Repatha access in Saudi Arabia: the SFDA Personal Importation Program

Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team.

Quick orientation

Repatha is the Amgen brand of evolocumab, a fully human IgG2 monoclonal antibody PCSK9 inhibitor that lowers LDL cholesterol by preventing degradation of hepatic LDL receptors. The US FDA first approved Repatha in August 2015 as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), and clinical atherosclerotic cardiovascular disease (ASCVD) requiring additional LDL-C lowering. In December 2017 the FDA added a cardiovascular risk reduction indication based on the FOURIER trial. In September 2021 the pediatric label was expanded to HeFH patients aged 10 and older, and the HoFH pediatric age threshold was lowered to 10 years. Repatha is registered with the Saudi Food and Drug Authority (SFDA), with availability concentrated in tertiary cardiology centers and select retail channels, but stocking depth outside the Riyadh-Jeddah-Eastern Province metropolitan corridor remains limited. The SFDA Personal Importation Program (PIP) is the lawful route for a patient-specific import.

Reserved for you.

Why Saudi families reach for Repatha through NPP

Repatha is registered in the Kingdom, and most Repatha NPP inquiries from Saudi families are not about absence of registration. They are about stocking depth and continuity. PCSK9 inhibitors are still concentrated at tertiary cardiology centers and a narrow set of private specialty pharmacies. A family in a tier-2 Saudi city (Madinah, Tabuk, Abha, Hail, Buraidah) or a smaller Eastern Province community can be many hours from any pharmacy that actually carries Repatha. For chronic therapy where LDL-C control is the entire point, a gap of several weeks between refills materially undoes the clinical benefit.

The familial hypercholesterolemia cohort is particularly relevant in the Kingdom. Consanguinity rates in Saudi Arabia produce higher relative frequency of HoFH than in many Western populations, and several Saudi tertiary centers (notably KFSH&RC) operate established FH registries with pediatric and adult clinics. For these families the choice is not Repatha versus an alternative; it is Repatha or untreated LDL-C levels that statin plus ezetimibe alone cannot control. When local supply is intermittent, families with means look cross-border for continuity. The second-largest cohort is post-myocardial-infarction secondary prevention: patients who have had a cardiovascular event and are at very high risk of a second event sometimes prefer the documented FOURIER trial regimen on a continuous, validated supply chain. The cash-pay international patient profile that Reserve Meds is built to serve aligns well with this use case.

The SFDA Personal Importation Program for Repatha

The SFDA Personal Importation Program allows a Saudi-licensed physician to request import of a specific medicine for a specific named patient when the medicine is approved by a recognised reference authority and a clinically equivalent locally registered alternative is not suitable for that patient. Applications are filed through the dispensing institution's import pharmacy and reviewed by SFDA's Drug Sector through the Ghad digital platform.

For Repatha the clinical-justification angle is indication-specific. A complete application typically includes:

• A clinical justification letter from the treating cardiologist, lipidologist, or pediatric-lipid specialist naming the on-label indication: HeFH (adult or pediatric 10 years and older), HoFH (adult or pediatric 10 years and older), primary hyperlipidemia with maximally tolerated statin requiring additional LDL-C lowering, or established cardiovascular disease for CV risk reduction
• The FH diagnosis documentation (Dutch Lipid Clinic Network criteria score, Simon Broome criteria, or genetic confirmation where available) for FH cases, or the prior cardiovascular event documentation (MI, stroke, coronary revascularization) for the CV-risk indication
• The current LDL-C level on maximally tolerated statin plus ezetimibe and the LDL-C target the prescriber is pursuing
• The treating physician's SCFHS license verification
• The patient identifier in SFDA's required format
• Product details: Repatha (evolocumab), the specific presentation (140 mg SureClick autoinjector, 140 mg prefilled syringe, or 420 mg Pushtronex on-body infusor), manufacturer Amgen, country of origin, pack size, quantity, lot, and expiry
• The destination dispensing facility license number for the SFDA-licensed pharmacy with validated refrigeration
• A cold-chain plan from the US specialty-pharmacy source through international transit with continuous temperature monitoring and excursion logging

Approval timelines for routine cases (registered drug, clear FH or ASCVD documentation) typically run 10 to 21 business days. For pediatric HeFH and HoFH cases the pediatric lipid specialist's letter and the FH diagnosis substantiation are the linchpins of the package.

