Category Archives: The Savvy Healthcare Consumer

Achieve better health care by understanding the politics and the marketplace of medicine.

Which is better: Syfovre or Izervay?

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Which is better: Syfovre or Izervay?

What are Syfovre and Izervay?
Syfovre and Izervay are medications used to treat geographic atrophy (GA) caused by dry-type age related macular degeneration (AMD).  It is given by injection into the eye.

What is geographic atrophy (GA)?

Geographic atrophy is a common cause of loss of central vision in AMD.  It occurs when retinal receptor cells die.  GA leaves blinds spots and missing areas in the vision.  It is different from wet AMD.  Until now, there was no treatment for geographic atrophy from AMD.    

How do Syfovre and Izervay work?

Syfovre and Izervay block the complement proteins in the body.  Complement is involved in the normal inflammatory response of the body.  The inflammatory response is important to fight infection.  However, in AMD the complement proteins appear to be involved in the development on geographic atrophy and loss of vision.  

How well do Syfovre and Izervay work?

Syfovre and Izervay are not cures for dry AMD.  They do not reverse the past damage by geographic atrophy.  Syfovre and Izervay, when given by monthly injection, was shown to reduce the rate of worsening of geographic atrophy by a small amount in a two-year study.  

What are the adverse effects of Syfovre and Izervay?

As with all intraocular injections there are risks.  The risks involved with the introduction of a needle into the eye include bleeding, inflammation, infection, and retinal detachment.  These problems may require surgery and risk loss of vision.  The known risks of Syfovre and Izervay include the new start of wet AMD threatening loss of vision.  This appears to occur in 10-20% of eyes.  This risk of new wet AMD may be reduced by avoiding treatment in high-risk eyes.  It is important to avert the development of new wet AMD because the treatment of wet AMD involves routine, long-term injection of another medication to prevent severe loss of vision. 

There is a risk of infection (endophthalmitis) after any eye injection.  There is some concern that Syfovre and Izervay may increase the risk of developing infection or worsen the final vision after infection.  The suppression of the natural defense against infection by both of these drugs, explains the concern over increased risk of infection. Not surprisingly, similar drugs given systemically have been shown to increase the risk of infection outside the eye.   

 Which is better: Syfovre or Izervay?

There have been no studies to date directly comparing Syfovre and Izervay.  However, Syfovre has rarely been associated with loss of vision from ischemic optic neuropathy (1-2%) and ischemic retinal vasculitis (~1 in 10,000).  To date it is not known if Izervay also shares this adverse effect.  Regardless, some doctors prefer Izervay because the injection may be given with a finer needle (i.e. it is less viscous), making the injection more comfortable compared with Syfovre.

The decision to use Syfovre or Izervay with the intent to slow the progression of dry AMD (geographic atrophy) must be weighed against the potential adverse effects in any given patient.  Your doctor will help you decide.

By Scott E Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright 2023-2024 Designs Unlimited of Florida. All Rights Reserved.

Lucentis Biosimilars: Byooviz and Cimerli

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Lucentis Biosimilars

What is a Lucentis biosimilar?

Lucentis is a medication used in the treatment of a variety of conditions including wet-type macular degeneration, diabetic retinopathy, and retinal vein occlusion.  Lucentis biosimilars are less-expensive medications manufactured to work in a fashion similar to Lucentis. It is important to remember that Lucentis biosimilars are not identical medications to Lucentis. In the US, Lucentis biosimilars include Byooviz and Cimerli.  

How effective are Lucentis biosimilars?      

Lucentis was proven in extensive studies to be very effective. In wet-type macular degeneration, a large study showed that monthly injections of Lucentis over a two-year period offered a 90% chance of stable or improved vision. Similar benefits are seen in other retinal conditions as well. The biosimilars were approved for use by the FDA as they appear to be non-inferior.  Further research will reveal more details.  

What are the risks of Lucentis biosimilars? 

Severe complications are very rare, but risks of Lucentis injection include bleeding, infection, inflammation, retinal detachment, glaucoma, cataract, and loss of vision. There may be a small increased risk (1%) of stroke or heart attack with Lucentis. The risk of stroke may be related to concurrent illness and the older age of patients in which these medications are used. Pregnancy should be avoided while on Lucentis therapy.  All of these risks apply to biosimilars, as well.  Furthermore, the question of whether biosimilars pose additional (or less) risk will be determined over time.                    

Why change from Lucentis to a biosimilar medication?

