Information about KEYTRUDA® (pembrolizumab)

Please click here to see updated dosing information (in sections 1.16 and 2.2) for KEYTRUDA® (pembrolizumab) Injection 100 mg1

Business Wire Press Release - Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program.

Pfizer Announcement-It is with great optimism to share yesterday’s announcement that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19 infection. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week.

Here is the press release link with more information. https://www.businesswire.com/news/home/20200505005474/en/Pfizer-BioNTech-Dose-Participants-U.S.-Part-Global

FDA approval of TABRECTA™ (capmatinib) tablets on May 6, 2020.

FDA approval of TABRECTA™ (capmatinib) tablets on May 6, 2020.

 

TABRECTA tablets is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

 

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. 

 

FoundationOne®CDx is the FDA-approved companion diagnostic test for TABRECTA. 

 

I would like to share the clinical safety and efficacy information associated with TABRECTA. I will contact you to continue our discussions about TABRECTA as a treatment option.

 

 

Important Safety Information

 

Interstitial Lung Disease (ILD)/Pneumonitis. ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA. ILD/pneumonitis occurred in 4.5% of patients treated with TABRECTA in the GEOMETRY mono-1 study, with 1.8% of patients experiencing grade 3 ILD/pneumonitis and 1 patient experiencing death (0.3%). Eight patients (2.4%) discontinued TABRECTA due to ILD/pneumonitis.

 

Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold TABRECTA in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified.

 

Hepatotoxicity. Hepatotoxicity occurred in patients treated with TABRECTA. Increased alanine aminotransferase (ALT)/aspartate aminotransferase (AST) occurred in 13% of patients treated with TABRECTA in GEOMETRY mono-1. Grade 3 or 4 increased ALT/AST occurred in 6% of patients. Three patients (0.9%) discontinued TABRECTA due to increased ALT/AST.

 

Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TABRECTA, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin. Based on the severity of the adverse reaction, withhold, reduce dose, or permanently discontinue TABRECTA.

 

Risk of Photosensitivity. Based on findings from animal studies, there is a potential risk of photosensitivity reactions with TABRECTA. In GEOMETRY mono-1, it was recommended that patients use precautionary measures against ultraviolet exposure, such as use of sunscreen or protective clothing, during treatment with TABRECTA. Advise patients to limit direct ultraviolet exposure during treatment with TABRECTA.

 

Embryo-Fetal Toxicity. Based on findings from animal studies and its mechanism of action, TABRECTA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose.

 

Most Common Adverse Reactions. The most common adverse reactions (≥20%) were peripheral edema (52%), nausea (44%), fatigue (32%), vomiting (28%), dyspnea (24%), and decreased appetite (21%). The most common grade 3 adverse reactions (≥2%) were peripheral edema (9%), fatigue (8%), dyspnea (7%), nausea (2.7%), vomiting (2.4%), and noncardiac chest pain (2.1%). 

 

Clinically Relevant Adverse Reactions. Clinically relevant adverse reactions observed in <10% of patients were pruritus (allergic and generalized), ILD/pneumonitis, cellulitis, acute kidney injury (including renal failure), urticaria, and acute pancreatitis.

 

Laboratory Abnormalities. Select laboratory abnormalities (≥20%) worsening from baseline in patients who received TABRECTA were decreased albumin (68%), increased creatinine (62%), decreased lymphocytes (44%), increased ALT (37%), increased alkaline phosphatase (32%), increased amylase (31%), increased gamma-glutamyltransferase (29%), increased lipase (26%), increased AST (25%), decreased hemoglobin (24%), decreased leukocytes (23%), decreased sodium (23%), decreased phosphate (23%), increased potassium (23%), and decreased glucose (21%). 

 

 

 

Please see full Prescribing Information for TABRECTA.

