Download Absorica - Blue Cross Blue Shield of Arizona

PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS:
ABSORICA® (isotretinoin) oral capsule
AMNESTEEM® (isotretinoin) oral capsule
CLARAVIS™ (isotretinoin) oral capsule
MYORISAN™ (isotretinoin) oral capsule
ZENATANE™ (isotretinoin) oral capsule
Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as
outlined in the member's specific benefit plan. This Pharmacy Coverage Guideline must be read in its
entirety to determine coverage eligibility, if any.
This Pharmacy Coverage Guideline provides information related to coverage determinations only and does
not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member
are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ
complete medical rationale when requesting any exceptions to these guidelines.
The section identified as “Description” defines or describes a service, procedure, medical device or drug
and is in no way intended as a statement of medical necessity and/or coverage.
The section identified as “Criteria” defines criteria to determine whether a service, procedure, medical
device or drug is considered medically necessary or experimental or investigational.
State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product
approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or
investigational and thus the drug, device or biological product may be assessed only on the basis of
medical necessity.
Pharmacy Coverage Guidelines are subject to change as new information becomes available.
For purposes of this Pharmacy Coverage Guideline, the terms "experimental" and "investigational" are
considered to be interchangeable.
BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered service marks of the
Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans.
All other trademarks and service marks contained in this guideline are the property of their respective
owners, which are not affiliated with BCBSAZ.
Description:
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne in individuals who are unresponsive
to conventional therapy, including systemic antibiotics. The nodules are inflammatory and generally have a
diameter of 5 millimeters (mm) or greater, in addition, they may become suppurative or hemorrhagic. Isotretinoin
is indicated in women of child bearing age who are not pregnant or are on adequate birth control. The exact
mechanism of action of isotretinoin is unknown, but it has been shown to inhibit sebaceous gland function and
keratinization and is associated with a reduction in sebum secretion.
Page 1 of 11
PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS (cont.)
The pathogenesis of acne in multifactorial and includes hyperkeratinization of follicles, bacterial infectious
process, production of sebum, androgens, and inflammation. Acne vulgaris is considered a chronic inflammatory
dermatologic disease that is notable for open and/or closed comedones (blackheads – dark or blackish bumps;
and whiteheads – tiny white bumps) and inflammatory lesions including papules (small, firm, may be painful pink
bumps), pustules (small, may be painful bumps with pus), or nodules/cysts (large, hard, inflamed and painful
bumps). Acne pimples occur on the face, neck, chest, shoulders, back, and upper arms caused by clogged pores
due to excessive sebum (oil) production.
The prevalent bacterium implicated in acne is Propionibacterium acnes (P acnes), a gram-positive anaerobe that
is normally found on the skin and is implicated in the inflammatory phase of acne. P acnes promotes lesions by
secreting chemotactic factors that attract leukocytes to the follicle resulting in inflammation.
All anti-acne agents are effective in reducing inflammatory and non-inflammatory lesions when compared to
placebo based on many years of clinical experience, multiple systematic reviews, and clinical practice guidelines.
There is no evidence that confirms superiority of any one branded option over available brand or generic
alternatives, including available over-the-counter (OTC) products. All anti-acne products have adequate track
records of safety; most are generally well tolerated, but all cause skin irritation.
Published guidelines on the treatment of acne consistently recommend the use of topical antimicrobial, topical
retinoid, azeleic acid, benzoyl peroxide, dapsone, and combination topical products, oral antibiotics or oral
isotretinoin. Isotretinoin is approved for the treatment of severe recalcitrant nodular acne vulgaris.
Use of Isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, and Zenatane) is subject to a Risk Evaluation and
Mitigation Strategies (REMS) program that requires provider, patient, and dispensing pharmacy be enrolled into
the program. Only providers and pharmacies enrolled into the REMS may prescribe and dispense the drug,
respectively, to individuals who are also in the program. A REMS program attempts to manage known or
potentially serious risks associated with a drug product and is required by the Food and Drug Administration
(FDA) for some drugs to ensure that the benefits of a drug outweigh its risks.
Definitions:
Isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, and Zenatane) REMS items
Enrollment and agreement information
Treatment initiation information
Treatment maintenance information
Pharmacy requirements and responsibilities
Counseling on contraception and avoidance of pregnancy
Pregnancy testing in females of childbearing potential
Counseling on serious risks, warnings, and precautions and safe use
Drug related events:
Ineffective / failure
Use of a drug employing optimal doses (FDA-recommended doses) for optimal duration; where the condition
being treated has not improved or worsened
Page 2 of 11
PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS (cont.)
A request for branded agent due to generic drug failure or ineffectiveness will be assessed for potential
approval with documentation of use of optimal dose / duration of the generic product and meeting other
criteria within the coverage guideline. When the drug in question is a combination product, there must be
documentation of failure / ineffectiveness of concurrent use (each ingredient used at the same time) of
individual generic components. When the drug in question is a low dose formulation, there must be
documentation of failure / ineffectiveness of low dose generic formulation.
Adverse Drug Event: Allergic reaction / Hypersensitivity / Intolerance
Use of a drug produced a significant reaction where continued use of the drug places the individual at risk for
either lack of improvement or worsening of the condition being treated or at risk for harm and the concern is
documented in medical record. A significant adverse drug event is when an individual’s outcome is death,
life-threatening, hospitalization (initial or prolonged), disability resulting in a significant, persistent, or
permanent change, impairment, damage or disruption in the individuals’ body function/structure, physical
activities or quality of life, or requires intervention to prevent permanent impairment or damage.
Allergic reaction / hypersensitivity – may or may not involve the active ingredient. When the active
ingredient is involved, use of same or a chemically similar agent places the individual at risk for harm
when the same or chemically similar agent is used. The subsequent reaction may be the same as the
original reaction or a more exaggerated response may be seen, potentially placing the individual at even
greater risk for harm.
If the reaction occurred from the active/main generic ingredient; request for branded agent with same
active ingredient will not be considered unless it is proven (documented) that active ingredient did not
cause reaction and the request meets other criteria within the coverage guideline
Intolerance – these events represent circumstance(s) where use of a drug produced a significant reaction
and continued use may result in non-adherence to proposed therapy and this concern is documented in
medical record
Contraindication
Use of a drug that is not recommended by the manufacturer or FDA labelling
Use of any drug in the face of a contraindication is outside of the FDA and manufacturer’s labelled
recommendation and is considered investigational or experimental
Non-adherence
Individual does not follow prescribe regimen that places the individual at risk for lack of improvement or
worsening of the condition being treated and this concern is documented in medical record
Precertification:
Precertification (Prior Authorization) is required for members with a Blue Cross Blue Shield of Arizona (BCBSAZ)
pharmacy benefit for medication(s) or product(s) indicated in this guideline.
Page 3 of 11
PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS (cont.)
This Pharmacy Coverage Guideline does not apply to FEP or other states’ Blues Plans.
Information about medications that require precertification is available at www.azblue.com/pharmacy.
Some large (100+) benefit plan groups may customize certain benefits, including adding or deleting precertification
requirements.
All applicable benefit plan provisions apply, e.g., waiting periods, limitations, exclusions, waivers and benefit
maximums.
Criteria:
See “Resources” section for FDA-approved dosage.

