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MYQORZO & You™ Patient Support Program Terms and Conditions

Free Trial Offer

The MYQORZO & You Free Trial Offer (“Program”) provides eligible government-insured patients with a one-month supply of MYQORZO™ (aficamten) at no cost to initiate therapy and, in consultation with their healthcare provider, determine whether continued treatment is appropriate. Patients must have active government insurance coverage (excluding Department of Defense, Veterans Affairs, and TRICARE), reside in the United States, Washington, DC, or Puerto Rico, have a valid prescription for MYQORZO™ with an FDA-approved indication, have never received MYQORZO™ or participated in the FTO, and complete a valid consent and signed start form with the MYQORZO & You Patient Support Program. Product is dispensed only through a Cytokinetics, Incorporated designated pharmacy, shipped to a valid U.S. or Puerto Rico residential address (no P.O. boxes), and limited to a lifetime one-month supply. No sale, trade, barter, export, distribution, or reimbursement from any insurer, government program, or third party is permitted, and the value may not be applied toward patient cost-sharing obligations, including Medicare Part D TrOOP expenses. For Medicare Part D beneficiaries, the applicable plan will be notified that the product is provided at no cost outside of the Part D benefit.

Copay Savings Program

The MYQORZO & You Copay Savings Program (“Program”) provides financial assistance to eligible commercially insured patients to reduce out-of-pocket costs for MYQORZO™ and certain required echocardiograms. Eligible patients may pay as little as $5 per month for MYQORZO™ and as little as $0 for eligible echocardiogram reimbursement (limited to out-of-pocket costs not covered by insurance). Patients must have active commercial prescription insurance, be prescribed MYQORZO™ for an FDA-approved indication, be at least 18 years old, reside in the United States or Puerto Rico, and be enrolled in the MYQORZO & You Copay Savings Program with valid consent. The Program is not valid for prescriptions reimbursed, in whole or in part, by any federal or state healthcare program (including Medicare, Medicaid, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, Puerto Rico Government Insurance, or any state pharmaceutical assistance programs) and is unavailable to residents of Massachusetts, Minnesota, or Rhode Island. Patients who move from commercial insurance to federal or state health insurance will no longer be eligible and agree to notify the Program of any such change. Enrollment may be renewed for up to 12 months if eligibility is maintained. Patients agree not to seek reimbursement from any health insurance or third party for all or any part of the benefit received through the Program. This offer is not conditioned on any past, present, or future purchase or prescription of MYQORZO™. Insurance entities may implement “accumulator” or “maximizer” programs, which restrict the application of manufacturer assistance toward a patient’s deductible or other cost-sharing obligations. The value of this program is intended exclusively to benefit patients by applying toward eligible out-of-pocket obligations, including co-payments, coinsurance, and deductibles. The Program uses advanced logic to identify whether a claim for an enrolled patient is subject to an “accumulator” or “maximizer” program. The use of “accumulator” or “maximizer” programs by insurance entities limit the program benefits. These limits can be modified without prior notice. Use of the program for any purpose related to “accumulator” or “maximizer” programs constitutes a violation of these Terms and Conditions. Cytokinetics, Incorporated reserves the right to audit program activity, investigate suspected violations, and modify or terminate the program, including these Terms and Conditions, at any time without prior notice.

Bridge Program

The MYQORZO & You Bridge Program (“Program”) provides, at no cost, up to a twelve (12) month supply of MYQORZO™ to eligible commercially insured patients for whom insurance coverage is being pursued but remains subject to delay. Patients must reside in the United States or Puerto Rico, have a valid prescription for MYQORZO™ with an FDA-approved indication, be enrolled in the MYQORZO & You Patient Support Program with valid consent and a signed start form, and not be enrolled in, eligible for, or receiving benefits from any federal or state healthcare program, including but not limited to Medicare (Part A, B, C, or D), Medicaid, Medigap, the Department of Defense (DoD) health programs, Veterans Affairs (VA) health programs, TRICARE, Puerto Rico Government Health Insurance, or any other similar federal or state patient or pharmaceutical assistance program, unless otherwise expressly permitted by applicable law. Product is dispensed only through Cytokinetics, Incorporated designated pharmacies, shipped to valid residential addresses (no P.O. boxes), and limited to quantities needed to bridge therapy until coverage is obtained or the Program ends. Enrollment is limited to one per qualifying event unless otherwise approved.

