CHANGES TO THE HIGHMARK DRUG FORMULARIES
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JANUARY 2020
JANUARY/FEBRUARY 2020 UPDATE
CHANGES TO THE HIGHMARK DRUG
FORMULARIES
Following is the update to the Highmark Drug Formularies and pharmaceutical management procedures
for January/February 2020. As of January 2020, the formularies and pharmaceutical management
procedures will be updated on a bimonthly basis, rather than quarterly, and the following changes reflect
the decisions made in November 2019 by our Pharmacy and Therapeutics Committee. These updates
are effective on the dates noted throughout this document.
Please reference the guide below to navigate this communication:
Section I. Highmark Commercial and Healthcare Reform Formularies
A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive
Healthcare Reform Formulary
B. Changes to the Highmark Progressive Formulary and the Highmark Progressive Healthcare
Reform Formulary
C. Changes to the Highmark Healthcare Reform Essential Formulary
D. Changes to the Highmark National Select Formulary
E. Updates to the Pharmacy Utilization Management Programs
1. Prior Authorization Program
2. Managed Prescription Drug Coverage (MRxC) Program
3. Quantity Level Limit (QLL) Programs
Section II. Highmark Medicare Part D Formularies
A. Changes to the Highmark Medicare Part D 5-Tier Incentive Formulary
B. Changes to the Highmark Medicare Part D 5-Tier Closed Formulary
C. Additions to the Specialty Tier
D. Updates to the Pharmacy Utilization Management Programs
1. Prior Authorization Program
2. Managed Prescription Drug Coverage (MRxC) Program
3. Quantity Level Limit (QLL) Program
As an added convenience, you can also search our drug formularies and view utilization management
policies on the Provider Resource Center (accessible via NaviNet® or our website). Click the Pharmacy
Program/Formularies link from the menu on the left.
Highmark Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an
independent company that provides a secure, web-based portal between providers and health insurance companies.Important Drug Safety Updates
Update: Health Professional and Consumer on Recent Recalled Products Due to
Detection of Impurities and Potential Risk of Cancer
As part of an ongoing investigation into the voluntary recall of products due to the detection of
probable human carcinogen impurities and increased risk of cancer, there were six additional
voluntary recalls. Health care professionals should be aware that the recalled products pose
an unnecessary risk to patients.
Pharmacists and physicians may direct patients to alternative treatment prior to returning to
their medications. Physicians should evaluate the risk versus the benefit if treatment is stopped
immediately, as stopping treatment immediately without alternative treatment may lead to a
higher risk of harm to the patient’s health.
The additional products that have been recalled due to the impurities are listed below. Not all
products from all the manufacturers are recalled. Patients and physicians should check the
FDA website to see if the lot number of their medication has been included in the recall.
Manufacturer Recalled Drugs Detected Impurity
Dr. Reddy’s Laboratories Ranitidine tablets and N-Nitrosodimethylamine
Ltd. capsules (NDMA)
N-Nitrosodimethylamine
Lannett Company Ranitidine syrup
(NDMA)
Ranitidine hydrochloride N-Nitrosodimethylamine
Novitium Pharma LLC
capsules (NDMA)
Aurobindo Pharma USA, Ranitidine tablets, capsules, N-Nitrosodimethylamine
Inc. and syrup (NDMA)
Amneal Pharmaceuticals, Ranitidine tablets and syrup N-Nitrosodimethylamine
LLC (NDMA)
Glenmark Pharmaceutical Ranitidine tablets N-Nitrosodimethylamine
Inc. (NDMA)
Mavyret, Zepatier, and Vosevi: Drug Safety Communication – FDA Warns About Rare
Occurrence of Serious Liver Injury
On August 28, 2019, the FDA announced it had received reports that the use of Mavyret,
Zepatier, or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver
impairment has resulted in rare cases of worsening liver function or liver failure. These
medicines are not indicated for use in patients with moderate to severe liver impairment.
Health care professionals should continue to prescribe Mavyret, Zepatier, or Vosevi as
indicated in the prescribing information for patients without liver impairment or with mild liver
impairment (Child-Pugh A). Discontinue these medicines in patients who develop signs and
symptoms of liver decompensation or as clinically indicated.
2Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety
Communication – FDA Warns About Rare But Severe Lung Inflammation
On September 13, 2019, the FDA issued a warning that Ibrance (palbociclib), Kisqali
(ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast
cancers may cause rare but severe inflammation of the lungs. The overall benefit of CDK 4/6
inhibitors is still greater than the risks when used as prescribed.
Health care professionals should monitor patients regularly for pulmonary symptoms indicative
of interstitial lung disease (ILD) and/or pneumonitis. Interrupt CDK 4/6 inhibitor treatment in
patients who have new or worsening respiratory symptoms, and permanently discontinue
treatment in patients with severe ILD and/or pneumonitis.
Alprazolam Tablets by Mylan Pharmaceuticals Inc.: Recall – Potential of Foreign
Substance
On October 25, 2019, Mylan Pharmaceuticals Inc. announced a recall of one lot of Alprazolam
tablets, schedule IV controlled substance (C-IV) 0.5 mg. The affected product was recalled due
to the potential presence of foreign substance.
Levetiracetam Oral Solution by Lannett Company, Inc.: Recall – Contamination
On December 18, 2019, Lannett Company, Inc. announced a recall of two lots of
Levetiracetam Oral Solution, 100mg/mL. The affected product was recalled due to
contamination with Bacillus subtilis, which makes it possible that a severe infection may occur
in immunocompromised patients.
Adverse events or side effects related to the use of these products should be reported to the
FDA's MedWatch Safety Information and Adverse Event Reporting Program.
3Highmark Formulary Update – January 2020
SECTION I. Highmark Commercial and Healthcare Reform Formularies
A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive
Healthcare Reform Formulary
The Highmark Pharmacy and Therapeutics Committee has reviewed the medications listed in the
tables below. Please note that the Highmark Comprehensive Closed/Incentive Formulary is a
complete subset of the Open Formulary; therefore, all medications added to the Comprehensive
Closed/Incentive Formulary are also added to the Open Formulary. These updates are effective on
the dates noted throughout this document. For your convenience, you can search the following
formularies online:
Highmark Comprehensive Formulary:
(https://client.formularynavigator.com/Search.aspx?siteCode=8103967260)
Highmark Comprehensive Healthcare Reform Formulary:
(https://client.formularynavigator.com/Search.aspx?siteCode=4906449921)
Highmark is happy to inform you that Table 1 includes products that have been added to the
formulary. Adding products to the formulary may mean lower copays or coinsurance rates for
members. By adding products to the formulary, Highmark hopes to promote adherence to
medication protocols and improve the overall health of our members.
Table 1. Products Added
(All products added to the formulary effective December 20, 2019, unless otherwise noted.)
Brand Name Generic Name Comments
Baqsimi nasal spray glucagon Nasal spray for treatment of severe
hypoglycemia in patients with diabetes mellitus.
Gvoke glucagon Prefilled syringe for treatment of severe
hypoglycemia in patients with diabetes mellitus.
Rinvoq** upadacitinib Janus Kinase (JAK) inhibitor for the treatment of
moderate-to-severe rheumatoid arthritis
Harvoni oral pellets* ledipasvir/sofosbuvir Direct acting antiviral (DAA) for the treatment of
chronic hepatitis C virus (HCV)
*Effective date to be determined.