Precertification for Absorica, Amnesteem, Claravis, Myorisan, and Zenatane requires completion of the
specific request form in its entirety. All requested data must be provided. Once completed the form must be
signed by the prescribing provider and faxed back to BCBSAZ Pharmacy Management at (602) 864-3126 or
emailed to [email protected]. Incomplete forms will be returned.

FDA-approved product labeling (indication, age, dosage, testing, contraindications, exclusions, etc.) of
Absorica, Amnesteem, Claravis, Myorisan, and Zenatane is considered medically necessary when ALL of
the following criteria are met:
1. Individual is 12 years of age or older
2. Individual has medical record documentation of a confirmed diagnosis of ONE of the following:
 Severe nodular acne
 Moderate nodular acne that is EITHER:
 Unresponsive to conventional therapy that includes ALL of the following: oral antibiotic used
simultaneously with a topical combination product containing a retinoid, antibiotic, benzoyl
peroxide
 Acne that has relapsed quickly after finishing oral antibiotic
 Acne that produced physical scarring or resulted in significant psychosocial distress
3. Dose will be 0.25-2 mg/kg/day depending on severity with a goal of achieving 150 mg/kg cumulative amount
4. Duration of use to be 4-8 months (16-32 weeks)
5. Any retreatment course is initiated after 2 months or more off therapy
6. For Absorica: individual is unable to use ALL of the following:
 Amnesteem (isotretinoin) oral capsule
 Claravis (isotretinoin) oral capsule
 Myorisan (isotretinoin) oral capsule
 Zenatane (isotretinoin) oral capsule
Page 4 of 11
PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS (cont.)
7. Absence of ALL of the following contraindications:
 Pregnancy in a woman of child bearing potential
 Hypersensitivity to Absorica, Amnesteem, Claravis, Myorisan, and Zenatane or any of their
components
8. Absence of ALL of the following exclusions:
 Concomitant use with tetracyclines
 Concurrent use of vitamin A
 Concurrent use with St. John’s Wort
 Chronic long term use at any dose
 Woman who is nursing an infant or child

Absorica, Amnesteem, Claravis, Myorisan, and Zenatane for all other indications not previously listed is
considered experimental or investigational based upon:
1.
2.
3.
4.
Lack of final approval from the Food and Drug Administration, and
Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and
Insufficient evidence to support improvement of the net health outcome, and
Insufficient evidence to support improvement of the net health outcome as much as, or more than,
established alternatives, and
5. Insufficient evidence to support improvement outside the investigational setting.
This includes but is not limited to the following:
 Use of any of these agents for cosmetic purpose, the contract benefit language will be applied to
determine coverage
 Liver spots
 Melasma
 Photo-aged skin
 Wrinkles
History:
Pharmacy and Therapeutics review
Director Pharmacy Mgmt. review
Pharmacy and Therapeutics review
Director Pharmacy Mgmt. review
Date:
07-21-2016
07-13-2016
03-17-2016
03-10-2016
Activity:
Approved revisions
Criteria revisions
Adopted guideline
Development
Criteria Revisions:
Date:
Criteria:
07-13-16
2. Individual has medical record
documentation of a confirmed diagnosis of
severe recalcitrant nodular acne in an
individual with ALL of the following:
 Multiple nodules of 5 mm or greater
Page 5 of 11
Revisions:
2. Individual has medical record
documentation of a confirmed diagnosis of
ONE of the following:
 Severe nodular acne
 Moderate nodular acne that is
EITHER:
PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS (cont.)


Unresponsive to conventional therapy
that includes ALL of the following:
generic topical retinoids, generic
topical antibiotics, generic oral
antibiotics, and generic combination
topical therapy
Unresponsive to oral antibiotics
07-13-16
 Unresponsive to conventional
therapy that includes ALL of the
following: oral antibiotic used
simultaneously with a topical
combination product containing a
retinoid, antibiotic, benzoyl peroxide
 Acne that has relapsed quickly after
finishing oral antibiotic
 Acne that produced physical
scarring or resulted in significant
psychosocial distress
Added
3. Dose will be 0.25-2 mg/kg/day depending
on severity with a goal of achieving 150
mg/kg cumulative amount
07-13-16
3. Duration of use to be 20 weeks per
treatment course 4-8 months (16-32
weeks) AND any retreatment course is
initiated after 2 months or more off therapy
07-13-16
Removed
5. ALL of the following baseline tests have
been completed before initiation of
treatment:
 Two pregnancy tests at least 19 days
apart, for females of reproductive
potential
 Negative pregnancy test for females of
reproductive potential before receiving
each refill
 Fasting lipid profile including
triglycerides
 Liver function tests
 Screened for significant psychiatric
disorders
07-13-16
Removed
8. For female individual of reproductive
potential, at least two (2) of the following
forms of effective contraception are being
used simultaneously:
 Tubal sterilization
 Partner’s vasectomy
 Intrauterine device
Page 6 of 11
4. Duration of use to be 4-8 months (16-32
weeks)
PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS (cont.)