Patient Assistance Program (PAP)

The MYQORZO & You Patient Assistance Program (“PAP” or “Program”) provides MYQORZO™ at no cost to eligible patients meeting financial criteria who have no insurance coverage, have been denied coverage with no available appeal options or cannot afford their medication. Patients must be prescribed MYQORZO™ for an FDA-approved indication, reside in the United States or Puerto Rico, meet financial eligibility criteria and have no insurance or inadequate coverage for MYQORZO™. Enrollment requires a completed start form with prescriber certification and patient attestation, and proof of income and insurance status may be required. Enrollment is valid for up to 12 months, or until the patient obtains insurance coverage, whichever occurs first, for commercially insured, underinsured, and uninsured patients. For government-insured patients, enrollment is valid through the end of the calendar year, unless otherwise restricted by applicable laws, regulations, or program terms and conditions. Continued participation in the Program beyond one year requires eligibility reassessment and re-enrollment. Patients may be required to re-verify insurance coverage status at any time during the Program. Program benefits are personal, non-transferable, and may not be sold, traded, or distributed. The Program does not guarantee continuous supply, and for Medicare Part D beneficiaries, the applicable plan will be notified that the product is provided at no cost outside of the Part D benefit, with no value applied toward TrOOP expenses.

General terms & conditions

All MYQORZO & You Patient Support Programs are intended for patients prescribed MYQORZO™ for an FDA-approved indication and are void where prohibited, restricted, or taxed by law. None of the programs constitute health insurance, a discount, rebate, coupon, or cost-sharing program. Participation is not conditioned on any past, present, or future purchase of MYQORZO™ or any other Cytokinetics, Incorporated product. Program benefits are personal to the enrolled patient, non-transferable, and may not be sold, purchased, traded, bartered, exported, or distributed. No party may seek reimbursement, credit, or other compensation from any insurer, government healthcare program, or third-party payer for products or services provided under these programs, unless otherwise permitted by law. No membership fees for the Program. Cytokinetics, Incorporated reserves the right, in its sole discretion, to interpret, modify, suspend, or terminate any program or its eligibility criteria at any time without prior notice. Certain other rules and restrictions may apply. Participation in any MYQORZO & You program constitutes agreement to the applicable program Terms and Conditions and authorization for the use of personal health and, if applicable, personally identifiable and financial information solely for program administration in accordance with applicable laws and the Cytokinetics, Incorporated Privacy Policy https://cytokinetics.com/privacy-policy/. If you are a resident of California or certain other states (Colorado, Connecticut, Delaware, Florida, Iowa, Nebraska, New Hampshire, New Jersey), please see our Privacy Policy for privacy rights that may apply to you or contact privacy@cytokinetics.com.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILURE

MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is <50% and ≥40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction.

Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program.

CONTRAINDICATIONS

MYQORZO is contraindicated with concomitant use of rifampin.

WARNING AND PRECAUTIONS

Heart Failure
MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure.

Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure.

Assess patients’ clinical status and LVEF prior to and during treatment and adjust the MYQORZO dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide may be signs and symptoms of heart failure.

Initiation of MYQORZO in patients with LVEF <55% is not recommended.

MYQORZO REMS Program

MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction.

Notable requirements of the MYQORZO REMS Program include:

  • Prescribers must be certified by enrolling in the MYQORZO REMS Program
  • Patients must enroll in the MYQORZO REMS Program and comply with ongoing monitoring requirements
  • Pharmacies must be certified by enrolling in the MYQORZO REMS Program and must only dispense to patients who are authorized to receive MYQORZO
  • Wholesalers and distributors must only distribute to certified pharmacies

Further information is available at www.MYQORZOREMS.com, or at 1-844-285-7367.

Cytochrome P450 Interactions Leading to Heart Failure or Loss of Effectiveness
MYQORZO is metabolized primarily by CYP2C9, and to a lesser extent by CYP3A, CYP2D6, and CYP2C19 enzymes. Initiation of medications that inhibit multiple P450 pathways of MYQORZO elimination (eg, fluconazole, voriconazole, or fluvoxamine) or strong CYP2C9 inhibitors, and discontinuation of moderate-to-strong CYP3A inducers may lead to increased blood concentrations of aficamten and increase the risk of heart failure due to systolic dysfunction. Conversely, initiation of medications that induce P450 pathways of MYQORZO (eg, rifampin, moderate-to-strong CYP3A inducers) may lead to decreased blood concentrations of aficamten and potential loss of effectiveness. Assess LVEF 2 to 8 weeks after initiation of such inhibitors or after discontinuation of such inducers and adjust the dose of MYQORZO accordingly.

Advise patients of the potential for drug interactions. Advise patients to inform their healthcare provider of all concomitant medications prior to and during MYQORZO treatment.

ADVERSE REACTIONS

Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo in the pivotal trial.

INDICATIONS AND USAGE

MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

Please see full Prescribing Information, including Boxed WARNING.