** Effective date 11/07/2019
Coverage may be contingent upon plan benefits.
4Table 2. Products Not Added**
Brand Name Generic Name Preferred Alternatives
Hadlima* adalimumab-bwwd Humira
Accrufer* ferric maltol ferrous sulfate tablet, ferrous gluconate tablet
Wakix pitolisant modafinil tablet, dextroamphetamine/
amphetamine tablet, methylphenidate HCl
tablet
pretomanid pretomanid Isoniazid tablet, Levofloxacin Hemihydrate
tablet
Rozlytrek entrectinib Vitrakvi, Xalkori
Inrebic fedratinib Jakafi
Xenleta oral lefamulin Moxifloxacin HCl, Levofloxacin Hemihydrate
Nourianz istradefylline selegiline capsule, selegiline tablet, entacapone
tablet
Riomet ER oral solution* metformin Metformin HCl ER tablet, extended release 24
hour
Ibsrela* tenapanor Amitiza, Linzess
Ozobax baclofen baclofen 10 mg tablet, baclofen 20 mg tablet
Rybelsus semaglutide Ozempic, Victoza
Fasenra autoinjector benralizumab Asmanex twisthaler/HFA, Flovent Diskus/HFA,
Arnuity Ellipta
Hemady* dexamethasone dexamethasone tablet
Bonsity* teriparatide Alendronate tablets, Ibandronate tablets,
Tymlos
Aklief trifaotene tretinoin cream, tretinoin gel (gram) 0.01%,
0.025%
Reyvow* lasmiditan sumatriptan succinate tablet, rizatriptan tablet,
zolmitriptan tablet
Secuado* asenapine olanzapine tablet, olanzapine ODT, risperidone
tablet
Amzeeq topical foam minocycline clindamycin phosphate gel (gram), clindamycin
phosphate solution non-oral, erythromycin
solution non-oral
Trikafta elexacaftor/ivacaftor/texacaftor Provider discretion
Sovaldi oral pellets* sofosbuvir Harvoni, ledipasvir-sofosbuvir
Coverage may be contingent upon plan benefits.
*Effective date to be determined.
**Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which
can be accessed online in Highmark’s Provider Resource Center. Under Provider Forms, select Miscellaneous
Forms, and select the form titled Request for Non-Formulary Drug Coverage.
5Table 3. Additions to the Specialty Tier Copay Option
Note: The specialty tier does not apply to Highmark Delaware Healthcare Reform members; see
Highmark Delaware’s online Provider Resource Center and access the Pharmacy
Program/Formularies link for details on the formularies and formulary options that apply to
Highmark Delaware Healthcare Reform members.
(Effective upon completion of internal review and implementation unless otherwise noted.)
Brand Name Generic Name
Hadlima addalimumab-bwwd
Accrufer ferric maltol
Wakix pitolisant
Rozlytrek entrectinib
Rinvoq upadacitinib
Inrebic fedratinib
Xenleta oral lefamulin
Nourianz istradefylline
Harvoni oral pellets ledipasvir/sofosbuvir
Sovaldi oral pellets sofosbuvir
Ozobax baclofen
Fasenra autoinjector benralizumab
Hemady dexamethasone
Bonsity teriparatide
Trikafta elexacaftor/ivacaftor/texacaftor
6B. Changes to the Highmark Progressive Formulary and the Highmark Healthcare Reform
Progressive Formulary
Note: The Progressive Formulary does not apply to Highmark Delaware members; see Highmark
Delaware’s online Provider Resource Center and access the Pharmacy Program/Formularies
link for details on the formularies and formulary options that apply to Highmark Delaware members.
For your convenience, you may search the following formularies online:
Highmark Progressive Formulary:
(https://client.formularynavigator.com/Search.aspx?siteCode=1176922773)
Highmark Healthcare Reform Progressive Formulary:
(https://client.formularynavigator.com/Search.aspx?siteCode=4909431197)
Table 1. Formulary Updates (All products added to the formulary effective December 20, 2019, unless
otherwise noted.)
Comments/Preferred
Brand Name Generic Name Tier Alternatives
Items listed below are preferred products
Baqsimi nasal spray glucagon 2 – Preferred brand Nasal spray for treatment of
severe hypoglycemia in patients
with diabetes mellitus.
Gvoke glucagon 2 – Preferred brand Prefilled syringe for treatment of
severe hypoglycemia in patients
with diabetes mellitus.
Rinvoq** upadacitinib 3 – Preferred Janus Kinase (JAK) inhibitor for
specialty the treatment of moderate-to-
severe rheumatoid arthritis
Additional preferred products:
Actemra (tocilizumab), Enbrel
(etanercept), Humira
(adalimumab), Xeljanz/Xeljanz XR
(tofacitinib)
Harvoni oral pellets* ledipasvir/sofosbuvir 3 – Preferred Direct acting antiviral (DAA) for
specialty the treatment of chronic HCV
Items listed below are non-preferred products
pretomanid pretomanid 3 – Non-preferred Isoniazid tablet, Levofloxacin
brand Hemihydrate tablet
Riomet ER oral metformin 3 – Non-preferred Metformin HCL ER tablet,
solution* brand extended release 24 hour
Ibsrela* tenapanor 3 – Non-preferred Provider discretion
brand
Rybelsus semaglutide 3 – Non-preferred Ozempic, Victoza
brand
Aklief trifaotene 3 – Non-preferred tretinoin cream, tretinoin gel
brand (gram) 0.01%, 0.025%
Reyvow* lasmiditan 3 – Non-preferred sumatriptan succinate tablet,
brand rizatriptan tablet, zolmitriptan
tablet
7Secuado* asenapine 3 – Non-preferred olanzapine tablet, olanzapine
brand ODT, risperidone tablet
Amzeeq topical foam minocycline 3 – Non-preferred clindamycin phosphate gel
brand (gram), clindamycin phosphate
solution non-oral, erythromycin
solution non-oral
Hadlima* adalimumab-bwwd 4 – Non-preferred Humira
specialty
Accrufer* ferric maltol 4 – Non-preferred Provider discretion
specialty
Wakix pitolisant 4 – Non-preferred modafinil tablet,
specialty dextroamphetamine/amphetamine
tablet, methylphenidate HCl tablet
Rozlytrek entrectinib 4 – Non-preferred Vitrakvi, Xalkori
specialty
Inrebic fedratinib 4 – Non-preferred Jakafi
specialty
Xenleta oral lefamulin 4 – Non-preferred Moxifloxacin HCl^, Levofloxacin
specialty Hemihydrate
Nourianz istradefylline 4 – Non-preferred selegiline capsule, selegiline
specialty tablet, entacapone tablet^
Ozobax baclofen 4 – Non-preferred baclofen 10 mg tablet, baclofen
specialty 20 mg tablet, tizanidine tablet
Fasenra autoinjector benralizumab 4 – Non-preferred Asmanex twisthaler/HFA, Flovent
specialty Diskus/HFA, Arnuity Ellipta
Hemady* dexamethasone 4 – Non-preferred dexamethasone tablet
specialty
Bonsity* teriparatide 4 – Non-preferred Alendronate tablets, Ibandronate
specialty tablets, Tymlos
Trikafta elexacaftor/ivacaftor/ 4 – Non-preferred Provider discretion
texacaftor specialty
Sovaldi oral pellets* sofosbuvir 4 – Non-preferred Harvoni, ledipasvir-sofosbuvir
specialty
Coverage may be contingent upon plan benefits.
