-evaluated. f. Once an effective dose is determined using the titration scheme outlined above, an alternate route of administration is sublingual (placing the tablet under the tongue.) The goal of dose titration is to find the individual patient s effective and tolerable dose. Individually titrate Lazanda to a dose that provides adequate analgesia with tolerable side effects. Initiate treatment with Lazanda for all patients (including those switching from another fentanyl product) using ONE 100 mcg spray of Lazanda (1 spray in one nostril). Due to differences in pharmacokinetic properties and individual variability, do not switch patients on a mcg per mcg basis from any other fentanyl product to Lazanda, as Lazanda is not equivalent with any other fentanyl product, nor is Lazanda a generic version of any other fentanyl product. If adequate analgesia is obtained within 30 minutes of administration of the 100 mcg single spray, treat subsequent episodes of breakthrough pain with this dose. Titration steps: If adequate analgesia is not achieved with the first 100 mcg dose, dose escalate in a step-wise manner over consecutive episodes of breakthrough pain until adequate analgesia with tolerable side effects is achieved. Patients MUST wait at least 2 hours before treating another episode of breakthrough cancer pain with Lazanda. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. When opioid therapy is no longer required, consider discontinuing the medication along with a gradual downward of other opioids to minimize possible withdrawal effects. Subsys is not bioequivalent with other fentanyl products. Do not convert patients on a mcg per mcg basis from other fentanyl products. There are no conversion directions available for patients on any other fentanyl products other than Actiq. (Note: This includes oral, transdermal, or parenteral formulations of fentanyl.) Subsys is NOT a generic version of any other oral transmucosal fentanyl product. The initial dose of Subsys is always 100 mcg with the only exception of patients already using Actiq (see table below). Prescribe an initial titration supply of 100 mcg Subsys units, which limits the number of units in the home during titration. Avoid prescribing a higher dose until patients have used up all units to prevent confusion and possible overdose. Current ACTIQ Dose (mcg) Initial SUBSYS Dose (mcg) mcg spray mcg spray mcg spray mcg spray mcg spray mcg spray Patients must be instructed to stop the use of Actiq and dispose of any remaining units. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. When opioid therapy is no longer required, consider discontinuing the medication along with a gradual downward of other opioids to minimize possible withdrawal effects. Page 6 of 11
7 TRANSMUCOSAL IMMEDIATE RELEASE FENTANYL (TIRF) RISK EVALUATION AND MITIGATION STRATEGY (REMS) In March, 2012, the FDA approved a single shared REMS for the TIRF products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system. TIRF medicines, which include the brand-name drugs Abstral, Actiq, Fentora, Lazanda, and Subsys are narcotic pain medicines called opioids used to manage pain in adults with cancer who routinely take other opioid pain medicines around-the-clock. The goals of the TIRF REMS Access Program are to ensure patient access to important medications and mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by: prescribing and dispensing TIRF medicines only to appropriate patients, including use only in opioidtolerant patients preventing inappropriate conversion between fentanyl products preventing accidental exposure to children and others for whom TIRF medicines were not prescribed educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose., Actiq, All TIRF products have an individual REMS in place. Prescribers and pharmacies enrolled in an individual REMS program for at least one TIRF medicine will automatically be transitioned to the shared TIRF REMS Access program. Health care professionals who prescribe TIRF medicines that will only be used in an inpatient setting (hospitals, hospices, or long-term care facilities) will not be required to enroll in the TIRF REMS Access program. Similarly, patients who receive TIRF medicines in an inpatient setting are not required to enroll in the program. Long term care and hospice patients who obtain their medications from outpatient pharmacies must still be enrolled. General Background Pharmacology Opioids produce analgesia by interacting with opioid receptors at several sites within and outside of the central nervous system. Fentanyl, a synthetic opioid, is approximately 100 times more potent than morphine for analgesia. Opioids, including fentanyl, are central nervous system depressants and exert effects on the gastrointestinal tract. (Gutstein, 2006) Guidelines National Comprehensive Cancer Network (NCCN) The National Comprehensive Cancer Network guidelines suggest transmucosal fentanyl is a treatment option for incidents of breakthrough pain which is not the result of insufficient dosing of scheduled opioids. Patients should be started at a low dose and individualized for response. (NCCN, 2018) Clinical Efficacy Product Efficacy Abstral Fentanyl sublingual tablet has not been compared to other treatments for cancer breakthrough pain in published trials. Fentanyl was more effective than placebo in 2 randomized placebo-controlled trials in patients with breakthrough cancer pain. One fixed-dose crossover study comparing fentanyl sublingual tablet in 100, 200, and 400 mcg strengths to placebo reported the 400 mcg strength was better than placebo (p<0.0001) for reducing the overall mean PID (pain intensity difference before and after treatment). The 100 mcg and 200 mcg doses were not statistically superior to placebo for PID at any time point. The other controlled trial compared fentanyl sublingual tablet at a dose identified during titration (range: mcg) to placebo (7 doses of active drug and 3 doses of placebo in random order). Fentanyl sublingual tablet produced greater reduction in pain (endpoint: the sum of PID) at 30 minutes and at 60 minutes compared with placebo (p<0.0004). Improvement in PID was statistically significant starting at 10 minute and continued throughout the 60-minute assessment period (p< vs placebo). One open-label study evaluating fentanyl sublingual for up to 12-months duration reported patient satisfaction with pain medication was improved at the end-of-study visit compared to screening. Page 7 of 11
