{"id":13101,"date":"2026-05-05T23:39:56","date_gmt":"2026-05-05T23:39:56","guid":{"rendered":"https:\/\/medical-article.com\/?p=13101"},"modified":"2026-05-05T23:39:56","modified_gmt":"2026-05-05T23:39:56","slug":"are-payers-becoming-more-restrictive-in-their-coverage-of-pharmaceuticals","status":"publish","type":"post","link":"https:\/\/medical-article.com\/?p=13101","title":{"rendered":"Are payers becoming more restrictive in their coverage of pharmaceuticals?"},"content":{"rendered":"

Let\u2019s say you\u2019re the CEO of a health plan. A new drug just received approval to treat patients with lung cancer. The drug\u2019s clinical trial examined how well the the drug worked on third line (3L) patients and patients with good funcional ability (e.g., performance status ECOG<\/a> score of 0 or 1). FDA approved the therapy for patients who have failed 2 previous lines of therapy. <\/p>\n

Which of the following coverage options would you choose as the CEO of a US commercial health plan? <\/p>\n

Broad coverage<\/strong>: Allow all lung cancer patient to use the treatmentLimit coverage to FDA label<\/strong>: Only allow patients who failed 2 prior therapies (i.e., 3L) to receive the therapyLimit coverage to clinical trial population<\/strong>. Only allow patients who failed 2 prior therapies (i.e., 3L) and<\/em> who have an ECOG performance score of 0 or 1 to receive the therapy. <\/p>\n

Broader coverage allows more patients to benefit from the therapy but it costs payers more and may include coverage for patients where benefit is likely but less certain. Limiting to the FDA (or even more so the trial population) saves money, but many patients who could benefit from the therapy would not be eligible with these restrictions.<\/p>\n

What would you do? What are payers doing? <\/p>\n

A number of recent studies speak to the trend of payers moving towards more restrictive coverage of therapies. Rucker et al. 2023<\/a> use data from the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database to look at trends in coverage. <\/p>\n

Overall, the proportion of policies that were consistent with the FDA label declined from 57.1% in 2017 to 45.1% in 2021; the proportion of policies that were more restrictive than the FDA label increased from 39.5% to 51.7%. The proportion of policies excluding drug
coverage remained approximately constant (3.4% in 2017; 3.2% in 2021).<\/p>\n

Payer restrictions among orphan drugs and drugs approved via accelerated approval pathways are also common. A paper by Jenkins et al. (2023)<\/a> also uses SPEC data and finds that payers impose subgroup restrictions on treatment access for about 1 in 5 drugs. Specifically, they conclude:<\/p>\n

Health plans imposed patient subgroup restrictions in 20.2% of orphan drug policies (frequency varied by health plan, 11.7%-36.6%), and in 21.8% of FDA-expedited drug policies (frequency varied by health plan, 11.1%-47.9%).<\/p>\n

What about cell & gene therapies? How often do US health plans impose restrictions on cell & gene therapies that are more stringent than FDA labels? Chambers et al. (2025)<\/a> use SPEC data as well and find that: <\/p>\n

Among 541 indication-plan pair coverage policies, 9 (1.7%) denied coverage. Of the remaining 532 policies, 256 (48.1%) were consistent with FDA labelling and 276 (51.9%) imposed additional coverage restrictions, including 220 (79.7%) using patient subgroup requirements; 25 (9.1%), step therapy protocols; and 31 (11.2%), both\u2026Additional restrictions were more common for non-cancer than cancer indications [62.7% vs. 44.0%, P<0.001]<\/p>\n

In short, while coverage denials are relatively rare in the US, many patients face significant subgroup restrictions and step therapies to be able to access advanced therapies.<\/p>","protected":false},"excerpt":{"rendered":"

Let\u2019s say you\u2019re the CEO of a health plan. A new drug just received approval to treat patients with lung cancer. The drug\u2019s clinical trial examined how well the the drug worked on third line (3L) patients and patients with good funcional ability (e.g., performance status ECOG score of 0 or 1). FDA approved the…<\/p>\n","protected":false},"author":0,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-13101","post","type-post","status-publish","format-standard","hentry","category-articles"],"_links":{"self":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts\/13101"}],"collection":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=13101"}],"version-history":[{"count":0,"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts\/13101\/revisions"}],"wp:attachment":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=13101"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=13101"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=13101"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}