Point/Counter

Would you recommend generic drugs to a family member?

Click here to read the Cover Story, "Drug shortages put ophthalmologists and their patients in difficult positions."

POINT

Good generic options available in glaucoma

Would I prescribe generics to my family? Yes. I believe that all physicians treat all of their patients like family. I do as well. I prescribe generic medications to the majority of my patients. For the classes of medications that I commonly use, there are only some examples in which generics may have additional considerations. For glaucoma medications, we have fantastic generic options for prostaglandin analogues (eg, latanoprost, travoprost and bimatoprost), beta-blockers (eg, timolol and betaxolol), carbonic anhydrase inhibitors (eg, dorzolamide), selective alpha-2 adrenergics (eg, brimonidine 0.15% and 0.2%) and combinations (eg, dorzolamide/timolol). In patients who are sensitive to benzalkonium chloride, it is great to have the preservative-free option of dorzolamide/timolol.

Douglas J. Rhee, MD
Douglas J. Rhee

Despite the number of generic options, there are many important gaps in treatment that can only be fulfilled by trade medications, such as Rho kinase inhibitors (ie, netarsudil), preservative-free tafluprost (ie, Zioptan), preservative-free timolol, SofZia-preserved travoprost (ie, Travatan Z) and important combinations Combigan (brimonidine/timolol) and Simbrinza (brinzolamide/brimonidine). These trade products are critical to patient care and necessary for all government and commercial agencies to include as part of their panels.

Topical antibiotics are well covered by generics. Although topical steroids have many generic options, there are important considerations; no generic equivalent of Durezol exists, and prednisolone acetate generic has been shown to not be as well dispersed as Pred Forte, requiring additional shaking of the bottle. Generic medications are important cost-effective options for our patients that are effective and safe. However, many therapeutic areas are only covered by branded medications; both generic and branded medications are vital and necessary for our patients.

Douglas J. Rhee, MD, is an OSN Glaucoma Board Member. Disclosure: Rhee reports he is on the speakers bureau for Bausch + Lomb, Aerie and Ivantis; is a consultant for Alcon, Allergan, Bausch + Lomb, Aerie and Ivantis; does research for Allergan, Glaukos and Ivantis; and does data safety monitoring for Ocular Therapeutix.

COUNTER

Branded medications offer less risk

Daniel F. Kiernan, MD, FACS
Daniel F. Kiernan

No. In general, when we talk about retina drugs, we are talking about on-label Lucentis (ranibizumab, Genentech) and Eylea (aflibercept, Regeneron) as anti-VEGF drugs or on-label Triesence (triamcinolone, Alcon), Ozurdex (dexamethasone intravitreal implant, Allergan) or Iluvien (fluocinolone acetonide, Alimera Sciences), to name a few corticosteroids. There are off-label or generally termed generic options, such as Avastin (bevacizumab, Genentech) or Kenalog (triamcinolone acetonide, Bristol-Myers Squibb), a steroid. I certainly prefer on-label options over the others because of the FDA approval process, which is rigorous, and the clinical trial data, which are robust.

In addition, specific to Kenalog, there is a black box warning prohibiting intraocular injection. There is a litigious aspect of using that as well as a patient safety aspect. There have been cases of pseudoendophthalmitis associated with off-label Kenalog, so that is definitely something I avoid using.

As far as bevacizumab, although it works fairly well, there have been compounding issues resulting in lack of the actual active drug activity in different batches between different compounding pharmacies or even the same compounding pharmacy, leading me to believe that the efficacy of it is reduced overall, especially due to handling and preparation by intermediaries of the compounding pharmacy. In addition, for certain diagnoses such as wet age-related macular degeneration, the CATT trial showed there was reduced retinal edema with on-label Lucentis compared with off-label bevacizumab, although the visual results were similar. If you are talking about diabetes and look at DRCR.net Protocol T study, we clearly see there is less fluid and improved vision with aflibercept, which is on-label Eylea, over off-label bevacizumab in the cohorts even after 2 years. Patients who started with better vision (20/40 or better) in the ranibizumab cohort also had significantly less fluid on average compared with bevacizumab.

For all these reasons, I prefer not to use off-label bevacizumab, although because of insurance step programs and requiring authorization, I still use quite a bit of it. It works, but I feel like at times I am forced to use it, which is another point of contention that prevents me from having more support for the off-label options.

Daniel F. Kiernan, MD, FACS, is a retina specialist with Ophthalmic Consultants of Long Island. Disclosure: Kiernan reports he is a consultant and speaker for Allergan, Genentech, Regeneron and Alimera Sciences.

