The effect of drug pricing on cataract surgery

April 4, 2016

Article

In a recent wave of drug price increases that can only be explained by pharmaceutical manufacturers’ desire for profit maximization and which doctors and patients may call price gouging, the drug price war has been brought to the doorsteps of many eyecare providers. As optometrists are increasing their practice of medical optometry, patients are now calling their doctors about prior authorizations and unaffordable drug copays.

Recently, we called our local CVS Pharmacies in Panama City, FL asking for the cash prices for common medications we prescribe, such as Pred Forte 1% (prednisolone acetate, Allergan)-a 5 mL bottle costs $135, and generic costs $57. A branded 5 mL-bottle of Tobradex (tobramycin and dexamethasone, Alcon) costs $356, and generic costs $199.

We are combating high drug prices by being creative because a majority of our patients are uninsured, underinsured, or using governmental assistance. We send our patients to retailers’ generic $4 drug lists, which typically includes a handful of tobramycin, neomycin-polymyxin b-dexamethasone, or timolol maleate ophthalmic drops. GoodRx.com provides patient drug coupons to offset prices. As a last resort for special branded drugs, we utilize manufacturer drug assistance programs for patients unable to afford their medications. However, a newcomer in the pharmaceutical industry, is getting involved in the battle for high drug prices.

Imprimis Pharmaceuticals made the headlines recently when Turing Pharmaceuticals acquired the antiprotozoal human immunodeficiency virus-(HIV) treating drug, Daraprim, in its portfolio and raised the price from $13 per pill to $750 per pill.¹ Imprimis decided to produce a similar alternative to Daraprim for just $1 per pill. Imprimis is expanding its more economical drug alternative portfolio into eye care with the introduction of formulations for dropless cataract surgeries and fewer drops for post-operative medications for laser-assisted in situ keratomileusis (LASIK) and other ocular surgeries.

Dropless cataract surgery

Cataract surgery is traditionally a refined and painless procedure. However, the required pre- and post-surgical topical pharmacotherapy regimen is often problematic for patients, especially the elderly. Some experience cost difficulties in obtaining their drops, and many find them inconvenient or difficult to administer, creating compliance concerns. These problems have been lessened with Imprimis’s injectable compounds, Tri-Moxi (triamcinolone acetonide and moxifloxacin hydrochloride) and Tri-Moxi-Vanc (triamcinolone acetonide and moxifloxacin hydrochloride with vancomycin).

These compounded formulations are prepared for an individual patient undergoing surgery at the order of the operating surgeon. In the case of Tri-Moxi and Tri-Moxi-Vanc, these steroid/antibiotic combinations are injected at the time of cataract surgery, typically through a transzonular approach at the conclusion of the procedure. The medication remains suspended in the anterior vitreous space where it releases over several days post surgery in order to help prevent infection and speed healing.⁷

Patients with diabetes or epiretinal membrane or those receiving a multifocal intracocular lens (IOL) can be pretreated with a single daily drop of a topical NSAID (nonsteroidal anti-inflammatory drug) the day before surgery. This is continued for two to four weeks post surgery in order to prevent cystoid macular edema (CME) in patients at increased risk for macular edema or in whom any macular edema would be problematic, such as multifocal patients.

Approximately 10 percent of our patients have slight breakthrough inflammation at one to four weeks post surgery with the dropless approach. We treat these cases with a topical NSAID as well. However, most patients will not need any additional drops.

In addition to eliminating cost, convenience, and compliance concerns, studies have proven the efficacy of dropless cataract surgery.⁷ Previously, topical therapies were necessary in order to combat infection and inflammation in post-operative eyes. However, with the injectible medications, these risks are greatly reduced without the concerns posed by ocular drops.

Intracameral vancomycin has repeatedly demonstrated its ability to significantly reduce and often eliminate cases of endophthalmitis.^2-6 One such study of 1,575 consecutive eyes concluded with no eyes developing endophthalmitis. Additionally, at three weeks post procedure, 98 percent remained free from anterior chamber inflammation and CME.⁶

A similar study of nearly 4,000 surgeries, in which either Tri-Moxi or Tri-Moxi-Vanc was injected using a transzonular approach during cataract surgery, resulted in no intraocular pressure (IOP) elevation, with 95 percent of patients healing without the use of supplemental steroids. A remarkable 98 percent remained free from CME, and the incidence of endophthalmitis or infection was significantly low with a rate of less than 0.005 percent.⁷

Next: Complications with postop medications

Complications with postop medications

The same concerns that arise for cataract patients affect LASIK patients as well. An estimated annual 700,000 LASIK patients nationwide are also subjected to several weeks of required drops that must be administered multiple times a day.⁸ As with cataract and other ocular surgery patients, this regimen creates a variety of reported compliance concerns, including problems with instillation and dosage, confusion, cost, and convenience.^9-10 As optometrists, many of these concerns fall under our jurisdiction as we assume care for patients at one day post-procedure and often prescribe the required medications. Therefore, if the surgeon recommends a certain medication and problems arise with insurance or cost, it is often the comanaging doctor’s responsibility to find an alternative.

While LASIK is private pay, insurance companies do occasionally cover the cost of the medications. When they do not, patients are often shocked by the cost involved. Having already paid thousands for the surgery, they are not prepared for the additional cost that is necessary for required medications. Many patients are compliant and will purchase the branded, and therefore more expensive, drops, but others are unable to assume the extra cost.