Usually an insurance company prompts the need to change from Lucentis to a biosimilar medication to lower their costs.  This may be a disadvantage to signing up for a Medicare Advantage insurance plan.  When a doctor must change from Lucentis to a biosimilar, he may need to take precautions in order to reduce the risk of problems.  For example, he may initially inject Byooviz or Cimerli at 4-week intervals before attempting to extend the treatment interval in order to assure effectiveness.  He may monitor the patient more closely to identify inflammation or high eye pressure.  After injection, patients should report any new symptoms without delay.   

Are doctors given financial incentives to prescribe Cimerli and Byooviz?

Manufacturers of new medications often provide incentives in the form of rebates to doctors. To determine if your doctor receives large payments from drug companies, visit the CMS website and enter your doctor’s name in the search box. I take great pride in advocating for my patients in the selection of medications, rather than pander to the drug companies.

By Scott E Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright ©2023 Designs Unlimited of Florida.  All Rights Reserved.

Save on AREDS Eye Vitamins

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Save on AREDS Eye Vitamins

What is age-related macular degeneration?

Age-related macular degeneration (AMD) is the most common cause of visual loss in older Americans.  It comes on with age and affects the central vision.  However, AREDS-2 vitamins lower the risk of vision loss.

What are AREDS-2 vitamins?

The AREDS-2 formula consists of carefully dosed vitamins, minerals and antioxidants aimed at protecting a patient against loss of vision from AMD.  It consists of vitamin C, vitamin E, Zinc, Copper, lutein, and zeaxanthin.  

Are there other vitamins in the market for AMD?

There are many vitamins and nutritional supplements marketed for AMD.  However, the AREDS-2 formula has undergone the most testing to date.  It offers the most assurance for protection against loss of vision.  Other supplements have been studied much less extensively and the safety is less certain.  For example, beta-carotene was used in AMD vitamins in the past, but it increases the risk of lung cancer in current and former smokers.  

What are the popular brands of AREDS-2 vitamins?

There are many brands of vitamins that contain the AREDS-2 formula.  PreserVision AREDS-2 and Ocuvite AREDS-2 are two popular brands.  They offer good quality; however, they are expensive.  

What is the least expensive brand of AREDS-2 vitamin?

There is now a high-quality alternative to the popular brands and it is much less expensive.  The name is Equate Advanced Eye Health Complex by Walmart.  In Tampa on September 9, 2023 the price for a box of 140 softgels (two-month’s supply) was $19.96.  This compares favorably with the price of PreserVision AREDS-2 of identical quantity selling for $34.47.  

By Scott E. Pautler, MD  

Note: Dr Pautler has no financial interest in any of the vitamin supplements.

Is Eylea HD for Me?

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Is Eylea HD for me?
anatomy of the eye (click on image to enlarge)

What is Eylea HD?

You may ask yourself, “Is Eylea HD for me?” Eylea HD is an FDA-approved medication for the treatment of wet AMD and diabetic retinopathy.  It is a more concentrated form of Eylea, a medication that has been approved for use and effectively used for many years.  Eyela contains 2mg of medication per injection, whereas Eylea HD has 8mg of medication per injection.

When is it helpful to use Eylea HD over Eylea?

There are several reasons Eylea HD may be better than Eylea.  For example, in some eyes with severe macular degeneration or diabetic damage, current medications may not appear to be strong enough to help.  Eylea HD may offer the strength needed to help prevent loss of vision in these cases.  In addition, if Eylea does not last as long as needed, injections may need to be given frequently.  Eylea HD offers a longer duration of action.  Therefore, it may allow more time between injections.  

What are the side effects?

The same side effects of Eylea remain for Eylea HD.  That is, they are both given by injection into the eye.  Therefore, risks include infection, inflammation, bleeding, and retinal detachment, among others.  Over time, these risks are less with Eylea HD if injections can be given less often; the fewer the number of injections, the lower the risk of complications from the injection procedure. However, because Eylea HD is more concentrated, there may be increased risk of complications outside the eye.  As Eylea leaves the eye and enters the blood stream, it may cause increased risk of hypertension, stroke, heart attack, and kidney disease.  There is much debate about whether this risk is significant or not, but evidence suggests the risk may be higher in diabetic patients.   

How can I decide if Eylea HD is right for me?

Your doctor will help you to decide.  If you do not have diabetes, or past history of stroke or heart attack, the decision may be easy.  However, if you have diabetes or are at high risk of stroke and heart attack, you may wish to hold off using Eylea HD until doctors have had more experience with the medication, which was newly approved for use in August 2023. 

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright  © 2023 Designs Unlimited of Florida.  All Rights Reserved.

Diet and Age-Related Macular Degeneration

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diet and age-related macular degeneration
anatomy of the eye (click on image to enlarge)

What is age-related macular degeneration?

