Prescribing companion
Myqorzo (aficamten)REMS, echocardiogram schedule, titration and prior authorization criteriaFor prescribers and their offices treating obstructive hypertrophic cardiomyopathy: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
REMS-certified prescriber and pharmacy, Patient Guide counseling, a baseline echocardiogram with LVEF 55% or higher, and a Patient Enrollment Form signed by patient and prescriber, with treatment started within 3 months of the form; the REMS authorizes every fill.
Example PA threshold
Cigna example: NYHA class II or III, wall thickness 15mm or more (13mm familial), LVOT gradient 30 mmHg at rest or 50 mmHg provoked, LVEF 55% or higher, 3 months of a beta blocker or non-dihydropyridine CCB unless contraindicated, cardiologist.
Monitoring
Echocardiogram 2 to 8 weeks after initiation and each dose change, then every 6 months, or every 3 months with LVEF from 50% to under 55%; a Patient Monitoring Form to the REMS within 60 days of each start or change, or the pharmacy cannot dispense.
Support line
MYQORZO & You, 833-697-6796 (833-MYQORZO), copay as low as $5 a month (to $15,000 a year) for commercial plans, echo copay to $0 up to $2,500 a year, a Bridge Program for up to 12 months after an initial denial, a 60-day Free Trial Offer for government-insured patients, and a Patient Assistance Program.
Give your patient their plan
A one-page handout for starting Myqorzo, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/myqorzoBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Certify in the MYQORZO REMS | Review the label, the REMS Overview and the Education Program, pass the Healthcare Provider Knowledge Assessment and submit the Healthcare Provider Enrollment Form. Only certified pharmacies dispense, and each dispense needs REMS authorization. The REMS line is 1-844-285-7367. | REMS Document |
| Baseline echocardiogram | The boxed warning says initiation with LVEF below 55% is not recommended. The prescriber documents review of the echo and authorizes treatment on the Patient Enrollment Form. | FDA label |
| Counsel and enroll the patient | Counsel on heart failure risk using the Patient Guide and give the patient a copy, then submit the Patient Enrollment Form signed by both, online or by fax to 1-844-285-7399. The initial dispense authorization is valid 3 months from receipt of the form; after that a new form is needed. | REMS Document |
| Medication reconciliation | Rifampin is contraindicated. Fluconazole beyond 3 days, voriconazole, fluvoxamine, strong CYP2C9 inhibitors, and discontinuation of moderate to strong CYP3A inducers change the dose. The label asks that patients report all medications before and during treatment. | FDA label |
| Pregnancy | No pregnancy test or contraception requirement in the label or the REMS. Human data are absent; rat studies showed malformations at 4 or more times the exposure at 20mg. Report exposure during treatment or within 3 weeks of the last dose to Cytokinetics at 1-833-633-2986. | FDA label |
| Dispensing limits | No more than a 30-day supply at initiation, a dose adjustment or re-titration; no more than 90 days on a maintenance dose. Additional fills at the starting dose are authorized up to 60 days' supply within the first 60 days. | REMS Document |
| MYQORZO & You and the PA | For commercial plans, a Bridge Program supplies Myqorzo at no cost for up to 12 months or until coverage is approved after an initial denial. Government-insured patients new to Myqorzo, excluding DoD, VA and TRICARE, may receive up to a 60-day supply free. | MYQORZO & You terms |
Prior authorization criteria and what to document
One public policy as the example: Cigna, April 1, 2026. Approval a year at a time. Renewal needs at least a year on therapy and a measured benefit or stable symptoms, still prescribed by a cardiologist. This policy was revised in April 2026, after the December 2025 label, to add the beta blocker or calcium channel blocker step. Its summary says therapy is interrupted below 50% and that certain drugs acting on liver enzymes are contraindicated. The label instead lowers the dose from 40% to under 50%, pauses it below 40%, and bans only rifampin. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Diagnosis | Obstructive hypertrophic cardiomyopathy with at least one symptom, age 18 or older | Imaging and the diagnosis note | Cigna policy |
| Symptom class | NYHA class II or III | The functional class in the note, with the limiting symptom | Cigna policy |
| Wall thickness | Maximal LV wall thickness 15mm or more, or 13mm or more with familial HCM | Echo or cardiac MRI report | Cigna policy |
| Outflow gradient | Peak LVOT gradient 30 mmHg or more at rest, or 50 mmHg or more after Valsalva or exercise | Echo report with date and the provocation used | Cigna policy |
| Ejection fraction | LVEF 55% or higher | Echo report with date | Cigna policy |
| Prior therapy | A beta blocker or non-dihydropyridine calcium channel blocker for at least 3 months, or a prescriber-stated contraindication or intolerance | Agent, dose, dates and the reason it failed or could not be used | Cigna policy |
| Prescriber | Prescribed by a cardiologist; the January 2026 revision removed the consultation option | Specialty on the request | Cigna policy |