8 Actiq Fentora Lazanda The efficacy of OTFC for the management of breakthrough cancer pain has been studied in a double-blind, placebo-controlled, randomized study in cancer patients receiving the oral morphine sulfate daily or transdermal fentanyl per hour for the management of chronic cancer pain and who experienced at least one occurrence of breakthrough pain daily. Following titration to an effective dose of OTFC, patients experienced substantially more pain relief than placebo. Additionally, when OTFC was used for breakthrough cancer pain, rescue drug therapy was required less frequently than when placebo was used for such breakthrough pain. A randomized, double-blind crossover study evaluated the tolerability, efficacy, and formulation preference of two formulations of OTFC in 14 patients with grade 3 or 4 radiation-induced mucositis. Patients received an OTFC unit 45 minutes before radiation treatment on four separate days. Two units had a sweetened matrix formulation, two had a compressed powder formulation, with one unit of each formulation containing 200 mcg fentanyl, and one was placebo. Results showed that there were no changes in oral mucosa, and fentanyl 200 mcg did not yield analgesia greater than placebo. In addition, there were no significant differences between formulations in tolerability, patient preference, or visual analog scale (VAS) pain scores. A single-dose, randomized, open-label, three-period comparative study evaluated the relative bioavailability of FEBT1,080 mcg with OTFC 1,600 mcg and the dose proportionality of FEBT from 270 µg to 1300 µg in 39 healthy adults. In the first two periods, each participant randomly received 1080 mcg FEBT and 1600 mcg OTFC. Following the completion of the second period, subjects were re-randomized to receive 1300, 810, or 270 mcg FEBT. Total systemic exposure was statistically similar between FEBT 1,080 mcg and OTFC 1,600 mcg. However, the rate of absorption was faster for FEBT than for OTFC, leading to an approximate 23% higher peak exposure and an earlier Tmax (1 hr vs 2 hr, p<0.0001). Early systemic exposure [the area-under- the curve (AUC) from time 0 to 1 hour) was significantly greater with FEBT compared with OTFC (p<0.001). Results showed that fentanyl AUC increased proportionally to dose from 270 mcg to 1300 mcg FEBT, and the doses above 810 mcg showed a less-than-dose-proportional increase in C (max). Based on the pharmacokinetic parameters (AUC, Cmax, and Tmax), fentanyl enters the systemic circulation to a significantly greater extent and significantly more rapidly with FEBT compared with OTFC. A double-blind, randomized, placebo-controlled study evaluated the efficacy, safety, and tolerability of FEBT in opioid-treated Individuals with cancer-related breakthrough pain (BTP) in 123 Individuals. After a titration to identify fentanyl buccal dose to treat BTP episodes, 77 Individuals were randomly assigned to one of 18 prespecified dose sequences of 10 tablets including seven fentanyl buccal tablet and three placebo. Pain intensity, pain relief (PR), and global performance of the medication were recorded at regular time intervals between 15 and 60 minutes. Pain intensity differences (PID), the summed PID (SPID), and summed total PR were calculated. The primary endpoint was the SPID at 30 minutes (SPID30). A total of 80 out of 123 Individuals (65%) were titrated to an effective dose. The mean SPID30 for fentanyl buccal tablet was 3.0+/-0.12 versus 1.8+/-0.18 for placebo (p<0.0001). Compared to placebo, significant improvement with the measures of PR, PID, SPID, and summed total PR were observed with FEBT. Reported adverse events were similar to other types of opioid drugs. Poor oral tolerability was reported in two Individuals. The efficacy of Lazanda was evaluated in one clinical trial in opioid tolerant adult patients experiencing breakthrough cancer pain. All patients were on stable doses of either long-acting oral opioids or transdermal fentanyl for their persistent cancer pain. The clinical trial included an openlabel titration phase where a dose was identified that provided adequate analgesia with tolerable side effects, within the range of 100 to 800 mcg. In the double-blind, placebo-controlled portion of the study, patients who were titrated to an adequate dose were randomized to a blinded sequence of 10 treatments with 7 being the identified dose of Lazanda and 3 being placebo. Of the patients who enrolled in the study, 73% achieved an adequate dose during the titration phase, 6% withdrew for lack of effective pain relief, and 5% withdrew due to adverse events. The primary outcome measure, the mean sum of the pain intensity difference at 30 minutes (SPID30), was statistically significantly higher for Lazanda than for placebo. Page 8 of 11
