Cost Effectiveness Study Supports Use Of EUFLEXXA(TM) By Rheumatologists For Pain Relief In Patients With Knee Osteoarthritis

Ferring Pharmaceuticals presented the
results of a cost-utility study supporting the adoption of EUFLEXXA(TM) (1%
sodium hyaluronate) intra-articular hyaluronic acid (HA) for the relief of
pain in patients with osteoarthritis (OA) of the knee at the American
College of Rheumatology's Annual Scientific Meeting in Boston, MA, November
6-11.



Using data from a larger trial, the study demonstrated that an intra-
articular treatment course of HA (EUFLEXXA(TM)) for knee OA, as compared
with non-HA therapy, provides a cost-utility benefit that supports adopting
this technology. The data also show that wider adoption of this technology
would result in greater financial savings to the health care system.
Osteoarthritis is one of the most common diseases seen in the
rheumatologist's office, costing the health care system nearly $100 billion
per year. (1)



"While the use of intra-articular HA is increasing, little has been
published about its cost-effectiveness," said Erol Onel, MD, Director of
Medical Affairs at Ferring. "This study is important because it not only
presents rheumatologists with significant analysis regarding the
cost-benefit of using this treatment, but it also demonstrates a
potentially significant savings to our overall health care system." More
information regarding the cost-effectiveness of various OA treatment
therapies is available in the Ferring-sponsored OA Trends in Managed Care
Report.



About the Study



The study of 160 patients with knee OA compared costs and the extension
of quality-adjusted life years (QALY) in patients using hyaluronic acid
(HA) with those using a non-HA treatment for this condition. Patients were
randomized either to receive three 2 ml injections of EUFLEXXA(TM) or to be
in a control group maintained on their prior non-HA therapy. Patients'
utility scores were estimated and used to calculate QALYs. To determine
costs, in addition to the costs of HA, patients who responded to HA
treatment were assigned costs of health care utilization attributed to
patients without OA, and non-responders were assigned costs of health care
resources consumed by OA patients. Cost- effectiveness was expressed as
average and incremental cost per QALY.



The responder rate for patients in the HA treatment arm was
approximately 83 percent, and the mean QALY gained was 0.0877 for each
patient responding to treatment with HA over baseline values. When the
change of QALY of the non- responders was set as zero, the HA treatment
yielded a cost-utility ratio of $38,964, while that of the control group
ranged from $36,077 (assuming a 75 percent response rate) to $139,648 (25
percent response rate).



The study concluded that the cost-utility ratio for EUFLEXXA(TM) is
within the range needed to adopt a new technology, and that the product's
wider adoption would result in greater savings to the health care system.



About EUFLEXXA(TM)
















EUFLEXXA(TM) (1% sodium hyaluronate) is the first and only non-avian
derived hyaluronic acid approved in the U.S. for the treatment of pain
caused by knee osteoarthritis and is indicated for a three-injection
treatment regimen for patients who have failed to respond adequately to
conservative non-pharmacologic therapy and simple analgesics (eg,
acetaminophen). In a prospective, randomized, double-blind, head-to-head
study versus the market leading HA therapy, significantly more patients
were "pain free" and "symptom free" with EUFLEXXA(TM).(2)



The process used to manufacture EUFLEXXA(TM) produces the HA that most
closely resembles the HA in healthy human synovial fluid and the most
highly purified HA product available today. In addition, since it is not
derived from an avian source (chicken or rooster combs), the risk of
reactions related to avian proteins is eliminated.(3-8)



EUFLEXXA(TM) received PMA approval from the U.S. Food and Drug
Administration (FDA) on December 3, 2004, and became available to the
public on November 8, 2005. For more information, visit EUFLEXXA.



About Ferring Pharmaceuticals Inc.



Ferring Pharmaceuticals Inc., part of the Ferring Group, is a privately
owned, international pharmaceutical company. Ferring's line of orthopaedic
products includes EUFLEXXA(TM), hyaluronic acid for pain from
osteoarthritis in the knee. Urology products include degarelix for prostate
cancer (Phase III) and Minirin Melt for bladder dysfunction (Phase III) ferringusa.



Ferring also markets BRAVELLE(R) (urofollitropin for injection,
purified), MENOPUR(R) and REPRONEX(R) (menotropins for injection, USP),
Novarel(R) (chorionic gonadotropin for injection, USP) and ENDOMETRIN
(progesterone) Vaginal Insert, 100 mg in the U.S. to infertility
specialists and their patients. Ferring also offers the Q.CAP(TM), the
first and only needle-free reconstitution device, for use with its
fertility treatments.



Other products include ACTHREL(R) (corticorelin ovine triflutate for
injection) for the differential diagnosis of Cushing's syndrome and
DESMOPRESSIN ACETATE in injectable and rhinal tube forms for the treatment
of diabetes insipidus and primary nocturnal enuresis.



The Ferring Group specializes in the research, development and
commercialization of compounds in general and pediatric endocrinology,
urology, gastroenterology, obstetrics/gynecology and infertility.


References


1. Centers for Disease Control and Prevention. MMWR. 2004;53:388-389



2. Kirchner M, Marshall D. A double-blind randomized controlled trial
comparing alternate forms of high molecular weight hyaluronan for the
treatment of osteoarthritis of the knee. Osteoarthritis Cartilage.
2006; 14:154-162.



3. Schiavinato A, Finesso M, Cortivo R, & Abatangelo G (2002). Comparison
of the effects of intra-articular injections of Hyaluronan and its
chemically cross-linked derivative (Hylan G-F20) in normal rabbit knee
joints. Clin Exp Rheumatol 20, 445-454.



4. Goomer RS, Leslie K, Maris T, & Amiel D (2005). Native hyaluronan
produces less hypersensitivity than cross-linked hyaluronan. Clin Orthop
Relat Res 239-245.



5. Leopold SS, Warme WJ, Pettis PD, & Shott S (2002). Increased frequency
of acute local reaction to intra-articular hylan GF-20 (synvisc) in
patients receiving more than one course of treatment. J Bone Joint Surg
Am 84-A, 1619-1623.



6. Puttick MP, Wade JP, Chalmers A, Connell DG, & Rangno KK (1995). Acute
local reactions after intraarticular hylan for osteoarthritis of the
knee. J Rheumatol 22, 1311-1314.



7. Pullman-Mooar S, Mooar P, Sieck M, Clayburne G, & Schumacher HR (2002).
Are there distinctive inflammatory flares after hylan g-f 20
intraarticular injections? J Rheumatol 29, 2611-2614.



8. Chen AL, Desai P, Adler EM, & Di Cesare PE (2002). Granulomatous
inflammation after Hylan G-F 20 viscosupplementation of the knee : a
report of six cases. J Bone Joint Surg Am 84-A, 1142-1147.


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