Where Repatha gets dispensed in Saudi Arabia

Repatha is a refrigerated biologic and must be stored at 2 to 8 degrees Celsius in the original carton, protected from light. The dispensing footprint in the Kingdom is the SFDA-licensed pharmacy network with validated refrigeration, with PCSK9 inhibitor expertise concentrated in tertiary cardiology and lipid centers. Institutions that handle named-patient imports for Repatha as established practice include the cardiology and lipid programs at King Faisal Specialist Hospital and Research Centre (KFSH&RC) in Riyadh and Jeddah (which operates one of the largest FH registries in the Kingdom); King Abdulaziz Medical City (KAMC) and the Ministry of National Guard Health Affairs network (MNGHA) cardiology and cardiac-surgery services; the cardiology programs at Dr. Sulaiman Al Habib Medical Group (HMG) across Riyadh, Jeddah, and the Eastern Province; Saudi German Health; Dr. Soliman Fakeeh Hospital in Jeddah; and Dallah Hospital in Riyadh. Pediatric FH cases route preferentially to KFSH&RC and the pediatric services at KAMC and HMG where pediatric-lipid subspecialty experience is present. Families in tier-2 cities typically route through one of these tertiary centers or through an SFDA-licensed specialty importer in Riyadh or Jeddah.

Once received, an unopened Repatha device may be kept at room temperature (up to 25 degrees Celsius) in the original carton for up to 30 days, after which any unused product must be discarded. This 30-day room-temperature window is genuinely useful for last-mile distribution from the dispensing pharmacy to the patient and for at-home self-administration scheduling.

Real cost picture for Repatha in Saudi Arabia

Amgen reduced the US list price of Repatha by 60 percent in October 2018 (from approximately USD 14,100 per year to USD 5,850 per year). The current WAC is approximately USD 572.70 per 140 mg autoinjector or prefilled syringe, which translates to roughly USD 6,875 per year on the 140 mg every-two-weeks regimen and a similar annual cost on the 420 mg monthly regimen. The Saudi riyal is pegged to the US dollar at approximately 3.75 SAR to 1 USD, so a 140 mg device at US WAC translates to roughly SAR 2,150, and an annual regimen sits at approximately SAR 25,800. By specialty-biologic standards Repatha is at the accessible end of the price spectrum, which materially changes the cross-border calculus relative to traditionally priced monoclonal antibodies.

International cold-chain logistics for Repatha typically runs USD 600 to USD 1,200 per shipment (approximately SAR 2,250 to SAR 4,500) within the validated 96-hour transit envelope Reserve Meds 3PL partners operate. SFDA permit handling fees are nominal. The US-only AmgenNow direct-to-patient program (offering Repatha at approximately USD 239 per month to US cash-paying patients) does not extend to international NPP sourcing. On the insurance side, Bupa Arabia, Tawuniya, and MedGulf Arabia each assess named-patient imports case by case; cardiovascular and FH coverage often appears on Saudi commercial plan formularies and pre-authorisation with the clinical justification letter is common. Reserve Meds supplies the documentation; the claim remains with you or your hospital.

Typical timeline for Repatha in Saudi Arabia

For an established Repatha patient or an FH or ASCVD candidate with a complete clinical letter and prior-therapy documentation, the typical end-to-end cycle is 4 to 7 weeks. The SFDA PIP step generally runs 10 to 21 business days. US-side sourcing through the specialty-pharmacy network adds approximately 1 to 2 weeks, and validated cold-chain transit with Saudi customs clearance typically adds 3 to 5 days. The Pushtronex on-body infusor (the 420 mg monthly device) carries slightly more pharmacy-side handling than the autoinjector or prefilled syringe, which can add 1 to 2 days. Device presentation is locked at firm-quote issuance.

