A specialty generic medication is an FDA-approved generic drug that meets the criteria for specialty management due to factors like route of administration, handling requirements, monitoring needs or safety considerations. While this medication is generic, its clinical complexity and intended use are comparable to the brand-name medication. These products are dispensed by specialty pharmacies.

Yes. Specialty generics approved by the FDA are reviewed for quality, strength, purity and performance. When a generic product receives an A-rating in the FDA Orange Book, the FDA considers it therapeutically equivalent to the reference product. CVS Specialty dispenses A-rated specialty generics. Prescribers can consult the FDA Orange Book for product-specific therapeutic equivalence information.

Generally, the dosing, route of administration and monitoring requirements for specialty generics are the same as the reference product. If the reference product is subject to a REMS (Risk Evaluation Mitigation Strategy) or other safety program, the specialty generic is typically subject to the same or similar requirements.

However, certain formulation details, delivery devices or ancillary supplies may vary by manufacturer. Review the prescribing information (PI) available on the manufacturer's website or the FDA Online Label Repository.

This depends on the medication and your patient’s prescription benefit plan. Some plans allow dispensing of an FDA‑approved generic under an existing prescription, while others require a new prescription specifying the covered product. CVS Specialty will contact you if additional documentation or a new prescription is required.

In some cases, an existing prior authorization may transition to the covered specialty generic. In other situations, a new PA is required. When needed, CVS Specialty will coordinate with your practice to facilitate the PA submission and help reduce delays.

Clinical treatment decisions remain between patients and their providers, and coverage requirements vary by plan. When a specific product is clinically necessary, supporting documentation may be required. CVS Specialty can work with your office to coordinate documentation, prior authorization updates and other information needed for payor review to help minimize delays.

Coverage varies by medication and payor. Specialty generics may be covered under either the pharmacy or medical benefit, depending on plan design and route of administration.

Formulary updates may also require a medication substitution, a new prescription or an updated prior authorization. CVS Specialty can notify prescribers when a patient may be eligible for a specialty generic substitution and support transition planning in accordance with their plan benefit design.

Specialty generics may help lower out-of-pocket costs compared with brand-name specialty therapies in some cases. However, patient cost sharing depends on the prescription benefit plan or medical benefit design, formulary placement, coverage requirements and any applicable financial assistance programs. Because costs can vary, providers should refer patients to CVS Specialty or their benefit plan for patient-specific coverage and cost information.

Once a medication's patent and exclusivity period have expired, lower development costs can help broaden access to a wider array of therapies. As a result, prescription benefit plans may update formularies to prefer specialty generics as part of their overall cost-management strategies.

Availability of manufacturer or third-party financial assistance programs varies by medication and program requirements. At CVS Specialty, our CareTeams can help patients identify programs that may be available and assist with the enrollment process when appropriate. Eligibility is determined by the program sponsor or administrator.

CVS Specialty supports brand to generic transitions by coordinating communications, access requirements and patient support activities throughout the process. When appropriate, CVS Specialty can notify prescribers and patients about specialty generic transitions, coverage changes and next steps to help support awareness and coordination. Throughout the transition, CVS Specialty provides:

• Clinical support from specialty pharmacists and nurses experienced in complex, rare and chronic conditions
• Benefit verification, prior authorization support and care coordination
• Medication access support, dispensing coordination and refill management to help maintain continuity of care
• Patient education, adherence outreach and ongoing support from experienced CareTeams
• Connections to third-party financial assistance programs and support when appropriate

Specialty generic prescriptions may be sent to any CVS Pharmacy® or directly to CVS Specialty. Providers may send prescriptions via ePrescribe: 1466033, call 1-800-237-2767 or fax prescriptions to 1-800-323-2445. Local CVS Specialty representatives are available to support your office as needed through this entire process.