*Effective date to be determined.
**Effective date 11/07/2019
Tier 1: Preferred generic drugs; Tier 2: Preferred brand drugs; Tier 3: Non-preferred generic drugs, non-preferred brand
drugs, preferred specialty drugs; Tier 4: Non-preferred specialty drugs.
^Applies to Commercial only.
8C. Changes to the Highmark Healthcare Reform Essential Formulary
The Essential Formulary is a closed formulary for select Healthcare Reform (HCR) Individual plans. A
list of drugs included on the Essential Formulary, listed by therapeutic class, is available at
https://client.formularynavigator.com/Search.aspx?siteCode=6571849149.
Table 1. Formulary Updates
(All formulary changes effective December 20, 2019 unless otherwise noted.)
Brand Name Generic Name Tier Comments/Preferred Alternatives
Items listed below were added to the formulary
Baqsimi nasal glucagon 3 Nasal spray for treatment of severe hypoglycemia
spray in patients with diabetes mellitus.
Gvoke glucagon 3 Prefilled syringe for treatment of severe
hypoglycemia in patients with diabetes mellitus.
Rinvoq** upadacitinib 4 Janus Kinase (JAK) inhibitor for the treatment of
moderate-to-severe rheumatoid arthritis
Additional preferred products: Actemra
(tocilizumab), Enbrel (etanercept), Humira
(adalimumab), Xeljanz/Xeljanz XR (tofacitinib)
Harvoni oral ledipasvir/sofosbuvir 4 Direct acting antiviral (DAA) for the treatment of
pellets* chronic HCV
Trikafta elexacaftor/ivacaftor/texacafto 4 Combination ion channel modulator for the
r treatment of cystic fibrosis in patients who have at
least one F508del mutation.
Items listed below were not added to the formulary
Hadlima* adalimumab-bwwd NF Humira
Accrufer* ferric maltol NF Provider discretion
Wakix pitolisant NF modafinil tablet, dextroamphetamine/amphetamine
tablet, methylphenidate HCl tablet
pretomanid pretomanid NF Isoniazid tablet, Levofloxacin Hemihydrate tablet
Rozlytrek entrectinib NF Vitrakvi, Xalkori
Inrebic fedratinib NF Jakafi
Xenleta oral lefamulin NF Moxifloxacin HCl, Levofloxacin Hemihydrate
Nourianz istradefylline NF selegiline capsule, selegiline tablet, entacapone
tablet
Sovaldi oral sofosbuvir NF Harvoni, ledispavir-sofosbuvir
pellets*
Riomet ER oral metformin NF Metformin HCL ER tablet, extended release 24
solution* hour
Ibsrela* tenapanor NF Amitiza, Linzess
Ozobax baclofen NF baclofen 10 mg tablet, baclofen 20 mg tablet,
tizanidine tablet
Rybelsus semaglutide NF Ozempic, Victoza
Fasenra benralizumab NF Asmanex twisthaler/HFA, Flovent Diskus/HFA,
autoinjector Arnuity Ellipta
Hemady* dexamethasone NF dexamethasone tablet
9Brand Name Generic Name Tier Comments/Preferred Alternatives
Bonsity* teriparatide NF Alendronate tablets, Ibandronate tablets, Tymlos
Aklief trifaotene NF tretinoin cream, tretinoin gel (gram) 0.01%,
0.025%
Reyvow* lasmiditan NF sumatriptan succinate tablet, rizatriptan tablet,
zolmitriptan tablet
Secuado* asenapine NF olanzapine tablet, olanzapine ODT, risperidone
tablet
Amzeeq topical minocycline NF clindamycin phosphate gel (gram), clindamycin
foam phosphate solution non-oral, erythromycin solution
non-oral
Formulary options: Tier 1, Tier 2, Tier 3, Tier 4, Non-formulary (NF).
*Effective date to be determined.
** Effective date 11/07/2019
D. Changes to the Highmark National Select Formulary
The National Select Formulary is an incentive formulary with a non-formulary drug list to manage
products in therapeutic categories for which preferred alternatives are available. The National Select
Formulary is available for select Commercial self-funded (ASO) plans. A list of drugs included on the
National Select Formulary, listed by therapeutic class, is available at
https://client.formularynavigator.com/Search.aspx?siteCode=3442182690.
Table 1. Formulary Updates
Brand Name Generic Name Tier Comments/Preferred Alternatives
Items listed below were added to the formulary (preferred)
Baqsimi nasal glucagon 2 Nasal spray for treatment of severe hypoglycemia
spray in patients with diabetes mellitus.
Rozlytrek entrectinib 2 Oral kinase inhibitor for the treatment of ROS1-
positive non-small cell lung cancer and for solid
tumors that have a neurotrophic tyrosine receptor
kinase (NTRK) gene fusion without a known
resistance mutation.
Fasenra benralizumab 2 Self-administered auto-injector formulation of
autoinjector Fasenra for the treatment of patients with severe
eosinophilic asthma.
Rybelsus semaglutide 2 Oral glucagon-like peptide-1 (GLP-1) receptor
agonist for the treatment of type 2 diabetes.
Gvoke glucagon 2 Prefilled syringe for treatment of severe
hypoglycemia in patients with diabetes mellitus.
Trikafta elexacaftor/ivacaftor/texacafto 2 Combination ion channel modulator for the
r treatment of cystic fibrosis in patients who have at
least one F508del mutation.
Rinvoq upadacitinib 2 Janus Kinase (JAK) inhibitor for the treatment of
moderate-to-severe rheumatoid arthritis
10Brand Name Generic Name Tier Comments/Preferred Alternatives
Additional preferred products: Actemra
(tocilizumab), Enbrel (etanercept), Humira
(adalimumab), Xeljanz/Xeljanz XR (tofacitinib)
Amzeeq topical minocycline 2 clindamycin phosphate gel (gram), clindamycin
foam phosphate solution non-oral, erythromycin solution
non-oral
Items listed below were added to the formulary (non-preferred)
Xenleta oral lefamulin 3 Moxifloxacin HCl, Levofloxacin Hemihydrate
Hadlima* adalimumab-bwwd 3 Humira
Accrufer* ferric maltol 3 ferrous sulfate tablet, ferrous gluconate tablet
Wakix* pitolisant 3 modafinil tablet, dextroamphetamine/
amphetamine tablet, methylphenidate HCl tablet
pretomanid* pretomanid 3 Isoniazid tablet, Levofloxacin Hemihydrate tablet
Nourianz* istradefylline 3 selegiline capsule, selegiline tablet, entacapone
tablet
Riomet ER oral metformin 3 Metformin HCL ER tablet, extended release 24
solution* hour
Ibsrela* tenapanor 3 Linzess, Trulance
Hemady* dexamethasone 3 dexamethasone tablet
Bonsity* teriparatide 3 Alendronate tablets, Ibandronate tablets, Tymlos,
Forteo
Aklief* trifaotene 3 tretinoin cream, tretinoin gel (gram) 0.01%,
0.025%
Reyvow* lasmiditan 3 sumatriptan succinate tablet, rizatriptan tablet,
zolmitriptan tablet
Secuado* asenapine 3 olanzapine tablet, olanzapine ODT, risperidone
tablet
Sovaldi oral sofosbuvir 3 Epclusa, Harvoni, Vosevi, Zepatier
pellets*
Harvoni oral ledipasvir/sofosbuvir 3 Epclusa, Harvoni, Vosevi, Zepatier
pellets*
Items listed below were not added to the formulary
Inrebic fedratinib NF Jakafi
Ozobax baclofen NF baclofen 10 mg tablet, baclofen 20 mg tablet,
tizanidine
Formulary options: Tier 1, Tier 2, Tier 3, Non-formulary (NF).