What your physician needs to provide

The clinical justification letter for Repatha is the centrepiece of the SFDA package. For this product the letter typically includes:

• The patient's on-label indication: HeFH (adult or pediatric 10 years and older), HoFH (adult or pediatric 10 years and older), primary hyperlipidemia on maximally tolerated statin requiring additional LDL-C lowering, or established ASCVD for CV risk reduction
• For FH cases: Dutch Lipid Clinic Network criteria score, Simon Broome criteria, or genetic confirmation; family history of premature cardiovascular disease; pediatric or adult age and weight
• For ASCVD cases: documentation of prior myocardial infarction, ischemic stroke, or coronary revascularization
• The current LDL-C level on maximally tolerated statin plus ezetimibe, and the LDL-C target the prescriber is pursuing (typically less than 70 mg/dL for ASCVD, less than 100 mg/dL for HeFH on primary prevention, often more aggressive in HoFH)
• The dosing plan: 140 mg subcutaneously every 2 weeks, or 420 mg subcutaneously once monthly (HoFH starts at 420 mg monthly with option to titrate to 420 mg every 2 weeks after 12 weeks if response is inadequate)
• The monitoring plan: LDL-C measured 4 to 8 weeks after initiation and dose titration, then periodically thereafter; no routine liver function or muscle enzyme monitoring required by the label, in contrast to high-intensity statin therapy
• The SFDA pharmacovigilance commitment for the full course of therapy

Public-sector physicians at KFSH&RC, KAMC, MNGHA, and Ministry of Health hospitals hold full signing authority. Private-sector cardiologists and pediatric-lipid specialists at HMG, Saudi German, Fakeeh, and Dallah sign under their institutional license.

Common questions about Repatha in Saudi Arabia

Will Bupa Arabia, Tawuniya, or MedGulf cover Repatha? Each insurer assesses named-patient imports case by case. PCSK9 inhibitor coverage for FH and post-MI patients often appears on Saudi commercial plan formularies, and pre-authorisation with the clinical justification letter is common. Reserve Meds does not promise coverage. We supply the documentation set that lets your insurer assess the case.

Can my pediatric child receive Repatha? Yes, for HeFH and HoFH the FDA label allows pediatric patients aged 10 and older. The clinical letter must document the FH diagnosis substantiation, the current LDL-C level on maximally tolerated statin plus ezetimibe, and the pediatric weight and age. Reserve Meds will not coordinate intake for patients younger than 10.

Why Repatha rather than alirocumab (Praluent)? Both PCSK9 inhibitors are clinically reasonable choices for the same indication set. Patient and family choice usually drives selection based on prior experience, prescriber familiarity, device preference (Repatha offers a 420 mg monthly Pushtronex on-body infusor that alirocumab does not), and continuity of supply in the patient's home country.

What is the safety profile? Repatha is generally well tolerated. The most common adverse reactions in clinical trials were nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection-site reactions. Serious hypersensitivity reactions including angioedema have been reported and require discontinuation. Refer to the FDA label for the complete safety profile.

Can Repatha be self-administered at home? Yes. The 140 mg autoinjector and the 420 mg on-body infusor are both designed for patient or caregiver self-administration after training. The receiving SFDA-licensed pharmacy provides injection training or refers to the manufacturer's instructions. Reserve Meds can coordinate equivalent training documentation with the patient's home-country prescriber prior to first shipment.

How does Repatha compare to inclisiran (Leqvio)? Inclisiran is a small-interfering-RNA therapy targeting PCSK9 mRNA, with a twice-yearly dosing alternative after initial loading. It is a different mechanism (gene silencing rather than monoclonal antibody) and dosing cadence. The choice between agents is a clinician-driven decision.

Where Reserve Meds fits in Repatha cases

Reserve Meds is a US-based concierge coordinator. We do not replace your cardiologist or lipid specialist, do not replace SFDA, and do not replace the dispensing pharmacy. For Repatha specifically we orchestrate the US-side sourcing through Amgen's specialty-pharmacy network (CVS Specialty, Accredo, Optum Specialty), the regulatory documentation kit your physician needs (on-label indication letter template, FH diagnosis substantiation framework, dosing reference by indication, monitoring plan summary, SFDA pharmacovigilance reference), validated cold-chain logistics with continuous temperature logging within the 96-hour transit envelope, and a single named coordinator who carries the case from intake through recurring fills. Common Saudi profiles include the FH family with pediatric or adult LDL-C uncontrolled on statin plus ezetimibe and the ASCVD secondary-prevention patient seeking continuity of supply.

Next step

If your cardiologist or lipid specialist has documented your FH or ASCVD indication and local stocking is the bottleneck for your Repatha continuity, the named-patient pathway through SFDA is the route. Join the waitlist below and we will confirm eligibility within 24 to 48 hours and route the documentation kit to your physician.

Join the Repatha waitlist

Reserved for you.