Menu – Part 14: Some Updates and a Few New Posts

Since the last menu posting on June 12th, I have added two new updates on the CATT Study; eight updates on Avastin vs. Lucentis; and three new postings. The new postings include a writeup on the use of femtosecond lasers in cataract surgery; a review of the history of customized ablation, and a little about an upgraded endoscope for use in ophthalmology (including some history on this device).

First, the CATT Study Updates:

CATT Study Update 9: The CATT Study is On Track

In June I learned that the CATT Study was on track, with 850 of the intended 1200 patients enrolled. I also included a review of the first eight updates (including links).

CATT Study Update 10 – From the 2009 AAO Meeting

In October, I received a report from the AAO meeting that enrollment was nearly completed, and that first results wouldn’t be published until all 1200 enrollees had completed their first year of results.


And, the Avastin/Lucentis Updates:

Avastin/Lucentis Update 25: Comparative Studies Proliferate – France Joins the Fray

In September I learned that France had started a comparative study, to join studies underway in five other countries.

Avastin/Lucentis Update 26: CMS Ups the Ante

In early October, I learned that Medicare was tilting the table towards Lucentis by lowering the reimbursement for Avastin.

Avastin/Lucentis Update 27: Dr. Rosenfeld’s Remarks at Retina Congress 2009

Dr. Phil Rosenfeld gave an interesting presentation about the search for optimal dosing for anti-VEGF drugs at the 2009 Retina Congress.

Avastin/Lucentis Update 28: Sustained Release Lucentis May Eventually Change the Equation

Roche and Genentech announced their licensing and developmental deal with Surmodics for a sustained release/delivery system for Lucentis. I provided a few comments.

Avastin/Lucentis Update 29: Six-Month Results of Controlled Comparison Study Published

The Boston University School of Medicine and the Veterans Administration of Boston announced their six-month results of comparative study of Avastin and Lucentis. This was the first published prospective, double-masked, randomized, controlled comparative study of the two drugs. However, this study only contains 20 subjects!

Avastin/Lucentis Update 30: A Followup to Update 26 – Sen. Herb Kohl Queries CMS

Following the implementation of the reimbursement cut for Avastin to ophthalmologists, and its implication for Medicare, Senator Herb Kohl got into the act, asking CMS why this cut took place and if Genentech had any involvement?

Avastin/Lucentis Update 31: Problems with Pharmacy Compounding of Avastin?

During the 2009 AAO Meeting in San Francisco, one ophthalmologist presented on problems he had experienced with compounded Avastin. (There is, however, one problem with this presentation – the good doctor is a paid consultant for Genentech.)

Avastin/Lucentis Update 32: More on the CMS Repricing of Avastin

Finally, just after posting a good summary of the pricing of Avastin reimbursement, I learned about the CMS reversal of its policy. I posted both the summary and the breaking new information.


Some New Postings on Other Subjects:

Femtosecond Lasers Proposed for Use in Cataract Surgery

In June, I received a writeup from old friend Larry Haimovitch, writing about femtosecond lasers under investigation for cataract surgery, his report from ASCRS 2009. After receiving permission from Larry and the publisher of his piece, Biomedical Business & Technology, I reproduced it in my Journal.

By the way, this is my third writeup on femtosecond lasers.

A Review of the History of Customized Corneal Ablation (Custom LASIK)

In July, I noticed an approval for an iris-tracking laser from Technolas Perfect Vision and decided that it would be a good time to review the history of what I had written about customized corneal ablation, basically, its history. So, I listed the nine articles I had written on this subject, along with links to each piece.

Endoscopy in Ophthalmology: The Latest News and Some History

And, finally, a brief note about an improved ophthalmic endoscopic system from Endo Optiks, and my 1992 writeup about this interesting company and product.

Avastin/Lucentis Update 32: More on the CMS Repricing of Avastin

During the 2009 AAO Meeting in San Francisco, there was much discussion of the CMS cuts in reimbursement of Avastin beginning at the beginning of October.

