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New Drugs Drugs introduced in 2001 contributed 1 percent to

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Title: New Drugs Drugs introduced in 2001 contributed 1 percent to


1
New Drugs of 2002/2003
2
New Drugs
  • Drugs introduced in 2001 contributed 1 percent to
    2000-2001 trend
  • Two-thirds of this contribution is attributable
    to increased utilization
  • Drugs introduced since 1992 accounted for
  • 52 percent of 2001 cost
  • and 33.7 percent of 2001 utilization

3
How Many People How Many Drugs Used
Use gt 3 Rxs PMPM
Use between 1.01 and 3 Rxs PMPM
Do not use drug benefit
Use 1 or fewer Rxs PMPM
Drug Trends report 2003
4
Cost of drugs Acquisition price from Scott-Levin
  • Average Rx price - 1980 8
  • Average Rx price - 1985 14
  • Average Rx price - 1990 20
  • Average Rx price - 1995 27
  • Average Rx price - 2000 39
  • Average Rx price - 2005 50 - 100
  • Average Rx price - 2010 250 - 500

5
Forecast PMPY AWP Costs 2002-2006
Drug Trends Report-Express Scripts, Inc.
6
2002 Top 10 Brand Prescriptions
  • Retail Dollars
  • Lipitor 5,203,982
  • Prevacid 3,359,319
  • Prilosec 3,103,305
  • Zocor 3,099,092
  • Celebrex 2,379,539
  • Zoloft 2,355,274
  • Paxil 2,307,032
  • Zyprexa 2,099,951
  • Norvasc 1,791,688
  • Nexium 1,790,703

Drug store news
7
Enbrel
  • Generic etanercept
  • Therapy Class Tissue Necrosis Factor Receptor
    blocker
  • Indication Rheumatoid Arthritis, psoriatic
    arthritis and ankylosing spondylitis
  • Dose Inject 25mg sub-q twice weekly
  • Alternate medication Remicade, Humira
  • Alternate therapies NSAIDs, DMARDS, Aspirin
  • Plan design Usually prior authorized,
    Rheumatologists
  • Impact Early dosing shows clinically significant
    improvements, reduces and possibly reverses RA.
    But expensive, a few patients can break the bank
  • Cost about 300 per week, about 15,000 per year
  • Manufacturer Immunex- Amgen and Wyeth market
  • Release date January 2002

8
Sustiva
  • Generic efavirenz
  • Therapy Class Non-nucleoside reverse
    transcriptase inhibitor
  • Indication Treatment of HIV-1 w/ other
    antiretrovirals
  • Dose Daily at bedtime 100mg, 200mg 600mg
    tabs recommended dose is 600mg per day.
  • Affect to plan design High cost as will be
    covered additions to therapy, adds to multiple
    drug cocktails
  • Cost About 400 per month. With other agents
    combination therapy will range from 15,000 to
    50,000 per year per patient
  • Manufacturer Bristol Myer Squibb
  • Release Date February 2002

9
Clarinex
  • Generic desloratadine (racemic isomer of
    Claritin)
  • Therapy Class Non-sedating antihistamine
  • Indication Allergies
  • Dose 5mg once daily
  • Alternate medication Zyrtec, Allegra
  • Alternate therapies INS, Singulair
  • Plan design Cost About 60 per month.
  • Impact Everyone needs a non sedating
    antihistamine, right? Top 25 drug on most plans
  • Manufacturer Schering Plough
  • Release date February 2002

10
Gleevec
  • Generic imatinib mesylate
  • Therapy Class Signal transduction inhibitor
  • Indication Chronic Myeloid Leukemia, metastatic
    malignant gastrointestinal stromal tumors
  • Dose 400 to 600mg daily orally
  • Plan design Prior auth usually required
  • Cost Over 2000 per month.
  • Impact High cost drug low prevalence disease,
    one patient makes an impact because this is a
    pharmacy budget item.
  • Manufacturer Novartis
  • Release date February 2002

11
Xopenex
  • Generic name levalbuterol (racemic isomer of
    albuterol)
  • Therapy class Beta-2-antagonist
  • Indication Bronchospasms
  • Dose Initially 0.63mg by neb TID _at_ 6-8hr
    intervals, may increase to 1.25mg TID
  • Alternative medication Albuterol Sol, Intal
  • Alternative therapies Serevent, Advair, others
  • Affect to plan design Little as product will
    have limited usage
  • Cost About 50 per month.
  • Manufacturer Sepracor
  • Release Date February 2002

