If your insurance denies coverage for a prescription, you’re likely encountering step therapy – a “fail first” protocol that affects nearly 40% of drug coverage policies. But there are legitimate ways around these requirements that most patients don’t know about.
Key Takeaways
- Step therapy is a health insurance protocol requiring patients to try a lower-cost medication before a more expensive one is covered by insurance.
- Insurance companies use step therapy to control rising prescription drug costs by encouraging the use of generic or preferred medications first.
- Common medications requiring step therapy include brand-name drugs with generic alternatives and specialized treatments for chronic conditions.
- Patients can appeal step therapy requirements through exception requests and prior authorization processes when the preferred medication isn’t suitable.
- Step therapy can delay treatment access but balances cost control with ensuring patients receive appropriate care.
For individuals managing chronic conditions, understanding how step therapy works can help navigate insurance coverage challenges and ensure access to necessary medications. This protocol affects millions of patients nationwide and plays a significant role in healthcare cost management.
Step Therapy Requires Trying Preferred or Lower-Cost Medications First
Step therapy, also known as “fail first” protocols, is a cost-control mechanism used by health insurance companies to manage prescription drug expenses. Under this system, patients must demonstrate that a less expensive medication has been ineffective or inappropriate before their insurance will cover a more costly alternative.
The process works by requiring patients to “step through” different medication tiers, starting with the most cost-effective option. Insurance companies implement this approach because many medical conditions can be treated with multiple medications that have similar therapeutic effects, but vastly different price points.
A 2021 review of data from 17 health plans found that step therapy was applied in 38.9% of drug coverage policies across health plans. Medicare beneficiaries and those considering Medicare options should particularly understand these requirements as they become more common in prescription drug coverage plans.
How Insurance Companies Use Step Therapy to Control Costs
Insurance companies structure step therapy around a tiered medication system designed to encourage the use of cost-effective treatments while maintaining clinical appropriateness. This approach helps manage the billions of dollars spent annually on prescription medications.
Medications Are Grouped Into Steps
Insurance formularies organize medications into distinct steps or tiers based on cost and clinical considerations. Step 1 medications typically include generic drugs and preferred brand-name medications that offer the best value. Step 2 and higher tiers contain more expensive alternatives, including newer brand-name drugs or specialized treatments.
The grouping process considers factors beyond just cost, including clinical effectiveness data, safety profiles, and manufacturer rebates that insurance companies negotiate. These negotiations can sometimes result in a newer, more expensive drug being placed in a lower tier if the manufacturer provides substantial rebates.
Step 1 Drugs Get Automatic Coverage
First-tier medications receive automatic approval and typically have the lowest copayments for patients. These drugs have established track records of safety and effectiveness, making them appropriate first-line treatments for many conditions.
Generic medications make up the majority of Step 1 drugs. In 2021, 91% of prescriptions filled in the United States were for generic drugs. These medications have the same active ingredients as their brand-name counterparts but cost significantly less due to competition among manufacturers.
Higher Steps Need Proof of Failure
Before approving higher-tier medications, insurance companies require documentation that Step 1 options have been tried and proven ineffective or caused intolerable side effects. This documentation typically comes from the prescribing physician and may include medical records showing treatment history and patient response.
The “proof of failure” requirement serves a dual purpose: it ensures that cost-effective treatments are given a fair trial, and it provides clinical justification for using more expensive alternatives. However, this process can create delays in accessing optimal treatment for some patients.
Common Medications That Require Step Therapy
Step therapy requirements vary significantly between insurance plans, but certain categories of medications commonly fall under these protocols. Understanding which types of drugs typically require step therapy can help patients and healthcare providers prepare for potential coverage challenges.
1. Brand-Name Drugs With Generic Alternatives
Medications like vortioxetine (Trintellix) for depression, suvorexant (Belsomra) for insomnia, and cariprazine (Vraylar) for schizophrenia often require patients to try generic alternatives first. Insurance companies prioritize generic versions because they provide equivalent therapeutic benefits at substantially lower costs.
Many insurance plans, including Cigna, require step therapy for these medications when effective generic alternatives exist in the same therapeutic class. Patients must demonstrate that generic antidepressants, sleep aids, or antipsychotic medications have been unsuccessful before gaining coverage for the brand-name alternatives.
2. Specialized Medications for Chronic Conditions
Chronic condition medications frequently require step therapy, particularly in categories like cholesterol management, diabetes treatment, and pain relief. Medications such as pitavastatin (Livalo) and insulin glulisine (Apidra Solostar) often fall under these requirements.
These protocols exist because many chronic conditions have multiple treatment options with similar effectiveness profiles. Insurance companies want to ensure that patients try established, cost-effective treatments before moving to newer, more expensive alternatives that may offer marginal additional benefits.
3. Non-First-Line Treatment Options
Medications that aren’t considered first-line treatments according to medical guidelines commonly require step therapy. Examples include certain migraine medications like eletriptan (Relpax) and some antidepressants like desvenlafaxine (Khedezla).
These requirements align with established medical practice guidelines that recommend trying proven, first-line treatments before considering alternatives. The step therapy process ensures that insurance coverage follows evidence-based treatment protocols while managing costs.
