Healthcare Services communicate to providers’ new …...The scope of the policy has been expanded to include medical necessity criteria for replacement of failing bioprosthetic valves,

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Healthcare Services

Medical & Pharmacy Policy Alerts

Number 229

November 1, 2018

This is the November 1, 2018 issue of the Providence Health Plans Medical and Pharmacy Policy Alert to our providers. The focus of this update is to communicate to providers’ new or revised Medical or Pharmacy policy changes. Providence Health Plans has a standard process to review all Medical & Pharmacy Policies annually. Policies will be available for review on ProvLink based on the Effective date noted below.

This Policy Alert, Prior Authorization Requirements, and Medical/Pharmacy policies are available through PHP ProvLink.

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Here’s what’s new from the following policy committees:

MEDICAL POLICY COMMITTEE

New Policies or Major Changes

Effective November 1, 2018

Eye: Corneal Collagen Cross-Linking (All Lines of Business Except Medicare) MED431

New Policy Recommendation: Policy created due to increased interest in corneal collagen cross-linking (CXL) as a treatment for corneal ectasias. Medical necessity criteria have been created only for conventional “epithelium-off” CXL, and only for the two FDA-approved indications (progressive keratoconus and corneal ectasia following refractive surgery). The medical necessity criteria are not based on strong evidence, but on FDA approved indications and CXL protocols, the inclusion/exclusion criteria for the trials on which the FDA approval was based, and clinical consensus. Additional CXL protocols and indications are considered to be investigational per the PHP’s definition of “investigational”.

Eye: Corneal Collagen Cross-Linking (Medicare Only) MED432

New Policy Recommendation: Based on difference in Medicare coverage, a separate Medicare policy was created. This procedure is considered not medically necessary and not covered for Medicare members.

Urine Drug Testing for Therapeutic or Substance Abuse Monitoring (All Lines of Business Except Medicare) LAB361

Interim Update Recommendation: This policy is being updated to clarify the Billing guideline language. The specific location language was removed because not all labs are billed with a location edit. By leaving the language vague, we can limit these labs at both the location and when they are billed without location edit but from locations we would consider inappropriate. In addition definitive testing will be limited to independent labs.

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Effective January 1, 2019

Cardiac: Transcatheter Aortic Valve Replacement (TAVR) (All Lines of Business Except Medicare) SUR179 Previously known as: Cardiac: Percutaneous Aortic Valve Replacement for Aortic Stenosis

Annual Update Recommendation: There are several changes to the policy, including:

The scope of the policy has been expanded to include medical necessity criteria for replacement of failing bioprosthetic valves, a procedure called valve-in-valve. (Criterion III.)

The title of the policy has been changed slightly for 2 reasons: 1. To use the common naming convention for the procedure: transcatheter aortic valve replacement (TAVR). This is also to be in-

line with the CPT code description of the service. 2. To remove the term “stenosis” from the title, since the valve-in-valve replacement procedure for bioprosthetic valve failure is

indicated in patients with aortic stenosis or regurgitation. Changes to Medical Necessity criterion (I.) for TAVR for aortic valve stenosis:

Added the requirement that the device must be FDA-approved and the approach must be consistent with the FDA indications for use.

Liberalized to allow for TAVR in patients with intermediate risk (or higher) for open procedure.

Clarified criterion I.C. (previously I.A. and I.D.) to remove outdated FDA language (when devices were only approved for patients of high or extreme risk for open surgery).

Removed previous criteria I.E. and I.F. as they came from the initial PARTNER trial inclusion criteria designed for patients who could not undergo surgery, published in 2010. These inclusion criteria were dropped from the more recent PARTNER 2 trial protocol.

Revised the list of contraindications (removed some and added others, criterion II.) based on current FDA indications for use. However, this list is NOT all-inclusive. Therefore, we have directed the reviewers to FDA indications for each of the three approved devices.

Cardiac: Transcatheter Aortic Valve Replacement (TAVR) (Medicare Only) SUR429

New Policy Recommendation: Based on differences in coverage, a new Medicare policy was created. Differences from all other LOB:

Medicare only covers TAVR under the Coverage with Evidence Development (CED) process or as an off label use as part of a clinical trial o We have added the “Clinical Trials and IDE Studies (Medicare Only)” policy to the Cross References section of the policy for

more information regarding the CED process.

Medicare requires consult and documentation with two cardiac surgeons, where all other LOB require one surgeon and one cardiologist.

Medicare has very specific requirements of the hospital and heart team.

Medicare requires that both the heart team and the hospital are participating in a prospective registry and outlines requirements of the registry study.

Medicare allows for coverage of TAVR outside FDA-approved indications for use when specific criteria are met.

Medicare does not address valve-in-valve TAVR for replacement of failing bioprosthetic valve. Therefore per the PHP hierarchy, commercial criteria applies.

There are a number of billing requirements outlined by the transmittal in the NCD and the Medicare Claims Processing manual, both non-specific requirements for clinical trials, and specific requirements for TAVR, that have been added to the policy.

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No Major Changes

Of note:

There is an NCA that is actively under review that addresses the NCDs requirement regarding procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs. However, any changes to the NCD as a result of this review are not anticipated until mid- to late 2019.

There are also several MLN Matters that have been published on TAVR, with the most recent being: MM8537, SE1515. However, all information in these documents have been addressed in the current policy.

Platelet-Rich Plasma (PRP) for Orthopedic Indications, Wound Care and Other Miscellaneous Conditions (All Lines of Business Except Medicare) MED307 Previously known as: Platelet Rich Plasma for Bone Healing, Wound Care, Tendinopathies

Annual Update Recommendation: We have expanded the scope of the policy to include new indications for which platelet-rich plasma (PRP) is currently being studied as a treatment. The expanded scope is also reflected in the modified title. New investigational indications added to the policy include: erectile dysfunction, as well as aesthetic indications such as skin rejuvenation and hair loss.