 

 

Genentech Seattle/Alaska Ecosystem 2020

Genentech Seattle/Alaska Ecosystem 2020

 

 

 

Gina Noh

Healthcare Executive Director

Noh.eugenia@gene.com

650-872-9946

 

Heather Freeborne, BSN, RN

Therapeutic Area Manager |Lung and Pan Tumor 

Freeborne.heather@gene.com

425-466-7550

 

Michael Fish, DC

Therapeutic Area Manager |Hematology

Fish.michael@gene.com

253-279-2716

 

Katie Ohtake

Therapeutic Area Manager| Breast

Ohtake.kathryn@gene.com

206-356-8722

 

Brent Haberman

Clinical Oncology Specialist |Venclexta

Haberman.brent@gene.com

206.795.1408

 

David Barhoum

Healthcare Market Director

barhoumd@gene.com

425-879-5309

 

Paul Castonguay

Healthcare Market Director

Castonguay.paul@gene.com

650-269-8950

 

Sally Dow

Healthcare Market Director

Dow.sally@gene.com

206-427-3807

 

MaryBeth Harley

Business Engagement Manager

Harley.mary_beth@gene.com

206-335-0596

 

 

 

 

 

Kyle Downey, PharmD, MS

Medical Affairs Executive Director

Downey.kyle@gene.com

509-344-9674

 

 

Renita Vance, MSN, RN

Nurse Education Lead

Vance.renita@gene.com

206-369-6897

 

Amy Hall,  PhD. 

Medical Science Liaison |Breast, GI, Gynecology 

Hall.amy@gene.com

253-329-6860

 

Dustin Schrader,  Pharm.D., BCPS, BCOP

Medical Liaison | Hematology

Schrader.dustin@gene.com

650-840-2244

 

 

Emily Ethan, MSN, RN, CPHON

Medical Science Liaison| Hematology

Ethen.emily@gene.com

206-379-6047

 

Ryan Cotton

Field Reimbursement Manager

Cotton.joseph@gene.com

602-561-6468

 

Brook Peters, CPC, CPMA

Field Reimbursement Manager

Peters.brook@gene.com

206-316-0054

 

 

 

 

 

 

 

 

 

Eastern Washington/ID/MT Ecosystem May 2020

 

Bill Ames

Healthcare Market Executive Director

Ames.william@gene.com

509-638-7832

 

Aleshia Hoover

Healthcare Market Director

Hoover.aleshia@gene.com

509-294-3975

 

 

Renita Vance, MSN, RN

Nurse Education Lead

Vance.renita@gene.com

206-369-6897

 

Amy Hall,    

Medical Science Liaison |Breast, GI, Gynecology 

Hall.amy@gene.com

253-329-6860

 

Dustin Schrader,  Pharm.D., BCPS, BCOP

Medical Liaison | Hematology

Schrader.dustin@gene.com

650-840-2244

 

 

Emily Ethan, MSN, RN, CPHON

Medical Science Liaison| Hematology

Ethen.emily@gene.com

206-379-6047

 

 

 

 

 

 

 

 

 

 

 

WSMOS COVID-19 Resources

Important: This information is provided for informational purposes only, please go to the source documents and websites for the most up-to-date information.

Centers for Medicare & Medicaid Services (CMS)

CMS webpage Coronavirus (COVID-19) Partner Toolkit Includes links to information and resources on COVID-19 from several government departments and includes information for clinicians, health plans, health care consumers, Medicare beneficiaries, caregivers and more at: https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-toolkit.

Centers for Disease Control (CDC)

Latest updates and information on COVID-19 is available at: https://www.cdc.gov/coronavirus/2019-ncov/index.html.  Information for healthcare professionals can be found at: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html.

Washington State Medical Association (WSMA)

Monitor the WSMA COVID-19 Response webpage for recent updates, resources, and Clinical and Practice Guidance on COVID-19 at: https://wsma.org/COVID-19

The WSMA also offers a private discussion forum for physicians and PAs in Washington state, regardless of membership status. 

About the COVID-19 Forum

To participate in forum discussions, you must have a WSMA account and be logged in. Any physician or PA licensed in Washington state can create an account, for free, to access the forum—you don’t have to be a WSMA member.

