We presented the following: (i) a detailed overview about the embolization microspheres and the therapies involved, (ii) in-depth market research (current market size, growth rates, and market projections); (iii) product research and their respective manufacturers; (iv) indications of use; (v) statistics related to liver cancer (hepatocellular carcinoma); (vi) overview of potential patient pool (consumer market research); (vii) cost of treatment in the USA, UK, and EU; (viii) cost-effectiveness analysis to demonstrate economically benefitial perspective; (ix) and an example sale price estimate obtained directly from the manufacturer.

Introduction to Embolization Microspheres:

 Microsphere embolization is an interventional radiology procedure that involves injecting microspheres into an artery in the liver, to block the blood flow to a tumor in the liver. There is currently no standard treatment for patients with hepatocellular carcinoma (HCC). Currently, four therapies are available which have been categorized based on their mode of delivery and mechanism of action. The choice of the therapy depends upon clinician’s feasibility, patient’s tumor size, cancer staging, disease prognosis, and clinical condition.  ​Most common therapies employed for the treatment of liver cancer are TACE, DEB-TACE, and TARE (refer to the description below)

1. Trans-arterial embolization (TAE) or Bland Embolization or Conventional Embolization: A thin, flexible tube (catheter) is inserted into the hepatic artery in the liver. Small particles (microspheres) are inserted into the artery which plugs off the artery, blocking the blood supply (carrying nutrients and oxygen) to the tumor for survival. Other indications of TAE therapy include: hypervascular tumors, uterine fibroids, and arteriovenous malformations.

2. Trans-arterial chemoembolization (TACE): This procedure is used for large liver cancers that cannot be treated with surgery or ablation. It combines embolization (TAE) with chemotherapy. The procedure is similar to TAE, except that chemotherapy is delivered alongside embolization microspheres.

3. Drug-eluting bead chemoembolization (DEB-TACE): This procedure is based on TACE, except that the chemotherapy drug is delivered in tiny drug-eluting beads. The drug-eluting beads slowly release the chemotherapy in a localized tumor region, which increases the chances of cancer cells to die. The most commonly employed chemotherapeutic agents include mitomycin C, cisplatin, and doxorubicin.

4. Transarterial radioembolization (TARE): A procedure that combines embolization with radiation therapy. Radioactive microspheres (isotope yttrium-90) are delivered to the localized tumor site by a similar TAE delivery phenomenon. The radioactive beads release small amounts of radiation to the tumor site for days to kill the cancer cells.

Product Research – Overview of Embolic Agents

  • [I] First Category: In order to deliver chemotherapeutic agents to tumors, a therapy known as transarterial chemoembolization (TACE) is employed. It involves the use of drug-eluting beads (DEB) – a novel drug delivery system that allows fixed and sustained doses to be delivered to tumor regions. Three DEB’s are available: (i) Tandem (CeloNova Biosciences Inc., USA), (ii) DC-Beads (BTG, UK) and (iii) HepaSphere(®) (BioSphere Medical, Inc., USA).
  • [II] Second Category: In order to deliver localized radiation therapy to a tumor region, a transarterial radioembolization (TARE) is used. It is efficient and safe for use in advanced liver cancers, and those with vascular complications. Two types of radioembolization microspheres are available: SIR-Spheres (Sirtex Medical Limited, Australia) and TheraSphere (BTG, UK).
  • [III] Third category: is non-drug eluting, non-radiological, polyvinyl-alcohol-based Embolization particles, which are used for permanent embolization therapy. It comprise of following products: (i) Contour SE® particles (Boston Scientific, Natick, USA), (ii) Bead Block® (BTG, Surrey UK), (iii) DC/LC Bead® (BTG, Surrey UK), (iv) Embosphere® (Merit Medical, Rockland, MA, USA), and (v) Embozene® (CeloNova BioSciences Inc., Atlanta, GA, USA).

Market Research:

  • The compound annual growth rate (CAGR) for the radioembolization market is projected at 10.01%, during the forecast period from 2017 to 2023.
  • Prominent players: Terumo, Guerbet, BTG International Ltd, Boston Scientific Corporation, Medtronics, Sirtex, Cook Medical, Varian Medical, and Merit Medical are prominent players of the global embolization particle market.
  • Detailed market research regarding the embolization market is available after purchase on this website.