9 Subsys The efficacy of Subsys was demonstrated in a double-blind, placebo-controlled, crossover study in opioid tolerant adult patients with cancer and breakthrough pain. The dose range studied was from 100 mcg per dose to 1600 mcg per dose. Patients entering the trial must have had on average 1-4 episodes of pain per day not controlled on stable, chronic maintenance doses of opioid medication of at least 60 mg/day of morphine, 25 mcg/hr of transdermal fentanyl, or an equianalgesic dose of another opioid for at least 7 days. The study began with an open-label dose titration period followed by a double-blind treatment period. The goal of titration was to find the dose of Subsys that provided adequate analgesia with acceptable side effects. Patients were titrated from a 100 mcg starting dose. Once a successful dose was established, patients were enrolled into the double-blind period and randomized to a sequence of 10 treatments; 7 with Subsys and 3 with placebo. Subsys produced a statistically significantly greater reduction in pain intensity compared to placebo as measured by the Summed Pain Intensity Differences scale (SPID) at 30 minutes. The primary outcome measure, the mean sum of the pain intensity difference at 30 minutes (SPID30), was statistically significantly higher for Subsys than for placebo. Experimental, Investigational, Unproven Uses Case series, randomized controlled trials and systematic reviews have investigated transmucosal fentanyl for various conditions/ indications, including the management of acute pain in children (intranasal fentanyl) (Murphy, 2014), outpatient treatment of acute refractory migraine headache pain in patients with history of opioid use refractory to conventional treatment (Landry, 2004), pain relief during childbirth (Fleet, 2015), pediatric dental sedation (Smith, 2010) and relief of episodic breathlessness in patients with advanced cancer (Simon, 2016). Coding/Billing Information Note: Transmucosal fentanyl is typically covered under pharmacy benefit plans. Certain prescription drugs require an authorization for coverage to ensure that appropriate treatment regimens are followed. Medical drug coding and diagnosis codes, however, are generally not required for pharmacy claims submissions, therefore, this section is not in use. References 1. Archimedes Pharma US Inc. Lazanda (fentanyl nasal spray) product information. Bedminster, NJ: Archimedes Pharma US Inc. March Cephalon, Inc. Actiq (fentanyl citrate) oral transmucosal lozenge product information. Frazer, PA: Cephalon, Inc. Dec Cephalon, Inc. Fentora (fentanyl buccal tablet) product information. Frazer, PA: Cephalon, Inc. April Fleet J, Belan I, Jones MJ, et al. A comparison of fentanyl with pethidine for pain relief during childbirth: a randomized controlled trial. BJOG. Jun 2015;122(7): Gutstein HB, Huda A. Opioid Analgesics. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 11th ed. New York, NY: McGraw Hill Medical Publishing; 2006: Insys Therapeutics, Inc. Subsys fentanyl sublingual spray product information. Phoenix, AZ: Insys Therapeutics, Inc. Dec Landy SH. Oral transmucosal fentanyl citrate for the treatment of migraine headache pain in outpatients: a case series. Headache. 2004;44: Murphy A, O Sullivan R, Wakai A, et al. Intranasal fentanyl for the management of acute pain in children. Cochrane Database Syst Rev Oct 10;10:CD DOI: / CD pub2. Page 9 of 11
10 9. NCCN Guidelines. Adult Cancer Pain. Jan National Comprehensive Cancer Network (NCCN). Available at PROPOSED TRANSMUCOSAL IMMEDIATE RELEASE FENTANYL (TIRF) RISK EVALUATION AND MITIGATION STRATEGY (REMS). Initial REMS Approval: 12/2012. Updated 12/2015 Accessed 3/10/2015. Available at Prostrakan Inc. Abstral (fentanyl) sublingual tablets product information. Bedminster, NJ: Prostrakan Inc. Dec Simon ST, Kloke M, Alt-Epping B, et al. EffenDys-Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine- Controlled, Crossover, Phase II Trial. J Pain Symptom Manage Nov;52(5): Smith, H. et. al. A comparison of four sedation techniques for pediatric dental surgery. Paediatric Anaesthesia. 20(10):924-30, 2010 Oct. Page 10 of 11
11 Cigna Companies refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc Cigna. Page 11 of 11
NATL. II. Health Net Approved Indications and Usage Guidelines: Diagnosis of cancer AND. Member is on fentanyl transdermal patches AND
Coverage of drugs is first determined by the member s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document I. FDA Approved Indications: The management of breakthrough
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Transmucosal Immediate Release Fentanyl Products Reference Number: CP.CPA.211 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Transmucosal Immediate Release Fentanyl Products Reference Number: CP.HNMC.211 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Medicaid Medi-Cal Revision Log See Important
More informationORAL TRANSMUCOSAL AND NASAL FENTANYL UTILIZATION MANAGEMENT CRITERIA
ORAL TRANSMUCOSAL AND NASAL FENTANYL UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: BRAND (generic) NAMES: Fentanyl by oral transmucosal and nasal delivery Actiq (fentanyl citrate) lozenge on a handle 200,
More informationEducation Program for Prescribers and Pharmacists
Transmucosal Immediate Release Fentanyl (TIRF) Products Risk Evaluation and Mitigation Strategy (REMS) Education Program for Prescribers and Pharmacists Products Covered Under this Program Abstral (fentanyl)
More informationCommittee Approval Date: September 12, 2014 Next Review Date: September 2015
Medication Policy Manual Topic: fentanyl-containing medications: - Actiq, fentanyl citrate oral transmucosal lozenges - Abstral fentanyl sublingual tablets - Fentora, fentanyl buccal tablet - fentanyl
More informationTransmucosal Immediate Release Fentanyl (TIRF) Prior Authorization, (Through Generic), and Quantity Limit Program Summary
Transmucosal Immediate Release Fentanyl (TIRF) Prior Authorization, (Through Generic), and Quantity Limit Program Summary FDA APPROVED INDICATIONS DOSAGE 1-5 Drug Indication Dosage Abstral (fentanyl sublingual
More informationFENTANYL CITRATE TRANSMUCOSAL UTILIZATION MANAGEMENT CRITERIA
FENTANYL CITRATE TRANSMUCOSAL UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: BRAND (generic) NAMES: HICL = H3AT Fentanyl citrate transmucosal Actiq (fentanyl citrate) lozenge on a handle 200, 400, 600, 800,
More informationLimitations of use: Subsys may be dispensed only to patients enrolled in the TIRF REMS Access program (1).