A Mediterranean diet can protect against loss of vision from AMD.  But first, what is AMD?  Age-related macular degeneration (AMD) is the most common cause of visual loss in older Americans.  The macula is the area of the retina in the back of the eye that is responsible for seeing details in the central vision.  The retina is a thin layer of delicate nerve tissue that lines the inside wall of the eye like the film in a camera.  In the eye, light is focused through the lens onto the retina, which “takes the picture” and sends the image to the brain.  Macular degeneration is a disease that affects the central vision. It does not affect peripheral vision— the ability to see objects off to the side when looking straight ahead.  This means that macular degeneration alone does not result in total blindness.  

What lifestyle changes offer protection against macular degeneration?

Over the years, mounting evidence shows that lifestyle changes appear helpful to limit the risk of vision loss from age-related macular degeneration.  For example, tobacco exposure appears to worsen macular degeneration.  This means do not smoke tobacco and limit second-hand exposure to tobacco. Conversely, exercise appears to lessen the risk of vision loss from AMD.  Try to walk 20 minutes a day for starters.  Later, try to add some light weight-bearing exercises with dumbbells.  Finally, there is marginal evidence to recommend protecting your eyes from excessive sunlight.  Wear a hat and sunglasses if outdoors for several hours.  Diet is another way in which a patient may afford protection against AMD.  The Mediterranean diet is associated with reduced risk of cardiovascular disease and reduced risk of vision loss from AMD.

What is a Mediterranean diet?

The Mediterranean diet includes high intake of extra-virgin olive oil, vegetables (especially, leafy greens), fruits, cereals, nuts/legumes, moderate intake of fish and other meat, dairy products, and red wine, and low intake of eggs and sweets.   Red meats appear inflammatory.  Therefore, many recommend eating red meat only on rare occasions.  Also, avoid high intake of alcohol (greater than two alcoholic beverages per day).  Fish and seafood, on the other hand appear protective.  Try to include a serving of fatty fish like salmon at least three times a week.  If you are not a fan of seafood, consider taking coated fish oil capsules once a day.  The coated formulations help to avoid a fishy aftertaste.    

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

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Copyright  © 2023 Designs Unlimited of Florida.  All Rights Reserved.

Computer Glasses

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Having trouble seeing the computer screen?

Do you have difficulty seeing the computer with your glasses?  Do you have difficulty keeping your head positioned to focus the progressive lenses on details at near?  Do your eyes feel fatigued after working on the computer?  You are not alone and there is a solution to your problem.  The problem frequently lies with the limitations of progressive lenses used to treat presbyopia.

What is presbyopia?

Presbyopia means “old eyes.”  It is the name given to the inability to focus at near that comes on with age.  Early in life, the eye has the ability to focus at distance and near with ease.  This property is called accommodation.  That is, the lens of the eye can change shape to alter the focus of the eye to adjust to different distances.  Therefore, presbyopia is the loss of accommodation due to the inability of the lens to change shape with age.  

Typically, when people reach the age of forty or fifty, if the eyes are focused at distance (either naturally or with glasses/contact lenses), the vision at near becomes difficult.  At that point, you need longer arms or “reading glasses” (also called, “cheaters”).      

What are readers, bifocals, trifocals, and progressive lenses?

There are a variety of lenses designed to treat presbyopia.  If a person has “normal” eyes focused at distance without glasses, standard over-the-counter reading glasses are used to treat presbyopia.  If a person needs glasses for distance vision, bifocal lenses are sometimes used. Bifocal lenses are designed with two lens segments.  The top segment is focused at distance and the bottom lens segment is focused at near.  There is usually a visible line on the lens that separates the top section from the bottom section.  The bifocal lens is helpful, but is limited by an inability to focus at an intermediate distance.  That is, the top section of the lens focuses well at 20 feet and beyond.  And the bottom section focuses well at near.  But the intermediate distance between distance and near is blurred for presbyopic eyes.  

So, trifocal lenses were developed.  Trifocals use a third lens segment.  The segment is located just below the distance segment and above the near segment to provide help with focusing at the intermediate distance.  Trifocals can be difficult to use.  It takes time to learn which lens to use for which distance (by tilting the head back the right amount).  And the intermediate lens power is less than ideal for focusing within the intermediate distance of three to twenty feet.  

Then came progressive lenses.  Progressive lenses are the most expensive lenses.  They are made to provide a top section of the lens for distance vision and this works well.  However, there is a compromise made in the lens in order to improve the focus in the intermediate and near range.  Specifically, the lens is molded to provide a narrow section of the lens leading from the top (distance) and bottom (near) sections of the lens.  This allows for accurate focusing at any point in the intermediate range (3-20 feet) as the head is tilted back slowly to find the appropriate section of the progressive lens to focus at any distance needed.  It takes time to learn how to hold the head in proper position to focus at intermediate and near distances in part because the zone of clear vision through the molded lens is very narrow.  Herein lies the difficulty with using progressive lenses for computer work.