Crystal Phend of MedPage Today provided a good summary of what has been transpiring in this controversy, including comments from the AAO. Now we await the results of Sen. Herb Kohl’s meeting with CMS officials.

Late Breaking News: (Courtesy of Dr. John Kitchens of Retina Associates of Kentucky)

According to CMS....

Effective January 1, we will be replacing the temporary HCPCS code, Q2024 (Injection, bevacizumab, 0.25 mg), with a new HCPCS C code with the same descriptor as Q2024. Because the C codes are only used by hospitals to bill for outpatient services, effective January 1, 2010, physicians should return to their billing practices prior to October 1, 2009 for small doses of Avastin, when administered in their offices to treat macular degeneration. If they have any questions, they should contact their local contractor.


AAO: CMS Payment Cuts for Eye Drug Counterproductive, Group Says

By Crystal Phend, Senior Staff Writer, MedPage Today
Published: October 27, 2009

SAN FRANCISCO -- The recent cut in Medicare reimbursement for intravitreal bevacizumab (Avastin) will hurt both patients and taxpayers by forcing a shift to more expensive options, according to American Academy of Ophthalmology officials.

The rule change that went into effect on Oct. 1 created a code to account for the tiny doses used in ophthalmology, requiring practices to bill in 0.25 mg increments at $1.25 each. That dropped reimbursement for the standard 1.25-mg intravitreal dose from about $50 to $6.25.

Reimbursement for its competitor ranibizumab (Lucentis) -- a closely related molecule generally considered to have equal efficacy -- remained unchanged at a whopping $2,039. Since ranibizumab costs under $2,000 for a single dose, ophthalmologists usually make around $120 with each injection.

But even at the prior reimbursement level, they usually didn't profit from choosing bevacizumab. One vial of bevacizumab -- originally developed for cancer treatment -- contains more than one intravitreal dose, but drawing multiple doses from the same container almost doubles the risk of infection. So, compounding pharmacies divide up the drug into individual doses, repackage, and sterilize them -- but at a price that typically pulled even with reimbursement before the Oct. 1 cut.

So the new rule actually creates a disincentive for using the drug that has been estimated to save Medicare $1.5 billion each year in treating macular degeneration alone, said William Rich, MD, the medical director for health policy at the AAO. The AAO and other ophthalmology organizations immediately started negotiating for a change that would reflect compounding charges, he said. One argument for the new rule is that CMS cannot legally pay for pharmacist costs, but that's not true, according to Rich, who said it is allowed for some asthma and pain management treatments.

Early talks were positive but led nowhere except to a Congressional inquiry, according to George Williams, MD, of William Beaumont Hospital in Royal Oak, Mich., and a member of the AAO Health Policy Committee. "We thought we had a solution," he told retinal surgeons at the AAO meeting here. After daily talks with CMS, "we were told two weeks ago it would be fixed. Two weeks have passed, and it is still not fixed."

Sen. Herb Kohl, D-Wis., who chairs the Senate Committee on Aging, has demanded an explanation for the change and questioned the role of Genentech, which manufactures both drugs and would stand to gain financially from greater use of its more expensive product.

The company has denied any part in the CMS decision, according to media reports.

CMS officials are set to meet with the Senate Committee on Aging later today, and Kohl has reportedly asked for a copy of all communication between CMS and Genentech. However, Rich was skeptical that CMS would have a remedy in place soon. "If the current policy is left in place, physicians lose, patients lose, and taxpayers lose," he said.

He has already heard reports of some ophthalmologists switching to the more expensive drug in order to avoid losing money. Because most patients with conditions treated off-label with bevacizumab are on Medicare, their 20% copays have increased dramatically. "Physicians who changed are getting tremendous pushback from patients," Rich said.

He urged a quick solution to avoid the shift in practice patterns from becoming set. As of 2007, bevacizumab held about 60% of the market share. "We're not interested in assigning blame, we just want to get it fixed" Rich said.

