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New Drugs and Patent Losses for 2014/2015 Their Effect on the Pharmacy Buyer Sherrie L. Lane PD Learning Objectives • Understand which new drug approvals are targeted for 2014/2015 • List the brand name drug patent losses that are targeted for 2014/2015 • Describe the impact new drugs and patent losses targeted for 2014/2015 will have on the Pharmacy’s budget Learning Objectives Cont: • Discuss the FDA’s implementation of a new breakthrough category for drug approvals and it’s budget impact • Compare and choose different inventory management strategies to maximize profit and minimize cost, for new drug additions to formulary as well as brand to generic product conversion Why Is This Important To A Buyer? • Pharmaceutical costs in U.S. hospitals (excluding Federal facilities) are projected to increase $285 million - $1.14 billion in 2014 over the 28.5 billion spent in 2013[1] • Your healthcare facility may have up to 20% of its total budget allotted to the Pharmacy Department.[1] Why Is This Important To A Buyer? • Of that 20% - 80% of the Pharmacy’s budget may be attributable to medication cost [1] • Declining reimbursement in healthcare facilities Why Is This Important To A Buyer? • Demonstrates your value! • Assists in making the case for your inclusion in the budgeting process and a seat on the P & T Committee Selected Drugs and Biologicals That May Receive FDA-Approved Labeling in 2014 [3,4,] Drug Indication PDUFA Date Tasimelteon Non-24-hr disorder in the totally blind 1/31/14 SABER-Bupivacaine Depot for post op pain management 2/12/14 Droxidopa Symptomatic neurogenic orthostatic hypotension 2/14/14 Treprostinil diolamine ER tablets Pulmonary arterial hypertension 2/16/14 Metreleptin Metabolic disorders assoc/w inherited or acquired lipodystrophy 2/27/14 Drug Indication PDUFA Date Elosulfase alfa Mucopolysaccharidosis type IVA Feb. 28, 2014 Recomb Factor VIII Fc fusion Protein Hemophilia A March 12, 2014 Empagliflozin Type 2 diabetes mellitus March 25, 2014 Recomb Fact IX Fc fusion Protein (rFIXFc) Hemophilia B April 4, 2014 Recomb human C1 esterase Inh Hereditary angioedema July 16, 2014 Cangrelor Acute coronary syndrome (patients undergoing percutaneous coronary intervention May 1, 2014 Idelalisib Indolent Non-Hodgkins Lymphoma May 11, 2014 Peginterferon beta-1a Multiple Schlerosis May 21, 2014 Dalbavancin (IV) Acute bacterial skin/skin structure gram pos organisms including MRSA May 26, 2014 Drug Indication PDUFA Date Buprenorphine-naloxone buccal film Opioid Dependence June 1, 2014 Ferric citrate coordination complex Hyperphosphatemia in patients with chronic kidney disease receiving dialysis June 7, 2014 Tedizolid (oral) Acute bacterial skin/skin June 22, 2014 structure gram+infections (including MRSA) Ramucirumab Advanced gastric cancer following disease progression June 23, 2014 Tavaborole Onychomycosis July 29, 2014 Recombinant human parathyroid hormone 1-84 Hypoparathyroidism October 24, 2014 Drug Indication PDUFA Date Ryanodex Malignant Hyperthermia 7/22/14 Zalviso Post op pain following open abdominal surgery 7/27/14 Tavaborole Topical onychomycosis 7/29/14 Hyqvia Primary Immunodeficiency 7/31/14 Oritavancin ABSSSI 8/6/14 Eliquis New indication 8/25/14 Xtandi MCRPC who have not received chemo 9/18/14 Iluvien Diabetic macular edema 9/16/14 Cobicistat HIV therapy 10/3/14 Elvitegravir HIV therapy 10/4/14 Drug Indication PDUFA Date Ibrutinab Refractory CLL/SLL 10/7/14 Ledipasvir/ Safosbuvir Chronic Hep C Genotype 1 10/10/14 Xiaflex Dupuytren’s Contracture 10/20/14 Natpara Hypoparathyroidism 10/24/14 AEZS-130 Adult Growth Deficiency 11/5/14 AVP-825 Acute Migraine 11/26/14 Ceftolozane/ tazobactam Comp UTI & Comp Intra abdominal infections 12/21/14 Peramivir Influenza 12/21/14 Selected Drugs and Biologicals That May Receive FDA-Approved Labeling in 2015 [4] Drug Indication PDUFA Date Triferic Fe def in chronic kidney disease receiving hemodialysis 1/24/15 Fibrocaps Aids in hemostasis during surgery 1/31/15 BEMA Buprenorphine Severe pain requiring around the clock opioid tmt Phase III clinical trial LBH589 Multiple Myeloma Phase III clinical trial Drug Indication PDUFA DATE Losmapimod Acute Coronary Syndrome Phase III Clinical Trial Nivolumab Melanoma Phase III Clinical Trial Brodalumab Moderate to severe plaque psoriasis Phase III Clinical Trial Peglispro Type 2 diabetes Phase III Clinical Trials Saxagliptin/dapagliflozin Type 2 diabetes