How are my progressive lenses giving me trouble at the computer?

Viewing the computer screen presents unique challenges.  First, the screen is situation two to three feet from the eyes.  Second, the screen is broad and requires some degree of scanning across the screen.  The progressive lens is not designed well to solve these challenges.  While the progressive lenses work well for routine use of the eyes, the narrow zone of focus of the lens at intermediate and near distances requires constant fine movement of the head to keep the image in focus across the breadth of the computer screen.  This effort causes fatigue and frustration.

What is the solution?

While some people can tolerate the limitations of progressive lenses while working on the computer, others require a different type of lens.  Computer glasses may be prescribed that employ the less expensive bifocal lens style.  The top part of the bifocal is focused on the computer screen (rather than for distance) and the bottom part of the bifocal is focused for deskwork.  This lens avoids the narrow bridge of focus that limits the progressive lens.  That is, the entire top lens is focused for scanning the computer screen.  Similarly, the entire bottom portion of the computer glasses (bifocal) is available to scan papers on the desk. 

To facilitate the process of obtaining computer glasses, I recommend an individual use a tape measure to record the number of inches from your forehead to the computer screen.  Similarly, measure the distance to the desk for near work.  With these measurements in hand, the optometrist or ophthalmologist can prescribe precise bifocal glasses for computer and near work.  These computer glasses will not work for distance vision, but will likely relieve the frustration and fatigue when working at the computer for an extended period of time.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright 2022. Designs Unlimited of Florida. All Rights Reserved.

Who Owns your Eye Doctor?

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In the old days, the doctor owned his own medical practice, but he was dependent on the confidence of his patients for success.  He was motivated to please his patients because they could choose any doctor they wanted.  In this regard, the patients owned their doctor.  The hospital was motivated to provide equipment the doctor needed for his patients because he could choose to bring his patients to any of the area hospitals.  The hospitals competed for the best doctors to bring their patients in for care.  

Then came government intervention.

In the name of cutting the cost of medical care, the government passed laws that pushed the balance of medicine in favor of insurance companies and hospitals.  For the first time, insurance companies began dictating treatment choices to the doctor and patient.  Hospitals took control of physician’s medical practices and turned their attention away from the doctor and his patients.  Consequently, the value of the doctor’s medical practice was eroded.  In addition to losing the decision-making privileges, physicians were burdened with regulations and requirements from the government that reduced the time available to care for their patients.     

Then came private equity (PE).

As doctors found the practice of medicine more complicated, frustrating, and less rewarding, businessmen (private equity) decided they could run the medical office more profitably than the doctor.  They began to purchase medical practices with the intent of increasing the value (profits) in order to sell the practice later at a higher price to another group of businessmen.  And so on, and so forth.  The businessmen have no interest in medical care for the patient.  Rather, they care about the profit derived from running the office. 

So, who owns your doctor? 

Is your doctor working for you, or is he working for a businessman?  You need to know.  And It is not always easy to tell.  For example, when private equity buys physicians’ practices, they usually do not change the name of the office.  And, initially, they may keep the same staff.  But the message within the office is clear.  The primary goal is efficiency and cost-cutting for the purpose of making greater profit.  The steps to achieve this goal may include reducing the quality of the health care givers.  It may include ordering more tests and procedures than what was done in the past.  The emphasis is not typically to provide the highest quality of care for the patient.

What can a patient do?

Ask around about your doctor.  Your doctor may or may not be at liberty to discuss this issue with you.  However, other doctors outside the practice may know.  It is essential to know if you “own” your doctor or if someone else does.  This is a critical question as the doctor answers to the boss.  And your health (and life) may depend on the answer.  In the Tampa Bay area, I am aware of several ophthalmology offices that have been purchased by private equity.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright  © 2022 Designs Unlimited of Florida.  All Rights Reserved.

Is a Drug Study for Me?

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What is a drug study?

In the United States, new drugs designed to treat disease must be approved by the Food and Drug Administration (FDA).  Drug companies must design and pay for studies that demonstrate reasonable safety and efficacy to gain FDA approval, after which they may market their drugs to doctors and patients for a profit.  Because pharmaceutical sales are so profitable, drug companies are highly motivated to develop new drugs.  This effort helps patients who need better drugs to treat disease.  

What are the phases of drug study?