Avastin/Lucentis Update 31: Problems with Pharmacy Compounding of Avastin?

A disturbing report from the 2009 AAO Meeting, as described on the OSN Supersite. Dr. Malik Kahook, speaking at the joint meeting, said that he had seen 16 cases of IOP spikes following injection of Avastin in his clinic, and has seen reports of at least 74 additional cases in five states. He went on to say that investigation was ongoing with both Lucentis and Avastin, but that "cases are overwhelmingly in the Avastin corner."

"By no means am I saying that Avastin is doing something to the trabecular meshwork or the eye cells, [but] certain compounding techniques are affecting the components that you're getting in the syringe, whether it's aggregation of proteins, formation of dimers and trimers, or other components that could be as large as 20 μm."

Inflammation and toxicity related to delivery of Avastin have been suggested as potentially causing IOP spikes. However, microflow imaging showed significant differences in total particle number in samples of Avastin drawn directly from a multidose vial, from the vehicle and from a dose supplied by a compounding pharmacy, Dr. Kahook said. The compounding pharmacy was selected because it [had] supplied doses to a Utah clinic that saw 42 post-injection IOP spikes.

This bears further watching.


November 10, 2009: A Update to the original story posted on October 27th.

I just received a copy of an email alert, Academy Alive, sent to Academy of Ophthalmology members during the recent meeting in San Francisco. One of the excerpts referenced the story above that I had originally sourced from Ocular Surgery News.

Here is more on this potentially troubling story:

Investigations continue into reports of IOP spikes following VEGF inhibitor use

Research is ongoing into the causes of cases of IOP spikes following bevacizumab (Avastin) or ranibizumab (Lucentis) use that have been reported around the United States, Malik Y. Kahook, MD, said at Glaucoma Subspecialty Day on Saturday. An active researcher on this topic, Dr. Kahook said he knows of more than 50 cases of IOP spikes after bevacizumab use and a smaller number after ranibizumab use. He said most of these patients don’t experience obvious inflammation, have no previous history of glaucoma or ocular hypertension, and sustain high IOP levels for weeks or months that often require laser therapy or surgery.

In an effort to elucidate the causes of these IOP elevation cases, Dr. Kahook and his colleagues tested bevacizumab samples from multiple compounding pharmacies and found noticeable variability in the concentration of the active monomer IgG, which in many cases was much less than the expected 25 mg/ml. Further investigations showed that some of the particles were much larger than expected.

“We believe that these molecules either plug the outflow pathway or may result in subclinical inflammation in the outflow pathway that then leads to elevation in eye pressure,” Dr. Kahook said during an interview. “We do not think that this is an issue with the active IgG monomer of Avastin, and we are not saying that people should stop using Avastin.”

Dr. Kahook recommends further study of the Avastin compounding and shipping processes to ensure greater product consistency between compounding pharmacies and to decrease the chances that high molecular weight adducts cause aqueous outflow obstruction and subsequent IOP elevation in additional patients. Studies are also being conducted to examine the potential link between IOP spikes and ranibizumab use.


Dr. Kahook has previously received research support from Genentech but has not received funding from Genentech for studies on this topic.



Reproduced from Academy Live, October 25, 2009, an e-mail service of the Academy of Ophthalmology to its members.


Q&A

I contacted Dr. Kahook several times asking him to name the five states that he said had reported at least 74 other occurrences; was there an online reference to these other reports; and who was doing the investigation – the FDA, NIH, or Genentech?

He refused to answer, responding that we would have to “await his further publications”.

CATT Study Update 10 – From the 2009 AAO Meeting

According to Dr. J. Kitchens, Tweeting from the Retina SubSpecialty Day Session at the 2009 AAO Meeting, Dan Martin, head of the CATT Study, reported this morning that the study is almost finished recruiting. To date, 1130 patients are enrolled and the 44 clinics involved hope to have 1200 patients by the end of next month, at which time the study will be closed.