In these cases, generic formulations can be a viable option. Generics are not our preference as they can cause side effects with less efficacy. They also may introduce a slight toxicity to the corneal epithelium that could delay healing or minimize the immediate “wow factor” effects of the surgery. Additionally, generic ophthalmic steroids require vigorous shaking in order for the suspensions to mix properly and get the best effect, a necessity some patients may not be willing or able to do. However, when obtaining the branded medications is not possible, generics do provide a cost effective alternative.

Next: Combined or lessdrops approach

Combined or lessdrops approach

Just as dropless formulations have improved cost, convenience, and compliance for cataract surgery patients, combined drop formulations are doing the same for LASIK patients and other types of ocular surgeries, including cataract patients unable to attain dropless cataract surgeries.¹² These formulations are compounded in Imprimis’ accredited pharmacies and can be customized to the needs of individual patients. Combining medications can reduce the necessary number of different drops patients need by 50 percent or more by decreasing from two separate bottles of antibiotics and steroids to just one combined antibiotic and steroid bottle to be used three times a day for post-operative LASIK patients.¹² This not only enhances the patient experience, but improves compliance, alleviates instillation and dosage problems, and lessens confusion.¹²

These formulations are significantly less expensive when compared to traditional ocular therapies as well. While the Pred-Moxi formulation, for instance, costs $25 per 3 mL bottle and $50 per 6 mL bottle, branded and generic drops can be significantly more costly. For example, a branded Vigamox (moxifloxacin, Alcon) 3mL bottle can be as much as $180 for each bottle at our local Panama City, FL, CVS Pharmacies, a significant cost difference especially when many patients will need to pay this out-of-pocket. Without insurance-covered medications or samples from companies that can be provided for patients, it can be difficult for patients to obtain their necessary medications. Combination ophthalmic medications are shipped directly to the patient or surgical center, adding additional convenience because patients will have their medications on hand immediately after surgery.

Comanaging optometrists should be aware that their surgeons may now be utilizing these new formulations. Currently, four proprietary formulation ophthalmic drops are available:

• Pred-Moxi (prednisolone acetate and moxifloxacin hydrochloride)

• Pred-Moxi-Ketor (prednisolone acetate, moxifloxacin hydrochloride, and ketorolac tromethamine)

• Pred-Ketor (prednisolone acetate and ketorolac tromethamine)

• Tri-Moxi (triamcinolone acetonide and moxifloxacin hydrochloride)

Doctors can order these formulations at lessdrops.com. When ordering, there must be a patient name on every prescription, and it is a good idea to order at least a few days in advance. Early orders can be stored because the medication has three- to six-month shelf life. Less-drops medications are currently available in every U.S. state.

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References

1. Humer, C. Express Scripts backs Imprimis’ $1 pill over $750 Daraprim. 2015 December 1. Available at: http://www.reuters.com/article/imprimis-express-scripts-idUSL1N13P1UB20151201. Accessed 12/20/15.

2. Lane SS, Osher RH, Masket S, Belani S. Evaluation of the safety of prophylactic intracameral moxifloxacin in cataract surgery. J Cataract Refract Surg. 2008 Sep;34(9):1451-9.

3. Anijeet DR, Palimar P, Peckar CO. Intracameral vancomycin following cataract surgery: An eleven-year study. Clin Ophthalmol. 2010 Apr 26;4:321-6.

4. Arshinoff SA, Bastianelli PA. Incidence of postoperative endophthalmitis after immediate sequential bilateral cataract surgery. J Cataract Refract Surg. 2011 Dec;37(12):2105-14.

5. Gimbel HV, Sun R, DeBrof BM. Prophylactic intracameral antibiotics during cataract surgery: the incidence of endophthalmitis and corneal endothelial cell loss. J Cataract Refract Surg. 1994 Oct;6(5):280-285.

6. O’Brien TP, Arshinoff SA, Mah FS. Perspectives on antibiotics for postoperative endophthalmitis prophylaxis: potential role of moxifloxacin. J Cataract Refract Surg. 2007 Oct;33(10):1790-800.

7. Galloway MS. Intravitreal placement of antibiotic/steroid as a substitute for post-operative drops following cataract surgery. Presented at the American Society for Cataract and Refractive Surgeons Annual Meeting. April 25-29. Boston, MA.

8. Liegner J. Better surgery through chemicals. Presented at the American Society for Cataract and Refractive Surgeons Annual Meeting. April 25-29. Boston, MA.

9. Gauthier P, Levine S, Sibley D, Stern S, Zuber J. LASIK Surgery: An analysis of how LASIK surgery became the dominant form of vision correction surgery in the United States. Tuck School of Business at Dartmouth. Available at: http://faculty.tuck.dartmouth.edu/images/uploads/faculty/ron-adner/18EIS_Main_Project_-_LASIK_Paper.pdf. Accessed 3/28/16.

10. Patel SC, Spaeth GL. Compliance in patients prescribed eye drops for glaucoma. Ophthalmic Surg. 1995 May-Jun;26(3):233-6.

11. An JA, Kasner O, Samek DA, Lévesque V. Evaluation of eye drop administration by inexperienced patients after cataract surgery. J Cataract Refract Surg. 2014 Nov;40(11):1857-61.

12. Campos M, Muccioli C, Malta JB, Gerade RA, LA Salame A, Belfort R. Efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK. Clinical Ophthalmology. 2011 Feb;5:209-214