as add on Phase III Clinical Trials therapy to Metformin Necitumumab Metastatic squamous cell carcinoma of the lung Phase III Clinical Trials Tofacitinib Moderate to severe plaque psoriasis Phase III Clinical Trials Drugs Indication PDUFA Date Hydrocodone Bitartrate ER Pain Phase III clinical trials Mepolizumab Severe eosinophilic asthma Phase III clinical trials Eluxadoline IBS-d Phase III clinical trials Resources For Determining New Drug Approvals Publications and Periodicals 1. Pharmacy Purchasing Outlook 2. American Journal of Health System Pharmacy has an annual article in March of each year with trends and projections The Ultimate Resources! http://www.accessdata.fda.gov/scripts/cder/dr ugsatfda/index.cfm?fuseaction=Reports.Mon thlyApprovalsAll http://www.biopharmcatalyst.com/pdufacalendar/ What is PDUFA? Prescription Drug User Fee Act PDUFA CALENDAR • Shows drugs up for approval or review for new indications on a monthly basis. 1. 2. 3. PDUFA Priority Reviews Advisory Committee PDUFA Selected Potential Patent Expirations in 2014 [2] Drug Manufacturer Indications Tolterodine ER (Detrol LA) Pfizer Overactive Bladder Sirolimus (Rapamune) Wyeth Prevention of organ transplant rejection Telmisartan (Micardis) Boehringer Ingelheim Hypertension Esomeprazole (Nexium) AstraZenica GERD Moxifloxacin (Avelox) Bayer Community-acquired Pneumonia, skin & skin structure infection Sevelamer Hcl (Renagel) Genzyme Hyperphosphatemia from Chronic kidney disease Risedronate (Actonel) Warner Chilcott Osteoporosis Mometasone furoate (Nasonex) Merck Allergic rhinitis Selected Potential Patent Expirations in 2014 Cont: Drug Manufacturer Indiations Raloxifene (Evista) Eli Lilly Osteoporosis Sandostatin Novartis Acromegaly Exforge Novartis Hypertension Celecoxib (Celebrex) Pfizer Osteoarthritis/ rheumatoid arthritis symptoms Budesonide/formoterol (Symbicort) AstraZeneca Asthma/COPD Eszopiclone (Lunesta) Sunovion Insomnia Selected Potential Patent Expirations in 2015 [2] Drug Manufacturer Indications Aripiprazole (Abilify) Otsuka Symptoms of schizophrenia and bipolar disorder Glatiramer acetate inj. (Copaxone) Teva Relapsing-remitting multiple sclerosis Imatinib mesylate (Gleevec) Novartis CML and GIST Memantine Hcl (Namenda) Forest Lab Moderate to severe Alzheimer’s disease Modofinil (Provigil) Teva Shift work sleep disorder and excessive sleepiness Albuterol/ ipratropium Inh(Combivent) Boehringer Ingelheim COPD symptoms Selected Potential Patent Expirations in 2015 Cont: Drug Manufacturer Indications Darunavir(Prezista) Janssen HIV Dutasteride(Avodart) GlaxoSmithKline Benign prostatic hyperplasia Linezolid (Zyvox) Inj. & oral Pfizer CA & nosocomial pneumonia, CSSSI, VRE, USSSI FDA’s New Breakthrough Therapy Designation • The drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or lifethreatening disease or condition [4] • “Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” [4] Criteria For Breakthrough Therapy Designation • • • • Serious Condition Existing (or Available) Therapies Preliminary Clinical Evidence May Demonstrate Substantial Improvement on at Least One Clinically Significant Endpoint FDA’s New Breakthrough Therapy Designation If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request. [5] CDER Breakthrough Therapy Products Approved Jan. 1, 2014 – June 27, 2014 [6] Proprietary Name Established Name Applicant Approval Date Arzerra Ofatumuab Glaxo 4/17/2014 Kalydeco Ivacaftor Vertex 2/21/2014 Zykadia Ceritinib Novartis 4/29/2014 Inventory Management Strategies • Utilize PDUFA dates to proactively plan for new drug approvals • Track brand to generic conversion by calendar • Plan brand stock depletion and formulary switches within category Inventory Management Strategies • Pareto’s Principle • Partner with a Clinical Pharmacist 1. Therapeutic Interchanges 2. IV to PO switches 3. Protocols and guidelines Remember the Two C’s! COLLABORATION COMMUNICATION References 1. Am J Health-Syst Pharm 2014; 71:482-99 2. http://pharma.about.com/od/BigPharma/a/Which-Popular-Drugs-Are-Going-OffPatent-In-2013-2016.htm 3. http://lab.express-scripts.com/insights/drug-options/fda-approvals-expected-in2014 4. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Re ports.MonthlyApprovalsAll 5. Sec 506(a) Food Drug and Cosmetic Act 6. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped andApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/ucm 373418.html 7. http://www.biopharmcatalyst.com/pdufa-calendar/ QUESTIONS?