Platelet-Rich Plasma (PRP) for Orthopedic Indications, Wound Care and Other Miscellaneous Conditions (Medicare Only) MED430

New Policy Recommendation: Medicare was split out into its own policy due to differences in coverage. Differences from All other LOB:

Medicare allows for PRP for the treatment of chronic non-healing diabetic, venous and/or pressure wounds when done in the context of a clinical trial and when criteria in the NCD are met.

Changes from previous Medicare criteria

Added one additional criterion required for coverage of PRP (criterion I.C.4) which had been omitted from the previous version of the policy.

Added 4 indications Medicare considers to be not medically necessary

Per the PHP hierarchy, all the indications not addressed in the NCD will follow the commercial criteria and deny as investigational.

https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=293&NCDId=355&ncdver=1&DocID=20.32+&kq=true&SearchType=Advanced&IsPopup=y&bc=AAAAAAAAQAAA&

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM8537.pdf

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE1515.pdf

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Effective November 1, 2018

Diabetes: Artificial Pancreas Devices and Other Integrated Systems (All Lines of Business Except Medicare) DME112

Interim Update Recommendation: The following changes have been made to the policy:

Based on new generation CGMs now available with integrated mobile phone use, we have removed not medically necessary criterion VI.D., which stated that combination devices that included a “blood glucose monitor combined with a cellular telephone” were not covered. These new generation devices rely completely on the use of mobile phones for glucose readings. One of these devices forgoes the use of a receiver completely and instead requires patients to download the appropriate application to their mobile device, which then acts as the receiver.

In addition, the minimum age for the MiniMed 670G APDS devices has been reduced from 14 to 7 years of age. This is now reflected in the device table in the policy.

Based on discussion at one of the last medical director’s meetings and consultation with Dr. Capp, the following statement has been added to the policy: “This policy does not apply to patients under the age of 2 year for whom artificial pancreas devices and other integrated systems may be considered medically necessary and covered.”

Diabetes: Artificial Pancreas Devices and Other Integrated Systems (Medicare Only) DME397

Interim Update Recommendation: Based on new generation CGMs now available with integrated mobile phone use and the updated language in the CMS local coverage article on glucose monitors to allow for coverage of these types devices, we have removed crierion VI.D..

Diabetes: Continuous Glucose Monitors (CGM) (All Lines of Business Except Medicare) DME207

Interim Update Recommendation: The following changes were made to the policy:

1. Since the last update of this policy, two new CGM devices have been approved and are available (DexCom G6 and Medtronic Guardian Connect). These new generation devices rely completely on the use of mobile devices for glucose readings. One of these devices forgoes the use of a receiver completely and instead requires patients to download the appropriate application to their mobile device, which then acts as the receiver. These new devices have been added to the device table in the policy.

2. In addition, as a result of these newer devices with integrated cellular use, we have removed crierion VIII.E., which stated that combination devices that included a “blood glucose monitor combined with a cellular telephone” were considered not medically necessary.

3. The following statement has been added to the policy: “This policy does not apply to patients under the age of 2 year for whom long-term CGM use may be considered medically necessary and covered.”

Diabetes: Continuous Glucose Monitors (CGM) (Medicare Only) DME392

Interim Update Recommendation: Based on new generation CGMs now available with integrated mobile phone use, CMS updated the local coverage article on glucose monitors to allow for coverage of these types devices (as long as they meet the definition of therapeutic and the medical necessity criteria are met.) In addition, the DexCom G6 has now been added to the policy, as it is marketed as a therapeutic CGM. Please see the CGM (All LOB except Medicare) policy agenda write up above for more detail.

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Effective December 1, 2019

Effective January 1, 2019

Changes to the policy based on the new language in the LCA are as follows:

Addition of a new section titled: NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES which outlines CMS’s new stance on the use of smart devices.

Removal of coding guidelines for CGM supplies. These have now been rolled into the new section mentioned above.

Removed crierion VIII.E., which stated that combination devices that included a “blood glucose monitor combined with a cellular telephone” were considered not medically necessary.

Heating Pads and Heat Lamps DME242

Annual Update Recommendation: Based on additional Medicare guidance documents identified and the updating of the previous guidance documents, four additional not medically necessary criteria were added (V., VIII., IX., and X.). Briefly, these criteria indicate that the following are non-covered:

heating pads billed with E1399

non-electric heating pads

hydrocollator units

infrared therapy devices and related supplies or accessories (this was not previously called out in the criteria but was stated in the description section of the policy)

Although these criteria are new, we had already indicated in the policy that the codes for these items were not covered. Therefore, this is just a clarification of our current stance on these items.

Orthognathic Surgery SUR296

Annual Update Recommendation:

Policy is primarily based on the Oregon House Bill.

Removed “chronic pain” as a reason for requiring orthognathic surgery. This is fairly liberal and difficult to define.

Added an additional criterion that states maxillofacial prosthetics may be considered medically necessary as an adjunctive treatment in order to control or eliminate infection and/or pain or to restore facial configurations or functions. This is in accordance with the Oregon House Bill.

Skin Substitutes MED378

Interim Update Recommendation: Coding section updated to PA two codes that were mistakenly denied. Claims volume is very low and so we expect little impact.

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Hearing Aids (All Lines of Business Except Medicare) DME240

Interim Update Recommendation: RCGA received some feedback from the state regarding our coverage of hearing aids and ear molds. Some benefit groups (WA and ASO) will have age restrictions for hearing aid use and this information will be available on KMS for review staff. In addition, ear molds are covered without any restrictions.

Investigational and Non-Covered Medical Technologies (All Lines of Business Except Medicare) MED288

Interim Update Recommendation: Adding several new codes to the commercial IMT policy. (These codes are already addressed for Medicare in the Medicare version of the same policy.)

