{"id":29685,"date":"2023-08-07T12:27:33","date_gmt":"2023-08-07T16:27:33","guid":{"rendered":"https:\/\/avalere.com\/?p=29685"},"modified":"2023-08-22T10:54:58","modified_gmt":"2023-08-22T14:54:58","slug":"therapeutic-vaccines-raise-regulatory-policy-pathway-questions","status":"publish","type":"post","link":"https:\/\/advisory.avalerehealth.com\/insights\/therapeutic-vaccines-raise-regulatory-policy-pathway-questions","title":{"rendered":"Therapeutic Vaccines Raise Regulatory, Policy Pathway Questions"},"content":{"rendered":"
[vc_row][vc_column][vc_column_text]Vaccines are conventionally administered prophylactically to prevent disease and associated morbidities. In recent years, manufacturers have increasingly used vaccine platform technology to develop therapeutic applications that treat or prevent disease exacerbation rather than prevent onset. In response to pipeline therapeutic vaccine progress toward late-stage development, policymakers are beginning to define policy and access pathways for these novel products. Recent policy action suggests that these products may move through drug-like access pathways, in contrast to currently available preventive vaccines and passive immunizations like preventive monoclonal antibodies.<\/p>\n

Background<\/h2>\n

Therapeutic vaccines typically stimulate a recipient\u2019s immune system to slow or stop chronic disease progression or target cancer cells. Unlike preventive vaccines, therapeutic vaccines may be customized to respond to specific mutations. There are myriad therapeutic vaccines currently in development that target a range of infectious diseases, chronic conditions, and cancers (see Table 1).<\/p>\n\n\n\n\n\n\n\n\n\n\n\n
Figure 1. Examples of Therapeutic Vaccines in Development<\/caption>\n
Indication<\/th>\nDevelopment Phase<\/th>\n<\/tr>\n<\/thead>\n
Acute Myelogenous Leukemia<\/td>\n3<\/td>\n<\/tr>\n
Mesothelioma<\/td>\n2<\/td>\n<\/tr>\n
Melanoma, Colorectal Cancer, Non-Small Cell Lung Cancer<\/td>\n2<\/td>\n<\/tr>\n
Chronic Hepatitis B<\/td>\n2<\/td>\n<\/tr>\n
Multiple Myeloma<\/td>\n1\/2<\/td>\n<\/tr>\n
Ovarian Cancer<\/td>\n1\/2<\/td>\n<\/tr>\n
Type I Diabetes<\/td>\nPreclinical<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Coverage of and access to preventive vaccines and therapeutic drugs are determined by decisions made along distinct pathways (Figure 1). These pathways directly or indirectly influence product pricing, coding, coverage, and reimbursement. Federal law mandates coverage without cost-sharing for Advisory Committee on Immunization Practices (ACIP)-recommended vaccines across markets; there is no similar statutory requirement for drugs, though the Affordable Care Act mandates that plans cover some drugs to comply with essential health benefits.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_single_image image=”29704″ img_caption=”Figure 1. Preventive Vaccine and Therapeutic Drug Regulatory and Access Pathways*” css=”.vc_custom_1691430786086{margin-top: 30px !important;}”][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]\n

\u00a0*Passive immunizations, including certain preventive monoclonal antibody products, may deviate from these pathways.<\/p>\n

ACIP: Advisory Committee on Immunization Practices; AMA: American Medical Association; CBER: Center for Biologics Evaluation and Research; CDER: Center for Drug Evaluation and Research; CMS: Centers for Medicare & Medicaid Services; CPT: Current Procedural Terminology; EHB: Essential Health Benefit; FDA: Food and Drug Administration; FFS: Fee-for-Service; HCPCS: Healthcare Common Procedure Coding System; MMC: Medicaid Managed Care; NDC: National Drug Code; PDL: Preferred Drug List; USP: United States Pharmacopoeia; VFC: Vaccines for Children<\/p>\n

Therapeutic vaccines leverage preventive vaccine platforms, and it is unclear which approval processes and policy frameworks will determine payer coverage and patient access. As these products approach late-stage development and market availability, policymakers are starting to provide clarity, creating opportunities for stakeholders to shape the therapeutic vaccine marketplace.<\/p>\n

Policy Developments<\/strong><\/h2>\n

Recent policy developments indicate therapeutic vaccines may be considered more like drugs than their preventive counterparts.<\/p>\n