| Renewal | At least 1 year on therapy, with a benefit on an objective measure or stabilized or improved symptoms | Gradient, NT-proBNP, KCCQ or symptom notes | Cigna policy |
Myqorzo dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 5mg once daily, with or without meals, at about the same time each day, swallowed whole. Tablets of 5mg, 10mg, 15mg and 20mg, in bottles of 30. | FDA label |
| Each echo, 2 to 8 weeks after a start or change | LVEF 55% or higher with Valsalva LVOT gradient 30 mmHg or higher: increase by 5mg, to 20mg maximum. LVEF 55% or higher with gradient under 30 mmHg: maintain. LVEF 50% to under 55%: maintain. | FDA label |
| LVEF 40% to under 50% | Decrease by 5mg (20 to 15, 15 to 10, 10 to 5); if already on 5mg, interrupt for at least 7 days. | FDA label |
| LVEF under 40% | Interrupt for at least 7 days. Resume no earlier than 7 days, when LVEF is 55% or higher, and re-titrate from 5mg. The REMS needs a Patient Monitoring Form documenting LVEF 55% or higher to resume. | REMS Patient Monitoring Form |
| Heart failure symptoms or worsening clinical status | Interrupt dosing when heart failure symptoms or worsening clinical status are due to systolic dysfunction, per the boxed warning. | FDA label |
| Intercurrent illness or new arrhythmia | Consider monitoring LVEF and adjusting the dose for a severe infection, COVID-19, or new or uncontrolled atrial fibrillation or other tachyarrhythmia; do not increase the dose until it resolves or stabilizes. | FDA label |
| Missed dose | Take it as soon as possible the same day and the next dose at the usual time the following day; never 2 doses on the same day. | FDA label |
Monitoring the Myqorzo label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | Echocardiogram with LVEF | Initiation not recommended below 55%; confirmed on the Patient Enrollment Form | FDA label |
| 2 to 8 weeks after initiation | Echocardiogram | LVEF category, any heart failure event and the next dose go on the Patient Monitoring Form, due within 60 days of the first dose | REMS Patient Monitoring Form |
| 2 to 8 weeks after each dose change | Echocardiogram, including changes made for a drug interaction | Dose decision on LVEF and Valsalva LVOT gradient per the label table; in SEQUOIA-HCM titration steps fell at weeks 2, 4 and 6 | FDA label |
| Maintenance | Echocardiogram every 6 months, or every 3 months with LVEF 50% to under 55% | Patient Monitoring Form on the same cycle from the last one; up to a 90-day supply | REMS Document |
| Any time | Heart failure signs: new or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or a rise in NT-proBNP | The label says these should prompt an evaluation of cardiac function; in SEQUOIA-HCM 4% had LVEF fall below 50% against 1% on placebo, all reversible without interruption | FDA label |
| Any time | Blood pressure | Hypertension 8% against 2%; SBP of 160 mmHg or more in about 16% against 8%; the label attributes the rise to relief of obstruction | FDA label |
| Pharmacokinetics | Half-life about 80 hours, steady state in about 17 days | LVEF and Valsalva gradient returned to baseline 4 weeks after stopping in SEQUOIA-HCM | FDA label |
Myqorzo drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Contraindicated | Rifampin, predicted by PBPK modeling to lower aficamten exposure by 79%; may reduce effectiveness | FDA label |
| Fluconazole (over 3 days) or voriconazole | On stable therapy, start at 5mg. Started during treatment: on 15mg or 20mg reduce to 5mg; on 5mg or 10mg avoid the combination; echo 2 to 8 weeks later. Fluconazole 400mg daily raised exposure 278% | FDA label |
| Fluvoxamine or strong CYP2C9 inhibitors | On stable therapy, start at 5mg. Started during treatment: reduce 20 to 10, 15 to 5, 10 to 5, or continue 5mg; echo 2 to 8 weeks later | FDA label |
| Stopping a moderate to strong CYP3A inducer | Such as carbamazepine: reduce 20 to 10, 15 to 5, 10 to 5, or continue 5mg; echo 2 to 8 weeks later. While the inducer continues, exposure is lower and effect may be reduced | FDA label |
| Measured, no dose rule | Itraconazole raised exposure 26%, paroxetine 27%, fluoxetine 32%; aficamten raised dabigatran exposure 26% | FDA label |
| CYP2C9 poor metabolizers | No additional adjustment; the label says titration accounts for metabolizer status | FDA label |
| Renal and hepatic | No meaningful change in mild to moderate impairment; severe renal (eGFR under 30) and Child-Pugh C effects are unknown | FDA label |
Why a first fill stalls, and the fix
- The REMS has not authorized the fillThe pharmacy needs authorization from the REMS before every single dispense. The usual gap is a Patient Monitoring Form not yet filed after an echo, due within 60 days of the start or a dose change. The REMS call center is at 1-844-285-7367 for questions.
- The enrollment form has lapsedThe first authorization lasts 3 months from the Patient Enrollment Form. If treatment did not start in that window, the cardiologist submits a new form.
- The prescription went to a pharmacy that is not certifiedCytokinetics says Myqorzo is only available through REMS-certified specialty pharmacies that ship each month. The prescriber's office resends it to a certified pharmacy, so this is a routing error rather than a denial.