12
Remicade
  • Generic infliximab
  • Therapy Class Tumor necrosis factor, IgI
  • Indication Used in combination with Methotrexate
    for Rheumatoid Arthritis and also for Crohns
    disease
  • Dose RA- 3mg/kg comes in 100mg vials average
    dose 200mg at 0,2,6 weeks then every 8 weeks
  • Crohns- 5mg/kg average dose 300-400mg at
    0,2,6 weeks then every 8 weeks
  • Alternate medication Enbrel, Humira, Kineret
  • Alternate therapies NSAIDS
  • IV admin and must be given in clinical or in
    hospital. Usually under medical coverage,
    specialty biologic agent.
  • Cost About 1200 per dose, drug cost only.
    10,000 -15,000 per year with admin costs.
  • Manufacturer Centocor
  • FDA Approval February 2002

13
Rebif
  • Generic interferon beta-1a
  • Therapy Class Interferon
  • Indication Multiple Sclerosis
  • Dose 44mcg injected sub-q 3 times per week
  • Alternate medication Avonex, Betaseron
  • Alternate therapies Copaxone
  • Shown to decrease the frequency of clinical
    exacerbations and delay the accumulation of
    physical disability
  • Affect to plan design Priced at a premium to
    other MS drugs, no advantages to interferon
    beta-1b (Betaseron)
  • Cost About 1200 per 2 week supply over 30,000
    per year
  • Impact Very costly, specialty biologic
    pharmaceutical, small number of patients on this
    drug will significantly increase your drug costs
  • Manufacturer Serono
  • Release Date Approved March 2002

14
Benicar
  • Generic olmesartan medoxomil
  • Therapy Class Cardiovascular ARB
  • Indication Hypertension
  • Dose 5mg, 20mg 40mg daily
  • Alternate medication Diovan, Cozaar, Micardis,
    Atacand and Avapro
  • Alternate therapies ACEs, Betas, CCBs
  • Blocks the vasoconstrictive effects of
    angiotensin II by selectively blocking the
    binding of angiotensin II to the AT receptor in
    vascular smooth muscle.
  • Affect to plan design second tier candidate, one
    of many available but offers good pricing
    alternatives
  • Cost Less than 40 a month-one of the best AWPs
  • Manufacturer Sankyo Pharma
  • Release Date April 2002

15
Altocor ER
  • Generic lovastatin
  • Therapy Class HMG-CoA reductase inhibitor
  • Indication Hypercholesterolemia
  • Dose 60mg once daily
  • Alternate medication Lipitor, Zocor
  • Alternate therapies Welchol, Zetia, Questran,
    Colestid
  • Plan design Alternate to generic
    lovastatin-different delivery mechanism. Extended
    release
  • Cost About 60 per month.
  • Impact Minor, as other products are more
    effective
  • Manufacturer Andrx Corporation
  • Release date June 2002

16
Geodon
  • Generic ziprasidone
  • Therapy Class Atypical antipsychotic
  • Indication Schizophrenia
  • Dose 20 to 80mg twice daily
  • Alternate medication Risperdal, Zyprexa
  • Alternate therapies Haldol, Thorazine, generic
    antipsychotics
  • Plan design Has many side effects and is not
    indicated with patients with QT interval
    elongation. Could cause death!
  • Cost About 200 to 250 per month.
  • Impact Significant as there is more than 1.2
    million people with schizophrenia in US
  • Manufacturer Pfizer
  • Release date June 2002

17
Zelnorm
  • Generic tegaserod maleate
  • Therapy Class 5-HT4 receptor agonist
  • Indication Irritable bowel syndrome (IBS)
  • Dose 2 or 6mg tablets, dosage normally starts at
    6mg twice daily for 4 to 6 weeks, if effective
    continue another 4 to 6 weeks.
  • Alternate medication None
  • Alternate therapies Imodium, hyoscamine, Bentyl
  • Product to be used on only female patients
  • High s spent on DTC
  • Affect to plan design much misdiagnosis for IBS,
    watch out for costs. May use this drug as
    diagnostic tool
  • Cost About 150 per 30 days
  • Manufacturer Novartis
  • Approved July 2002

