PHARMACY UTILIZATION MANAGEMENT GUIDELINE – 5.01.560

Excessively High Cost Drug Products with Lower Cost

Alternatives Effective Date: April 1, 2020

Last Revised: March 10, 2020

Replaces: N/A

RELATED MEDICAL POLICIES:

10.01.511 Medical Policy and Clinical Guidelines: Definitions and Procedures

Select a hyperlink below to be directed to that section.

POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING

RELATED INFORMATION | REFERENCES | HISTORY

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Introduction

Often, several very similar drugs are available to treat the same condition. In some cases, a drug

will be very expensive, while much lower cost drugs that are appropriate therapeutic alternatives

may be prescribed instead and will work just as well. This policy defines the criteria that must be

met and the drugs that must be tried first before specific excessively high cost drugs can be

approved.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

service may be covered.

The drug products listed in this medical policy will be reviewed on a case by case basis and are

subject to the criteria outlined below. These products are excessively high priced and have

much lower cost alternatives that are equally safe and effective. Suggested alternatives are listed

in the table below.

https://www.lifewisewa.com/medicalpolicies/10.01.511.pdf

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Note: Documentation in the form of chart notes is required with every prior authorization

request for the drugs listed in this policy.

High Cost Drug Product Suggested Alternatives

Absorica® (isotretinoin), Absorica LD™

(isotretinoin)

Trial and failure of two of the following medications: Claravis,

Zenatane, or Myorisan

Alcortin-A® Generic prescription topical corticosteroids

Allzital, Vanatol LQ, Vanatol S Bultalbital with acetaminophen (generics)

Amrix® (cyclobenzaprine extended-release)

Cyclobenzaprine extended-release

Generic cyclobenzaprine AND generic tizanidine or generic

methocarbamol

Auvi-Q® Epinephrine Auto-Injector (generic Epipen and generic

Adrenaclick)

Adrenaclick®

Brand name EpiPen®

EpiPen Authorized Generic, Adrenaclick Authorized Generic

Lorzone® (chlorzoxazone)

Chlorzoxazone 250 mg, 375 mg and 750 mg

Generic chlorzoxazone 500 mg

Pennsaid® Generic topical diclofenac gel 1% AND generic topical

diclofenac solution 1.5%

Evzio® Narcan (nasal spray), generic naloxone solution for injection

Bethkis®, Kitabis®, Tobi® Podhaler™ Generic tobramycin solution

Fluoxetine Three tablets or capsules of generic fluoxetine 20mg.

Fortamet®

Generic for Fortamet®

Glumetza®

Generic for Glumetza®

Generic metformin extended-release (generic for Glucophage

XR®)

Jublia®

Kerydin®

Generic ciclopirox AND either generic terbinafine OR generic

itraconazole

Natpara® (parathyroid horomone) Calcium supplements and active forms of vitamin D (eg,

calcitriol, cholecalciferol, doxercalciferol, ergocalciferol)

Northera® Generic midodrine

Kits Non-kit version of the active ingredients found within the kit.

(such as: Livixil (lidocaine 2.5%/prilocaine 2.5% cream),

Dermacinrx Silapak (triamcinolone acetonide cream 0.1%

+dimethicone cream) etc.)

Topical lidocaine products:

Adazin

Anastia

Generic lidocaine HCL cream and generic lidocaine HCL lotion

Page | 3 of 18 ∞

High Cost Drug Product Suggested Alternatives

Astero

Elenza Patch

Kamdoy

Ldo Plus

L.E.T.

Lidocaine 3.88%

Lidocaine-Epinephrine-Tetracaine

Lidocaine HCl

Lidocaine-Tetracaine

Lido-K

Lidodextrapine

Lidopin

Lidorx

Lidotral

Lidotrex

Lidovex

Lidozion

Lidtopic Max

Numbonex

Pain Relief

Pliaglis

Reciphexamine

Regenecare

Relyyks

Scar

Silvera

Suvicort

Synvexia TC

Tranzarel

Velma

Vexa

Vexasyn

Lidoderm Patches

Synera

ZTlido

Generic lidocaine patch, AND generic lidocaine HCL cream,

AND generic lidocaine HCL lotion

Paingo KFT Generic lidocaine/prilocaine cream, AND generic lidocaine

HCL cream, AND generic lidocaine HCL lotion

Omeprazole ODT Generic forms of: esomeprazole magnesium, AND

lansoprazole, AND omeprazole, AND pantoprazole, AND

rabeprazole.

