Many people with tuberous sclerosis complex (TSC) rely on several medications to treat different manifestations of the disease. Disruptions to medication can have negative impacts on an individual with TSC and create undue stress for them and their family. Continue reading to discover some of the potential barriers to medication access and how to plan ahead and mitigate potential issues.

Prior authorization issues

Medications prescribed for TSC-related manifestations often require a prior authorization (PA). It is important to know what medications will require this, and how long the PA is approved for each medication. For medications that are controlled substances or non-preferred medications, it is common that a new PA cannot be initiated until four days from the last dose covered by the preceding PA. Therefore, it is essential to know exactly what your healthcare team will need to have to initiate the new PA before you run out of mediation. Medications requiring a PA will also be listed on your pharmacy drug list (PDL). Download a Sample Prior Authorization Letter for AMLs or a Sample Prior Authorization Letter for SEGAs.

Insurance Barriers

One of the most common insurance barriers is getting out-of-state healthcare visits covered. Because of the challenges associated with out-of-state healthcare, it is important to have a local team (pediatrician or internist and, if needed, a neurologist) who can help provide stability in your care. Here are some helpful tips on this process:

  • The individual being seen MUST have an established primary care provider (who is licensed in the state the individual lives in) who sees them routinely. This primary care provider needs to have seen the individual at least once within the current calendar year, BEFORE an out-of-state referral is made. Medicaid coverage for out-of-state referrals is often delayed because:
    • Your primary care office staff typically need 30 days to request records and be able to review
    • Your primary care office staff must justify to your home state’s Medicaid why services need to be rendered OUTSIDE of the state, and they cannot do so without making a complete evaluation of the patient’s records.
  • Ensure insurance information is up to date. This needs to be confirmed YEARLY in January by you or the primary caregiver/parent. Especially if there are multiple insurances. Most require annual submission of forms so insurance does not lapse. Not knowing and having them “termed” or “inactive” will always result in a DELAYED care.
  • When referred to out of state care with Medicaid, ensure ACCURATE information is provided and the out-of-state provider is enrolled with that state’s Medicaid program.
    • Contact the out-of-state clinic prior to the referral being placed to see the provider(s) are enrolled.
    • IF NOT, the out-of-state team will need to complete enrollment BEFORE appointments or tests, such as imaging, can be scheduled at an out-of-state location.
    • This goes for every individual specialist that will be seeing you or your child.
    • Why does this matter? If these individuals are not properly enrolled, claims will be denied and the institution will not get paid for services rendered.
    • For those with commercial insurance, this may also be an issue; if this is not properly done on the front-end, insurance can deny service all together and leave you with the entire bill to be paid as “out of network.”
  • Understand what your local healthcare team can provide versus what you can complete at the out-of-state clinic. All services to be completed out of state need to be documented on the referral form to obtain insurance approval on the front end.
    • EVERYTHING must be approved by the state of residency’s insurance before out-of-state care can be given. Most of this is done behind the scenes and families are usually unaware of this process, but it is a common reason why things get denied “last minute.” Per Medicaid guidelines, many procedures and tests cannot even receive prior authorization too far in advance before a test. Thus, you cannot have something pre-authorized in April for an encounter in November. Most institutions have a policy on this; typically, they begin the submission of pre-approval paperwork 7-14 days before an appointment. This is why it’s very important to ensure perfect accuracy in the information you provide (local provider name, insurance information, etc.).

Pharmacy coverage

Prescription drug plans are part of all commercial and government insurance plans in the United States; however, each plan is different per corporation / organization and state. When starting to understand your coverage you should immediately get familiar with your plan’s prescription drug list known as a PDL. This list will not only list what medications will be covered under your plan (called a formulary), but what category or “tier” each of these medications are listed into. Tiers represent a cost level. There are 4 tiers to a formulary list, tier 1 being the lowest cost and tier 4 being the highest cost. Tiers 1 – 3 usually require some co-pay, and it is not uncommon to have your co–pay cost listed on your pharmacy drug card. Most of these medications are generic, and brand name medications are often higher up on the tier list. If you have Medicaid or Medicare, it is not uncommon for your insurance to cover brand names. Some states have restrictions on how many brand-named drugs you can use per month (this included antibiotics). Tier 4, also known as the “specialty tier,” is where most specialty medications for rare diseases and new epilepsy medications are found.