18
Lexapro
  • Generic escitalopram oxalate
  • Therapy Class SSRI
  • Indication Major depressive disorder
  • Dose 5mg, 10mg or 20mg tablets 10mg daily is
    starting dose. 20mg is debated to be more
    effective than 10mg.
  • Alternate medication Prozac, Zoloft, Celexa,
    Luvox, Paxil
  • Alternate therapies Effexor, TCAs, Wellbutrin
  • Single active isomer of Celexa
  • Affect to plan design same price , less side
    effects, works faster
  • Cost Moderately expensive agent, about 70 per
    month.
  • Impact Significant as depression is high
    prevalent disease
  • Manufacturer Forest
  • Release approved August 2002

19
Hepsera
  • Generic adefovir dipivoxil
  • Therapy Class Antiviral nucleotide analogue
    reverse transcriptase inhibitor
  • Indication Chronic Hepatitis B
  • Dose 10mg tablet daily
  • Tablet size 10mg tablet
  • Alternate medication None
  • Alternate therapies None
  • Phosphorylated to the active metabolite (adefovir
    diphosphate) by cellular kinases. Inhibits HBV
    DNA polymerase by competing w/ natural substrate
    deoxyadenosine triphosphate causing DNA chain
    termination after incorporation into viral DNA
  • Cost About 500 per month
  • Impact Low, as incidence of Hep B should be low.
    But one patient can have significant impact on
    employer cost
  • Manufacturer Gilead Sciences
  • Approved 9/20/2002

20
Zetia
  • Generic ezetimibe
  • Therapy Class Cholesterol absorption inhibitor
  • Indication Hypercholesterolemia
  • Dose 10mg daily with or without food
  • Alternate medication Welchol
  • Alternate therapies Lipitor, Pravachol, Zocor,
    Altocor and Lescol
  • Distinct mechanism of action unlike other
    cholesterol drugs not processed in liver and
    inhibits absorption of cholesterol in intestines.
    Can be used alone or with a statin.
  • Affect to plan design increases costs, as it is
    used with the other agents, more than by itself.
    Not monotherapy.
  • Cost About 60 per 30 day supply
  • Manufacturer collaboration between Merck
    Schering Plough
  • Release Date October 2002

21
Pegasys
  • Generic peg-interferon alfa 2b
  • Therapy Class Immunomodulator
  • Indication Chronic Hepatitis C in patients with
    compensated liver disease not previously treated
    with interferon-alfa
  • Dose 180mcg/mL vial, single dose vials weekly
    for 24-48 weeks.
  • Alternate medication Peg-Intron
  • Alternate therapies Other interferons
  • Affect to plan design One patient can
    significantly effect drug costs
  • Cost About 200 per week or 8,000-10,000 per
    therapy.
  • Used in conjunction with anti-viral agent,
    Copegus (about 10,000/year)
  • Manufacturer Hoffman LaRoche
  • Release Date October 2002

22
Avandamet
  • Generic rosiglitazone maleate metformin HCL
  • Therapy Class thiazolidinedione biguanide
  • Indication Type 2 Diabetes
  • Dose 2mg/500mg tablet twice a day
  • Alternate medication Metaglip, Glucovance, other
    oral ADs
  • Alternate therapies Diet exercise
  • Combination therapy, two drugs in one tablet
  • Cost About 80-150 per month, Avandia and
    generic may be cheaper
  • Impact One Rx one co-pay, vs two Rxs and two
    copays
  • Manufacturer GlaxoSmithKline
  • Release date October 2002

23
Metaglip
  • Generic glipizide metformin HCL
  • Therapy Class sulfonylurea biguanide
  • Indication Type 2 Diabetes
  • Dose 5mg/500mg tablet twice a day
  • Alternate medication Avandamet, Glucovance,
    other oral ADs
  • Alternate therapies Diet exercise
  • Combination therapy, two drugs in one tablet
  • Cost About 90 per 100 , generics are about 30
  • Impact One Rx one co-pay, vs two Rxs and two
    copays
  • Manufacturer BMS
  • Release date October 2002

24
Abilify
  • Generic aripiprazole
  • Therapy Class Atypical anti-psychotic agent
  • Indication Schizophrenia
  • Dose 10mg, 15mg, 20mg and 30mg tablets, Usually
    starting dose is 15mg daily
  • One tablet daily dosing
  • Alternate medication Risperdal, Zyprexa,
    Remeron, Geodon Clozaril
  • Alternate therapies Thorazine, Haldol, Mellaril
    and ECT
  • No titration needed take with or without food..
  • Plan design Determine if third tier product due
    to cost
  • Cost Expensive 300-400 per month.
  • Manufacturer Bristol Myers Squibb
  • Release date November 2002

