Ziihera's August 25 Gastric Decision: Bispecific vs Trastuzumab Biosimilars

On August 25, 2026, the U.S. Food and Drug Administration (FDA) is scheduled to act on the supplemental Biologics License Application (sBLA) for Ziihera (zanidatamab-hrii, BLA 761416), submitted by Jazz Pharmaceuticals with regimens that pair it with BeOne Medicines' (formerly BeiGene) Tevimbra (tislelizumab-jsgr). The sBLA seeks approval for zanidatamab in combination with fluoropyrimidine- and platinum-based chemotherapy, with or without Tevimbra, for the first-line (1L) treatment of adult patients with HER2-positive locally advanced unresectable or metastatic gastroesophageal adenocarcinoma (GEA), encompassing gastric and gastroesophageal junction (GEJ) cancers.

The pending decision represents a pivotal moment in oncology market access and therapeutic pathway design. For more than fifteen years—dating back to the landmark ToGA trial that established trastuzumab combined with cisplatin and fluorouracil or capecitabine in 2010—the first-line treatment foundation for HER2-positive gastric and GEJ adenocarcinoma has been anchored to trastuzumab. Over the past decade, patent expiries and biologic competition have transformed trastuzumab into a deeply commoditized multi-source molecule represented by six licensed biosimilar products across 12 distinct presentation rows in the FDA Purple Book.

Ziihera’s pivotal global Phase 3 trial, HERIZON-GEA-01, demonstrated a statistically significant and clinically meaningful overall survival (OS) advantage when zanidatamab was administered as a triplet alongside tislelizumab and chemotherapy. But for oncology pathway committees, commercial health plans, Medicare Advantage medical directors, and hospital buy-and-bill administrators, Ziihera’s arrival creates a profound structural challenge: displacing an inexpensive, multi-source biosimilar backbone with a premium, dual-branded antibody combination that dramatically increases per-patient drug spend.

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What FDA is deciding by August 25, 2026: sBLA scope and label asymmetry

FDA accepted Jazz’s sBLA with Priority Review on April 27, 2026, setting the August 25, 2026 PDUFA target action date. The submission is supported by the global Phase 3 HERIZON-GEA-01 trial (n = 914), which randomized treatment-naive patients across centers in North America, Europe, Asia, and Latin America (ClinicalTrials.gov NCT05152147).

The critical regulatory and formulary question is which treatment combinations the FDA will include in the approved labeled indication. The trial evaluated two experimental zanidatamab regimens against an active control arm:

1. The Triplet Arm (Zanidatamab + Tislelizumab + Chemotherapy): This arm demonstrated superior progression-free survival (PFS) and definitive, statistically significant overall survival (OS) superiority compared to the trastuzumab plus chemotherapy control arm.
2. The Doublet Arm (Zanidatamab + Chemotherapy): This arm met its primary PFS endpoint with statistical significance, but its OS advantage had not crossed the prespecified statistical significance boundary at the primary data cutoff (October 2025).

This evidence structure creates three possible regulatory outcomes that payers must prepare for:

• Broad Approval (Both Triplet and Doublet): FDA approves zanidatamab with chemotherapy with or without tislelizumab. This outcome grants oncologists clinical flexibility to omit immunotherapy in patients with autoimmune comorbidities, poor performance status, or low PD-L1 expression.
• Restricted Approval (Triplet Only): FDA restricts first-line approval exclusively to the triplet combination based on the definitive overall survival superiority. In this scenario, every first-line zanidatamab patient will require concurrent administration of Tevimbra, establishing a dual-branded biologic standard.
• Split Labeling by Biomarker Subgroups: FDA approves the triplet for patients with concurrent PD-L1 expression (e.g., CPS ≥ 1) and restricts the doublet to PD-L1 negative cohorts.