0274T/0275T: image-guided minimally invasive laminotomy/laminectomy cervical or thoracic/lumbar

0396T: intra-operative use of a kinetic balance sensor for implant stability during knee replacement

0397T: endoscopic retrograde cholangiopancreatography with optical endomicroscopy

0398T: intracranial MRgFUS for movement disorder

0405T: oversight of the care of an extracorporeal liver assist system patient

0406T/0407T: nasal endoscopy with drug eluting implant (i.e., Sinuva implant)

Investigational and Non-Covered Medical Technologies (Medicare Only) MED393

Interim Update Recommendation: Noridan removed one code (32998- ablation for pulmonary tumors) from the Non-Covered Services LCD. This code is not addressed by any other Medicare guidance or on any other PHP medical policy; therefore, it will be set to pay.

Seat Lift Chair Mechanism DME341

Annual Update Recommendation: Based on additional Medicare guidance documents identified and the updating of the previous guidance documents, the following has been added to the policy: Criterion I.:

Requirement that the ordering physician must also be the treating or consulting physician. (new, criterion I.A.)

Have moved two statements up from the Billing Guidelines section of the policy and changed them into criteria for ease of review. (criteria I.F. and G.) Other criteria additions:

Added medical necessity criteria for commode chairs with seat lift mechanisms. (criterion II.) This addition is based on the following rationale:

We already address seat lift mechanisms that go onto the toilet, so addressing these mechanisms for commodes is reasonable. The commode LCD/LCA specifically call out commodes with seat lift mechanisms and indicate that they must meet medical

necessity criteria for seat lift mechanisms. These guidance documents also include and address codes for standard seat lift mechanisms as well as commode seat lift mechanisms. This indicates that they may be coming in together.

Plan survey: 5 payers address the commode seat lift mechanisms in their seat mechanisms policy, only 1 plan does not. The cost for electric commode chair with seat lift mechanism (E0170) is anticipated to be high.

Added not medically necessary criteria for: o Seat lift mechanisms when medical necessity criteria are not met (criterion III.) o Seat lifts that operate by spring release mechanisms (criterion IV.). This was moved up from the Billing Guidelines section of the policy and

changed into criteria for ease of review.

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PHARMACY & THERAPEUTICS COMMITTEE

Oregon Region P&T Committee Meeting October 12, 2018 Go-Live Date: Tuesday, January 01, 2019, unless otherwise noted

New Drugs and Combinations:

Avatrombopag Maleate (Doptelet®) Tablet

Indication: For the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to

Other additions:

Added a Policy Guidelines section that indicates that a Certificate of Medical Necessity (CMN) has to be completed, signed and dated by the treating physician.

Additional Billing Guidelines were identified in the new LCA. These have been added to the policy.

Standing Systems DME345 Previously: Standing Frames

Annual Update Recommendation: Several changes have been made this update, including:

Title changed to reflect the naming convention for these devices used in the CPT code descriptions and in Medicare coverage guidance documents.

Removed the following criteria as it is not based in evidence, guidelines or supported by other payer policies: o Criterion I: Medically necessary is “the patient has a history of, or is at risk for lower limb or trunk contracture, or muscle or bone wasting;

and does not have complete paralysis of the hips and legs, and the alignment of the foot and ankle is such that the foot and ankle can tolerate weight-bearing.”

Clarification of the medical necessity criteria to indicate the following: o Medical necessity criteria only applies to non-powered standing systems. Electric, battery-powered and motorized systems will now be

considered not medically necessary. This is based on plan consensus. o All patients must have sufficient residual strength in the lower extremities to allow for use of the device. We previously only required this if

a patient had a history of lower limb or trunk contracture, or muscle or bone wasting.

Added one additional indication which would demonstrate a functional benefit of a standing device: improvement of skin integrity, by off-loading weight through standing would now be sufficient. This was based on plan consensus.

Added not medically necessary criteria for: o when criterion II. is not met, including a patient with complete paralysis and standing systems devices that require fixation to property

structures such as the ceiling o for combination sit-to-stand systems (E0637).These are considered by the majority of plans to not have a primarily medical function.

Therefore, these systems do not meet our definition of DME, as defined in the member handbooks.

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undergo a procedure.

Commercial: Non- Formulary, Specialty, Prior Authorization, Quantity Limit (15 tablets per month)

Medicaid: Non-Formulary, Specialty, Prior Authorization Quantity Limit (15 tablets per month)

Medicare Part D: Non-Formulary

Prior Authorization Criteria:

1. Diagnosis of chronic liver disease

2. Platelet count of less than 50,000 platelets/µL 3. Documentation that patient will have a scheduled medical or dental procedure within the next 30 days and therapy will

be started 10-13 days prior to the procedure

Age Restrictions: 18 years of age and older.

Prescriber Restrictions: Must be prescribed by or in consultation with a hematologist, hepatologist or gastroenterologist

Erenumab-AOOE (Aimovig®) Auto Inject Update

Indication: Preventive treatment of migraine in adults.

Formulary Alternatives: topiramate, propranolol, timolol, valproate, and onabotulinomtoxina

Commercial: Non-Formulary, Prior Authorization

Medicaid: Non-Formulary, Prior Authorization



Diagnosis of migraine headaches; AND

Documentation of trial and failureΔ, intolerance, or contraindication to at least one prophylactic medication from three (3) of the following categories:

o Anticonvulsants (e.g., divalproex, valproate, topiramate) o Beta-blockers (e.g., metoprolol, propranolol, timolol) o Antidepressants (e.g., amitriptyline, venlafaxine) o Botulinum toxin

AND

Documentation that patient has not, and will not, initiate treatment with botulinum toxin ΔAn adequate trial and failure is defined as minimal to no improvement after at least three (3) months of therapy

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Reauthorization:

Documented reduction in the severity or frequency of headaches.

Elagolix Sodium (Orilissa®) Tablet

Indication: For the treatment of endometriosis related pain.