25
Humira
  • Generic adalimumab
  • Therapy Class DMARD Recombinant human IgG1
    monoclonal antibody specific for human tumor
    necrosis factor (TNF)
  • Indication Rheumatoid Arthritis
  • Dose 40mg QOW, sub-Q
  • Alternate medication Methotrexate, Enbrel,
    Remicade
  • Alternate therapies Arava, Plaquenil
  • Plan Design PA or medical delivery, specialty
    biological agent can be used in combination with
    other agents. Self administered product versus
    Remicade which is IV and must be given in
    clinical or hospital
  • Cost about 600 per injection (15,000 to
    20,000) per year
  • Manufacturer Abbott Laboratories
  • Approved December 2002

26
Forteo
  • Generic teriparatide
  • Therapy Class hormone human parathyroid
    recombinant hormone
  • Indication Postmenopausal osteoporosis in women
    who are at great risk for fracture. To increase
    bone mass in men primarily or hypogonadal
    osteoporosis
  • Dose 20 mcg injected daily
  • Alternate medication Miacalcin
  • Alternate therapies Fosamax , Actonel and Evista
  • Affect to plan design Should be PA or through
    medical only
  • Cost Expensive 500 per three injections
  • Manufacturer Lilly
  • Approved December 2002

27
Strattera
  • Generic atomoxetine
  • Therapy Class SNRI
  • Indication ADHD
  • Dose 80 to 100mg daily
  • Alternate medication Adderal, Ritalin
  • Alternate therapies Amphetamines
  • Affect to plan design An alternative to
    stimulating agents
  • Cost Expensive 75 to 150 per month about
    twice other agents
  • Manufacturer Lilly
  • Approved December 2002

28
Relpax
  • Generic eletriptan
  • Therapy ClassAnalgesic Seratonin Receptor
    Agonist
  • Indication Migraine
  • Dose 20 to 40mg tablets
  • Alternate medication Imitrex, Zomig, Amerge,
    Maxalt
  • Alternate therapies ASA, APAP, Midrin, DHE
  • Product seems to work in 30 minutes , slightly
    faster than Imitrex tabs
  • Affect to plan design Another alternate migraine
    drug, should mark a movement towards preferred
    products 40mg seems to work better than 20mg in
    most patients, 80 mg is maxi daily dose.
    Quantities limits good idea perhaps 10-12 per
    month supply.
  • Cost Level pricing about 160 for 12 doses
  • Manufacturer Pfizer
  • Release Date December 2002

29
Finacea
  • Generic azelaic acid gel
  • Therapy Class Derm anti bacterial
  • Indication Inflammatory papules pustules of
    mild to moderate Rosacea
  • Dose Rub on daily-30g tube
  • Alternate medication Metrogel, Metrocream
  • Alternate therapies doxycycline tabs
  • Cost About 40 per 30g tube, comparable to
    Metrogel
  • Impact Low as with other derm agents not a high
    cost impact.
  • Manufacturer Berlex Labs
  • Release Date approved January 2003

30
Amevive
  • Generic alefacept
  • Therapy Class Immunosuppresant
  • Indication Moderate to severe psoriasis
  • Dose 7.5mg once weekly IV bolus or 15mg once
    weekly IM injection.
  • Alternate medication None
  • Alternate therapies Steroid creams , tars and
    other derm products
  • First injectable psoriasis drug.
  • Plan design Medical coverage or PA
  • Cost 1000 per treatment or more
  • Manufacturer Biogen
  • Release date January 2003

31
Oxytrol
  • Generic transdermal oxybutynin
  • Therapy Class Anticholinergic
  • Indication Incontinence
  • Dose 3.9mg/day transdermal patch
  • Alternate medication None
  • Alternate therapies Detrol, Detrol LA, Ditropan
  • Delivers medicine slowly and constantly through
    the skin into the bloodstream over 3-4 days
    (3.9mg/kg QD) providing relief of overactive
    bladder
  • Affect to plan design Not much, as patch may not
    be covered
  • Cost Under 75 for 8 patches. About a 30 day
    supply.
  • Manufacturer Watson
  • Release Date March 2003