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HERIZON-GEA-01 evidence read: PFS gains and the OS survival delta

The pivotal Phase 3 HERIZON-GEA-01 trial enrolled 914 patients with centrally confirmed HER2-positive locally advanced unresectable or metastatic gastroesophageal adenocarcinoma. Patients were randomized 1:1:1 to:

• Arm A: Trastuzumab + Chemotherapy (n = 308, active control)
• Arm B: Zanidatamab + Chemotherapy (n = 304, doublet)
• Arm C: Zanidatamab + Tislelizumab + Chemotherapy (n = 302, triplet)

Chemotherapy was investigator-selected prior to randomization between a CAPOX backbone (capecitabine plus oxaliplatin) or an FP backbone (infusional fluorouracil plus cisplatin).

Primary efficacy outcomes

At the primary analysis (data cutoff October 2025, median follow-up 25.9 months), blinded independent central review (BICR) confirmed, per the New England Journal of Medicine publication:

1. Progression-Free Survival:
   • Triplet Arm: Median PFS was 12.4 months compared to 8.1 months in the trastuzumab control arm (95% CI 9.8–18.5 vs 7.0–8.9 per the ASCO GI symposium report), representing a 37% reduction in the risk of disease progression or death (Hazard Ratio [HR] = 0.63; 95% CI: 0.51–0.78; p < 0.001).
   • Doublet Arm: Median PFS was also 12.4 months, with a statistically significant improvement over trastuzumab control (HR = 0.65; 95% CI: 0.52–0.81; p < 0.001). Both zanidatamab arms met the PFS primary endpoint.
2. Overall Survival:
   • Triplet Arm: Median OS was 26.4 months for zanidatamab plus tislelizumab plus chemotherapy versus 19.2 months for trastuzumab plus chemotherapy. This 7.2-month absolute survival extension was statistically significant (HR = 0.72; 95% CI: 0.57–0.90; p = 0.004).
   • Doublet Arm: Median OS was 24.4 months, a numerical advantage that did not reach statistical significance at this interim analysis (HR = 0.80; 95% CI: 0.64–1.01; p = 0.06).

Biological mechanism of biparatopic engagement

Zanidatamab is an engineered humanized IgG1 bispecific antibody utilizing Azymetric heterodimerization technology. Unlike trastuzumab (which binds exclusively to juxtamembrane extracellular domain IV) or pertuzumab (which binds exclusively to dimerization extracellular domain II), zanidatamab simultaneously engages both subdomain IV and subdomain II on opposite sides of the same HER2 receptor, as well as cross-linking adjacent HER2 homodimers and HER2/HER3 heterodimers.

This biparatopic binding produces three synergistic anti-tumor mechanisms:

• Trans-Receptor Crosslinking and Clustering: Induces massive spatial clustering of HER2 receptors on the cell membrane, preventing lateral diffusion and trans-activation with HER3, EGFR, and HER4.
• Rapid Receptor Endocytosis and Downregulation: Accelerates internalization and lysosomal degradation of surface HER2, depleting the oncogenic driving signal.
• Potent Immune Effector Function: The engineered Fc domain retains full binding affinity for FcγRIIIa receptors on natural killer (NK) cells and macrophages, stimulating robust antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

When combined with tislelizumab—an anti-PD-1 monoclonal antibody engineered with a modified Fc region that minimizes binding to FcγR on macrophages, thereby reducing antibody-dependent macrophage-mediated killing of effector T cells—the combination reverses tumor-mediated immune exhaustion while simultaneously driving antibody-dependent tumor lysis.

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First-line gastric cancer competitive landscape: cross-regimen comparison

To understand how Ziihera fits into clinical pathways, managed care pharmacy directors must compare HERIZON-GEA-01 data against competing first-line biomarker-driven regimens in gastroesophageal adenocarcinoma:

Within this set of front-line benchmarks, HERIZON-GEA-01's triplet reports the longest median overall survival—though cross-trial comparisons are not head-to-head evidence, and each trial enrolled different biomarker populations and control regimens.

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Current Ziihera label vs the expanded 1L gastric setting

Ziihera currently holds a single FDA indication granted under accelerated approval on November 20, 2024:

• Current Accelerated Label: Treatment of adult patients with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved companion diagnostic. This approval was based on the Phase 2b HERIZON-BTC-01 trial demonstrating an objective response rate of 52% (95% CI: 39–65) and a median duration of response of 14.9 months. Continued approval remains contingent upon verification of clinical benefit in the ongoing confirmatory Phase 3 HERIZON-BTC-302 trial.
• Pending First-Line GEA Label: The sBLA seeks traditional, full approval for first-line treatment of HER2-positive gastroesophageal adenocarcinoma based on statistically verified progression-free and overall survival endpoints from the randomized Phase 3 HERIZON-GEA-01 study.