*Effective date and final formulary position to be determined.
11Table 2. Additions to the Specialty Tier Copay Option
(Effective upon completion of internal review and implementation unless otherwise noted.)
Brand Name Generic Name
Hadlima adalimumab-bwwd
Accrufer ferric maltol
Wakix pitolisant
Rozlytrek entrectinib
Rinvoq upadacitinib
Inrebic fedratinib
Xenleta oral lefamulin
Nourianz istradefylline
Harvoni oral pellets ledipasvir/sofosbuvir
Sovaldi oral pellets sofosbuvir
Ozobax baclofen
Fasenra autoinjector benralizumab
Hemady dexamethasone
Bonsity teriparatide
Trikafta elexacaftor/ivacaftor/texacaftor
E. Updates to the Pharmacy Utilization Management Programs
1. Prior Authorization Program
Policy
Policy Name* Effective Updates and/or Approval Criteria
Date**
Anti-Obesity – Commercial 11/7/2019 Policy revised to allow for reauthorization for maintenance
and Healthcare Reform therapy as long as the member has maintained weight loss
from baseline.
Accrufer (ferric maltol) – Best Date New policy created for Accrufer (ferric maltol) to ensure
Commercial and Healthcare appropriate use in adults with iron deficiency. Member has
Reform tried and failed dietary modification and over-the-counter iron
replacement therapy for at least 3 months. Reauthorization
attesting positive clinical response added.
Adalimumab BIOSIMILARS TBD Policy revised to include the newly FDA-approved Hadlima
– Commercial and (adalimumab biosimilar). The policy split out the recommended
Healthcare Reform age group for each diagnosis. Policy revised to include
exception criteria for members that may require initial biologic
therapy for juvenile idiopathic arthritis and revise step through
two immunosuppressants to one corticosteroid for severe
ulcerative colitis. The maintenance therapy quantity limit was
updated to allow use of four (4) prefilled syringes every four (4)
weeks when there is clinical documentation that treatment with
two (2) prefilled syringes every four (4) weeks was ineffective
for plaque psoriasis and ulcerative colitis indications. The
induction therapy quantity limit was updated to allow for six (6)
12Policy
Policy Name* Effective Updates and/or Approval Criteria
Date**
prefilled syringes within the first four (4) weeks of therapy to
mirror the quantity limit in place for Crohn’s disease.
Adcirca and Alyq (tadalafil) 11/25/2019 Policy revised for Adcirca (tadalafil) by adding Alyq (tadalafil)
– Healthcare Reform and removing criteria that prescriber has ruled out other
Essential Formulary causes of pulmonary hypertension. If request is for brand
Adcirca or Alyq, trial and failure of generic tadalafil.
Reauthorization attesting positive clinical response added.
Androgen Receptor 12/10/2019 New policy created to ensure appropriate use of the androgen
Inhibitors – Commercial and receptor inhibitors Nubeqa (darolutamide) and Erleada
Healthcare Reform (apalutamide) for the treatment of non-metastatic castration-
resistant prostate cancer, and Xtandi (enzalutamide) for the
treatment of castration-resistant prostate cancer. Criteria
require these agents be used in combination with a
gonadotropin releasing hormone analog or bilateral
orchiectomy. Reauthorization criteria added to Erleada and
Nubeqa to ensure the member has had disease improvement
or delayed disease progression. Reauthorization criteria for
Erleada changed to require documentation of disease
improvement or delayed disease progression. Authorization
duration for Xtandi changed from 12 months to 2 years.
Additional criteria for Xtandi added requiring utilization in
combination with a gonadotropin-releasing hormone (GnRH)
analog or previous orchiectomy.
Anti-Angiogenesis and 11/25/2019 Policy revised for Cabometyx (cabozantinib) for approval of
VEGF Kinase Inhibitors – additional quantities when taken concurrently with a strong
Commercial and Healthcare cytochrome P450 3A4 (CYP3A4) inducer.
Reform
Anti-EGFR and HER2 10/14/2019 Policy revised for Nerlynx (neratinib) to remove criteria for
Kinase Inhibitors – Hormone Receptor (HR)-positive status to align with FDA-
Commercial and Healthcare approved indication.
Reform
Arakoda and Krintafel 11/25/2019 Policy revised to reflect updated CDC guidelines that Krintafel
(tafenoquine) – Commercial (tafenoquine) can be used for the treatment of malaria, added
and Healthcare Reform age restrictions based upon FDA approved indications, and
added a limitation of coverage for Arakoda (tafenoquine) in
patients with a history of psychotic disorders or current
psychotic symptoms.
BCR-ABL Kinase Inhibitors 11/25/2019 Policy revised to add criteria for Sprycel (dasatinib) in adults
– Commercial and HCR with Philadelphia chromosome-positive acute lymphoblastic
leukemia with resistance or intolerance to prior therapy.
Bruton’s Tyrosine Kinase 11/26/2019 Policy revised for Calquence (acalabrutinib) for approval of
Inhibitors – Commercial and additional quantities when taken concurrently with a strong
Healthcare Reform CYP3A4 inducer.
CaroSpir (spironolactone) – 12/7/2019 Policy revised for CaroSpir (spironolactone) to ensure
Commercial and Healthcare appropriate use in members 18 years of age or older, has
Reform inability to swallow tablets, and has experienced trial and
failure of spironolactone tablets which can be crushed.
13Policy
Policy Name* Effective Updates and/or Approval Criteria
Date**
Reauthorization attesting positive clinical response and
continues to have an inability to swallow tablets added.
CFTR Modulators – 12/16/2019 Policy revised to include Trikafta (elexacaftor/tezacaftor
Commercial and Healthcare ivacaftor) and criteria for age, diagnosis of cystic fibrosis and
Reform appropriate cystic fibrosis transmembrane (CFTR) mutation
Chelating Agents – 4/1/2020 New policy created for Exjade and Jadenu (deferasirox) and
Commercial and Healthcare Ferriprox (deferiprone) for chronic iron overload due to blood
Reform transfusions in those of appropriate age, transfusion history
with packed red blood cells, serum ferritin, and trial and failure
of generic deferasirox. Reauthorization attesting positive
clinical response, and serum ferritin. For chronic iron overload
in non-transfusion dependents member is appropriate age,
liver iron concentration, serum ferritin, and trial and failure of
generic deferasirox. Reauthorization attesting positive clinical
response and liver iron concentration.