Formulary Alternatives: leuprolide (Lupron®)

Commercial: Formulary, Non-Preferred Brand, Prior Authorization

Medicaid: Formulary, Brand, Prior Authorization

Medicare Part D: Formulary, Non-Preferred Drug, Prior Authorization


Initial Authorization

1. Documentation that other causes of gynecologic pain have been ruled out (e.g., irritable bowel syndrome, interstitial cystitis, urinary tract disorders)

2. Documentation that GnRH therapy will be used with “add-back” hormonal therapy (e.g., norethindrone) to help prevent bone mineral density loss

Reauthorization:

1. Documentation of response to therapy (e.g., reduction in pain)

Documentation of continued use of “add-back” hormonal therapy (e.g., norethindrone) to help prevent bone mineral density loss.

Fostamatinib Disodium (Tavalisse®) Tablet

Indication: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment

Formulary Alternatives: corticosteroids, Promacta®, azathioprine

Commercial/Medicaid: Non-Formulary, Prior Authorization, Quantity Limit (60 tablets per 30 days)

Medicare Part D: Formulary, Specialty, Prior Authorization, Quantity Limit (60 tablets per 30 days)

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Initial authorization:

1. Diagnosis of chronic immune thrombocytopenia (ITP)

2. Platelet count of less than 30,000/uL

3. Inadequate response to at least TWO of the following therapies:

a. Corticosteroids

b. Immunoglobulins

c. Splenectomy

d. Thrombopoietin receptor agonists

e. Rituximab

Age Restrictions: 18 years of age and older.

Prescriber Restrictions: Must be prescriber by or in consultation with an oncologist or hematologist

Reauthorization:

Documentation of an improvement in platelet count to 50,000 /uL or greater

Baricitinib (Olumiant®) Tablet

Indication: Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Formulary Alternatives: Humira®, Remicade®, Simponi Aria®, Stelara®, Xeljanz®, Xeljanz XR®

Commercial/Medicaid: Non-Formulary, Specialty, Prior Authorization, Quantity Limit (1 tablet per day)

Medicare Part D: Non-Formulary, FDA Max Dose Quantity Limit (1 tablet per day):

Prior Authorization Criteria for Commercial:

1. For all requests, the patient must have an FDA labeled indication for the requested agent, or use to treat the indication is

supported in drug compendia (i.e., American Hospital Formulary Service-Drug Information (AHFS-DI) or Truven Health Analytics’ DRUGDEX® System.)

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AND 2. The requested agent will not be given concurrently with another therapeutic immunomodulator agent or apremilast (Otezla®) AND 3. One of the following:

a. For patients already established on the requested therapeutic immunomodulator (starting on samples will not be considered as established on therapy):

i. Documentation of response to therapy (e.g., slowing of disease progression or decrease in symptom severity and/or frequency)

b. Patients not established on the requested therapeutic immunomodulator must meet ALL of the following indication-specific criteria:

i. For Rheumatoid Arthritis: 1. Documentation of trial and failure∆, intolerance, or contraindication to at least one conventional

therapy (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) 2. For non-preferred TIMs therapies:

a. Documentation of trial and failure∆, intolerance, or contraindication to two of the following agents:

i. etanercept (Enbrel®) ii. adalimumab (Humira®) iii. golimumab (Simponi®)

AND If patient has satisfied criteria above (iii.2.a.), documentation of trial and failure∆, intolerance, or contraindication to tofactinib (Xeljanz/Xeljanz XR®)

Prescriber Restrictions: Rheumatoid arthritis, ankylosing spondylitis: must be prescribed by, or in consultation with, a rheumatologist

Prior Authorization Criteria for Medicaid: For rheumatoid arthritis:

1. Use of disease-modifying anti-rheumatic drugs (DMARDs): a. Documented inadequate response to at least one DMARD after at least 6 months of therapy: methotrexate, leflunomide, sulfasalazine or hydroxychloroquine

OR b. Documented intolerance or contraindication to DMARDs

2. For non-preferred TIMs agent: a. Documented adequate trial and failureΔ, intolerance or contraindication to at least one of the following preferred TIMs agents: adalimumab (Humira®), etanercept (Enbrel®), or infliximab biosimilar (Inflectra® or Renflexis®)

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AND

b. If patient has satisfied criteria above (i.2.a.), documented trial, failure, intolerance or contraindication to tofacitinib (Xeljanz®/Xeljanz XR®)

1. Prescriber Resctrictions: Rheumatoid arthritis: must be prescribed by, or in consultation with, a rheumatologist.

Pegvaliase-PQPZ (Palynziq®) Syringe

Indication: To reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.

Formulary Alternatives: sapropterin (Kuvan®)

Commercial: Formulary, Non-Preferred Specialty, Prior Authorization

Medicaid: Formulary, Specialty, Prior Authorization

Medicare Part D: Formulary, Specialty, Prior Authorization

Prior Authorization Criteria for Commercial/Medicaid: For initial authorization all of the following criteria must be met:

1. Diagnosis of phenylketonuria (PKU) AND 2. Blood phenylalanine concentration > 600 micromol/L despite management with dietary phenylalanine restriction or

sapropterin (Kuvan®) For reauthorization one of the following criteria must be met: 4. Documentation that blood phenylalanine concentration levels have decreased by at least 20% from baseline and remain at

least 20% below pretreatment baseline OR

5. Documentation of a blood phenylalanine concentration less than or equal to 600 micromol/L

Age Restrictions: 18 years and older

Prescriber Restrictions: Prescribed by or in consultation with a metabolic disease specialist or a provider who specializes in the treatment of PKU

Prior Authorization Criteria for Medicare Part D: For initial authorization all of the following criteria must be met:

1. Diagnosis of phenylketonuria (PKU) AND

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2. Blood phenylalanine concentration > 600 micromol/L despite management with dietary phenylalanine restriction or sapropterin (Kuvan®)

For reauthorization one of the following criteria must be met: 1. Documentation that in blood phenylalanine concentration levels have decreased by at least 20% from baseline and

remain at least 20% below pretreatment baseline OR

2. Documentation of a blood phenylalanine concentration less than or equal to 600 micromol/L

Age Restrictions: 18 years and older

Prescriber Restrictions: Prescribed by or in consultation with a metabolic disease specialist or a provider who specializes in the treatment of PKU

Encorafenib (Braftovi®) Capsule

Indication: In combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA approved test.

