Roche: cross-border access for the specialty portfolio

Quick orientation

F. Hoffmann-La Roche AG is a Swiss multinational pharmaceutical company headquartered in Basel. In the United States, Roche markets its pharmaceuticals through its wholly owned subsidiary Genentech, headquartered in South San Francisco, California. For cross-border named-patient programs sourcing US product, the operative entity at the FDA-approval and US-wholesale level is typically Genentech; the parent group and global brand is Roche.

The Roche specialty footprint is anchored in oncology and hematology (Kadcyla, Perjeta, Phesgo; the Tecentriq franchise; Polivy and Columvi in lymphoma), neuroscience (Ocrevus in multiple sclerosis; Evrysdi in spinal muscular atrophy), hematology (Hemlibra in hemophilia A), ophthalmology (Vabysmo), and rare disease (Esbriet, Xolair co-marketed with Novartis).

Portfolio in cross-border NPP scope

Ocrevus (ocrelizumab)

Anti-CD20 monoclonal antibody approved for relapsing forms of multiple sclerosis and for primary progressive MS (the first FDA-approved therapy for PPMS). US WAC at twice-yearly maintenance runs at approximately $74,000 per year. Cross-border requests cluster heavily around PPMS patients in MENA and India where locally registered MS biologics cover only relapsing-remitting MS.

Hemlibra (emicizumab)

Bispecific antibody for hemophilia A prophylaxis with or without factor VIII inhibitors. US WAC at maintenance has historically run at approximately $480,000 per patient per year. Cross-border requests come predominantly from pediatric hemophilia A patients in MENA, India, and Egypt where the subcutaneous schedule replaces a prior factor VIII intravenous burden and where inhibitor-positive coverage is locally limited.

Evrysdi (risdiplam)

Oral SMN2 splicing modifier for spinal muscular atrophy age two months and older. US WAC at weight-banded adult dosing runs at approximately $340,000 per year. Cross-border requests come from SMA patients in MENA and India where intrathecal nusinersen requires repeat lumbar punctures or where the oral route is preferred for very young infants.

Enspryng (satralizumab)

IL-6 receptor antagonist for anti-AQP4-IgG-positive neuromyelitis optica spectrum disorder. International requests cluster around adolescent and adult NMOSD patients in MENA and India where local options are limited to off-label rituximab.

Kadcyla, Perjeta, and Phesgo

The HER2-targeted franchise: Kadcyla (trastuzumab emtansine) for HER2-positive early breast cancer residual disease and metastatic disease; Perjeta plus trastuzumab plus chemotherapy as standard for HER2-positive neoadjuvant and metastatic; Phesgo is the subcutaneous fixed-dose combination. Cross-border requests cluster around the early-breast adjuvant Kadcyla indication and around Phesgo subcutaneous where Gulf and India clinics prefer the lower chair-time alternative.

Polivy (polatuzumab vedotin)

CD79b-directed antibody-drug conjugate approved (in combination with R-CHP) for previously untreated diffuse large B-cell lymphoma. Reserve Meds coordinates Polivy primarily for first-line DLBCL patients in MENA where Pola-R-CHP has not yet been added to the local payer formulary despite NCCN category 1 listing.

Columvi (glofitamab)

CD20 and CD3-directed bispecific T-cell engager for relapsed and refractory DLBCL after two or more prior lines. International requests come from relapsed and refractory DLBCL patients in MENA and India where salvage options after CAR-T failure are limited.

Vabysmo (faricimab)

Bispecific antibody targeting VEGF-A and Ang-2 for neovascular AMD, diabetic macular edema, and macular edema following retinal vein occlusion. International requests cluster around AMD and DME patients in the Gulf and India where the extended dosing interval (up to every 16 weeks) reduces clinic burden.

Why patients route Roche products through cross-border NPP

Three patterns dominate. First, primary progressive MS and inhibitor-positive hemophilia A are indication-specific gaps where Ocrevus and Hemlibra are the FDA-labeled answer and locally registered alternatives are off-label or unavailable. Second, the HER2 franchise carries indication-expansion gaps in MENA payer systems where adjuvant or neoadjuvant use, or the Phesgo subcutaneous presentation, may not be added locally for one or two years after FDA approval. Third, Genentech Access Solutions is restricted to US residents. International patients route as cash-pay.

Manufacturer engagement posture

Reserve Meds coordinates Roche-manufactured, Genentech-distributed US product through DSCSA-compliant specialty wholesaler channels. We are not an authorized Roche or Genentech distributor; we are an independent named-patient program coordinator. Patient assistance program coverage does not extend to cross-border patients. All Reserve Meds orders are cash-pay at firm-quote pricing.

For Roche and Genentech market access, medical affairs, and international new product planning teams: Reserve Meds maintains structured demand visibility across oncology, neurology, ophthalmology, and rare-disease franchises. If your group is sizing pre-registration demand or evaluating named-patient program activity in MENA and India, we are open to a structured conversation under NDA.

Common cross-border destinations for the Roche portfolio

Ocrevus and Evrysdi demand concentrates in the UAE, Saudi Arabia, India, and Egypt. Hemlibra is heaviest in pediatric hemophilia centers in India, Egypt, and the Gulf. The HER2 oncology franchise tracks oncology specialist concentration in Saudi Arabia, UAE, India, and Egypt. Vabysmo and ophthalmology requests originate primarily from the Gulf.

What Reserve Meds provides

For every Roche 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 Roche product and want a firm quote can start a request below.

Start a request for a Roche product

Next step for Roche teams

If you are on the Roche 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.

Reserved for you.