Prescribing companion
Camzyos (mavacamten) Camzyos REMS, echocardiogram schedule, titration and prior authorization criteriaFor prescribers and their offices treating 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 Enrollment Form carrying the baseline echo with LVEF 55% or higher, a negative pregnancy test where it applies, and the pharmacy's medication review; the REMS authorizes every fill.
Example PA threshold
FEP example: obstructive HCM with NYHA class II or III symptoms, a beta blocker or calcium channel blocker failed, not tolerated or contraindicated, LVEF 55% or higher, REMS enrollment, an echo monitoring commitment.
Monitoring
Echocardiogram at weeks 4, 8 and 12, then every 3 to 6 months on a stable dose, plus 4 and 12 weeks after any dose change; a Patient Status Form to the REMS after each, or the pharmacy cannot ship.
Support line
MyCAMZYOS, 1-855-226-9967, Patient Access Specialist, copay to $10 for commercial plans, a free 35-day first supply, a bridge supply after a 5-day delay, and an echo copay program.
Before 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 CAMZYOS REMS | Only certified prescribers and certified pharmacies; Bristol Myers Squibb says no local pharmacy can fill it. The REMS line is 1-833-628-7367. | Camzyos REMS |
| Baseline echocardiogram | The boxed warning says Camzyos is not recommended with LVEF below 55%. The echo date and LVEF go on the Patient Enrollment Form, and the pharmacy is not authorized to ship without them. The form allows a start date up to 90 days after submission. | Camzyos REMS |
| Counsel and enroll the patient | The REMS requires the patient brochure and a conversation on heart failure risk, warning signs, interactions and the echo schedule, then the patient's signature on the Patient Enrollment Form. | Camzyos REMS |
| Pregnancy test and contraception | The label requires excluding pregnancy before the first dose and effective contraception during treatment and for 4 months after the last dose. Camzyos can reduce the effectiveness of some hormonal contraceptives; the label names ethinyl estradiol with norethindrone as unaffected and says other hormonal methods may need a backup. | FDA label |
| Medication reconciliation | Strong CYP2C19 inhibitors and moderate or strong CYP2C19 or CYP3A4 inducers are contraindicated. The certified pharmacy reviews every prescription and supplement with the patient before each fill and files a checklist with the REMS, so the office's list should be current. | FDA label |
| MyCAMZYOS and the PA | Enrollment gives the patient a Patient Access Specialist, a free 35-day first supply for first-time patients, and a bridge supply if a commercial plan's decision is delayed 5 days. The REMS asks that a first dose delayed more than 7 days after delivery be reported to the prescriber. | MyCAMZYOS |
Prior authorization criteria and what to document
One public policy as the example: Blue Cross Blue Shield Federal Employee Program, July 1, 2026. Approval a year at a time, renewed if symptoms improved or stabilized and the same monitoring promises are made, with a limit of 90 capsules per 90 days. This policy was last reviewed in June 2026, before the FDA extended Camzyos to children weighing 30kg (about 66 lb) or more, so it still says adults only. Other plans set their own criteria and some ask for the outflow gradient figure. 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 | Symptomatic obstructive hypertrophic cardiomyopathy, age 18 or older in this policy; the September 2026 label extends to children weighing 30kg (about 66 lb) or more | Imaging and the diagnosis note | FEP Blue policy |
| Symptom class | NYHA class II or III | The functional class in the note, with the limiting symptom | FEP Blue policy |
| Prior therapy | A beta blocker or non-dihydropyridine calcium channel blocker was inadequate, not tolerated or contraindicated | Agent, dose, dates and the reason it failed | FEP Blue policy |
| Ejection fraction | LVEF 55% or higher | Echo report with date; some plans also ask for the outflow gradient | FEP Blue policy |
| Monitoring commitment | The prescriber agrees to monitor echocardiograms, ECG, LVEF and the outflow gradient during treatment | A statement on the request | FEP Blue policy |
