Both the magnitude and duration of pain relief provided by ZILRETTA in The benefits and risks of repeat injections have not been demonstrated. o The proportion of patients who experienced arthralgia in any joint was nearly doubled ZILRETTA is not for people allergic to corticosteroids, triamcinolone acetonide or any other component of the product. Nanoformulations can also help manage the dose-limiting toxicities associated with conventional chemotherapeutic agents. 12/30/2020 Annual review: no policy changes. The dose, frequency, and duration of use may not exceed the safety and efficacy data supporting the Hold the syringe and the needle at an angle and express excess gel suspension over a sterile surface. The theory behind this injections is that in arthritic knees the molecular weight of the hyaluronic acid decreases. • ZILRETTA must be prepared using only the diluent supplied in the kit. Dose and frequency for indication are supported by standard reference compendium listed in Table 2 b. The dose, frequency, and duration of use may not exceed the safety and efficacy data supporting the medically accepted indication Requested Product Preferred Alternative Agent(s) ... Zilretta J3304 Kenlaog J3301 Khapzory J0642 Leucovorin J0640 Sustol (for all indications) J1627 Ondansetron Granisetron Aloxi J2405 J1626 MEDICAL PRECERTIFICATION REQUEST FORM EOC ID: Prolia (denosumab) injection 56 Phone: 1-866-461-7273 Fax back to: 1-888-447-3430 Humana manages the … Humana has adopted the following guidelines: Adult immunizations. Reduce joint stiffness and improve mobility 25. Flexion Therapeutics (FLXN) is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis, referred to as OA. Interest expense was $5.2 million and $4.7 million for the three months ended March 31, 2021 and 2020 respectively. It is administered by intra-articular injection once a week (one week apart) for a total of 3 injections. Clinical practice guidelines are resources* for Humana participating physicians and other Humana-contracted healthcare professionals. OBJECTIVE. The five-year follow-up data was similarly encouraging, with 90% of patients having an average seizure frequency of one or less per month. Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. Your plan includes online health tools, award-winning customer service, health and wellness programs, travel coverage, and many more benefits and services. If you have knee inflammation and pain, ask your doctor if it may be osteoarthritis of the knee. Providers can call Optum ® Specialty Pharmacy and Optum ® Infusion Pharmacy at 1-855-427-4682 to enroll the member. Company withdraws 2020 ZILRETTA … • Promptly inject ZILRETTA after preparation to avoid settling of the suspension. In particular, the 40 mg dose conferred more durable pain relief (see Figure 2). The need for long-term treatments of chronic diseases has motivated the widespread development of long-acting parenteral formulations (LAPFs) with the… ING-CC-0136 Drug dosage, frequency, and route of administration ING-CC-0024 Elaprase (idursulfase) ING-CC-0051 Enzyme Replacement Therapy for Gaucher Disease ... ING-CC-0177 Zilretta (triamcinolone acetonide extended-release) ING-CC-0171 Zepzelca (lurbinectedin) ING-CC-0019 Zoledronic acid agents Overview#. Monovisc PMA P090031 IFU Draft 20DEC2013 Confidential Page 3 of 11 CLINICAL STUDIES . Here are some resources for locating an appropriate practitioner or provider when making a referral or authorization request. We anticipate full-year 2021 ZILRETTA sales in … When the injections are administered bilaterally, list J7321, J7323 or J7324 in item 24 (FAO-09 electronically) with a 2 in the unit’s field. HCPCS code J7321, J7323, and J7324 are per dose codes. 1 On October 6, 2017, the U.S Food and Drug Administration, or FDA, approved Zilretta, as the … Dosage and Frequency. A small study in 2012 showed that 67% of patients taking low-dose fenfluramine were seizure free for at least one year, and nine of 12 patients saw a 75% or greater reduction in monthly seizures. The research concludes that a significant number of the Avastin study … Continued serotonin and the frequency of carcinoid syndrome diarrhea. Using image guidance for joint access is a valuable fundamental skill. Here you will find information for assessing coverage options, guidelines for clinical utilization management, practice policies, the provider manual and support for delivering benefits to our members. Patient management. • The recommended dosage of Zilretta is 32 mg (5 mL) administered as a single intra-articular injection in the knee. Additional injections after the second dose were not allowed. It is supplied as a single-dose kit containing a vial of triamcinolone acetonide extended-release microsphere powder, a vial of sterile diluent, and a sterile vial adapter. It’s administered via injection and is not intended for repeat use, but that one injection can often produce months of freedom from arthritis symptoms. Synvisc-One (hylan G-F 20) is the only treatment that can give you up to six months of osteoarthritis (OA) knee pain relief with a single injection. 