Initially, drugs are developed by basic scientists who have reason to believe a new drug may be useful based on its chemical interaction with the body.  Initial studies are performed in the laboratory and often involve animal studies.  If basic safety criteria are met in the lab, the drugs may be brought to Phase 1 study in which some human subjects (usually, a dozen or two) are given the drug to look for a beneficial effect and lack of adverse effects.  If a drug passes Phase 1, a Phase 2 study is designed to help determine the best dose of drug.  More patients are recruited for these studies, but often number fewer than one hundred.  If successful, a Phase 3 study is planned to gain approval by the FDA.  These studies randomly assign drug treatment to patients in a manner that neither the treating doctor nor the patient knows what drug they are using.  It is hoped that this method will avoid bias and offer a true assessment of the drug effect.  The schedule of administration is completely designed by the drug company, but must be approved by the FDA.  Unfortunately, this oversight may lack rigor.  Phase 3 studies often include several hundred patients.  Key endpoints of treatment are diligently recorded and adverse drug effects are monitored carefully.  Finally, after FDA approval, drugs may be studied in a Phase 4 study looking further for adverse effects and/or new uses for other diseases.  It is obvious that more is known about the effectiveness and safety of a drug the further along the study sequence it passes.  Nonetheless, some adverse effects are not discovered until years after a drug has been approved for use by the FDA.   

What are the benefits of participating in a drug study?

Apart from feeling good about being a part of drug development, patients may benefit from participating in drug studies.  For example, the patient may gain access to a helpful drug that would not have been available otherwise.  In addition, the drug company usually offers to pay for the medication and treatment visits during the course of the study.  They often offer to pay cash to the patient in the form of a stipend for transportation to study visits.

What are the risks of being in a drug study?

Not surprisingly, with potential benefits come potential risks.  For example, most drugs that enter the process of study, do not meet with success.  That is, they are found to be inferior to existing medications or they are found to have unacceptable adverse effects.  This is one risk a patient must accept.  Secondly, the decision to treat and method of treatment is guided by strict protocols aimed to favor the study drug; not necessarily in the best interest of the patient.  The doctor is given limited independent authority to alter treatment within the study.  However, the patient may always exit the study at any time should he or his doctor decide.  It is critical to remember that exposure to an unproven drug carries with it the risk of unknown risk of adverse effects.  Complicating matters more, the doctor is highly compensated by drug companies to recruit patients for drug studies.  During these times of decreasing physician compensation by Medicare and insurance companies, doctors may be under financial duress to cover the high cost of office overhead. There is a risk that the doctor may be motivated more by financial compensation than the best interest of the patient.  Hopefully, this risk is not significant.  The risk of adverse effects is highest in the early stages of study when less is known about the drug.  Therefore, caution must be exercised with phase 1 and phase 2 studies.  Phase 3 studies are safer, but still not without risk.  Phase 4 studies are the safest because the drug has already been approved for use by the FDA; however, sometimes the full extent of adverse effects is still not known.  Therefore, when considering study participation, at a minimum a patient should ask what phase study is being offered them.

So, should I participate in a drug study?

In the end, drug studies are an essential part of discovering new medicines to treat disease.  If you feel you may benefit from a study drug and/or currently-approved drugs are not satisfactory to you, a drug study may be worth considering. However, you must accept the risks of being treated by a drug that has not been studied extensively for safety and efficacy in the past and is being used under a protocol designed by a drug company whose primary interest is gaining drug approval by the FDA.  If in doubt, it may be best to seek a second opinion from a doctor outside of the drug study.  

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright  © 2022-2023 Designs Unlimited of Florida.  All Rights Reserved

Medicare Advantage: a Medical Disadvantage

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What is Medicare Advantage?

Medicare Advantage is an insurance plan available through Medicare Part B.  Medicare Part B is the insurance that covers the cost of physician services.  The traditional Medicare Part B insurance covers 80% of the physician’s fee after an annual deductible has been met.  Medicare Advantage is a program designed to cut costs of medical care.  It covers a greater part of the physician’s fee and also covers some accessory services such as eye glasses.  However, it restricts access to some services compared with the traditional Medicare Part B insurance.      

Why might someone choose Medicare Advantage?      

The main reason for choosing Medicare Advantage is to reduce the out-of-pocket costs of health care.  The benefits are obvious.  However, the costs in terms of limited access to treatment must be carefully considered.    

What are the limitations of Medicare Advantage? 

