Prior Authorization, Exceptions, & Appeals

Prior Authorization, Exceptions, & Appeals

There are 3 primary categories of requests:

  • Prior authorizations
  • Coverage determinations (including exception requests)
  • Appeals

These resources will help your practice better understand and manage payer processes.

Supporting Appropriate Payer Coverage Decisions Brochure — Helps you understand the information that payers may require for your patient's coverage of medically necessary drug therapies.

Checklists for Submitting Requests to Payers

Prior Authorization Considerations Checklist — Presents general information on prior authorization processes, including items and information that may be requested from your patient's insurer.

Exception Considerations Checklist — Gives an overview of exception processes for your patient's coverage of medically necessary drug therapies.

Appeal Considerations Checklist — Provides general information on insurance appeals processes, useful if your patient's insurer denies coverage.

Letter of Medical Necessity

Below is a Letter of Medical Necessity template that you can use to create and submit your letter for medical necessity with either the initial claim to support the medical necessity of treatment with RYBREVANT® for your patient or submit to support the medical necessity of treatment with RYBREVANT® when requesting reconsideration of a denied claim.

Access the Provider Portal to customize a Letter of Medical Necessity for your patient. Log In or Sign Up here.

Or download an editable Letter of Medical Necessity template for RYBREVANT®.

Letter of Exception

Each payer follows a different process when filing exceptions. Below is a template letter you can use when requesting an exception for RYBREVANT®.

Access the Provider Portal to customize a Letter of Exception for your patient. Log In or Sign Up here.

Or download an editable Letter of Exception template for RYBREVANT®.

Prior Authorization

A standardized, or "uniform," prior authorization (PA) form may be required in certain states to submit PA requests to a health plan for review, along with the necessary clinical documentation. These standard forms can be used across payers and health benefit managers.

  • Standardized PA Forms are only applicable to prescription drug benefits; they are not applicable to medical services or procedures.
  • Standardized PA Forms are typically not applicable to self-funded employer-sponsored health plans, Medicare Part D plans, and Medicaid fee-for-service plans.

Please visit the Know Your State Interactive Tool to learn what is required for your state.

Additional information on the PA process at major payers is shown below. Please see table below or contact Janssen CarePath at 877-CarePath (877-227-3728) for assistance in obtaining PA forms.

Collected in 11/21 and may change.

This information is not a promise of coverage or payment. It is not intended to give reimbursement advice or increase reimbursement by any payer. Legal requirements and plan information can be updated frequently. Contact the plan for more information about current coverage, reimbursement policies, restrictions, or requirements that may apply.

Click on the payer link to be taken to the payer's website.