32
Fuzeon
  • Generic enfuvirtide
  • Therapy Class Fusion inhibitor T-20 1st of
    its type.
  • Indication HIV-1 infection with other
    antiretroviral therapy
  • Dose 90mg BID SC injection in upper arm, thigh
    or abdomen, rotate sites
  • Alternate medication None
  • Alternate therapies Other antiretrovirals,
    protease inhibitors,
  • Blocks HIVs ability to infect healthy CD4 cells,
    use with other meds leads to decrease of HIV in
    blood and increase of CD4 cells
  • Affect to plan design Will be covered as all
    other HIV drugs
  • Cost Expensive, added to other therapies,
    10,000-15,000 cocktails
  • Manufacturer Roche
  • Approved March 2003

33
Iressa
  • Generic gefitinib
  • Therapy Class antineoplastic agent
  • Indication Advanced or metastic non-small cell
    lung cancer after failure of both platinum-based
    and docetaxel chemotherapies
  • Dose 250mg tablets QD
  • EGFR tyrosine kinase inhibitor that blocks
    signals outside cancer cells that make them want
    to replicate
  • Affect to plan design Covered item because it is
    for cancer
  • Cost About 1700 for 30 days. Moderately priced
    for cancer agent much less than IV therapies,
    because no need for hospitalization. Could be
    prior authorized.
  • Manufacturer AstraZeneca
  • Approved May 2003

34
Xolair
  • Generic omalizumab
  • Therapy Class Recombinant DNA-derived humanized
    IgG1 monoclonal antibody. Inhibits IgE binding
    to receptor on Mast Cells and basophils thereby
    reducing the allergic response.
  • Indication Moderate to severe persistent asthma
    not controlled by ICS
  • Dose 150 to 375 mg SQ every 2 to 4 weeks
  • Alternate medication Inhaled Corticosteroids
  • Alternate therapies Singular, Accolate and Zyflo
  • Plan design Self injected or by physician,
    should be limited through Prior Auth, not for
    everyone, about 500K people in US as target
  • Drug dispensed in a franchised system through
    specialty network pharmacy including Caremark,
    ESI-Curascript, Priority Healthcare, Nova Factor
    Inc and Option Care Inc
  • Cost Very expensive, up to 10,000 per year
  • Manufacturer Genentech
  • Release date June 20, 2003

35
Reyataz
  • Generic atazanavir sulfate
  • Therapy Class HIV-1 protease inhibitor (First
    once daily protease inhibitor.)
  • Indication Treatment of HIV-1 infection with
    other antiretrovirals
  • Dose w/ food 400mg (2 x 200mg capsules QD, with
    other antiretrovirals) Comes in 100, 150 and 200
    mg capsules
  • Alternate medication Emtriva, Sustiva, Viracept
  • Alternate therapies Fuzeon, Norvir, Kaletra
  • Inhibits the virus specific processing preventing
    formation of mature virions. It is given as one
    of a three or four med combo.
  • Affect to plan design Additional costs
  • Cost Expensive 700 for 30 days
  • Manufacturer BMS
  • Approved July 2003

36
Crestor
  • Generic rosuvastatin calcium
  • Therapy Class Statin, HMG-CoA inhibitor
  • Indication Hypercholesterolemia, Dyslipidemia
    isolated Hypertriglyceridemia
  • Dose 5mg, 10mg , 20mg 40mg
  • Alternate medication Lipitor, Pravachol, Lescol,
    Altocor, Zocor and Mevacor (all other HMG-CoAs)
  • Alternate therapies Zetia, Welchol
  • Affect to plan design Should make significant
    impact as many patients will be placed on product
  • Cost About 70 for 30 day supply
  • Impact Could be a significant player with
    greater than 30 of market by this year
  • Manufacturer AstraZeneca
  • Release Date August 2003

37
Levitra
  • Generic vardenafil
  • Therapy Class PDE5 inhibitor
  • Indication Erectile dysfunction
  • Dose Initial dose 10mg daily. 2.5mg, 5mg, 10mg
    20mg tablets 1hr before sexual activity, no
    more than one tablet per day.
  • Alternate medication Viagra , Cialis
  • Alternate therapies Caverject, Penile Implants
  • Affect to plan design Significant Impact-
    Quantity limits required
  • Has Mike Ditka as spokesperson lots of DTC
  • Cost Level pricing about 90 for 10 tablets.
  • Manufacturer Bayer and GSK
  • Approved September 2003