The forum is divided into four topic areas:

  • Testing & Treatment
  • Telemedicine
  • Caring for the Caregiver
  • General

American Society of Clinical Oncology (ASCO)

ASCO maintains a web page of information and resources on COVID-19 including patient care information, provider and practice information, government, reimbursement and regulatory updates and an electronic form to submit COVID-19 questions to ASCO. Access these resources at: https://www.asco.org/asco-coronavirus-information

American Society for Radiation Oncology (ASTRO)

The ASTRO COVID-19 Recommendations to Radiation Oncology Practices includes COVID-19 Clinical Guidance, COVID-19 FAQs, a sample Patient Communication – COVID letter. Access this information at:  https://www.astro.org/Daily-Practice/COVID-19-Recommendations-and-Information

The Society of Surgical Oncology (SSO)

The SSO website contains resources for many surgical oncology specialties which can be useful advice for dealing with delaying surgery, guidelines for triage of cancer surgery patients, managing COVID-19 in surgical systems and more.  Access SSO’s website at: https://www.surgonc.org/resources/covid-19-resources/

Washington Health Care Authority (HCA)

HCA maintains a webpage with resources on COVID-19 for providers that includes operational and billing information for Washington Apple Health (Medicaid) providers, billers and partners including information on telehealth services and technology at: https://www.hca.wa.gov/information-about-novel-coronavirus-covid-19. For COVID-19 billing, coding, or telehealth policy questions contact: HCAAH_COVID19@hca.wa.gov.  

Office of the Insurance Commissioner WA

The Office of the Insurance Commissioner, WA State maintains COVID-19 information, resources and FAQs for consumers, providers, and insurers & regulated entities at: https://www.insurance.wa.gov.

Washington Health Benefit Exchange

Update April 1, 2020 – The special enrollment period due to COVID-19 is now extended through May 8, 2020. Existing enrollees who are facing income changes can self-serve by signing in to report a change. New enrollees are encouraged to search for a local insurance expert or call customer support between 7:30a.m. - 5:30p.m. Monday through Friday to learn about coverage options. Learn More

UW Medicine

The UW Medicine COVID-19 Resource Site includes policies and protocols, developed in response to the outbreak in Western Washington, by the clinical and administrative teams in their system (Harborview Medical Center, UW Medical Center-Montlake, UW Medical Center-Northwest, Valley Medical Center, UW Neighborhood Clinics and Airlift Northwest) and partners Seattle Cancer Care Alliance.  Access the documents at: https://covid-19.uwmedicine.org/Pages/default.aspx.

Association for Community Cancer Centers (ACCC)

ACCC maintains a webpage with updated information on COVID-19 and includes links to information and resources from the Centers for Disease Control (CDC), Centers for Medicare & Medicaid Services (CMS) the Food and Drug Administration (FDA) as well as patient advocacy foundations.  

https://www.accc-cancer.org/home/news-media/coronavirus-response

TELEHEALTH SERVICES RESOURCES & INFORMATION

From the American Medical Association (AMA)

The AMA maintains updated information on telemedicine including: a quick guide, policy, coding and payment, practice implementation and other helpful resources on telemedicine:

https://www.ama-assn.org/practice-management/digital/ama-quick-guide-telemedicine-practice

From the Department of Health and Human Services (HHS)

On March 20, 2020, the HHS Office for Civil Rights (OCR) announced that it is exercising its enforcement discretion and, effective immediately, will not impose penalties on physicians using telehealth in the event of noncompliance with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA). Covered health care providers subject to the HIPAA Rules may seek to communicate with patients, and provide telehealth services, through remote communications technologies.  Some of these technologies, and the manner in which they are used by HIPAA covered health care providers, may not fully comply with the requirements of the HIPAA.  

The notice from HHS, which includes examples of technology that may be used by providers, can be accessed here:  

https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html

Medicare Telemedicine Health Care Provider Fact Sheet:

https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet

From the New England Journal of Medicine (NEJM)

The NEJM hosts a collection of articles and other resources on the Coronavirus (COVID-19) outbreak, including clinical reports, management guidelines, and commentary on their website at: https://www.jejm.org/coronavirus?query=main_nav_lg. 