Hormonal (combination oral
contraceptives, transdermal patch,
injectables, implantables, or vaginal
ring)
Male latex condom with or without
spermicide
Diaphragm with spermicide
Cervical cap with spermicide
Vaginal sponge (contains spermicide)
Resources:
Absorica. Package Insert. Revised by manufacturer 09/2015. Accessed 03/10/2016.
Amnesteem. Package Insert. Revised by manufacturer 03/2015. Accessed 03/15/2016.
Claravis. Package Insert. Revised by manufacturer 01/2015. Accessed 03/15/2016.
Myorisan. Package Insert. Revised by manufacturer 09/2015. Accessed 03/15/2016.
Zenatane. Package Insert. Revised by manufacturer 06/2015. Accessed 03/15/2016.
FDA-approved indication and dosage:
Indication
Recommended Dose
ABSORICA is a retinoid indicated for the treatment of
severe recalcitrant nodular acne in patients 12 years of age
and older.

Recommended dosage of 0.5 to 1 mg/kg/day given in
two divided doses without regards to meals for 15 to
20 weeks.
Limitations of Use
ABSORICA may only be administered to patients enrolled
in the iPLEDGE program.

Once daily dosing is not recommended.

Perform pregnancy tests prior to prescribing, each
month during therapy, end of therapy, and one month
after discontinuation.

Prior to prescribing, perform fasting lipid profile and
liver function tests.