Payer Prior Authorization Information
Aetna Formularies & Pharmacy Clinical Policy Bulletins
Provider Precertification Lists
Health Care Professional Forms: Specialty Pharmacy Medication Request
Prior Authorization Form
Anthem Blue Cross Blue Shield Prior Authorization (Select state)
Blue Cross and Blue Shield of Alabama Prescription Coverage Guidelines (Search by product name)
Provider-Administered Drug Policies Precertification Requests
General Prescription Drug Coverage Authorization Request Form
Blue Cross and Blue Shield of Florida/Florida Blue Prior Authorization Program Information (Search by product name)
Medical Pharmacy Prior Authorization Lists and Utilization Management
Physician and Provider Forms
Blue Cross and Blue Shield of Illinois Prior Authorization and Step Therapy Programs
Specialty Pharmacy and Referral Form
Prior Authorization Request Form
Online Prior Authorization Form
Blue Cross Blue Shield of Massachusetts Prior Authorization - Pharmacy Forms
Blue Cross Blue Shield of Michigan Provider Prior Authorization for Medical Drugs
Prior Authorization and Step Therapy Coverage Criteria
Medication Prior Authorization Request
Blue Cross and Blue Shield of Minnesota Prescription Drugs (Search by product name)
Pharmacy Utilization Management
Tools & Resources for Health Care Providers: Electronic Prior Authorization
Blue Cross and Blue Shield of Montana Prior Authorization and Step Therapy Programs
Provider Forms and Documents
Online Prior Authorization Form
Blue Cross and Blue Shield of New Mexico Prior Authorization and Step Therapy Programs
Prior Authorization Forms (Select pharmacy tab)
Online Prior Authorization Form
Blue Cross and Blue Shield of North Carolina Prior Review and Limitations
Prior Authorization Facsimile Form
Online Prior Authorization Requests
Blue Cross and Blue Shield of Oklahoma Prior Authorization and Step Therapy Programs: Request Forms
Online Prior Authorization Form
BlueCross BlueShield of Tennessee Pharmacy Resources & Forms
Prior Authorization Process for Provider-Administered Specialty Medications
BlueCross BlueShield of Texas Prior Authorization and Step Therapy Programs: Request Forms
Prior Authorization Criteria and Forms for Drugs
Online Prior Authorization Form
CareFirst BlueCross BlueShield Drug Policies and Online Prior Authorization
Pharmacy Prior Authorization
Prior Authorization Inquiries and Appeals
Cigna Provider Resources
Pharmacy Resources: Prior Authorization Forms
Medication Prior Authorization Form
Provider Quick Access Links
CVS Caremark Electronic Prior Authorization Information
Clinical Prior Authorization Criteria Request Form
Prior Authorization for Professionally Administered Drugs
EmblemHealth Pharmacy Resources and Forms
Injectables and Specialty Pharmacy Program and Form
Prior Authorizations/Coverage Determinations
Harvard Pilgrim Health Care, Inc. Medication Request Forms and Clinical Coverage Criteria
Medical Drugs Prior Authorization
Massachusetts Standard Form for Medication Prior Authorization Requests
Health Net Pharmacy and Prior Authorization Forms
Prior Authorization Forms for Specific Drugs
Highmark Blue Cross Blue Shield Prescription Drug Medication Request Form
Provider Resources for Prior Authorization Submissions
Pharmacy Prior Authorization Forms
Medical Injectable Drug Forms
Pharmacy Policy Search
Horizon Blue Cross Blue Shield of New Jersey Pharmacy Guidelines
Prior Authorization/Medical Necessity Determination Medicine List
Online Prior Authorization Form
Prior Authorization/Medical Necessity Determination Fax Form
Humana Medical and Pharmacy Coverage Policies
Prescribing Specialty Drugs
Pharmacy Prior Authorizations
Online Pharmacy Prior Authorization Portal (Members)
Independence Blue Cross Prior Authorization: Pharmacy Benefit
Specialty Medical Benefit Drugs (Search by product name)
Prior Authorization Forms
Kaiser Permanente (Kaiser Foundation Health Plan, Inc.)
Kaiser Permanente Washington
Formulary and Formulary Exceptions Form (Select Region)
Injectable Drugs Requiring Prior Authorization (WA members)
Non-Medicare Injectable Drugs Requiring Prior Authorization List (WA members)
Premera Blue Cross Drugs Requiring Approval
Pharmacy Services Prior Authorization Request Form
Wellmark Blue Cross and Blue Shield Provider Drug Information
Provider Prior Authorization

R8

Back to Top

INDICATION

RYBREVANT® (amivantamab-vmjw) is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

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 the confirmatory trials.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions

RYBREVANT® can cause infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting.

Based on the safety population, IRR occurred in 66% of patients treated with RYBREVANT®. Among patients receiving treatment on Week 1 Day 1, 65% experienced an IRR, while the incidence of IRR was 3.4% with the Day 2 infusion, 0.4% with the Week 2 infusion, and cumulatively 1.1% with subsequent infusions. Of the reported IRRs, 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range 0.1 to 18 hours) after start of infusion. The incidence of infusion modifications due to IRR was 62% and 1.3% of patients permanently discontinued RYBREVANT® due to IRR.

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT® as recommended. Administer RYBREVANT® via a peripheral line on Week 1 and Week 2. Monitor patients for any signs and symptoms of infusion reactions during RYBREVANT® infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity.

Interstitial Lung Disease/Pneumonitis

RYBREVANT® can cause interstitial lung disease (ILD)/pneumonitis. Based on the safety population, ILD/pneumonitis occurred in 3.3% of patients treated with RYBREVANT®, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) discontinued RYBREVANT® due to ILD/pneumonitis.

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT® in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

Dermatologic Adverse Reactions

RYBREVANT® can cause rash (including dermatitis acneiform), pruritus and dry skin. Based on the safety population, rash occurred in 74% of patients treated with RYBREVANT®, including Grade 3 rash in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% of patients, and RYBREVANT® was permanently discontinued due to rash in 0.7% of patients.

Toxic epidermal necrolysis occurred in one patient (0.3%) treated with RYBREVANT®.

Instruct patients to limit sun exposure during and for 2 months after treatment with RYBREVANT®. Advise patients to wear protective clothing and use broad-spectrum UVA/UVB sunscreen. Alcohol-free emollient cream is recommended for dry skin.

If skin reactions develop, start topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. Withhold, dose reduce or permanently discontinue RYBREVANT® based on severity.

Ocular Toxicity

RYBREVANT® can cause ocular toxicity including keratitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, and uveitis. Based on the safety population, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients treated with RYBREVANT®. All events were Grade 1-2. Promptly refer patients presenting with eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT® based on severity.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal models, RYBREVANT® can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment and for 3 months after the final dose of RYBREVANT®.

Adverse Reactions

The most common adverse reactions (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).

Please read full Prescribing Information for RYBREVANT®.

cp-213274v2