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USP COMMENTS TO THE DRAFT GUIDANCE –

CMS FORMULARY REVIEW FOR THE MEDICARE PRESCRIPTION DRUG BENEFIT

ATTACHMENTS

USP Comments to the CMS Draft Guidance – Attachment A: USP Model Guidelines

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ATTACHMENT A

USP MODEL GUIDELINES For a detailed discussion of the USP Model Guidelines, please refer to the document entitled Medicare Prescription Drug Benefit – Model Guidelines submitted to CMS under Cooperative Agreement No. 18-C-92305/3-01.

MODEL GUIDELINES NOTES

No. THERAPEUTIC CATEGORY PHARMACOLOGIC CLASS ADDITIONAL INFORMATION

1 Analgesics Opioid Analgesics See Antimigraine Agents Therapeutic Category for similar/related therapies

2 Non-opioid Analgesics See Anti-inflammatories

Therapeutic Category for similar/related therapies

3 Anesthetics

4 Antibacterials Beta-lactam, Cephalosporins

5 Beta-lactam, Penicillins

6 Beta-lactam, Other Includes drugs such as Loracarbef

7 Macrolides

8 Quinolones

9 Sulfonamides

10 Tetracyclines

11 Antibacterials, Other

Includes drugs such as Trimethoprim, Vancomycin, Lincomycin, Clindamycin,

Furazolidone, Nitrofurantoin, Linezolid,

Bacitracin, Chloramphenicol, Daptomycin, Fosfomycin,

Methenamine, Metronidazole, Mupirocin, Rifaximin, Spectinomycin

12 Anticonvulsants Calcium Channel Modifying Agents

13 Gamma-aminobutyric Acid

(GABA) Augmenting Agents


2



14 Glutamate Reducing Agents

15 Sodium Channel Inhibitors

16 Antidementia Agents Cholinesterase Inhibitors

17 Glutamate Pathway Modifiers

18 Antidementia Agents, Other Includes drugs such as Ergoloid Mesylates

19 Antidepressants Monoamine Oxidase (Type A) Inhibitors

20 Reuptake Inhibitors

21 Antidepressants, Other Includes drugs such as

Bupropion, Maprotiline, Mirtazapine, Trazodone

22 Antiemetics

23 Antifungals

24 Antigout Agents

25 Anti-inflammatories Glucocorticoids See Adrenal Pharmacologic

Class for similar/related therapies

26 Nonsteroidal Anti-inflammatory Drugs

See Non-opioid Analgesics Pharmacologic Class for similar/related therapies

27 Antimigraine Agents Abortive See Analgesics Therapeutic Category for similar/related

therapies

28 Prophylactic

See Autonomic Agents and Cardiovascular Agents

Therapeutic Categories for similar/related therapies

29 Antimycobacterials Antituberculars

30 Antimycobacterials, Other Includes drugs such as Clofazimine, Dapsone,

Rifabutin

31 Antineoplastics Alkylating Agents

32 Antimetabolites

33 Immune Modulators and Vaccines


3



34 Molecular Target Inhibitors

35 Nucleoside Analogues

36 Protective Agents

37 Topoisomerase Inhibitors

38 Antineoplastics, Other Includes drugs such as Carboplatin, Cisplatin,

Oxaliplatin

39 Antiparasitics Anthelmintics

40 Antiprotozoals

41 Pediculicides/Scabicides

42 Antiparkinson Agents Catechol O-methyltransferase (COMT) Inhibitors

43 Dopamine Agonists

44 Antiparkinson Agents, Other

Includes drugs such as Benztropine, Biperidin,

Bromocriptine, Diphenhydramine,

Procyclidine, Selegiline, Trihexyphenidyl

45 Antipsychotics Non-phenothiazines

46 Non-phenothiazines/Atypicals

47 Phenothiazines

48 Antivirals Anti-cytomegalovirus (CMV) Agents

49 Antiherpetic Agents

50 Anti–human

immunodeficiency virus (HIV) Agents, Fusion Inhibitors

51 Anti-HIV Agents, Non-

nucleoside Reverse Transcriptase Inhibitors

52 Anti-HIV Agents, Nucleoside

and Nucleotide Reverse Transcriptase Inhibitors


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53 Anti-HIV Agents, Protease Inhibitors

