New Drugs and Patent Losses for 2014/2015 Their Effect on the Pharmacy Buyer Sherrie L. Lane PD.

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 structure gram+infections(including MRSA)

June 22, 2014

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 RefractoryCLL/SLL

10/7/14

Ledipasvir/ Safosbuvir Chronic Hep C Genotype 1 10/10/14

Xiaflex Dupuytren’sContracture

10/20/14

Natpara Hypoparathyroidism 10/24/14

AEZS-130 Adult GrowthDeficiency

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 therapy to Metformin

Phase III Clinical Trials

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/drugsatfda/index.cfm?

fuseaction=Reports.MonthlyApprovalsAll

http://www.biopharmcatalyst.com/pdufa-calendar/

What is PDUFA?

Prescription

DrugUserFeeAct

PDUFA CALENDAR

• Shows drugs up for approval or review for new indications on a monthly basis.

1. PDUFA Priority Reviews 2. Advisory Committee 3. 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

Drug Manufacturer Indications

Darunavir(Prezista) Janssen HIV

Dutasteride(Avodart) GlaxoSmithKline Benign prostatic hyperplasia

Linezolid (Zyvox) Inj. & oral Pfizer CA & nosocomial pneumonia, CSSSI, VRE, USSSI

Selected Potential Patent Expirations in 2015 Cont:

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 life-threatening 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 Interchanges2. IV to PO switches3. Protocols and guidelines

Remember the Two C’s!

COLLABORATION

COMMUNICATION

References

1. Am J Health-Syst Pharm 2014; 71:482-992. http://pharma.about.com/od/BigPharma/a/Which-Popular-Drugs-Are-Going-Off-

Patent-In-2013-2016.htm3. http://lab.express-scripts.com/insights/drug-options/fda-approvals-expected-in-

20144. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?

fuseaction=Reports.MonthlyApprovalsAll5. Sec 506(a) Food Drug and Cosmetic Act6. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/

HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/ucm373418.html

7. http://www.biopharmcatalyst.com/pdufa-calendar/

QUESTIONS?