From the American College of Physicians (ACP)

The ACP website https://www.acponline.org  includes a COVID-19 Practice Management Toolkit, information and resources on telehealth coding and billing, and a tutorial Telemedicine: A Practical Guide for Incorporation into your Practice – access this tutorial at:  https://assets.acponline.org/telemedicine/scormcontent/?&_ga=2.50834473.1228759002.1584542301-395527866.1580950498#/.

From the Community Oncology Alliance (COA)

COA’s webpage for COVID-19 Practice Resources and Protocols contains many links to resources and information and tools for the oncology practice including COA’s webpage for COVID-19 Practice Resources and Protocols contains many links to helpful information including a very helpful Medicare Telehealth Cheat Sheet: https://communityoncology.org/wp-content/uploads/2020/03/MedicareTelehealthGuideFinal031820.pdf

Access the COA COVID-19 resources here:

https://communityoncology.org/coronavirus-covid-19-practice-resources-and-protocols/

Policy Updates from Private Payors – Expanded Telehealth Services and More

Note: please go directly to the payor’s website for the most up-to-date information.

From Regence BlueCross BlueShield – Updated April 7, 2020

Telehealth expansion

We are temporarily expanding medical and behavioral health telehealth services. This expansion will remain in effect through each state’s emergency declaration. 

Telehealth services can be provided if: 

  • You provide telehealth services to our Individual, group (including administrative only services groups who have opted in to the telehealth expansion) and Medicare Advantage members. View instructions for verifying ASO groups who will temporarily cover virtual services to replace in-person visits
  • You are an out-of-network provider and provide services to our Medicare Advantage PPO members. 
  • You conduct the telehealth visit with your patient using audio or video. We are following the U.S. Department of Health and Human Services’ (HHS’) lead on discretion with respect to HIPAA compliant platform requirementsPulsara offers a free, HIPAA-compliant, video-enabled platform. 
  • The services: 
    • Are safely and effectively delivered via telehealth 
    • Meet the code definition that is billed when provided via telehealth 
    • Meet existing coverage criteria, including pre-authorization requirements and medical necessity 

Member benefits and provider reimbursement 

  • The visits are considered the same as in-person visits and are paid at the same rate as in-person visits. 
  • The member’s copay, coinsurance and deductible will apply to telehealth services, if applicable. 
  • We will cover the telehealth visit related to COVID-19 testing at no member cost share for our Individual, group (including ASO group) and Medicare Advantage members. See below for information about coverage for COVID-19 testing
  • For claims to process correctly and for you to receive reimbursement consistent with an in-office visit, the place of service (POS) must be either POS 11, intensive outpatient (IOP) or partial hospitalization (PHP). The GT modifier will indicate that the services were rendered via telehealth.
    • Note: The location of the service does not need to be in an office. However, claims must be submitted using the instructions above to be paid at the same rate as an in-person visit. 
  • Claims can be submitted for dates of service beginning on March 19, 2020. 
  • Note: We will continue to cover the medical and behavioral health codes, as outlined in our Virtual Care (Administrative #132) reimbursement policy. Claims submitted following the guidelines in this policy will be paid as they have been. View instructions for verifying members' telehealth benefits


BCBS FEP telehealth expansion

In-network providers can provide telehealth services to Blue Cross and Blue Shield Federal Employee Program® (BCBS FEP®) members. View the BCBS FEP telehealth expansion information

TriWest telehealth expansion
TriWest has determined that providers who wish to use virtual or phone visits to treat patients and provide continued care while staying in compliance with the Centers for Disease Control and Prevention (CDC) guidelines may do so, as long as the provider has an authorization on file first. View TriWest’s Community Providers COVID-19page for more information.

Credentialing

Temporary providers and expedited credentialing

During this health emergency, we are allowing an exception to our Locum tenens policy and expediting credentialing to help meet emerging demands for health care providers and to ensure that our members have access to care. 

Locum tenens

We are making the following exceptions to our Locum tenens policy to allow a provider to identify and authorize care for his or her patients by another provider, during this pandemic: 

  • The use of a locum tenens provider by a participating provider has been expanded to 180 days during this emergency. 
  • A locum tenens can have a valid license in a different state than the one in which they are practicing in. 

Expedited credentialing

If your practice has been directly impacted by COVID-19, please: 

View information below regarding temporary updates to telehealth.