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.21 Subject: Subsys Page: 1 of 5 Last Review Date March 17, 2017 Subsys Description Subsys (fentanyl
More informationEmbeda. Embeda (morphine sulfate and naltrexone hydrochloride) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.39 Subject: Embeda Page: 1 of 6 Last Review Date: March 18, 2016 Embeda Description Embeda (morphine
More informationScottish Medicines Consortium
Scottish Medicines Consortium fentanyl 50 micrograms / dose, 100 micrograms/dose, 200 micrograms / dose nasal spray (Instanyl ) No. (579/09) Nycomed UK Ltd 09 October 2009 The Scottish Medicines Consortium
More informationDuragesic patch. Duragesic patch (fentanyl patch) Description
1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.31 Subject: Duragesic patch Page: 1 of 6 Last Review Date: March 18, 2016 Duragesic patch Description Duragesic patch (fentanyl
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Opioid Therapy Table of Contents Coverage Policy... 1 General Background... 4 Coding/Billing Information... 7 References... 7 Effective Date..1/1/2018 Next
More informationShort-Acting Fentanyl
Short-Acting Fentanyl Policy Number: 5.01.528 Last Review: 08/2018 Origination: 9/2007 Next Review: 08/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for oral short-acting
More informationOxymorphone (Opana ) is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate.
Page 1 of 7 Policies Repository Policy Title Policy Number Schedule II Prior Authorization FS.CLIN.16 Application of Pharmacy Policy is determined by benefits and contracts. Benefits may vary based on
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Apremilast Table of Contents Coverage Policy... 1 General Background... 2 Coding/Billing Information... 4 References... 4 Effective Date... 1/1/2018 Next
More informationMorphine Sulfate Hydromorphone Oxymorphone
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.02.33 Subject: Morphine Drug Class Page: 1 of 8 Last Review Date: June 19, 2015 Morphine Sulfate Hydromorphone
More information1. Developed: February Revised: December 2017; December 2015; March 2014; May 2012; July 2010; July 2007; January 2006.
Texas Vendor Drug Program Drug Use Criteria: Fentanyl (inhalation, oral and transdermal) Publication History 1. Developed: February 2003 2. Revised: December 2017; December 2015; March 2014; May 2012;
More informationNew Medicines Committee Briefing November 2011 Abstral (sublingual fentanyl citrate tablet) for the management of breakthrough cancer pain
New Medicines Committee Briefing November 2011 Abstral (sublingual fentanyl citrate tablet) for the management of breakthrough cancer pain Abstral is to be reviewed for use within: Primary Care Secondary
More informationDemerol (meperidine oral tablet, oral solution), Meperitab (oral tablet)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subsection: Analgesics and Opioids Original Policy Date: May 8, 2015 Subject: Meperidine Page: 1 of 5 Last
More informationFentanyl Agents Clinical Edit Criteria
Fentanyl Agents Clinical Edit Criteria Drug/Drug Class: Fentanyl Agents Superior HealthPlan follows the guidance of the Texas Vendor Drug Program (VDP) for all clinical edit criteria. Superior has adjusted
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Reference Number: CP.CPA.259 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important regulatory
More informationTo report SUSPECTED ADVERSE REACTIONS, contact Insys Therapeutics, Inc., at or FDA at FDA-1088 or medwatch.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SUBSYS safely and effectively. See full prescribing information for SUBSYS. SUBSYS (fentanyl sublingual
More informationNucynta IR/ Nucynta ER (tapentadol immediate-release and extendedrelease)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Nucynta Page: 1 of 7 Last Review Date: March 18, 2016 Nucynta Description Nucynta IR/ Nucynta
More informationPharmacy Medical Necessity Guidelines: Opioid Analgesics
Pharmacy Medical Necessity Guidelines: Effective: January 1, 2019 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy (RX) or Medical (MED) Benefit
More informationBree Collaborative AMDG Opioid Prescribing Guidelines Workgroup. Opioid Prescribing Metrics - DRAFT
Bree Collaborative AMDG Opioid Prescribing Guidelines Workgroup Opioid Prescribing Metrics - DRAFT Definitions: Days Supply: The total of all opioid prescriptions dispensed during the calendar quarter
More informationBreakthrough Cancer Pain (BTCP) 25 Years of Study: Key Insights
Breakthrough Cancer Pain (BTCP) 25 Years of Study: Key Insights Steven Wong, MD Assistant Professor of Medicine, Department of Medicine, Division of Hematology/Oncology, UCLA David Geffen School of Medicine
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Romiplostim Table of Contents Coverage Policy... 1 General Background... 2 Coding/Billing Information... 4 References... 4 Effective Date... 12/15/2017 Next
More informationMethadone. Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.41 Subject: Methadone Page: 1 of 8 Last Review Date: March 18, 2016 Methadone Description Dolophine
More informationLong-Acting Opioid Analgesics