| REMS | Patient and prescriber enrolled in the Camzyos REMS | Enrollment confirmation | FEP Blue policy |
| Pregnancy | No pregnancy confirmed and contraception advised during treatment and for 4 months after, for anyone who can become pregnant | Test result and counseling note | FEP Blue policy |
| Prescriber | Prescribed by or on the advice of a cardiologist | Specialty on the request, or the consult note | FEP Blue policy |
Camzyos dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 5mg once daily, swallowed whole, with or without food. Available doses after titration are 2.5mg, 5mg, 10mg and 15mg, moved only on echo results. A bottle holds 30 capsules; in the first year the pharmacy may dispense no more than a 35-day supply. | FDA label |
| Weeks 4, 8 and 12 | Dose held, reduced or interrupted on the LVEF and outflow gradient at each echo. LVEF below 50% means an interruption. | Camzyos REMS |
| Missed dose | Take it as soon as possible that day and the next dose at the usual time the following day; never 2 doses on the same day. | FDA label |
| Serious illness or arrhythmia | The label says a serious infection or an arrhythmia such as atrial fibrillation raises heart failure risk, and tells prescribers to delay dose increases and consider interrupting the drug. | FDA label |
Monitoring the Camzyos label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | Echocardiogram with LVEF and outflow gradient; pregnancy test where it applies | LVEF must be 55% or higher; recorded on the REMS enrollment form | Camzyos REMS |
| Week 4 | Echocardiogram | Patient Status Form to the REMS; dose decision | Camzyos REMS |
| Week 8 | Echocardiogram | Same; after any dose change, echoes at 4 and 12 weeks after the change | Camzyos REMS |
| Week 12 | Echocardiogram | Last initiation echo; then every 3 to 6 months on a stable dose, by results; the pharmacy can move to a 90-day supply after the first year | Camzyos REMS |
| Any time | Heart failure signs: new or worse dyspnea, edema, chest pain, palpitations, fatigue, rapid weight gain | The label says these should prompt an echo rather than wait for the scheduled one; in EXPLORER-HCM 6% had LVEF fall below 50% against 2% on placebo, all recovered on interruption | FDA label |
| Any time | Syncope, dizziness | Dizziness 27% against 18%, syncope 6% against 2% in EXPLORER-HCM; syncope was the only reaction that led to discontinuation | FDA label |
Camzyos drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Contraindicated | Strong CYP2C19 inhibitors; moderate to strong CYP2C19 or CYP3A4 inducers | FDA label |
| Avoid | Disopyramide, ranolazine, and verapamil or diltiazem combined with a beta blocker, because of additive negative inotropy | FDA label |
| Disclose and review | Omeprazole, esomeprazole, cimetidine, sold over the counter; grapefruit juice per the Medication Guide; any new agent, even for a week, can change the dose or interrupt the drug | FDA label |
| Contraception | Reduced effectiveness of some hormonal contraceptives; ethinyl estradiol with norethindrone is named as usable; report any pregnancy on treatment or within 4 months of the last dose to 1-800-721-5072 | FDA label |
| Overdose | The label's overdosage section records an infant death after ingestion of three 15mg capsules | FDA label |
Why a first fill stalls, and the fix
- The REMS has not authorized the fillThe pharmacy must get authorization from the REMS before every dispense. The usual gap is a Patient Status Form the cardiologist's office has not yet filed after an echo. The REMS line is 1-833-628-7367, and the office can file the form online.
- The prescription went to a pharmacy that is not certifiedOnly REMS-certified pharmacies can dispense Camzyos, and Bristol Myers Squibb says no local pharmacy can. The prescriber's office resends it to a certified pharmacy. This is a routing error, not a denial.
- Prior authorization pending or deniedInsurers ask for the criteria below, most often the diagnosis, the symptom class, an ejection fraction of 55% or more, and REMS enrollment. Many also want a beta blocker or calcium channel blocker tried first. If a commercial plan's decision is delayed 5 days, the MyCAMZYOS bridge program supplies the drug at no cost while it is sorted out.