Rayos® Generic prednisone AND generic methylprednisolone

Riomet® Generic metformin tablet

Page | 4 of 18 ∞

High Cost Drug Product Suggested Alternatives

Riomet ER™

Zegerid®, Zegerid OTC, omeprazole/sodium

bicarbonate, OmePPi

Generic forms of: esomeprazole magnesium, AND

lansoprazole, AND omeprazole, AND pantoprazole, AND

rabeprazole.

Zyflo CR & Zileuton ER, Zyflo & Zileuton Generic montelukast

Policy Coverage Criteria

Drug Medical Necessity Absorica® (isotretinoin),

Absorica LD™ (isotretinoin)

Brand Absorica® and Absorica LD™ may be considered

medically necessary when the provider submits

documentation in the form of medical records to show the

following:

• Patient has severe, recalcitrant, nodular acne and is 12 years of

age or older

AND

• Patient has documented trial and failure (at least 3-month trial)

of two of the following generic medications: Amnesteem,

Claravis, Isotretinoin, Myorisan or Zenatane

Alcortin-A® (iodoquinol,

hydrocortisone, aloe

polysaccharides)

Alcortin-A® may be considered medically necessary when

provider submits documentation in the form of medical

records to show that the patient had an adequate trial and

failure with two generic prescription topical corticosteroids.

Allzital®, Vanatol LQ®,

Vanatol S®

(butalbital/acetaminophen)

Allzital®, Vanatol LQ® or Vanatol S® (butalbital/acetamino-

phen) may be considered medically necessary for patients age

16 and above when:

• Patient has documented trial and failure of at least two generic

butalbital/acetaminophen products

• For Vanatol LQ or Vanatol S, documentation must be provided

of why a liquid form is required (eg, patient is unable to

swallow tablets)

Amrix® (cyclobenzaprine

extended-release)

Brand Amrix® and generic cyclobenzaprine extended-release

may be considered medically necessary when provider submits

documentation in the form of medical records to show that

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Drug Medical Necessity Cyclobenzaprine extended-

release

the patient had an adequate trial and failure (at least 3

months) of generic cyclobenzaprine AND an additional muscle

relaxant: tizanidine or methocarbamol

Auvi-Q® (epinephrine

injection)

Auvi-Q® 0.15 mg/0.15 mL and Auvi-Q® 0.3 mg/0.3 mL may

be considered medically necessary when ONE of the following

is true:

• Patient or caregiver lacks the manual dexterity or visual acuity

needed to use Epinephrine Auto-Injector (generic Epipen and

generic Adrenaclick)

OR

• The patient or caregiver lacks the mental capacity to be trained

on how to use Epinephrine Auto-Injector (generic Epipen and

generic Adrenaclick)

Auvi-Q® 0.1 mg/0.1 mL may be considered medically

necessary when the following is true:

• Patient body weight is between 16.5 to 33 pounds (7.5 to 15

kilograms)

AND

• Caregiver lacks the manual dexterity or visual acuity needed to

use Epinephrine Auto-Injector (generic Epipen and generic

Adrenaclick)

OR

• The caregiver lacks the mental capacity to be trained on how to

use Epinephrine Auto-Injector (generic Epipen and generic

Adrenaclick)

Brand name EpiPen® and

Adrenaclick® (epinephrine

injection)

Brand EpiPen® and Adrenaclick® may be considered

medically necessary when provider submits documentation in

the form of medical records to explain why patient is not a

candidate for the use of the following preferred options:

• EpiPen® Authorized Generic*

OR

• Adrenaclick® Authorized Generic*

*An authorized generic is defined by the Food and Drug Administration as: “The

term “authorized generic” drug is most commonly used to describe an approved,

brand name drug that is marketed as a generic product without the brand name

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Drug Medical Necessity on its label. Other than the fact that it does not have the brand name on its label,

it is the exact same drug product as the branded product. It may be marketed by

the brand name drug company, or another company with the brand company’s

permission. In some cases, even though it is the same as the brand name product,

the authorized generic may be sold at a lower cost than the brand name drug.”

Lorzone® (chlorzoxazone),

chlorzoxazone 250 mg, 375

mg and 750 mg

Brand Lorzone® 750 mg tablets and generic chlorzoxazone

250 mg or 750 mg tablets may be considered medically

necessary when:

• Provider submits documentation that the patient has tried and

did not tolerate chlorzoxazone 500 mg tablets or achieve

therapeutic response with chlorzoxazone 500 mg tablets

AND

• Patient or caregiver lacks the manual dexterity or visual acuity

needed to cut chlorzoxazone 500 mg tablets

Brand Lorzone® 375 mg tablets and generic chlorzoxazone

375 mg tablets may be considered medically necessary when:

• Provider submits documentation that the patient has tried and

did not tolerate chlorzoxazone 500 mg tablets

Note: Chlorzoxazone 500 mg tablets are scored and can be cut in half to

deliver a 250 mg dose or a 750 mg dose.