38
Seasonale
  • Generic levonorgestrel/ethinyl estradiol
  • Therapy Class Oral contraceptive
  • Indication Prevention of pregnancy
  • Dose 1 tablet QD for 3 month cycle 84 active
    pills 7 placebos. Only 4 menses per year, could
    be well accepted. Increased productivity.
  • Alternate medication Other oral contraceptives
  • Alternate therapies Other contraceptives,
    family planning, abstinence
  • Suppress gonadotropins to prevent fertile
    conditions for female eggs
  • Affect to plan design Possibly better usage
    through mail order
  • Cost about 30 per month
  • Manufacturer Barr
  • Approved September 2003

39
Cubicin
  • Generic daptomycin
  • Therapy Class Antibacterial Cyclic lipopeptide
  • Indication Complicated skin infections due to
    Gram bacteria (staph)
  • Dose 4 mg/kg should be administered over a
    30-min period by IV infusion in 0.9 sodium
    chloride injection once every 24 hours for 7-14
    days.
  • New class, distinct mechanism of action
  • Once a day--the only QD agent approved for
    treatment of MRSA and MSSA
  • Affect to plan design This product could be
    hospital use only because of side effect profile
    and therefore not have large impact on plan
    design
  • Cost Over 1,000 per therapy.
  • Manufacturer Cubist Pharmaceuticals with Chiron
  • Approved September 2003

40
Namenda
  • Generic memantine
  • Therapy Class NMDA receptor antagonist
  • Indication Moderate to severe Alzheimer's
  • Dose 20mg daily. Starting dose is 5mg increase
    weekly to 20mg.
  • Alternate medication Cognex, Aricept
  • NMDA receptors excited by glutamate is thought to
    aggravate the symptoms of Alzheimers. This drug
    inhibits that reaction. Therefore this is a drug
    that is taken with other drugs for Alzheimers.
  • Affect to plan design Additional cost, but what
    ya gonna do?
  • Cost About 300 per month added to 300 per
    month
  • Manufacturer Forest Labs
  • Approved October 2003

41
Cialis
  • Generic tadalafil
  • Therapy Class PDE5 inhibitor
  • Indication Erectile dysfunction
  • Dose 5mg, 10mg 20mg tablets 1hr before sexual
    activity no more than one tablet per day.
    Recommended starting dose is 10mg
  • Lasts up to 36 hours ( weekend drug?)
  • Alternate medication Viagra , Levitra,
  • Alternate therapies Caverject, Penile Implants
  • Affect to plan design Significant Impact-
    Quantity limits required
  • Cost Level pricing about 90 for 10. Lots of
    DTC
  • Manufacturer Lilly
  • Approved November 2003

42
Symbyax
  • Generic olanzapine/fluoxetine Zyprexa/Prozac
  • Therapy Class Psychotropics
  • Indication Bipolar depression
  • Dose 6mg/25mg, 6mg/50mg, 12mg/25mg, 12mg/50mg
    capsules
  • One capsule at bedtime
  • Alternate medication Lithium,
  • Alternate therapies SSRIs SNRIs
  • Affect to plan design possible increase as it
    becomes standard of therapy
  • Cost Available in pharmacies in mid January.
    Close to 500 per month Prior authorization drug
    for at least 6 months
  • Manufacturer Lilly
  • Approved December 29, 2003

43
Other New Products
Generic Brand Mfg Indication
  • nitazoxanide Alinia Romark
    Diarrhea caused by Cryptosporidium
  • in children
    aged 12 mo to 11 yrs
  • morphine sulfate Avinza Elan/Ligand
    Chronic pain
  • oxaliplatin/ Eloxatin Sanofi-
    Colon or rectum carcinomas
  • 5-fluorouracil/
    Synthelabo
  • leucovorin
  • urofollitropin Bravelle Ferring
    Ovulation induction/infertility
  • leuprolide acetate Eligard Atrix
    Prostate Cancer
  • fosamprenavir Lexiva GSK
    AIDS- Protease Inhibitor

44
Other New Products
Generic Brand Mfg Indication
  • pegfilgrastim Neulasta Amgen
    Decreases infection by febrile
    neutropenia in
    chemo patients
  • fulvestrant Faslodex AstraZeneca
    Breast cancer
  • cyclosporine Restasis Allergan
    Low tear production due to ocular
  • opth emulsion inflammation-keratoconjunctivi
    tis
  • estradiol/ Climara Pro Berlex
    Osteoporosis- patch
  • levonorgestrel
  • carbi-/levodopa/ Stalevo
    Novartis Anti-Parkinsons agent
  • entacapone
  • emtricitabine Emtriva Gilead
    Sciences HIV-1 infection