What Happens When Your Medication Gets Denied
When a pharmacy submits a claim for a medication requiring step therapy, the insurance system automatically flags the prescription if the patient hasn’t met the step therapy requirements. This triggers a specific process designed to either find an alternative or justify the original prescription.
Your Pharmacist Contacts Your Doctor
The pharmacy receives an immediate electronic notification explaining the step therapy requirement and any alternative medications that would be automatically covered. The pharmacist then contacts the prescribing physician to discuss options, including switching to a preferred alternative or pursuing an authorization for the original prescription.
This communication typically happens quickly, often while the patient is still at the pharmacy. Modern electronic prescribing systems help streamline this process by showing physicians which medications require step therapy before they write the prescription.
You’ll Try the Preferred Alternative First
In many cases, the physician and pharmacist will agree to try the insurance company’s preferred alternative first. This approach allows the patient to start treatment immediately while potentially saving money on copayments.
The preferred alternative will be monitored closely for effectiveness and side effects. If the medication works well, the patient continues with the cost-effective option. If problems arise, the treatment history provides documentation needed for step therapy exceptions.
Appeal Process If Step Therapy Fails
When preferred medications prove ineffective or cause intolerable side effects, patients can appeal through their insurance company’s exception process. This involves submitting medical documentation showing why the originally prescribed medication is medically necessary.
The appeal process typically requires detailed information from the healthcare provider, including treatment history, patient response to previous medications, and clinical justification for the requested drug. Success rates for these appeals vary, but detailed documentation significantly improves the chances of approval.
How Step Therapy Can Delay Your Treatment
While step therapy serves important cost-control functions, it can create treatment delays that impact patient health and quality of life. Understanding these potential delays helps patients and providers plan treatment strategies more effectively.
Waiting Periods Before Stepping Up
Insurance companies typically require patients to try Step 1 medications for specific time periods before approving higher-tier alternatives. These waiting periods can range from several weeks to several months, depending on the condition and medication involved.
For chronic conditions requiring ongoing management, these delays can mean prolonged symptoms or disease progression. Patients may experience frustration when they know from previous experience that certain medications don’t work for them but must still go through the step therapy process.
Starting Over With New Insurance Plans
Patients who change insurance plans often face the challenge of restarting step therapy requirements, even if they’ve already proven that certain medications are ineffective. Different insurers may have varying formularies and step therapy protocols, requiring patients to repeat processes they’ve already completed. However, at least 37 states have enacted legislation providing some protections for patients in this situation.
This situation commonly occurs when people change jobs, retire, or select different plans during open enrollment periods. Healthcare providers can help by maintaining detailed records of previous medication trials and being prepared to advocate for step therapy exceptions with new insurance companies.
Ways to Get Around Step Therapy Requirements
Several legitimate strategies exist for patients who need to bypass step therapy requirements due to medical necessity or previous treatment failures. These approaches require collaboration between patients, healthcare providers, and sometimes insurance companies.
1. Step Therapy Exception Requests
Healthcare providers can request step therapy exceptions when they believe the preferred medication would be inappropriate or ineffective for a specific patient. These requests must include clinical documentation supporting the medical necessity of the higher-tier medication.
Successful exception requests typically include information about the patient’s medical history, previous medication trials, contraindications to preferred medications, or unique clinical circumstances that make the requested medication the most appropriate choice.
2. Prior Authorization Appeals
The prior authorization process allows healthcare providers to request coverage for non-preferred medications by providing detailed clinical justification. This process is separate from step therapy but can achieve similar results in accessing needed medications.
Prior authorization appeals require detailed documentation and may involve peer-to-peer reviews where the prescribing physician discusses the case directly with the insurance company’s medical director. These conversations often provide opportunities to explain complex clinical situations that aren’t easily conveyed in written documentation.
3. Alternative Payment Options
When insurance coverage isn’t available, patients may consider manufacturer copay assistance programs, patient assistance programs, or prescription discount services. These options can significantly reduce out-of-pocket costs for expensive medications.
Many pharmaceutical manufacturers provide copay cards or patient assistance programs that can make brand-name medications affordable even without insurance coverage. Additionally, prescription discount services like GoodRx can provide substantial savings on medications not covered by insurance.
4. State-Specific Step Therapy Laws
At least 37 states have enacted legislation to streamline step therapy exception processes and protect patient access to medically necessary medications. These laws typically establish timeframes for insurance company responses and create standardized exception procedures.
State laws may also provide additional protections for patients with certain conditions or establish requirements for insurance companies to consider previous medication trials completed under different insurance plans. Patients should research their state’s specific step therapy regulations to understand available protections.
Step Therapy Balances Cost Control With Patient Access
Step therapy represents a fundamental tension in healthcare between controlling rising prescription drug costs and ensuring patients have access to optimal treatments. While the system can create barriers and delays, it also serves important functions in promoting cost-effective care and appropriate medication use.
The protocol encourages healthcare providers and patients to consider proven, cost-effective treatments before moving to more expensive alternatives. This approach aligns with evidence-based medicine principles that recommend trying established first-line treatments before considering newer or more specialized options.
However, critics argue that step therapy can prioritize cost savings over individualized patient care, potentially leading to treatment delays or forcing patients to use medications that may be less effective for their specific situations. The key lies in implementing step therapy policies that include robust exception processes and maintain focus on patient outcomes alongside cost control.