54 Anti-influenza Agents

55 Antivirals, Other Includes drugs such as Adefovir and Ribavirin

56 Anxiolytics Antidepressants

57 Anxiolytics, Other Includes drugs such as Buspirone and Meprobamate

58 Autonomic Agents Parasympatholytics

59 Parasympathomimetics

60 Sympatholytics

See Cardiovascular Agents and Genitourinary Agents Therapeutic Categories for

similar/related therapies

61 Sympathomimetics See Cardiovascular Agents Therapeutic Category for similar/related therapies

62 Bipolar Agents

63 Blood Glucose Regulators Antihypoglycemics

64 Hypoglycemics, Oral

65 Insulins

66 Blood Products/Modifiers/Volume Expanders Anticoagulants

67 Blood Formation Products

68 Coagulants

69 Platelet Aggregation Inhibitors

70 Cardiovascular Agents Alpha-adrenergic Agonists See Autonomic Agents


71 Alpha-adrenergic Blocking Agents

See Autonomic Agents Therapeutic Category for similar/related therapies

72 Antiarrhythmics

73 Beta-adrenergic Blocking Agents


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74 Calcium Channel Blocking Agents

75 Direct Cardiac Inotropics

76 Diuretics

77 Dyslipidemics

78 Renin-angiotensin-aldosterone System Inhibitors

79 Vasodilators

80 Central Nervous System Agents Amphetamines

81 Non-amphetamines

82 Dental and Oral Agents

83 Dermatological Agents Dermatological Anesthetics

84 Dermatological Antibacterials

85 Dermatological Antifungals

86 Dermatological Anti-inflammatories

87 Dermatological Antipruritic Agents

88 Dermatological Antivirals

89 Dermatological Keratolytics

90 Dermatological Mitotic Inhibitors

91 Dermatological Photochemotherapy Agents

92 Dermatological Retinoids

93 Dermatological Tar Derivatives

94 Dermatological Vitamin D Analogs

95 Dermatological Wound Care Agents

96 Deterrents/Replacements Alcohol Deterrents


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97 Enzyme Replacements/Modifiers

98 Gastrointestinal Agents Antispasmodics, Gastrointestinal

99 Histamine2 (H2) Blocking Agents

100 Irritable Bowel Syndrome Agents

101 Protectants

102 Proton Pump Inhibitors

103 Gastrointestinal Agents, Other

Includes drugs such as Balsalazide, Mesalamine,

Olsalazine, Sevelamer, Ursodiol

104 Genitourinary Agents Antispasmodics, Urinary

105 Benign Prostatic Hypertrophy Agents



106 Impotence Agents

107 Prostaglandins

See Hormonal Agents, Stimulant/Replacement/ Modifying Therapeutic

Category for similar/related therapies

108 Hormonal Agents, Stimulant/Replacement/Modifying Adrenal

See Anti-inflammatories Therapeutic Category for similar/related therapies

109 Parathyroid/Metabolic Bone Disease Agents

110 Pituitary

111 Prostaglandins See Genitourinary Agents Therapeutic Category for similar/related therapies

112 Sex Hormones/Modifiers


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113 Thyroid

114 Hormonal Agents, Suppressant Adrenal

115 Pituitary

116 Sex Hormones/Modifiers

117 Thyroid

118 Immunological Agents Immune Stimulants

119 Immune Suppressants

120 Immunomodulators

121 Inflammatory Bowel Disease Agents Glucocorticoids



122 Salicylates

123 Sulfonamides See Antibacterials


124 Ophthalmic Agents Ophthalmic Anti-allergy Agents

125 Ophthalmic Antibacterials

126 Ophthalmic Antifungals

127 Ophthalmic Antiglaucoma Agents

128 Ophthalmic Anti-inflammatories

129 Ophthalmic Antivirals

130 Ophthalmics, Other Includes drugs such as Formivirsen

131 Otic Agents Otic Antibacterials

132 Otic Anti-inflammatories

133 Respiratory Tract Agents Antihistamines

134 Antileukotrienes


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135 Bronchodilators, Anticholinergic

136 Bronchodilators, Anti-inflammatories

137 Bronchodilators,

Phosphodiesterase 2 Inhibitors (Xanthines)