First one-year results on all enrolled patients expected in Spring of 2011.

Avastin/Lucentis Update 30: A Followup to Update 26 – Sen. Herb Kohl Queries CMS

As reported by Alicia Mundy in a Wall Street Journal Health Blog yesterday evening, Senator Herb Kohl wants to know if Genentech had any input into the CMS decision to reduce the Medicare reimbursement rate for Avastin when used in small doses in the treatment for AMD.

Here is a copy of the WSJ blog and a link to Senator Kohl’s letter to CMS.


WSJ Health Blog
October 13, 2009, 5:41 PM ET

Senator Wants to Know About Medicare Shift on Eye Drugs
By Alicia Mundy

Sen. Herb Kohl wants to know whether Genentech was involved in a recent Medicare shift that could prompt eye doctors to use a more expensive drug. Genentech, which recently became part of Roche, says it wasn’t involved.

As we noted recently, Medicare introduced a new payment code that cut payments to doctors for small doses of Avastin, a cancer drug that many doctors use off-label to treat patients with macular degeneration. That could prompt doctors to switch to Lucentis, a similar but far more expensive drug approved for macular degeneration. (When used to treat the eye, Avastin costs less than $50 per dose; Lucentis costs about $2,000.)

Genentech had “no involvement” in the government’s decision to create a new payment code, a company spokeswoman told the Health Blog

Ophthalmologists are now using Avastin about as much as Lucentis, according to Dr. Philip Rosenfeld, a retina specialist in Florida. Both drugs are sold by Genentech, so its revenues would increase if eye doctors used less Avastin and more Lucentis. Rosenfeld, who was an early proponent of using Avastin in the eye, told us he thinks the change could cost the government nearly $500 million a year, based on estimates of usage he and other eye doctors have compiled.

In a recent letter to CMS, the agency that oversees Medicare, Kohl wrote that he was “disturbed to learn from members of the medical eye care community that Genentech may have communicated directly with CMS officials about this proposed coding change, reportedly suggesting that CMS was over-paying for the small amounts of Avastin being used off-label for intraocular treatments.”

Kohl wants all communication between Genentech and CMS on the matter. CMS says it is currently reviewing the letter and will respond to the senator.

Here is a link to Sen. Kohl’s letter.

Avastin/Lucentis Update 29: Six-Month Results of Controlled Comparison Study Published

Apparently, Boston University School of Medicine and the VA Boston, have published the first six-month results of a comparison study of Lucentis vs. Avastin, and found no difference in effectiveness. An abstract of the results have just been published online in the American Journal of Ophthalmology.

NOTE: This study is NOT part of the CATT Study, but an independent study.

Here is the news release from BU/VA as published on Science Codex:

Cancer drug is no different in effectiveness as gold standard treatment for macular degeneration

Posted On: October 9, 2009 - 1:50pm

(Boston) - Investigators from Boston University School of Medicine (BUSM) and the VA Boston Healthcare System have shown, at 6 months in a small group of patients, that there is no difference in efficacy between Bevacizumab (Avastin) and Ranibizumab (Lucentis) for the treatment of age-related macular degeneration (AMD). The study, which appears currently on-line in the American Journal of Ophthalmology, is the first to report early outcomes of a prospective, double-masked, randomized, controlled trial comparing Bevacizumab to Ranibizumab for the treatment of exudative (wet) age-related macular degeneration.

AMD is the leading cause of blindness over the age of 50 in developed Western countries. It can present in 2 forms, exudative (wet) or nonexudative (dry). While dry AMD can lead to severe vision loss, wet AMD is often more visually devastating with a higher risk of blindness. The gold standard of treatment is ranibizumab (Lucentis, Genentech Inc.), which was FDA approved for AMD in 2006. Bevacizumab (Avastin, Genentech Inc.) was FDA approved for colo-rectal cancer in 2004, and has since been used worldwide as an off-label, local intravitreal treatment for wet AMD. Both have shown to be efficacious in the treatment of AMD, however, it is unknown which one is more effective.