Cost-sharing is the major difference between the specialty tier and those preceding it. While for lower tier medications you’d typically be charged a flat copayment for your prescription, specialty tier medicines usually come with a coinsurance payment. Coinsurance is a percentage-based rate – so if your coinsurance payment rate is 20%, you’ll find yourself paying for 20% of the medication’s overall retail cost. Because some medications can cost several thousands of dollars per month, you may end up meeting your insurance deductible very quickly just on coinsurance payments alone. Once you’ve met your annual deductible, insurers usually begin covering more (up to 80%-100%) of medication costs.

This is why it is very important to understand what your deductible plan is. Because each year in January, your progress toward “meeting your deductible” (i.e., the amount of money you spend each year) resets.

Many people utilize copay assistance cards so medications can be affordable; however, under the current copay accumulator programs, this can end up costing you more money in the long run. The TSC Alliance is advocating for co-pay accumulator programs to be removed. For more information on prescription process, including quick videos on these important topics check out the Alliance for Patient Access (AfPA) who advocate for patient access to approved therapies and appropriate clinical care.

Another important aspect of pharmacy coverage is step therapy. This is also called “fail first” policy that was developed by insurers to help control cost. This means some plans require you to try cheaper and outdated drugs FIRST before they will cover a specific drug prescribed by your healthcare provider. This is a very frustrating process and can be risky for those with a rare disease and epilepsy. As you are understanding your pharmacy benefits, pay attention and ask which medications require step therapy. It is equally important to understand that many other advocacy groups have taken a proactive stance on getting step therapy legislation changed. Here is a great resource to find out if there is an override request available in your state, and what to do if your override request was denied.

Tips to mitigate issues

Medication denials by insurers are an unfortunate reality that can occur. It is helpful to understand why many denials are made and what can be done to prevent them. Usually, medication denials are associated with a medication that is not covered under your current drug plan, also known as a formulary or pharmacy drug list (PDL). These lists will also let you know what tier medications are and what will be required to approve your medication. If you are in a situation where your medications have been denied, do not panic. Here are some helpful steps to understand the denial.

  1. Call your insurance company to clarify why the medication was denied.
    • Were there any coverage restrictions? One such restriction may be a prior authorization (PA). The PA approval process on average is 72 hours. Urgent PA requests may be completed within 24 hours.
    • Is there an emergency fill option while the denial is being approved?
    • Is there a quantity restriction? This is the amount (number of pills, for example) of medication prescribed. Some plans will only cover a certain amount per month.
    • Does this medication require step therapy?
  2. Is this medication included in the formulary (or PDL)? If not, what are the formulary exceptions to this medication on your specific plan?
  3. Is there an alternative to this medication that will be covered? For example, when your provider prescribes the brand name (Sabril®) but your plan will only cover generic (vigabatrin). If this substitution is allowed, then call your prescribing providers office to let them know as soon as possible. Never assume your providing office will be notified of this denial in a timely manner.
  4. Are compounded medications covered under the current plan for “off-labeled” use? Compounded medications are ones that undergo a transformation within the pharmacy to change their delivery method – for example, a medication that is typically taken in its pill form may be ground up into a fine powder and reconstituted as a drinkable liquid.

Emergency Medication Needs (Help!) One way to prevent delays in medication refills is keeping track of when your medications can be refilled and starting the refill process as soon as you can, which may include needing another round of prior authorization. However, even the most precise planning may not prevent running low on medication, creating a difficult situation outside of your control. It is essential to know how to overcome this as soon as possible. Have a clear plan discussed with your prescribing provider at the time new medications are prescribed to what you should do in case you find yourself in the situation. Many individuals end up in this situation usually from a prolonged prior authorization process or from an unexpected denial. Rarely, lifesaving medications can experience a drug shortage. Medication drug shortages are tracked by the FDA and can be located here. Here is a guide on Emergency Medication Checklist if you find yourself in this situation. The key is to prevent getting to this point as much as possible.

If you are experiencing any barriers or need further assistance on navigating medication access issues, please reach out to a TSC Alliance Support Navigator for additional assistance at support@tscalliance.org.

Reviewed by Ashley Pounders, MSN, FNP-C, November 2023.

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