IOLs designated as ‘new technology’
Two categories of IOLs will receive an extra $50 reimbursement. Four other lenses were rejected.
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WASHINGTON The Health Care Financing Administration (HCFA) granted two IOLs status as new technology IOLs (NTIOLs), which allows ambulatory surgical centers (ASCs) to collect an extra $50 reimbursement for their implantation.
Allergans (Irvine, Calif.) Array Multifocal Intraocular Lens Model SA40N and STAAR Surgical Co.s (Monrovia, Calif.) Elastic Ultraviolet-Absorbing Silicone Posterior Chamber IOL models AA4203T, AA4203TF and AA4203TL qualified for the extra $50 payment. HCFA rejected claims for four other IOLs.
ASCs that implant approved lenses will collect an extra $50. The adjustment will remain in effect until May 18, 2005. The new technology designation was granted to lenses that HCFA determined to have substantiated specific clinical advantages and superiority over existing IOLs (Additional payments for NTIOLs is coming soon, Ocular Surgery News, November 1, 1999 issue, page 18).
Criteria include:
- reduced risk of intraoperative or postoperative complications or trauma;
- accelerated recovery;
- reduced induced astigmatism;
- improved postoperative visual acuity; and
- more stable postoperative vision.
HCFA stated in its May 3 Federal Register, In determining which lenses meet the criteria and definition of an NTIOL, we relied on the clinical data and evidence submitted to the FDA [Food and Drug Administration] by the various manufacturers, demonstrating that these lenses have specific clinical advantages and superiority over existing lenses. These claims must be approved by the FDA for use in advertising and labeling.
Market impact
Mike Judy, Allergans director of U.S. marketing for the Array, told Ocular Surgery News that, Were anxious to see the impact this is going to have with our Array sales. We have some pretty good ideas and were very encouraged about comments weve heard from surgeons.
The Array received NTIOL status, while the companys silicone lens did not, because it offered a noticeable benefit of reducing the patients postoperative dependence on glasses.
Jonathan C. Javitt, MD, conducted a study based on the lens phase 3 clinical trials and found that 41% of the patients who received an Array lens did not need glasses afterward, compared with 11% of patients who received monofocal lenses. For near tasks, 38.4% of multifocal patients did not have to wear glasses, while 9.8% did. Additionally, 84.9% of patients with a multifocal did not have to wear glasses for distance vision, compared with 52.4% of monofocal lens patients.
Despite the clinical advantages, one of the biggest hurdles to surgeons using the Array was the extra cost of reimbursement, he said. Allergan asked a premium price for the lens, and the extra $50 reimbursement will cover that extra cost to the facility.
The government has answered that with awarding the Array the NTIOL status, Mr. Judy said. Since the Array technology has been validated in over 100,000 procedures and we are able to put this cost barrier behind us, we should see some significant opportunity in the next couple of years.
Bill Huddleston, chief operating officer of STAAR, said in a press release that, This designation provides STAAR an advantage in the IOL marketplace and recognition for our superior technology. We believe the new regulation is an appropriate reward for ophthalmic manufacturers that have invested in the development of new technology, such as the Toric IOL, and will serve as an incentive for further technological advancement in the field.
Clinical trials of more than 300 cataract patients with pre-existing astigmatism showed that 47% had uncorrected visual acuity of 20/30 or better following implantation with a STAAR Toric lens (U.S. roll-out of STAAR Toric IOL underway, Ocular Surgery News, March 1, 1999 issue, page 5).
Four lenses rejected
HCFA considered only the labeling approved by the FDA to determine if lenses met the NTIOL criteria. Four IOLs did not meet the agencys requirements: Alcons (Fort Worth, Texas) AcrySof, Allergans AMO Silicone lens, Pharmacias (Peapack, N.J.) CeeOn Heparin Surface Modified lens and CIBA Visions (Duluth, Ga.) MemoryLens, which has since been recalled for unrelated reasons.
Manufacturers of the rejected IOLs each expressed disappointment that HCFA turned down their request for NTIOL status.