Medicare Advantage attempts to reduce the cost of medical care.  They do this by limiting access to expensive treatments.  For example, they require that physicians use the least expensive drug (called Avastin) for retinal disorders such as diabetic retinopathy, macular degeneration and retinal vein occlusion.  Avastin must be compounded by a pharmacy after it has been manufactured because it is not FDA-approved for use in the eye.  Therefore, there are increased risks including infection and floaters from silicone oil droplets.  Other, more expensive drugs (called Lucentis) reduce the risk of stroke and heart attack after injection into the eye, especially in people who require repeated injections (such as in diabetic retinopathy).

 Patients who are on the traditional Medicare Part B plan currently have access to the newest drug for macular degeneration and diabetic retinopathy, called Vabysmo.  As of the time of this article, Medicare Advantage plans do not allow doctors to use this drug even though it offers the potential for fewer injections compared with other drugs such as Avastin.  As with most things in life, you get what you pay for.  If you opt to save money by signing up for Medicare Advantage, you can expect less in terms of medical care.  Medicare Advantage plans may turn out to put you at a disadvantage.

By Scott E. Pautler, MD

Copyright ©2022 Designs Unlimited of Florida.  All Rights Reserved.

COVID-19 and Facial Fillers

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How can COVID-19 affect cosmetic fillers?

            COVID-19 infection or COVID-19 vaccines may cause cosmetic facial fillers to swell.  The swelling may occur hours to a few weeks after exposure.  Fortunately, this appears to be a rare adverse effect.  The true frequency is not known because it represents a fairly minor reaction among the spectrum of symptoms of COVID-19.    

What causes the swelling to occur?

            Not much is known about this uncommon reaction.  It is suspected to be due to an immune reaction to the spike protein on the virus surface.  It does not appear to be due to direct infection of the COVID-19 virus in the filler material itself.   

How long does the swelling last?

            The duration of swelling varies.  Usually, the swelling lasts only a few days, but it may wax and wane over several weeks.  Treatment may make the swelling go away more rapidly.  Fortunately, swelling of facial fillers does not appear to be a permanent problem.     

What treatment is available?

            Many different treatments have been used.  The effectiveness of treatment is difficult to assess because of the rarity of the problem.  Local treatment may include cold compresses.  Oral antihistamines have not been universally effective.  Anti-inflammatory medications such as prednisone may help; however, there is some concern about the potential interference in developing protective immunity.  Of interest, lisinopril (commonly used to treat high blood pressure) may be useful to resolve the swelling.  More knowledge will come with experience. 

By Scott E. Pautler, MD 

Copyright © 2021 Designs Unlimited of Florida. All Rights Reserved.

Step Therapy

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What is Step Therapy?

In August 2018 the Centers for Medicare and Medicaid Services (CMS) introduced “step therapy” to Medicare Advantage plans.  CMS is the federal government agency that administers the Medicare program.  Step therapy is concept in which doctors are required to use inexpensive medications before they use more expensive medications without regard to how well the medications work and what side effects might be caused by the medications.  Medicare Advantage is a type of medical insurance provided by Medicare with the primary goal of reducing the costs of medical care.  Private insurance companies have followed the Medicare Advantage lead in implementing step therapy in 2019.

What eye medications are affected by step therapy?

The most common effect step therapy has had on eye care is in the use of antiVEGF medications. AntiVEGF medications are a group of drugs that have in common the ability to stop abnormal blood vessels from growing and leaking in the eye.  They help control abnormal blood vessels that can lead to blindness from a number of diseases including macular degeneration (caused by age, near-sightedness, and other conditions) macular edema, retinal vein occlusion, and diabetic eye disease.  

Why are antiVEGF medications targeted?

There is a large price difference among antiVEGF drugs.  The most commonly used antiVEGF drugs include Avastin, Lucentis, Eylea, Beovu, and Vabysmo. While a dose of Avastin costs about $50, the price of Lucentis, Eylea, and Beovu is about $2,000 per dose.  Due to an unexpected fluke, Avastin was found to be very effective in the treatment of eye disease AFTER it had been approved by the FDA and priced by the drug company for the treatment of colon cancer.  Because only a fraction of a vial of Avastin is used in the eye, the cost to treat eye disease is fairly low.  Lucentis and Eylea underwent lengthy study to gain approval by the FDA for the treatment of eye disease.  As a result, the drug companies were allowed under current law to set a higher price. 

Are the antiVEGF drugs equal in safety and effectiveness?

Although there are no major differences in safety and effectiveness in most patients, there are some differences among the antiVEGF drugs that might be important in individual patients.  Silicone oil droplets from the syringe may cause bothersome, persistent floaters.  This appears to be more common with Avastin.  Also, Avastin may place an eye at increased risk of infection and blindness because it must be packaged twice.  The potency of the drugs appears to be less with Avastin than Lucentis, which appears to be less potent than Eylea.  This difference in effectiveness may be important in certain patients.  The ophthalmologist (fellowship-trained retinal specialist) is in the best position to make recommendations for the patient. 