ABSORICA is not substitutable with other forms of
isotretinoin.
AMNESTEEM is indicated for the treatment of severe
recalcitrant nodular acne. Nodules are inflammatory lesions
with a diameter of 5 mm or greater. The nodules may
AMNESTEEM should be administered with a meal (see
PRECAUTIONS: Information for Patients).
Page 7 of 11
PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS (cont.)
become suppurative or hemorrhagic. “Severe,” by
definition, means “many” as opposed to “few or several”
nodules. Because of significant adverse effects associated
with its use, Amnesteem should be reserved for patients
with severe nodular acne who are unresponsive to
conventional therapy, including systemic antibiotics. In
addition, Amnesteem is indicated only for those female
patients who are not pregnant, because Amnesteem can
cause severe birth defects (see Boxed
CONTRAINDICATIONS AND WARNINGS).
A single course of therapy for 15 to 20 weeks has been
shown to result in complete and prolonged remission of
disease in many patients. If a second course of therapy is
needed, it should not be initiated until at least 8 weeks after
completion of the first course, because experience has
shown that patients may continue to improve while off
Amnesteem. The optimal interval before retreatment has
not been defined for patients who have not completed
skeletal growth (see WARNINGS: Skeletal: Bone Mineral
Density, Hyperostosis, and Premature Epiphyseal
Closure).
The recommended dosage range for Amnesteem is 0.5 to 1
mg/kg/day given in two divided doses with food for 15 to 20
weeks. In studies comparing 0.1, 0.5 and 1 mg/kg/day, it
was found that all dosages provided initial clearing of
disease, but there was a greater need for retreatment with
the lower dosages. During treatment, the dose may be
adjusted according to response of the disease and/or the
appearance of clinical side effects — some of which may be
dose related. Adult patients whose disease is very severe
with scarring or is primarily manifested on the trunk may
require dose adjustments up to 2 mg/kg/day, as tolerated.
Failure to take Amnesteem with food will significantly
decrease absorption.
Before upward dose adjustments are made, the patients
should be questioned about their compliance with food
instructions.
The safety of once daily dosing with Amnesteem has not
been established. Once daily dosing is not recommended.
If the total nodule count has been reduced by more than
70% prior to completing 15 to 20 weeks of treatment, the
drug may be discontinued. After a period of 2 months or
more off therapy, and if warranted by persistent or recurring
severe nodular acne, a second course of therapy may be
initiated. The optimal interval before retreatment has not
been defined for patients who have not completed skeletal
growth. Long-term use of Amnesteem, even in low doses,
has not been studied, and is not recommended. It is
important that Amnesteem be given at the recommended
doses for no longer than the recommended duration. The
effect of long-term use of Amnesteem on bone loss is
unknown (see
WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis,
and Premature Epiphyseal Closure).
Contraceptive measures must be followed for any
subsequent course of therapy (see PRECAUTIONS).
CLARAVIS (isotretinoin capsules, USP) is indicated for the
treatment of severe recalcitrant nodular acne. Nodules are
inflammatory lesions with a diameter of 5 mm or greater.
The nodules may become suppurative or hemorrhagic.
“Severe,” by definition, means “many” as opposed to “few
or several” nodules. Because of significant adverse effects
associated with its use, Claravis should be reserved for
patients with severe nodular acne who are unresponsive to
conventional therapy, including systemic antibiotics. In
addition, Claravis is indicated only for those female patients
who are not pregnant,
CLARAVIS should be administered with a meal (see
PRECAUTIONS, Information for Patients).
The recommended dosage range for Claravis is 0.5 to 1
mg/kg/day given in two divided doses with food for 15 to 20
weeks. In studies comparing 0.1, 0.5, and 1 mg/kg/day, it
was found that all dosages provided initial clearing of
disease, but there was a greater need for retreatment with
the lower dosages. During treatment, the dose may be
adjusted according to response of the disease and/or the