Market DC Long-Acting Opioid Analgesics Override(s) Prior Authorization Step Therapy Quantity Limit Approval Duration Initial request: 3 months Maintenance Therapy: Additional prior authorization required
More informationLong-Acting Opioid Analgesics
Market DC Long-Acting Opioid Analgesics Override(s) Prior Authorization Step Therapy Quantity Limit Approval Duration Initial request: 3 months Maintenance Therapy: Additional prior authorization required
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Antiemetic Therapy Table of Contents Coverage Policy... 1 General Background... 6 Coding/Billing Information... 8 References... 8 Effective Date... 1/1/2018
More informationEXTENDED RELEASE OPIOID DRUGS
RATIONALE FOR INCLUSION IN PA PROGRAM Background Hydrocodone (Hysingla ER, Vantrela ER, Zohydro ER), hydromorphone (Exalgo), morphine sulfate (Arymo ER, Avinza, Embeda, Kadian, MorphaBond, MS Contin),
More informationNDA MF REMS ASSESSMENT ACKNOWLEDGMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 REMS ASSESSMENT ACKNOWLEDGMENT Insys Development Co. c/o Insys Therapeutics, Inc. 1333 South Spectrum Blvd.,
More informationPublic Assessment Report. Scientific discussion. Abstral, sublingual tablet 50, 100, 200, 300, 400, 600 and 800 μg. (Fentanyl citrate)
Public Assessment Report Scientific discussion Abstral, sublingual tablet 50, 100, 200, 300, 400, 600 and 800 μg (Fentanyl citrate) SE/H/575/01-07/DC This module reflects the scientific discussion for
More informationImmediate release fentanyl (DROP-List)
Bulletin 132 April 2016 Community Interest Company Immediate release fentanyl (DROP-List) This is one of a number of bulletins providing further information on medicines contained in the PrescQIPP DROP-List
More informationB. Long-acting/Extended-release Opioids
4 Opioid tolerance is assumed in patients already taking fentanyl 25 mcg/hr OR daily doses of the following oral agents for 1 week: 60 mg oral morphine, 30 mg oxycodone, 8 mg hydromorphone, 25 mg of oxymorphone
More informationDose titration of sublingual fentanyl, in relation to transdermal fentanyl dosing in cancer patients
74 Dose titration of sublingual fentanyl, in relation to transdermal fentanyl dosing in cancer patients Amaniti E MD, PhD, Zaralidou A MD, Maidatsi P MD, PhD, Mitos G MD, Thoma G MD, Vasilakos D MD, PhD.
More informationLong Term Care Formulary HCD - 08
1 of 5 PREAMBLE Opioids are an important component of the pharmaceutical armamentarium for management of chronic pain. The superiority of analgesic effect of one narcotic over another is not generally
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Voriconazole Effective Date... 3/15/2018 Next Review Date... 3/15/2019 Coverage Policy Number... 4004 Table of Contents Coverage Policy... 1 General Background...
More informationClinical Policy: Opioid Analgesics Reference Number: OH.PHAR.PPA.13 Effective Date: 10/2017 Last Review Date: 6/2018 Line of Business: Medicaid
Clinical Policy: Reference Number: OH.PHAR.PPA.13 Effective Date: 10/2017 Last Review Date: 6/2018 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationOpioid Conversions Mixture of Science and Art
Opioid Conversions Mixture of Science and Art Matthew J. Pingree, MD Assistant Professor Division of Pain Medicine Physical Medicine and Rehabilitation and Anesthesiology Mayo Clinic, Rochester Pingree.Matthew@Mayo.edu
More informationHOPE. Considerations. Considerations ISING. Safe Opioid Prescribing Guidelines for ACUTE Non-Malignant Pain
Due to the high level of prescription drug use and abuse in Lake County, these guidelines have been developed to standardize prescribing habits and limit risk of unintended harm when prescribing opioid
More informationNOVIDADES NO TRATAMENTO COM OPIOIDES. Novelties in therapeutic with opioids. V Congresso National de Cuidados Palliativos Marco 2010, Lisboa
NOVIDADES NO TRATAMENTO COM OPIOIDES Novelties in therapeutic with opioids V Congresso National de Cuidados Palliativos 11 12 Marco 2010, Lisboa Friedemann Nauck Department Palliative Medicine Center Anesthesiology,
More informationA Pharmacokinetic Study to Compare Two Simultaneous 400 µg Doses with a Single 800 µg Dose of Oral Transmucosal Fentanyl Citrate
Vol. 26 No. 2 August 2003 Journal of Pain and Symptom Management 743 Original Article A Pharmacokinetic Study to Compare Two Simultaneous 400 µg Doses with a Single 800 µg Dose of Oral Transmucosal Fentanyl
More informationfacilities that prescribe for inpatient use), patient and prescriber enrollment is not required.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ACTIQ safely and effectively. See full prescribing information for ACTIQ. ACTIQ (fentanyl citrate)
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Reference Number: HIM.PA.139 Effective Date: 12.01.17 Last Review Date: 02.18 Line of Business: Health Insurance Marketplace Revision Log See Important Reminder at the end of this policy
More informationCigna Drug and Biologic Policy
Cigna Drug and Biologic Policy Subject Collagenase clostridium histolyticum Effective Date... 11/15/2017 Next Review Date... 11/15/2018 Coverage Policy Number... 1021 Table of Contents Coverage Policy...