Ziihera is licensed under BLA 761416 in the FDA Purple Book. Third-party regulatory aggregators that have erroneously cited BLA 761375 for the pending decision (761375 is an unrelated biologic—the lecanemab-irmb product licensed August 2025) should be disregarded by coding and contracting teams.

For broader analysis of how bispecific platforms are reshaping market access across solid and hematologic tumors, see our bispecific antibody access landscape. For meeting-wide practice shifts, see ASCO 2026 practice-changing results and formulary implications.

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The trastuzumab displacement economics: 6 biosimilars vs dual-branded mAbs

The core dilemma for managed care organizations is financial displacement.

In first-line HER2-positive gastric cancer, trastuzumab has served as the universal therapeutic anchor since 2010. Today, the FDA Purple Book records six licensed trastuzumab biosimilar products across 12 presentation rows:

• Ogivri (trastuzumab-dkst, BLA 761074 / Biocon Biologics, commercialized by Viatris): Licensed Dec 1, 2017
• Herzuma (trastuzumab-pkrb, BLA 761091 / Celltrion): Licensed Dec 14, 2018
• Ontruzant (trastuzumab-dttb, BLA 761100 / Samsung Bioepis, commercialized by Organon): Licensed Jan 18, 2019
• Trazimera (trastuzumab-qyyp, BLA 761081 / Pfizer): Licensed Mar 11, 2019
• Kanjinti (trastuzumab-anns, BLA 761073 / Amgen): Licensed Jun 13, 2019
• Hercessi (trastuzumab-strf, BLA 761346 / Accord BioPharma, developed with Shanghai Henlius): Licensed Apr 25, 2024

None of the six is licensed as interchangeable, so pharmacy-level substitution does not apply, but payer preferred-biosimilar tiering has driven multi-source competition and deep acquisition-cost discounts relative to originator Herceptin across the past several years.

The budget multiplication effect

When an oncology pathway transitions from biosimilar-discounted trastuzumab to Ziihera:

1. Doublet Regimen: Replaces a biosimilar-discounted HER2 antibody with a premium branded bispecific carrying newly launched, undiscounted pricing.
2. Triplet Regimen: Adds a second premium branded antibody (Tevimbra) on top of Ziihera—two undiscounted branded biologics in the same infusion cycle, versus a backbone that payers currently acquire at biosimilar economics.

Plans should model the delta from their own trastuzumab biosimilar ASP experience against the branded components' list pricing and expected gross-to-net, rather than relying on any single published figure; the local snapshots used for this analysis carry no pricing fields.

Contrast with KEYNOTE-811 standard

Payers will also compare Ziihera triplet economics to the regimen established by KEYNOTE-811: pembrolizumab (Keytruda) + trastuzumab biosimilar + chemotherapy.

In KEYNOTE-811, only one component (pembrolizumab) is a premium-priced branded biologic, while the HER2 backbone remains low-cost biosimilar trastuzumab. In the Ziihera triplet, both antibodies are premium-priced branded biologics, creating substantial gross-to-net budget sensitivity for commercial plans and Medicare Advantage sponsors.

To review comparative biosimilar pricing dynamics, see our deep dive on Herceptin biosimilars compared.

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Tevimbra's role: expanding beyond HER2-negative gastric cancer

The second component of the triplet—Tevimbra (tislelizumab-jsgr)—holds three FDA approvals:

• March 13, 2024: Second-line (2L) esophageal squamous cell carcinoma (ESCC) monotherapy after prior chemotherapy.
• December 26, 2024: First-line (1L) HER2-negative gastric or GEJ adenocarcinoma with PD-L1 score ≥ 1 plus fluoropyrimidine- and platinum-based chemotherapy (Orphan Drug Exclusivity through December 26, 2031).
• March 4, 2025: First-line (1L) unresectable locally advanced or metastatic ESCC with chemotherapy.