appearance of clinical side effects – some of which may be
dose related. Adult patients whose disease is very severe
Page 8 of 11
PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS (cont.)
because Claravis can cause severe birth defects (see
Boxed CONTRAINDICATIONS AND
WARNINGS).
A single course of therapy for 15 to 20 weeks has been
shown to result in complete and prolonged remission of
disease in many patients. If a second course of therapy is
needed, it should not be initiated until at least 8 weeks after
completion of the first course, because experience has
shown that patients may continue to improve while off
Claravis. The optimal interval before retreatment has not
been defined for patients who have not completed skeletal
growth (see WARNINGS, Skeletal, Bone Mineral Density,
Hyperostosis, and Premature Epiphyseal Closure).
with scarring or is primarily manifested on the trunk may
require dose adjustments up to 2 mg/kg/day, as tolerated.
Failure to take Claravis with food will significantly decrease
absorption. Before upward dose adjustments are made, the
patients should be questioned about their compliance with
food instructions.
The safety of once daily dosing with Claravis has not been
established. Once daily dosing is not recommended.
If the total nodule count has been reduced by more than
70% prior to completing 15 to 20 weeks of treatment, the
drug may be discontinued. After a period of 2 months or
more off therapy, and if warranted by persistent or recurring
severe nodular acne, a second course of therapy may be
initiated. The optimal interval before retreatment has not
been defined for patients who have not completed skeletal
growth. Long-term use of Claravis, even in low doses, has
not been studied, and is not recommended. It is important
that Claravis be given at the recommended doses for no
longer than the recommended duration. The effect of longterm use of Claravis on bone loss is unknown (see
WARNINGS, Skeletal, Bone Mineral Density, Hyperostosis
and Premature Epiphyseal Closure).
Contraceptive measures must be followed for any
subsequent course of therapy (see PRECAUTIONS).
MYORISAN is indicated for the treatment of severe
recalcitrant nodular acne. Nodules are inflammatory lesions
with a diameter of 5 mm or greater. The nodules may
become suppurative or hemorrhagic. “Severe,” by
definition, means “many” as opposed to “few or several”
nodules. Because of significant adverse effects associated
with its use, Myorisan should be reserved for patients with
severe nodular acne who are unresponsive to conventional
therapy, including systemic antibiotics. In addition,
Myorisan is indicated only for those female patients who
are not pregnant, because Myorisan can cause severe
birth defects (see Boxed CONTRAINDICATIONS AND
WARNINGS).
A single course of therapy for 15 to 20 weeks has been
shown to result in complete and prolonged remission of
disease in many patients. If a second course of therapy is
needed, it should not be initiated until at least 8 weeks after
completion of the first course, because experience has
shown that patients may continue to improve while off
Myorisan. The optimal interval before retreatment has not
been defined for patients who have not completed skeletal
MYORISAN should be administered with a meal (see
PRECAUTIONS: Information for Patients).
The recommended dosage range for Myorisan is 0.5 to 1
mg/kg/day given in two divided doses with food for 15 to 20
weeks. In studies comparing 0.1, 0.5, and 1 mg/kg/day, it
was found that all dosages provided initial clearing of
disease, but there was a greater need for retreatment with
the lower dosages. During treatment, the dose may be
adjusted according to response of the disease and/or the
appearance of clinical side effects — some of which may be
dose related. Adult patients whose disease is very severe
with scarring or is primarily manifested on the trunk may
require dose adjustments up to 2 mg/kg/day, as tolerated.
Failure to take Myorisan with food will significantly decrease
absorption.
Before upward dose adjustments are made, the patients
should be questioned about their compliance with food
instructions.
The safety of once daily dosing with Myorisan has not been
established. Once daily dosing is not recommended.
Page 9 of 11
PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS (cont.)