Pharmacy pre-authorization and medication refills

Pharmacy pre-authorizations

All pharmacy pre-authorizations that are due to expire between March 23, 2020, and June 30, 2020, will be extended six months from the current expiration date to alleviate work by providers’ offices. Members will be notified via letter that their pre-authorization has been extended with the new expiration date. We will evaluate any pre-authorizations that expire after this period at a later date. 

Early prescription medication refills

We are allowing for an extended supply of medications:

Commercial members (with the exception of a few self-funded groups)

Allowing for a 90-day refill on medications used for chronic conditions, such as multiple sclerosis, diabetes, asthma and heart disease

Members can order home-delivery prescriptions through the AllianceRx Walgreens Primewebsite or by calling 1 (844) 765-2894.

Medicare Advantage members who have medical and pharmacy benefits

Allowing for a 100-day refill on medications used for chronic conditions, such as multiple sclerosis, diabetes, asthma and heart disease

Members can order home-delivery prescriptions through the Postal Prescription Services.

Members who have a Medicare Part D prescription drug plan

Allowing for a 90-day refill on medications used for chronic conditions, such as multiple sclerosis, diabetes, asthma and heart disease.

Members can order home-delivery prescriptions through the Postal Prescription Services.

Note: Some drugs are not eligible for extended day supply, including controlled substances and certain specialty drugs. Drugs listed on our formularies in the Narcotics and section marked SP are not eligible for an extended supply.

Note: BCBS FEP members: 

  • Can receive early medication refills for 30-day prescription maintenance medications 
  • Have access to a 90-day mail order benefit for prescription medications 
  • Do not have a cost share for prescriptions for up to a 14-day supply

For more information on Regence BC/BS Covid-19 updates and resources go to: https://www.regence.com/provider/library/whats-new/covid-19

From UnitedHealthcare – Updated April 5, 2020:

COVID-19 Telehealth Services

Last update: April 5, 2020, 11:00 p.m. CDT

Starting March 18, 2020, UnitedHealthcare expanded our policies around telehealth services for Medicare Advantage, Medicaid, and Individual and Group Market health plan members. In addition, effective from March 31, 2020 until June 18, 2020, we will also waive cost sharing for in-network telehealth visits for medical, outpatient behavioral and PT/OT/ST, with opt-in available for self-funded employers.

Expanded Provider Telehealth Access

UnitedHealthcare is waiving the Centers for Medicare and Medicaid’s (CMS) originating site restriction and audio-video requirement for Medicare Advantage, Medicaid, and Individual and Group Market health plan members from March 18, 2020 until June 18, 2020. Eligible care providers can bill for telehealth services performed using interactive audio-video or audio-only, except in the cases where we have explicitly denoted the need for interactive audio/video, such as with PT/OT/ST, while a patient is at home.  

NEW! Cost Share Waived for In-Network Telehealth Services 

We will also waive cost sharing for in-network telehealth services for medical, outpatient behavioral and PT/OT/ST services from March 31, 2020 until June 18, 2020 for Medicare Advantage, Medicaid, and Individual and fully insured Group Market health plan with opt-in available for self-funded employers.

For medical and outpatient behavioral telehealth visits, providers can utilize both interactive audio/video and audio-only.

Cost sharing will be waived for in-network telehealth visits. According to plan benefits, out-of-network providers also qualify for telehealth and member benefit and cost sharing will apply, if applicable.

NEW! Expanded List of Services for Telehealth and Virtual Check-Ins.

From March 30, 2020 until June 18, 2020, UnitedHealthcare has expanded the services that can be covered using telehealth, as well as through a Virtual Check-In for Medicare Advantage, Medicaid, and Individual and Group Market health plan members. A list of reimbursable codes that can be used during the waiver period can be found under the Billing Guidance section of Telehealth or Virtual Check-Ins.

Link to UnitedHealthcare's telehealth services update: https://www.uhcprovider.com/en/resource-library/news/Novel-Coronavirus-COVID-19/covid19-telehealth-services.html

Learn more about UnitedHealthcare's response to COVID-19.