Chronic Inflammatory 11/15/2019 Policy revised to add Rinvoq (upadacitinib) for rheumatoid
Diseases – Commercial arthritis, Taltz's (ixekizumab) expanded indication for
and Healthcare Reform ankylosing spondylitis, and move Xeljanz (tofacitinib) to non-
preferred for ulcerative colitis. Stelara (ustekinumab) expanded
indication and Cimzia (certolizumab pegol) prescriber
attestation of diagnosis.
Copaxone and Glatopa TBD Policy revised to include additional FDA-approved indications,
(glatiramer acetate) – added HCR into policy (preliminarily). Criteria revised to
Commercial require use of Glatopa OR glatiramer acetate prior to coverage
of Copaxone. This policy has not been active yet, and will
continue to be on hold until additional cost/rebate information is
available and discussed.
Cystic Fibrosis Inhaled 12/8/2019 Policy revised to ensure exclusion of diagnoses of
Medications – Commercial, Burkholderia cepacia complex.
Commercial NSF, and
Healthcare Reform
Delaware - Step Therapy 3/18/2020 New policy created to allow a step therapy override when
Exception – Commercial appropriate criteria are met. This policy is mandated by DE
and Healthcare Reform legislative House Bill 105, effective 3/18/2020.
Diclofenac Containing 1/1/2020 Policy revised to remove 'excluding National Select formulary'
Products – Commercial and disclaimer. Criteria now aligned between Commercial
Healthcare Reform formularies.
Diclofenac Containing 1/1/2020 NSF policy terminated. NSF combined back into Commercial
Products – Commercial policy.
NSF
Dupixent (dupilumab) – 11/18/2019 Policy revised to remove steroid and crisaborole step and add
Commercial and Healthcare that a specialist attested to the member has a diagnosis of
Reform moderate-to-severe atopic dermatitis. For asthma, replaced
statement about forced expiratory volume (FEV) reversibility
with documentation of FEV % based upon age.
14Policy
Policy Name* Effective Updates and/or Approval Criteria
Date**
EGFR-Targeting Kinase 12/7/2019 Policy revised for Tarceva (erlotinib) for approval of additional
Inhibitors – Commercial and quantities when taken concurrently with a strong CYP3A4
Healthcare Reform inducer or if the member smokes cigarettes.
Entresto (sacubitril; 12/8/2019 Policy revised for Entresto (sacubritil; valsartan) to include
valsartan) – Commercial expanded indication of pediatric heart failure with left
and Healthcare Reform ventricular ejection fraction less than or equal to 40% and is
not receiving concomitant angiotensin converting enzyme
(ACE) inhibitor angiotensin II receptor blockers (ARB). Policy
revised to include pediatric situations when quantity limit
override is appropriate. Prior authorization only applies to
HCR. Quantity limit applies to Commercial and HCR.
Erleada (apalutamide) – 12/11/2019 Policy terminated to be combined into new policy Androgen
Commercial and Healthcare Receptor Inhibitors - Commercial and Healthcare Reform
Reform
Hemady (dexamethasone) Best Date New policy created for Hemady (dexamethasone) to ensure
– Commercial and appropriate use in adults with Multiple Myeloma in combination
Healthcare Reform with other anti-myeloma agents who have tried generic
dexamethasone.
Hepatitis C Oral Agents – Best Date Policy revised to include criteria for Harvoni
Commercial, Commercial (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) oral pellet
Core, and Healthcare formulations in the treatment of patients 3 years of age and
Reform older with chronic hepatitis C virus (HCV), who have the
inability to swallow tablets. Policy revised to include updated
treatment duration of Mavyret (glecaprevir/pibrentasvir) for
patients with chronic HCV with compensated cirrhosis.
Increlex (mecasermin) – 12/8/2019 Policy revised to require documentation of height standard
Commercial and Healthcare deviation less than or equal to 3 standard deviations below
Reform normal for approval of Increlex (mecasermin).
Interleukin (IL)-5 12/16/2019 Policy revised to include Nucala's (mepolizumab) expanded
Antagonists – Commercial indication for severe asthma in patients 6 years of age or older
and Healthcare Reform and Fasenra (benralizumab) to the policy now that it is
available as a self-administered product.
Interleukin-1β blockers – 12/8/2019 Policy revised to include age restrictions (12 and older for
Commercial and Healthcare Arcalyst [rilonacept] and 4 and over for Illaris [canakinumab]),
Reform updated references.
JAK Inhibitors – 12/16/2019 Policy revised for Jakafi (ruxolitinib) and Inrebic (fedratinib) to
Commercial and Healthcare expand risk factors for risk status stratification. New criteria
Reform created for Inrebic to ensure intermediate-2 or high risk primary
or secondary myelofibrosis in adults, for new starts to therapy
baseline platelet count and trial and failure to Jakafi. If
continuing therapy or requesting reauthorization there is
reduction in spleen size or improvement in symptoms for
polycythemia vera or myelofibrosis.
Market Watch Programs – 12/26/2019 Policy revised to include Relafen DS (nabumetone) as a target
PA, WV, and DE for the High Cost Low Value Program with therapeutic
alternatives of nabumetone, meloxicam, and ibuprofen.
Ozobax (baclofen) as a target with therapeutic alternatives of
15Policy
Policy Name* Effective Updates and/or Approval Criteria
Date**
baclofen and tizanidine. Hemady (dexamethasone) as a target
with therapeutic alternative of dexamethasone.
Nitisinone (Nityr and 1/1/2020 Policy revised to remove 'excluding National Select formulary'
Orfadin) – Commercial and disclaimer. Criteria now aligned between Commercial
Healthcare Reform formularies.
Nitisinone (Nityr and 1/1/2020 NSF policy terminated. NSF combined back into Commercial
Orfadin) – Commercial NSF policy.
Nourianz (istradefylline) – 12/17/2019 New policy created to ensure appropriate use of Nourianz
Commercial and Healthcare (istradefylline) as an adjunct to levodopa/carbidopa for
Reform Parkinson's disease "off" episodes in patients who have tried
and failed selegiline and entacapone. Reauthorization criteria
added to ensure that the member has experienced a positive
clinical response.
NTRK Inhibitors – 12/12/2019 Policy revised to include criteria for Rozlytrek (entrectinib) in
Commercial and Healthcare the treatment of solid tumors with NTRK gene fusion and
Reform ROS1-mutated non-small cell lung cancer (NSCLC); and for
approval of additional quantities of Vitrakvi (entrectinib) if taken
concurrently with a strong CYP3A4 inducer.
Ofev (nintedanib) and 12/7/2019 Policy revised to include criteria for Ofev's (nintedanib)
Esbriet (pirfenidone) – expanded systemic sclerosis-associated interstitial lung
Commercial and Healthcare disease indication including member's diagnosis,
Reform pulmonologist prescriber, appropriate baseline pulmonary
function tests, patient is a non-smoker, and step through
cyclophosphamide and renamed policy as medications are no
longer only indicated for idiopathic pulmonary fibrosis.
Orilissa (elagolix) – 12/8/2019 Policy revised to remove requirement of the member receiving
Commercial and Healthcare a 150 mg dose once daily for reauthorization of Orilissa
Reform (elagolix).
