NEPHROLOGY BUSINESS UNIT ONTARIO PLAN 2002 1998 Actual 1999 Actual 2000 Actual 2001F/C 2002 F/C Total Canada EPREX$ $ 83,552,290 $ 99,021,852 $ 106,000,000 $ 118,601,941 Total Ontario EPREX$ 37,556,728 43,526,641 48,063,792 57,686,003 TBD Territory EPREX$ 5,627,827 7,067,660 7,689,891 9,149,000 % chg vs. YAG (year ago) 200.0% 24.0% 8.8% 19.0% SOM District 15.0% 16.2% 16.0% 15.9% SOM National 6.7% 7.1% 7.3% 7.7% Territory EPREX $ Hospital 5,627,827 7,067,660 7,689,891 9,149,000 % chg vs YAG (year ago) 196.0% 25.6% 8.8% 19.0% SOM (territory number) 100.0% 100.0% 100.0% 100.0% Territory EPREX $ Retail % chg vs YAG (year ago) SOM (territory number) 0.0% 0.0% Observations: - MoH data is collected for each account. As of Sept 24, 2001, total teritory sales for Eprex* in the hsp segment that is as follows: Humber $7,100, CVH, Orillia, St. Joe's, Oakville = $0.00 - It is assumed that the majority of sales coming out of the hsp segment represent CRF sales. - The territory saw a sales increase of 9% in 2000 due to patient expansion. - IV Iron had a significant impact on Eprex* sales in all accounts affecting both the adoption rates and the average weekly dosages acheived in the centres. Hb levels > 110 significantly increased in all accounts. - The sales have not been adjusted for the clinical trial use of Eprex* in the territory which has been estimated at ~ $200,000 . - The impact of a competitor (NESP) has not been built into the sales forecast for 2001. - Territory is forecasting to exceed 2001 sales budget. Many programs who have had expansions pending for the last few years have finnaly seen these expansion realize. Combined with higher Hb's and steady adoption rates, the territory should complete 2001 above expectations awith several more expansion projects to take place in 2002-2003 (for HD , PD and PRI).
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NEPHROLOGY BUSINESS UNITONTARIO PLAN 2002
1998 Actual 1999 Actual 2000 Actual 2001F/C 2002 F/C
Observations:- MoH data is collected for each account. As of Sept 24, 2001, total teritory sales for Eprex* in the hsp segment that is as follows: Humber $7,100, CVH, Orillia, St. Joe's, Oakville = $0.00 - It is assumed that the majority of sales coming out of the hsp segment represent CRF sales.- The territory saw a sales increase of 9% in 2000 due to patient expansion. - IV Iron had a significant impact on Eprex* sales in all accounts affecting both the adoption rates and the average weekly dosages acheived in the centres. Hb levels > 110 significantly increased in all accounts.- The sales have not been adjusted for the clinical trial use of Eprex* in the territory which has been estimated at ~ $200,000 .- The impact of a competitor (NESP) has not been built into the sales forecast for 2001.-
Territory is forecasting to exceed 2001 sales budget. Many programs who have had expansions pending for the last few years have finnaly seen these expansion realize. Combined with higher Hb's and steady adoption rates, the territory should complete 2001 above expectations awith several more expansion projects to take place in 2002-2003 (for HD , PD and PRI).
NEPHROLOGY BUSINESS UNITTERRITORY PLAN 2002
KEY ACCOUNTS
EXPRE SALES ($) HOSPITAL
Key Account 1999 Actual 2000 Actual 2001 Forecast 2001 Actual (Oct YTD) % Change YTD 2002 F/C
1. Credit Valley Hsp $ 2,289,990 $ 2,653,090 2,434,444 17.3%
Territory sales (Oct ytd) demonstrates HUGE growth of 29% predicting 2001 sales performance at 108% to forecast (yes, the 2001 sales f/c was large!) This growth is due to increases in patient numbers for HD, PD and PRI with the PRI patient segment comprising the largest patient group in most centres. Percent of patients with Hb's >110 remained above 73-75% in all patient segments but the feeling is that this # may be higher if the data were collected more frequently......HD expansions took place at CVH-24, Peel-2, Barrie-6, Collingwood-2 and Oakville-8. The PD segment finally experienced some growth in all programs - it has been on a decline for years. There is a significant increase in the use of Eprex* in PRI patients.