What can a patient do?

If step therapy is deemed not desirable by a patient, he or she may consider avoiding medical insurance coverage that mandates step therapy, such as Medicare Advantage.  If step therapy is required by an existing insurer, the doctor may be forced to use Avastin for initial treatment.  Often, the choice of medication may be changed after three or more injections if the treatment effect can be shown to be ineffective to the satisfaction of the insurance company.  

How might the government have handled this issue better?

A better solution to the problem of controlling the costs of medications is competition.  Competition fosters efficiency.  Current federal laws inhibit competition by not allowing Medicare to negotiate prices of medications.  Other laws require excessively expensive and inefficient processes to develop new drugs.  The unintended consequence of these laws was that drug companies lost incentive to develop better drugs.  To compensate drug companies for the laws that cause the high costs required to bring new drugs to market, the government passed more laws that barred competition and allowed drug companies to charge high prices for their drugs.  This was supposed to help drug companies recoup the costs of drug development.  However, the price of lack of competition and high drug costs is born by the patient.    

The government can lower drug costs by increasing competition.  Although Europe is not efficient by any stretch of the imagination, even they have more efficient systems in place for drug development compared with the United States.  The FDA attempts to manage new drug development, but its regulations and processes need to be streamlined.  Patent laws that prevent competition need to be reviewed.  The government can provide a platform to open price negotiation with drug companies.  Doctors should be allowed back into the scene as advocates for their patients instead being gagged by insurance companies due to government regulations.  Patients should be given a transparent view of the process of drug efficacy and pricing. 

By Scott E. Pautler, MD  

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Over-the-Counter Pain Medications

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What are over-the-counter pain medications?

Over-the-counter (OTC) pain medications are pills that can be purchased without a prescription. There are a number of brands available. Examples include ibuprofen (Motrin) and acetaminophen (Tylenol). As ibuprofen and acetaminophen work via different pathways, they can be used together for improved pain control.

What side effects might be expected?

Most drugs have many possible side-effects. The major concern with acetaminophen is liver damage especially seen in patients with known liver disease. The major concern with ibuprofen is kidney damage in patients with known kidney disorders. Also, ibuprofen may irritate the stomach and increase the risk of stomach ulcers. This is especially seen in patients over the age of 65, history of stomach ulcers, or taking medications such as aspirin, steroids, or warfarin (Coumadin). Ibuprofen thins the blood and, therefore, may increase the tendency to bleed by slowing the ability of the blood to clot. The risk of stomach problems with ibuprofen may be reduced by using Zantac or Pepcid, which are available over-the-counter.

How can OTC pain medications be optimally used to control post-operative pain?

Because pain from surgery is short-lived, drug dependence is not a significant issue. The best strategy is to stay ahead of severe pain rather than trying to catch up due a lapse in medication. The optimal use of OTC medication may reduce the need for prescription narcotic pain medication. Prescription narcotic pain medications have side-effects such as sedation, constipation, nausea, and vomiting. With the proper use of OTC pain medications, the need for narcotics can be minimized.

As most narcotic pain medication is combined with acetaminophen, the dosage of OTC acetaminophen (Tylenol) must be decreased so as to avoid exceeding the maximal daily dosage (3,000mg per day).

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Maximal Use of OTC Pain Medication for Pain Control after Surgery
Dosing Schedule: 8AM 2PM 8PM 2AM Daily Maximum
Ipubrofen 800mg 800mg 800mg 800mg 3200mg
Dosing Schedule: 11AM 5PM 11PM Daily Maximum
Tylenol Extra-Strength 1000mg 1000mg 1000mg 3,000mg
Note: This schedule may need to be altered if you have kidney or liver disease.
This schedule is designed not to exceed maximum dosages of these medications.
Decrease the dosage as the pain improves after surgery.
Do not take additional medications that contain ibuprofen or acetaminophen without
adjusting the OTC medication dosage so as not to exceed the maximal daily dosages.
Consult with your doctor prior to using this medication schedule.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Do I need a retina scan?

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With all of the technological advances in eye care, there are many ways to visualize the eye and a retina scan is often offered during an eye examination. A retina scan is another name for a photograph of the retina. Is it really needed? Is it worth the money? The answers to these important questions depend on the circumstances of the eye exam.

Is a retina scan really needed?

For routine eye exams in which the patient has no symptoms of a retinal condition, a retina scan may not be necessary. Important symptoms of retinal problems include: straight lines looking crooked, a blind spot or missing area in the vision, a loss of peripheral vision. If these symptoms are present, a retina scan or a referral to a retinal specialist may be in order.