Ozobax (baclofen) – 12/26/2019 New policy created for Ozobax (baclofen) to ensure
Commercial and Healthcare appropriate use in patients with spasticity due to multiple
Reform sclerosis, spinal cord injury, or spinal cord disease who are
unable to swallow tablets, have therapeutic failure or
intolerance to generic baclofen and in patients over 18,
therapeutic failure or intolerance to tizanidine tablets.
Parathyroid Hormone Best Date Policy revised to include Bonsity (teriparatide) to require
Analogs – Commercial and appropriate diagnosis and risk of fracture, trial and failure of a
Healthcare Reform bisphosphonate, if postmenopausal female with high risk of
fracture trial and failure of Tymlos (abaloparatide), and
cumulative dose does not exceed 24 months.
Parathyroid Hormone Best Date Policy revised to include Bonsity (teriparatide) to require
Analogs – NSF appropriate diagnosis and risk of fracture, trial and failure of a
bisphosphonate, if postmenopausal female with high risk of
fracture trial and failure of Tymlos (abaloparatide) and Forteo
(teriparatide), if male requiring increase of bone mass or male
or female with sustained systemic glucocorticoid therapy trial
16Policy
Policy Name* Effective Updates and/or Approval Criteria
Date**
and failure of Forteo, and cumulative dose does not exceed 24
months.
PARP Kinase Inhibitors – 12/8/2019 Policy revised to add FDA expanded indication for Zejula
Commercial and Healthcare (niraparib) in advanced ovarian, fallopian tube, or primary
Reform peritoneal cancer in adults; criteria revised for coverage
approval in adults with recurrent epithelial ovarian, fallopian
tube, or primary peritoneal cancer per FDA-approved
indication. Policy revised to add for Lynparza (olaparib) (in
ovarian cancer indications only), Rubraca (rucaparib), and
Talzenna (talazoparib): approval criteria for adults.
Pretomanid – Commercial 12/26/2019 New policy created for Pretomanid (pretomanid) to ensure
and Healthcare Reform appropriate use for extensively drug resistant (XDR),
treatment-intolerant or nonresponsive multidrug-resistant
tuberculosis in patients who have tried and failed first-line
medications.
Pulmonary Hypertension – TBD Policy revised to require all drugs to try and fail generic
Commercial and Select sildenafil. If request is for brand Adcirca/Alyq (tadalafil), Letairis
Healthcare Reform (ambrisentan), Tracleer (bosentan), or Revatio (sildenafil) the
member must also try and fail the respective generic.
Rybelsus (semaglutide) – 12/17/2019 New policy created for Rybelsus (semaglutide) to ensure
Commercial and Healthcare appropriate use in patients with type 2 diabetes mellitus who
Reform have experienced therapeutic failure, contraindication or
intolerance to a metformin-containing product, or taking
Rybelsus (semaglutide) in addition to a metformin-containing
product. Attestation that the member requires additional
therapy with Rybelsus (semaglutide) is required for
reauthorization.
Thrombopoiesis Stimulating 12/8/2019 Policy revised to add approvable quantity limit overrides for
Agents – Commercial and Promacta (eltrombopag). Policy revised for Nplate
Healthcare Reform (romiplostim) to include expanded indication of immune
thrombocytopenia.
Topical Non-Steroid 1/1/2020 Policy revised to remove 'excluding National Select formulary'
Therapy for Atopic disclaimer. Criteria now aligned between Commercial
Dermatitis – Commercial formularies.
Topical Non-Steroid 1/1/2020 NSF policy terminated. NSF combined back into Commercial
Therapy for Atopic policy.
Dermatitis – Commercial
NSF
Turalio (pexidartinib) – 12/12/2019 New policy created to ensure appropriate use of Turalio
Commercial and Healthcare (pexidartinib) for the treatment of adult patients with
Reform symptomatic tenosynovial giant cell tumor (TGCT) associated
with severe morbidity or functional limitations and not
amenable to improvement with surgery. Reauthorization
criteria added to ensure the member has tolerated the therapy
and experienced a therapeutic response.
17Policy
Policy Name* Effective Updates and/or Approval Criteria
Date**
Veltassa (patiromer) and TBD Policy revised for Veltassa (patiromer) and Lokelma (sodium
Lokelma (sodium zirconium zirconium cyclosilicate) to remove requirement that chronic
cyclosilicate) – Commercial kidney disease patients have discontinued or reduced
and Select Healthcare medications known to cause hyperkalemia.
Reform
Vimpat (lacosamide) – TBD New policy created to ensure appropriate use of Vimpat
Commercial (lacosamide) for the treatment of partial-onset seizures as
monotherapy and adjunctive therapy in patients 4 years of age
or older.
Vivlodex (meloxicam) – 12/8/2019 Policy revised to add reauthorization criteria and reduce
Commercial and Healthcare authorization duration to 6 months.
Reform
Vyleesi (bremelanotide) – 12/8/2019 Policy revised to remove requirement of increased satisfying
Commercial and Healthcare sexual events from reauthorization criteria.
Reform
Wakix (pitolisant) – 12/12/2019 New policy created to require a documented diagnosis of
Commercial and Healthcare narcolepsy, documentation of baseline excessive daytime
Reform sleepiness (EDS), documented treatment failure, intolerance or
contraindication to modafinil as well as one additional central
nervous system (CNS) stimulant OR wakefulness/stimulant
meds are clinically inappropriate or there is a legitimate
concern of illegal drug diversion.
West Virginia - Step TBD Policy revised with administrative changes; also, to add initial
Therapy/Prior Authorization authorization and reauthorization criteria as well as
Override Exception – authorization.
Commercial and Healthcare
Reform
Xtandi (enzalutamide) – 12/11/2019 Policy terminated to be combined into new policy Androgen
Commercial and Healthcare Receptor Inhibitors - Commercial and Healthcare Reform.
Reform
Yosprala 11/25/2019 Policy revised for Yosprala (aspirin and omeprazole) to ensure
(aspirin/omeprazole) – appropriate use in members with need for secondary
Commercial and Healthcare prevention of cardiovascular and cerebrovascular events.
Reform Reauthorization attesting positive clinical response and
requires additional courses of treatment.
Zytiga and Yonsa 12/9/2019 Policy revised for Zytiga (abiraterone acetate) in Healthcare
(abiraterone acetate) – Reform, and Yonsa (abiraterone acetate): that generic
Commercial and Healthcare abiraterone was ineffective or not tolerated; and for approval of
Reform additional quantities of Zytiga (abiraterone acetate) and Yonsa
(abiraterone acetate) when taken concurrently with a strong
CYP3A4 inducer.
*For policies that require step therapy, an exception may be made for commercial and HCR members enrolled in a West
Virginia plan. For additional details, refer to pharmacy policy bulletin J-513 (West Virginia – Step Therapy Override
Exception).
**All effective dates are tentative and subject to delay pending internal review or approval.
182. Managed Prescription Drug Coverage (MRxC) Program
Policy
Policy Name Effective Updates and Automatic Approval Criteria
Date
Acute Migraine Therapies – Best Date Policy revised to include Reyvow (lasmiditan). Limitations of
Commercial and Healthcare coverage updated to reflect Reyvow quantity limit.
Reform
Ampyra (dalfampridine) – TBD Policy revised to require trial or intolerance to generic
Commercial and Healthcare dalfampridine for requests for brand Ampyra.