-Territory growth expected this year as several HD expansions will occur. - High use of IV Iron in all sites dramatically reduced Average weekly Eprex dosages and some adoption rates but increased percent of patients in the target Hb range (110-120)- 2002 f/c yet to be approved. - 2001 f/c has not been adjusted to reflect patients in JOI clinical trials who receive Eprex* for free (~$200,000) and for the pending introduction of a competitor.- using indication specific sales data from TSA which is not always similar to the MoH data ollected by account
NEPHROLOGY BUSINESS UNITTERRITORY PLAN
KEY ACCOUNTS
EPREX SALES ($)
RETAIL
Key Account 1999 Actual 2000 LE 2001 BP Latest Forecast Latest Actuals % vs Forecast
It is assumed that there are no sales for renal captured in the retail sector.Similarly, the colletion of MoH data for each account has confirmed thatapproximately $87,000 of Erpex* sales from the hospital segment can be attributed to surgery and oncology sales.
Observations: -Extensive use of IV iron has allowed more patients to achieve t-Hb's without Eprex* AND has resulted in more patients having their Eprex* held when Hb's rise quickly following a course of IV iron.- Patients whose Hb is in the t-Hb range of 110-120 will experience rapid Hb rises if IV iron therapy is given when the t-ferritin of 250 - 500 ng/ml is set as goal.- Many units now strive for a t-ferritin between 250-500 ng/ml which has served to reduce Eprex* weekly dosages and adoption rates.-PRI patients captured here do include ERI patients (pts with CrLl < 250 umol/L who do not yet qualify for MoH funded Eprex therapy.
YTD there has been a 29% increase in total CKD patients:13% growth in HD, 9.5% in PD and 49% in the PRI population. The PRI patient group now represents 51% of all CKD patients. HD Expansions have ocurred to date: CVH-24 HD, Peel - 2 HD, Barrie - 6 HD, Collingwood - 2 HD, Oakville - 8 HD stations. There are more patients being seen who have CrCl's < 250 (Nephropathy Clinics) but these patients are not yet candidates for Eprex* therapy. Eprex* AR's increased for HD and PD but remained the same for PRI - presumably due to early identification of patients, many of which who are not yet anemic. Similarly, the PRI patient # includes the ERI patient group whi have CrCl < 250 and are not yet eligible for Eprex* therapy.
-Extensive use of IV iron has allowed more patients to achieve t-Hb's without Eprex* AND has resulted in more patients having their Eprex* held when Hb's rise quickly following a course of IV iron.- Patients whose Hb is in the t-Hb range of 110-120 will experience rapid Hb rises if IV iron therapy is given when the t-ferritin of 250 - 500 ng/ml is set as goal.- Many units now strive for a t-ferritin between 250-500 ng/ml which has served to reduce Eprex* weekly dosages and adoption rates.-PRI patients captured here do include ERI patients (pts with CrLl < 250 umol/L who do not yet qualify for MoH funded Eprex therapy.
NEPHROLOGY BUSINESS UNITTERRITORY PLAN 2002
Key Account Summary - CREDIT VALLEY HOSPITAL & Satellites
Observations: - HD: CVH=248, Watline=36, Peel=100, Headwaters=23, (Sussex=40). PRI: CVH=230, Peel = 89, Etobicoke = 88- Predialysis includes Predialysis and Transplant patients at CVH, Peel & Etobicoke- ERI patients do not yet qualify for funded Eprex* therapy as CrCl < 250 mmol/L- PD and Predialysis patients exist only at CVH site - none at the satellites- Satellites include Watline, Orangeville, Peel and Etobicoke Hospitals (Sussex included in the above #'s).- Dr. Wu and Wadgymar are invloved in 2 clinical trials with 25 pts expected to be enrolled by year end 2001. -
CVH has finally realized it's long awaited expansion to the "Watline site" effective September 1/01. HD, PD and PRI growth YTD is 20% (without Sussex), 14% and 22% (ERI & PRI pts).Eprex* adoption rates have remained the same in HD and increased in PD and PRI.Satellites = Watline, Orangeville, WOHC-Brampton & Etobicoke Sites, Sussex Centre (not previously included)
NEPHROLOGY BUSINESS UNIT
TERRITORY PLAN 2002
Key Account Summary - Humber River Regional Hospital
- Predialysis includes Predialysis and Transplant patients- ERI patients do not yet qualify for funded Eprex* therapy as CrCl < 250 mmol/L- potential HD expansion 2002-2003 - Keele Street site.- very strong OCC representation at this site.- KOL - David Mendelssohn at this site.
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The HD, PD and PRI groups have grown 15%, 0% and 13% to date with the PRI population accounting for 51% of all CKD patients. While patient stats (lab values) are dated (spring '01), 2 OCC's are now in place and will drive routine patient assessments on a regular basis. The HD adoption rate grew to 88% but understand that the nocturnal patients are included in this calculation and Eprex* AR in this patient group is only 70%. PD AR remained the same and PRI increased to 52%.
Observations: - Predialysis includes Predialysis and Transplant patients- ERI patients do not yet qualify for funded Eprex* therapy as CrCl < 250 mmol/L- potential HD expansion 2002-2003 - Keele Street site.- very strong OCC representation at this site.- KOL - David Mendelssohn at this site.
