Study Summaries

HYADD4® versus methylprednisolone acetate in symptomatic knee osteoarthritis: a single-centre single blind prospective randomised controlled clinical study with a 1-year follow-up

S. Bisicchia, G. Bernardi, C. Tudisco

Hymovis (HYADD®4, Fidia Farmaceutici Spa, Abano Terme, Italy) is a new hydrogel HA-based product, which is a new hyaluronan (HA)-based highly viscoelastic hydrogel for the treatment of osteoarthritis knee pain, which has improved shock absorbing and lubricating properties.*

This is a single-center, single-blind, prospective randomized controlled clinical study to compare clinical results and quality of life in patients with symptomatic knee osteoarthritis randomized to either Hymovis® or corticosteroid (CS). An additional analysis was conducted for safety and tolerability.

Patients were evaluated at baseline, 6, 12, 26 and 52 week post-injection.

Primary end point: WOMAC total score at 26 weeks;
Secondary end points: WOMAC total score, VAS for pain, and SF-36 score at any time point.

Results

  • Patients in the Hymovis® group obtained significantly better WOMAC total scores than the CS group at 6 (p<0.0001), 12 (p=0.01) and 26 weeks (p<0.0001) (fig 1).
  • Considering VAS for pain, patients in the Hymovis® group obtained significantly better results than the CS group at 12 weeks (p=0.0001) and 26 weeks (p=0.0004), indicating that Hymovis® has a greater therapeutic effect (fig 2).
  • Considering SF-36 scores, patients significantly improved compared to baseline data and scores remained quite stable in the Hymovis® group up to 26 weeks.

Hymovis® clinical performance

​ While patients in both groups obtained good results in the short term (6 weeks), patients in the Hymovis® group obtained better results at 26 weeks in terms of knee function, WOMAC total score (p<0.0001), pain VAS (p=0.004) and quality of life.

HYMOVIS®-treated patients had significantly greater improvement in total WOMAC scores, VAS for pain scores, and SF-36 scores at 26 weeks



Efficacy outcomes in patients treated with 2 weekly IA injections of either Hymovis (HYADD®4) or corticosteroid: Total WOMAC Scores; VAS for Pain Scores; and quality of life as shown by patient responses on the SF-36 questionnaire.

*Data on file

Fidia offers COMPREHENSIVE SUPPORT for your patients and your practice

The HYMOVIS Support Hotline*: 1-866-HYMOVIS (1-866-496-6847)

or www.HYMOVISonline.com

Available 9 AM to 8 PM ET, Monday through Friday
Dedicated reimbursement support
Three ways to enroll: phone, fax, or web
Patient-specific insurance verifications for medical and specialty pharmacy benefits
Comprehensive prior authorization support
Claims and appeal assistance
Billing and coding guidelines
Specialty pharmacy triage upon request
Simplified ordering, billing, and return processing
Report adverse events or a product quality complaint
Contact sales representative to order posters or brochures
Medical information
* The Hotline does not file claims for callers, nor can it guarantee that you will be successful in obtaining reimbursement. Third-party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or solved by the Hotline.
No minimum order quantity
Low thresholds for contract pricing
Easy online ordering

Henry Schein

Besse

Each carton contains two blister packs, each with a single-use syringe
3.0 mL of HYMOVIS® in a 5.0-mL single-use syringe
A hyaluronan concentration of 8 mg/mL, dissolved in physiologic saline
J-Code: J7322
CPT 20610; 20611 physician administration
Intra-articular hyaluronans are covered by most insurance plans
For reimbursement assistance, please call 1-866-HYMOVIS (1-866-496-6847)
For patient insurance verification on the web register/login to: www.fidiacomplete.com
Reimbursement Guide
Prior Authorization Checklist 2017
Tips for Clean Claims Submission
Patient Enrollment Form
Coding information for HYMOVIS
Overview of Reimbursement Support
Samples CMS 1450 Form for HYMOVIS
Samples CMS 1500 Form for HYMOVIS
Strategies to Appeal Denied Claims
Available 9 AM to 8 PM ET, Monday through Friday
Hotline: 1-866-HYMOVIS (1-866-496-6847)
Dedicated reimbursement support including:
Comprehensive prior authorization support
Patient-specific insurance verifications
Billing and coding information
Claims and appeals assistance
Simple ordering process
Report adverse event or product complaints
For Customer Service, please email us at customerservice@fidiapharma.us
For product-related specific information, please contact the Medical Office at medicaloffice@fidiapharma.us
For additional information please email us at hymovis@fidiapharma.us

Fidia offers COMPREHENSIVE SUPPORT

for your patients and your practice

The HYMOVIS Support Hotline*: 1-866-HYMOVIS (1-866-496-6847)

or www.HYMOVISonline.com

Available 9 AM to 8 PM ET, Monday through Friday
Dedicated reimbursement support
Three ways to enroll: phone, fax, or web
Patient-specific insurance verifications for medical and specialty pharmacy benefits
Comprehensive prior authorization support
Claims and appeal assistance
Billing and coding guidelines
Specialty pharmacy triage upon request
Simplified ordering, billing, and return processing
Report adverse events or a product quality complaint
Contact sales representative to order posters or brochures
Medical information
* The Hotline does not file claims for callers, nor can it guarantee that you will be successful in obtaining reimbursement. Third-party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or solved by the Hotline.

Hotline: 1-866-HYMOVIS (1-866-496-6847)

FIDIA offers

Comprehensive HYMOVIS® support

for your patients and your practice

Hotline: 1-866-HYMOVIS (1-866-496-6847)

Intended for US Residents Only

*Mechanical testing may not be indicative of human clinical outcomes
** From a multi-center open label study in 49 patients treated with HYMOVIS®

.