This study was supported with resources and the use of facilities at the Veterans Affairs Boston Healthcare System, Jamaica Plain, MA. The VA funded the cost of medications for this study. Patients were enrolled by a 2:1 randomization to either the bevacizumab (2) or ranibizumab (1) arm of the study. Once inclusion criteria were met, patients were given intravitreal injection of bevacizumab or ranibizumab every month for the first three months (as they began the trial, month one, and month two). Following the third injection, patients returned for monthly examination and testing and received further injections on an as needed basis for one year.

"Our study aimed to offer early, six-month results of a randomized, double-masked, single center clinical trial comparing the off-label use of bevacizumab with the current gold standard ranibizumab. With a total of 20 subjects and a 2:1 randomization, early results of this trial suggest that at 6 months, visual outcomes of bevacizumab appear to be no different from ranibizumab," said lead author and Principal Investigator Manju Subramanian, MD, an assistant professor in Ophthalmology at BUSM.

Genentech Pharmaceuticals (the manufacturer of both drugs) has refused to sponsor a head to head trial comparing the 2 treatments. The open market cost of a single injection of Ranibizumab (Lucentis) is approximately $2000.00. Comparatively, the cost of a single injection of Bevacizumab (Avastin) for AMD is $40.00. Patients potentially undergo up to 13 injections per year, leading to a large cost differentiation for treatment of this common eye disease.

The National Eye Institute is sponsoring the Comparison of AMD Treatment Trials Study (CATT Study), a multi-centered, randomized, double-masked, clinical trial designed to assess the efficacy of bevacizumab compared to ranibizumab therapy and will be conducted in 44 clinical centers throughout the United States. Early results are expected in 2011.

Source: Boston University Medical Center

Avastin/Lucentis Update 28: Sustained Release Lucentis May Eventually Change the Equation

In an announcement this morning, Roche and Genentech announced that they had struck a licensing and development deal with Surmodics, Inc., for the latter’s proprietary, biodegradable microparticle drug delivery system. The companies plan on developing a sustained release delivery formulation for Lucentis to treat age-related macular degeneration.

The agreement also provides Roche and Genentech with the opportunity to develop additional compounds, using a sustained drug delivery system, for the treatment of other ophthalmic diseases.

If the new sustained release version of Lucentis provides a better mechanism for delivering this anti-VEGF drug to the retina, acting over a sustained period, it could change the number of doses required for treatment. If one long-lasting Lucentis treatment provides a better outcome than several monthly injections, the patient and doctor interaction could be drastically reduced from the current need for five or six injections per year, to possibly a single or two doses!

However, a development program of this type will probably require a full Phase 3 study and might take close to five years to reach the market.

So, for now, don’t hold your breath!

Avastin/Lucentis Update 27: Dr. Rosenfeld’s Remarks at Retina Congress 2009

The following abstract of Dr. Rosenfeld’s remarks were reported by OSN Supersite in their continuing coverage of Retina Congress 2009.

Search for optimal anti-VEGF dosing strategy in AMD continues

Although the optimal dosing of anti-VEGF therapy remains unknown, pharmacokinetics of the two most popular agents suggest that adjusting the current dosing strategies may better serve patient needs.

Head-to-head trials of Lucentis (ranibizumab, Genentech) and Avastin (bevacizumab, Genentech) should help steer future treatment decisions, Philip J. Rosenfeld, MD, PhD, said during the J. Donald M. Gass Award Lecture, sponsored by the Retina Society, here at the Retina Congress 2009.

Yet, despite the absence of definitive clinical trials at the present time, there is suggestive evidence that either shortening the dosing frequency to 2 weeks, at least during the loading phase, or increasing the dose strength may result in significantly improved biological activity, Dr. Rosenfeld said.

Lucentis has a 5- to 20-fold higher binding affinity than Avastin, and Avastin has a longer half-life than Lucentis; correspondingly, studies have shown that Lucentis has greater biological activity on day 0 than Avastin.