45
Other New Products
Generic Brand Mfg
Indication
  • testosterone Testim Auxillium
    Low testosterone
  • voriconazole Vfend
    Pfizer Invasive Aspergillosis
  • buprenorphine/ Suboxone
    Reckitt Opioid dependence
  • naloxone
    Benckiser
  • tazarotene Avage
    Allergan Facial fine wrinkles, hyper-


  • hypopigmentation
  • diltiazem HCl Cardizem LA
    Biovail Hypertension
  • estradiol acetate Femring
    Galen HRT

46
Other New Products
Generic Brand Mfg Indication
  • etonogestrel/ Nuvaring Organon
    Contraception
  • ethinyl estradiol
  • N/A (vaccine) Daptacel Aventis
    Diphtheria, tetanus pertussis
  • pegvisomant Somavert Pfizer
    Acromegaly
  • agalsidase beta Fabrazyme Genzyme
    Fabrys Disease
  • flu vaccine FluMist
    MedImmune Flu vaccination
  • palonosetron Aloxi MGI
    Pharma Nausea/vomiting due to chemo

47
Products in Pipeline
48
Major Pipeline Issues
  • RD productivity
  • RD focus by the industry
  • Cost of RD
  • Financing of RD
  • Pricing of new drugs
  • Marketing of new drugs
  • Replacing older drugs with newer drugs

49
Major Pipeline Issues
  • Declining RD productivity
  • Unmet medical needs involve complex diseases
  • Pressure on drug reimbursement
  • Pressure on pricing of newer drugs
  • Pressure on price increase of approved drugs

50
Most Important Issues Facing the Industry
  • Declining RD productivity
  • Older drugs remain popular not replaced by
    newer and better drugs
  • Most newer drugs offer little or no additional
    benefits
  • Generic copies are now perceived as quality
    substitutes

51
Cymbalta (duloxetine) Lilly
  • Indicated for the treatment of major depressive
    disorder (urinary stress incontinence)
  • Pharmacology selective serotonin/norepinephrine
    reuptake inhibitor
  • Cost about 2.50/day - 60mg
  • Therapeutic gain
  • Stress incontinence indication
  • Not much else

52
Exanta (ximelagatran) AstraZeneca
  • Oral direct thrombin inhibitor for prevention of
    venous thromboembolism following orthopedic
    surgery and for stroke in atrial fibrillation
  • Dose 35mg BID
  • Therapeutic gain
  • Less monitoring, drug interactions than warfarin
    no dosage titration
  • Future indications
  • Treatment of VTE (2006)
  • Secondary prevention post-MI (2006)

53
Inhaled Insulin
  • Pharmacokinetic differences
  • Larger quantity of insulin required vs SC
  • Longer amount of time to be dispersed and reach
    blood
  • Long-term impact of protein in lungs unknown
  • Antibodies produced
  • Exubra Aventis/Pfizer powder
  • 1/200 cough
  • AERx Aradigm liquid inhalation
  • Increased absorption

54
Symlin (pramlintide acetate) Amylin/Lilly
  • Synthetic version of human hormone amylin for
    Type 2 diabetic patient not at target control
    with sulfonylurea or metformin
  • Pharmacology (as adjunct to insulin)
  • Prevents post-prandial rise in glucagon
  • Slows rate of gastric emptying
  • Reduces post-meal variation in blood glucose
  • Adverse effects
  • Nausea
  • Hypoglyemia
  • Dose 60-120 mcg bid SC injections
  • Cost ?

55
Ketek (telithromycin) Aventis
  • Ketolide for the treatment of CAP, acute
    exacerberation of chronic bronchitis, acute
    bacterial sinusitis, (macrolide-resistant S.
    pneumoniae)
  • Dose 800mg orally telithromycin daily for 7-10
    days
  • As or more effective than amoxicillin
  • Therapeutic gain
  • Resistance