138 Bronchodilators, Sympathomimetic

139 Mast Cell Stabilizers

140 Mucolytics

141 Respiratory Tract Agents, Other

Includes drugs such as Alpha-1-proteinase Inhibitor,

Human; Benzonatate; Guaifenesin; Iodinated

Glycerol; Potassium Iodide; Tetrahydrozoline

142 Sedatives/Hypnotics

143 Skeletal Muscle Relaxants

144 Therapeutic Nutrients/Minerals/Electrolytes Electrolytes/Minerals

145 Vitamins All others except prenatal vitamins excluded from

coverage

146 Toxicologic Agents Opioid Antagonists

USP Comments to the CMS Draft Guidance – Attachment B: USP Formulary Key Drug Types

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ATTACHMENT B

USP LIST OF FORMULARY KEY DRUG TYPES Below is an alphabetical listing of formulary key drug types that USP is providing for CMS use in the formulary review process (as proposed in the CMS Draft Regulatory Guidance). A column entitled Notes has been added to provide additional information and clarification regarding certain drug types. Because this is an alphabetical listing, items that my have similar therapeutic indications or mechanisms of action may dispersed throughout the list. Some items listed include parentheses after the key drug type name with the prefix “non-”, e.g., Antiprotozoals (Non-Antimalarials). This indicates that Antimalarials are addressed elsewhere within the list and not appropriate for this item. Similarly, the Notes section of some items (e.g., Antiarrhythmics (Other)) includes the wording “does not refer to…” Again, the items listed after “does not refer to” are addressed elsewhere in the listing and are not appropriate for this particular key drug type. Items excluded from Part D coverage by law (e.g., barbiturates) are not included in the listing. It is recognized that some medications currently covered by Part B may in time be covered under Part D. To accommodate these and other changes in therapeutic uses of covered drugs as well as the additions of new Part D drugs, the USP Model Guidelines Expert Committee will revise the therapeutic categories, pharmacologic classes, and listing of formulary key drug types over time.

USP LIST OF FORMULARY KEY

DRUG TYPES NOTES

3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)

Reductase Inhibitors

5 Alpha-reductase Inhibitors

5-hydroxytryptamine 3 (5-HT3) Antagonists

Aldosterone Receptor Antagonists

Allylamine Antifungals Includes drugs such as Terbinafine

Alpha-adrenergic Agonists

Alpha-adrenergic Agonists, Ophthalmic

Alpha-adrenergic Blocking Agents

Alpha-beta–adrenergic Agonists


2


DRUG TYPES NOTES

Alpha-beta–adrenergic Blocking Agents

Alpha Glucosidase Inhibitors

Amino Derivative Penicillins

Androgens/Anabolic Steroids

Angiotensin II Receptor Antagonists

Angiotensin-converting Enzyme (ACE) Inhibitors

Antiandrogens

Antiarrhythmics - Class II

Antiarrhythmics - Class III

Antiarrhythmics - Class IV

Antiarrhythmics - Classes I A, B and C

Antiarrhythmics (Other) Includes drugs such as Adenosine; does not refer to Classes I, II, III,

or IV

Anticoagulants, Oral

Anticonvulsants (Other)

Includes drugs such as Levetiracetam; does not refer to

Calcium Channel Modifying Agents, GABA Augmenting Agents, Glutamate Reducing Agents, or Sodium Channel

Inhibitors

Antiemetics (Non-5-HT3 Antagonists)

Includes drugs such as Aprepitant, Chlorpromazine,

Dimenhydrinate, Diphenhydramine, Dronabinol,

Droperidol, Hydroxyzine, Meclizine, Metoclopramide,

Perphenazine, Prochlorperazine, Promethazine, Scopolamine,

Thiethylperazine, Trimethobenzamide

Antiestrogens/Modifiers

Antifolate Antibacterials Includes drugs such as


3


DRUG TYPES NOTES

Trimethoprim

Antifungals (Other)

Includes drugs such as Griseofulvin; does not refer to

Allylamines, Azoles, Polyenes, or Pyrimidines

Antigout Agents (Non-Renal Tubular Blocking Agents and

Non-Xanthine Oxidase Inhibitors)

Includes drugs such as Colchicine

Antimalarials

Antimigraine Agents, Prophylactic (Non-Beta-

adrenergic Blocking Agents)