Currently, Tevimbra's gastric indication is explicitly restricted to HER2-negative tumors. If the Ziihera sBLA is approved, it will mark the first time Tevimbra is utilized in a HER2-positive gastric population, creating a unified gastric footprint across both HER2-negative and HER2-positive subtypes.

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HER2 diagnostic workflow: IHC/ISH standards and PA denial prevention

Securing timely access for 1L GEA patients requires navigating strict companion diagnostic criteria. Gastric cancer HER2 biology differs fundamentally from breast cancer:

1. Spatial Heterogeneity: Gastric adenocarcinomas exhibit high rates of focal and heterogeneous HER2 expression (up to 30% of cases), requiring lower cell-percentage thresholds for positivity.
2. Incomplete Basolateral Staining: Due to glandular architecture, complete circular membrane staining is not required for gastric biopsy specimens; lateral or basolateral membranous reactivity is sufficient.
3. FDA Testing Criteria:
   • IHC 3+ (Positive): Strong complete, basolateral, or lateral membranous reactivity in ≥ 10% of surgical cells (or a cluster of ≥ 5 biopsy cells).
   • IHC 2+ (Equivocal): Weak-to-moderate basolateral staining; must be reflex-tested by In-Situ Hybridization (ISH) showing HER2:CEP17 ratio ≥ 2.0 or HER2 gene copy number ≥ 6.0 signals/cell.

Pathology billing and coding

Clinical pathology laboratories utilize the following CPT codes when evaluating HER2 status in gastric specimens:

• CPT 88360: Morphometric analysis, tumor immunohistochemistry (IHC) quantitative or semiquantitative, each antibody (manual).
• CPT 88361: Morphometric analysis, tumor IHC, using computer-assisted image analysis, each antibody.
• CPT 88365: In situ hybridization (ISH), each probe (e.g., FISH/SISH reflex testing for IHC 2+ equivocal specimens).
• CPT 88368: Morphometric analysis, in situ hybridization, manual, each probe.

Payers must align prior authorization criteria with NCCN and CAP/ASCO gastric scoring guidelines. Rejecting claims because a pathology report documents "IHC 2+ with ISH amplification" rather than "IHC 3+" represents a major point of administrative friction that delays first-line cycle initiation.

For an operational blueprint on avoiding companion diagnostic coverage rejections, see our guide on companion diagnostic denials in oncology prior authorization.

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Buy-and-bill and coding mechanics: dual-antibody infusion management

Because Ziihera and Tevimbra are administered via intravenous infusion in outpatient hospital and community oncology clinics, health plans and practice managers must coordinate several operational touchpoints:

1. HCPCS Reimbursement: Both components already have permanent product-specific J-codes: Ziihera bills under J9276 (injection, zanidatamab-hrii, 2 mg; effective July 1, 2025, after a brief transitional C9302 window) and Tevimbra under J9329 (injection, tislelizumab-jsgr, 1 mg; effective October 1, 2024). That means no interim miscellaneous-code (J9999/J3590) billing window for this regimen—a meaningful operational simplification—but practices must still track the two products' different dose units and NDCs on the same claim.
2. Chair Time and Sequencing: Administering two monoclonal antibodies alongside multi-agent chemotherapy materially extends infusion chair time per cycle versus a single-antibody regimen. Clinical order sets should sequence the two antibodies with premedication to minimize infusion-related reaction (IRR) overlap.
3. Site of Care Management: Commercial payers enforce site-of-care steerage policies redirecting infusions from high-cost hospital outpatient departments (HOPDs) to freestanding community oncology clinics or ambulatory infusion centers.

For detailed guidance on mitigating claim rejections during interim billing windows, review our analysis of J-code timing and interim billing risk for buy-and-bill biologics and site-of-care edits for IV specialty drugs.

