Bayer: cross-border access for the specialty portfolio

Quick orientation

Bayer AG is a German multinational headquartered in Leverkusen, Germany, with the US Pharmaceuticals operations based in Whippany, New Jersey. Bayer's specialty footprint is anchored in oncology (Nubeqa for non-metastatic and metastatic castration-resistant prostate cancer; Vitrakvi in NTRK-fusion solid tumors; Stivarga in advanced GI cancers), ophthalmology (Eylea and Eylea HD), cardiovascular and renal (Xarelto co-marketed with Janssen, Kerendia for diabetic kidney disease, Verquvo for heart failure, Adempas joint venture with Merck), and women's health (Mirena, Yaz, and the legacy hormonal contraception franchise).

Portfolio in cross-border NPP scope

Eylea and Eylea HD (aflibercept)

VEGF inhibitor approved for neovascular AMD, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and retinopathy of prematurity. Eylea HD is the high-dose 8mg formulation for extended-interval dosing. International requests come from AMD and DME patients in the Gulf and India where the Eylea HD extended dosing interval is preferred over standard 2mg dosing.

Nubeqa (darolutamide)

Androgen receptor inhibitor approved for non-metastatic CRPC and for metastatic hormone-sensitive prostate cancer in combination with docetaxel. International requests come from prostate cancer patients in MENA and India where Nubeqa specifically is preferred for tolerability over apalutamide or enzalutamide.

Vitrakvi (larotrectinib)

TRK inhibitor approved for adult and pediatric patients with solid tumors harboring NTRK gene fusions. International requests are by definition very small but high-acuity: NTRK-fusion-positive tumors are rare, and cross-border NPP is often the only on-label option in MENA and India.

Kerendia (finerenone)

Non-steroidal mineralocorticoid receptor antagonist approved for chronic kidney disease associated with type 2 diabetes and for symptomatic heart failure. Cross-border requests come from diabetic CKD patients in MENA and India where the locally registered indication is narrower than the US label.

Verquvo (vericiguat)

Soluble guanylate cyclase stimulator approved for symptomatic chronic heart failure with reduced ejection fraction following a recent worsening event. International requests come from heart failure patients in MENA who have failed standard quadruple therapy.

Xarelto (rivaroxaban, co-marketed with Janssen)

Direct factor Xa inhibitor approved for stroke prevention in non-valvular atrial fibrillation, VTE treatment and prophylaxis, peripheral artery disease, and pediatric VTE in children with congenital heart disease. Cross-border requests cluster around the pediatric VTE indication where local registration is limited to adults.

Adempas (riociguat, joint venture with Merck)

Soluble guanylate cyclase stimulator approved for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. International requests come from CTEPH patients in MENA where the CTEPH indication is locally narrow.

Mirena, Kyleena, Jaydess (levonorgestrel intrauterine systems)

Long-acting hormonal contraception IUS products. International requests come from patients in MENA and India where the specific dose presentation or the heavy menstrual bleeding indication is not locally available.

Why patients route Bayer products through cross-border NPP

Three patterns dominate. First, Nubeqa is preferred over alternative androgen-receptor inhibitors specifically because of its tolerability profile. Second, Eylea HD is a recent approval; the extended-interval 8mg dose has not yet been registered in many MENA and India markets. Third, the Vitrakvi NTRK-fusion-tumor population is so small that local availability is the exception. The Bayer Patient Assistance Program is restricted to US residents.

Manufacturer engagement posture

Reserve Meds coordinates Bayer-manufactured US product through DSCSA-compliant specialty wholesaler channels. We are not an authorized Bayer distributor. All Reserve Meds orders are cash-pay at firm-quote pricing.

For Bayer market access teams: Reserve Meds maintains structured demand visibility across the ophthalmology, oncology, cardiometabolic, and rare-disease franchises. If your group is sizing pre-registration demand in MENA and India, we are open to a structured conversation under NDA.

Common cross-border destinations for the Bayer portfolio

The ophthalmology franchise (Eylea, Eylea HD) is heaviest in the Gulf and India. Nubeqa concentrates in prostate cancer specialist centers in India, the UAE, and Saudi Arabia. The cardiovascular and renal franchise (Kerendia, Verquvo, Xarelto) is broad across MENA. Vitrakvi is by definition tertiary specialty referral.

What Reserve Meds provides

For every Bayer product order, Reserve Meds coordinates DSCSA chain-of-custody documentation; cold-chain validated logistics where required; country regulatory pathway expertise covering named-patient import approval, customs clearance, and any required physician declaration; and a single patient-facing coordinator. We do not replace the patient's treating physician. A US-licensed pharmacist reviews every prescription before dispensing.

Next step for patients

Patients or caregivers who have a treating physician's prescription for a Bayer product and want a firm quote can start a request below.

Start a request for a Bayer product

Next step for Bayer teams

If you are on the Bayer access, medical affairs, or international market access team and want to discuss coordinated named-patient program demand from MENA and India, reach us at [email protected]. We will share aggregated demand views under NDA.

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