Alcon Vice President and General Manager for surgical, Cary Rayment, said the company was surprised because it had filed a substantial, well-supported document to the HCFA. FDA labeling specifically states that the lens reduces lens epithelial cell migration, which leads to posterior capsular opacification.
However, HCFA stated in its Federal Register notice that Alcon claimed these lenses provide a reduction in the rate of Nd:YAG capsulotomy and posterior capsular opacification. The FDA determined that these lenses did not demonstrate clinical advantages over existing lenses with respect to the claims made by the manufacturer.
Mr. Rayment said, Were obviously disappointed and surprised. AcrySof has FDA-approved claims of superiority versus both silicone and PMMA lenses of similar design, so we believe that we met the criteria. AcrySof is the number 1 implanted lens in the world. That speaks to the acceptance around the world, where surgeons are seeing the benefits that the lens provides to their patients.
Pharmacia also expressed disappointment that its heparin surface modified lens, which reduces postoperative inflammation in high-risk eyes, did not receive approval, according to spokeswoman Rosemarie Yancosek.
HCFA stated in the Federal Register that, Pharmacia claimed that the amount of cellular deposits and the number of giant cells are reduced with their lenses. The FDA determined that these lenses did not demonstrate a clinical advantage over other approved IOLs.
No appeals
According to Michael Romansky, JD, a partner in McDermott Will and Emery and counsel to the Outpatient Ophthalmic Surgery Society, I was surprised that in the final notice, [HCFA] didnt give any information as to their basis for their decisions.
Mr. Romansky, who worked with ophthalmic societies on the legislation, said that Congress legislated in 1994 that HCFA should establish a process to pay additional fees to ASCs that implant NTIOLs. The statute required that NTIOLs be FDA approved, but left the criteria for NTIOL status unspecified.
HCFA grappled for a number of years how to determine whether something is new and innovative technology, Mr. Romansky said. Ultimately, the agency determined that rather than have HCFA study a multitude of claims that manufacturers make and then assess whether those claims have been substantiated, before the government makes an additional payment above and beyond what the standard ASC facility fees provide for, such innovative lenses should pass FDA muster.
In HCFAs view, the FDA is in a better position to evaluate claims than HCFA. This method makes sense in some respects but not in others, Mr. Romansky said. The FDA has experts that look at each products safety and efficacy, but not at their relative efficacy.
Manufacturers to a great extent have not submitted data regarding relative effectiveness, he said. So there may be newer products that may be superior to existing IOLs in terms of patient outcomes, but for which data was never submitted to the FDA.
Also, there was a 6-year lag between the time Congress passed the law and the time HCFA implemented it. The definition of NTIOL includes the definition that it is superior to existing technologies. However, HCFA does not define at what point an IOL is existing and at what point it is new. And HCFA has not provided any appeals process or remedy, he said.
For Your Information:
- Mike Judy can be reached at Allergan, 575 Anton Blvd., Ste. 900, Costa Mesa, CA 92626; (714) 246-6473; fax: (714) 246-2440. Mr. Judy is director of marketing at Allergan for the Array multifocal lens.
- Cary Rayment can be reached at Alcon, 6201 South Freeway, Fort Worth, TX 76134; (817) 551-8058; fax: (817) 568-7126. Mr. Rayment is vice president and general manager for Alcon surgical.
- Bill Huddleston can be reached at STAAR Surgical Co., 1911 Walker Ave., Monrovia, CA 91016; (626) 303-7902; fax: (626) 359-8402. Mr. Huddleston is chief operating officer of STAAR. Rosemarie Yancosek can be reached at Pharmacia Corporation, 100 Route 206 N, Peapack, NJ 07977; (908) 901-8517; fax: (908) 901-1874. Ms. Yancosek is a director of public relations and patient education for Pharmacia.
- Michael Romansky, JD, can be reached at McDermott Will & Emery, 600 13th St. NW, Washington, DC 20005-8000; (202) 756-8069; fax: (202) 756-8087.