- A copay you cannot payCommercial insurance: the MyCAMZYOS copay program, as little as $10 a month, with program maximums. Medicare, TRICARE and VA: the copay program is closed to you by its terms. Bristol Myers Squibb says Medicare patients pay about $38 a month on average, under Part D's yearly cap. Our help paying page lists charity funds.
- The echocardiograms themselves cost moneyThe REMS requires them. The MyCAMZYOS echo copay program covers the out-of-pocket cost for eligible commercially insured patients up to $2,500 a year, except in Massachusetts, Minnesota and Rhode Island.
MyCAMZYOS Patient Support
- Patient Access Specialists who explain your coverage and out-of-pocket costs
- A copay program for commercial insurance, as little as $10 per 30-day supply, with monthly, annual or per-claim maximums, not open to Medicare, TRICARE, VA or cash payers
- A one-time free 35-day supply for first-time patients, regardless of insurance type, and a bridge supply at no cost when a commercial plan's decision is delayed 5 days
- An echo copay program for commercial insurance, as little as $0 for required echocardiograms up to $2,500 a year
- Educational emails through the first 3 to 4 months and text reminders, plus a finder for REMS-certified cardiologists
Questions prescribers' offices ask about Camzyos
How often is an echocardiogram required on Camzyos?
At baseline, then at weeks 4, 8 and 12, then every 3 to 6 months on a stable dose, plus 4 and 12 weeks after any dose change. The cardiologist files a Patient Status Form with the REMS after each echo, and the pharmacy cannot ship without REMS authorization.
What LVEF is needed to start Camzyos?
55% or higher. The boxed warning says Camzyos is not recommended below 55%, and an LVEF below 50% on treatment means an interruption.
What does the Camzyos REMS require before the first fill?
A certified prescriber and pharmacy, the patient brochure and counseling, the patient's signed enrollment form carrying the baseline echo date and LVEF, and REMS authorization before every dispense. The REMS line is 1-833-628-7367.
Which drugs are contraindicated with Camzyos?
Strong CYP2C19 inhibitors and moderate to strong CYP2C19 or CYP3A4 inducers. The label also says to avoid disopyramide, ranolazine, and verapamil or diltiazem combined with a beta blocker, and singles out omeprazole, esomeprazole and cimetidine for disclosure.
What do insurers ask for to approve Camzyos?
The FEP policy shown on this page, dated July 1, 2026, asks for obstructive HCM with NYHA class II or III symptoms, a failed or contraindicated beta blocker or calcium channel blocker, LVEF of 55% or higher, a cardiologist, a monitoring commitment and REMS enrollment.
Sources
- CAMZYOS (mavacamten) prescribing information and Medication Guide, revised September 2026, Bristol Myers Squibb, via DailyMed, 2026-09-30.
- CAMZYOS REMS Program, patient page, Patient Enrollment Form, Patient Status Form and pharmacy page, Bristol Myers Squibb, 2026-09-01.
- MyCAMZYOS Patient Support, affordability and support, Bristol Myers Squibb, 2026-11-06.
- Pharmacy Policy 5.40.033, Camzyos (mavacamten), Blue Cross Blue Shield Federal Employee Program, 2026-07-01.
- NDA 214998/S-013 approval letter, pediatric indication and 1mg capsule, FDA, 2026-09-30.
- NDA 214998/S-010 approval letter, interaction, monitoring and dispensing changes, FDA, 2025-04-17.
- NDA 214998/S-009 approval letter, contraception and overdosage labeling, FDA, 2024-04-30.
- NDA 214998/S-008 REMS modification letter, FDA, 2023-12-19.
- NDA 214998/S-001 approval letter, VALOR-HCM results, FDA, 2023-06-15.
A reference drawn from the September 30, 2026 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. Not a treatment recommendation and not a substitute for the prescribing information. Trial Friend takes no money from any drugmaker, pharmacy, insurer or program named here.