AstraZeneca: cross-border access for the specialty portfolio

Quick orientation

AstraZeneca PLC is a UK-headquartered biopharmaceutical company based in Cambridge, England, with substantial US operations in Wilmington, Delaware, and Gaithersburg, Maryland. The 2021 acquisition of Alexion brought the complement-pathway rare-disease franchise under the AstraZeneca umbrella as the Alexion Rare Disease division. AstraZeneca's specialty footprint is anchored in oncology (Tagrisso, Imfinzi, Calquence, Lynparza co-marketed with Merck, Enhertu co-marketed with Daiichi Sankyo, Truqap), respiratory and immunology (Fasenra, Tezspire, Saphnelo), cardiovascular and renal (Farxiga, Wainua for hATTR amyloidosis), and rare disease through Alexion.

Portfolio in cross-border NPP scope

Tagrisso (osimertinib)

Third-generation EGFR-TKI approved for first-line metastatic EGFR-mutated NSCLC, adjuvant EGFR-mutated NSCLC after tumor resection, and unresectable stage III EGFR-mutated NSCLC after chemoradiation. US WAC at the 80mg daily dose runs above $19,000 per month. Cross-border requests cluster around adjuvant NSCLC patients in India and the Gulf where adjuvant Tagrisso has not yet been added to the local formulary.

Enhertu (trastuzumab deruxtecan)

HER2-directed antibody-drug conjugate co-marketed with Daiichi Sankyo, approved across HER2-positive breast cancer (post-trastuzumab), HER2-low and HER2-ultralow breast cancer, HER2-positive gastric cancer, HER2-mutant NSCLC, and HER2-expressing solid tumors. Cross-border demand is heavy across all three breast cancer expansion indications where MENA and India payer formularies have lagged.

Calquence (acalabrutinib)

Second-generation BTK inhibitor approved for chronic lymphocytic leukemia, small lymphocytic lymphoma, and mantle cell lymphoma. International requests come from CLL and MCL patients in MENA and India who experience cardiovascular tolerability issues on ibrutinib.

Imfinzi (durvalumab)

PD-L1 inhibitor approved across unresectable stage III NSCLC after chemoradiation, extensive-stage SCLC, biliary tract cancer, hepatocellular carcinoma, and other indications. Cross-border requests come from oncology patients in MENA where indication-specific PD-L1 access is constrained.

Lynparza (olaparib, co-marketed with Merck)

PARP inhibitor approved across BRCA-mutated breast, ovarian, prostate, and pancreatic cancers. International requests come from patients with homologous-recombination-deficient tumors in MENA and India where the latest combination indication or HRD-subgroup labeling is not yet locally registered.

Truqap (capivasertib)

AKT inhibitor approved for HR-positive HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations. Cross-border requests come from advanced breast cancer patients with confirmed AKT-pathway mutations.

Fasenra (benralizumab) and Tezspire (tezepelumab)

Fasenra is an anti-IL-5-receptor monoclonal antibody for severe eosinophilic asthma; Tezspire is an anti-TSLP monoclonal antibody for severe asthma regardless of phenotype. International requests come from severe asthma patients in the Gulf and India who have failed biologics targeting other inflammatory pathways.

Saphnelo (anifrolumab)

Anti-type-I-interferon-receptor monoclonal antibody approved for moderate to severe systemic lupus erythematosus. International requests come from SLE patients in MENA and India where the locally available SLE biologics are limited.

Wainua (eplontersen, co-marketed with Ionis)

Antisense oligonucleotide for hereditary transthyretin-mediated amyloidosis polyneuropathy. Reserve Meds coordinates Wainua predominantly for hATTR patients in MENA and India where the genetic-mutation-confirmed indication is recognized but local product is not yet available.

Soliris, Ultomiris, Voydeya, Strensiq, Kanuma (Alexion Rare Disease)

The Alexion complement and metabolic rare-disease franchise. Cross-border requests for the C5 franchise concentrate in PNH, aHUS, and gMG specialty centers in MENA and India.

Why patients route AstraZeneca products through cross-border NPP

Three patterns dominate. First, the oncology indication expansion velocity outpaces MENA and India payer formulary updates. Second, the Alexion Rare Disease franchise is by definition for very small patient populations where local registration may simply not exist. Third, AZandMe Patient Savings Program and Alexion OneSource are restricted to US residents.

Manufacturer engagement posture

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

For AstraZeneca and Alexion Rare Disease market access teams: Reserve Meds maintains structured demand visibility across the oncology, rare-disease, and respiratory 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 AstraZeneca portfolio

The oncology franchise (Tagrisso, Enhertu, Calquence, Imfinzi, Lynparza, Truqap) concentrates in India, Saudi Arabia, UAE, and Egypt. Respiratory and immunology (Fasenra, Tezspire, Saphnelo) skews to the Gulf and India. The Alexion Rare Disease franchise serves tertiary specialty centers in the UAE, Saudi Arabia, India, and Egypt.

What Reserve Meds provides

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

Start a request for a AstraZeneca product

Next step for AstraZeneca teams

If you are on the AstraZeneca 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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