Merck: cross-border access for the specialty portfolio

Quick orientation

Merck and Co., Inc. is a US-headquartered research-based pharmaceutical company based in Rahway, New Jersey. Outside the United States and Canada, the company operates as Merck Sharp and Dohme (MSD) to distinguish itself from the German Merck KGaA. For Reserve Meds named-patient program purposes, the US FDA-approved product is Merck-branded and the cross-border patient may already know the same molecule under MSD branding in their home country.

Merck's specialty footprint is anchored in oncology and immuno-oncology (Keytruda), pulmonary and cardiovascular rare disease (Winrevair for PAH; the Adempas joint venture), vaccines (Gardasil 9, Pneumovax, M-M-R II), antibiotics and infectious disease (Zerbaxa, Recarbrio, Bridion, Prevymis), diabetes (Januvia, Janumet legacy), and rare oncology (Welireg for VHL and RCC).

Portfolio in cross-border NPP scope

Keytruda (pembrolizumab)

Anti-PD-1 monoclonal antibody approved across more than thirty oncology indications spanning lung cancer, melanoma, head and neck cancer, urothelial carcinoma, gastric cancer, breast cancer (triple-negative), endometrial cancer, hepatocellular carcinoma, classical Hodgkin lymphoma, and others. US WAC at the 200mg every-three-weeks or 400mg every-six-weeks adult schedule runs at approximately $11,000 per dose. Cross-border requests cluster around newly added indications (triple-negative breast cancer adjuvant, gastric cancer first-line combinations, perioperative non-small-cell lung cancer) that have not yet been added locally.

Winrevair (sotatercept)

Activin signaling inhibitor approved 2024 for pulmonary arterial hypertension in combination with background PAH therapy. International requests come overwhelmingly from PAH patients in MENA and India who have failed triple combination therapy.

Welireg (belzutifan)

Oral HIF-2-alpha inhibitor for VHL disease-associated RCC, CNS hemangioblastomas, pancreatic neuroendocrine tumors, and advanced RCC following PD-1 and VEGF therapy. Cross-border requests come predominantly from VHL patients and RCC patients in MENA and India who have failed prior systemic therapy.

Lynparza (olaparib, co-marketed with AstraZeneca)

PARP inhibitor approved across BRCA-mutated breast, ovarian, prostate, and pancreatic cancers. US WAC at the 600mg daily dose runs above $17,000 per month. International requests come from patients in MENA and India routing through specialist oncology centers where the latest combination indication or homologous-recombination-deficient subgroup is not yet locally registered.

Reblozyl (luspatercept, co-marketed with BMS)

Erythroid maturation agent approved for anemia in beta-thalassemia requiring transfusions and for anemia in MDS. Reserve Meds coordinates Reblozyl primarily for adult beta-thalassemia patients in MENA where the transfusion-dependent indication is locally narrow.

Prevymis (letermovir) and Bridion (sugammadex)

Prevymis for prophylaxis of CMV infection in allogeneic HSCT and high-risk kidney transplant. Bridion for reversal of rocuronium- or vecuronium-induced neuromuscular blockade. Cross-border requests come from transplant centers in the Gulf.

Gardasil 9

Nine-valent HPV vaccine for prevention of cervical and other HPV-related cancers and genital warts in ages 9 through 45. International requests come from adult patients in MENA and India who fall outside the locally reimbursed adolescent age band but want the catch-up schedule.

Why patients route Merck products through cross-border NPP

Two patterns dominate. First, Keytruda indication expansion: the gap between US approval of a new Keytruda indication and the corresponding MSD label addition in MENA and India can be one to three years. Second, Winrevair and Welireg are too new globally for most MENA and India labels to have caught up.

The Merck Patient Assistance Program is restricted to US residents. International patients route as cash-pay through the named-patient pathway.

Manufacturer engagement posture

Reserve Meds coordinates Merck-manufactured US product through DSCSA-compliant specialty wholesaler channels. We are not an authorized Merck or MSD distributor. The Merck Patient Assistance Program does not extend to cross-border patients. All Reserve Meds orders are cash-pay at firm-quote pricing.

For Merck and MSD market access, medical affairs, and international new product planning teams: Reserve Meds maintains structured demand visibility across Keytruda combinations, Winrevair and Welireg rare-disease, and Lynparza PARP. If your group is sizing pre-registration or post-FDA-pre-MSD-label demand in MENA and India, we are open to a structured conversation under NDA.

Common cross-border destinations for the Merck portfolio

The Keytruda oncology franchise concentrates in Saudi Arabia, UAE, India, and Egypt. Winrevair and Welireg are heaviest in tertiary PAH and rare-disease centers in the Gulf and India. Lynparza tracks oncology demand. Reblozyl and beta-thalassemia demand is heaviest in India and Egypt.

What Reserve Meds provides

For every Merck product order, Reserve Meds coordinates DSCSA chain-of-custody documentation from the US specialty wholesaler through to the patient's destination clinician; 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 who carries the case from initial inquiry through delivery confirmation. We do not replace the patient's treating physician. A US-licensed pharmacist reviews every prescription before the order is released for dispensing.

Next step for patients

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

Start a request for a Merck product

Next step for Merck teams

If you are on the Merck 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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