56
Antegren (natalizumab) Biogen/Elan
  • Therapy Class alpha 4 integrin inhibitors
    (monoclonal antibody)
  • Indication Multiple Sclerosis Crohns disease
  • Dose 3mg/kg IV infusion
  • Alternate therapies Avonex ,Betaseron, Rebif
    (for MS),
  • Binds to receptors to block white blood cells
    from moving inside blood vessels to the tissues
    of the body at sites of inflammation
  • Plan design Medical not pharmacy or specialty
    care
  • Cost in excess of 10,000 per year for MS
  • Manufacturer Elan/Biogen Inc.
  • Release date sometime 2004

57
Avastin (bevacizumab) Genentech
  • Therapy Class vascular endothelial cell growth
    factor
  • Indication Cancer many types
  • Anti-angiogenesis drug
  • Stops tumors from growing by shutting off the
    blood supply
  • bind to and inhibit Vascular Endothelial Growth
    Factor (VEGF), a protein that plays a critical
    role in tumor angiogenesis
  • This product could be of immense significance
    multi-Billion dollar sales
  • This product could double Genentechs revenues
  • Manufacturer Genentech/Roche
  • Phase III trials since last May, may come this
    year

58
Others
  • Climarelle 17b estradiol patch Osteoporosis Berle
    x
  • NS 2330 DNSRI Alzheimers B-I
  • Tipranavir Non-peptide Protease Inhibitor HIV
    B-I
  • Avodart 5-a reductase inhibitor Prostate CA GSK
  • Caduet Lipitor/Norvasc Combo Hypertension Pfizer
  • CS-502 Cox Inhibitor ( like Vioxx) Pain Sankyo
  • Rotigotine Dopamine agonist patch Parkinsons Schw
    arz
  • Estorra eszopiclone Sleep Sepracor
  • Onercept Monoclonal Antibody Psoriasis Serono
  • Bazedoxifene Tissue selective estrogen
    Osteoporosis Wyeth

59
What to Expect
  • Industry has recognized its RD problems
  • Increasing focus on unmet medical needs
  • Increasing focus on high risk projects
  • Increasing focus on niche small markets
  • Only blockbuster sales level can justify
    investment
  • Expect very high prices in the future

60
Biopharmaceutical Pipeline
61
I. Biopharmaceutical Defined
  • Characteristics
  • Recombinant DNA technology
  • Target indications with high unmet medical need
  • Novel mechanism (pathology vs. symptoms)
  • Advance in efficacy
  • Unique safety profile
  • Injectables infusibles other (not oral)
  • Premium priced
  • Most relatively new to market

62
II. Biological Pipeline
  • As of April 2003, late-stage US development
  • 102 unique biopharmaceuticals
  • 156 indications
  • 36 disease categories
  • 86 manufacturers
  • 90 therapeutic proteins, antibodies, peptides

63
II. Biological Pipeline
64
II. Biological Pipeline
  • Excluding cancer, 60 of biopharmaceuticals will
    require chronic therapy
  • Another 15 require intermediate/intermittent

65
II. Biological Pipeline
  • Expected approvals within 4 years
  • 81 biopharmaceuticals
  • 123 indications
  • Wide range of diseases
  • Wide range of physician specialties
  • Infusions injections
  • HC provider administered
  • Chronic

66
We see the Pipeline, Now What?
  • What are the implications for employers?
  • What are the most pressing issues?
  • What are the opportunities?
  • What do you need to do to prepare?
  • Who can help?

67
IV. Payment Issues
Drug
Specialty Pharmacy
Manufacturer (whol, dist)
for Drug
for Drug
Co-pay or co-ins for drug
Drug Claim
Drug
Infusion Claim
Payer
Provider (in-office)
Patient
Drug
Appropriate infusion fee
Infusion service Co-pay
  • Compliance
  • Education
  • Support
  • provided by many

Flow of Drug
Flow of
Flow of Claims
68
Opportunities and Preparations
  • Stay updated on the new meds
  • Understand their impact
  • Move products to pharmacy benefit
  • Utilize Prior Authorization approach
  • Fourth Tier Co-pay
  • Higher amount
  • co-payment
  • Contract with Specialty Pharmacy Provider

69
Who Can Help
  • Your Director of Pharmacy Services
  • The Pharmaceutical Industry
  • Your PBM
  • Specialty Pharmacy Providers

70
Conclusion
  • Biologic will continue to the market
  • Many will come under the pharmacy benefit
  • They will be of considerable cost
  • They will need to be managed
  • Consider solutions now
  • They take time to implement
  • No template
  • No quick fix
  • Assistance? SPPs, manufacturers, etc.

71
New Drugs of 2002/2003
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