3,383. Zilretta is a suspension product and it is normal for some residue to be left behind on the vial walls after withdrawing the contents. 3 OA Studies: ZILRETTA Superior to Off the Shelf Steroids. Harjes: Today's topic, we're calling 3 Under 30, as in three stocks trading for $30 or less. It accomplishes this because it’s made up of extended-release microspheres. Best answers. Become a provider. Medications that are being used outside their FDA approved dose, indication, or frequency require review in accordance with our off-label policy PP/O001. The dose of Zilretta is 32 mg administered as a single intra-articular injection in the knee. The investigators will recruit 35 symptomatic knee OA patients for this study. • The dose, frequency, and duration of use may not exceed the safety and efficacy data supporting the medically accepted indication; AND • The patient is considered a new start to the non-preferred product (defined as no use in the previous 365 days) Requested Product Preferred Alternative Agent(s) Go-live date Special Comments We are studying Zilretta in a repeat dose safety clinical trial and if the data from the repeat dose trial are supportive, we intend to seek inclusion of these data in a supplemental NDA and expansion of the label for Zilretta to include repeat dosing. Triamcinolone acetonide is an injectable suspension that delivers 32 mg of triamcinolone acetonide. Triamcinolone acetonide extended-release (ER) 32 mg (Zilretta®) is approved in the USA for the management of osteoarthritis (OA) pain of the knee and is administered as a single, 5 mL intra-articular (IA) injection. OA knee pain profile. The ZILRETTA knee injection is an FDA approved, extended release corticosteroid for in patients with knee osteoarthritis and has been shown to reduced knee pain for 3 months in approximately 70% of patients. The cost of sales for full-year 2019 was $10.0 million. ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), for intra-articular use Initial U.S. Approval: 1957 _____ RECENT MAJOR CHANGES _____ Indications and Usage (1) 12/2019 Dosage and Administration (2.1) 12/2019 • The dose for CLL is 375 mg/m 2 in the first cycle and 500 mg/m 2 in cycles 2−6, in combination with FC, administered every 28 days (2.3). Referral and authorization requirements. April 4, 2018. Repeated corticosteroid injections to the joint may speed cartilage degeneration. “This valuable study suggests that repeat administration of ZILRETTA can provide patients suffering from knee OA consistent, substantial, and durable pain relief, and is generally well-tolerated. Print Post. About ZILRETTA On October 6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. A small study in 2012 showed that 67% of patients taking low-dose fenfluramine were seizure free for at least one year, and nine of 12 patients saw a … SUPARTZ FX is one of the most trusted hyaluronic acid therapies on the market, chosen by millions of knee osteoarthritis patients and their doctors worldwide to: 39. Zilretta. How to access Cigna coverage policies. Who you are and your health plan will determine: How to book an appointment. Synvisc. 1, 2, 5 Many cancer chemotherapies are hydrophobic and relatively insoluble in aqueous solutions. Bragantini A, Cassini M, De Bastiani G, Perbellini A. The dose and frequency of use of triamcinolone will depend on the condition being treated. See if something is covered or not by keyword, or browse common categories. Zilretta™, Flexion’s non-opioid lead drug candidate (also known as FX006), completed pivotal Phase 2b and Phase 3 clinical registration trials, in patients with osteoarthritis (OA) of the kneePositive data from these trials, presented at the Osteoarthritis Research Society International (OARSI) 2016 World Congress, demonstrated consistent efficacy across both studies with… Revisions . A BED value of 30 Gy can be obtained with, for instance, 1 single acute dose of 13 Gy, 2 fractions of 8 Gy, or 3 fractions of 6 Gy, or 1 single dose of 27 Gy at low-dose rate. Flexion Therapeutics, Inc. (NASDAQ:FLXN) Q1 2021 Earnings Conference Call May 12, 2021 4:30 a.m. Net sales of ZILRETTA were $23.7 million for fourth-quarter 2019 and totaled $73 million for full-year 2019. In a report published Monday, H.C. Wainwright & Co. analyst Andrew S. Fein initiated coverage on BioCryst Pharmaceuticals (NASDAQ: BCRX ) … These shots are given in the doctor’s office and are often covered by medical insurance, but pre-authorization may be required. Gel injections are composed of hyaluronic acid. Dosage Euflexxa. ZILRETTA is an extended-release corticosteroid approved to manage osteoarthritis knee pain. Claims and billing. A complete listing of the frequency and rate of adverse events identified in the clinical studies is provided in the Safety section. • ZILRETTA is supplied as a single-dose kit and The frequency of treatment-related