"But it's not how we start the month, it's how we finish the month," Dr. Rosenfeld said.

Studies of decay kinetics suggest similar activity of the two agents out to 30 days. However, Dr. Rosenfeld said, increasing either the dosing strength or dosing frequency of Lucentis or Avastin, provided it is safe, would yield significantly higher biological activity at 30 days.

A novel anti-VEGF agent, VEGF Trap-Eye (Regeneron and Bayer), may convey even greater affinity and result in 450 times the amount of biological activity at the end of 1 month than either Avastin or Lucentis.

Avastin/Lucentis Update 26: CMS Ups the Ante

A few days ago, Dr. Philip Rosenfeld told me that Medicare was slashing the reimbursement for Avastin to $7.20 a dose, an unintended consequence of their new Avastin code for small doses, as used by ophthalmologists. He also told me that the AAO is fighting this, but it would go into effect on October 1st.

Today, two stories describing the impact of this new ruling on ophthalmologists, their patients, and Medicare were published by both The New York Times and The Wall Street Journal


October 2, 2009
New York Times

A Rule on Eye Treatment Is Likely to Cost Millions
By Andrew Pollack

Medicare is putting in place a new policy that may sharply curtail the use of the cancer drug Avastin as a treatment for eye diseases. But the way the bureaucratic gears mesh in this case, the move could end up costing Medicare itself hundreds of millions of dollars a year, and individual patients thousands of dollars.

For several years, eye doctors have been using Avastin off-label as a treatment for retinal diseases, particularly age-related macular degeneration, the leading cause of blindness in the elderly. Avastin is similar in its mechanism of action to Lucentis, a drug approved to treat macular degeneration. Both drugs are made by Genentech, a subsidiary of Roche.

Lucentis costs about $2,000 per injection — with an injection needed as often as every month. Although Avastin can cost thousands of dollars a month as a cancer treatment, when used in the tiny portions required for eye-disease injections, it costs only about $30 to $50 per shot. But it was unclear how Medicare should reimburse eye doctors for that use of Avastin. Payment policies varied regionally, though ophthalmologists say their costs for the drug were essentially covered.

Medicare has now introduced a special reimbursement code just for the smaller doses of Avastin. And starting Thursday (October 2nd), the reimbursement of Avastin dropped to about $7.20 for the dose typically used in the eye. That would mean eye doctors — who purchase Avastin and then are reimbursed when using it on patients — would lose money administering the drug.

The new policy would give eye doctors a financial incentive to switch to Lucentis, for which they would be fully reimbursed even though that drug is significantly more expensive. If doctors do shift to Lucentis, “this will have a huge economic impact on Medicare, in the range of hundreds of millions of dollars,” said Dr. David W. Parke II, chief executive of the American Academy of Ophthalmology. “Members view this as a bureaucratic decision that is maybe necessary, based on statutes, but highly short-sighted.”

Dr. Parke said about a million injections a year were given for macular degeneration, about half of them Avastin and the other half Lucentis. He said there was no indication that Genentech, which would make more money if more patients used Lucentis, had anything to do with Medicare’s policy change.

Dr. George A. Williams, an ophthalmologist at William Beaumont Hospital in Royal Oak, Mich., said patients themselves could also be affected. The 20 percent Medicare co-payment for Lucentis is about $400, compared with only a few dollars for Avastin.

Medicare apparently calculated the reimbursement rate for the tiny eye doses based on the average sales price of Avastin for cancer. But it did not take into account the markup charged to eye doctors by compounding pharmacies — the chemists that divide up the Avastin into tiny doses under sterile conditions.

The ophthalmology academy (AAO) has talked to Medicare this week and is hopeful the situation can be resolved, Dr. Parke said. “They truly do understand the problem and are looking for solutions,” he said.

A spokesman for Medicare said in an e-mail message, “We don’t know why the drug is only available to doctors through compounding pharmacies.” He said Medicare would continue to monitor the use of Lucentis and Avastin.