Formulary Alternatives: Zelboraf® plus Cotellic®, Tafinlar® plus Mekinist®, Keytruda®, Opdivo®




Prior Authorization Criteria for Commercial/Medicaid: For initial authorization: 1. Use must be for a FDA approved indication or indication supported by National Comprehensive Cancer Network guidelines with recommendation 2A or higher

2. For Erleada®, high risk for progression as evidenced by documentation of Prostate Specific Antigen Doubling time of less than or equal to 10 months

For reauthorization: documentation of adequate response to the medication must be provided.

Prior Authorization Criteria for Medicare Part D: Added to Oral ANTI-Cancer Medications policy

Binimetinib (Mektovi®) Tablet

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Indication: In combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA approved test.

Formulary Alternatives: Zelboraf® + Cotellic®, Tafinlar® + Mekinist®, Keytruda®, Opdivo®





2. For Erleada®, high risk for progression as evidenced by documentation of Prostate Specific Antigen Doubling time of less than or equal to 10 months



Ivosidenib (Tibsovo®) Tablet

Indication: Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation.






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Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza®) Tablet

Indication: Complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who have no prior antiretroviral treatment history or who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir.

Formulary Alternatives: Biktarvy® and Genvoya®

Commercial: Non-formulary

Medicaid: Non-formulary

Medicare: Formulary, Specialty

Lofexidine HCL (Lucemyra®) Tablet – updated from August 2018 ORPTC

Indication: Mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

Formulary Alternatives: Clonidine (off-label)

Commercial: Formulary, Non-Preferred Brand, Step Therapy, Quantity Limit (168 tablets per 90 days)

Medicaid: Formulary, Step Therapy, Quantity Limit (168 tablets per 90 days)

Medicare Part D: Formulary, Non-Preferred Drug, Step Therapy, Quantity Limit (168 tablets per 90 days)

Step Therapy Criteria for Commercial/Medicaid:

Patient must have tried clonidine

Step Therapy Criteria for Medicare Part D:

Patient must have tried clonidine:

Netarsudil Mesylate (Rhopressa®) Drops – update from August 2018 ORPTC

Indication: Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

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Commercial: Non-Formulary

Medicaid: Non-Formulary

Medicare Part D: Non-Formula

New Strengths and Formulations:

Dermatophagoides pteronyssinus and dermatophagoides farinae tablet (Odactra®) Tab Subl

Indication: Immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts.

Commercial: Formulary, Non-Preferred Brand, Prior Authorization

Medicaid: Formulary, Prior Authorization


Prior Authorization Criteria for Commercial/Medicaid:

1. Diagnosis of allergic rhinitis, with or without conjunctivitis AND 2. Documentation that member remains symptomatic despite treatment with at least two conventional formulary allergy medications (e.g. levocetirizine, fluticasone nasal spray) AND 3. Documentation of a positive skin test or in vitro testing for IgE antibodies to house dust mites AND

5. No other allergens are being treated concurrently with subcutaneous immunotherapy

Age Restrictions: 18 to 65 years of age

Prescriber Restrictions: Prescribed by or in consultation with an Allergist, an Immunologist, an Otolaryngologist, or other physician currently providing subcutaneous immunotherapy to patients in their practice.

New Indications:

Rituxan

Expanded FDA-approved or New Indication:

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Moderate to severe Pemphigus Vulgaris (PV) in adult patients.

Inform prescribers via Healthcare Services Medical & Pharmacy Policy Alert and update rituximab policy with new indication.

Mircera


Treatment of anemia associated with chronic kidney disease (CKD) in: o Pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin

level was stabilized with an ESA.

Inform prescribers via Healthcare Services Medical & Pharmacy Policy Alert and update Mircera policy with new indication criteria.

Keytruda


Cervical cancer o for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after

chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA- approved test.2

Primary Mediastinal Large B-Cell Lymphoma (PMBCL) o for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of

therapy.2

Urothelial Carcinoma o For the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-

containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10], or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.2

2This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Inform prescribers via Healthcare Services Medical & Pharmacy Policy Alert. Prior authorization policy coverage criteria are based on recommendations from the National Comprehensive Cancer Network (NCCN) so no updates to the policy are warranted.

Avastin


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Epithelial ovarian, fallopian tube, or primary peritoneal cancer: o In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for stage III or IV disease

following initial surgical resection.


Venclexta


Treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.


Signifor LAR


Patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

Inform prescribers via Healthcare Services Medical & Pharmacy Policy Alert and update Signifor LAR policy with new indication and criteria.

Alimta


In combination with carboplatin and pembrolizumab for the initial treatment of patients with metastatic, non-squamous NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.


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Tecentriq

Expanded FDA-approved or New Indication: Locally advanced or metastatic urothelial carcinoma who:

o are not eligible for cisplatin-containing chemotherapy and whose tumors express PD‐L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area), as determined by an FDA-approved test, or

o are not eligible for any platinum‐containing chemotherapy regardless of PD‐L1status.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.


Xeomin

Expanded FDA-approved or New Indication: The treatment or improvement of adult patients with:

o Chronic sialorrhea

Inform prescribers via Healthcare Services Medical & Pharmacy Policy Alert.

Yervoy


Treatment of adult and pediatric patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.


Opdvio


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Adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.


Xtandi

Expanded FDA-approved or New Indication: Treatment of patients with both non-metastatic and metastatic castration-resistant prostate cancer.

Inform prescribers via Healthcare Services Medical & Pharmacy Policy Alert. Prior authorization policy coverage criteria are based on recommendations from the National Comprehensive Cancer Network (NCCN) so no updates to the oral anti-cancer medications policy are warranted.

Intelence


Treatment of HIV-1 infection in treatment-experienced patients 2 years of age and older with viral strains resistant to an NNRTI and other antiretroviral agents.