More informationProposed Changes to Existing Measure for HEDIS : Use of Opioids at High Dosage (UOD)
Proposed Changes to Existing Measure for HEDIS 1 2020: Use of Opioids at High Dosage (UOD) NCQA seeks comments on proposed revisions to the Use of Opioids at High Dosage HEDIS measure. The current measure
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Controlled Substance Analgesic and Narcotic Antagonist Quantity Limitations Table of Contents Coverage Policy... 1 General Background... 6 Coding/Billing
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Opioid Analgesics Reference Number: HIM.PA.139 Effective Date: 12.01.17 Last Review Date: 11.17 Line of Business: Health Insurance Marketplace Revision Log See Important Reminder at the
More informationPharmacologic Considerations for Managing Sickle Cell Pain Claire Saadeh, PharmD, BCOP May 5, 2015
Pharmacologic Considerations for Managing Sickle Cell Pain Claire Saadeh, PharmD, BCOP May 5, 2015 Table 1: Physiologic changes that occur during sickle cell pain crisis 1-3 Phase Description / Complications
More informationMedication Guide. Medication Guide. Lazanda (La-ZAN-da) CII. (fentanyl) nasal spray 100 mcg, 400 mcg
Medication Guide Medication Guide Lazanda (La-ZAN-da) CII (fentanyl) nasal spray 100 mcg, 400 mcg IMPORTANT: Do not use Lazanda unless you are regularly using another opioid pain medicine around-the-clock
More informationWhat stronger oxycodone 15 or morphine ir 15
What stronger oxycodone 15 or morphine ir 15 Here's the problem. I'm on Oxycodone for break through pain, and MSContin for long term pain relief. The problem is Morphine makes me too tired. Posts about
More informationSuffolk PCT Drug & Therapeutics Committee New Medicine Report
Suffolk PCT Drug & Therapeutics Committee New Medicine Report This drug has been reviewed because it is a product that may be prescribed in primary care. Medicine Fentanyl citrate oral and intranasal preparations
More information1/21/14. Cancer Related Pain: Case-Based Pharmacology. Conflicts of Interest. Learning Objective
Cancer Related Pain: Case-Based Pharmacology Jeannine M. Brant, PhD, APRN, AOCN Oncology Clinical Nurse Specialist Nurse Scientist Billings Clinic Conflicts of Interest Jeannine Brant has served on the
More informationSuboxone, Zubsolv, Bunavail (buprenorphine with naloxone sublingual tablets and film), Buprenorphine sublingual tablets
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.32 Subject: Suboxone Drug Class Page: 1 of 7 Last Review Date: June 24, 2016 Suboxone Drug Class Description
More informationOpioid Step Policy. Description. Section: Prescription Drugs Effective Date: April 1, 2018
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Opioid Step Policy Page: 1 of 6 Last Review Date: March 16, 2018 Opioid Step Policy Description
More information6. Never give SUBSYS to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.
Medication Guide SUBSYS (sub sis) CII (fentanyl) sublingual spray 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg IMPORTANT: Do not use SUBSYS unless you are regularly using another opioid pain medicine around-the-clock
More informationFact Sheet. Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII
Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII Fact Sheet Zohydro ER (hydrocodone bitartrate) Extended-Release Capsule, CII, is a long-acting (extendedrelease) type of pain medication
More informationReference ID: NDA was approved on December 12, The product was not formulated with properties to deter abuse,
tablets (NDA 020553). 1 According to Purdue, the reformulated OxyContin (OCR) had controlled-release features that would be less easily compromised by tampering than the original OxyContin (OC), and thereby
More informationAETNA BETTER HEALTH Prior Authorization guideline for Narcotic Analgesic Utilization
AETNA BETTER HEALTH Prior Authorization guideline for Narcotic Analgesic Utilization Policy applies to all formulary and non-formulary schedules II V opioid narcotics, including tramadol and codeine, as
More informationClinical Policy: Opioid Analgesics Reference Number: CP.PMN.97 Effective Date: Last Review Date: 02.19
Clinical Policy: Reference Number: CP.PMN.97 Effective Date: 02.11 Last Review Date: 02.19 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE. Opinion. 20 February 2008
The legally binding text is the original French version TRANSPARENCY COMMITTEE Opinion 20 February 2008 DUROGESIC 12 micrograms/hour (2.1 mg/5.25 cm²), transdermal patch Box of 5 sachets (CIP: 369 851-5)
More informationShining a Light on MEDs Understanding morphine equivalent dose
Shining a Light on MEDs Understanding morphine equivalent dose In the workers compensation industry, 60.2 percent of claimants utilize opioid analgesics for the treatment of pain caused by a workplace
More informationPrior Authorization Guideline
Guideline GL-35952 Opioid Quantity Limit Overrides Formulary OptumRx Formulary Note: Approval Date 7/10/2017 Revision Date 7/10/2017 Technician Note: P&T Approval Date: 2/16/2010; P&T Revision Date: 7/12/2011