October 2, 2009, 9:28 AM ET
WSJ Health Blog

How Cutting Payments for a Drug Could Cost Medicare More
Jacob Goldstein

EyeMedicare just started reimbursing doctors less for very small amounts of the cancer drug Avastin. Oddly enough, that could mean Medicare will start spending lots more money on the eye drug Lucentis. Here’s why.

Lucentis and Avastin are very similar molecules. A few years back, before Lucentis was on the market, eye doctors realized that they could inject Avastin in patients’ eyes to treat macular degeneration, a condition that can lead to significant loss of vision and occurs mostly in the elderly.

Avastin costs tens of thousands of dollars to treat cancer patients, but the tiny dose doctors inject into patients’ eyes costs a very small fraction of that –the specialty pharmacy chain The Apothecary Shops repackages Avastin for use in the eye and sells it to doctors for $27 per dose, John Musil, the company’s CEO, told the Health Blog.

This week, Medicare cut its reimbursement for the dose of Avastin commonly used in the eye to about $7. Previously, when there was no specific billing code for tiny doses of Avastin, doctors could get reimbursed about $50 for using the drug in the eye, Philip Rosenfeld, an eye doctor at the University of Miami, told the Health Blog.

For a dose of Lucentis, Medicare reimburses doctors $2,039. Doctors pay just under $2,000 for a dose of Lucentis, Rosenfeld said. That means that eye doctors will now lose a bit of money when they use Avastin to treat patients’ eyes, and make a bit of money when they use Lucentis. Avastin hasn’t been approved for use in the eye, but it’s legal for doctors to use it in that way. Many eye doctors use both Avastin and Lucentis, depending on patient preference, Rosenfeld said.

Rosenfeld, like many docs, believes both drugs work equally well to treat macular degeneration; the NIH is currently sponsoring a head-to-head trial. But the new payment structure could push eye docs away from Avastin and toward the far more expensive Lucentis.

“Doctors will do what’s in the best interest of the patients,” Rosenfeld said. “Given that both drugs are equal, it’s not surprising that they’ll do what’s in their financial interest.” That could mean a hit for Medicare, as well as for Medicare patients who are on the hook for co-pays.

Both Lucentis and Avastin were developed by Genentech, now owned by Roche. U.S. sales of Lucentis were over $550 million in the first half of this year, Roche reported. Because the drug is primarily used by the elderly, much of that is paid for by Medicare.

Until now, there was no specific Medicare billing code for small doses of Avastin. A Medicare spokeswoman said the new reimbursement level is based on a formula that is determined by law, and doesn’t take into account the costs of repackaging the drug.

Update October6, 2009 – as reported from the Retina Congress 2009 by OSN SuperSite:


Retina specialists could face compensation issues regarding bevacizumab, other procedures

NEW YORK — A new rule currently under review by the Centers for Medicare and Medicaid Services (CMS) could drastically reduce the compensation for bevacizumab, while other billing codes germane to the practice of retina are also being reconsidered.

A new rule passed last week by the CMS mandates compensation for Avastin (bevacizumab, Genentech) based on average price of the drug. According to Trexler M. Topping, MD, however, the new rate does not account for associated expenses.

"They recently announced the development of code Q2024 for Avastin at a $1.24 per 0.025 mg, giving you a little over $7 for a typical intravitreal dose," Dr. Topping said here during a presentation at the Retina Congress 2009. "The particular methodology that CMS used ignores the medical, legal and risk management issues of separating individual doses from a large vial of drug."

The decision could significantly affect reimbursement for practicing retinal specialists, and it comes at a time when other codes are being revalued by the relative value update committee, the body that recommends code reimbursement rates to the CMS.

According to Dr. Topping, both the injection code and the code for optical coherence topography have been called up for review, and while the American Academy of Ophthalmology is working closely with the relative value update committee, there is early indication that both codes will be significantly devalued.