Includes drugs such as Divalproex, Topiramate

Antiprotozoals (Non-antimalarials)

Includes drugs such as Atovaquone, Nitazoxanide, Pentamidine, Tinidazole,

Trimetrexate

Azole Antifungals Includes drugs such as

Clotrimazole, Fluconazole, Ketoconazole, Voriconazole

Beta-adrenergic Agonists

Beta-adrenergic Blocking Agents

Beta-adrenergic Blocking Agents, Ophthalmic

Biguanides

Bile Acid Sequestrants

Bisphosphonates

Calcium Channel Blocking Agents (Non-dihydropyridines)

Includes drugs such as Bepridil, Diltiazem, Verapamil

Calcium Regulating Hormones

Carbacephem Antibacterials Includes drugs such as Loracarbef

Carbonic Anhydrase Inhibitors

Carbonic Anhydrase Inhibitors, Ophthalmic

Cardioselective Beta-adrenergic Blocking Agents


4


DRUG TYPES NOTES

Cephalosporin Antibacterials, 1st Generation

Cephalosporin Antibacterials, 2nd Generation

Cephalosporin Antibacterials, 3rd Generation

Cyclooxygenase-2 (COX-2) Inhibitors

Dihydropyridines

Ergot Alkaloids

Erythromycins

Estrogens

Extended Spectrum Penicillins

Fibrates

Glucocorticoids

Glucocorticoids-Topical-High Potency

Glucocorticoids-Topical-Low Potency

Glucocorticoids-Topical-Medium Potency

Glucocorticoids-Topical-Very High Potency

Glycopeptide Antibacterials Includes drugs such as Vancomycin

Histamine1 (H1) Blocking Agents, Mildly/Non-sedating

H1 Blocking Agents, Sedating

Immune Stimulants (Non-vaccines)

Includes drugs such as Interferons

Immune Suppressants (Non-TNF Inhibitors)

Includes drugs such as Azathioprine, Muromonab-CD3,

Mycophenolate

Insulin, Intermediate-acting

Insulin, Long-acting


5


DRUG TYPES NOTES

Insulin, Rapid-acting

Insulin, Short-acting

Ketolides

Lincomycin Antibacterials Includes drugs such as Lincomycin and Clindamycin

Lipid Absorption Inhibitors

Local Anesthetics

Loop Diuretics

Macrolides (Non-Erythromycins, Non-Ketolides)

Includes drugs such as Azithromycin, Clarithromycin, Dirithromycin, Troleandomycin

Meglitinides

Mineralocorticoids

Miotics, Ophthalmic

Miscellaneous Antibacterials

Includes drugs such as Bacitracin, Chloramphenicol, Daptomycin,

Fosfomycin, Methenamine, Metronidazole, Mupirocin, Rifaximin, Spectinomycin

Nicotinic Acid

Nitrofuran Antibacterials Includes drugs such as Furazolidone and Nitrofurantoin

Nonselective Beta-adrenergic Blocking Agents

Nonsteroidal Anti-inflammatory Drugs, Non-

specific

Includes drugs such as Diclofenac, Diflunisal, Etodolac, Fenoprofen,

Flurbiprofen, Ibuprofen, Indomethacin, Ketoprofen, Ketorolac, Meclofenamate, Meloxicam, Nabumetone,

Naproxen, Oxaprozin, Piroxicam, Salsalate, Sulindac, Tolmetin

Opioid Analgesics, Long-acting

Opioid Analgesics, Short-acting

Osmotic Agents, Ophthalmic


6


DRUG TYPES NOTES

Osmotic Diuretics

Oxazolidinone Antibacterials Includes drugs such as Linezolid

Parathyroid Includes drugs such as Cinacalcet

Parathyroid/Metabolic Bone Disease Agents (Other)

Includes drugs such as Gallium; does not refer to Bisphosphonates, Calcium Regulating Hormones, or