Observations: - Predialysis includes Predialysis and Transplant patients- ERI patients do not yet qualify for funded Eprex* therapy as CrCl < 250 mmol/L- PD and Predialysis patients exist only at Orillia site - none at the satellite units.- There are no planned clinical trials expected for Orillia in 2001.
Orillia has 5 satellites: Collingwood, Huntsville, Penetaguishine, Alliston and Barrie. There has been a small growth in the HD segment, primarily due to expansions in Barrie and Collingwood. The PD program increased significantly and the PRI program remained static. the PRI program is currently working through Momentum to devlop the infastructure tand services to support more PRI patient access. Adoption rates for all modalities increased in 2001 with string support from the OCC.
- Predialysis includes Predialysis and Transplant patients- ERI patients do not yet qualify for funded Eprex* therapy as CrCl < 250 mmol/L- PD and Predialysis patients exist only at Orillia site - none at the satellite units.- There are no planned clinical trials expected for Orillia in 2001.
Observations: - Predialysis includes Predialysis and Transplant patients- ERI patients do not yet qualify for funded Eprex* therapy as CrCl < 250 mmol/L- There are no clinical trials taking place at this centre now. - HD expansions are scheduled for Q2-3, 2002 (20 HD stations, offsite).- There was no PRI co-ordinator, Nurse Manager or Clinical Coordinator for 5 months in 2001.
St. Joe's has seen an increase in patient # for each modality (HD -+19%, PD - +30%, PRI - +36%) as previous staffing issues have finally been addressed.), Eprex* adoption rates have stayed the same (HD, PD) and icnreased in the PRI pt segment. The unit will plan an off-site HD expansion for the summer of 2002. The team is currently looking for another Nephrologist .
- Predialysis includes Predialysis and Transplant patients- ERI patients do not yet qualify for funded Eprex* therapy as CrCl < 250 mmol/L- There are no clinical trials taking place at this centre now. - HD expansions are scheduled for Q2-3, 2002 (20 HD stations, offsite).- There was no PRI co-ordinator, Nurse Manager or Clinical Coordinator for 5 months in 2001.
NEPHROLOGY BUSINESS UNITTERRITORY PLAN 2002
Key Account Summary- Oakville Trafalgar Memorial Hospital
Observations: - Predialysis includes Predialysis, ERI and Transplant patients- ERI patients do not yet qualify for funded Eprex* therapy as CrCl < 250 mmol/L- There is currently NO PD program at Oakville.- There is currently NO clinical trials taking place at this centre. Centre may enroll in the LVH study (Dr. Pandeya) in 2001.- 8 station HD expansion opened September '01.
Oakville Trafalgar has experienced growth in their HD and PRI programs in 2001 (HD - +23%, PRI - 241%). They have opended another HD room with 8 stations and have expanded their ERI/PRI program to 3 full days / week. Future emphasis will be on expansing the PRI program and to consider a PD program in 2002-2003.
- Average Hb's remained in the target range in 2001.- note that the ability of the data to truely reflect the % of patients in the t-Hb range is limited as stats collections are completed in some centres monthly (greater degree of accuracy), but in most 2-3 times per year.- Average Hb's by modailty may change up or down a few points but the key is that the averages remain in the 110-120 range and that more patients are seeing Hb's > 120.
IV Iron has clearly had a significantnetres,-------
The average weekly dose of Eprex* in HD patients decreased in 2 accounts and increased slightly in 3 - impact of IV Iron in HD programs is key with a note that IV iron is not used as frequently in satellite centres. The dosages for PD patients stayed the same or increased in all centres. The most notable change is that the Eprex* dosages for PRI patients did increase in all programs as a result of ramping Hb's higher and starting patients sooner on Eprex* therapy. Please note the limitations of analyzing averages when data may only be collected 2-3 times per year.
- increasing use of IV Iron in ALL modalities- cost still an issue but the higher Hb benefit seems to justify the cost so less concern.----
Increasing use of IV Iron and Ferritin thresholds persisted in 2001.While cost of IV iro, whether in conbination with an oral iron preparation or on it's own, centres arecomplaining less of the IV Iron cost and noticing more the higher Hb's that can be acheived with lower doseages of Eprex*. In maintaining these high ferritins, there is the frequent scenario of patients having very high Hb' peaks following a course of IV Iron to maintitain high ferritin levels(> 200-300). This has shed some concern about the future potential for clotting incidents.