Kisqali


In combination with: o An aromataseinhibitorforthetreatment of pre/perimenopausalor postmenopausal women with hormone receptor (HR)-

positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; or

o Fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy

Inform prescribers via Healthcare Services Medical & Pharmacy Policy Alert. Prior authorization policy coverage criteria are based on recommendations from the National Comprehensive Cancer Network (NCCN) so no updates to the oral anti-cancer

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medications policy are warranted.

Zomacton


Pediatric: short stature associated with Turner syndrome, idiopathic short stature (ISS), short stature, or growth failure in short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years.


Lotemax


Treatment of post-operative inflammation and pain following ocular surgery in pediatric patients.


Drug Safety Monitoring:

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

ISSUE:

FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.

RECOMMENDATION:

The new label changes will add that low blood sugar levels, also called hypoglycemia, can lead to coma and the new label will also make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. The mental health side effects to be added to or updated across all the fluoroquinolones are:

• disturbances in attention • disorientation

• agitation • nervousness • memory impairment • serious disturbances in mental abilities called delirium.

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FDA continues to monitor and evaluate the safety and effectiveness of medicines after we approve them and they go on the market. In the case of fluoroquinolones, we reviewed reports of cases submitted to FDA and the published medical literature of apparently healthy patients who experienced serious changes in mood, behavior, and blood sugar levels while being treated with systemic fluoroquinolones. Patients should tell your health care professionals if you are taking a diabetes medicine when your health care professional is considering prescribing an antibiotic, and also if you have low blood sugar or symptoms of it while taking a fluoroquinolone. For patients with diabetes, your health care professional may ask you to check your blood sugar more often while taking a fluoroquinolone. Early signs and symptoms of low blood sugar include:

confusion

pounding heart or very fast pulse

dizziness

pale skin

feeling shaky

sweating

unusual hunger

trembling

headaches

weakness

irritability

unusual anxiety Health care professionals should be aware of the potential risk of hypoglycemia sometimes resulting in coma, occurring more frequently in the elderly and those with diabetes taking an oral hypoglycemic medicine or insulin.

• Alert patients of the symptoms of hypoglycemia and carefully monitor blood glucose levels in these patients, and discuss with them how to treat themselves if they have symptoms of hypoglycemia. • Inform patients about the risk of psychiatric adverse reactions that can occur after just one dose. • Stop fluoroquinolone treatment immediately if a patient reports any central nervous system side effects, including psychiatric adverse reactions, or blood glucose disturbances and switch to a non-fluoroquinolone antibiotic if possible.

• Stop fluoroquinolone treatment immediately if a patient reports serious side effects involving the tendons, muscles, joints, or nerves, and switch to a non-fluoroquinolone antibiotic to complete the patient’s treatment course.


Other Formulary Changes:

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Drug/Policy Name Recommendation

Omega-3-acid ethyl esters (Lovaza®) Medicaid: Add to formulary

Niacin extended-release (Niaspan®) Commercial: Add to formulary, non-preferred generic tier

Medicaid: Add to formulary

Medicare: Remove quantity limit

Sildenafil citrate 20mg tablet (Revatio®) All lines of business: Remove quantity limit

Commercial/Medicaid: Retire prior authorization

Fluoxetine 10mg and 20mg tablets Commercial: Remove from formulary

Clindamycin phosphate 1% gel (clindagel®) High-cost generic with several alternatives

Commercial/Medicaid: Add prior authorization

Add to “New drugs and formulations without established benefit” policy

Dorzolamide/timolol (Cosopt PF®) Preservative-free generic option. Add to formulary:

Commercial: Formulary, non-preferred generic tier

Medicaid: Formulary

Medicare: Formulary, non-preferred drug tier

Imvexxy® (estradiol vaginal insert) High-cost product with formulary alternatives

All lines of business: Non-formulary

Kapspargo® sprinkle (metoprolol succinate) High-cost product with formulary alternatives

All lines of business: Non-formulary

Ketoprofen 75mg capsule Obsolete drug

Commercial/Medicaid: Remove from formulary

Ketoprofen 25mg capsule Return of Generic

Commercial/Medicaid: Non-formulary

Medicare: Formulary, Non-preferred drug tier, quantity limit 4 capsules per day

sodium polystyrene sulfon/sorb (Kionex®) Medicaid: Add to formulary

Mesalamine (Asacol HD®) Generic availability; Add to formulary

Commercial: Formulary, Non-preferred generic

Perseris® (risperidone extended-release injectable suspension)

First once-monthly injectable; similar to Risperdal Consta®

Commercial/Medicaid: Covered medical benefit

Medicare: Formulary, Specialty tier

Siklos® (hydroxyurea) tablet New strength

Commercial: Formulary, Non-preferred brand tier, Quantity

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limit (1 tablet per day)

Medicaid: Formulary, Quantity limit (1 tablet per day)

Medicare: Non-formulary

Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate) tablet

Commercial: Move from preferred brand tier to Non-preferred brand tier

Trulance® (plecanatide) tablet Commercial/Medicaid: Add quantity limit (1 tablet per day)

Zoladex® (goerelin acetate) implant Medical implant; add prior authorization:

Commercial: Medical benefit, prior authorization

Medicaid: Remove from formulary, medical benefit, prior authorization

Medicare Part B: Add prior authorization Add to “GnRH analogs” policy

Heplisav-B (hepatitis B vaccine/ CPG1018/PF) Add to Medicare Part D formulary: Formulary, Preferred Brand tier, Prior Authorization for Part B vs. D coverage

Pitavastatin Magnesium (Zypitamag®) Tablet New entity. Line extend to Livalo®.

Commercial/Medicaid/ Medicare Part D: Non-Formulary

2019 Commercial: Formulary, Non-Preferred Brand

Aripiprazole Lauroxil, Submicronized (Aristada Initio® ER) Suser Syr

New entity. Line extend to long-acting aripiprazole, Aristada®.

Commercial/Medicaid: Medical Benefit

Medicare Part D: Formulary, Specialty

Nitroprusside in 0.9% NaCl (Nipride RTU) Vial New Strength. Line extend as medical.