From Aetna and CVS Health:

  • If you request testing related to COVID-19, we’ll waive your Aetna patient’s cost sharing.
  • Aetna Commercial patients pay $0 for covered telemedicine visits until June 4, 2020.
  • Until further notice, Aetna is also expanding coverage of telemedicine visits to its Aetna Medicare members, so they can receive the care they need from you without leaving their homes. With this change and new flexibilities announced by the Centers for Medicare and Medicaid Services to help combat the virus, Aetna Medicare members can now see their providers virtually via telephone or video. 
  • Aetna is offering its Medicare Advantage brief virtual check-in and remote evaluation benefits to all Aetna Commercial members and waiving the co-pay. 
  • Care packages will be sent to Aetna patients diagnosed with COVID-19. Through Aetna’s Healing Better program, Aetna Commercial and Medicare Advantage members will receive CVS items to help relieve symptoms as well as personal and household cleaning supplies to help keep others in the home protected from potential exposure. Call the number on your Aetna patient’s ID card to register a recently diagnosed patient. 
  • Patients won’t have to pay a fee for home delivery of prescription medications from CVS Pharmacy®.
  • We’re waiving early refill limits on 30-day prescription maintenance medications for all Commercial members with pharmacy benefits administered through CVS Caremark.
  • Aetna Medicare members may request early refills on 90-day prescription maintenance medications at retail or mail pharmacies if needed. For drugs on a specialty tier, we're waiving early refill limits for a 30-day supply.
  • Through existing care management programs, Aetna will proactively reach out to your patients who are most at-risk for COVID-19.

    Read the lastest updates at:

https://www.aetna.com/health-care-professionals/provider-education-manuals/covid19-letter.html 

From Premera Blue Cross

Updates as of April 7, 2020

  • As of April 7, Premera is following CMS guidance on telehealth payments during the COVID-19 health crisis. 
  • Providers who normally bill POS 11 for a patient in-office visit should continue to use POS 11 for telehealth visits and the procedure code appended with either modifier 95 or GT (GT can't be used for a Medicare claim). This allows claims to process for reimbursement consistent with an in-office visit during the public health emergency. This change is in effect through June 30, per CMS guidance. We'll be reviewing claims back to March 6 and will remit any additional funds due.

Cost shares waived for telehealth services: 

Telehealth cost shares will be waived for all in-network providers.  If a telehealth provider charges you a copay, deductible, or coinsurance for telehealth services through June 30, Premera will reimburse when the claim is processed.

Who is eligible for this in-network expansion?

  • This will not apply to shared admin, FEP, BlueCard, Providence, HCA, Medicare Supplement, Medicare Advantage, and self-funded plans who opt out.
  • Fully insured plans will be loaded and available on March 25, 2020. Self-funded plans that opt in will be loaded and available by end of day March 26, 2020.
  • This cost share waiver applies to all providers that offer telehealth services through June 30, 2020.

Extensions for prior authorizations for prescriptions:

For drugs with an initial length authorization of 3 months, we’ll extend the authorization for 180 days for reviews performed between March 30, 2020 through June 30, 2020.

We’ll also pull a list of expiring authorizations and anything that expires in the next 3 months will have the authorization extended for 180 days from March 30, 2020.

Be sure to check the latest updates at: https://www.premera.com/wa/provider/coronavirus-faq/.

From PacificSource:

PacificSource has expanded coverage to allow most provider types to bill appropriate E/M services that can be performed in real time via telehealth. PacificSource reimburses for telehealth services as if the service was done in the clinic setting (for services appropriate for telehealth delivery).

PacificSource is suspending prior authorization (PA) and referral requirements related to medical necessity for care rendered March 27 through June 30 for services included on the Prior Authorization Grid. To determine if a service formerly required preauthorization, consult the Prior Authorization Grid at https://authgrid.pacificsource.com. 

Prior authorizations are still required for all benefit coverage exceptions. 

PacificSource has extended most prescriptions and medical drug authorizations that expire between now and June 30 an additional 90 days. New CMS and state regulations will be incorporated into our processes as released. New requests will follow standard prior authorization procedures for medical and prescription drugs. 