Hepatocellular Carcinoma Statistics:

Consumer Market Research for TACE:

The estimated annual patient pool of intermediate-stage HCC, in the U.S. (specifically for 2020) can be calculated using the following calculation:

  • 42810(estimated incidence of primary liver cancer)*0.1287(estimated percentage of intermediate-stage HCC cases) = 5509 potential cases of intermediate-stage HCC in the USA in 2020.
  • 5509 * 0.6 (percentage of cases treated with TACE) = 3305 potential cases treated with TACE in 2020.
  • For an estimated treatment cost with TACE therapy: 3305 * 74,788(cost of one TACE therapy) = USD 247.17 million

Estimated total annual medical cost of treating HCC patients with TACE therapy in the USA = USD 247.17 million (representative of total consumer market size)

Cost of TACE & Cost-Effectiveness of TACE therapy in the USA:

  • As indicated earlier, recent years’ searches and scientific papers do not reveal much information about the cost of embolization particles. However, the cost of the overall treatment, and per-session treatment has been obtained from some cost-effectiveness-based scientific publications.
  • According to a U.S-based research publication from 2013, which used Medicare database and SEER database (Surveillance, Epidemiology and End-Results Program), to estimate the treatment expenditure for primary HCC patients treated with TACE therapy (without transplant or surgical resection), between 2000-2007.

– Cost of single course of TACE therapy (57% of patients) = $74,788 (95% confidence interval, CI: $71,890–$77,686)- Cost of two courses of TACE therapy (24% of patients) = $101,126 (95% CI $94,395–$107,856),- Cost of three courses of TACE therapy (11% of patients) = $111,776 (95% CI $101,931–$121,621)- Cost of four courses of TACE therapy (8% of patients) = $148,878 (95% CI $136,346–$161,409).

  • According to Canadian-based scientific publication from 2013, presenting healthcare costs (in USD), and cost-effectiveness analysis of TACE therapy for the treatment of liver cancer (HCC), between 2002-2010.

– The average total cost of Monotherapy for the treatment of HCC per person:(i) Radiofrequency Ablation (RFA) = $55,925 ($52,123–$59,727)(ii) Surgical Resection (SR) = $119,032 ($115,799–$122,265)(iii) Liver Transplantation (LT) = $211,286 ($203,566–$219,007)- The average total cost of “Dual-Treatment with TACE” for the treatment of HCC per person:(i) TACE + RFA = $48,485 ($43,663–$53,307)(ii) TACE + SR = $126,514 ($114,451–$138,577)(iii) TACE + LT = $178,354 ($163,494–$193,215)- The average total cost of no treatment for HCC would still be $38,472 per person

– For monotherapy ICER would be:RFA= $7,919SR= $41,301LT=$47,930000000000- For dual treatment ICER would be:TACE plus RFA= $1,261TACE plus SR=$87,759TACE plus LT=$43,392

Cost of TACE therapy in the UK and EU:

  • According to a scientific article of 2017, the healthcare costs of transarterial chemoembolization in the treatment of hepatocellular carcinoma in the UK reveal the following costs:

– The cost of drug-eluting beads is £550- Based on National Health Services (NHS) costing:(i) TACE =£9070.44(ii) DEB-TACE = £5300.14- Based on Local costing:(i) TACE =£9033.19(ii) DEB-TACE = £5222.89

Cost of TARE therapy in the USA:

(i) The cost of TheraSphere in the US market is US$13,000. (ii) Per treatment with SIR-Spheres costs US$14,000

  • The SIR-Spheres coding guide for January 2019 gave an insight about per session cost of microsphere administration which is detailed below. SIR-Spheres® Y-90 resin microspheres (by SIR TEX company) are based on the radioembolization procedure, indicated for unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy.

Facility Payment: (i) For Hospital out-patient = $9,669(ii) For Ambulatory Surgery Center = $4056- Physician Payment: (i) For Hospital-based facility = $589(ii) For Non-facility or Office Environment = $9861

Direct Selling Price of Embolization Microspheres (USA):

As indicated earlier, the direct costs (or sale prices) for the embolic particles is not available. To get an idea of sale price, an attempt was done to reach out to customer services department of CeloNova BioSciences – manufacturer of Embozene microspheres. These microspheres are indicated for embolization for the following conditions: hepatocellular carcinoma, hypervascular tumors, arteriovenous malformations, uterine fibroids, tumors (of head, neck, torso, and skeletal system), bleeding and trauma, and pre-operative reduction of bleeding other than in the central nervous system.

  • The direct sale price to most hospitals in the U.S. is USD 250
  • For specific hospitals recieving a healthy discount, the sale price is around USD 165.

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