Reform
Amrix (cyclobenzaprine) – 1/1/2020 Policy revised to change authorization duration from 12 months
Commercial and Healthcare to 3 months, and remove automatic criteria.
Reform
Atypical Antipsychotics – 1/1/2020 Policy revised to include step through generic quetiapine ER or
Commercial aripiprazole prior to Rexulti (brexpiprazole) and Vraylar
(cariprazine). Coverage criteria added for Seroquel XR
(quetiapine fumarate) when used for the adjunctive treatment of
major depressive disorder. Automatic approval language
updated to align with current rule coding. Reauthorization criteria
also added.
Atypical Antipsychotics – 1/1/2020 Policy revised to include step through generic quetiapine ER or
Healthcare Reform aripiprazole prior to Rexulti (brexpiprazole). Automatic approval
language updated to align with current rule coding.
Reauthorization criteria also added.
Azilect (rasagiline) – 1/1/2020 New policy created requiring age of 18 years old, diagnosis of
Commercial Parkinson’s Disease (PD), failure/intolerance to generic
selegiline and one additional medication from specified list.
Azilect (rasagiline) – Best Date Policy revised to remove orphenadrine (off-label use) and
Healthcare Reform procyclidine and biperiden (no longer available). Reauthorization
criteria added and authorization duration changed to 2 years.
Benzonatate – Commercial Best Date Policy revised to change authorization duration and automatic
and Healthcare Reform approval criteria from 1 year to 3 months.
Brand and Extended Best Date Policy revised to add Riomet ER (metformin hydrochloride) to
Release Metformin – ensure members have tried and failed metformin ER (generic
Commercial and Healthcare Glucophage XR), and to ensure appropriate utilization in
Reform members who are unable to swallow tablets containing
metformin.
Branded Antiandrogen 11/25/2019 Policy revised to change authorization duration from lifetime to 2
Therapy – Commercial years.
Branded Aromatase 11/26/2019 Policy revised to change authorization duration from lifetime to 2
Inhibitors – Commercial years.
Buprenorphine (non-opioid 11/26/2019 Policy revised to move quantity limit information to background
dependence use) – section, added an age restriction to those 18 years of age and
Commercial, Healthcare older.
Reform
Duaklir (aclidinium bromide Best Date New policy created to ensure appropriate use for patients with
and formoterol fumarate) – chronic obstructive pulmonary disease (COPD) and trial of Anoro
Commercial and Healthcare Ellipta (umeclidinium and vilanterol) and Stiolto Respimat
Reform (tiotropium bromide and olodaterol).
19Policy
Policy Name Effective Updates and Automatic Approval Criteria
Date
Duexis (ibuprofen, 1/1/2020 Policy revised to add a limitation of coverage that Duexis
famotidine) – Commercial, (ibuprofen/famotidine) will not be approved to increase patient
Commercial NSF, and adherence or convenience and removed automatic approval
Healthcare Reform criteria.
Ibsrela (tenapanor) – Best Date New policy created for Ibsrela (tenapanor) to ensure appropriate
Commercial and Healthcare use in adults with irritable bowel syndrome with constipation
Reform (IBS-C) in adults and trial and failure of Amitiza (lubiprostone)
and Linzess (linaclotide). Reauthorization criteria attesting
positive clinical response.
Leukotriene Modifiers Best Date Policy revised to add a single step through an inhaled
(Accolate, Zyflo) – corticosteroid (ICS) or ICS/long-acting beta agonist (LABA) and
Commercial and Healthcare montelukast for Accolate (zafirlukast) and added additional step
Reform through generic zileuton ER for Zyflo/Zyflo CR (zileuton/zileuton
ER) and zafirlukast (Accolate) for brand Accolate
Naproxen and Fenoprofen Best Date Policy revised to include another agent, Relafen DS
Containing Products and (nabumetone). Policy approval criteria include a diagnosis of
Relafen DS – Commercial osteoarthritis or rheumatoid arthritis (RA) and a failure or
and HCR intolerance to three formulary oral generic non-steroidal anti-
inflammatory drugs (NSAIDs), one of which must be generic
nabumetone.
Non-Preferred Benign 1/1/2020 Policy revised to include brand Cialis 5 mg (tadalafil) as a target
Prostatic Hyperplasia requiring a step through 1 alpha blocker, 1 alpha reductase
Therapy – Healthcare inhibitor, and generic tadalafil.
Reform
Non-Preferred Sodium- Best Date Policy revised to include a trial and failure of a metformin
Glucose Co-Transporter 2 containing product for the approval criteria and the automatic
Inhibitors – Commercial and approval criteria. Policy revised to include reauthorization criteria
Healthcare Reform to ensure the member requires additional therapy. Policy
updated with recent indications for cardiovascular benefit.
Non-Preferred Statins – Best Date Policy revised for rosuvastatin to require trial and failure of 1
Healthcare Reform preferred generic statin.
Essential Formulary
Nuedexta 12/8/2019 Policy revised to change authorization duration from lifetime to
(dextromethorphan- 12 months, and add reauthorization criteria.
quinidine) – Commercial
and Healthcare Reform
Opioid Management – 1/1/2020 Policy revised to incorporate safety rule modification of short
Commercial and Healthcare acting opioid 3-day supply limitation for first time pediatric users.
Reform Policy approval criteria for additional days of therapy of this
safety rule update will include cancer diagnosis, hospice, end-of-
life care, or palliative care. In addition, policy criteria will also
include approval for demonstration of chronic pain management
or severe pain treatment strategy following trial of non-opioid
therapy, state prescription drug monitoring program review and
parent/guardian education. Butrans and Belbuca
(buprenorphine) added to listing of Extended Release Opioid
examples, information added to background: CDC recommends
20Policy
Policy Name Effective Updates and Automatic Approval Criteria
Date
when starting opioid therapy, IR opioids should be used instead
of ER/LA opioids.
Qbrelis and Epaned – 12/8/2019 Policy revised for Qbrelis (lisinopril oral solution) and Epaned
Commercial and Healthcare (enalapril oral solution) to require trial and failure of enalapril or
Reform lisinopril tablets as they can be crushed. Reauthorization added
attesting positive clinical response.
Ryvent (carbinoxamine) 6 1/1/2020 Policy revised to include brand Ryvent (carbinoxamine maleate)
mg – Healthcare Reform as a target in addition to generic carbinoxamine. Policy also
updated to reflect the effective start date as 1/1/2020.
Topical Acne Medications – Best Date Policy revised to include Aklief (trifarotene) and Amzeeq
Commercial (minocycline).
Topical Acne Medications – Best Date Policy revised for Topical Acne Medications to add Aklief
Healthcare Reform (trifarotene) and Amzeeq (minocycline) and to list specific try and
fail alternatives such as adapalene, clindamycin,
clindamycin/benzoyl peroxide, erythromycin, tretinoin, and
sulfacetamide. Reauthorization criteria expanded to include
prescriber attestation that member's acne requires additional
courses of treatment.
Topical Psoriasis 1/1/2020 New policy created to ensure appropriate use of topical
Treatments – Healthcare Dovonex, Sorilux, and Vectical (calictriol) for the treatment of
Reform plaque psoriasis. Policy requires a step through a preferred
topical corticosteroid and through generic topical calciptriene.