Vitamin D-related/Metabolic Bone Disease Agents

Penicillinase-resistant Penicillins

Phosphodiesterase Inhibitors

Polyene Antifungals Includes drugs such as Amphotericin B, Nystatin

Porphyrin Derivative Photochemotherapy

Potassium-sparing Diuretics

Prenatal Vitamins All others except prenatal vitamins excluded from coverage

Progestins

Prostaglandins, Ophthalmic

Psoralen Photochemotherapy

Pyrimidine Antifungals Includes drugs such as Flucytosine

Quinolones, Fluorinated

Quinolones, Non-fluorinated

Renal Tubular Blocking Agents

Selective Estrogen Receptor Modifying Agents

Selective Serotonin Reuptake Inhibitors (SSRIs)

Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)

Sulfonylureas

Thiazide Diuretics


7


DRUG TYPES NOTES

Thiazolidinediones

Tricyclics

Triptans

Tumor Necrosis Factor (TNF) Inhibitors

Vaccines

Vitamin D–related/Metabolic Bone Disease Agents

Wound Debriding Agents

Xanthine Oxidase Inhibitors

USP Comments to the CMS Draft Guidance – Attachment C: USP Model Guidelines Shown with the USP Formulary Key Drug Types

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ATTACHMENT C

USP MODEL GUIDELINES SHOWN WITH THE USP LIST OF FORMULARY KEY DRUG TYPES

The purpose of the Formulary Key Drug Types listing is to provide additional guidance to CMS regarding drug types that the Expert Committee believes CMS should look for in Plans’ formularies. By checking a Plan’s formulary for at least one item in each of the USP Formulary Key Drug Types – and requesting justification if a formulary excludes and of these items – CMS can help ensure that a formulary is comprehensive and will not substantially discourage enrollment of eligible beneficiaries. The Formulary Key Drug Types is shown with the USP Model Guidelines in the table that follows to provide a tool that may facilitate CMS’ review of formularies that have elected to be consistent with the USP Model Guidelines.


1

USP MODEL GUIDELINES SHOWN WITH THE USP LIST OF FORMULARY KEY DRUG TYPES

MODEL GUIDELINES FORMULARY KEY DRUG TYPES NOTES

No. THERAPEUTIC CATEGORY PHARMACOLOGIC CLASS

FOR CMS REGULATORY GUIDANCE

ADDITIONAL INFORMATION

1 Analgesics Opioid Analgesics Opioid Analgesics, Long-acting

See Antimigraine Agents Therapeutic Category for similar/related therapies

Opioid Analgesics, Short-acting

See Antimigraine Agents Therapeutic Category for similar/related therapies

2 Non-opioid Analgesics Nonsteroidal Anti-

inflammatory Drugs, Non-specific

See Anti-inflammatories Therapeutic Category for similar/related therapies;




Cyclooxygenase-2 (COX-2) Inhibitors


3 Anesthetics Local Anesthetics

4 Antibacterials Beta-lactam, Cephalosporins

Cephalosporin Antibacterials, 1st

Generation


2





Cephalosporin

Antibacterials, 2nd Generation

Cephalosporin

Antibacterials, 3rd Generation

5 Beta-lactam, Penicillins Amino Derivative Penicillins

Extended Spectrum Penicillins

Penicillinase-resistant Penicillins

6 Beta-lactam, Other Carbacephem Antibacterials

Includes drugs such as Loracarbef

7 Macrolides Erythromycins

Ketolides

Macrolides (Non-

Erythromycins, Non-Ketolides)