Pennsaid®

(topical nonsteroidal anti-

inflammatory drugs

[NSAIDs])

The agents may be considered medically necessary when:

• Patient has a documented diagnosis of osteoarthritis of the

knee(s)

AND

• Patient has a documented trial* and failure of both, generic

diclofenac topical gel 1% AND generic topical diclofenac

solution 1.5%

*Trial is defined as 3 months of continuous therapy.

Evzio® (naloxone) Evzio® may be considered medically necessary when a

documented reason as to why BOTH of the other available

dosage forms are not appropriate for the patient is provided:

1. Patient is unable to use or be taught how to use Narcan®

(nasal spray) because at least ONE of the following is true:

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Drug Medical Necessity o The patient has suffered physical damage to their nasal

passages that prevent proper absorption of naloxone when

delivered by nasal routes

OR

o The patient or caregiver lacks the manual dexterity or visual

acuity needed to use Narcan® (nasal spray)

OR

o The patient or caregiver lacks the mental capacity to be

trained to use Narcan® (nasal spray)

AND

2. Patient is unable to use or be taught how to use naloxone

solution for injection because at least ONE of the following is

true:

o The patient or caregiver lacks the mental capacity to be

trained to give naloxone solution for injection

OR

o The patient or care giver lacks the manual dexterity or

visual acuity needed to give naloxone solution for injection

Bethkis® (tobramycin

inhalation solution),

Kitabis® Pak (tobramycin

inhalation solution),

TOBI® (tobramycin

inhalation solution),

TOBI® Podhaler™

(tobramycin inhalation

powder)

Bethkis® (tobramycin inhalation solution), Kitabis® Pak

(tobramycin inhalation solution) and TOBI® (tobramycin

inhalation solution) may be considered medically necessary for

the management of cystic fibrosis when:

• Patient has tried generic tobramycin inhalation solution and

had an inadequate response after 1-month of treatment or had

intolerance to generic tobramycin inhalation solution

TOBI® Podhaler™ (tobramycin inhalation powder) may be

considered medically necessary for the management of cystic

fibrosis when:

• Patient has tried generic tobramycin inhalation solution and

had an inadequate response after 1-month of treatment or had

intolerance to generic tobramycin inhalation solution

AND

• Patient has tried Bethkis® (tobramycin inhalation solution) or

Kitabis® Pak (tobramycin inhalation solution)

Initial approval will be for 3-years.

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Drug Medical Necessity

Reauthorization criteria:

• Continued therapy will be approved for 3-years as long as the

medical necessity criteria are met and chart notes demonstrate

that the patient continues to show a positive clinical response

to therapy.

Fluoxetine 60mg Fluoxetine 60mg tablets may be considered medically

necessary when BOTH (1 and 2) of the following criteria are

met:

1. Patient has ONE of the following conditions, as documented by

the chart notes:

o Major Depressive Disorder (MDD)* in those 8 years of age

or older

o Obsessive Compulsive Disorder (OCD)* in those 7 years of

age or older

o Bulimia Nervosa in an adult patient

o Panic Disorder with or without agoraphobia in an adult

patient

AND

2. Patient is non-adherent** on therapy with 3 tablets or capsules

of generic fluoxetine 20mg, as documented by the chart notes.

*Fluoxetine 60mg is FDA-approved for use in pediatric patients only for MDD and

OCD. The safety and efficacy in those < 8 and < 7 years of age, respectively has

not been established.

**Non-adherence is defined as less than 50% adherence over a 6-months period.

Glumetza®, Fortamet®

(metformin extended

release) and their generic

Glumetza® and Fortamet®, as well as the generic version of

these medications may be considered medically necessary,

when ALL of the following criteria must be met:

• Patient has tried and failed generic metformin immediate

release

AND

• Patient has tried and failed generic metformin extended

release (generic for Glucophage XR®):

o In an event such that patient experiences intolerance to a

generic metformin extended release (generic for

Glucophage XR®), documentation of the attempts to

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Drug Medical Necessity minimize the adverse effects where appropriate is

necessary to qualify for Glumetza® and/or its generic

version.

o Dose de-escalation, in addition to taking the drug with

meals before attempting a re-challenge of the preferred

agent, metformin extended release (generic for Glucophage

XR®) are required to establish and confirm intolerance to

the preferred agent.

▪ Metformin extended release should be started at a low

dose with gradual dose escalation over 4 to 8 weeks

▪ Re-challenge period should last at a minimum of ≥3

months.