More informationProposed Revision to Med (i)
Proposed Revision to Med 501.02 (i) I. Purpose This rule has been adopted to enable the Board to best protect public health and safety while providing a framework for licensees to effectively treat and
More informationPALLIATIVE TREATMENT BY DR. KHRONGKAMOL SIHABAN MEDICAL ONCOLOGIST
PALLIATIVE TREATMENT BY DR. KHRONGKAMOL SIHABAN MEDICAL ONCOLOGIST TREATMENT IN ONCOLOGY Main treatment : surgery Neoadjuvant treatment : RT, CMT Adjuvant treatment : Tx micrometastatic disease -CMT,Targeted
More informationInterprofessional Webinar Series
Interprofessional Webinar Series Opioids in the Medically Ill: Principles of Administration Russell K. Portenoy, MD Chief Medical Officer MJHS Hospice and Palliative Care Director MJHS Institute for Innovation
More informationOpioid Stewardship and Managing the Opioid Crisis: A Health-Care Perspective
Opioid Stewardship and Managing the Opioid Crisis: A Health-Care Perspective February 13, 2018 Frank Vocci, PhD New Therapies on the Horizon The planners, editors, faculty and reviewers of this activity
More informationOpioid Management of Chronic (Non- Cancer) Pain
Optima Health Opioid Management of Chronic (Non- Cancer) Pain Guideline History Original Approve Date 5/08 Review/Revise Dates 11/09, 9/11, 9/13, 09/15, 9/17 Next Review Date 9/19 These Guidelines are
More informationUSE OF BUPRENORPHINE FOR CHRONIC PAIN
Psychiatry and Addictions Case Conference UW Medicine Psychiatry and Behavioral Sciences USE OF BUPRENORPHINE FOR CHRONIC PAIN MARK SULLIVAN, MD, PHD PSYCHIATRY AND BEHAVIORAL SCIENCES ANESTHESIOLOGY AND
More informationMEDICAL ASSISTANCE BULLETIN
ISSUE DATE September 4, 2015 SUBJECT EFFECTIVE DATE September 9, 2015 MEDICAL ASSISTANCE BULLETIN NUMBER *See below BY Prior Authorization of Analgesics, Narcotic Long Acting and Analgesics, Narcotic Short
More informationHydrocodone/Acetaminophen Extended-Release Tablets M Clinical Study Report R&D/09/1109
2.0 Synopsis Abbott Laboratories Individual Study Table Referring to Part of Dossier: (For National Authority Use Only) Name of Study Drug: ABT-712 Volume: Hydrocodone/Acetaminophen Extended-Release Name
More informationFinal Appraisal Report. Fentanyl (Instanyl ) Nycomed UK Ltd. Advice No: 0710 April Recommendation of AWMSG
Final Appraisal Report Fentanyl (Instanyl ) Nycomed UK Ltd Advice No: 0710 April 2010 Recommendation of AWMSG Fentanyl intranasal spray (Instanyl ) is recommended as an option for use within NHS Wales
More informationConversion chart from fentanyl to opana er
Conversion chart from fentanyl to opana er (e.g., Nucynta). Both opioid products involved in conversion are one of the following: morphine, oxycodone, oxymorphone, hydromorphone (not extended- release),
More informationMorphine er to oxycontin conversion
Morphine er to oxycontin conversion The Borg System is 100 % Morphine er to oxycontin conversion 17-4-2011 Conversion dose from Oxycontin 40mg 3x a day to morphine sulfate 15 mg?. Oxycontin vs morphine
More informationOpioid Conversion Guidelines
Opioid Conversion Guidelines March 2015 Gippsland Region Palliative Care Consortium Clinical Practice Group Title Keywords Ratified Opioid, Conversion, Drug, Therapy, Palliative, Guideline, Palliative,
More informationFighting the Good Fight: How to Convert Opioids Just Right!
Fighting the Good Fight: How to Convert Opioids Just Right! Tanya J. Uritsky, PharmD, BCPS, CPE Clinical Pharmacy Specialist - Pain Medication Stewardship Hospital of the University of Pennsylvania - Philadelphia,
More informationAPC/DTC Briefing Document
Page 1 London New Drugs Group APC/DTC Briefing Document FENTANYL BUCCAL TABLETS (EFFENTORA) Contents Summary 1 Points for consideration 2 Background 2 Fentanyl 3 Fentanyl buccal tablets 3 US FDA Safety
More informationSlide 1. Slide 2. Slide 3. Opioid (Narcotic) Analgesics and Antagonists. Lesson 6.1. Lesson 6.1. Opioid (Narcotic) Analgesics and Antagonists
Slide 1 Opioid (Narcotic) Analgesics and Antagonists Chapter 6 1 Slide 2 Lesson 6.1 Opioid (Narcotic) Analgesics and Antagonists 1. Explain the classification, mechanism of action, and pharmacokinetics
More informationMEDICARE Program Policies & Procedures POLICY NUMBER: Medicare D-111
POLICY: Medicare Part D Formulary-Level Cumulative Opioid and Opioid/Buprenorphine POS Edits MEDICARE Program Policies & Procedures POLICY NUMBER: Medicare D-111 Policy for contracts H3351, S3521 and H3335
More informationGuide for Prescribers
N FENTORA Fentanyl Buccal/Sublingual Effervescent Tablets 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg fentanyl as fentanyl citrate Opioid Analgesic Guide for Prescribers Manufactured for: Teva Canada
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Alpha1-Proteinase Inhibitors Table of Contents Coverage Policy... 1 General Background... 3 Coding/Billing Information... 5 References... 6 Effective Date...