Includes drugs such as Azithromycin,

Clarithromycin, Dirithromycin,

Troleandomycin

8 Quinolones Quinolones, Fluorinated

Quinolones, Non-fluorinated

9 Sulfonamides

10 Tetracyclines


3





11 Antibacterials, Other Antifolate Antibacterials Includes drugs such as Trimethoprim

Glycopeptide Antibacterials Includes drugs such as Vancomycin

Lincomycin Antibacterials Includes drugs such as Lincomycin and Clindamycin

Nitrofuran Antibacterials Includes drugs such as

Furazolidone and Nitrofurantoin

Oxazolidinone Antibacterials

Includes drugs such as Linezolid

Miscellaneous Antibacterials

Includes drugs such as Bacitracin, Chloramphenicol,

Daptomycin, Fosfomycin, Methenamine, Metronidazole,

Mupirocin, Rifaximin, Spectinomycin

12 Anticonvulsants Calcium Channel Modifying Agents

13 Gamma-aminobutyric

Acid (GABA) Augmenting Agents

14 Glutamate Reducing Agents

15 Sodium Channel Inhibitors

Anticonvulsants, Other

Includes drugs such as Levetiracetam; does not refer

to Calcium Channel Modifying Agents, GABA


4





Augmenting Agents, Glutamate Reducing Agents,

or Sodium Channel Inhibitors

16 Antidementia Agents Cholinesterase Inhibitors

17 Glutamate Pathway Modifiers

18 Antidementia Agents, Other Includes drugs such as

Ergoloid Mesylates

19 Antidepressants Monoamine Oxidase (Type A) Inhibitors

20 Reuptake Inhibitors Selective Serotonin Reuptake Inhibitors

(SSRIs)

Serotonin and

Norepinephrine Reuptake Inhibitors (SNRIs)

Tricyclics

21 Antidepressants, Other Includes drugs such as

Bupropion, Maprotiline, Mirtazapine, Trazodone

22 Antiemetics 5-hydroxytryptamine 3 (5-HT3) Antagonists

Antiemetics (Non -5-HT3 Antagonists)

Includes drugs such as Aprepitant, Chlorpromazine,

Dimenhydrinate, Diphenhydramine,

Dronabinol, Droperidol, Hydroxyzine, Meclizine,

Metoclopramide,


5





Perphenazine, Prochlorperazine,

Promethazine, Scopolamine, Thiethylperazine,

Trimethobenzamide

23 Antifungals Allylamine Antifungals Includes drugs such as Terbinafide

Azole Antifungals Includes drugs such as

Clotrimazole, Fluconazole, Ketoconazole, Voriconazole

Polyene Antifungals Includes drugs such as Amphotericin B, Nystatin

Pyrimidine Antifungals Includes drugs such as Flucytosine

Antifungals (Other)

Includes drugs such as Griseofulvin; does not refer to Allylamines, Azoles, Polyenes,

or Pyrimidines

24 Antigout Agents Renal Tubular Blocking Agents

Xanthine Oxidase Inhibitors

Antigout Agents (Non-Renal Tubular Blocking

Agents and Non-Xanthine Oxidase Inhibitors)

Includes drugs such as Colchicine

25 Anti-inflammatories Glucocorticoids See Adrenal Pharmacologic

Class for similar/related therapies


6





26 Nonsteroidal Anti-inflammatory Drugs

Nonsteroidal Anti-inflammatory Drugs, Non-

specific

See Non-opioid Analgesics Pharmacologic Class for similar/related therapies;




27 Antimigraine Agents Abortive Ergot Alkaloids See Analgesics Therapeutic Category for similar/related

therapies

Triptans See Analgesics Therapeutic Category for similar/related

therapies

28 Prophylactic Beta-adrenergic Blocking Agents



Antimigraine Agents, Prophylactic (Non-Beta-

adrenergic Blocking Agents)

Includes drugs such as Divalproex, Topiramate

29 Antimycobacterials Antituberculars

30 Antimycobacterials, Other Includes drugs such as

Clofazimine, Dapsone,


7





Rifabutin

31 Antineoplastics Alkylating Agents

32 Antimetabolites

33 Immune Modulators and Vaccines

34 Molecular Target Inhibitors

35 Nucleoside Analogues

36 Protective Agents

37 Topoisomerase Inhibitors

38 Antineoplastics, Other Includes drugs such as Carboplatin, Cisplatin,

Oxaliplatin

39 Antiparasitics Anthelmintics

40 Antiprotozoals Antimalarials

Antiprotozoals (Non-antimalarials)

