1. Osteoarthritis Disease State and Recommendations for Hyalgan®

2. Characteristics of Osteoarthritis
Osteoarthritis (OA) refers to a group of overlapping distinct diseases with different causes
OA is characterized by:
Clinical: Joint pain, tenderness, and limitation of movement
Pathological: Irregularly distributed loss of cartilage in the joint, presence of subchondral cysts and osteophytes
Biomechanical: Alteration of cartilage properties resulting in increased water content in the joint and excessive swelling with stiffness of the joint

3. High Burden of OA in the US
Affects approximately 27 million Americans
Incidence increases significantly after age 50
OA and related musculoskeletal disorders have huge impact on US economy with approximately US $215 billion loss on healthcare and productivity

4. Classification of OA Classification of OA of the knee:
Primary (idiopathic): Usually associated with aging and “wear and tear” of the joint. However, exact cause is not known.
Secondary: Associated with an apparent cause
Trauma: Most common cause.
Obesity: Increases risk for OA due to increased pressure at the knee joint.

5. Clinical Features of OA
Signs:
Crepitus in joint
Joint tenderness and restriction of movement
Bony swelling and deformity
Muscle wasting/weakness with or without effusion and instability
Symptoms:
Pain and stiffness of the joint
Alteration in joint shape
Functional impairment

6. Overall Goals of OA Management
The overall goals of the management of OA of the knee include:
Elimination of risk factors for disease progression
Treat associated pain
Maintain mobility
Minimize disability

7. ACR 2000 Guideline Recommendations on Use of Hyaluronans
Intra-articular hyaluronan therapy is recommended as an alternative therapy or in conjunction with oral agents in patients who do not get adequate symptom relief with NSAIDs

8. 2002 Consensus Committee Guidelines on Use of Hyaluronans
Intra-articular hyaluronan therapy is considered beneficial particularly in patients in whom NSAIDs are contraindicated, ineffective, or poorly tolerated
Hyaluronans can also be considered prior to initiating NSAIDs

9. Hyalgan® PI Description: Indications: Contraindications: Warnings:
Hyalgan® (sodium hyaluronate) is a viscous solution composed of high-molecular-weight fraction of purified natural sodium hyaluronate
Extracted from rooster combs and identical in structure to the natural hyaluronan found in humans
Indications:
Treatment of pain with OA of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy or to simple analgesics
Contraindications:
Known hypersensitivity to hyaluronate preparations
Infections or skin diseases in the knee area
Warnings:
Disinfectants containing quaternary ammonium salts should not be used to clean the knees
Rarely associated with anaphylactoid reactions and allergic reactions
Temporary worsening of inflammation in the injected knee in inflammatory arthritis

10. Hyalgan® PI—Contd. Precautions: Adverse events:
Efficacy of a single treatment cycle of less than three injections is yet to be established
Hyalgan® use in joints other than the knee joint and with other intra-articular injections is yet to be established with respect to safety and effectiveness
Adverse events:
Hyalgan® has an excellent safety and tolerability profile
Almost all AEs with Hyalgan® have been related to local symptoms, such as injection site pain, swelling/effusion, and warmth or redness at injection site

11. Hyalgan® PI—Contd.
The pivotal clinical study that supported the efficacy of Hyalgan® in patients with OA of the knee was conducted by Altman and Moskowitz, which demonstrated that Hyalgan®:
Had a clinical efficacy that was similar to naproxen and significantly more than that of placebo in reducing evaluators’ and subjects’ assessments of pain at 26 weeks
Was an effective therapeutic alternative to conventional therapy in the treatment of OA in patients not responding to baseline nonpharmacologic measures

12. Hyalgan® PI—Contd.
Detailed device description: Each vial or syringe* of Hyalgan® contains:
Sodium hyaluronate 20 mg—the active ingredient
Sodium chloride 17 mg
Monobasic sodium phosphate 0.1 mg
Dibasic sodium phosphate 1.2 mg
Water for injection
How supplied:
Hyalgan® is supplied as a sterile, nonpyrogenic solution in 2-mL vials or in 2-mL syringes
Directions for administering Hyalgan®:
Hyalgan® is administered by intra-articular injection
One treatment cycle consists of one injection each week for 5 weeks
*Contract pricing only available on syringes