Natpara®

(parathyroid hormone)

Natpara® (parathyroid hormone) may be considered

medically necessary when ALL of the following criteria have

been met:

• Patient is 18 years and older and diagnosed with hypocalcemia

with hypoparathyroidism within the last year

AND

• Patient is using calcium supplements

AND

• Patient is using an active form of vitamin D (eg, calcitriol,

cholecalciferol, ergocalciferol)

AND

• Albumin-corrected serum calcium is at least 7.5 mg/dL

AND

• Patients does not have acute post-surgical hypoparathyroidism

AND

• Prescribed by or in consultation with an endocrinologist

AND

• The quantity prescribed is limited to two cartridges per 28 days

Initial approval will be for 1-year.

Reauthorization criteria:

• Continued therapy will be approved for 1-year when

documentation shows the albumin-corrected total serum

calcium concentration is between 7.5 mg/dL and 10.6 mg/dL

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Drug Medical Necessity Northera® (droxidopa) Northera® (droxidopa) may be considered medically

necessary when ALL of the following criteria have been met:

• Patient is 18 years and older and diagnosed with symptomatic

neurogenic orthostatic hypotension

AND

• Patient has tried and failed non-pharmacologic therapy (eg,

adjusting salt intake, drinking adequate water, avoiding

alcohol, reducing meal size, elevating the head of bed, use of

compression stockings)

AND

• Patient has tried and failed one-month of therapy with the

maximum tolerated dose of midodrine unless there is a

contraindication to use of midodrine

AND

• Northera® is prescribed by a neurologist or cardiologist

Initial approval will be for 1 month.

Reauthorization criteria:

• Continued therapy will be approved for 12 months when

documented evidence shows the patient experienced

improvement in symptoms for neurogenic orthostatic

hypotension.

Kits Excessively high cost kits (containing one or more drugs, often

packaged with medical supplies such as sterile gloves) may be

considered medically necessary when:

• Patient has a documented trial and failure on continuous use,

for at least 3 months with ALL dosage forms of ALL active

ingredients in the kit

AND

• There is a documented specific clinical rationale for the patient

not being able to use each of the ingredients within the kit

separately

The use of excessively high cost kits solely for the convenience

of either provider or patient is considered not medically

necessary.

Page | 11 of 18 ∞

Drug Medical Necessity Jublia® and Kerydin®

(topical antifungal agents)

Jublia® and Kerydin® may be considered medically necessary

when:

• Patient has a documented diagnosis of onychomycosis

confirmed by a positive KOH (potassium hydroxide) test AND a

fungal culture

o Copy of the KOH test and culture results are required

AND

• Patient has a documented trial* and failure of:

o Generic ciclopirox (topical)

AND

o Generic terbinafine OR itraconazole, unless such are

contraindicated or not tolerated

AND

• Total duration of therapy is not to exceed 48 weeks

*Trial is defined as 3 months of continuous therapy.

Topical lidocaine products

• Adazin

• Anastia

• Astero

• Elenza Patch

• Kamdoy

• Ldo Plus

• L.E.T.

• Lidocaine 3.88%

• Lidocaine-Epinephrine-

Tetracaine

• Lidocaine HCl

• Lidocaine-Tetracaine

• Lido-K

• Lidodextrapine

• Lidopin

• Lidorx

• Lidotral

• Lidotrex

• Lidovex

• Lidozion

• Lidtopic Max

Adazin, Anastia, Astero, Elenza Patch, Kamdoy, Ldo Plus, L.E.T.,

Lidocaine 3.88%, Lidocaine-Epinephrine-Tetracaine, Lidocaine

HCl, Lidocaine-Tetracaine, Lido-K, Lidodextrapine, Lidopin,

Lidorx, Lidotral, Lidotrex, Lidovex, Lidozion, Lidtopic Max,

Numbonex, Pain Relief, Pliaglis, Reciphexamine, Regenecare,

Relyyks, Scar, Silvera, Suvicort, Synvexia TC, Tranzarel, Velma,

Vexa and Vexasyn may be considered medically necessary

when patient has a documented trial* and failure of generic

lidocaine HCL cream AND generic lidocaine HCL lotion.

*Trial is defined as 3 months of continuous therapy.

Page | 12 of 18 ∞

Drug Medical Necessity • Numbonex

• Pain Relief

• Pliaglis

• Reciphexamine

• Regenecare

• Relyyks

• Scar

• Silvera

• Suvicort

• Synvexia TC

• Tranzarel

• Velma

• Vexa

• Vexasyn

Lidoderm Patches

Synera

ZTlido

Lidoderm patches, Synera, and ZTlido may be considered

medically necessary when patient has a documented trial* and

failure of generic lidocaine patch, AND generic lidocaine HCL

cream, AND generic lidocaine HCL lotion.