More informationDrug Information Common to the Class of Extended-Release and Long-Acting Opioid Analgesics (ER/LA opioid analgesics) Avinza Butrans
FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics 7/9/2012 Drug Information Common to the Class of Extended-Release and Long-Acting Opioid Analgesics (ER/LA
More informationBlueprint for Prescriber Continuing Education Program
CDER Final 10/25/11 Blueprint for Prescriber Continuing Education Program I. Introduction: Why Prescriber Education is Important Health care professionals who prescribe extended-release (ER) and long-acting
More informationRule Governing the Prescribing of Opioids for Pain
Rule Governing the Prescribing of Opioids for Pain 1.0 Authority This rule is adopted pursuant to Sections 14(e) and 11(e) of Act 75 (2013) and Sections 2(e) and 2a of Act 173 (2016). 2.0 Purpose This
More informationPo dilaudid versus iv dilaudid
Po dilaudid versus iv dilaudid Search IM/IV/SC 120 mg ratios of morphine to methadone in patients with neuropathic pain versus non-neuropathic an equianalgesic ratio for PO. Dilaudid official prescribing
More informationNarcotic Equivalence Converter Narcotic Route Dose Duration; Select a drug: mg Convert to: mg Adapted from Tarascon Pocket Pharmacopoeia.
Narcotic Equivalence Converter Narcotic Route Dose Duration; Select a drug: mg Convert to: mg Adapted from Tarascon Pocket Pharmacopoeia. Created: Monday, March 12. Online calculator to convert equianalgesic
More informationEquianalgesic Dosing: Making Opioid Interchange Easier. Joseph Bubalo PharmD, BCPS, BCOP Oncology Clinical Pharmacist Assistant Professor Of Medicine
Equianalgesic Dosing: Making Opioid Interchange Easier Joseph Bubalo PharmD, BCPS, BCOP Oncology Clinical Pharmacist Assistant Professor Of Medicine 1 Why Change Opioids? Side Effects Insufficient Pain
More informationOpioids, Extended Release (ER) Quantity Limit Criteria Program Summary
Opioids, Extended Release (ER) Quantity Limit Criteria Program Summary This program applies to Commercial, GenPlus, NetResults A series, Netresults F series and Health Insurance Marketplace. Belbuca is
More information10 mg hydrocodone equals how much oxycodone
Cari untuk: Cari Cari 10 mg hydrocodone equals how much oxycodone Posts about dilaudid 8 vs oxycodone 30 written by buyprescriptionmedication. Can you help me with the conversion of Oxycodone IR (5mg tab)
More informationA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Analgesic Efficacy of MNK-795 Controlled-Release
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Analgesic Efficacy of MNK-795 Controlled-Release Oxycodone/Acetaminophen Tablets (CR OC/APAP) in an Acute Pain Model Neil
More informationClinical Policy: Opioid Analgesics Reference Number: CP.PMN.97 Effective Date: Last Review Date: 02.18
Clinical Policy: Reference Number: CP.PMN.97 Effective Date: 02.11 Last Review Date: 02.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory
More informationDURATION LIMIT WITH QUANTITY LIMIT AND POST LIMIT PRIOR AUTHORIZATION CRITERIA IMMEDIATE-RELEASE OPIOID ANALGESICS (BRAND AND GENERIC)*
Carelirst. +.V Family of health care plans cvs caremarktm DURATION LIMIT WITH QUANTITY LIMIT AND POST LIMIT PRIOR AUTHORIZATION CRITERIA DRUG CLASS generic name, dosage form IMMEDIATE-RELEASE OPIOID ANALGESICS
More informationMEDICATION GUIDE. ACTIQ (AK-tik) CII (fentanyl citrate) oral transmucosal lozenge 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, 1600 mcg
MEDICATION GUIDE ACTIQ (AK-tik) CII (fentanyl citrate) oral transmucosal lozenge 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, 1600 mcg IMPORTANT: Do not use ACTIQ unless you are regularly using another
More informationImmediate Release Opioid Analgesics (Brand and Generic): Acute Pain Duration Limit with MME Limit and Post Limit Policy
BENEFIT APPLICATION DRUG POLICY Immediate Release Opioid Analgesics (Brand and Generic): Acute Pain Duration Limit with MME Limit and Post Limit Policy Benefit determinations are based on the applicable
More informationDsuvia (sufentanil) NEW PRODUCT SLIDESHOW
Dsuvia (sufentanil) NEW PRODUCT SLIDESHOW Introduction Brand name: Dsuvia Generic name: Sufentanil Pharmacological class: Opioid agonist Strength and Formulation: 30mcg; sublingual tabs (housed in a disposable,
More informationAPPROVED PA CRITERIA. Initial Approval: January 10, 2018 Revised Dates: April 11, 2018 CRITERIA FOR PRIOR AUTHORIZATION
Initial Approval: January 10, 2018 Revised Dates: April 11, 2018 CRITERIA FOR PRIOR AUTHORIZATION PROVIDER GROUP Pharmacy Opioid Products Indicated for Pain Management MANUAL GUIDELINES All dosage forms
More informationOpioid Analgesics. Recommended starting dose for opioid-naïve patients
Opioid Analgesics Goals: Restrict use of opioid analgesics to OHP-funded conditions with documented sustained improvement in pain and function and with routine monitoring for opioid misuse and abuse. Promote
More information