For more information go to: https://www.pacificsource.com/providers/

Reminder: This information is provided for informational purposes only, please go to the source documents for the most up-to-date information.

Approval Announcement for KOSELUGO™ (selumetini)

The US Food and Drug Administration (FDA) has approved KOSELUGOTM (selumetinib) capsules for the treatment of children two years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas (PN) that cannot be completely removed by surgery. It is not known if KOSELUGO is safe and effective in children under two years of age.1 (See Important Safety Information below.)

The approval by the FDA was based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored Phase II SPRINT Stratum 1 trial coordinated by the NCI’s Center for Cancer Research, Pediatric Oncology Branch. Results showed an overall response rate (ORR) of 66% (n=33/50 patients; confirmed partial response) in pediatric patients with NF1 who have symptomatic, inoperable PN when treated with KOSELUGO as a twice-daily oral monotherapy.1 ORR is defined as the percentage of patients with a confirmed complete response or confirmed partial response of at least 20% reduction in PN volume.1 The most common adverse reactions (reported in ?0% of patients) are vomiting, rash (all), abdominal pain, diarrhea, nausea, dry skin, fatigue, musculoskeletal pain, pyrexia, acneiform rash, stomatitis, headache, paronychia, and pruritus.1

Having this new treatment option for pediatric patients with NF1 PNs is pivotal for addressing an unmet medical need for this patient population.

For more information regarding the approval, please see AstraZenec release announcing the newshere.

For more information about KOSELUGO including Important Safety Information, please see below.

 

IMPORTANT SAFETY INFORMATION

 

Before taking KOSELUGO, tell your healthcare provider about all of your medical conditions, including if you:

· have heart problems

· have eye problems

· are pregnant or plan to become pregnant. KOSELUGO can harm your unborn baby.

o Females who could become pregnant and males with female partners who could become pregnant should use effective birth control (contraception) during treatment with KOSELUGO and for 1 week after your last dose

o Tell your healthcare provider right away if you become pregnant during treatment with KOSELUGO

· are breastfeeding or plan to breastfeed. It is not known if KOSELUGO passes into your breast milk.

o Do not breastfeed during treatment with KOSELUGO and for 1 week after your last dose

o Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your healthcare provider if you are taking aspirin, blood thinners, or other medicines to treat blood clots. KOSELUGO contains vitamin E which may increase your risk of bleeding

 

KOSELUGO may cause serious side effects, including:

· Heart Problems. KOSELUGO can lower the amount of blood pumped by your heart which is common and can also be severe. Your healthcare provider will do tests before and during treatment with KOSELUGO to check how well your heart is working. Tell your healthcare provider right away if you get any of the following signs or symptoms:

o persistent coughing or wheezing

o shortness of breath

o swelling of your ankles and feet

o tiredness

o increased heart rate

· Eye Problems. KOSELUGO can cause eye problems that can lead to blindness. Your healthcare provider will check your vision before and during treatment with KOSELUGO. Tell your healthcare provider right away if you get any of the following signs or symptoms:

o blurred vision

o loss of vision

o dark spots in your vision (floaters)

o other changes to your vision

· Severe diarrhea. Diarrhea is common with KOSELUGO and can also be severe. Tell your healthcare provider right away the first time that you get diarrhea during treatment with KOSELUGO. Your healthcare provider may give you medicine to help control your diarrhea and may tell you to drink more fluids

· Skin Rash. Skin rashes are common with KOSELUGO and can also be severe. Tell your healthcare provider if you get any of the following signs or symptoms:

o rash that covers a large area of your body

o blisters

o peeling skin

 

· Muscle problems (rhabdomyolysis). Muscle problems are common with KOSELUGO and can also be severe. Treatment with KOSELUGO may increase the level of a muscle enzyme in your blood which may be a sign of muscle damage. Your healthcare provider should do a blood test to check your muscle enzyme levels before you start taking KOSELUGO and during treatment. Tell your healthcare provider right away if you get any of the following signs or symptoms:

o muscle aches or pain

o muscle spasms and weakness

o dark, reddish urine

Your healthcare provider may change your dose, temporarily stop, or permanently ask you to stop taking KOSELUGO if you have any of these side effects.