- Prior authorization pending or deniedThe Cigna policy below, one example, asks for the symptom class, wall thickness and outflow gradient. It also wants an ejection fraction of 55% or more and a beta blocker or calcium channel blocker tried first. With commercial insurance, the MYQORZO & You Bridge Program may cover the gap after an initial denial.
- A copay you cannot payCommercial insurance: the copay program, as little as $5 a month up to $15,000 a year. Medicare, Medicaid, TRICARE and VA are excluded from it by its terms. A Patient Assistance Program gives free drug to people who meet its financial criteria.
- The echocardiograms themselves cost moneyThe MYQORZO & You echo copay program covers out-of-pocket echo costs for eligible commercially insured patients, as little as $0 up to $2,500 a year. It is not available in Massachusetts, Minnesota or Rhode Island.
MYQORZO & You Patient Support
- MYQORZO Navigators who help you start and stay on track, reached at 833-MYQORZO
- A copay program for commercial insurance, as little as $5 a month up to $15,000 a year, not valid with Medicare, Medicaid, TRICARE, VA or other government coverage
- An echocardiogram copay program for commercial insurance, as little as $0 up to $2,500 a year, except in Massachusetts, Minnesota and Rhode Island
- A Bridge Program for commercial insurance, Myqorzo at no cost for up to 12 months after an initial insurance denial or until coverage is approved
- A Free Trial Offer of up to a 60-day supply for government-insured patients new to Myqorzo, excluding TRICARE, VA and military plans, and a Patient Assistance Program for those who meet financial criteria
Questions prescribers' offices ask about Myqorzo
How often is an echocardiogram required on Myqorzo?
The December 2025 label requires one at baseline and 2 to 8 weeks after initiation or any dose adjustment, including one made for a drug interaction. On a maintenance dose it is every 6 months, or every 3 months with LVEF from 50% to under 55%. The REMS needs a Patient Monitoring Form within 60 days of initiation or each dose change, then on the 6 or 3 month cycle, or the pharmacy cannot be authorized to dispense.
How is Myqorzo titrated?
The December 2025 label starts at 5mg once daily and raises it by 5mg every 2 to 8 weeks, to a 20mg maximum, while LVEF is 55% or higher and the Valsalva LVOT gradient is 30 mmHg or higher. Below a 30 mmHg gradient, or with LVEF from 50% to under 55%, the dose is held. From 40% to under 50% it drops by 5mg (interrupted for at least 7 days if already on 5mg), and below 40%, or with heart failure symptoms or worsening clinical status, treatment is interrupted.
What does the Myqorzo REMS require before the first fill?
Under the December 2025 label, the REMS, last updated March 26, 2026, requires a certified prescriber who has passed the knowledge assessment, counseling with the Patient Guide, a baseline echocardiogram and a Patient Enrollment Form signed by patient and prescriber. The pharmacy must be certified and obtain authorization for every dispense. Treatment must start within 3 months of the enrollment form. The REMS line is 1-844-285-7367.
Which drugs interact with Myqorzo?
The December 2025 label contraindicates only rifampin. Starting fluconazole for more than 3 days, voriconazole, fluvoxamine or a strong CYP2C9 inhibitor, or stopping a moderate to strong CYP3A inducer such as carbamazepine, calls for a dose reduction or avoidance and an echo 2 to 8 weeks later.
What do insurers ask for to approve Myqorzo?
The Cigna policy on this page, reviewed April 1, 2026, after the December 2025 label, asks for age 18 or older, NYHA class II or III symptoms, wall thickness of 15mm or more, or 13mm with familial HCM, and an LVOT gradient of 30 mmHg at rest or 50 mmHg provoked. It also asks for LVEF of 55% or higher, 3 months of a beta blocker or non-dihydropyridine calcium channel blocker unless contraindicated, and a cardiologist.
Sources
- MYQORZO (aficamten) tablet, film coated: prescribing information and Medication Guide, revised December 2025, Cytokinetics, via DailyMed, 2025-12-16.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Myqorzo (aficamten), NDA 219083, FDA, 2026-03-26.
- MYQORZO (aficamten) REMS Document, Cytokinetics, approved by FDA, 2026-03-26.
- MYQORZO REMS Patient Guide, Cytokinetics, approved by FDA, 2026-03-26.
- MYQORZO REMS Patient Monitoring Form, Cytokinetics, approved by FDA, 2026-03-26.
- MYQORZO REMS Program | MYQORZO™ (aficamten), Cytokinetics, 2026-11-07.
- MYQORZO and You Patient Support | MYQORZO™ (aficamten), Cytokinetics, 2026-11-07.
- MYQORZO & You program terms and conditions (US-MYQ-00242 05/2026), Cytokinetics, 2026-11-07.
- Cardiology – Myqorzo Prior Authorization with Step Therapy Policy, Cigna, 2026-04-01.
- CAMZYOS (mavacamten) prescribing information and Medication Guide, revised September 2026, Bristol Myers Squibb, via DailyMed, 2026-09-30.
- NDA 219083/S-001 supplement approval letter, REMS modification, FDA, 2026-02-05.
- NDA 219083 approval letter, FDA, 2025-12-19.
A reference drawn from the December 16, 2025 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 7, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.