PRI 0% 0 11% 0% 0 17% 0% 0 22% 0% 0 50%% TOTAL HEMO 16% 12 11% 21% 16 16% 28% 39 32% 35% 34 41%% TOTAL P.D. 14% 12 9% 16% 13 16% 32% 27 32% 37% 47 43%% TOTAL PRI 10% 15% 31% 44%
Observations: - The percent of patients with Hb's > 110 has remained > 73% for HD and > 75% for PD & PRI.- Note - data sets refelct a snapshot in time - the less frequently the data is collected, the less accurate the data.- Most data sets are collected 3-4 times per year, some 1x/year, two accounts, bi-monthly.-
The cardiomyopthay message continues to have a positive impact on the percent of patients who are in or above the 110-120 g/L Hb range. Similar to last year, the % of patients with Hb's > 110 are: HD: 73%, PD & PRI- 75%. While we would expect more patients in the t-Hb range (>110) versus 2000, this is not surprisingly demonstrated in the data. First, centres feel that > 80-85% of patients do have t-Hb > 110 most of the time. However, data management systems do not yet exist that would allow accurate tracking of patient data on a bi-weekly or monthly basis. Secondly, centres do know that they are frequently asked to reduce or hold Eprex* doses when Hb's exceed 125-135 - usually due to a course of IV iron that shoots the Hb up necessitating a fast change in Eprex dose which is quickly followed by a plunging Hb. In fact, the OCC's have identified that this oscillating Hb level in patients is becoming very common and of high concern in those patients with cardiac and clotting risks. In summary, Hb's have remained within the target range for 2001 but there is a need to identify a data management system that will allow accurate pt assessments on a regular basis. The CSN guideline of 110-120 g/L and the cardiomyopathy message are working welll to raise the committment of Nephrologists to maintain improved anemia status is all renal patients. The OCC's are also continuing to drive this approach effectively.
NEPHROLOGY BUSINESS UNITTERRITORY PLAN 2002
Program Assessment
Program Objectives Costs Assessment
1 PRI Workshop Continue in 2002
2 Momentum Continue in 2002
3 OCC Continue in 2002
4 Contractual Agreements Head Office Continue in 2002
5 Cardiomyopathy Message Continue in 2002
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Observations:
Impact on Business/Incremental
Sales
Expand ERI/PRI base and Eprex* use
Covered previously by Marketing
More pts receive Eprex* therapy. Are identifying more ERI pts which is our future Eprex* PRI base. Anti-competitive as building relations with key customers
To have all programs operating a stage 3-4 program in 2-3 years
Shared by centre and marketing
The more PRI clinic settings we can establish, the more patients that can be seen, managed and available for Eprex* therapy. Cardiomyopathy message will be key in 2001 for this patient group.
To have an OCC in place in each centre. To imrpove the anemia status of all patients followed by the OCC. To have a database program to assist the OCC in this monitoring endeavour.
Shared by centre and marketing
The OCC position will afford our timely access to data which will allow us to effectively facilitate patient management strategies (CV risk factors) and to monitor our impact in the marketplace.
To have all accounts registered in a contract by the end of Q2 2001. To use the funds to develop value-added initiatives that will support Eprex* therapy and proetct the business in the event a competitor enters the market.
To provide an anti-competitive barrier to our business. To wrap significant value-added programs around Eprex* to eliminate the desire for customers to switch significant market share to the competitor.
To raise Hb's in all patient groups with key emphasis on the ERI / PRI patient poopulation.
shared by territory and marketing
To raise Hb levels in all modalities which will require increased Eprex* use - note that IV Iron use may blunt this response.
JOI continues to be recognized for facilitating programs that affect improvements in renal management policies, processes and health status of patiients, of which anemia management is only one facet. Continuing these initiatives should strengthen customer commitment to Eprex* and the programs ilinked to JOI - this trust and patient focussed strategy will represent the greatest anti-competitive barrier we could implement.
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NEPHROLOGY BUSINESS UNITTERRITORY PLAN
COMPETITIVE INTELLIGENCE
Company Hospital / Customer Nature of Activity
Roche
Amgen NESP Trial, in HD and PRI patients. At Humber, they are also participating in the Ca PO4 product trial.
HMR (RPR) CVH - Dr. Wu
Other Venofer/Ferrlicit
Increased use of IV Iron represents a serious impact on Eprex* consumption as per weekly average dosages and adoption rates.
CVH - Dr. Wu, Wadgymar, Humber (Berall, Hercz)
NESP trials continue at Credit Valley and Humber well into 2001. IIV Iron use is on the rise. Should an IV Iron preparation receive NOC in 2001, IV Iron use will increase and this will continue to have a negative impact on Eprex* weekly dosages and adoption rates, Most centres are now pursuing ferritin levels of 250-500 ng/ml versus the 100 ng/ml outlined in our product monograph, It is interesting to note that centres have absorbed the cost of IV Iron without complaint but know that it will be a money maker once a DIN # is attained as billing can then be applied to ODB, including a prescription upcharge fee.