side effects was comparable across all treatment arms in the trial. Flexion cautions that these forward-looking statements are subject to various assumptions, risks, and uncertainties which change over time. (1) Limitation of Use The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. Adult Dosage: Give 32mg (5mL) as a single intra-articular inj. itching, numbness, or tingling; headache, dizziness; back pain; swelling, pain, redness, or mild discomfort where the medicine was injected. Triamcinolone acetonide is supplied as a single-dose kit, containing: One vial of triamcinolone acetonide white to off-white microsphere powder. Tony Alter/CC-BY 2.0. Most Cost-effective Setting Program. • Approval will be granted for a maximum of 1 dose of Zilretta (triamcinolone acetonide extended-release injection) per knee per lifetime • Patients who are allergic to corticosteroids, triamcinolone acetonide, or any other component of the product. Eur J Rheumatol Inflamm. Buckeye Health Plan offers comprehensive Ohio health insurance plans that include coordinated healthcare, pharmacy, vision and transportation services. Net sales of ZILRETTA were $26.3 million for fourth quarter 2020 and totaled $85.6 million for full year 2020, an increase of 17% compared to full year 2019. Dosage for Zilretta The dose of Zilretta is 32 mg administered as a single intra-articular injection in the knee. Zilretta may interact with: aminoglutethimide, amphotericin B injection, potassium-depleting agents, antibiotics, anticholinesterases, anticoagulants, antidiabetics, antitubercular drugs, barbiturates, phenytoin, 10. Zilretta is an extended-release corticosteroid for relieving osteoarthritis knee pain. Of a total of 208 patients who received a first injection of Zilretta, a second injection was administered to 179 patients (median time to second injection was 16.6 weeks). All are Q codes and they help patients with opioid addiction, knee pain, cystic fibrosis, and hemophilia. 3. Medicare Advantage members, you can request a copy of your Evidence of Coverage or Formulary if you need one. ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. ZILRETTA is an extended-release corticosteroid approved to manage osteoarthritis knee pain. The FDA approved Flexion Therapeutics’ supplemental NDA to update the product label for Zilretta (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis knee pain. Confidentiality notice: This transmission contains confidential information belonging to the sender that is legally privileged. • The dose for NHL is 375 mg/m 2 (2.2). Warnings & Precautions Euflexxa #1 prescribed HA is based on rolling 12-month average of IQVIA claims data from unique patients (August 2018-August 2019). Applicable Procedure Codes • Dose, frequency and duration of use may not exceed the safety and efficacy data supporting the ... Zilretta J3304 Triamcinolone inj. Prescription Settings. … Dosing Limits A. #2. *Site of Care Criteria Applies (PC/S009) A list of drugs subject to Site of Care can be found here ... • Zilretta (triamcinolone acetonide) J3304 • Zulresso (brexanolone) C9055 The new 0.1mg dose is anticipated to launch in the first half of 2018. ZILRETTA® For authorization, please answer each question and fax this form PLUS chart notes back to the U of U Health Plans Prior Authorization Department at 801-213-1547. In April 2016, we initiated a double-blind, randomized, parallel group, single dose Phase 2 clinical trial of Zilretta in patients with OA of the knee who also have type 2 (adult) diabetes. Dogs were evaluated for body condition scoring, orthopedic examination and radiographic scores of the hip joints, goniometric measurements of the hip joints, visual gait score, and kinetic analysis. Get a jump on five new HCPCS Level II code s going into effect July 1. Zilretta is supplied as a single-dose kit and administered as a suspension containing microspheres. Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. There are different types of knee injections, including corticosteroids, hyaluronic acid, infliximab, Botox (botulinum neurotoxin), and platelet-rich plasma (PRP). Zilretta Dosage. The purpose of this article is to review fluoroscopic and ultrasound-guided techniques and the medications used for injection into the glenohumeral, elbow, wrist, hip, knee, and ankle joints. Coverage will be provided for one dose per knee and may NOT be renewed. Elizabeth Hofheinz, M.P.H., M.Ed. If refrigeration is unavailable, store the ZILRETTA single-dose kit in the sealed, unopened kit at temperatures not … In this phase 3b, single-arm, open-label study, patients aged ≥ 40 years received the first intra-articular TA-ER injection on day 1. Medicare Coverage for Zilretta. See what others have said about Monovisc(Intra-Articular), including the … Relieve knee osteoarthritis pain safely and more effectively than routine pain medications 28. The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements... | May 25, 2021 The main and immediate side effect of an