Includes drugs such as Atovaquone, Nitazoxanide, Pentamidine, Tinidazole,

Trimetrexate

41 Pediculicides/Scabicides

42 Antiparkinson Agents Catechol O-

methyltransferase (COMT) Inhibitors


8





43 Dopamine Agonists

44 Antiparkinson Agents, Other

Includes drugs such as Benztropine, Biperidin,

Bromocriptine, Diphenhydramine,

Procyclidine, Selegiline, Trihexyphenidyl

45 Antipsychotics Non-phenothiazines

46 Non-phenothiazines/Atypicals

47 Phenothiazines

48 Antivirals Anti-cytomegalovirus (CMV) Agents

49 Antiherpetic Agents

50

Anti–human immunodeficiency virus

(HIV) Agents, Fusion Inhibitors

51 Anti-HIV Agents, Non-

nucleoside Reverse Transcriptase Inhibitors

52

Anti-HIV Agents, Nucleoside and Nucleotide

Reverse Transcriptase Inhibitors

53 Anti-HIV Agents,


9





Protease Inhibitors

54 Anti-influenza Agents

55 Antivirals, Other Includes drugs such as Adefovir and Ribavirin

56 Anxiolytics Antidepressants

57 Anxiolytics, Other Includes drugs such as Buspirone and Meprobamate

58 Autonomic Agents Parasympatholytics

59 Parasympathomimetics

60 Sympatholytics Alpha-adrenergic Blocking Agents

See Cardiovascular Agents and Genitourinary Agents Therapeutic Categories for


Beta-adrenergic Blocking Agents

See Antimigraine Agents and Cardiovascular Agents


61 Sympathomimetics Alpha-adrenergic Agonists See Cardiovascular Agents Therapeutic Category for similar/related therapies

Alpha-beta–adrenergic Agonists

Beta-adrenergic Agonists

62 Bipolar Agents


10





63 Blood Glucose Regulators Antihypoglycemics

64 Hypoglycemics, Oral Alpha Glucosidase Inhibitors

Biguanides

Meglitinides

Sulfonylureas

Thiazolidinediones

65 Insulins Insulin, Intermediate-acting

Insulin, Long-acting

Insulin, Rapid-acting

Insulin, Short-acting

66 Blood Products/Modifiers/Volume Expanders Anticoagulants Anticoagulants, Oral

67 Blood Formation Products

68 Coagulants

69 Platelet Aggregation Inhibitors

70 Cardiovascular Agents Alpha-adrenergic Agonists

See Autonomic Agents Therapeutic Category for similar/related therapies

71 Alpha-adrenergic Blocking Agents See Autonomic Agents

Therapeutic Category for


11






72 Antiarrhythmics Antiarrhythmics - Classes I A, B and C

Antiarrhythmics - Class II

Antiarrhythmics - Class III

Antiarrhythmics - Class IV

Antiarrhythmics, Other Includes drugs such as

Adenosine; does not refer to Classes I, II, III, or IV

73 Beta-adrenergic Blocking Agents

Alpha-beta–adrenergic Blocking Agents

Cardioselective Beta-adrenergic Blocking Agents

Nonselective Beta-adrenergic Blocking Agents

74 Calcium Channel Blocking Agents Dihydropyridines

Calcium Channel Blocking

Agents (Non-dihydropyridines)