What types of retina scans are available?

The following are scans that may be ordered by the eye doctor:

  1. Color Fundus Photography: an image of the retina as seen by the examining eye care specialist.  It may be helpful to monitor and compare lesions from visit to visit.
  2. Fundus Autofluorescence Photography: an image of the fluorescence of the retinal layers taken with a short-wave light.  Helpful in diagnosis of many degenerative conditions such as age-related macular degeneration.
  3. Optical Coherence Tomography (OCT): a cross-sectional image of the retina (or other part of the eye).  This test is helpful to diagnose fluid leakage in or under the retina and to assess macular hole.  
  4. Fluorescein Angiography: a specialized image of the retina taken after an organic dye is injected into the vein of your arm.  It shows blood flow and sites of abnormal leakage.
  5. Indocyanine Green Angiography: similar to fluorescein angiography, but with a different dye that is used to see deeper into the eye to examine the choroid.  Useful in macular degeneration and posterior uveitis.

Is a retina scan worth the money?

An examination of the retina is included in a complete eye exam without further charge. A retina scan is sometimes used as an additional step (with additional charges) if the examining doctor is not comfortable with his/her ability to diagnose a retinal condition. The cost of a retina scan may be avoided in some cases by choosing an eye doctor who is comfortable examining the dilated eye for retinal problems without the use of a scan.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

How to find a good retina doctor?

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Why is it necessary to find a good retinal doctor?

Finding a good retinal doctor is important to receive the best level of care. Your doctor should be up-to-date on the latest treatments and be able to choose from among the many choices of treatment to determine which is the best for you as an individual. Some doctors may not keep up with new treatment options and, therefore, may not offer these choices to you as a patient. Moreover, some treatments work better for some patients, but do not work well for others. You must rely on your retinal specialist to offer the best treatment for you. To do so, your doctor must get to know your eyes and you as a person in order to choose what is best for you. The retinal specialist must then review the options and explain why he/she has chosen your treatment plan. All treatments have benefits, risks, and limitations. All of this information must be explained to you. It is helpful if the doctor gives you written information to take home to review after the visit.

How do you go about finding a good retina doctor?

This task is not easy or as obvious as it may seem. At a minimum, your retina doctor should be a medical doctor (MD or DO) and completed a residency in ophthalmology and should be board-certified by the American Board of Ophthalmology.  You can find out online if your doctor is certified. Board certification is essential, but it is only the first step in finding your retina doctor.

Be aware that some ophthalmologists call themselves retina specialists, but they have not completed a retina fellowship program. A retina fellowship is a one or two-year program of highly specialized training, which is undertaken after a general ophthalmology residency program. You may ask your doctor if he/she completed a fellowship in retinal disease and for how long (one or two years). Some information is available to you at the web site of the American Society of Retinal Specialists. You may prefer a doctor who has been trained at a highly reputable university. One source of information is Castle Connolly.

A number of additional factors may be important in the decision to choose the best retina doctor for you:

Does your doctor do research? This issue has a good side and a possible bad side. In general, research may help a doctor to stay up-to-date on diagnosis and treatment. On the other hand, intensive research may draw the doctor’s attention away from information that does not pertain to his/her research interest. In this scenario, the doctor may become an expert in a small area of research and fall behind in the general knowledge of patient care that is important to your care. Simply put, you may prefer a doctor whose primary interest is patient care, not scientific research. Having said that, there are superb retina doctors who excel at both research and patient care. When interviewing a retinal specialist, try to gain a sense as to whether the doctor is more interested in you and your eye problem or his/her research.

Who referred you to the retinal specialist? Although this may not be an important issue, it is something to consider. In years past, doctors referred their patients to other doctors primarily on the basis of their knowledge about who provided the best care. There was no incentive to refer to anyone but the best for their patients. Due in large part to considerable financial duress imposed by government regulation and the insurance industry, general eye doctors have found the need to reap financial gains by hiring retina doctors to work for them. In this setting, the referring doctor may choose a retina doctor who works in the same clinic (or a separate building owned by the same clinic) because he/she makes money from doing so. The clinic retinal doctor may well not be the best doctor available in the area for your care. When in doubt, get a second opinion outside the clinic.

Are you comfortable with your retina doctor? This is a simple, but exceedingly important question to ask yourself. If you do not feel comfortable with your doctor, you may not follow through with instructions properly. You may not ask questions and gain an understanding of your problem. Never hesitate to seek a second opinion. A good doctor is not threatened by second opinions. In fact, good doctors often offer second opinions to their patients who appear uncertain or distressed.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.