injection can be bleeding within the joint if a small blood vessel is nicked during the arthrocentesis. *Site of Care Criteria Applies (PC/S009) A list of drugs subject to Site of Care can be found here PRODUCTS THAT REQUIRE PRIOR AUTHORIZATION Anti-Neoplastic agents (Oncology) 4. Health Care. Back to Top. Important Dosage and Administration Information ZILRETTA is administered as a single intra-articular extended-release injection of triamcinolone acetonide, to deliver 32 mg (5 mL). The benefits and risks of repeat injections have not been demonstrated. Different brands have different dosing schedules, usually either one injection per week for 3 or 5 weeks. “Hot to trot with Zilretta, Flexion rolls $100M-plus stock offering to fund the launch” Tracy Staton, October 11, 2017, FiercePharma, fiercepharma.com Policies, Guidelines & Manuals We’re committed to supporting you in providing quality care and services to the members in our network. Knee injection is a procedure in which medications are injected into the knee joint to treat pain. • The dose as a component of Zevalin (ibritumomab tiuxetan) Therapeutic Regimen is 250 mg/m 2 (2.4). The purpose of this study is to examine the pre-post effects of a single ZILRETTA knee injection on physiological measures of self-reported pain and disability, physical performance, and physical activity in individuals with knee osteoarthritis (OA). It is supplied as a single-dose kit containing one vial of ZILRETTA microsphere powder, one vial of 5 mL diluent, and one sterile vial adapter. One sterile vial adapter. The Zilretta powder vial contains an overfill to allow the appropriate dose to be withdrawn. When used correctly, corticosteroid injections can be a useful part of therapy to treat the pain of acute and chronic inflammatory disease. The Company’s lead product candidate, Zilretta™ (also known as FX006), is a late-stage, injectable, sustained-release, intra-articular, or IA, meaning “in the joint,” investigational steroid that is being developed as a treatment for patients with moderate to severe knee OA pain. The authors recommend that radiation treatment should be administered within 2 days following surgery. The plunger is correctly positioned to provide the recommended dose of 4 mg/0.05 mL when white compound is no longer visible between the plunger and the fill line on the syringe. The dose, frequency, and duration of use may not exceed the safety and efficacy data supporting the medically accepted indication; AND The patient is considered a new start to the non-preferred product (defined as no use in the previous 365 days) The aim of this work is to assess the safety and efficacy of repeat administration of triamcinolone acetonide extended-release (TA–ER) in patients with symptomatic knee osteoarthritis (OA), including those with advanced radiographic severity. 1. Temporary side effects of cortisone knee injections include localized pain, elevated blood sugar, facial redness and whitening of skin around the injection site, explains About.com. FDA announced on April 13, 2017 the elimination of the risk evaluation and mitigation strategy (REMS) for Epogen/Procrit (epoetin alfa). Search Support Sign Up Sign In Privacy Policy | Cookies Policy | Cookies Policy Apr 12, 2020. For Members. Approval will be granted for a maximum of 1 dose of Zilretta (triamcinolone acetonide extended-release injection) per knee per lifetime Coverage cannot be renewed Revisions 12/3/2018 – Added J3304 and removed Q9993 from Applicable Procedure Codes. The dose, frequency, and duration of use may not exceed the safety and efficacy data supporting the medically accepted indication The patient is considered a new start to the non-preferred product (defined as no use in the previous 365 days) Requested Product Preferred Alternative Agent(s) Go-live date Special Comments Watch a doctor who specializes in OA management explain treatment with EUFLEXXA. Dosage for Zilretta. — Zilretta is for intra-articular use only and should not be administered by the following routes: epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous. ZILRETTA combines a commonly administered steroid, triamcinolone acetonide, or TA, with poly lactic-co-glycolic acid, referred to as PLGA, delivering a 32 mg dose of TA to provide extended therapeutic concentrations in the joint and persistent analgesic effect. injectable suspenson (i Zilretta) not medically necessary because it has not demonstrated a significant improvement in osteoarthritis pain compared with the immediate -release formulation of triamcnoi lone acetonide. Dosage and Administration: Zilretta is administered as a single intra-articular injection that delivers 32 mg triamcinolone acetonide in 5 mL of diluent. View your benefits. This information is intended only for use of the individual or entity named above. Prescription drug plan members (SilverScript Choice, Plus, or SmartRx), you can request a copy of your Evidence of Coverage, formulary and pharmacy directory. If refrigeration