*Trial is defined as 3 months of continuous therapy.

Paingo KFT Paingo KFT may be considered medically necessary when

patient has a documented trial* and failure of generic

lidocaine/prilocaine cream, AND generic lidocaine HCL cream,

AND generic lidocaine HCL lotion.

*Trial is defined as 3 months of continuous therapy.

Omeprazole ODT Omeprazole ODT may be considered medically necessary when

patient has a documented trial* and failure of EACH of the

following generically available proton-pump inhibitors:

• Esomeprazole magnesium

AND

• Lansoprazole

AND

• Omeprazole

AND

• Pantoprazole

AND

Page | 13 of 18 ∞

Drug Medical Necessity • Rabeprazole

*Trial is defined as 3 months of continuous therapy.

Rayos® (prednisone

delayed-release)

Rayos® may be considered medically necessary when patient

has a documented trial* and failure of both, generic

prednisone AND methylprednisolone.

*Trial is defined as 3 months of continuous therapy.

Riomet® (metformin oral

solution),

Riomet ER™ (metformin

extended-release oral

suspension)

Riomet® and Riomet ER™ may be considered medically

necessary when one of the following documented reasons is

provided as to why the oral tablet of the generically available

metformin is not appropriate for the patient:

• Patient is unable to swallow tablets

OR

• Patient has compromised ability to absorb tablets

Zegerid®

(omeprazole/sodium

bicarbonate) and its

generic and OmePPi

(omeprazole/sodium

bicarbonate)

Zegerid® and its generic and OmePPi may be considered

medically necessary when patient has a documented trial* and

failure of EACH of the following generically available proton-

pump inhibitors:

• Esomeprazole magnesium

AND

• Lansoprazole

AND

• Omeprazole

AND

• Pantoprazole

AND

• Rabeprazole

*Trial is defined as 3 months of continuous therapy.

Zyflo CR® & zileuton ER;

Zyflo® & zileuton

Brand Zyflo CR®, zileuton ER, Zyflo®, or zileuton may be

considered medically necessary when provider submits

documentation in the form of medical records to show that

patient had an adequate trial and failure (at least 3 months) of

generic montelukast.

Page | 14 of 18 ∞

Drug Not Medically Necessary As listed All other uses of the drugs listed in this policy are considered

not medically necessary.

Length of Approval

Approval Criteria Initial authorization Unless noted otherwise for specific drugs under the medical

necessity criteria the drugs listed in policy may be approved up

to 12 months.

Re-authorization criteria Unless noted otherwise for specific drugs under the medical

necessity criteria future re-authorization of the drugs listed

may be approved up to 12 months as long as the medical

necessity criteria are met, and chart notes demonstrate that

the patient continues to show a positive clinical response to

therapy.

Documentation Requirements The patient’s medical records submitted for review for all conditions should document that

medical necessity criteria are met. The record should include the following:

• Office visit notes that contain the diagnosis, relevant history, physical evaluation and

medication history

Coding

N/A

Related Information

Page | 15 of 18 ∞

Definition of Medical Necessity

Those covered services and supplies that a physician, exercising prudent clinical judgment,

would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an

illness, injury, disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate, in terms of type, frequency, extent, site and duration, and considered

effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician, or other health care provider,

and

4. Not more costly than an alternative service or sequence of services at least as likely to

produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that

patient’s illness, injury or disease.

For these purposes, “generally accepted standards of medical practice” means standards that are

based on reliable scientific evidence published in peer-reviewed medical literature generally

recognized by the relevant medical community, physician specialty society recommendations,

and the views of physicians practicing in relevant clinical areas and any other relevant factors.

A recent disturbing trend threatens to drive substantial increases in pharmaceutical

expenditures. Opportunistic pharmaceutical companies are buying up products and raising the

prices by 500% or more overnight. In addition, these companies are marketing kits, which

combine a prescription medication with a medical supply or OTC products. These kits far exceed

the cost of each individual product alone. These companies do not do research to originate new

products and add no value to what they purchase. Unfortunately, some of these products are

one of a kind, and thus have a captive audience. Recent media attention has been drawn to

Daraprim® (pyrimethamine), an antiprotozoal drug for which there are no comparable

alternatives that was purchased by Turing Pharmaceuticals, who raised the price overnight from

$13.50 per tablet to $750.

Fortunately for consumers, a number of these products do have reasonable and much lower

cost clinical alternatives and therefore do not meet the definition of medical necessity, which is

cited above. The drugs included in this policy do not meet the definition, having the alternatives

specified in the table above. Therefore, they are considered not medically necessary.