13. Hyalgan Contract Pricing Program through Henry Schein
Option 1: Quarterly Commitment Pricing (LOC Required):
Prices from $85.00 to as low as $65.00 per syringe for a quarterly purchase commitment.
Customer must complete and sign the attached Letter of Commitment (LOC). This form is also available for iPAD in PDF Expert.
A mandatory 1st order must be placed by the customer upon completion of the LOC (see details of order size on LOC form and in table below).
Selling prices cannot be increased or decreased from the agreed upon pricing on the LOC unless (1) Manufacturer has a price increase or decrease (2) Customer fails to meet their purchase commitments during the measurement period.
If a customer has multiple ship-tos, we will load the pricing at the ship-to level but measure the account against their agreed upon tier commitment at the bill-to level.
Use item code # – Hyalgan Syringe LOC - for those customers completing the LOC.
Upon submitting the LOC to our Contracts Team per instructions on the LOC, the Contracts Team will load the customer to the applicable contract. Then, the initial order will be entered for the customer by the Medical Fax Order Entry Team in Greenville. You will receive an confirmation once completed. After the initial order is placed, then moving forward, normal ordering processes will apply.

14. Quarterly Commitment Pricing Tiers
Quarterly Volume Hyalgan
Syringe Commitment
Contract Selling Price
Mandatory size of 1st Order
(Qty. of Syringes)
50 units
$85.00 20
51 to 100 units
$78.00 25
101 to 200 units
$74.00 50
201 to 500 units
$70.00 70
501 or more
$65.00
140

15. Option 2: No Commitment Pricing (No LOC Required):
For customers who do not wish to participate in the Quarterly Commitment option provided in #1 above, we have pricing available of either $89.00 or $87.00 per syringe.
Pricing will be $89.00 per syringe for orders of 1-9 syringes or $87.00 per syringe for orders of 10+ syringes.
The selling prices are established by the manufacturer and cannot be increased or decreased until which time we are notified by the manufacturer of a price increase or decrease. There are 2 skus set up with pricing based on the quantity of syringes ordered at the time of order (this is similar to how we handle Euflexxa® today).
Use item code # for order quantities between 1- 9 syringes. Pricing is $89.00 per syringe.*
Use item code # for order quantities of 10 syringes or more. Pricing is $87.00 per syringe.*
*This is for customers who do not want to commit to a quarterly quantity via the Quarterly Commitment LOC process

16. Additional Information
What GP $ and GP% will I earn?
Henry Schein representatives will earn $9.00 in GP dollars for every syringe sold regardless of whether the account is signed up under our LOC program or whether they choose to buy without a commitment. The GP% range will be between 10.1% at the $89.00 non-committed selling price to as high as 13.8% at the highest commitment level with pricing at $65.00 per syringe.
Am I allowed to sell to any customer or customer type?
Per our agreement with Fidia, we can only sell to physician, clinic, or hospital customers. We cannot sell to pharmacies or distributors under this program. In addition, there is a list of 105 physician accounts that we are restricted from selling Hyalgan based on Fidia’s agreement with Besse.  After matching the list of customers to our database, there are 50 bill-to accounts that are current physician customers that we are restricted from selling Hyalgan. The complete list of restricted accounts is included as an excel file attached to this announcement.  
Does this opportunity apply to syringes and vials?
No – this program only applies to syringes.
Competition
Only Henry Schein and Besse currently have access to the special contract pricing program for Hyalgan.

17. Reimbursement
Admin Code: 20610: Non-Hospital Price (National):  $60.90 (Medicare National Average)
For informational purposes only. Source: Reimbursementcodes.com and/or Customer is responsible for verification of billing/coding in accordance with applicable specific circumstances.
Reimbursement Hotline
The Hyalgan Support Hotline is available to assist medical professionals and billing staff who have questions about insurance coverage, claims, or billing.
Call toll free: HYALGAN (Monday-Friday, 9:00am to 8:00pm ET) ( )
Product
J Code
Medicare
Regimen
Hyalgan
J7321
$    89.86
3-5 doses

18. Need Help?
Contact DxRx Solutions: or
Fidia Sales Roster is on TSX and Rep Resource Roadmap. Contact Fidia for technical/clinical assistance with customers