Click here to read the Cover Story, "Drug shortages put ophthalmologists and their patients in difficult positions."

POINT

Good generic options available in glaucoma

Would I prescribe generics to my family? Yes. I believe that all physicians treat all of their patients like family. I do as well. I prescribe generic medications to the majority of my patients. For the classes of medications that I commonly use, there are only some examples in which generics may have additional considerations. For glaucoma medications, we have fantastic generic options for prostaglandin analogues (eg, latanoprost, travoprost and bimatoprost), beta-blockers (eg, timolol and betaxolol), carbonic anhydrase inhibitors (eg, dorzolamide), selective alpha-2 adrenergics (eg, brimonidine 0.15% and 0.2%) and combinations (eg, dorzolamide/timolol). In patients who are sensitive to benzalkonium chloride, it is great to have the preservative-free option of dorzolamide/timolol.

Douglas J. Rhee, MD
Douglas J. Rhee

Despite the number of generic options, there are many important gaps in treatment that can only be fulfilled by trade medications, such as Rho kinase inhibitors (ie, netarsudil), preservative-free tafluprost (ie, Zioptan), preservative-free timolol, SofZia-preserved travoprost (ie, Travatan Z) and important combinations Combigan (brimonidine/timolol) and Simbrinza (brinzolamide/brimonidine). These trade products are critical to patient care and necessary for all government and commercial agencies to include as part of their panels.

Topical antibiotics are well covered by generics. Although topical steroids have many generic options, there are important considerations; no generic equivalent of Durezol exists, and prednisolone acetate generic has been shown to not be as well dispersed as Pred Forte, requiring additional shaking of the bottle. Generic medications are important cost-effective options for our patients that are effective and safe. However, many therapeutic areas are only covered by branded medications; both generic and branded medications are vital and necessary for our patients.

Douglas J. Rhee, MD, is an OSN Glaucoma Board Member. Disclosure: Rhee reports he is on the speakers bureau for Bausch + Lomb, Aerie and Ivantis; is a consultant for Alcon, Allergan, Bausch + Lomb, Aerie and Ivantis; does research for Allergan, Glaukos and Ivantis; and does data safety monitoring for Ocular Therapeutix.

PAGE BREAK

COUNTER

Branded medications offer less risk

Daniel F. Kiernan, MD, FACS
Daniel F. Kiernan

No. In general, when we talk about retina drugs, we are talking about on-label Lucentis (ranibizumab, Genentech) and Eylea (aflibercept, Regeneron) as anti-VEGF drugs or on-label Triesence (triamcinolone, Alcon), Ozurdex (dexamethasone intravitreal implant, Allergan) or Iluvien (fluocinolone acetonide, Alimera Sciences), to name a few corticosteroids. There are off-label or generally termed generic options, such as Avastin (bevacizumab, Genentech) or Kenalog (triamcinolone acetonide, Bristol-Myers Squibb), a steroid. I certainly prefer on-label options over the others because of the FDA approval process, which is rigorous, and the clinical trial data, which are robust.

In addition, specific to Kenalog, there is a black box warning prohibiting intraocular injection. There is a litigious aspect of using that as well as a patient safety aspect. There have been cases of pseudoendophthalmitis associated with off-label Kenalog, so that is definitely something I avoid using.

As far as bevacizumab, although it works fairly well, there have been compounding issues resulting in lack of the actual active drug activity in different batches between different compounding pharmacies or even the same compounding pharmacy, leading me to believe that the efficacy of it is reduced overall, especially due to handling and preparation by intermediaries of the compounding pharmacy. In addition, for certain diagnoses such as wet age-related macular degeneration, the CATT trial showed there was reduced retinal edema with on-label Lucentis compared with off-label bevacizumab, although the visual results were similar. If you are talking about diabetes and look at DRCR.net Protocol T study, we clearly see there is less fluid and improved vision with aflibercept, which is on-label Eylea, over off-label bevacizumab in the cohorts even after 2 years. Patients who started with better vision (20/40 or better) in the ranibizumab cohort also had significantly less fluid on average compared with bevacizumab.

For all these reasons, I prefer not to use off-label bevacizumab, although because of insurance step programs and requiring authorization, I still use quite a bit of it. It works, but I feel like at times I am forced to use it, which is another point of contention that prevents me from having more support for the off-label options.

Daniel F. Kiernan, MD, FACS, is a retina specialist with Ophthalmic Consultants of Long Island. Disclosure: Kiernan reports he is a consultant and speaker for Allergan, Genentech, Regeneron and Alimera Sciences.