Page | 16 of 18 ∞

Definition of Kit

Kits are defined as a combination of a prescription medication with a medical supply or OTC

product, in which the combination of these products far exceeds the cost of each individual

product.

Consideration of Age

The ages noted in the policy statements are based on the FDA labeling for these agents.

2019 Update

Reviewed prescribing information and updated drug lists documented for each therapeutic

class. No new evidence was identified that require changes to existing criteria.

2020 Update

Reviewed prescribing information and added Absorica LD to policy with same criteria as

Absorica. Updated criteria for Alcortin-A to require trial of two generic prescription topical

corticosteroids first.

References

1. Rocco P, Gellad W, Donohue J. How Much Does Congress Care About Drug Prices? Less Than It Should. Health Affairs Blog,

1/13/2016, available at http://healthaffairs.org/blog/2016/01/13/how-much-does-congress-care-about-drug-prices-less-

than-it-should Accessed February 2020.

2. Luo J, Sarpatwari A, Kesselheim AS. Regulatory Solutions to the Problem of High Generic Drug Costs. Open Forum Infect Dis.

2015 Dec; 2(4): ofv179.

3. Gallant J. Get Rich Quick With Old Generic Drugs! The Pyrimethamine Pricing Scandal. Open Forum Infect Dis. 2015 Dec; 2(4):

ofv177.

4. Rockoff JD, Silverman E. Pharmaceutical Companies Buy Rivals’ Drugs, Then Jack Up the Prices. Wall Street Journal April 26,

2015. Available at http://www.wsj.com/articles/pharmaceutical-companies-buy-rivals-drugs-then-jack-up-the-prices-

1430096431 Accessed February 2020

http://healthaffairs.org/blog/2016/01/13/how-much-does-congress-care-about-drug-prices-less-than-it-shouldhttp://healthaffairs.org/blog/2016/01/13/how-much-does-congress-care-about-drug-prices-less-than-it-shouldhttp://www.wsj.com/articles/pharmaceutical-companies-buy-rivals-drugs-then-jack-up-the-prices-1430096431http://www.wsj.com/articles/pharmaceutical-companies-buy-rivals-drugs-then-jack-up-the-prices-1430096431

Page | 17 of 18 ∞

5. AHF: Gilead’s $28K ‘Predatory Pricing’ of New AIDS Drug Prompts Ballot Measure in S.F. to Reign in Drug Costs. Fierce Pharma.

8/28/2012. Available at http://www.fiercepharma.com/press-releases/ahf-gilead-s-28k-predatory-pricing-new-aids-

drug-prompts-ballot-measure-sf Accessed February 2020.

6. Stiglitz JE. Don't Trade Away Our Health. New York Times. January 30, 2015. Available at

http://www.nytimes.com/2015/01/31/opinion/dont-trade-away-our-health.html?_r=0 Accessed February 2020.

7. Martin AB, Hartman M, Benson J, et al. National Health Spending In 2014: Faster Growth Driven By Coverage Expansion And

Prescription Drug Spending. Health Affairs 2016 35:150-160.

8. Pollack A, Tavernise S. Valeant’s Drug Price Strategy Enriches It, but Infuriates Patients and Lawmakers. New York Times October

4, 2015. Available at http://www.nytimes.com/2015/10/05/business/valeants-drug-price-strategy-enriches-it-but-

infuriates-patients-and-lawmakers.html?_r=0 Accessed February 2020.

History

Date Comments 02/09/16 New Utilization Management Guideline, add to Prescription Drug section. Excessively

high cost drug products with lower cost alternatives are considered not medically

necessary for all indications.

05/01/16 Annual Review, approved April 12, 2016. Addition of a new agent, Evzio®, and its

criteria to the policy. Revision of the criteria for Glumetza® and its generic agent.

11/01/16 Interim Review, approved October 11, 2016. Inclusion of new agents and their

associated criteria to the policy: DermacinRx Lexitral PharmaPak®, Diclotral Pak®,

Pennsaid®, Xrylix®, Rayos®, Jublia®, Kerydin®, and Zegerid.

12/01/16 Interim Review, approved November 8, 2016. Adding Zegerid’s generic to the edit.

01/01/17 Interim Review, approved December 13, 2016. Criteria for fluoxetine 60mg tablets has

been added to the policy.

01/26/17 Interim Update. Added Auvi-Q® and its related criteria.

02/01/17 Annual Review, approved January 10, 2017. Added Xelitral®, Sure Result DSS Premium

Pack®, and Diclo Gel with Xrylix Sheets 1% kit to the topical NSAIDs criteria.

