Specialty Pharmacy. Oncology

Transcription

1 Specialty Pharmacy Oncology

2 Background What are specialty drugs? Not an FDA designation No standard industry definition Categorized as: High cost (>$1,200 / month) Require special handling and administration May require unique inventory management May have an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) program in place that require more intense support such as physician certifications, diagnostic results, physician/pharmacist training, and/or other requirements that must be met prior to dispensing Treat very complicated high touch patients Treat chronic and/or niche or orphan disease states Require careful monitoring to achieve optimal health outcomes Require prior authorization and insurance verification 136 take home medica/ons 119 clinic administered medica/ons

3 Background Trends in specialty pharmacy Specialty take home prescriptions - $100 billion national market 20% annual growth 2% of overall prescription volume 20-30% of overall spend Development pipeline is primarily specialty drugs >50% of late-stage pipeline drugs >70% of applications for new indications are for specialty drugs

4 Background What is a specialty pharmacy? No precise definition Specialty Pharmacy designation is considered self-proclaimed Not generally recognized as such by any government licensing agency Drug manufacturers and Payers recognize the distinction Handle reimbursement investigation, prior authorization requirements, dispensing, education/counseling services, patient assistance, and compliance/persistence programs Improve persistency significantly vs a retail store with proactive patient touch points Can fill under a patients medical benefit and/or pharmacy benefit New specialty drug launches and early-stage products are often restricted to specialty pharmacy fulfillment exclusivity Models vary in size and structure May look like a normal retail store or may be mail order only or combo retail/mail order

5 Background Common Specialty Categories Oncology Transplant Rheumatology HIV/AIDS Hepatitis C Pulmonary Hypertension Chron s Multiple sclerosis Infertility Psoriasis Hemophilia Growth Hormone Deficiency

6 Background Success Stories - Health systems with experience 1. University of Michigan 2. Rush University Medical Center 3. University of Illinois Hospital and Health Sciences System 4. The Johns Hopkins Hospital 5. University of Michigan Health System 6. Cleveland Clinic 7. University of Wisconsin Hospital and Clinics 8. Mayo Clinic 9. Froedtert 10. UNC Health Care System 11. Tampa General Hospital 12. University of Kansas Hospital 13. UK HealthCare 14. University of Minnesota Medical Center, Fairview 15. Oregon Health & Science University

7 Why develop a specialty pharmacy? Access to the patients Our patients have complex, chronic or life threatening conditions that receive their diagnosis and ongoing care from providers in academic health systems. Our providers are experts in specialty medications due to their involvement in clinical trials, post marketing research, safety surveillance and academic teachings Advantages to having our own Specialty Pharmacy Ensure, simplify and expedite patient access to specialty drugs Better clinical outcomes and safety management Patient and provider satisfaction Generate a new revenue stream for the system Why not continue to utilize the existing Specialty Pharmacies Fragmented system Delays in start of therapy; increased length of stay Gaps in communication between providers and specialty pharmacies Safety and therapy risks because specialty pharmacies do not have access to the medical records or access to important patient information Generate a new revenue stream for the system Potential erosion of clinic administered drug business Cost of the medical benefit versus the pharmaceutical benefit >40% of specialty pipeline either oral or self administered drugs

8 Specialty Pharmacy Practice What does it look like?

9 Specialty Pharmacies The competition CuraScript, Caremark, Walgreens Specialty, Accredo largest targeted and contracted with for access inclusion by the manufacturer and payer Number of mid-sized, regional and local Local - Southside, SP in Dallas for transplant Some are payer or PBM-owned like CuraScript (ESI), Accredo (ESI), Optum (UnitedHealth group), Caremark (CVS/Caremark)

10 Target Specialty Pharmacy - Oncology Building a case Houston Methodist Cancer Center 12 Oncologists and growing 40 oral oncology agents on the market and growing Average price per prescription - $4500 Estimated gross profit margin 5% Limited prescription data (estimated potential opportunity) estimate prescriptions (new and refill) per year per physician 2,400 6,000 prescriptions per year $10.8m - $27m potential revenue $540k - $1.35m gross profit Preliminary Numbers

11 Specialty Pharmacy Anticipated/Example Pro Forma Preliminary Numbers Year 1 Year 2 Year 3 Year 4 Year 5 Total script volume 2,400 3,120 3,744 4,306 4,736 Avg. price per Specialty script $ 4,500 $ 4,995 $ 5,544 $ 6,154 $ 6,831 % Gross margin / Rx $ Gross margin / Rx $ 225 $ 250 $ 277 $ 308 $ 342 Total Gross Margin $ 540,000 $ 779,220 $ 1,037,921 $ 1,324,906 $ 1,617,710 Labor and Benefits $ 232,932 $ 249,786 $ 257,270 $ 264,699 $ 271,779 Other Expenses $ 31,381 $ 35,971 $ 39,729 $ 43,132 $ 45,784 Start Up Cost $ 419,000 Total Expenses $ 683,313 $ 285,758 $ 296,999 $ 307,832 $ 317,564 Cash Flow $ (143,313) $ 493,462 $ 740,922 $ 1,017,075 $ 1,300,147 Cumulative Cash Flow $ (143,313) $ 350,149 $ 1,091,071 $ 2,108,146 $ 3,408,293 Start Up Costs $ 419,000 POS System $ 20,000 Additional Computers $ 8,000 Added Fixtures $ 350,000 Refrigerators $ 17,000 Extra printers $ 4,000 Compounding Equipment $ 5,000 Extra Drug Inventory $ 15,000 Other Operating Expenses Year 1 Year 2 Year 3 Year 4 Year 5 POS Maintenance $ 5,000 $ 5,000 $ 5,000 $ 5,000 $ 5,000 Third Party Claims $ 600 $ 780 $ 936 $ 1,076 $ 1,184 Advertising $ 5,000 $ 5,000 $ 5,000 $ 5,000 $ 5,000 Other Operating Expenses $ 7,221 $ 7,743 $ 7,975 $ 8,206 $ 8,425 Payer Contracting Fee $ 600 $ 600 $ 600 $ 600 $ 600 Shipping & Handling $ 12,960 $ 16,848 $ 20,218 $ 23,250 $ 25,575 Total $ 31,381 $ 35,971 $ 39,729 $ 43,132 $ 45,784

12 Timeline Approval Hire staff From day 1 Develop clinical workflow Develop outcome measures Develop financial workflows Market program Apply NPI provider number Licensure requirements Payer Contracting Go Live Consider: Transplant Rheumatology Day days days Other factors to consider: URAC accreditation

13 Oncology Specialty Pharmacy Map

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15 Specialty Pharmacy Medication Flow Current Future HM Cancer Center Clinics HM Cancer Center Clinics External Specialty Pharmacy Insurance Company Contracted Specialty Pharmacy Manufacturer HUBS Insurance benefit verification Prior authorization Medication assistance HM Specialty Pharmacy Pa/ents Insurance Company Pa/ents Prior authorization Prescription Revenue Education Medication Dispensed

16 Thank you! 16