is not available, the sealed, unopened ZILRETTA kit can be stored at temperatures not exceeding 77°F (25°C) for up to 6 weeks and then discarded your doctor. Ozone gas at a dose of 45 μg/ml was incorporated into HA by insufflation. • Fri, April 6th, 2018. Storage And Handling Storage. Courtesy of Flexion Therapeutics. Inject 2mL intra-articularly in each affected knee weekly for 3 weeks. An extended release formula called Zilretta was approved in 2017. The Office of Statewide Health Planning and Development (OSHPD) has released to the public the mandatory reporting of information related to increases to the Wholesale Acquisition Cost (WAC) of prescription drugs by drug product as identified by the drug product’s National Drug Code (NDC). Usual dose range is 40 to 80 mg IM per day. The recommended dosage is an intravenous infusion of 60 mg administered over a 60-minute period according to the following schedule: An initial treatment cycle with daily dosing for 14 consecutive days followed by a 14 day drug-free period. Pharmacy information. Some patients may be well controlled on doses as low as 20 mg or less. Preparation of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) requires close attention to the Instructions for Use to ensure successful administration. Refer to the Instructions for Use for directions on the preparation and administration of ZILRETTA. Employer Group Services: 1-888-499-6922. Zilretta. Zilretta Overdose. frequency of dosing than is recommended in the drug label for them. III. Changes In Emotions Or Moods. ), but Boston University researchers recently found that walking is the best treatment for knee OA. It helps to reduce swelling and treat pain. A request for prior authorization that if determined in the time allowed for non-urgent requests could seriously jeopardize the life or health of the covered person or the ability of the covered person to regain For example, if we receive marketing approval for Zilretta as a single-dose therapy for knee OA, physicians may nevertheless use Zilretta for their patients in a manner that is inconsistent with the approved label, potentially including repeat dosing or as an injection in other joints. ZILRETTA safely and effectively. TTY: 711. Ohio Health Insurance Plans from Buckeye Health Plan. Drug Launch Dosing Frequency Active Dose (mg) Dose Volume (ml) Drug Concentration (mg/ml) Delivery Technology Risperdal Consta 2003 2 weeks 25 37.5 50 2 2 2 12.5 mg/ml active (32.8 mg/ml solids) 50 mg/ml active (132 mg/ml solids) PLGA Microsphere suspension 381 mg/g miscrospheres 38% by weight Invega Sustenna 2006 1 month 156 234 1 1.5 When Zilretta (triamcinolone acetonide extended-release) is considered medically necessary, treatment will be approved only once at the following FDA approved dosing of 32 mg administered as a single intra-articular injection in the knee once. PHC Medi-Cal P & T: October 08, 2020 Approved New & Revised PA Criteria: Effective 01/01/2021 . Without Part B Medicare benefits, your out-of-pocket costs for one dose of Zilretta is over $600.00. Medscape - Osteoarthritis knee pain dosing for Zilretta (triamcinolone acetonide extended-release injectable suspension), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. Storage To maintain expiry period, refrigerate the ZILRETTA single-dose kit (36° to 46°F; 2° to 8°C) before use. 1995;15(1):25-31. Excessive Hair Growth On The Face Or Body. Tools and resources. Maximum Dosage and Frequency – Commercial Medical Benefit Drug Policy Last Published 07.01.2021 Effective Date: 07.01.2021 – This policy addresses the maximum dosage per administration and dosing frequency for certain medications administered by a medical professional. From the largest reported experience (n=1514, age range: 1 to 49 months), triamcinolone (1 to 2 mg/kg once every month) alone or in combination with oral corticosteroid (if no response after 6 injections of monotherapy) showed lesion size decrease of 50% or more in 90.3% of infants (age <1 year) and 80% in those >1 year (Pandey, 2009). Although researchers have investigated cathepsin K inhibitors as potential treatments for osteoporosis, the development of many potential compounds has stopped due to its association with the increased frequency of morphea or stroke. Serious complications include infection, nerve damage and damage to nearby bones, says Mayo Clinic. Zilretta is not intended for repeat administration. DOSAGE AND ADMINISTRATION: Apply to the affected area as a thin film as follows: Triamcinolone Acetonide Ointment USP, 0.025% two to four times daily; Triamcinolone Acetonide Ointment USP, 0.1% two or three times daily depending on the severity of the condition. Failure to submit clinical documentation to support this request will result in delay and/or denial of the request. Across both the Phase 2b and Phase 3 studies, there were no drug related serious adverse events for Zilretta and the frequency of treatment-related side effects was comparable across all study arms.