Includes drugs such as Bepridil, Diltiazem,

Verapamil

75 Direct Cardiac Inotropics

76 Diuretics Carbonic Anhydrase Inhibitors

Loop Diuretics


12





Osmotic Diuretics

Potassium-sparing Diuretics

Thiazide Diuretics

77 Dyslipidemics Bile Acid Sequestrants

Fibrates

3-hydroxy-3-methylglutaryl

coenzyme A (HMG CoA) Reductase Inhibitors

Lipid Absorption Inhibitors

Nicotinic Acid

78 Renin-angiotensin-aldosterone System

Inhibitors

Aldosterone Receptor Antagonists

Angiotensin-converting Enzyme (ACE) Inhibitors

Angiotensin II Receptor Antagonists

79 Vasodilators

80 Central Nervous System Agents Amphetamines

81 Non-amphetamines

82 Dental and Oral Agents


13





83 Dermatological Agents Dermatological Anesthetics

84 Dermatological Antibacterials

85 Dermatological Antifungals

86 Dermatological Anti-inflammatories

87 Dermatological Antipruritic Agents

88 Dermatological Antivirals

89 Dermatological Keratolytics

90 Dermatological Mitotic Inhibitors

91 Dermatological

Photochemotherapy Agents

Porphyrin Derivatives Photochemotherapy

Psoralen Photochemotherapy

92 Dermatological Retinoids

93 Dermatological Tar Derivatives

94 Dermatological Vitamin D Analogs

95 Dermatological Wound Care Agents Wound Debriding Agents

96 Deterrents/Replacements Alcohol Deterrents


14





97 Enzyme Replacements/Modifiers

98 Gastrointestinal Agents Antispasmodics, Gastrointestinal

99 Histamine2 (H2) Blocking Agents

100 Irritable Bowel Syndrome Agents

101 Protectants

102 Proton Pump Inhibitors

103 Gastrointestinal Agents, Other

Includes drugs such as Balsalazide, Mesalamine,

Olsalazine, Sevelamer, Ursodiol

104 Genitourinary Agents Antispasmodics, Urinary

105 Benign Prostatic Hypertrophy Agents

Alpha1-adrenergic Blocking Agents



5 Alpha-reductase Inhibitors

106 Impotence Agents Phosphodiesterase Inhibitors

107 Prostaglandins




15





108 Hormonal Agents, Stimulant/Replacement/Modifying Adrenal Glucocorticoids


Glucocorticoids-Topical-Low Potency

Glucocorticoids-Topical-Medium Potency

Glucocorticoids-Topical-High Potency

Glucocorticoids-Topical-Very High Potency

Mineralocorticoids

109 Parathyroid/Metabolic Bone Disease Agents Bisphosphonates

Calcium Regulating Hormones

Vitamin D–

related/Metabolic Bone Disease Agents

Parathyroid/Metabolic Bone Disease Agents Other

Includes drugs such as Gallium; does not refer to Bisphosphonates, Calcium Regulating Hormones, or

Vitamin D-related/Metabolic Bone Disease Agents

110 Pituitary

111 Prostaglandins See Genitourinary Agents Therapeutic Category for similar/related therapies


16





112 Sex Hormones/Modifiers Androgens/Anabolic Steroids

Estrogens

Progestins

Selective Estrogen Receptor Modifying Agents

113 Thyroid

114 Hormonal Agents, Suppressant Adrenal

115 Pituitary

116 Sex Hormones/Modifiers Antiandrogens

Antiestrogens/Modifiers

117 Thyroid

Parathyroid Includes drugs such as Cinacalcet

118 Immunological Agents Immune Stimulants Vaccines

Immune Stimulants (Non-vaccines)

Includes drugs such as Interferons

119 Immune Suppressants Tumor Necrosis Factor (TNF) Inhibitors

Immune Suppressants (Non-TNF Inhibitors)

Includes drugs such as Azathioprine, Muromemab-

CD3, Mycophenolate

120 Immunomodulators Includes drugs such as


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Leflunomide, Thalidomide

121 Inflammatory Bowel Disease Agents Glucocorticoids



122 Salicylates

123 Sulfonamides See Antibacterials


124 Ophthalmic Agents Ophthalmic Anti-allergy Agents

125 Ophthalmic Antibacterials

126 Ophthalmic Antifungals

127 Ophthalmic Antiglaucoma Agents

Alpha-adrenergic Agonists, Ophthalmic

Beta-adrenergic Blocking Agents, Ophthalmic

Carbonic Anhydrase Inhibitors, Ophthalmic

Miotics, Ophthalmic

Osmotic Agents, Ophthalmic

Prostaglandins, Ophthalmic


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128 Ophthalmic Anti-inflammatories

129 Ophthalmic Antivirals

130 Ophthalmics, Other Includes drugs such as Formivirsen

131 Otic Agents Otic Antibacterials

132 Otic Anti-inflammatories

133 Respiratory Tract Agents Antihistamines Histamine1 (H1) Blocking

Agents, Mildly/Non-sedating

H1 Blocking Agents, Sedating

134 Antileukotrienes

135 Bronchodilators, Anticholinergic

136 Bronchodilators, Anti-inflammatories

137 Bronchodilators,

Phosphodiesterase 2 Inhibitors (Xanthines)

138 Bronchodilators, Sympathomimetic

139 Mast Cell Stabilizers

140 Mucolytics

141 Respiratory Tract Agents, Other Includes drugs such as Alpha-

1-proteinase Inhibitor,


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Human; Benzonatate; Guaifenesin; Iodinated

Glycerol; Potassium Iodide; Tetrahydrozoline

142 Sedatives/Hypnotics

143 Skeletal Muscle Relaxants

144 Therapeutic Nutrients/Minerals/Electrolytes Electrolytes/Minerals

145 Vitamins Prenatal Vitamins All others except prenatal vitamins excluded from

coverage

146 Toxicologic Agents Opioid Antagonists

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