Camzyos access in Pakistan: the DRAP named-patient pathway
How Pakistani patients with symptomatic obstructive hypertrophic cardiomyopathy legally access Camzyos (mavacamten), the first-in-class cardiac myosin inhibitor, through the Drug Regulatory Authority of Pakistan Special Provision pathway when conventional therapy has not delivered adequate symptom control.
Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.
Ask about Camzyos in Pakistan
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Quick orientation
Camzyos (mavacamten) is the first-in-class oral selective allosteric cardiac myosin inhibitor approved by the US Food and Drug Administration in April 2022 for adults with symptomatic NYHA class II to III obstructive hypertrophic cardiomyopathy. Manufactured by Bristol-Myers Squibb, the medicine reduces actin-myosin cross-bridge formation, lowering excessive cardiac contractility, reducing left ventricular outflow tract obstruction, and improving exercise capacity. The EXPLORER-HCM and VALOR-HCM pivotal trials demonstrated improvements in peak VO2, NYHA class, and a substantial reduction in the proportion of patients meeting criteria for invasive septal reduction therapy. The medicine is dispensed only through the Camzyos REMS program in the US due to the risk of heart failure from systolic dysfunction. Camzyos is not registered with the Drug Regulatory Authority of Pakistan (DRAP), and access for Pakistani patients runs through the Special Provision personal-use import combined with rigorous local cardiology follow-up.
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How Camzyos reaches patients in Pakistan
Camzyos (mavacamten, the first-in-class cardiac myosin inhibitor approved by the FDA in April 2022 for symptomatic obstructive hypertrophic cardiomyopathy in NYHA class II to III adults) is not visible on the DRAP registered-product verification portal at dra.gov.pk/e-services/online-data-verification as of 2026-05-31. Access in Pakistan runs through the Special Permission for Import of Therapeutic Goods for Personal Use, administered by DRAP's QA and LT Division Import and Export Section under the Drugs Act 1976 and the Drugs (Import and Export) Rules 1976. The application is filed online at dra.gov.pk/therapeutic-goods/import-export/special-permissions. The Camzyos-specific clinical justification must demonstrate: obstructive HCM diagnosis (peak left ventricular outflow tract gradient at least 50 mmHg by echocardiography), NYHA class II to III symptoms, baseline left ventricular ejection fraction of 55% or greater per the FDA REMS, and a cytochrome P450 2C19 phenotype assessment to support starting-dose selection (CYP2C19 poor metabolisers start at 2.5 mg; normal, intermediate, and rapid metabolisers start at 5 mg). The REMS dispensing-and-monitoring requirements in the US do not transfer to Pakistan, but DRAP reviewers expect the prescribing cardiologist to commit in writing to the FDA-label echocardiographic surveillance schedule (weeks 4, 8, 12, 24, then every 12 weeks). DRAP does not publish a fixed processing-time SLA; expect several working days once documentation is complete. The NOC is single-consignment.
Where Camzyos is dispensed in Pakistan
Camzyos is an oral, self-administered chronic cardiology therapy requiring serial echocardiography and HCM-trained interpretation; the dispensing setting in Pakistan is an HCM-capable cardiology outpatient service rather than an oncology centre. Centres without an in-house import pharmacy route the application through a DRAP-licensed pharmaceutical establishment under chain-of-custody documentation into the prescribing cardiologist's outpatient pharmacy.
What Camzyos costs in Pakistan
Medicine price: quote on request. You get a written quote for your case before you commit. The State Bank of Pakistan outward remittance allowance for medical purposes governs wire sequencing.
Funding and access barriers for Camzyos in Pakistan
HCM is a relatively common monogenic cardiomyopathy (population prevalence approximately 1 in 500), but Camzyos as a first-in-class targeted therapy sits in a class with no Pakistani-registered alternative and no precedent for routine public funding. The Sehat Sahulat Programme inpatient cover does not extend to outpatient chronic-cardiomyopathy oral therapy; coverage of Camzyos via the federal card is not documented. Provincial Sehat Card Plus (Khyber Pakhtunkhwa) has the broadest specialty cover but a Camzyos claim through this route is not a documented precedent and would be case-by-case. Pakistan Bait-ul-Mal at pbm.gov.pk grants for high-cost foreign-sourced treatment are means-tested and case-by-case. Major private insurers typically exclude or sub-limit unregistered named-patient imports in retail policies; corporate group policies underwritten by these carriers may include coverage with the policyholder's documented prior authorisation but require step-therapy documentation (here, demonstrated inadequate response to or intolerance of beta-blockers or non-dihydropyridine calcium channel blockers per the HCM treatment guidelines from the American Heart Association). Out-of-pocket self-pay supplemented by family contribution dominates funding for Camzyos in Pakistan as of 2026-05-31. The import-permit experience is straightforward for a stable oral capsule; the operational complexity sits with the serial-echocardiogram surveillance rather than the import itself.
Recent regulatory and access news for Camzyos
FDA expanded the Camzyos label and modified the REMS in June 2025 to remove the requirement for left ventricular ejection fraction monitoring frequency at specific intervals beyond week 12 in stable maintenance patients; the FDA REMS modification is referenced on the FDA REMS page at accessdata.fda.gov/scripts/cder/rems. The FDA also approved Camzyos for non-obstructive HCM in adult patients in 2025; the expanded indication broadens the clinical population eligible for the NPP pathway in Pakistan. No DRAP-specific bulletin on Camzyos has been observed over the last 12 months as of 2026-05-31. The DRAP consolidated Guidance Document for Imports and Exports of Therapeutic Goods (QALT/GL/IP/004) referenced at dra.gov.pk regulatory updates remains the operative procedural reference.
Where Reserve Meds fits in Camzyos cases
Reserve Meds is a US-based digital health company. For Camzyos cases originating in Pakistan, we orchestrate US-side sourcing through DSCSA-compliant channels, build the DRAP documentation packet your cardiologist submits, coordinate shipment, and assign a single point of contact who works with your local cardiology team on the REMS-equivalent monitoring schedule.
Next step
If your Pakistani cardiologist is considering Camzyos for a symptomatic oHCM patient, the next step is a short intake request. We respond within one business day.
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