Commercial/Medicaid: Medical Benefit


Medicare Part B: Medical Benefit

Pimavanserin Tartrate (Nuplazid®) 10MGTablet New Strength. Line extend to Nuplazid® capsules. Add to Nuplazid policy.

Commercial/Medicaid: Non-Formulary, Prior Authorization, Quantity Limit (3 tablets per day)

Medicare Part D: Formulary, Specialty, Prior Authorization, Quantity Limit (3 tablets per day)

Pimavanserin Tartrate (Nuplazid®) 34MG Capsule New Strength. Line extend to Nuplazid® capsules. Add to Nuplazid policy.

Commercial/Medicaid: Non-Formulary, Prior Authorization, Quantity Limit (1 tablet per day)

Medicare Part D: Formulary, Specialty, Prior Authorization, Quantity Limit (1 tablet per day)

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Carfilzomib (Kyprolis®) Vial New Strength. Line extend to Kyprolis® 30mg and 60mg vials. Add to Injectable Anti-Cancer Medications policy.

Commercial/Medicaid: Medical Benefit, Prior Authorization


Medicare Part B: Medical Benefit, Prior Authorization

Lumacaftor/Ivacaftor (Orkambi®) Granule Packets New dosage form. Line extend to Orkambi® tablets. Add to CTFR Modulators policy.

Commercial/Medicare Part D: Formulary, Specialty, Prior Authorization, Quantity Limit (2 packets per day)

Medicaid: Formulary, Prior Authorization, Quantity Limit (2 packets per day)

Peg3350/sod sul/NaCl/KCl/asb/C (Plenvu®) Powd PK SQ New Strength. Line extend to Moviprep®.

Commercial: Formulary, Non-Preferred Brand

Medicaid: Formulary

Medicare Part D: Formulary, Non-Preferred Drug

Lenvatinib Mesylate (Lenvima®) Capsule New Strength. Line extend to Lenvima®. Add to Oral Anti-Cancer Medications policy.

Commercial/Medicaid/Medicare Part D: Formulary, Specialty, Prior Authorization

2019 Commercial: Change from Specialty to Non-Preferred Specialty

Pasireotide Pamoate (Signifor LAR®) Vial New Strength. Line extend to Signifor LAR®. Add to Signifor LAR policy.

Commercial/Medicaid: Medical Benefit, Prior Authorization


Medicare Part B: Medical Benefit, Prior Authorization

Adalimumab (Humira®) Pen IJ Kit New Strength. Line extend to Humira®.

Commercial/Medicaid: Formulary, Specialty, Prior Authorization Quantity Limit (2 doses per 28 days)

o Add to Therapeutic Immunomodulators (TIMs) policy

Medicare Part D: Formulary, Specialty

Health Plan Clinical Policy Changes:

Policy Name Change Summary

Alinia Due to concerns for inappropriate utilization, a prior authorization

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policy was developed to support quantity limitations on this medication.

Aranesp, Epogen, Procrit Removed criteria that patients with chronic disease also must be taking myelosuppressive chemotherapy.

GnRH Analogs Added Zoladex® to policy. Added criteria for endometrial thinning. Updated criteria for central precocious puberty and removed trial of Lupron prior to Trelstar and Histrelin base on expert feedback. Also updated criteria for endometriosis to ensure that other causes of pain have been ruled out.

Juxtapid/Kynamro Clarified language regarding definition of statin intolerance.

Pulmonary Arterial Hypertension - Commercial and Medicaid (formerly Flolan, Remodulin, Veletri)

Combining all affected medications into one policy by line of business, as all products have the same criteria; included pre-requisite therapy with generic sildenafil tablets prior to getting tadalafil (Adcirca®) or sildenafil oral suspension or infusion (Revatio®); increased coverage duration for initial authorization to one year and reauthorization to lifetime.

Pulmonary Arterial Hypertension - Medicare Part B (formerly Letairis, Opsumit, Orenitram, Tracleer, Uptravi)

Combining all affected medications into one policy by line of business, as all products have the same criteria; increased coverage duration for initial authorization to one year and reauthorization to lifetime.

Vytorin The coverage duration was updated to allow for lifetime approvals.

Actinic Keratosis Clarified that Zyclara® 3.75% is the only agent that may be covered for external genital and perianal warts/condyloma acuminate.

Amitiza, Linzess, Movantik, Symproic, Trulance Changed reauthorization criteria to documented response to therapy, instead of requiring patients to attempt resuming standard therapies for constipation (e.g. stool softeners); will add a quantity limit to Trulance of one tablet per day to align with other products on this policy.

Antifungal Agents Combined oropharyngeal and esophageal candidiasis criteria and clarified that itraconazole solution is preferred over itraconazole capsules, based on Infectious Diseases Society of America (IDSA) guidelines; updated coverage duration to allow for longer coverage when using for prophylaxis.

Antimalarial agents (Coartem and Daraprim) Updated criteria to align with Centers for Disease Control and Prevention (CDC) recommendations.

Belsomra/Intermezzo Combined with Rozerem and Silenor policies due to same criteria and

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less operational burden to maintain one policy. Renamed to Insomnia Agents.

Benign Prostatic Hypertrophy Clarified the quantity limits for Cialis®, which are different based on the patient’s benefit.

Blood Glucose Test Strip QL Adding criteria related to test strip quantity restrictions for patients using continuous glucose monitors. In addition, modified criteria to broaden the disabilities that may affect use of preferred test strips.

CAR-T Updated policy due to new FDA indication for one of the agents.

CTFR Modulators Removed age restrictions.

Evzio Changed the reauthorization criteria to apply to any reauthorization instead of just for quantity limit exceptions.

Human Growth Hormones for Adults All growth hormone products are considered comparable; therefore, the product specific language was removed from the short-bowel syndrome criteria.

Human Growth Hormones for Pediatrics Removed the reauthorization criteria for the first year of therapy, so that all reauthorizations will be reviewed based on: 1. Evidence of growth velocity of greater than 2.5 cm/year AND 2. Evidence of open epiphyses.