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Toxicity profile and utilization management: diarrhea mitigation and dosing rules

P&T committees and oncology nursing teams must incorporate specific adverse-event monitoring and dose-modification protocols into order sets before opening pathway access for Ziihera combinations:

• Diarrhea Management: Diarrhea was the most common grade 3 or higher adverse event in HERIZON-GEA-01, and the NEJM publication quantifies it precisely: grade 3 or higher diarrhea occurred in 24.8% of triplet-arm patients and 20.0% of doublet-arm patients versus 12.9% on trastuzumab plus chemotherapy—roughly double the control rate. Order sets should ensure antidiarrheal access and patient counseling from Cycle 1 Day 1, and utilization management should expect the higher toxicity-driven dose-interruption rate in the triplet.
• Infusion-Related Reactions (IRRs): IRRs occur predominantly during Cycle 1 (manifesting as fever, chills, rigors, flushing, or dyspnea). Order sets should provide premedication consistent with the labeling before the first infusion.
• Cardiotoxicity and LVEF Monitoring: Like all HER2-targeted biologics, zanidatamab carries left-ventricular dysfunction risk. Prior authorization criteria should require baseline LVEF assessment (echocardiogram or MUGA scan) with periodic re-assessment during therapy, consistent with HER2-targeted labeling conventions.
• Immune-Mediated Adverse Reactions: In the triplet regimen, the tislelizumab component requires baseline and periodic monitoring of thyroid function tests (TSH, free T4), liver function tests (AST, ALT, total bilirubin), and serum creatinine, with clinical surveillance for immune-mediated pneumonitis, colitis, and endocrinopathies.

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Second-line sequencing after first-line Ziihera: the ADC transition

A critical unanswered question for formulary planners is how front-line zanidatamab exposure affects subsequent second-line (2L) efficacy:

• Incumbent Sequencing: Patients progressing on first-line trastuzumab plus chemotherapy traditionally transition to Enhertu (fam-trastuzumab deruxtecan-nxki, BLA 761139) based on the DESTINY-Gastric01 and DESTINY-Gastric02 trials, or receive ramucirumab (Cyramza) plus paclitaxel.
• Post-Zanidatamab ADC Sensitivity: Whether HER2 expression persists after prolonged zanidatamab exposure at a level that supports subsequent HER2-directed ADC activity is an open biological question—zanidatamab's mechanism includes receptor internalization, and the trials have not yet characterized re-biopsy HER2 status after progression. Payers should prepare re-biopsy or liquid-biopsy circulating tumor DNA (ctDNA) coverage policies to confirm persistent HER2 amplification prior to approving second-line HER2-directed ADCs.

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P&T Committee Action Plan ahead of August 25

Oncology pathway committees and payer medical directors should prepare for the August 25 decision with four proactive steps:

1. Model Pathway Budget Impact: Quantify the financial impact of shifting 30% to 50% of 1L HER2+ GEA patients from biosimilar trastuzumab regimens to the Ziihera triplet, weighing the 7.2-month OS gain against net drug cost increases.
2. Establish Label-Specific Prior Authorization: Draft flexible PA criteria that accommodate both doublet and triplet approvals, ensuring clear step-therapy exceptions for patients with contraindications to immunotherapy.
3. Engage in Value-Based Pathway Contracting: Seek value-based net pricing agreements with Jazz and BeOne that offer risk-sharing rebates if real-world treatment duration or survival fails to mirror HERIZON-GEA-01 benchmarks.
4. Preserve Biosimilar Trastuzumab Utilization in Non-Converting Cohorts: Maintain strict preferred biosimilar tiering for patients who remain on standard trastuzumab plus chemotherapy or who progress to second-line HER2-directed antibody-drug conjugates (ADCs).

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Frequently Asked Questions

When is the FDA decision expected for Ziihera in first-line gastric cancer?

FDA accepted the sBLA with Priority Review, setting the PDUFA target action date for August 25, 2026.

What did the HERIZON-GEA-01 trial demonstrate?

The Phase 3 trial demonstrated that zanidatamab + tislelizumab + chemotherapy (triplet) significantly prolonged median progression-free survival (12.4 vs 8.1 months, HR 0.63) and median overall survival (26.4 vs 19.2 months, HR 0.72, p = 0.004) compared to standard trastuzumab + chemotherapy. The zanidatamab + chemotherapy doublet also prolonged progression-free survival (12.4 months, HR 0.65), but its overall survival advantage had not reached statistical significance at the interim analysis (24.4 months, HR 0.80, p = 0.06).