The most common side effects of KOSELUGO are:

o vomiting

o stomach pain

o nausea

o dry skin

o feeling of tiredness, weakness or lacking energy

o muscle and bone pain

o fever

o inflammation of the mouth

o headache

o redness around the fingernails

o itching

These are not all the possible side effects of KOSELUGO.

 

What is KOSELUGO?

KOSELUGO is a prescription medicine that is used to treat children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cannot be completely removed by surgery.

It is not known if KOSELUGO is safe and effective in children under 2 years of age.

 

Please click here for the full Prescribing Information, including Patient Information (Medication Guide).

If you have any questions, please do not hesitate to contact me at 916-956-2906

REFERENCE

  1. KOSELUGOTM (selumetinib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

Seattle Genetics

Seattle Genetics, to announce the approval of TUKYSA (tucatinib) tablets, for oral use, by the U.S. Food and Drug Administration (FDA) on 04/17/2020. TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. 

The recommended dosage of TUKYSA is 300 mg administered orally twice daily. 

Please see Important Safety Information below and click to access the Full Prescribing Information for TUKYSA.¹ 

Product NameNDC-11 Code²StrengthDosage FormPackage DescriptionWholesale Acquisition Cost (WAC)TUKYSA (tucatinib)51144-0002-60*150 mgTabletBottle of 60 tablets$9,250TUKYSA (tucatinib)51144-0001-60*50 mgTabletBottle of 60 tablets$4,600
*The NDC has been “zero‑filled” to ensure creation of an 11‑digit code that meets Health Insurance Portability and Accountability Act (HIPAA) standards. The zero‑fill location is indicated in bold. 

IMPORTANT SAFETY INFORMATION 
Warnings and Precautions 

  • Diarrhea: TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 and 0.5% with Grade 4. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. Median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to TUKYSA dose reductions in 6% of patients and TUKYSA discontinuation in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB. 
    If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
  • Hepatotoxicity: TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 6% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to TUKYSA dose reductions in 8% of patients and TUKYSA discontinuation in 1.5% of patients. 
    Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
  • Embryo-Fetal Toxicity: TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose.


Adverse Reactions 
Serious adverse reactions occurred in 26% of patients who received TUKYSA; those occurring in ≥2% of patients were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock. 

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%). 

The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash. 

Lab Abnormalities 
In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were decreased phosphate, increased ALT, decreased potassium, and increased AST. 

The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed. 

Drug Interactions 

  • Strong CYP3A/Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
  • Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
  • CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
  • P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.


Use in Specific Populations 

  • Lactation: Advise women not to breastfeed while taking TUKYSA and for at least 1 week after the last dose.
  • Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr <30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
  • Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.


For questions regarding TUKYSA, please contact Seattle Genetics Medical Information at 1-855-4SEAGEN (1-855-473-2436) or medinfo@seagen.com

For more information, please visit http://www.tukysahcp.com


**NEW INDICATION: BRAFTOVI® (encorafenib) 75-mg capsules from Pfizer Inc.

Pfizer Inc. is pleased to announce that the US Food and Drug Administration has approved BRAFTOVI®

(encorafenib) for a new indication. The following information is for State Society review:

Approval information: https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_braftovi_encorafenib_in_combination_with_cetuximab_for_the_treatment_of_brafv600e_mutant_metastatic_colorectal_cancer_crc_after_prior_therapy

Prescribing Information: http://labeling.pfizer.com/ShowLabeling.aspx?id=12990

Procurement information

BRAFTOVI 75-mg capsules:

• 120 capsules: NDC # 70255-025-03

For information about ordering and dispensing BRAFTOVI, please call 1-844-492-7729.

 

I expect to be fully trained on BRAFTOVI + cetuximab on May 1, 2020, if you have any questions before that

time, please refer to Pfizer Medical Information at 1-800-438-1985 or www.pfizermedicalinformation.com

 

© 2020 Pfizer Inc. All right reserved. BRAFTOVI® is a registered trademark of Array BioPharma Inc. in the United

States and various other countries. NP-US-BC-0026 v4