03/01/17 Interim Review, approved February 14, 2017. Addition of brand name EpiPen®,

Adrenaclick®, Fortamet®, and its generic, Riomet®, and Alcortin-A®.

04/01/17 Interim Review, approved March 14, 2017. Addition of brand drug Differen and its

generic version adapalene.

08/01/17 Interim Review, Approved July 25, 2017. Addition of excessively high cost kits.

09/01/17 Interim Review, approved August 22, 2017. Addition of Amrix ER, omeprazole ODT,

and Zyflo CR/Zileuton ER & Zyflo/Zileuton. Addition of Absorica and new criteria for

Differin.

10/01/17 Interim Review, approved September 21, 2017. Changed criteria for Differin, clarified

criteria for auvi-q, added criteria for omePPi.

01/01/18 Interim Review, approved December 20, 2017. Updated drugs targeted by topical

NSAIDs edit.

03/01/18 Annual Review, approved February 27, 2018. Addition of various topical lidocaine

products to policy as well as criteria for these products.

http://www.fiercepharma.com/press-releases/ahf-gilead-s-28k-predatory-pricing-new-aids-drug-prompts-ballot-measure-sfhttp://www.fiercepharma.com/press-releases/ahf-gilead-s-28k-predatory-pricing-new-aids-drug-prompts-ballot-measure-sfhttp://www.nytimes.com/2015/01/31/opinion/dont-trade-away-our-health.html?_r=0http://www.nytimes.com/2015/10/05/business/valeants-drug-price-strategy-enriches-it-but-infuriates-patients-and-lawmakers.html?_r=0http://www.nytimes.com/2015/10/05/business/valeants-drug-price-strategy-enriches-it-but-infuriates-patients-and-lawmakers.html?_r=0

Page | 18 of 18 ∞

Date Comments 07/01/18 Interim Review, approved June 5, 2018. Addition of various topical lidocaine products

and generic Alcortin-A to existing criteria. Generic Daraprim name was corrected.

09/12/18 Interim Review, approved September 11, 2018. Added Consideration of Age

information. Added Vexasyn, removed Differin/Adapalene criteria from this policy as it

was moved to policy 5.01.605.

11/01/18 Interim Review, approved October 26, 2018. Added Allzital, Vanatol LQ, Vanatol S, and

multiple topical lidocaine products.

02/01/19 Interim Review, approved January 4, 2019. Added Suvicort as topical lidocaine product.

03/01/19 Interim Review, approved February 25, 2019. Updated Absorica criteria. Updated

Glumetza, Fortamet and their generic criteria.

05/01/19 Annual Review, approved April 9, 2019. Added ZTlido to policy and generic

cyclobenzaprine extended-release. Added criteria for Natpara (parathyroid horomone)

to policy. Added Auvi-Q 0.1 mg/0.1 mL criteria.

06/01/19 Interim Review, approved May 23, 2019. Added L.E.T. as topical lidocaine product.

Added criteria for Lorzone and generic chlorzoxazone to policy.

08/01/19 Interim Review, approved July 9, 2019. Added criteria for the deferasirox products

Exjade®, Jadenu® and Jadenu® Sprinkle. Added criteria for the tobramycin inhaled

products Bethkis®, Kitabis® Pak, TOBI® and TOBI® Podhaler™.

10/01/19 Interim Review, approved September 19, 2019. Moved the deferasirox products

Exjade®, Jadenu® and Jadenu® Sprinkle to policy 5.01.613 Oral Iron Chelating

Agents.

03/01/20 Annual Review, approved February 20, 2020. Added Absorica LD to policy with same

criteria as Absorica. Updated criteria for Alcortin-A.

04/01/20 Interim Review, approved March 10, 2020. Added criteria for Northera (droxidopa) for

treatment of symptomatic neurogenic orthostatic hypotension. Added Riomet ER to

policy with same criteria as Riomet.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

booklet or contact a member service representative to determine coverage for a specific medical service or supply.

CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2020 Premera

All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

the limits and conditions of the member benefit plan. Members and their providers should consult the member

benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Discrimination is Against the Law

LifeWise Health Plan of Washington complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. LifeWise does not exclude people or treat them differently because of race, color, national origin, age, disability or sex.