Is Ziihera currently FDA-approved for any other indication?

Yes. Ziihera received accelerated approval on November 20, 2024, for previously treated HER2-positive (IHC 3+) unresectable or metastatic biliary tract cancer (BTC).

Why does Ziihera displace trastuzumab biosimilars?

Trastuzumab has been the first-line HER2 backbone for over a decade and is available from six licensed biosimilars. Ziihera's Phase 3 superiority data positions it to replace trastuzumab as the new preferred HER2-targeted agent in 1L GEA.

How does Ziihera's mechanism differ from trastuzumab?

Zanidatamab is a biparatopic bispecific antibody that binds simultaneously to two distinct HER2 domains (subdomains II and IV), promoting dual receptor blockade, receptor clustering, rapid internalization, and enhanced immune-mediated tumor killing.

What is the correct BLA number for Ziihera?

Ziihera is licensed under BLA 761416 in the FDA Purple Book (correcting third-party calendar references to 761375).

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Sources

• Jazz Pharmaceuticals plc. Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental Biologics License Application for Ziihera (zanidatamab-hrii) Combinations in First-Line HER2-Positive Gastroesophageal Adenocarcinoma. PR Newswire, April 27, 2026.
  https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-supplemental-biologics-license-application-for-ziihera-zanidatamab-hrii-combinations-in-first-line-her2-locally-advanced-or-metastatic-gea-302753741.html
• New England Journal of Medicine (NEJM). Zanidatamab with and without Tislelizumab in HER2-Positive Gastroesophageal Cancer (HERIZON-GEA-01). Shitara K, Elimova E, Liu T, et al. N Engl J Med 2026;394(20):2002-2014. PubMed ID: 42202319.
  https://pubmed.ncbi.nlm.nih.gov/42202319/
• Journal of Clinical Oncology (JCO). Zanidatamab + chemotherapy +/- tislelizumab for first-line HER2-positive gastroesophageal adenocarcinoma: Primary results from the phase 3 HERIZON-GEA-01 study. ASCO GI Cancers Symposium 2026, Abstract LBA285.
  https://ascopubs.org/doi/10.1200/JCO.2026.44.2_suppl.LBA285
• U.S. Food and Drug Administration (FDA). FDA Grants Accelerated Approval to Zanidatamab-hrii for Previously Treated, Unresectable or Metastatic HER2-Positive Biliary Tract Cancer. FDA Approval Notice, November 20, 2024.
  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanidatamab-hrii-previously-treated-unresectable-or-metastatic-her2
• FDA Purple Book: Database of Licensed Biological Products. Biologics License Application Records: Ziihera (BLA 761416) and Trastuzumab Biosimilars (351(k) Licensures snapshot 20260724).
  https://purplebooksearch.fda.gov/
• U.S. Food and Drug Administration (FDA) & BeOne Medicines. Tevimbra (tislelizumab-jsgr) FDA Approval Records (BLA 761232, BLA 761380, BLA 761417) and Orphan Product Designations.
  https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=738120
• The Lancet. Pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma: interim analyses from the phase 3 KEYNOTE-811 randomised placebo-controlled trial. Janjigian YY, et al. Lancet 2023;402(10418):2197-2208. PubMed ID: 37871604.
  https://pubmed.ncbi.nlm.nih.gov/37871604/
• Journal of Clinical Oncology (JCO). First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial. J Clin Oncol 2024;42(17):2012-2020. PubMed ID: 38382001.
  https://pubmed.ncbi.nlm.nih.gov/38382001/
• The Lancet. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT). Shah MA, et al. Lancet 2023;401(10389):1655-1668. PubMed ID: 37068504.
  https://pubmed.ncbi.nlm.nih.gov/37068504/
• CMS. HCPCS Quarterly Update (permanent J-code assignments: J9276 injection, zanidatamab-hrii, 2 mg; J9329 injection, tislelizumab-jsgr, 1 mg).
  https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system/quarterly-update