Vimovo (naproxen, 1/1/2020 Policy revised to add a limitation of coverage that Vimovo
esomeprazole) – (naproxen/esomeprazole) will not be approved to increase
Commercial, Commercial patient adherence or convenience and removed automatic
NSF, and Healthcare approval criteria.
Reform
Xeloda (capecitabine) – 12/8/2019 Policy revised to update FDA-approved indications as listed in
Commercial package insert; criteria updated with FDA-approved indications
for Xeloda (capecitabine).
Xhance (fluticasone 11/25/2019 Policy revised to add reauthorization criteria attesting the
propionate) – Commercial member has experienced positive clinical response to therapy.
and Healthcare Reform
For policies that require step therapy, an exception may be made for Commercial and HCR members enrolled in a West
Virginia plan. For additional details, refer to pharmacy policy bulletin J-513 (West Virginia – Step Therapy Override
Exception).
All effective dates are tentative and subject to delay pending internal review or approval.
Standard prior authorization criteria will apply for members who do not meet the automatic approval criteria.
213. Quantity Level Limit (QLL) Programs*
(Effective immediately upon completion of internal review and implementation, unless otherwise
noted.)
Table 1. Quantity Level Limits – Quantity per Duration for Commercial and Healthcare
Reform Plans
Drug Name Retail Edit Limit Mail Edit Limit
Bonsity (teriparatide) 1 pen per 28 days 3 pens per 84 days
Fasenra (benralizumab) autoinjector 1 pen per 56 days 1 pen per 56 days
Hadlima (adalimumab-bwwd) 2 prefilled syringes or 6 prefilled syringes or
autoinjectors per 28 days autoinjectors per 84 days
Ingrezza (valbenazine) initiation pack 1 pack per year 1 pack per year
pretomanid 270 tablets per 365 days 270 tablets per 365 days
Reyvow (lasmiditan) 50 mg 4 tablets per 30 days 12 tablets per 90 days
Reyvow (lasmiditan) 100 mg 8 tablets per 30 days 24 tablets per 90 days
Trikafta (elexacaftor/ivacaftor/texacaftor) 1 carton per 28 days 3 cartons per 84 days
Table 2. Quantity Level Limits – Quantity per Dispensing Event – Commercial and Healthcare
Reform Plans
Drug Name Retail Edit Limit Mail Edit Limit
Baqsimi (glucagon) nasal spray 2 bottles 2 bottles
Gvoke (glucagon) 2 syringes 2 syringes
Riomet ER (metformin) oral solution 2 bottles 4 bottles
Quantity per dispensing event limits the quantity of medication that can be dispensed per each fill. If the submitted day
supply on a claim is 34 days or less, the retail limit will apply. If the submitted day supply on a claim is greater than 34
days, the mail limit will apply.
22Table 3. Maximum Daily Quantity Limits – Commercial and Healthcare Reform Plans
Drug Name Daily Limit
Accrufer (ferric maltol) 2 capsules per day
Alunbrig (brigatinib) 30 mg tablets 4 tablets per day
Bosulif (bosutinib) 100 mg tablets 3 tablets per day
Harvoni (ledipasvir/sofosbuvir) oral pellets 1 packet per day
Hemady (dexamethasone) 2 tablets per day
Ibsrela (tenapanor) 2 tablets per day
Iclusig (ponatinib) 15 mg 1 tablet per day
Idhifa (enasidenib) 50 mg tablets 1 tablet per day
Imbruvica (ibrutinib) 140 mg capsules 3 capsules per day
Ingrezza (valbenazine) 40 mg 1 capsule per day
Inlyta (axitinib) 1 mg tablets 6 tablets per day
Inrebic (fedratinib) 4 capsules per day
Jakafi (ruxolitinib) 2 tablets per day
Northera (droxidopa) 100 mg 3 capsules per day
Northera (droxidopa) 200 mg and 300 m 6 capsules per day
Nourianz (istradefylline) 1 tablet per day
Ozobax (baclofen) 80 mL per day
pretomanid 1 tablet per day
Promacta (eltrombopag) 12.5 mg and 25 mg tablets 1 tablet per day
Promacta (eltrombopag) 50 mg and 75 mg tablets 2 tablets per day
Promacta (eltrombopag) powder in packet 1 packet per day
Rinvoq (upadacitinib) 1 tablet per day
Rozlytrek (entrectinib) 20 mg capsules 3 capsules per day
Rozlytrek (entrectinib) 100 mg capsules 5 capsules per day
Rybelsus (semaglutide) 1 tablet per day
Secuado (asenapine) 1 patch per day
Sovaldi (sofosbuvir) oral pellets 1 packet per day
Tarceva (erlotinib) 25 mg tablets 2 tablets per day
Targretin 75 mg capsules 4 capsules per day
Venclexta (venetoclax) 100 mg tablets 6 tablets per day
Venclexta (venetoclax) 50 mg tablets 2 tablets per day
Wakix (pitolisant) 4 tablets per day
Xenleta (lefamulin) oral 2 tablets per day
Members can receive up to the maximum day supply according to their benefits, but the daily limit must not be
exceeded for each individual day.
Requests for coverage of select medications exceeding the defined quantity level limits may be submitted for clinical
review. Maximum-day supply on certain medications may vary depending on member’s benefit design.
23SECTION II. Highmark Medicare Part D Formularies
A. Changes to the Highmark Medicare Part D 5-Tier Incentive Formulary
The Highmark Pharmacy and Therapeutics Committee has reviewed the medications listed in the tables
below. For your convenience, you can search the Highmark Medicare Part D Formularies online at:
Performance Formulary: https://client.formularynavigator.com/Search.aspx?siteCode=1349658900
Venture Formulary: https://client.formularynavigator.com/Search.aspx?siteCode=1347236614
Incentive Formulary: https://client.formularynavigator.com/Search.aspx?siteCode=1344627998
Table 1. Preferred Products*
(Effective immediately pending CMS approval and upon completion of internal review and
implementation.)
Brand Name Generic Name Comments
Baqsimi nasal spray glucagon Provider discretion
Gvoke glucagon Provider discretion
Jynneos smallpox and monkeypox Provider discretion
vaccine
Table 2. Non-Preferred Products
(Effective immediately pending Centers for Medicare and Medicaid Services (CMS) approval and
upon completion of internal review and implementation.)
Brand Name Generic Name Preferred Alternatives
Angiomax RTU bivalirudin Heparin
pretomanid pretomanid Isoniazid tablet, Levofloxacin Hemihydrate tablet
Riomet ER oral solution metformin Metformin HCL ER tablet, extended release 24
hour (Dose ID: 613)
Ibsrela tenapanor Amitiza, Linzess
Rybelsus semaglutide Ozempic, Victoza
Hemady dexamethasone dexamethasone tablet
Quzyttir injection cetirizine cetirizine oral solution, hydroxyzine
Aklief trifaotene tretinoin cream, tretinoin gel (gram) 0.01%,
0.025%
Reyvow lasmiditan sumatriptan succinate tablet, zolmitriptan tablet,
rizatriptan tablet
Amzeeq topical foam minocycline clindamycin phosphate gel (gram), clindamycin
phosphate solution non-oral, erythromycin
solution non-oral
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