LifeWise: • Provides free aids and services to people with disabilities to communicate

effectively with us, such as: • Qualified sign language interpreters • Written information in other formats (large print, audio, accessible

electronic formats, other formats) • Provides free language services to people whose primary language is not

English, such as: • Qualified interpreters • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that LifeWise has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator - Complaints and Appeals PO Box 91102, Seattle, WA 98111 Toll free 855-332-6396, Fax 425-918-5592, TTY 800-842-5357 Email AppealsDepartmentInquiries@LifeWiseHealth.com

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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037336 (07-2016)

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https://www.hhs.gov/ocr/office/file/index.htmlhttps://ocrportal.hhs.gov/ocr/portal/lobby.jsfmailto:AppealsDepartmentInquiries@LifeWiseHealth.com

้

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ភាសាែខមរ (Khmer):

ມູ ຮັ ສິ

ມູ ຂໍ້

ສໍ

ຈ່

ວັ

ມູ ຂໍ້ ມີ ໝັ

ຊ່

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េសចកតជី ូ នដំ ងេនះមានព័ ី

ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់ តមានយា ខាន ំ ទរមងែបបបទ ឬការរា

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ក sin costo alguno. Llame al 800-592-6804 (TTY: 800-842-5357). ជ ំ យេចញៃថ កមានសិ េដាយមិ ុ ើ ូ ូ នអសលយេឡយ។ សមទ

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800-592-6804 (TTY: 800-842-5357)។

រស័

ਅੰ

ਜਾਬੀ (Punjabi): paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon ਇਸ ਨੋ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋ ਿਟਸ ਿਵਚ LifeWise Health Plan of tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng LifeWise

Health Plan of Washington. Maaaring may mga mahalagang petsa dito sa Washington ਵਲ ਤੁ ਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹਤਵਪੂ ੋ ਸਕਦੀ ਹਾਡੀ ਕਵਰੇ ੱ ਰਨ ਜਾਣਕਾਰੀ ਹ

ពទ

paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang ਹੈ ੋ ਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹੋ ਂ ਹਨ. ਜੇ ੁ ੇ ੱ ਖਣੀ ਹੋ ੇ mga itinakdang panahon upang mapanatili ang iyong pagsakop sa . ਇਸ ਨ ਸਕਦੀਆ ਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰ ਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱਚ ਮਦਦ ਦੇ ੱ ੁ ੋ ਤਾਂ ਤੁ ੰ ੂ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ਇਛਕ ਹ ਹਾਨ ੱ ਝ ਖਾਸ

ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag ਕਦਮ ਚੁਕਣ ਦੀ ਲੜ ਹੋ ਸਕਦੀ ਹ ੈ,ਤੁ ੰ ੂ ਮੁ ੱ ਚ ਤੇ ੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ੱ ੋ ਹਾਨ ਫ਼ਤ ਿਵ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਮਦਦ sa 800-592-6804 (TTY: 800-842-5357). ਪ੍ਰ ੈਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-592-6804 (TTY: 800-842-5357).

ਪੰ

Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang

ไทย (Thai): ประกาศน ้ีมีข้อมลูสําคญั ประกาศน ้ีอาจมีข้อมลูที่สําคญัเกี่ยวกบัการการสมคัรหรือขอบเขตประกนั

(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين . ميباشد ھمم اطالعات یوحا يهمالعا اين

สขุภาพของคณุผ่าน LifeWise Health Plan of Washington และอาจมีกําหนดการในประกาศ طريق از ماش ای مهبي وششپ يا و تقاضا LifeWise Health Plan of Washington به .باشدี น جهتو يهمالعا اين در ھمم ھای خيتار يا تان بيمه وششپ حقظ برای است کنمم ماش . يدماين کمک คณุอาจจะต้องดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกนัสขุภาพของคณุ

اجتياح صیاخ کارھای امانج برای صیمشخ ھای خيتار به تان، انیمدر ھای زينهھ پرداخت درหรือการช่วยเหลือที่มีค่าใช้จ่าย คณุมีสิทธิที่จะได้รับข้อมลูและความช่วยเหลือน ้ีในภาษาของคณุโดยไม่ม ีباشيد داشته . رايگان ورط به ودخ انزب به را مکک و اطالعات اين که داريد را اين حق ماش

(ค่าใช้จ่าย โทร 800-592-6804 (TTY: 800-842-5357 مارهش با اطالعات سبک برای . نماييد دريافت 800-592-6804 . اييد نم برقرار استم ) 5357-842-800 مارهباش اس تم TTY کاربران(

Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez LifeWise Health Plan of Washington. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod 800-592-6804 (TTY: 800-842-5357).

Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do LifeWise Health Plan of Washington. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter esta informação e ajuda em seu idioma e sem custos. Ligue para 800-592-6804 (TTY: 800-842-5357).

Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через LifeWise Health Plan of Washington. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-592-6804 (TTY: 800-842-5357).

Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình LifeWise Health Plan of Washington. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-592-6804 (TTY: 800-842-5357).