The Centers for Medicare and Medicaid Services (CMS) has instructed Medicare Advantage (MA) plans that they may institute step therapy for drugs administered by intravitreal injection. Here we discuss how this affects retina specialists.

Q. What is step therapy?

A. Historically, step therapy was only used to control costs within private insurance plans. But in August 2018, CMS announced plans to institute step therapy for some Medicare beneficiaries enrolled in MA plans beginning in 2019. CMS has touted the step therapy rule as a cost-saving measure for MAs with few drawbacks to most patients.¹ Because MAs now cover more than 30% of Medicare beneficiaries, with increased market penetration expected in the future, retina specialists need to understand the CMS rules affecting this population of patients to avoid costly claim denials.

Step therapy requires a physician to initially use a “step 1” drug to treat a disease for qualifying beneficiaries. Step 1 drugs are “cost-effective” biosimilar drugs, sometimes generic. Step therapy treatments require that the patient demonstrate Step 1 treatment failure, also known as “fail first,” before the physician is permitted to apply for prior approval to use a more expensive treatment.

Ophthalmologists may encounter step therapy when treating certain patients with ranibizumab (Lucentis; Genentech) or aflibercept (Eylea; Regeneron). Some MA plans now require step therapy for wet age-related macular degeneration (AMD), diabetic macular edema (DME), macular edema from retinal vein occlusion, choroidal neovascularization, or radiation retinopathy macular edema.

Q. What if step 1 drugs are not effective?

A. Once started on step therapy, if the patient and/or physician do not believe that bevacizumab is providing an adequate treatment response, then the MA plan’s prior authorization process should be followed to “step up” to ranibizumab or aflibercept.

Q. How is ineffective therapy with bevacizumab defined?

A. The answer is not yet clear, but one approach employs the FDA-approved directions for use as a starting point. The prescribing information for aflibercept for wet AMD is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days, or monthly) for the first 3 months, followed by the same dose every 8 weeks (2 months). For ranibizumab, the prescribing information is 0.5 mg (0.05 mL) once a month (approximately 28 days); it directs that patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment. It is clear that no change is contemplated in dosing until the 3 initial doses are administered and the patient evaluated for a therapeutic response; this is known as “loading doses.”

Q. Are MA plans required to allow the more expensive drug?

A. No; some MAs could deny the request for a “step up.” The physician needs clear chart documentation of treatment failure that can be submitted for prior approval or, if necessary, appeal of a rejection. Such documentation might include the following:

• Serial OCT showing persistent subretinal fluid;
• Serial OCT showing lack of consistent anatomic improvement;
• Eye exam showing vision impairment secondary to persistent subretinal or intraretinal fluid; or
• Fluorescein angiography showing lack of reduction of leakage of the area of neovascularization.

Q. Are there exceptions to the step therapy requirement?

A. Yes. Patients who started treatment prior to the rule’s implementation (January 1, 2019) will not be forced to switch from ranibizumab or aflibercept to bevacizumab; the policy only applies to patients not currently undergoing treatment. Beneficiaries not properly notified by the MA plan of the step therapy provision in their policies are likewise not obliged to follow it. Beneficiaries with allergies or medical contraindications to bevacizumab, or the inability to tolerate the side effects of bevacizumab, may also seek exception to step therapy.

The exceptions do not automatically entitle the beneficiary access to alternative drugs, however. If the physician believes the patient qualifies for an exception, he or she must apply for an expedited exemption, which the MA must complete “as expeditiously as the beneficiary’s condition requires.” CMS expects that most MAs will respond to an expedited request within 72 hours.

Q. How can you know if the beneficiary has been properly notified of the step therapy provision?

A. CMS hasn’t offered much guidance on that subject yet. The practice may only find out after a patient has been denied and the decision appealed.

Q. Is this currently in effect anywhere?

A. The American Academy of Ophthalmology has learned that MA plans serving the states of Idaho, Montana, and Oregon are requiring that patients lose “greater than 15 letters of visual acuity” or have proven failure after 3 treatments prior to approving a medication switch. Physicians who do not want to subject their MA patients to potential vision loss through failed step therapy are encouraged by some MA plans to refer the patient to a physician who will provide step therapy treatment. A policy that requires patients to lose vision in order to qualify for alternative treatments is seen as inappropriate by most ophthalmologists.

Q. Are there efforts to change this policy?

A. Some physicians are concerned that the full implementation of step therapy for MA beneficiaries will ultimately result in higher costs as patients fail treatment, lose vision, and then require additional care in an attempt to regain sight. The American Academy of Ophthalmology and the American Society of Retina Specialists, along with other professional societies, are actively engaged with Congress to review the rule to assure patients are not denied access to sight-saving therapies.² The organization Prevent Blindness is also gathering data from physicians and patients to present to Congress to help form rational policies regarding patients’ eye care.³ RP

REFERENCES

1. Medicare Advantage prior authorization and step therapy for Part B drugs. August 7, 2018. Available at: https://www.cms.gov/newsroom/fact-sheets/medicare-advantage-prior-authorization-and-step-therapy-part-b-drugs . Accessed November 13, 2019.
2. American Academy of Ophthalmology. Congress’ physicians prep strong message opposing step therapy in Medicare. June 27, 2019. Available at: https://www.aao.org/eye-on-advocacy-article/congress-physicians-prep-strong-message-opposing . Accessed November 13, 2019.
3. Prevent Blindness. Coalition seeks patient stories regarding step therapy and prior authorization. https://www.preventblindness.org/patient-step-therapy-stories . Accessed November 13, 2019.