growth (see WARNINGS: Skeletal: Bone Mineral Density,
Hyperostosis , Premature Epiphyseal Closure)
If the total nodule count has been reduced by more than
70% prior to completing 15 to 20 weeks of treatment, the
drug may be discontinued. After a period of 2 months or
more off therapy, and if warranted by persistent or recurring
severe nodular acne, a second course of therapy may be
initiated. The optimal interval before retreatment has not
been defined for patients who have not completed skeletal
growth. Long-term use of Myorisan, even in low doses, has
not been studied, and is not recommended. It is important
that Myorisan be given at the recommended doses for no
longer than the recommended duration. The effect of longterm use of Myorisan on bone loss is unknown (see
WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis,
and Premature Epiphyseal Closure).
Contraceptive measures must be followed for any
subsequent course of therapy (see PRECAUTIONS).
Zenatane™ is indicated for the treatment of severe
recalcitrant nodular acne. Nodules are inflammatory lesions
with a diameter of 5 mm or greater. The nodules may
become suppurative or hemorrhagic. “Severe,” by
definition, means “many” as opposed to “few or several”
nodules. Because of significant adverse effects associated
with its use, Zenatane™ should be reserved for patients
with severe nodular acne who are unresponsive to
conventional therapy, including systemic antibiotics. In
addition, Zenatane™ is indicated only for those female
patients who are not pregnant, because Zenatane™ can
cause severe birth defects (see Boxed
CONTRAINDICATIONS AND WARNINGS).
A single course of therapy for 15 to 20 weeks has been
shown to result in complete and prolonged remission of
disease in many patients. If a second course of therapy is
needed, it should not be initiated until at least 8 weeks after
completion of the first course, because experience has
shown that patients may continue to improve while off
Zenatane™. The optimal interval before retreatment has
not been defined for patients who have not completed
skeletal growth (see WARNINGS: Skeletal: Bone Mineral
Density, Hyperostosis, and Premature Epiphyseal
Closure).
Zenatane™ should be administered with a meal (see
PRECAUTIONS: Information for Patients).
The recommended dosage range for Zenatane™ is 0.5 to
1.0 mg/kg/day given in two divided doses with food for 15 to
20 weeks. In studies comparing 0.1, 0.5, and 1.0
mg/kg/day, it was found that all dosages provided initial
clearing of disease, but there was a greater need for
retreatment with the lower dosages. During treatment, the
dose may be adjusted according to response of the disease
and/or the appearance of clinical side effects — some of
which may be dose related. Adult patients whose disease is
very severe with scarring or is primarily manifested on the
trunk may require dose adjustments up to 2.0 mg/kg/day, as
tolerated. Failure to take Zenatane™ with food will
significantly decrease absorption.
Before upward dose adjustments are made, the patients
should be questioned about their compliance with food
instructions.
The safety of once daily dosing with Zenatane™ has not
been established. Once daily dosing is not recommended.
If the total nodule count has been reduced by more than
70% prior to completing 15 to 20 weeks of treatment, the
drug may be discontinued. After a period of 2 months or
more off therapy, and if warranted by persistent or recurring
severe nodular acne, a second course of therapy may be
initiated. The optimal interval before retreatment has not
been defined for patients who have not completed skeletal
growth. Long-term use of Zenatane™, even in low doses,
has not been studied, and is not recommended. It is
important that Zenatane™ be given at the recommended
doses for no longer than the recommended duration. The
Page 10 of 11
PHARMACY COVERAGE GUIDELINES
SECTION:
DRUGS
NEXT REVIEW DATE:
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
3rd QUARTER 2017
03/17/16
07/21/16
07/13/16
ISOTRETINOIN ORAL PRODUCTS (cont.)
effect of long-term use of Zenatane™ on bone loss is
unknown (see
WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis,
and Premature Epiphyseal Closure).
Contraceptive measures must be followed for any
subsequent course of therapy (see PRECAUTIONS).
Page 11 of 11