IL-5 Inhibitors Simplified reauthorization criteria to require documented response to therapy.

Ketoconazole (oral) Clarified that medication will only be covered for certain diagnoses when prescribed by, or in consultation with, an infectious disease specialist.

Lumigan Step Therapy Updated coverage duration to lifetime authorization and changed criteria to trial instead of “trial and failure” as failure cannot be assessed through step therapy.

Luxturna Added requirement that patient has been evaluated by an ophthalmologist within the previous 6 months to document appropriateness for gene therapy in the intended treatment eye.

Natpara Made concomitant use with alendronate an exclusion for both the initial and reauthorization by moving to the exclusion criteria section.

Ocaliva Clarified coverage duration to align with clinical criteria.

Orphan Drug Added criteria related to ensuring appropriate dosing.

Provenge Corrected units for testosterone level requirements (ng/mL ng/dL).

Rozerem Combined with Belsomra/Intermezzo policy due to same criteria and less operational burden to maintain one policy.

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Sandostatin/Sandostatin LAR Corrected portion of AIDS diarrhea criteria that stated diarrhea had to be due to chemotherapy.

Silenor Combined with Belsomra/Intermezzo policy due to same criteria and less operational burden to maintain one policy.

The following policies were retired effective 11/1/2018.

Entresto - high rate of approval and medication is now considered a first-line option for patient in clinical guidelines.

Niaspan - availability of low-cost generic with little risk of overutilization.

Lovaza - availability of low-cost generic with little risk of overutilization.

Adempas - this policy was combined with ORPTCCAR023 to have all PAH medications in one policy for Commercial and Medicaid lines of business.

Adcirca/Revatio - this policy was combined with ORPTCCAR023 to have all PAH medications in one policy for Commercial and Medicaid lines of business.

The prior authorization will be retired altogether for generic sildenafil tablets.

Heplisav-B – improved efficacy of this vaccine and low risk of inappropriate utilization.

New Generic Medications:

First time generics to market

Methylphenidate HCL (Relexxii® ER) Tablet ER 24 - New Strength. Line extend to generic Concerta®. Add to Long-Acting Stimulant Medications QL and Stimulant Medications – Medicaid policies.

o Medicare Part D: Formulary, Non-Preferred Drug, Prior Authorization, Quantity Limit (1tablet per day) Budesonide ER Tablet - First Generic (Uceris®). Line extend as generic. Add to Uceris policy.

o Commercial: Formulary, Non-Preferred Generic, Prior Authorization o Medicaid: Formulary, Prior Authorization o Medicare Part D: Formulary, Specialty, Prior Authorization

Norethindrone (Incassia®) Tablet - Line extend with generic (Nor-Q-D). o Commercial/Medicaid: Formulary o Medicare Part D: Formulary, Non-Preferred Generic

Colesevelam 3.75G Packet - First Generic (Welchol®). Line extend as generic. Add to Welchol policy. o Commercial: Formulary, Non-preferred generic, Prior Authorization o Medicaid: Non-Formulary, Prior Authorization o Medicare Part D: Formulary, Non-Preferred Drug, Prior Authorization

Succinylcholine Chloride Vial - Return of Generic (Anectine® and Quelicin®). Line extend to brand. o Commercial/Medicaid: Medical Benefit

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o Medicare Part D: Non-Formulary o Medicare Part B: Medical Benefit

Dexamethasone 1.5MG (35) Tab DS PK - Return of Generic. Line extend to Dexpak®. Non-formulary for all lines of business.

Dexamethasone 0.25% Spray - First generic (Topicort®). Line extend as brand. Add to New Medications and Formulations without Established Benefit policy.

o Commercial/Medicaid: Non-Formulary, Prior Authorization o Medicare Part D: Non-Formulary

Luliconazole - First generic (Luzu®). Line extend to brand. Non-formulary for all lines of business.

Bendamustine HCL Vial - First generic (Bendeka®). Line extend to Bendeka®. Add to Injectable Anti-Cancer Medications policy.

o Commercial/Medicaid: Medical Benefit, Prior Authorization o Medicare Part D: Non-Formulary o Medicare Part B: Medical Benefit, Prior Authorization

Clindamycin Phos-Benzoyl Perox Gel - First generic (Acanya®). Line extend as brand. Add to New Medications and Formulations without Established Benefit policy.

o Commercial/Medicaid: Non-Formulary, Prior Authorization o Medicare Part D: Non-Formulary

Temsirolimus Vial - First generic (Torsiel®). Line extend. Add to Injectable Anti-Cancer Medications policy. o Commercial/Medicaid: Medical Benefit, Prior Authorization o Medicare Part D: Non-Formulary o Medicare Part B: Medical Benefit, Prior Authorization

Hydroxyprogesterone Caproate Vial - First generic (Makena®). Line extend. o Commercial/Medicaid: Medical Benefit o Medicare Part D: Non-Formulary o Medicare Part B: Medical Benefit

Tadalafil Tablet - First generic (Adcirca®). Line extend as generic. o Commercial: Formulary, Preferred Specialty, Prior Authorization, Quantity Limit (2 tablets per day)

Add to Pulmonary Arterial Hypertension policy o Medicaid: Formulary, Specialty, Prior Authorization, Quantity Limit (2 tablets per day)

Add to Pulmonary Arterial Hypertension policy o Medicare Part D: Formulary, Specialty, Prior Authorization, Quantity Limit (2 tablets per day) o Add to Adcirca/Revatio policy

Imiquimod CRM MD PMP - First generic (Zyclara®). Line extend to brand. o Commercial: Formulary, Non-Preferred Brand, Prior Authorization

Add to Actinic Keratosis policy

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o Medicaid/Medicare Part D: Non-Formulary

Documents

Healthcare Services communicate to providers’ new …...The scope of the policy has been expanded to include medical necessity criteria for replacement of failing bioprosthetic valves,